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David Lock QC

David Lock QC

David Lock QC is a barrister at the Landmark Chambers.

180 Fleet Street
London, EC4A 2HG
DX 1042 (London)

He was called to the Bar in 1985 and was appointed Queens Counsel in 2011.

David Lock QC is Head of the Administrative & Public Law Group and the Judicial Review & high Court Challenges Group at No5 Chambers. - See more at: http://www.no5.com/barristers/barrister-details/137-david-lock-qc/#sthash.PcnGl1Eh.dpuf
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Background

 

1.              The legal structure of the NHS is governed by the present version of the National Health Service Act 2006 (“the NHS Act”) as amended on numerous occasions by subsequent Acts of Parliament, and in particular by the Health and Social Care Act 2012. There are also numerous Statutory Instruments, known as "Regulations" which are made by the Secretary of State under the NHS Act. The role that GP practices and individual GPs play within the wider legal structures of NHS is widely misunderstood. Almost all GP practices are private sector businesses that contract with the NHS Commissioning Board (known as "NHS England") to provide primary care services to NHS patients. GPs are not thus employees of an NHS body but are contractors who run their own practices or are employed by a partnership or medical company which holds a practice contract. The GP practice owes contractual duties to NHS England and, at the same time, GPs owe private law duties in negligence to NHS patients. The legal position is further complicated because all GP practices are members of their local Clinical Commissioning Groups ("the CCGs"). The CCGs are corporate public bodies that commission a wide range of services for their local populations. This website seeks to make sense of the myriad of confusing and conflicting legal obligations that exist within General Practice, and to explain the duties resting on GPs and those who manage their practices.

 

2.              The legal obligations set up the NHS Act require a series of public bodies (the Secretary of State, NHS England and other NHS organisations) to make arrangements so that healthcare services are available to the public.  The statutory duty is fulfilled if the services are made available to potential patients.  But the NHS Act does not impose public law duties on NHS bodies to provide healthcare to individual patients.  The NHS Act imposes duties on the NHS bodies to set up arrangements so that services are in place if the public want to access them.  However it is a matter for individuals to decide if they want to take advantage of NHS services. 

 

3.              No one who has the legal capacity to make their own decisions is under any legal obligation to consult a doctor or attend a hospital. Save in unusual situations such as compulsory mental health treatment, patients have the right to take their own decisions about receiving medical treatment. So the NHS Act cannot impose any duties on patients to receive medical care. The NHS delivers on its statutory duties to a patient by making the patient an offer to provide medical treatment. It is then up to the patient to accept or reject that offer of medical treatment. If the patient agrees then the NHS, acting through a GP, hospital doctor or a nurse, will provide the treatment that is requested. If the patient refuses the treatment that the NHS has offered then, depending on the circumstances, this can wholly discharge the statutory obligations that the NHS has to the patient. There can be circumstances where an NHS doctor is obliged to discuss and then offer other treatment options to a patient. However patients have no legal right to demand medical treatment that a doctor is either unwilling to provide because the doctor does not believe that this treatment is in the best interests of the patient or is not permitted by NHS commissioning policies to offer to the patient as part of NHS funded treatment.

 

4.              Equally the NHS does not have an unlimited budget.  This means that NHS cannot offer unlimited care to any patient or guarantee that patients will have access to NHS funds to support any medical care which might be clinically effective for that patient.  NHS bodies have a duty to break even financially and so are entitled to ration care (see chapter 2).

 

5.              The NHS is a complex legal system and GPs working in the NHS undertake a variety of different functions.  A GP wears a large number of legal “hats” depending on which function the GP is undertaking.  An individual GP can be:

 

·      A doctor who owes duties in tort (i.e. in negligence) to patients;

·      A partner in a GP practice with legal duties to her partners

·      An employer with legal duties to his employees,

·      Part of a CCG and thus taking commissioning decisions.  These are administrative decisions which are taken within the scope of the public law duties of the CCG.

·      A professional who has regulatory obligations to the General Medical Council.

 

6.              In order to provide a description of the legal rights and obligations of a GP in any individual situation, it is essential to identify which role or role the GP is undertaking.  The next section seeks to help GPs and those advising them to identify which “legal hat” the GP is wearing?  But first it is necessary to say a little about the different types of legal obligation.  It is not enough to ask if something is lawful or unlawful.  It is essential to identify the type of legal obligation engaged in any particular set of facts.

 

The different meanings of “law” and legal obligations in the NHS.

7.              Patients and the public often only have a vague understanding of what is meant by “legal” or “lawful” in relation to the NHS.  The patient may demand treatment and say “I know my rights”, but it can be wholly unclear what type of legal obligation is being referred to.  GPs work under different types of legal obligations and alleged breaches of each type can have different consequences. 

 

8.              The different types of legal obligations which arise for a GP can, in general terms, be summarised as follows:

 

a)    Criminal Law obligations:  Criminal statutes and the common law define criminal offences which apply to everyone in defined circumstances.  If a GP acts in breach of those duties then he or she may be prosecuted for breach of the criminal law in the same way as any other citizen.  Hence, for example, a GP who assists a person to commit suicide may be prosecuted under section 2 of the Suicide Act 1961.  The outcome of a prosecution for the breach of the criminal law is a punishment imposed by the criminal courts, which can vary from a sentence of imprisonment to a fine depending on the circumstances;

 

b)    Contractual Law obligations:  GPs, whether individually or as part of a partnership, can acquire legal duties and have legal rights under a wide range of legally binding contracts[1].  Partnership agreements are a contract between the individual partners.  GP practices will hold a contract with NHS England[2] which defines their obligations and set out the duties of NHS England to make payments to the practice.  Patients who are treated by a GP privately will have a contractual relationship with the GP.  Employees of a GP practice are owed duties under their contracts of employment and, on a smaller scale, a GP may be a party to a contract to lease a photocopier.  Each of these contracts give rise to private law legal obligations.  Contractual rights can be enforced by the GP or by another party against the GP in the civil courts.  If a breach is proved, the remedies available include damages and/or injunctions;

 

c)     Non-contractual private law legal obligations:  There is no contract between a GP and his NHS patients.  However every GP owes a legal duty of care to his or her patients for treatment which is given or omitted to be given.  Other legal duties owed by a GP include the duty to maintain the confidentiality of patient related information held by the GP.  These are private law duties which are owed because the relationship between a GP and his or her patients.  It is the nature of the relationship which gives rise to the duty of care owed by the GP to the patient for medical treatment and to maintain confidentiality.  Any allegations of breach of this duty would be an allegation that the GP has committed a civil wrong, which can give rise to a claim for damages.  Such claims are tried in the civil courts if not otherwise resolved.  GPs who are not direct NHS employees are professionally required to be insured against such claims, usually with the Medical Protection Society or the Medical Defence Union;

 

d)    Professional Regulatory Obligations:  In order to be lawfully entitled to deliver medical services to NHS patients all GPs are required to be included on the list of medical practitioners maintained by the General Medical Council (“GMC”) and to be on the Performers List maintained by NHS England.  The purpose of the GMC is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine. Breaches of the GMC Code of Conduct will not necessarily amount to a breach of any other legal obligation owed by the GP to his or her patient or indeed to anyone else, but may do so.  A breach of the Code of Conduct may result in the GMC taking regulatory action against the GP to seek removal from the Medical List or the imposition of conditions on the GP’s continuing inclusion on the list;

 

e)    Performers List Obligations:  In addition to the regulatory role of the GMC, Regulations require that every GP delivering services to NHS patients (as opposed to treating patients privately) is included on a Performers List maintained by NHS England.  NHS England are entitled to seek the removal of a GP from the Performers List in a variety of circumstances including where NHS England conclude that it would be “prejudicial to the efficiency of the services which those included in that performers list perform” to maintain the GP on the Performers List or that the Practitioner is “unsuitable to be included in that performers list”;

 

f)     Statutory duties:  A huge variety of Acts of Parliament or Regulations made under Acts of Parliament impose legal obligations on GPs.  These are known as “statutory duties”.  There are, for example, statutory duties arising out the Health and Safety at Work Act 1974 which require GP practices to make their premises reasonably safe for visitors and those who work there.  The Employment Rights Act 1996 imposes duties on GPs towards their staff and prohibits GPs from unfairly dismissing staff.  The Equality Act 2010 imposes a range of duties on everyone providing public services not to discriminate when undertaking public functions.  The obligation to pay a wide variety of taxes is all set out in statutes and enforced by HMRC.  All these statutes create legal obligations and then provide a variety of mechanisms for determining whether there has been a breach of the statutory duty.  Breach of statutory duty can result in a criminal case (as with health and safety breaches), a case before a tribunal (such as with employment rights that are heard before an Employment Tribunal) or may result in a civil claim for damages;

 

g)    Public law obligations:  Lastly there are specific legal obligations that are owed by public bodies which, on occasions, can engage GPs.  Public bodies have a range of specific legal obligations both at common law and under a huge variety of statutory schemes.  A GP practice can become a “public body” These include duties to disclose certain types of information when requested under the Freedom of Information Act 2000 (“FOIA”) and duties to act fairly when commissioning NHS services.  Different public law obligations are enforced in different ways.  For example, breaches of the duties under FOIA are enforced by the Information Commissioner and on appeal to the First Tier Tribunal (Information Rights).  If there is no other enforcement mechanism laid down in legislation, breaches of public law duties are enforced by way of applications for Judicial Review in the High Court.

 

9.              A single act or sequence of events involving a GP may engage more than one of the above legal duties.  Hence, to take an extreme example, it may be alleged that a GP has delivered seriously sub-standard care to a patient who has subsequently died as a result of the failure of the care provided by the GP.  Such a GP may find himself or herself having to meet the following legal problems:

 

a)    The GP may be prosecuted for breach of the criminal law, probably for the offence of manslaughter.  That criminal case will be brought in the Crown Court;

 

b)    The actions of the GP will be a breach of the contract the GP holds with NHS England (such as a General Medical Services Contract) and may entitle NHS England to terminate the GMS contract;

 

c)     The actions of the GP may leave him or her in breach of his duties to his partners and may lead to expulsion from the partnership;

 

d)    The GP will have breached his duties to the patient and thus the patient’s executors or administrators may sue the GP for damages.  That claim would be brought in the civil courts;

 

e)    The GMC may take action to remove the GP from the Medical List by bringing the GP before a Fitness to Practice Panel; and

 

f)     The GP may also face action from NHS England to remove him or her from the Performers List. 

 

10.           Each of the above legal consequences will involve different legal considerations even though they arise from the same set of primary facts.  In such a case the GP will have to work closely with lawyers he or she has appointed (and possibly more than one set of lawyers) to protect his or her position.  Some aspects of this legal work will be covered by professional indemnity insurance but others aspects may have to be funded by the GP or the partnership within which he or she works.  However, in assessing and understanding the legal options and risks for the GP, it will be essential to understand the particular legal framework within which the GP is working, and the legal principles that apply to that particular legal action.

 

11.           The chapters of this website look in detail at the legal obligations on GPs and their rights in a variety of different situations.  However it is important that GPs and those who advise them recognise that legal problems rarely exist in individual silos.  The same set of primary facts can give rise to multiple legal issues with the GP wearing different “hats”.  Individual sections of this website are able to point out some occasions where there are likely to be multiple legal effects but it would be impossible to predict every situation where one set of facts or allegations will give rise to multiple legal issues. 

 

12.           There are limitations to the extent to which a general guide can assist in a particular set of circumstances.  If the text of site is in sufficient to answer all relevant questions, readers would be well advised to seek expert legal advice in relation to the particular facts, building on the initial guidance obtained from this site.

 

 

DAVID LOCK QC



[1] A “contract” for these purposes is an agreement of sufficient certainty of terms concluded between 2 or more parties who intend to create legal relations supported by adequate consideration and where there is no other legal objection to the creation of enforceable legal obligations between the parties.

[2] NHS England is the operating name for the National Health Service Commissioning Board.  For details see http://www.england.nhs.uk/

The NHS delivers on its statutory duties to a patient by making the patient an offer to provide medical treatment. It is then up to the patient to accept or reject that offer of medical treatment. If the patient agrees then the NHS, acting through a GP, hospital doctor or a nurse, will provide the treatment that is requested. If the patient refuses the treatment that the NHS has offered then, depending on the circumstances, this can wholly discharge the statutory obligations that the NHS has to the patient. There can be circumstances where an NHS doctor is obliged to discuss and then offer other treatment options to a patient. However patients have no legal right to demand medical treatment that a doctor is either unwilling to provide because the doctor does not believe that this treatment is in the best interests of the patient or is not permitted by NHS commissioning policies to offer to the patient as part of NHS funded treatment.

Breaches of GP practice contracts, Remedial and Breach Notices

and termination of GP Practice Contracts.

 

This Chapter contains:

 

1                Introduction.

2                NHS England Guidance on responding to breaches of contract by GP practices.

3                Termination of a GP practice contract by resignation or by agreement.

4                Action by the GP practice if NHS England fails to pay monies due to the GP practice.

5                Termination on the death of an individual medical practitioner.

6                Termination by NHS England:  General provisions

7                Termination of a GP contract where a single handed GP is struck off by the GMC.

8                What happens if a GP with a contract in sole practice is suspended by the GMC?

9                What happens if one GP in a partnership is struck off by the GMC?

10             Termination by NHS England for the provision of untrue information.

11             Termination where contractors fail to comply with the conditions in Regulations 4 and 5 of the GMS Regulations.

12             Termination due to a change in the identity of the partners to a GMS contract.

13             Termination of the Practice contract for a serious breach of contract by the GP practice.

14             Termination by NHS England for unlawful sub-contracting.

15             Remedial and Breach Notices.

16             Contract sanctions.

17             The role of the NHS Disputes Procedures and the FHSAU in breach and contract termination decisions.

18             Public law challenges to contracting decisions by NHS England.

 

 

1.             Introduction

 

1.1           A GP practice contract is a legally binding agreement under which the GP practice takes on a large number of obligations, although primarily to deliver primary care services to NHS patients, and NHS England agrees to make payments to the GP practice in accordance with the contract.  Although, to a great extent, the terms of a GMS or PMS contract is prescribed by Regulations, once the contract has been signed it takes effect as a normal commercial contract between the parties.  The position was explained by Hickinbottom J in Tomkins v Knowsley Primary Care Trust [2010] EWHC 1194 (QB) who said at §8:

 

“.. once a contract [1]  had been agreed between the PCT and a dentist, it took effect as an ordinary contract, enforceable as such”

 

1.2           The rights and obligations of both the contractor and NHS England are set out in the wording of the GMS or PMS contract and it takes effect as a normal contract between the parties.  That document defines the totality of the rights and obligations of both parties and defines how each party is entitled to react if there is a breach of contract by the other party (for more details see chapter 3).  For the purposes of this chapter it is rarely relevant whether the GP practice has an NHS contract or a legally binding contract.  Please click here for an explanation of the differences between an NHS contract and a legally binding contract.  The only difference is that a dispute about the termination of an NHS Contract can only be raised within the NHS Disputes Resolution process.

 

1.3           The scheme described in this chapter is based around a General Medical Services Contract (“GMS”) [2]  contract.  Personal Medical Services (“PMS [3] ”) and Alternative Personal Medical Services (“APMS”) contracts ought to have an largely identical scheme for breaches and termination because the relevant parts of the GMS Regulations are replicated in the PMS Regulations.

 

1.4           There are a large number of obligations that GP practices take on within a practice contract.  NHS England is thus entitled to require GP practices to perform all of the obligations.  Thus, for example, the practice is obliged to be open for core hours as defined in the GMS Regulations.  Christmas day is excluded from core hours but the practice must be open on Christmas Eve.  A practice that fails to provide services to NHS patients on either Christmas Eve would be acting in breach of contract and NHS England would therefore be entitled to take enforcement action against the practice for that breach. 

 

1.5           However NHS England is rarely able to terminate a GP practice for a single breach of contract of that type.  The contract sets out a scheme under which NHS England is entitled to respond to breaches of contract in a measured and proportionate way.  This scheme requires the contractor to respond appropriately to an alleged breach.  The scheme seeks to avoid unnecessary confrontation and to manage the relationship between the contractor and NHS England in a sensible way.  However a contractor which does not co-operate with NHS England by responding appropriately to action by NHS England under the contract can find that his, her or its contract is lawfully terminated.

 

2.             NHS England Guidance on responding to breaches of contract by GP practices.

 

2.1           NHS England issued Guidance to its own staff in June 2013 about how to respond to breaches of contract by GP Practices called “Contract breaches, sanctions and termination for primary medical services:  Standard operating policies and procedures for primary care”.  The Guidance set out the policies that NHS England excepts its staff to follow when responding to actual or perceived breaches of contract by GP practices.  The Guidance starts with the following:

 

Whilst most health care professionals practise to a very high standard, some individuals may occasionally work in ways that pose a serious risk to patient safety. In many instances this can be unintentional and the clinician’s performance may be affected by a combination of personal and situational factors, such as illness or professional isolation and in these cases NHS England shall refer to the policy for Identification management and support of independent contractors whose performance gives cause for concern”

 

2.2           At paragraphs 14 to 16 the Guidance then explains the basic approach that NHS England staff are expected to take to contract breaches as follows:

 

“14.  In most cases, the issue of a breach notice, application of a sanction or a move to terminate a contract should be considered as the final stages in a process where NHS England and contractor have endeavoured to resolve matters satisfactorily, without the need to take formal contractual steps.

 

15.  However, there will be occasions when a contract or is either unable or unwilling to change their behaviour or remedy a situation which may then result in a direct breach of their contracted terms and/or pose a significant risk to patient safety, requiring immediate action by NHS England to quickly resolve the matter.

 

16.  This policy is designed to give an overview of the procedure to be followed by NHS England when taking formal steps in resolving contractual and performance related issues of independent contractors providing primary medical care services”

 

2.3           The Guidance then sets out a clear warning to NHS staff that they have to be accountable for the actions they take in connection with GP contracts.  It states:

 

Given that any decision to issue a breach or remedial notice, apply sanctions or terminate a contract or agreement can be challenged by the contractor under appeal, it is essential that NHS England follows, and can demonstrate that they have followed, due process in investigating, communicating and implementing actions in this respect and that NHS England has acted fairly and reasonably throughout”

 

2.4           The Guidance refers to the role played by the Local Medical Committee (“LMC”) in cases where there are disputes between NHS England and a GP practice.  The Guidance provides at paragraphs 30 and 31:

 

“30.  Whenever NHS England is considering –

 

a. terminating the contract;

 

b. which of the alternative notices in writing it will serve; or

 

c. imposing a contract sanction,

 

it shall, whenever it is reasonably practicable to do so, consult with the Local Medical Committee before taking action.

 

31 Whether or not the LMC has been consulted, whenever NHS

England imposes a contract sanction on a contractor or terminates a contract, it shall, as soon as reasonably practicable, notify the

LMC in writing of the contract sanction imposed or of the termination of the contract (as the case may be)”

 

2.5           Thus local GP practices are entitled to expect NHS England to consult with the local LMC before taking action against a local GP practice under the contract, and to pay careful attention to any views expressed by the LMC.

 

3.             Termination of a GP practice contract by resignation or by agreement.

 

3.1           The GP contractor is entitled to resign the GP practice contract by serving notice in writing on NHS England.  Clause 26.6 of the standard GMS Contract provides that if a sole practitioner serves notice of resignation, the contract will end at the end date of the month 3 months after the date when notice of resignation is served.  If a partnership or company which holds a GP practice contract serves notice of resignation, the contract will end at the end date of the month 6 months after the date when notice of resignation is served. 

 

3.2           It is possible for NHS England and the contractor to agree that a GP practice contract should end on any date by mutual agreement.  This is expressed in clause 26.4 of the standard GMS contract which provides:

 

The Board and the Contractor may agree in writing to terminate the Contract, and if the parties so agree, they shall agree the date upon which that termination will take effect and any further terms upon which the Contract should be terminated”

                              

3.3           There should be a like provision in every PMS contract under paragraph 99 of Schedule 5 to the PMS Regulations which provides that every PMS contract should contain the following term:

 

The Board and the contractor may agree in writing to terminate the agreement, and if the parties so agree, they shall agree the date upon which that termination should take effect and any further terms upon which the agreement should be terminated”

 

4.             Action by the GP practice if NHS England fails to pay monies due to the GP practice.

 

4.1           In most circumstances where NHS England do not pay monies owing under the GP practice contract, the GP practice will, of course, not wish to terminate its contract because that will effectively bring an end to its business.  The options open to the GP practice if it wishes to force NHS England to pay monies that are said to be owing depend on whether the GP practice has a legally binding contract or a an NHS contract. 

 

a)             If the GP Practice has a legally binding contract then the terms of a standard PMS or GMS contract will mean that the GP practice will have the option of suing NHS England in the courts or referring the dispute to the NHS Disputes Resolution process for determination (through the Family Health Services Appeal Unit (“the FHSAU”)).  The advantage of this route is that the GP practice will not expose itself to the risk of a legal costs order if the FHSAU finds against the GP practice.  If debt proceedings are commenced in the courts then the GP practice is likely to secure a legal costs order if the practice succeeds in its claim but is likely to find itself having to pay NHS England’s legal costs if it loses.   The FHSAU is also a specialist decision maker which is familiar with all of the NHS contracts and so the GP practice is likely to get a quicker (and far cheaper) result by referring the dispute to the NHSLA;

 

b)             If the GP practice has a legally binding contract, its only option is to refer a dispute to the FHSAU to resolve when NHS England does not pay the monies that are owing to the GP practice.  An NHS contract does not give rise to any legally enforceable legal rights and so cannot be the subject of an action in the County Court or the High Court. 

 

4.2           There is usually nothing to prevent a GP practice suing NHS England for sums that are claimed to be owing under the contract (or referring a dispute to the FHSAU for dispute resolution) and continuing the contract at the same time.  However there is a separate scheme under the GMS Contract for the contractor serving notice to terminate if the contractor asserts that NHS England has failed to pay monies due to the GP practice.  Failure to pay monies due to the GP practice is a breach of contract by NHS England.  The sums due to a GP practice are set out in Directions made by the Secretary of State.  NHS England has a duty to pay ums owing “promptly” under clause 18.1 of the GMS Contract.  If NHS England fails to do so, the contractor may serve a “late payment notice” under clause 26.6.4.  The clause provides:

 

The Contractor shall specify in the late payment notice the payments that the Board has failed to make in accordance with Part 18 of the Contract>”

 

4.3           In such a case the period of notice is reduced from 6 or 3 months to 28 days because, if NHS England continues to fail to pay sums 28 days after the contractor serves a notice, the contractor can serve a further notice on NHS England terminating the contract.  That period of 28 days is however extended if, within the period of 28 days, NHS England dispute that they owe money to the contactor and make an application to the FHSAU under the NHS Disputes Resolution Procedures to determine whether any money is owing by NHS England to the contractor or not.  There is a like term for PMS contracts under paragraph 101 of Schedule 5 to the PMS Regulations.

 

5.             Termination on the death of an individual medical practitioner.

 

5.1           If a sole practitioner dies, the GP practice contract will automatically come to an end 7 days after the death of the GP who held the contract unless NHS England agrees with the personal representatives that there should be an extension of not more than 28 days before the contract comes to an end.

 

5.2           The relevant clause provides:

 

“26.5.1  Where the Contractor is an individual medical practitioner and the Contractor dies, the Contract must terminate at the end of the period of 7 days after the death of the Contractor unless, before the end of that period, clause 26.5.2 applies.

 

26.5.2  This clause 26.5 applies where the Contractor’s personal representatives have confirmed in writing to the Board that they wish to employ or engage one or more general medical practitioners to assist in the continuation of the provision of clinical services under the Contract and after discussions with the Board—

 

the Board agrees to provide reasonable support which would enable the provision of clinical services under the Contract to continue;        

 

a)    the Board and the personal representatives agree the terms upon which clinical services under the Contract can continue to be provided; and

 

b)    the Board and the personal representatives agree the period during which clinical services must continue to be provided and such a period must not exceed 28 days starting on the day after the end of the period of 7 days referred to in clause 26.5.1.

 

26.5.3  In clauses 26.5.1 and 26.5.2 “general medical practitioner” has the same meaning as in regulation 4(1) of the Regulations

 

5.3           There are a number of potential difficulties with the operation of this scheme.  It appears that it was originally drafted to allow the widow or widower of the GP to find another GP to take over the practice with the intention that the incoming GP would take over the practice and would purchase any part of the practice that could be sold from the widow or widower.   GPs are prohibited from selling the goodwill of a GP practice but there is nothing to prevent the widow or widower of a GP from selling the buildings from which the practice was delivered (if owned by the deceased GP) and the fixtures, fittings and equipment of the practice.

 

5.4           However this scheme meant that, subject to NHS England giving their agreement, the selection of the incoming GP was mainly made by the widow or widower of the deceased GP.  Such an arrangement may have benefitted the financial position of the widow or widower of the GP but was not a defensible process for the selection of the holder of a contract to deliver public services.  NHS England are now obliged to follow a transparent and open process under the National Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013 before appointing a new contractor to take over any GP practice. 

 

5.5           Any extension of a contract under clause 26.5 can therefore only be for an extension of 28 days as set out in the above clause and there is no power for a further extension.  Unless NHS England agree to provide the incoming contractor with a temporary contract (which would have to be an APMS contract) it is difficult to see an incoming GP practitioner taking the risk of buying the practice equipment and buildings when he or she has no guarantee that they will secure the contract.   Few ne sole practitioner contracts are being let by NHS England, and so it is possible that NHS England would prefer a sole practice to be taken over by a neighbouring multi-handed practice.  NHS England would still be obliged to run a procurement process in due course.

 

5.6           There is a similar but slightly more straightforward provision for PMS Contracts under paragraph 99A of Schedule 5 to the PMS Regulations which provides:

 

“(1)     Where the agreement is with a single individual and that individual dies, the agreement shall terminate at the end of the period of seven days after the date of his death unless, before the end of that period the Board has agreed in writing with the contractor's personal representatives that the agreement should continue for a further period, not exceeding 28 days after the end of the period of seven days.

 

(2)     Sub-paragraph (1) does not affect any other rights to terminate the agreement which the Board may have under paragraphs 104 to 107”

 

6.             Termination by NHS England:  General provisions

 

6.1           A significant feature of GMS contracts is that they are public sector contracts which do not have a time limit attached to them.  Unlike almost any other form of contract under which a contractor is appointed to provide public services, NHS primary care contracts are not time limited.  Further they are almost unique amongst public sector contracts in allowing the contractors to change the identity of the contractor without the specific consent of NHS England.  A GP partnership contract is held by the GP partnership as it is constituted from time to time.  When a new GP is brought into the partnership, that person automatically becomes a contractor to NHS England.  However in virtually all other public sector contracts a person does not get the right to deliver public services unless selected by the contracting authority.

 

6.2           However the position is different for PMS contracts.  The contracts were originally permanent contracts in the same way as PMS contracts are permanent contracts.  However the position was changed by the National Health Service (Primary Medical Services) (Miscellaneous Amendments) Regulations 2010 which came into force on 1st April 2010.  These Regulations amended the terms of all PMS contracts by requiring the following terms to be introduced:

 

(1)     The contractor or the relevant body may terminate the agreement by serving notice in writing on the other party at any time.

 

(2)     Where a notice is served pursuant to sub-paragraph (1) and the period of notice in relation to such termination (which must be a period of not less than six months) has previously been agreed between the parties and provided for in the agreement, the date of termination under the notice must be calculated in accordance with such agreed period of notice, and the agreement will terminate on the date so calculated.

 

(3)     Where a notice is served pursuant to sub-paragraph (1) and no period of notice has previously been agreed between the parties and provided for in the agreement in relation to such termination, the period of notice required must be six months and the date of termination under the notice must be calculated accordingly, and the agreement will terminate on the date so calculated.

 

(4)     This paragraph is without prejudice to any other rights to terminate the agreement which the contractor and the relevant body may have”

 

6.3           Thus this term (which ought now to be incorporated into every PMS contract) entitles NHS England to serve a notice on the contractor terminating the contract without any breach by the GP practice on 6 months notice.  A challenge to the lawfulness of this change to the law was rejected by the High Court in R (Flasz & Ors) v Havering Primary Care Trust [2011] EWHC 1487 (Admin).  This was only a permission decision and so is of limited weight, but it is nonetheless a decision of a high court judge after contested argument.  It follows that GP practices that hold PMS contracts can find their contracts ended by NHS England serving them with a 6 month termination notice even if the GP practice has not acted in breach of any term of its contract.

 

6.4           PMS contracts which are held by GPs (or anyone else who can hold a GMS contract under regulations 4 and 5 of the GMS Regulations) can apply to NHS England to revert to GMS status by serving a 3 month notice under Regulation 19 of the PMS Regulations and, if the paperwork is in order, NHS England have a statutory duty to award the practice a GMS contract.  It follows that the “6 month notice” provision under the above Regulations does not make the business run by PMS practices as precarious as they might have thought because, as long as they act swiftly, they can use Regulation 19 to convert from PMS to GMS status.

 

7.             Termination of a GP contract where a single handed GP is struck off by the GMC.

 

7.1           There are a limited number of circumstances in which NHS England is obliged to terminate a GP practice contract (as opposed to circumstances in which NHS England has an option to do so and so must make a discretionary decision whether to do so). 

 

7.2           Clause 26.8.1 of the GMS contract covers the situation where an individual GP is removed from the GMC Register of General Practitioners.  In such a case it is not surprising that the GMS Contract provides that the GMS contract should come to an end.  The clause provides:

 

Subject to clauses 26.8.2 and 26.8.11, the Board shall serve notice in writing on the Contractor terminating the Contract forthwith if the Contractor is an individual medical practitioner, and the medical practitioner no longer satisfies the condition specified in regulation 4(1) of the Regulations”

 

7.3           This clause refers to regulation 4 of the GMS Regulations which provides as follows with regard to an individual GP:

 

“(1)     In the case of a contract to be entered into with a medical practitioner, that practitioner must be a general medical practitioner.

 

7.4           A “general medical practitioner” is defined in Regulation 2 as follows:

 

“general medical practitioner” means, unless the context otherwise requires, a medical practitioner whose name is included in the General Practitioner Register kept by the General Medical Council”

 

7.5           The GP Register was established on 31 March 2006. From 1 April 2006, all doctors working in general practice in the health service in the UK, other than doctors in training such as GP Registrars, have been required to be included on the GP Register.  Details about the register are at http://www.gmc-uk.org/doctors/register/gp_register.asp and the register of all GPs can be found at http://www.gmc-uk.org/doctors/register/LRMP.asp  However there is an exemption for GPs who were in practice on 15th February 1981 because these GPs are exempt from the need to undergo the specialist training needed to become a member of the register.  There are other minor exemptions in Regulation 5 of the National Health Service (Vocational Training for General Medical Practice) Regulations 1997.

 

7.6           A doctor who is removed from the General Practitioner List cannot hold a practice contract.  However a GP who is suspended from the list but is not permanently removed is in a different category.  In such a case the contract will usually continue if the Contractor is able to satisfy the Board that it has in place adequate arrangements for the provision of clinical services under the Contract for so long as the suspension continues.  However NHS England have a residual power to remove the contract if

 

“the Board is satisfied that the circumstances of the suspension are such that if the Contract is not terminated forthwith—

 

i)      the safety of the Contractor’s patients is at serious risk; or

 

ii)   the Board is at risk of material financial loss”

 

7.7           There is a like provision for PMS contractors in paragraph 105(3)(b) of the PMS Regulations which permits NHS England to terminate a PMS contract if the contract holder is “disqualified or suspended (other than by an interim suspension order or direction pending an investigation or a suspension on the grounds of ill-health) from practising by any licensing body anywhere in the world”.  

 

8.             What happens if a GP with a contract in sole practice is suspended by the GMC?

 

8.1           The automatic termination of a GMS GP contract does not apply if a sole GP is suspended by the GMC.  However during the period of suspension the GP is obviously unable to deliver services to NHS patients.  The GMS contract gives NHS England an option to terminate the contract in 2 circumstances, namely:

 

a)      If the Contractor is unable to satisfy the Board that it has in place adequate arrangements for the provision of clinical services under the Contract for so long as the suspension continues; or

 

b)      the Board is satisfied that the circumstances of the suspension are such that if the Contract is not terminated forthwith:

 

(i)              the safety of the Contractor’s patients is at serious risk; or

 

(ii)            the Board is at risk of material financial loss.

 

8.2           There is a potential contradiction between (a) and (b)(i) here because in any case where the GP has made adequate arrangements for the provision of clinical services it is hard to imagine circumstances in which the patients remain at serious risk.  However that would arise if, for example, the GP was continuing to adversely affect how patients were treated despite his or her suspension.  Equally, if the GP has put in place adequate arrangements for the practice to be run by another GP, it is hard to see how NHS England could be at material financial risk. 

 

8.3           When considering whether to terminate a contract where a single handed GP is suspended, NHS England are required to consider the GP’s rights as well as other relevant factors.  It is not a correct approach to equate the removal of a contract with the initial grant of such a contract.  This was made clear in the NHSLA judgment in the case of Dr Ikwueke v Haringey PCT where the NHSLA said:

 

There is a significant difference between a suspended applicant looking to build a career in PMS hoping to persuade a PCT to grant him a contract and the Applicant in this case who has been in PMS practice for many years; has built up experience; developed a lifestyle consistent with the income generated by the contract and devoted most of his professional life to the patient’s of that practice thereby developing goodwill in the non technical sense. It is one thing not to grant a contract – quite another to take away established rights in possession. In many suspension cases the difference may be illusory but in the present case use of the word ‘Similarly’ and its context suggests the Respondent failed to give proper consideration to the Applicant’s interests when exercising the unquestioned discretion”

 

8.4           If the contract is terminated when a GP is suspended, NHS England can continue it during the interim period of the suspension.  The GMS contract is silent about what is supposed to happen if the GP’s suspension is lifted by the GMC but it appears to be implicit that the contract will be reinstated.   There are no equivalent provisions for PMS contractors, but there equally no automatic termination of a PMS contract when a PMS doctor is suspended or removed from practice.  It follows that a similar decision making process needs to be followed if NHS England wishes to terminate a PMS contract in such circumstances.

 

9.             What happens if one GP in a partnership is struck off by the GMC?

 

9.1           A GP Practice contract with multiple partners does not necessarily come to an end if one of the partners is struck off.  However NHS England may have a duty to terminate the contract if the other GP partners who are not stuck off are only limited partners (i.e. they have a limited liability under the Limited Partnerships Act 1907) because, in such a case, the partnership cannot continue to hold a GMS contract. 

 

9.2           The conditions which a GP partnership must satisfy to hold a GMS practice contract are set out in regulation 4(2) of the GMS Regulations which provides:

 

“(2)     In the case of a contract to be entered into with two or more individuals practising in partnership—

 

(a)     at least one partner (who must not be a limited partner) must be a general medical practitioner; and

 

(b)     any other partner who is a medical practitioner must—

 

(i)     be a general medical practitioner, or

 

(ii)     be employed by . . . a Local Health Board, (in England and Wales and Scotland) an NHS Trust, an NHS foundation trust, (in Scotland) a Health Board or (in Northern Ireland) a Health and Social Services Trust”

 

9.3           Clause 26.8.3 of the GMS contract provides that where the only full partner (i.e where others are limited partners) ceases to be a general medical practitioner, the mandatory termination provisions in clause 26.8.4 apply.  The mandatory termination provisions in clause 26.8.4 are as follows:

 

“… the Board shall-

 

(a)  serve notice in writing on the Contractor terminating the Contract forthwith; or

 

(b)  serve notice in writing on the Contractor confirming that the Board will allow the Contract to continue, for a period specified by the Board in accordance with clause 26.8.2 (the “interim period”), during which time the Board shall, with the consent of the Contractor, employ or supply one or more general medical practitioners to the Contractor for the interim period to assist the Contractor in the provision of clinical services under the Contract”

 

9.4           Thus where the only full partner in a GP practice is struck off by the GMC, the GMS contract must be ended by NHS England unless the removal of the doctor’s name from the GMC list arises because of a suspension.  NHS England can extend the notice period before the termination takes effect for up to 6 months under clause 26.8.5 or, if the main partner has been suspended, for the period of the suspension.  The scheme appears to suggest that the contract will be reinstated if the suspension is lifted although the exact mechanism by which this operates is not entirely clear. There are also clauses in the GMS contract which give NHS England the right to terminate the contract if there are problems with the GP practice during an interim period.

 

9.5           These provisions do not apply to PMS practices because NHS England is not under a mandatory obligation to terminate the contract if a GP is struck off by the GMC.

 

10.          Termination by NHS England for the provision of untrue information.

 

10.1        Those who hold GP practice contracts are required to provide a large amount of information to satisfy NHS England (or the PCT before them if the contract was originally granted by a PCT) that they satisfy the conditions in Regulations 4 and 5 of the GMS Regulations.   Hence, for example, each GP who is a party to a contract must not have been removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated.

 

10.2        The GP practice also has a contractual duty to inform NHS England if there are changes to the partners in a GP partnership contract or, in the case of a medical company which holds the contract, there are changes to the shareholders, directors or company information (see clauses 16.9 and 16.10). 

 

10.3        Clause 28.9.1 provides that NHS has the power (but not the duty) to terminate the contract if the GP practice provides any false information in relation to the conditions set out in Regulations 4 and 5.  It provides:

 

“The Board may serve notice in writing on the Contractor terminating the contract forthwith, or from such date as may be specified in the notice if, after this Contract was entered into, it has come to the attention of the Board that written information provided to the Board by the Contractor—

 

(a)  before the Contract was entered into; or

 

(b)  pursuant to clauses 16.9.2, 16.9.3 or 16.10.2,

 

in relation to the conditions set out in regulation 4 and 5 of the Regulations (and compliance with those conditions) was, when given, untrue or inaccurate in a material respect”

 

 

10.4        This is not a mandatory ground for termination of the GP practice contract but the provision of any false information by a GP practice to NHS England puts the contract at risk.  There is a like provision for PMS contracts in paragraph 104 of Schedule 5 to the PMS Regulations.

 

11.          Termination where contractors fail to comply with the conditions in Regulations 4 and 5 of the GMS Regulations.

 

11.1        GMS contracts can only be granted to a GP practice if the conditions in regulations 4 and 5 are satisfied (see chapter 3.8 for details).  Clause 26.10.2 provides that the discretionary right for NHS England to terminate a GMS contract for breach of the Regulation 4 and 5 conditions if:

 

a)      in the case of a contract with a single medical practitioner, that medical practitioner in in breach of the Regulation 4 and 5 conditions;

 

b)      in the case of a contract with two or more individuals practising in partnership, any individual or the partnership is in breach of the Regulation 4 and 5 conditions; and

 

c)       in the case of a contract with a company limited by shares, the company, any person both legally and beneficially owning a share in the company, or any director or secretary of the company, is in breach of the Regulation 4 and 5 conditions.

 

11.2        The relevant Regulation 4 and 5 conditions are as follows:

 

a)      The person does not satisfy the conditions prescribed in section 86(2)(b) or (3)(b) of the 2006 Act, namely the person is no longer an:

 

                                       i)              an NHS employee;

 

                                     ii)              a section 92 employee, section 107 employee, section 50 employee, section 64 employee, section 17C employee or Article 15B employee;

 

                                   iii)              a health care professional who is engaged in the provision of services under the NHS Act or the National Health Service (Wales) Act 2006 (c 42), or

 

                                    iv)              an individual falling within section 93(1)(d) [4] ;

 

b)      the person is the subject of a national disqualification from the NHS England Performers List;

 

c)       subject to clause 26.10.3 (which provides for an added layer of discretion where a person is suspended by a foreign licensing body), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation or a suspension on the grounds of ill-health) from practising by any licensing body anywhere in the world;

 

d)      subject to clause 26.10.4 (which provides that this clause does not apply if a person secures a finding that he was unfairly dismissed), he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body unless before the Board has served a notice terminating the Contract pursuant to this clause, he is employed by the health service body that dismissed him or by another health service body;

 

e)      he or it is removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 151(2), (3) and (4) of the 2006 Act respectively) unless his or its name has subsequently been included in such a list;

 

f)        he has been convicted in the United Kingdom of murder or an offence referred to in Schedule 1 to the Children and Young Persons Act 1933 or Schedule 1 to the Criminal Procedure (Scotland) Act 1995;

 

g)       he has been convicted in the United Kingdom of a criminal offence other than murder, and has been sentenced to a term of imprisonment of over six months;

 

h)      he has been convicted elsewhere (i.e. outside of the United Kingdom) of an offence which would, if committed in England and Wales-

 

                                       i)              constitute murder, or

 

                                     ii)              constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months,

 

Unless NHS England is satisfied that the conviction does not make the person unsuitable to be a contractor, a partner, a person both legally and beneficially holding a share in the company, or a director or secretary of the company, as the case may be;

 

i)        he or it has:-

 

                                       i)              been adjudged bankrupt or had sequestration of his estate awarded unless (in either case) he has been discharged or the bankruptcy order has been annulled,

 

                                     ii)              been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986 or Schedule 2A to the Insolvency (Northern Ireland) Order 1989, unless that order has ceased to have effect or has been annulled,

 

                                   iii)              made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it,

 

                                    iv)              been wound up under Part IV of the Insolvency Act 1986,

 

                                      v)              had an administrator, administrative receiver or receiver appointed in respect of it, or

 

                                    vi)              had an administration order made in respect of it under Schedule B1 to the Insolvency Act 1986;

 

j)        that person is a partnership and:-

 

                                       i)              a dissolution of the partnership is ordered by any competent court, tribunal or arbitrator, or

 

                                     ii)              an event happens that makes it unlawful for the business of the partnership to continue, or for members of the partnership to carry on in partnership together;

 

k)       he has been:-

 

                                       i)              removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated, or

 

                                     ii)              removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 or under section 34 of the Charities and Trustee Investment (Scotland) Act 2005 (powers of Court of Session), from being concerned in the management or control of any body;

 

l)        he is subject to a disqualification order under the Company Directors Disqualification Act 1986, the Companies (Northern Ireland) Order 1986 or to an order made under section 429(2)(b) of the Insolvency Act 1986;

 

m)     he has refused to comply with a request by the Board for him to be medically examined on the grounds that it is concerned that he is incapable of adequately providing services under the Contract and, in a case where the Contract is with two or more individuals practising in partnership or with a company, the Board is not satisfied that the Contractor is taking adequate steps to deal with the matter.

 

11.3        NHS England is not obliged to terminate a contract with a multi-handed partnership if one of the partners falls into a category set out above, but it has the contractual right to do so.  However, in such a case, the partnership will usually have a measure of warning that one of the partners is likely to fall into a category which puts the contract at risk and thus will act to remove the person from the partnership.  The contract is held between NHS England and the partnership as it is constituted from time to time.  Thus the removal of a partner from the partnership by the other partners before the material event happens (such as a criminal conviction for a serious offence or a bankruptcy) will prevent the practice contract from being at risk.  However if these steps are not taken the remaining partners put their practice contract at potential risk.

 

12.          Termination due to a change in the identity of the partners to a GMS contract.

 

12.1        A GMS partnership contract is held between NHS England and the partners in a partnership as it is form time to time constituted:  see Regulation 13(1) of the GMS Regulations.  This means that the GPs can take someone into partnership and, on doing so, that person becomes a party to the practice contract.  Regulation 13(2) of the GMS Regulations provides:

 

Where the contract is with two or more individuals practising in partnership, the contractor must be required by the terms of the contract to ensure that any person who becomes a member of the partnership after the contract has come into force is bound automatically by the contract whether by virtue of a partnership deed or otherwise”

 

12.2        If a partner leaves the partnership then that person ceases to be a contracting party to the GMS contract.  Clause 16.10 requires the GP practice to inform NHS England in writing if any partner leaves or joins the partnership.

 

12.3        This right to have a contract with a fluctuating number of individuals (all of whom must satisfy the conditions in regulations 4 and 5 of the GMS Regulations) may lead to a situation where NHS England is not satisfied that the remaining partners have the skills or experience to hold a GMS contract or there are other factors operating which make it inappropriate for the remaining partners to hold the contract.  This situation is covered in clause 26.15.1 which provides:

 

Where the Contractor is two or more persons practising in partnership, the Board shall be entitled to terminate the Contract by notice in writing on such date as may be specified in that notice where one or more partners have left the practice during the existence of the Contract if in its reasonable opinion, the Board considers that the change in membership of the partnership is likely to have a serious adverse impact on the ability of the Contractor or the Board to perform its obligations under the Contract”

 

12.4        The test is whether NHS England considers that the change in the identity of the partners is likely to have a serious adverse impact on the ability of the Contractor or the Board to perform its obligations under the Contract.  NHS England would need to have conducted a proper investigation and have reasoned grounds before it could say that it was likely (i.e. more probable than not) that the remaining partners could not manage the practice so that the practice continued to deliver on its obligations.  In practice this situation is likely to occur most often then the partner who leaves the practice has departed “under a cloud” and there are serious questions as to whether the remaining partners are able to turn the practice around so that it is able to deliver on its contractual obligations.

 

12.5        This problem does not arise with PMS practices because there is no provision in the PMS Regulations which permits the GPs to change the identity of the contracting parties.  Accordingly if a PMS contract is concluded with a partnership it can only be varied when a partner leaves or joins by signing a new PMS contract or by agreeing a variation with NHS England.

 

13.          Termination of the Practice contract for a serious breach of contract by the GP practice.

 

13.1        Clause 26.11 of the GMS contract is the “nuclear” option for NHS England and is used very rarely in practice.  It allows NHS England to serve notice on the contractor terminating the practice contract forthwith if the GP practice commits one or more serious breaches of contract.  It provides:

 

“The Board may serve notice in writing on the Contractor terminating the Contract forthwith or with effect from such date as may be specified in the notice if

 

a)      the Contractor has breached the Contract and the Board considers that as a result of that breach, the safety of the Contractor’s patients is at serious risk if the Contract is not terminated; or

 

b)      the Contractor’s financial situation is such that the Board considers that the Board is at risk of material financial loss”

 

13.2        In practice only a very serious risk to patient safety could justify NHS England from relying on this forthwith notice provision.  The scope for NHS England terminating the contract for “material financial loss” is also only likely to arise in the most serious of situations, particularly if NHS England cannot rely on the bankruptcy and insolvency provisions set out above. 

 

13.3        The relevant part of the NHS England Guidance makes it clear that the use of these powers will be very rare.  It provides:

 

“66.  The grounds for this form of termination are much more complex than those already covered in this policy. Though they are most likely to relate to the conditions set out in Regulation 4, this is not defined in either the GMS or PMS regulations. In most cases there is likely to have been significant dialogue and engagement between NHS England and the contractor prior to any such grounds being established.

 

67.  There will, of course, always be the exception to this rule where a breach is so significant that it warrants an immediate termination of the contract, however, in general most cases resulting in this action will have taken some time to investigate thoroughly and to gather the evidence to support a termination on these grounds”

 

13.4        Any GP practice which finds itself in receipt of a termination notice under these provisions should seek urgent specialist legal advice.

13.5        There is a like provision for PMS contracts at paragraph 106 of Schedule 5 to the PMS Regulations.

 

14.          Termination by NHS England for unlawful sub-contracting.

 

14.1        The provisions in the GMS contract concerning sub-contracting are fairly complex but there is one provision which is specifically designed to avoid a sub-contract arrangement being used by a GP contractor to attempt to get around the prohibition in the NHS Act on the sale by GPs of goodwill in their practice contracts [5] .  This prohibition is expressed in clause 15.9.10 which provides:

 

The Contractor shall not sub-contract any of its rights or duties under the Contract in relation to the provision of essential services to a company or firm-

 

a)         owned wholly or partly by the Contractor, or by any former or current employee of, or partner or shareholder in, the Contractor;

 

b)         formed by or on behalf of the Contractor, or from which it derives or may derive a pecuniary benefit; or

 

c)         formed by or on behalf of a former or current employee of, or partner or shareholder in, the Contractor, or from which such a person derives or may derive a pecuniary benefit,

 

where that company or firm is or was formed wholly or partly for the purpose of avoiding the restrictions on the sale of the goodwill of a medical practice in section 259 of the 2006 Act or any Regulations made wholly or partly under that section”

 

14.2        If NHS England learns that a GP practice has undertaken any subcontracting in breach of this clause, the GP contract can be terminated forthwith or an instruction can be given to terminate the sub-contracting arrangements that give rise to the breach forthwith (where any failure to do so will result in the contract being terminated forthwith).

 

14.3        There is a like provision for PMS contracts at paragraph 106A of Schedule 5 to the PMS Regulations.

 

15.          Remedial and Breach Notices.

 

15.1        Apart from the specific circumstances set out in the paragraphs above, the structure of the GMS Contract is that NHS England is entitled to respond to a breach by the GP practice of any of the terms of the contract by serving either a “remedial notice” or a “breach notice”.  These are 2 different types of notices which have subtlety different consequences for the GP practice.

 

15.2        A “remedial notice” is served under clause 26.13 which provides:

 

26.13.1 Where the Contractor has breached the Contract other than as specified in clauses 26.8.1 to 26.12.2 and the breach is capable of remedy, the Board shall, before taking any action it is otherwise entitled to take by virtue of the Contract, serve a notice on the Contractor requiring it to remedy the breach (“remedial notice”).

 

26.13.2.   A remedial notice shall specify:

 

a)         details of the breach;

 

b)         the steps the Contractor must take to the satisfaction of the Board in order to remedy the breach; and

 

c)         the period during which the steps must be taken (“the notice period”).

 

26.13.3.  The notice period shall, unless the Board is satisfied that a shorter period is necessary to protect the safety of the Contractor’s patients or protect itself from material financial loss, be no less than 28 days from the date that notice is given.

 

26.13.4.  Where the Board is satisfied that the Contractor has not taken the required steps to remedy the breach by the end of the notice period, the Board may terminate the Contract with effect from such date as the Board may specify in a further notice to the Contractor”

 

15.3        The service of a remedial notice thus gives rights to both NHS England and the contractor.  It can be served for any breach (however trivial) of the obligations of the GP practice as set out in the GMS contract.   Once it is served the GP practice has the notice period (which must be not less than 28 days) to remedy the breach.  The NHS England Guidance explains the steps that its Area Teams are required to take when considering serving a Remedial Notice.  This provides a series of steps that the Area Team are required to follow at paragraph 36 as follows:

 

ATs [Area Teams]shall take the following steps:

 

1. Initially the AT should contact the contractor and discuss the breach with them and the action that they may be entitled to take, i.e. the issue of a remedial notice.

 

2. The contractor should be afforded the opportunity to provide an explanation as to the circumstances that lead to the breach and this discussion should be recorded accurately in writing for the contract file.

 

3. The AT shall then investigate the breach and any details recorded during the contractor discussion which are pertinent to the matter at hand and examine any evidence in relation to the breach.

 

4. If the AT is satisfied that the matter is a breach which is capable of remedy then they may issue a remedial notice to the contractor, requiring them to remedy the breach,

 

5. The AT may then consider any further action NHS England is otherwise entitled to take by virtue of the contract, at the earliest opportunity after the initial matter was raised.

 

6. It is important that when steps 1 to 4 are undertaken, this is completed as quickly as is reasonably possible as long delays between the breach occurring, or NHS England becoming aware of the breach, and the notice being issued are inappropriate and can lead to further complications once, and if, the matter proceeds to a full breach, possible termination and dispute”

 

15.4        The NHS Guidance also explains at paragraphs 36(10) and (11):

 

“10.  Where the AT is satisfied that the contractor has taken the required steps to remedy the breach within the notice period, a letter will be issued to the contractor informing them that the terms of the remedial notice have been satisfied and that no further action will be taken at this stage.

 

11.  The letter should also set out the consequences of the contractor further breaching their agreement in that if, following a breach notice or a remedial notice, the contractor –

 

a. repeats the breach that was the subject of the breach notice or the remedial notice; or

 

b. otherwise breaches the contract resulting in either a remedial

notice or a further breach notice,

 

NHS England may serve notice on the contractor terminating the contract with effect from such date as may be specified in that notice. (Annex 3)”

 

15.5        The reference to “Annex 3” is a reference to a standard form letter which is annexed to the Guidance.  Thus, if the GP practice does not act to remedy the breach to NHS England’s satisfaction (or later repeats the same breach or breaches the contract in a different way), NHS England acquires the right to terminate the contract by serving a further notice after the notice period has ended.    The wording provides that NHS England obtains the right to terminate if NHS England is not “satisfied” that the breach has been remedied.  This provision has not been, as far as the author is aware, ever been tested in the High Court.  However it is possible to envisage a situation where the contractor contends that he has taken sufficient steps to remedy the breach but NHS England say that they are not satisfied with those actions.  In such a case (unless possibly the dispute about whether the breach is remedied is referred to the NHSLA for determination) NHS England would still appear to have the contractual right to terminate the contract. 

 

15.6        There is also no time period set within the terms of the contract within which NHS England have to respond to a failure to remedy a breach.  The contractual terms appear to permit NHS England a theoretically unending period within which to serve a termination notice.  However if there is a significant delay of many months or years, there may be arguments that NHS England has affirmed the contract and thus cannot serve a termination notice.

 

15.7        There are other breaches of contract which cannot be remedied.  For example, the GP Practice is required to be open from Monday to Friday for all days except from except Good Friday, Christmas Day or bank holidays (see the definition of “core hours” in the GMS Contract).   If a GP practice failed to open on, say Christmas Eve, this would be a breach of contract.  However it cannot be “remedied” because, by the time a notice is served, it is all in the past.  However NHS England is entitled to respond to such a breach by serving a breach Notice.  Clause 26.13.5 provides:

 

Where the Contractor has breached the Contract other than as specified in clauses 26.8.1 to 26.12.2 [6]  and the breach is not capable of remedy, the Board may serve notice on the Contractor requiring it not to repeat the breach (“breach notice”)”

 

15.8        Thus the primary effect of the breach notice is that it acts as a “yellow card” to warn the GP practice that NHS England considers that they have breached the contract and to warn the GP practice not to repeat the breach.  However clause 26.13.6 explains the extensive powers that NHS England has once a breach notice has been served.  It provides:

 

If, following a breach notice or a remedial notice, the Contractor-

 

(a)  repeats the breach that was the subject of the breach notice or the remedial notice; or

 

(b)  otherwise breaches the Contract resulting in either a remedial notice or a further breach notice,

 

the Board may serve notice on the Contractor terminating the Contract with effect from such date as may be specified in that notice”

 

15.9        This clause gives a very considerable power to NHS England.  The first part covers the circumstance where the GP practice breaches the same term of the contract for a second time following the service of a breach notice.  In such circumstances NHS England can respond to the second breach by serving a notice to terminate the GP practice contract.

 

15.10     However the effect of a breach notice is far wider than the particular breach.  If, following the service of a breach notice, the GP practice act in breach of any of the terms of a GP contract, NHS England are entitled to serve a further breach notice or, as the case may be, a remedial notice and then get the right to serve a termination notice.  However this seemingly wide power is cut down by the following clause which provides:

 

“The Board shall not exercise its right to terminate the Contract under the previous clause unless it is satisfied that the cumulative effect of the breaches is such that it would be prejudicial to the efficiency of the services to be provided under the Contract to allow the Contract to continue”

 

15.11     This is the “cumulative effect” clause under which NHS England consider must be satisfied before they have the right to terminate the contract.  It is thus not quite a “two strikes and you are out” provision.  However the power to serve a termination notice applies if NHS England are “satisfied” that the breaches have a cumulative effect, and thus gives a considerable amount of discretion to NHS England staff to determine whether the breaches have this effect or not.  

 

15.12     The NHS England Guidance refers to the “cumulative effect” test but does not provide any specific guidance to Area Teams on who the test is to be applied.  It says, for example at paragraphs 36(13) and (14):

 

13.  NHS England shall not exercise its right to terminate the contract unless it is satisfied that the cumulative effect of the breaches is such that NHS England considers that to allow the contract to continue would be prejudicial to the efficiency of the services to be provided under the contract.

 

14. When considering a cumulative effect ATs must act proportionately and reasonably having full regard of the nature and timeframe of the notices issued”

 

15.13     Thus the Guidance does little more than reproduce the words of the contract.  However the expression “prejudicial to the efficiency of the services” has a specific meaning under Regulation 14 of the National Health Service (Performers List) (England) Regulations 2013 which refers to the test that NHS England must apply when considering the removal of a GP from the Performer List.   Regulation 15 sets out a list of factors that NHS England (or the First Tier Tribunal on appeal) must take into account when considering whether to remove a practitioner from the Performers List under the 2013 Regulations.  The factors are as follows:

 

“(5) Where the Board is considering whether to remove a Practitioner from a performers list under regulation 14(3)(b) (an efficiency case), it must consider—

 

(a)  any information relating to that Practitioner which it has received under regulation 9;

 

(b)  any information held by the NHSLA about past or current investigations or proceedings involving or relating to that Practitioner, which information the NHSLA must supply if the Board so requests; and

 

(c)  the matters referred to in paragraph (6).

 

(6) Those matters are—

 

(a)  the nature of any incident which was prejudicial to the efficiency of the services which the Practitioner performed;

 

(b)  the length of time since the last incident occurred and since any investigation into it was concluded;

 

(c)  any action taken by any regulatory or other body (including the police or courts) as a result of any such incident;

 

(d)  the relevance of the incident to the Practitioner’s performance of the services which those included in the relevant performers list perform, and the likely risk to patients or to public finances;

 

(e)  whether the Practitioner has ever failed to comply with a request to undertake an assessment by the NCAA on or before 31st March 2005, by the NPSA between 1st April 2005 and 31st March 2012 inclusive, by the NICE between 1st April 2012 and 31st March 2013 inclusive, or thereafter by the NHSLA;

 

(f)    whether the Practitioner has previously failed to supply information, make a declaration or comply with an undertaking required on inclusion in a performers list;

 

(g)  whether, in respect of any list, the Practitioner—

 

(i)  was refused inclusion in it,

 

(ii) was included in it subject to conditions,

 

(iii)            was removed from it, or

 

(iv)            is currently suspended from it,

 

and, if so, the facts relating to the incident which led to such action and the reasons given for such action by the holder of the list; and

 

(h)  whether, in respect of any list, the Practitioner was at the time of the originating event or in the six months preceding that event, a director of a body corporate, which —

 

(i)  was refused inclusion in it,

 

(ii) was included in it subject to conditions,

 

(iii)            was removed from it, or

 

(iv)            is currently suspended from it,

 

and, if so, the facts relating to that event and the reasons given for such action by the holder of the list”

 

15.14     The use of the same language in both the GMS Contract and the National Health Service (Performers List) (England) Regulations 2013 means that it seems that NHS England ought to consider each of these factors before making a decision whether the “cumulative effect” test has been met.

 

15.15     The NHS England Guidance provides the following concerning the steps that should be followed by NHS England Area Teams before a decision is made to terminate an NHS Contract:

 

“1. NHS England must establish that they have grounds to move to terminate a contract or agreement under the terms laid out in Regulations, following due process and investigation of the facts and providing the contractor the opportunity to provide a response to allegations, wherever possible.

 

2. NHS England will consider the available information and decide an appropriate course of action and will determine by reference to, and in accordance with, the appropriate statutory regulations:

 

·       Whether the contract or agreement should be terminated with

immediate effect, or

 

·       Whether the contract should be allowed to continue for an interim period [not normally to exceed six months] if NHS England is satisfied that the contractor has in place adequate arrangements for the provision of services during the interim period.

.

3. The AT shall provide a notice of termination to the contractor, as soon as is practicably possible, to include:

 

a.     the reasons for termination of the contract with reference to the relevant contractual, agreement clauses,

 

b.     the evidenced relied on in making the decision to terminate,

 

c.     the date when termination will become effective,

 

d.     the actions that the contractor must take leading up to the termination in respect of their duty of cooperation and on-going patient safety, ie. any other arrangements included in the contract/agreement on the arrangements on termination, and

 

e.     the Contractor’s right to invoke the NHS Dispute Resolution Process or court proceedings.

 

4. Where NHS England determines that a contract or agreement should be terminated with immediate effect, the AT shall serve notice of termination in writing on the contractor terminating the contract or agreement immediately in accordance with the details set out in sub paragraph 3 above.

 

5. Where NHS England determines that the contract or agreement should be allowed to continue for an interim period, the AT should serve written notice on the contractor confirming the arrangements as set out in sub paragraph 3 above.

 

6. When issuing a notice of termination it is essential that the AT retains a record that the contractor has received the notice and the date of its delivery. This can be achieved either by hand delivery of the notice upon which the contractor should be asked to sign a Received Receipt (Annex 3), or by recorded or special delivery arrangements through the Royal Mail, when all tracking records must be retained on file”

 

15.16     Unlike in the case of a Performers List matter where a specific committee of NHS England has been constituted to make the decision, the NHS England Policy does not precisely specific who within NHS England is entitled to make a decision on behalf of the organisation to serve a notice on a GP terminating a contract.  The policy set out in this Guidance simply states that “NHS England will consider the available information and decide an appropriate course of action and will determine” what decision should be made.   It is thus unclear from the published policies what level of management decision making within NHS England should take the decision to serve a termination notice on a GP practice.  It seems unlikely that these decisions need to be made on an individual basis at director level but, unless there has been a specific delegation of this function by the directors to Area Teams, the guidance and policy does not appear to vest decision making responsibility in the Area Team.  This issue will no doubt be made clear if a decision of NHS England is the subject of a legal challenge at some point in the future.

 

15.17     There are like provisions for remedial and breach notices at paragraph 107 of the PMS Regulations.

 

16.          Contract sanctions.

 

16.1        One of the key features of GP Practice contracts is the power of NHS England to impose “contract sanctions” on a GP practice that acts in breach of contract as an alternative to termination of the contract.  The imposition of contract sanctions is thus a “half way house” between informal management of a contract breach and termination of the contract.

 

16.2        The power to impose contract sanctions on a GP practice that acts in breach of contract arises under clause 26.16 of the GMS contract which provides as follows:

 

“26.16.1  In clauses 26.16.2 to 26.17.4 “contract sanction” means-

 

(a)  termination of specified reciprocal obligations under the Contract;

 

(b)  suspension of specified reciprocal obligations under the Contract for a period of up to six months; or

 

(c)  withholding or deducting monies otherwise payable under the Contract.

 

26.16.2  Where the Board is entitled to terminate the Contract pursuant to clauses 26.9.1 to 26.11.1, 26.13.4, 26.13.6 and 26.14.1 to 26.15.2, it may instead impose any of the contract sanctions if the Board is reasonably satisfied that the contract sanction to be imposed is appropriate and proportionate to the circumstances giving rise to the Board’s entitlement to terminate the Contract.

 

26.16.3  The Board shall not, under clause 26.16.2, be entitled to impose any contract sanction that has the effect of terminating or suspending any obligation to provide, or any obligation that relates to, essential services.

 

26.16.4  If the Board decides to impose a contract sanction, it must notify the Contractor of the contract sanction that it proposes to impose, the date upon which that sanction will be imposed and provide in that notice an explanation of the effect of the imposition of that sanction.

 

26.16.5  Subject to clauses 26.17.1 to 26.17.4 the Board shall not impose the contract sanction until at least 28 days after it has served notice on the Contractor pursuant to clause 26.16.4 unless the Board is satisfied that it is necessary to do so in order to protect the safety of the Contractor’s patients, or protect itself from material financial loss.

 

26.16.6  Where the Board imposes a contract sanction, the Board shall be entitled to charge the Contractor the reasonable costs of additional administration that the Board has incurred in order to impose, or as a result of imposing, the contract sanction”

 

16.3        It follows that NHS England only obtains the right to impose contract sanctions where it has a contractual right to terminate the GP practice contract.  If the circumstances do not give NHS England the right to serve a notice of termination, NHS England does not have the contractual right to impose contract sanctions.

 

16.4        The NHS England Guidance gives the following advice to Area Teams about the imposition of contract sanctions:

 

“41.  Sanctions cannot be applied to a contract unless NHS England is in a position to move to terminate. As an alternative to terminating a contract or agreement, NHS England may, in certain circumstances consider the application of sanctions.

 

42.  Where the termination of a contract or agreement is being considered on the grounds that a contractor has breached the contract or agreement or has failed to respond to a remedial notice, NHS England will in all cases consider the option of applying sanctions as an alternative.   Such sanctions may involve:

 

·       Termination of specified reciprocal obligations, such as the right to provide additional or enhance services, under the contract or agreement;

 

·       Suspension of specified reciprocal obligations under the contract or agreement for a period of up to six months; or

 

·       Withholding or deducting monies otherwise payable under the contract or agreement.

 

43.  The choice of which sanction to use would ordinarily depend on the nature of the breach, or cumulative effect, and what is felt to be the most appropriate and proportionate action in those circumstances. For example, if the breaches have occurred in relation to a specific service element under the contract, it might be most appropriate to move to terminate that specific service, such as an additional service.

 

44.  Where NHS England decides that the most appropriate sanction would be to withhold or deduct monies, this must be calculated in accordance with set criteria in order to establish a consistent, fair and measured approach:

 

1. The AT shall issue a notice of their intent to apply a sanction to the contractor which should include:

 

a.     The nature of the sanction to be applied;

 

b.     If withholding or deducting monies, how this has been calculated and the duration of any such sanction,

 

c.     If services are to be terminated, which services and from what date,

 

d.     If suspension of specified reciprocal obligations under the contract or agreement, the period of that suspension and its end date; and

 

e.     The contractors right to appeal to this decision  (Annex 7)

 

2. If there is a dispute between NHS England and the contractor in relation to a contract sanction that the AT is proposing to impose, the AT shall not, subject to paragraph 5 below, impose the proposed contract sanction except in the circumstances specified in paragraph (3)(a) or (b) below.

 

3. If the contractor refers the dispute relating to the contract sanction to the NHS dispute resolution procedure or court proceedings within 28 days beginning on the date on which NHS England served notice on the contractor (or such longer period as may be agreed in writing with the AT), and notifies the AT in writing that it has done so, the AT shall not impose the contract sanction unless−

 

a.     there has been a determination of the dispute and that determination permits NHS England to impose the contract sanction; or

 

b.     the contractor ceases to pursue NHS dispute resolution procedure or court proceedings, whichever is the sooner.

 

4. If the contractor does not invoke NHS dispute resolution procedure or court proceedings within the time specified in paragraph (3), the AT shall be entitled to impose the contract sanction immediately.

 

5. If NHS England is satisfied that it is necessary to impose the contract sanction before the NHS dispute resolution procedure or court proceedings is concluded in order to–

a. protect the safety of the contractor’s patients;  or

 

b. protect itself from material financial loss,

 

the AT shall be entitled to impose the contract sanction immediately, pending the outcome of that procedure”

 

16.5        The right to impose sanctions includes the right impose a financial penalty on the GP practice.  The level of financial penalty is not set out in the contract and the Guidance only states that it should be fixed by applying “set criteria in order to establish a consistent, fair and measured approach”, but does not say what those criteria should be in practice.  Clause 26.12.2 states that the contract sanction must be “appropriate and proportionate to the circumstances giving rise to the Board’s entitlement to terminate the Contract”.

 

16.6        There are like provisions about the imposition of contract sanctions as an alternative to termination for PMS contracts at paragraph 109 of Schedule 5 to the PMS Regulations.

 

17.          The role of the NHS Disputes Procedures and the FHSAU in breach and contract termination decisions.

 

17.1        The NHS has operated a Disputes Resolution Service for individuals and organisations operating in the NHS for many years.  Section 9(6) of the NHS Act 2006 provides that if any dispute arises with respect to an NHS Contract, either party may refer the matter to the Secretary of State for determination.  The Secretary of State does not become personally troubled with the resolution of such disputes because he has delegated the discharge of this function to the Family Health Services Appeal Unit (known as the FHSAU) which is part of the National Health Service Litigation Authority (“NHSLA”) which is a Special Health Authority.  The delegation is found in Directions made by the Secretary of State, namely the Directions as to the Functions of the National Health Service Litigation Authority (GMS Contract Disputes) 2005 and the Functions of the National Health Service Litigation Authority (PMS Agreement Disputes) 2005

 

17.2        If the GP Practice has signed an NHS Contract then the GP practice cannot sue NHS England in the courts (because an NHS Contract gives rise to no rights or liabilities) and therefore the only route to resolving a dispute is to refer the matter to the FHSAU for determination.  If the GP Practice has signed a legally binding contract then it has the option of litigating in the courts or referring the matter to the FHSAU for determination.  However if the matter is referred to the FHSAU the GP practice is bound by the outcome of the determination which will be binding on both the GP Practice and the NHSLA unless it is set aside by the High Court in a Judicial Review challenge.

 

17.3        The procedures adopted by the FHSAU for resolving GP contract disputes are explained on their website in a series of Factsheets.  The majority of decisions are taken by the FHSAU on the basis of written material provided by both sides with only occasional oral hearings where this is needed to resolve disputes of fact.

 

17.4        Parties are entitled to be legally represented in the written material they put before the FHSAU or at an oral hearing but neither party will be awarded their legal costs as part of any determination. The FHSAU publishes decisions that it makes on its website, either with the names of the relevant parties or in an anonymised form.  However there is no clear mechanism to search against the content of such decisions and therefore it is difficult to find decisions which are a precedent on any particular point.

 

17.5        One of the issues that is unclear from both the NHS England Guidance and in some decisions of the FHSAU itself is the remit of the FHSAU’s dispute resolution powers.   The GMS contract gives considerable discretion to NHS England to decide whether to serve a remedial notice or, for example, whether to impose contract sanctions or to move straight to a termination of a GP contract.   There are 3 possible roles that the FHSAU could adopt as part of its dispute resolution function, namely:

 

a)      The FHSAU could act as a discretionary decision maker in place of NHS England and could exercise the discretion afresh in place of officers of NHS England;

 

b)      The FHSAU could confine itself to asking whether NHS England had the power to make the decision that it purported to make (such as serving as notice of termination), and provided NHS England had the power to do so, the FHSAU will not seek to interfere in the exercise of NHS England’s discretionary decision making; or

 

c)       The FHSAU could ask itself both whether NHS England had the power to make the decision in question and whether it acted in a procedurally correct manner in seeking to exercise that power, including asking whether NHS England acted in accordance with its internal guidance and policies in doing so.  Decisions will be upheld if NHS England had the power to take the relevant decision and also can demonstrate that it followed its internal policy guidance in the process leading up to the making of the decision. 

 

17.6        In practice the FHSAU tends to adopt the last of these three approaches.  This approach recognises that there can only be a “dispute” between the GP practice and NHS England (or previously a PCT) if the GP practice can legitimately complain about the way in which NHS England has acted.  If NHS England has a discretion to exercise and has properly considered all relevant factors, there is no real basis for the GP Practice to complain.  The discretionary powers under a GP practice contract are given to the parties to the contract and not the FHSAU.  However if NHS England has failed to follow its own guidance or has acted outside its powers, the GP Practice has a legitimate complaint which can be adjudicated upon by the FHSAU.

 

17.7        Some guidance on this was given by Lawrence Collins LJ in R (on the application of Assura Pharmacy Ltd) v E Moss Ltd (t/a Alliance Pharmacy) [2008] EWCA Civ 1356 who said as follows at paragraphs 59 to 62:

 

“59.  First, decision letters such as the ones which are the subject of this appeal are to be considered on a "straightforward down-to-earth reading… without excessive legalism or exegetical sophistication": Clarke Homes Ltd v Secretary of State for the Environment (1993) 66 P&CR 263 at page 272-3, per Sir Thomas Bingham MR), applied in, e.g. MR Dean & Sons (Edgware) v First Secretary of State[2007] EWCA Civ 1083, at [43].

 

60.  Second, questions of adequacy, need and desirability are to be decided by the decision-makers, and provided that the proper approach is adopted, the answer will inevitably become a question of fact and degree eminently suitable for resolution by a committee of laymen, and not susceptible to sophisticated legal analyses: R v The Family Health Services Appeal Authority, ex parte E. Moss Ltd (1999) 48 BMLR 204, 215 (CA).

 

61.  Third, the mere absence of mention of a factor in the text of the decision does not necessarily mean that it was not considered. The reasons given should contain sufficient detail to enable the reader to know what conclusion has been reached on the principal important issue or issues and why, but it is not a requirement that they should rehearse every consideration to which they have had regard.

 

62.  Fourth, if the Secretary of State issues non-statutory guidance for decision-makers, and there is a radical departure from the guidance, then, although not relevant to the construction of the relevant provisions, the guidance may be relevant to a challenge because the decision-maker may be under an obligation to take it into account and to explain why he has taken that radically different approach”

 

17.8        NHS England has a discretion not to implement a decision whilst it is the subject of a reference to the NHSAU and will usually do so.  However it will implement a decision even if it is the subject of a reference if there are serious issues of patient safety or financial loss to NHS England.

 

17.9        If the GP practice is dissatisfied with a determination by the FHSAU, there are 2 possible appeal routes to the High Court.  There is an established right for the GP practice to apply for judicial review of a decision of the NHSLA.  For an example of this in a case that went to the Court of Appeal see R (on the application of Hussain & Ors) v Secretary of State for the Health Department & Anor.  However a public law challenge should only be accepted by the Judicial Review court if there is a significant public element to the dispute.  If the determination is, in reality, a dispute about the amount of money that NHS England should pay to the practice there may well be an insufficient public law element to the dispute to persuade the High Court that it is suitable for a public law hearing.   In R (on the application of Shah) v National Health Service Litigation & Ors [2010] EWHC 2575 (Admin) Silber J was faced with the argument that the determination by the FHSAU did not have a sufficient public law element to support a claim for judicial review following the guidance given by Dyson LJ in R (Beer) v Hampshire Farmers Markets Limited [2004] 1WLR 233.  Silber J decided that it was arguable that the GP did have a right to seek judicial review and did not decide the point.  The GP’s claim was dismissed on other grounds and thus the point remains to be finally determined.

 

17.10     There is an argument (which the author believes to be likely to be correct) that a determination by the FHSAU is an “arbitration” and that accordingly any challenge to that decision should only be made by way of the more limited rights under the Arbitration Act 1996.  That argument was rejected by Cranston J in the High Court in see R (on the application of Hussain & Ors) v Secretary of State for the Health Department & Anor but that judgment was overturned on a different point in the Court of Appeal.  The argument that a GP practice must use the FHSAU route was successful in the unreported case of Pitalia v Central Lancashire PCT [7] .  At the date of writing this judgment is the subject of an appeal to the Court of Appeal (listed in March 2014) and it is therefore unclear whether this argument will be sustained.  However any challenge to the decision of the FHSAU by way of an arbitration challenge must be commenced in the High Court within 28 days of the date of the determination.  There is no power under the Arbitration Act 1996 to extend that time period.  It follows that, in order to protect its position, a GP Practice would be well advised to apply to the High Court under the Arbitration Act within the 28 day period and apply for Judicial Review.

 

18.          Public law challenges to contracting decisions by NHS England.

 

18.1        NHS England is a public body and accordingly, in as much as it is making decisions about the grant, variation and termination of GP practice contracts, it is obliged to act reasonably and in a way that is consistent with its overall statutory obligations.  This duty to act reasonably is set out in clause 2.1.5 of the GMS Contract which provides:

 

In complying with this Contract, and in exercising its rights under the Contract, the Board must act reasonably and in good faith and as a responsible public body required to discharge its functions under the 2006 Act

 

However a breach by NHS England of this term does not discharge the contractor from performance of any other part of the contract as a result of clause 2.1.6.

 

18.2        it is an open question as to how far discretionary decisions taken by NHS England to exercise powers under a GP practice contract can be challenged on a public law basis.  This issue was considered in detail in the context of a General Dental Contract case by Turner J in Krebs v NHS Commissioning Board [2013] EWHC 3474 (Admin) [8] .   The Judge referred to Hampshire County Council v Supportways Community Services Ltd [2006] EWCA Civ 1035 in which the Claimant provided housing related support services under a contract with the defendant local authority. After nine months, the defendant purported to terminate the contract on the basis that the claimant was charging too much. The claimant sought to challenge the decision by way of judicial review. Turner J then quoted at length from the judgment of Neuberger LJ (as he then was) as follows:

 

"Can the Company seek a public law remedy?

 

34 … The primary question in this context is whether the Company should have been seeking only a private law remedy (as the Council contended), whether its remedy lay both in public and in private law (as the Company contended, albeit that it put its case primarily in public law), or whether it does not matter how its remedy is characterised (as the Judge held).

 

35 In my judgment, the basis of the Company's case was not in public law, but only in private law. The Company's complaint was that the Council had failed to comply with the Agreement, and the Company accordingly was seeking to enforce the Council's compliance. Subject to being contradicted by a closer analysis of the principles or by binding authority, such a complaint and such enforcement would appear to me respectively to involve a private law claim and a private law remedy, both of which are contractually based, albeit with common law and equitable aspects.

 

36 In answer to this, Mr Knafler first relied on the fact that the Council's obligations under clause 11.3 were, in reality, public law duties in that they can be traced directly to section 93 and to paragraph 71 of the 2003 Guidance. The fact that a contractual obligation is framed by reference to a statutory duty does not, in my view, render that obligation a public law duty. Of course, where the statutory duty is owed to a contracting party independently of the contractual obligation, he can normally expect to be able to seek a public law remedy by reference to the duty, as well as, or instead of, a private law remedy by reference to the obligation. However in the present case, the Council's public law duty, namely that arising under section 93, was owed to the Secretary of State in relation to the provision of grants. There was, as it seems to me, no question of that duty being owed to providers such as the Company.

 

37 Mr Knafler next relied on the fact that the nature of the Agreement, involving as it did the Council performing public administrative functions, was such that a claim brought under it would be a public law claim. That cannot, I think, be right. Virtually any contract entered into by a local authority, almost by definition, will involve it acting in such a way, as otherwise it would be acting ultra vires. Yet, it is clear that, as Mr Knafler rightly accepts, in the case of alleged breaches of many such contracts, a private law claim is the only type of claim which can be brought.

 

38 Thus, the mere fact that the party alleged to be in breach of contract is a public body plainly cannot, on its own, transform what would otherwise be a private law claim into a public law claim. There are, of course, circumstances where, in a contractual context, a public body is susceptible to public law remedies. However, where the claim is fundamentally contractual in nature, and involves no allegation of fraud or improper motive or the like against the public body, it would, at least in the absence of very unusual circumstances, be right, as a matter of principle, to limit a claimant to private law remedies.

 

39 Mr Knafler referred to a passage in the sixth (1999) edition of de Smith, Woolf and Jowell's Principles of Judicial Review , at paragraph 3–019, which includes the following three sentences:

 

"If a public function is being performed, and contract law does not provide an aggrieved person with an appropriate remedy, then action taken under or in pursuance of a contract should be subject to control by judicial review principles. Where a public body enters into a contract with a supplier, a dispute about the rights and duties arising out of the contract will often be determined by private law. However, the decision of a public body to enter, or not [to] enter, into a contract may be subject to judicial review."

 

40 The point made in the third sentence of that passage (which is expanded in paragraph 5–035 of the book) has no application here. It is true that the result of the review of which the Company complains did result in the determination of the Agreement and in the offer of a new contract whose terms it considered objectionable. This does not mean, however, that its claim is within the scope of the third sentence in that passage. Its claim is that the 2004 review was not carried out in accordance with the Agreement, not, for instance, that the Council acted in bad faith or was guilty of an improper motive in carrying out, or in failing to carry out, the 2004 review in accordance with clause 11.3. The Company's complaints that the Agreement was not properly determined, and that it was not offered a new contract on appropriate terms, are solely based on the contention that the Council failed to comply with its (purely contractual) obligation to carry out the 2004 review in accordance with clause 11.3.

 

41 Mr Knafler relied on the first sentence in the passage I have quoted from de Smith, on the basis that, if private law could not provide a satisfactory remedy in the present case, then the Company should be entitled to resort to public law remedies. As discussed above, it does indeed appear that the Company is only entitled, in terms of private law remedies, to damages for breach of clause 11.3, and it seems likely that such damages would be very difficult to assess. Indeed, it is quite possible that they would only be nominal, as the only consequence of the breach of clause 11.3 was its reflection in the terms of the new contract offered to the Company, and, as the Judge pointed out when considering the terms of the order, the Council had no obligation to enter into a new contract with the Company.

 

42 However, it cannot be right that a claimant suing a public body for breach of contract, who is dissatisfied with the remedy afforded him by private law, should be able to invoke public law simply because of his dissatisfaction, understandable though it may be. If he could do so, it would place a party who contracts with a public body in an unjustifiably more privileged position than a party who contracts with anyone else, and a public body in an unjustifiably less favourable position than any other contracting party.

 

43 Equally importantly, it appears to me that it would be wrong in principle for a person who would otherwise be limited to a private law claim should be entitled to base his claim in public law merely because private law does not afford him a sufficiently attractive remedy. It is one thing to say that, because a contracting party is a public body, its actions are, in principle, susceptible to judicial review. It is quite another to say that, because a contracting party is a public body, the types of relief which may be available against it under a contract should include public law remedies, even where the basis of the claim is purely contractual in nature.

 

44 Mr Knafler relied on a number of cases relating to the circumstances in which, when making a claim in relation to a contract with a public body, the other contracting party can make a claim in public law. Two of those cases appear to me to be of some relevance to the present dispute, and, indeed, to support the conclusion that the Company cannot rely on public law in this case.

 

45 In Mercury Energy Ltd -v- Electricity Corporation of New Zealand Ltd [1994] 1 WLR 521, Lord Templeman, giving the judgment of the Privy Council, said this at 529B:

 

"It does not seem to me likely that a decision by a state enterprise to enter into or determine a commercial contract to supply goods or services will ever be the subject of judicial review in the absence of fraud, corruption or bad faith."

 

That statement is plainly unhelpful to the Company's case: the only basis on which its claim is founded is breach of contract. Later, at 529G, Lord Templeman made the following observation, which also seems to apply to the present case:

 

"The causes of action based on breach of statutory duty, abuse of monopoly position and administrative impropriety are only relevant if the causes of action based on contract are rejected. If the causes of action based on contract are rejected, the other causes of action will only constitute attempts to obtain, by the declaration sought, specific performance of a non-existing contract. The exploitation and extension of remedies such as judicial review beyond their proper sphere should not be encouraged."

 

46 In Mercury Communications Ltd -v- Director-General of Telecommunications [1996] 1 WLR 48, Lord Slynn of Hadley, (who gave the only reasoned speech) referred in a passage at 57E–G to the importance of maintaining a degree of "flexibility as to the use of different procedures", namely public law and private law procedures. That case was concerned with the question of procedure than with that of remedy. Lord Slynn explained in the same passage that the plaintiff had properly brought private law proceedings because the dispute was "in substance and in form … as to the effect of the terms of the contract even if it can also be expressed as a dispute as to the terms of the licence". In the present case, the issues which we are considering concern the meaning and effect of the Agreement.

 

47 In these circumstances, I conclude that the Company has no claim which it can pursue by way of judicial review, and in particular by seeking public law remedies. Since preparing this judgment, I have had the opportunity of reading the judgment of Mummery LJ which deals with this aspect of the appeal on a somewhat broader basis, and with which I agree."

 

18.3        Turner J in Krebs considered that the Supportways Community Services case provided strong support for the conclusion that it would be wrong to admit a public law element into a private law claim about how NHS England had exercised their contractual powers in a GDS contract. The Judge decided that the position in summary was as follows:

 

“i) It would be difficult on any convincing jurisprudential basis to distinguish the Supportways case from the instant case so as to invest the latter with any more compelling element of public law;

 

ii) There is no allegation of fraud or improper motive or the like against the defendant in this case and there are no "very unusual circumstances" which would otherwise render it inappropriate to limit the claimant to private law remedies;

 

iii) In the circumstances of this case, if the claimant were afforded public law remedies the nature and extent of which went beyond those available in private law then it would place him in an unjustifiably more privileged position than a party who had contracted with a private health provider. It would also place the defendant in an unjustifiably less favourable position than any other contracting party”

 

18.4        However the Judge then went on to consider whether, as a matter of policy, public law concepts should be introduced to restrain the contractual rights that NHS England had under DGS contracts.  He said

 

“Furthermore, I take the view that if public law concepts were routinely introduced into otherwise straightforward contractual disputes merely because one of the contracting parties was a public body then the advantage of relative certainty would be lost and (as this case has clearly demonstrated) litigation would become more uncertain, more prolonged and more expensive”

 

18.5        It is difficult to see any differences in principle between dental contracts and medical contracts since both are based on a statutory template.  It follows that (unless this case is overturned in the Court of Appeal), in the absence of allegations of fraud or bad faith, it is likely to be very difficult for GP practices to mount public law challenges against NHS England arising out of discretionary decisions made under GP contracts.

 



[1] The Tomkins case concerned a dental contract but the same principles apply to a GP medical contract.

[2] GMS stands for “General Medical Services”.  It is the default form of agreement for GP practices.  For details of the different types of contracts that a GP practice can hold please see chapter 3.  The original Regulations setting up GMS contracts were the National Health Service (General Medical Services Contracts) Regulations 2004.  These Regulations are at http://www.legislation.gov.uk/ssi/2004/291/contents/made. However the www.legislation.gov.uk website has not been updated to show all the changes made by the numerous amending regulations made since the Regulations were introduced in 2004.  The wording quoted in this chapter is the version which is current at 1 January 2014 when this chapter has been written. 

[3] PMS stands for “Personal Medical Services”, a form of GP Practice contract originally brought in by the National Health Service (Primary Care) Act 1997.  For details please see chapter 3.  The original PMS Regulations are the National Health Service (General Medical Services Agreements) Regulations 2004.  These Regulations are at http://www.legislation.gov.uk/ssi/2004/619/contents/made. However the www.legislation.gov.uk website has not been updated to show all the changes made by the numerous amending regulations made since the Regulations were introduced in 2004.  The wording quoted in this chapter is the version which is current at 1 January 2014 when this chapter has been written. 

 

[4] For a detailed explanation of the meaning of these terms please see chapter 3.8 and 3.9.

[5] Interestingly there has never been a prohibition on the sale of the goodwill value of contracts held by by NHS dentists.

[6] These clauses refer to the breaches which entitle NHS England to take action without serving a breach notice and are referred to above.

[7] David Lock QC acted for the PCT in this case.  For details please contact him at This email address is being protected from spambots. You need JavaScript enabled to view it.

[8] Although this case has an “Admin” citation it was not an Administrative Court case but was a private law claim in the Queen’s Bench Division.  David Lock QC acted for NHS England in this case.  At the time of writing the Claimant is seeking permission to appeal from this decision but no decision has been given on that paper application.

When can fees be charged to a patient by a GP Practice?

 

 

This chapter contains:

 

1.     Introduction.

2.     The general prohibition on an NHS GP Practice charging fees to patients.

3.     Medical certificates that a GP practice must provide free of charge.

4.     Charges where the GP practice has reasonable doubts as to whether a patient is on the practice list.

5.     Charges permitted by Schedule 5 of the GMS Regulations and Schedule 3 of the PMS Regulations.

6.     Charges for meeting the requirements of other statutory bodies.

7.     Fees for conducting routine medical examinations.

8.     Services provided by a specialist GP for private patients in hospitals or a care home.

9.     Payment for emergency treatment of traffic casualties.

10.     Fees for attending a police station.

11.     Fees for preparing medical reports and issuing medical certificates.

12.     Fees for preparing medico-legal reports.

13.     Fees for preparing reports for seat belt purposes, following a traffic accident, a criminal assault or for fitness to travel.

14.     Eye examinations by GPs.

15.     Dispensing doctors and scheduled drugs.

 

1.             Introduction.

 

1.1          NHS services are generally free at the point of use for patients.  However the NHS has always imposed charges for some healthcare services and there are other functions undertaken by NHS doctors which are outside their NHS duties and hence attract a fee.  It follows that full legal position is somewhat more nuanced.   The general requirement that services should generally be provided free of charge is set out in section 1(4) of the National Health Service Act 2006 (“the NHS Act”) which provides:

 

The services provided as part of the health service in England must be free of charge except in so far as the making and recovery of charges is expressly provided for by or under any enactment, whenever passed”

 

1.2          There are a number of areas where Regulations provide that charges may be imposed for NHS services including:

 

a)             Prescriptions;

b)             Dental services;

c)              Optical services;

d)             Contraceptive services;

e)             Hospital services for persons who are not usually ordinarily resident in the UK.

 

1.3          Primary care services provided under a GMS[1] or PMS[2] contract to patients on the practice list or temporary residents are required to be provided free of charge.  The GMS and PMS contracts also provide that GP practices have a contractual obligation to provide a range of other services to patients[3].   However GP practices are (almost all) private sectors businesses that have contracted with NHS England to provide defined primary care services to a defined group of patients and to provide defined level of emergency medical services in limited circumstances.  If a registered patient or temporary resident[4] seeks primary care services from an NHS GP practice outside the terms of the contract held by that practice, the NHS GP practice has no obligation to provide services to that person.  However the GP practice cannot charge for treatment provided outside the GP Practice contract unless the service falls within a limited categories of specific services.

 

2.             The general prohibition on an NHS GP Practice charging fees to patients.

 

2.1          The general prohibition on an NHS GP Practice charging fees for services provided to patients is set out in Regulation 24 of the GMS Regulations[5] which provides:

 

The contractor shall not, either itself or through any other person, demand or accept from any patient of its a fee or other remuneration, for its own or another's benefit, for—

 

(a)     the provision of any treatment whether under the contract or otherwise; or

 

(b)     any prescription or repeatable prescription for any drug, medicine or appliance,

 

except in the circumstances set out in Schedule 5”

 

There is a like provision in the PMS Regulations. 

 

2.2          The prohibition covers any charge which is made for the provision of treatment or any prescription to a patient, not just treatment that the GP is required to provide under the practice contract.  A GP practice cannot therefore charge a third party, such as an employer or the parent of a child, for medical treatment provided to a patient.

 

2.3          The word “patient” is defined for the purposes of Regulation 24 in Regulation 2 of the GMS Regulations.  It provides as follows:

 

““patient” means—

 

(a)           a registered patient,

 

(b)           a temporary resident,

 

(c)           persons to whom the contractor is required to provide immediately necessary treatment under regulation 15(6) or (8) respectively,

 

(d)           any other person to whom the contractor has agreed to provide services under the contract,

 

(e)           any person for whom the contractor is responsible under regulation 31, and

 

(f)             any person for whom the contractor is responsible under arrangements made with another contractor in accordance with Schedule 7”

 

2.4          Every GP practice which is contracted to the NHS is prohibited from imposing any charge for treatment or drugs to any of the categories of “patient” as defined above.  Most of the categories of “patient are” self evident.  The meanings of “registered patient” and a “temporary resident are set out in Chapter 6 as is the categories of persons to whom a GP is required to provide “immediately necessary treatment”.  Regulation 31 and Schedule 7 refers to GP Practices that have Out of Hours responsibilities which may be owed to a wider class of persons than just the patients of the practice.

 

2.5          The general prohibition on imposing charges for treatment means that a GP with a GMS or PMS contract cannot charge a “patient” for the delivery of any form of medical treatment even if that treatment is not provided as part of NHS funded healthcare.  Thus a GP who provides, for example, osteopathy, acupuncture or homeopathy outside of NHS funded care is prohibited from charging patients (as that term is defined above) for the provision of such a service.  There is nothing to prevent a GP practice from offering such services on a commercial basis to persons who are not patients of the practice and do not otherwise come within the definition of being a “patient” under the GMS or PMS Regulations.  However Regulation 24 provides that a GP practice which holds an NHS contract cannot charge for offering any form of medical treatment (even outside NHS services) to patients of an NHS practice.

 

3.             Medical certificates that a GP practice must provide free of charge.

 

3.1          The GMS and PMS Regulations contain a list of statutory certificates that GP practices are required to provide without charge.  Regulation 21 of the GMS Regulations[6] provides:

 

“(1)     A contract must contain a term which has the effect of requiring the contractor to issue free of charge to a patient or his personal representatives any medical certificate of a description prescribed in column 1 of Schedule 4, which is reasonably required under or for the purposes of the enactments specified in relation to the certificate in column 2 of that Schedule, except where, for the condition to which the certificate relates, the patient—

 

(a)     is being attended by a medical practitioner who is not—

 

(i)     employed or engaged by the contractor,

 

(ii)     in the case of a contract with two or more individuals practising in partnership, one of those individuals; or

 

(iii)     in the case of a contract with a company limited by shares, one of the persons legally or beneficially owning shares in that company; or

 

(b)     is not being treated by or under the supervision of a health care professional.

 

(2)     The exception in paragraph (1)(a) does not apply where the certificate is issued in accordance with regulation 2(1) of the Social Security (Medical Evidence) Regulations 1976 (evidence of incapacity for work, limited capability for work and confinement) or regulation 2(1) of the Statutory Sick Pay (Medical Evidence) Regulations 1985 (medical information)”

 

3.2          This provision is somewhat clumsily worded but it means that a GP must issue one or more statutory certificates without charge where the following apply:

 

a)             The GP is asked to produce the certificate by a patient (as that term is defined as to which see above) or his personal representative;

 

b)             The certificate is of a description prescribed in column 1 of Schedule 4 to the GMS Regulations.  These are listed below;

 

c)              The certificate must be reasonably required under or for the purposes of the enactments specified in relation to the certificate in column 2 of Schedule 4 to the GMS Regulations;

 

d)             The exemption in sub-paragraphs (a) and (b) does not apply (as to which see below); and

 

e)             The exemption in Regulation 21(2) to the exemption in Regulation 21(1)(b) does not apply.

 

3.3          Column 1 of Schedule 4 to the GMS Regulations lists the types of certificates which have to be provided free of charge and column 2 lists the Acts of Parliament under which the certificates have to be provided. 

 

Column 1:  Purpose of certificate

Column 2:  Enactments

To support a claim or to obtain payment either personally or by proxy; to prove incapacity to work or for self-support for the purposes of an award by the Secretary of State; or to enable proxy to draw pensions etc

Naval and Marine Pay and Pensions Act 1865
Air Force (Constitution) Act 1917
Pensions (Navy, Army, Air Force and Mercantile Marine) Act 1939
Personal Injuries (Emergency Provisions) Act 1939
Pensions (Mercantile Marine) Act 1942
Polish Resettlement Act 1947
Social Security Administration Act 1992
Social Security Contributions and Benefits Act 1992
Social Security Act 1998

To establish pregnancy for the purpose of obtaining welfare foods

Section 13 of the Social Security Act 1988 (schemes for distribution etc of welfare foods)

To secure registration of still-birth

Section 11 of the Births and Deaths Registration Act 1953 (special provision as to registration of still-birth)

 To enable payment to be made to an institution or other person in case of mental disorder of persons entitled to payment from public funds

Section 142 of the Mental Health Act 1983 (pay, pensions etc of mentally disordered persons)

To establish unfitness for jury service

Juries Act 1974

To support late application for reinstatement in civil employment or notification of non-availability to take up employment owing to sickness

Reserve Forces (Safeguarding of Employment) Act 1985

To enable a person to be registered as an absent voter on grounds of physical incapacity

Representation of the People Act 1983

To support applications for certificates conferring exemption from charges in respect of drugs, medicines and appliances

National Health Service Act 2006

 To support a claim by or on behalf of a severely mentally impaired person for exemption from liability to pay the Council Tax or eligibility for a discount in respect of the amount of Council Tax payable

Local Government Finance Act 1992

 

 

3.4          The wording of the exemption in sub-paragraph (a) means that none of the above certificates have to be provided free of charge where the medical condition to which the certificate relates is being treated by a doctor or other healthcare professional who is not either a partner of the practice (including a corporate partner) or is employed by the GP practice.  In such a case the Regulations effectively signpost the patient to obtaining the certificate from the doctor or other healthcare professional who is treating the patient.  This could be a private doctor or is more likely to be a consultant in secondary care.  This exception does not apply where the certificate is sought in accordance with regulation 2(1) of the Social Security (Medical Evidence) Regulations 1976 (evidence of incapacity for work, limited capability for work and confinement) or regulation 2(1) of the Statutory Sick Pay (Medical Evidence) Regulations 1985 (medical information).  In such cases the GP practice must issue the certificate free of charge even though the patient is being treated by another doctor or other healthcare professional.

 

3.5          The exemption in sub-paragraph (b) provides that where the medical condition to which the certificate relates is not being treated by a health care professional at all, the GP practice is not required to provide a certificate free of charge.

 

3.6          The BMA reports that it has clarified with the Department of Work and Pensions that it is not obligatory for GPs to fill in the factual reports for the Disability Living Allowance, Attendance Allowance and form DS1500 (Special Rules).  These forms attract a separate fee paid by the DWP.

 

3.7          Once a certificate has been issued to the Department of Work and Pensions (“DWP”), the person to whom the certificate is sent is entitled to come back with follow up questions.  The terms of the GMS and PMS contracts provide that the GP practice must seek the consent of the patient before answering and questions but, if consent is given, no charge can be made by the GP practice for answering questions which follow on from a report that must be provided free of charge.  This is set out in paragraph 80 of Schedule 6 to the GMS Regulations[7] which provides that GMS Contract must contain a term that:

 

(1)     The contractor must, if satisfied that the patient consents—

 

(a)     supply in writing to any person specified in sub-paragraph (3), within such reasonable period as that person may specify, such clinical information as any of the persons mentioned in sub-paragraph (3)(a) to (d) considers relevant about a patient to whom the contractor or a person acting on behalf of the contractor has issued or has refused to issue a medical certificate; and

 

 

(b)     answer any inquiries by any person mentioned in sub-paragraph (3) about—

 

(i)     a prescription form or medical certificate issued or created by, or on behalf of, the contractor, or

 

(ii)     any statement which the contractor or a person acting on behalf of the contractor has made in a report.

 

(2)     For the purposes of being satisfied that a patient consents, a contractor may rely on an assurance in writing from any person mentioned in sub-paragraph (3) that the consent of the patient has been obtained, unless the contractor has reason to believe that the patient does not consent.

 

(3)     For the purposes of sub-paragraph (1) and (2), the persons are—

 

(a)     a medical officer;

 

(b)     a nursing officer;

 

(c)     an occupational therapist;

 

(d)     a physiotherapist; or

 

(e)     an officer of the Department for Work and Pensions who is acting on behalf of, and at the direction of, any person specified in paragraphs (a) to (d).

 

(4)     In this paragraph—

 

(a)     “medical officer” means a medical practitioner who is—

 

(i)     employed or engaged by the Department for Work and Pensions, or

 

(ii)     provided by an organisation under a contract entered into with the Secretary of State for Work and Pensions;

 

(b)     “nursing officer” means a health care professional who is registered on the Nursing and Midwifery Register and—

 

(i)     employed or engaged by the Department for Work and Pensions, or

 

(ii)     provided by an organisation under a contract entered into with the Secretary of State for Work and Pensions;

 

(c)     “occupational therapist” means a health care professional who is registered in the part of the register maintained by the Health Professions Council under article 5 of the Health and Social Work Professions Order 2001 relating to occupational therapists and—

 

(i)     employed or engaged by the Department for Work and Pensions, or

 

(ii)     provided by an organisation under a contract entered into with the Secretary of State for Work and Pensions; and

 

(d)     “physiotherapist” means a health care professional who is registered in the part of the register maintained by the Health Professions Council under article 5 of the [Health and Social Work Professions Order 2001] relating to physiotherapists and—

 

(i)     employed or engaged by the Department for Work and Pensions, or

 

(ii)     provided by an organisation under a contract entered into with the Secretary of State for Work and Pensions”

 

3.8          Paragraph (d)(ii) of Schedule 5 to the GMS Regulations provides that where a GP practice is asked by a commercial, educational or not-for-profit organisation to attend and/or examine (but not otherwise treat) a patient for the purpose of creating any other form of medical report or certificate the GP practice is entitled to charge a reasonable fee.   This seems to cover virtually all types of reports that are requested concerning patients other than the certificates issued under the various statutes listed above.

 

4.             Charges where the GP practice has reasonable doubts as to whether a patient is on the practice list.

 

4.1          Both the PMS and the GMS Regulations contain the following provision to cover someone who presents seeking treatment but where the GP has genuine doubts about whether the GP practice has a duty to provide services to that person under Regulation 24(3).  In such a case the GP practice can impose a charge as follows:

 

“(3) Where a person applies to a contractor for the provision of essential services and claims to be on that contractor’s list of patients, but fails to produce his medical card on request and the contractor has reasonable doubts about that person’s claim, the contractor shall give any necessary treatment and shall be entitled to demand and accept a reasonable fee in accordance with paragraph 1(e) of Schedule 5, subject to the provision for repayment contained in paragraph (4).

 

(4) Where a person from whom a contractor received a fee under paragraph 1(e) of Schedule 5 applies to the Board for a refund within 14 days of payment of the fee (or such longer period not exceeding a month as the Board may allow if it is satisfied that the failure to apply within 14 days was reasonable) and the Board is satisfied that the person was on the contractor’s list of patients when the treatment was given, the Board may recover the amount of the fee from the contractor, by deduction from its remuneration or otherwise, and shall pay that amount to the person who paid the fee”

 

4.2          This Regulation imposes  a duty on the GP to provide “essential services” to the person notwithstanding the fact that the GP practice has “reasonable doubts” that the practice contract requires the GP practice to treat the person.  However, in such a case the GP practice can impose a reasonable charge and recover this sum from the patient.  The exemption is also referred to in paragraph (d) of Schedule 5 to the GMS Regulations (and in like form in the PMS Regulations).

 

4.3          The reasonable fee will, of course, depend on the circumstances and the precise nature of the treatment provided.  The Regulations provide that the individual can then claim the fee back from NHS England if that person can prove they were on the list of patients for the practice at the relevant time.   NHS England will then claim the fee back from the GP practice if the patient was a “patient” of the practice.

 

4.4          The above provision only applies if a GP practice has “reasonable doubts” whether a person is on the practice list or not.  If the GP practice knows (without any reasonable doubt) that the patient is not on the practice list, then there is no duty to provide essential services to that person.  Hence if, for example, a patient has been removed from the practice list because they have moved away, registered with anther GP practice or have been violent, attends the surgery seeking treatment, the GP practice owes no duty to provide essential services to that person (unless there is a medical emergency) and can require the patient to leave the premises.  The person will be a trespasser and thus, if they do not leave, the person may commit a civil wrong.  If there is a suggestion of a breach of the peace the police can be called.

 

5.             Charges permitted by Schedule 5 of the GMS Regulations and Schedule 3 of the PMS Regulations.

 

5.1          The specific circumstances in which GP practices can impose charges on “patients”[8] is set out in Schedule 5 of the GMS Regulations (with like provision in Schedule 3 to the PMS Regulations) which provides as follows:

 

“The contractor may demand or accept a fee or other remuneration—

 

(a)     from any statutory body for services rendered for the purposes of that body's statutory functions;

 

(b)     from any body, employer or school for a routine medical examination of persons for whose welfare the body, employer or school is responsible, or an examination of such persons for the purpose of advising the body, employer or school of any administrative action they might take;

 

(c)     for treatment which is not primary medical services or otherwise required to be provided under the contract and which is given—

 

(i)     pursuant to the provisions of section 65 of the Act (accommodation and services for private patients), or

 

(ii)     in a registered nursing home which is not providing services under that Act,

 

if, in either case, the person administering the treatment is serving on the staff of a hospital providing services under the Act as a specialist providing treatment of the kind the patient requires and if, within 7 days of giving the treatment, the contractor or the person providing the treatment supplies the Board, on a form provided by it for the purpose, with such information about the treatment as it may require;

 

(d)     under section 158 of the Road Traffic Act 1988 (payment for emergency treatment of traffic casualties);

 

(e)     when it treats a patient under regulation 24(3), in which case it shall be entitled to demand and accept a reasonable fee (recoverable in certain circumstances under regulation 24(4)) for any treatment given, if it gives the patient a receipt;

 

(f)     for attending and examining (but not otherwise treating) a patient—

 

(i)     at his request at a police station in connection with possible criminal proceedings against him,

 

(ii)     at the request of a commercial, educational or not-for-profit organisation for the purpose of creating a medical report or certificate,

 

(iii)     for the purpose of creating a medical report required in connection with an actual or potential claim for compensation by the patient;

 

(g)     for treatment consisting of an immunisation for which no remuneration is payable by the Board and which is requested in connection with travel abroad;

 

(h)     for prescribing or providing drugs, medicines or appliances (including a collection of such drugs, medicines or appliances in the form of a travel kit) which a patient requires to have in his possession solely in anticipation of the onset of an ailment or occurrence of an injury while he is outside the United Kingdom but for which he is not requiring treatment when the medicine is prescribed;

 

(i)     for a medical examination—

 

(i)     to enable a decision to be made whether or not it is inadvisable on medical grounds for a person to wear a seat belt, or

 

(ii)     for the purpose of creating a report—

 

(aa)     relating to a road traffic accident or criminal assault, or

 

(bb)     that offers an opinion as to whether a patient is fit to travel;

 

(j)     for testing the sight of a person to whom none of paragraphs (a), (b) or (c) of section 38(1) of the Act (arrangements for general ophthalmic services) applies (including by reason of regulations under section 38(6) of that Act);

 

(k)     where it is a contractor which is authorised or required in accordance with arrangements made with the Board under section 126 (arrangements for pharmaceutical services) and in accordance with regulations made under section 129 (regulations as to pharmaceutical services) of the 2006 Act to provide drugs, medicines or appliances to a patient and provides for that patient, otherwise than by way of dispensing services, any Scheduled drug;

 

(l)     for prescribing or providing drugs or medicines for malaria chemoprophylaxis”

 

5.2          There is a like provision in Regulation 15 of the PMS Regulations[9] with the exceptions set out in Schedule 3 to those Regulations.    The particular circumstances relating to each of these exemptions is set out below.  APMS contractors are likely to have the same restrictions on charging and the same exemptions introduced through a contractual term.

 

6.             Charges for meeting the requirements of other Statutory bodies.

 

6.1          GP practices are under contract to NHS England.  They are obliged to undertake the functions set out in the contract but are not obliged to spend time responding to requests from other statutory bodies including local authorities unless the request is based on another form of statutory authority including, for example, requests under the Freedom of Information Act 2000.  In practice this it can often be difficult for GP practices to set out clear limits on what they are prepared to do because statutory bodies assume that GP practices have a duty to co-operate with them in the discharge of their public functions.

 

6.2          The right to charge for doing work in response to requests by other public bodies includes where a GP is asked to attend a Child Protection Conferences at the request of the local authority for a child who is a practice patient or the GP has seen.  The relevant Guidance from the RCGP provides:

 

“The contribution of GPs to safeguarding children is invaluable and priority should be given to attendance and sending a report wherever possible. GPs may claim a fee for attendance at Child Protection Conferences, under the Collaborative Arrangements for Work for Local Authorities 1974, to defray their expenses. Different arrangements exist in different areas: consult your health authority or Local Medical Committee for details”

 

6.3          The BMA explains that prior to the 2005-06 report, the Doctors and Dentists Review Body (DDRB) used to recommend national fees under the collaborative arrangements for doctors providing work in the field of education, social services and public health to local authorities.  They include a number of services provided in the community health service (particularly sessional work in family planning, see Fees Guidance Schedule 4) which were transferred to the NHS in 1974.  However following concerns from the profession that the existing fee rates were no longer economic and that many doctors had lost confidence in the collaborative arrangements system with a significant number refusing to work within the current fee scales, the DDRB ceased to recommend fees for this work.    The BMA therefore advises individual doctors and GP practices to establish and agree their own fees in advance of undertaking the work.

 

6.4          If a GP practice is asked to undertake work for any other statutory agency, the GP practice is entitled to levy a reasonable fee.  However no fee can be claimed if a GP is required to do something under a different statutory scheme (which may or may not give rise to a right to payment depending on that statutory scheme).  Hence if a GP is summoned to court as a witness of fact by the Crown Prosecution Service no fee is payable because the legal duty to attend arises from the summons.   It is, of course, different if the GP is attending court as an expert where fees can be claimed.

 

7.             Fees for conducting routine medical examinations.

 

7.1          It is not part of the duties of a GP to undertake medical examinations of persons who are not and do not believe themselves to be ill.  Hence the second exemption to the rule against charges in Schedule 5 provides that if an employer, a school or any other body asks a GP to do a medical examination of a well patient “for the purpose of advising the body, employer or school of any administrative action they might take”, a fee can be charged.  The request for such a service is outside the terms of the duty to provide “essential services” under a GMS or PMS contract and yet it is not in the interests of the patient for the GP to refuse to provide such a report.  Hence the Regulations allow the GP practice to charge a fee for this work.

 

7.2          If a patient of the practice asks for a medical examination to provide reassurance to an employer that they can undertake a physical job or a student wants a report to confirm he or she is fit to go on an expedition, the GP practice is entitled to charge a reasonable fee for this service.

 

8.             Services provided by a specialist GP for private patients in hospitals or a care home.

 

8.1          The third circumstance in which a GP practice can charge a fee in Schedule 5 needs a little explanation.  The wording is as follows:

 

“The contractor may demand or accept a fee or other remuneration—

 

 

(c)     for treatment which is not primary medical services or otherwise required to be provided under the contract and which is given—

 

(i)     pursuant to the provisions of section 65 of the Act (accommodation and services for private patients), or

 

(ii)     in a registered nursing home which is not providing services under that Act,

 

if, in either case, the person administering the treatment is serving on the staff of a hospital providing services under the Act as a specialist providing treatment of the kind the patient requires and if, within 7 days of giving the treatment, the contractor or the person providing the treatment supplies the Board, on a form provided by it for the purpose, with such information about the treatment as it may require;

 

8.2          There is no difficulty in a GP practice charging a fee for providing services to a nursing home or receiving remuneration for working in an NHS hospital if the patients who are being treated are not “patients” of the GP practice within the above definition.  However there are only very limited circumstances in which a GP practice can charge for medical services provided in a hospital or care home to practice patients or others who come within the above definition.  In order for the GP practice lawfully to be able to impose a charge under the above exemption:

 

a)             The location requirement must be met.  The services must be provided in either a registered care home or to a private patient in an NHS hospital.  This exemption does not extend to providing services in a private hospital;

 

b)             The services requirement must be met.  The services provided to the patient must not be “primary care services” under this exemption.  The meaning of “primary care services” is explored in chapter 7.  The fact that a general management service for a resident patient in a care home or a private patient in an NHS hospital is provided in the home rather than requiring the patient to come to the surgery does not take the service outside being a primary care service.   Thus charges can only be made if the service provided by the GP Practice is something which cannot properly be described as being a primary care service.  It thus effectively means that the GP is contracted by the care home (or private wing in an NHS hospital) to provide a service that is different to the services that GPs usually provide in the surgery;

 

c)              The person requirement must be met.  The person from the GP practice who is providing the services must be employed by a hospital providing services under the NHS Act as a specialist providing treatment of the kind the patient requires; and

 

d)             The procedural requirement must be met.  Within 7 days of giving the treatment, the contractor or the person providing the treatment must supply the Board with such information about the treatment as the Board may require on a form provided by the Board for this purpose.

 

8.3          This is the provision which is used by some GP practices to charge for providing medical cover to nursing homes.  If the patients at a nursing home are not registered patients of a GP practice (because they are registered with another practice) and do not come within the definition of “patients” as set out above, then there is no prohibition on a GP practice providing medical cover for the care home and charging for that service.  However if the residents are registered patients of the GP practice, the right to charge is strictly limited by the above 4 provisions.  This exemption probably only applies in practice to a partner or salaried doctor in a GP practice who is employed by a local NHS Trust to deliver a specialist skill and, as part of that work, finds himself or herself treating a patient from his or her own practice.  It is thus a very limited exemption.

 

9.             Payment for emergency treatment of traffic casualties.

 

9.1          Section 158 of the Road Traffic Act 1988 provides for very modest payments to any doctor who treats a victim of a road traffic accident.  It provides:

 

“(1)     Subsection (2) below applies where—

 

(a)     medical or surgical treatment or examination is immediately required as a result of bodily injury (including fatal injury) to a person caused by, or arising out of, the use of a motor vehicle on a road or in some other public place, and

 

(b)     the treatment or examination so required (in this Part of this Act referred to as “emergency treatment”) is effected by a legally qualified medical practitioner.

 

(2)     The person who was using the vehicle at the time of the event out of which the bodily injury arose must, on a claim being made in accordance with the provisions of section 159 of this Act, pay to the practitioner (or, where emergency treatment is effected by more than one practitioner, to the practitioner by whom it is first effected)—

 

(a)     a fee of £21.30 in respect of each person in whose case the emergency treatment is effected by him, and

 

(b)     a sum, in respect of any distance in excess of two miles which he must cover in order—

 

(i)     to proceed from the place from which he is summoned to the place where the emergency treatment is carried out by him, and

 

(ii)     to return to the first mentioned place,

equal to 41 pence for every complete mile and additional part of a mile of that distance”

 

9.2          This exemption to the general rules against charging practice patients only applies if a GP attends on a road accident on a road or in some other public place (i.e. not in the doctor’s surgery) and the victim happens to be a “patient” within the meaning of the above definition.  In such a case a GP who administers any treatment to such a patient is allowed to claim a fee of £21.30 from the accident victim and 41p per mile for any travelling over 2 miles.  The fee must be claimed from the patient and it can then be reclaimed from whoever caused the accident in the first place (unless that was the person being so treated of course).

 

9.3          If the person who is treated by the GP is not a “patient” of the practice then the GP can still claim the fee under section 158.  However this arrangement is entirely outside the contract and so there are no relevant restrictions on the GP.

 

10.          Fees for attending a police station.

 

10.1       Many GPs are under contract to the police service to attend police stations in order to provide healthcare services to those who are arrested or otherwise detained by the police.  There will, of course, be occasions where the person who the GP is called upon by the police to treat is a patient of the practice where the GP is a partner or works as a salaried doctor.  Exemption (e)(i) provides that a GP can still claim his fee (usually from the police) in such circumstances.

 

10.2       This exemption would also entitle a GP to claim a fee if he was asked to attend a police station by anyone else to see a patient of the practice (or any other person coming within the above definition of being a “patient”) including for example a solicitor for the patient.

 

11.          Fees for preparing medico-legal reports.

 

11.1       Paragraph (d)(ii) of Schedule 5 to the GMS Regulations provides that where a GP practice is asked to attend and/or examine (but not otherwise treat) a patient for the purpose of creating a medical report required in connection with an actual or potential claim for compensation by the patient, the GP practice is entitled to charge a reasonable fee.  

 

11.2       The fee can be payable by the patient or by the solicitors firm who have made the request, depending on the circumstances.

 

12.          Requests by patients who are about to travel abroad.

 

12.1       Where a patient asked for treatment consisting of an immunisation for which no remuneration is payable by NHS England (because it is not usually provided as part of NHS funded treatment) and which is requested in connection with travel abroad, a fee can be charged.  

 

12.2       Travellers also frequently request a prescription of drugs to prevent them from contracting a condition.  The GP practice can also charge for prescribing or providing drugs, medicines or appliances (including a collection of such drugs, medicines or appliances in the form of a travel kit) which a patient requires to have in his possession solely in anticipation of the onset of an ailment or occurrence of an injury while he is outside the United Kingdom but for which he is not requiring treatment when the medicine is prescribed.

 

12.3       A fee can also be charged for prescribing or providing drugs or medicines for malaria chemoprophylaxis.

 

13.          Fees for preparing reports for seat belt purposes, following a traffic accident, a criminal assault or for fitness to travel.

 

13.1       A fee can be charged where a GP practice is asked to undertake a medical examination to enable a decision to be made whether or not it is inadvisable on medical grounds for a person to wear a seat belt.

 

13.2       A fee can also be charged where a GP practice is asked to undertake a medical examination for the purpose of creating a report relating to a road traffic accident or criminal assault or that offers an opinion as to whether a patient is fit to travel.

 

14.          Eye examinations by GPs.

 

14.1       Part 6 of the NHS Act 2006 places a requirement on NHS England to arrange ophthalmic services for specific classes of people, notably those who are under 16, over 60, who are on state benefits or have defined medical conditions.  These services are generally delivered by opticians and not by GPs.  However, unlike other areas of NHS services, the ophthalmic service is not universal and there are individuals who are not included in NHS provision.  If such persons come to a GP practice then a fee can be charged for undertaking an eye examination.

 

15.          Dispensing doctors and scheduled drugs.

 

15.1       The last exemption in Schedule 5 of the MS Regulations only applies to dispensing GP practices.  It permits dispensing practices to charge a fee to patients if a “scheduled drug” is prescribed to that patient.  A “scheduled drug” means a drug which has been prohibited by the Secretary of State from being prescribed to NHS patients generally or has been prohibited for prescription as part of NHS funded treatment apart from a limited class of patients[10].  This is known as the “black list” or the “black/grey list”.

 

15.2       The list of drugs which cannot be prescribed in general practice in any circumstances is set out at Schedule 1[11] to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) Regulations 2004.  It includes substances such as cod liver oil and Allisons Wholemeal Flour.  The Regulations have been amended from time to time to add new substances to the list.  Click here for an up to date list of the substances on the current list.

 

15.3       Regulation 3 of the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) Regulations 2004 provides:

 

“A drug, medicine or other substance specified in an entry in column 1 of Schedule 2 may not be ordered for a patient in the provision of medical services under a general medical services contract unless—

 

(a)     that patient is a person of a description mentioned in column 2 of that entry; and

 

(b)     that drug, medicine or other substance is prescribed for that patient only for the purpose specified in column 3 of that entry”

 

15.4       Thus substances on the list in Schedule 2 can only be proscribed for the specific conditions set out in the schedule.  Click here for the present text of schedule 2.  Hence, for example, this is the schedule which restricts the circumstances in which Tamiflu can be provided as part of NHS funded treatment.



[1] GMS stands for “General Medical Services”.  It is the default form of agreement for GP practices.  For details of the different types of contracts that a GP practice can hold please see chapter 3.

[2] PMS stands for “Personal Medical Services”, a form of GP Practice contract originally brought in by the National Health Service (Primary Care) Act 1997.  For details please see chapter 3.

[3] Please see chapter 7 for details of the range of services that a GMS or PMS practice is obliged to provide.

[4] Please see chapter 6 for details about how GP practice lists work and the persons to whom a GP is obliged to provide services.

[5] The electronic version of the National Health Service (General Medical Services) Regulations 2004 on the www.legislation.gov.uk website has not yet been updated to show all the changes made by the numerous amending regulations made since the Regulations were introduced in 2004.  The original Regulations are at http://www.legislation.gov.uk/ssi/2004/115/contents/made but the wording quoted in this chapter is the version which is current at 1 January 2014 when this chapter has been written. 

[6] There is a like provision in the PMS Regulations.

[7] There is a similar provision in the PMS Regulations.

[8] As that term is defined in the GMS and PMS Regulations as explained above.

[9] The electronic version of the National Health Service (Personal Medical Services Agreements) Regulations 2004 on the www.legislation.gov.uk website has not yet been updated to show all the changes made by the numerous amending regulations made since the Regulations were introduced in 2004.  The original Regulations are at http://www.legislation.gov.uk/ssi/2004/691/contents/madebut the wording quoted in this chapter is the version which is current at 1 January 2014 when this chapter has been written. 

[10] The GMS Regulations define a Scheduled Drug as (a) a drug, medicine or other substance specified in any directions given by the Secretary of State under section 28U of the Act(38) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract, or (b) except where the conditions in paragraph 42(2) of Schedule 6 are satisfied, a drug, medicine or other substance which is specified in any directions given by the Secretary of State under section 28U of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes.

[11] The original Regulations are at http://www.legislation.gov.uk/uksi/2004/629/contents/made.  However

The services an NHS GP Practice is obliged to provide to patients

 

 

This Chapter contains:

 

1.     Introduction.

2.     What are Essential Services within primary care?

3.     Who is owed a duty of “management” by a GP practice?

4.     Core hours.

5.     Home visits and other treatment outside the surgery.

6.     Out of Hours Services.

7.     The duty on GPs to provide emergency services.

8.     Additional Services.

9.     Enhanced Services.

10.  Other services that a GP practice is obliged to provide.

 

 

1.             Introduction.

 

1.1           This chapter seeks to identify which medical services GP Practices are obliged to provide as part of NHS funded treatment and where a GP is entitled to refer a patient to another NHS provider.  Section 83 of the National Health Service Act 2006[1] (“the NHS Act”) provides:

 

The Board[2] must, to the extent that it considers necessary to meet all reasonable requirements, exercise its powers so as to secure the provision of primary medical services throughout England”


1.2           “The Board” in the above section is a reference to the National Health Service Commissioning Board, known as NHS England.  The Board is referred to within this chapter as NHS England but citation from statutes refer to it as “the Board”.  Section 83(1) means that NHS England is under a statutory duty to secure the provision of primary medical services throughout England.   Sections 83(5) and (6) provide:

 

(5)      Regulations may provide that services of a prescribed description must, or must not, be regarded as primary medical services for the purposes of this Act.

 

(6)                        Regulations under this section may in particular describe services by reference to the manner or circumstances in which they are provided”

 

1.3           The relevant regulations under section 83 are the National Health Service (Primary Medical Services) (Miscellaneous Amendments and Transitional Provisions) Regulations 2013 (“the 2013 Regulations”).  However several sets of Regulations were made under the statutory predecessors of section 83[3] which remain in force to the extent that they have not been amended by the 2013 Regulations. 

 

1.4           The 2013 Regulations make extensive changes to the National Health Service (General Medical Services Contracts) Regulations 2004[4] (“the GMS Regulations) and the National Health Service (Personal Medical Services Agreements) Regulations 2004 (the “PMS Regulations”).  These Regulations define the contents of GMS and PMS contracts (and have been updated on numerous occasions since they were first published).  There are no Regulations for APMS contracts but the form of these contracts usually follows the GMS/PMS model, with amendments made to the model as required.

 

1.5           The current definitions of what are and are not “primary medical services” for the purposes of section 83 are contained within the GMS Regulations.   These Regulations define the services that those delivering primary care within the NHS are obliged to provide.  These definitions take effect as terms of practice contracts with NHS England held by GP practices.  The definitions of primary medical services include:

 

a)      essential services;

 

b)      additional services;

 

c)       enhanced services; and

 

d)      emergency services.

 

2               What are Essential Services within primary care?

 

2.1           The current definition of “essential services” for primary care is set out at Regulation 15 of the GMS Regulations as follows:

 

“(1)     Subject to paragraph (1A), for the purposes of section 28R(1)[5] of the Act (requirement to provide certain primary medical services), the services which must be provided under a general medical services contract (“essential services”) are the services described in paragraphs (3), (5), (6) and (8).

 

(1A)     The services described in paragraphs (3), (5), (6) and (8) are not required to be provided by the contractor during any period in respect of which the Care Quality Commission has suspended the contractor as a service provider under section 18 of the Health and Social Care Act 2008 (suspension of registration).

 

(2)     Subject to regulation 20, a contractor must provide the services described in paragraphs (3) and (5) throughout the core hours.

 

(3)     The services described in this paragraph are services required for the management of its registered patients and temporary residents who are, or believe themselves to be—

 

(a)     ill, with conditions from which recovery is generally expected;

 

(b)     terminally ill; or

 

(c)     suffering from chronic disease,

 

delivered in the manner determined by the practice in discussion with the patient.

 

(4)     For the purposes of paragraph (3)—

 

“disease” means a disease included in the list of three-character categories contained in the tenth revision of the International Statistical Classification of Diseases and Related Health Problems; and

 

“management” includes—

 

(a)     offering consultation and, where appropriate, physical examination for the purpose of identifying the need, if any, for treatment or further investigation; and

 

(b)     the making available of such treatment or further investigation as is necessary and appropriate, including the referral of the patient for other services under the Act and liaison with other health care professionals involved in the patient's treatment and care.

 

(5)     The services described in this paragraph are the provision of appropriate ongoing treatment and care to all registered patients and temporary residents taking account of their specific needs including—

 

(a)     the provision of advice in connection with the patient's health, including relevant health promotion advice; and

 

(b)     the referral of the patient for other services under the Act”

 

 

2.2           The PMS Regulations do not contain a definition of essential services for primary care.  However most PMS contracts provide that GP practices are required to provide essential services following the defined terms set out in the GMS Regulations.

 

2.3           The above provisions need to be interpreted in the light of the whole of the NHS Act as a whole which divides healthcare services into different categories.  Acute medical services come within Part 1 of the NHS Act and primary care services fall within Part 4 of the NHS Act.  Other parts of the Act provide for dental and pharmaceutical services to be delivered as part of NHS funded care.

 

2.4           Although there is an inevitable measure of overlap between acute services and primary care services, where services are classified as “acute services” under Part 1, they are generally not primary care services under Part 4.  Acute services are widely defined in section 3(1) of the NHS Act as follows:

 

“(a)     hospital accommodation,

 

(b)     other accommodation for the purpose of any service provided under this Act,

 

(c)     medical, dental, ophthalmic, nursing and ambulance services,

 

(d)     such other services or facilities for the care of pregnant women, women who are breastfeeding and young children [as the group considers] are appropriate as part of the health service,

 

(e)     such other services or facilities for the prevention of illness, the care of persons suffering from illness and the after-care of persons who have suffered from illness [as the group considers] are appropriate as part of the health service,

 

(f)     such other services or facilities as are required for the diagnosis and treatment of illness”

 

2.5           Where a CCG commissions relevant services under section 3(1) of the NHS Act, a GP can discharge his or her obligations as a provider of primary care by referring an NHS patient onto another NHS provider where his or her patient requires one of those acute services.  The “essential services” that are required to be provided by GPs are therefore a much narrower group of services. 

 

2.6           The core requirement on a GP who provides essential services to NHS patients is “the management of” such patients.  “Management” of a patient includes:

 

a)      offering consultation and, where appropriate, physical examination for the purpose of identifying the need, if any, for treatment or further investigation; and

 

b)      the making available of such treatment or further investigation as is necessary and appropriate, including the referral of the patient for other services under the Act and liaison with other health care professionals involved in the patient’s treatment and care.

 

2.7           This is expanded by Regulation 15(5) which provides that management of the GP’s patients includes the provision of appropriate ongoing treatment and care to all registered patients and temporary residents taking account of their specific needs including:

 

a)      the provision of advice in connection with the patient's health, including relevant health promotion advice; and

 

b)      the referral of the patient for other services under the NHS Act (which normally means referral for acute and community services under section 3 of the NHS Act).

 

2.8           These definitions need little further explanation because they define the essential core obligations of a GP working in the NHS.  These are however the contractual obligations that a GP practice owes to NHS England under a GMS Contract or a PMS Contract which imports these definitions.  There is a separate legal duty in tort (i.e. negligence) to the patient which exists alongside the contractual duty.  The doctor’s duty in tort will obviously be very substantially informed by the contractual duties owed by the practice under the relevant practice contract.  How those precise non-contractual duties work themselves out is examined in the chapter on negligence[6].

 

3               Who is owed a duty of “management” by a GP practice?

 

3.1           The persons to who the GP is obliged to offer this “management” service are:

 

a)      The patients on the list for the GP practice held by NHS England;

 

b)      Temporary patients. 

 

These are precisely defined terms under the GMS Regulations.  For more details about how practice lists operate please see chapter 6.

 

3.2           The GP practice is not obliged to offer “management services” to every patient on their list for every minute of the core hours (because that would be an impossible task to fulfil and would mean offering services where they were not needed).  The contractual duty is to provide services to patients who are, or believe themselves to be:

 

a)      ill, with conditions from which recovery is generally expected;

 

b)      terminally ill; or

 

c)       suffering from chronic disease.

 

3.3           The expression “illness” is widely defined in section 275 of the NHS Act as follows:

 

“illness” includes any disorder or disability of the mind and any injury or disability requiring medical or dental treatment or nursing”

 

3.4           Thus a GP practice is obliged to see and offer a management services to a patient who believes himself or herself to be ill even if that person is not, in fact, suffering from any diagnosable illness.   The wide definition means that, for example, a drug addiction is likely to be an “illness” because drug addiction changes the brain in fundamental ways, disturbing a person's normal hierarchy of needs and desires and substituting new priorities connected with procuring and using the drug. The resulting compulsive behaviours that override the ability to control impulses despite the consequences are similar to hallmarks of other mental illnesses.  The behaviour can be classified as an illness in ICM 10 within the International Statistical Classification of Diseases and Related Health Problems and thus GP practices have the same management duty to such patients as they have to patients with any other illness.

 

3.5           A GP is obliged to provide a management service to a patient “in the manner determined by the practice in discussion with the patient”.  Thus the patient is entitled to be consulted about the way in which general medical services are provided to the patient but the final decision about the manner in which services should be provided (including the location at which the services should be provided) rests with the GP.

 

4               Core hours.

 

4.1           The GMS Contract (and virtually all PMS Contracts) provides that the contractual duty on the GP practice to provide the essential services is only operative during “core hours”.   These hours are defined in Regulation 2 of the GMS Regulations as follows:

 

core hours” means the period beginning at 8am and ending at 6.30pm on any day from Monday to Friday except Good Friday, Christmas Day or bank holidays”

 

4.2           However the GMS Contract does not require the GP practice to make a GP available in person to provide routine services to patients throughout the core hours.  Under Regulation 20 the duty to provide services within core hours has 2 parts, namely:

 

a)      to provide the essential services within core hours, “as are appropriate to meet the reasonable needs” of its patients; and

 

b)      to have in place arrangements for its patients to access such services throughout the core hours in case of emergency.

 

4.3           Thus if GP practice premises are closed at any point during the core hours, the GP practice either must provide a means for patients to be able to access one of the practice GPs throughout that period or must make arrangements with an out of hours provider to provide emergency GP services to patients during that period.  There are no set surgery hours within the GMS GP contract but the opening hours need to be sufficient to “meet the reasonable needs of its patients”. 

 

4.4           There is considerable discussion in the professional press about practices which do not provide sufficient surgery slots to meet the needs of patients and thus patients find themselves having to wait for an appointment time.  The Labour government had a policy that patients should have a maximum period of waiting of 48 hours before seeing a GP.  However that target was abandoned by the coalition government in 2010.  The present position is that there is no specific time target but the NHS website states:

 

“Your surgery should be able to offer you an appointment to see a GP or other healthcare professional quickly if necessary. However, if it is more convenient, you should also be able to book appointments in advance”

 

4.5           GP practices which fail to provide a sufficient number of surgery appointments to meet the reasonable needs of their patient populations are probably acting in breach of the contractual requirement to provide services to meet the reasonable needs of its patients” and could find that NHS England serves a Remedial Notice to require them to extend the number of surgery appointments. 

 

5               Home visits and other medical treatment outside the surgery.

 

5.1           Patients who seek assistance from their GP are ill (or at least consider themselves to be ill).  Some of these patients will be too ill to be able to attend the surgery premises or, if they have an infectious condition, it may not be medically appropriate for them to attend the GP surgery because they may spread their condition to other patients.  Thus treating patients at their own home has always been part of the work of a GP.

 

5.2           The GMS and PMS contracts have the following provisions which define when a GP is obliged to treat a patient outside the surgery premises:

 

“(1)     In the case of a patient whose medical condition is such that in the reasonable opinion of the contractor—

 

(a)     attendance on the patient is required; and

 

(b)     it would be inappropriate for him to attend at the practice premises,

 

the contractor shall provide services to that patient at whichever in its judgement is the most appropriate of the places set out in sub-paragraph (2).

 

(2)     The places referred to in sub-paragraph (1) are—

 

(a)     the place recorded in the patient's medical records as being his last home address;

 

(b)     such other place as the contractor has informed the patient and the Board is the place where it has agreed to visit and treat the patient; or

 

(c)     some other place in the contractor's practice area.

 

(3)     Nothing in this paragraph prevents the contractor from—

 

(a)     arranging for the referral of a patient without first seeing the patient, in a case where the medical condition of that patient makes that course of action appropriate; or

 

(b)     visiting the patient in circumstances where this paragraph does not place it under an obligation to do so”

 

5.3           Thus a patient is entitled to medical treatment from the GP practice if, in the reasonable opinion of the GP practice, two conditions are satisfied, namely:

 

a)      attendance on the patient is required; and

 

b)      it would be inappropriate for him to attend at the practice premises.

 

5.4           At the stage that the GP is making this assessment it is likely that the GP will not have seen the patient and therefore can only make this decision based upon the information that the patient has given to the GP practice (or has been provided on the patient’s behalf) and on the medical history of the patient as set out in the notes.  It seems clear however that the decision whether to make a home visit is a matter for the GP’s judgment and is not something that could properly be left to reception staff or even the practice nurse because the contract requires the contractor to make the assessment.  The first test is whether the patient requires “attendance” which must mean whether the patient has a need for the provision of the type of patient management services defined in the essential services.  The second test is whether it is inappropriate for the patient to attend at the practice premises.  There is no limit to the reasons why a GP might consider that it could be inappropriate for the patient to attend at the practice premises.  It may be that the patient is too ill to attend, has an infectious illness which makes it inappropriate to attend or has a medical such as agoraphobia which makes it difficult for the patient to attend the surgery.  This provision could also be used to manage a violent patient who the GP practice does not wish to remove from its list but nonetheless wishes to treat in a location where there is a measure of protection for the GP (such as a room at a local police station if he police were to agree to that arrangement).

 

5.5            Once the GP practice has reached the opinion that the patient needs treatment (from a GP) outside the surgery, the place at which the GP must offer treatment is set out in the Regulations.  It must be offered at the “most appropriate” of the following places:

 

a)      at the patient’s home;

 

b)      at another place agreed between the GP practice and the patient; or

 

c)       at some other place within the practice area.

 

5.6           The final provision appears to be a catch all provision but that place must still pass the test of being the most appropriate place to provide services to the patient. 

 

5.7           A GP practice which asserted that it did not offer home visits under any circumstances or applied a requirement for a patient who sought a home visit which was different to those set out above would be acting in breach of contract and could, in an extreme case, have the contract cancelled by NHS England.

 

6               Out of Hours Services.

 

6.1           Until 2004 GP practices were required to provide essential service to patients at all times of the day and night.  Many practices used deputising services to provide services to patients outside of core hours.  Thus, in practice, prior to 2004 many patients would not see their family doctor if they sought GP services out of hours (OOH”).  However as part of the changes in 2004 GP practices were entitled to opt-out of responsibility for providing OOH services.  The vast majority of GP practices did so and accordingly the responsibility for OOH GP provision fell to primary care trusts to arrange.

 

6.2           The present duty to commission OOH primary care services lies with the CCG and not NHS England.  It follows that CCGs need to be careful to observe the rules on conflicts of interest in any contract process where one of the bidders includes GPs who work within a local GP practice (and are therefore members of the CCG).

 

6.3           Primary care trusts entered into contracts with a wide range of OOH providers.  Some were GP co-operatives such as Devon Doctors, who arranged for out of hours cover to be provided by their on GP members or by GPs who were contracted to the service provider.  There have been a series of scandals and problems with OOH providers, such as the case involving a German doctor, Dr Daniel Ubani, who came to the UK for the weekend to do a double OOH shift and gave a patient 10 times the normal dose of morphine, resulting in the death of the patient.  There have also been serious problems with OOH providers failing properly to record management data and thus seeking to hide their shortcomings.

 

6.4           A GP practice that does provide OOH services must meet the quality requirements set out in the document entitled “National Quality Requirements in the Delivery of Out of Hours Services” published on 20th July 2006:  see paragraph 11 of Schedule 6 to the GMS Regulations.

 

6.5           The government has indicated its intention to move responsibility for out of hours cover back to GP practices.  If this happens it seems highly unlikely that GP practices will agree to cover all OOH periods themselves, and is far more likely that contracts with local OOH providers will remain in place.  However, even if a GP practice has a contract in place, GP practices will remain contractually liable to NHS England to provide these services.

 

7               The duty on GP practices to provide emergency services.

 

7.1           GPs are not para-medics and will not usually be called to a medical emergency within their practice area.  However the GMS Regulations provide that GP practices must provide a limited range of emergency services.  Regulations 15(6) and (7) provide:

 

“(6)     A contractor must provide primary medical services required in core hours for the immediately necessary treatment of any person to whom the contractor has been requested to provide treatment owing to an accident or emergency at any place in its practice area.

 

(7)     In paragraph (6), “emergency” includes any medical emergency whether or not related to services provided under the contract”

 

7.2           This is an obligation to react to requests for assistance made at any time throughout the core hours.  The contractual duty to provide services only comes into effect if the GP practice has been “requested” to provide emergency primary care services in the event of an accident or emergency taking place anywhere in the practice area.  The identity of the person making the request is not specified in the Regulations and the request therefore could be made by the police, fire brigade, paramedics or a member of the public (whether a patient on the practice list or not).  The Regulation does not specify what sort of service the GP is required to provide beyond saying that the GP must provide primary medical services.  Thus the GP has to provide the same type of “management” services for the patient in an emergency situation as he or she would provide in the surgery.  This includes:

 

a)      physical examination for the purpose of identifying the need, if any, for treatment or further investigation; and

 

b)      the making available of such treatment or further investigation as is necessary and appropriate, including the referral of the patient for other services under the Act and liaison with other health care professionals involved in the patient’s treatment and care.

 

7.3           It seems clear that, in order to comply with the contractual obligation, the practice would have to send out a qualified GP who could administer such services as could be reasonably expected from a GP as opposed to a specialist in emergency medicine.  The contractual obligation is likely to be fulfilled if the GP arrives at the scene of the accident or emergency reasonably promptly and provides a primary medical service whilst, at the same time, calling for help from specialist emergency practitioners.

 

7.4           The second type of emergency service that a GP practice is required to provide “immediately necessary treatment” to someone who is not on the list of patients for the practice and is not a temporary patient but who comes within certain specified categories.  Regulation 15(8) to (10) provides the contractual duty is as follows:

 

“(8)     A contractor must provide primary medical services required in core hours for the immediately necessary treatment of any person falling within paragraph (9) who requests such treatment, for the period specified in paragraph (10).

 

(9)     A person falls within paragraph (8) if he is a person—

 

(a)     whose application for inclusion in the contractor's list of patients has been refused in accordance with paragraph 17 of Schedule 6 and who is not registered with another provider of essential services (or their equivalent) . . .;

 

(b)     whose application for acceptance as a temporary resident has been rejected under paragraph 17 of Schedule 6; or

 

(c)     who is present in the contractor's practice area for less than 24 hours.

 

(10)     The period referred to in paragraph (8) is—

 

(a)     in the case of paragraph (9)(a), 14 days beginning with the date on which that person's application was refused or until that person has been subsequently registered elsewhere for the provision of essential services (or their equivalent), whichever occurs first;

 

(b)     in the case of paragraph (9)(b), 14 days beginning with the date on which that person's application was rejected or until that person has been subsequently accepted elsewhere as a temporary resident, whichever occurs first; and

 

(c)     in the case of paragraph (9)(c), 24 hours or such shorter period as the person is present in the contractor's practice area”

 

7.5           The contractual duty on a GP practice to provide emergency services is thus limited in 3 ways:

 

a)      It is not a duty to provide a full primary care service to these patients but only to provide immediately necessary treatment to such patients.  There is clearly a measure of judgment that the GP practice will have to make as to what services are within this requirement and which services can be left for another GP to provide in due course;

 

b)      The duty is limited to those categories of patients set out in Regulation 15(9) namely individuals who have applied to join the practice list and been refused, who have been rejected as temporary residents or are in the practice area for less than 24 hours;

 

c)       The duty is time limited in that for patients who have been rejected from the practice list either as permanent or temporary patients, the duty only lasts for a maximum of 14 days but can come to an end if the patient secures another GP in that period and, in the case of a person only in the practice area for 24 hours, is limited to a maximum of 24 hours.

 

7.6           A person who has been accepted onto the practice list and is then removed from the list because, for example, the patient has been violent to staff members, does not come within Regulation 15(8) of the GMS Regulations unless that person applies to re-join the practice list and is refused.  Equally, a person who has applied to join the practice list but has not yet been accepted or refused does not come with this provision.  The GP practice is therefore under no contractual duty to provide services to such a patient. 

 

7.7           The Regulations do not explain what happens if, at the end of the 14 day period, the rejected patient presents at the surgery seeking a further course of “immediately necessary treatment”.  It seems likely that the duty under Regulation 15(8) of the GMS Regulations is a “one off” duty to an individual and that, once the period specified in Regulation 15(10) has ended the GP practice has no further duty to provide medical services to that individual.  If it were otherwise a patient who had been refused entry onto the practice list as a result of violence to staff could, for example, keep seeking services under this provision and thus remain a threat to staff.

 

8               Additional Services

 

8.1           Essential services are the range of services that GP practices are obliged to provide as a minimum to their practice patients and temporary residents.  However GP practices can contract to provide extra services to patients and thus avoid the need for the GP practice to refer patients who need such services elsewhere.  Services which are extra to the essential services (as described above) are classified as “additional services” and “enhanced services”.  GP practices are not obliged to contract to provide additional services but they are paid additional sums (usually as part of the global sum) where they agree to do so.

 

8.2           “Additional services” are defined in the standard GMS Contract as follows:

 

“additional services” means one or more of-

 

(a)  cervical screening services;

 

(b)  contraceptive services;

 

(c)  vaccines and immunisations;

 

(d)  childhood vaccines and immunisations;

 

(e)  child health surveillance services;

 

(f)    maternity medical services; and

 

(g)  minor surgery”

 

8.3           The standard GMS Contract provides details of the way in which each of services are required to be provided.  Hence, for example, GP practices that agree to provide contraceptive services are required to provide services in the following way:

 

“The Contractor shall make available the following services to all of its patients who request such services:

 

(a)  the giving of advice about the full range of contraceptive methods;

 

(b)  where appropriate, the medical examination of patients seeking such advice;

 

(c)  the treatment of such patients for contraceptive purposes and the prescribing of contraceptive substances and appliances (excluding the fitting and implanting of intrauterine devices and implants);

 

(d)  the giving of advice about emergency contraception and where appropriate, the supplying or prescribing of emergency hormonal contraception or, where the Contractor has a conscientious objection to emergency contraception, prompt referral to another provider of primary medical services who does not have such conscientious objections;

 

(e)  the provision of advice and referral in cases of unplanned or unwanted pregnancy, including advice about the availability of free pregnancy testing in the practice area and, where appropriate, where the Contractor has a conscientious objection to the termination of pregnancy, prompt referral to another provider of primary medical services who does not have such conscientious objections;

 

(f)    the giving of initial advice about sexual health promotion and sexually transmitted infections; and

 

(g)  the referral as necessary for specialist sexual health services, including tests for sexually transmitted infections”

 

8.4           There are extended definitions in the Standard Contract for the services to be provided by GP practices that contract to provide other additional services.

 

8.5           The contract can specific that the GP practice should provide additional services to the practice patients and persons accepted by the GP practice as temporary residents.  However the GMS contract can also be extended so that such services are provided to a wider range of patients.  Hence, for example, a GP practice could develop a specialism in minor surgery or be contracted to provide contraceptive services to a wider range of patients than just those on its practice list.

 

9               Enhanced Services.

 

9.1           Enhanced services are defined in the standard GMS Contract as follows:

 

“enhanced services” are-

 

services other than essential services, additional services or out of hours services; or

essential services, additional services or out of hours services or an element of such a service that a contractor agrees under a contract to provide in accordance with

specifications set out in a plan, which requires of the contractor an enhanced level of service provision compared to that which it needs generally to provide in relation to that service or element of service;

 

9.2           There is no limit on the type of enhanced services that a commissioner and a GP practice can agree to be provided to NHS patients, provided that the service can properly be considered to be part of the health service.  The terms fall to be agreed between the commissioner and the provider.

 

10            Other services that a GP practice is obliged to provide.

 

10.1        Part 1 of Schedule 6 to the GMS Regulations provide a list of other services that GMS contracts must specify all GMS practices must provide to their patients.  There is a similar list in the PMS Regulations.   The following paragraphs summarise these requirements.

 

10.2        Premises:  The contract provides that the contractor shall ensure that the premises used for the provision of services under the contract are:

 

a)      suitable for the delivery of those services; and

 

b)      sufficient to meet the reasonable needs of the contractor's patients.

 

10.3        Telephone lines:  NHS GP practices are prohibited from using premium rate telephone numbers which start with the digits 087, 090 or 091 or consists of a personal number, unless the service is provided free to the caller.  There are also provisions to prevent NHS GP practices using other types of premium rate telephone services.

 

10.4        New Patients:  GP practices must take steps to ensure that any patient who has not previously made an appointment and attends at the practice premises during the normal hours for essential services is provided with such services by an appropriate health care professional during that surgery period.  There is an exemption to this obligation for new patients who have to be referred elsewhere, in which case another appointment should be booked.

 

10.5        A slightly overlapping provision is that patients who are new to the practice list (but not temporary residents) must also be offered a “consultation” with the GP practice within 6 months at which the GP must make such inquiries and undertake such examinations as appear to it to be appropriate in all the circumstances.  The wording of this requirement (in paragraph 4 of Schedule 6 to the GMS Regulations) is as follows:

 

“(1)     Where a patient has been—

 

(a)     accepted on a contractor's list of patients under paragraph 15; or

 

(b)     assigned to that list by the Board,

 

the contractor shall, in addition and without prejudice to its other obligations in respect of that patient under the contract, invite the patient to participate in a consultation either at its practice premises or, if the medical condition of the patient so warrants, at one of the places referred to in paragraph 3(2).

 

(2)     An invitation under sub-paragraph (1) shall be issued within six months of the date of the acceptance of the patient on, or their assignment to, the contractor's list.

 

(3)     Where a patient (or, where appropriate, in the case of a patient who is a child, his parent) agrees to participate in a consultation mentioned in sub-paragraph (1) the contractor shall, in the course of that consultation make such inquiries and undertake such examinations as appear to it to be appropriate in all the circumstances”

 

10.6        Patients who are not seen for 3 yearsWhere a registered patient between the ages of 16 and 75 who has not attended the surgery for 3 years requests a consultation the GP practice must take advantage of the opportunity to this individual attending the surgery to “make such inquiries and undertake such examinations as appear to it to be appropriate in all the circumstances”.  However there is no duty on the GP practice to seek out patients who have not attended for 3 years to offer them a check-up.  The duty only arises if the patient requests a consultation.

 

10.7        Patients over the age of 75:  The time period of non-attendance which needs to elapse before the GP practice has a duty to “make such inquiries and undertake such examinations as appear to it to be appropriate in all the circumstances” is reduced to 12 months.   However once again, there is no duty on the GP practice to seek out patients over the age of 75 who have not attended the practice for 12 months to offer them a check-up.  The duty only arises if such a patient requests a consultation with the GP practice.

 

10.8        Clinical Reports on patients on the list of another practice:  Where the GP practice provides any clinical services, other than under a private arrangement, to a patient who is not on its list of patients, it shall, as soon as reasonably practicable, provide a clinical report relating to the consultation, and any treatment provided, to NHS England.  Thus every time medical care is provided to a temporary resident or emergency care is provided to a patient who is not registered with the practice, a report should be sent to NHS England explaining what care has been provided and the clinical findings.  NHS England then has the task of sending the report to the patient’s own practice so that it can form part of the clinical notes for that practice.

 

10.9        Storage of vaccines:  GP practices must ensure that all vaccines are stored in accordance with the manufacturer's instructions and that all refrigerators in which vaccines are stored have a maximum/minimum thermometer and that readings are taken on all working days.

 

10.10     Infection control:  Each GP practice must ensure that it has appropriate arrangements for infection control and decontamination.  The content of Infection Control policies are a matter for each GP Surgery.  However NICE has published Guidance about infection control in primary care.  Whilst there is a measure of discretion, GP practices would have to have good reasons for adopting policies which departed from the infection control guidance published by NICE.

 

10.11     The MPS has identified the following as the highest areas of breaches of infection control in GP practices:

 

a)      The cleaning of premises was inadequate because no schedule of cleaning was available;

 

b)      Reception staff were handling specimens at the reception desk;

 

c)       Hand washing was not addressed within the practice;

 

d)       Risks associated with clinical waste and the management of sharps. For example not using pedal operated clinical waste bins, clinical waste bins not being provided in the consulting room and inappropriate storage of clinical waste awaiting collection;

 

e)      GP practices were not providing spillage kits, either purchased or made up in-house, for dealing with spillages such as body fluids, blood and mercury (if applicable);

 

f)        Failing to provide staff training on infection control;

 

g)       Waiting room toys that were not cleaned routinely.  The Guidance observed that soft toys are hard to disinfect and tend to rapidly become re-contaminated after cleaning and that conversely, hard toys can be cleaned and disinfected easily.

 

10.12     Duty of Co-operation:  Paragraph 12 of Schedule 6 to the GMS Regulations provides that GP practices which do not provide additional services, enhanced services or OOH services must co-operate with those providers who do deliver those services for NHS patients.  The GP practice must:

 

a)      co-operate, insofar as is reasonable, with any person responsible for the provision of that service or those services;

 

b)      comply in core hours with any reasonable request for information from such a person or from NHS England relating to the provision of that service or those services; and

 

c)       in the case of out of hours services, take reasonable steps to ensure that any patient who contacts the practice premises during the out of hours period is provided with information about how to obtain services during that period.

 

10.13     However these obligations do not extend to requiring the GP practice to make care for its patients available during the out of hours period.

 

10.14     Handover requirements:  Where a contractor is to cease to be required to provide to its patients a particular additional service, a particular enhanced service or out of hours services, either at all or in respect of some periods or some services, the GO practice is obliged to comply with any reasonable request for information relating to the provision of that service or those services made by NHS England or by any person with whom NHS England intends to enter into a contract for the provision of such services.



[1] The electronic version of the National Health Service Act 2006 on the www.legislation.gov.uk website has not yet been updated to show all the changes to the 2006 Act made by the Health and Social Care Act 2012.  Hence the present publicly accessible version of section 83 at http://www.legislation.gov.uk/ukpga/2006/41/section/83 still refers to the duty to provide primary care services being a duty resting on primary care trusts.

[2] Under the NHS Act 2006 as originally passed this duty rested on primary care trusts.  It was transferred to NHS England in April 2013 as a result of amendments made in the Health and Social Care Act 2012.

[3] Transitional provisions mean that Regulations made under the equivalent of section 83 in the National Health Service Act 2006 continue to have effect./

[4] The electronic version of the National Health Service (General Medical Services) Regulations 2004 on the www.legislation.gov.uk website has not yet been updated to show all the changes made by the numerous amending regulations made since the Regulations were introduced in 2004.  The original Regulations are at http://www.legislation.gov.uk/ssi/2004/115/contents/made but the wording quoted in this chapter is the version which is current at 1 January 2014 when this chapter has been written. 

[5] “Section 28R” is a reference to section 28R of the National Health Service Act 1977 which was brought in by section 175 of the National Health Service (Community Health and Standards) Act 2003.  This provision is now in section 85 of the National Health Service Act 2006 is a consolidating Act and thus references in these Regulations to sections of the 1977 act are required to be read as references to the relevant provision of the National Health Service Act 2006, which in this case is section 83.  See section 17 of the Interpretation Act 1978 and Schedule 2 to the National Health Service (Consequential Provisions) Act 2006.

[6] This chapter is being written by Jonathon Jones QC and will be put on the website when completed.

Management of the Practice list of patients

 

This chapter contains:

 

1.              Introduction.

2.              The sources of the rules relating to GP Practice Lists.

3.              To whom is a GP practice obliged to provide primary care services?

4.              The registered patients of the practice.

5.              Temporary residents.

6.              The practice area for a GP practice.

7.              Applications by patients to join the list of a GP practice.

8.              Appeals by patients against decisions to refuse them entry to a practice list.

9.              Introduction to removal of patients from as GMS practice list.

10.           Removal of violent patients from GP Practice lists.

11.           Discretionary removal of patients from a GP practice list.

12.           Closure and reopening of GP practice lists.

 

1.             Introduction.

 

1.1           GP services are the building block of NHS services because, other than attendance at an Accident and Emergency Department of an NHS hospital, the GP is the gateway by which the vast majority of NHS services are accessed by patients[1].  However the provision of all medical services to patients only usually occur where the patient seeks those services from a GP practice where the patient is registered (although  GP practice must provide services to other persons as set out below).  There is no obligation on anyone living in England to register with an NHS GP practice.  This is a matter of free choice for each individual.   But the patient can only generally access services by first getting themselves registered with a local GP practice.

 

1.2           The legal duty for the NHS to commission GP services rests on the National Health Service Commissioning Board, known as “NHS England”.  Section 84 of the National Health Service Act 2006 (“the NHS Act”) provides that NHS England is required to set up “arrangements” so as to provide primary medical services throughout England “to the extent that it considers necessary to meet all reasonable requirements”. 

 

1.3           The wording of the statutory duty means that there is no absolute legal requirement on NHS England to ensure that every individual is able to register with a GP practice which is local to their home.  The duty is to set a network of GP services to meet the reasonable requirements of patients, and what is reasonable will depend in part on the resources available to NHS England. 

 

1.4           There are occasions when a person cannot find a GP who is prepared to admit that person to their list (either as a registered patient or as a temporary patient).  There can be many reasons why an individual patient may find it difficult to find a place on a GP list of a local practice.  There are very occasional circumstances where all local GP practices are full and have closed their lists.  In such circumstances NHS England will probably have a duty to secure additional GP services in the area to meet its duty under section 84.  However the more common reason why a person finds difficulty in registering with a GP practice is because that person has previously been removed from lists of other GP practices in the area for being violent, offensive or for another permissible reason.  Most NHS areas have a reserve facility to provide GP services to patients who have been excluded from the lists of other practices.  The details of removal and its consequences are explored below.

 

1.5           The fact that a patient is having difficulty finding a GP will not usually, of itself, be sufficient to demonstrate a breach by NHS England of their duty under section 84.  A breach of the section 84 duty would only be established if NHS England had failed to make a proper assessment of the level of local need for GP services in an area or had not produced a plan to deliver services to meet the identified needs.  NHS England cannot form a judgment as to whether it is delivering on its duty to provide services to meet the reasonable requirements of the local population for GP services unless it has knowledge of the needs of the population for those services.   That knowledge could be based on a needs assessment or could be judged by the number of practices who are open to new patients in an area (and the number of registered patients per GP).

 

1.6           NHS England’s role is to commission a GP practice to deliver services to NHS patients.  Once the commissioning contract is in place the onus shifts to the relationship between the GP and the individual patient because a doctor/patient relationship will only work if there is a measure of trust on both sides.  The patient has to have confidence in the medical practice and, if the patient does not have that confidence, the statutory scheme allows the patient to leave the practice and register with another medical practice.  However a measure of trust is also required the other way – namely from the doctor to the patient.  This can be a very delicate area in practice because there are conflicting interests.  On the one hand the NHS ought not to foist a patient on a GP with whom the practice cannot build any form of therapeutic relationship.  On the other hand GPs are delivering public services and so should have a duty to work with any member of the public who wishes to access their services.  Teachers and social workers cannot, for example, pick and choose the members of the public to whom they are obliged to provide public services as part of their occupation (paid for by taxpayers money).   GPs should certainly not be able to react to complaints by removing a patient from their practice list. 

 

1.7           This chapter explores the legal rules which apply to doctors admitting patients to their lists, removing patients from their lists and the powers of NHS England to force an NHS GP practice to take a patient onto the practice list.

 

2               The sources of the rules relating to GP Practice Lists.

 

2.1           All NHS GP practices hold a contract with NHS England.  These contracts define the contractual obligations of the GP practice.    Most NHS GP practices hold General Medical Services (“GMS”) or Personal Medical Services Contracts (“PMS”).  A smaller number of practices hold Alternative Personal Medical Services Contracts (“APMS”) contracts.  The difference between the forms of contract is explained at Chapter 3.   The contracts seek to hold the ring between the interests of individual patients and the interests of the practice, with NHS England having an adjudication role if there is a dispute to attempt to ensure that patients are not left without a GP. 

 

2.2           The scheme for the management of NHS patients is broadly the same under all forms of NHS Contract.  There is a standard form developed by NHS England for a GMS contract.  This contract is based on the National Health Service (General Medical Services Contracts) Regulations 2004 (as amended) (“the GMS Regulations”).  However many GMS practices will be working under a previous version of the contract with a completely different numbering system for the clauses.  There is no standard form PMS contract but every PMS contract is required by the National Health Service (Personal Medical Services Agreements) Regulations 2004 (as amended) (“the PMS Regulations”) to contain terms which govern the admission and removal of patients to a practice list.  The terms of APMS contracts are not governed by Regulations but they usually have terms concerning the admission and removal of patients to a practice list which follow the GMS/PMS scheme.

 

2.3           In order to make this Guide readable it will refer to the GMS provisions by reference to the GMS Regulations.  The equivalent reference in the PMS Regulations will be set out in a footnote.

 

3               To whom is a GP practice obliged to provide primary care services?

 

3.1           The word “patient” is defined in Regulation 2 of the GMS Regulations as follows:

 

(a)            a registered patient,

 

(b)            a temporary resident,

 

(c)            persons to whom the contractor is required to provide immediately necessary treatment as part of its obligation to provide essential services, and

 

(d)            any other person to whom the contractor has agreed to provide services under the agreement”

 

3.2           This definition means that there are 4 categories of persons who a GP practice may be required to provide primary medical services under a GMS agreement[2], namely:

 

a)      Registered patients of the practice;

b)      Temporary residents;

c)       Persons to whom the contractor is required to provide emergency services; and

d)      Patients who are required to be provided with services under Regulation 31 of the GMS Regulations following the failure of an application to close a practice list.

 

3.3           Regulation 18(1)(b) of the GMS Regulations requires every GMS contract[3] to specify:

 

“to whom such services are to be provided”

 

3.4           Thus the contract has to specify the categories or persons who the GP practice are contracted to provide primary care services, which is a reference to the 4 categories of persons  set out above.  It is therefore necessary to look at each group separately in order to identify the extent of the contractor’s obligations.

 

3.5           Further details of the clinical services that a GP is obliged to provide are set out in the chapter on “What a GP Practice is obliged to provide”.

 

4               The registered patients of the practice.

 

4.1           Regulation 2 of the GMS Regulations defines a “registered patient”[4] of a GP practice as follows:

 

“registered patient” means—

 

(a)     a person who is recorded by the Board as being on the contractor's list of patients, or

 

(b)     a person whom the contractor has accepted for inclusion on its list of patients, whether or not notification of that acceptance has been received by the Board and who has not been notified by the Board as having ceased to be on that list

 

4.2           The wording of this definition is unfortunately not entirely clear.  There are 2 categories of patients or patients who are clearly included as registered patients with a GP practice, namely:

a)      Patients who are on the GP practice list held by NHS England (because the practice has notified NHS England that the person is on the practice list and NHS England have put that name on the list); and

 

b)      Patients who have been accepted by the practice into the practice list but where the practice has yet to pass their name on to NHS England.

 

4.3           However it is not clear from this wording whether a patient was formerly on the practice list can be readmitted at any point before his or her name is accepted (or perhaps re-accepted) by NHS England.  The drafting may be slightly unfortunate because it was probably the intention of the draftsman that such patients would be re-admitted as practice patients if they were accepted by the practice.  However this is not quite what the Regulation says.

 

4.4           The literal meaning of the words suggests that persons who have been removed from the list of a practice, for whatever reason, can only regain their status as a practice patient by being included by NHS England on the practice list.  The purpose of this arrangement appears to be to ensure that disruptive or violent patients who are excluded from a practice list and are properly notified, cannot claim that the practice has accepted them back as a result of an informal agreement.  Once a notified former patient is excluded the patient can only regain their status as a practice patient by getting onto the list for the practice held by NHS England.  In practice this will mean that the practice has to forward the relevant name to NHS England and ask that the patient be restored to the list of registered patients.

 

5               Temporary residents.

 

5.1           A person can only be permanently on the list of one NHS GP practice at a time.  However a person may be in need of primary care services when temporarily away from the area in which they are registered as a GP.  Both the GMS and PMS contracts enable patients to access services in such circumstances by registering with a GP as a “temporary resident”.  The GMS contract set out the scheme for dealing with temporary residents at clause 13.6 of the present form of standard GMS contract (which is mandated by paragraph 16 of Schedule 6 to the GMS Regulations)[5].  The clauses provide:

 

“13.6.1. The Contractor may if its list of patients is open accept a person as a temporary resident provided it is satisfied that the person is-

 

(a) temporarily resident away from his normal place of residence and is not being provided with essential services under any other arrangement in the locality where he is temporarily residing; or

 

(b) moving from place to place and not for the time being resident in any place.

 

13.6.2. For the purposes of clause 13.6.1, a person shall be regarded as temporarily resident in a place if, when he arrives in that place, he intends to stay there for more than 24 hours but not more than three months”

 

5.2           The following points are relevant to temporary residents:

 

a)      It is irrelevant whether the temporary resident is or is not usually, ordinarily or habitually[6] resident in the UK at the time that they seek primary care services from a GP or is a UK citizen.  A temporary resident will often be someone who is usually resident abroad.  Although NHS services are provided primarily for the “physical and mental health of the people of England” (see section 1(1) of the NHS Act) there is nothing in the statutory scheme which requires a person to be a UK national or usually, ordinarily or habitually resident in the UK before that person can take advantage of NHS services.  Hence it is probably unlawful to refuse to register someone as a temporary resident solely on the grounds that the person is not usually, ordinarily or habitually resident in the UK;

 

b)      It is irrelevant whether the proposed temporary resident is registered with another GP practice (either as part of the NHS or in another part of the world).  A person can apply to be accepted by a practice as a temporary resident if they have a GP in another part of the country and if they have no other GP;

 

c)       The proposed temporary resident is not required to be temporarily living in the GP practice area.  However if the person is temporarily living outside the GP “practice area”, the contractor has the right to refuse to register the person as a temporary resident.  See below for a further discussion on the definition of a GP practice area;

 

d)      If the person intends being resident in their present “temporary” home for more than 3 months then the person cannot be registered as a temporary resident.  The only option here would be for the GP practice to register the patient as a permanent patient;

 

e)      Once a person is registered as a temporary resident, the GP practice has the same duties to that patient as the GP practice has to all its other patients;

 

f)        At the point that the temporary resident is accepted onto the practice list (as a temporary resident), the contract requires the GP practice to agree the period of time that the practice agrees to provide primary care services to the patient.  If, for example, a patient seeks services during a 2 week holiday it is sensible to agree with the patient that he or she will be admitted to the practice list as a temporary resident for a period of 2 weeks.  Once a patient is admitted to the practice list as a temporary patient the usual rules about removal of patients from the practice list apply during the agreed period or, if no period is agreed, the usual rules apply for a period of 3 months.  After the agreed period has expired, clause 13.6.3 of the standard GMS contract provides that the practice has an absolute right to terminate the patient's status as a temporary resident[7];

 

g)       If the practice does not take steps to end the person’s status as a temporary resident, the person remains indefinitely registered with the practice as a temporary resident and, if the person presents seeking services, the GP practice has an obligation to provide those services to the patient.

 

5.3           A GMS or PMS practice can refuse to admit a patient as a temporary patient provided the reason for refusal is not one of the prohibited reasons set out in the GMS or PMS Regulations.  The rules on refusing to accept a patient as a temporary patient are the same as those for refusing to accept a person as a permanent patient and are discussed below. 

 

6               The practice area for a GP practice.

 

6.1           Regulation 18(1)(d) of the GMS Standard Contract requires the contact to specify:

 

the area as respects which persons resident in it will, subject to any other terms of the contract relating to patient registration, be entitled to—

 

(i)     register with the contractor, or

 

(ii)     seek acceptance by the contractor as a temporary resident

 

6.2           This provision is replicated as an option in Regulation 11(1A) of the present version of the PMS Regulations.   The “practice area” under Regulation 18(1)(c) is referred to as a “patient registration area” in clause 13.2.1 of the GMS standard contract.

 

6.3           The purpose of the practice area is to create a geographical area outside of which the GP practice are entitled, as of right, to refuse to register patients on the grounds that the patient lives outside the practice area.  However a contractor is not obliged to refuse to register someone who lives outside the practice area.  The practice can register a patient with a GMS practice regardless as to whether that person lives within the practice area or not but, where the area is defined, the contractor is under no duty to do so.  The GMS and PMS Regulations provide that an application by the patient can be refused because living outside the area gives the contractor a “good reason” to refuse to register the patient. 

 

6.4           The Regulations use the test as to whether a person “lives” in the contractor’s practice area.   There is no definition of the meaning of “lives” in the GMS or PMS Regulations but it seems likely that this refers to a person’s place of ordinary residence.  It is well established that a person can be ordinarily resident in more than one place at a time.  For example, students regularly register with a GP practice near their university and thus can only be treated during the vacation by registering as a temporary resident on the practice list at place of vacation residence (which may be their parent’s home).  Students are usually accepted to be “ordinarily resident” in both places at the same time and can thus, for example, register to vote in both places[8] but can only be on one GP list as a permanent residence at a time. 

 

6.5           However there will be more borderline cases.  A person who has a second home that is used exclusively for holidays for a few weeks in each year probably does not “live” at the place of the second home and therefore a GP in the area of the holiday home would be under no duty to accept such a person on their list as a registered patient.  

 

6.6           The GMS and PMS schemes only permit an NHS patient to be registered with one GP practice at a time.  There appear to be 3 potential reasons for providing that a patient can only be registered with one practice at a time:

 

a)      A complete set of the patient’s medical notes need to be in a single place and, if additions are made to those notes, additions should all be made to the same set of notes.  This may become less important with the emergence of electronic records but unless the electronic patient records improve vastly (and there is greater standardisation of GP electronic records systems) if a patient is registered with more than one GP practice there will always be a danger of inconsistent records in different practices;

 

b)      If the patient has a long term or complex condition, a single practice needs to take lead clinical responsibility for the management of the patient.  Permitting a patient with say diabetes or recovering from a stroke to be registered with more than one practice may lead to inconsistent treatment protocols; and

 

c)       GP practices get paid (in part) on a capitation basis.  The NHS would incur additional costs if patients were able to register at multiple practices.

 

6.7           Accordingly individuals who live in more than one place need to decide where to register for primary care services.  The NHS Choices website[9] recommends students to register with a GP at college for the following reasons:

 

Health professionals who understand students' needs can support you. Dr Chris Allen, a GP at Imperial College in London’s Health Centre, says, "Many students will be having sex, some for the first time, so it’s important to get advice on safe sex, sexual health and contraception.

 

"Being away from home for the first time, along with the academic and financial pressures of being a student, can lead to mental health problems, including anxiety and depression."

 

Below are Dr Allen's five health tips for new students.

 

Register with a local GP

 

If, like most students, you spend more weeks of the year at your college address than your family’s address, you need to register with a GP near your college as soon as possible. That way you can receive emergency care if you need it and access health services quickly and easily while you're at college.

 

"It’s especially important if you have an ongoing health condition such as asthma, diabetes or epilepsy," says Dr Allen. "Ideally, I like to see these patients within a few days of them starting college to check their health and medication."

 

6.8           However students, and everyone else who lives in more than one location, should be advised that registering with one practice will inevitably lead to their removal from the practice list in their other place of residence.  If a person needs primary medical treatment in their other place of residence the person can register with the practice as a temporary resident. 

 

6.9           The outer practice area for a GP practice:  There are instances of people who continue be registered with a practice, despite living outside its boundary area.  As explained above, a GP practice is entitled (but not obliged) to register a person who lives outside the practice area.  However changes to the GMS contract in 2012 made provision for patients who were originally living inside the GP practice area but then move to live in an area which is reasonably proximate to the practice but is nonetheless outside the GP practice area.

 

6.10        Part of the agreement reached between NHS Employers (on behalf of the Secretary of State for Health) and the General Practitioners’ Committee of the British Medical Association through the negotiations on changes to the GMS contract for 2012/13 [10]  in respect of choice of GP practice was that:

 

“GP practices will agree with their PCT an outer practice boundary area where they will retain, where appropriate, existing patients who have moved house into the outer boundary area.”

 

6.11        This agreement resulted is in a new set of clauses to the GMS agreement which now provide:

 

“13.3.1. The area, other than the area referred to in clause 13.2.1, which is to be known as the outer boundary area is [ ].

 

13.3.2. Where a patient moves into the outer boundary area referred to in clause 13.3.1 and wishes to remain on the Contractor’s list of patients, the patient may remain on that list if the Contractor so agrees, notwithstanding the patient no longer resides in the area referred to in clause 13.2.1.

 

13.3.3. Where a patient remains on the Contractor’s list of patients as a consequence of clause 13.3.2, the outer boundary area is to be treated as part of the practice area for the purposes of the application of any other terms and conditions of this contract in respect of that patient”

 

6.12        There is no obligation on GP practices to agree to vary their GMS agreement to include an Outer Boundary Area, but the above provision operates if the practice agrees to do so.

 

7               Applications by patients to join the list of a GP practice.

 

7.1           Paragraph 14 of Schedule 6 requires the GMS contract to include the following term:

 

The Board shall prepare and keep up to date a list of the patients—

 

(a)     who have been accepted by the contractor for inclusion in its list of patients under paragraph 15 and who have not subsequently been removed from that list under paragraphs 19 to 27; and

 

(b)     who have been assigned to the contractor under paragraph 32 or 33 and whose assignment has not subsequently been rescinded”

 

7.2           Hence the primary duty to keep a list of registered patients for each primary care practice falls on NHS England.   However there are also duties on the contractor to inform NHS England “as soon as possible” when a patient is accepted onto the practice list[11] or when a patient is removed from the contractor’s list[12].  In addition, of course, GP practices keep their own lists of NHS patients.

 

7.3           Anyone can apply to join the practice list of a GMS GP practice either as a permanent or temporary resident by “delivering to the practice premises a medical card or an application signed (in either case) by the applicant or a person authorised by the applicant to sign on his behalf[13].  The application is made by the patient themselves if the person is an adult and is capable of making the application.    The application can be made on behalf of the proposed patient[14] as follows:

 

An application may be made—

 

(a)     on behalf of any child—

 

(i)     by either parent, or in the absence of both parents, the guardian or other adult who has care of the child,

 

(ii)     by a person duly authorised by a local authority to whose care the child has been committed under the Children Act 1989, or

 

(iii)     by a person duly authorised by a voluntary organisation by which the child is being accommodated under the provisions of that Act; or

 

(b)     on behalf of any adult who lacks the capacity to make such an application, or to authorise such an application to be made on their behalf, by a relative of that person, the primary carer of that person, a donee of a lasting power of attorney granted by that person or a deputy appointed for that person by the court under the provisions of the Mental Capacity Act 2005

 

 

7.4           A “medical card” means a “card issued by the Board, Local Health Board, Health Authority, Health Board or Health and Social Services Board to a Standard General Medical Services Contract person for the purpose of enabling him to obtain, or establishing his title to receive, primary medical services [15] .  However it is not necessary for a prospective patient to present a medical card.  Any document which can reasonably be taken by the contractor as being an application by a person to be registered at the practice and is signed by or on behalf of the patient is sufficient to constitute an application by the prospective patient.

 

7.5           Once the contractor receives the application the GP practice must decide whether to accept the patient onto the practice list as either a permanent patient or a temporary resident, or refuse to register the patient.  If the practice list is closed (see the separate section of this guide for provisions regarding the opening and closure of lists of patients) the only person who can be accepted onto the list is an immediate family member of a registered patient.  This is provided for in clause 13.5.2[16] of the standard GMS Contract which provides:

 

“The Contractor may, if its list of patients is closed, only accept an application for inclusion in its list of patients from a person who is an immediate family member of a registered patient whether or not resident in its practice area or included, at the time of that application, in the list of patients of another contractor or provider of primary medical services”

 

7.6           An “immediate family member” means[17]:

 

(a)     a spouse or civil partner,

(b)     a person (whether or not of the opposite sex) whose relationship with the registered patient has the characteristics of the relationship between husband and wife,

(c)     a parent or step-parent,

(d)     a son,

(e)     a daughter,

(f)     a child of whom the registered patient is—

(i)     the guardian, or

(ii)     the carer duly authorised by the local authority to whose care the child has been committed under the Children Act 1989, or

(g)     a grandparent”

 

7.7           This provision prevents a GP practice from having a closed list but being selective about who is admitted to the practice in the period when the list is closed (so as to avoid a situation where, for example, only patients who are straightforward to manage are accepted onto the practice list).  Only immediate family members can be added to a closed list regardless as to where that person lives.  However there is no obligation on a GMS contracting practice to take an immediate family member who lives outside the practice area onto the list.  In the case of immediate family members who live in the practice area, the practice needs to have reasonable grounds for refusing to take the person onto the list.  However, although this is not expressly stated in the Regulations, the fact that the practice list is (depending on the circumstances) closed is capable of amounting to such a reason.

 

7.8           If the practice list is open then, clause 13.7.1 of the standard GMS contract provides that the contractor may only refuse the application to join the practice list either on a permanent basis or as a temporary resident:

 

“... if it has reasonable grounds for doing so which do not relate to the applicant’s race, gender, social class, age, religion, sexual orientation, appearance, disability or medical condition”

 

There will be a like provision in PMS agreements as a result of paragraph 16 of Schedule 5 to the PMS Regulations. 

 

7.9           It follows that an NHS practice cannot refuse to admit a patient to its list either on a permanent basis or as a temporary resident because the patient suffers from a medical which will be time consuming for the doctors working at the practice or will result in the practice having to prescribe expensive drugs or other treatment for the patient.  Equally the patient cannot be refused admission to the practice list on grounds which might give rise to a free standing discrimination claim under the Equality Act 2010, such as on the basis of race or sexual orientation.  This provision raises some interesting and potentially difficult questions as to whether GP practices can refuse to register patients with alcohol or drug problems.  A GP practice would not be entitled to refuse to register a person because they suffered from such an addiction but may be entitled to refuse to register such a patient if their conduct (related to their addiction) makes it difficult or impossible for the GP to be able to provide primary care services to the patient.  This can be a difficult area in practice and GP practices may well find it sensible to seek legal advice in borderline cases.

 

7.10        However if a patient is refused admission to a practice list it is difficult if not impossible to see how the patient would be able to commence a sustainable legal action against the practice to challenge the decision unless the patient brought an action for disability discrimination.   The patient could allege that the practice has acted in breach of its duties under the GMS contract but that would not assist the patient because the contract does not give rise to any rights which can be enforced by a person who is not a party to the contract (see above).   It seems unlikely that the practice would be acting as a public body in making this decision and therefore a judicial review claim would probably not be possible.  In any event the patient would have an alternative remedy of asking NHS England to assign the patient to the practice list, and so a judicial review claim (which is a remedy of last resort) would be premature.

 

7.11        However a patient who was refused admission to a practice list could report the doctors to the General Medical Council (“GMC”).  The issue of reports to the GMC is considered in more detail below in relation to the removal of patients from a GP list but it could apply equally to a refusal to take a patient onto a list in the first place.

 

7.12        If NHS England considered that the practice had refused one or more patients access to the patient list in circumstances which amounted to a breach of contract (because the practice did not have good reasons for the refusal), NHS England would be entitled to serve a Remedial Notice on the practice under clause 26.13.1 of the standard GMS contract.  The consequences of such a notice are explored below.

 

8               Appeals by patients against decisions to refuse them entry to a practice list

 

8.1           A patient who has been refused admission to a practice list by a GMS or PMS contractor (either on a permanent or temporary basis) is entitled to apply to NHS England to be admitted to the practice list, even if that list is closed, after the contractor has made the decision to refuse to permit the patient to be admitted to the list.  The fact that the decision was made by the GP practice for a good reason (as the GP practice sees matters) does not prevent the patient from having this right.

 

8.2           Clauses 13.23 to 13.25 of the standard GMS contract (which is mandated by the provisions of paragraphs 32 to 34 of Schedule 6 of the GMS Regulations[18]) provides how the decision is to be made by NHS England when a patient appeals against the refusal by the practice to admit a patient to its list (either permanently or on a temporary basis).  These clauses are as follows:

 

“13.23.1. The Board may, subject to clause 13.24.1, assign a new patient to the Contractor whose list of patients is open.

 

13.23.2. In this clause, and in clauses to 13.24.1 to 13.24.2 and clauses 13.26.1 to 13.28.3, a “new patient” means a person who-

 

(a)  has been refused inclusion in a list of patients or has not been accepted as a temporary resident by the Contractor; and

 

(b)  wishes to be included in the list of patients of the Contractor in whose area (as specified in clause 13.2.1) that person resides

 

13.24.1. The Board may not assign a new patient to the Contractor where it has closed its list of patients except in the circumstances specified in clause 13.24.2.

 

13.24.2. The Board may, subject to clause 13.25.1, assign a new patient to the Contractor when it has closed its list of patients if –

 

(a) the assessment panel has determined under paragraph 35(7) of Schedule 6 to the Regulations that patients may be assigned to the Contractor, and that determination has not been overturned either by a determination of the Secretary of State under paragraph 36(13) of Schedule 6 to the Regulations or (where

applicable) by a court; and

 

(b) the Board has entered into discussions with the Contractor regarding the assignment of a patient if such discussions are required under clause 13.28.

 

13.25.1. In making an assignment to the Contractor under clauses 13.23.1 to 13.24.2, the Board must have regard to-

 

(a) the wishes and circumstances of the patient to be assigned;

 

(b) the distance between the patient’s place of residence and the Contractor’s practice premises;

 

(c) any request made by any contractor to remove the patient from its list of patients within the preceding period of 6 months starting on the date on which the application for assignment is received by the Board;

 

(d) whether, during the preceding period of 6 months starting on the date on which the application for assignment is received by the Board, the patient has been removed from a list of patients on the grounds referred to in-

 

(i) clause 13.10 (removal from the list at the request of the contractor),

 

(ii) clause 13.11 (removal from the list of patients who are violent), or (iii) the equivalent provisions to those clauses in relation to arrangements made under section 83(2) of the 2006 Act or under section 92 arrangements;

 

(e) in a case to which clause (d)(ii) (or the equivalent provisions mentioned in clause (d)(iii)) applies, whether the Contractor has appropriate facilities to deal with such patients; and

 

(f) such other matters as the Board considers relevant”

 

 

8.3           The first step in this process is that the patient is required to approach the practice to apply to be admitted to the list, and the practice is required to make the initial decision.  NHS England has no power to impose a patient on a practice unless the patient has first applied and been refused admission to the practice (either on a permanent basis or as a temporary patient).

 

8.4           If the practice list is closed there are only very limited circumstances in which NHS England are entitled to require a practice to take on a new patient.  The scheme for requiring admission of a patient to a closed list is looked at in detail in the section of this guide relating to closed practice lists. 

 

8.5           If the practice list is open, NHS England has a discretion to decide whether to require a GMS contracting practice to accept a patient onto its list or to accept a patient as a temporary resident.  The decision is generally made on paper by NHS England officials.  In making that decision the terms of the contract (as mandated by the GMS Regulations) require NHS England to take account of the following factors:

 

a)      The wishes and circumstances of the patient to be assigned.  The “wishes” of the patient to be admitted to the practice list are a material factor but they are not conclusive.   NHS England is also required to take account of the “circumstances of the patient”, which in practice must mean such of the circumstances as are known to NHS England and the GMS contractor.  There can be no duty on the patient to disclose all of their personal circumstances but clearly NHS England can only take account of circumstances that are known;

 

b)      The distance between the patient’s place of residence and the contractor’s practice premises.   The usual significance of this will be that the nearer the patient lives to the practice premises (or one of the practice premises), the stronger case can be made for the patient being admitted to that particular practice;

 

c)       Any request made by any contractor to remove the patient from its list of patients within the preceding period of 6 months starting on the date on which the application for assignment is received by the Board.  It is a relevant factor as to whether the practice has asked NHS England to remove the patient from the list within the previous 6 months and the circumstances which led to that request being made (whether it was granted or not).  The patient may be applying to be re-admitted to the list after NHS England agreed to remove the patient from the list.  Alternatively it is possible that the request was refused but that the patient had been removed from the practice list for a different reason and was now seeking to rejoin the list;

 

d)      The wording under sub-paragraph (d) requires NHS England to take into account whether, during the preceding period of 6 months starting on the date on which the application for assignment is received by the Board, the patient has been removed from the list of patients of any NHS GP practice:

 

                               i.         at the request of the contractor; or

                             ii.         because the patient had been violent;

 

e)      Sub-paragraph (e) requires NHS England to take into account whether, in a case where the patient has been removed from the list of patients of any NHS GP practice because the patient had been violent, the Contractor has appropriate facilities to deal with such patients; and

 

f)        NHS England is required to take such other matters into account as NHS England considers relevant.

 

8.6           There is no provision in the rules for an oral hearing, but NHS England is a public body making a decision which potentially affects the article 8 rights of the patient.  It would be required to follow a fair process in reaching the decision.  The procedural requirements of this decision have not been tested in the courts but are is likely to require:

 

a)      giving the person the opportunity to explain why he or she wishes to be included on the practice list;

 

b)      giving the practice the opportunity to explain why the person has been refused admission to the list; and

 

c)       taking reasonable steps to consider any other relevant information provided by the patient; and

 

d)      Although this is not expressly stated in the Regulations, it seems highly likely that a fair decision could only be given by NHS England if reasons are given for the decision.  Those reasons should explain how the decision maker has taken account of the various factors set out above and the weight given to each factor.  Some weight should be given by the decision maker to every factor because each factor is one which is required to be included by the GMS Regulations.  However, provided some weight is attached to each factor, the decision maker is entitled to exercise a wide margin of discretionary decision making in reaching the view as to which factor or factors are more important than other factors in the particular circumstances of each case.

 

8.7           There is no appeal provided within the GMS or PMS Regulations by either the patient or the practice against the decision of NHS England to order or not to order a patient to be admitted to a GP practice list.  The patient would have the right to challenge the decision by way of Judicial Review if the patient considered that the decision was made unlawfully.  However this would not be an appeal on the merits because the relevant Regulations make NHS England the discretionary decision making body.  It could only be a challenge asserting that the decision was made in an unlawful way or was an irrational decision. 

 

8.8           If NHS England decides in favour of the patient, if the practice still disagrees with the decision it has 2 options.  It may have the right to exercise its rights to remove a patient from the list.  Removal of patients from the practice list is considered below.  Secondly, if the practice believed that the decision had been taken on an improper basis (as opposed to a decision on the merits with which they disagreed) it may be possible for the practice to refer the matter to the NHSLA under the dispute resolution process.  The details of the dispute resolution process are considered elsewhere in this guide.  However the NHSLA will recognise that decision making about this matter is given to NHS England and accordingly it will only look to see whether the decision has been properly taken by NHS England.  The NHSLA ought not to attempt to reconsider the decision on its merits but only ask itself whether NHS England have reached a proper decision.  However the patient would remain on the practice list and thus must be provided with general practice services until (at least) the NHSLA have reached a decision.

 

9               Removal of patients from as GMS practice list.

 

9.1           The removal of patients from the lists of GP practices is a hugely contentious area and has been the subject of a report by the Parliamentary and Health Service Ombudsman.  It is the subject of a specific paragraph in the GMC Code of Conduct and guidance has been issued on the subject by the Department of Health, the Medical Protection Society and the BMA.  There can be particularly difficult issues arising from violent patients or patients whose family members are violent.  It is thus an area where GP practices need to tread carefully but where they do occasionally need to act to preserve the working environment (and sometimes the sanity) of GPs, their staff and other patients.

 

9.2           The GMC’s Good Medical Practice provides:

 

“62.  You should end a professional relationship with a patient only when the breakdown of trust between you and the patient means you cannot provide good clinical care to the patient”

 

9.3           The GMC has published guidance about this area of practice.  It provides:

 

Things to consider

 

3. In rare circumstances, the trust between you and a patient may break down, for example, if the patient has:

 

·       been violent, threatening or abusive to you or a colleague

·       stolen from you or the premises

·       persistently acted inconsiderately or unreasonably

·       made a sexual advance to you.

 

4. You should not end a professional relationship with a patient solely because of a complaint the patient has made about you or your team, or because of the resource implications of the patient’s care or treatment. 

 

Before you end the relationship

 

5. Before you end a professional relationship with a patient you should:
 

a. warn the patient that you are considering ending the relationship

 

b. do what you can to restore the professional relationship

 

c. explore alternatives to ending the professional relationship

 

d. discuss the situation with an experienced colleague or your employer or contracting body 

 

and you must be satisfied that your reason for wanting to end the relationship is fair and does not discriminate against the patient (see paragraph 59 of Good medical practice).

 

When you’ve made a decision to end the relationship

 

6. If you decide to end your professional relationship with a patient you must:

 

a. make sure the patient is told of your decision to end the professional relationship, and your reasons for doing so; where practical, the patient should be told in writing

 

b. follow relevant guidance and regulations

 

c. record your decision to end the professional relationship – information recorded in the patient’s records must be factual and objective, and should not include anything that could unfairly prejudice the patient’s future treatment

 

d. make sure arrangements are made promptly for the continuing care of the patient, and you must pass on the patient’s records without delay

 

e. be prepared to justify your decision”

 

9.4           Thus a doctor will act in breach of the professional standards set by the GMC by ending a relationship with a patient unless 2 things are present, namely:

 

a)      There must be a breakdown of trust between the doctor and the patient; and

 

b)      The doctor must be unable to provide good clinical care to the patient as a result of that breakdown.


9.5           Asking NHS England to remove a patient from a practice list because of one or more complaints is a breach of the professional standards unless the number and/or nature of the complaints means that there has been a breakdown of trust between the patient and the doctor.  It is also clear that a doctor must work at a relationship with a patient and cannot give at the first sign of difficulties. A warning must usually be given and then the doctor must attempt to make the relationship work before concluding that it is the interests of both parties for medical care for the patient to be provided by someone else.

 

9.6           There are however a number of special situations in which a patient can be removed from a practice list without there being a breakdown of trust between the doctor and the patient.  These are examined next before looking at the more difficult area of removal at the request of the doctor on discretionary grounds.

 

9.7           End of a period of temporary residence:  A patient can be removed by a GP practice from a practice list as a temporary resident by the GP practice serving notice on the patient at any time after the period when the practice agreed the patient would be entitled to be a temporary resident or, if no period was agreed, at any time after the patient has been a temporary resident for 3 months (see clause 13.6.3 of the standard GMS contract).  No further reasons need to be given to justify the removal of such a patient from the practice list.

 

9.8           The death of a registered patient:  If NHS England are informed that a patient has died, NHS England have a duty to remove the patient from the practice list (see clause 13.4.1 of the standard GMS Contract).  A GP may not, of course, necessarily be aware that a patient on its practice list has died but where the practice learns that a registered patient has died it is plain that the person cannot continue to be a patient of the practice.  There is no specific duty placed on a contractor to inform NHS England that a patient has died but it seems plain that a contactor should not continue to include the name of a patient on the practice list where the contractor is aware that the patient has died.  NHS practices get paid in accordance with the size of the patient list and maintaining a list with patients who are known to have died because that would lead to payments being made to the contractor for services to one or more named patients that, by definition, cannot be delivered.  It would therefore be fraudulent activity by a contractor to keep the name of a patient on the practice list knowing that the patient had died.  Clause 2.1.4 of the standard GMS contract requires all contractors to act “reasonably and in good faith”.  As well as being potentially fraudulent, maintaining the name of a knowingly dead patient on a practice list would probably amount to a breach of this clause and thus jeopardise the continuing GMS contract.  It is therefore important that contractors notify NHS England as soon as is reasonably practical where they learn that a practice patient has died. 

 

9.9           The patient who asks to be removed from a practice list:  A patient has the right to be removed from the list of an NHS practice at any time.  It is not necessary for the patient to give any reason or explain why the patient wishes to be removed from the practice list.  Clause 13.9.1 of the standard GMS contract provides “the Contractor shall notify the Board in writing of any request for removal from its list of patients received from a registered patient”.  If NHS England receives notification from the practice that the patient wishes to leave the list of a practice or receives that notification directly from the patient, NHS England (which holds the list of patients for each NHS practice) have a duty to remove the name of the patient from the list (see clause 13.9.2).

 

9.10        The patient who registers with another practice:  NHS England are obliged to remove a patient from a practice list of the patient is registered with another GP practice in the UK.  There is no discretion to exercise in this instance because, as noted above, a patient can only be registered with one NHS GP practice at a time.  Clause 13.12 of the Standard GMS Contract explains the position as follows:

 

“13.12.1The Board must remove a patient from the Contractor’s list of patients if –

 

(a)  that patient has subsequently been registered with another provider of essential services (or their equivalent) within England; or

 

(b)  it has received notice from a Local Health Board, a Health Board or a Health and Social Services Board that the patient has subsequently been registered with a provider of essential services (or their equivalent) outside England”

 

9.11        The removal of the patient from the practice list takes effect on the date on which notification of acceptance by the new provider is received by NHS England or, with the consent of the NHS England, on such other date as has been agreed between the Contractor and the new provider.

 

9.12        Patients who move out of the practice area:  The general approach of the GMS and PMS Regulations is that patients should be registered with a practice which is within the practice area and thus local to where they live.  However GP practice is entitled to keep a patient on its practice list even if the patient moves out of the practice area.   Patients who move house to live just out of the practice area may well not wish to register with a new NHS practice (either at all or for an extended period).  In those circumstances the name of the patient will continue to appear on a practice list. 

 

9.13        The GMS contract provides that the onus is on NHS England to take action if it becomes aware that a patient has moved out of a practice area.  It is difficult to envisage the circumstances in which NHS England would become aware that a patient had moved house unless the patient sought to register with a new NHS practice.  However clause 13.13 regulates this situation as follows:

 

“13.13.1. Subject to clause 13.13.2, where the Board is satisfied that a person on the Contractor’s list of patients no longer resides in that Contractor’s practice area, the Board shall-

 

(a) inform that patient and the Contractor that the Contractor is no longer obliged to visit and treat the patient;

 

(b) advise the patient in writing either to obtain the Contractor’s agreement to the continued inclusion of the patient on its list of patients or to apply for registration with another provider of essential services (or their equivalent); and

 

(c) inform the patient that if, after the expiration of 30 days from the date of the advice referred to in sub-clause (b), he has not acted in accordance with the advice and informed it accordingly, the Board will remove him from the Contractor’s list of patients.

 

13.13.2. If, at the expiration of the period of 30 days referred to in clause 13.13.1(c), the Board has not been notified of the action taken, it shall remove the patient from the Contractor’s list of patients and inform him and the Contractor accordingly.

 

13.13.3. Where the address of a patient who is on the Contractor’s list is no longer known to the Board, the Board shall-

 

(a) give to the Contractor notice in writing that it intends, at the end of the period of six months commencing with the date of the notice, to remove the patient from the Contractor’s list of patients; and

 

(b) at the end of that period, remove the patient from the Contractor’s list of patients unless, within that period, the Contractor satisfies the Board that it is still responsible for providing essential services to that patient”

 

9.14        Patients who are sentenced to more than 2 years in prison:  General medical services for prisoners are commissioned by NHS England directly with providers who work in prisons.  NHS England had a duty to remove any patient from the list of a practice if they are informed that the patient has been sentenced to a term of imprisonment of more than 2 years[19].  The prisoner would, of course, be unable to access the services of the GP practice whilst in prison and thus retaining the name on the practice list would mean that the practice were being paid for services for a person who could not access those services.  Accordingly the NHS would be funding the same services twice if a prisoner were to be retained on the list of a GP practice. The period of 2 years appears to have been chosen to prevent the prisoner being removed from a practice list if the sentence is short and thus the individual can be expected to return to the community in a short period.

 

9.15        A practice will not necessarily learn that a patient on its list has been sent to prison and, even if it does learn this information, may well not be aware of the sentence that the prisoner was given.  If the practice is aware that a patient has been sentenced to a term of imprisonment there is no specific duty on the practice to inform NHS England of this fact and thus have the patient’s name removed from the list.  However the GP practice under a GMS contract will have a duty to act reasonably and in good faith (see clause 2.1.4 of the Standard Contract).  It may well be a breach of that duty to take a decision not to tell NHS England that a patient on the practice list was sentenced to a long term of imprisonment.

 

9.16        Patients who join HM Forces:  General medical services for members of HM forces are commissioned by NHS England directly with providers who work with soldiers, sailors and members of the RAF.  NHS England had a duty to remove any patient from the list of a practice if they are informed that the patient has joined HM Forces [20] .  Neither the Regulations not do not specify that this provision only applies to permanent members of the forces and not reservists.   However the logic of the provision only applies to full time members of the forces as opposed to those who retain their civilian role for most of the year (and can thus have a need for general medical services at home) and only serve for limited times in the forces.

 

9.17        A practice will probably learn from the forces GP services (if not otherwise) that a patient on its list has joined the forces.  If the practice is aware that a patient has joined the forces on a full time basis there is no specific duty on the practice to inform NHS England of this fact and thus have the patient’s name removed from the list.  However the GP practice under a GMS contract will have a duty to act reasonably and in good faith (see clause 2.1.4 of the Standard Contract).  It may well be a breach of that duty to take a decision not to tell NHS England that a patient on the practice list has joined HM forces on a full time basis.

 

9.18        Patients who are abroad for more than 3 months:  NHS England had a duty (i.e. there is no discretion) to remove any patient from the list of a practice if they are informed that the patient has “been absent from the United Kingdom for a period of more than three months”.  Unlike the situation where a patient has been sentenced to a term of imprisonment or joined HM Forces, a person who is absent from the United Kingdom for a period of more than three months is not necessarily being provided with NHS funded GP services by another route.  The GP practice therefore has to exercise a degree of judgment in deciding whether to apply to NHS England to remove such a patient from the list.  Neither the GMS nor the PMS contract places a duty on the GP practice to inform NHS England that a patient has been absent from the United Kingdom for a period of more than three months, and so the practice will not act in breach of its contract by taking the decision not to do so.  The test for the practice ought to be this person has retained a sufficient connection to the UK to continue to be habitually resident here and thus can justify remaining on the practice list.  Hence, for example, it would plainly be inappropriate to apply to remove an elderly person from the practice list who spends 3 months across the winter in Spain but 9 months of the year in the UK.  Equally a patient whose family comes from the Indian sub-continent who travels to, for example, Bangladesh for an extended visit of 4 months plainly should not be removed.  But a GP practice ought not to be paid for someone who has substantially moved to another country. 

 

9.19        Removal of patient who have registered as temporary patients elsewhere and remained on a longer term basis:  Patients can commence registration with a practice as a temporary resident and then find themselves staying in the location for a longer period than anticipated.  This can particularly happen with elderly residents who move to live with a relative or in a care home and then decide not to return to their previous home.  Normally in such cases the patient would apply to convert their temporary status to a permanent status with the new GP practice on the basis that they now “live” in the area of the new practice.  However the patient is still on the list of their former practice.  There is therefore a residual power for NHS England to de-register a patient if they learn that they have moved permanently elsewhere.  The onus to take action here is on NHS England and not on the contactor.

 

9.20        The provision is in clause 13.15 which is self-explanatory and provides as follows:

 

“13.15.1  The Board shall remove from the Contractor’s list of patients a patient who has been accepted as a temporary resident by another contractor or other provider of essential services (or their equivalent) where it is satisfied, after due inquiry-

 

(a) that the patient’s stay in the place of temporary residence has exceeded three months; and

 

(b) that the patient has not returned to his normal place of residence or any other place within the Contractor’s practice area.

 

13.15.2. The Board shall notify the Contractor and, where practicable, the patient, of a removal under clause 13.15.1.

 

13.15.3. A notification to the patient under clause 13.15.2 shall inform him of-

 

(a) his entitlement to make arrangements for the provision to him of essential services (or their equivalent), including by the Contractor by whom he has been treated as a temporary resident; and

 

(b) the name, postal and email address of the Board”

 

9.21        Addition and removal of the names of patients at a school:  GP practices can accept registration of all of the residents of a school at which pupils and staff live.  This is particularly the case for residential schools where the students have particular medical needs, including learning difficulties.  However there will inevitably be a turnover of both students and staff at such institutions.  The GMS contract therefore has the following provisions to ensure that everyone on a practice list is currently living at the school:

 

“13.16.1. Where the Contractor provides essential services under the Contract to persons on the grounds that they are pupils at, or staff or residents of, a school, the Board shall remove from the Contractor’s list of patients any such persons who do not appear on particulars of persons who are pupils at, or staff or residents of, that school provided by that school.

 

13.16.2. Where the Board has made a request to a school to provide the particulars mentioned in clause 13.16.1 and has not received them, it shall consult the Contractor as to whether it should remove from its list of patients any persons appearing on that list as pupils at, or staff or residents of, that school”

 

9.22        There is an equivalent provision in paragraph 26 of Schedule 5 to the PMS Regulations.

 

10            Removal of violent patients from GP Practice lists.

 

10.1        There are special rules for GP practices covering the removal of violent patients from a general practice list.  This issue was raised in Heath Service Circular 2001/001 “Tackling Violent towards GPs and their staff”.  The Guidance required local NHS commissioners (at that point Health Authorities) to develop a “Local Development Scheme” to provide access to GP services to patients who are violent and are removed from lists of general practices.   There are a variety of schemes around the country which set up alternative arrangements, staffed by GPs who provide services in secure settings.

 

10.2        The GMS contract [21]  includes the following term permitting the contractor to notify NHS England that it wishes to remove a violent patient with immediate effect[22].  This is now set out in clause 13.11.1 which provides:

 

“Where the Contractor wishes a patient to be removed from its list of patients with immediate effect on the grounds that-

 

(a) the patient has committed an act of violence against any of the persons specified in clause 13.11.2 or behaved in such a way that any such person has feared for his safety; and

 

(b) it has reported the incident to the police,

 

the Contractor shall notify the Board in accordance with clause 13.11.3”

 

 

10.3        The persons specified in clause 13.11.2 against whom the patient has committed the act of violence are any of the following:

 

The persons referred to in sub-paragraph (1) are—

 

(a)     the contractor where it is an individual medical practitioner;

 

(b)     in the case of a contract with two or more individuals practising in partnership, a partner in that partnership;

 

(c)     in the case of a contract with a company, both a legal and beneficial owner of shares in that company;

 

(d)     a member of the contractor's staff;

 

(e)     a person engaged by the contractor to perform or assist in the performance of services under the contract; or

 

(f)     any other person present—

 

(i)     on the practice premises, or

 

(ii)     in the place where services were provided to the patient under the contract”

 

10.4        The notification can be given to NHS England orally or in writing but, if given orally, must be confirmed in writing within 7 days.  A faxed message does not count as a written message but it is unclear if an email counts as a written message.  There does not appear to be any reason why an email should not be sufficient because there will be an audit trail relating to the message at both ends.

 

10.5        There is no precise definition in the contract of the phrase “committed an act of violence”.   However the World Health Organisation published a report on Violence and Health in 2002[23].  This defines violence as follows:

 

“The intentional use of physical force or power, threatened or actual, against oneself, another person, or against a group or community, that either results in or has a high likelihood of resulting in injury, death, psychological harm, maldevelopment or deprivation”

 

10.6        This seems an appropriate test against which to judge the act complained about.  It can include a threat of violence if the threat, if carried out, would result in injury.  The alternative formulation of conduct which can lead to a patient being removed instantly from a practice list is that the patient must have “behaved in such a way that any such person has feared for his safety”.  This test has a potentially wider scope because it focuses on the reaction of the person to the actions of the patient and not just on the actions of the patient himself or herself. 

 

10.7        However in order to come within the terms of the GMS contract the incident must be reported to the police.  If the incident, however frightening the incident may have seemed to staff at the time, has not been reported to the police then the GP practice cannot bring itself within the terms of the immediate removal provisions under the contract.   The trigger however is a report to the police and not any form of defined action by the police.  It is therefore not necessary to show that the police attended, arrested the patient or even took the matter in any way seriously.  All that is necessary to come within the terms of the contract is for a report to have been made to the police following an incident.   It would therefore be sensible for the contractor to keep a record of that report and ideally to obtain a crime report number from the police.  The requirement that the incident is reported to the police suggests that the incident ought to be considered by the GP practice of sufficient seriousness that the contactor considered that a criminal offence was or may have been committed.  The lowest level of offence is likely to be section 5 of the Public Order Act 1986 which provides:

 

A person is guilty of an offence if he—

 

(a)     uses threatening, abusive or insulting words or behaviour, or disorderly behaviour, or

 

(b)     displays any writing, sign or other visible representation which is threatening, abusive or insulting,

 

within the hearing or sight of a person likely to be caused harassment, alarm or distress thereby”

 

10.8        It seems highly likely that any action by a patient that comes within clause 13.11.1 will, at the least, amount to a potential offence under section 5 of the Public Order Act 1986 and thus justify a report by a GP to the police. 

 

10.9        Clause 13.11.15 then provides that a removal requested in accordance with clause 13.11.1 shall take effect at the time the Contractor makes the telephone call to the Board, or sends or delivers the notification to the Board.  It follows that the duty on the contractor to provide continuing medical care to the patient ceases immediately the contractor has made a report to NHS England of violence and made a “request” for the patient to be removed from the practice list.  If the patient was in need of emergency care then the contractor would have a duty to continue to provide emergency care to the patient in the same way as emergency care is required for any other individual, whether a registered patient or not.  However there is no contractual duty on the GP practice to take steps to ensure that the violent patient is able to access alternative primary medical services before the patient is removed from the list.

 

10.10     The violence or threats must come from the patient themselves.  A patient cannot be removed under clause 13.11 because a friend or relative has used or threatened violence to the GP or anyone else in the surgery.  However if the violence comes from a person other than the patient the GP practice may report a potential offence to the police under section 119 of the Criminal Justice and Immigration Act 2008 which provides:

 

A person commits an offence if—

  

(a)     the person causes, without reasonable excuse and while on NHS premises, a nuisance or disturbance to an NHS staff member who is working there or is otherwise there in connection with work,

  

(b)     the person refuses, without reasonable excuse, to leave the NHS premises when asked to do so by a constable or an NHS staff member, and

  

(c)     the person is not on the NHS premises for the purpose of obtaining medical advice, treatment or care for himself or herself

 

This provision could enable the police to attend the surgery in order to arrest and hence remove the offending relative or friend. 

 

10.11     Violence or threats of violence by a relative or friend of the patient may also be a good reason for the GP practice to seek the removal of the patient from the practice list under clause 13.10.  However that removal will not take place immediately and the GP practice will continue to have duties to provide medical care to the patient until the removal takes effect.

 

10.12     It is difficult to see any legal basis other than an action in defamation upon which a patient can challenge the decision of a GP practice to remove the patient from the list, particularly if (as is usually the case) NHS England have a local scheme for offering alternative primary care services to patients who have been ejected from practice lists due to violence or threats of violence.  However a patient who disputes that he or she has been violent to a GP or a member of his or her staff could make a complaint to the GMC about the GP alleging a breach of paragraph 62 of Good Medical Practice (see above).  At this point the conduct of the GP will be judged against the GMC Code and the relevant guidance as opposed to being purely judged under the terms of the relevant practice contract.

 

10.13     The patient who has been removed for violent conduct should generally be informed of the reasons for his or her removal.  Clause 13.11.6 provides:

 

“Where, pursuant to clauses 13.11.1 to 13.11.5 the Contractor has notified the Board that it wishes to have a patient removed from its list of patients, it shall inform the patient concerned unless-

 

(a) it is not reasonably practicable for it to do so; or

 

(b) it has reasonable grounds for believing that to do so would be harmful to the physical or mental health of the patient or would put at risk the safety of one or more of the persons specified in clause 13.11.2”

 

10.14     The contract permits the patient to be informed orally or in writing.  However there is an exemption to notification if the contractor has reasonable grounds for believing that to do so would be harmful to the physical or mental health of the patient or would put at risk the safety of one or more of the relevant persons.  It is difficult to see how a contractor would be acting properly if it failed to inform a patient because the inevitable result would appear to be that the patient will still believe that he or she is on the surgery list and hence will present seeking treatment at some point in the future.

 

11            Discretionary removal of patients from a GP practice list.

 

11.1        There are, of course, numerous reasons why a GP practice may wish to remove a patient from a practice list.  The BMA Guidance makes it clear that this should be an exceptional and rare event. 

 

11.2        Prohibited reasons:  Both GMS and PMS contracts are required to contain terms which prevent a GP practice applying to NHS England to remove a patient for any of the following reasons:

 

·      race

·      gender

·      social class

·      age

·      religion

·      sexual orientation

·      appearance

·      disability

·      medical condition

 

11.3        Save in the case of violent patients, NHS GP practices do not have the right to remove patients from their own practice list but they have the right to apply to NHS England to have a patient’s name removed from the practice list.  In cases other than violent patients, the decision making process is governed by clauses in the contract which are mandated by paragraph 20 of Schedule 6 to the GMS Regulations and a like provision in the PMS Regulations. 

 

11.4        The approach of the GMS Regulations is generally to permit a contractor to require NHS England to remove a patient from the practice list provided:

 

a)      The contactor has a good reason for wanting to remove the patient (the reason cannot be a prohibited reason);

 

b)      (Save in a specified set of cases) the patient has been warned about the conduct which led to the decision and has failed to heed the warning; and

 

c)       The patient is generally entitled to know the reason that the GP wants to remove the patient from the practice list.

 

11.5        However a practice will continue to have clinical responsibility for a patient until the removal of the patient comes into effect in accordance with the contractual scheme described below.  The practice has a full duty to provide services to the patient until the removal takes effect.

 

11.6        The general right for a practice to be entitled to apply to NHS England to remove a patient from the practice list is set out in clause 13.10.1 of the standard GMS Contract [24]  which provides:

 

“Subject to clauses 13.11.1 to 13.11.8, where the Contractor has reasonable grounds for wishing a patient to be removed from its list of patients which do not relate to the patient’s race, gender, social class, age, religion, sexual orientation, appearance, disability or medical condition, the Contractor shall-

 

(a) notify the Board in writing that it wishes to have the patient removed; and

 

(b) subject to clause 13.10.2, notify the patient in writing of its specific reasons for requesting removal”

 

11.7        The warning for the patient:  The first stage in the process of removing a patient from a GP practice list is that a warning should has to be given to the patient about the patient’s conduct which is causing the practice concern and which may lead to the practice seeking to have the patient removed.  Clause 13.10.3 of the standard GMS Contract which provides:

 

“Except in the circumstances specified in clause 13.10.4, the Contractor may only request a removal under clause 13.10.1, if, within the period of 12 months prior to the date of its request to the Board, it has warned the patient that he is at risk of removal and explained to him the reasons for this”

 

11.8        There are a limited number of exceptions to the need to warn the patient before a request is made to NHS England to remove the patient from the practice list.  The exceptions are set out in clause 13.10.4 as follows: 

 

a)      the reason for removal relates to a change of address; or

 

b)      the Contractor has reasonable grounds for believing that the issue of such a warning would be harmful to the physical or mental health of the patient or would put at risk the safety of one or more of the persons specified in clause 13.10.5; or

 

c)       it is, in the opinion of the Contractor, not otherwise reasonable or practical for a warning to be given.

 

11.9        The list of persons who are referred to in the above exemption (at sub-paragraph b) whose health or safety can be claimed as a reason not to warn the patient are set out in clause 13.10.5 as follows:

 

“(a) if the Contractor is an individual medical practitioner, the Contractor;

 

(b) if the Contractor is a partnership, a partner in the partnership;

 

(c) if the Contractor is a company, both a legal and beneficial owner of shares in that company;

 

(d) a member of the Contractor’s staff;

 

(e) a person engaged by the Contractor to perform or assist in the performance of services under the Contract; or

 

(f) any other person present on the practice premises or in the place where services are being provided to the patient under the Contract”

 

11.10     Once a warning has been given and the GP practice reaches the view that it has not been heeded or if the contractor considers that it is entitled to dispense with a warning in accordance with the above provisions, clause 13.10.1 provides that the contractor should write to NHS England saying that it “wishes” to remove the patient.   At the same time the GP practice is required to notify the patient of the specific reasons for requesting removal.  Those reasons cannot be any of the prohibited reasons namely reasons connected to the patient’s race, gender, social class, age, religion, sexual orientation, appearance, disability or medical condition. Subject to these specific limitations, there are a wide range of potential reasons why a practice could seek to have a patient removed from its list.  The most obvious reasons are that the patient has moved out of the practice area or that the doctors do not feel able to continue to provide services to the patient.   Some guidance on reasons is provided in clause 13.10.2 which provides:

 

“Where, in the reasonable opinion of the Contractor, the circumstances of the removal are such that it is not appropriate for a more specific reason to be given, and there has been an irrevocable breakdown in the relationship between the patient and the Contractor, the reason given under clause 13.10.1 may consist of a statement that there has been such a breakdown”

 

11.11     This language echoes the grounds on which a doctor can terminate a relationship with a patient in the GMC Code.  The NHS practice contract gives the patient no right to object to the proposed removal or to challenge the factual basis of the decision to remove him or her from the practice list.  The provisions in the contract treat this mater as being solely to be decided between the practice and NHS England.  Neither the GMS Regulations nor the GMS contract gives any legal right to the patient to object to being removed from a practice list.

 

11.12     Where notification is given to NHS England that a practice wishes to remove a patient from its list there is no provision for a separate decision to be made by NHS England as to whether the practice has properly made out a case to have the patient removed.  The next step is that the removal takes effect automatically on the date when the patient is registered with another practice or 8 days after the notice is sent to NHS England, whichever is the sooner unless the patient is being treated at intervals of less than seven days.  If the patient is in receipt of medical treatment at less than 7 day intervals, the removal does not take effect until the eighth day after the Trust receives notification from the Contractor that the person no longer needs such treatment, or on the date on which the person is registered with another provider of essential services, whichever is the sooner[25].

 

11.13     This scheme seeks to preserve the balance between the interests of the contractor who wishes to have the patient removed from the practice list and the interests of the patient who may have a need for on-going medical treatment.  It however has the potential to cause a difficulty in the case of a patient who has a chronic condition which will require treatment at less than 7 days intervals indefinitely.  The patient is under no obligation to seek out a new GP practice and cannot be registered with a new practice unless he or she makes an application to join the list of that practice.  If the patient prefers to stay with their existing practice then the patient cannot be compelled to join another practice.  The contractor continues to have a full duty to provide medical treatment to the patient until the removal notice takes effect, and cannot reduce the level of input for the patient because a removal has been requested.  However in such circumstances the removal notice cannot take effect unless the contractor can certify that the person no longer needs such treatment.  In such a case neither of the 2 conditions in clause 13.10.9 will arise and the notice may be incapable of taking effect and so the GP practice will continue to have clinical responsibility for the patient.  The only option in such circumstances would appear to be mediation to attempt to agree a mutually agreed way forward.

 

11.14     The GP is a sub-contractor of NHS England’s statutory duty to make arrangements for patients to have access to primary care services, and accordingly any public law action by a patient would have to be against NHS England and not the GP practice.  However that could only be based on an overall alleged failure by NHS England to provide primary care services and so could be cured by NHS England offering to arrange for the patient to be registered at another practice or offering the GP services under arrangements for patients who are excluded from GP practices generally in an area.  It is therefore difficult if not impossible to see how a patient could construct a cause of public law action arising out of the decision of a GP practice to remove a patient from their list of registered patients.  The patient’s only remedies appear to be to sue in defamation or to complain to the GMC.

 

11.15     If the patient is removed from the practice list pursuant to this scheme, NHS England has a duty to write to both the patient and the contractor to inform them that the patient has been removed and the date of removal.  However NHS England does not need to explain the reasons for the patient’s removal since this will usually have already been explained by the contractor to the patient.

 

11.16     NHS England and the contracting GP are required to keep proper records relating to the removal of patients from a list of registered patients including, in the case of the GP practice, proper records of any warnings that have been in advance of any removal.

 

12            Closure and reopening of GP practice lists.

 

12.1        GP practices lists vary enormously but it is not in the interests of patients or doctors for a GP practice to have too many patients and not enough doctors.  A GP practice has a contractual and professional duty to deliver services of an acceptable quality for patients and this will not be possible if the GP practice does not have enough capacity.  Until 2004 a sole practice GP was only allowed to have 2,500 patients on his or her list, increasing to 3,500 if the GP was in a partnership.   There are no limits in force at present.

 

12.2        An NHS document on improving primary care access estimated demand as follows[26]:

 

Using data on average demand in England shows that a patient has a consultation with their Doctor 3.4 times per year.  This average will vary based on local patients’ needs and behaviours and the types of services provided, for example the availability of nurse-led or telephone appointments. 1,000 patients would require 3,400 appointments per year; divided by 52 weeks this would give 66 appointments per week per 1,000 patients on the registered list. In reality however, many GP practices have found that their patient population requires more appointments than this number”

 

12.3        One way of managing demand is for a GP practice to close its list to new patients.  However a closure is anticipated to be a strictly temporary measure whilst the GP practice takes the necessary steps to increase its capacity to deliver services to patient.  Lists are held by NHS England and not the individual practice and therefore the decision maker on any closure application is NHS England and not the GP practice.

 

12.4        The scheme [27]  under the GMS and PMS Regulations starts with an application by the Contractor to NHS England to close its list.  The Application must include the following details:

 

a)      the options which the Contractor has considered, rejected or implemented in an attempt to relieve the difficulties which the Contractor has encountered in respect of its open list and, if any of the options were implemented, the level of success in reducing or extinguishing such difficulties;

 

b)      any discussions between the Contractor and its patients and a summary of those discussions including whether in the opinion of those patients the list of patients should or should not be closed;

 

c)       any discussions between the Contractor and other contractors in the practice area and a summary of the opinion of the other contractors as to whether the list of patients should or should not be closed;

 

d)      the period of time during which the Contractor wishes its list of patients to be closed and that period must not be less than 3 months and not more than 12 months;

 

e)      any reasonable support from the Board which the Contractor considers would enable its list of patients to remain open or would enable the period of proposed closure to be minimised;

 

f)        any plans the Contractor may have to alleviate the difficulties mentioned in the Application during the period the list of patients may be closed in order for that list to reopen at the end of the proposed closure period without the existence of those difficulties; and

 

g)       any other information which the Contractor considers ought to be drawn to the attention of the Board.

 

12.5        NHS England must then enter into discussions with the practice, about what support it can provide or any changes that can be made, with both doing everything possible to keep the list open. The Local Medical Committee (“LMC”) may be invited at any stage during these discussions to attend any meetings that have been arranged. Also, NHS England may consult anyone who might be affected by the closure of the list, and if so, must provide the practice with a summary of any views expressed. NHS England must give the practice the opportunity to comment on all the information relating to the application before they make their decision. The practice may withdraw its application at any time before NHS England makes its decision. This must be made within 21 days from the date it received the application (or within a longer period if both parties agree). The decision will be either to:

 

a)      Approve the application and set the dates of closure and reopening of the list; or

 

b)      Reject the application.

 

12.6        A practice will not be able to make another application to close its list within 12 months of the date of this decision unless the application has been rejected (in which case different time limits) or there has been a change in circumstances affecting the ability of the practice to deliver services under its contract.

 

12.7        A decision by NHS England to give approval to an application to close a list of patients must be sent in writing to the practice as soon as possible. This should also be copied at the same time to others who were involved in this process such as the LMC and/or anyone affected by the list closure who was consulted.

 

12.8        The closure notice must include:

 

a)      The period of time the list will be closed, which must be either the period stated in the practice’s application, or a period agreed subsequently. In either case, this must be 3 months or over but cannot be longer then 12 months;

 

b)      The date the list will close; and

 

c)       The date the list will reopen (which may change should the practice and NHS England agree that the closure period will be extended or the list will reopen sooner).

 

12.9        A decision by a PCT to reject an application to close a list of patients must be sent in writing to the practice as soon as possible. This should also be copied at the same time to others who were involved in this process such as the LMC and/or anyone who was consulted.  A practice will not be able to make another application to close its list within 3 months of the date of a PCT’s decision to reject an application, or the date of any final determination in a dispute on this matter, whichever is the later. This time limit will not apply where there has been a change in circumstances affecting the ability of the practice to deliver services under its contract.

 

12.10     During a period of closure, a practice may apply to have this extended. The application must be made in writing at least 8 weeks in advance of the date the list will reopen.   The application to extend must include:

 

a)      any options the practice has considered, rejected or implemented to try to relieve the difficulties it has encountered during the closure period and, if any of these options were implemented, the level of success in reducing or eliminating these difficulties;

 

b)      the period of time during which the practice wishes its list to remain closed, which must not be more than 12 months;

 

c)       any reasonable support from NHS England which the practice considers would enable its list to reopen or would enable the period of proposed extension of closure to be minimised;

 

d)      details of any plans the practice may have to reduce or eliminate the difficulties mentioned in their application to extend the closure which would allow their list to reopen when this period elapses; and

 

e)      any other information which the practice considers necessary to bring to the attention of NHS England.

 

12.11     NHS England must acknowledge receipt of the application within 7 days of receiving it.  It must consider the application and may request any information from the practice to enable it to do so.  NHS England may enter into discussions with the practice, about what support it can provide or any changes that can be made, with both doing everything possible to enable the list to reopen.

 

12.12     Within 14 days of the receipt of the application to extend the closure period, NHS England must make a decision either to approve or reject it. Where NHS England approves an application to extend the closure period, it must notify the practice in writing as soon as possible.   A copy of the decision letter should be sent to others who were involved in discussions on the original list closure application.  This can include the LMC and/or anyone affected by the list closure who was consulted.

 

12.13     The extended closure notice must include:

 

a)      The period of time the list will be closed, which must be either the period stated in the practice’s application to extend the closure period, or a period agreed in writing between NHS England and the practice subsequently. In either case, this must be 3 months or over but not longer than 12 months;

 

b)      The date from when the closure period will be extended; and

 

c)       The date the list will reopen.

 

12.14     GP practices which disagree with decisions made by NHS England on patient list matters can invoke the NHS Disputes Resolution process by registering a dispute with the Family Health Appeal Unit of the NHSLA.



[1] There are limited exceptions to this approach, particularly for services for those suffering from Sexually Transmitted Diseases.  STI clinics can be accessed by patients without a referral from their GP.

[2] The same definition is in Regulation 2 of the PMS Regulations.

[3] The same provision is in Regulation 11(1)(c) of the PMS Regulations.

[4] The same provision is in Regulation 2 of the PMS Regulations.

[5] This provision is at paragraph 15 of Schedule 5 to the PMS Regulations.

[6] There can be subtle differences between the concepts of usual, ordinary and habitual residence but these are not relevant for present purposes.

[7] The wording of clause 13.6.3 is “Where the Contractor wishes to terminate its responsibility for a person accepted as a temporary resident before the end of three months or such shorter period for which it had agreed to accept him as a patient, the Contractor shall notify the patient either orally or in writing and its responsibility for that person shall cease 7 days after the date on which the notification was given”.  There ought to be a like provision in PMS contracts for temporary patients as a result of the wording of paragraph 15 of Schedule 5 to the PMS Regulations.

[8] See Fox v Stirk [1970] 2 QB 463 at 475E.  See also Lord Scarman in R v Barnet LBC ex parte Shah [1983] AC 309 at 342F.

[10] See paragraph 2.3 of the Guidance Note published by the Department of Health at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216467/dh_133707.pdf

[11] See paragraph 15(5) of Schedule 6 to the GMS Regulations and clause 13.5.5 of the standard GMS contract.

[12] See paragraph 19(1) of Schedule 6 to the GMS Regulations and clause 13.9.1 of the standard GMS contract.

[13] See paragraph 15(3) of Schedule 6 to the GMS Regulations and clause 13.5.3 of the standard GMS contract.

[14] See paragraph 15(4) of Schedule 6 to the GMS Regulations and clause 13.5.4 of the standard GMS contract

[15] See the definitions in Regulation 2 of the GMS Regulations.

[16] This clause is required by paragraph 15(2) of Schedule 6 to the GMS Regulations.

[17] See the definition in Regulation 2 of the GMS Regulations.

[18] The relevant provision is in paragraph 31 of Schedule 5 to the PMS Regulations.

[19] See clause 13.14.1 of the standard GMS contract as required by paragraph 25 of Schedule 6 to the GMS Regulations.  There is a like provision in 24 of Schedule 5 to the PMS Regulations.

[20] See clause 13.14.1 of the standard GMS contract as required by paragraph 25 of Schedule 6 to the GMS Regulations.  There is a like provision in 24 of Schedule 5 to the PMS Regulations.

[21] There should be like provisions included in every PMS contract.

[22] See paragraph 21 of Schedule 6 to the GMS Regulations.

[24] The same scheme is set out in paragraph 19 of Schedule 5 to the PMS Regulations.

[25] The wording of the relevant clauses is “13.10.8. A removal requested in accordance with clause 13.10.1 shall, subject to clause 13.10.9, take effect from the date on which the person is registered with another provider of essential services, or the eighth day after the Board receives the notice, whichever is the sooner. 13.10.9. Where, on the date on which the removal would take effect under clause 13.10.8, the Contractor is treating the patient at intervals of less than seven days, the Contractor shall inform the Board in writing of that fact and the removal shall take effect on the eighth day after the Trust receives notification from the Contractor that the person no longer needs such treatment, or on the date on which the person is registered with another provider of essential services, whichever is the sooner”

[26] See http://www.productiveprimarycare.co.uk/Data/Sites/1/dh_accessguide.pdf

[27] This description is taken from the relevant Guidance.

GPs and the law on commissioning NHS services.

 

This chapter contains:

 

1.          What is NHS commissioning?

2.          The legal duties on CCGs in the commissioning process.

3.          The legal duties on CCGs relevant to the commissioning process.

4.          The outputs from the commissioning process.

5.          Services that a CCG are legally required to commission.

6.          The CCG Healthcare Needs Assessment and joint strategic needs assessments.

7.          The CCG Annual Commissioning Plan.

8.          The development of CCG Commissioning Policies.

9.          Exception Policies and pick-up funding for clinical trials.

10.       The Individual Funding Request process.

11.       In year service developments.

12.       Public and patient involvement in the commissioning process.

 

 

1           What is NHS commissioning?

 

1.1           There are many definitions of the word “commissioning”.  The NHS Improvements Website describes commissioning the achievement of high quality and value-for-money services for the NHS. It states:

 

“Commissioning is a cycle of activities that includes assessing the needs of a population; analysing 'gaps'; setting priorities and developing commissioning strategies; influencing the market to best secure services and monitoring and evaluating outcomes. In other words, it involves buying in services from a range of health service providers (including GPs, dentists, community pharmacists, NHS and private hospitals, and voluntary sector organisations) to meet the health needs of local people, and monitoring how well they are being delivered. Commissioning is an on-going process that applies to all services, whether they are provided by the local authority, NHS, other public agencies, or by the independent sector”

 

1.2           The placing of contracts with a provider is thus the final act of the procurement stage of the commissioning process.  The contract is the last step in a long sequence of events that ought to take place before the decision is made by the CCG that the NHS ought to contract for any specific service.  However commissioning is a continuing process because, after the contract has been placed, the commissioner is then responsible for monitoring the performance of the contractor.

 

1.3           Hence commissioning process is thus complex.  This chapter describes some of the legal challenges which arise in the commissioning process.  It also contains an outline as to how NHS bodies are able to make lawful commissioning decisions.  The model will not be followed by every CCG in every case, but the steps which are set out below are the essential building blocks of a lawful commissioning process.

 

1.4           Commissioning is challenging for GPs who want to do the best for their patients because the demand for clinically effective healthcare treatment for individual patients (suffering from both common and rare medical conditions) vastly exceeds the ability of the NHS to fund such treatment.  NHS bodies have a finite budgets and this means that difficult choices have to be made about how services are organised and structured and, in the end, which drugs and other treatments can and cannot be provided to patients suffering from both common and rare conditions.  Once it is recognised that choices have to be made as to which treatments the NHS can afford to provide to patients, it is a legal necessity that the process of making those policy choices should be transparent and rational.

 

1.5           Section 1 of the National Health Service Act 2006 imposes a duty on the Secretary of State to continue the promotion of “a comprehensive health service”.   Some patients and clinicians rely on this section to argue that the NHS is obliged to provide them with a comprehensive service and so argue that rationing NHS services is inherently unlawful.  However inevitably it is not that straightforward.  Section 1(1) of the NHS Act provides:

 

“The Secretary of State must continue the promotion in England of a comprehensive health service designed to secure improvement—

 

(a)     in the physical and mental health of the people of England, and

 

(b)     in the prevention, diagnosis and treatment of physical and mental illness”

 

1.6           The Court of Appeal decided in Coughlan v North and East Devon Health Authority that the “duty of promotion” on the Secretary of State was not a duty to provide a comprehensive health service.  The Court accepted that budget considerations may mean that the Secretary of State could never in fact provide a service that was truly comprehensive, in that it provided services to meet all healthcare needs.  The court decided that the section meant the Secretary of State was required to use his or her powers to focus on providing as comprehensive a service as the NHS budget would permit, recognising that the NHS may never get to that state of healthcare nirvana.

 

1.7           In Coughlan the Court of Appeal was considering the wording of section 1(1) in the NHS Act 1977.  The only change since that time is that is the Health and Social Care Act 2012 changed the words in sub-section (b) from “illness” to “physical and mental illness”.  Illness” already had a wide definition in section 275 of the NHS Act which states that “includes mental disorder within the meaning of the Mental Health Act 1983 and any injury or disability requiring medical or dental treatment or nursing”.  This change accordingly appears to make no difference at all, save that it emphasises that the NHS has a duty to provide mental health services as well as services to meet physical illnesses.

 

1.8           So what is the legal effect, if any, of the duty on the Secretary of State to “continue the promotion in England of a comprehensive health service”?  The practical answer is that this section has little if any legal effect because it is difficult to imagine any set of circumstances in which the decision is required to be different because the Secretary of State has the section 1 duty.  There has been no court case concerning reorganisation of NHS services or access to NHS funded medical a treatment which (and there have been many) which, as far as I am aware, has criticised the Secretary of State for failing to discharge the section 1 duty.

 

1.9           The Court of Appeal in R (on the application of YA) v Secretary of State for Health noted that the Secretary of State has a duty to continue the promotion in England of a comprehensive health service.  The court then said:

 

“His duty under section 3 is subject to the qualification that his obligation is limited to providing the services identified to the extent that he considers that they are necessary to meet all reasonable requirements. He does not automatically have to meet all the requirements and in certain circumstances he can exercise his judgment and legitimately decline to provide them. In exercising that judgment he is entitled to take into account the resources available to him and the demands on those resources”

 

1.10        It is therefore clear that the Secretary of State does not have a statutory duty to deliver a comprehensive health service.  NHS commissioners are required to remain focused on the fact that the Secretary of State has a duty to promote the delivering of a comprehensive health service remains the ultimate aim of the NHS even if that is unachievable in practice. 

 

1.11        The real world of restricted budgets (which is fully recognised by the courts) means that lawful commissioning needs to focus on how decisions are made.  Commissioning is concerned with the process by which decisions are made in the NHS because, whenever a decision is made, there will be winners and losers.  There will be patients and clinicians who secure the funds for the services they have been seeking and there will be those that are disappointed (and often angry) and feel that the wrong decision has been taken.  The focus of this chapter will therefore be on the process of taking decisions and the challenges of ensuring that the decision making process is legally robust.

 

1.12        The NHS has a Constitution to which all NHS bodies, including Clinical commissioning Groups (“CCGs”) are required to “have regard to the NHS Constitution”:  see section 2 of the Health Act 2009.   The duty to “have regard” to the NHS Constitution during a decision making process means that the CCG is obliged to understand the terms of the NHS Constitution and act in accordance with the principles set out in that document unless it has a very good reason to depart from those principles.  The relevant part of the NHS Constitution on commissioning provides:

 

“The NHS commits to make decisions in a clear and transparent way, so that patients and the public can understand how services are planned and delivered.”

 

1.13        Hence, throughout the commissioning process, there is a need for CCGs to act in a clear and transparent way, and to ensure that they can defend their reasoning at all times within the commissioning decision making process.  It also ties in to the central importance of public participation in the commissioning process which is considered at chapter 11 below.

 

2           The legal duties on CCGs in the commissioning process.

 

2.1           Regulation 34(1) of the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (“the 2012 Regulations”) imposes a legal obligation on every CCG to have “arrangements for making decisions and adopting policies on whether a particular health care intervention is to be made available for persons for whom the relevant body has responsibility”.  This legal duty means that the CCG must set up transparent processes which explain how it will go about making decisions in its annual commissioning round, who will be consulted, who will take the decisions and how these will be translated into contracts with its providers. 

 

2.2           The wording of the legal duty is to “make arrangements”.  This form of words is used in many other places in the NHS Act and in other legislation which imposes statutory duties on public bodies.  The nature of the duty to make arrangements gives a considerable amount of discretion to the CCGs.  Subject to other legal constraints (some of which are described below), CCGs are able to decide for themselves what decision making processes they should adopt.   However once the CCG has its “arrangements” in place the CCG comes under a public law legal duty to follow its own procedures when making commissioning decisions.

 

2.3           Some guidance about the meaning of a duty to make “arrangements” was given by Underhill LJ in the first instance decision of R (Nash) v Barnet London Borough Council (Capita plc and others, interested parties [2013] EWHC 1067 (Admin).  The case was only a permission decision and so is of limited weight but it is a full judgment by a distinguished judge and was subsequently upheld by the Court of Appeal.  The Judge was concerned with a duty to make arrangements to secure best value under local government legislation.   However his approach may have relevance for understanding the nature of the duty on CCGs to make arrangements under section 14O of the NHS Act.  He said at paragraph 70:

 

“..  the reference to 'making arrangements' would make it clear that the duty was concerned with intentions rather than outcome. It may also be that the draftsman wanted to emphasise the need to build the fulfilment of the best value duty into authorities' plans and procedures. Or perhaps it is just circumlocution. But, whatever the explanation, the important point for present purposes is what the arrangements are aimed at, namely securing improvements in the way in which authorities perform their functions”

 

2.4           Thus the legal duty is to ensure that the way in which the CCG undertakes its commissioning functions is clearly set out in an overarching CCG policy.  The "arrangements" which the CCG is required to put in place under section 14O need to describe the commissioning process from its initial assessment of needs through to how the CCG takes commissioning contracting decisions.   In Tandy v East Sussex CC [1998] A.C. 714 Mummary LJ emphasised the width of the discretion on a public body which had a duty to make arrangements (in that case about the education of children with special educational needs).  He said:

 

“In the interests of fairness, consistency and administrative efficiency a local education authority is entitled to formulate a policy setting norms, standards and criteria to be applied in the consideration of the circumstances of individual children. Such a policy is lawful if it promotes the specified statutory purpose and is sufficiently flexible not to fetter the decision-making process in individual cases. Further, once a policy has been formulated, it is permissible (and advisable) to review it from time to time in the light of experience and of changing circumstances”

 

2.5           The importance of a CCG having a clear policy which formally guides decision making in this difficult area was recognised by the courts in North West Lancashire Health Authority v A & Ors [1999] EWCA Civ 2022 where Auld LJ said:

 

“.. it is an unhappy but unavoidable feature of state funded health care that Regional Health Authorities have to establish certain priorities in funding different treatments from their finite resources. It is natural that each Authority, in establishing its own priorities, will give greater priority to life-threatening and other grave illnesses than to others obviously less demanding of medical intervention. The precise allocation and weighting of priorities is clearly a matter of judgment for each Authority, keeping well in mind its statutory obligations to meet the reasonable requirements of all those within its area for which it is responsible. It makes sense to have a policy for the purpose - indeed, it might well be irrational not to have one …”

 

2.6           However the overall purpose of the arrangements must be borne in mind and the fact that, whatever arrangements the CCG sets up, they must achieve the aim of describing the commissioning decision making process of the CCG, thus ensuring that patients and the public have a clear understanding as to how decisions are made.   Speaking in the House of Lords in Tandy case Lord Browne-Wilkinson said at Page 747:

 

The duty is to make arrangements for what constitutes suitable education for each child. That duty will not be fulfilled unless the arrangements do in fact provide suitable education for each child”

 

2.7           Thus the arrangements made by the CCG must in fact deliver a proper system for decision making on commissioning matters within the CCG.

 

2.8           Once the CCG has settled on its commissioning arrangements, Regulation 36 of the 2012 Regulations provides that the CCG must publicise those arrangements.  It provides :

 

“Each relevant body must compile information in writing describing the arrangements it has made pursuant to the requirements in regulation 34 and must ensure that that information is—

 

(a)  published on the website of the relevant body; and

 

(b)  available to inspect at the head or main office of the relevant body”

 

2.9           Thus the “arrangements” that the CCG has in place which set out how it will make commissioning decisions, which lead to the decisions that the CCG makes about its  policies on whether a particular health care intervention is to be made available for persons for whom the relevant body has responsibility must be clearly set out on the CCG website.  A trawl of CCG websites in December 2013 (without naming names) suggests that relatively few CCGs have complied with this duty. 

 

3           The legal duties on CCGs relevant to the commissioning process.

 

3.1           The Health and Social Care Act 2012, which created CCGs, imposed a series of legal duties on the new NHS commissioning bodies.  These are in general, target duties which are required to guide and focus the CCG’s decision making processes.  GPs who play a part in CCGs therefore need to understand the nature and effect of the duties and to pay careful attention to each of the statutory duties imposed on the CCG within the commissioning process.  The audit trial of documents produced by the CCG needs to demonstrate that the CCG understands each of these duties and records the extent to which it is has focused upon each duty when making relevant decisions. 

 

3.2           The general legal duties imposed on CCGs are:

 

a)         A duty to act with a view to securing that health services are provided in a way which promotes the NHS Constitution:  see section 14P of the NHS Act;

 

b)         A duty to exercise the CCG functions effectively, efficiently and economically:  see section 14Q of the NHS Act;

 

c)          A duty to exercise CCG functions with a view to securing continuous improvement in the quality of services provided to individuals for or in connection with the prevention, diagnosis or treatment of illness:  see section 14R(1) of the NHS Act;

 

d)         A duty to act with a view to securing continuous improvement in the outcomes that are achieved from the provision of the services:  see section 14R(2) of the NHS Act.  “Relevant outcomes” for these purposes means outcomes which show—

 

(a)  the effectiveness of the services,

(b)  the safety of the services, and

(c)   the quality of the experience undergone by patients

 

e)         A duty to regard to any guidance published by NHS England on the discharge of their commissioning functions (see section 14Z8 of the NHS Act);

 

f)           A duty to assist NHS England in NHS England’s duty to secure that there is continuous improvement in the quality of services provided to individuals for or in connection with the prevention, diagnosis or treatment of illness and continuous improvement in the outcomes that are achieved from the provision of the services:  see section 14S of the NHS Act;

 

g)          A duty to have regard to the need to—

 

(a)  reduce inequalities between patients with respect to their ability to access health services, and

(b)  reduce inequalities between patients with respect to the outcomes achieved for them by the provision of health services:  (see section 14T of the NHS Act).

 

h)         A duty to promote the involvement of patients, and their carers and representatives (if any), in decisions which relate to—

 

(a)  the prevention or diagnosis of illness in the patients, or

 

(b)  their care or treatment (see section 14U(1) of the NHS Act);

 

i)           A duty to have regard to guidance published by NHS England concerning the duty to involve patients in decision making under section 14U(1) of the NHS Act (see section 14U(3) of the NHS Act);

 

j)            A duty to act with a view to enabling patients to make choices with respect to aspects of health services provided to them (see section 14V of the NHS Act);

 

k)          A duty to promote innovation in the provision of health services (including innovation in the arrangements made for their provision) (See section 14X of the NHS Act);

 

l)           A duty to promote research on matters relevant to the health service and the use in the health service of evidence obtained from research (see section 14Y of the NHS Act);

 

m)        A duty to promote education and training for persons who are employed, or who are considering becoming employed, in an activity which involves or is connected with the provision of services as part of the health service in England (see a combination of section 1F(1) and section 14Y of the NHS Act);

 

n)         A duty to promote integration between the services that the CCG commissions and other health and social care services (see sections 14Z1 of the NHS Act).

 

3.3           Each of these duties are legal obligations which are concerned with the way in which commissioning functions are undertaken and which impose duties on the CCG to have regard to particular factors when commissioning decisions are taken.  They do not require the CCG to make commissioning decisions (such as commissioning a specific service or keeping a specific hospital open) but are concerned with ensuring that CCG take into account defined factors when making these decisions.  It is difficult to describe precisely what each of these duties mean in practice in any particular circumstances because the relevance of each factor will depend on the circumstances of each commissioning decision.  However the following is general guidance which emerges from the observations of Aitkens LJ in R (Brown) v Secretary of State for Work and Pensions [2008] EWHC 3158 (Admin) which was concerned with the similarly worded duties under the Equality Act 2010:

 

a)         Decision makers in a CCG must be made aware of each of the above duties.  A CCG is likely to be in difficulties in asserting that it has followed its legal obligations in making commissioning decisions if those who have made the decisions were not aware of each one of the legal duties set out above;

 

b)         The mind of the decision maker must be focused on each of the above duties at some relevant point during the commissioning decision making processes.  Decision makers must have a “conscious approach and state of mind” which is focused upon the legal obligation when they are taking commissioning decisions;

 

c)          Each legal duty must be exercised in substance, with rigour and with an open mind;

 

d)         The duties are non–delegable duties;

 

e)         The duties are continuing duties throughout the commissioning process;

 

f)           It is good practice for those exercising public functions in public authorities to keep an adequate record showing that they had actually considered their duties and pondered relevant questions. Proper record-keeping encourages transparency and will discipline those carrying out the relevant function.

 

3.4           There is a specific legal duty to seek public health advice.  Interestingly, despite the myriad of legal duties on a CCG, there is no duty to seek legal advice.  In undertaking commissioning duties, there is a legal duty on a CCG to seek external advice in specific areas.  The wording of the duty is as follows:

 

“Each clinical commissioning group must obtain advice appropriate for enabling it effectively to discharge its functions from persons who (taken together) have a broad range of professional expertise in—

 

(a)  the prevention, diagnosis or treatment of illness, and

 

(b)  the protection or improvement of public health”

 

3.5           The reference to the requirement to seek advice from a “broad range of professional expertise” means that the CCG is required to seek advice from more than one person.  The CCG almost certainly will not discharge this duty of it only relies on the expertise of its own GP professionals because these individuals are potential decision makers.  It is to see that the duty is discharged if the CCG relies purely on internal expertise because that would mean that one or more persons would be acting both advisors and decision makers.   These appear to be incompatible roles.  NHS England has a power (but not a duty) to publish advice on how the CCG should seek advice in order to discharge this duty.  At this point (December 2013) no guidance appears to have been published by NHS England about how they recommend CCGs exercise this statutory duty.

 

3.6           Unlike some of the target duties set out above, the duty to seek advice is clear.  A CCG will act unlawfully if it fails to seek appropriate advice within the commissioning processes.  There is no specific obligation in the NHS Act to require the CCG to publish the advice that it receives.  However the advice would not be covered by legal professional privilege because it is not legal advice.  It is therefore difficult to see any exemption under the Freedom of Information Act 2000 which the CCG could rely on refuse to publish any advice that it has received.

 

3.7           Regulation 34 of the 2012 Regulations provides that the arrangements that the CCG has in place for making commissioning decisions will ensure that the CCG funds Technology Assessment Guidance published by the National Institute for Health and Clinical Effectiveness (“NICE”).  The requirement to fund NICE TAGs is explored at chapter 5 below.

 

3.8           Regulation 34(2) also provides:

 

“(2) Arrangements under paragraph (1) must—

 

..

 

(b)  include arrangements for the determination of any request for the funding of a health care intervention for a person, where there is no relevant NICE recommendation and the relevant body’s general policy is not to fund that intervention”

 

 

3.9           Regulation 34(2) thus requires the CCG to set up an Individual Funding Request (“IFR”) process, the details of which are explored below.

 

4           The outputs from the commissioning process.

 

4.1           The ultimate question for the GP sitting in his or her surgery (and of course for the patient) is whether a local hospital will continue to provide a full A & E service, whether physiotherapy services will be commissioned by each GP practices or across a wider area and whether an individual patient will be funded by the NHS for a clinically appropriate treatment or intervention for that patient.  Each of the examples above is a commissioning decision which flow ought to flow from the annual commissioning process operated by the CCG.  At the level of an individual patient (which is often the issue facing a GP in his or her consulting room) the outcome of commissioning process is that a decision to approve funding for a patient to be provided with NHS funded treatment can be made by an NHS commissioners based on only one of 3 routes, namely:

 

a)         By applying the terms of an approved CCG or NHS England commissioning policy (funding through a “a Commissioning Policy Decision”);

 

b)         By making a decision that a patient is within a recognised exception to a CCG or NHS England commissioning policy PCT (funding through an “Exception Policy Decision”); or

 

c)          By making an individual funding decision outside of CCG or NHS England existing commissioning policies (“An Individual Funding Request ("IFR") policy Decision”).

 

4.2           A lawful commissioning decision referable to an individual patient is typically made at the end of a 4 stage decision making process which is adopted by most NHS bodies.  Every stage of the commissioning process is not undertaken every year because decisions referable to many treatment areas are rolled over from year to year but elements of the 4 stage process should be present each year as part of any rational CCG commissioning process.  The 4 main stages within the decision making process for those commissioning NHS care, and thus carrying the responsibility for managing NHS budgets, are as follows:

 

a)         The development of a healthcare needs assessment;

 

b)         Using the outputs of the healthcare needs assessment to construct an Annual Commissioning Plan;

 

c)          Setting commissioning policies for individual medical conditions; and

 

d)         Agreeing policies concerning In-Year Service Developments and Individual Funding Requests.

 

4.3           Thus the “arrangements” that the CCG is obliged to have in place in order to discharge its legal duty under Regulation 34 of the 2102 Regulations ought to describe the processes that the CCG will follow to go through each of the above processes, and thus allow patients to understand the decision making process which leads up to a final decision on whether the treatment they are requesting will or will not be routinely funded under a commissioning policy.  It should also describe whether funding could be secured through an Exception Policy and how the CCG Individual Funding Request process will operate.

 

4.4           Getting through the above procedures requires GPs to be involved in the difficult business of priority setting.  In conducting this exercise it is important for commissioners to bear in mind that it is potentially lawful for CCG to adopt a policy which provides that provides the NHS will not fund medically appropriate treatment even if this has the capacity to benefit a group of patients.  Commissioning involves making tough (and sometimes near impossible) choices.  GP commissioners are entitled to decide that their substantial but nonetheless limited financial resources should be used to fund other treatments for one group of patients in preference to another group.  That will inevitably leave disappointed patients and clinicians where clinically effective medical interventions are decided not to have a sufficient priority to justify funding.  These decisions will, almost inevitably, come under intense public scrutiny.  It is thus essential that they are taken in a transparent and lawful manner The primary duty on GP commissioners is therefore for take these decisions in a rational way by following a lawful procedure.  That procedure needs to ensure that the CCG complies with all of the legal duties set out above.

 

4.5           There are a large number of people who have either a legitimate or a commercial interest (and sometimes both) of having a say within the commissioning process.  These include:

 

a)         Patients (whose rights to be involved are discussed at chapter 12 below);

b)         The GP members of the CCG;

c)          Non-GP members of the CCG;

d)         Provider NHS Trusts;

e)         Other providers of healthcare services to the NHS;

f)           Universities and other providers of training for clinical staff;

g)          Persons who are engaged in clinical research which may be affected by CCG decisions;

h)         Clinicians;

i)           Drug companies and other organisations that  supply goods and services to the NHS.

 

4.6           A key part of that decision making process is recognising the right of everyone who has a proper interest in the outcome of the commissioning process to have their say during the process.  The CCG will remain the final decision maker but many of the above have the right to have an input into the process and to have their views properly considered by the CCG before final decisions are made.  The commissioning process thus involves a series of complex challenges which GPs need to surmount in order to be confident that CCG decisions are legally robust.

 

5           Services that a CCG are legally required to commission.

 

5.1           The Secretary of State has never taken on the role of deciding what medical treatment should be provided to specific patients.  The political realities of the NHS mean that it is virtually impossible for an elected politician to make the decision that a specific medical treatment should not be funded for a patient or group of patients.  Politicians need to get elected and, once in ministerial office, are understandably concerned to ensure they do not do anything which adversely affects their chances of being re-elected.  The NHS was therefore set up from 1948 to 2013 with a series of local decision makers who, acting on delegated authority form the Secretary of State, decided what services should be available in their locality to NHS patients.  Large capital spending was controlled from Whitehall but decisions about how to spend local budgets and hence what treatment was funded for what patient have always been matters for local decision making.

 

5.2            “Local decision making” creates the inevitability that different localities will make different decisions.  This is the origin of the common complaint against the NHS of “Post Code Prescribing”.  However the only logical way to remove Post Code Prescribing is to make resource allocation decisions at a regional or even national level.  That has 2 significant policy problems.  First, it means that the Minister comes much closer to deciding which patient gets which drug or medical treatment.  Second, it makes it very difficult to hold local NHS units financially accountable for the performance of the NHS in their area.  The local NHS can only be required to operate within financial balance if it is able to control where the money is spent.  But, on the other hand, Ministers have wanted to ensure that the “national” health service provides as equal a service as possible across the whole nation.

 

5.3           The Labour government of 1997 to 2001 recognised the tension between local decision making and post code prescribing.  Its solution was to create the National Institute for Clinical Excellence, later renamed as the National Institute for Health and Clinical Excellence, commonly known as “NICE”.   NICE’s function is to evaluate specific medical interventions and make “recommendations” to the NHS and local authorities about the intervention under consideration.  NICE describes its own functions as:

 

“NICE guidance supports healthcare professionals and others to make sure that the care they provide is of the best possible quality and offers the best value for money.

 

We provide independent, authoritative and evidence-based guidance on the most effective ways to prevent, diagnose and treat disease and ill health, reducing inequalities and variation

 

In other words, it is driven by the twin aims of producing guidance which recognises that NHS services should be both cost-effective and clinically effective.

 

5.4           Although NICE may not see it this way, GP commissioners can divide the guidance that NICE produces broadly into 2 types:

 

a)         Technology Appraisal Guidance (“TAGs”); and

 

b)         All other NICE Guidance.

 

5.5           The TAG process assesses the clinical and cost effectiveness of health technologies, such as new pharmaceutical and biopharmaceutical products, but also include procedures, devices and diagnostic agents. NICE suggests that its intention is to attempt to ensure that “all NHS patients have equitable access to the most clinically - and cost -effective treatments that are available”.  However that ambition would only be achieved if all medical treatments had been subject to binding NICE Guidance.  In fact only a tiny proportion of the medical delivered by the NHS is set out in binding NICE Guidance and so this ambition is still a very long way from being achieved.

 

5.6           In 2003 the Secretary of State converted NICE TAGs which “recommended” NHS commissioners fund a particular treatment for a particular patient group into a legal obligation by issuing directions to require primary care trusts to fund interventions in accordance with the relevant NICE TAG.  The directions required the PCT to allocate funding for recommended treatment for patients within the cohort described in the TAG within 90 days of the publication of the final TAG (unless the Secretary of State exempted the TAG from the scheme).  There were a few exemptions but in the vast majority of cases a decision from NICE by-passed any prioritisation process because it effectively top sliced an NHS commissioner’s budget by requiring funds to be made available for a particular treatment for a particular group of patients.

 

5.7           The Health and Social Care Act 2012 abolished PCTs and replaced them with clinical commissioning groups.  One key difference between PCTs and CCGs was that the Secretary of State was not given power by the 2012 Act to issue directions to CCGs.  The omission of the power for the Secretary of State to give directions to CCGs was not an error.  The then Secretary of State, Andrew Lansley, thought that the role of the Secretary of State was to set the strategic framework for the NHS and then allow local decision making to operate to run the NHS at a local level without being impeded by Whitehall.  It followed that CCGs were deliberately not included in the list of bodies to whom the Secretary of State could give directions in section 8 of the NHS Act.  On effect of this policy was that from April 2013, the legal requirement on local NHS commissioners to fund medical treatments set out in NICE TAGs could therefore not be enforced through directions.

 

5.8           The new mechanism to reduce Post Code Prescribing in the NHS is section 237 of the Health and Social Care Act 2012.  This allows the Secretary of State to make Regulations which replicate the former system which was enforced by Directions.  The relevant Regulations are the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013.  Regulation 7 provides:

 

“NICE may make a technology appraisal recommendation—

 

(a)  in relation to a health technology identified in a direction given by the Secretary of State;

 

(b)  that recommends that relevant health bodies provide funding within a specified period to ensure that the health technology be made available for the purposes of treatment of patients”

 

5.9           Regulation 7(6) then provides that a CCG must comply with a technology appraisal recommendation.  CCGs must also provide funding to support patients who could benefit from TAGs which were included in Directions to PCTs which were made prior to 1 April 2013 (see Regulations 34 and 34 of the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012).

 

5.10        The remaining Guidance produced by NICE is hugely useful for CCGs in assessing whether a particular medical intervention or care pathway provides clinically effective and/or cost effective medical treatment.  However, other than TAGs, there is no legal requirement on CCGs to follow guidance issued by NICE.  Some NICE guidance is routinely followed by virtually all CCGs but other guidance is departed from by many CCGs throughout the country.  Hence, for example, NICE Guidance 156 recommends that CCGs should fund up to 3 cycles of In-Vitro Fertilisation for infertile women up to the age of 42.  There are relatively few CCGs which fund IVF to that extent.

 

5.11        However even though CCGs do not have a legal obligation to implement CCG Guidance, they have a legal obligation to look at the guidance, understand what it is recommending and to consider whether to implement it.  This was explained by Dyson J in R (on the application of Fisher) v North Derbyshire Health Authority [1997] EWHC Admin 675 who said:

 

“If the Circular provided no more than guidance, albeit in strong terms, then the only duty placed upon health authorities was to take it into account in the discharge of their functions. They would be susceptible to challenge only on Wednesbury principles if they failed to consider the Circular, or they misconstrued or misapplied it whether deliberately or negligently: see Grandsden & Co Ltd and another -v- Secretary of State and Another (1985) 54 P&CR 86, 93 – 94”

 

5.12        A CCG will act thus unlawfully if it does not consider relevant NICE guidance (or potentially other relevant guidance which it would be unlawful to fail to consider) when making a commissioning policy decision or if the CCG misunderstands the guidance or misapplies it.  In contrast the CCG will be acting lawfully if it considers relevant guidance as part of a decision making process but makes the decision not to follow the guidance for a good reason.  Allocating the medical treatment a lower level of priority than suggested by NICE is a potentially good reason.  See for example R (Condliff) v North Staffordshire Primary Care Trust [2011] EWHC 872 (Admin) and the same case in the Court of Appeal.  In order to ensure that the CCG can show that it has acted lawfully it is preferable if the document trail leading up to the commissioning decision shows on the face of the relevant documents that the relevant NICE Guideline has been properly considered.

 

6           The CCG Healthcare Needs Assessment and joint strategic needs assessments.

 

6.1           The development of a healthcare needs assessment for either a patient group (e.g. breast cancer patients) or a particular service area (e.g. rehabilitation services) is the first step in CCG deciding what medical services should be commissioned for its population.  Unless the CCG has a clear understanding of the needs of the local population for medical services it cannot carry out any meaningful priority setting exercise.  This was previously a task for NHS bodies alone but the need to integrate health and social care services means that this task is now very largely undertaken jointly by a CCG with the relevant local social services authority working, through the Health and Wellbeing Board.

 

6.2           Section 116 of the Local Government and Public Involvement in Health Act 2007, required NHS bodies to carry out joint strategic health needs assessments.  This legal obligation was effective from April 2008.  The legal structure of obligations around joint strategic health needs assessments was amended by sections 192 and 193 of the Health and Social Care Act 2012, and Health and Wellbeing Boards were created by section 194 of the 2012 Act.  The present legal structure is as follows:

 

a)         CCGs are required to work with the relevant local authority (which in a 2 tier local authority areas is the County Council) to prepare a joint strategic health needs assessment for the delivery of health and social care functions for the  Health and Wellbeing Board;

 

b)         There is a duty under section 116A(5) to involve the Local Healthwatch organisation and to involve the “the people who live or work in the area” in the preparation of that strategy;

 

c)          The joint strategic health needs assessment must be published by the local authority;

 

d)         Once the joint strategic health needs assessment has been prepared, the CCG have a duty to “have regard” to that strategy when exercising any of its functions (see section 116B(1) of the Local Government and Public Involvement in Health Act 2007).

 

6.3           The duty to “have regard” to a plan or set or assessment is a term of art in public law statutes.  It means that, when exercising relevant statutory functions:

 

a)         Decision makers in a CCG must be made aware of the joint strategic health needs assessment when making commissioning decisions.  A CCG cannot assert that it has followed its legal obligation to have regard to the joint strategic health needs assessment in making commissioning decisions if those who made the decisions were not aware of the relevant recommendations in the assessment document.  In practice this means that relevant decision makers must be focused on the recommendations of the joint strategic health needs assessment during the commissioning processes.  Decision makers must have a “conscious approach and state of mind” which is focused upon this particular legal obligation when they are taking commissioning decisions;

 

b)         The duty to have regard to the joint strategic health needs assessment must be exercised in substance, with rigour and with an open mind;

 

c)          The duty is non–delegable.  It rests on the key decision makers within the CCG and cannot be discharged by officers of the CCG alone considering the joint strategic health needs assessment;

 

d)         The duty to have regard to the joint strategic health needs assessment is a continuing duty throughout the commissioning process;

 

e)         It is good practice for the CG to keep an adequate record showing that they had actually considered this duty and pondered relevant questions. Proper record-keeping encourages transparency and will discipline those carrying out the relevant function.

 

6.4           However the CCG is not bound to adopt each and every one of the priorities in the joint strategic health needs assessment.  It can reach its own view about priorities provided, in doing so, it has properly had regard to the joint strategic health needs assessment.  The CCG does need to have good reasons to depart from the priorities set out in the joint strategic health needs assessment. 

 

6.5           The CCG healthcare needs assessment should  explain the need for health and social care of each particular patient group or service area, consider the options for funded treatment and explore the costs, benefits and priorities within the services that could be provided to that patient group or service area.  The healthcare needs assessment is only concerned with the needs of a particular patient group (or a particular service) but can offer a view on the options and priorities for investment for the development of services for that patient group or service area.

 

6.6           The healthcare needs assessment is often an “ideal” description of the service to be provided to a patient group or sometimes ends up describing an ideal healthcare service which is either impractical or unaffordable.  It is a common complaint that the cumulative cost to NHS commissioners of all the healthcare needs assessments vastly exceeds the resources available to the NHS Commissioners to fund all of the services in the assessments.  However the joint strategic health needs assessment feeds into the next stage of the CCG commissioning process, namely the preparation of an annual commissioning plan.

 

7           The Annual Commissioning Plan

 

7.1           The next stage for the GP Commissioners is to make decisions about which elements of which healthcare services for which patient groups are affordable for the CCG in the coming financial year. To do this NHS Commissioners are required to consider the relative priority to be allocated to the different proposed services for the coming financial year.  This process needs to be informed by the joint strategic health needs assessment.   This was formerly known as the annual commissioning plan process and is now largely known as the commissioning framework

 

7.2           In making choices between investments in different patient groups the GP Commissioners have a legal duty to consult patients, representative organisations, the local Healthwatch, the public, clinicians and key stakeholders such as the local Health and Overview Scrutiny Committee.  Further details about the duty to involve the public within the commissioning process is set out at chapter 12 below.

 

7.3           Decisions about the relative priorities of different calls on the CCG budget will be guided by a number of factors including:

 

·       Guidance from NHS England;

·       Legal requirements such as NICE Technology Assessment Guidance (where the NHS Commissioner is legally obliged to offer treatment and thus strictly the decisions sit outside a priority setting process);

·       The outcome of local consultations and any agreed local priories;

·       National NHS policy;

·       The CCG’s own policy on ethical decision making including the requirement to tackle health inequalities;

·       The evidence of the clinical effectiveness and cost effectiveness of the various treatments set out in the healthcare needs assessment; and

·       Where investment is presently provided, new opportunities for investment and where existing services should be reduced in order to fund new investment areas.

 

7.4           The assessment of relative priorities ought to involve both new investments and existing services and treatments.   There should be no assumption that, as a matter of law, an NHS treatment which is provided in one financial year will be continued in subsequent years.  A commissioner could take a lawful decision to cease a service or a treatment for an individual patient which did not have sufficient priority to justify the continuance of the treatment or service.  Funding will be released either by efficiency savings or by stopping a low priority treatment or service.  A process for doing this is programming budgeting.

 

7.5           NHS commissioners often decide that a medical treatment may be clinically effective but decline to fund the treatment because they conclude that it is not “cost effective”. Cost effectiveness is central to commissioning because CCGs have duties to exercise their functions effectively, efficiently and economically (see section 14Q of the NHS Act) and also have a strict legal duty to balance the books at the end of the year:  see section 223H of the NHS Act.  CCGs not entitled to spend more money that the government gives them each year (although there are so many “fiddles” when NHS organisations are going through hard times that this legal duty is not as absolute in practice as it seems in theory).  That means that CCGs will have to make choices about how to use their resources to deliver the most benefits to the most patients.

 

7.6           Hence a key issue is whether a proposed treatment delivers value for money or, in the language of the NHS, is cost effective.  But how can you compare money spent on cancer treatment, GP surgeries or stop smoking campaigns?  All are intended to deliver health benefits and all are funded out of the same budget, but commissioners need a system to compare one investment against another.  NICE use a scheme for assessing cost effectiveness called the “Quality Adjusted Life year”.  For details see NICE’s website but the following is an adapted version of their explanation.

 

7.7           Although one treatment might help someone live longer, it might also have serious side effects.  For example, it might make them feel sick, put them at risk of other illnesses or leave them permanently disabled.  Another treatment might not help someone to live as long, but it may improve their quality of life while they are alive (for example, by reducing their pain or disability).  The QALY method helps NICE measure these factors so that they can compare different treatments for the same and different conditions. A QALY gives an idea of how many extra months or years of life of a reasonable quality a person might gain as a result of treatment (particularly important when considering treatments for chronic conditions).

 

7.8           A number of factors are considered when measuring someone's quality of life, in terms of their health. They include, for example, the level of pain the person is in, their mobility and their general mood. The quality of life rating can range from negative values below 0 (worst possible health) to 1 (the best possible health). Having used the QALY measurement to compare how much someone's life can be extended and improved, NICE then consider cost effectiveness - that is, how much the drug or treatment costs per QALY.  This is the cost of using the drugs or other interventions to provide a year of the best quality of life available - it could be one person receiving one QALY, but is more likely to be a number of people receiving a proportion of a QALY - for example 20 people receiving 0.05 of a QALY.

 

7.9           Cost effectiveness is expressed as ‘£ per QALY'.  Each drug is considered on a case-by-case basis. Generally, however, if a treatment costs more than £20,000-30,000 per QALY, then it would not be considered cost effective.  It gets more complicated if the drug only delivers benefits for a proportion of the patient population.  Even where the patient population for a drug can be identified carefully by reference to clinical factors, the drug may still only have beneficial effects for 1 in 3 or even 1 in 20 of the population.  That affects the cost effectiveness because all of the patients in the group need to be started on a treatment in order to see who will benefit.  Thus the “cost effectiveness” calculations need to take account of the costs of treating all the other patients who have not shown a positive reaction to the drug.

 

7.10        CCGs do not have the resources to undertake comprehensive cost effectiveness calculations for every treatment that they fund.  However they should be guided by these principles in reaching decisions as to what to fund and, crucially, what not to fund.

 

7.11        It is likely that investments in the services presently funded will have been developed as services have developed over several years.  However the fact that funding has been provided to a service in the past should not create any necessary presumption that funding for that service should continue in future years.   Funding for new investments planned for the service ought to compete with existing investments and the need to make efficiency savings, with the NHS body attempting annually to determine how to expend monies in the most effective way for the cohort of patients it serves.  This annual process determines the pace of investment and also the order in which investment in any particular service are made.

 

7.12        Until April 2013 it was good practice for a primary care commissioning body to prepare an annual commissioning plan.  This is now a statutory duty under section 14Z11 of the NHS Act 2006.  This provides:

 

(1)     Before the start of each relevant period, a clinical commissioning group must prepare a plan setting out how it proposes to exercise its functions in that period.

 

(2)     In subsection (1), “relevant period”, in relation to a clinical commissioning group, means—

 

(a)     the period which—

 

(i)     begins on such day during the first financial year of the group as the Board may direct, and

 

(ii)     ends at the end of that financial year, and

 

(b)     each subsequent financial year.

 

(3)     The plan must, in particular, explain how the group proposes to discharge its duties under—

 

(a)     sections 14R, 14T and 14Z2, and

 

(b)     sections 223H to 223J.

 

(4)     The clinical commissioning group must publish the plan.

 

(5)     The clinical commissioning group must give a copy of the plan to the Board before the date specified by the Board in a direction.

 

(6)     The clinical commissioning group must give a copy of the plan to each relevant Health and Wellbeing Board.

 

(7)     The Board may publish guidance for clinical commissioning groups on the discharge of their functions by virtue of this section and sections 14Z12 and 14Z13.

 

(8)     A clinical commissioning group must have regard to any guidance published by the Board under subsection (7).

 

(9)     In this Chapter, “relevant Health and Wellbeing Board”, in relation to a clinical commissioning group, means a Health and Wellbeing Board established by a local authority whose area coincides with, or includes the whole or any part of, the area of the group”

 

7.13        Each CCG must therefore publish a commissioning plan before the start of each financial year.  This must explain what services the CCG proposes to commission in the coming year and in particular the commissioning plan must cover:

 

a)         How the CCG proposes to exercise its functions with a view to securing continuous improvement in the quality of services provided to individuals for or in connection with the prevention, diagnosis or treatment of illness;

 

b)         How, in the exercise of its functions, the CCG proposes to have regard to the need to:

 

                           i)            reduce inequalities between patients with respect to their ability to access health services, and

 

                         ii)            reduce inequalities between patients with respect to the outcomes achieved for them by the provision of health services;

 

c)          How the CCG proposes to undertake its patient involvement duties under section 14Z2 (as to which see below);

 

d)         How it proposes to discharge its functions in order to stay within its revenue resource limit and thus comply with its statutory duty under section 223H of the NHS Act; and

 

e)         How it proposes to discharge its functions in order to ensure that its capital expenditure does not exceed the limit set by NHS England and thus comply with its statutory duty under section 223J of the NHS Act.

 

7.14        The commissioning plans that CCGs are under a statutory duty to publish in advance of April each year will have considerable legal consequences for CCGs.  A failure to publish a commissioning plan would be an unlawful act by a CCG which can be challenged by way of a Judicial Review.  Equally publishing a plan which fails to comply with the above requirements could be challenged by way of Judicial Review.  Once a plan is published the CCG will be required (as a matter of public law) to make decisions in accordance with the plan unless the CCG has good reasons for departing from the plan.  In such a case, in order to ensure that the CCG can take lawful decisions, it would be advisable for the CCG to publish amendments to the plan during the year to take account of changes that happen after the plan is published. 

 

8           The development of CCG Commissioning Policies.

 

8.1           Once the annual commissioning plan has been agreed, the precise details of the services that are to be commissioned for each patient group or specialised service need to be formulated in Commissioning policies, which must also be informed by the joint strategic health needs assessment. These policies set out agreed care pathways and define clinical criteria which set out which patients are entitled to NHS funded healthcare for each medical condition.  Once a policy has been agreed, patients are entitled to expect that the CCG will routinely agree to fund the medical treatment set out in the policy patients who fulfil for the stated clinical criteria.  Patients whose clinical criteria are outside the policy will not be routinely funded even if the medical treatment has the potential to benefit an individual patient.  However there is always the possibility of the CCG making an individual decision to depart from its own policy.

 

8.2           Regulation 35(1) of the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 imposes a duty on the CCG to give reasons for its decisions in favour or against funding any particular healthcare intervention.  It provides:

 

“(1)  A relevant body must—

 

(a)  publish on its website a written statement of its reasons for any general policy it has on whether a particular healthcare intervention is to be made available for persons for whom it has responsibility; or

 

(b)  where it has not published such a statement, provide a written statement of the reasons for any such policy when any person makes a written request for such a statement.

 

(2) Where a relevant body—

 

(a)  makes a decision to refuse a request for the funding of a health care intervention for a person; and

 

(b)  its general policy is not to fund that intervention,

 

the relevant body must provide that person with the reasons for that decision in writing”

 

8.3           These are potentially onerous responsibilities because they require the CCG to formulate reasons as to why it funds or declines to fund a particular healthcare intervention.  There is a considerable amount of caselaw on the duty to give reasons which is beyond the scope of this guide.  However the general principle is that reasons was explained by Lord Brown in South Bucks DC v Porter (No2) [2004] 1 WLR 1953 as follows:

 

The reasons for a decision must be intelligible and they must be adequate. They must enable the reader to understand why the matter was decided as it was and what conclusions were reached on the "principal important controversial issues", disclosing how any issue of law or fact was resolved. Reasons can be briefly stated, the degree of particularity required depending entirely on the nature of the issues falling for decision. The reasoning must not give rise to a substantial doubt as to whether the decision-maker erred in law, for example by misunderstanding some relevant policy or some other important matter or by failing to reach a rational decision on relevant grounds. But such adverse inference will not readily be drawn. The reasons need refer only to the main issues in the dispute, not to every material consideration

 

8.4           If the CCG fails to give proper reasons for a decision then the decision itself may be unlawful because it will not be clear whether the CCG has properly understood the statutory function that it was undertaking:  see R (on the application of Ermakov) v Westminster [1995] EWCA Civ 42.  There are however occasions on which an NHS body is entitled to give supplementary detail to support initially inadequate reasons and may then, as a whole, be held to have acted lawfully.

 

8.5           Once the CCG has decided what it will and will not fund, the next step is to incorporate the policies into the schedules of the Acute Services Contracts between the CCG and its providers. 

 

9           Exception Policies and pick-up funding for clinical trials.

 

9.1           Commissioning policies define what care will be funded by the NHS for defined cohorts of patients.  However there are always a minority of patients whose circumstances do not precisely fit the general pattern and thus are entitled to be treated separately from other patients.   CCGs routinely develop exception policies to apply to such patientsThe essence of an exception policy is that a patient who comes within the policy will be provided with NHS funding to support a medical treatment even though the other patients with the same clinical presentation are denied funding for the same treatment.  

 

9.2           The formulation of exception policies is problematic but they are used to over situations where the NHS has decided that particular circumstances justify making a different decision for one group of patients in comparison to other patients with a like condition.  The CCG needs to formulate the justification for exception policies very carefully in order to avoid challenges by other patients who are denied the relevant treatment.

 

9.3           The following are examples of areas where exception policies have been developed:

 

a)         Funding can be agreed for patients who have taken part in an NHS sponsored clinical trial of a new drug or medical treatment and have shown a capacity to benefit from the treatment; and

 

b)         To continue NHS funded medical treatment which has been commenced by another NHS commissioner and now falls to the CCG as a result of the patient moving from one CCG area where a treatment is funded to an area where it is not routinely funded.

 

9.4           The limitations on funding for trial pick-up costs is a hugely contentious area.  NHS commissioners can come under considerable pressure from patients, clinicians and drug companies to continue to fund the treatment after the trial has been completed.  However the policy position adopted by most NHS commissioners is that funding will only be provided to support successful treatment if an agreement to fund was obtained before the trial began.  Funding for trial pick up costs should be rarely (if ever) agreed by NHS commissioners where funding has not been agreed in advance of the trial because it ought to be unnecessary.  Every clinical trial is required by the Medicines for Human Use (Clinical Trials) Regulations 2004 to operate in accordance the Helsinki Declaration published by the World Medical Association.  The requirement to identify a source of funding to allow the treatment to continue for patients who have a capacity to benefit is part of the present version of the Helsinki Declaration.  It provides:

 

“In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions”

 

9.5           There is an argument that the version of the Helsinki Declaration referred to in the Regulations does not include this wording.  However the spirit of the Regulations is that the Helsinki Declaration should be followed and thus Medical Ethics Committees ought only to give approval for a clinical the trial if those running the proposed trial have identified the source of funding for post-trial treatment for successful patients at the outset. 

 

10        The Individual Funding Request process

 

10.1        The vast majority of NHS patients ought to be provided with medical treatment or refused NHS funded medical treatment in accordance existing commissioning policies.  However Regulation 34(2)(b) of the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 requires the CCG to have:

 

“arrangements for the determination of any request for the funding of a health care intervention for a person, where there is no relevant NICE recommendation and the relevant body’s general policy is not to fund that intervention”

 

10.2        The reference to a “relevant NICE recommendation” is a reference to those NICE recommendations where the CCG has a duty to fund the treatment.  Thus CCGs must have an Individual Funding Request (“IFR”) policy which explains how decisions will be made in cases where the general approach of the CCG is not to fund a particular drug or other treatment generally or outside a defined patient population.  IFR policies vary from one PCT to another but they generally provide that NHS funding should only be provided for drugs or other medical treatments which lie outside established policies where:

 

a)         That patient can show that the application is supported by an NHS referring clinician.  If the patient does not have a clinician who is prepared to provide the treatment for the patient then the CCG should not entertain the application because the NHS does not generally fund medical treatment which is not recommended by clinicians;

 

b)         The patient is able to demonstrate exceptional clinical circumstances;

 

c)          The patient, supported by his or her clinician, can show that the requested treatment is likely to be clinically effective;

 

d)         The patient, supported by his or her clinician, can show that the requested treatment is likely to be cost effective;

 

e)         The circumstances are such that there are not likely to be other patients in a clinically similar situation.  If there are other patients then the CCG should respond to the request by devising a policy and/or considering the request as an “in year service development” but should not process the request as an IFR case.

 

10.3        The NHS Confederation has produced an excellent guide to the IFR process.  That Guide was specifically approved by the Court of Appeal in the R (Condliff) v North Staffordshire Primary Care Trust [2011] EWCA Civ 910.  Commenting on the requirement to show exceptionality, the Court approved a statement in the NHS Confederation Guide saying:

 

"Exceptionality is essentially an equity issue that is best expressed by the question: On what grounds can the PCT justify funding this patient when others from the same patient group are not being funded?"

 

10.4        The reason that NHS bodies have traditionally operated an IFR process is that, within a patient group with the same disease, there may be clinical situations which are so unusual that a decision to deny funding to a patient is inequitable.   The patient may, for example, have a genetic condition which means that the patient cannot tolerate the treatment which is usually provided to patients with that medical condition.  If another treatment is available, even if it is more expensive, then it would be equitable to permit the patient to have that more expensive treatment.

 

10.5        However it is almost impossible to define what is meant by “exceptional clinical circumstances”.  The Courts have said that it is permissible (and perhaps preferable) to leave the term undefined.  In  R (AC) v Berkshire West Primary Care Trust & Anor [2011] EWCA Civ 247 Lord Justice Hooper said:

 

“The use of the phrase "exceptional circumstances" tells the decision maker that the number of persons who will succeed under the proviso is expected to be a small minority. It does not otherwise provide a helpful legal test for the decision maker (see Huang v. Secretary of State for the Home Department  [2007] 2 AC 167 paragraph 20)”

 

 

10.6        Overall the IFR process is intended not to be an appeal on the merits of an individual case.  Funding can almost always be justified on an individual basis.  The IFR process exists to preserve a measure of flexibility to ensure the equitable distribution of NHS resources in the competition between patients.  Whilst the individual clinical circumstances of each patient are, of course, unique, only very few patients are likely to be able to show that they genuinely have exceptional clinical circumstances.

 

10.7        It follows that challenges to decisions of IFR Panels are almost always based on an attack on the decision making process adopted by the IFR Panel rather than a challenge to the reasonableness of the decision.

 

11        In year service developments.

 

11.1        During the lifetime of the annual commissioning plan there can be new unanticipated developments in the form of new drugs or medical treatments which emerge as options for CCG funding during the year.   If there is insufficient evidence that a new treatment is clinically effective then it is highly likely that the new treatment will not be supported with CCG funds (unless it is funded as an experimental treatment).  However the fact that there is evidence that a new treatment is likely to be clinically effective should not, of itself, be sufficient to justify funding because the annual CCG budget for commissioning healthcare will be fully committed.  In contrast there will be the occasional new treatment which is so stunningly good (i.e. It is highly clinically effective and cost effective) that a responsible commissioner ought to fund it straightaway rather than waiting for the treatment to compete for funding in the next annual plan, and thus not being funded until the following April.

 

11.2        Each CCG therefore needs to have a policy which sets out how it will respond to requests for funding for in-year service developments.  Policies usually provide that any such applications need to go through an in-year prioritisation process to determine:

 

a)         the evidence base to support a case that the treatment is likely to be clinically effective;

 

b)         the evidence base to support a case that the treatment is likely to be cost effective;

 

c)          what level of relative priority should be applied to the new proposed treatment in comparison to the other treatments that are already funded; and

 

d)         what services should cease to be funded (i.e decommissioned) in order to redirect funding to any new investment area that has been viewed as a high priority.

 

11.3        The assessment of new treatments therefore is a process of re-evaluating the overall priorities for a new service.  Even if a new service is considered an important priority, the service development still has to compete with other potential investments from other services in the annual commissioning process.  Occasionally a treatment may be considered so important that it should be funded immediately (an in-year service development).   Usually can only be done if reserves are available or if funding can be released from elsewhere to fund the investment.

 

12        Public and patient involvement in the commissioning process.

 

12.1        One of the biggest challenges for commissioners in the NHS has been securing public involvement in the commissioning processes.  The NHS is paid for by the public through their taxes and the public are the “customers” of our services.   NHS services are almost all free at the point of use (see section 1(3) of the NHS Act) but that does not mean that the public are not using their hard earned monies to meet the costs of NHS hospitals, ambulances, GP services and the myriad of community health services that the NHS provides.   The public hold the NHS very close to their hearts.  The former Conservative Lord Chancellor, Rt Hon Nigel Lawson MP (now Lord Lawson), said the NHS was "the closest thing the English have to a religion". 

 

12.2        However despite the warmth which the public have for the NHS, senior NHS managers and senior clinicians do not have a great record for involving the public successfully in decisions about the shape of NHS services.  Part of the reason for the NHS’s appalling record of effective patient involvement may be that the high level of attachment that the public have for their health services.  This level of attachment and loyalty to local services makes it very difficult for NHS managers and clinicians to persuade the public that changes to local health services are necessary, sensible or even desirable.  NHS managers always fear that a “save our hospital” campaign will emerge, run by local politicians or aspirant politicians making life a nightmare for the local NHS.  Thus there has been a tendency for NHS managers to keep their heads down to duck the flack they foresee whenever changes are proposed to NHS services.

 

12.3        Some patient engagement exercises have been successful but far too often the experience of those dealing with the NHS is that decisions are made by professionals first, without any patient involvement and the decision is only put out to public consultation after all the effective decision making has been completed. 

 

12.4        The NHS had established practices of consulting with patients over changes that affected them and with the public generally before taking major reconfiguration decisions.  The law in this area was considered in R (Coughlan) v North and East Devon Health Authority [2001] QB 213.  This case confirmed that whether consultation of interested parties and the public is a legal requirement, if it is embarked upon it must be carried out properly.  Hence an NHS body can act unlawfully (in a public law sense) by purporting to carry out a consultation but not doing the consultation in a lawful manner.  The Coughlan case also confirmed that the local government rules for consultation, which were developed by the Court in R v Brent London Borough Council, Ex p Gunning (1985) 84 LGR 168, applied to NHS bodies.  The Gunning case established 4 broad rules for a lawful consultation, namely:

 

a)         To be proper, consultation must be undertaken at a time when proposals are still at a formative stage;

 

b)         The body undertaking the consultation must provide those who are consulted with sufficient reasons for particular proposals to allow those consulted to give intelligent consideration and an intelligent response;

 

c)          Adequate time must be given for this purpose; and

 

d)         The product of consultation must be conscientiously taken into account when the ultimate decision is taken.

 

12.5        These rules continue to apply to any consultation exercises undertaken by the NHS.  It follows that if NHS managers “decide first and consult afterwards”, the consultation will be unlawful because it will breach the first of the Gunning rules, namely that consultation must be carried out at a time when proposals are still at a formative stage.  However that does not mean that there is a duty on an NHS body to consult on more than one option, particularly if there has been substantial public engagement on the options prior to formal consultation.  In R. v Worcestershire Health authority ex parte Kidderminster and District Community Health Council [1999] EWCA Civ 1525 the Health Authority considered 7 options for reorganising acute health services in Worcestershire, and undertook considerable public engagement about those options.   All but one of the options were dropped and the Health Authority went out to consultation on just one option.  The High Court and the Court of Appeal held that was lawful.  Auld LJ said:

 

Having reached the stage of retaining just one proposal under consideration, albeit in a formative state, the authority was entitled to proceed to consultation ..”

 

12.6        The first statutory duty on NHS bodies to engage with the public in the commissioning process emerged in section 11 of the Health and Social Care Act 2001.  It provided:

 

“It is the duty of every body to which this section applies to make arrangements with a view to securing, as respects health services for which it is responsible, that persons to whom those services are being or may be provided are, directly or through representatives, involved in and consulted on—

 

(a)  the planning of the provision of those services,

 

(b)  the development and consideration of proposals for changes in the way those services are provided, and

 

(c)  decisions to be made by that body affecting the operation of those services”

 

12.7        The section 11 duty was imposed on Health Authorities, Primary Care Trusts (which were just then coming into existence and NHS trusts.  This legislation was passed before the creation of NHS Foundation Trusts.  Although the legislation has been amended since it was originally passed, the origin of the present duties of public involvement arise from this section.  The National Health Service Reform and Health Care Professions Act 2002 added Strategic Health Authorities to the bodies under the public involvement duty and then NHS Foundation Trusts were added by the Health and Social Care (Community Health and Standards) Act 2003. 

 

12.8        The statutory duty is a duty to make “arrangements” to involve patients.  The legal obligation is thus not directly a duty to involve patients but a duty to adopt a policy which explains how patients will be involved at each stage when the NHS body carries out a relevant function.  The legal consequences of a duty to make “arrangements” are explained at paragraph 2.2 above and are not repeated here save to say that once the NHS body has a policy which explains how the public are to be “involved”, this is likely to raise a legitimate expectation that the NHS body will follow through its own policy when undertaking relevant functions.  Thus the NHS body may well be acting unlawfully if it attempts to force through changes to NHS services without properly following its own policy about patient and public involvement.

 

12.9        The public involvement duty was then included in section 242 of the National Health Service Act 2006 and the ambit of the duty was slightly changed by the Local Government and Public Involvement in Health Act 2007.   The new duty to involve members of the public in how NHS health services were provided was as follows:

 

“Each relevant English body must make arrangements, as respects health services for which it is responsible, which secure that users of those services, whether directly or through representatives, are involved (whether by being consulted or provided with information, or in other ways) in—

 

(a)  the planning of the provision of those services,

 

(b)  the development and consideration of proposals for changes in the way those services are provided, and

 

(c)  decisions to be made by that body affecting the operation of those services”

 

12.10     The government published guidance to assist NHS bodies in discharging their duties under section 11.  An iteration of the Guidance was published in 2008 called “Real Involvement:  Working with people to improve health services”.  This Guidance set out the rationale for engaging with patients as well as the formal statutory duties.  It explained the outcome of a proper engagement process as follows:

 

Commissioners act on behalf of the public and patients. They are responsible for investing funds on behalf of their communities, and building local trust and legitimacy through the process of engagement with their local population. In order to make commissioning decisions that reflect the needs, priorities and aspirations of the local population, world class commissioners will engage with the public, and actively seek the views of patients, carers and the wider community. This new relationship with the public is long term, inclusive and enduring, and has been forged through a sustained effort and commitment on the part of commissioners. Decisions are made with a strong mandate from the local population and other partners”

 

12.11     The Guidance explained that:

 

Good involvement practice:

• happens early and continues throughout the process;

• is inclusive;

• is informed;

• is fit for purpose;

• is transparent;

• is influential – it makes a difference;

• is reciprocal – includes feedback; and

• is proportionate to the issue”

 

12.12     The Guidance also explained the different stages as which users must be involved at different parts of the commissioning cycle, as identified in the separate parts of the statutory duty.  It said:

 

Under a), users must always be involved when the provision of health services is being planned. For example, this may follow a needs assessment or a strategic or service review. Planning the provision of services can take place at:

 

• strategic level, for example the reconfiguration of mental health services across

an SHA or PCT area;

 

• service level, when plans are being developed for the configuration of a service or services, for example maternity services; or

 

• NHS trust or NHS foundation trust level, for example when planning to provide

a service from a different site.

 

Under b) and c), users must only be involved if the implementation of the proposal

or the decision, if made, “would have an impact on –

 

a) the manner in which the services are delivered to users of those services, or

 

b) the range of health services available to those users”

 

Users must be involved not only in the consideration of proposals to change services, but also in the development of any proposal that will change the manner in which a health service is provided or the range of services offered.

 

For example, users must be involved in the development of a range of options for the way community services could be provided within a PCT area, not just asked for their opinion on a model that has been developed behind closed doors by health professionals and managers.

 

Users must be involved where a decision will change the way a service operates if the change affects the manner in which those services are delivered or the range of services offered; for example, the time a family planning clinic is open or when an NHS trust plans to provide a service from a different hospital/site”

 

12.13     The most significant part of this guidance is perhaps the statement that “users must be involved in the development of a range of options for the way community services could be provided within a PCT area, not just asked for their opinion on a model that has been developed behind closed doors by health professionals and managers”.  It is inevitable that initial proposals and options for possible change to local health services will be worked up by clinicians and NHS managers without a large degree of public input at that stage.  However the Guidance makes it clear that NHS bodies cannot lawfully leave public involvement to a late stage when all the main features of the new configuration have been agreed between professionals.  The very least that the public are entitled to receive is “information” about the proposals and thus the right to feed their views into the planning process on receipt of that information.  Leaving public involvement to the later stages when all the key decisions have de facto been taken is highly likely to lead to an NHS body being in breach of their legal duties.  This view of the nature of the duty of “involvement” was set by Mr Justice Collins in R (Smith) v North Eastern Derbyshire Primary Care Trust & Anor [2006] EWHC 1338 (Admin) who said:

 

Thus 'involved in' really means no more than informed and able to express a view (which adds little to 'consulted on'). What is important is that the public must know what is proposed or what changes are to take place or how the services which affect them are to be operated and must have the opportunity, at least through a representative body, to comment on such matters. Their views must be obtained”

 

12.14     However to every minute change in NHS services comes within the public involvement duty.  Section 242(1C) and (1D) provide that the duty is only engaged if it is likely to result in changes to the services that a patient will receive will change either “the manner in which the services are delivered to users of those services”, or “the range of health services available to those users”.  Thus the public do not have a right to be involved every time a GP retires or a new GP is appointed.  However if the new appointment will lead to changes in the way that the services will be provided (or may be provided) the public involvement duty is triggered.  This issues was examined by Collins J in R (Smith) v North Eastern Derbyshire Primary Care Trust & Anor [2006] EWHC 1338 (Admin) who said:

 

“Thus I accept that a change of personnel or of contractual terms or of the form of a contract may not of themselves be covered by s.11. But the background is highly relevant. The need to replace a failed service should mean that the reasons for the failure are addressed and that may well, as was the case here, lead to a need to consider whether any different arrangements to deal with any problems which have manifested themselves are required. Thus public input may assist the PCT and will certainly help to allay concerns”

 

12.15     The next step in the legislative maze was the Health and Social Care Act 2012 which created CCGs.  It would have been possible for parliament simply to have added the new CCGs to the list of bodies to whom the section 242 duty applied but the government decided that greater public involvement duties were required.  The original text of the Bill (where it is clause 22 which introduces a new section 14P into the NHS Act 2006) made several significant changes to the section 242 duty.  The new wording was consistent with the numerous statements made in parliament about the desire of the government to strengthen public and patient involvement in the delivery of NHS services.

 

12.16     The public engagement duty on CCGs are now in section 14Z2 of the NHS Act 2006 (introduced by section 26 of the 2012 Act).  The duty is as follows:

 

“(1) This section applies in relation to any health services which are, or are to be, provided pursuant to arrangements made by a clinical commissioning group in the exercise of its functions (“commissioning arrangements”).

 

(2) The clinical commissioning group must make arrangements to secure that individuals to whom the services are being or may be provided are involved (whether by being consulted or provided with information or in other ways)—

 

(a)  in the planning of the commissioning arrangements by the group,

 

(b)  in the development and consideration of proposals by the group for changes in the commissioning arrangements where the implementation of the proposals would have an impact on the manner in which the services are delivered to the individuals or the range of health services available to them, and

 

(c)  in decisions of the group affecting the operation of the commissioning arrangements where the implementation of the decisions would (if made) have such an impact.

 

(3) The clinical commissioning group must include in its constitution—

 

(a)  a description of the arrangements made by it under subsection (2), and

 

(b)  a statement of the principles which it will follow in implementing those arrangements.

 

(4) The Board may publish guidance for clinical commissioning groups on the discharge of their functions under this section.

 

(5) A clinical commissioning group must have regard to any guidance published by the Board under subsection (4).

 

(6) The reference in subsection (2)(b) to the delivery of services is a reference to their delivery at the point when they are received by users”

 

12.17     There is one notable difference between the wording of the duty on NHS bodies under section 242 and the wording of the duty under section 14Z2.  The 242 duty can be discharged by setting up arrangements which provide that users can be involved either “directly or through representatives”.  The option of discharging this duty to setting up arrangements to involve “representatives” of patients has been excluded from the duty on CCGs.   A CCG therefore cannot discharge its patient involvement duty by selecting a handpicked committee of representative patients to whom information is provided, often on a confidential basis.  It is highly unlikely that such an approach would have been consistent with the Guidance published under section 242 (as set out above) but, regardless as to whether that remains a lawful option for NHS bodies, that is not a course that a CCG can take.

 

12.18     NHS England has published guidance about the way in which CCGs should set up their patient and public involvement arrangements.  It is called “Transforming Participation in Health and Care:  The NHS belongs to us all”.  It starts with the following statement of principle:

 

“The NHS is a cherished national institution. Its founding principle is to provide healthcare which is free at the point of delivery, to anyone who needs it, regardless of their circumstances. The NHS must be more responsive to the needs and wishes of the public, all of whom will use its services at some point in their lives.

 

NHS England will ensure that public, patient and carer voices are at the centre

of our healthcare services, from planning to delivery. Every level of our commissioning system will be informed by insightful methods of listening to those who use

and care about our services.

 

12.19     The Guidance then provide practical guidance as to what a CCG should do in order to involve patients in its decision making.  It explains how the duty to involve patients links in with other duties on a CCG, including the duty to tackle health inequalities.  The Guidance explains:

 

“The Marmot Review, Fair Society health Lives (2010) clearly demonstrated the difference in life expectancy between socio-economic groups. At a local level, Joint Strategic Needs Assessments (JSNAs) tell a similar story. If we are to truly address these inequalities, all our activity should start from the stance of those who experience the greatest inequality, whether in the individual’s own care, or as part of wider public participation in health and care. We should take an asset based approach to working with and empowering communities.  To understand what is and is not working for patients and communities we need to ensure that:

 

·       all participation activity reaches communities and groups with distinct health needs and those who experience poor health outcomes.

 

·       people who have characteristics that are protected under the Equality Act 2010 are integral to all participation and measures taken to enable patients to participate in their own health are designed in a way which meets the individual needs

 

·       we consider how to reach people that experience difficulties accessing health services or have health problems that are caused or affected by their socio- economic circumstances.

 

·       People who lack capacity are protected and empowered and that the provisions of the Mental Capacity Act 2005 are met”

 

12.20     The section of the guidance

 

“Evidence suggests that engaging and involving communities in the planning, design and delivery of health and care services can lead to a more joined-up, co-ordinated and efficient services that are more responsive to local community needs. Public participation can also help to build partnerships with communities and identify areas for service improvement. NHS England will work with partners to identify any further evidence and disseminate it widely”

 

12.21     There is one paragraph which perhaps explains in a pithy way why merely rely on professional opinions as to what works within the NHS is insufficient.  It states:

 

“Insight gathered from the public helps to improve services and outcomes as well as potentially helping to spot failures.  Listening to and using the voice of patients and the public were never more forcefully presented than in the Francis report”

 

12.22     The Guidance then goes on to explain what steps individual CCGs should take to involve patients at all stages of the commissioning cycle.  Whilst there is a measure of discretion for CCGs to decide the way in which they will set up their own patient engagement processes, CCGs have a legal duty to “have regard” to the NHS England Guidance and therefore need to think carefully before devising engagement systems which depart from the Guidance to any material extent.

 

12.23     The duties on NHS bodies to consult have been considered by the courts in a number of cases.  The majority of these cases have been complaints that a consultation process to make changes to a local hospital was inadequate.  The courts have looked at the consultation processes and generally backed the lawfulness of the consultation process.  An example of this is R (Bullmore & Anor) v West Hertfordshire Hospitals NHS Trust [2007] EWHC 1636 (Admin).   A flawed consultation exercise is not always so procedurally unfair as to be unlawful. In R (Greenpeace) v Secretary of State for Trade and Industry [2007] Env LR 29 Mr Justice Sullivan (as he then was) said

 

“the true test is whether the consultation process was so unfair that it was unlawful…"

 

12.24     However where there is a duty to involve patients, a decision taken without involvement can be quashed by the High Court on an application for judicial review.  Equally if decisions have been taken, public and patient involvement after those decisions are taken does not remedy the earlier unlawful actions.  The Court of Appeal explained this in Smith v North East Derbyshire Primary Care Trust [2006] EWCA Civ 1291 where May LJ said:

 

The simple fact is that the defendants had a duty to consult and they did not properly perform it. Mobilising the patients' function after the decision had been taken without proper consultation was no remedy. The possibility that the Patients' Forum might have been mobilised before the decision was made, when it was not, neither provides a remedy nor relieves the defendant from their breach of duty”

 

12.25     Duties of public engagement are therefore required to be woven into every part of the commissioning cycle.  A CCG will not discharge its legal obligations if it only “consults” the public at the end of the commissioning process after all of the key decisions have been taken.

Managing conflicts of interest for GPs.

 

This chapter contains:

 

1.     An introduction to the issues raised by conflicts of interest.

2.     The Nolan Principles.

3.     What is an “interest”?

4.     Registration of Interests by a CCG.

5.     The duty on CCGs to make arrangements to manage conflicts of interest.

6.     What arrangements for managing conflicts of interest are suggested by the CCG Model Constitution?

7.     What rules are necessary to ensure that an interest does not affect and is not seen to affect the integrity of the decision making process?

8.     Potential legal consequences where decisions are made in breach of the rules about managing conflicts of interest.

 

1.              An introduction to the issues raised by conflicts of interest.

1.1          Managing actual or potential conflicts of interest is essential for every professional.  General Practitioners are in no different position to lawyers, accountants or many other professionals who ply their professional trade for the benefit of clients but, to a greater or lesser extent, are not paid by clients but by a third party (and often the government).  No professional can avoid conflicts of interest, every professional must be acutely aware of them, understand how differing interests are seen by others and act in a professional manner to manage these interests properly.  This is far from easy for all professionals but the present NHS structures have created particularly difficult issues around conflict of interests for GPs.

 

1.2          NHS England has published Guidance concerning the management of conflicts of interest.  It explains their understanding of a conflict of interest as follows:

 

“A conflict of interest occurs where an individual’s ability to exercise judgement or act in one role is or could be impaired or otherwise influenced by his or her involvement in another role or relationship. The individual does not need to exploit his or her position or obtain an actual benefit, financial or otherwise. A potential for competing interests and/or a perception of impaired judgement or undue influence can also be a conflict of interest”

 

1.3          Helpful guidance on identifying what is meant by a conflict of interest is also set out in a Paper prepared by the NHS Confederation and the Royal College of General Practitioners dated September 2011.  This defined a conflict of interest as follows:

 

“A conflict of interest can be defined as: “a set of conditions in which professional judgement concerning a primary interest (such as patients’ welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial

gain)”  or a situation in which “one’s ability to exercise judgement in one role is impaired by one’s obligation in another”.

 

For a GP or other clinical commissioner, therefore, a conflict of interest may arise when their own judgment as an NHS commissioner could be, or be perceived to be, influenced and impaired by their own concerns and obligations as a healthcare provider or as a member of a particular peer, professional or special interest group, or those of a close family member”

 

1.4          It is impossible to describe and provide guidance about every single all factual situation which might give rise to a conflict of interest for GPs in practice.  The arrangements which have been set up the government which involve GPs in commissioning will inevitably involve GPs in many situations where they potentially have more than one interest in a proposed decision.  However it is important to remember that conflicts of interest can never be eliminated.  They existed for GPs before the creation of CCGs (in particular under the old fundholding system) are an inevitable feature of all professional practice. 

 

1.5          Hence the key requirements for GPs are to identify where conflicts arise and to make sure that these are properly disclosed and registered, and then managed in accordance the arrangements that CCGs have put in place are the proper disclosure and management of actual and potential conflicts. 

 

1.6          Every GP Practice which holds an NHS practice contract is required to be a member of the local Clinical Commissioning Group (“CCG”) : See section 14A(1) of the NHS Act.  The constitution of the CCG will define how members of a practice can become involved in the workings of the CCG, stand for election to its committees and otherwise become involved in its work.  There is an obvious potential for conflicts of interest where a GP practice, which is a member of a CCG, bids for a contract where the NHS commissioner is the local CCG.

 

1.7          However there are many other circumstances where a GP, acting perfectly properly, may become involved in a situation where a conflict of interest or potential conflict of interest arises.  Many GPs are also shareholders, directors, employees or partners in medical or social care businesses that provide medical services to NHS patients or provide primary medical services to such businesses.  These businesses may have contracts with NHS commissioners.  There is a potential conflict of interest if any of these businesses tender for a contract with the CCG of which the GP is a part.

 

1.8          There can be both legal and professional consequences for a GP who fails to recognise and properly manage a conflict of interest.  However managing conflicts of interest is part of the professional duties of a GP as the Royal College of GPs and NHS Confederation observed in their Paper in September 2011:

 

“..  seeking to eliminate conflicts of interest completely is unlikely to be possible or desirable”

 

1.9          Issues around conflicts of interest do not usually arise with general practice contracts (i.e. GMS, PMS and APMS contracts) because those contracts are awarded and managed by NHS England and not by the local CCG.  However local GP practices, either individually or through consortia, are in a prime position to contract for the delivery of a large number of services in addition to those governed by GMS, PMS and APMS contracts.  These are very often contracts which are let by the local CCG, whose members are the local GP practices.  The transfer of NHS services out of hospital settings and into the community over the coming years means that the volume of such contracts is certain to increase and hence managing the actual and potential conflicts of interest inherent in such arrangements will become a problem that GPs, CCGs and those who advise them will need to focus on with particular care.

 

1.10       The legal obligations on practising doctors concerning conflicts of interest arise in a number of different ways.  There are provisions of the GMC Code about managing conflicts of interest (which are set out below).  There are also provisions in both the NHS Act (as amended by the Health and Social Care 2012) and the in National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013 (“the 2013 Regulations”) around managing conflicts of interest.  Rules for managing conflicts exist within CCG constitutions and standing orders and guidance on this subject has also been given by both NHS England and Monitor.  Much of this Guidance from different bodies covers the same grounds.

 

1.11       It follows that all GPs who are working the NHS must have a working understanding of the concepts that lie behind managing conflicts of interest and have a legal and professional duty to ensure that they know and abide by the national and local rules to manage potential conflicts.  Obligations of openness and proper management of conflicts of interest have been imposed on elected councillors and local government officers for many years.  These rules are, to a large extent, an inevitable consequence of their roles within a tax payer funded public service.  The rules referred in this chapter impose similar obligations on those working in the NHS.  Whilst GPs may resent the level of openness that properly managing conflicts inherently entails, doctors (and CCG staff) have to take difficult decisions about how tax-payers monies are spent and what services are received by NHS patients. Patients pay the taxes that fund the service.  The openness about decision making required by the present arrangements is part of the system under which those who make public service decisions are accountable to their paymasters for the decisions that are made.

 

2.              The Nolan Principles.

 

2.1          The starting point of any analysis of the duties of those who hold public office (including those GPs who take part in CCG business) are the Nolan principles.  The Nolan Committee, which is properly called the “Committee on Standards in Public Life”, is an independent advisory non-departmental public body which was set up by Prime Minister John Major in 1994.  It was set up in response to concerns about the standards in public life, particularly around the issue of MPs taking “cash for questions”.  The committee developed 7 principles which ought to guide all holders of public office.  These are as follows:

 

·       Selflessness – Holders of public office should act solely in terms of the public interest. They should not do so in order to gain financial or other benefits for themselves, their family or their friends.

 

·       Integrity – Holders of public office should not place themselves under any financial or other obligation to outside individuals or organisations that might seek to influence them in the performance of their official duties.

 

·       Objectivity – In carrying out public business, including making public appointments, awarding contracts, or recommending individuals for rewards and benefits, holders of public office should make choices on merit.

 

·       Accountability – Holders of public office are accountable for their decisions and actions to the public and must submit themselves to whatever scrutiny is appropriate to their office.

 

·       Openness – Holders of public office should be as open as possible about all the decisions and actions they take. They should give reasons for their decisions and restrict information only when the wider public interest clearly demands.

 

·       Honesty – Holders of public office have a duty to declare any private interests relating to their public duties and to take steps to resolve any conflicts arising in a way that protects the public interest.

 

·       Leadership – Holders of public office should promote and support these principles by leadership and example.

 

2.2          These principles ought to provide a general guide to GPs who are elected to CCG Boards, serve on CCG committees or take any decisions where they are acting on behalf the public or spending public money.  However, of themselves, they have no legal effect.  They are however important because GPs should have the security of knowing that, in seeking to judge whether they are responding properly to a conflict of interest problem, exactly the same standards are required of holders of every other type of public office across a very wide range of statutory and non-statutory bodies. 

 

2.3          However even if the principles themselves have no direct legal effect, they can create legal obligations if they are incorporated into a CCG Constitution.  The Nolan Principles are expressly incorporated in to the constitutions of many CCGS as they appear at Appendix F of the Department of Health Model Constitution for CCGs.  Clause 8.1.1 of the Model Constitution provides:

 

Employees, members, committee and sub-committee members of the group and members of the governing body (and its committees) will at all times comply with this constitution and be aware of their responsibilities as outlined in it. They should act in good faith and in the interests of the group and should follow the Seven Principles of Public Life, set out by the Committee on Standards in Public Life (the Nolan Principles)   The Nolan Principles are incorporated into this constitution at Appendix F”

 

2.4          The precise legal effect of the Nolan Principles being included within a CCG Constitution is unclear and will depend on the precise facts of any individual case.  However it seems that, at least, it would raise a legitimate expectation that the CCG would conduct its affairs in in accordance with the Nolan Principles.  That would entitle a judicial review challenge to be made if he CCG adopted a course of action that was clearly in breach of the principles.

 

3.              What is an interest?

 

3.1          GPs, like other members of their communities, are likely to have a wide range of interests in the communities in which they live and serve.  It is not the case that everything that a GP, as a member of the public, is interested in counts as an “interest” under the statutory scheme.  Some of these interests go no further than the “interest” of the average member of the public.  Hence all GPs are likely to be registered with a General Practice as a patient and are potential users of the NHS for their own health needs, those of their families and for their friends.  These general interests are not “interests” that need to be registered.  However where a person who is required to registers their interests has an involvement in a particular organisation or matter (whether that amounts to a pecuniary interest or not) which goes beyond that of the average member of the public, a question arises as to whether this is an “interest” that ought to be declared.  The NHS Act does not define what interests ought to registered or declared.  However the concept to declaring interests has existed for many years in local government and so it is to local government that we should first go to find out what is meant by an interest.

 

3.2          The Local Authority Model Code of Conduct  for councillors defines the “interests” that a councillor must register as follows:

 

“You have a personal interest in any business of your authority where either—

 

(a)  it relates to or is likely to affect—

 

(i)             any body of which you are a member or in a position of general control or management and to which you are appointed or nominated by your authority;

 

(ii)           any body—

 

(aa)     exercising functions of a public nature;

 

(bb)     directed to charitable purposes; or

 

(cc)     one of whose principal purposes includes the influence of public opinion or policy (including any political party or trade union),

 

of which you are a member or in a position of general control or management;

 

(iii)          any employment or business carried on by you;

 

(iv)          any person or body who employs or has appointed you;

 

(v)           any person or body, other than a relevant authority, who has made a payment to you in respect of your election or any expenses incurred by you in carrying out your duties;

 

(vi)          any person or body who has a place of business or land in your authority’s area, and in whom you have a beneficial interest in a class of securities of that person or body that exceeds the nominal value of £25,000 or one hundredth of the total issued share capital (whichever is the lower);

 

(vii)        any contract for goods, services or works made between your authority and you or a firm in which you are a partner, a company of which you are a remunerated director, or a person or body of the description specified in paragraph (vi);

 

(viii)       the interests of any person from whom you have received a gift or hospitality with an estimated value of at least £25;

 

(ix)          any land in your authority’s area in which you have a beneficial interest;

 

(x)           any land where the landlord is your authority and you are, or a firm in which you are a partner, a company of which you are a remunerated director, or a person or body of the description specified in paragraph (vi) is, the tenant;

 

(xi)          any land in the authority’s area for which you have a licence (alone or jointly with others) to occupy for 28 days or longer; or

 

3.3          All of the above categories refer to commercial or non-commercial relationships that the individual councillor has with a variety of persons who might have dealings with the Council of which that councillor is a member.  However the Code also gives guidance on where an interest which is held by someone other than the councillor can give rise to an interest that a councillor is required to disclose.  The local authority Model Code provides:

 

“(b)  a decision in relation to that business might reasonably be regarded as affecting your well-being or financial position or the well-being or financial position of a relevant person to a greater extent than the majority of—

 

(i)             (in the case of authorities with electoral divisions or wards) other council tax payers, ratepayers or inhabitants of the electoral division or ward, as the case may be, affected by the decision;

 

(ii)           (in the case of the Greater London Authority) other council tax payers, ratepayers or inhabitants of the Assembly constituency affected by the decision; or

 

(iii)          (in all other cases) other council tax payers, ratepayers or inhabitants of your authority’s area”

 

3.4          That definition make reference to a “relevant person” being a person in a close relationship with a councillor where that relationship might be thought to influence the decision making of the councillor, and thus leads to an interest which must be declared.  The term “relevant person” is defined in the local authority Model Code as follows:

 

“In sub-paragraph (1)(b), a relevant person is—

 

(a)  a member of your family or any person with whom you have a close association; or

 

(b)  any person or body who employs or has appointed such persons, any firm in which they are a partner, or any company of which they are directors;

 

(c)  any person or body in whom such persons have a beneficial interest in a class of securities exceeding the nominal value of £25,000; or

 

(d)  any body of a type described in sub-paragraph (1)(a)(i) or (ii)”

 

3.5          In contrast to the Model Code for councillors (which is Regulations), the NHS Act does not define what is meant by an “interest”.  However paragraph 8.2.3 of the model CCG Constitution produced by NHS England suggests that the following are all potential “interests” which require registration by a GP member of a CCG or an employee of a CCG:

 

a)         a direct pecuniary interest: these are interests where an individual may directly or indirectly financially benefit from the consequences of a commissioning decision (for example, where a GP or a close relative has a financial interest in a potential provider of services);

 

b)         an indirect pecuniary interest: for example, where an individual is a partner, member or shareholder in an organisation that will benefit financially from the consequences of a commissioning decision;

 

c)          a non-pecuniary interest: where an individual holds a non-remunerative or not-for profit interest in an organisation, that will benefit from the consequences of a commissioning decision (for example, where an individual is a trustee of a voluntary provider that is bidding for a contract);

 

d)         a non-pecuniary personal benefit: where an individual may enjoy a qualitative benefit from the consequence of a commissioning decision which cannot be given a monetary value (for example, a reconfiguration of hospital services which might result in the closure of a busy clinic next door to an individual’s house);

 

e)         where an individual is closely related to, or in a relationship, including friendship, with an individual in the above categories.

 

3.6          Thus the concept of “interests” that need to be registered by a GP member of a CCG or an employee of the CCG is wide and extends far beyond situations where a GP (or someone else) can say that their personal financial position will be affected by a proposed decision.  The test adopted by the courts is generally that of the informed and interested bystander.  Whether a GP (or someone else on the above list) has a particular involvement in a body or organisation, or where someone closely connected to the GP has such an interest, depends on whether an interested bystander may consider that it would be appropriate for the interest to be openly declared.  Hence, if there is any doubt, any person who comes within the categories listed above should ensure that their interest is registered with the CCG (see also the GMC Guidance set out below).

 

3.7          There are subtle differences between the definitions of interests which need to be disclosed under the CCG Model Constitution and the slightly wider category of interests that fall to be disclosed in local government.  However it would be prudent to interpret the general descriptions of interests in the CCG Model constitution through the prism of the defined list of interests in the Model Code for councillors.  It is difficult to identify any “interest” which a councillor would be required to register under the Model Code which should not be registered by a CCG member or employee.

 

4.              Registration of Interests by a CCG.

 

4.1          Having identified the meaning of an “interest”, the next question for a CCG is the recording and registering of interests.  Section 14O of the NHS Act, which was introduced by the Health and Social Care Act 2012, brought in the following provisions relating to the registration of interest by CCGs for their members and staff:

 

“(1)     Each clinical commissioning group must maintain one or more registers of the interests of—

 

(a)     the members of the group,

 

(b)     the members of its governing body,

 

(c)     the members of its committees or sub-committees or of committees or sub-committees of its governing body, and

 

(d)     its employees.

 

(2)     Each clinical commissioning group must publish the registers maintained under subsection (1) or make arrangements to ensure that members of the public have access to the registers on request.

 

4.2          CCGs are thus under a statutory duty to set up “one or more registers” to record the “interests” of each of the four categories of persons listed in section 14O(1).  These 4 categories are:

 

a)         The members of the CCG.  These are the individuals, partnerships or corporate bodies that hold the GP practice contracts with NHS England which operate within the CCG area.  If the practice contract is held by a partnership then the disclosure duties affect each member of the partnership;

 

b)         The members of the CCG governing body of the CCG (as defined in the CCG Constitution).  These will typically be the GPs, members of staff and other individuals including health care professionals and the lay members of the CCG;

 

c)          All members of any committees set up by the CCG;

 

d)         All members of staff employed by the CCG.

 

4.3          The registers are required to record all of the “interests” of the relevant individuals.  The duty to register arises whether there is any conflict associated with that interest or is even likely to be any conflict of interest.  There is also no concept a “personal sphere” for GPs which is detached from their public activities.  If a GP (or other relevant person) is within the categories of people set out above it is necessary to register all of the relevant interests of a GP.

 

4.4          This section thus places a duty on CCGs to ensure transparency by having a publicly accessible register which sets out all of the interests held by the members of the CCG (who are all of the local GP practices), committee members (who include persons other than GPs such as a local consultant and non-executive members) and by staff of the CCG.

 

4.5          The Model CCG Constitution published by NHS England does not define the number of registers that a CCG is required to maintain. Whether the information is contained within a single register for all of the above categories or in different registers is, to a large extent, irrelevant.  However the registers are public documents which the CCG must make available to the public (including journalists).  Section 14O(2) provides:

 

“Each clinical commissioning group must publish the registers maintained under subsection (1) or make arrangements to ensure that members of the public have access to the registers on request”

 

4.6          These are also documents which a member of the public could ask to inspect under the Freedom of Information Act 2000.  The relevant NHS England Guidance suggests that CCGs take greater steps to make details of the registers freely available.  It provides:

 

In the interest of transparency, the clinical commissioning group’s registers of interest must either be published or made publicly available. Groups may wish to consider other ways of making these registers available to patients and the public (especially those who don’t have access to the internet), which could be outlined in this constitution. Examples include:

 

·       confirming you will make these registers available upon request for inspection at your headquarters or local health premises

 

·       confirming that the registers will be available upon application, either by post - in which case you will need to include the postal address of your headquarters

 

·       email – you’ll need to provide an email address

 

·       making arrangements with your local authority(ies) for copies to be made available via local libraries”

 

4.7          The NHS England Model Constitution for CCGs suggests that disclosure of interests should be made by a relevant person “as soon as they become aware of it” and in any event within 28 days.  The model also provides as follows for a situation where an interest only becomes apparent during a meeting.  It provides paragraph 8.3.4:

 

Where an individual is unable to provide a declaration in writing, for example, if a conflict becomes apparent in the course of a meeting, they will make an oral declaration before witnesses, and provide a written declaration as soon as possible thereafter”

 

Those provisions reflect the requirements in section 14O(3) of the NHS Act which are set out above.

 

4.8          If a GP or a relevant person either acquires or loses an interest then the register should be amended to show the changed position.  However the Model Constitution also recognises the need for the CCG to review the declarations by relevant persons at regular intervals in order to ensure that the register is up to date.   Paragraph 8.3.5 of the Model Constitution provides that the CCG should name a specific officer who is required to “will ensure that the register(s) of interest is reviewed regularly, and updated as necessary”.  The Guidance on reviewing the register suggests that the register should be reviewed on a quarterly basis.  It provides:

 

For example a group may delegate responsibility for this task [i.e. reviewing the register] to:

 

·       the group’s governing body (or through the governing body, the governing body’s audit committee)

 

·       the lay member identified in Towards establishment as leading on remuneration, audit and conflict of interest matters

 

·       the accountable officer

 

·       an individual member or employee of the group.

 

·       The body / person with this delegated responsibility should also be included in the group’s scheme of reservation and delegation.

 

The NHS Commissioning Board Authority’s “Towards Establishment annex” on managing conflicts of interest suggests that register(s) of interest should be reviewed every quarter. Clinical commissioning groups may wish to specify how regularly they wish to review registers in paragraph 8.3.5 above”

 

4.9          The legal obligation on the CCG is thus to maintain an open register of interests.  Most CCGs publish their Register of Interests on the CCG website.  However some CCGs appear to consider that it is sufficient if the members of the governing body of the CCG register their interests but it appears that no declarations are routinely made by each of the constituent GP practices.   However section 14O provides that declarations must be made by every “member” of a CCG, which means every provider of primary medical services in the CCG area.   In the case of a partnership, the “member” is the partnership rather than the individual doctors.  However the rules about declaration of interests require the partnership to declare all relevant interests which must mean the interests held by the individual members of the partnership.

 

5.              The duty on CCGs to make arrangements to manage conflicts of interest.

 

5.1          Having identified and registered relevant interests, the next issue for a CCG is how the business of the CCG is to be managed so as to ensure that any conflicts of interest are properly recognised and managed.   Section 14O of the NHS Act does not mandate a single scheme which dictates how CCGs should approach this difficult task.  Instead the legislation requires CCGs to devise their own rules for the management of conflicts of interests.  The implication is that, once the rules have been set by the CCG, the CCG will have a public law duty to act in accordance with its own rules.

 

5.2          Sections 14O(3) to (7) provide:

 

“(3)     Each clinical commissioning group must make arrangements to ensure—

 

(a)     that a person mentioned in subsection (1) declares any conflict or potential conflict of interest that the person has in relation to a decision to be made in the exercise of the commissioning functions of the group,

 

(b)     that any such declaration is made as soon as practicable after the person becomes aware of the conflict or potential conflict and, in any event, within 28 days, and

 

(c)     that any such declaration is included in the registers maintained under subsection (1).

 

(4)     Each clinical commissioning group must make arrangements for managing conflicts and potential conflicts of interest in such a way as to ensure that they do not, and do not appear to, affect the integrity of the group's decision-making processes.

 

(5)     The Board must publish guidance for clinical commissioning groups on the discharge of their functions under this section.

 

(6)     Each clinical commissioning group must have regard to guidance published under subsection (5).

 

(7)     For the purposes of this section, the commissioning functions of a clinical commissioning group are the functions of the group in arranging for the provision of services as part of the health service”

 

5.3          The legal duty to “make arrangements” is used in many other places in the NHS Act and in other legislation which imposes statutory duties on public bodies.  The nature of the duty places a considerable degree of discretionary decision making on CCGs to decide for themselves how to manage their affairs so that the existence of GP members or staff who have interests does not affect or is seen to affect the integrity of the group's decision-making processes. 

 

5.4          Some guidance about the meaning of a duty to make arrangements was given by Underhill LJ in the first instance decision of R (on the application of Nash) v Barnet London Borough Council (Capita plc and others, interested parties [2013] EWHC 1067 (Admin).  The case was only a permission decision and so is of limited weight but it is a full judgment by a distinguished judge.  The Judge was concerned with a duty to make arrangements under local government legislation but his approach may have relevance for understanding the nature of the duty under section 14O.  He said at paragraph 70:

 

“..  the reference to 'making arrangements' would make it clear that the duty was concerned with intentions rather than outcome. It may also be that the draftsman wanted to emphasise the need to build the fulfilment of the best value duty into authorities' plans and procedures. Or perhaps it is just circumlocution. But, whatever the explanation, the important point for present purposes is what the arrangements are aimed at, namely securing improvements in the way in which authorities perform their functions”

 

5.5          Thus the legal duty is to ensure that the way in which the CCG conducts its business ensures that the interests held by GP members or staff do not affect (and are not seen to affect) the integrity of the decisions made by the CCG.  The CCG must therefore have a system which records conflicts of interests when these are relevant to an issue that the CCG is considering, and that those with some types of interest are removed from the decision making process.  The "arrangements" which the CCG is required to put in place under section 14O are the means by which that end is to be achieved.  In Tandy v East Sussex CC [1998] A.C. 714 Mummary LJ emphasised the width of the discretion on a public body which had a duty to make arrangements (in that case about the education of children with special educational needs).  He said:

 

“In the interests of fairness, consistency and administrative efficiency a local education authority is entitled to formulate a policy setting norms, standards and criteria to be applied in the consideration of the circumstances of individual children. Such a policy is lawful if it promotes the specified statutory purpose and is sufficiently flexible not to fetter the decision-making process in individual cases. Further, once a policy has been formulated, it is permissible (and advisable) to review it from time to time in the light of experience and of changing circumstances”

 

5.6          However the overall purpose of the arrangements must be borne in mind and the fact that, whatever arrangements the CCG sets up, it must achieve the aim of ensuring that the interests held by GP members or staff do not affect (and are not seen to affect) the integrity of the decisions made by the CCG.   Speaking in the House of Lords in the same case Lord Browne-Wilkinson said at Page 747:

 

The duty is to make arrangements for what constitutes suitable education for each child. That duty will not be fulfilled unless the arrangements do in fact provide suitable education for each child”

 

5.7          Thus the arrangements made by the CCG must in fact deliver a proper system for the management of conflicts of interests within the CCG.  Paragraph 5 of Schedule 1A to the NHS Act (which was introduced by Schedule 2 of the Health and Social Care Act 2012) provides that the constitution for each CCG must specify the arrangements made by the CCG for discharging its duties to manage conflicts of interest under section 14O(1) to (4). 

 

6.              What arrangements for managing conflicts of interest are suggested by the CCG Model Constitution?

 

6.1          Paragraph 5 of Schedule 1A to the NHS Act provides:

 

“The constitution must specify the arrangements made by the clinical commissioning group for discharging its duties under section 14O(1) to (4)”

 

6.2          The constitution for CCG is thus required to “specify” the arrangements which the CCG will operate in order to manage conflicts of interest.  Unfortunately the Model Constitution published by NHS England does not appear fully to comply with this legal requirement.

 

6.3          The model constitution provides at clause 8.2.2:

 

Where an individual, i.e. an employee, group member, member of the governing body, or a member of a committee or a sub-committee of the group or its governing body has an interest, or becomes aware of an interest which could lead to a conflict of interests in the event of the group considering an action or decision in relation to that interest, that must be considered as a potential conflict, and is subject to the provisions of this constitution”

 

6.4          This paragraph thus identifies the circumstances in which the CCG has a legal obligation to operate its business in accordance with the rules about managing conflicts of interests.   That duty arises if any individual becomes aware that a potential conflict arises.  The “individual” is not limited to the person who has the relevant interest.  It comes into play if the potential conflict becomes apparent to anyone who understands the circumstances and appreciates the emergence of the potential conflict.  The circumstances which bring the rules about conflicts of interest into play are that the CCG is considering or may be considering an “action or decision” in relation to which anyone at a CCG has “an interest which could lead to a conflict of interests”.   There is a potential problem with this formulation because it appears to set up a subjective test which only triggers the conflict of interest rules if anyone in the CCG realises that there is a potential or actual conflict of interest which means that attention must be paid to the conflict of interest rules.  That raises the obvious question as to what happens if the CCG makes a decision which is infected with a conflict of interest but, at the time the decision was made, no one at the CCG appreciated that one or more of the relevant decision makers had a relevant interest.  The resolution of that issue may require a court ruling but it seems highly unlikely that a CCG could rely on its own lack of perception to justify the lawfulness of its decision making.

 

6.5          Once a potential conflict of interest has been identified, the key question is how the CCG should manage the conflict within its decision making processes in order to ensure that the integrity of the decision making process is maintained.  The steps that a CCG should take to manage an interest depend, of course, on the nature of the interest of that individual and in particular whether it is a pecuniary interest or a non-pecuniary interest, and whether this is a direct interest of the person or is an indirect interest (because for example it is an interest held by a member of his or her family.  There are 3 broad approaches that are possible where a person who is a member of a relevant committee has a relevant interest:

 

a)         The interest is declared and noted in the minutes of the meeting but the person with the interest is still able to take a full part in the decision making process;

 

b)         The interest is declared and that person with the interest cannot vote on any decision.  However the person remains as a member of the relevant committee, can see papers relating to the decision and remains in the room and can contribute to any debate about the decision;

 

c)          The interest is declared and that person is excluded from the decision making process.  That would mean that the person should not be provided with the committee papers relating to the decision and cannot have any part in the decision-making process (formally or informally).   That would exclude any informal lobbying as well as making formal representations in favour of a particular decision.

 

6.6          Regrettably the model CCG Model Constitution does not provide a clear answer to this problem.  It says at paragraph 8.4.1: 

 

“Individual members of the group, the governing body, committees or sub-committees, the committees or sub-committees of its governing body and employees will comply with the arrangements determined by the group for managing conflicts or potential conflicts of interest”

 

6.7          That must lead to the question “well what are the arrangements”?  The model CCG Constitution suggests that it is sufficient for the CCG to delegate the detailed decision about how the CCG should operate where a conflicts of interest is identified to an officer of the CCG.  It appears to assume that the job of this officer is to make up the rules about how the committees of the CCG should operate when there is a conflict.  However specifying that a named individual will make up the rules (i.e. determine the “arrangements”) does not fulfil an obligation to specify what those rules are.  Hence the Model Constitution probably does not fulfil the obligation in paragraph 5 of schedule 1A to the NHS Act.

 

6.8          The full text of the relevant provisions within the model constitution is as follows:

 

“8.4.3  “Arrangements for the management of conflicts of interest are to be determined by the [insert the name of the body / person overseeing the management of conflicts of interest on behalf of the group] and will include the requirement to put in writing to the relevant individual arrangements for managing the conflict of interests or potential conflicts of interests, within a week of declaration. The arrangements will confirm the following:  

 

a)         when an individual should withdraw from a specified activity, on a temporary or permanent basis;

b)         monitoring of the specified activity undertaken by the individual, either by a line manager, colleague or other designated individual.

 

8.4.4.  Where an interest has been declared, either in writing or by oral declaration, the declarer will ensure that before participating in any activity connected with the group’s exercise of its commissioning functions, they have received confirmation of the arrangements to manage the conflict of interest or potential conflict of interest from the [insert the name of the body / person overseeing the management of conflicts of interest on behalf of the group].

 

8.4.5  Where an individual member, employee or person providing services to the group is aware of an interest which:

 

a)    has not been declared, either in the register or orally, they will declare this at the start of the meeting;

b)    has previously been declared, in relation to the scheduled or likely business of the meeting, the individual concerned will bring this to the attention of the chair of the meeting, together with details of arrangements which have been confirmed for the management of the conflict of interests or potential conflict of interests.

 

The chair of the meeting will then determine how this should be managed and inform the member of their decision. Where no arrangements have been confirmed, the chair of the meeting may require the individual to withdraw from the meeting or part of it. The individual will then comply with these arrangements, which must be recorded in the minutes of the meeting.

 

8.4.6  Where the chair of any meeting of the group, including committees, sub-committees, or the governing body and the governing body’s committees and sub-committees, has a personal interest, previously declared or otherwise, in relation to the scheduled or likely business of the meeting, they must make a declaration and the deputy chair will act as chair for the relevant part of the meeting. Where arrangements have been confirmed for the management of the conflict of interests or potential conflicts of interests in relation to the chair, the meeting must ensure these are followed. Where no arrangements have been confirmed, the deputy chair may require the chair to withdraw from the meeting or part of it. Where there is no deputy chair, the members of the meeting will select one.

 

8.4.7  Any declarations of interests, and arrangements agreed in any meeting of the clinical commissioning group, committees or sub-committees, or the governing body, the governing body’s committees or sub-committees, will be recorded in the minutes.

 

8.4.8  Where more than 50% of the members of a meeting are required to withdraw from a meeting or part of it, owing to the arrangements agreed for the management of conflicts of interests or potential conflicts of interests, the chair (or deputy) will determine whether or not the discussion can proceed.

 

8.4.8  In making this decision the chair will consider whether the meeting is quorate, in accordance with the number and balance of membership set out in the group’s standing orders. Where the meeting is not quorate, owing to the absence of certain members, the discussion will be deferred until such time as a quorum can be convened. Where a quorum cannot be convened from the membership of the meeting, owing to the arrangements for managing conflicts of interest or potential conflicts of interests, the chair of the meeting shall consult with [insert the name of the body / person overseeing the management of conflicts of interest on behalf of the group] on the action to be taken”

 

8.4.10  This may include:

 

a)    requiring another of the group’s committees or sub-committees, the group’s governing body or the governing body’s committees or sub-committees (as appropriate) which can be quorate to progress the item of business, or if this is not possible,

 

b)    inviting on a temporary basis one or more of the following to make up the quorum (where these are permitted members of the governing body or committee / sub-committee in question) so that the group can progress the item of business:

 

i)          a member of the clinical commissioning group who is an individual;

 

ii)         an individual appointed by a member to act on its behalf in the dealings between it and the clinical commissioning group;

 

iii)        a member of a relevant Health and Wellbeing Board;

 

iv)        a member of a governing body of another clinical commissioning group.

 

These arrangements must be recorded in the minutes.

 

8.4.11  In any transaction undertaken in support of the clinical commissioning group’s exercise of its commissioning functions (including conversations between two or more individuals, e-mails, correspondence and other communications), individuals must ensure, where they are aware of an interest, that they conform to the arrangements confirmed for the management of that interest. Where an individual has not had confirmation of arrangements for managing the interest, they must declare their interest at the earliest possible opportunity in the course of that transaction, and declare that interest as soon as possible thereafter. The individual must also inform either their line manager (in the case of employees), or the [insert the name of the body / person overseeing the management of conflicts of interest on behalf of the group] of the transaction.

 

8.4.12  The [insert the name of the body / person overseeing the management of conflicts of interest on behalf of the group] will take such steps as deemed appropriate, and request information deemed appropriate from individuals, to ensure that all conflicts of interest and potential conflicts of interest are declared

 

6.9          These paragraphs do not provide proper guidance to CCGs on the key issues as to how to manage conflicts of interest in practice.  They require the CCG to appoint someone whose job it is to set up arrangements for the management of conflicts.  However they do not provide any clear guidance as to how those rules should be or how the conflicts should be managed.  The joint paper from the RCGP and the NHS Confederation was slightly more helpful in that it suggested that CCGs might wish to adopt guidance provided by the General Practice Committee of the GMS which advised:

 

·       Directors of provider companies or those with holdings above 5 per cent should not be on a clinical commissioning management board if their company does business or is likely to do business with the CCG.

 

·       CCGs must keep a register of the interests of anyone who might be able to influence a decision. This must be available to the public. It should also extend to the interests of family members and those closely connected to the member.

 

·       Interests must be declared at the beginning of meetings even if it is included in the register. They should not be allowed to speak or vote on the issue unless the group has decided that the interest is non-prejudicial.

 

·       If the interest would be considered prejudicial by a reasonable person, the member should leave the room while the item is discussed.

 

·       If the meeting is left non quorate because of this, an independent body should be appointed to verify any decisions made.

 

·       When a CCG decides to commission enhanced services from its GP members, the issue should always be referred to the local overview and scrutiny committee for approval”

 

6.10       This approach appears sensible and balanced. However NHS England the Department decided not to introduce them into a model CCG constitution.  This has the advantage that the detail of the rules about management of conflicts are not “set in stone” for the CCG and can therefore be amended reasonably easily if changes are needed to make them workable.  However it leaves 3 potential problems for those working with CCGs, namely:

 

a)         The CCG Constitution may be in breach of paragraph 5 of Schedule 1A to the NHS Act;

 

b)         It may be difficult for members of the public to find out the details of the present rules (unless these are included on the CCG website which is not always the case); and

 

c)          Even if a decision is made in accordance with locally agreed rules, there is no guarantee that a decision will be a lawful decision for the reasons set out below.

 

7.              What rules are necessary to ensure that an interest does not affect and is not seen to affect the integrity of the decision making process?

 

7.1          Section 14O(4) requires a CCG to have arrangements which manage conflicts of interest in such a way that the interests do not  affect and are not seen to affect the integrity of the decision making process.  There are 2 separate parts to this test.  The first is that the existence of interests must not in fact affect the decision making process.  The second is that the existence of interests must not be seen to affect the decision making process.  The first test broadly requires a CCG to have rules which ensure decisions are not affected by any interest that a member or member of staff has which is relevant to the decision.  The second is a much wider test because it is concerned with how the decision making process appears from the outside.

 

7.2          When public bodies (which include CCGs) are making administrative decisions s series of Judicial Review cases have established that the test is “whether there was objectively a real danger of bias” in the decision.  This approach was demonstrated by Brooke J in R v Chesterfield BC, ex p Darker Enterprises Ltd [1992] COD 466 which concerned an application to renew a sex shop licence had been refused by a sub-committee of the local authority.  The council committee was chaired by a councillor known to be strongly opposed to sex shops in general and to the applicants' shop in particular but it also had included a councillor who was a director of the Co-operative Society which owned the neighbouring retail premises and which hoped to expand into the sex shop premises if its licence was not renewed.  The latter councillor took part in the meeting but abstained from voting because of his declared interest.  Brooke J, following the decision of Kennedy J in R v Reading BC, ex p Quietlynn Ltd, held that the chairman's participation was unobjectionable provided that, whatever his views, he was prepared to listen.  Hence a GP who expresses strong views in advance in favour or against a particular form of medical provision is not obliged to remove himself from a meeting just because of these pre-existing views.  However in the Quietlynn case the Judge held that the participation of the other councillor, despite his properly registered declaration of an interest and consequent abstention from voting, would have persuaded a fair-minded observer who knew of his Co-op connection, that it was unfair for the councillor to be present and to have participated in questioning the applicants.  The decision was therefore quashed.  The Judge said:

 

'I am satisfied that in a situation like this, where the involvement of a councillor is challenged not because of his public views on the merits of the matter being discussed but in relation to his private interests, in relation to companies of which he is a director, the question as to whether a decision to which he is party can be successfully quashed is not to be tested by the principle laid down by Kennedy J in the Reading case but in accordance with the general line of cases on bias which culminated in the decision of the Divisional Court in R v Liverpool City Justices, ex p Topping [1983] 1 All ER 490, [1983] 1 WLR 119”

 

7.3          This approach was followed by Sedley J in R v Secretary of State for the Environment ex parte Kirkstall Valley Campaign Group [1]  who said:

 

'The mere fact that the power affects rights or interests is what makes it “judicial” and so subject to the procedures required by natural justice.' (My emphasis.) The reference to interests as well as to rights is important. Public law is concerned not only with the vindication of positive rights, but with the redress of public wrongs wherever the court's attention is called to them by a person or body with a sufficient interest.

 

I hold, therefore, that the principle that a person is disqualified from participation in a decision if there is a real danger that he or she will be influenced by a pecuniary or personal interest in the outcome, is of general application in public law and is not limited to judicial or quasi-judicial bodies or proceedings.

 

7.4          This approach means that a GP who has either any significant form pecuniary interest or a non-pecuniary interest which is not trivial should be required entirely to remove himself from any decision which relates to his interest.  This may make decision making difficult in practice but the standard against which these matters are tested is not whether the objector is able to show bias but whether there was any real danger of bias in the making of the decision. 

 

8.              Potential legal consequences where decisions are made in breach of the rules about managing conflicts of interest.

 

8.1          What happens if a CCG makes a decision where it fails properly to manage a conflict of interest of one of its members?   There are several potential legal consequences if the CCG fails to follow its own rules about managing conflicts of interest.  These are:

 

a)         A damages claim by a disappointed alternative contractor;

b)         A judicial review;

c)          An NHS compliant; and

d)         A complaint to the GMC.

 

8.2          In almost every procurement or contracting decision made by public body there are winners and losers.  The successful party has got the contract but there are other bidders who will feel bruised and disappointed at not being awarded the contract.  Section 75 of the Health and Social Care Act 2012 gave a power to the Secretary of State to make Regulations for NHS England and CCGs concerning the way in which health services were procured.  Section 76(7) provided that a breach of those Regulations would result in a damages claim.  It provides:

 

“A failure to comply with a requirement imposed by regulations under section 75 which causes loss or damage is actionable, except in so far as the regulations restrict the right to bring such an action”

 

8.3          The relevant Regulations are the National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013.  Regulation 6 of these Regulations which makes provision for circumstances where there is a real or apparent of interest between the NHS commissioner and the supplier of services to the NHS.  It provides:

 

(1) A relevant body must not award a contract for the provision of health care services for the purposes of the NHS where conflicts, or potential conflicts, between the interests involved in commissioning such services and the interests involved in providing them affect, or appear to affect, the integrity of the award of that contract.

 

(2) In relation to each contract that it has entered into for the provision of health care services for the purposes of the NHS, a relevant body must maintain a record of how it managed any conflict that arose between the interests in commissioning the services and the interests involved in providing them.

 

(3) An interest referred to in paragraph (1) includes an interest of—

 

(a)   a member of the relevant body,

 

(b)   a member of its governing body,

 

(c)  a member of its committees or sub-committees or committees or sub-committees of its governing body, or

 

(d)   an employee”

 

8.4          This Regulation uses the same wording as section 14O(4) namely that a contract must not be awarded if “the interests involved in providing them affect, or appear to affect, the integrity of the award of that contract”.  Thus a CCG would act in breach of the Regulations if it awarded a contract in circumstances which appeared to an outside observer to affect the integrity of the award of the contract even if, properly examined from inside the CCG, the process was scrupulously fair.

 

8.5          The tie up between the 2013 Regulations and section 14O means that a contract which is awarded by a CCG in breach of its own conflicts of interest rules will open up the possibility of damages being awarded to the disappointed contractor.  Damages will usually be based on the commercial value of the loss of the chance to secure the contract.  Hence damages will be minimal if the CCG can show that the disappointed contractor would not have had any real chance of being awarded the contract even if the conflicts rules had been followed.  However if there was a real prospect that the disappointed contractor might have gained a contract from the CCG then damages could be very substantial.

 

8.6          The second risk is that a judicial review challenge will be made to the decision.  Any challenger would have to have a “sufficient interest” in the decision.  However any patient in the CCG area would probably be entitled to challenge a decision that was taken in breach of the rules.  Any challenger must act promptly and in any event within 3 months of the relevant decision but if a breach of the rules is proved the decision of the CCG is likely to be quashed.

 

8.7          Thirdly, a potential contractor who wishes to challenge a decision of a CCG or NHS England that he claims has been made in breach of the rules about managing conflicts of interest could make a complaint to Monitor and invite Monitor to investigate and make a decision whether there had been a breach of Regulation 6.  However a breach of Regulation 6 cannot lead to Monitor declaring the contract to be ineffective because Regulation 6 is omitted from the list of breaches where that power arises:  see Regulation 14(2).  If a complaint is made Monitor could issue a Direction to prevent the CCG from repeating the conduct under Regulation 15(1) but this is unlikely to be effective to change the present position.  It is thus difficult to understand why a disappointed contractor should take such an approach.

 

8.8          The fourth possibility is that an NHS complaint is made that the CCG has acted in breach of its own rules on the management of conflicts of interest.  This may, on appeal, lead to the matter being looked at by the Parliamentary and Health Service Ombudsman.  That could lead to a finding that the CCG was guilty of maladministration and a “recommendation” that the CCG issue apologies or provide compensation to the complainant.

 

8.9          Finally, failing to follow the rules relating to the management of conflicts of interest may result in a GP being referred to the General Medical Council.  The GMC Code of Conduct “Good Medical Practice has the following sections about managing conflicts of interest:

 

77. You must be honest in financial and commercial dealings with patients, employers, insurers and other organisations or individuals.

 

78. You must not allow any interests you have to affect the way you prescribe for, treat, refer or commission services for patients.

 

79. If you are faced with a conflict of interest, you must be open about the conflict, declaring your interest formally, and you should be prepared to exclude yourself from decision making.

 

80. You must not ask for or accept – from patients, colleagues or others – any inducement, gift or hospitality that may affect or be seen to affect the way you prescribe for, treat or refer patients or commission services for patients. You must not offer these inducements”

 

8.10       This part of the Code has been expanded by new Guidance published in 2013 called Financial and Commercial Arrangements and Conflicts of Interest which sets out general principles that all doctors are required to follow.  The section on Conflicts of Interest provides as follows:

 

“10. Trust between you and your patients is essential to maintaining effective professional relationships, and your conduct must justify your patients’ trust in you and the public’s trust in the profession. Trust may be damaged if your interests affect, or are seen to affect, your professional judgement. Conflicts of interest may arise in a range of situations. They are not confined to financial interests, and may also include other personal interests.

 

11. Conflicts of interest are not always avoidable, and whether a particular conflict creates a serious concern will depend on the circumstances and what steps have been taken to mitigate the risks, for example, by following established procedures for declaring and managing a conflict.

 

12. You should:

 

a. use your professional judgement to identify when conflicts of interest arise

 

b. avoid conflicts of interest wherever possible

 

c. declare any conflict to anyone affected, formally and as early as possible, in line with the policies of your employer or the organisation contracting your services

 

d. get advice about the implications of any potential conflict of interest

 

e. make sure that the conflict does not affect your decisions about patient care.

 

13. If you are in doubt about whether there is a conflict of interest, act as though there is”

 

8.11       The final “if in doubt” provision in the GMC Guidance is replicated at paragraph 8.2.4 of the Model Constitution prepared by the Department of Health for CCGs which provides:

 

If in doubt, the individual concerned should assume that a potential conflict of interest exists”

                   

8.12       A breach of professional obligations may lead to a GP being referred to the GMC for disciplinary action.  However it will not, of itself, necessarily create any other legal right for proceedings to be taken against the GP or the organisation which is said to have benefitted from the failure of the GP properly to address the conflict of interest.

 

8.13       There are some difficult issues about the effect of a legal challenge on the private law contractual rights of the successful contractor, particularly if that contractor was wholly innocent of the procedural flaws which affected the decision.  Thus a CCG which acts in breach of the rules relating to the management of conflicts of interest may find itself under a legal liability to both a successful and unsuccessful contractor.



[1] [1996] 3 All ER 304.

This chapter was updated in June 2014

 

GPs and Practice Contracts with NHS England. 

 

This chapter contains:

 

1.          Background to GP contracting.

2.