Citation, commencement and application

1

(1)    These Regulations may be cited as the National Health Service (General Medical Services Contracts) Regulations 2004 and shall come into force on 1st March 2004.

(2)    These Regulations apply in relation to England only.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see para (1) above.

Extent

These Regulations apply to England only: see para (2) above.

Interpretation

2

Interpretation2

(1)    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;

“additional services” means one or more of—

(a)    cervical screening services,

(b)    contraceptive services,

(c)    vaccinations and immunisations,

(d)    childhood vaccinations and immunisations,

(e)    child health surveillance services,

(f)    maternity medical services, and

(g)    minor surgery;

“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 101(5) of Schedule 6;

“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;

“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 contract in question) appointed to exercise functions under paragraphs 31 and 35 of Schedule 6;

“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—

(a)    is generated by a computer and not signed by a prescriber,

(b)    relates to a particular repeatable prescription and contains the same dates as that prescription,

(c)    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

(d)    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;

“cervical screening services” means the services described in paragraph 2(2) of Schedule 2;

“charity trustee” means one of the persons having the general control and management of the administration of a charity;

“chemist” means—

(a)    a registered pharmacist,

(b)    a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968, or

(c)    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;

“child health surveillance services” means the services described in paragraph 6(2) of Schedule 2;

“childhood vaccinations and immunisations” means the services described in paragraph 5(2) of Schedule 2;

“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;

“contraceptive services” means the services described in paragraph 3(2) of Schedule 2;

“contract” means, except where the context otherwise requires, a general medical services contract under section 28Q of the Act;

“contractor's list of patients” means the list prepared and maintained by the Primary Care Trust under paragraph 14 of Schedule 6;

“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;

“enhanced services” are—

(a)    services other than essential services, additional services or out of hours services, or

(b)    essential services, additional services or out of hours services or an element of such a service that a contractor agrees under the 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;

“essential services” means the services required to be provided in accordance with regulation 15;

“FHSAA” means the Family Health Services Appeal Authority constituted under section 49S of the Act;

“general medical practitioner” means—

(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 otherwise than by virtue of paragraph 1(d) of Schedule 6 to that Order, and

(b)    until the coming into force of that article, a medical practitioner who is either—

(i)    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

(ii)    upon the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, an eligible general practitioner pursuant to that paragraph other than by virtue of having an acquired right under paragraph 1(d) of Schedule 6 to the 2003 Order;

“General Practitioner Register” means the register kept by the General Medical Council under article 10 of the 2003 Order;

“global sum” has the same meaning as in the GMS Statement of Financial Entitlements;

“GMS Statement of Financial Entitlements” means the directions given by the Secretary of State under section 28T of the Act;

“GP Registrar”—

(a)    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—

(i)    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

(ii)    performs primary medical services, and

(b)    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—

(a)    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

(b)    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 Article 10(1) of the Health and Personal Social Services (Northern Ireland) Order 1991;

“Health Board” means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978;

“health care professional” has the same meaning as in section 28M of the Act 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)    a spouse,

(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;

“independent nurse prescriber” means a person—

(a)    who is either engaged or employed by the contractor or is party to the contract,

(b)    who is registered in the Nursing and Midwifery Register, and

(c)    in respect of whom an annotation signifying that he is qualified to order drugs, medicines and appliances from—

(i)    the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part XVIIB(i) of the Drug Tariff, or

(ii)    the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff, is also recorded in that register;

“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;

“limited partnership” means a partnership registered in accordance with section 5 of the Limited Partnerships Act 1907;

“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;

“maternity medical services” means the services described in paragraph 7(1) of Schedule 2;

“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—

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

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

“medical performers list” means a list of medical practitioners prepared in accordance with regulations made under section 28X of the Act;

“Medical Register” means the registers kept under section 2 of the Medical Act 1983;

“minor surgery” means the services described in paragraph 8(2) of Schedule 2;

“NCAA” means the National Clinical Assessment Authority established as a Special Health Authority under section 11 of the Act;

“national disqualification” means—

(a)    a decision made by the FHSAA under section 49N of the Act,

(b)    a decision under provisions in force in Scotland or Northern Ireland corresponding to section 49N of the Act, or

(c)    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 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—

(a)    in paragraphs 101 and 102 of Schedule 6; or

(b)    in a case to which paragraph 36 of Schedule 6 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 those days and hours on which and the times at which services under the contract 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 15 of Schedule 6;

“out of hours period” means—

(a)    the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8am on the following day,

(b)    the period between 6.30pm on Friday and 8am on the following Monday, and

(c)    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—

(a)    would be essential services if provided in core hours, or

(b)    are included in the contract as additional services funded under the global sum;

“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)    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;

“PCT 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;

“pilot scheme” means an agreement made under Part 1 of the National Health Service (Primary Care) Act 1997;

“the POM Order” means the Prescription Only Medicines (Human Use) Order 1997;

“practice” means the business operated by the contractor for the purpose of delivering services under the contract;

“practice area” means the area referred to in regulation 18(1)(d);

“practice leaflet” means a leaflet drawn up in accordance with paragraph 76 of Schedule 6;

“practice premises” means an address specified in the contract as one at which services are to be provided under the contract;

“prescriber” means—

(a)    a medical practitioner,

(b)    an independent nurse prescriber, and

(c)    a supplementary prescriber,

who is either engaged or employed by the contractor or is a party to the contract;

“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)    a list of persons performing primary medical or dental services prepared in accordance with regulations made under section 28X of the Act,

(b)    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, 36, 39, 42 or 43 of the Act,

(c)    a list of persons approved for the purposes of assisting in the provision of any services mentioned in paragraph (b) prepared in accordance with regulations made under section 43D of the Act,

(d)    a services list referred to in section 8ZA of the National Health Service (Primary Care) Act 1997,

(e)    a list corresponding to a services list prepared by virtue of regulations made under section 41 of the Health and Social Care Act 2001, or

(f)    a list corresponding to any of the above lists in Scotland or Northern Ireland;

“Primary Care Trust” means, unless the context otherwise requires, the Primary Care Trust which is a party, or prospective party, to the contract;

“primary carer” means, in relation to an adult, the adult or organisation primarily caring for him;

“registered patient” means—

(a)    a person who is recorded by the Primary Care Trust 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 Primary Care Trust and who has not been notified by the Primary Care Trust as having ceased to be on that list;

“relevant register” means—

(a)    in relation to a nurse, the Nursing and Midwifery Register, and

(b)    in relation to a pharmacist, the register 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;

“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—

(a)    is generated by a computer but signed by a prescriber, and

(b)    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)    a drug, medicine or other substance 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 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;

“section 28C provider” means a person who is providing services under a pilot scheme or in accordance with section 28C arrangements;

“supplementary prescriber” means a person—

(a)    who is either engaged or employed by the contractor or is a party to the contract,

(b)    whose name is registered in—

(i)    the Nursing and Midwifery Register,

(ii)    the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of the Pharmacy Act 1954, or

(iii)    the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976, and

(c)    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 16 of Schedule 6 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;

“writing”, except in paragraph 104(1) of Schedule 6 and unless the context otherwise requires, includes electronic mail and “written” shall be construed accordingly.

(2)    In these Regulations, the use of the term “it” in relation to the contractor shall be deemed to include a reference to a contractor that is an individual medical practitioner or two or more individuals practising in partnership and related expressions shall be construed accordingly.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Professions & Ethics59 Partnership & Limited Partnership59 Health Professions59 Boards & Tribunals59 Company Law & Business Entities59 Trusts & Trustees59 Equity & Trusts59 Pharmacy, Drugs & Medicinal Products79 Limited Partnerships59 Civil Procedure & Administration of Justice59 Health Law79 Medical Procedure & Treatment79

Conditions: general

3

Part2Contractors Conditions: general3

Subject to the provisions of any order made by the Secretary of State under section 176 of the Health and Social Care (Community Health and Standards) Act 2003 (general medical services: transitional), a Primary Care Trust may only enter into a contract if the conditions set out in regulations 4 and 5 are met.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Conditions relating solely to medical practitioners

4

Conditions relating solely to medical practitioners4

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

(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 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 the case of a contract to be entered into with a company limited by shares—

(a)    at least one share in the company must be legally and beneficially owned by a general medical practitioner; and

(b)    any other share or shares in the company that are legally and beneficially owned by a medical practitioner must be so owned by—

(i)    a general medical practitioner, or

(ii)    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.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

National Health Service (NHS)99 Medical Procedure & Treatment96 Health Law99

General condition relating to all contracts

5

General condition relating to all contracts5

(1)    It is a condition in the case of a contract to be entered into—

(a)    with a medical practitioner, that the medical practitioner;

(b)    with two or more individuals practising in partnership, that any individual or the partnership; and

(c)    with a company limited by shares, that—

(i)    the company,

(ii)    any person legally and beneficially owning a share in the company, and

(iii)    any director or secretary of the company,

must not fall within paragraph (2).

(2)    A person falls within this paragraph if—

(a)    he or it is the subject of a national disqualification;

(b)    subject to paragraph (3), 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 contract or commencement of the contract, 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 (4) 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 contract or commencement of the contract, 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 other than murder, committed on or after 14th December 2001, and has been sentenced to a term of imprisonment of over six months;

(g)    subject to paragraph (5) he has been convicted elsewhere of an offence—

(i)    which would, if committed in England and Wales, constitute murder, or

(ii)    committed on or after 14th December 2001, 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 this 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 March 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 unless that order has ceased to have effect or has been annulled, or

(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;

(j)    an administrator, administrative receiver or receiver is appointed in respect of it;

(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 (powers of the Court of Session to deal with management of charities), from being concerned in the management or control of any body; or

(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 (failure to pay under county court administration order).

(3)    A person shall not fall within paragraph (2)(b) where the Primary Care Trust 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 contractor;

(b)    a partner, in the case of a contract with two or more individuals practising in partnership;

(c)    in the case of a contract with a company limited by shares—

(i)    a person legally and beneficially holding a share in the company, or

(ii)    a director or secretary of the company,

as the case may be.

(4)    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.

(5)    A person shall not fall within paragraph (2)(g) where the Primary Care Trust is satisfied that the conviction does not make the person unsuitable to be—

(a)    a contractor;

(b)    a partner, in the case of a contract with two or more individuals practising in partnership;

(c)    in the case of a contract with a company limited by shares—

(i)    a person legally and beneficially holding a share in the company, or

(ii)    a director or secretary of the company,

as the case may be.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Criminal Procedure99 Offences against the Person96 Company Law & Business Entities94 Trusts & Trustees94 Equitable Remedies97 Equity & Trusts94 Companies & Corporate Bodies94 Offences Relating to Children, Young Persons & Vulnerable Adults91 Criminal Law & Disposition of Offenders96 Murder96 Young Persons99

Reasons

6

Reasons6

(1)    Where a Primary Care Trust is of the view that the conditions in regulation 4 or 5 for entering into a contract are not met it shall notify in writing the person or persons intending to enter into the contract of its view and its reasons for that view and of his, its or their right of appeal under regulation 7.

(2)    The Primary Care Trust shall also notify in writing of its view and its reasons for that view, any person legally and beneficially owning a share in, or a director or secretary of, a company that is notified under paragraph (1) where its reason for the decision relates to that person or those persons.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Appeal

7

Appeal7

A person who has been served with a notice under regulation 6(1) may appeal to the FHSAA against the decision of the Primary Care Trust 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 Primary Care Trust served its notice.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Prescribed period under section 28D(1)(bc) of the Act

8

Prescribed period under section 28D(1)(bc) of the Act8

The period prescribed for the purposes of section 28D(1)(bc) of the Act (persons with whom agreements may be made) is six months.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Pre-contract disputes

9

Part3Pre-contract Dispute Resolution Pre-contract disputes9

(1)    Except where both parties to the prospective contract are health service bodies (in which case section 4(4) of the 1990 Act (NHS contracts) applies), if, in the course of negotiations intending to lead to a contract, the prospective parties to that contract are unable to agree on a particular term of the contract, 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 101(3) to (14) and 102(1) of Schedule 6, 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 contract;

(b)    may require the Primary Care Trust to proceed with the proposed contract, but may not require the proposed contractor to proceed with the proposed contract; and

(c)    shall be binding upon the prospective parties to the contract.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Health service body status

10

Part4Health Service Body Status Health service body status10

(1)    Where a proposed contractor elects in a written notice served on the Primary Care Trust at any time prior to the contract being entered into to be regarded as a health service body for the purposes of section 4 of the 1990 Act, it shall be so regarded from the date on which the contract is entered into.

(2)    If, pursuant to paragraph (1) or (5), 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 contract with a health service body entered into by a contractor before the date on which the contractor is to be so regarded.

(3)    Where a contract is made with an individual medical practitioner or two or more persons practising in partnership, and that individual, or that partnership is to be regarded as a health service body in accordance with paragraph (1) or (5), the contractor shall, subject to paragraph (4), continue to be regarded as a health service body for the purposes of section 4 of the 1990 Act for as long as that contract continues irrespective of any change in—

(a)    the partners comprising the partnership;

(b)    the status of the contractor from that of an individual medical practitioner to that of a partnership; or

(c)    the status of the contractor from that of a partnership to that of an individual medical practitioner.

(4)    A contractor may at any time request in writing a variation of the contract to include provision in or remove provision from the contract that the contract is an NHS contract, and if it does so—

(a)    the Primary Care Trust shall agree to the variation; and

(b)    the procedure in paragraph 104(1) of Schedule 6 shall apply.

(5)    If, pursuant to paragraph (4), the Primary Care Trust agrees to the variation to the contract, the contractor shall—

(a)    be regarded; or

(b)    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 pursuant to paragraph 104(1) of Schedule 6.

(6)    Subject to paragraph (7), a contractor shall cease to be a health service body for the purposes of section 4 of the 1990 Act if the contract terminates.

(7)    Where a contractor ceases to be a health service body pursuant to—

(a)    paragraph (5) or (6), it shall continue to be regarded as a health service body for the purposes of being a party to any other NHS contract entered into after it became a health service body but before the date on which the contractor 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 Primary Care Trust 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 100 of Schedule 6;

(c)    paragraph (6), 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 contract, or

(ii)    after the termination of the contract, whether in connection with or arising out of the termination of the contract or otherwise,

for which purposes it ceases to be such a body on the conclusion of that procedure.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Contract Law93 National Health Service (NHS)96 Breach, Discharge & Rescission of Contract93 Discharge by Agreement92 Health Law96

Parties to the contract

11

Part5Contracts: Required Terms Parties to the contract11

A contract must specify—

(a)    the names of the parties;

(b)    in the case of a partnership—

(i)    whether or not it is a limited partnership, and

(ii)    the names of the partners and, in the case of a limited partnership, their status as a general or limited partner; and

(c)    in the case of each party, the address to which official correspondence and notices should be sent.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Health service contract

12

Health service contract12

If the contractor is to be regarded as a health service body pursuant to regulation 10, the contract must state that it is an NHS contract.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Contracts with individuals practising in partnership

13

Contracts with individuals practising in partnership13

(1)    Where the contract is with two or more individuals practising in partnership, the contract shall be treated as made with the partnership as it is from time to time constituted, and the contract shall make specific provision to this effect.

(2)    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.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Duration

14

Duration14

(1)    Except in the circumstances specified in paragraph (2), a contract must provide for it to subsist until it is terminated in accordance with the terms of the contract or the general law.

(2)    The circumstances referred to in paragraph (1) are that the Primary Care Trust wishes to enter into a temporary contract for a period not exceeding twelve months for the provision of services to the former patients of a contractor, following the termination of that contractor's contract.

(3)    Either party to a prospective contract to which paragraph (2) applies may, if it wishes to do so, invite the Local Medical Committee for the area of the Primary Care Trust to participate in the negotiations intending to lead to such a contract.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Essential services

15

Essential services15

(1)    For the purposes of section 28R(1) 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).

(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.

(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.

(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) in the area of the Primary Care Trust;

(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.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Additional services

16

Additional services16

A contract which includes the provision of any additional services must—

(a)    in relation to all such services as are included in the contract, contain a term which has the same effect as that specified in paragraph 1 of Schedule 2; and

(b)    in relation to each such service as is included in the contract, contain terms which have the same effect as those specified in Schedule 2 which are relevant to that service.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Contract Law93 Terms93

Opt outs of additional and out of hours services

17

Opt outs of additional and out of hours services17

(1)    Where a contract provides for the contractor to provide an additional service that is to be funded through the global sum the contract must contain terms relating to the procedure for opting out of additional services which have the same effect as those specified in paragraphs 1, 2, 3 and 6 of Schedule 3, except paragraph 3(12) to (14).

(2)    Where a contract which is entered into before 1st October 2004 provides for the contractor to provide out of hours services pursuant to regulation 30 or 31, the contract must contain terms relating to the procedure for opting out of those services which have the same effect as those specified in paragraphs 4, 5 and 6 of Schedule 3, except paragraphs 4(9) and 5(17) in so far as those paragraphs relate to paragraph 3(12) to (14).

(3)    Where a contract which is entered into on or after 1st October 2004 provides for the contractor to provide out of hours services pursuant to regulation 30 or 31, the contract must contain terms relating to the procedure for opting out of those services which have the same effect as those specified in paragraphs 4 and 6 of Schedule 3, except paragraph 4(8) in so far as that paragraph relates to paragraph 3(12) to (14).

(4)    Paragraph 3(12) to (14) and paragraphs 4(9) and 5(17), in so far are those paragraphs relate to paragraph 3(12) to (14) of Schedule 3, shall have effect in relation to the matters set out in those paragraphs.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Services generally

18

Services generally18

(1)    A contract 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)    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; and

(e)    whether, at the date on which the contract 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, on the date on which the contract is signed, the Primary Care Trust is not satisfied that all or any of the premises specified in accordance with paragraph (1)(b) meet the requirements set out in paragraph 1 of Schedule 6, the contract must include a plan, drawn up jointly by the Primary Care Trust and the contractor, which specifies—

(a)    the steps to be taken by the contractor to bring the premises up to the relevant standard;

(b)    any financial support that may be available from the Primary Care Trust; and

(c)    the timescale on which the steps referred to in sub-paragraph (a) will be taken.

(4)    Where, in accordance with paragraph (1)(e), the contract 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 29(8)(a) to (d) of Schedule 6.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

19

19

(1)    Except in the case of the services referred to in paragraph (2), the contract must state the period (if any) for which the services are to be provided.

(2)    The services referred to in paragraph (1) are—

(a)    essential services;

(b)    additional services funded under the global sum; and

(c)    out of hours services provided pursuant to regulations 30 and 31.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

20

20

A contract must contain a term which requires the contractor in core hours—

(a)    to provide—

(i)    essential services, and

(ii)    additional services funded under the global sum,

at such times, 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.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Certificates

21

Certificates21

(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) 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).

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Finance

22

Finance22

(1)    Subject to paragraph (2), the contract must contain a term which has the effect of requiring the Primary Care Trust to make payments to the contractor under the contract promptly and in accordance with both the terms of the contract and any other conditions relating to the payment contained in directions given by the Secretary of State under section 28T of the Act (GMS contracts: payments).

(2)    The obligation referred to in paragraph (1) is subject to any right the Primary Care Trust may have to set off against any amount payable to the contractor under the contract any amount—

(a)    that is owed by the contractor to the Primary Care Trust under the contract; or

(b)    that the Primary Care Trust may withhold from the contractor in accordance with the terms of the contract or any other applicable provisions contained in directions given by the Secretary of State under section 28T of the Act.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

23

23

The contract must contain a term to the effect that where, pursuant to directions under section 17 (Secretary of State's directions: exercise of functions) or 28T of the Act, a Primary Care Trust is required to make a payment to a contractor under a contract but subject to conditions, those conditions are to be a term of the contract.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Fees and charges

24

Fees and charges24

(1)    The contract 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 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.

(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 Primary Care Trust for a refund within 14 days of payment of the fee (or such longer period not exceeding a month as the Primary Care Trust may allow if it is satisfied that the failure to apply within 14 days was reasonable) and the Primary Care Trust is satisfied that the person was on the contractor's list of patients when the treatment was given, the Primary Care Trust 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.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Arrangements on termination

25

Arrangements on termination25

A contract shall make suitable provision for arrangements on termination of a contract, including the consequences (whether financial or otherwise) of the contract ending.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Other contractual terms

26

Other contractual terms26

(1)    A contract must, unless it is of a type or nature to which a particular provision does not apply, contain other terms which have the same effect as those specified in Schedule 6 except paragraphs 31(6) to (8), 35(5) to (9), 36(5) to (17), 101(5) to (14) and 102.

(2)    The paragraphs specified in paragraph (1) shall have effect in relation to the matters set out in those paragraphs.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Contract Law94 Terms94

27

Part6Functions of Local Medical Committees 27

(1)    The functions of a Local Medical Committee which are prescribed for the purposes of section 45A(9) (Local Medical Committees) of the Act are—

(a)    the consideration of any complaint made to it by any medical practitioner against a medical practitioner specified in paragraph (2) providing services under a contract in the relevant area involving any question of the efficiency of those services;

(b)    the reporting of the outcome of the consideration of any such complaint to the Primary Care Trust with whom the contract is held in cases where that consideration gives rise to any concerns relating to the efficiency of services provided under a contract;

(c)    the making of arrangements for the medical examination of a medical practitioner specified in paragraph (2), where the contractor or the Primary Care Trust is concerned that the medical practitioner is incapable of adequately providing services under the contract and it so requests with the agreement of the medical practitioner concerned; and

(d)    the consideration of the report of any medical examination arranged in accordance with sub-paragraph (c) and the making of a written report as to the capability of the medical practitioner of adequately providing services under the contract to the medical practitioner concerned, the contractor and the Primary Care Trust with whom the contractor holds a contract.

(2)    The medical practitioner referred to in paragraph (1)(a) and (c) is a medical practitioner who is—

(a)    a contractor;

(b)    one of two or more individuals practising in partnership who hold a contract; or

(c)    a legal and beneficial shareholder in a company which holds a contract.

(3)    In this regulation, “the relevant area” means the area for which the Local Medical Committee is formed.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Medical Procedure & Treatment95 Health Law95

Commencement

28

Part7Transitional Provisions Commencement28

The contract shall provide for services to be provided under it from any date after 31st March 2004.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Additional services

29

Additional services29

(1)    Where the contract is with one of the persons specified in paragraph (2), the contract must, subject to regulation 17, provide for the contractor to provide in core hours to the contractor's registered patients and persons accepted by it as temporary residents, such of the additional services as are equivalent to services which that medical practitioner or practitioners was or were providing to his or their patients on the date that the contract is entered into except to the extent that—

(a)    the provision of any of those services by that medical practitioner or practitioners is due to come to an end on or before the date on which services are required to start being provided under the contract; or

(b)    prior to the signing of the contract, the Primary Care Trust has accepted in writing a written request from the contractor that the contract should not require it to provide all or any of those additional services.

(2)    The persons referred to in paragraph (1) are—

(a)    an individual medical practitioner who, on 31st March 2004, was providing services under section 29 of the Act (general medical services);

(b)    two or more individuals practising in partnership at least one of whom was, on 31st March 2004, a medical practitioner providing services under that section; or

(c)    a company in which one or more of the shareholders was, on 31st March 2004, a medical practitioner providing services under that section.

(3)    This regulation applies only to contracts under which services which are to be provided from 1st April 2004.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Medical Procedure & Treatment97 Health Law97

Out of hours services

30

Out of hours services30

(1)    Subject to paragraph 10 of Schedule 6, a contract under which services are to be provided before 1st January 2005 (whether or not such services will be provided after that date) must provide for the services specified in paragraph (2) to be provided throughout the out of hours period unless—

(a)    the Primary Care Trust has accepted in writing, prior to the signing of the contract, a written request from the contractor that the contract should not require the contractor to make such provision;

(b)    the contract is, at the date on which it is signed, with—

(i)    a medical practitioner who is, or was on 31st March 2004, relieved of responsibility for providing services to his patients under paragraph 18(2) of Schedule 2 to the National Health Service (General Medical Services) Regulations 1992,

(ii)    a partnership in which all of the partners who are general medical practitioners are a or were on 31st March 2004, relieved of responsibility for providing services to their patients under that paragraph, or

(iii)    a company in which all of the general medical practitioners who own shares in that company are, or were on 31st March 2004, relieved of responsibility for providing services to their patients under that paragraph;

(c)    the contractor has opted out in accordance with paragraph 4 or 5 of Schedule 3; or

(d)    the contract has been otherwise varied to exclude a requirement to make such provision.

(2)    The services referred to in paragraph (1) are—

(a)    the services which must be provided in core hours under regulation 15; and

(b)    such additional services as are included in the contract pursuant to regulation 29.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

31

31

(1)    Where the contract is with—

(a)    an individual medical practitioner who is, or was on 31st March 2004, responsible for providing services during all or part of the out of hours period to the patients of a medical practitioner who meets the requirements in paragraph (2);

(b)    two or more individuals practising in partnership at least one of whom is, or was on 31st March 2004, a medical practitioner responsible for providing such services; or

(c)    a company in which one or more of the shareholders is, or was on 31st March 2004, a medical practitioner responsible for providing such services,

the contract with that contractor must require the contractor to continue to provide such services to the patients of the exempt contractor until the happening of one of the events in paragraph (3).

(2)    The requirements referred to in paragraph (1)(a) are that—

(a)    the medical practitioner was relieved of responsibility for providing services to his patients under paragraph 18(2) of Schedule 2 to the National Health Service (General Medical Services) Regulations 1992; and

(b)    he—

(i)    has entered or intends to enter into a contract which does not include out of hours services pursuant to regulation 30(1)(b)(i),

(ii)    is one of two or more individuals practising in partnership who have entered or intends to enter into a contract which does not include out of hours services pursuant to regulation 30(1)(b)(ii), or

(iii)    is the owner of shares in a company which has entered or intends to enter into a contract which does not include out of hours services pursuant to regulation 30(1)(b)(iii).

(3)    The events referred to in paragraph (1) are—

(a)    the contractor has opted out of the provision of out of hours services in accordance with paragraph 4 or 5 of Schedule 3; or

(b)    the Primary Care Trust (and, if it is different, the Primary Care Trust with whom the exempt contractor holds its contract) has or have agreed in writing that the contractor need no longer provide some or all of those services to some or all of those patients.

(4)    In this regulation “exempt contractor” means a contractor who is exempt from providing out of hours services pursuant to regulation 30(1)(b).

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Medical Procedure & Treatment97 Health Law97

32

32

A contract which includes the provision of out of hours services pursuant to regulation 30 or 31 must contain terms which have the same effect as those set out in Schedule 7.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Signature

Signed by authority of the Secretary of State

John Hutton

Minister of State,

Department of Health

8th February 2004

SCHEDULE 2 Additional Services

SCHEDULE 2Additional Services Regulation 16

Additional services generally

1

The contractor shall provide, in relation to each additional service, such facilities and equipment as are necessary to enable it properly to perform that service.

Cervical screening

2

(1)    A contractor whose contract includes the provision of cervical screening services shall—

(a)    provide all the services described in sub-paragraph (2); and

(b)    make such records as are referred to in sub-paragraph (3).

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

(a)    the provision of any necessary information and advice to assist women identified by the Primary Care Trust as recommended nationally for a cervical screening test in making an informed decision as to participation in the NHS Cervical Screening Programme;

(b)    the performance of cervical screening tests on women who have agreed to participate in that Programme;

(c)    arranging for women to be informed of the results of the test; and

(d)    ensuring that test results are followed up appropriately.

(3)    The records referred to in sub-paragraph (1)(b) are an accurate record of the carrying out of a cervical screening test, the result of the test and any clinical follow up requirements.

Contraceptive services

3

(1)    A contractor whose contract includes the provision of contraceptive services shall make available to all its patients who request such services the services described in sub-paragraph (2).

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

(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.

Vaccinations and immunisations

4

(1)    A contractor whose contract includes the provision of vaccinations and immunisations shall comply with the requirements in sub-paragraphs (2) and (3).

(2)    The contractor shall—

(a)    offer to provide to patients all vaccinations and immunisations (excluding childhood vaccinations and immunisations) of a type and in the circumstances for which a fee was provided for under the 2003–04 Statement of Fees and Allowances made under regulation 34 of the National Health Service (General Medical Services) Regulations 1992 other than influenza vaccination;

(b)    provide appropriate information and advice to patients about such vaccinations and immunisations;

(c)    record in the patient's record kept in accordance with paragraph 73 of Schedule 6 any refusal of the offer referred to in paragraph (a);

(d)    where the offer is accepted, administer the vaccinations and immunisations and include in the patient's record kept in accordance with paragraph 73 of Schedule 6—

(i)    the patient's consent to the vaccination or immunisation or the name of the person who gave consent to the vaccination or immunisation and his relationship to the patient,

(ii)    the batch numbers, expiry date and title of the vaccine,

(iii)    the date of administration,

(iv)    in a case where two vaccines are administered in close succession, the route of administration and the injection site of each vaccine,

(v)    any contraindications to the vaccination or immunisation, and

(vi)    any adverse reactions to the vaccination or immunisation.

(3)    The contractor shall ensure that all staff involved in administering vaccines are trained in the recognition and initial treatment of anaphylaxis.

Childhood vaccinations and immunisations

5

(1)    A contractor whose contract includes the provision of childhood vaccinations and immunisations shall comply with the requirements in sub-paragraphs (2) and (3).

(2)    The contractor shall—

(a)    offer to provide to children all vaccinations and immunisations of a type and in the circumstances for which a fee was provided for under the 2003–04 Statement of Fees and Allowances made under regulation 34 of the National Health Service (General Medical Services) Regulations 1992;

(b)    provide appropriate information and advice to patients and, where appropriate, their parents, about such vaccinations and immunisations;

(c)    record in the patient's record kept in accordance with paragraph 73 of Schedule 6 any refusal of the offer referred to in paragraph (a);

(d)    where the offer is accepted, administer the vaccinations and immunisations and include in the patient's record kept in accordance with paragraph 73 of Schedule 6—

(i)    the name of the person who gave consent to the vaccination or immunisation and his relationship to the patient;

(ii)    the batch numbers, expiry date and title of the vaccine;

(iii)    the date of administration;

(iv)    in a case where two vaccines are administered in close succession, the route of administration and the injection site of each vaccine;

(v)    any contraindications to the vaccination or immunisation; and

(vi)    any adverse reactions to the vaccination or immunisation.

(3)    The contractor shall ensure that all staff involved in administering vaccines are trained in the recognition and initial treatment of anaphylaxis.

Child health surveillance

6

(1)    A contractor whose contract includes the provision of child health surveillance services shall, in respect of any child under the age of five for whom it has responsibility under the contract—

(a)    provide all the services described in sub-paragraph (2), other than any examination so described which the parent refuses to allow the child to undergo, until the date upon which the child attains the age of five years; and

(b)    maintain such records as are specified in sub-paragraph (3).

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

(a)    the monitoring—

(i)    by the consideration of any information concerning the child received by or on behalf of the contractor, and

(ii)    on any occasion when the child is examined or observed by or on behalf of the contractor (whether pursuant to paragraph (b) or otherwise),

of the health, well-being and physical, mental and social development (all of which characteristics are referred to in this paragraph as “development”) of the child while under the age of 5 years with a view to detecting any deviations from normal development;

(b)    the examination of the child at a frequency that has been agreed with the Primary Care Trust in accordance with the nationally agreed evidence based programme set out in the fourth edition of “Health for all Children”.

(3)    The records mentioned in sub-paragraph (1)(b) are an accurate record of—

(a)    the development of the child while under the age of 5 years, compiled as soon as is reasonably practicable following the first examination of that child and, where appropriate, amended following each subsequent examination; and

(b)    the responses (if any) to offers made to the child's parent for the child to undergo any examination referred to in sub-paragraph (2)(b).

Maternity medical services

7

(1)    A contractor whose contract includes the provision of maternity medical services shall—

(a)    provide to female patients who have been diagnosed as pregnant all necessary maternity medical services throughout the antenatal period;

(b)    provide to female patients and their babies all necessary maternity medical services throughout the postnatal period other than neonatal checks;

(c)    provide all necessary maternity medical services to female patients whose pregnancy has terminated as a result of miscarriage or abortion or, 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.

(2)    In this paragraph—

“antenatal period” means the period from the start of the pregnancy to the onset of labour;

“maternity medical services” means—

(a)    in relation to female patients (other than babies) all primary medical services relating to pregnancy, excluding intra partum care, and

(b)    in relation to babies, any primary medical services necessary in their first 14 days of life;

“postnatal period” means the period starting from the conclusion of delivery of the baby or the patient's discharge from secondary care services, whichever is the later, and ending on the fourteenth day after the birth.

Minor surgery

8

(1)    A contractor whose contract includes the provision of minor surgery shall comply with the requirements in sub-paragraphs (2) and (3).

(2)    The contractor shall make available to patients where appropriate—

(a)    curettage;

(b)    cautery; and

(c)    cryocautery of warts, verrucae and other skin lesions.

(3)    The contractor shall ensure that its record of any treatment provided under this paragraph includes the consent of the patient to that treatment.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

SCHEDULE 3 Opt Outs of Additional and Out of Hours Services

SCHEDULE 3Opt Outs of Additional and Out of Hours Services Regulation 17

Opt outs of additional services: general

1

(1)    In this Schedule—

“opt out notice” means a notice given under sub-paragraph (5) to permanently opt out or temporarily opt out of the provision of the additional service;

“permanent opt out” in relation to the provision of an additional service that is funded through the global sum, means the termination of the obligation under the contract for the contractor to provide that service; and “permanently opt out” shall be construed accordingly;

“permanent opt out notice” means an opt out notice to permanently opt out;

“preliminary opt out notice” means a notice given under sub-paragraph (2) that a contractor wishes to temporarily opt out or permanently opt out of the provision of an additional service;

“temporary opt out” in relation to the provision of an additional service that is funded through the global sum, means the suspension of the obligation under the contract for the contractor to provide that service for a period of more than six months and less than twelve months and includes an extension of a temporary opt out and “temporarily opt out” and “temporarily opted out” shall be construed accordingly; and

“temporary opt out notice” means an opt out notice to temporarily opt out.

(2)    A contractor who wishes to permanently or temporarily opt out shall give to the relevant Primary Care Trust in writing a preliminary opt out notice which shall state the reasons for wishing to opt out.

(3)    As soon as is reasonably practicable and in any event within the period of 7 days beginning with the receipt of the preliminary opt out notice by the Primary Care Trust, the Primary Care Trust shall enter into discussions with the contractor concerning the support which the Primary Care Trust may give the contractor, or concerning other changes which the Primary Care Trust or the contractor may make, which would enable the contractor to continue to provide the additional service and the Primary Care Trust and the contractor shall use reasonable endeavours to achieve this aim.

(4)    The discussions mentioned in sub-paragraph (3) shall be completed within the period of 10 days beginning with the date of the receipt of the preliminary opt out notice by the Primary Care Trust or as soon as reasonably practicable thereafter.

(5)    Subject to sub-paragraph (9), if following the discussions mentioned in sub-paragraph (3), the contractor still wishes to opt out of the provision of the additional service, it shall send an opt out notice to the Primary Care Trust.

(6)    An opt out notice shall specify—

(a)    the additional service concerned;

(b)    whether the contractor wishes to—

(i)    permanently opt out, or

(ii)    temporarily opt out;

(c)    the reasons for wishing to opt out;

(d)    the date from which the contractor would like the opt out to commence, which must—

(i)    in the case of a temporary opt out be at least 14 days after the date of service of the opt out notice, and

(ii)    in the case of a permanent opt out must be the day either three or six months after the date of service of the opt out notice, and

(e)    in the case of a temporary opt out, the desired duration of the opt out.

(7)    Where a contractor has given two previous temporary opt out notices within the period of three years ending with the date of the service of the latest opt out notice (whether or not the same additional service is concerned), the latest opt out notice shall be treated as a permanent opt out notice (even if the opt out notice says that it wishes to temporarily opt out).

(8)    Paragraph 2 applies following the giving of a temporary opt out notice and paragraph 3 applies following the giving of a permanent opt out notice or a temporary opt out notice which pursuant to sub-paragraph (7) is treated as a permanent opt out notice.

(9)    No temporary opt out notice may be served by a contractor prior to 1st April 2004.

Temporary opt outs and permanent opt outs following temporary opt outs

2

(1)    As soon as is reasonably practicable and in any event within the period of 7 days beginning with the date of receipt of a temporary opt out notice under paragraph 1(5), the Primary Care Trust shall—

(a)    approve the opt out notice and specify in accordance with sub-paragraphs (3) and (4) the date on which the temporary opt out is to commence and the date that it is to come to an end (“the end date”); or

(b)    reject the opt out notice in accordance with sub-paragraph (2),

and shall notify the contractor of its decision as soon as possible, including reasons for its decision.

(2)    A Primary Care Trust may reject the opt out notice on the ground that the contractor—

(a)    is providing additional services to patients other than its own registered patients or enhanced services; or

(b)    has no reasonable need temporarily to opt out having regard to its ability to deliver the additional service.

(3)    The date specified by the Primary Care Trust for the commencement of the temporary opt out shall wherever reasonably practicable be the date requested by the contractor in its opt out notice.

(4)    Before determining the end date, the Primary Care Trust shall make reasonable efforts to reach agreement with the contractor.

(5)    Where the Primary Care Trust approves an opt out notice, the contractor's obligation to provide the additional service specified in the notice shall be suspended from the date specified by the Primary Care Trust in it's decision under sub-paragraph (1), and shall remain suspended until the end date unless—

(a)    the contractor and the Primary Care Trust agree in writing an earlier date, in which case the suspension shall come to an end on the earlier date agreed;

(b)    the Primary Care Trust specifies a later date under sub-paragraph (6), in which case the suspension shall end on the later date specified;

(c)    sub-paragraph (7) applies and the contractor refers the matter to the NHS dispute resolution procedure or the court, in which case the suspension shall end—

(i)    where the outcome of the dispute is to uphold the decision of the Primary Care Trust, on the day after the date of the decision of the Secretary of State or the court,

(ii)    where the outcome of the dispute is to overturn the decision of the Primary Care Trust, 28 days after the decision of the Secretary of State or the court, or

(iii)    where the contractor ceases to pursue the NHS dispute resolution procedure or court proceedings, on the day after the date that the contractor withdraws its claim or the procedure is or proceedings are otherwise terminated by the Secretary of State or the court;

(d)    sub-paragraph (9) applies and—

(i)    the Primary Care Trust refuses the contractor's request for a permanent opt out within the period of 28 days ending with the end date, in which case the suspension shall come to an end 28 days after the end date,

(ii)    the Primary Care Trust refuses the contractor's request for a permanent opt out after the end date, in which case the suspension shall come to an end 28 days after the date of service of the notice, or

(iii)    the Primary Care Trust notifies the contractor after the end date that the relevant Strategic Health Authority has not approved its proposed decision to refuse the contractor's request to permanently opt out under sub-paragraph (14), in which case the suspension shall come to an end 28 days after the date of service of the notice under this paragraph.

(6)    Before the end date, a Primary Care Trust may, in exceptional circumstances and with the agreement of the contractor, notify the contractor in writing of a later date on which the temporary opt out is to come to an end, being a date no more than six months later than the end date.

(7)    Where the Primary Care Trust considers that—

(a)    the contractor will be unable to satisfactorily provide the additional service at the end of the temporary opt out; and

(b)    it would not be appropriate to exercise its discretion under sub-paragraph (6) to specify a later date on which the temporary opt out is to come to an end or the contractor does not agree to a later date,

the Primary Care Trust may notify the contractor in writing at least 28 days before the end date that a permanent opt out shall follow a temporary opt out.

(8)    Where a Primary Care Trust notifies the contractor under sub-paragraph (7) that a permanent opt out shall follow a temporary opt out, the permanent opt out shall take effect immediately after the end of the temporary opt out.

(9)    A contractor who has temporarily opted out may, at least three months prior to the end date, notify the relevant Primary Care Trust in writing that it wishes to permanently opt out of the additional service in question.

(10)    Where the contractor has notified the Primary Care Trust under sub-paragraph (9) that it wishes to permanently opt out, the temporary opt out shall be followed by a permanent opt out beginning on the day after the end date unless the Primary Care Trust refuses the contractor's request to permanently opt out by giving a notice in writing to the contractor to this effect.

(11)    A Primary Care Trust may only give a notice under sub-paragraph (10) with the approval of the relevant Strategic Health Authority.

(12)    Where a Primary Care Trust seeks the approval of a Strategic Health Authority to a proposed decision to refuse a permanent opt out, it shall notify the contractor of having done so.

(13)    If the relevant Strategic Health Authority has not reached a decision as to whether or not to approve the Primary Care Trust's proposed decision to refuse a permanent opt out before the end date, the contractor's obligation to provide the additional service shall remain suspended until the date specified in sub-paragraph (5)(d)(ii) or (iii) (whichever is applicable).

(14)    Where after the end date the relevant Strategic Health Authority notifies the Primary Care Trust that it does not approve the Primary Care Trust's proposed decision to refuse a permanent opt out, the Primary Care Trust shall notify the contractor in writing of this fact as soon as is reasonably practicable.

(15)    A temporary opt out or permanent opt out commences, and a temporary opt out ends, at 08.00 on the relevant day unless—

(a)    the day is a Saturday, Sunday, Good Friday, Christmas Day, or a bank holiday, in which case the opt out shall take effect on the next working day at 08.00; or

(b)    the Primary Care Trust and the contractor agree a different day or time.

Permanent opt outs

3

(1)    In this paragraph—

“A day” is the day specified by the contractor in its permanent opt out notice to a Primary Care Trust for the commencement of the permanent opt out;

“B day” is the day six months after the date of service of the permanent opt out notice; and

“C day” is the day nine months after the date of service of the permanent opt out notice.

(2)    As soon as is reasonably practicable and in any event within the period of 28 days beginning with the date of receipt of a permanent opt out notice under paragraph 1(5) (or temporary opt out notice which is treated as a permanent opt out notice under paragraph 1(7)), the Primary Care Trust shall—

(a)    approve the opt out notice; or

(b)    reject the opt out notice in accordance with sub-paragraph (3),

and shall notify the contractor of its decision as soon as possible, including reasons for its decision where its decision is to reject the opt out notice.

(3)    A Primary Care Trust may reject the opt out notice on the ground that the contractor is providing an additional service to patients other than its registered patients or enhanced services.

(4)    A contractor may not withdraw an opt out notice once it has been approved by the Primary Care Trust in accordance with sub-paragraph (2)(a) without the Primary Care Trust's agreement.

(5)    If the Primary Care Trust approves the opt out notice under sub-paragraph (2)(a), it shall use its reasonable endeavours to make arrangements for the contractor's registered patients to receive the additional service from an alternative provider from A day.

(6)    The contractor's duty to provide the additional service shall terminate on A day unless the Primary Care Trust serves a notice under sub-paragraph (7) (extending A day to B day or C day).

(7)    If the Primary Care Trust is not successful in finding an alternative provider to take on the provision of the additional service from A day, then it shall notify the contractor in writing of this fact no later than one month before A day, and—

(a)    in a case where A day is three months after service of the opt out notice, the contractor shall continue to provide the additional service until B day unless at least one month before B day it receives a notice in writing from the Primary Care Trust under sub-paragraph (8) that despite using its reasonable endeavours, it has failed to find an alternative provider to take on the provision of the additional service from B day;

(b)    in a case where A day is six months after the service of the opt out notice, the contractor shall continue to provide the additional service until C day unless at least one month before C day it receives a notice from the Primary Care Trust under sub-paragraph (11) that it has made an application to the relevant Strategic Health Authority under sub-paragraph (10) seeking its approval of a decision to refuse a permanent opt out or to delay the commencement of a permanent opt out until after C day.

(8)    Where in accordance with sub-paragraph (7)(a) the permanent opt out is to commence on B day and the Primary Care Trust, despite using its reasonable endeavours has failed to find an alternative provider to take on the provision of the additional service from that day, it shall notify the contractor in writing of this fact at least one month before B day, in which case the contractor shall continue to provide the additional service until C Day unless at least one month before C day it receives a notice from the Primary Care Trust under sub-paragraph (11) that it has applied to the relevant Strategic Health Authority under sub-paragraph (10) seeking the approval of the relevant Strategic Health Authority to a decision to refuse a permanent opt out or to postpone the commencement of a permanent opt out until after C day.

(9)    As soon as is reasonably practicable and in any event within 7 days of the Primary Care Trust serving a notice under sub-paragraph (8), the Primary Care Trust shall enter into discussions with the contractor concerning the support that the Primary Care Trust may give to the contractor or other changes which the Primary Care Trust or the contractor may make in relation to the provision of the additional service until C day.

(10)    The Primary Care Trust may, if it considers that there are exceptional circumstances, make an application to the relevant Strategic Health Authority for approval of a decision to—

(a)    refuse a permanent opt out; or

(b)    postpone the commencement of a permanent opt out until after C day.

(11)    As soon as practicable after making an application under sub-paragraph (10) to the Strategic Health Authority, the Primary Care Trust shall notify the contractor in writing that it has made such an application.

(12)    On receiving an application under sub-paragraph (10) for approval of a decision to refuse a permanent opt out, the Strategic Health Authority shall—

(a)    approve the Primary Care Trust's application;

(b)    reject the Primary Care Trust's application, but nonetheless recommend a different date for the commencement of the permanent opt out which shall be later than C day; or

(c)    reject the Primary Care Trust's application.

(13)    On receiving an application under sub-paragraph (10) for approval of a decision to postpone the commencement of a permanent opt out until after C day, the Strategic Health Authority shall—

(a)    approve the Primary Care Trust's application;

(b)    reject the Primary Care Trust's application, but nonetheless recommend—

(i)    that the permanent opt out commence on an earlier date to that proposed by the Primary Care Trust in its application, or

(ii)    that the permanent opt out be refused; or

(c)    reject the Primary Care Trust's application.

(14)    The relevant Strategic Health Authority shall notify the Primary Care Trust and the contractor in writing of its decision under sub-paragraph (12) or (13) as soon as is practicable, including reasons for its decision.

(15)    Where the Strategic Health Authority—

(a)    approves a decision to refuse an opt out under sub-paragraph (12)(a); or

(b)    recommends that a permanent opt out be refused under sub-paragraph (13)(b)(ii),

the Primary Care Trust shall notify the contractor in writing that it may not opt out of the additional service.

(16)    Where a Primary Care Trust notifies a contractor under sub-paragraph (15), the contractor may not serve a preliminary opt out notice in respect of that additional service for a period of 12 months beginning with the date of service of the Primary Care Trust's notice under sub-paragraph (15) unless there has been a change in the circumstances of the contractor which affects its ability to deliver services under the contract.

(17)    Where the Strategic Health Authority—

(a)    recommends a different date for the commencement of the permanent opt out under sub-paragraph (12)(b);

(b)    approves a Primary Care Trust's application to postpone a permanent opt out under sub-paragraph (13)(a); or

(c)    recommends an earlier date to that proposed by the Primary Care Trust in its application under sub-paragraph (13)(b)(i),

the Primary Care Trust shall in accordance with the decision of the Strategic Health Authority notify the contractor in writing of its decision and the notice shall specify the date from which the permanent opt out shall commence.

(18)    Where the Strategic Health Authority rejects the Primary Care Trust's application under sub-paragraph (12)(c) or (13)(c), the Primary Care Trust shall notify the contractor in writing that there shall be a permanent opt out and the permanent opt out shall commence on C day or 28 days after the date of service of the Primary Care Trust's notice, whichever is the later.

(19)    If the relevant Strategic Health Authority has not reached a decision on the Primary Care Trust's application under sub-paragraph (10) before C day, the contractor's obligation to provide the additional service shall continue until a notice is served on it by the Primary Care Trust under sub-paragraph (17) or (18).

(20)    Nothing in sub-paragraphs (1) to (19) above shall prevent the contractor and the Primary Care Trust from agreeing a different date for the termination of the contractor's duty under the contract to provide the additional service and accordingly, varying the contract in accordance with paragraph 104(1) of Schedule 6.

(21)    The permanent opt out takes effect at 08.00 on the relevant day unless—

(a)    the day is a Saturday, Sunday, Good Friday, Christmas Day, or a bank holiday, in which case the opt out shall take effect on the next working day at 08.00; or

(b)    the Primary Care Trust and the contractor agree a different day or time.

Out of hours opt outs where the opt out notice is served after 30th September 2004

4

(1)    This paragraph applies where a contractor wishes to serve or serves an out of hours opt out notice after 30th September 2004.

(2)    A contractor which wishes to terminate its obligation to provide out of hours services which was included in the contract pursuant to regulation 30 shall notify the relevant Primary Care Trust in writing to that effect (“an out of hours opt out notice”).

(3)    An out of hours opt out notice shall specify the date from which the contractor would like the opt out to take effect, which must be either three or six months after the date of service of the out of hours opt out notice.

(4)    As soon as is reasonably practicable and in any event within 28 days of receiving the out of hours opt out notice, the Primary Care Trust shall approve the notice and specify in accordance with sub-paragraph (6) the date on which the out of hours opt out is to commence (“OOH day”).

(5)    The Primary Care Trust shall notify the contractor of its decision as soon as possible.

(6)    The date specified in sub-paragraph (4) shall be the date specified in the out of hours opt out notice.

(7)    A contractor may not withdraw an out of hours opt out notice once it has been approved by the Primary Care Trust under sub-paragraph (4) without the Primary Care Trust's agreement.

(8)    Following receipt of the out of hours opt out notice, the Primary Care Trust must use its reasonable endeavours to make arrangements for the contractor's registered patients to receive the out of hours services from an alternative provider from OOH day.

(9)    Sub-paragraphs (6) to (21) of paragraph 3 shall apply to an out of hours opt out as they apply to a permanent opt out and as if the reference to “A day” was a reference to “OOH day” and the reference in paragraph 3(16) to a “preliminary opt out notice” was a reference to “an out of hours opt out notice”.

Out of hours opt outs where the opt out notice is served before 1st October 2004

5

(1)    This paragraph shall apply where a contractor wishes to serve or serves an out of hours opt out notice before 1st October 2004.

(2)    In this paragraph—

“OOH day” is the day specified by the Primary Care Trust for the commencement of the out of hours opt out in its decision under sub-paragraph (5);

“OOHB day” is the day six months after the date of service of the out of hours opt out notice; and

“OOHC day” is the day specified by the Primary Care Trust in its decision under sub-paragraph (11) or (13) (which must be nine months after the date of service of the out of hours opt out notice or before 2nd January 2005).

(3)    A contractor which wishes to terminate its obligation to provide out of hours services which was included in the contract pursuant to regulation 30 shall notify the relevant Primary Care Trust in writing to that effect (“an out of hours opt out notice”).

(4)    An out of hours opt out notice shall state the date on which the contractor would like the opt out to take effect, which must be either three or six months after the date of service of the out of hours opt out notice.

(5)    As soon as is reasonably practicable and in any event within 28 days of receiving the out of hours opt out notice, the Primary Care Trust shall approve the notice and specify in accordance with sub-paragraphs (6) and (7) the date on which the out of hours opt out is to commence (OOH day) and the Primary Care Trust shall notify the contractor in writing of its decision as soon as possible, including reasons for its decision.

(6)    Subject to sub-paragraph (7), OOH day shall be—

(a)    the date specified in the out of hours opt out notice; or

(b)    any other date before 2nd January 2005.

(7)    A Primary Care Trust may not specify under sub-paragraph (5) a date earlier than the date specified in the out of hours opt out notice.

(8)    A contractor may not withdraw an out of hours opt out notice once it has been approved by a Primary Care Trust under sub-paragraph (5) without the Primary Care Trust's agreement.

(9)    Following receipt of the out of hours opt out notice, the Primary Care Trust must use its reasonable endeavours to make arrangements for the contractor's registered patients to receive out of hours services from an alternative provider from OOH day.

(10)    The contractor's duty to provide the out of hours services shall terminate on OOH day unless the Primary Care Trust—

(a)    serves a notice under sub-paragraph (11) (extending OOH day to OOHB day or OOHC day); or

(b)    makes an application under sub-paragraph (14) (seeking the approval of the relevant Strategic Health Authority to a decision to refuse an opt out or to delay the taking of effect of an opt out until after OOH day).

(11)    If the Primary Care Trust is not successful in finding an alternative provider to take on the provision of the out hours services from OOH day, then it shall notify the contractor in writing of this fact no later than one month before OOH day, and—

(a)    in a case where OOH day is three months after service of the out of hours opt out notice, the contractor shall continue to provide the out of hours services until OOHB day unless at least one month before OOHB day it receives a notice in writing from the Primary Care Trust under sub-paragraph (13) that despite using its reasonable endeavours, it has failed to find an alternative provider to take on the provision of the out of hours services from OOHB day;

(b)    in a case where OOH day is after the day three months after the service of the out of hours opt out notice, the contractor shall continue to provide the out of hours services until OOHC day (which shall be specified by the Primary Care Trust in accordance with sub-paragraph (12) and included in its notice to the contractor under this sub-paragraph) unless at least one month before OOHC day it receives a notice from the Primary Care Trust under sub-paragraph (16) that it has made an application to the relevant Strategic Health Authority under sub-paragraph (14) seeking its approval to a decision to refuse an opt out or to delay the commencement of the opt out until after OOHC day.

(12)    OOHC day shall be any day before 2nd January 2005 or the day nine months after the service of the out of hours opt out notice.

(13)    Where in accordance with sub-paragraph (11)(a) the out of hours opt out is to commence on OOHB day and the Primary Care Trust, despite using its reasonable endeavours has failed to find an alternative provider to take on the provision of the out of hours services from that day, it shall notify the contractor in writing of this fact at least one month before OOHB day, in which case the contractor shall continue to provide the out of hours services until OOHC day (which shall be specified by the Primary Care Trust in accordance with sub-paragraph (12) and included in its notice to the contractor under this sub-paragraph) unless at least one month before OOHC day it receives a notice from the Primary Care Trust under sub-paragraph (16) that it has applied to the relevant Strategic Health Authority under sub-paragraph (14) seeking the approval of the relevant Strategic Health Authority to a decision to refuse an opt out or to postpone the commencement of an opt out until after OOHC day.

(14)    The Primary Care Trust may, if it considers there are exceptional circumstances, make an application to the relevant Strategic Health Authority for approval of a decision to—

(a)    refuse an opt out; or

(b)    postpone the commencement of an opt out until after—

(i)    OOHC day, or

(ii)    OOH day where OOH day is 1st January 2005 and 1st January 2005 is nine months or more after the date of the out of hours opt out notice.

(15)    Where OOH day is 1st January 2005, and 1st January 2005 is nine months or more after the date of the out of hours opt out notice, an application under sub-paragraph (14) shall be made at least one month before OOH day.

(16)    As soon as practicable after making an application under sub-paragraph (14) to the Strategic Health Authority, the Primary Care Trust shall notify the contractor in writing that it has made such an application.

(17)    Sub-paragraphs (12) to (21) of paragraph 3 shall apply to an out of hours opt out as they apply to a permanent opt out and as if the reference to “C day” was a reference to OOHC day or OOH day where OOH day is 1st January 2005 and 1st January 2005 is nine months or more after the date of the out of hours opt out notice.

Informing patients of opt outs

6

(1)    Prior to any opt out taking effect, the Primary Care Trust and the contractor shall discuss how to inform the contractor's patients of the proposed opt out.

(2)    The contractor shall, if requested by the Primary Care Trust inform its registered patients of an opt out and the arrangements made for them to receive the additional service or out of hours services by—

(a)    placing a notice in the practice's waiting rooms; or

(b)    including the information in the practice leaflet.

(3)    In this paragraph “opt out” means an out of hours opt out, a permanent opt out or a temporary opt out.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Contract Law59 Breach, Discharge & Rescission of Contract59

SCHEDULE 4 List of Prescribed Medical Certificates

SCHEDULE 4List of Prescribed Medical Certificates Regulation 21
Description of medical certificateEnactment under or for the purpose of which certificate required
1 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 etcNaval 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
2 To establish pregnancy for the purpose of obtaining welfare foodsSection 13 of the Social Security Act 1988 (schemes for distribution etc of welfare foods)
3 To secure registration of still-birthSection 11 of the Births and Deaths Registration Act 1953 (special provision as to registration of still-birth)
4 To enable payment to be made to an institution or other person in case of mental disorder of persons entitled to payment from public fundsSection 142 of the Mental Health Act 1983 (pay, pensions etc of mentally disordered persons)
5 To establish unfitness for jury serviceJuries Act 1974
6 To support late application for reinstatement in civil employment or notification of non-availability to take up employment owing to sicknessReserve Forces (Safeguarding of Employment) Act 1985
7 To enable a person to be registered as an absent voter on grounds of physical incapacityRepresentation of the People Act 1983
8 To support applications for certificates conferring exemption from charges in respect of drugs, medicines and appliancesNational Health Service Act 1977
9 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 payableLocal Government Finance Act 1992
NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Criminal Procedure93 Property Taxes93 Elections92 Claims Involving Fatalities, Children & Mentally Incapacitated Claimants93 Mental Health93 Real Property Law93 Council Tax95 Constitutional Law92 Tort93 Claims Involving Mentally Incapacitated Claimants96 Health Law93 Tax Law93 Personal Injuries Proceedings & Damages93 Jury93 Personal Injury93

SCHEDULE 5 Fees and Charges

SCHEDULE 5Fees and Charges Regulation 24

1

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 Primary Care Trust, 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 Primary Care Trust 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 by a Primary Care Trust under regulation 20 of the Pharmaceutical Regulations or paragraphs 47 or 49 of Schedule 6 to provide drugs, medicines or appliances to a patient and provides for that patient, otherwise than by way of pharmaceutical services or dispensing services, any Scheduled drug;

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

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Road Transport97 Transport Law97

SCHEDULE 7 Out of Hours Services

SCHEDULE 7Out of Hours Services Regulation 32

Temporary arrangements for transfer of obligations and liabilities in relation to certain out of hours services

1

(1)    In this Schedule—

“accredited service provider” has the meaning given to it by regulation 2 of the Out of Hours Regulations;

“Out of Hours Regulations” means the National Health Service (Out of Hours Medical Services) and National Health Service (General Medical Services) Amendment Regulations 2002;

“out of hours arrangement” means an arrangement under sub-paragraph (2); and

“transferee doctor” means a person referred to in sub-paragraph (5)(b) who has undertaken to carry out the obligations of a contractor during all or part of the out of hours period in accordance with an out of hours arrangement referred to in sub-paragraph (2).

(2)    Subject to the provisions of this Schedule, where a contractor is required to provide out of hours services pursuant to regulation 30 or 31, it may, with the approval of the Primary Care Trust, make an arrangement with one of the persons specified in sub-paragraph (5) as if regulations 1 to 11 of the Out of Hours Regulations, subject to the modifications specified in sub-paragraph (6), were still in force.

(3)    Any arrangement made pursuant to sub-paragraph (2) shall cease to have effect on 1st January 2005.

(4)    An arrangement made in accordance with sub-paragraph (2) shall, for so long as it continues, or is not suspended under paragraph 7(1), relieve the contractor of—

(a)    its obligations to provide out of hours services pursuant to regulation 30 or 31; and

(b)    all liabilities under the contract in respect of those services.

(5)    The persons referred to in sub-paragraph (2) are—

(a)    an accredited service provider; or

(b)    a person who holds a general medical services contract with the Primary Care Trust which includes the provision of out of hours services.

(6)    The modifications referred to in sub-paragraph (2) are—

(a)    as if out of hours period had the meaning given in regulation 2 of these Regulations;

(b)    as if the requirements relating to an assessing authority in regulation 4(5) to (8) did not apply in cases where, in the opinion of the accrediting authority, it was appropriate and safe to dispense with them;

(c)    as if the reference to a medical practitioner in regulation 11(2)(c) was a reference to a contractor;

(d)    as if the reference to section 44 in regulation 11(2)(d) was to section 45A of the Act; and

(e)    as if the reference to a medical list or supplementary list in paragraph 7 of the Schedule was to a medical performers list and the words “or he is named in an agreement under section 2 of the 1997 Act as a performer of personal medical services” were omitted.

(7)    A contractor may make more than one out of hours arrangement and may do so (for example) with different transferee doctors or accredited service providers and in respect of different patients, different times and different parts of its practice area.

(8)    A contractor may retain responsibility for, or make separate out of hours arrangements in respect of, the provision to any patients of maternity medical services during the out of hours period which the contractor is required to provide pursuant to regulation 30 or 31 and any separate out of hours arrangements it makes may encompass all or any part of the maternity medical services it provides.

(9)    Nothing in this paragraph prevents a contractor from retaining or resuming its obligations in relation to named patients.

Application for approval of an out of hours arrangement

2

(1)    An application to the Primary Care Trust for approval of an out of hours arrangement shall be made in writing and shall state—

(a)    the name and address of the accredited service provider or the proposed transferee doctor;

(b)    the periods during which the contractor's obligations under the contract are to be transferred;

(c)    how the accredited service provider or proposed transferee doctor intends to meet the contractor's obligations during the periods specified under paragraph (b);

(d)    the arrangements for the transfer of the contractor's obligations under the contract to and from the accredited service provider or transferee doctor at the beginning and end of the periods specified under paragraph (b);

(e)    whether the proposed arrangement includes the contractor's obligations in respect of maternity medical services; and

(f)    how long the proposed arrangements are intended to last and the circumstances in which the contractor's obligations under the contract during the periods specified under paragraph (b) would revert to it.

(2)    The Primary Care Trust shall determine the application before the end of the period of 28 days beginning with the day on which the Primary Care Trust received it.

(3)    The Primary Care Trust shall grant approval to a proposed out of hours arrangement if it is satisfied—

(a)    having regard to the overall provision of primary medical services provided in the out of hours period in its area, that the arrangement is reasonable and will contribute to the efficient provision of such services in the area;

(b)    having regard, in particular, to the interests of the contractor's patients, that the arrangement is reasonable;

(c)    having regard, in particular, to all reasonably foreseeable circumstances, that the arrangement is practicable and will work satisfactorily;

(d)    that any arrangement with a person referred to in paragraph 1(5)(b) will be of an equivalent standard to an arrangement with a person referred to in paragraph 1(5)(a);

(e)    that in the case of an arrangement with a person referred to in paragraph 1(5)(a), the practice premises are within the geographical area in respect of which approval is given under regulation 5 of the Out of Hours Regulations;

(f)    that it will be clear to the contractor's patients how to seek primary medical services during the out of hours period;

(g)    where maternity medical services are to be provided under the out of hours arrangement, that they will be performed by a medical practitioner who has such medical experience and training as are necessary to enable him properly to perform such services; and

(h)    that if the arrangement comes to an end, the contractor has in place proper arrangements for the immediate resumption of its responsibilities,

and shall not refuse to grant approval without first consulting the Local Medical Committee (if any) for its area.

(4)    The Primary Care Trust shall give notice to the contractor of its determination and, where it refuses an application, it shall send the contractor a statement in writing of the reasons for its determination.

(5)    A contractor which wishes to refer the matter in accordance with the NHS dispute resolution procedure must do so before the end of the period of 30 days beginning with the day on which the Primary Care Trust's notification under sub-paragraph (4) was sent.

Effect of approval of an arrangement with a transferee doctor

3

Where the Primary Care Trust has approved an out of hours arrangement with a transferee doctor the Primary Care Trust and the transferee doctor shall be deemed to have agreed a variation of their contract which has the effect of including in it, from the date on which the out of hours arrangement commences and for so long as that arrangement is not suspended or terminated, the services covered by that arrangement and paragraph 104(1) of Schedule 6 shall not apply.

Review of approval

4

(1)    Where it appears to the Primary Care Trust that it may no longer be satisfied of any of the matters referred to in paragraphs (a) to (h) of paragraph 2(3), it may give notice to the contractor that it proposes to review its approval of the out of hours arrangement.

(2)    On any review under sub-paragraph (1), the Primary Care Trust shall allow the contractor a period of 30 days, beginning with the day on which it sent the notice, within which to make representations in writing to the Primary Care Trust.

(3)    After considering any representations made in accordance with sub-paragraph (2), the Primary Care Trust may determine to—

(a)    continue its approval;

(b)    withdraw its approval following a period of notice; or

(c)    if it appears to it that it is necessary in the interests of the contractor's patients, withdraw its approval immediately.

(4)    Except in the case of an immediate withdrawal of approval, the Primary Care Trust shall not withdraw its approval without first consulting the Local Medical Committee (if any) for its area.

(5)    Where the Primary Care Trust determines to withdraw its approval immediately, it shall notify the Local Medical Committee (if any) for its area.

(6)    The Primary Care Trust shall give notice to the contractor of its determination under sub-paragraph (3).

(7)    Where the Primary Care Trust withdraws its approval, whether immediately or on notice, it shall include with the notice a statement in writing of the reasons for its determination.

(8)    A contractor which wishes to refer the matter in accordance with the NHS dispute resolution procedure must do so before the end of the period of 30 days beginning with the day on which the Primary Care Trust's notification under sub-paragraph (6) was sent.

(9)    Where the Primary Care Trust determines to withdraw its approval following a period of notice, the withdrawal shall take effect at the end of the period of two months beginning with—

(a)    the date on which the notice referred to in sub-paragraph (6) was sent; or

(b)    where there has been a dispute which has been referred under the NHS dispute resolution procedure and the dispute is determined in favour of withdrawal, the date on which the contractor receives notice of the determination.

(10)    Where the Primary Care Trust determines to withdraw its approval immediately, the withdrawal shall take effect on the day on which the notice referred to in sub-paragraph (6) is received by the contractor.

Suspension of approval

5

(1)    Where the Primary Care Trust suspends its approval of an accredited service provider under regulation 9 of the Out of Hours Regulations or receives notice of suspension of such approval under regulation 11 of those Regulations, it shall forthwith suspend its approval of any out of hours arrangement made by the contractor with that accredited service provider.

(2)    A suspension of approval under sub-paragraph (1) shall take effect on the day on which the contractor receives notice of suspension of approval of the accredited service provider under regulation 11 of the Out of Hours Regulations.

Immediate withdrawal of approval other than following review

6

(1)    The Primary Care Trust shall withdraw its approval of an out of hours arrangement immediately—

(a)    in the case of an arrangement with a person referred to in paragraph 1(5)(a), if it withdraws its approval of the accredited service provider under regulation 8 of the Out of Hours Regulations or receives notice of withdrawal of such approval under regulation 11 of those Regulations;

(b)    in the case of an arrangement with a person referred to in paragraph 1(5)(b), if the person with whom it is made ceases to hold a general medical services contract with the Primary Care Trust which includes the provision of out of hours services; or

(c)    where, without any review having taken place under paragraph 4, it appears to the Primary Care Trust that it is necessary in the interests of the contractor's patients to withdraw its approval immediately.

(2)    The Primary Care Trust shall give notice to the contractor of a withdrawal of approval under sub-paragraph (1)(b) or (c) and shall include with the notice a statement in writing of the reasons for its determination.

(3)    An immediate withdrawal of approval under sub-paragraph (1) shall take effect—

(a)    in the case of a withdrawal under sub-paragraph (1)(a), on the day on which the contractor receives notice of withdrawal of approval of the accredited service provider under Regulation 11 of the Out of Hours regulations; or

(b)    in the case of a withdrawal under sub-paragraph (1)(b) or (c), on the day on which the notice referred to in sub-paragraph (2) is received by the contractor.

(4)    The Primary Care Trust shall notify the Local Medical Committee (if any) for its area of a withdrawal of approval under sub-paragraph (1)(c).

(5)    A contractor which wishes to refer a withdrawal of approval under sub-paragraph (1)(c) in accordance with the NHS dispute resolution procedure must do so before the end of the period of 30 days beginning with the day on which the Primary Care Trust's notification under sub-paragraph (2) was sent.

Suspension or termination of an out of hours arrangement

7

(1)    The contractor shall suspend an arrangement made with an accredited service provider under paragraph 1(2) on receipt of the notice of suspension of approval of that provider under regulation 11 of the Out of Hours Regulations.

(2)    The contractor shall terminate an out of hours arrangement made under paragraph 1(2) with effect from the date of the taking effect of the withdrawal of the Primary Care Trust's approval of that arrangement under paragraph 4 or 6.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Contract Law89 Breach, Discharge & Rescission of Contract89 Medical Procedure & Treatment89 Health Law89

SCHEDULE 8 Closure Notice

SCHEDULE 8Closure Notice Schedule 6, paragraph 29(8)
Application for List Closure
From: Name of ContractorTo: Name of Primary Care Trust
Date:

In accordance with paragraph 29 of Schedule 6 to the National Health Service (General Medical Services Contract) Regulations 2004, on behalf of the above named contractor I/we wish to make formal application for our list to be closed to new patients and assignments, as follows:

(1) Length of period of closure (which may not exceed 12 months and, in the absence of any agreement, shall be 12 months)
(2) Date from which closure will take effect
(3) Date from which closure will cease to have effect
(4) Current number of registered patients
(5) Reduction in terms of either a percentage of the number indicated in (4) above or an actual number of patients which would trigger a re-opening (or suspension of list closure) of the list
(6) Increase in terms of either a percentage of the number indicated in (4) above or an actual number of patients which would trigger a re-closure (or lifting of the suspension of list closure) of the list
(7) Any withdrawal or reduction of additional or enhanced services
Signed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For: [Name of contractor]
NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Contract Law94 Breach, Discharge & Rescission of Contract94

SCHEDULE 9 Primary Care Trusts Specified for the Purposes of Repeatable Prescribing

SCHEDULE 9Primary Care Trusts Specified for the Purposes of Repeatable Prescribing Schedule 6, paragraph 40(2)

Amber Valley Primary Care Trust

Bath and North East Somerset Primary Care Trust

Bebington and West Wirral Primary Care Trust

Bedfordshire Heartlands Primary Care Trust

Birkenhead and Wallasey Primary Care Trust

Blackburn with Darwen Primary Care Trust

Blackwater Valley and Hart Primary Care Trust

Bradford South and West Primary Care Trust

Bristol North Primary Care Trust

Bristol South and West Primary Care Trust

Bromley Primary Care Trust

Burnley Pendle and Rossendale Primary Care Trust

Burntwood, Lichfield and Tamworth Primary Care Trust

Camden Primary Care Trust

Castle Point and Rochford Primary Care Trust

Central Cornwall Primary Care Trust

Charnwood and North West Leicestershire Primary Care Trust

Chelmsford Primary Care Trust

Cheltenham and Tewkesbury Primary Care Trust

Cheshire West Primary Care Trust

Cotswold and Vale Primary Care Trust

Coventry Primary Care Trust

Durham and Chester-le-Street Primary Care Trust

Durham Dales Primary Care Trust

East Devon Primary Care Trust

East Elmbridge and Mid Surrey Primary Care Trust

East Hampshire Primary Care Trust

East Leeds Primary Care Trust

East Yorkshire Primary Care Trust

Eastern Birmingham Primary Care Trust

Erewash Primary Care Trust

Exeter Primary Care Trust

Gateshead Primary Care Trust

Great Yarmouth Primary Care Trust

Harrow Primary Care Trust

Hartlepool Primary Care Trust

Herefordshire Primary Care Trust

Hounslow Primary Care Trust

Hyndburn and Ribble Valley Primary Care Trust

Ipswich Primary Care Trust

Leicester Primary Care Trust

Medway Primary Care Trust

Mendip Primary Care Trust

Mid Devon Primary Care Trust

Newbury and Community Primary Care Trust

Newcastle Primary Care Trust

New Forest Primary Care Trust

Newham Primary Care Trust

North Birmingham Primary Care Trust

North Hertfordshire and Stevenage Primary Care Trust

North Liverpool Primary Care Trust

North Peterborough Primary Care Trust

North Sheffield Primary Care Trust

Northamptonshire Heartlands Primary Care Trust

Northumberland Primary Care Trust

Norwich Primary Care Trust

Portsmouth City Primary Care Trust

Preston Primary Care Trust

Redditch and Bromsgrove Primary Care Trust

Sheffield West Primary Care Trust

Somerset Coast Primary Care Trust

South East Hertfordshire Primary Care Trust

South East Oxfordshire Primary Care Trust

South East Sheffield Primary Care Trust

South Gloucestershire Primary Care Trust

South Peterborough Primary Care Trust

South Warwickshire Primary Care Trust

South West Dorset Primary Care Trust

South West Oxfordshire Primary Care Trust

South Worcestershire Primary Care Trust

Southern Norfolk Primary Care Trust

Southwark Primary Care Trust

Stockport Primary Care Trust

Suffolk Coastal Primary Care Trust

Sunderland Teaching Primary Care Trust

Sutton and Merton Primary Care Trust

Taunton Deane Primary Care Trust

Torbay Primary Care Trust

Vale of Aylesbury Primary Care Trust

Wakefield West Primary Care Trust

Walsall Teaching Primary Care Trust

West Hull Primary Care Trust

West Lincolnshire Primary Care Trust

West of Cornwall Primary Care Trust

Western Sussex Primary Care Trust

Witham, Braintree and Halstead Primary Care Trust

Wolverhampton Primary Care Trust

Wycombe Primary Care Trust

Wyre Forest Primary Care Trust

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Contract Law96 Breach, Discharge & Rescission of Contract96

SCHEDULE 10 Information to be Included in Practice Leaflets

SCHEDULE 10Information to be Included in Practice Leaflets Schedule 6, paragraph 76

A practice leaflet shall include—

1

The name of the contractor.

2

In the case of a contract with a partnership—

(a)    whether or not it is a limited partnership; and

(b)    the names of all the partners and, in the case of a limited partnership, their status as a general or limited partner.

3

In the case of a contract with a company—

(a)    the names of the directors, the company secretary and the shareholders of that company; and

(b)    the address of the company's registered office.

4

The full name of each person performing services under the contract.

5

In the case of each health care professional performing services under the contract his professional qualifications.

6

Whether the contractor undertakes the teaching or training of health care professionals or persons intending to become health care professionals.

7

The contractor's practice area, by reference to a sketch diagram, plan or postcode.

8

The address of each of the practice premises.

9

The contractor's telephone and fax numbers and the address of its website (if any).

10

Whether the practice premises have suitable access for disabled patients and, if not, the alternative arrangements for providing services to such patients.

11

How to register as a patient.

12

The right of patients to express a preference of practitioner in accordance with paragraph 18 of Schedule 6 and the means of expressing such a preference.

13

The services available under the contract.

14

The opening hours of the practice premises and the method of obtaining access to services throughout the core hours.

15

The criteria for home visits and the method of obtaining such a visit.

16

The consultations available to patients under paragraphs 5 and 6 of Schedule 6.

17

The arrangements for services in the out of hours period (whether or not provided by the contractor) and how the patient may contact such services.

18

If the services in paragraph 17 are not provided by the contractor, the fact that the Primary Care Trust referred to in paragraph 28 is responsible for commission the services.

19

The name and address of any local walk-in centre.

20

The telephone number of NHS Direct and details of NHS Direct online.

21

The method by which patients are to obtain repeat prescriptions.

22

If the contractor offers repeatable prescribing services, the arrangements for providing such services.

23

If the contractor is a dispensing contractor, the arrangements for dispensing prescriptions.

24

How patients may make a complaint or comment on the provision of service.

25

The rights and responsibilities of the patient, including keeping appointments.

26

The action that may be taken where a patient is violent or abusive to the contractor, its staff, persons present on the practice premises or in the place where treatment is provided under the contract or other persons specified in paragraph 21(2) of Schedule 6.

27

Details of who has access to patient information (including information from which the identity of the individual can be ascertained) and the patient's rights in relation to disclosure of such information.

28

The name, address and telephone number of the Primary Care Trust which is a party to the contract and from whom details of primary medical services in the area may be obtained.

NOTES
Initial Commencement
Specified date

Specified date: 1 March 2004: see reg 1(1).

Extent

These Regulations apply to England only: see reg 1(2).

Professions & Ethics93 Health Professions93 Contract Law92 Company Law & Business Entities93 Breach, Discharge & Rescission of Contract92 Companies & Corporate Bodies93 Health Law93

EXPLANATORY NOTE

EXPLANATORY NOTE (This note is not part of the Regulations)

These Regulations set out, for England, the framework for general medical services contracts under section 28Q of the National Health Service Act 1977 (“the Act”).

Part 2 of the Regulations prescribes the conditions which, in accordance with section 28S of the Act, must be met by a contractor before the Primary Care Trust may enter into a general medical services contract with it.

Part 3 of the Regulations prescribes the procedure for pre-contract dispute resolution, in accordance with section 28W(2) of the Act. Part 3 applies to cases where the contractor is not a health service body. In cases where the contractor is such a body, the procedure for dealing with pre-contract disputes is set out in section 4 of the National Health Service and Community Care Act 1990.

Part 4 of the Regulations sets out the procedures, in accordance with section 28W(3) of the Act, by which the contractor may obtain health service body status.

Part 5 of (and Schedules 2 to 6, and 8 to 10 to) the Regulations prescribe the terms which, in accordance with sections 28V and 28W of the Act, must be included in a general medical services contract (in addition to those contained in the Act). It includes, in regulation 15, a description of the services which must be provided to patients under general medical services contracts pursuant to section 28R of the Act.

The prescribed terms include terms relating to—

(a)    the type and duration of the contract (regulations 12 to 14);

(b)    the services to be provided (regulations 15, 16 and 18 to 20 and Schedule 2), the manner in which they are to be provided (Part 1 of Schedule 6) and the procedures for opting out of additional and out of hours services (regulation 17 and Schedule 3);

(c)    the issuing of medical certificates (regulation 21 and Schedule 4);

(d)    finance, fees and charges (regulations 22 to 24 and Schedule 5);

(e)    patient registration and removal, lists closures and assignments (Schedule 6, Part 2, and Schedule 8);

(f)    prescribing and dispensing (Schedule 6, Part 3);

(g)    the conditions to be met by those who perform services or are employed or engaged by the contractor (Schedule 6, Part 4);

(h)    patient records, the provision of information and rights of entry (Schedule 6, Part 5, and Schedule 10);

(i)    complaints (Schedule 6, Part 6);

(j)    procedures for dispute resolution (Schedule 6, Part 7); and

(k)    procedures for variation and termination of contracts (Schedule 6, Part 8).

Part 6 of the Regulations prescribes functions for Local Medical Committees.

Part 7 of the Regulations and Schedule 7 make transitional provision.

Contract Law93 Breach, Discharge & Rescission of Contract93