NATIONAL HEALTH SERVICE, ENGLAND PART 1 GENERAL Citation, commencement and application 1 1 These Regulations may be cited as the National Health Service (Personal Medical Services Agreements) Regulations 2004 and shall come into force on 1st April 2004. 2 These Regulations apply in relation to England only . Interpretation 2 In these Regulations— “ the Act ” means the National Health Service Act 1977; “the 1990 Act ” means the National Health Service and Community Care Act 1990; “the 2003 Order ” means the General and Specialist Medical Practice (Education, Training and Qualifications) Order 2003 ; “ Abolition of the Tribunal Regulations ” means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2001 ; “ Abolition of the Tribunal (Wales) Regulations ” means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002 ; “adjudicator” means the Secretary of State or a person or persons appointed by the Secretary of State under section 4(5) of the 1990 Act or paragraph 95(5) of Schedule 5; “agreement” means, except where the context otherwise requires, an agreement for primary medical services made under section 28C of the Act; “appliance” means an appliance which is included in a list for the time being approved by the Secretary of State for the purposes of section 41 of the Act; “approved medical practice” shall be construed in accordance with section 11(4) of the Medical Act 1983 ; “ armed forces GP ” means a medical practitioner, who is employed on a contract of service by the Ministry of Defence, whether or not as a member of the United Kingdom Armed Forces of Her Majesty; “assessment panel” means a committee or sub-committee of a Primary Care Trust (other than the Primary Care Trust which is a party to the agreement in question) appointed to exercise functions under paragraphs 30 and 34 of Schedule 5; “bank holiday” means any day that is specified or proclaimed as a bank holiday pursuant to section 1 of the Banking and Financial Dealings Act 1971 ; “batch issue” means a form provided by a Primary Care Trust and issued by a prescriber at the same time as a repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services which is in the format specified in Part 2 of Schedule 1, and which— is generated by a computer and not signed by a prescriber, relates to a particular repeatable prescription and contains the same dates as that prescription, is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs, medicines or appliances ordered on the repeatable prescription may be provided, and specifies a number denoting its place in the sequence referred to in paragraph (c); “ CCT ” means Certificate of Completion of Training awarded under article 8 of the 2003 Order, including any such certificate awarded in pursuance of the competent authority functions of the Postgraduate Medical Education and Training Board specified in article 20(3)(a) of that Order; “charity trustee” means one of the persons having the general control and management of the administration of a charity; “chemist” means— a registered pharmacist, a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 , or a supplier of appliances, who is included in the list of a Primary Care Trust or a Local Health Board under section 42 of the Act, or who provides local pharmaceutical services in accordance with LPS arrangements; “child” means a person who has not attained the age of 16 years; “closed”, in relation to the contractor’s list of patients, means closed to applications for inclusion in the list of patients other than from immediate family members of registered patients; “contractor” means, except where the context otherwise requires— where a Primary Care Trust is not providing services under the agreement, a person or persons other than a Primary Care Trust, who is a party, or are parties, to the agreement, or where a Primary Care Trust is providing services under the agreement, that Primary Care Trust and any other person or persons (other than a Strategic Health Authority) who is a party, or are parties, to the agreement; “contractor’s leaflet” means a leaflet drawn up in accordance with paragraph 72 of Schedule 5; “contractor’s list of patients” means the list prepared and maintained by the Primary Care Trust under paragraph 13 of Schedule 5 and references to the contractor having a list of patients shall be interpreted accordingly; “contractor’s practice area” means the area specified in the agreement as the area in which essential services are to be provided; “contractor’s premises” means an address specified in the agreement as one at which services are to be provided under the agreement; “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; “dispensing services” means the provision of drugs, medicines or appliances that may be provided as pharmaceutical services by a medical practitioner in accordance with arrangements made under regulation 20 of the Pharmaceutical Regulations ; “Drug Tariff” has the same meaning as in regulation 18 of the Pharmaceutical Regulations; “essential services” means the services described in regulation 15(3), (5), (6) and (8) of the General Medical Services Contracts Regulations ; “ FHSAA ” means the Family Health Service Appeal Authority constituted under section 49S of the Act ; “ FHSAA (SHA) ” means the Family Health Services Appeal Authority (Special Health Authority) established by article 2 of the Family Health Services Appeal Authority (Establishment and Constitution) Order 1995 ; “general medical practitioner” means, except where the context otherwise requires— on or after the coming into force of article 10 of the 2003 Order, a medical practitioner whose name is included in the General Practitioner Register, and before the coming into force of that article, a medical practitioner who is either— until the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, suitably experienced within the meaning of section 31(2) of the Act, section 21 of the National Health Service (Scotland) Act 1978 or Article 8(2) of the Health and Personal Social Services (Northern Ireland) Order 1978 , or has an acquired right to practise as a general medical practitioner pursuant to regulation 5(1)(d) of the Vocational Training for General Medical Practice (European Requirements) Regulations 1994 , or upon the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, an eligible general practitioner pursuant to that paragraph; “General Medical Services Contracts Regulations” means the National Health Services (General Medical Services Contracts) Regulations 2004 ; “General Practitioner Register” means the register kept by the General Medical Council under article 10 of the 2003 Order; “ GP Registrar”— until the coming into force of article 5 of the 2003 Order, means a medical practitioner who is being trained in general practice by a medical practitioner who— has been approved for that purpose by the Joint Committee on Postgraduate Training for General Practice under regulation 7 of the National Health Service (Vocational Training for General Medical Practice) Regulations 1997 , and performs primary medical services, and from the coming into force of that article, means a medical practitioner who is being trained in general practice by a GP Trainer whether as part of training leading to the award of a CCT or otherwise; “GP Trainer” means a general medical practitioner who is— until the coming into force of article 4(5)(d) of the 2003 Order, approved as a GP Trainer by the Joint Committee on Postgraduate Training for General Practice under regulation 7 of the National Health Service (Vocational Training for General Medical Practice) Regulations 1997, or from the coming into force of that article, approved by the Postgraduate Medical Education and Training Board under article 4(5)(d) of the 2003 Order for the purposes of providing training to a GP Registrar under article 5(1)(c)(i); “Health and Social Services Board” means a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 1972 ; “Health and Social Services Trust” means a Health and Social Services Trust established under the Health and Personal Social Services (Northern Ireland) Order 1991 ; “Health Board” means a Health Board established under the National Health Service (Scotland) Act 1978; “health care professional” has the same meaning as in section 28M of the Act (persons eligible to enter into GDS contracts) and “health care profession” shall be construed accordingly; “health service body” has, unless the context otherwise requires, the meaning given to it in section 4(2) of the 1990 Act ; “immediate family member” means— a spouse, 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, a parent or step parent, a son, a daughter, a child of whom the registered patient is— the guardian, or the carer duly authorised by a local authority to whose care the child has been committed under the Children Act 1989 , or a grandparent; “independent nurse prescriber” means a person— who is either engaged or employed by the contractor or is a party to the agreement, who is registered in the Nursing and Midwifery Register, and in respect of whom there is an annotation signifying that he is qualified to order drugs, medicines and appliances from— the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part XVIIB(i) of the Drug Tariff, or the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff; “licensing authority” shall be construed in accordance with section 6(3) of the Medicines Act 1968 ; “licensing body” means any body that licenses or regulates any profession; “Local Medical Committee” means a committee recognised under section 45A of the Act ; “local pharmaceutical services” has the same meaning as in regulation 2 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002 ; “medical card” means a card issued by a Primary Care Trust, Local Health Board, Health Authority, Health Board or Health and Social Services Board to a person for the purpose of enabling him to obtain, or establishing his title to receive, primary medical services; “medical officer” means a medical practitioner who is— employed or engaged by the Department for Work and Pensions, or provided by an organisation in pursuance of an agreement entered into with the Secretary of State for Work and Pensions; “medical performers list” means a list of medical practitioners prepared and published by a Primary Care Trust pursuant to regulation 3(1) of the National Health Service (Performers Lists) Regulations 2004 ; “Medical Register” means the registers kept under section 2 of the Medical Act 1983 ; “ NCAA ” means the National Clinical Assessment Authority established as a Special Health Authority under section 11 of the Act; “national disqualification” means— a decision made by the FHSAA under section 49N of the Act (national disqualification) , a decision under provisions in force in Scotland or Northern Ireland corresponding to section 49N of the Act, or a decision by the NHS Tribunal which is treated as a national disqualification by the FHSAA by virtue of regulation 6(4)(b) of the Abolition of the Tribunal Regulations or regulation 6(4)(b) of the Abolition of the Tribunal (Wales) Regulations; “NHS trust” in relation to Scotland means a NHS trust established under the National Health Service (Scotland) Act 1978; “NHS contract” has the meaning assigned to it in section 4 of the 1990 Act; “the NHS dispute resolution procedure” means the procedure for resolution of disputes specified— in paragraphs 95 and 96 of Schedule 5, or in a case to which paragraph 35 of Schedule 5 applies, in that paragraph; “the NHS Tribunal” means the Tribunal constituted under section 46 of the Act for England and Wales, and which, except for prescribed cases, had effect in relation to England only until 14th December 2001 and in relation to Wales only until 26th August 2002 ; “normal hours” means, except in Schedule 6, those days and hours on which and the times at which services under the agreement are normally made available and may be different for different services; “Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under the Nursing and Midwifery Order 2001 ; “open”, in relation to a contractor’s list of patients, means open to applications from patients in accordance with paragraph 14 of Schedule 5; “out of hours period” means— the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8am on the following day, the period between 6.30pm on Friday and 8am on the following Monday, and Good Friday, Christmas Day and bank holidays, and “part” of an out of hours period means any part of any one or more of the periods described in paragraphs (a) to (c); “out of hours services” means services required to be provided in all or part of the out of hours period which would be essential services if provided in core hours; “parent” includes, in relation to any child, any adult who, in the opinion of the contractor, is for the time being discharging in respect of that child the obligations normally attaching to a parent in respect of his child; “patient” means— a registered patient, a temporary resident, persons to whom the contractor is required to provide immediately necessary treatment as part of its obligation to provide essential services, and any other person to whom the contractor has agreed to provide services under the agreement; “Patients' Forum” means a Patients' Forum established for a Primary Care Trust under section 15 of the National Health Service Reform and Health Care Professions Act 2002 ; “Pharmaceutical Regulations” means the National Health Service (Pharmaceutical Services) Regulations 1992 ; “the POM Order ” means the Prescription Only Medicines (Human Use) Order 1997 ; “prescriber” means— a medical practitioner, an independent nurse prescriber, and a supplementary prescriber, who is either engaged or employed by the contractor or is a party to the agreement; “prescription form” means a form provided by the Primary Care Trust and issued by a prescriber to enable a person to obtain pharmaceutical services or local pharmaceutical services and does not include a repeatable prescription; “prescription only medicine” means a medicine referred to in article 3 of the POM Order (medicinal products on prescription only); “primary care list” means— a list of persons performing primary medical or dental services prepared in accordance with regulations made under section 28X of the Act (persons performing primary medical and dental services) , a list of persons undertaking to provide general medical services, general dental services, general ophthalmic services or, as the case may be, pharmaceutical services prepared in accordance with regulations made under sections 29 (arrangements and regulations for general medical services), 36 (arrangements for general dental services), 39 (regulations as to section 38), 42 (regulations as to pharmaceutical services) or 43 (persons authorised to provide pharmaceutical services) of the Act, a list of persons approved for the purposes of assisting in the provision of any such services mentioned in paragraph (b) prepared in accordance with regulations made under section 43D of the Act (supplementary lists) , a services list referred to in section 8ZA of the National Health Service (Primary Care) Act 1997 (lists of persons who may perform personal medical services or personal dental services) , a list corresponding to a services list prepared by virtue of regulations made under section 41 of the Health and Social Care Act 2001 (corresponding provision and application of enactments) , or a list corresponding to any of the above lists in Scotland or Northern Ireland; “Primary Care Trust” means, except where the context otherwise requires, the Primary Care Trust which is a party, or prospective party, to an agreement; “primary carer” means, in relation to an adult, the adult or organisation primarily caring for him; “registered patient” means— a person who is recorded by the Primary Care Trust pursuant to paragraph 13 of Schedule 5 as being on the contractor’s list of patients or its list of patients, or a person whom the contractor has accepted for inclusion on its list of patients, whether or not, in the case of a contractor which is not a Primary Care Trust, notification of that acceptance has been received by the Primary Care Trust and who has not been notified by the Primary Care Trust as having ceased to be on that list; “relevant body” means— in a case where a contractor is a party to an agreement with a Primary Care Trust, that Primary Care Trust, and in a case where a contractor is a party to an agreement with a Strategic Health Authority, that Strategic Health Authority; “relevant register” means— in relation to a nurse, the Nursing and Midwifery Register, and in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 (the registers and registration) or the register maintained in pursuance of articles 6 (the registers) and 9 (the registrar) of the Pharmacy (Northern Ireland) Order 1976 ; “relevant Strategic Health Authority” means the Strategic Health Authority established for an area which includes the area for which the Primary Care Trust is established; “repeat dispensing services” means pharmaceutical services or local pharmaceutical services which involve the provision of drugs, medicines or appliances by a chemist in accordance with a repeatable prescription; “repeatable prescribing services” means services which involve the prescribing of drugs, medicines or appliances on a repeatable prescription; “repeatable prescription” means a prescription contained in a form provided by a Primary Care Trust and issued by a prescriber to enable a person to obtain pharmaceutical services or local pharmaceutical services, which is in the format specified in Part 1 of Schedule 1 and which— is generated by a computer but signed by a prescriber, and indicates that the drugs, medicines or appliances ordered on that form may be provided more than once and specifies the number of occasions on which they may be provided; “restricted availability appliance” means an appliance which is approved for particular categories of persons or particular purposes only; “Scheduled drug” means— a drug, medicine or other substance specified in any directions given by the Secretary of State under section 28U of the Act ( GMS contracts: prescription of drugs etc ) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under a general medical services contract, or except where the conditions in paragraph 41(2) of Schedule 5 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; “Strategic Health Authority” means, except where the context otherwise requires, the Strategic Health Authority which is a party, or prospective party, to an agreement; “supplementary prescriber” means a person— who is either engaged or employed by the contractor or is a party to the agreement, whose name is registered in— the Nursing and Midwifery Register, the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of the Pharmacy Act 1954, or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976, and against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber; “temporary resident” means a person accepted by the contractor as a temporary resident under paragraph 15 of Schedule 5 and for whom the contractor’s responsibility has not been terminated in accordance with that paragraph; “walk-in centre” means a centre at which information and treatment for minor conditions is provided to the public under arrangements made by or on behalf of the Secretary of State; “working day” means any day apart from Saturday, Sunday, Christmas Day, Good Friday or a bank holiday; and “writing”, except in paragraph 98(1) of Schedule 5 and unless the context otherwise requires, includes electronic mail and “written” should be construed accordingly. 2 In these Regulations, the use of the term “it” in relation to a contractor shall be deemed to include a reference to a contractor which is an individual or two or more persons contracting together to provide services under an agreement and related expressions shall be construed accordingly. PART 2 AGREEMENTS Conditions: introductory 3 A relevant body may make an agreement only if the conditions set out in regulations 4 and 5 are met. Conditions relating solely to medical practitioners 4 1 A relevant body may make an agreement with a medical practitioner (whether he falls within section 28D(1)(b) or another paragraph of section 28D(1)), only if he— a is a general medical practitioner; or b is employed by a Primary Care Trust, 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. 2 A relevant body may make an agreement with a qualifying body only if any share or shares in the qualifying body are legally and beneficially owned by a medical practitioner who is— a a general medical practitioner; or b a medical practitioner who is employed by a Primary Care Trust, 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. 3 In paragraph (1)(a) and (2)(a) “general medical practitioner” does not include— a from the coming into force of article 10 of the 2003 Order, a medical practitioner whose name is included in the General Practitioner Register by virtue of paragraph 1(d) of Schedule 6 to that Order; and b until the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, a medical practitioner who either— i has an acquired right to practise as a general medical practitioner pursuant to regulation 5(1)(d) of the Vocational Training for General Medical Practice (European Requirements) Regulations 1994 , or ii upon the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, is an eligible general practitioner pursuant to that paragraph by virtue of an acquired right under paragraph 1(d) of Schedule 6 to the 2003 Order. General condition relating to all agreements 5 1 A relevant body may make an agreement with an individual falling within section 28D(1)(b) to (d) only if that individual does not fall within paragraph (3). 2 A relevant body may make an agreement with a qualifying body only if— a the qualifying body; b any person legally and beneficially owning a share in the qualifying body; and c any director or secretary of the qualifying body, does not fall within paragraph (3). 3 A person falls within this paragraph if— a he or it (in the case of a qualifying body), is the subject of a national disqualification; b subject to paragraph (4), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world; c within the period of five years prior to the signing of the agreement or commencement of the agreement, whichever is the earlier, he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body unless he has subsequently been employed by that health service body or another health service body and paragraph (5) applies to him or that dismissal was the subject of a finding of unfair dismissal by any competent tribunal or court; d within the period of five years prior to signing the agreement or commencement of the agreement, whichever is the earlier, he or it has been removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act respectively ) unless his name has subsequently been included in such a list; e he has been convicted in the United Kingdom of murder; f he has been convicted in the United Kingdom of a criminal offence, committed on or after 1st April 2002, and has been sentenced to a term of imprisonment of over six months; g subject to paragraph (6) he has been convicted elsewhere of an offence— i which would, if committed in England and Wales, constitute murder, ii committed on or after 3rd November 2003 which would, if committed in England and Wales, constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months; h he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of the Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply) committed on or after 1st April 2004; 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 , 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, or iv an administrator, administrative receiver or receiver appointed in respect of it; j 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 (powers of the Court of Session to deal with management of charities) , from being concerned in the management or control of any body; or k 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 (failure to pay under county court administration order) . 4 A person shall not fall within paragraph (3)(b) where the relevant body is satisfied that the disqualification or suspension from practising is imposed by a licensing body outside the United Kingdom and it does not make the person unsuitable to be— a a party to an agreement; or b in the case of an agreement with a qualifying body— i a person legally and beneficially owning a share in the qualifying body, or ii a director or secretary of the qualifying body, as the case may be. 5 Where a person has been employed as a member of a health care profession any subsequent employment must also be as a member of that profession. 6 A person shall not fall within paragraph (3)(g) where the relevant body is satisfied that the conviction does not make the person unsuitable to be— a a party to an agreement; b in the case of an agreement with a qualifying body— i a person legally and beneficially owning a share in the qualifying body, or ii a director or secretary of the qualifying body, as the case may be. Reasons 6 1 Where a relevant body is of the view that the conditions in regulation 4 or 5 for making an agreement are not met it shall notify in writing the person or persons intending to make the agreement of its view and the reasons for that view and of his, its or their right of appeal under regulation 7. 2 The relevant body shall also notify in writing of its view and the reasons for that view any person legally and beneficially owning a share in, or a director or secretary of, a qualifying body that is notified under paragraph (1) where its reason for the decision relates to that person or those persons. Appeal 7 A person who has been served with a notice under regulation 6(1) may appeal to the FHSAA against the decision of the relevant body that the conditions in regulation 4 or 5 are not met by giving notice in writing to the FHSAA within the period of 28 days beginning on the day that the relevant body served its notice. PART 3 PRE-AGREEMENT DISPUTE RESOLUTION Pre-agreement disputes 8 1 Except where both parties to the prospective agreement are health service bodies (in which case section 4(4) of the 1990 Act applies), if, in the course of negotiations intending to lead to an agreement, the prospective parties to that agreement are unable to agree on a particular term of the agreement, either party may refer the dispute to the Secretary of State to consider and determine the matter. 2 Disputes referred to the Secretary of State in accordance with paragraph (1) or section 4(4) of the 1990 Act shall be considered and determined in accordance with the provisions of paragraphs 95(3) to (14) and 96(1) of Schedule 5, and paragraph (3) (where it applies) of this regulation. 3 In the case of a dispute referred to the Secretary of State under paragraph (1), the determination— a may specify terms to be included in the proposed agreement; b may require the relevant body to proceed with the proposed agreement, but may not require the proposed contractor to proceed with the proposed agreement; and c shall be binding upon the prospective parties to the agreement. PART 4 HEALTH SERVICE BODY STATUS Health service body status 9 1 A contractor shall be regarded as a health service body for the purposes of section 4 of the 1990 Act from the date that it makes an agreement unless— a in the case of an agreement with a single individual or qualifying body, that individual or body; or b in the case of any other agreement, any of the proposed parties to the agreement (other than the relevant body), objects in a written notice served on the relevant body at any time prior to the agreement being made. 2 Where a contractor is to be regarded as a health service body for the purposes of section 4 of the 1990 Act pursuant to paragraph (1), any change in the parties comprising the contractor shall not affect the health service body status of the contractor. 3 If, pursuant to paragraph (1) or (4) a contractor is to be regarded as a health service body, that fact shall not affect the nature of, or any rights or liabilities arising under, any other agreement or contract with a health service body entered into by that contractor before the date on which the contractor is to be so regarded. 4 A contractor may at any time request a variation of the agreement to include provision or remove provision from the agreement that the agreement is an NHS contract, and if it does so— a the relevant body shall agree to the variation; and b the procedure in paragraph 98(1) of Schedule 5 shall apply. 5 If, pursuant to paragraph (4), the relevant body agrees to the variation of the agreement so as to remove provision from the agreement that the agreement is an NHS contract, the contractor shall, subject to paragraph (7), cease to be regarded as a health service body for the purposes of section 4 of the 1990 Act from the date that variation is to take effect. 6 If, pursuant to paragraph (4), the relevant body agrees to the variation of the agreement so as to include a provision in the agreement that the agreement is an NHS contract, the contractor shall be regarded as a health service body for the purposes of section 4 of the 1990 Act from the date that the variation takes effect. 7 Subject to paragraph (8), a party or parties who were to be regarded as a health service body pursuant to paragraph (1) or (4), as the case may be, shall cease to be a health service body for the purposes of section 4 of the 1990 Act if the agreement terminates. 8 Where a contractor ceases to be a health service body pursuant to— a paragraph (5) or (7), it shall continue to be regarded as a health service body for the purposes of being a party to any other NHS contracts entered into after it became a health service body but before the date on which it ceased to be a health service body (for which purpose it ceases to be such a body on the termination of that NHS contract); b paragraph (5), it shall, if it or the relevant body has referred any matter to the NHS dispute resolution procedure before it ceases to be a health service body, be bound by the determination of the adjudicator as if the dispute had been referred pursuant to paragraph 94 of Schedule 5; or c paragraph (7), it shall continue to be regarded as a health service body for the purposes of the NHS dispute resolution procedure where that procedure has been commenced— i before the termination of the agreement, or ii after the termination of the agreement, whether in connection with or arising out of the termination of the agreement or otherwise, until the conclusion of that procedure. PART 5 AGREEMENTS: REQUIRED TERMS Health service contract 10 If the contractor is to be regarded as a health service body, the agreement must state that the agreement is an NHS contract. Agreements: general 11 1 An agreement must specify— a the services to be provided; b subject to paragraph (2), the address of each of the premises to be used by the contractor or any sub-contractor for the provision of such services; c to whom such services are to be provided; d where the agreement requires the contractor to provide essential services, the area as respects which persons resident in it will, subject to any other terms of the agreement relating to patient registration, be entitled to— i register with the contractor, or ii seek acceptance by the contractor as a temporary resident; and e subject to paragraph (4), where the agreement requires the contractor to provide essential services, whether, at the date on which the agreement comes into force, the contractor’s list of patients is open or closed. 2 The premises referred to in paragraph (1)(b) do not include— a the homes of patients; or b any other premises where services are provided on an emergency basis. 3 Where, in accordance with paragraph (1)(e), the agreement specifies that the contractor’s list of patients is closed, it must also specify in relation to that closure each of the items listed in paragraph 28(8)(a) to (d) of Schedule 5. 4 Where the contractor is a Primary Care Trust, the agreement must specify that its list of patients is open. Certificates 12 1 An agreement which requires the contractor to provide essential services 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 2, 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 a party to the agreement, or iii a shareholder in a qualifying body which is a party to the agreement; or b is not being treated by or under the supervision of a health care professional. 2 The exception in paragraph (1)(a) shall not apply where the certificate is issued pursuant to regulation 2(1)(b) of the Social Security (Medical Evidence) Regulations 1976 (which provides for the issue of a certificate in the form of a special statement by a doctor on the basis of a written report made by another doctor) . Finance 13 1 Subject to paragraph (2), the agreement must contain a term which has the effect of requiring the relevant body to make payments to the contractor under the agreement promptly and in accordance with both the terms of the agreement and any other terms based on which the payment is made and any other conditions relating to the payment contained in directions given by the Secretary of State under section 17 (Secretary of State’s directions: exercise of functions) or 28E(3A) of the Act . 2 The obligation referred to in paragraph (1) is subject to any right the relevant body may have to set off against any amount payable to the contractor under the agreement any amount— a that is owed by the contractor to the relevant body under the agreement; or b that the relevant body may withhold from the contractor in accordance with the terms of the agreement or any other applicable provisions contained in directions given by the Secretary of State under section 17 or 28E(3A). 14 The agreement must contain a term to the effect that where, pursuant to directions under section 17 or 28E(3A), a relevant body is required to make a payment to a contractor under an agreement but subject to conditions, those conditions are to be a term of the agreement. Fees and charges 15 1 The agreement must contain terms relating to fees and charges which have the same effect as those set out in paragraphs (2) to (4). 2 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 agreement or otherwise; or b any prescription or repeatable prescription for any drug or appliance, except in the circumstances set out in Schedule 3. 3 Where a person applies to a contractor for the provision of services and claims to be entitled to be treated by the contractor without paying a fee or other remuneration, 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 accordingly in accordance with paragraph (e) of Schedule 3, subject to the provision for repayment contained in paragraph (4). 4 Where a person from whom a contractor received a fee under paragraph (e) of Schedule 3 applies to the relevant body for a refund within 14 days of payment of the fee (or such longer period not exceeding a month as the relevant body may allow if it is satisfied that the failure to apply within 14 days was reasonable) and the relevant body is satisfied that the person was entitled to be treated by the contractor without paying a fee or other remuneration when the treatment was given, the relevant body may recover the amount of the fee from the contractor, by set off or otherwise, and shall pay that amount to the person who paid the fee. Opt outs of out of hours services 16 1 Where— a an agreement which is made before 1st October 2004 with a contractor (other than a Primary Care Trust) requires the contractor to provide out of hours services pursuant to regulation 20; and b the contractor has contracted to provide out of hours services only to patients which it is required to provide essential services to under the agreement, the agreement must contain terms relating to the procedure for opting out of those services which have the same effect as those specified in paragraphs 1 to 3 of Schedule 4 except paragraph 1(15) to (17) and paragraph 2(17) in so far as that sub-paragraph relates to paragraph 1(15) to (17). 2 Where— a an agreement which is made on or after 1st October 2004 with a contractor (other than a Primary Care Trust) requires the contractor to provide out of hours services pursuant to regulation 20; and b the contractor has contracted to provide out of hours services only to patients which it is required to provide essential services to under the agreement, the agreement must contain terms relating to the procedure for opting out of those services which have the same effect as those specified in paragraphs 1 and 3 of Schedule 4 except paragraph 1(15) to (17) of that Schedule. 3 Paragraph 1(15) to (17) and paragraph 2(17) in so far as that sub-paragraph relates to paragraph 1(15) to (17) of Schedule 4 shall have effect in relation to the matters set out in those paragraphs. Consequences of termination 17 An agreement shall make suitable provision for arrangements on termination of an agreement, including the consequences (whether financial or otherwise) of the agreement ending, subject to any specific requirements in these Regulations. Other contractual terms 18 1 An agreement must, unless it is of a type or nature to which the particular term does not apply, contain other terms which have, or make provision having, the same effect as those specified in Schedule 5 except paragraphs 30(6) to (8), 34(5) to (9), 35(5) to (17), 95(5) to (14) and 96. 2 Paragraphs 30(6) to (8), 34(5) to (9), 35(5) to (17), 95(5) to (14) and 96 shall have effect in relation to the matters set out in those paragraphs. PART 6 RIGHT TO A GENERAL MEDICAL SERVICES CONTRACT Right to a general medical services contract 19 1 A contractor which is providing essential services and which wishes a general medical services contract to be entered into pursuant to this regulation shall notify the relevant body in writing at least three months before the date on which it wishes the general medical services contract to be entered into. 2 A notice under paragraph (1) shall— a state that the contractor wishes to terminate the agreement and the date on which the contractor wishes the agreement to terminate which must be at least three months after the date of service of the notice; b subject to paragraph (3), give the name or names of the person or persons whom the contractor wishes the relevant body to enter into a general medical services contract with; and c confirm that the person or persons so named meet the conditions set out in section 28S of the Act (persons eligible to enter into GMS contracts) and regulations 4 and 5 of the General Medical Services Contracts Regulations or, where the contractor is not able so to confirm, the reason why it is not able to do so and confirmation that the person or persons immediately prior to entering into the general medical services contract will meet those conditions. 3 A person’s name may only be given in a notice referred to in paragraph (1) if that person is a party to the agreement. 4 The relevant body shall acknowledge receipt of the notice served under paragraph (1) within the period of 7 days beginning on the day that it received the notice. 5 Provided that the conditions set out in section 28S of the Act and regulations 4 and 5 of the General Medical Services Contracts Regulations are met, the relevant body shall enter into a general medical services contract with the person or persons named in the notice served under paragraph (1). 6 In addition to the terms required by the Act and the General Medical Services Contracts Regulations, a general medical services contract entered into pursuant to this regulation shall provide for— a the general medical services contract to commence immediately after the termination of the agreement; b the names of the patients included in the contractor’s list of patients immediately before the termination of the agreement to be included in the first list of patients to be prepared and maintained by the Primary Care Trust pursuant to paragraph 14 of Schedule 6 to the General Medical Services Contracts Regulations; c the same services to be provided under the general medical services contract as were provided under the agreement immediately before it was terminated unless the parties otherwise agree; and d the opt out of out of hours services referred to in paragraph (7) in accordance with the terms specified in Schedule 3 to the General Medical Services Contracts Regulations. 7 The out of hours services are the services which the contractor was providing under the agreement pursuant to regulation 20 immediately before its termination and which the general medical services contract continues to require the contractor to provide. 8 An agreement shall terminate on the date stated in the notice given by the contractor under paragraph (1) unless a different date is agreed by the contractor and the relevant body or no general medical services contract is entered into by the relevant body pursuant to this regulation. 9 Where there is a dispute as to whether or not a person satisfies the conditions set out in section 28S of the Act or regulation 4 or 5 of the General Medical Services Contracts Regulations, the contractor may appeal to the FHSAA and the relevant body shall be the respondent. 10 Any other dispute relating to this regulation shall be determined by the Secretary of State in accordance with regulation 9(2) and (3) of the General Medical Services Contracts Regulations. 11 The parties to a dispute referred to the Secretary of State in accordance with paragraph (10) shall be the contractor and the relevant body. PART 7 TRANSITIONAL PROVISIONS Out of hours services 20 Subject to paragraph 8 of Schedule 5, an agreement under which essential services are to be provided before 1st January 2005 (whether or not such services will be provided after that date) must provide for out of hours services to be provided throughout the out of hours period unless— a the relevant body has accepted in writing, prior to the signing of the agreement, a written request from the contractor that the agreement should not require the contractor to make such provision; b the contractor has opted out of providing such services in the out of hours period in accordance with paragraph 1 or 2 of Schedule 4; or c the agreement has been otherwise varied to exclude a requirement to make such provision. 21 An agreement which includes the provision of out of hours services pursuant to regulation 20 must contain terms which have the same effect as those specified in Schedule 6. Signed by authority of the Secretary of State John Hutton Minister of State, Department of Health 8th March 2004