National Health Service Act 2006

Part 1Promotion and provision of the health service in England

The Secretary of State and the health service in England

1Secretary of State’s duty to promote health service

(1)The Secretary of State must continue the promotion in England of a comprehensive health service designed to secure improvement—

(a)in the physical and mental health of the people of England, and

(b)in the prevention, diagnosis and treatment of illness.

(2)The Secretary of State must for that purpose provide or secure the provision of services in accordance with this Act.

(3)The services so provided must be free of charge except in so far as the making and recovery of charges is expressly provided for by or under any enactment, whenever passed.

General power to provide services

2Secretary of State’s general power

(1)The Secretary of State may—

(a)provide such services as he considers appropriate for the purpose of discharging any duty imposed on him by this Act, and

(b)do anything else which is calculated to facilitate, or is conducive or incidental to, the discharge of such a duty.

(2)Subsection (1) does not affect—

(a)the Secretary of State’s powers apart from this section,

(b)Chapter 1 of Part 7 (pharmaceutical services).

Provision of particular services

3Secretary of State’s duty as to provision of certain services

(1)The Secretary of State must provide throughout England, to such extent as he considers necessary to meet all reasonable requirements—

(a)hospital accommodation,

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

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

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

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

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

(2)For the purposes of the duty in subsection (1), services provided under—

(a)section 83(2) (primary medical services), section 99(2) (primary dental services) or section 115(4) (primary ophthalmic services), or

(b)a general medical services contract, a general dental services contract or a general ophthalmic services contract,

must be regarded as provided by the Secretary of State.

(3)This section does not affect Chapter 1 of Part 7 (pharmaceutical services).

4High security psychiatric services

(1)The Secretary of State’s duty under section 1 includes a duty to provide hospital accommodation and services for persons who—

(a)are liable to be detained under the Mental Health Act 1983 (c. 20), and

(b)in the opinion of the Secretary of State require treatment under conditions of high security on account of their dangerous, violent or criminal propensities.

(2)The hospital accommodation and services mentioned in subsection (1) are referred to in this section and paragraph 15 of Schedule 4 (NHS trusts) as “high security psychiatric services”.

(3)High security psychiatric services may be provided only at hospital premises at which services are provided only for the persons mentioned in subsection (1).

(4)“Hospital premises” means—

(a)a hospital, or

(b)any part of a hospital which is treated as a separate unit.

5Other services

Schedule 1 makes further provision about the Secretary of State and services under this Act.

Provision of services otherwise than in England

6Performance of functions outside England

(1)The Secretary of State may provide or secure the provision of anything mentioned in section 3(1) outside England.

(2)The Secretary of State’s functions may be performed outside England and Wales, in so far as they relate to—

(a)holidays for patients,

(b)the transfer of patients to or from Scotland, Northern Ireland, the Isle of Man or the Channel Islands, or

(c)the return of patients who have received treatment in England and Wales, to countries or territories outside the British Islands (including for this purpose the Republic of Ireland).

Exercise and distribution of functions

7Distribution of health service functions

(1)The Secretary of State may direct a Strategic Health Authority, a Primary Care Trust or a Special Health Authority to exercise any of his functions relating to the health service which are specified in the directions.

(2)The Secretary of State may direct a Special Health Authority to exercise any functions of a Strategic Health Authority or a Primary Care Trust which are specified in the directions.

(3)The functions which may be specified in directions include functions under enactments relating to mental health and care homes.

8Secretary of State’s directions to health service bodies

(1)The Secretary of State may give directions to any of the bodies mentioned in subsection (2) about its exercise of any functions.

(2)The bodies are—

(a)Strategic Health Authorities,

(b)Primary Care Trusts,

(c)NHS trusts, and

(d)Special Health Authorities.

(3)Nothing in provision made by or under this or any other Act affects the generality of subsection (1).

NHS contracts

9NHS contracts

(1)In this Act, an NHS contract is an arrangement under which one health service body (“the commissioner”) arranges for the provision to it by another health service body (“the provider”) of goods or services which it reasonably requires for the purposes of its functions.

(2)Section 139(6) (NHS contracts and the provision of local pharmaceutical services under pilot schemes) makes further provision about acting as commissioner for the purposes of subsection (1).

(3)Paragraph 15 of Schedule 4 (NHS trusts and NHS contracts) makes further provision about an NHS trust acting as provider for the purposes of subsection (1).

(4)“Health service body” means any of the following—

(a)a Strategic Health Authority,

(b)a Primary Care Trust,

(c)an NHS trust,

(d)a Special Health Authority,

(e)a Local Health Board,

(f)a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978 (c. 29),

(g)a Health and Social Services Board constituted under the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)),

(h)the Common Services Agency for the Scottish Health Service,

(i)the Wales Centre for Health,

(j)the Health Protection Agency,

(k)the Commission for Healthcare Audit and Inspection,

(l)the Scottish Dental Practice Board,

(m)the Secretary of State,

(n)the Welsh Ministers,

(o)the Northern Ireland Central Services Agency for the Health and Social Services established under the Health and Personal Social Services (Northern Ireland) Order 1972,

(p)a special health and social services agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990 (S.I. 1990/247 (N.I.3)),

(q)a Health and Social Services trust established under the Health and Personal Social Services (Northern Ireland) Order 1991 (S.I. 1991/194 (N.I.1)),

(r)the Department of Health, Social Services and Public Safety.

(5)Whether or not an arrangement which constitutes an NHS contract would apart from this subsection be a contract in law, it must not be regarded for any purpose as giving rise to contractual rights or liabilities.

(6)But if any dispute arises with respect to such an arrangement, either party may refer the matter to the Secretary of State for determination under this section.

(7)If, in the course of negotiations intending to lead to an arrangement which will be an NHS contract, it appears to a health service body—

(a)that the terms proposed by another health service body are unfair by reason that the other is seeking to take advantage of its position as the only, or the only practicable, provider of the goods or services concerned or by reason of any other unequal bargaining position as between the prospective parties to the proposed arrangement, or

(b)that for any other reason arising out of the relative bargaining position of the prospective parties any of the terms of the proposed arrangement cannot be agreed,

that health service body may refer the terms of the proposed arrangement to the Secretary of State for determination under this section.

(8)Where a reference is made to the Secretary of State under subsection (6) or (7), he may determine the matter himself or appoint a person to consider and determine it in accordance with regulations.

(9)“The appropriate person” means the Secretary of State or the person appointed under subsection (8).

(10)By the determination of a reference under subsection (7) the appropriate person may specify terms to be included in the proposed arrangement and may direct that it be proceeded with.

(11)A determination of a reference under subsection (6) may contain such directions (including directions as to payment) as the appropriate person considers appropriate to resolve the matter in dispute.

(12)The appropriate person may by the determination in relation to an NHS contract vary the terms of the arrangement or bring it to an end (but this does not affect the generality of the power of determination under subsection (6)).

(13)Where an arrangement is so varied or brought to an end—

(a)subject to paragraph (b), the variation or termination must be treated as being effected by agreement between the parties, and

(b)the directions included in the determination by virtue of subsection (11) may contain such provisions as the appropriate person considers appropriate in order to give effect to the variation or to bring the arrangement to an end.

10Provision for bodies in Northern Ireland

(1)Subsection (2) applies where a Health and Social Services Board constituted under the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)) or a body mentioned in paragraph (o), (p), (q) or (r) of section 9(4) is a party or prospective party to an arrangement or proposed arrangement which—

(a)falls within the definition of NHS contract in section 9(1), and

(b)also falls within the definition of HSS contract in Article 8 of the Health and Personal Social Services (Northern Ireland) Order 1991 (S.I. 1991/194 (N.I.1)).

(2)Subsections (5) to (13) of section 9 apply in relation to the arrangement or proposed arrangement with the substitution for references to the Secretary of State of references to the Secretary of State and the Department of Health, Social Services and Public Safety acting jointly.

11Arrangements to be treated as NHS contracts

(1)This section applies to any arrangement under which a Strategic Health Authority, a Primary Care Trust or such other health service body as may be prescribed arrange for the provision to it—

(a)by a contractor under a general ophthalmic services contract,

(b)by a person on an ophthalmic list,

(c)by a person on a pharmaceutical list, or

(d)by a person who has entered into a pharmaceutical care services contract under section 17Q of the National Health Service (Scotland) Act 1978 (c. 29),

of the goods or services mentioned in subsection (2).

(2)The goods or services are those that the body reasonably requires for the purposes of its functions, other than functions under—

(a)section 115 (primary ophthalmic services),

(b)Chapter 1 or 2 of Part 7 (pharmaceutical services and local pharmaceutical services under pilot schemes), or

(c)Part 6 of, or Chapter 1 or 2 of Part 7 of, the National Health Service (Wales) Act 2006 (c. 42) (general ophthalmic services and pharmaceutical services and local pharmaceutical services under pilot schemes).

(3)Any such arrangement must be treated as an NHS contract for the purposes of section 9 (other than subsections (7) and (10)).

(4)“Health service body” means a body which is a health service body for the purposes of section 9.

(5)“Ophthalmic list” means a list published in accordance with regulations made under—

(a)section 72(1)(a) of the National Health Service (Wales) Act 2006,

(b)section 26(2)(a) of the National Health Service (Scotland) Act 1978, or

(c)Article 62(2)(a) of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)).

(6)The reference to a list published in accordance with regulations made under paragraph (a) of section 26(2) of the National Health Service (Scotland) Act 1978 is a reference to the first part of the list (referred to in sub-paragraph (i) of that paragraph) which is published in accordance with regulations under that paragraph.

(7)“Pharmaceutical list” includes a list published in accordance with regulations made under—

(a)section 83(2)(a) of the National Health Service (Wales) Act 2006, or

(b)Article 63(2A)(a) of the Health and Personal Social Services (Northern Ireland) Order 1972.

Provision of services otherwise than by the Secretary of State

12Secretary of State’s arrangements with other bodies

(1)The Secretary of State may arrange with any person or body to provide, or assist in providing, any service under this Act.

(2)Arrangements may be made under subsection (1) with voluntary organisations.

(3)The Secretary of State may make available any facilities provided by him for any service under this Act—

(a)to any person or body carrying out any arrangements under subsection (1), or

(b)to any voluntary organisation eligible for assistance under section 64 or section 65 of the Health Services and Public Health Act 1968 (c. 46).

(4)Where facilities are made available under subsection (3), the Secretary of State may make available the services of any person employed in connection with the facilities by—

(a)the Secretary of State,

(b)a Strategic Health Authority,

(c)a Primary Care Trust,

(d)a Special Health Authority, or

(e)a Local Health Board.

(5)Powers under this section may be exercised on such terms as may be agreed, including terms as to the making of payments by or to the Secretary of State.

(6)Goods or materials may be made available either temporarily or permanently.

(7)Any power to supply goods or materials under this section includes—

(a)a power to purchase and store them, and

(b)a power to arrange with third parties for the supply of goods or materials by those third parties.

Part 2Health service bodies

Chapter 1Strategic Health Authorities

13Strategic Health Authorities

(1)The Strategic Health Authorities established by the Secretary of State continue in existence.

(2)But the Secretary of State may by order—

(a)vary the area in England for which a Strategic Health Authority is established,

(b)abolish a Strategic Health Authority,

(c)establish a new Strategic Health Authority for an area in England,

(d)change the name by which a Strategic Health Authority is known.

(3)A Strategic Health Authority is called such name, in addition to the title “Strategic Health Authority”, as—

(a)appears to the Secretary of State appropriately to signify the connection of the authority with the area for which it is established, and

(b)is specified in the order establishing the authority or in an order changing the name by which the authority is known.

(4)No order may be made under this section until after the completion of such consultation as may be prescribed.

(5)Consultation requirements in regulations under subsection (4) are in addition to, and not in substitution for, any other consultation requirements which may apply.

(6)The Secretary of State must act under this section so as to ensure that the areas for which Strategic Health Authorities are at any time established together comprise the whole of England.

(7)The power under section 272(8) to make incidental or supplemental provision includes, in particular, in its application to orders made under this section, power to make provision for the transfer of staff, property and liabilities.

(8)The liabilities which may be transferred by virtue of this section and section 272(8) to a relevant transferee on the abolition of a Strategic Health Authority include criminal liabilities.

(9)“Relevant transferee” means—

(a)another Strategic Health Authority,

(b)a Primary Care Trust,

(c)an NHS trust,

(d)a Special Health Authority, or

(e)an NHS foundation trust.

(10)Schedule 2 makes further provision about Strategic Health Authorities.

14Exercise of Strategic Health Authority functions

(1)This section applies to functions exercisable by a Strategic Health Authority under or by virtue of this Act (including this section) or any prescribed provision of any other Act.

(2)Regulations may provide for any of the functions to be exercised—

(a)by another Strategic Health Authority,

(b)by a Special Health Authority, or

(c)jointly with any one or more of the bodies mentioned in subsection (3).

(3)The bodies are—

(a)Primary Care Trusts,

(b)Local Health Boards,

(c)other Strategic Health Authorities.

(4)Regulations may provide—

(a)for any functions to which this section applies to be exercised, on behalf of the Strategic Health Authority by whom they are exercisable, by a committee, sub-committee or officer of the Strategic Health Authority,

(b)for any functions exercisable jointly under subsection (2)(c) to be exercised, on behalf of the health service bodies in question, by a joint committee or joint sub-committee.

15Strategic Health Authorities' directions

(1)A Strategic Health Authority may, in relation to any specified function of the Strategic Health Authority, direct a Primary Care Trust any part of whose area falls within the Strategic Health Authority’s area to exercise the function.

(2)But a Strategic Health Authority may not so direct a Primary Care Trust in relation to any functions of the Strategic Health Authority arising under section 92 arrangements or section 107 arrangements if the Primary Care Trust is providing any services in accordance with those arrangements.

(3)The Secretary of State may direct Strategic Health Authorities that specified functions of theirs—

(a)are exercisable, or exercisable to (or only to) any specified extent, by Primary Care Trusts, or

(b)are not exercisable by Primary Care Trusts,

and that the power in subsection (1) must be exercised accordingly.

(4)Directions under subsection (3)(a) may include directions that any of the specified functions must be exercised (or exercised to, or only to, any specified extent) jointly with the Strategic Health Authority, or jointly by two or more Primary Care Trusts.

(5)But such directions may be given only if regulations providing for the joint exercise of those functions have been made under section 14 or 19.

(6)“Specified” means specified in the directions.

16Section 92 arrangements and section 107 arrangements

(1)Each Strategic Health Authority must, in accordance with regulations, perform such functions in relation to section 92 arrangements and section 107 arrangements as may be prescribed.

(2)The regulations may, in particular—

(a)prescribe functions in relation to training,

(b)provide for appeals to the Secretary of State or a prescribed body in relation to prescribed functions.

17Advice for Strategic Health Authorities

Each Strategic Health Authority must make arrangements with a view to securing that it receives advice appropriate for enabling it effectively to exercise the functions exercisable by it from persons with professional expertise relating to the physical or mental health of individuals.

Chapter 2Primary Care Trusts

18Primary Care Trusts

(1)The Primary Care Trusts established by the Secretary of State continue in existence.

(2)But the Secretary of State may by order (a “PCT order”)—

(a)vary the area in England for which a Primary Care Trust is established,

(b)abolish a Primary Care Trust,

(c)establish a new Primary Care Trust for the area in England specified in the order with a view to it exercising functions in relation to the health service.

(3)The Secretary of State must act under this section so as to ensure that the areas for which Primary Care Trusts are at any time established together comprise the whole of England.

(4)A Primary Care Trust must exercise its functions in accordance with any prohibitions or restrictions in a PCT order relating to it.

(5)If any consultation requirements apply, they must be complied with before a PCT order is made.

(6)“Consultation requirements” means requirements about consultation contained in regulations.

(7)Regulations must impose requirements about consultation where a PCT order establishes a Primary Care Trust.

(8)Schedule 3 makes further provision about Primary Care Trusts.

19Exercise of Primary Care Trust functions

(1)This section applies to functions exercisable by a Primary Care Trust under or by virtue of this Act (including this section) or any prescribed provision of any other Act.

(2)Regulations may provide for any functions to which this section applies to be exercised—

(a)by another Primary Care Trust,

(b)by a Special Health Authority, or

(c)jointly with any one or more of the bodies mentioned in subsection (3).

(3)The bodies are—

(a)Strategic Health Authorities,

(b)NHS trusts,

(c)Local Health Boards, and

(d)other Primary Care Trusts.

(4)Regulations may provide—

(a)for any functions to which this section applies to be exercised, on behalf of the Primary Care Trust by whom they are exercisable, by a committee, sub-committee or officer of the Primary Care Trust,

(b)for any functions which, under this section, are exercisable by a Primary Care Trust jointly with one or more Strategic Health Authorities or other Primary Care Trusts (but not with any NHS trusts) to be exercised, on behalf of the health service bodies in question, by a joint committee or joint sub-committee.

(5)Subsection (6) applies where, by virtue of subsection (2)(b), a Special Health Authority exercises functions of a Primary Care Trust in relation to a general dental services contract.

(6)The Secretary of State may by order make provision for the transfer to the Special Health Authority of the rights and liabilities of the Primary Care Trust under the contract (and for their transfer back to the Primary Care Trust where the Special Health Authority ceases to exercise the functions).

20Strategic Health Authority directions to Primary Care Trusts

(1)A Strategic Health Authority may give directions to a Primary Care Trust about its exercise of any function.

(2)Directions under this section are subject to any directions given under section 8.

21Provision of services etc

(1)A Primary Care Trust may provide services under an agreement under—

(a)section 92 (primary medical services), or

(b)section 107 (primary dental services),

and may do so as a member of a qualifying body (within the meaning given by section 93 or section 108).

(2)A Primary Care Trust may arrange for the provision by it to another health service body of goods or services which are of the same description as those which, at the time of making the arrangement, the Primary Care Trust has power to provide in carrying out its other functions.

(3)A Primary Care Trust may provide premises for the use of persons—

(a)providing pharmaceutical services, or

(b)providing or performing primary medical services, primary dental services or primary ophthalmic services,

on any terms it considers appropriate.

(4)A Primary Care Trust which manages any health service hospital may make accommodation or services available there for patients who give undertakings (or for whom undertakings are given) to pay any charges imposed by the Primary Care Trust in respect of the accommodation or services.

(5)A Primary Care Trust has power to do anything specified in section 7(2) of the Health and Medicines Act 1988 (c. 49) (provision of goods, services etc), other than make accommodation or services available for patients at any health service hospital it manages, for the purpose of making additional income available for improving the health service.

(6)A Primary Care Trust may exercise a power conferred by subsection (4) or (5) only—

(a)to the extent that its exercise does not to any significant extent interfere with the performance by the Primary Care Trust of its functions or of its obligations under NHS contracts or under agreements or arrangements made with NHS foundation trusts, and

(b)in circumstances specified in directions under section 8, with the Secretary of State’s consent.

(7)In this section—

• “health service body” means a body which is a health service body for the purposes of section 9,

• “hospital” includes any establishment or facility managed for the purposes of the health service.

22Administration and management of services

Each Primary Care Trust must, in accordance with regulations—

(a)administer the arrangements made in pursuance of this Act for the provision for its area of primary medical services, primary dental services, primary ophthalmic services, pharmaceutical services and local pharmaceutical services, and

(b)perform such management and other functions relating to those services as may be prescribed.

23Advice for Primary Care Trusts

Each Primary Care Trust must make arrangements with a view to securing that it receives advice appropriate for enabling it effectively to exercise the functions exercisable by it from persons with professional expertise relating to the physical or mental health of individuals.

24Plans for improving health etc

(1)Each Primary Care Trust must, at such times as the Secretary of State may direct, prepare a plan which sets out a strategy for improving—

(a)the health of the people for whom it is responsible, and

(b)the provision of health care to such people.

(2)Each Primary Care Trust must keep under review any plan prepared by it under this section.

(3)Each local authority whose area falls wholly or partly within the area of a Primary Care Trust must participate in the preparation or review by the Primary Care Trust of any plan under this section.

(4)In preparing or reviewing any plan under this section, a Primary Care Trust—

(a)must consult, or seek the participation of, such persons as the Secretary of State may direct, and

(b)may consult, or seek the participation of, such other persons as it considers appropriate.

(5)The Secretary of State may give directions as to—

(a)the periods to be covered by plans under this section,

(b)the action to be taken by Strategic Health Authorities, Primary Care Trusts and local authorities in connection with the preparation or review of plans under this section,

(c)the matters to be taken into account in connection with the preparation or review of plans under this section,

(d)the matters to be dealt with by plans under this section,

(e)the form and content of plans under this section,

(f)the publication of plans prepared or reviewed under this section,

(g)the sharing of information between Strategic Health Authorities, Primary Care Trusts, Local Health Boards and local authorities in connection with the preparation or review of plans under this section or section 17 of the National Health Service (Wales) Act 2006 (c. 42),

(h)the provision by Strategic Health Authorities, Primary Care Trusts and Local Health Boards of reports or other information to the Secretary of State in connection with plans under this section or section 17 of the National Health Service (Wales) Act 2006 (c. 42).

(6)In exercising its functions—

(a)a Primary Care Trust must have regard to any plan prepared or reviewed by it, and to any plan in relation to which it has participated by virtue of subsection (4).

(b)a Strategic Health Authority must have regard to any plan prepared or reviewed by a Primary Care Trust any part of whose area falls within its area, and

(c)a local authority must have regard to any plan in relation to which it has participated.

(7)For the purposes of this section, the persons for whom a Primary Care Trust is responsible are—

(a)the people in the area of the Primary Care Trust, and

(b)such of the people outside the area as may be specified in directions given by the Secretary of State.

(8)“Health care” means—

(a)services provided to individuals for or in connection with the prevention, diagnosis or treatment of illness, and

(b)the promotion and protection of public health.

Chapter 3NHS trusts

25NHS trusts

(1)The Secretary of State may by order establish bodies, called National Health Service trusts (“NHS trusts”), to provide goods and services for the purposes of the health service.

(2)An order under subsection (1) is referred to in this Act as “an NHS trust order”.

(3)No NHS trust order may be made until after the completion of such consultation as may be prescribed.

(4)Schedule 4 makes further provision about NHS trusts.

26General duty of NHS trusts

An NHS trust must exercise its functions effectively, efficiently and economically.

27Financial provisions relating to NHS trusts

Schedule 5 makes provision about the financing of NHS trusts.

Chapter 4Special Health Authorities

28Special Health Authorities

(1)The Secretary of State may by order establish special bodies for the purpose of exercising any functions which may be conferred on them by or under this Act.

(2)The Secretary of State may make such further provision relating to a body established under subsection (1) as he considers appropriate.

(3)A body established under this section is called a Special Health Authority.

(4)An order may, in particular, contain provisions as to—

(a)the membership of the body established by the order,

(b)the transfer to the body of officers, property and liabilities, and

(c)the name of the body.

(5)The liabilities which may be transferred by virtue of this section, section 272(8) and section 273(1) to an NHS body on the abolition of a Special Health Authority include criminal liabilities.

(6)In this Act (apart from in Schedule 15) “NHS body” means—

(a)a Strategic Health Authority,

(b)a Primary Care Trust,

(c)an NHS trust,

(d)a Special Health Authority,

(e)an NHS foundation trust, and

(f)a Local Health Board.

(7)The Secretary of State must, before he makes an order under this section, consult with respect to the order such bodies as he may recognise as representing officers who in his opinion are likely to be transferred or affected by transfers in pursuance of the order.

(8)Schedule 6 makes further provision about Special Health Authorities.

29Exercise of Special Health Authority functions

(1)Regulations may provide for any functions which are exercisable by a Special Health Authority under section 7 to be exercised—

(a)by another Special Health Authority, or

(b)jointly with one or more other Special Health Authorities.

(2)Regulations may provide—

(a)for any functions which are exercisable by a Special Health Authority under section 7, section 14, section 19 or this section to be exercised on behalf of that Special Health Authority by a committee, sub-committee or officer of the Special Health Authority,

(b)for any functions exercisable jointly under subsection (1)(b) to be exercised, on behalf of the Special Health Authorities in question, by a joint committee or joint sub-committee.

Chapter 5NHS foundation trusts

Introductory

30NHS foundation trusts

(1)An NHS foundation trust is a public benefit corporation which is authorised under this Chapter to provide goods and services for the purposes of the health service in England.

(2)A public benefit corporation is a body corporate which, in pursuance of an application under this Chapter, is constituted in accordance with Schedule 7.

31Independent Regulator of NHS Foundation Trusts

(1)There continues to be a body corporate known as the Independent Regulator of NHS Foundation Trusts (referred to in this Act as “the regulator”).

(2)Schedule 8 makes further provision about the regulator.

32General duty of regulator

The regulator must exercise its functions in a manner consistent with the performance by the Secretary of State of his duties under sections 1, 3 and 258.

Authorisation

33Applications by NHS trusts

(1)An NHS trust may make an application to the regulator for authorisation to become an NHS foundation trust, if the application is supported by the Secretary of State.

(2)The application must—

(a)describe the goods and services which the applicant proposes should be provided by the NHS foundation trust, and

(b)be accompanied by a copy of the proposed constitution of the NHS foundation trust,

and must give any further information which the regulator requires the applicant to give.

(3)The applicant may modify the application with the agreement of the regulator at any time before authorisation is given under section 35.

(4)Once an NHS trust has made the application—

(a)the provisions of the proposed constitution which give effect to paragraphs 3 to 19 of Schedule 7 have effect, but only for the purpose of establishing the initial membership of the NHS foundation trust and of the board of governors, and the initial directors, and enabling the board of governors and board of directors to make preparations for the performance of their functions,

(b)the NHS trust may do anything (including the things mentioned in paragraph 14 of Schedule 4) which appears to it to be necessary or expedient for the purpose of preparing it for NHS foundation trust status.

34Other applications

(1)An application may be made to the regulator by persons (other than an NHS trust) to be incorporated as a public benefit corporation and authorised to become an NHS foundation trust, if the application is supported by the Secretary of State.

(2)The application must—

(a)describe the goods and services which the applicants propose should be provided by the NHS foundation trust, and

(b)be accompanied by a copy of the proposed constitution of the NHS foundation trust,

and must give any further information which the regulator requires the applicants to give.

(3)If it appears to the regulator that—

(a)provision of the goods and services described in the application is likely to assist in the performance of the duties mentioned in section 32,

(b)the trust as proposed to be constituted will be able to provide those goods and services, and

(c)the proposed constitution accords with Schedule 7 and is otherwise appropriate,

the regulator may issue a certificate of incorporation.

(4)The applicants may modify the application with the agreement of the regulator at any time before the certificate is issued.

(5)On the issue of the certificate, the applicants are incorporated as a public benefit corporation.

(6)The certificate is conclusive evidence of incorporation.

(7)Once the certificate has been issued—

(a)the proposed constitution has effect, but the applicants may exercise the functions of the corporation on its behalf until a board of directors is appointed in accordance with the constitution,

(b)the corporation may do anything (including the things mentioned in section 47) which appears to it to be necessary or expedient for the purpose of preparing it for NHS foundation trust status.

35Authorisation of NHS foundation trusts

(1)The regulator may give an authorisation under this section—

(a)to an NHS trust which has applied under section 33, or

(b)to a public benefit corporation,

if the regulator is satisfied as to the following matters.

(2)The matters are that—

(a)the applicant’s constitution will be in accordance with Schedule 7 and will otherwise be appropriate,

(b)the applicant has taken steps to secure that (taken as a whole) the actual membership of any public constituency, and (if there is one) of the patients' constituency, will be representative of those eligible for such membership,

(c)there will be a board of governors, and a board of directors, constituted in accordance with the constitution,

(d)the steps necessary to prepare for NHS foundation trust status have been taken,

(e)the applicant will be able to provide the goods and services which the authorisation will require it to provide, and

(f)any other requirements which the regulator considers appropriate are met.

(3)In deciding whether it is satisfied as to the matters referred to in subsection (2)(e), the regulator must consider (among other things)—

(a)any report or recommendation in respect of the applicant made by the Commission for Healthcare Audit and Inspection,

(b)the financial position of the applicant.

(4)The authorisation may be given on any terms the regulator considers appropriate.

(5)The regulator must not give an authorisation unless it is satisfied that the applicant has sought the views about the application of the following—

(a)if the applicant is an NHS trust, the Patients' Forum for the NHS trust and the staff employed by the NHS trust,

(b)individuals who live in any area specified in the proposed constitution as the area for a public constituency,

(c)any local authority that would be authorised by the proposed constitution to appoint a member of the board of governors,

(d)if the proposed constitution provides for a patients' constituency, individuals who would be able to apply to become members of that constituency,

(e)any prescribed persons.

(6)If regulations make provision about consultation, the regulator may not give an authorisation unless it is satisfied that the applicant has complied with the regulations.

(7)The generality of the power in subsection (4) is not affected by the following provisions of this Chapter.

36Effect of authorisation

(1)On an authorisation being given to a body corporate which is an NHS trust—

(a)it ceases to be an NHS trust and becomes an NHS foundation trust,

(b)the proposed constitution has effect, and

(c)any order under section 25(1) is revoked.

(2)On an authorisation being given to a body corporate which is a public benefit corporation, it becomes an NHS foundation trust.

(3)The authorisation is conclusive evidence that the body in question is an NHS foundation trust.

(4)Subsections (1) to (3) do not affect the continuity of the body or of its property or liabilities (including its criminal liabilities).

(5)The validity of any act of an NHS foundation trust is not affected by any vacancy among the directors or by any defect in the appointment of any director.

(6)An NHS foundation trust must not be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown; and an NHS foundation trust’s property must not be regarded as property of, or property held on behalf of, the Crown.

37Amendments of constitution

An NHS foundation trust may make amendments of its constitution with the approval of the regulator.

38Variation of authorisation

(1)The regulator may vary an authorisation.

(2)In deciding whether or not to vary an authorisation, the regulator must have regard (among other things) to—

(a)any report or recommendation made to it by virtue of section 21(2)(f) of the Local Government Act 2000 (c. 22) (overview and scrutiny committees),

(b)any report or recommendation made to it by the Commission for Patient and Public Involvement in Health under section 243(5)(b) or (6).

39Register of NHS foundation trusts

(1)The regulator must continue to maintain a register of NHS foundation trusts.

(2)The register must contain in relation to each NHS foundation trust—

(a)a copy of the current constitution,

(b)a copy of the current authorisation,

(c)a copy of the latest annual accounts and of any report of the auditor on them,

(d)a copy of the latest annual report,

(e)a copy of the latest document sent to the regulator under paragraph 27 of Schedule 7 (forward planning),

(f)a copy of any notice given under section 52 (failing NHS foundation trusts).

(3)In relation to any time before an NHS foundation trust is first required to send an annual report to the regulator, the register must contain a list of the persons who were first elected or appointed as—

(a)the members of the board of governors,

(b)the directors.

(4)Members of the public may inspect the register at any reasonable time.

(5)Any person who requests it must be provided with a copy of, or extract from, any document contained in the register on payment of a reasonable charge.

Financial matters

40Power of Secretary of State to give financial assistance

(1)The Secretary of State may give financial assistance to any NHS foundation trust.

(2)The financial assistance may be given by way of loan, public dividend capital, grant or other payment.

(3)The Secretary of State may guarantee the payment of any amount payable by an NHS foundation trust under an externally financed development agreement.

(4)“Externally financed development agreement” has the same meaning as in paragraph 23 of Schedule 4, reading references in sub-paragraphs (3) and (5) of that paragraph to the NHS trust as references to the NHS foundation trust.

41Prudential borrowing code

(1)The regulator may revise the code made under section 12(1) of the Health and Social Care (Community Health and Standards) Act 2003 (c. 43) for determining the limit on the total amount of the borrowing of any NHS foundation trust.

(2)In revising the code the regulator must have regard (among other things) to any generally accepted principles used by financial institutions to determine the amounts of loans to non profit making bodies.

(3)A body is non profit making if it does not carry on activities for the purpose of making profits for distribution to its members or others.

(4)Before revising the code, the regulator must consult—

(a)the Secretary of State,

(b)each NHS foundation trust,

(c)each NHS trust intending to make an application to become an NHS foundation trust,

(d)such other persons as the regulator considers appropriate.

(5)The regulator must lay a copy of the revised code before Parliament.

42Public dividend capital

(1)Where an NHS trust becomes an NHS foundation trust, the amount which was the public dividend capital of the NHS trust immediately before the giving of the authorisation continues as public dividend capital of the NHS foundation trust held on the same conditions (“initial public dividend capital”), but subject to this section.

(2)Any amount issued to an NHS foundation trust as public dividend capital under section 40 is (like initial public dividend capital) an asset of the Consolidated Fund.

(3)The Secretary of State may, with the consent of the Treasury, decide the terms on which any public dividend capital of an NHS foundation trust must be treated as having been issued.

(4)But the dividend to be paid by the trust must be the same as that payable by NHS trusts in England under paragraph 1(6) of Schedule 5.

(5)Before exercising the power in subsection (3), the Secretary of State must consult the regulator.

(6)Any amount paid to the Secretary of State by an NHS foundation trust by way of repayment of public dividend capital must be paid into the Consolidated Fund.

Functions

43Authorised services

(1)An authorisation must authorise the NHS foundation trust to provide goods and services for purposes related to the provision of health care.

(2)But the authorisation must secure that the principal purpose of the NHS foundation trust is the provision of goods and services for the purposes of the health service in England.

(3)The NHS foundation trust may also carry on activities other than those mentioned in subsection (1), subject to any restrictions in the authorisation, for the purpose of making additional income available in order better to carry on its principal purpose.

(4)The authorisation may require the provision, wholly or partly for the purposes of the health service in England, of goods and services by the NHS foundation trust.

(5)The authorisation must authorise and may require the NHS foundation trust—

(a)to carry out research in connection with the provision of health care,

(b)to make facilities and staff available for the purposes of education, training or research carried on by others,

and, in deciding how to exercise its functions under this subsection in a case where any of the corporation’s hospitals includes a medical or dental school provided by a university, the regulator must have regard to the need to establish and maintain appropriate arrangements within the university.

(6)In deciding whether or not to require the NHS foundation trust to provide, wholly or partly for the purposes of the health service in England, any goods or services the regulator must have regard (among other things) to—

(a)the need for the provision of goods or services in the area in question,

(b)any provision of goods or services by other health service bodies in the area in question,

(c)any other provision by the NHS foundation trust with which the provision of the goods or services is connected,

(d)any agreement or arrangement to which the body corporate which is the NHS foundation trust is or was a party.

(7)Such a requirement as is mentioned in subsection (4) may be framed by reference (among other things) to—

(a)goods or services in general or of a particular description,

(b)goods or services required to meet the needs of health service bodies in general or those of a particular description,

(c)goods or services required to meet the needs of other persons of a particular description,

(d)the volume of goods or services provided,

(e)the place where goods or services are provided,

(f)the period within which goods or services are provided.

44Private health care

(1)An authorisation may restrict the provision, for purposes other than those of the health service in England, of goods and services by an NHS foundation trust.

(2)The power must be exercised, in particular, with a view to securing that the proportion of the total income of an NHS foundation trust which was an NHS trust in any financial year derived from private charges is not greater than the proportion of the total income of the NHS trust derived from such charges in the base financial year.

(3)“Base financial year” means the first financial year throughout which the body corporate was an NHS trust or, if it was an NHS trust throughout the financial year ending with 31st March 2003, that year.

(4)“Private charges” means charges imposed in respect of goods and services provided to patients other than patients being provided with goods and services for the purposes of the health service.

(5)Section 43(7) applies for the purposes of this section.

(6)According to the nature of its functions, an NHS foundation trust may, in the case of patients being provided with goods and services for the purposes of the health service, make accommodation or further services available for patients who give undertakings (or for whom undertakings are given) to pay any charges imposed by the NHS foundation trust in respect of the accommodation or services.

(7)An NHS foundation trust may exercise the power conferred by subsection (6) only to the extent that its exercise does not to any significant extent interfere with the performance by the NHS foundation trust of its functions.

45Protection of property

(1)An NHS foundation trust may not dispose of any protected property without the approval of the regulator.

(2)Disposing of property includes disposing of part of it or granting an interest in it.

(3)Protected property is property of the trust designated as protected in its authorisation.

(4)The regulator may designate property as protected if it considers it is needed—

(a)for the purposes of any goods or services which the authorisation requires the trust to provide wholly or partly for the purposes of the health service in England, or

(b)for the purpose of doing anything which the trust is required to do under section 43(5).

(5)The regulator may give approval under subsection (1) on any terms it considers appropriate.

(6)An NHS foundation trust may not create a floating charge on its property.

46Financial powers

(1)An NHS foundation trust may borrow money for the purposes of or in connection with its functions.

(2)But the total amount of the NHS foundation trust’s borrowing is subject to the limit imposed by its authorisation.

(3)The limit must be reviewed annually by the regulator.

(4)An NHS foundation trust may invest money (other than money held by it as trustee) for the purposes of or in connection with its functions.

(5)The investment may include investment by—

(a)forming, or participating in forming, bodies corporate,

(b)otherwise acquiring membership of bodies corporate.

(6)An NHS foundation trust may give financial assistance (whether by way of loan, guarantee or otherwise) to any person for the purposes of or in connection with its functions.

47General powers

(1)An NHS foundation trust may do anything which appears to it to be necessary or expedient for the purpose of or in connection with its functions.

(2)In particular it may—

(a)acquire and dispose of property,

(b)enter into contracts,

(c)accept gifts of property (including property to be held on trust for the purposes of the NHS foundation trust or for any purposes relating to the health service),

(d)employ staff.

(3)Any power of the NHS foundation trust to pay remuneration and allowances to any person includes power to make arrangements for providing, or securing the provision of, pensions or gratuities (including those payable by way of compensation for loss of employment or loss or reduction of pay).

(4)“The purposes of the NHS foundation trust” means the general or any specific purposes of the trust (including the purposes of any specific hospital at or from which services are provided by the trust).

48Information

(1)An authorisation—

(a)must require an NHS foundation trust to disclose such information to the regulator as the Secretary of State specifies,

(b)may require an NHS foundation trust to disclose other information to the regulator.

(2)The regulator may require any other health service body to disclose any information which the regulator requires for the purposes of its functions.

49Entry and inspection of premises

An authorisation may require an NHS foundation trust to allow the regulator to enter and inspect premises owned or controlled by the trust.

50Fees

An authorisation may require an NHS foundation trust to pay a reasonable annual fee to the regulator.

51Trust funds and trustees

(1)The Secretary of State may by order provide for the appointment of trustees for an NHS foundation trust to hold property on trust—

(a)for the purposes of the NHS foundation trust, or

(b)for any purposes relating to the health service.

(2)The order may—

(a)make provision as to the persons by whom trustees must be appointed and generally as to the method of their appointment,

(b)make any appointment subject to such conditions as may be specified in the order (including conditions requiring the consent of the Secretary of State),

(c)make provision as to the number of trustees to be appointed, including provision under which that number may from time to time be determined by the Secretary of State after consultation with such persons as he considers appropriate,

(d)make provision with respect to the term of office of any trustee and his removal from office.

(3)Where trustees have been appointed for an NHS foundation trust under this section, the Secretary of State may by order provide for the transfer of any trust property from the NHS foundation trust to the trustees.

(4)Where an NHS trust for which trustees have been appointed under paragraph 10 of Schedule 4 is given an authorisation, the order appointing the trustees has effect as an order under this section.

(5)“The purposes of the NHS foundation trust” means the general or any specific purposes of the trust (including the purposes of any specific hospital at or from which services are provided by the trust).

Failure

52Failing NHS foundation trusts

(1)If the regulator is satisfied—

(a)that an NHS foundation trust is contravening, or failing to comply with, any term of its authorisation or any requirement imposed on it under any enactment and that the contravention or failure is significant, or

(b)that an NHS foundation trust has contravened, or failed to comply with, any such term or requirement and is likely to do so again and that the contravention or failure was significant,

the regulator may by a notice to the trust exercise one or more of the powers in subsections (3) and (4).

(2)The regulator may also by a notice to the trust exercise one or more of those powers if the regulator is satisfied that the trust has contravened or failed to comply with a previous notice.

(3)The regulator may require the trust, the directors or the board of governors to do, or not to do, specified things or things of a specified description within a specified period.

(4)The regulator may remove any or all of the directors or members of the board of governors and appoint interim directors or members of the board.

(5)The regulator’s power to remove a director, or member of the board of governors, of the trust includes power to suspend him from office, or to disqualify him from holding office, as a director or member of the board of governors of the trust for a specified period.

53Voluntary arrangements

(1)If the regulator is satisfied that it is necessary or expedient to do so, it may by a notice to an NHS foundation trust require the directors—

(a)to take steps to obtain a moratorium, or

(b)to make a proposal for a voluntary arrangement.

(2)An order may provide for Part 1 of the Insolvency Act 1986 (c. 45) (company voluntary arrangements), including any related provision of that Act, to apply with modifications in relation to NHS foundation trusts.

(3)References in this Chapter to a moratorium are to a moratorium under section 1A of that Act as modified by the order.

(4)References in this Chapter to a voluntary arrangement are to a voluntary arrangement under Part 1 of that Act as modified by the order.

54Dissolution etc

(1)The powers conferred by this section are exercisable where—

(a)an NHS foundation trust contravenes or fails to comply with a notice under section 52 or 53 or the trust’s compliance with a notice under section 53 does not result in the implementation of a voluntary arrangement, and

(b)the regulator considers that further exercise of any of the powers conferred by those sections would not be likely to secure the provision of the goods and services which the authorisation requires the trust to provide.

(2)Before the powers conferred by this section are exercised, the regulator must consult specified persons about specified matters.

(3)“Specified” means specified in an order.

(4)An order may transfer, or provide for the transfer of, any property or liabilities of the trust to—

(a)another NHS foundation trust,

(b)a Primary Care Trust,

(c)an NHS trust,

(d)the Secretary of State.

(5)The liabilities which may be transferred by virtue of subsection (4) to any of the bodies mentioned in paragraphs (a) to (c) of that subsection include criminal liabilities.

(6)Schedule 9 makes provision for the transfer of employees.

(7)An order may provide for the dissolution of the trust.

(8)An order may apply any provision of Part 4 of the Insolvency Act 1986 (c. 45) (winding up of companies), including any related provision of that Act, with modifications.

(9)Where the regulator refuses to give an authorisation to a public benefit corporation—

(a)the powers conferred by this section are also exercisable, and

(b)references in this section and Schedule 9 to an NHS foundation trust are references to the corporation.

55Sections 53 and 54: supplementary

(1)In sections 53 and 54, an order means an order made by the Secretary of State.

(2)The modifications of the Insolvency Act 1986 that may be made by an order include—

(a)provision for securing that the goods and services which the trust is required by the authorisation to provide continue to be provided (whether by the trust or another),

(b)provision for securing the protection of property needed for the purposes of those goods and services.

(3)The power conferred by section 54(3) must be exercised with a view to securing the provision of the goods and services which the authorisation requires the trust to provide.

(4)That power must also be exercised (together, if required, with the power conferred by section 40(2)) with a view to securing that any transfer of property in pursuance of the exercise of the power does not result in a net loss of value to the trust; and the question whether a transfer would result in a net loss of value must be determined in accordance with regulations.

(5)The Insolvency Act 1986 may not be modified under section 54(8) so as to alter the priority of debts or the ranking of debts between themselves.

Mergers

56Mergers

(1)An application may be made jointly by—

(a)an NHS foundation trust, and

(b)another NHS foundation trust or an NHS trust,

to the regulator for authorisation of the dissolution of the trusts and the transfer of some or all of their property and liabilities to a new NHS foundation trust established under this section.

(2)The application must—

(a)be supported by the Secretary of State if one of the parties to it is an NHS trust,

(b)specify the property and liabilities proposed to be transferred to the new NHS foundation trust,

(c)describe the goods and services which it is proposed should be provided by the new trust, and

(d)be accompanied by a copy of the proposed constitution of the new trust,

and must give any further information which the regulator requires the applicants to give.

(3)The applicants may modify the application with the agreement of the regulator at any time before authorisation is given under this section.

(4)The regulator may—

(a)issue a certificate incorporating the directors of the applicants as a public benefit corporation, and

(b)give an authorisation under this section to the corporation to become an NHS foundation trust,

if the regulator is satisfied as to the following matters.

(5)The matters are that—

(a)the constitution of the new trust will be in accordance with Schedule 7 and will otherwise be appropriate,

(b)the applicants have taken steps to secure that (taken as a whole) the actual membership of any public constituency, and (if there is one) of the patients' constituency, will be representative of those eligible for such membership,

(c)the new trust will be able to provide the goods and services which the authorisation will require it to provide, and

(d)any other requirements which the regulator considers appropriate are met.

(6)In deciding whether it is satisfied as to the matters referred to in subsection (5)(c), the regulator must consider (among other things)—

(a)any report or recommendation in respect of either of the applicants made by the Commission for Healthcare Audit and Inspection,

(b)the financial position of the applicants.

(7)The applicants must consult about the application in accordance with regulations.

(8)In the course of the consultation the applicants must seek the views of—

(a)any Patients' Forum for an applicant,

(b)the staff employed by the applicants,

(c)individuals who live in any area specified in the proposed constitution as the area for a public constituency,

(d)any local authority that would be authorised by the proposed constitution to appoint a member of the board of governors,

(e)if the proposed constitution provides for a patients' constituency, individuals who would be able to apply to become members of that constituency,

(f)any prescribed persons.

(9)The regulator may not give an authorisation under this section unless it is satisfied that the applicants have complied with the regulations.

(10)The certificate is conclusive evidence of incorporation; and the authorisation is conclusive evidence that the corporation is an NHS foundation trust.

(11)On an authorisation being given under this section, the proposed constitution of the NHS foundation trust has effect, but the directors of the applicants may exercise the functions of the trust on its behalf until a board of directors is appointed in accordance with the constitution.

57Section 56: supplementary

(1)Where an authorisation is given under section 56, the regulator must specify the property and liabilities to be transferred to the new NHS foundation trust.

(2)Where such an authorisation is given, the Secretary of State must make an order—

(a)dissolving the trusts in question, and

(b)transferring, or providing for the transfer of, the property and liabilities specified by the regulator to the new NHS foundation trust.

(3)The order may—

(a)transfer, or provide for the transfer of, any of the remaining property or liabilities to the persons mentioned in section 54(3),

(b)include provisions corresponding to those of Schedule 9.

(4)In section 56(1) and (2), and subsections (1) and (2) of this section, “liabilities” includes criminal liabilities; and an order under subsection (3) of this section may transfer any remaining criminal liabilities to any of the bodies mentioned in section 54(4)(a) to (c).

(5)Where one of the parties to an application under section 56 is an NHS trust, the powers conferred on the Secretary of State by Part 3 of Schedule 4 are not exercisable in relation to the trust.

(6)Section 35(4) applies to an authorisation under section 56 as it does in relation to an authorisation under that section.

Miscellaneous

58Taxation

Section 61(3) of the National Health Service and Community Care Act 1990 (c. 19) (health service bodies: stamp duty) applies to an NHS foundation trust as it applies to an NHS trust.

59Conduct of elections

(1)Regulations may make provision as to the conduct of elections for membership of the board of governors of an NHS foundation trust.

(2)The regulations may in particular provide for—

(a)nomination of candidates and obligations to declare their interests,

(b)systems and methods of voting, and the allocation of places on the board of governors, at contested elections,

(c)filling of vacancies,

(d)supervision of elections,

(e)elections expenses and publicity,

(f)questioning of elections and the consequences of irregularities.

(3)Regulations under this section may create offences punishable on summary conviction with a maximum fine not exceeding level 4 on the standard scale.

(4)An NHS foundation trust must secure that its constitution is in accordance with regulations under this section.

(5)Pending the coming into force of regulations under this section, elections for membership of the board of governors of an NHS foundation trust, if contested, must be by secret ballot.

60Voting and standing for election

(1)A person may not vote at an election for the board of governors of an NHS foundation trust unless, within the specified period, he has made a declaration in the specified form of the particulars of his qualification to vote as a member of the constituency, or class within a constituency, for which the election is being held.

(2)A person may not stand for election to the board unless—

(a)he has within the specified period made a declaration in the specified form of the particulars of his qualification to vote as a member of the constituency, or class within a constituency, for which the election is being held, and

(b)he is not prevented from being a member of the board by paragraph 8 of Schedule 7.

(3)A person elected to the board may not vote at a meeting of the board unless—

(a)he has within the specified period made a declaration in the specified form of the particulars of his qualification to vote as a member of the trust, and

(b)he is not prevented from being a member of the board by paragraph 8 of Schedule 7.

(4)This section does not apply to an election held for the staff constituency.

(5)“Specified” means specified in the trust’s constitution.

(6)A person is guilty of an offence if he—

(a)makes a declaration under this section which he knows to be false in a material particular, or

(b)recklessly makes such a declaration which is false in a material particular.

(7)A person guilty of an offence under this section is liable on summary conviction to a fine not exceeding level 4 on the standard scale.

61Representative membership

An authorisation may require an NHS foundation trust to take steps to secure that (taken as a whole) the actual membership of any public constituency and (if there is one) of the patients' constituency is representative of those eligible for such membership.

62Audit

Schedule 10 makes provision in relation to the audit of accounts of NHS foundation trusts.

63General duty of NHS foundation trusts

An NHS foundation trust must exercise its functions effectively, efficiently and economically.

Supplementary

64Orders and regulations under this Chapter

(1)Any power under this Chapter to make an order or regulations is exercisable by statutory instrument.

(2)Subject to subsections (3) and (4), a statutory instrument made by virtue of this Chapter is subject to annulment in pursuance of a resolution of either House of Parliament.

(3)A statutory instrument containing—

(a)the first regulations under section 55(4) or 59, or

(b)an order or regulations under this Chapter making, by virtue of subsection (5)(b), provision which amends or repeals any part of the text of an Act,

may not be made unless a draft of the instrument has been laid before, and approved by resolution of, each House of Parliament.

(4)Subsection (2) does not apply to a statutory instrument containing an order under—

(a)section 51,

(b)section 54(4), or

(c)section 57.

(5)Any order or regulations under this Chapter—

(a)may make different provision for different purposes, and

(b)may make incidental, supplementary, consequential, transitory or transitional or saving provision.

(6)Any power under this Chapter to make an order or regulations (as well as being exercisable in relation to all cases to which it extends) may be exercised in relation to all those cases subject to exceptions or in relation to any particular case or class of case.

65Interpretation of this Chapter

(1)In this Chapter—

• “authorisation” means an authorisation under section 35 or 56,

• “health service body” means a Strategic Health Authority, a Primary Care Trust, an NHS trust, a Special Health Authority or an NHS foundation trust.

(2)Any references in this Chapter to goods and services include, in particular, facilities, education and training.

Chapter 6Miscellaneous

Intervention orders and default powers

66Intervention orders

(1)This section applies to NHS bodies other than NHS foundation trusts.

(2)If the Secretary of State—

(a)considers that a body to which this section applies is not performing one or more of its functions adequately or at all, or that there are significant failings in the way the body is being run, and

(b)is satisfied that it is appropriate for him to intervene under this section,

he may make an order under this section in respect of the body (an “intervention order”).

(3)An intervention order may make any provision authorised by section 67 (including any combination of such provisions).

67Effect of intervention orders

(1)In this section—

(a)“member” means a member of a Strategic Health Authority, Primary Care Trust, Special Health Authority or Local Health Board, or a member of the board of directors of an NHS trust,

(b)“employee member” means a member of a Strategic Health Authority, Primary Care Trust, Special Health Authority or Local Health Board who is an officer of the body, or an executive director of an NHS trust.

(2)An intervention order may provide for the removal from office of—

(a)all the members, or

(b)those specified in the order,

and for their replacement with individuals specified in or determined in accordance with the order (who need not be the same in number as the removed individuals).

(3)An intervention order may provide for the suspension (either wholly, or in respect only of powers and duties specified in or determined in accordance with the order) of—

(a)all the members, or

(b)those specified in the order,

and for the powers of the suspended members to be exercised, and their duties performed, during their suspension by individuals specified in or determined in accordance with the order (who need not be the same in number as the suspended individuals).

(4)The powers and duties referred to in subsection (3) are, in the case of an employee member, only those which he has in his capacity as a member.

(5)An intervention order may contain directions to the body to which it relates to secure that a function of the body specified in the directions—

(a)is performed, to the extent specified in the directions, on behalf of the body and at its expense, by such person as is specified in the directions, and

(b)is so performed in such a way as to achieve such objectives as are so specified,

and the directions may require that any contract or other arrangement made by the body with that person contains such terms and conditions as may be so specified.

(6)If the person referred to in subsection (5)(a) is a body to which section 66 applies, the functions of that body include the performance of the functions specified in the directions under subsection (5).

(7)Subsection (8) applies in relation to any provision in this Act, or in any order or regulations made, or directions given, under this Act, relating to—

(a)the membership of the body to which an intervention order relates (or in the case of an NHS trust to the membership of its board of directors), or

(b)the procedure of the body.

(8)The intervention order may provide in relation to any provision specified in the order—

(a)that it does not apply in relation to the body while the order remains in force, or

(b)that it applies in relation to the body, while the order remains in force, with modifications specified in the order.

(9)An intervention order may contain such supplementary directions to the body to which it relates as the Secretary of State considers appropriate for the purpose of giving full effect to the order.

68Default powers

(1)This section applies to NHS bodies other than NHS foundation trusts.

(2)If the Secretary of State considers that a body to which this section applies—

(a)has failed to carry out any functions conferred or imposed on it by or under this Act, or

(b)has in carrying out those functions failed to comply with any regulations or directions relating to those functions,

he may after such inquiry as he considers appropriate make an order declaring it to be in default.

(3)The members of the body in default must immediately vacate their office, and the order—

(a)must provide for the appointment, in accordance with the provisions of this Act, of new members of the body, and

(b)may contain such provisions as seem to the Secretary of State expedient for authorising any person to act in the place of the body pending the appointment of new members.

(4)An order under this section may contain such supplementary and incidental provisions as appear to the Secretary of State to be necessary or expedient, including—

(a)provision for the transfer to the Secretary of State of property and liabilities of the body in default, and

(b)where any such order is varied or revoked by a subsequent order, provision in the subsequent order for the transfer to the body in default of any property or liabilities acquired or incurred by the Secretary of State in discharging any of the functions transferred to him.

Protection of members and officers of health service bodies

69Protection from personal liability

(1)Section 265 of the Public Health Act 1875 (c. 55) (which relates to the protection of members and officers of certain authorities) has effect as if there were included in the authorities referred to in that section a reference to an NHS body.

(2)Any reference in that section to the Public Health Act 1875 has effect as if it included a reference to this Act and the National Health Service (Wales) Act 2006 (c. 42).

Transfer of residual liabilities

70Transfer of residual liabilities

(1)If a Strategic Health Authority, a Primary Care Trust, an NHS trust or a Special Health Authority ceases to exist, the Secretary of State must exercise his functions so as to secure that all of the body’s liabilities (other than any criminal liabilities) are dealt with.

(2)A liability is dealt with by being transferred to an NHS body, the Secretary of State or the Welsh Ministers.

Losses and liabilities of certain health service bodies

71Schemes for meeting losses and liabilities etc of certain health service bodies

(1)The Secretary of State may by regulations made with the consent of the Treasury establish a scheme whereby any of the bodies specified in subsection (2) may make provision to meet—

(a)expenses arising from any loss of or damage to their property, and

(b)liabilities to third parties for loss, damage or injury arising out of the carrying out of the functions of the bodies concerned.

(2)The bodies referred to in subsection (1) are—

(a)Strategic Health Authorities,

(b)Primary Care Trusts,

(c)NHS trusts,

(d)Special Health Authorities,

(e)NHS foundation trusts,

(f)the Commission for Healthcare Audit and Inspection, and

(g)the Health Protection Agency,

but a scheme under this section may limit the class or description of bodies which are eligible to participate in it.

(3)A scheme under this section may, in particular—

(a)provide for the scheme to be administered by the Secretary of State or by a Strategic Health Authority, Primary Care Trust, NHS trust, Special Health Authority or NHS foundation trust specified in the scheme,

(b)require any body which participates in the scheme to make payments in accordance with the scheme, and

(c)provide for the making of payments for the purposes of the scheme by the Secretary of State.

(4)If the Secretary of State so directs, a body which is eligible to participate in a scheme must do so.

(5)The Secretary of State may not make a direction under subsection (4) in relation to an NHS foundation trust.

(6)Where a scheme provides for the scheme to be administered by the Secretary of State, a Strategic Health Authority, Primary Care Trust, NHS trust, Special Health Authority or NHS foundation trust must carry out such functions in connection with the administration of the scheme by the Secretary of State as he may direct.

(7)Subsections (4) and (6) do not affect any other power of direction of the Secretary of State.

(8)A person or body administering a scheme under this section does not require permission under any provision of the Financial Services and Markets Act 2000 (c. 8) as respects activities carried out under the scheme.

Co-operation between NHS bodies

72Co-operation between NHS bodies

It is the duty of NHS bodies to co-operate with each other in exercising their functions.

Directions and regulations under this Part

73Directions and regulations under this Part

(1)This section applies to directions and regulations under any of—

(a)section 7,

(b)section 8,

(c)section 14,

(d)section 15,

(e)section 19,

(f)section 20,

(g)section 29.

(2)Except in prescribed cases, the directions and regulations must not preclude a person or body by whom the function is exercisable apart from the directions or regulations from exercising the function.

Part 3Local authorities and the NHS

74Supply of goods and services by local authorities

(1)In the Local Authorities (Goods and Services) Act 1970 (c. 39) the expression “public body” includes—

(a)any Strategic Health Authority, Special Health Authority or Primary Care Trust, and

(b)so far as relates to his functions under this Act, the Secretary of State.

(2)Subsection (1) has effect as if made by an order under section 1(5) of the Local Authorities (Goods and Services) Act 1970 and may be varied or revoked by such an order.

(3)Each local authority must make services available to each NHS body acting in its area, so far as is reasonably necessary and practicable to enable the NHS body to discharge its functions under this Act.

(4)“Services” means the services of persons employed by the local authority for the purposes of its functions under the Local Authority Social Services Act 1970 (c. 42).

75Arrangements between NHS bodies and local authorities

(1)The Secretary of State may by regulations make provision for or in connection with enabling prescribed NHS bodies (on the one hand) and prescribed local authorities (on the other) to enter into prescribed arrangements in relation to the exercise of—

(a)prescribed functions of the NHS bodies, and

(b)prescribed health-related functions of the local authorities,

if the arrangements are likely to lead to an improvement in the way in which those functions are exercised.

(2)The arrangements which may be prescribed include arrangements—

(a)for or in connection with the establishment and maintenance of a fund—

(i)which is made up of contributions by one or more NHS bodies and one or more local authorities, and

(ii)out of which payments may be made towards expenditure incurred in the exercise of both prescribed functions of the NHS body or bodies and prescribed health-related functions of the authority or authorities,

(b)for or in connection with the exercise by an NHS body on behalf of a local authority of prescribed health-related functions of the authority in conjunction with the exercise by the NHS body of prescribed functions of the NHS body,

(c)for or in connection with the exercise by a local authority on behalf of an NHS body of prescribed functions of the NHS body in conjunction with the exercise by the local authority of prescribed health-related functions of the local authority,

(d)as to the provision of staff, goods or services in connection with any arrangements mentioned in paragraph (a), (b) or (c),

(e)as to the making of payments by a local authority to an NHS body in connection with any arrangements mentioned in paragraph (b),

(f)as to the making of payments by an NHS body to a local authority in connection with any arrangements mentioned in paragraph (c).

(3)Regulations under this section may make provision—

(a)as to the cases in which NHS bodies and local authorities may enter into prescribed arrangements,

(b)as to the conditions which must be satisfied in relation to prescribed arrangements (including conditions in relation to consultation),

(c)for or in connection with requiring the consent of the Secretary of State to the operation of prescribed arrangements (including provision in relation to applications for consent, the approval or refusal of such applications and the variation or withdrawal of approval),

(d)in relation to the duration of prescribed arrangements,

(e)for or in connection with the variation or termination of prescribed arrangements,

(f)as to the responsibility for, and the operation and management of, prescribed arrangements,

(g)as to the sharing of information between NHS bodies and local authorities.

(4)The provision which may be made by virtue of subsection (3)(f) includes provision in relation to—

(a)the formation and operation of joint committees of NHS bodies and local authorities,

(b)the exercise of functions which are the subject of prescribed arrangements (including provision in relation to the exercise of such functions by joint committees or employees of NHS bodies and local authorities),

(c)the drawing up and implementation of plans in respect of prescribed arrangements,

(d)the monitoring of prescribed arrangements,

(e)the provision of reports on, and information about, prescribed arrangements,

(f)complaints and disputes about prescribed arrangements,

(g)accounts and audit in respect of prescribed arrangements.

(5)Arrangements made by virtue of this section do not affect—

(a)the liability of NHS bodies for the exercise of any of their functions,

(b)the liability of local authorities for the exercise of any of their functions, or

(c)any power or duty to recover charges in respect of services provided in the exercise of any local authority functions.

(6)The Secretary of State may issue guidance to NHS bodies and local authorities in relation to consultation or applications for consent in respect of prescribed arrangements.

(7)The reference in subsection (1) to an improvement in the way in which functions are exercised includes an improvement in the provision to any individuals of any services to which those functions relate.

(8)In this section—

• “health-related functions”, in relation to a local authority, means functions of the authority which, in the opinion of the Secretary of State—

  (a)

  have an effect on the health of any individuals,

  (b)

  have an effect on, or are affected by, any functions of NHS bodies, or

  (c)

  are connected with any functions of NHS bodies,

• “NHS body” does not include a Special Health Authority.

(9)Schedule 18 makes provision with respect to the transfer of staff in connection with arrangements made by virtue of this section.

76Power of local authorities to make payments

(1)A local authority may make payments to a Strategic Health Authority, a Primary Care Trust or a Local Health Board towards expenditure incurred or to be incurred by the body in connection with the performance by it of prescribed functions.

(2)A payment under this section may be made in respect of expenditure of a capital or of a revenue nature or in respect of both kinds of expenditure.

(3)The Secretary of State may by directions prescribe conditions relating to payments under this section.

(4)The power under subsection (3) may in particular be exercised so as to require, in such circumstances as may be specified—

(a)repayment of the whole or part of a payment under this section, or

(b)in respect of property acquired with payments under this section, payment of an amount representing the whole or part of an increase in the value of the property which has occurred since its acquisition.

(5)No payment may be made under this section in respect of any expenditure unless the conditions relating to it conform with the conditions prescribed for payments of that description under subsection (3).

77Care Trusts

(1)Where—

(a)a Primary Care Trust or an NHS trust is, or will be, a party to any existing or proposed LA delegation arrangements, and

(b)the Secretary of State considers that designation of the body as a Care Trust would be likely to promote the effective exercise by the body of prescribed health-related functions of a local authority (in accordance with the arrangements) in conjunction with prescribed NHS functions of the body,

the Secretary of State may designate the body as a Care Trust.

(2)A Primary Care Trust or NHS trust may, however, be designated only in pursuance of an application made to the Secretary of State jointly by each prescribed body.

(3)If the application under subsection (2) requests the Secretary of State to do so, he may when designating a body as a Care Trust make a direction under subsection (4).

(4)The direction is that while the body is designated it may (in addition to exercising health-related functions of the local authority as mentioned in subsection (1)(b)) exercise such prescribed health-related functions of the local authority as are specified in the direction in relation to persons in any area so specified, even though it does not exercise any NHS functions in relation to persons in that area.

(5)Where a body is designated as a Care Trust under this section—

(a)its designation may be revoked by the Secretary of State at any time—

(i)of the Secretary of State’s own motion, and

(ii)after such consultation as he considers appropriate,

(b)if an application for the revocation of its designation is made to the Secretary of State by one or more of the parties to the LA delegation arrangements, its designation must be revoked by the Secretary of State at the earliest time at which he considers it practicable to do so, having regard, in particular, to any steps that need to be taken in relation to those arrangements in connection with the revocation.

(6)The designation of a body as a Care Trust under this section must be effected by an order under section 18 or 25 which—

(a)(in the case of an existing body) amends the order establishing the body so as to change its name to one that includes the words “Care Trust”, or

(b)(in the case of a new body) establishes the body with a name that includes those words,

and any revocation of its designation must be effected by a further order under section 18 or 25 which makes such provision for changing the name of the body as the Secretary of State considers expedient.

(7)The power of the Secretary of State to dissolve a Primary Care Trust or an NHS trust includes power to dissolve such a Primary Care Trust or NHS trust where he considers that it is appropriate to do so in connection with the designation of any other such body (whether existing or otherwise) as a Care Trust.

(8)Regulations may make such incidental, supplementary or consequential provision (including provision amending, repealing or revoking enactments) as the Secretary of State considers expedient in connection with the preceding provisions of this section.

(9)Regulations under subsection (8) may, in particular, make provision—

(a)prescribing—

(i)the manner and circumstances in which, and

(ii)any conditions which must be satisfied before,

an application may be made for a body to be designated as a Care Trust under this section, or to cease to be so designated, and the information to be supplied with such an application,

(b)enabling the Secretary of State to terminate appointments of persons as members of a Primary Care Trust or of the board of directors of an NHS trust (or of a committee of such a Primary Care Trust or NHS trust) where he considers that it is appropriate to do so in connection with the designation of the Primary Care Trust or NHS trust as a Care Trust,

(c)requiring the consent of the Secretary of State to be obtained before any prescribed change is made with respect to the governance of a body so designated,

(d)for supplementing or modifying, in connection with the operation of subsection (3), any provision made by regulations under section 75.

(10)The designation of a body as a Care Trust under this section does not affect any of the functions, rights or liabilities of that body in its capacity as a Primary Care Trust or NHS trust.

(11)In connection with the exercise by a body so designated of any relevant social services functions under LA delegation arrangements—

(a)section 7 of the Local Authority Social Services Act 1970 (c. 42) (authorities to exercise social services functions under guidance), and

(b)section 7A of that Act (directions as to exercise of such functions),

apply to the body as if it were a local authority within the meaning of that Act.

(12)In this section—

• “health-related functions” has the meaning given by section 75(8),

• “LA delegation arrangements” means arrangements falling within section 75(2)(b), whether or not made in conjunction with any pooled fund arrangements,

• “NHS functions” means functions exercisable by a Primary Care Trust or NHS trust in its capacity as such,

• “pooled fund arrangements” means arrangements falling within section 75(2)(a),

• “relevant social services functions” means health-related functions which are social services functions within the meaning of the Local Authority Social Services Act 1970.

78Directed partnership arrangements

(1)If the Secretary of State is of the opinion—

(a)that a body to which this section applies (“the failing body”) is not exercising any of its functions adequately, and

(b)that it would be likely to lead to an improvement in the way in which that function is exercised if it were to be exercised—

(i)by another body to which this section applies under delegation arrangements, or

(ii)in accordance with pooled fund arrangements made with another such body,

the Secretary of State may direct those bodies to enter into such delegation arrangements or pooled fund arrangements in relation to the exercise of the appropriate function or functions as are specified in the direction.

(2)In subsection (1) “the appropriate function or functions” means—

(a)the function of the failing body mentioned in that subsection, and

(b)such other function of that body (if any) as the Secretary of State considers would, if exercised under or in accordance with the arrangements in question, be likely to contribute to an improvement in the exercise of the function referred to in paragraph (a).

(3)The bodies to which this section applies are—

(a)Strategic Health Authorities,

(b)Primary Care Trusts,

(c)NHS trusts,

(d)Local Health Boards, and

(e)local authorities,

but in subsections (1) and (2) any reference to functions is, in relation to a local authority, a reference only to relevant social services functions of the authority.

(4)In this section any reference to an improvement in the way in which any function is exercised includes an improvement in the provision to any individuals of any services to which that function relates.

(5)In this section—

• “delegation arrangements” means arrangements falling within section 75(2)(b) or (c), whether or not made in conjunction with any pooled fund arrangements,

• “health-related functions” has the meaning given by section 75(8),

• “pooled fund arrangements” means arrangements falling within section 75(2)(a),

• “relevant social services functions” means health-related functions which are social services functions within the meaning of the Local Authority Social Services Act 1970 (c. 42).

79Further provision about directions and directed partnership arrangements

(1)A direction under section 78(1) (a “principal direction”) may make provision with respect to—

(a)any of the matters with respect to which provision is required to be made by the specified arrangements by virtue of regulations under section 75, and

(b)such other matters as the Secretary of State considers appropriate.

(2)The Secretary of State may in particular (either in a principal direction or in any subsequent direction) make provision—

(a)for the determination, whether—

(i)by agreement, or

(ii)(in default of agreement) by the Secretary of State or an arbitrator appointed by him,

of the amount of any payments which need to be made by one body to another for the purposes of the effective operation of the specified arrangements, and for the variation of any such determination,

(b)specifying the manner in which the amount of any such payments must be so determined (or varied),

(c)requiring a body specified in the direction to supply to the Secretary of State or an arbitrator, for the purpose of enabling any such amount to be so determined (or varied), such information or documents as may be so specified,

(d)requiring any amount so determined (or varied) to be paid by and to such bodies as are specified in the direction,

(e)requiring capital assets specified in the direction to be made available by and to such bodies as are so specified.

(3)The Secretary of State may, when giving a principal direction to any bodies to which section 78 applies, give such directions to any other such body as he considers appropriate for or in connection with securing that full effect is given to the principal direction.

(4)Before giving a principal direction to any bodies to which section 78 applies, the Secretary of State may—

(a)direct either or both of the bodies in question to take such steps specified in the direction, or

(b)give such other directions,

as he considers appropriate with a view to enabling him to determine whether the principal direction should be given.

(5)The revocation of a principal direction does not affect the continued operation of the specified arrangements.

(6)“The specified arrangements”, in relation to a principal direction, means the arrangements specified in the direction in pursuance of section 78(1).

80Supply of goods and services by the Secretary of State

(1)The Secretary of State may supply to—

(a)local authorities, and

(b)such public bodies or classes of public bodies as he may determine,

any goods or materials of a kind used in the health service.

(2)In subsection (1) “public bodies” includes public bodies in Northern Ireland.

(3)The Secretary of State may make available to persons falling within subsection (1)—

(a)any facilities provided by him or by a Primary Care Trust for any service under this Act, and

(b)the services of persons employed by the Secretary of State or by a Strategic Health Authority, a Primary Care Trust, a Special Health Authority or a Local Health Board.

(4)The Secretary of State may carry out maintenance work (including minor renewals, minor improvements and minor extensions) in connection with any land or building for the maintenance of which a local authority is responsible.

(5)The Secretary of State may supply or make available to persons—

(a)providing pharmaceutical services,

(b)providing services under a general medical services contract, a general dental services contract or a general ophthalmic services contract,

(c)providing services in accordance with section 92 arrangements or section 107 arrangements, or

(d)providing services under a pilot scheme or an LPS scheme,

such goods, materials or other facilities as may be prescribed.

(6)The Secretary of State must make available to local authorities—

(a)any services (other than the services of any person) or other facilities provided under this Act,

(b)the services provided as part of the health service by any person employed by the Secretary of State, a Strategic Health Authority, a Primary Care Trust, a Special Health Authority or a Local Health Board, and

(c)the services of any medical practitioner, dental practitioner or nurse employed by the Secretary of State, a Strategic Health Authority, a Primary Care Trust, a Special Health Authority or a Local Health Board otherwise than to provide services which are part of the health service,

so far as is reasonably necessary and practicable to enable local authorities to discharge their functions relating to social services, education and public health.

(7)The Secretary of State may arrange to make available to local authorities the services of persons—

(a)providing pharmaceutical services,

(b)performing services under a general medical services contract, a general dental services contract or a general ophthalmic services contract,

(c)providing services in accordance with section 92 arrangements or section 107 arrangements,

(d)performing services under a pilot scheme or an LPS scheme, or

(e)providing Strategic Health Authorities, Primary Care Trusts, Special Health Authorities or Local Health Boards with services of a kind provided as part of the health service,

so far as is reasonably necessary and practicable to enable local authorities to discharge their functions relating to social services, education and public health.

81Conditions of supply under section 80

(1)The Secretary of State must, before he makes available the services of any officer under subsection (3)(b) of section 80, or subsection (6)(b) or (c) of that section—

(a)consult the officer or a body recognised by the Secretary of State as representing the officer, or

(b)satisfy himself that the body who employs the officer has consulted the officer about the matter.

(2)The Secretary of State may disregard the provisions of subsection (1) in a case where he—

(a)considers it necessary to make the services of an officer available for the purpose of dealing temporarily with an emergency, and

(b)has previously consulted a body such as is mentioned in subsection (1)(b) about making services available in an emergency.

(3)The Secretary of State may, for the purposes of subsection (3)(b) of section 80, or subsection (6)(b) or (c) of that section, give such directions to Strategic Health Authorities, Primary Care Trusts, Special Health Authorities and Local Health Boards to make the services of their officers available as he considers appropriate.

(4)Powers under this section and section 80 may be exercised on such terms as may be agreed, including terms as to the making of payments to the Secretary of State.

(5)The Secretary of State may make such charges in respect of services or facilities provided under section 80(6) as may be agreed between the Secretary of State and the local authority or, in default of agreement, as may be determined by arbitration.

(6)Any power to supply goods or materials under section 80 includes—

(a)a power to purchase and store them, and

(b)a power to arrange with third parties for the supply of goods or materials by those third parties.

82Co-operation between NHS bodies and local authorities

In exercising their respective functions NHS bodies (on the one hand) and local authorities (on the other) must co-operate with one another in order to secure and advance the health and welfare of the people of England and Wales.

Part 4Medical services

Duty of Primary Care Trusts in relation to primary medical services

83Primary medical services

(1)Each Primary Care Trust must, to the extent that it considers necessary to meet all reasonable requirements, exercise its powers so as to provide primary medical services within its area, or secure their provision within its area.

(2)A Primary Care Trust may (in addition to any other power conferred on it)—

(a)provide primary medical services itself (whether within or outside its area),

(b)make such arrangements for their provision (whether within or outside its area) as it considers appropriate, and may in particular make contractual arrangements with any person.

(3)Each Primary Care Trust must publish information about such matters as may be prescribed in relation to the primary medical services provided under this Act.

(4)Each Primary Care Trust must co-operate with each other Primary Care Trust and each Local Health Board in the discharge of their respective functions relating to the provision of primary medical services under this Act and the National Health Service (Wales) Act 2006 (c. 42).

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

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

General medical services contracts

84General medical services contracts: introductory

(1)A Primary Care Trust may enter into a contract under which primary medical services are provided in accordance with the following provisions of this Part.

(2)A contract under this section is called in this Act a “general medical services contract”.

(3)A general medical services contract may make such provision as may be agreed between the Primary Care Trust and the contractor or contractors in relation to—

(a)the services to be provided under the contract,

(b)remuneration under the contract, and

(c)any other matters.

(4)The services to be provided under a general medical services contract may include—

(a)services which are not primary medical services,

(b)services to be provided outside the area of the Primary Care Trust.

(5)In this Part, “contractor”, in relation to a general medical services contract, means any person entering into the contract with the Primary Care Trust.

85Requirement to provide certain primary medical services

(1)A general medical services contract must require the contractor or contractors to provide, for his or their patients, primary medical services of such descriptions as may be prescribed.

(2)Regulations under subsection (1) may in particular describe services by reference to the manner or circumstances in which they are provided.

86Persons eligible to enter into GMS contracts

(1)A Primary Care Trust may, subject to such conditions as may be prescribed, enter into a general medical services contract with—

(a)a medical practitioner,

(b)two or more individuals practising in partnership where the conditions in subsection (2) are satisfied, or

(c)a company limited by shares where the conditions in subsection (3) are satisfied.

(2)The conditions referred to in subsection (1)(b) are that—

(a)at least one partner is a medical practitioner, and

(b)any partner who is not a medical practitioner is either—

(i)an NHS employee,

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

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

(iv)an individual falling within section 93(1)(d).

(3)The conditions referred to in subsection (1)(c) are that—

(a)at least one share in the company is legally and beneficially owned by a medical practitioner, and

(b)any share which is not so owned is legally and beneficially owned by a person referred to in subsection (2)(b).

(4)Regulations may make provision as to the effect, in relation to a general medical services contract entered into by individuals practising in partnership, of a change in the membership of the partnership.

(5)In this section—

• “health care professional”, “NHS employee”, “section 92 employee”, “section 107 employee”, “section 50 employee”, “section 64 employee”, “section 17C employee” and “Article 15B employee” have the meaning given by section 93.

87GMS contracts: payments

(1)The Secretary of State may give directions as to payments to be made under general medical services contracts.

(2)A general medical services contract must require payments to be made under the contract in accordance with directions under this section.

(3)Directions under subsection (1) may in particular—

(a)provide for payments to be made by reference to compliance with standards or the achievement of levels of performance,

(b)provide for payments to be made by reference to—

(i)any scheme or scale specified in the direction, or

(ii)a determination made by any person in accordance with factors specified in the direction,

(c)provide for the making of payments in respect of individual practitioners,

(d)provide that the whole or any part of a payment is subject to conditions (and may provide that payments are payable by a Primary Care Trust only if it is satisfied as to certain conditions),

(e)make provision having effect from a date before the date of the direction, provided that, having regard to the direction as a whole, the provision is not detrimental to the persons to whose remuneration it relates.

(4)Before giving a direction under subsection (1), the Secretary of State—

(a)must consult any body appearing to him to be representative of persons to whose remuneration the direction would relate, and

(b)may consult such other persons as he considers appropriate.

(5)“Payments” includes fees, allowances, reimbursements, loans and repayments.

88GMS contracts: prescription of drugs, etc

(1)A general medical services contract must contain provision requiring the contractor or contractors to comply with any directions given by the Secretary of State for the purposes of this section as to the drugs, medicines or other substances which may or may not be ordered for patients in the provision of medical services under the contract.

(2)A direction under this section must, subject to subsection (3), be given by regulations.

(3)A direction under this section may be given by an instrument in writing where it gives effect to a request made in writing to the Secretary of State by a person who is a holder of a Community marketing authorization or United Kingdom marketing authorisation in respect of the drug, medicine or other substance to which the request relates.

(4)“Community marketing authorization” and “United Kingdom marketing authorisation” have the meaning given by regulation 1 of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144).

89GMS contracts: other required terms

(1)A general medical services contract must contain such provision as may be prescribed (in addition to the provision required by the preceding provisions of this Part).

(2)Regulations under subsection (1) may in particular make provision as to—

(a)the manner in which, and standards to which, services must be provided,

(b)the persons who perform services,

(c)the persons to whom services will be provided,

(d)the variation of contract terms (other than terms required by or under this Part),

(e)rights of entry and inspection (including inspection of clinical records and other documents),

(f)the circumstances in which, and the manner in which, the contract may be terminated,

(g)enforcement,

(h)the adjudication of disputes.

(3)Regulations making provision under subsection (2)(c) may make provision as to the circumstances in which a contractor or contractors—

(a)must or may accept a person as a patient to whom services are provided under the contract,

(b)may decline to accept a person as such a patient, or

(c)may terminate his or their responsibility for a patient.

(4)Regulations under subsection (2)(d) may—

(a)make provision as to the circumstances in which a Primary Care Trust may impose a variation of contract terms,

(b)make provision as to the suspension or termination of any duty under the contract to provide services of a prescribed description.

(5)Regulations making provision of the kind described in subsection (4)(b) may prescribe services by reference to the manner or circumstances in which they are provided.

(6)Regulations under subsection (1) must make provision as to the right of patients to choose the persons from whom they receive services.

90GMS contracts: disputes and enforcement

(1)Regulations may make provision for the resolution of disputes as to the terms of a proposed general medical services contract.

(2)Regulations under subsection (1) may make provision—

(a)for the referral of the terms of the proposed contract to the Secretary of State, and

(b)for the Secretary of State, or a person appointed by him, to determine the terms on which the contract may be entered into.

(3)Regulations may make provision for a person or persons entering into a general medical services contract to be regarded as a health service body for any purposes of section 9, in circumstances where he or they so elect.

(4)Regulations under subsection (3) may include provision as to the application of section 9 in cases where—

(a)persons practising in partnership elect to become a health service body, and

(b)there is a change in the membership of the partnership.

(5)Where—

(a)by virtue of regulations under subsection (3), section 9(11) applies in relation to a general medical services contract, and

(b)a direction as to payments is made under that subsection in relation to the contract,

the direction is enforceable in a county court (if the court so orders) as if it were a judgment or order of that court.

Performance of primary medical services

91Persons performing primary medical services

(1)Regulations may provide that a health care professional of a prescribed description may not perform any primary medical service for which a Primary Care Trust is responsible unless he is included in a list maintained under the regulations by a Primary Care Trust.

(2)For the purposes of this section—

(a)“health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17),

(b)a Primary Care Trust is responsible for a medical service if it provides the service, or secures its provision, by or under any enactment.

(3)Regulations under this section may make provision in relation to lists under this section and in particular as to—

(a)the preparation, maintenance and publication of a list,

(b)eligibility for inclusion in a list,

(c)applications for inclusion (including provision as to the Primary Care Trust to which an application must be made, and for the procedure for applications and the documents to be supplied on application),

(d)the grounds on which an application for inclusion may or must be granted or refused,

(e)requirements with which a person included in a list must comply (including the declaration of financial interests and gifts and other benefits),

(f)suspension or removal from a list (including provision for the grounds for, and consequences of, suspension or removal),

(g)circumstances in which a person included in a list may not withdraw from it,

(h)payments to be made in respect of a person suspended from a list (including provision for the amount of the payment, or the method of calculating the payment, to be determined by the Secretary of State or a person appointed by him),

(i)the criteria to be applied in making decisions under the regulations,

(j)appeals against decisions made by a Primary Care Trust under the regulations, and

(k)disclosure of information about applicants for inclusion, grants or refusals of applications or suspensions or removals,

and may make any provision corresponding to anything in sections 151 to 159.

(4)Regulations under this section may, in particular, also provide for—

(a)a person’s inclusion in a list to be subject to conditions determined by a Primary Care Trust,

(b)a Primary Care Trust to vary the conditions or impose different ones,

(c)the consequences of failing to comply with a condition (including removal from a list),

(d)the review by a Primary Care Trust of decisions made by it by virtue of the regulations.

(5)The imposition of such conditions must be with a view to—

(a)preventing any prejudice to the efficiency of the services to which a list relates, or

(b)preventing fraud.

(6)Regulations making provision as to the matters referred to in subsection (3)(k) may in particular authorise the disclosure of information—

(a)by a Primary Care Trust to the Secretary of State, and

(b)by the Secretary of State to a Primary Care Trust.

Other arrangements for the provision of primary medical services

92Arrangements by Strategic Health Authorities for the provision of primary medical services

(1)A Strategic Health Authority may make one or more agreements with respect to its area under which primary medical services are provided (otherwise than by the Strategic Health Authority).

(2)An agreement must be in accordance with regulations under section 94.

(3)An agreement may not combine arrangements for the provision of primary medical services with arrangements for the provision of primary dental services.

(4)An agreement may not combine arrangements for the provision of primary medical services with arrangements for the provision of local pharmaceutical services.

(5)But an agreement may include arrangements for the provision of services which are not primary medical services but which may be provided under this Act, other than under Chapter 1 or 2 of Part 7 (pharmaceutical services and local pharmaceutical services under pilot schemes).

(6)This Act has effect, in relation to primary medical services provided under an agreement, as if those services were provided as a result of the delegation by the Secretary of State of his functions (by directions given under section 7).

(7)Regulations may provide—

(a)for functions which are exercisable by a Strategic Health Authority in relation to an agreement to be exercisable on behalf of the Strategic Health Authority by a Health Board, and

(b)for functions which are exercisable by a Health Board in relation to an agreement made under section 17C of the National Health Service (Scotland) Act 1978 (c. 29) to be exercisable on behalf of the Board by a Strategic Health Authority.

(8)In this Act, arrangements for the provision of services made under this section are called “section 92 arrangements”.

93Persons with whom agreements may be made under section 92

(1)A Strategic Health Authority may make an agreement under section 92 only with one or more of the following—

(a)an NHS trust or an NHS foundation trust,

(b)a medical practitioner who meets the prescribed conditions,

(c)a health care professional who meets the prescribed conditions,

(d)an individual who is providing services—

(i)under a general medical services contract or a general dental services contract or a Welsh general medical services contract or a Welsh general dental services contract,

(ii)in accordance with section 92 arrangements, section 107 arrangements, section 50 arrangements, section 64 arrangements, section 17C arrangements or Article 15B arrangements, or

(iii)under section 17J or 25 of the 1978 Act or Article 57 or 61 of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)),

or has so provided them within such period as may be prescribed,

(e)an NHS employee, a section 92 employee, a section 107 employee, a section 50 employee, a section 64 employee, a section 17C employee or an Article 15B employee,

(f)a qualifying body,

(g)a Primary Care Trust or Local Health Board.

(2)The power under subsection (1) to make an agreement with a person falling within paragraph (d) or (e) of that subsection is subject to such conditions as may be prescribed.

(3)In this section—

• “the 1978 Act” means the National Health Service (Scotland) Act 1978 (c. 29),

• “Article 15B arrangements” means arrangements for the provision of services made under Article 15B of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)),

• “Article 15B employee” means an individual who, in connection with the provision of services in accordance with Article 15B arrangements, is employed by a person providing or performing those services,

• “health care professional” means a person who is a member of a profession regulated by a body mentioned (at the time the agreement in question is made) in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17),

• “NHS employee” means an individual who, in connection with the provision of services in the health service, the Scottish health service or the Northern Ireland health service, is employed by—

  (a)

  an NHS trust, an NHS foundation trust or (in Northern Ireland) a Health and Social Services Trust,

  (b)

  a Primary Care Trust or Local Health Board,

  (c)

  a person who is providing services under a general medical services contract or a general dental services contract or a Welsh general medical services contract or a Welsh general dental services contract,

  (d)

  an individual who is providing services as specified in subsection (1)(d)(iii),

• “the Northern Ireland health service” means the health service within the meaning of the Health and Personal Social Services (Northern Ireland) Order 1972,

• “qualifying body” means a company which is limited by shares all of which are legally and beneficially owned by persons falling within paragraph (a), (b), (c), (d), (e) or (g) of subsection (1),

• “the Scottish health service” means the health service within the meaning of the National Health Service (Scotland) Act 1978,

• “section 17C arrangements” means arrangements for the provision of services made under section 17C of the 1978 Act,

• “section 17C employee” means an individual who, in connection with the provision of services in accordance with section 17C arrangements, is employed by a person providing or performing those services,

• “section 50 arrangements” means arrangements for the provision of services made under section 50 of the National Health Service (Wales) Act 2006 (c. 42),

• “section 64 arrangements” means arrangements for the provision of services made under section 64 of that Act,

• “section 107 employee” means an individual who, in connection with the provision of services in accordance with section 107 arrangements, is employed by a person providing or performing those services,

• “section 92 employee” means an individual who, in connection with the provision of services in accordance with section 92 arrangements, is employed by a person providing or performing those services,

• “section 50 employee” means an individual who, in connection with the provision of services in accordance with section 50 arrangements, is employed by a person providing or performing those services,

• “section 64 employee” means an individual who, in connection with the provision of services in accordance with section 64 arrangements, is employed by a person providing or performing those services,

• “Welsh general medical services contract” means a contract under section 42(2) of the National Health Service (Wales) Act 2006 (c. 42), and

• “Welsh general dental services contract” means a contract under section 57(2) of that Act.

94Regulations about section 92 arrangements

(1)The Secretary of State may make regulations about the provision of services in accordance with section 92 arrangements.

(2)The regulations must include provision for participants other than Strategic Health Authorities to withdraw from section 92 arrangements if they wish to do so.

(3)The regulations may, in particular—

(a)provide that section 92 arrangements may be made only in prescribed circumstances,

(b)provide that section 92 arrangements may be made only in prescribed areas,

(c)provide that only prescribed services, or prescribed categories of service, may be provided in accordance with section 92 arrangements,

(d)impose conditions (including conditions as to qualifications and experience) to be satisfied by persons performing services in accordance with section 92 arrangements,

(e)require details of section 92 arrangements to be published,

(f)make provision with respect to the variation and termination of section 92 arrangements,

(g)provide for parties to section 92 arrangements to be treated, in such circumstances and to such extent as may be prescribed, as health service bodies for the purposes of section 9,

(h)provide for directions, as to payments, made under section 9(11) (as it has effect as a result of regulations made by virtue of paragraph (g)) to be enforceable in a county court (if the court so orders) as if they were judgments or orders of that court.

(4)The regulations may also require payments to be made under the arrangements in accordance with directions given for the purpose by the Secretary of State.

(5)A direction may make provision having effect from a date before the date of the direction, provided that, having regard to the direction as a whole, the provision is not detrimental to the persons to whose remuneration it relates.

(6)The regulations may also include provision requiring a Primary Care Trust, in prescribed circumstances and subject to prescribed conditions, to enter into a general medical services contract on prescribed terms with any person who is providing services under section 92 arrangements and who so requests.

(7)The regulations may also include provision for the resolution of disputes as to the terms of any proposed section 92 arrangements, and in particular may make provision—

(a)for the referral of the terms of the proposed arrangements to the Secretary of State, and

(b)for the Secretary of State or a person appointed by him to determine the terms on which the arrangements may be entered into.

(8)The regulations must provide for the circumstances in which a person providing primary medical services under section 92 arrangements—

(a)must or may accept a person as a patient to whom such services are so provided,

(b)may decline to accept a person as such a patient,

(c)may terminate his responsibility for a patient.

(9)The regulations must make provision as to the right of patients to choose the persons from whom they receive services under section 92 arrangements.

95Transfer of liabilities relating to section 92 arrangements

(1)The Secretary of State may by order make provision for any rights and liabilities arising under an agreement to provide primary medical services under section 92 to be transferred from Strategic Health Authorities to Primary Care Trusts and from Primary Care Trusts to Strategic Health Authorities.

(2)Subsection (1) does not affect any other power of the Secretary of State to transfer rights and liabilities under this Act.

Assistance and support

96Assistance and support: primary medical services

(1)A Primary Care Trust may provide assistance or support to any person providing or proposing to provide—

(a)primary medical services under a general medical services contract, or

(b)primary medical services in accordance with section 92 arrangements.

(2)Assistance or support provided by a Primary Care Trust under subsection (1) is provided on such terms, including terms as to payment, as the Primary Care Trust considers appropriate.

(3)“Assistance” includes financial assistance.

Local Medical Committees

97Local Medical Committees

(1)A Primary Care Trust may recognise a committee formed for its area, or for its area and that of one or more other Primary Care Trusts, which it is satisfied is representative of—

(a)the persons to whom subsection (2) applies, and

(b)the persons to whom subsection (3) applies.

(2)This subsection applies to—

(a)each medical practitioner who, under a general medical services contract entered into by him, is providing primary medical services in the area for which the committee is formed, and

(b)each medical practitioner who, under a general ophthalmic services contract entered into by him, is providing primary ophthalmic services in that area.

(3)This subsection applies to each other medical practitioner—

(a)who is performing primary medical services or primary ophthalmic services in the area for which the committee is formed—

(i)pursuant to section 83(2)(a) or section 115(4)(a),

(ii)in accordance with section 92 arrangements, or

(iii)under a general medical services contract or a general ophthalmic services contract, and

(b)who has notified the Primary Care Trust that he wishes to be represented by the committee (and has not notified it that he wishes to cease to be so represented).

(4)A committee recognised under this section is called the Local Medical Committee for the area for which it is formed.

(5)Any such committee may delegate any of its functions, with or without restrictions or conditions, to sub-committees composed of members of that committee.

(6)Regulations may require a Primary Care Trust, in the exercise of its functions relating to primary medical services, to consult any committee recognised by it under this section on such occasions and to such extent as may be prescribed.

(7)Regulations may require a Strategic Health Authority, in the exercise of any of its functions which relate to section 92 arrangements, to consult, on such occasions and to such extent as may be prescribed, any committee—

(a)which is recognised by a Primary Care Trust under this section for the area where the services are (or will be) provided under those arrangements, and

(b)which is representative of persons providing or performing those services under those arrangements.

(8)A committee recognised under this section has such other functions as may be prescribed.

(9)A committee recognised under this section must in respect of each year determine—

(a)the amount of its administrative expenses for that year attributable to persons of whom it is representative under subsection (1)(a), and

(b)the amount of its administrative expenses for that year attributable to persons of whom it is representative under subsection (1)(b).

(10)A Primary Care Trust may—

(a)on the request of a committee recognised by it, allot to that committee such sums for defraying the expenses referred to in subsection (9)(a) as the Primary Care Trust may determine, and

(b)deduct the amount of such sums from the remuneration of persons of whom the committee is representative under subsection (1)(a) under the general medical services contracts entered into by those persons with the Primary Care Trust.

(11)A committee recognised under this section must apportion the amount determined by it under subsection (9)(b) among the persons of whom it is representative under subsection (1)(b); and each such person must pay in accordance with the committee’s directions the amount so apportioned to him.

(12)The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.

Provision of accommodation by the Secretary of State

98Use of accommodation: provision of primary medical services

If the Secretary of State considers that any accommodation provided by him by virtue of this Act is suitable for use in connection with the provision of primary medical services, he may make the accommodation available on such terms as he considers appropriate to persons providing those services.

Part 5Dental services

Duty of Primary Care Trusts in relation to primary dental services

99Primary dental services

(1)Each Primary Care Trust must, to the extent that it considers necessary to meet all reasonable requirements, exercise its powers so as to provide primary dental services within its area, or secure their provision within its area.

(2)A Primary Care Trust may (in addition to any other power conferred on it) provide primary dental services itself (whether within or outside its area).

(3)Each Primary Care Trust must publish information about such matters as may be prescribed in relation to the primary dental services for which it makes provision under this Act.

(4)Each Primary Care Trust must co-operate with each other Primary Care Trust and each Local Health Board in the discharge of their respective functions relating to the provision of primary dental services under this Act and the National Health Service (Wales) Act 2006 (c. 42).

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

(6)Regulations under subsection (5) may in particular describe services by reference to the manner or circumstances in which they are provided.

General dental services contracts

100General dental services contracts: introductory

(1)A Primary Care Trust may enter into a contract under which primary dental services are provided in accordance with the following provisions of this Part.

(2)A contract under this section is called in this Act a “general dental services contract”.

(3)A general dental services contract may make such provision as may be agreed between the Primary Care Trust and the contractor in relation to—

(a)the services to be provided under the contract (which may include services which are not primary dental services),

(b)remuneration under the contract, and

(c)any other matters.

(4)In this Part, “contractor”, in relation to a general dental services contract, means any person entering into the contract with the Primary Care Trust.

101Requirement to provide certain primary dental services

(1)A general dental services contract must require the contractor or contractors to provide, for his or their patients, primary dental services of such descriptions as may be prescribed.

(2)Regulations under subsection (1) may in particular describe services by reference to the manner or circumstances in which they are provided.

102Persons eligible to enter into GDS contracts

(1)A Primary Care Trust may, subject to such conditions as may be prescribed, enter into a general dental services contract with—

(a)a dental practitioner,

(b)a dental corporation,

(c)two or more individuals practising in partnership where the conditions in subsection (2) are satisfied.

(2)The conditions referred to in subsection (1)(c) are that—

(a)at least one partner is a dental practitioner, and

(b)any partner who is not a dental practitioner is either—

(i)an NHS employee,

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

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

(iv)an individual falling within section 108(1)(d).

(3)Regulations may make provision as to the effect, in relation to a general dental services contract entered into by individuals practising in partnership, of a change in the membership of the partnership.

(4)In this section—

• “dental corporation” means a body corporate which is carrying on the business of dentistry in accordance with the Dentists Act 1984 (c. 24)

• “health care professional”, “NHS employee”, “section 92 employee”, “section 107 employee”, “section 50 employee”, “section 64 employee”, “section 17C employee” and “Article 15B employee” have the meaning given by section 108.

103GDS contracts: payments

(1)The Secretary of State may give directions as to payments to be made under general dental services contracts.

(2)A general dental services contract must require payments to be made under the contract in accordance with directions under this section.

(3)A direction under subsection (1) may in particular—

(a)provide for payments to be made by reference to compliance with standards or the achievement of levels of performance,

(b)provide for payments to be made by reference to—

(i)any scheme or scale specified in the direction, or

(ii)a determination made by any person in accordance with factors specified in the direction,

(c)provide for the making of payments in respect of individual practitioners,

(d)provide that the whole or any part of a payment is subject to conditions (and may provide that payments are payable by a Primary Care Trust only if it is satisfied as to certain conditions),

(e)make provision having effect from a date before the date of the direction, provided that, having regard to the direction as a whole, the provision is not detrimental to the persons to whose remuneration it relates.

(4)Before giving a direction under subsection (1), the Secretary of State—

(a)must consult any body appearing to him to be representative of persons to whose remuneration the direction would relate, and

(b)may consult such other persons as he considers appropriate.

(5)“Payments” includes fees, allowances, reimbursements, loans and repayments.

104GDS contracts: other required terms

(1)A general dental services contract must contain such provision as may be prescribed (in addition to the provision required by the preceding provisions of this Part).

(2)Regulations under subsection (1) may in particular make provision as to—

(a)the manner in which, and standards to which, services must be provided,

(b)the persons who perform services,

(c)the persons to whom services will be provided,

(d)the variation of contract terms (other than terms required by or under this Part),

(e)rights of entry and inspection (including inspection of clinical records and other documents),

(f)the circumstances in which, and the manner in which, the contract may be terminated,

(g)enforcement,

(h)the adjudication of disputes.

(3)Regulations under subsection (2)(d) may make provision as to the circumstances in which a Primary Care Trust may impose a variation of contract terms.

(4)Regulations under subsection (1) must make provision as to the right of patients to choose the persons from whom they receive services.

105GDS contracts: disputes and enforcement

(1)Regulations may make provision for the resolution of disputes as to the terms of a proposed general dental services contract.

(2)Regulations under subsection (1) may make provision—

(a)for the referral of the terms of the proposed contract to the Secretary of State, and

(b)for the Secretary of State, or a person appointed by him, to determine the terms on which the contract may be entered into.

(3)Regulations may make provision for a person or persons entering into a general dental services contract to be regarded as a health service body for any purposes of section 9, in circumstances where he or they so elect.

(4)Regulations under subsection (3) may include provision as to the application of section 9 in cases where—

(a)persons practising in partnership elect to become a health service body, and

(b)there is a change in the membership of the partnership.

(5)Where—

(a)by virtue of regulations under subsection (3), section 9(11) applies in relation to a general dental services contract, and

(b)a direction as to payments is made under that provision in relation to the contract,

the direction is enforceable in a county court (if the court so orders) as if it were a judgment or order of that court.

Performance of primary dental services

106Persons performing primary dental services

(1)Regulations may provide that a health care professional of a prescribed description may not perform any primary dental service for which a Primary Care Trust is responsible unless he is included in a list maintained under the regulations by a Primary Care Trust.

(2)For the purposes of this section—

(a)“health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17),

(b)a Primary Care Trust is responsible for a dental service if it provides the service, or secures its provision, by or under any enactment.

(3)Regulations under this section may make provision in relation to lists under this section and in particular as to—

(a)the preparation, maintenance and publication of a list,

(b)eligibility for inclusion in a list,

(c)applications for inclusion (including provision as to the Primary Care Trust to which an application must be made, and for the procedure for applications and the documents to be supplied on application),

(d)the grounds on which an application for inclusion may or must be granted or refused,

(e)requirements with which a person included in a list must comply (including the declaration of financial interests and gifts and other benefits),

(f)suspension or removal from a list (including provision for the grounds for, and consequences of, suspension or removal),

(g)circumstances in which a person included in a list may not withdraw from it,

(h)payments to be made in respect of a person suspended from a list (including provision for the amount of the payment, or the method of calculating the payment, to be determined by the Secretary of State or a person appointed by him),

(i)the criteria to be applied in making decisions under the regulations,

(j)appeals against decisions made by a Primary Care Trust under the regulations, and

(k)disclosure of information about applicants for inclusion, grants or refusals of applications or suspensions or removals,

and may make any provision corresponding to anything in sections 151 to 159.

(4)Regulations under this section may, in particular, also provide for—

(a)a person’s inclusion in a list to be subject to conditions determined by a Primary Care Trust,

(b)a Primary Care Trust to vary the conditions or impose different ones,

(c)the consequences of failing to comply with a condition (including removal from a list),

(d)the review by a Primary Care Trust of decisions made by it by virtue of the regulations.

(5)The imposition of such conditions must be with a view to—

(a)preventing any prejudice to the efficiency of the services to which a list relates, or

(b)preventing fraud.

(6)Regulations making provision as to the matters referred to in subsection (3)(k) may in particular authorise the disclosure of information—

(a)by a Primary Care Trust to the Secretary of State, and

(b)by the Secretary of State to a Primary Care Trust.

Other arrangements for the provision of primary dental services

107Arrangements by Strategic Health Authorities for the provision of primary dental services

(1)A Strategic Health Authority may make one or more agreements with respect to its area under which primary dental services are provided (otherwise than by the Strategic Health Authority).

(2)An agreement must be in accordance with regulations under section 109.

(3)An agreement may not combine arrangements for the provision of primary dental services with arrangements for the provision of primary medical services.

(4)An agreement may not combine arrangements for the provision of primary dental services with arrangements for the provision of local pharmaceutical services.

(5)But an agreement may include arrangements for the provision of services which are not primary dental services but which may be provided under this Act, other than under Chapter 1 or 2 of Part 7 (pharmaceutical services and local pharmaceutical services under pilot schemes).

(6)This Act has effect, in relation to primary dental services provided under an agreement, as if those services were provided as a result of the delegation by the Secretary of State of his functions (by directions given under section 7).

(7)Regulations may provide—

(a)for functions which are exercisable by a Strategic Health Authority in relation to an agreement to be exercisable on behalf of the Authority by a Health Board, and

(b)for functions which are exercisable by a Health Board in relation to an agreement made under section 17C of the National Health Service (Scotland) Act 1978 (c. 29) to be exercisable on behalf of the Board by a Strategic Health Authority.

(8)In this Act, arrangements for the provision of services made under this section are called “section 107 arrangements”.

108Persons with whom agreements may be made under section 107

(1)A Strategic Health Authority may make an agreement under section 107 only with one or more of the following—

(a)an NHS trust or an NHS foundation trust,

(b)a dental practitioner who meets the prescribed conditions,

(c)a health care professional who meets the prescribed conditions,

(d)an individual who is providing services—

(i)under a general medical services contract or a general dental services contract or a Welsh general medical services contract or a Welsh general dental services contract,

(ii)in accordance with section 107 arrangements, section 92 arrangements, section 50 arrangements, section 64 arrangements, section 17C arrangements or Article 15B arrangements, or

(iii)under section 17J or 25 of the 1978 Act or Article 57 or 61 of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)),

or has so provided them within such period as may be prescribed,

(e)an NHS employee, a section 107 employee, a section 92 employee, a section 50 employee, a section 64 employee, a section 17C employee or an Article 15B employee,

(f)a qualifying body,

(g)a Primary Care Trust or Local Health Board.

(2)The power under subsection (1) to make an agreement with a person falling within paragraph (d) or (e) of that subsection is subject to such conditions as may be prescribed.

(3)In this section—

• “the 1978 Act” means the National Health Service (Scotland) Act 1978 (c. 29),

• “Article 15B arrangements” means arrangements for the provision of services made under Article 15B of the Health and Personal Social Services (Northern Ireland) Order 1972,

• “Article 15B employee” means an individual who, in connection with the provision of services in accordance with Article 15B arrangements, is employed by a person providing or performing those services,

• “health care professional” means a person who is a member of a profession regulated by a body mentioned (at the time the agreement in question is made) in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17),

• “NHS employee” means an individual who, in connection with the provision of services in the health service, the Scottish health service or the Northern Ireland health service, is employed by—

  (a)

  an NHS trust, an NHS foundation trust or (in Northern Ireland) a Health and Social Services Trust,

  (b)

  a Primary Care Trust or Local Health Board,

  (c)

  a person who is providing services under a general medical services contract or a general dental services contract or a Welsh general medical services contract or a Welsh general dental services contract,

  (d)

  an individual who is providing services as specified in subsection (1)(d)(iii),

• “the Northern Ireland health service” means the health service within the meaning of the Health and Personal Social Services (Northern Ireland) Order 1972,

• “qualifying body” means—

  (a)

  a company which is limited by shares all of which are legally and beneficially owned by persons falling within paragraph (a), (b), (c), (d), (e) or (g) of subsection (1), and

  (b)

  a body corporate which is carrying on the business of dentistry in accordance with the Dentists Act 1984 (c. 24),

• “the Scottish health service” means the health service within the meaning of the National Health Service (Scotland) Act 1978,

• “section 17C arrangements” means arrangements for the provision of services made under section 17C of the 1978 Act,

• “section 17C employee” means an individual who, in connection with the provision of services in accordance with section 17C arrangements, is employed by a person providing or performing those services,

• “section 50 arrangements” means arrangements for the provision of services made under section 50 of the National Health Service (Wales) Act 2006 (c. 42),

• “section 64 arrangements” means arrangements for the provision of services made under section 64 of that Act,

• “section 107 employee” means an individual who, in connection with the provision of services in accordance with section 107 arrangements, is employed by a person providing or performing those services,

• “section 92 employee” means an individual who, in connection with the provision of services in accordance with section 92 arrangements, is employed by a person providing or performing those services,

• “section 50 employee” means an individual who, in connection with the provision of services in accordance with section 50 arrangements, is employed by a person providing or performing those services,

• “section 64 employee” means an individual who, in connection with the provision of services in accordance with section 64 arrangements, is employed by a person providing or performing those services,

• “Welsh general medical services contract” means a contract under section 42(2) of the National Health Service (Wales) Act 2006, and

• “Welsh general dental services contract” means a contract under section 57(2) of that Act.

109Regulations about section 107 arrangements

(1)The Secretary of State may make regulations about the provision of services in accordance with section 107 arrangements.

(2)The regulations must include provision for participants other than Strategic Health Authorities to withdraw from section 107 arrangements if they wish to do so.

(3)The regulations may, in particular—

(a)provide that section 107 arrangements may be made only in prescribed circumstances,

(b)provide that section 107 arrangements may be made only in prescribed areas,

(c)provide that only prescribed services, or prescribed categories of service, may be provided in accordance with section 107 arrangements,

(d)impose conditions (including conditions as to qualifications and experience) to be satisfied by persons performing services in accordance with section 107 arrangements,

(e)require details of section 107 arrangements to be published,

(f)make provision with respect to the variation and termination of section 107 arrangements,

(g)provide for parties to section 107 arrangements to be treated, in such circumstances and to such extent as may be prescribed, as health service bodies for the purposes of section 9,

(h)provide for directions, as to payments, made under section 9(11) (as it has effect as a result of regulations made by virtue of paragraph (g)) to be enforceable in a county court (if the court so orders) as if they were judgments or orders of that court.

(4)The regulations may also require payments to be made under the arrangements in accordance with directions given for the purpose by the Secretary of State.

(5)A direction may make provision having effect from a date before the date of the direction, provided that, having regard to the direction as a whole, the provision is not detrimental to the persons to whose remuneration it relates.

(6)The regulations may also include provision requiring a Primary Care Trust, in prescribed circumstances and subject to prescribed conditions, to enter into a general dental services contract on prescribed terms with any person who is providing services under section 107 arrangements and who so requests.

(7)The regulations may also include provision for the resolution of disputes as to the terms of any proposed section 107 arrangements, and in particular may make provision—

(a)for the referral of the terms of the proposed arrangements to the Secretary of State, and

(b)for the Secretary of State or a person appointed by him to determine the terms on which the arrangements may be entered into.

(8)The regulations must provide for the circumstances in which a person providing primary dental services under section 107 arrangements—

(a)must or may accept a person as a patient to whom such services are so provided,

(b)may decline to accept a person as such a patient,

(c)may terminate his responsibility for a patient.

(9)The regulations must make provision as to the right of patients to choose the persons from whom they receive services under section 107 arrangements.

110Transfer of liabilities relating to section 107 arrangements

(1)The Secretary of State may by order make provision for any rights and liabilities arising under an agreement to provide primary dental services under section 107 to be transferred from Strategic Health Authorities to Primary Care Trusts and from Primary Care Trusts to Strategic Health Authorities.

(2)Subsection (1) does not affect any other power of the Secretary of State to transfer rights and liabilities under this Act.

Dental public health

111Dental public health

(1)A Primary Care Trust has such functions in relation to dental public health in England as may be prescribed.

(2)The functions of a Primary Care Trust under this section may be discharged—

(a)by the Primary Care Trust itself,

(b)by the Primary Care Trust and one or more other Primary Care Trusts acting jointly, or

(c)by any other person or body in accordance with arrangements made by the Primary Care Trust.

Assistance and support

112Assistance and support: primary dental services

(1)A Primary Care Trust may provide assistance or support to any person providing or proposing to provide—

(a)primary dental services under a general dental services contract, or

(b)primary dental services in accordance with section 107 arrangements.

(2)Assistance or support provided by a Primary Care Trust under subsection (1) is provided on such terms, including terms as to payment, as the Primary Care Trust considers appropriate.

(3)“Assistance” includes financial assistance.

Local Dental Committees

113Local Dental Committees

(1)A Primary Care Trust may recognise a committee formed for its area, or for its area and that of one or more other Primary Care Trusts, which it is satisfied is representative of—

(a)the persons to whom subsection (2) applies, and

(b)the persons to whom subsection (3) applies.

(2)This subsection applies to each dental practitioner who, under a general dental services contract entered into by him, is providing primary dental services in the area for which the committee is formed.

(3)This subsection applies to each other dental practitioner—

(a)who is performing primary dental services in the area for which the committee is formed—

(i)pursuant to section 99(2),

(ii)in accordance with section 107 arrangements, or

(iii)under a general dental services contract, and

(b)who has notified the Primary Care Trust that he wishes to be represented by the committee (and has not notified it that he wishes to cease to be so represented).

(4)A committee recognised under this section is called the Local Dental Committee for the area for which it is formed.

(5)Any such committee may delegate any of its functions, with or without restrictions or conditions, to sub-committees composed of members of that committee.

(6)Regulations may require a Primary Care Trust, in the exercise of its functions relating to primary dental services, to consult any committee recognised by it under this section on such occasions and to such extent as may be prescribed.

(7)Regulations may require a Strategic Health Authority, in the exercise of any of its functions which relate to section 107 arrangements, to consult, on such occasions and to such extent as may be prescribed, any committee—

(a)which is recognised by a Primary Care Trust under this section for the area where the services are (or will be) provided under those arrangements, and

(b)which is representative of persons providing or performing those services under those arrangements.

(8)A committee recognised under this section has such other functions as may be prescribed.

(9)A committee recognised under this section must in respect of each year determine—

(a)the amount of its administrative expenses for that year attributable to persons of whom it is representative under subsection (1)(a), and

(b)the amount of its administrative expenses for that year attributable to persons of whom it is representative under subsection (1)(b).

(10)A Primary Care Trust may—

(a)on the request of a committee recognised by it, allot to that committee such sums for defraying the expenses referred to in subsection (9)(a) as the Primary Care Trust may determine, and

(b)deduct the amount of such sums from the remuneration of persons of whom it is representative under subsection (1)(a) under the general dental services contracts entered into by them with the Primary Care Trust.

(11)A committee recognised under this section must apportion the amount determined by it under subsection (9)(b) among the persons of whom it is representative under subsection (1)(b); and each such person must pay in accordance with the committee’s directions the amount so apportioned to him.

(12)The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.

Provision of accommodation by the Secretary of State

114Use of accommodation: provision of primary dental services

If the Secretary of State considers that any accommodation provided by him by virtue of this Act is suitable for use in connection with the provision of primary dental services, he may make the accommodation available on such terms as he considers appropriate to persons providing those services.

Part 6Ophthalmic services

Duty of Primary Care Trusts in relation to primary ophthalmic services

115Primary ophthalmic services

(1)Each Primary Care Trust must exercise its powers so as to provide or secure the provision, within its area, of the following primary ophthalmic services—

(a)the sight-testing service mentioned in subsection (2),

(b)such other primary ophthalmic services as may be prescribed, and

(c)to the extent that it considers necessary to meet all reasonable requirements, any further primary ophthalmic services.

(2)The sight-testing service mentioned in subsection (1)(a) is a service for testing the sight of all of the following persons (except any such testing which takes place in prescribed circumstances)—

(a)those aged under 16,

(b)those aged 16, 17 or 18 who are receiving qualifying full-time education,

(c)those whose resources must be treated in accordance with regulations as being less than or equal to their requirements,

(d)those aged 60 or over,

(e)those of such other description as may be prescribed.

(3)Regulations may—

(a)prescribe what “qualifying full-time education” is for the purposes of subsection (2)(b),

(b)make provision for the purposes of subsection (2)(c) about how a person’s resources and requirements must be calculated.

(4)A Primary Care Trust may (in addition to any other power conferred on it)—

(a)provide primary ophthalmic services itself (whether within or outside its area),

(b)make such arrangements for their provision (whether within or outside its area) as it considers appropriate, and may in particular make contractual arrangements with any person.

(5)Each Primary Care Trust must publish information about such matters as may be prescribed in relation to the primary ophthalmic services provided under this Act.

(6)A Primary Care Trust must co-operate with each other Primary Care Trust in the discharge of their respective functions relating to the provision of primary ophthalmic services under this Act.

(7)Regulations may provide that services of a prescribed description must, or must not, be regarded as primary ophthalmic services for the purposes of this Act (but these regulations may not affect the duty in subsection (1)(a)).

(8)Regulations under subsection (7) may in particular describe services by reference to the manner or circumstances in which they are provided.

(9)Regulations may provide that a person—

(a)whose sight is tested by a person who is a party to a general ophthalmic services contract, and

(b)who is shown during the testing or within a prescribed time after it to fall within any of paragraphs (a) to (d) of subsection (2),

must be taken for the purposes of the testing to have so fallen immediately before his sight was tested.

(10)In the case mentioned in subsection (9), the testing of his sight must (unless it took place in circumstances prescribed under subsection (2)) be treated as a testing under the sight-testing service mentioned in subsection (1)(a)—

(a)for the purposes of remuneration in respect of the testing, and

(b)for any such other purpose as may be prescribed.

116Regulations under section 115: supplementary

(1)Regulations under section 115 which refer to an Act of Parliament or an instrument made under an Act of Parliament may direct that the reference must be construed as a reference to that Act or instrument—

(a)as it has effect at the time when the regulations are made, or

(b)both as it has effect at that time and as amended subsequently.

(2)Descriptions of persons may be prescribed under section 115(2)(e) by reference to any criterion, including the following—

(a)their age,

(b)the fact that a prescribed person or a prescribed body accepts them as suffering from a prescribed medical condition,

(c)the fact that a prescribed person or a prescribed body accepts that a prescribed medical condition from which they suffer arose in prescribed circumstances,

(d)their receipt of benefit in money or kind under any enactment or their entitlement to receive any such benefit,

(e)the receipt of any such benefit by other persons satisfying prescribed conditions or the entitlement of other persons satisfying prescribed conditions to receive such benefits.

(3)Regulations under section 115(3)(b) may direct that a person’s resources and requirements be calculated—

(a)by a method set out in the regulations,

(b)by a method described by reference to a method of calculating or estimating income or capital specified in an enactment other than this section or in an instrument made under an Act of Parliament or by reference to such a method but subject to prescribed modifications,

(c)by reference to an amount applicable for the purposes of a payment under an Act of Parliament or an instrument made under an Act of Parliament, or

(d)by reference to the person’s being or having been entitled to payment under an Act of Parliament or an instrument made under an Act of Parliament.

General ophthalmic services contracts

117General ophthalmic services contracts: introductory

(1)A Primary Care Trust may enter into a contract under which primary ophthalmic services are provided in accordance with the following provisions of this Part.

(2)A contract under this section is called in this Act a “general ophthalmic services contract”.

(3)A general ophthalmic services contract may make such provision as may be agreed between the Primary Care Trust and the contractor or contractors in relation to—

(a)the services to be provided under the contract,

(b)remuneration under the contract, and

(c)any other matters.

(4)The services to be provided under a general ophthalmic services contract may include—

(a)services which are not primary ophthalmic services,

(b)services to be provided outside the area of the Primary Care Trust.

(5)In this Part, “contractor”, in relation to a general ophthalmic services contract, means any person entering into the contract with the Primary Care Trust.

118Persons eligible to enter into GOS contracts

(1)A Primary Care Trust may, subject to such conditions and exceptions as may be prescribed, enter into a general ophthalmic services contract with any person.

(2)But it may not enter into such a contract with a person who has been disqualified from doing so by an order of disqualification made by virtue of regulations under section 119.

119Exclusion of contractors

(1)The Secretary of State may make regulations conferring on a Primary Care Trust, or another prescribed person, a right to apply to the FHSAA in prescribed circumstances for an order that a person (“P”) be disqualified from entering into a general ophthalmic services contract.

(2)The regulations may in particular provide for—

(a)the review by the FHSAA of an order of disqualification made by virtue of regulations under this section,

(b)what will happen in relation to general ophthalmic services contracts to which P is a party when the order is made.

120GOS contracts: payments

(1)The Secretary of State may give directions as to payments to be made under general ophthalmic services contracts.

(2)A general ophthalmic services contract must require payments to be made under the contract in accordance with directions under this section.

(3)A direction under subsection (1) may in particular—

(a)provide for payments to be made by reference to compliance with standards or the achievement of levels of performance,

(b)provide for payments to be made by reference to—

(i)any scheme or scale specified in the direction, or

(ii)a determination made by any person in accordance with factors specified in the direction,

(c)provide for the making of payments in respect of individual practitioners,

(d)provide that the whole or any part of a payment is subject to conditions (and may provide that payments are payable by a Primary Care Trust only if it is satisfied as to certain conditions),

(e)make provision having effect from a date before the date of the direction, provided that, having regard to the direction as a whole, the provision is not detrimental to the persons to whose remuneration it relates.

(4)Before giving a direction under subsection (1), the Secretary of State—

(a)must consult any body appearing to him to be representative of persons to whose remuneration the direction would relate, and

(b)may consult such other persons as he considers appropriate.

(5)“Payments” includes fees, allowances, reimbursements, loans and repayments.

121GOS contracts: other required terms

(1)A general ophthalmic services contract must contain such provision as may be prescribed (in addition to the provision required by the preceding provisions of this Part).

(2)Regulations under subsection (1) may in particular make provision as to—

(a)the manner in which, and standards to which, services must be provided,

(b)the persons who perform services,

(c)the persons to whom services will be provided,

(d)the variation of contract terms (other than terms required by or under this Part),

(e)rights of entry and inspection (including inspection of clinical records and other documents),

(f)the circumstances in which, and the manner in which, the contract may be terminated,

(g)enforcement,

(h)the adjudication of disputes.

(3)Regulations under subsection (2)(d) may—

(a)make provision as to the circumstances in which a Primary Care Trust may impose a variation of contract terms,

(b)make provision as to the suspension or termination of any duty under the contract to provide services of a prescribed description.

(4)Regulations making provision of the kind described in subsection (3)(b) may prescribe services by reference to the manner or circumstances in which they are provided.

(5)Regulations under subsection (1) must make provision as to the right of persons to whom services are provided to choose the persons from whom they receive them.

122GOS contracts: disputes and enforcement

(1)Regulations may make provision for the resolution of disputes as to the terms of a proposed general ophthalmic services contract.

(2)Regulations under subsection (1) may make provision—

(a)for the referral of the terms of the proposed contract to the Secretary of State, and

(b)for the Secretary of State, or a person appointed by him, to determine the terms on which the contract may be entered into.

(3)Regulations may make provision for a person or persons entering into a general ophthalmic services contract to be regarded, in circumstances where he or they so elect, as a health service body for the purposes of section 9, but only so far as concerns the general ophthalmic services contract (and not for any other purpose).

(4)Regulations under subsection (3) may include provision as to the application of section 9 in cases where—

(a)persons practising in partnership elect to become a health service body, and

(b)there is a change in the membership of the partnership.

(5)Where—

(a)by virtue of regulations under subsection (3), subsection section 9(11) applies in relation to a general ophthalmic services contract, and

(b)a direction as to payments is made under that provision in relation to the contract,

the direction is enforceable in a county court (if the court so orders) as if it were a judgment or order of that court.

Performance of primary ophthalmic services

123Persons performing primary ophthalmic services

(1)Regulations may provide that a health care professional of a prescribed description may not perform any primary ophthalmic service for which a Primary Care Trust is responsible unless he is included in a list maintained under the regulations by a Primary Care Trust.

(2)For the purposes of this section—

(a)“health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17),

(b)a Primary Care Trust is responsible for an ophthalmic service if it provides the service, or secures its provision, by or under any enactment.

(3)Regulations under this section may make provision in relation to lists under this section and in particular as to—

(a)the preparation, maintenance and publication of a list,

(b)eligibility for inclusion in a list,

(c)applications for inclusion (including provision as to the Primary Care Trust to which an application must be made, and for the procedure for applications and the documents to be supplied on application),

(d)the grounds on which an application for inclusion may or must be granted or refused,

(e)requirements with which a person included in a list must comply (including the declaration of financial interests and gifts and other benefits),

(f)suspension or removal from a list (including provision for the grounds for, and consequences of, suspension or removal),

(g)circumstances in which a person included in a list may not withdraw from it,

(h)payments to be made in respect of a person suspended from a list (including provision for the amount of the payment, or the method of calculating the payment, to be determined by the Secretary of State or a person appointed by him),

(i)the criteria to be applied in making decisions under the regulations,

(j)appeals against decisions made by a Primary Care Trust under the regulations, and

(k)disclosure of information about applicants for inclusion, grants or refusals of applications or suspensions or removals,

and may make any provision corresponding to anything in sections 151 to 159.

(4)Regulations under this section may, in particular, also provide for—

(a)a person’s inclusion in a list to be subject to conditions determined by a Primary Care Trust,

(b)a Primary Care Trust to vary the conditions or impose different ones,

(c)the consequences of failing to comply with a condition (including removal from a list),

(d)the review by a Primary Care Trust of decisions made by it by virtue of the regulations.

(5)The imposition of such conditions must be with a view to—

(a)preventing any prejudice to the efficiency of the services to which a list relates, or

(b)preventing fraud.

(6)Regulations under this section may, in particular, also prescribe the qualifications and experience which a medical practitioner who applies for inclusion in a list under this section must have, and may—

(a)provide for the practitioner to show to the satisfaction of a committee recognised by the Secretary of State for the purpose that he possesses such qualifications and experience,

(b)confer on a person who is dissatisfied with the determination of such a committee a right of appeal to a committee appointed by the Secretary of State, and

(c)provide for anything which appears to the Secretary of State to be appropriate in connection with that right of appeal.

(7)Regulations making provision as to the matters referred to in subsection (3)(k) may in particular authorise the disclosure of information—

(a)by a Primary Care Trust to the Secretary of State, and

(b)by the Secretary of State to a Primary Care Trust.

Assistance and support

124Assistance and support: primary ophthalmic services

(1)A Primary Care Trust may provide assistance or support to any person providing or proposing to provide primary ophthalmic services under a general ophthalmic services contract.

(2)Assistance or support provided by a Primary Care Trust under subsection (1) is provided on such terms, including terms as to payment, as the Primary Care Trust considers appropriate.

(3)“Assistance” includes financial assistance.

Local Optical Committees

125Local Optical Committees

(1)A Primary Care Trust may recognise a committee formed for its area, or for its area and that of one or more other Primary Care Trusts, which it is satisfied is representative of—

(a)the persons to whom subsection (2) applies, and

(b)the persons to whom subsection (3) applies.

(2)This subsection applies to each person who, under a general ophthalmic services contract entered into by him, is providing primary ophthalmic services in the area for which the committee is formed.

(3)This subsection applies to each optometrist not falling within subsection (2)—

(a)who is performing primary ophthalmic services in the area for which the committee is formed, whether under section 115(4)(a), or under a general ophthalmic services contract, and

(b)who has notified the Primary Care Trust that he wishes to be represented by the committee (and has not notified it that he wishes to cease to be so represented).

(4)A committee recognised under this section is called the Local Optical Committee for the area for which it is formed.

(5)Any such committee may delegate any of its functions, with or without restrictions or conditions, to sub-committees composed of members of that committee.

(6)Any such committee may co-opt persons not falling within subsection (2) or (3) on such terms as it considers appropriate.

(7)Regulations may require a Primary Care Trust, in the exercise of its functions relating to primary ophthalmic services, to consult any committee recognised by it under this section on such occasions and to such extent as may be prescribed.

(8)A committee recognised under this section has such other functions as may be prescribed.

(9)A committee recognised under this section must in respect of each year determine the amount of its administrative expenses for that year.

(10)A Primary Care Trust may—

(a)on the request of a committee recognised by it, allot to that committee such sums as the Primary Care Trust may determine for defraying the committee’s administrative expenses, and

(b)deduct the amount of such sums from the remuneration of persons of whom the committee is representative under subsection (1)(a) under the general ophthalmic services contracts entered into by those persons with the Primary Care Trust.

(11)The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.

Part 7Pharmaceutical services and local pharmaceutical services

Chapter 1Provision of pharmaceutical services

126Arrangements for pharmaceutical services

(1)Each Primary Care Trust must, in accordance with regulations, make the arrangements mentioned in subsection (3).

(2)The Secretary of State must make regulations for the purpose of subsection (1).

(3)The arrangements are arrangements as respects the area of the Primary Care Trust for the provision to persons who are in that area of—

(a)proper and sufficient drugs and medicines and listed appliances which are ordered for those persons by a medical practitioner in pursuance of his functions in the health service, the Scottish health service, the Northern Ireland health service or the armed forces of the Crown,

(b)proper and sufficient drugs and medicines and listed appliances which are ordered for those persons by a dental practitioner in pursuance of—

(i)his functions in the health service, the Scottish health service or the Northern Ireland health service (other than functions exercised in pursuance of the provision of services mentioned in paragraph (c)), or

(ii)his functions in the armed forces of the Crown,

(c)listed drugs and medicines and listed appliances which are ordered for those persons by a dental practitioner in pursuance of the provision of primary dental services or equivalent services in the Scottish health service or the Northern Ireland health service,

(d)such drugs and medicines and such listed appliances as may be determined by the Secretary of State for the purposes of this paragraph and which are ordered for those persons by a prescribed description of person in accordance with such conditions, if any, as may be prescribed, in pursuance of functions in the health service, the Scottish health service, the Northern Ireland health service or the armed forces of the Crown, and

(e)such other services as may be prescribed.

(4)The descriptions of persons which may be prescribed for the purposes of subsection (3)(d) are the following, or any sub-category of such a description—

(a)persons who are registered in the register maintained under article 5 of the Health Professions Order 2001,

(b)persons who are registered pharmacists,

(c)persons who are registered in the dental care professionals register established under section 36B of the Dentists Act 1984 (c. 24),

(d)persons who are optometrists,

(e)persons who are registered osteopaths within the meaning of the Osteopaths Act 1993 (c. 21),

(f)persons who are registered chiropractors within the meaning of the Chiropractors Act 1994 (c. 17),

(g)persons who are registered nurses or registered midwives,

(h)persons not mentioned above who are registered in any register established, continued or maintained under an Order in Council under section 60(1) of the Health Act 1999 (c. 8),

(i)any other description of persons which appears to the Secretary of State to be a description of persons whose profession is regulated by or under a provision of, or made under, an Act of the Scottish Parliament or Northern Ireland legislation and which the Secretary of State considers it appropriate to specify.

(5)A determination under subsection (3)(d) may—

(a)make different provision for different cases,

(b)provide for the circumstances or cases in which a drug, medicine or appliance may be ordered,

(c)provide that persons falling within a description specified in the determination may exercise discretion in accordance with any provision made by the determination in ordering drugs, medicines and listed appliances.

(6)The arrangements which may be made by a Primary Care Trust under subsection (1) include arrangements for the provision of a service by means such that the person receiving it does so otherwise than at the premises from which it is provided.

(7)Where a person with whom a Primary Care Trust makes arrangements under subsection (1) wishes to provide services to persons outside the area of the Primary Care Trust he may, subject to any provision made by regulations in respect of arrangements under this section, provide such services under the arrangements.

(8)The services provided under this section are, together with additional pharmaceutical services provided in accordance with a direction under section 127, referred to in this Act as “pharmaceutical services”.

(9)In this section—

• “armed forces of the Crown” does not include forces of a Commonwealth country or forces raised in a colony,

• “listed” means included in a list approved by the Secretary of State for the purposes of this section,

• “the Scottish health service” means the health service within the meaning of the National Health Service (Scotland) Act 1978 (c. 29), and

• “the Northern Ireland health service” means the health service within the meaning of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)).

127Arrangements for additional pharmaceutical services

(1)The Secretary of State may—

(a)give directions to a Primary Care Trust requiring it to arrange for the provision to persons within or outside its area of additional pharmaceutical services, or

(b)by giving directions to a Primary Care Trust authorise it to arrange for such provision if it wishes to do so.

(2)Directions under this section may require or authorise a Primary Care Trust to arrange for the provision of a service by means such that the person receiving it does so otherwise than at the premises from which it is provided (whether those premises are inside or outside the area of the Primary Care Trust).

(3)The Secretary of State must publish any directions under this section in the Drug Tariff or in such other manner as he considers appropriate.

(4)In this section—

• “additional pharmaceutical services”, in relation to directions, means the services (of a kind that do not fall within section 126) which are specified in the directions, and

• “Drug Tariff” means the Drug Tariff published under regulation 18 of the National Health Service (Pharmaceutical Services) Regulations 1992 (S.I. 1992/662) or under any corresponding provision replacing, or otherwise derived from, that regulation.

128Terms and conditions, etc

(1)Directions under section 127 may require the Primary Care Trust to which they apply, when making arrangements—

(a)to include, in the terms on which the arrangements are made, such terms as may be specified in the directions,

(b)to impose, on any person providing a service in accordance with the arrangements, such conditions as may be so specified.

(2)The arrangements must secure that any service to which they apply is provided only by a person—

(a)whose name is included in a pharmaceutical list, or

(b)who has entered into a pharmaceutical care services contract under section 17Q of the National Health Service (Scotland) Act 1978.

(3)Different arrangements may be made with respect to—

(a)the provision of the same service by the same person but in different circumstances, or

(b)the provision of the same service by different persons.

(4)A Primary Care Trust must provide details of proposed arrangements (including the remuneration to be offered for the provision of services) to any person who asks for them.

(5)After making any arrangements, a Primary Care Trust must publish, in such manner as the Secretary of State may direct, such details of the arrangements as he may direct.

(6)“Pharmaceutical list” includes, subject to any provision of the directions in question, a list published in accordance with regulations made under—

(a)section 83(2)(a) of the National Health Service (Wales) Act 2006 (c. 42), or

(b)Article 63(2A)(a) of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)).

129Regulations as to pharmaceutical services

(1)Regulations must provide for securing that arrangements made by a Primary Care Trust under section 126 will—

(a)enable persons for whom drugs, medicines or appliances mentioned in that section are ordered as there mentioned to receive them from persons with whom such arrangements have been made, and

(b)ensure the provision of services prescribed under subsection (3)(e) of that section by persons with whom such arrangements have been made.

(2)The regulations must include provision—

(a)for the preparation and publication by a Primary Care Trust of one or more lists of persons, other than medical practitioners and dental practitioners, who undertake to provide pharmaceutical services from premises in the area of the Primary Care Trust,

(b)that an application to a Primary Care Trust for inclusion in a pharmaceutical list must be made in the prescribed manner and must state—

(i)the services which the applicant will undertake to provide and, if they consist of or include the supply of appliances, which appliances he will undertake to supply, and

(ii)the premises from which he will undertake to provide those services,

(c)that, except in prescribed cases (which may, in particular, include cases of applications for the provision only of services falling within subsection (7))—

(i)an application for inclusion in a pharmaceutical list by a person not already included, and

(ii)an application by a person already included in a pharmaceutical list for inclusion also in respect of services or premises other than those already listed in relation to him,

may be granted only if the Primary Care Trust is satisfied, in accordance with the regulations, that it is necessary or expedient to grant the application in order to secure in the neighbourhood in which the premises are located the adequate provision by persons included in the list of the services, or some of the services, specified in the application, and

(d)for the removal of an entry in respect of premises from a pharmaceutical list if it has been determined in the prescribed manner that the person to whom the entry relates—

(i)has never provided from those premises, or

(ii)has ceased to provide from them,

the services, or any of the services, which he is listed as undertaking to provide from them.

(3)The regulations may prescribe the extent to which the provision of LP services (within the meaning given by paragraph 1 of Schedule 12) must be taken into account in determining whether to grant an application for inclusion in a pharmaceutical list.

(4)The regulations may include the provision mentioned in subsection (5) for the case where—

(a)two or more applications referred to in subsection (2)(c)(i) or (ii) relate to the same neighbourhood,

(b)they are considered together by the Primary Care Trust, and

(c)the Primary Care Trust would be satisfied as mentioned in subsection (2)(c) in relation to each application taken on its own, but is not so satisfied in relation to all of them taken together.

(5)The provision mentioned in this subsection is provision for the Primary Care Trust, in determining which application (or applications) to grant, to take into account any proposals specified in the applications in relation to the sale or supply at the premises in question, otherwise than by way of pharmaceutical services or in accordance with a private prescription, of—

(a)drugs and medicines, and

(b)other products for, or advice in relation to, the prevention, diagnosis, monitoring or treatment of illness or handicap, or the promotion or protection of health.

(6)The regulations may include provision—

(a)that an application to a Primary Care Trust may be granted in respect of some only of the services specified in it,

(b)that an application to a Primary Care Trust relating to services of a prescribed description may be granted only if it appears to the Primary Care Trust that the applicant has satisfied such conditions with regard to the provision of those services as may be prescribed,

(c)that an application to a Primary Care Trust by a person who qualified to have his name registered under the Pharmacy Act 1954 (c. 61) by virtue of section 4A of that Act (qualification by European diploma) may not be granted unless the applicant satisfies the Primary Care Trust that he has the knowledge of English which, in the interest of himself and persons making use of the services to which the application relates, is necessary for the provision of pharmaceutical services in the area of the Primary Care Trust,

(d)that the inclusion of a person in a pharmaceutical list in pursuance of such an application may be for a fixed period,

(e)that, where the premises from which an application states that the applicant will undertake to provide services are in an area of a prescribed description, the applicant may not be included in the pharmaceutical list unless his inclusion is approved by reference to prescribed criteria by the Primary Care Trust in whose area those premises are situated,

(f)that that Primary Care Trust may give its approval subject to conditions,

(g)as to other grounds on which a Primary Care Trust may, or must, refuse to grant an application (including grounds corresponding to the conditions referred to in section 151(2), (3) or (4) as read with section 153),

(h)as to information which must be supplied to a Primary Care Trust by a person included, or seeking inclusion, in a pharmaceutical list (or by arrangement with him),

(i)for the supply to a Primary Care Trust by an individual—

(i)who is included, or seeking inclusion, in a pharmaceutical list, or

(ii)who is a member of the body of persons controlling a body corporate included, or seeking inclusion, in a pharmaceutical list,

of a criminal conviction certificate under section 112 of the Police Act 1997 (c. 50), a criminal record certificate under section 113 of that Act or an enhanced criminal record certificate under section 115 of that Act,

(j)for grounds on which a Primary Care Trust may defer a decision whether or not to grant an application,

(k)for the disclosure by a Primary Care Trust, to prescribed persons or persons of prescribed descriptions, of information of a prescribed description about applicants for inclusion in a pharmaceutical list, and refusals by the Primary Care Trust to grant such applications,

(l)as to criteria to be applied in making decisions under the regulations (other than decisions required by virtue of paragraph (e)),

(m)as to the making of declarations about—

(i)financial interests,

(ii)gifts above a prescribed value, and

(iii)other benefits received.

(7)A service falls within this subsection if the means of providing it is such that the person receiving it does so otherwise than at the premises from which it is provided.

(8)The regulations may, in respect of services falling within subsection (7), include provision—

(a)requiring persons to be approved for the purposes of providing such services, or

(b)requiring the Primary Care Trust to make the grant of an application subject to prescribed conditions.

(9)The approval mentioned in subsection (8)(a) is approval by the Secretary of State or such other person as may be specified in the regulations, in accordance with criteria to be specified in or determined under the regulations (whether by the Secretary of State or by another person so specified).

(10)Before making regulations by virtue of subsection (6)(m), the Secretary of State must consult such organisations as he considers appropriate appearing to him to represent persons providing pharmaceutical services.

(11)In this Act a “pharmaceutical list” means a list published in accordance with regulations made under subsection (2)(a).

130Regulations under section 129: appeals, etc

(1)Regulations under section 129 must include provision conferring on such persons as may be prescribed rights of appeal from decisions made by virtue of that section.

(2)If regulations made by virtue of section 129(6)(g) provide that a Primary Care Trust may refuse to grant an application, they must also provide for an appeal (by way of redetermination) to the FHSAA against the decision of the Primary Care Trust.

(3)Regulations under section 129 must be so framed as to preclude—

(a)a person included in a pharmaceutical list, and

(b)an employee of such a person,

from taking part in the decision whether an application such as is mentioned in section 129(2)(c) should be granted or an appeal against such a decision brought by virtue of subsection (1) of this section should be allowed.

131Power to charge

(1)The Secretary of State may give directions to a Primary Care Trust requiring it to charge a fee in cases or descriptions of case specified in the directions to persons who make an application referred to in section 129(2)(c)(i) or (ii).

(2)The Secretary of State may in the directions—

(a)specify the fee himself, or

(b)require the Primary Care Trust to determine the amount of the fee in accordance with any requirements set out in the directions.

(3)Before determining the amount of the fee-

(a)in a subsection (2)(a) case, the Secretary of State must consult such organisations as he considers appropriate that appear to him to represent persons providing pharmaceutical services and such organisations as he considers appropriate that appear to him to represent Primary Care Trusts,

(b)in a subsection (2)(b) case, the Primary Care Trust must undertake any consultation required by the directions.

(4)The Secretary of State must publish in such manner as he considers appropriate any directions he gives under this section.

(5)In a subsection (2)(b) case, the Primary Care Trust must publish in such manner as it considers appropriate the fee which it determines.

132Persons authorised to provide pharmaceutical services

(1)Except as may be provided for by or under regulations, no arrangements may be made by a Primary Care Trust with a medical practitioner or dental practitioner under which he is required or agrees to provide pharmaceutical services to any person to whom he is rendering primary medical services or primary dental services.

(2)Except as may be provided for by or under regulations, no arrangements for the dispensing of medicines may be made under this Chapter with persons other than persons who—

(a)are registered pharmacists or persons lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 (c. 67), and

(b)undertake that all medicines supplied by them under the arrangements will be dispensed either by or under the supervision of a registered pharmacist.

(3)Regulations must provide for the preparation and publication by each Primary Care Trust of one or more lists of medical practitioners who undertake to provide drugs, medicines or listed appliances (within the meaning given by section 126) under arrangements with the Primary Care Trust.

(4)The regulations may, in particular, include provision—

(a)as to grounds on which a Primary Care Trust may, or must, refuse to grant an application for inclusion in a list of medical practitioners referred to in subsection (3) (including grounds corresponding to the conditions referred to in section 151(2), (3) or (4) as read with section 153(2)),

(b)as to information which must be supplied to a Primary Care Trust by a medical practitioner included, or seeking inclusion, in such a list (or by arrangement with him),

(c)for the supply to a Primary Care Trust by a medical practitioner who is included, or seeking inclusion, in such a list of a criminal conviction certificate under section 112 of the Police Act 1997 (c. 50), a criminal record certificate under section 113 of that Act or an enhanced criminal record certificate under section 115 of that Act,

(d)for grounds on which a Primary Care Trust may defer a decision whether or not to grant an application for inclusion in such a list,

(e)for the disclosure by a Primary Care Trust to prescribed persons or persons of prescribed descriptions, of information of a prescribed description about applicants for inclusion in such a list, and refusals by the Primary Care Trust to grant such applications,

(f)as to criteria to be applied in making decisions under the regulations.

(5)If regulations made by virtue of subsection (4)(a) provide that a Primary Care Trust may refuse to grant an application for inclusion in such a list, they must also provide for an appeal (by way of redetermination) to the FHSAA against the decision of the Primary Care Trust.

(6)The regulations must include provision for the removal of an entry from a list in prescribed circumstances.

(7)No arrangements for the provision of—

(a)pharmaceutical services falling within section 126(3)(e), or

(b)additional pharmaceutical services provided in accordance with a direction under section 127,

may be made with persons other than those who are registered pharmacists or are of a prescribed description.

(8)Where—

(a)arrangements for the provision of pharmaceutical services have been made with a registered pharmacist, and

(b)a suspension order or an interim suspension order is made with respect to him,

he may not provide pharmaceutical services in person during the period of suspension.

(9)“Suspension order” and “interim suspension order” have the same meaning as in the Pharmacy Act 1954 (c. 61).

133Inadequate provision of pharmaceutical services

(1)Subsection (2) applies if the Secretary of State is satisfied, after such inquiry as he considers appropriate, that—

(a)as respects the area, or part of the area, of a Primary Care Trust, the persons whose names are included in any pharmaceutical list are not such as to secure the adequate provision of pharmaceutical services in that area or part, or

(b)for any other reason any considerable number of persons in any such area or part are not receiving satisfactory services under the arrangements in force under this Chapter.

(2)Where this subsection applies, the Secretary of State—

(a)may authorise the Primary Care Trust to make such other arrangements as he may approve, or may himself make such other arrangements, and

(b)may dispense with any of the requirements of regulations made under this Part (other than Chapters 2 to 4) so far as appears to him necessary to meet exceptional circumstances and enable such arrangements to be made.

Chapter 2Local pharmaceutical services: pilot schemes

134Pilot schemes

(1)Primary Care Trusts may establish pilot schemes.

(2)In this Act, a “pilot scheme” means one or more agreements—

(a)made by a Primary Care Trust in accordance with this Chapter,

(b)under which local pharmaceutical services will be provided (otherwise than by the Primary Care Trust), and

(c)the parties to which do not include any other Primary Care Trust.

(3)A pilot scheme may include arrangements—

(a)for the provision of services which are not local pharmaceutical services, but which may be provided under this Act, other than under Chapter 1 of this Part, and whether or not of the kind usually provided by pharmacies,

(b)for the provision of training and education (including training and education for persons who are, or may become, involved in the provision of local pharmaceutical services).

(4)A pilot scheme may not combine arrangements for the provision of local pharmaceutical services with arrangements for the provision of primary medical services or primary dental services.

(5)In determining the arrangements it needs to make in order to comply with section 126, a Primary Care Trust may take into account arrangements under a pilot scheme made by it.

(6)The functions of an NHS trust and an NHS foundation trust include power to provide any services to which a pilot scheme applies.

(7)In this Chapter—

• “local pharmaceutical services” means such services of a kind which may be provided under section 126, or by virtue of section 127 (other than practitioner dispensing services) as may be prescribed for the purposes of this Chapter, and

• “piloted services” means services provided under a pilot scheme (including any services to which the scheme applies as a result of subsection (3)).

(8)“Practitioner dispensing services” means the provision of drugs, medicines or listed appliances (within the meaning given by section 126) by a medical practitioner or dental practitioner to a patient of his pursuant to arrangements made by virtue of section 132(1).

135Making pilot schemes

Schedule 11 makes provision with respect to making pilot schemes, including provision with respect to the procedure to be followed.

136Designation of priority neighbourhoods or premises

(1)The Secretary of State may make regulations allowing a Primary Care Trust to designate—

(a)neighbourhoods,

(b)premises, or

(c)descriptions of premises,

for the purposes of this section.

(2)The regulations may, in particular, make provision—

(a)as to the circumstances in which, and the neighbourhoods or premises in relation to which, designations may be made or maintained,

(b)allowing a Primary Care Trust to defer consideration of pharmaceutical list applications relating to neighbourhoods, premises or descriptions of premises that have been designated,

(c)allowing a designation to be cancelled in prescribed circumstances,

(d)requiring a designation to be cancelled—

(i)if the Secretary of State gives a direction to that effect, or

(ii)in prescribed circumstances.

(3)“Pharmaceutical list applications” means applications for inclusion in a pharmaceutical list.

137Reviews of pilot schemes

(1)At least one review of the operation of each pilot scheme must be conducted by the Secretary of State.

(2)Each pilot scheme must be reviewed under this section before the end of the period of three years beginning with the date on which piloted services are first provided under the scheme.

(3)When conducting a review of a pilot scheme, the Secretary of State must give—

(a)the Primary Care Trust concerned, and

(b)any person providing services under the scheme,

an opportunity to comment on any matter relevant to the review.

(4)Otherwise, the procedure on any review must be determined by the Secretary of State.

138Variation and termination of pilot schemes

(1)The Secretary of State may give directions authorising Primary Care Trusts to vary pilot schemes (otherwise than in response to directions given under subsection (2)) in such circumstances, and subject to such conditions, as may be specified in the directions.

(2)The Secretary of State may by directions require a pilot scheme to be varied by the Primary Care Trust concerned in accordance with the directions.

(3)If satisfied that a pilot scheme is (for any reason) unsatisfactory, the Secretary of State may give directions to the Primary Care Trust concerned requiring it to bring the scheme to an end in accordance with the terms of the directions.

139NHS contracts and the provision of piloted services

(1)In the case of a pilot scheme entered into, or to be entered into, by a single individual or body corporate (other than an NHS foundation trust), that individual or body may make an application under this section to become a health service body.

(2)In the case of any other pilot scheme, all of those providing, or proposing to provide, piloted services under the scheme may together make an application under this section to become a single health service body.

(3)An application must—

(a)be made to the Secretary of State in accordance with such provisions as may be made by regulations, and

(b)specify the pilot scheme in relation to which it is made.

(4)Except in such cases as may be prescribed, the Secretary of State may grant an application.

(5)If an application is granted, the Secretary of State must specify a date in relation to that application and, as from that date—

(a)in the case of an application under subsection (1), the applicant is, and

(b)in the case of an application under subsection (2), the applicants together are,

a health service body for the purposes of section 9.

(6)That section has effect in relation to such a health service body (“a PHS body”), acting as commissioner, as if the functions referred to in section 9(1) were the provision of piloted services.

(7)Except in such circumstances as may be prescribed, a PHS body resulting from an application under subsection (2) must be treated, at any time, as consisting of those who are providing piloted services under the scheme.

(8)A direction as to payment made under section 9(11) against, or in favour of, a PHS body is enforceable in a county court (if the court so orders) as if it were a judgment or order of that court.

(9)Regulations may provide for a PHS body to cease to be a PHS body in prescribed circumstances.

(10)The Secretary of State must—

(a)maintain and publish a list of PHS bodies,

(b)publish a revised copy of the list as soon as is reasonably practicable after any change is made to it.

(11)The list must be published in such manner as the Secretary of State considers appropriate.

140Funding of preparatory work

(1)Provision may be made by regulations for Primary Care Trusts to make payments of financial assistance for preparatory work.

(2)“Preparatory work” means work which it is reasonable for a person to undertake—

(a)in connection with preparing proposals for a pilot scheme, or

(b)in preparing for the provision by him of any piloted services.

(3)The regulations may, in particular, include provision—

(a)prescribing the circumstances in which payments of financial assistance may be made,

(b)imposing a limit on the amount of any payment of financial assistance which a Primary Care Trust may make in any prescribed period in respect of any one person or any one pilot scheme,

(c)imposing a limit on the aggregate amount which a Primary Care Trust may pay by way of financial assistance in any one financial year,

(d)requiring a person to whom assistance is given under this section to comply with such conditions as may be imposed in accordance with prescribed requirements, and

(e)for repayment in the case of a failure to comply with any condition so imposed.

141Application of this Act

This Act has effect in relation to piloted services—

(a)subject to any provision of, or made under, this Chapter, section 145 (application of enactments) or section 178 (charges for local pharmaceutical services), but

(b)otherwise as if those services were provided as a result of the delegation by the Secretary of State of his functions (by directions given under section 7).

142Premises from which piloted services may be provided

The Secretary of State may by regulations—

(a)prevent (except in such circumstances and to such extent as may be prescribed) the provision of both piloted services and pharmaceutical services from the same premises,

(b)make provision with respect to the inclusion, removal, re-inclusion or modification of an entry in respect of premises in a pharmaceutical list.

143Control of entry regulations

The power to make regulations under section 129 includes power to prescribe the extent to which the provision of piloted services must be taken into account in determining whether to grant an application for inclusion in a pharmaceutical list.

Chapter 3Local pharmaceutical services: LPS schemes

144Local pharmaceutical services schemes

Schedule 12 makes provision with respect to the provision of local pharmaceutical services in accordance with schemes made by Primary Care Trusts.

Chapter 4Local pharmaceutical services: miscellaneous

Application of enactments

145Application of enactments

(1)The Secretary of State may by regulations make, in relation to local pharmaceutical services arrangements or persons providing or assisting in the provision of services under such arrangements, provision corresponding (whether or not exactly) to enactments containing provision relating to—

(a)section 92 arrangements or section 107 arrangements, or

(b)persons who provide or perform services under section 92 or section 107.

(2)The regulations may, in particular, provide for the application of any such enactment with such modifications, if any, as the Secretary of State considers appropriate.

(3)The provision which may be made under this section includes provision amending, repealing or revoking enactments.

(4)“Local pharmaceutical services arrangements” means arrangements made under an LPS scheme or a pilot scheme.

Performance of local pharmaceutical services

146Persons performing local pharmaceutical services

(1)Regulations may provide that a health care professional of a prescribed description may not perform any local pharmaceutical service for which a Primary Care Trust is responsible unless he is included in a list maintained under the regulations by a Primary Care Trust.

(2)For the purposes of this section—

(a)“health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17),

(b)a Primary Care Trust is responsible for a local pharmaceutical service if it secures its provision by or under any enactment.

(3)Regulations under this section may make provision in relation to lists under this section and in particular as to—

(a)the preparation, maintenance and publication of a list,

(b)eligibility for inclusion in a list,

(c)applications for inclusion (including provision as to the Primary Care Trust to which an application must be made, and for the procedure for applications and the documents to be supplied on application),

(d)the grounds on which an application for inclusion may or must be granted or refused,

(e)requirements with which a person included in a list must comply (including the declaration of financial interests and gifts and other benefits),

(f)suspension or removal from a list (including provision for the grounds for, and consequences of, suspension or removal),

(g)circumstances in which a person included in a list may not withdraw from it,

(h)payments to be made in respect of a person suspended from a list (including provision for the amount of the payment, or the method of calculating the payment, to be determined by the Secretary of State or a person appointed by him),

(i)the criteria to be applied in making decisions under the regulations,

(j)appeals against decisions made by a Primary Care Trust under the regulations, and

(k)disclosure of information about applicants for inclusion, grants or refusals of applications or suspensions or removals,

and may make any provision corresponding to anything in sections 151 to 159.

(4)Regulations under this section may, in particular, also provide for—

(a)a person’s inclusion in a list to be subject to conditions determined by a Primary Care Trust,

(b)a Primary Care Trust to vary the conditions or impose different ones,

(c)the consequences of failing to comply with a condition (including removal from a list),

(d)the review by a Primary Care Trust of decisions made by it by virtue of the regulations.

(5)The imposition of such conditions must be with a view to—

(a)preventing any prejudice to the efficiency of the services to which a list relates, or

(b)preventing fraud.

(6)Regulations making provision as to the matters referred to in subsection (3)(k) may in particular authorise the disclosure of information—

(a)by a Primary Care Trust to the Secretary of State, and

(b)by the Secretary of State to a Primary Care Trust.

Assistance and support

147Assistance and support: local pharmaceutical services

(1)A Primary Care Trust may provide assistance or support to any person providing local pharmaceutical services.

(2)Assistance or support provided by a Primary Care Trust under subsection (1) is provided on such terms, including terms as to payment, as the Primary Care Trust considers appropriate.

(3)“Assistance” includes financial assistance.

Chapter 5Conditional inclusion in pharmaceutical lists, and supplementary lists

148Conditional inclusion in pharmaceutical lists

(1)Regulations may provide—

(a)that if a person is included in a pharmaceutical list he is subject, while he remains included in the list, to conditions determined by the Primary Care Trust in whose list he is included,

(b)for the Primary Care Trust to vary that person’s terms of service for the purpose of or in connection with the imposition of any such conditions,

(c)for the Primary Care Trust to vary the conditions or impose different ones,

(d)for the consequences of failing to comply with a condition (including removal from the list), and

(e)for the review by the Primary Care Trust of any decision made by virtue of the regulations.

(2)The imposition of conditions must be with a view to—

(a)preventing any prejudice to the efficiency of the services in question, or

(b)preventing any acts or omissions within section 151(3)(a).

(3)If regulations provide for a practitioner’s removal from the list for breach of condition—

(a)the regulations may provide that he may not withdraw from the list while the Primary Care Trust is investigating whether there are grounds for exercising their power to remove him, or after the Primary Care Trust has decided to remove him but before it has given effect to that decision, and

(b)the regulations must include provision—

(i)requiring the practitioner to be given notice of any allegation against him,

(ii)giving him the opportunity of putting his case at a hearing before the Primary Care Trust makes any decision as to his removal from the list, and

(iii)requiring him to be given notice of the decision of the Primary Care Trust and the reasons for it and of his right of appeal under subsection (4).

(4)If regulations provide as mentioned in subsection (1), they must also provide for an appeal by the person in question to the FHSAA against the decision of the Primary Care Trust—

(a)to impose conditions, or any particular condition,

(b)to vary a condition,

(c)to vary his terms of service,

(d)on any review of an earlier such decision of the Primary Care Trust,

(e)to remove him from the list for breach of condition,

and the appeal must be by way of redetermination of the decision of the Primary Care Trust.

(5)The regulations may provide for any such decision not to have effect until the determination by the FHSAA of any appeal against it, and must so provide in relation to a decision referred to in subsection (4)(e).

(6)Regulations under this section may provide for the disclosure by a Primary Care Trust, to prescribed persons or persons of prescribed descriptions, of information of a prescribed description—

(a)about persons whose inclusion in a pharmaceutical list is subject to conditions imposed under this section, and

(b)about the removal of such persons from a pharmaceutical list for breach of condition.

(7)In this Part, “terms of service” means the terms upon which, by virtue of regulations, a person undertakes to provide pharmaceutical services.

149Supplementary lists

(1)The Secretary of State may make regulations providing for the preparation and publication by each Primary Care Trust of one or more lists of persons approved by the Primary Care Trust for the purpose of assisting in the provision of pharmaceutical services.

(2)Such a list is referred to in this section, section 150 and section 159 as a “supplementary list”.

(3)The regulations may, in particular, include provision as to—

(a)the Primary Care Trust to which an application for inclusion in a supplementary list must be made,

(b)the procedure for applying for inclusion, including any information to be supplied to the Primary Care Trust (whether by the applicant or by arrangement with him),

(c)grounds on which the Primary Care Trust may, or must, refuse a person’s application for inclusion in a supplementary list (including his unsuitability for inclusion in such a list), or on which it may defer its decision on the application,

(d)requirements with which a person included in a supplementary list must comply (including the declaration of financial interests and of gifts and other benefits),

(e)grounds on which a Primary Care Trust may, or must, suspend or remove a person from a supplementary list, the procedure for doing so, and the consequences of doing so,

(f)payments to or in respect of persons who are suspended from a supplementary list (including provision for the amount of the payments, or the method of calculating the amount, to be determined by the Secretary of State or by another person appointed for the purpose by the Secretary of State),

(g)the supply to the Primary Care Trust by an applicant for inclusion in a supplementary list, or by a person included in one, of a criminal conviction certificate under section 112 of the Police Act 1997 (c. 50), a criminal record certificate under section 113 of that Act or an enhanced criminal record certificate under section 115 of that Act,

(h)circumstances in which a person included in a supplementary list may not withdraw from it,

(i)criteria to be applied in making decisions under the regulations,

(j)appeals against decisions of Primary Care Trusts under the regulations,

(k)the disclosure by a Primary Care Trust, to prescribed persons or persons of prescribed descriptions, of information of a prescribed description about applicants for inclusion in a supplementary list, refusals of such applications, and suspensions and removals from that list.

(4)The regulations may, in particular, also provide for—

(a)a person’s inclusion in a supplementary list to be subject to conditions determined by the Primary Care Trust,

(b)the Primary Care Trust to vary the conditions or impose different ones,

(c)the consequences of failing to comply with a condition (including removal from the list), and

(d)the review by the Primary Care Trust of its decisions made by virtue of regulations under this subsection.

(5)The imposition of such conditions must be with a view to—

(a)preventing any prejudice to the efficiency of the services to which the supplementary list relates, or

(b)preventing any acts or omissions of the type described in section 151(3)(a).

(6)Regulations made by virtue of subsection (3)(e) may (but need not) make provision corresponding to anything in sections 151 to 159.

(7)If the regulations provide under subsection (3)(e) or (4) that a Primary Care Trust may suspend or remove a person from a supplementary list, they must include provision—

(a)requiring him to be given notice of any allegation against him,

(b)giving him the opportunity of putting his case at a hearing before the Primary Care Trust makes any decision as to his suspension or removal, and

(c)requiring him to be given notice of the decision of the Primary Care Trust and the reasons for it and of any right of appeal under subsection (8) or (9).

(8)If the regulations provide under subsection (3)(c) or (e) that a Primary Care Trust may refuse a person’s application for inclusion in a supplementary list, or remove a person from one, the regulations must provide for an appeal (by way of redetermination) to the FHSAA against the decision of the Primary Care Trust.

(9)If the regulations make provision under subsection (4), they must provide for an appeal (by way of redetermination) by the person in question to the FHSAA against the decision of the Primary Care Trust—

(a)to impose conditions, or any particular condition,

(b)to vary a condition,

(c)to remove him from the supplementary list for breach of condition,

(d)on any review of an earlier such decision of the Primary Care Trust.

150Further provision about regulations under section 149

(1)Regulations under section 149 may require a person (“A”) included in—

(a)a pharmaceutical list, or

(b)a list under section 132(3) (provision of drugs, medicines or listed appliances),

not to employ or engage a person (“B”) to assist him in the provision of the service to which the list relates unless B is included in a list mentioned in subsection (2).

(2)The lists are—

(a)a list referred to in subsection (1),

(b)a supplementary list,

(c)a list under section 91, 106 or 123,

(d)a list under section 146 or a list corresponding to a list under section 91 prepared by a Primary Care Trust by virtue of regulations made under section 145,

(e)a list corresponding to a list mentioned in any of paragraphs (a) to (d) prepared by a Local Health Board under or by virtue of the National Health Service (Wales) Act 2006 (c. 42),

or, in any of the cases in paragraphs (a) to (e), such a list of a prescribed description.

(3)If regulations do so require, they—

(a)need not require both A and B to be included in lists prepared by the same Primary Care Trust, but

(b)may, in particular, require that both A and B be included in lists prepared by Primary Care Trusts.

Chapter 6Disqualification

151Disqualification of practitioners

(1)If it appears to a Primary Care Trust that any of the conditions set out in subsections (2) to (4) is established in relation to a person included in a pharmaceutical list it may (or, in cases falling within subsection (5), must) decide to remove him from that list.

(2)The first condition is that the continued inclusion of the practitioner in the list would be prejudicial to the efficiency of the services which those included in the list undertake to provide (and such a case is referred to in this Chapter as an “efficiency case”).

(3)The second condition is that the practitioner—

(a)has (whether on his own or together with another) by an act or omission caused, or risked causing, detriment to any health scheme by securing or trying to secure for himself or another any financial or other benefit, and

(b)knew that he or the other was not entitled to the benefit,

(and such a case is referred to in this Chapter as a “fraud case”).

(4)The third condition is that the practitioner is unsuitable to be included in the list (and such a case is referred to in this Chapter as an “unsuitability case”).

(5)In unsuitability cases, the Primary Care Trust must remove the practitioner from the list in prescribed circumstances.

(6)The Primary Care Trust must state which condition (or conditions) it is relying on when removing a practitioner from a list.

(7)“Health scheme” means—

(a)any of the health services under section 1(1) of this Act, section 1(1) of the National Health Service (Wales) Act 2006 (c. 42), or any enactment corresponding to section 1(1) of this Act and extending to Scotland or Northern Ireland, and

(b)any prescribed scheme,

and regulations may prescribe any scheme for the purposes of this subsection which appears to the Secretary of State to be a health or medical scheme paid for out of public funds.

(8)Detriment to a health scheme includes detriment to any patient of, or person working in, that scheme or any person liable to pay charges for services provided under that scheme.

(9)In this Chapter a “practitioner” means a person included in a pharmaceutical list.

152Contingent removal

(1)In an efficiency case or a fraud case, the Primary Care Trust may, instead of deciding to remove a practitioner from its list, decide to remove him contingently.

(2)If it so decides, it must impose such conditions as it may decide on his inclusion in the list with a view to—

(a)removing any prejudice to the efficiency of the services in question (in an efficiency case), or

(b)preventing further acts or omissions within section 151(3)(a) (in a fraud case).

(3)If the Primary Care Trust determines that the practitioner has failed to comply with a condition, it may decide to—

(a)vary the conditions, or impose different conditions, or

(b)remove him from its list.

(4)The Primary Care Trust may decide to vary the terms of service of the person concerned for the purpose of or in connection with the imposition of any conditions by virtue of this section.

153Fraud and unsuitability cases: supplementary

(1)Where the practitioner is a body corporate providing pharmaceutical services, the body corporate must be treated for the purposes of this Chapter as meeting a condition referred to in section 151(3) or (4) if any one of the body of persons controlling the body meets that condition (whether or not he first did so when he was such a person).

(2)A practitioner must be treated for the purposes of this Chapter as meeting the condition referred to in section 151(3) if—

(a)another person, because of an act or omission of his occurring in the course of providing any services mentioned in section 151(1) on the practitioner’s behalf, meets that condition, and

(b)the practitioner failed to take all such steps as were reasonable to prevent acts or omissions within section 151(3)(a) occurring in the course of the provision of those services on his behalf.

154Suspension

(1)If the Primary Care Trust is satisfied that it is necessary to do so for the protection of members of the public or is otherwise in the public interest, it may suspend a practitioner from its list—

(a)while it decides whether or not to exercise its powers under section 151 or 152 (other than in circumstances falling within paragraph (b)), or

(b)while it waits for a decision affecting the practitioner of a court or of a body which regulates—

(i)the practitioner’s profession,

(ii)the profession of a person providing any of the services mentioned in section 151(1) on the practitioner’s behalf, or

(iii)if the practitioner is a body corporate, the profession of one of its directors, or one of the body of persons controlling it or (if it is a limited liability partnership) one of its members,

or one of that regulatory body’s committees.

(2)The references in subsection (1)(b) to a court or regulatory body are to a court or such a body anywhere in the world.

(3)In a case falling within subsection (1)(a), the Primary Care Trust must specify the length of the period of suspension.

(4)In a case falling within subsection (1)(b), the Primary Care Trust may specify that the practitioner remains suspended after the decision referred to there for an additional period which the Primary Care Trust must specify.

(5)In either case—

(a)before that period expires it may extend, or further extend, the suspension for a further specified period, or

(b)if that period has expired, it may impose a further suspension, for a period which it must specify.

(6)The period of suspension (in a subsection (1)(a) case) or the additional period (in a subsection (1)(b) case), including in both cases the period of any further suspension imposed under subsection (5)(b), may not exceed six months in aggregate, except—

(a)in prescribed circumstances, when it may not extend beyond any prescribed event (which may be the expiry of a prescribed period),

(b)if, on the application of the Primary Care Trust, the FHSAA orders accordingly before the expiry of the period of suspension, or

(c)if the Primary Care Trust has applied under paragraph (b) before the expiry of the period of suspension, but the FHSAA has not made an order by the time it expires, in which case it continues until the FHSAA has made an order.

(7)If the FHSAA does so order, it must specify—

(a)the date on which the period of suspension will end, or

(b)an event beyond which it will not continue.

(8)The FHSAA may, on the application of the Primary Care Trust, make a further order (complying with subsection (7)) at any time while the period of suspension pursuant to the earlier order is still continuing.

(9)The Secretary of State may make regulations providing for payments to practitioners who are suspended.

(10)Those regulations may include provision for the amount of the payments, or the method of calculating the amount, to be determined by the Secretary of State or by another person appointed for the purpose by the Secretary of State.

155Suspension pending appeal

(1)This section applies if the Primary Care Trust decides to remove a practitioner from a list under section 151.

(2)In such a case it may also decide to suspend the practitioner from the list pending any appeal by him, if it is satisfied that it is necessary to do so for the protection of members of the public or is otherwise in the public interest.

(3)If it does suspend the practitioner under this section, the suspension has effect from the date when the Primary Care Trust gave him notice of the suspension.

(4)The suspension has effect until its revocation under subsection (5) or (6) or, if later, until the expiry of the period of 28 days referred to in section 158(1), or, if the practitioner appeals under section 158, until the FHSAA has disposed of the appeal.

(5)The Primary Care Trust may revoke a suspension imposed under this section.

(6)If the practitioner appeals under section 158 against the decision of the Primary Care Trust to remove him from the list, the FHSAA may also revoke a suspension imposed on him under this section.

(7)Subsections (9) and (10) of section 154 apply for the purposes of this section as they apply for the purposes of that.

156Effect of suspension

While a practitioner is suspended (whether under section 154 or under section 155) he must be treated as not being included in the list from which he has been suspended even though his name appears in it.

157Review of decisions

(1)The Primary Care Trust may, and (except in prescribed cases) if requested in writing to do so by the practitioner must, review a contingent removal or a suspension (other than a contingent removal or a suspension imposed by, or a suspension continuing pursuant to, an order of the FHSAA, or a suspension imposed under section 155).

(2)The practitioner may not request a review before the expiry of the period of—

(a)three months beginning with the date of the decision of the Primary Care Trust to suspend or contingently remove him, or (as appropriate),

(b)six months beginning with the date of its decision on the previous review.

(3)On such a review, the Primary Care Trust may—

(a)confirm the contingent removal or the suspension,

(b)in the case of a suspension, terminate it,

(c)in the case of a contingent removal, vary the conditions, impose different conditions, revoke the contingent removal, or remove the practitioner from the list.

158Appeals

(1)A practitioner may appeal to the FHSAA against a decision of a Primary Care Trust mentioned in subsection (2) by giving notice in writing to the FHSAA within the period of 28 days beginning with the date on which the Primary Care Trust gave him notice of the decision.

(2)The Primary Care Trust decisions in question are—

(a)to remove the practitioner from a list (under section 151 or 152(3) or under subsection (5)(b) of this section),

(b)to remove him contingently (under section 152),

(c)to impose any particular condition under section 152, or to vary any condition or to impose any different condition under that section,

(d)to vary his terms of service (under section 152(4)),

(e)any decision on a review of a contingent removal under section 157.

(3)The appeal must be way of redetermination of the decision of the Primary Care Trust.

(4)On an appeal, the FHSAA may make any decision which the Primary Care Trust could have made.

(5)If the FHSAA decides to remove the practitioner contingently—

(a)the Primary Care Trust and the practitioner may each apply to the FHSAA for the conditions imposed on the practitioner to be varied, for different conditions to be imposed, or for the contingent removal to be revoked, and

(b)the Primary Care Trust may remove him from its list if it determines that he has failed to comply with a condition.

(6)The Primary Care Trust may not remove a person from a list, or impose a contingent removal—

(a)until the expiry of the period of 28 days referred to in subsection (1), or

(b)if the practitioner appeals within that period, until the FHSAA has disposed of the appeal.

(7)Regulations may provide for payments by Primary Care Trusts to practitioners who are removed from lists pursuant to decisions of the FHSAA under this section, but whose appeals against those decisions are successful.

(8)Regulations under subsection (7) may include provision for the amount of the payments, or the method of calculating the amount, to be determined by the Secretary of State or by another person appointed for the purpose by the Secretary of State.

159National disqualification

(1)If the FHSAA removes the practitioner from a list, it may also decide to disqualify him from inclusion in—

(a)the pharmaceutical lists prepared by each Primary Care Trust,

(b)the supplementary lists prepared by each Primary Care Trust,

(c)the lists under section 91, 106, or 123 prepared by each Primary Care Trust,

(d)the lists under section 146 prepared by each Primary Care Trust, or the lists corresponding to the lists under section 91 prepared by each Primary Care Trust by virtue of regulations made under section 145,

(e)the lists corresponding to the lists mentioned in paragraphs (a) to (d) prepared by each Local Health Board under or by virtue of the National Health Service (Wales) Act 2006 (c. 42),

or only from inclusion in one or more descriptions of such lists prepared by each Primary Care Trust and each Local Health Board, the description being specified by the FHSAA in its decision.

(2)A decision by the FHSAA to do what is mentioned in subsection (1) is referred to in this section as the imposition of a national disqualification.

(3)The FHSAA may also impose a national disqualification on a practitioner if it dismisses an appeal by him against the refusal by a Primary Care Trust to include him in such a list.

(4)The Primary Care Trust may apply to the FHSAA for a national disqualification to be imposed on a person after the Primary Care Trust has—

(a)removed him from a list prepared by it of any of the kinds referred to in subsection (1)(a) to (d), or

(b)refused to include him in such a list.

(5)Any such application must be made before the end of the period of three months beginning with the date of the removal or of the Primary Care Trust’s refusal.

(6)If the FHSAA imposes a national disqualification on a person—

(a)no Primary Care Trust or Local Health Board may include him in a list of any of the kinds prepared by it from which he has been disqualified from inclusion, and

(b)if he is included in such a list, each Primary Care Trust and each Local Health Board in whose list he is included must remove him from it.

(7)The FHSAA may at the request of the person upon whom it has been imposed review a national disqualification, and on a review may confirm it or revoke it.

(8)Subject to subsection (9), the person may not request such a review before the end of the period of—

(a)two years beginning with the date on which the national disqualification was imposed, or

(b)one year beginning with the date of the FHSAA’s decision on the last such review.

(9)The Secretary of State may provide in regulations for subsection (8) to have effect in prescribed circumstances as if the reference there to “two years” or “one year” were a reference to a different period specified in the regulations.

160Notification of decisions

Regulations may require a Primary Care Trust to notify prescribed persons, or persons of prescribed descriptions, of any decision it makes under this Chapter, and of any information relevant to the decision which it considers appropriate to include in the notification.

161Withdrawal from lists

Regulations may provide for circumstances in which a practitioner—

(a)whom a Primary Care Trust is investigating in order to see whether there are grounds for exercising its powers under section 151, 152 or 154,

(b)whom a Primary Care Trust has decided to remove from a list under section 151 or 152, or contingently remove under section 152, but who has not yet been removed or contingently removed, or

(c)who has been suspended under section 154,

may not withdraw from a list in which he is included.

162Regulations about decisions under this Chapter

(1)Any decision by a Primary Care Trust referred to in this Chapter must be reached in accordance with regulations about such decisions.

(2)The regulations must include provision—

(a)requiring the practitioner to be given notice of any allegation against him,

(b)giving him the opportunity of putting his case at a hearing before a Primary Care Trust makes any decision affecting him under this Chapter,

(c)requiring him to be given notice of the decision of the Primary Care Trust and the reasons for it and of any right of appeal which he may have.

(3)The regulations may, in particular, make provision as to criteria which the Primary Care Trust must apply when making decisions in unsuitability cases.

163Corresponding provisions in Scotland and Northern Ireland

(1)This section applies where it appears to the Secretary of State that there is provision in Scotland or Northern Ireland under which a person may be dealt with in any way which corresponds (whether or not exactly) with a way in which a person may be dealt with under this Chapter.

(2)A decision in Scotland or Northern Ireland to deal with such a person in such a way is referred to in this section as a “corresponding decision”.

(3)If this section applies, the Secretary of State may make regulations providing for the effect to be given in England to a corresponding decision.

(4)That effect need not be the same as the effect of the decision in the place where it was made.

(5)The regulations may not provide for a corresponding decision to be reviewed or revoked in England.

Chapter 7Miscellaneous

Remuneration

164Remuneration for persons providing pharmaceutical services

(1)The remuneration to be paid to persons who provide pharmaceutical services under this Part must be determined by determining authorities.

(2)Determining authorities may also determine the remuneration to be paid to persons who provide those services in respect of the instruction of any person in matters relating to those services.

(3)For the purposes of this section and section 165 determining authorities are—

(a)the Secretary of State, and

(b)so far as authorised by him to exercise the functions of determining authorities, any Primary Care Trust or other person appointed by him in an instrument.

(4)The instrument mentioned in subsection (3)(b) is called in this section an “instrument of appointment”.

(5)An instrument of appointment—

(a)may contain requirements with which a determining authority appointed by that instrument must comply in making determinations, and

(b)may be contained in regulations.

(6)Subject to this section and section 165, regulations may make provision about determining remuneration under this section and may in particular impose requirements with which determining authorities must comply in making, or in connection with, determinations (including requirements as to consultation and publication).

(7)Regulations may provide that determinations may be made by reference to any of—

(a)rates or conditions of remuneration of any persons or any descriptions of persons which are fixed or determined, or will be fixed or determined, otherwise than by way of a determination under this section,

(b)scales, indices or other data of any description specified in the regulations.

(8)Where regulations provide as mentioned in subsection (7)(b), they may provide that any determination which falls to be made by reference to a scale, index or other data may be made by reference to the scale, index or data—

(a)in the form current at the time of the determination, and

(b)in any subsequent form taking effect after that time.

(9)Regulations may—

(a)provide that determining authorities may make determinations which have effect in relation to remuneration in respect of a period beginning on or after a date specified in the determination, which may be the date of the determination or an earlier or later date, but may be an earlier date only if, taking the determination as a whole, it is not detrimental to the persons to whose remuneration it relates,

(b)provide that any determination which does not specify such a date has effect in relation to remuneration in respect of a period beginning—

(i)if it is required to be published, on the date of publication,

(ii)if it is not so required, on the date on which it is made.

(10)A reference in this section or section 165 to a determination is to a determination of remuneration under this section.

165Section 164: supplementary

(1)Before a determination is made by the Secretary of State which relates to all persons who provide pharmaceutical services, or a category of such services, he—

(a)must consult a body appearing to him to be representative of persons to whose remuneration the determination would relate, and

(b)may consult such other persons as he considers appropriate.

(2)Determinations may make different provision for different cases, including different provision for any particular case, class of case or area.

(3)Determinations may be—

(a)made in more than one stage,

(b)made by more than one determining authority,

(c)varied or revoked by subsequent determinations.

(4)A determination may be varied—

(a)to correct an error, or

(b)where it appears to the determining authority that it was made in ignorance of or under a mistake as to a relevant fact.

(5)Determinations may, in particular, provide that the whole or any part of the remuneration—

(a)is payable only if the determining authority is satisfied as to certain conditions, or

(b)must be applied for certain purposes or is otherwise subject to certain conditions.

(6)Remuneration under section 164 may be determined from time to time and may consist of payments by way of—

(a)salary,

(b)fees,

(c)allowances,

(d)reimbursement (in full or in part) of expenses incurred or expected to be incurred in connection with the provision of the services or instruction.

(7)At the time a determination is made or varied, certain matters which require determining may be reserved to be decided at a later time.

(8)The matters which may be reserved include in particular—

(a)the amount of remuneration to be paid in particular cases,

(b)whether any remuneration is to be paid in particular cases.

(9)Any determination may be made only after taking into account all the matters which are considered to be relevant by the determining authority.

(10)Such matters may include in particular—

(a)the amount or estimated amount of expenses (taking into account any discounts) incurred in the past or likely to be incurred in the future (whether or not by persons to whose remuneration the determination will relate) in connection with the provision of pharmaceutical services or of any category of pharmaceutical services,

(b)the amount or estimated amount of any remuneration paid or likely to be paid to persons providing such services,

(c)the amount or estimated amount of any other payments or repayments or other benefits received or likely to be received by any such persons,

(d)the extent to which it is desirable to encourage the provision, either generally or in particular places, of pharmaceutical services or the category of pharmaceutical services to which the determination will relate,

(e)the desirability of promoting pharmaceutical services which are—

(i)economic and efficient, and

(ii)of an appropriate standard.

(11)If the determination is of remuneration for a category of pharmaceutical services, the reference in subsection (10)(a) to a category of pharmaceutical services is a reference to the same category of pharmaceutical services or to any other category of pharmaceutical services falling within the same description.

Indemnity cover

166Indemnity cover

(1)Regulations may make provision for the purpose of securing that, in prescribed circumstances, prescribed persons included in a pharmaceutical list hold approved indemnity cover.

(2)The regulations may, in particular, make provision as to the consequences of a failure to hold approved indemnity cover, including provision—

(a)for securing that a person must not be added to a pharmaceutical list unless he holds approved indemnity cover,

(b)for the removal from a pharmaceutical list prepared by a Primary Care Trust of a person who does not within a prescribed period after the making of a request by the Primary Care Trust in the prescribed manner satisfy the Primary Care Trust that he holds approved indemnity cover.

(3)For the purposes of this section—

• “approved body” means a person or persons approved in relation to indemnity cover of any description, after such consultation as may be prescribed, by the Secretary of State or by such other person as may be prescribed,

• “approved indemnity cover” means indemnity cover made—

  (a)

  on prescribed terms, and

  (b)

  with an approved body,

• “indemnity cover”, in relation to a person included in a pharmaceutical list (or a person who proposes to provide pharmaceutical services), means a contract of insurance or other arrangement made for the purpose of indemnifying him, and any person prescribed in relation to him, to any prescribed extent against any liability which—

  (a)

  arises out of the provision of pharmaceutical services in accordance with arrangements made by him with a Primary Care Trust, and

  (b)

  is incurred by him or any such person in respect of the death or personal injury of a person,

• “personal injury” means any disease or impairment of a person’s physical or mental condition and includes the prolongation of any disease or such impairment,

and a person holds approved indemnity cover if he has entered into a contract or arrangement which constitutes approved indemnity cover.

(4)The regulations may provide that a person of any description who has entered into a contract or arrangement which is—

(a)in a form identified in accordance with the regulations in relation to persons of that description, and

(b)made with a person or persons so identified,

must be treated as holding approved indemnity cover for the purposes of the regulations.

Local Pharmaceutical Committees

167Local Pharmaceutical Committees

(1)A Primary Care Trust may recognise a committee formed for its area, or for its area and that of one or more other Primary Care Trusts, which it is satisfied is representative of—

(a)the persons providing pharmaceutical services from premises in the area for which the committee is formed (“pharmaceutical services providers”),

(b)pharmaceutical services providers and the persons to whom subsections (2) and (3) apply,

(c)pharmaceutical services providers and the persons to whom subsection (2) applies, or

(d)pharmaceutical services providers and the persons to whom subsection (3) applies.

(2)This subsection applies to each person who—

(a)is providing local pharmaceutical services in the Primary Care Trust’s area under an LPS scheme made (whether with himself or another person) by the Primary Care Trust, and

(b)has notified the Primary Care Trust that he wishes to be represented by the committee (and has not notified it that he wishes to cease to be so represented).

(3)This subsection applies to each person who—

(a)is providing local pharmaceutical services in the Primary Care Trust’s area under a pilot scheme made (whether with himself or another person) by the Primary Care Trust, and

(b)has notified the Primary Care Trust that he wishes to be represented by the committee (and has not notified it that he wishes to cease to be so represented).

(4)A committee recognised under this section is called the Local Pharmaceutical Committee for the area for which it is formed.

(5)Any such committee may delegate any of its functions, with or without restrictions or conditions, to sub-committees composed of members of that committee.

(6)Regulations may require a Primary Care Trust, in the exercise of functions relating to pharmaceutical services or local pharmaceutical services, to consult committees recognised by it under this section on such occasions and to such extent as may be prescribed.

(7)Subsection (6) does not affect any other power to require a Primary Care Trust to consult committees recognised by it under this section.

(8)A committee recognised under this section has such other functions as may be prescribed.

(9)A Primary Care Trust may, on the request of any committee recognised by it under this section, allot to that committee such sums for defraying the committee’s administrative expenses (other than any determined under subsection (12)) as may be determined by the Primary Care Trust.

(10)Any sums so allotted must be out of the moneys available to the Primary Care Trust for the remuneration of persons of whom the committee is representative under subsection (1)(a).

(11)The amount of any such sums must be deducted from the remuneration of those persons in such manner as may be determined by the Primary Care Trust.

(12)A committee recognised under subsection (1)(b), (c) or (d) must, in respect of each year, determine the amount of its administrative expenses for that year attributable to the persons of whom it is representative under subsection (2) or (3).

(13)The committee must apportion the amount determined under subsection (12) among the persons of whom it is representative under subsection (2) or (3), and each such person must pay in accordance with the committee’s directions the amount so apportioned to him.

(14)The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.

Provision of accommodation by the Secretary of State

168Use of accommodation: provision of pharmaceutical services and local pharmaceutical services

If the Secretary of State considers that any accommodation provided by him by virtue of this Act is suitable for use in connection with the provision of pharmaceutical services or local pharmaceutical services, he may make the accommodation available on such terms as he considers appropriate to persons providing those services.

Part 8Family Health Services Appeal Authority

169FHSAA

(1)There continues to be a body known as the Family Health Services Appeal Authority (“FHSAA”).

(2)The FHSAA has such functions as are conferred on it by this Act or by any other enactment.

(3)The Secretary of State may direct the FHSAA to exercise any of his functions relating to the determination of appeals to him which are specified in the directions.

(4)The Secretary of State may make available to the FHSAA any facilities provided by him or by an NHS trust or Special Health Authority for any service under this Act, and the services of persons employed by the Secretary of State or by an NHS trust or Special Health Authority.

(5)Schedule 13 makes further provision about the FHSAA.

170FHSAA: financial provisions

(1)The Secretary of State may make such payments in respect of expenses incurred by the FHSAA as he may determine.

(2)The Secretary of State may pay to the members of the FHSAA—

(a)such remuneration, and

(b)such travelling and other allowances, including compensation for loss of remunerative time,

as he may determine.

(3)Payments under this section are subject to such conditions as to records, certificates, or otherwise as the Secretary of State may determine.

171Conditions of use of services of persons under section 169

(1)Subsections (1) to (3) of section 81 (conditions of supply under section 80) apply in relation to the services of persons employed by a Special Health Authority and made available under section 169(4) as they apply in relation to the services of officers of Special Health Authorities to be made available under section 80 (supply of goods and services by the Secretary of State).

(2)For the purposes of section 169(4)—

(a)the Secretary of State may give directions to an NHS trust requiring it to make facilities or the services of persons available as mentioned there, but

(b)subsections (1) and (2) of section 81 apply in relation to the services of such persons as they apply in relation to the services of officers to be made available by virtue of section 80.

Part 9Charging

Power to charge generally

172Charges for drugs, medicines or appliances, or pharmaceutical services

(1)Regulations may provide for the making and recovery in such manner as may be prescribed of such charges as may be prescribed in respect of—

(a)the supply under this Act (otherwise than under Chapter 1 of Part 7) of drugs, medicines or appliances (including the replacement and repair of those appliances), and

(b)such of the pharmaceutical services referred to in that Chapter as may be prescribed.

(2)Regulations under this section may in particular make provision in relation to the supply of contraceptive substances and appliances under paragraph 8 of Schedule 1.

(3)This section does not apply in relation to the provision of any relevant dental service (within the meaning of section 176).

173Exemptions from general charging

(1)No charge may be made under regulations under section 172(1) in respect of—

(a)the supply of any drug, medicine or appliance for a patient who is resident in hospital,

(b)the supply of any drug or medicine for the treatment of sexually transmitted disease (otherwise than in the provision of primary medical services or in accordance with a pilot scheme or an LPS scheme),

(c)the supply of any appliance (otherwise than in pursuance of paragraph 8(d) of Schedule 1) for a person who is under 16 years of age or is under 19 years of age and receiving qualifying full-time education, or

(d)the replacement or repair of any appliance in consequence of a defect in the appliance as supplied.

(2)In subsection (1)(c) “qualifying full-time education” means full-time instruction at a recognised educational establishment or by other means accepted as comparable by the Secretary of State.

(3)For the purposes of subsection (2)—

(a)“recognised educational establishment” means an establishment recognised by the Secretary of State as being, or as comparable to, a school, college or university, and

(b)regulations may prescribe the circumstances in which a person must, or must not, be treated as receiving full-time instruction.

174Pre-payment certificates

(1)Regulations under section 172(1) may provide for the grant, on payment of such sums as may be prescribed, of a pre-payment certificate.

(2)A pre-payment certificate is a certificate which confers on the person to whom it is granted exemption from charges otherwise chargeable under the regulations in respect of drugs, medicines and appliances supplied during such period as may be prescribed.

(3)Different sums may be prescribed in relation to different periods.

175Charges in respect of non-residents

(1)Regulations may provide for the making and recovery, in such manner as may be prescribed, of such charges as the Secretary of State may determine in respect of the services mentioned in subsection (2).

(2)The services are such services as may be prescribed which are—

(a)provided under this Act, and

(b)provided in respect of such persons not ordinarily resident in Great Britain as may be prescribed.

(3)Regulations under this section may provide that the charges may be made only in such cases as may be determined in accordance with the regulations.

(4)The Secretary of State may calculate charges under this section on any basis that he considers to be the appropriate commercial basis.

Charging for dental services

176Dental charging

(1)Regulations may provide for the making and recovery, in such manner as may be prescribed, of charges for relevant dental services.

(2)Regulations under subsection (1) may in particular include provision—

(a)specifying the amount, or maximum amount, of any charge (or aggregate charge in respect of the provision for two or more relevant dental services),

(b)for calculating the amount of any charge,

(c)for the variation of the amount, or maximum amount, of any charge in cases of a prescribed description,

(d)for any charge not to be payable in cases of a prescribed description,

(e)for power to direct that a charge is not payable in any particular case,

(f)for the repayment of any charge (including provision as to the persons by whom, and manner in which, repayments must be made).

(3)Regulations under subsection (1) may provide for sums which would otherwise be payable by a Primary Care Trust or Special Health Authority to persons providing relevant dental services to be reduced by the amount of the charges authorised by the regulations.

(4)In this section and section 177 “relevant dental services” means—

(a)dental treatment provided—

(i)under section 99(2),

(ii)under a general dental services contract, or

(iii)in accordance with section 107 arrangements, and

(b)the supply of dentures and other dental appliances under this Act.

(5)Any reference in this section or 177 to the supply of an appliance includes a reference to its repair, adjustment, refitting or replacement and, in the case of dentures, to their being relined or having additions made to them.

177Exemptions from dental charging

(1)No charge may be made under regulations under section 176(1) in respect of a relevant dental service provided for any person who at the prescribed time—

(a)was under 18,

(b)was under 19 and receiving qualifying full-time education,

(c)was pregnant, or

(d)had given birth to a child within the previous 12 months.

(2)No charge may be made under regulations under section 176(1) in respect of—

(a)the repair or replacement of any appliance,

(b)any appliance supplied to a patient who is resident in a hospital,

(c)the arrest of bleeding.

(3)Subsections (1) and (2)(a) do not apply in relation to—

(a)the repair or replacement of any appliance of a prescribed description,

(b)the repair or replacement of any appliance where it is determined in the prescribed manner—

(i)in any case, that the repair or replacement was necessitated by an act or omission of the person supplied, or

(ii)in a case where the person supplied was under the age of 16, that the repair or replacement was necessitated by an act or omission, occurring while that person was under that age, of a person having charge of him.

(4)Subsection (2)(b) does not apply where an appliance is supplied—

(a)under section 99(2),

(b)under a general dental services contract, or

(c)in accordance with section 107 arrangements.

(5)Regulations may provide, with respect to any exemption under this section, that it must be a condition of the exemption that—

(a)a declaration of the prescribed kind is made in the prescribed form and manner,

(b)a certificate or other evidence of the prescribed kind is supplied in the prescribed form and manner.

(6)In subsection (1)(b) “qualifying full-time education” means full-time instruction at a recognised educational establishment or by other means accepted as comparable by the Secretary of State.

(7)For the purposes of subsection (6)—

(a)“recognised educational establishment” means an establishment recognised by the Secretary of State as being, or as comparable to, a school, college or university, and

(b)regulations may prescribe the circumstances in which a person must, or must not, be treated as receiving full-time instruction.

(8)In subsection (1)(d), “child” includes a still-born child (within the meaning of the Births and Deaths Registration Act 1953 (c. 20).

Charging for local pharmaceutical services

178Charges, recovery of payments and penalties

(1)Regulations may provide for the making and recovery, in such manner as may be prescribed, of charges for—

(a)local pharmaceutical services provided under pilot schemes, or

(b)local pharmaceutical services provided under LPS schemes.

(2)The regulations may in particular provide for—

(a)exemptions from charges,

(b)the liability to pay charges to be disregarded in prescribed circumstances or for prescribed purposes,

(c)section 192 (recovery of certain charges and payments) to apply also in relation to local pharmaceutical services (with or without modification),

(d)section 193 (penalties) to apply also in relation to local pharmaceutical services (with or without modification).

(3)The regulations must secure that the amount charged for any service is the same as the amount that would be charged for that service if it were provided under Chapter 1 of Part 7.

Charging for optical appliances

179Charges for optical appliances

(1)Regulations may provide for the making and recovery, in such manner as may be prescribed, of charges in respect of the supply under this Act of optical appliances.

(2)The amount of the charges may be determined—

(a)in regulations, or

(b)by or in accordance with directions given by the Secretary of State.

(3)Regulations or directions may—

(a)vary the amount or maximum amount of charges, or

(b)provide that the charges are not payable.

(4)A reference to supply includes a reference to replacement.

(5)In this Act “optical appliances” means glasses and contact lenses, but regulations may provide for a different definition of optical appliances to have effect for the purposes of this Act.

180Payments in respect of costs of optical appliances

(1)The Secretary of State must provide by regulations for payments to be made by him or a relevant body to meet, or to contribute towards, the cost incurred (whether by way of charge under this Act or otherwise) for the supply of optical appliances for which—

(a)a prescription has been given for a person mentioned in subsection (2) in consequence of a sight test under this Act, or

(b)a prescription has been given for a person mentioned in subsection (2) in consequence of a sight test otherwise than under this Act which took place in prescribed circumstances.

(2)The persons are—

(a)a child,

(b)a person whose resources fall to be treated under the regulations as being less than or equal to his requirements,

(c)any person falling within section 115(2)(d), or

(d)a person of such other description as may be prescribed.

(3)The Secretary of State may by regulations—

(a)provide for himself or such relevant body as may be prescribed to contribute to the cost of a sight test which he or the prescribed body accepts as having been incurred by a person whose resources fall to be treated under the regulations as exceeding his requirements but only by an amount calculated under the regulations, and

(b)provide for payments to be made by him or by such relevant body as may be prescribed to meet, or to contribute towards, any cost accepted by him or by the prescribed body as having been incurred (whether by way of charge under this Act or otherwise) for the replacement or repair in prescribed circumstances of optical appliances for which a prescription was given in consequence of a sight test of a person of a prescribed description.

(4)Regulations under this section may direct how a person’s resources and requirements must be calculated and may, in particular, direct that they must be calculated—

(a)by a method set out in the regulations,

(b)by a method described by reference to a method of calculating or estimating income or capital specified in an enactment other than this section or in an instrument made under an Act of Parliament or by reference to such a method but subject to prescribed modifications,

(c)by reference to an amount applicable for the purposes of a payment under an Act of Parliament or an instrument made under an Act of Parliament, or

(d)by reference to the person’s being or having been entitled to payment under an Act of Parliament or an instrument made under an Act of Parliament.

(5)Descriptions of persons may be prescribed for the purposes of this section by reference to any criterion and, in particular, by reference to any of the following criteria—

(a)their age,

(b)the fact that a prescribed person or a prescribed body accepts them as suffering from a prescribed medical condition,

(c)the fact that a prescribed person or a prescribed body accepts that a prescribed medical condition from which they suffer arose in prescribed circumstances,

(d)their receipt of benefit in money or in kind under any enactment or their entitlement to receive any such benefit,

(e)the receipt of any such benefit by other persons satisfying prescribed conditions or the entitlement of other persons satisfying prescribed conditions to receive such benefits, and

(f)the relationship, as calculated in accordance with the regulations by a prescribed person, between their resources and their requirements.

(6)Regulations under this section which refer to an Act of Parliament or an instrument made under an Act of Parliament may direct that the reference must be construed as a reference to that Act or instrument—

(a)as it has effect at the time when the regulations are made, or

(b)both as it has effect at that time and as amended subsequently.

(7)In subsection (2)(a) “child” means—

(a)a person who is under the age of 16 years, or

(b)a person who is under the age of 19 years and receiving qualifying full-time education.

(8)In subsection (7)(b) “qualifying full-time education” means full-time instruction at a recognised educational establishment or by other means accepted as comparable by the Secretary of State.

(9)For the purposes of subsection (8)—

(a)“recognised educational establishment” means an establishment recognised by the Secretary of State as being, or as comparable to, a school, college or university, and

(b)regulations may prescribe the circumstances in which a person must, or must not, be treated as receiving full-time instruction.

(10)If regulations under this section provide for payments to be made by a relevant body, the Secretary of State must pay to the body, in respect of each financial year, the sum attributable to the body’s disbursements under the regulations.

(11)Sums falling to be paid in pursuance of regulations under this section are payable subject to such conditions as to records, certificates or otherwise as the Secretary of State may determine.

(12)“Relevant body” means a Strategic Health Authority, a Primary Care Trust or a Special Health Authority.

181Section 180: supplementary

(1)Regulations under section 180 providing for payments for meeting or contributing towards the cost incurred for the supply of optical appliances or their replacement or repair may also provide as follows.

(2)They may make provision for such payments not to be made to any person falling within a prescribed description.

(3)They may make provision for the Secretary of State to give notice as mentioned in subsection (4) to a person to whom such payments have been made (whether by the Secretary of State or by a relevant body).

(4)Such a notice is notice that no further such payments in respect of the supply, replacement or repair of optical appliances at a particular location or in a particular area, in either case specified in the notice, will be made to him after a date specified in the notice.

(5)If such a notice is given, no further payments as mentioned in subsection (4) may be made to him after the date specified in the notice, unless the notice is cancelled by the Secretary of State.

(6)The regulations may make provision conferring on the Secretary of State the right, if he has given a notice by virtue of subsection (3), to apply to the FHSAA for a stop order.

(7)A stop order is an order that no further such payments may be made (whether by the Secretary of State or by any relevant body) to the person in question in respect of the supply, replacement or repair of optical appliances, wherever the supply, replacement or repair occurred.

(8)If the regulations make the provision mentioned in subsection (3), they must also make provision conferring prescribed rights of appeal to the FHSAA upon the person to whom the notice was given.

(9)“Relevant body” means a Strategic Health Authority, a Primary Care Trust or a Special Health Authority.

Exemptions, etc

182Remission and repayment of charges

Regulations may provide in relation to prescribed descriptions of person for the remission or repayment of the whole or any part of any charges which would otherwise be payable by virtue of section 172, 176 or 179.

183Payment of travelling expenses

Regulations may provide in relation to prescribed descriptions of persons—

(a)for the payment by the Secretary of State, a Primary Care Trust, an NHS trust or an NHS foundation trust, in such cases as may be prescribed, of travelling expenses (including the travelling expenses of a companion) incurred or to be incurred for the purpose of their obtaining any services provided under this Act,

(b)for the reimbursement by a Primary Care Trust to an NHS trust or an NHS foundation trust and, in such cases as may be prescribed, to another Primary Care Trust, of such payments,

(c)for the reimbursement by a Primary Care Trust to an NHS trust and, in such cases as may be prescribed, to a Local Health Board, of payments made by virtue of section 131(a) of the National Health Service (Wales) Act 2006 (c. 42).

184Sections 182 and 183: supplementary

(1)Descriptions of persons may be prescribed for the purposes of section 182 or 183 by reference to any criterion and, in particular, by reference to any of the following criteria—

(a)their age,

(b)the fact that a prescribed person or a prescribed body accepts them as suffering from a prescribed medical condition,

(c)the fact that a prescribed person or a prescribed body accepts that a prescribed medical condition from which they suffer arose in prescribed circumstances,

(d)their receipt of benefit in money or in kind under any enactment or their entitlement to receive any such benefit,

(e)the receipt of any such benefit by other persons satisfying prescribed conditions or the entitlement of other persons satisfying prescribed conditions to receive such benefits, and

(f)the relationship, as calculated in accordance with the regulations by a prescribed person, between their resources and their requirements.

(2)Regulations under section 182 or 183 may direct how a person’s resources and requirements must be calculated and may, in particular, direct that they must be calculated—

(a)by a method set out in the regulations,

(b)by a method described by reference to a method of calculating or estimating income or capital specified in an enactment other than this section or in an instrument made under an Act of Parliament or by reference to such a method but subject to prescribed modifications,

(c)by reference to an amount applicable for the purposes of a payment under an Act of Parliament or an instrument made under an Act of Parliament, or

(d)by reference to the person’s being or having been entitled to payment under an Act of Parliament or an instrument made under an Act of Parliament.

(3)Regulations under section 182 or 183 which refer to an Act of Parliament or an instrument made under an Act of Parliament may direct that the reference must be construed as a reference to that Act or instrument—

(a)as it has effect at the time when the regulations are made, or

(b)both as it has effect at that time and as amended subsequently.

Other provisions relating to charging

185Charges for more expensive supplies

(1)Regulations may provide for the making and recovery of such charges falling within subsection (2) as may be prescribed.

(2)The charges are charges by the Secretary of State, a Primary Care Trust, an NHS trust or an NHS foundation trust—

(a)in respect of the supply of any appliance or vehicle which is, at the request of the person supplied, of a more expensive type than the prescribed type, or

(b)in respect of the repair or replacement of any such appliance, or the replacement of any such vehicle, or the taking of any such action in relation to the vehicle as is mentioned in paragraph 10(2) of Schedule 1.

186Charges for repairs and replacements in certain cases

(1)Regulations may provide for the making and recovery of such charges falling within subsection (2) as may be prescribed.

(2)The charges are charges by the Secretary of State, a Primary Care Trust, an NHS trust or an NHS foundation trust, in respect of the repair or replacement of any appliance or vehicle, where it is determined in the prescribed manner—

(a)in any case, that the repair or replacement was necessitated by an act or omission of the person supplied, or

(b)in a case where the person supplied was under the age of 16, that the repair or replacement was necessitated by an act or omission, occurring while that person was under that age, of a person having charge of him.

187Charges for designated services or facilities

Regulations may provide for the making and recovery of charges in respect of services or facilities designated by the regulations as services or facilities provided in pursuance of section 3(1)(d) or (e).

188Sums otherwise payable to those providing services

(1)Subsection (2) applies to regulations under—

(a)section 172 (charges for drugs, medicines or appliances, or pharmaceutical service),

(b)section 179 (charges for optical appliances),

(c)section 185 (charges for more expensive supplies), or

(d)section 186 (charges for repairs and replacements in certain cases),

which provide for the making and recovery of charges in respect of any services.

(2)The regulations may provide for the sums which would otherwise be payable by a Primary Care Trust or Special Health Authority to the persons by whom the services are provided, to be reduced by the amount of the charges authorised by the regulations in respect of the services.

189Hospital accommodation on part payment

(1)The Secretary of State—

(a)may authorise accommodation to be made available for patients to such extent as he may determine, and

(b)may recover such charges as he may determine in respect of such accommodation and calculate them on any basis that he considers to be the appropriate commercial basis.

(2)Accommodation means—

(a)accommodation in single rooms or small wards which is not needed by any patient on medical grounds,

(b)accommodation at any health service hospital or group of hospitals, or a hospital in which patients are treated under arrangements made by virtue of section 12, or at the health service hospitals in a particular area or a hospital in which patients are so treated.

(3)References in subsection (2) to a health service hospital include references to such a hospital within the meaning of section 206 of the National Health Service (Wales) Act 2006 (c. 42), but do not include references to a hospital vested in an NHS trust or an NHS foundation trust.

190Expenses payable by employed patients

(1)The Secretary of State may require any person—

(a)who is a resident patient for whom the Secretary of State provides services under this Act, and

(b)who is absent during the day from the hospital where he is a patient for the purpose of engaging in remunerative employment,

to pay such part of the cost of his maintenance in the hospital and any incidental cost as may seem reasonable to the Secretary of State having regard to the amount of that person’s remuneration.

(2)The Secretary of State may recover the amount required under subsection (1).

Recovery, etc

191Recovery of charges

(1)All charges recoverable under this Act by—

(a)the Secretary of State,

(b)a local social services authority, or

(c)any body established under this Act,

may be recovered summarily as a civil debt (but this does not affect any other method of recovery).

(2)If any person, for the purpose of evading the payment of any charge under this Act, or of reducing the amount of any such charge—

(a)knowingly makes any false statement or false representation, or

(b)produces or furnishes, or causes or knowingly allows to be produced or furnished, any document or information which he knows to be false in a material particular,

the charge or the balance of the charge, may be recovered from him by the person by whom the cost of the service in question was defrayed.

192Recovery of charges and payments in relation to goods and services

(1)Where goods or services to which this section applies are provided and—

(a)any charge payable by any person under this Act in respect of the provision of the goods or services is reduced, remitted or repaid, but that person is not entitled to the reduction, remission or repayment, or

(b)any payment under this Act is made to, or for the benefit of, any person in respect of the cost of obtaining the goods or services, but that person is not entitled to, or to the benefit of, the payment,

the amount mentioned in subsection (2) is recoverable summarily as a civil debt from the person in question by the responsible authority.

(2)That amount—

(a)in a case within subsection (1)(a), is the amount of the charge or (where it has been reduced) reduction,

(b)in a case within subsection (1)(b), is the amount of the payment.

(3)Where two or more persons are liable under section 191(1) or this section to pay an amount in respect of the same charge or payment, those persons are jointly and severally liable.

(4)For the purposes of this section, the circumstances in which a person is treated as not entitled to a reduction, remission or repayment of a charge, or to (or to the benefit of) a payment, include in particular those in which it is received (wholly or partly)—

(a)on the ground that he or another is a person of a particular description, where the person in question is not of that description,

(b)on the ground that he or another holds a particular certificate, when the person in question does not hold such a certificate or does hold such a certificate but is not entitled to it,

(c)on the ground that he or another has made a particular statement, when the person in question has not made such a statement or the statement made by him is false.

(5)In this section and section 193, “responsible authority” means—

(a)in relation to the recovery of any charge under section 191(1) in respect of the provision of goods or services to which this section applies, the person by whom the charge is recoverable,

(b)in relation to the recovery by virtue of this section of the whole or part of the amount of any such charge, the person by whom the charge would have been recoverable,

(c)in a case within subsection (1)(b), the person who made the payment.

(6)But the Secretary of State may by directions provide for—

(a)the functions of any responsible authority of recovering any charges under this Act in respect of the provision of goods or services to which this section applies,

(b)the functions of any responsible authority under this section and section 193,

to be exercised on behalf of the authority by another health service body.

(7)This section applies to the following goods and services—

(a)dental treatment and appliances provided in pursuance of this Act,

(b)drugs and medicines provided in pursuance of this Act,

(c)sight tests,

(d)optical appliances,

(e)any other appliances provided in pursuance of this Act.

(8)“Health service body” means a body which is a health service body for the purposes of section 9.

193Penalties relating to charges

(1)Regulations may provide that, where a person fails to pay—

(a)any amount recoverable from him under section 191(1) in respect of the provision of goods or services to which section 192 applies, or

(b)any amount recoverable from him under section 192,

a notice (referred to in this section as a penalty notice) may be served on the person by the responsible authority.

(2)A penalty notice is a notice requiring the person on whom it is served to pay the amount to the authority within a prescribed period, together with a charge (referred to in this section as a penalty charge) of an amount determined in accordance with the regulations.

(3)The regulations may not provide for the amount of the penalty charge to exceed whichever is the smaller of—

(a)£100,

(b)the amount referred to in subsection (1)(a) or (b) multiplied by 5.

(4)The Secretary of State may by order provide for subsection (3) to have effect as if, for the sum specified in paragraph (a) or the multiplier specified in paragraph (b) (including that sum or multiplier as substituted by a previous order), there were substituted a sum or multiplier specified in the order.

(5)Regulations may provide that, if a person fails to pay the amount he is required to pay under a penalty notice within the period in question, he must also pay to the responsible authority by way of penalty a further sum determined in accordance with the regulations.

(6)The further sum must not exceed 50 per cent of the amount of the penalty charge.

(7)Any sum payable under the regulations (including the amount referred to in subsection (1)(a) or (b)) may be recovered by the responsible authority summarily as a civil debt.

(8)But a person is not liable by virtue of a penalty notice—

(a)to pay at any time so much of any amount referred to in subsection (1)(a) or (b) for which he is jointly and severally liable with another as at that time has been paid, or ordered by a court to be paid, by that other, or

(b)to a penalty charge, or a further sum by way of penalty, if he shows that he did not act wrongfully, or with any lack of care, in respect of the charge or payment in question.

194Offences relating to charges

(1)A person is guilty of an offence if he does any act mentioned in subsection (2) with a view to securing for himself or another—

(a)the evasion of the whole or part of any charge under this Act in respect of the provision of goods or services to which section 192 applies,

(b)the reduction, remission or repayment of any such charge, where he or the other is not entitled to the reduction, remission or repayment,

(c)a payment under this Act (whether to, or for the benefit of, himself or the other) in respect of the cost of obtaining such goods or services, where he or the other is not entitled to, or to the benefit of, the payment.

(2)The acts referred to in subsection (1) are—

(a)knowingly making, or causing or knowingly allowing another to make, a false statement or representation, or

(b)in the case of any document or information which he knows to be false in a material particular, producing or providing it or causing or knowingly allowing another to produce or provide it.

(3)A person guilty of an offence under this section is liable on summary conviction to a fine not exceeding level 4 on the standard scale.

(4)A person, although he is not a barrister or solicitor, may conduct any proceedings under this section before a magistrates' court if he is authorised to do so by the Secretary of State.

(5)Proceedings for an offence under this section may be begun within—

(a)the period of three months beginning with the date on which evidence, sufficient in the opinion of the Secretary of State to justify a prosecution for the offence, comes to his knowledge, or

(b)the period of 12 months beginning with the commission of the offence.

(6)For the purposes of subsection (5), a certificate purporting to be signed by or on behalf of the Secretary of State as to the date on which such evidence as is mentioned in paragraph (a) of that subsection came to his knowledge, is conclusive evidence of that date.

(7)Where a person is convicted of an offence under this section in respect of any charge or payment under this Act, he is not liable in respect of the charge or payment to pay any penalty charge or further sum by way of penalty which would otherwise be recoverable from him under section 193.

(8)Where a person pays any penalty charge, or further charge by way of penalty, recoverable under section 193 in respect of any charge or payment under this Act, he must not be convicted of an offence under this section in respect of the charge or payment.

(9)Subsection (4) of section 192 applies for the purposes of this section as it applies for the purposes of that.

Part 10Protection of NHS from fraud and other unlawful activities

Preliminary

195Compulsory disclosure of documents

(1)This Part confers power to require the production of documents in connection with the exercise of the Secretary of State’s counter fraud functions or security management functions in relation to the health service.

(2)The Secretary of State’s “counter fraud functions” in relation to the health service means his power (by virtue of section 2(1)(b)) to take action for the purpose of preventing, detecting or investigating fraud, corruption or other unlawful activities carried out against or otherwise affecting—

(a)the health service, or

(b)the Secretary of State in relation to his responsibilities for the health service.

(3)The Secretary of State’s “security management functions” in relation to the health service means his power (by virtue of section 2(1)(b)) to take action for the purpose of protecting and improving the security of—

(a)persons employed by the Secretary of State or an NHS body in the provision of services for the purposes of the health service (“NHS services”),

(b)health service providers and persons employed by them so far as they or persons so employed are engaged in any activity directly related to the provision of NHS services,

(c)NHS contractors and persons employed by them so far as they or persons so employed are engaged in any activity directly related to the provision of NHS services,

(d)persons not within paragraphs (a) to (c) who work in any capacity on premises used by the Secretary of State, an NHS body, a health service provider, or an NHS contractor, in connection with the provision of NHS services,

(e)persons on such premises—

(i)who are there for the purpose of receiving, or are receiving or have received, treatment or other services as patients, or

(ii)who are accompanying persons within sub-paragraph (i),

(f)property and information used or held by the Secretary of State, an NHS body, a health service provider, or an NHS contractor, in connection with the provision of NHS services.

(4)In this Part, the Secretary of State’s counter fraud functions and security management functions in relation to the health service are collectively referred to as functions to which this Part applies.

(5)“Investigating” means investigating in relation to civil or criminal proceedings.

196Persons and bodies about which provision is made by this Part

(1)This section applies for the purposes of this Part.

(2)Subject to subsection (3), and any provision made under subsection (7), “NHS body” has the meaning given by section 28(6).

(3)In section 195(3), and in section 197(1) so far as having effect in relation to the Secretary of State’s security management functions referred to in section 195(3), an “NHS body” means—

(a)a Strategic Health Authority,

(b)a Special Health Authority, so far as performing functions in respect of England,

(c)a Primary Care Trust,

(d)an NHS trust all or most of whose hospitals, establishments and facilities are situated in England, or

(e)an NHS foundation trust.

(4)A “health service provider” means any person (other than an NHS body) providing—

(a)primary medical services, primary dental services or pharmaceutical services under this Act or the National Health Service (Wales) Act 2006 (c. 42),

(b)general ophthalmic services under that Act, or

(c)primary ophthalmic services.

(5)An “NHS contractor” means any person (other than an NHS body or a person within subsection (4)) providing services of any description under arrangements made with an NHS body.

(6)A “statutory health body” means any body (other than an NHS body, or a person within subsection (4) or (5)) established by or under an enactment and—

(a)providing services in connection with the provision of, or

(b)exercising functions in relation to,

the health service in either England or Wales or both.

(7)The Secretary of State may by order—

(a)make such amendments of any of subsections (2) to (6) as he considers appropriate,

(b)make such consequential amendments of this Part as he considers appropriate.

Disclosure notices

197Notice requiring production of documents

(1)This section applies if it appears to the Secretary of State that there are reasonable grounds for suspecting—

(a)that any documents containing information relevant to the exercise of any of his functions to which this Part applies are in the possession or under the control of any NHS body, statutory health body, health service provider or NHS contractor (“the relevant organisation”), and

(b)that a person within subsection (3) is accountable for the documents.

(2)The Secretary of State may serve on that person a notice requiring him to produce the documents to an authorised officer.

(3)The persons within this subsection are—

(a)any member, officer or director of the relevant organisation,

(b)any other person who takes part in the management of the affairs of that organisation,

(c)any person employed by that organisation, and

(d)(in the case of a health service provider or NHS contractor who is an individual) that individual.

(4)A notice under this section must specify or describe the documents to which it relates.

(5)Subject to subsections (6) and (7), the notice may require those documents to be produced—

(a)at or by such time as is specified in the notice, or at once, and

(b)at such place, and in such manner, as is so specified.

(6)When specifying a time at or by which the documents must be produced, the notice must not require them to be produced otherwise than at a reasonable hour.

(7)If the notice requires documents to be produced at once, it may only be served at a reasonable hour.

(8)An authorised officer may, by agreement with the person served with a notice within subsection (6) or (7), vary the notice so as to extend the time for compliance with it.

(9)Any notice under this section, and any variation of such a notice under subsection (8), must be in writing.

(10)An individual is “accountable” for any documents if he has either day-to-day, or an overall, responsibility for the custody or control of the documents.

198Production of documents

(1)This section applies where a notice has been served under section 197.

(2)An authorised officer may—

(a)take away any documents produced in compliance with the notice,

(b)take copies of or extracts from any documents so produced,

(c)require the person producing any such documents to provide an explanation of any of them.

(3)If—

(a)the officer takes away any such document,

(b)the person producing it requests the officer to provide him with a copy of it, and

(c)the request appears to the officer to be reasonable in the circumstances,

the officer must, as soon as is reasonably practicable, provide that person with a copy of the document (in such form as the officer considers appropriate).

(4)Documents produced in compliance with a notice under section 197 may be retained for so long as the Secretary of State considers that it is necessary to retain them (rather than copies of them) in connection with the exercise of any of his functions to which this Part applies.

(5)If the Secretary of State has reasonable grounds for believing—

(a)that any such documents may have to be produced for the purposes of any legal proceedings, and

(b)that they might otherwise be unavailable for those purposes,

they may be retained until the proceedings are concluded.

(6)If a person who is required by a notice under section 197 to produce any documents does not produce the documents in compliance with the notice, an authorised officer may require that person to state, to the best of his knowledge and belief, where they are.

(7)A person is not bound to comply with any requirement imposed by a notice under section 197 or any requirement under subsection (6) unless evidence of authority is given—

(a)at the time when the notice is served, or

(b)at the time when the requirement is imposed under subsection (6).

(8)In addition, a person may not be required under section 197 or subsection (6) to produce any document or disclose any information which he would be entitled to refuse to produce or disclose in proceedings in the High Court on grounds of legal professional privilege.

199Delegation of functions

(1)This section applies if the Secretary of State gives a direction under section 7 directing a Special Health Authority to exercise so much of his functions under sections 197 and 198 as is specified in the directions (“the delegated functions”).

(2)The Secretary of State may give directions providing for senior officers of the Special Health Authority to exercise the delegated functions on behalf of the Special Health Authority.

(3)“Senior officer” means an officer of or above a level specified in the directions.

(4)The Secretary of State may by regulations make such provision as he considers appropriate in connection with the exercise of the delegated functions.

(5)The regulations may, in particular, make provision—

(a)specifying conditions as to training that must be satisfied in relation to officers of the Special Health Authority involved in the exercise of the delegated functions,

(b)for requiring officers to obtain specific authorisation before the delegated functions are exercised in relation to personal records,

(c)providing for the designation of officers for the purpose of giving such authorisations,

(d)otherwise prescribing the manner in which the delegated functions may be exercised.

200Code of practice relating to delegated functions

(1)The Secretary of State may issue a code of practice relating to—

(a)the exercise of functions under section 197 or 198 by or on behalf of a Special Health Authority,

(b)procedures to be followed in relation to the disclosure (in accordance with sections 201 and 202) of information obtained by or on behalf of a Special Health Authority in the exercise of such functions.

(2)The Secretary of State must keep the code under review and may from time to time—

(a)revise the whole or any part of the code, and

(b)issue a revised code.

(3)Where the Secretary of State proposes to issue a code of practice under this section he must—

(a)prepare a draft of the code, and

(b)consult such persons as he considers appropriate about the draft.

(4)Where the Secretary of State proposes to issue a revised code under this section which in his opinion would result in a substantial change in the code, he must—

(a)prepare a draft of the revised code, and

(b)consult such persons as he considers appropriate about the change.

(5)Where, following consultation under subsection (3) or (4), the Secretary of State issues the code or revised code (whether in the form of the draft or with such modifications as he considers appropriate), it comes into force at the time when it is issued by the Secretary of State.

(6)A failure to observe any provision of a code or revised code issued under this section does not of itself make a person liable to any criminal or civil proceedings.