Legalize / United Kingdom / Scotland / Scottish-Statutory-Instrument

The National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004

Type Scottish-Statutory-Instrument

Publication 2004-03-10

State In force

Jurisdiction Scotland

Department Queen's Printer for Scotland

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

Made: 10th March 2004

Laid before the Scottish Parliament: 11th March 2004

Coming into force: 1st April 2004

The Scottish Ministers, in exercise of the powers conferred by sections 9(6), 17D, 17E, 28(1), 105(7), 106(a) and 108(1) of the National Health Service (Scotland) Act 1978[^f00001] and of all other powers enabling them in that behalf, hereby make the following Regulations:

PART 1 — GENERAL

Citation and commencement

1

These Regulations may be cited as the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004 and shall come into force on 1st April 2004.

Interpretation

2

In these Regulations–

“the Act” means the National Health Service (Scotland) Act 1978;

“the 2004 Act” means the Primary Medical Services (Scotland) Act 2004[^f00002];

“the 2003 Order” means the General and Specialist Medical Practice (Education, Training and Qualifications) Order 2003[^f00003];

“additional services” means one or more of– cervical screening services; contraceptive services; vaccinations and immunisations; childhood vaccinations and immunisations; child health surveillance services; maternity medical services; and minor surgery;

“adjudicator” means the Scottish Ministers or a panel of 3 persons appointed by the Scottish Ministers under paragraph 56 of Schedule 1;

“agreement” means, unless the context otherwise requires, an agreement pursuant to section 17C of the Act[^f00004] (personal medical or dental services) under which primary medical services are provided;

“appliance” means an appliance which is included in a list for the time being approved by the Scottish Ministers for the purposes of section 27(1)[^f00005] of the Act;

“approved medical practice” shall be construed in accordance with section 11(4) of the Medical Act 1983[^f00006];

“area medical committee” means the committee of that name recognised under section 9 of the Act (local consultative committees) in the area of the Health Board;

“area pharmaceutical committee” means the committee of that name recognised under section 9 of the Act (local consultative committees) in the area of the Health Board;

“assessment panel” means a committee or sub-committee of a Health Board (“the first Health Board”) (other than the Health Board (“the second Health Board”) which is a party to the agreement in question) appointed by the first Health Board at the request of the second Health Board to exercise functions under paragraph 23 or paragraph 27 of Schedule 2 and which shall consist of– the Chief Executive of the first Health Board or an Executive Director of that Health Board nominated by that Chief Executive; a person representative of patients in an area other than that of the second Health Board; and a person representative of the area medical committee which does not represent practitioners in the area of the second Health Board;

“CCT” means a 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 3;

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

“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 3;

“childhood vaccinations and immunisations” means the services described in paragraph 5(2) of Schedule 3;

“closed”, in relation to a provider’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 3;

“core hours” means the period beginning at 8 a.m. and ending at 6.30 p.m. on any working day;

“dispensing services” means the provision of drugs, medicines and appliances;

“disqualified” means, unless the context otherwise requires, local or national disqualification by the Tribunal (or a decision under provisions in force in England, Wales or Northern Ireland corresponding to local or national disqualification), but does not include conditional disqualification;

“Drug Tariff” means the statement published under regulation 9 (payments to pharmacists and standards of drugs and appliances) of the Pharmaceutical Regulations;

“enhanced services” are– services other than essential services, additional services or out of hours services; or essential services or additional services or out of hours services or an element of such a service that a provider agrees in the agreement to provide in accordance with specifications set out in a plan, which requires of the provider an enhanced level of service provision compared to that which the provider needs generally to provide in relation to that service or element of service;

“essential services” means the services described in paragraph 1(2),(4), (5) and (7) of Schedule 2;

“general medical practitioner” means– 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 until the coming into force of that article, a medical practitioner who is either– until the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, suitably experienced within the meaning of section 21(2) of the Act, section 31(2) of the National Health Service Act 1977[^f00007] or Article 8(2) of the Health and Personal Social Services (Northern Ireland) Order 1978[^f00008]; or 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 medical services contract” means a general medical services contract under section 17J of the Act[^f00009] (Health Boards power to enter into general medical services contracts);

“general medical services contractor” means a person who is providing primary medical services in accordance with a general medical services contract;

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

“GMS Contracts Regulations” means the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004[^f00010];

“GP Registrar”– until the coming into force of article 5 of the 2003 Order, means a medical practitioner who is being trained in general practice by a medical practitioner who– has been approved for that purpose by the Joint Committee on Postgraduate Training for General Practice under regulation 7 of the National Health Service (Vocational Training for General Medical Practice) (Scotland) Regulations 1998[^f00011]; and performs primary medical services; and from the coming into force of that article, means a medical practitioner who is being trained in general practice by a GP Trainer whether as part of training leading to the award of a CCT or otherwise;

“GP Trainer” means a general medical practitioner who is– until the coming into force of article 4(5)(d) of the 2003 Order, approved as a GP Trainer by the Joint Committee on Postgraduate Training for General Practice under regulation 7 of the National Health Service (Vocational Training for General Medical Practice) (Scotland) Regulations 1998; or from the coming into force of that article, approved by the Postgraduate Medical Education and Training Board under article 4(5)(d) of the 2003 Order for the purposes of providing training to a GP Registrar under article 5(1)(c)(i) of that Order;

“Health and Social Services Board” means a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 1972[^f00012];

“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[^f00013];

“Health Authority” means a Health Authority established under section 8 of the National Health Service Act 1977;

“Health Board” means, unless the context otherwise requires, the Health Board which is a party, or prospective party, to an agreement;

“health care professional” has the same meaning as in section 17D(2) of the Act[^f00014] and “health care profession” shall be construed accordingly;

“health service body” means any person or body referred to in section 17A(2)[^f00015] of the Act (NHS contracts) and includes, except where otherwise expressly provided, any provider who is to be treated as a health service body in accordance with regulation 8;

“immediate family member” means– a spouse; a person (whether or not of the opposite sex) whose relationship with the registered patient has the characteristics of the relationship between husband and wife; a parent or step-parent; a son; a daughter; a child of whom the registered patient is– the guardian; or the carer duly authorised by the local authority to whose care the child has been committed under the Children (Scotland) Act 1995[^f00016]; or a grandparent;

“independent nurse prescriber” means a person– who is either engaged or employed by the provider, is a party to the agreement or is a partner in a partnership that is a party to the agreement; who is registered in the Nursing and Midwifery Register; and in respect of whom an annotation is also recorded in that register signifying that the person is qualified to order drugs, medicines and appliances from– the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part 8B of the Drug Tariff; or the Nurse Prescribers' Extended Formulary in Part 8C of the Drug Tariff;

“licensing authority” shall be construed in accordance with section 6(3) of the Medicines Act 1968[^f00017];

“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[^f00018];

“list” has, unless the context otherwise requires, the meaning assigned to it in section 29(8) of the Act[^f00019] and includes a list corresponding to such a list in England, Wales or Northern Ireland;

“Local Health Board” means a Local Health Board established under section 16BA of the National Health Service Act 1977[^f00020] (local health boards);

“local or national disqualification” has the meaning indicated in section 29B(2) of the Act[^f00021]

“maternity medical services” means the services described in paragraph 7 of Schedule 3;

“medical card” means a card issued by a Health Board, Primary Care trust, Local Health Board, Health Authority or Health and Social Services Board to a person for the purpose of enabling that person to obtain, or establishing that person’s title to receive, primary medical services;

“medical officer” means a medical practitioner who is– employed or engaged by the Department for Work and Pensions; or provided by an organisation in pursuance of a contract entered into with the Secretary of State for Work and Pensions;

“Medical Register” means the registers kept under section 2 of the Medical Act 1983[^f00022];

“minor surgery” means the services described in paragraph 8(2) of Schedule 3;

“national disqualification” means– a national disqualification by the Tribunal; or a decision under provisions in force in England, Wales or Northern Ireland corresponding to a national disqualification by the Tribunal;

“NHS contract” means an agreement which is an NHS contract within the meaning of section 17A(3) of the Act as a result of the provider being treated as a health service body pursuant to regulation 8(1) or (5);

“NHS dispute resolution procedure” means the procedure for resolution of disputes specified in paragraphs 56 and 57 of Schedule 1;

“NHS foundation trust” has the same meaning as in section 1 of the Health and Social Care (Community Health and Standards) Act 2003[^f00023];

“NHS trust” means a National Health Service trust established under section 5 of the National Health Service and Community Care Act 1990[^f00024];

“normal hours” means those days and hours on which and the times at which services under the agreement are normally made available and may be different for different services;

“Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under the Nursing and Midwifery Order 2001[^f00025];

“open” in relation to a provider’s list of patients, means open to applications from patients in accordance with paragraph 9 of Schedule 2;

“out of hours period” means– the period beginning at 6.30 p.m. on any day from Monday to Thursday and ending 8 a.m. on the following day; the period between 6.30 p.m. on Friday and 8 a.m. on the following Monday; and Christmas Day, New Year’s Day and other public or local holiday, and “part” of an out of hours period means any part of any one or more of the periods described in sub-paragraphs (a) to (c);

“out of hours services” means services agreed to be provided in all or part of the out of hours period which would be essential services or additional services if provided in core hours, and in the case of a provider who does not provide essential services or additional services in core hours, would be such services if the provider provided them;

“parent” includes, in relation to any child, any adult who, in the opinion of the provider, is for the time being discharging in respect of that child the obligations normally attaching to a parent in respect of a child;

“party to the agreement” means where a Health Board makes an agreement with– one person, the provider; and more than one person, one of those persons;

“patient” means– where the provider has a provider’s list of patients– a registered patient; a temporary resident; and person to whom the provider is required to provide immediately necessary treatment under paragraph 1(5) or (7) of Schedule 2 respectively; and in all cases any person (or, where the provider has a provider’s list of patients, any other person) to whom the provider has agreed to provide services under the agreement;

“Pharmaceutical Regulations” means the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995[^f00026];

“pharmacist” means– a registered pharmacist within the meaning of the Medicines Act 1968[^f00027] who provides pharmaceutical services; or a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968[^f00028] who provides such services; or a supplier of appliances, who is included in the list of a Health Board under section 27 of the Act (arrangements for provision of pharmaceutical services);

“the POM Order” means the Prescription Only Medicines (Human Use) Order 1997[^f00029];

“practice” means the business operated by the provider for the purpose of delivering services under the agreement;

“practice area” means the area referred to in regulation 11(1)(a);

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

“prescriber” means– a medical practitioner; an independent nurse prescriber; and a supplementary prescriber, who is either engaged or employed by the provider or is a party to the agreement or is a partner in a partnership that is a party to the agreement;

“prescription form” means a form provided by a Health Board and issued by a prescriber to enable a person to obtain pharmaceutical services;

“prescription only medicine” means a medicine referred to in article 3 of the POM Order (medicinal products on prescription only);

“Primary Care trust” means a Primary Care trust established under section 16A of the National Health Service Act 1977[^f00030] (primary care trusts);

“primary medical services performers list” means the list of primary medical services performers prepared in accordance with regulations made under section 17P of the Act[^f00031] (persons performing primary medical services);

“provider”, means, unless the context otherwise requires, where the Health Board makes an agreement with– one person, that person; and more than one person, all those persons, but references to employment, engagement or sub–contracting by those persons shall be deemed to include employment, or engagement or sub-contracting by any one of them;

“provider’s list of patients” means the list prepared and maintained by the Health Board under paragraph 8 of Schedule 2;

“public or local holiday” means any public or local holiday which is agreed in writing between the Health Board and the provider and which shall, in aggregate, be no less than those available to NHS staff employed by the Health Board;

“registered patient” means– a person who is recorded by the Health Board as being on a provider’s list of patients; or a person whom a provider has accepted for inclusion on the provider’s list of patients, whether or not notification of that acceptance has been received by the Health Board and who has not been notified by the Health Board as having ceased to be on that list;

“relevant register” means– in relation to a nurse, the Nursing and Midwifery Register; and in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954[^f00032] or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976[^f00033];

“restricted availability appliance” means an appliance which is approved for particular categories of persons or particular purposes only;

“type=start time=1185528763136Scheduled drugtype=end time=1185528763136” means– a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act[^f00034] as being a drug, medicine or other substance which may not be ordered for patients in the provision of primary medical services under a general medical services contract; or a drug, medicine or other substance which is specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract;

“supplementary prescriber” means a person– who is either engaged or employed by the provider or is a party to the agreement or a partner in a partnership that is a party to the agreement; and whose name is registered in– the Nursing and Midwifery Register; the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of the Pharmacy Act 1954; or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976, and against whose name is recorded in the relevant register an annotation signifying that that person is qualified to order drugs medicines and appliances as a supplementary prescriber;

“temporary resident” means a person accepted by a provider as a temporary resident under paragraph 10 of Schedule 2 and for whom the provider’s responsibility has not been terminated in accordance with that paragraph;

“working day” means any day apart from Saturday, Sunday, Christmas Day, New Year’s Day and any other public or local holiday;

“writing” includes, unless otherwise expressly provided, transmission by electronic means and “written” should be construed accordingly.

(2) In these Regulations , the use of the term “it” in relation to–

(a) a provider, shall be deemed to include a reference to a provider who is

(i) comprised of more than one party to the agreement; or

(ii) an individual; and

(b) the adjudicator, shall be deemed to refer either to the Scottish Ministers or the panel of 3 persons appointed by them as the case may be,

and related expressions shall be construed accordingly.

(3) Any reference in these Regulations to a numbered regulation or Schedule or to a numbered paragraph of such a Schedule is, unless otherwise expressly provided, a reference to a regulation or Schedule bearing that number in these Regulations or, as the case may be, to a paragraph bearing that number in such a regulation or Schedule.

PART 2 — PROVIDERS

General conditions relating to providers

3

(1) Subject to the provisions of any order made by the Scottish Ministers under section 7 (ancillary provision) of the 2004 Act a Health Board may only make an agreement with one or more of the persons falling within section 17D(1)(b), (d) or (e) of the Act[^f00035], where–

(a) if a person is an individual, the individual;

(b) if a person is a partnership, any member of the partnership and the partnership; and

(i) the company;

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

(iii) any director or secretary of the company,

satisfies the condition set out in paragraph (2).

(2) It is a condition that the person must not–

(a) be the subject of a national disqualification;

(b) subject to paragraph (3), be disqualified or suspended (otherwise 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 5 years prior to the signing of the agreement or commencement of the agreement, whichever is the earlier, have been dismissed (otherwise than by reason of redundancy) from any employment by a health service body unless the person has subsequently been employed by that health service body or another health service body and paragraph (4) applies to that person, or that dismissal was the subject of a finding of unfair dismissal by any competently established tribunal or court;

(d) within the period of 5 years prior to signing the agreement or commencement of the agreement, whichever is the earlier, have been disqualified from a list unless the person’s name has subsequently been included in such a list;

(e) have been convicted in the United Kingdom of murder;

(f) have been convicted in the United Kingdom of a criminal offence, other than murder, and been sentenced to a term of imprisonment of over 6 months;

(g) subject to paragraph (5), have been convicted elsewhere of an offence which would if committed in Scotland, constitute–

(i) murder; or

(ii) a criminal offence other than murder, and been sentenced to a term of imprisonment of over 6 months;

(h) have been convicted of an offence referred to in Schedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply)[^f00036] or Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions apply)[^f00037];

(i) have–

(i) had sequestration of the person’s estate awarded or been adjudged bankrupt unless (in either case) the person 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[^f00038] 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, the person’s creditors unless the person has been discharged in respect of it;

(j) have an administrator, administrative receiver or receiver appointed in respect of the person;

(k) have been–

(i) removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990[^f00039] (powers of the Court of Session to deal with the management of charities), from being concerned in the management or control of any body; or

(ii) 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 the person was responsible or to which the person was privy, or which the person by that person’s conduct contributed to or facilitated;

(l) be subject to a disqualification order under the Company Directors Disqualification Act 1986[^f00040], the Companies (Northern Ireland) Order 1986[^f00041]or to an order made under section 429(2)(b) of the Insolvency Act 1986[^f00042] (failure to pay under county court administration order); or

(m) fall within regulation 5(2)(m) of the GMS Contracts Regulations.

(3) A person shall not fall within paragraph (2)(b) where the Health Board is satisfied that the disqualification or suspension from practising is imposed by a licensing body outside the United Kingdom and it does not make the person unsuitable to be–

(a) a party to the agreement;

(b) in the case where the person is a partner in a partnership that is a proposed party to the agreement, a partner in that partnership;

(i) a person legally and beneficially holding a share in a company limited by shares that is a proposed party to the agreement; or

(ii) a director or secretary of a company limited by shares that is a proposed party to the agreement,

a person legally and beneficially holding a share in that company, or a director or secretary of that 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 Health Board is satisfied that the conviction does not make the person unsuitable to be–

(a) a party to the agreement;

(b) in the case where the person is a partner in a partnership that is a proposed party to the agreement, a partner in that partnership;

(i) a person legally and beneficially holding a share in a company limited by shares that is a proposed party to the agreement; or

(ii) a director or secretary of a company limited by shares that is a proposed party to the agreement,

a person legally and beneficially holding a share in that company, or a director or secretary of that company (as the case may be).

(6) In this regulation, “health service body” does not include any provider who is to be treated as a health service body in accordance with regulation 8.

Reasons

4

(1) Where a Health Board is of a view that a person does not satisfy the condition in regulation 3(2), it shall notify in writing the person intending to make an agreement of the Health Board’s view and its reasons for that view, and of that person’s right of appeal under regulation 5.

(2) The Health Board shall also notify in writing of its view and its reasons for that view–

(a) any other persons intending to make the agreement;

(b) any partner in a partnership that is notified under paragraph (1); and

(c) 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 reasons for that view relate to that person or persons.

Appeal

5

A person who has been served with a notice under regulation 4(1) may appeal to the Scottish Ministers against the decision of the Health Board by giving notice in writing to the Scottish Ministers within the period of 28 days beginning on the day that the Health Board served its notice.

Prescribed period under section 17D(3) of the Act

6

The period prescribed for the purposes of section 17D(3) of the Act (persons with whom agreements may be made)[^f00043] is 6 months.

PART 3 — PRE-AGREEMENT DISPUTE RESOLUTION

Pre-agreement dispute resolution

7

(1) Except where the proposed provider is a health service body (in which case section 17A(5)[^f00044] of the Act applies), if, in the course of negotiations intending to lead to any agreement, the proposed parties to that agreement are unable to agree on a particular term of the agreement, either the Health Board or the proposed provider may refer the terms of the proposed agreement to the Scottish Ministers to consider and determine the matter.

(2) Disputes as to the terms of any proposed agreement referred to the Scottish Ministers in accordance with paragraph (1) shall be determined in accordance with–

(a) the NHS dispute resolution procedure, as if, in Schedule 1–

(i) in paragraph 56(3)(b) “agreement” read “terms of the proposed agreement”; and

(ii) paragraph 57(2) and (3) were omitted; and

(b) paragraph (3) of this regulation.

(3) In a dispute referred to the Scottish Ministers under paragraph (1), the determinationof the adjudicator–

(a) may specify terms to be included in the proposed agreement;

(b) may require the Health Board to proceed with the proposed agreement, but may not require the proposed provider to proceed with the proposed agreement; and

(4) In this regulation “health service body” does not include any provider who is to be treated as a health service body in accordance with regulation 8.

PART 4 — HEALTH SERVICE BODY STATUS

Health service body status

8

(1) Where a proposed provider elects in a written notice served on the Health Board at any time prior to the agreement being entered into to be treated as a health service body for the purposes of section 17A of the Act (NHS contracts), the proposed provider shall be so treated from the date on which the agreement is made.

(2) If, pursuant to paragraph (1) or (5), a provider is to be treated as a health service body, it shall not be treated as a health service body to the extent that–

(a) the nature of, or any rights or liabilities arising under, any other arrangement or proposed arrangement with a health service body entered into or to be entered into by a provider is affected; and

(b) a matter referred to the Scottish Ministers for the purposes of section 17A(4) of the Act shall be determined under the provisions of section 17A.

(3) Where an agreement is made with a provider, and that provider is to be treated as a health service body in accordance with paragraph (1) or (5), the provider shall, subject to paragraph (4) continue to be treated as a health service body for the purposes of section 17A of the Act, for as long as that agreement continues irrespective of any change in–

(a) where a partnership is a party to the agreement, the membership of the partnership; and

(b) the parties to the agreement comprising the provider.

(4) A provider may at any time request in writing to be treated or cease to be treated as a health service body for the purposes of section 17A of the Act, and if the provider does so–

(a) the procedure in paragraph 59(1) of Schedule 1 shall have effect; and

(b) the Health Board shall agree to the variation.

(5) If the provider makes a request under paragraph (4), the provider shall

(a) be treated; or

(b) subject to paragraph (7) cease to be treated,

as a health service body for the purposes of section 17A of the Act from the date that variation is to take effect pursuant to paragraph 59(1) of Schedule 1.

(6) Subject to paragraph (7) a provider shall cease to be treated as a health service body for the purposes of section 17A of the Act if the agreement terminates.

(7) Where a provider ceases to be treated as a health service body pursuant to–

(a) paragraph (5), the provider shall, if the provider or the Health Board has referred any matter to the Scottish Ministers for the purposes of section 17A(4) of the Act before the provider ceases to be a health service body, be bound by the determination of the adjudicator;

(b) paragraph (6), the provider shall continue to be treated as a health service body for the purposes of the NHS dispute resolution procedure where that procedure has been commenced–

(i) before the termination of the agreement; or

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

for which purpose the provider shall cease to be treated as such a body on the conclusion of that procedure.

PART 5 — PROVISION OF PRIMARY MEDICAL SERVICES

Provision of primary medical services

9

(1) Whether or not the agreement includes arrangements for the provision of services which are not primary medical services, an agreement must include arrangements for the provision of one or more of the following primary medical services:–

(a) essential services;

(b) additional services;

(d) out of hours services, in respect of, subject to regulation 26 and paragraph 3 of Schedule 4, part or all of the out of hours period and some or all services.

Primary medical services and content of agreements

10

(1) An agreement shall contain terms which have the same effect as those specified in Schedule 1 (content of agreements), unless it is of a type or nature to which a particular provision does not apply, except paragraphs 56(5) to (15), and 57.

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

Essential services and content of agreements

11

(1) An agreement which includes the provision of essential services shall specify–

(a) the area as respects which persons resident in it will, subject to any other terms of the agreement relating to patient registration, be entitled to–

(i) register with the provider; or

(ii) seek acceptance by the provider as a temporary resident; and

(b) whether, at the date on which the agreement comes into force, the provider’s list of patients is open or closed.

(2) Where, in accordance with sub-paragraph (1), the agreement specifies that the provider’s list of patients is closed it must also specify in relation to that closure each of the items listed in paragraph 22(8)(a) to (d) of Schedule 2 (agreements to provide essential services).

(3) An agreement which includes the provision of essential services shall, in addition to any other terms required by these Regulations, unless it is of a type or nature to which a particular provision does not apply contain terms with the same effect as those specified in Schedule 2, except paragraphs 23(6) to (8) and 28(3).

(4) The paragraphs specified in paragraph (3) shall have effect in relation to matters set out in those paragraphs.

(5) An agreement which does not include the provision of essential services shall not specify the matters referred to in paragraph (1) nor contain terms with the same effect as those specified in Schedule 2.

Additional services and content of agreements

12

An agreement which includes the provision of additional services must, in addition to any other terms required by these Regulation–

(a) in relation to all such services included in the agreement, contain a provision which has the same effect as that specified in paragraph 1 of Schedule 3;

(b) in relation to each such service included in the agreement, contain provisions which have the same effect as those specified in Schedule 3, which are relevant to that service.

Out of hours services and content of agreements

13

An agreement which includes the provision of out of hours services by virtue of this regulation or regulation 26 must, in addition to any other terms required by these Regulations, unless it is of a type or nature to which a particular provision does not apply, contain terms with the same effect as those specified in Schedule 4.

PART 6 — CONTENT OF AGREEMENTS

Parties to the agreement

14

An agreement must specify–

(a) the names of the parties;

(b) where a party to the agreement is a partnership–

(i) whether or not that partnership is a limited partnership; and

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

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

NHS contracts

15

If the provider is to be treated as a health service body the agreement must state that it is an NHS contract.

Agreements with one or more partnerships

16

(1) Where a partnership is a party to the agreement, the agreement shall be treated as made with that partnership as it is from time to time constituted, and the agreement shall make specific provision to this effect.

(2) Where a partnership is a party to the agreement, the provider must be required by the terms of the agreement to ensure that any person who becomes a member of the partnership after the agreement has been made is bound automatically by the agreement, whether by virtue of the partnership deed or otherwise.

Arrangements on termination

17

An agreement shall make suitable provision for arrangements on termination of an agreement, including the consequences (whether financial or otherwise) of the agreement ending.

Services generally

18

(1) An agreement must specify–

(a) the services to be provided;

(b) subject to paragraph (2), the address of each of the premises to be used by the provider or any sub-contractor for the provision of such services;

(d) the period (if any) for which the services are to be provided; and

(e) where the agreement does not include the provision of essential services, the area (if any) in which the provider agrees to attend on patients outside the practice premises.

(2) The premises referred to in paragraph (1)(b) do not include–

(a) the homes of patients;

(b) any other premises where services are provided on an emergency basis.

(3) Where on the date on which the agreement is to be made, the Health Board is not satisfied that all or any of the premises specified in accordance with sub-paragraph (1)(b) meet the requirements set out in paragraph 1 of Schedule 1, the agreement may not be made unless it includes a plan, drawn up jointly by the Health Board and the provider, which specifies–

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

(b) any financial support that may be made available from the Health Board; and

Certificates

19

(1) An agreement must contain a term which has the effect of requiring the provider to issue free of charge to a patient or a patient’s personal representatives any medical certificate of a description prescribed in column 1 of Schedule 3 (list of prescribed medical certificates) to the GMS Contracts Regulations, 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 provider;

(ii) a party to the agreement;

(iii) in the case where a partnership is a party to the agreement, a partner in such a partnership; or

(iv) in the case where a company limited by shares is a party to the agreement, a person legally or beneficially owning shares in such a 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[^f00045] (which provides for the issue of a certificate in the form of a special statement by a doctor on the basis of a written report made by another doctor).

Finance

20

(1) Subject to paragraph (2), the agreement must contain a term which has the effect of requiring the Health Board to make payments to the provider under the agreement promptly and in accordance with both the terms of the agreement and, as respects the provision or performance of primary medical services, any other conditions relating to the payment contained in directions by the Scottish Ministers under section 17E(3A) of the Act[^f00046].

(2) The obligation referred to in paragraph (1) is subject to any right the Health Board may have to set off, against any amount payable to the provider under the agreement, any amount–

(a) that is owed by the provider to the Health Board under the agreement; or

(b) that the Health Board may withhold from the provider in accordance with the terms of the agreement or any other applicable provisions contained in directions given by the Scottish Ministers under section 17E(3A) of the Act.

Finance

21

An agreement must contain a term to the effect that where, pursuant to directions of the Scottish Ministers under sections 2(5)[^f00047] or section 17E(3A) of the Act, a Health Board is required to make a payment to a provider under an agreement but subject to conditions, those conditions shall be a term of the agreement.

Fees and charges

22

(1) An agreement must contain terms relating to fees and charges to the effect that, subject to provisions of paragraph 7 of Schedule 2, the provider shall not, directly or indirectly, demand or accept a fee or other remuneration from any patient of the provider for–

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

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

except in the circumstances set out in sub-paragraphs (a) to (d) and (f) to (l) of Schedule 4 (Fees and Charges) to the GMS Contracts Regulations, subject to the modifications specified in paragraph (2).

(2) The modifications to referred to in paragraph (1) of sub-paragraphs (a) to (d) and (f) to (l) of Schedule 4 are–

(a) for “contractor” read “provider” in each place where it occurs;

(b) for “contract” read “agreement” in each place where it occurs; and

PART 7 — FUNCTIONS OF AREA MEDICAL COMMITTEE

Functions of area medical committee

23

(1) The functions of an area medical committee which are prescribed for the purposes of section 9(6) of the Act (local consultative committees) are–

(a) the functions which are conferred upon it by these Regulations or by any order made under section 7 of the 2004 Act;

(b) the making of arrangements for the medical examination of a medical practitioner specified in paragraph (2), where the provider or the Health Board is concerned that the medical practitioner is incapable of adequately providing services under the agreement and the provider so requests with the agreement of the medical practitioner concerned; and

(c) the consideration of the report of any medical examination arranged in accordance with sub-paragraph (b) and the making of a written report as to the capability of the medical practitioner of adequately providing services under the agreement to the medical practitioner concerned, the provider and the Health Board with whom the provider has made the agreement.

(2) The medical practitioner referred to in paragraph (1)(b) is a medical practitioner who is–

(a) a party to the agreement;

(b) a partner in a partnership that is a party to the agreement;

PART 8 — RIGHT TO A GENERAL MEDICAL SERVICES CONTRACT

Right to a general medical services contract

24

(1) A provider which is providing essential services under an agreement and which wishes a general medical services contract to be entered into pursuant to this regulation shall notify the Health Board in writing at least three months before the date on which it wishes the general medical services contract to be entered into.

(2) A notice under paragraph (1) shall–

(a) state that the provider wishes to terminate the agreement and the date on which the provider wishes the agreement to terminate, which must be at least three months after the date of service of the notice;

(b) subject to paragraph (3), give the name of the person with whom the provider wishes the Health Board to enter into a general medical services contract; and

(c) confirm that the person so named meet the conditions set out in section 17L of the Act (eligibility to be contractor under general medical services contract)[^f00048] and regulations 4 (conditions relating solely to medical practitioners) and 5 (general conditions relating to all contracts) of the GMS Contracts Regulations or, where the provider is not able so to confirm, the reason why it is not able to do so and confirmation that the person immediately prior to entering into the general medical services contract will meet those conditions.

(3) A person’s name may only be given in a notice referred to in paragraph (1) if that person is a party to the agreement.

(4) The Health Board shall acknowledge receipt of the notice served under paragraph (1) within the period of 7 days beginning on the day that it received the notice.

(5) Provided that the conditions set out in section 17L of the Act and regulations 4 and 5 of the GMS Contracts Regulations are met, the Health Board shall enter into a general medical services contract with the person named in the notice served under paragraph (1).

(6) In addition to the terms required by the Act and the GMS Contracts Regulations, a general medical services contract entered into pursuant to this regulation shall provide for—

(a) the general medical services contract to commence immediately after the termination of the agreement;

(b) the names of the patients included in the provider’s list of patients immediately before the termination of the agreement to be included in the first list of patients to be prepared and maintained by the Health Board pursuant to paragraph 14 of Schedule 5 to the GMS Contracts Regulations; and

(c) the same services to be provided under the general medical services contract as were provided under the agreement immediately before it was terminated unless the parties otherwise agree.

(7) An agreement shall terminate on the date stated in the notice given by the provider under paragraph (1) unless a different date is agreed by the provider and the Health Board or no general medical services contract is entered into by the Health Board pursuant to this regulation.

(8) Where the Health Board is of the view that the conditions in section 17L of the Act or regulation 4 or 5 of the GMS Contracts Regulations are not met it shall notify in writing the provider of its view and its reasons for that view and of the provider’s right of appeal under sub-paragraph (9).

(9) The provider may appeal to the Scottish Ministers against the decision of the Health Board by giving notice in writing to the Scottish Ministers within the period of 28 days beginning on the day that the Health Board served its notice.

(10) Any other dispute relating to this regulation may be referred by the prospective party to the general medical services contract or the Health Board to the Scottish Ministers to consider and determine the matter in accordance with regulation 9(2) and (3) of the GMS Contracts Regulations.

PART 9 — TRANSITIONAL PROVISIONS

Commencement

25

An agreement shall provide for services to be provided under it from any date on or after 1st April 2004.

Out of hours services

26

Subject to paragraph 1 of Schedule 4, where a party to the agreement to provide essential services is a person who, on 31st March 2004, was providing personal medical services under section 17C of the Act, the agreement 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 services which would be essential services, if provided in core hours, to be provided throughout the out of hours period unless–

(a) the Health Board has accepted in writing, prior to the signing of the agreement, a written request from the provider that the agreement should not require the provider to make such provision; or

(b) the agreement has been otherwise varied to exclude a requirement to make such provision.

Revocation

27

Subject to the provisions of any order made by the Scottish Ministers section 7 of the 2004 Act (ancillary provisions), the National Health Service (Personal Medical Services) (Scotland) Regulations 2001[^f00049] are hereby revoked.

SCHEDULE 1 — CONTENT OF AGREEMENTS

PART 1 — PROVISION OF SERVICES

Premises

1

Subject to any plan which is included in the agreement pursuant to regulation 18(3), the provider shall ensure that the premises used for the provision of services under the agreement are–

(a) suitable for the delivery of those services; and

(b) sufficient to meet the reasonable needs of the provider’s patients.

Attendance outside practice premises

2

(1) In the case of a patient whose medical condition is such that in the reasonable opinion of the provider–

(a) attendance on the patient is required; and

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

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

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

(a) the place recorded in the patient’s medical records as being the patient’s last home address or (where the patient’s medical record is not immediately available) the place confirmed by the patient as being the patient’s home address;

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

(d) where the provider has no list of patients, some other place within the area specified in the agreement pursuant to regulation 18(1)(e).

(3) Nothing in this paragraph prevents the provider from–

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

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

Clinical reports

3

(1) Where the provider provides any clinical services other than under a private arrangement, to a patient and either–

(a) the provider has no list of patients; or

(b) the patient is not on the provider’s list of patients,

the provider shall, as soon as reasonably practicable, provide a clinical report relating to the consultation and any treatment provided, to the Health Board.

(2) The Health Board shall send any report received under sub-paragraph (1)–

(a) to the person with whom the patient is registered for the provision of essential services (or their equivalent); or

(b) if the person referred to in paragraph (a) is not known to it, to the Health Board in whose area the patient is resident.

Storage of vaccines

4

The provider shall ensure that–

(a) all vaccines are stored in accordance with the manufacturer’s instructions; and

(b) all refrigerators in which vaccines are stored have a maximum/minimum thermometer and that readings are taken on all working days.

Infection control

5

The provider shall ensure that the provider has effective arrangements for infection control and decontamination.

Duty of co-operation in relation to primary medical services

6

(1) A provider which does not provide to its patients–

(a) essential services;

(b) a particular additional service;

(d) out of hours services, either at all or in respect of some periods or services,

shall comply with the requirements specified in paragraph (2).

(2) The requirements referred to in paragraph (1) are that the provider shall–

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

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

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

(3) Nothing in this paragraph shall require a provider, whose agreement does not include the provision of out of hours services, to make itself available during the out of hours period.

Duty of co-operation in relation to primary medical services

7

(1) Where a provider will cease to be required to provide to its patients–

(a) essential services;

(b) a particular additional service;

(d) out of hours services, either at all or in respect of some periods of services,

the provider shall comply with any reasonable request for information relating to the provision of that service or those services made by the Health Board or by any person with whom the Board intends to make arrangements for the provision of such services.

PART 2 — PATIENTS

Patient preference of practitioner

8

(1) Where the provider has accepted a person as a patient the provider shall–

(a) subject to sub-paragraph (3), notify the patient of the patient’s rights to express a preference to receive services from a particular performer or class of performer either generally or in relation to any particular condition; and

(b) record in writing any such preference expressed by or on behalf of the patient.

(2) The provider shall endeavour to comply with any preference expressed under sub paragraph (1) but need not do so if the preferred performer–

(a) has reasonable grounds for refusing to provide services to the patient; or

(b) does not routinely perform the service in question within the practice.

(3) Where the patient is–

(a) a child, the provider may notify–

(i) a parent, guardian, or other adult person who has care of the care of the child;

(ii) a person duly authorised by a local authority, where the child is in the care of the local authority under the Children (Scotland) Act 1995[^f00050]; or

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

(b) an adult person who is incapable of expressing such a preference or authorising such a preference to be made on their behalf, the provider may notify the primary carer of that person or by the person authorised under the Adults with Incapacity (Scotland) Act 2000[^f00051] to act on the patients behalf,

of the right to express a preference for the patient to receive services from a particular performer or class of performer either generally or in relation to any particular condition.

Termination of responsibility for patients not registered with the provider

9

(1) Where the provider–

(a) has no provider’s list of patients but is required in terms of the agreement to accept a person as a patient for the provision of an additional service, an enhanced service or out of hours services; or

(b) has a provider’s list of patients and has received an application for the provision of clinical services other than essential services–

(i) from a person who is not included in the provider’s list of patients;

(ii) from a person whom the provider has not accepted as a temporary resident; or

(iii) on behalf of a person mentioned in (i) or (ii) above, from one of the persons specified in paragraph 9(4) of Schedule 2;

and has accepted that person as a patient for the provision of the service in question, the provider’s responsibility for that patient may be terminated in one of the circumstances referred to in sub-paragraph (2).

(2) The circumstances referred to in sub-paragraph (1) are–

(a) the patient informs the provider that the patient no longer wishes the provider to be responsible for the provision of the service in question;

(b) in cases where the provider has reasonable grounds for terminating the provider’s responsibility which do not relate to the person’s race, gender, social class, age, religion, sexual orientation, appearance, disability or medical condition, the provider informs the patient that the provider no longer wishes to be responsible for providing the patient with the service in question;

(i) an individual that is a party to the agreement;

(ii) a partner in a partnership that is a party to the agreement;

(iii) a legal and beneficial owner of shares in a company that is a party to the agreement;

(iv) a member of the provider’s staff;

(v) a person engaged by the provider to perform or assist in the performance of services under the agreement; or

(vi) any other person present–

(aa) on the practice premises; or

(bb) in the place where services were provided to the patient under the agreement,

or behaved in such a way that any such person has feared for that person’s own safety and, in either case, the provider has reported that incident to the police or the Procurator Fiscal;

(d) it comes to the notice of the provider that the patient–

(i) no longer resides in the area for which the provider has agreed to provide the service; or

(ii) is no longer a person to which the provider has agreed to provide the service.

(3) A provider who wishes to terminate its responsibility for a patient under sub paragraph (2)(b) or (c) shall notify the patient of the termination and the reason for it.

(4) The provider shall keep a written record of terminations under this paragraph and of the reason for them and shall make this record available to the Health Board on request.

(5) A termination under–

(a) sub-paragraph (2)(b) shall take effect 14 days from the date on which notice is given; and

(b) sub-paragraph (2)(c) shall take effect from the date on which notice is given.

PART 3 — PRESCRIBING AND DISPENSING

Prescribing

10

The provider shall ensure that any prescription form for drugs, medicines or appliances issued by a prescriber complies as appropriate with the requirements in paragraphs 11 to 13.

Prescribing

11

(1) Subject to paragraphs 13 and 14, a prescriber shall order any drugs, medicines or appliances which are needed for the treatment of any patient who is receiving treatment under the agreement by issuing to that patient a prescription form and such a prescription form shall not be used in any other circumstances.

(2) In issuing any such prescription form, the prescriber shall sign the prescription form in ink with the prescriber’s initials, or forenames, and surname in the prescriber’s own handwriting and not by means of a stamp and shall so sign only after particulars of the order have been inserted in the prescription form, and–

(a) the prescription form shall not refer to any previous prescription form; and

(b) a separate prescription form shall be used for each patient.

(3) In a case of urgency a prescriber may request a pharmacist to dispense a drug or medicine before a prescription form is issued, only if–

(a) that drug or medicine is not a Scheduled drug;

(b) that drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971[^f00052], other than a drug which is for the time being specified in Schedules 4 or 5 to the Misuse of Drugs Regulations 2001[^f00053]; and

(c) the prescriber undertakes to furnish the pharmacist, within 72 hours, with a prescription form or repeatable prescription completed in accordance with sub-paragraph (2).

(4) In a case of urgency a prescriber may request a pharmacist to dispense an appliance before a prescription form is issued only if–

(a) that appliance does not contain a Scheduled drug or a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001;

(b) in the case of a restricted availability appliance, the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

(c) the prescriber undertakes to furnish the pharmacist, within 72 hours, with a prescription form completed in accordance with sub-paragraph (2).

Restrictions on prescribing by medical practitioners

12

(1) In the course of treating a patient to whom a medical practitioner is providing treatment under the agreement, the medical practitioner shall not order on a prescription form a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act[^f00054] as being drugs, medicines or other substances which may not be ordered for patients in the provision of primary medical services under a general medical services contract but may, subject to regulation 22, prescribe such a drug, medicine or other substance for that patient in the course of that treatment under a private arrangement.

(2) In the course of treating a patient to whom a medical practitioner is providing treatment under the agreement, the medical practitioner shall not order on a prescription form or repeatable prescription a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which may only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract unless:

(a) that patient is a person of the specified description;

(b) that drug, medicine or other substance is prescribed for that patient only for the specified purpose; and

but may, subject to regulation 22, prescribe such a drug, medicine or other substance for that patient in the course of that treatment under a private arrangement.

(3) In the course of treating a patient to whom a medical practitioner is providing treatment under the agreement, the medical practitioner shall not order on a prescription form a restricted availability appliance unless–

(a) the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

(b) the practitioner endorses the face of the form with the reference “SLS”,

but may, subject to regulation 22, prescribe such an appliance for that patient in the course of that treatment under a private arrangement.

Restrictions on prescribing by supplementary prescribers

13

(1) The provider shall have arrangements in place to secure that a supplementary prescriber will–

(a) give a prescription for a prescription only medicine;

(b) administer a prescription only medicine for parental administration; or

as a supplementary prescriber under the conditions set out in sub-paragraph (2).

(2) The conditions referred to in sub-paragraph (1) are that–

(a) the supplementary prescriber satisfies the applicable conditions set out in article 3B(3) of the POM Order (prescribing and administration by supplementary prescribers)[^f00055], unless those conditions do not apply by virtue of any of the exemptions set out in the subsequent provisions of that Order;

(b) the medicine is not a controlled drug within the meaning of the Misuse of Drugs Act 1971;

(c) the drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of primary medical services under a general medical services contract;

(d) the drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract unless–

(i) the patient is a person of the specified description;

(ii) the medicine is prescribed for that patient only for the specified purposes; and

(iii) if the supplementary prescriber is giving a prescription, the supplementary prescriber endorses the face of the form with the reference “SLS”.

(3) Where the functions of a supplementary prescriber include prescribing, the provider shall have arrangements in place to secure that that person will only give a prescription for–

(a) an appliance; or

(b) a medicine which is not a prescription only medicine,

as a supplementary prescriber under the conditions set out in sub-paragraph (4).

(4) The conditions referred to in sub-paragraph (3) are that–

(a) the supplementary prescriber acts in accordance with a clinical management plan which is in effect at the time the supplementary prescriber acts and which contains the following particulars:–

(i) the name of the patient to whom the plan relates;

(ii) the illness or conditions which may be treated by the supplementary prescriber;

(iii) the date on which the plan is to take effect, and when it is to be reviewed by the medical practitioner or dentist who is a party to the plan;

(iv) reference to the class or description of medicines or types of appliances which may be prescribed or administered under the plan;

(v) any restrictions or limitations as to the strength or dose of any medicine which may be prescribed or administered under the plan, and any period of administration or use of any medicine or appliance which may be prescribed or administered under the plan;

(vi) relevant warnings about known sensitivities of the patient to, or known difficulties of the patient with, particular medicines or appliances;

(vii) the arrangements for notification of–

(aa) suspected or known adverse reactions to any medicine which may be prescribed or administered under the plan, and suspected or known adverse reactions to any other medicine taken at the same time as any medicine prescribed or administered under the plan; and

(bb) incidents occurring with the appliance which might lead, might have led or has led to the death or serious deterioration of state of health of the patient; and

(viii) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the medical practitioner or dentist who is a party to the plan;

(b) the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any medical practitioner or dentist who is a party to the plan;

(c) if it is a prescription for a medicine, the medicine is not a controlled drug within the meaning of the Misuse of Drugs Act 1971;

(d) if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of primary medical services under a general medical services contract;

(e) if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes in the provision or primary medical services under a general medical services contract unless–

(i) the patient is a person of the specified description;

(ii) the medicine is prescribed for that patient only for the specified purposes; and

(iii) when giving the prescription, the supplementary prescriber endorses the face of the form with the reference SLS;

(f) if it is a prescription for a medicine–

(i) the medicine is the subject of a product licence, a marketing authorisation or a homeopathic certificate of registration granted by the licensing authority or the European Commission; or

(ii) subject to paragraph (6), the use of the medicine is for the purposes of a clinical trial and–

(aa) that trial is the subject of a clinical trial certificate issued in accordance with the Medicines Act 1968[^f00056]; or

(bb) a clinical trial certificate is not needed in respect of that trial by virtue of any exemption conferred by or under that Act;

(g) if it is a prescription for an appliance, the appliance is listed in Parts 2 to 6 or 8 to 10 of the Drug Tariff; and

(h) if it is a prescription for a restricted availability appliance–

(i) the patient is a person of a description mentioned in the entry in Part 3 of the Drug Tariff in respect of that appliance;

(ii) the appliance is prescribed only for the purposes specified in respect of that person in that entry; and

(iii) when giving the prescription, the supplementary prescriber endorses the face of the form with the reference “SLS”.

(5) In sub-paragraph (4)(a), “clinical management plan” means a plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by–

(a) the patient to whom the plan relates;

(b) the medical practitioner or dentist who is a party to the plan; and

(6) In relation to any time from the coming into force of any regulations made by the Secretary of State under section 2(2) of the European Communities Act 1972 (general implementation of treaties)[^f00057] to implement Directive 2001/83/EC on the Community code relating to medicinal products for human use[^f00058], sub-paragraph (4)(f)(ii) shall be read as if it referred to a clinical trial which has been authorised, or is treated as having been authorised by the licensing authority for the purposes of those regulations.

Excessive prescribing

14

(1) The provider shall not prescribe drugs, medicines or appliances whose cost or quantity, in relation to any patient, is, by reason of the character of the drug, medicine or appliance in question in excess of that which was reasonably necessary for the proper treatment of that patient.

(2) In considering whether a provider has breached its obligations under sub-paragraph (1), the Health Board shall seek the views of the area medical committee for its area.

Provision of dispensing services

15

(1) A provider may secure the provision of dispensing services to its patients under the agreement only if it is authorised or required to do so by the Health Board in accordance with the following provisions of this paragraph.

(2) Where the Health Board is satisfied, after consultation with the area pharmaceutical committee that a person, by reason of–

(a) distance;

(b) inadequacy of means of communication; or

will have serious difficulty in obtaining from a pharmacist any drugs, medicines or appliances, other than Scheduled drugs, required for that person’s treatment, the Health Board shall require or authorise the provider with whom the person is a registered patient to supply such drugs, medicines and appliances to that person until further notice.

(3) Notwithstanding anything in sub-paragraph (2)–

(a) a provider shall not be required to undertake the supply of drugs, medicines and appliances under sub-paragraph (2) if the provider satisfies the Health Board that the provider is not in the habit of dispensing drugs, medicines and appliances for the provider’s patients;

(b) a provider shall be entitled to receive reasonable notice from the Health Board that the provider is required to undertake the supply of drugs, medicines and appliances under sub-paragraph (2) or that such apply is to be discontinued.

(4) Subject to sub paragraph (6), a provider, who is required by the Health Board to supply drugs, medicines and appliances under sub-paragraph (2) to a patient, in the course of treating that patient under these Regulations–

(a) shall, subject to sub-paragraph (7), record on a prescription form completed in accordance with paragraph 11, an order for supply of any drugs, medicines or appliances which are needed for the treatment of that patient, but shall not be required to issue that form to that patient;

(b) shall supply those drugs, medicines or appliances for that patient under sub paragraph (2) but–

(i) shall not supply under sub paragraph (2) for that patient any Scheduled drug specified as being a drug, medicine or other substance which may not be ordered for patients in the provision of primary medical services under a general medical services contract, except that, where the provider has ordered a drug which has an appropriate non proprietary name either by that name or by its formula, the provider may supply a drug which has the same specification notwithstanding that it is such a Scheduled drug (but, in the case of a drug which combines more than one drug, only if the combination has an appropriate non proprietary name);

(ii) shall supply under sub paragraph (2) for that patient any Scheduled drug specified as being a drug, medicine or other substance which may only be ordered for specific patients and purposes in the provision of primary medical services under a general medical services contract, only where—

(aa) that patient is a person of the specified description; and

(bb) that drug, medicine or other substance is supplied to that patient only for the specified purpose;

(iii) shall supply under sub paragraph (2) for that patient a restricted availability appliance only if it is for a patient in a category of person or a purpose specified in the Drug Tariff;

(c) may supply for that patient with the provider’s consent, in respect of that treatment but otherwise than under sub paragraph (2), any Scheduled drug.

(5) A provider shall comply with any arrangements made by the Scottish Ministers, or made by the Health Board after consultation with the area medical committee and the area pharmaceutical committee and approved by the Scottish Ministers, under which the provider may obtain and have available any drugs, medicines or appliances which the provider is required or entitled to supply in terms of this paragraph.

(6) Sub paragraph (4) does not apply to drugs, medicines or appliances ordered on a prescription form by a supplementary prescriber or an independent nurse prescriber.

(7) Where a patient presents an order on a prescription form for listed drugs or medicines, or appliances, signed by a supplementary prescriber or an independent nurse prescriber, to a provider who is required under sub paragraph (2) to provide drugs or appliances to that patient, the provider may provide to the patient such drugs, medicines or appliances so ordered as the provider supplies in the normal course of the provider’s practice.

(8) A drug supplied by a provider unless administered in person shall be supplied in a suitable container.

(9) Before supplying the drugs, medicines or appliances recorded on a prescription form in accordance with sub paragraph (4) or providing the drugs or medicines or appliances ordered on a prescription form signed by a supplementary prescriber or an independent nurse prescriber in accordance with sub paragraph (7) a provider who is required by the Health Board under sub paragraph (2) to provide drugs, medicines or appliances to a patient shall request any person who makes a declaration on the prescription form claiming either charge exemption under regulation 7 of the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2001[^f00059] (“the 2001 Regulations”) or charge remission under the National Health Service (Travelling Expenses and Remission of Charges) (Scotland) (No 2) Regulations 2003[^f00060] to provide evidence of the patient’s entitlement to such exemption or remission.

(10) Sub paragraph (9) shall not apply in respect of claims for exemption under regulation 7(1)(a) to (f) of the 2001 Regulations where the dispensing provider has information in the provider’s possession at the time of supplying the item which confirms that the patient is entitled to the exemption claimed.

(11) Where the person presenting the prescription form does not show valid evidence of entitlement and the dispensing provider, in respect of a claim for exemption made under regulation 7(1)(a) to (f) of the 2001 Regulations does not have evidence in the contractor’s possession to confirm that the patient is entitled to make that claim, the dispensing provider shall mark the patient’s prescription form accordingly before supplying the prescribed item.

(12) The provisions of regulation 22 apply in respect of the provision of any drugs, medicines or appliances by a provider providing dispensing services as they apply in respect of prescriptions for drugs, medicines or appliances.

(13) Nothing in this paragraph shall prevent a provider providing a Scheduled drug or a restricted availability appliance in the course of treating a patient under a private arrangement.

Provision of drugs, medicines and appliances for immediate treatment or personal administration

16

(1) Subject to sub-paragraph (2), a provider–

(a) shall provide to a patient any drug, medicine or appliance, not being a Scheduled drug, where such provision is needed for the immediate treatment of that patient before a provision can otherwise be obtained; and

(b) may provide to a patient any drug, medicine or appliance, not being a Scheduled drug, which the provider personally administers or applies to that patient,

but shall, in either case, provide a restricted availability appliance only if it is for a person or a purpose specified in the Drug Tariff.

(2) Nothing in sub-paragraph (1) authorises a person to supply any drug or medicine to a patient otherwise than in accordance with Part 3 of the Medicines Act 1968[^f00061] or any regulations or orders made thereunder.

PART 4 — PERSONS WHO PERFORM SERVICES

Qualifications of performers

17

(1) Subject to sub-paragraph (2), no medical practitioner shall perform medical services under the agreement unless the practitioner is–

(a) included in the primary medical services performers list for the Health Board which is under a duty to provide or secure the provision of the service to be performed;

(b) not suspended from that list or from the Medical Register; and

(2) Sub-paragraph (1) shall not apply in the case of–

(a) a medical practitioner employed in Scotland by a Health Board, in England and Wales by a NHS trust, a NHS foundation trust, or in Northern Ireland by a Health and Social Services trust who is providing services other than primary medical services at the practice premises;

(b) a person who is provisionally registered under section 15 (provisional registration), 15A (provisional registration for EEA nationals) or 21 (provisional registration) of the Medical Act 1983[^f00063] acting in the course of the person’s employment in a resident medical capacity in an approved medical practice; or

Qualifications of performers

18

No health care professional other than one to whom paragraph 17 applies shall perform clinical services under the agreement unless the health care professional is appropriately registered with the health care professional’s relevant professional body and the health care professional’s registration is not currently suspended.

Qualifications of performers

19

Where the registration of a health care professional or, in the case of a medical practitioner, the practitioner’s inclusion in a list, is subject to conditions, the provider shall ensure compliance with those conditions insofar as they are relevant to the agreement.

Qualifications of performers

20

No health care professional shall perform any clinical services unless the health care professional has such clinical experience and training as are necessary to enable the health care professional properly to perform such services.

Conditions for employment and engagement

21

(1) Subject to sub-paragraphs (2) and (3), a provider shall not employ or engage a medical practitioner (other than one falling within paragraph 17(2)) unless–

(a) that practitioner has provided the provider with the name and address of the Health Boards on whose primary medical services performers lists the practitioner appears; and

(b) the provider has checked that the practitioner meets the requirements in paragraph 17.

(2) Where the employment or engagement of a medical practitioner is urgently needed and it is not possible for the provider to check the matters referred to in paragraph 17 in accordance with sub-paragraph (1)(b) before employing or engaging the practitioner, the practitioner may be employed or engaged on a temporary basis for a single period of up to 7 days whilst such checks are undertaken.

(3) Where the prospective employee is a GP Registrar, the requirements set out in sub paragraph (1) shall apply with the modifications that–

(a) the name and address provided under sub-paragraph (1) may be the name and address of the Health Boards on whose primary medical services performers lists the GP Registrar has applied for inclusion; and

(b) confirmation that the GP Registrar’s name appears on those lists shall not be required until the end of the first two months of the GP Registrar’s training period.

Conditions for employment and engagement

22

(1) A provider shall not employ or engage–

(a) a health care professional (other than one to whom paragraph 17 applies) unless the provider has checked that the health care professional meets the requirements in paragraph 18;

(b) a health care professional to perform clinical services unless the provider has taken reasonable steps to satisfy the provider that the health care professional meets the requirements in paragraph 20.

(2) Where the employment or engagement of a health care professional is urgently needed and it is not possible to check the matters referred to in paragraph 18 in accordance with sub paragraph (1) before employing or engaging the health care professional, the health care professional may be employed or engaged on a temporary basis for a single period of up to 7 days whilst such checks are undertaken.

(3) When considering a health care professional’s experience and training for the purposes of sub-paragraph (1)(b) the provider shall have regard in particular to–

(a) any post-graduate or post-registration qualification held by the health care professional; and

(b) any relevant training undertaken by the health care professional and any relevant clinical experience gained by the health care professional.

Conditions for employment and engagement

23

(1) The provider shall not employ or engage a health care professional to perform medical services under the contract unless–

(a) that person has provided two clinical references, relating to two recent posts (which may include any current post) as a health care professional which lasted for three months without a significant break, or where this is not possible, a full explanation and alternative referees; and

(b) the provider has checked and is satisfied with the references.

(2) Where the employment or engagement of a medical practitioner is urgently needed and it is not possible to obtain and check the references in accordance with sub-paragraph (1)(b) before employing or engaging the practitioner, the practitioner may be employed or engaged on a temporary basis for a single period of up to 14 days whilst the practitioner’s references are checked and considered, and for an additional single period of a further 7 days if the provider believes the person supplying those references is ill, on holiday or otherwise temporarily unavailable.

(3) Where the provider employs or engages the same person on more than one occasion within a period of three months, it may rely on the references provided on the first occasion, provided that those references are not more than twelve months old.

Conditions for employment and engagement

24

(1) Before employing or engaging any person to assist the provider in the provision of services under the agreement, the provider shall take reasonable care to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which the person is to be employed or engaged.

(2) The duty imposed by sub-paragraph (1) is in addition to the duties imposed by paragraphs 21 to 23.

(3) When considering the competence and suitability of any person for the purpose of sub paragraph (1), the provider shall have regard, in particular, to–

(a) that person’s academic and vocational qualifications;

(b) the person’s education and training; and

Training

25

The provider shall ensure that for any health care professional who is–

(a) performing clinical services under the agreement; or

(b) employed or engaged to assist in the performance of such services,

has in place arrangements for the purpose of maintaining and updating the health care professional’s skills and knowledge in relation to the services which the health care professional is performing or assisting in performing.

Training

26

The provider shall afford to each employee reasonable opportunities to undertake appropriate training with a view to maintaining that employee’s competence.

Arrangements for GP registrars

27

(1) The provider shall only employ a GP Registrar for the purpose of being trained by a GP Trainer with the agreement of the Scottish Ministers and subject to the conditions in sub paragraph (2).

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.