Part 1 Promotion and provision of the health service in Wales

The Welsh Ministers and the health service in Wales

1 Welsh Ministers' duty to promote health service

(1) The Welsh Ministers must continue the promotion in Wales of a comprehensive health service designed to secure improvement—

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

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

(2) The Welsh Ministers 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

2 Welsh Ministers' general power

(1) The Welsh Ministers may—

(a) provide such services as they consider appropriate for the purpose of discharging any duty imposed on them 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 powers of the Welsh Ministers apart from this section,

(b) Part 6 and Chapter 1 of Part 7 (ophthalmic and pharmaceutical services).

Provision of particular services

3 Welsh Ministers' duty as to provision of certain services

(1) The Welsh Ministers must provide throughout Wales, to such extent as they consider 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 they consider 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 they consider 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 41(2) (primary medical services) or 56(2) (primary dental services), or

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

must be regarded as provided by the Welsh Ministers.

(3) This section does not affect Part 6 and Chapter 1 of Part 7 (ophthalmic and pharmaceutical services).

4 High security psychiatric services

(1) The Welsh Ministers' 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 Welsh Ministers 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 3 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.

5 Other services

Schedule 1 makes further provision about the Welsh Ministers and services under this Act.

Provision of services otherwise than in Wales

6 Performance of functions outside Wales

(1) The Welsh Ministers may provide or secure the provision of anything mentioned in section 3(1) outside Wales.

(2) The Welsh Ministers' 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).

NHS contracts

7 NHS 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 97(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 3 (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 to 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 Welsh Ministers 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 Welsh Ministers for determination under this section.

(8) Where a reference is made to the Welsh Ministers under subsection (6) or (7), they may determine the matter themselves or appoint a person to consider and determine it in accordance with regulations.

(9) “The appropriate person” means the Welsh Ministers 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.

8 Provision 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 7(4) is a party or prospective party to an arrangement or proposed arrangement which—

(a) falls within the definition of NHS contract in section 7(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 7 apply in relation to the arrangement or proposed arrangement with the substitution for references to the Welsh Ministers of references to the Welsh Ministers and the Department of Health, Social Services and Public Safety acting jointly.

9 Arrangements to be treated as NHS contracts

(1) This section applies to any arrangement under which a Local Health Board or such other health service body as may be prescribed arranges 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) Part 6 (general ophthalmic services),

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

(c) section 115 of, or Chapter 1 or 2 of Part 7 of, the National Health Service Act 2006 (c. 41) (primary ophthalmic services and pharmaceutical services and local pharmaceutical services under pilot schemes).

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

(4) In this section—

• “general ophthalmic services contract” and “contractor” under such a contract have the meanings given by section 117 of the National Health Service Act 2006,

• “health service body” means a body which is a health service body for the purposes of section 7,

• “ophthalmic list” includes a list published in accordance with regulations made under—

  (a)

  section 26(2)(a) of the National Health Service (Scotland) Act 1978 (c. 29), or

  (b)

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

• “pharmaceutical list” includes a list published in accordance with regulations made under—

  (a)

  section 129(2)(a) of the National Health Service Act 2006, or

  (b)

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

(5) 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.

Provision of services otherwise than by the Welsh Ministers

10 Welsh Ministers' arrangements with other bodies

(1) The Welsh Ministers 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 Welsh Ministers may make available any facilities provided by them 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 Welsh Ministers may make available the services of any person employed in connection with the facilities by—

(a) the Welsh Ministers,

(b) a Primary Care Trust,

(c) a Special Health Authority, or

(d) 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 Welsh Ministers.

(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 2 Health service bodies

Chapter 1 Local Health Boards

11 Local Health Boards

(1) The Welsh Ministers may establish bodies to be known as Local Health Boards.

(2) Each Local Health Board is established by order made by the Welsh Ministers (referred to in this Act as an LHB order), and an order may establish more than one Local Health Board.

(3) A Local Health Board is established for the area of Wales specified in its LHB order.

(4) If any consultation requirements apply, they must be complied with before an LHB order is varied or revoked.

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

(6) Schedule 2 makes further provision about Local Health Boards.

12 Functions of Local Health Boards

(1) The Welsh Ministers may direct a Local Health Board to exercise in relation to its area—

(a) functions which were transferred to the National Assembly for Wales by the Health Authorities (Transfer of Functions, Staff, Property, Rights and Liabilities and Abolition) (Wales) Order 2003 (S.I. 2003/813 (W.98)),

(b) such other of their functions relating to the health service as are specified in the direction.

(2) The functions which may be specified in directions under subsection (1) include functions under enactments relating to mental health and care homes.

(3) The Welsh Ministers may give directions to a Local Health Board about its exercise of any functions.

13 Exercise of Local Health Board functions

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

(2) The Welsh Ministers may give directions providing for any functions to which this section applies to be exercised—

(a) by another Local Health Board,

(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) NHS trusts, and

(c) other Local Health Boards.

(4) Directions given by the Welsh Ministers may provide—

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

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

(c) for any functions which, under this section, are exercisable by a Local Health Board jointly with one or more other Local Health Boards (but not with any NHS trusts) to be exercised, on behalf of the Local Health Boards 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 Local Health Board in relation to a general dental services contract.

(6) The Welsh Ministers may by order make provision for the transfer to the Special Health Authority of the rights and liabilities of the Local Health Board under the contract (and for their transfer back to the Local Health Board where the Special Health Authority ceases to exercise the functions).

14 Section 50 arrangements and section 64 arrangements

(1) Each Local Health Board must, in accordance with regulations, perform such functions in relation to section 50 arrangements (primary medical services) and section 64 arrangements (primary dental services) as may be prescribed.

(2) The regulations may, in particular—

(a) prescribe functions in relation to training,

(b) provide for appeals to the Welsh Ministers or a prescribed body in relation to prescribed functions.

15 Administration and management of services

Each Local Health Board 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, general ophthalmic services and pharmaceutical services, and

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

16 Advice for Local Health Boards

Each Local Health Board 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.

17 Plans for improving health etc

(1) Each Local Health Board must, at such times as the Welsh Ministers 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 Local Health Board must keep under review any plan prepared by it under this section.

(3) Each of the bodies specified in subsection (4) must participate in the preparation or review by a Local Health Board of any plan under this section.

(4) Those bodies are—

(a) any local authority whose area falls wholly or partly within the area of the Local Health Board, and

(b) any NHS trust which provides services at or from a hospital or other establishment or facility which falls within the area of the Local Health Board.

(5) In preparing or reviewing any plan under this section, a Local Health Board—

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

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

(6) The Welsh Ministers may give directions as to—

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

(b) the action to be taken by Local Health Boards, NHS 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, NHS trusts, Local Health Boards and local authorities in connection with the preparation or review of plans under this section or section 24 of the National Health Service Act 2006 (c. 41),

(h) the provision by Strategic Health Authorities, Primary Care Trusts and Local Health Boards of reports or other information to the Welsh Ministers in connection with plans under this section or section 24 of the National Health Service Act 2006 (c. 41).

(7) In exercising its functions—

(a) a Local Health Board must have regard to any plan prepared or reviewed by it, and

(b) an NHS trust and a local authority must have regard to any plan in relation to which it has participated.

(8) For the purposes of this section, the persons for whom a Local Health Board is responsible are—

(a) the people in the area of the Local Health Board, and

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

(9) “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 2 NHS trusts

18 NHS trusts

(1) The Welsh Ministers 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 3 makes further provision about NHS trusts.

19 Welsh Ministers' directions to NHS trusts

(1) The Welsh Ministers may give directions to an NHS trust about its exercise of any functions.

(2) The Welsh Ministers may not give directions under this section in respect of matters concerning xenotransplantation, surrogacy agreements, embryology or human genetics.

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

20 General duty of NHS trusts

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

21 Financial provisions relating to NHS trusts

Schedule 4 makes provision about the financing of NHS trusts.

Chapter 3 Special Health Authorities

22 Special Health Authorities

(1) The Welsh Ministers 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 Welsh Ministers may make such further provision relating to a body established under subsection (1) as they consider 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 203(10) and section 204(1) to an NHS body on the abolition of a Special Health Authority include criminal liabilities.

(6) In this Act (apart from in Schedule 12) “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 Welsh Ministers must, before they make an order under this section, consult with respect to the order such bodies as they may recognise as representing officers who in the opinion of the Welsh Ministers are likely to be transferred or affected by transfers in pursuance of the order.

(8) Schedule 5 makes further provision about Special Health Authorities.

23 Welsh Ministers' directions to Special Health Authorities

(1) The Welsh Ministers may give directions to a Special Health Authority about its exercise of any functions.

(2) The Welsh Ministers may not give directions under this section in respect of matters concerning xenotransplantation, surrogacy agreements, embryology or human genetics.

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

24 Exercise of health service functions by Special Health Authorities

(1) The Welsh Ministers may direct a Special Health Authority to exercise any of the functions of the Welsh Ministers relating to the health service which are specified in the directions.

(2) Subsection (1) does not apply to the functions of the Welsh Ministers in relation to pilot schemes.

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

25 Exercise of Special Health Authority functions

(1) Regulations may provide for any functions which are exercisable by a Special Health Authority under section 24 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 24 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 4 Miscellaneous

Intervention orders and default powers

26 Intervention orders

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

(2) If the Welsh Ministers—

(a) consider 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) are satisfied that it is appropriate for them to intervene under this section,

they 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 27 (including any combination of such provisions).

27 Effect 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 26 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 Welsh Ministers consider appropriate for the purpose of giving full effect to the order.

28 Default powers

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

(2) If the Welsh Ministers consider 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,

they may after such inquiry as they consider 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 Welsh Ministers 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 Welsh Ministers to be necessary or expedient, including—

(a) provision for the transfer to the Welsh Ministers 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 Welsh Ministers in discharging any of the functions transferred to them.

Transfer of residual liabilities

29 Transfer of residual liabilities

(1) If a Local Health Board, an NHS trust or a Special Health Authority ceases to exist, the Welsh Ministers must exercise their 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 Welsh Ministers or the Secretary of State.

Losses and liabilities of certain health service bodies

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

(1) The Welsh Ministers may by regulations 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) Local Health Boards,

(b) NHS trusts,

(c) Special Health Authorities,

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

(e) 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 Welsh Ministers or by an NHS trust or Special Health Authority 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 Welsh Ministers.

(4) If the Welsh Ministers so direct, a body which is eligible to participate in a scheme must do so.

(5) Where a scheme provides for the scheme to be administered by the Welsh Ministers, a Special Health Authority or NHS trust must carry out such functions in connection with the administration of the scheme as the Welsh Ministers may direct.

(6) Subsections (4) and (5) do not affect any other power of direction of the Welsh Ministers.

(7) 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.

Directions and regulations under this Part

31 Directions and regulations under this Part

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

(a) section 12,

(b) section 13,

(c) section 19,

(d) section 23,

(e) section 24,

(f) section 25.

(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 3 Local authorities and the NHS

32 Supply 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 Local Health Board, and

(b) so far as relates to their functions under this Act, the Welsh Ministers.

(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).

33 Arrangements between NHS bodies and local authorities

(1) The Welsh Ministers 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 Welsh Ministers 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 Welsh Ministers 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 Welsh Ministers—

  (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 12 makes provision with respect to the transfer of staff in connection with arrangements made by virtue of this section.

34 Power 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 Welsh Ministers 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).

35 Care Trusts

(1) Where—

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

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

the Welsh Ministers may designate the NHS trust as a Care Trust.

(2) An NHS trust may, however, be designated only in pursuance of an application made to the Welsh Ministers jointly by each prescribed body.

(3) If the application under subsection (2) requests the Welsh Ministers to do so, they may when designating an NHS trust as a Care Trust make a direction under subsection (4).

(4) The direction is that, while it is designated, the NHS trust 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 an NHS trust is designated as a Care Trust under this section—

(a) its designation may be revoked by the Welsh Ministers at any time—

(i) of their own motion, and

(ii) after such consultation as they consider appropriate,

(b) if an application for the revocation of its designation is made to the Welsh Ministers by one or more of the parties to the LA delegation arrangements, its designation must be revoked by the Welsh Ministers at the earliest time at which they consider 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 an NHS trust as a Care Trust under this section must be effected by an order under section 18 which—

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

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

and any revocation of its designation must be effected by a further order under section 18 which makes such provision for changing the name of the NHS trust as the Welsh Ministers consider expedient.

(7) The power of the Welsh Ministers to dissolve an NHS trust includes power to dissolve an NHS trust where they consider that it is appropriate to do so in connection with the designation of any other NHS trust (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 Welsh Ministers consider 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 an NHS trust 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 Welsh Ministers to terminate appointments of persons as members of the board of directors of an NHS trust (or of a committee of such a trust) where they consider that it is appropriate to do so in connection with the designation of the NHS trust as a Care Trust,

(c) requiring the consent of the Welsh Ministers to be obtained before any prescribed change is made with respect to the governance of an NHS trust so designated,

(d) for supplementing or modifying, in connection with the operation of subsection (3), any provision made by regulations under section 33.

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

(11) In connection with the exercise by an NHS trust 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 NHS trust 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 33(8),

• “LA delegation arrangements” means arrangements falling within section 33(2)(b), whether or not made in conjunction with any pooled fund arrangements,

• “NHS functions” means functions exercisable by an NHS trust in its capacity as such,

• “pooled fund arrangements” means arrangements falling within section 33(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.

36 Directed partnership arrangements

(1) If the Welsh Ministers are 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 Welsh Ministers 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 Welsh Ministers consider 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 33(2)(b) or (2)(c), whether or not made in conjunction with any pooled fund arrangements,

• “health-related functions” has the meaning given by section 33(8),

• “pooled fund arrangements” means arrangements falling within section 33(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).

37 Further provisions about directions and directed partnership arrangements

(1) A direction under section 36(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 33, and

(b) such other matters as the Welsh Ministers consider appropriate.

(2) The Welsh Ministers 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 Welsh Ministers or an arbitrator appointed by them,

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 Welsh Ministers 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 Welsh Ministers may, when giving a principal direction to any bodies to which section 36 applies, give such directions to any other such body as they consider 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 36 applies, the Welsh Ministers 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 the Welsh Ministers consider appropriate with a view to enabling them 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 36(1).

38 Supply of goods and services by the Welsh Ministers

(1) The Welsh Ministers may supply to—

(a) local authorities, and

(b) such public bodies or classes of public bodies as the Welsh Ministers 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 Welsh Ministers may make available to persons falling within subsection (1)—

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

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

(4) The Welsh Ministers 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 Welsh Ministers may supply or make available to persons—

(a) providing general ophthalmic services or pharmaceutical services,

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

(c) providing services in accordance with section 50 arrangements or section 64 arrangements,

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

(6) The Welsh Ministers 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 Welsh Ministers, 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 Welsh Ministers, 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 Welsh Ministers may arrange to make available to local authorities the services of persons—

(a) providing general ophthalmic services or pharmaceutical services,

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

(c) providing services in accordance with section 50 arrangements or section 64 arrangements,

(d) providing Local Health Boards, Primary Care Trusts or Special Health Authorities 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.

39 Conditions of supply under section 38

(1) The Welsh Ministers must, before they make available the services of any officer under subsection (3)(b) of section 38, or subsection (6)(b) or (c) of that section—

(a) consult the officer or a body recognised by the Welsh Ministers as representing the officer, or

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

(2) The Welsh Ministers may disregard the provisions of subsection (1) in a case where they—

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

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

(3) The Welsh Ministers may, for the purposes of subsection (3)(b) of section 38, or subsection (6)(b) or (c) of that section, give such directions to Primary Care Trusts, Special Health Authorities and Local Health Boards to make the services of their officers available as the Welsh Ministers consider appropriate.

(4) Powers under this section and section 38 may be exercised on such terms as may be agreed, including terms as to the making of payments to the Welsh Ministers.

(5) The Welsh Ministers may make such charges in respect of services or facilities provided under section 38(6) as may be agreed between the Welsh Ministers 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 38 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.

40 Health and well-being strategies in Wales

(1) Each local authority in Wales, and each Local Health Board any part of whose area lies within the area of the local authority, must jointly formulate and implement a strategy for the health and well-being of members of the public in the local authority’s area (a “health and well-being strategy”).

(2) The local authority and the Local Health Board (or Boards) responsible for a health and well-being strategy are referred to in this section as the “responsible bodies”.

(3) The responsible bodies must have regard to their strategy in the exercise of their functions.

(4) Each strategy must be formulated in relation to a period of time specified in regulations.

(5) The Welsh Ministers may by regulations make further provision about health and well-being strategies.

(6) The regulations may, in particular, make provision as to—

(a) the imposition of a duty on the responsible bodies to co-operate in formulating their strategy with prescribed persons or descriptions of person (including, for example, NHS trusts, Community Health Councils, voluntary bodies, and local businesses),

(b) steps which the responsible bodies must take before formulating the strategy,

(c) matters which the strategy must address,

(d) publication of the strategy,

(e) monitoring and review by the responsible bodies of the strategy and its implementation,

(f) the production of information and reports by the responsible bodies in relation to the strategy,

(g) the avoidance of duplication in the preparation of health and well-being strategies and other prescribed strategies or plans provided for under any other enactment.

(7) The Welsh Ministers may—

(a) give directions to local authorities in Wales, Local Health Boards and NHS trusts in connection with health and well-being strategies,

(b) issue guidance to responsible bodies in connection with them.

(8) The power to give directions under subsection (7)(a) does not affect any other power to give directions.

(9) In this section—

• “local authority” means a county council or county borough council,

• “NHS trust” means an NHS trust all or most of whose hospitals, establishments and facilities are situated in Wales.

Part 4 Medical services

Duty of Local Health Boards in relation to primary medical services

41 Primary medical services

(1) Each Local Health Board 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 Local Health Board 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 Local Health Board must publish information about such matters as may be prescribed in relation to the primary medical services provided under this Act.

(4) Each Local Health Board must co-operate with each other Local Health Board and each Primary Care Trust in the discharge of their respective functions relating to the provision of primary medical services under this Act and the National Health Service Act 2006 (c. 41).

(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

42 General medical services contracts: introductory

(1) A Local Health Board 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 Local Health Board 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 Local Health Board.

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

43 Requirement 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.

44 Persons eligible to enter into GMS contracts

(1) A Local Health Board 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 50 employee, section 64 employee, section 92 employee, section 107 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 Act 2006 (c. 41), or

(iv) an individual falling within section 51(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 50 employee”, “section 64 employee”, “section 92 employee”, “section 107 employee”, “section 17C employee” and “Article 15B employee” have the meaning given by section 51.

45 GMS contracts: payments

(1) The Welsh Ministers 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 Local Health Board 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 Welsh Ministers—

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

(b) may consult such other persons as they consider appropriate.

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

46 GMS 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 Welsh Ministers 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 Welsh Ministers 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).

47 GMS 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 Local Health Board 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.

48 GMS 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 Welsh Ministers, and

(b) for the Welsh Ministers, or a person appointed by them, 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 7, in circumstances where he or they so elect.

(4) Regulations under subsection (3) may include provision as to the application of section 7 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 7(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

49 Persons 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 Local Health Board is responsible unless he is included in a list maintained under the regulations by a Local Health Board.

(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 Local Health Board 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 Local Health Board 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 Welsh Ministers or a person appointed by them),

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

(j) appeals against decisions made by a Local Health Board 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 107 to 115.

(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 Local Health Board,

(b) a Local Health Board 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 Local Health Board 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 Local Health Board to the Welsh Ministers, and

(b) by the Welsh Ministers to a Local Health Board.

Other arrangements for the provision of primary medical services

50 Arrangements by Local Health Boards for the provision of primary medical services

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

(2) An agreement must be in accordance with regulations under section 52.

(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 Part 6 (general ophthalmic services) or Chapter 1 or 2 of Part 7 (pharmaceutical services and local pharmaceutical services under pilot schemes).

(6) Regulations may provide—

(a) for functions which are exercisable by a Local Health Board in relation to an agreement to be exercisable on behalf of the Local Health Board 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 the Local Health Board.

(7) In this Act, arrangements for the provision of services made under this section are called “section 50 arrangements”.

51 Persons with whom agreements may be made under section 50

(1) A Local Health Board may make an agreement under section 50 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 an English general medical services contract or an English general dental services contract,

(ii) in accordance with section 50 arrangements, section 64 arrangements, section 92 arrangements, section 107 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 50 employee, a section 64 employee, a section 92 employee, a section 107 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,

• “English general dental services contract” means a contract under section 100(2) of the National Health Service Act 2006 (c. 41),

• “English general medical services contract” means a contract under section 84(2) of that Act,

• “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 an English general medical services contract or an English 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 (S.I. 1972/1265 (N.I.14)),

• “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 (c. 29),

• “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 92 arrangements” means arrangements for the provision of services made under section 92 of the National Health Service Act 2006 (c. 41),

• “section 107 arrangements” means arrangements for the provision of services made under section 107 of that Act,

• “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 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 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.

52 Regulations about section 50 arrangements

(1) The Welsh Ministers may make regulations about the provision of services in accordance with section 50 arrangements.

(2) The regulations must include provision for participants other than Local Health Boards to withdraw from section 50 arrangements if they wish to do so.

(3) The regulations may, in particular—

(a) provide that section 50 arrangements may be made only in prescribed circumstances,

(b) provide that section 50 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 50 arrangements,

(d) impose conditions (including conditions as to qualifications and experience) to be satisfied by persons performing services in accordance with section 50 arrangements,

(e) require details of section 50 arrangements to be published,

(f) make provision with respect to the variation and termination of section 50 arrangements,

(g) provide for parties to section 50 arrangements to be treated, in such circumstances and to such extent as may be prescribed, as health service bodies for the purposes of section 7,

(h) provide for directions, as to payments, made under section 7(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 Welsh Ministers.

(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 Local Health Board, 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 50 arrangements and who so requests.

(7) The regulations may also include provision for the resolution of disputes as to to the terms of any proposed section 50 arrangements, and in particular may make provision—

(a) for the referral of the terms of the proposed arrangements to the Welsh Ministers, and

(b) for the Welsh Ministers or a person appointed by them 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 50 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 50 arrangements.

Assistance and support

53 Assistance and support: primary medical services

(1) A Local Health Board 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 50 arrangements.

(2) Assistance or support provided by a Local Health Board under subsection (1) is provided on such terms, including terms as to payment, as the Local Health Board considers appropriate.

(3) “Assistance” includes financial assistance.

Local Medical Committees

54 Local Medical Committees

(1) A Local Health Board may recognise a committee formed for its area, or for its area and that of one or more other Local Health Boards, 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 is providing general ophthalmic services in that area.

(3) This subsection applies to each other medical practitioner—

(a) who is performing primary medical services in the area for which the committee is formed—

(i) pursuant to section 41(2)(a),

(ii) in accordance with section 50 arrangements, or

(iii) under a general medical services contract, and

(b) who has notified the Local Health Board 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 Local Health Board, 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) A committee recognised under this section has such other functions as may be prescribed.

(8) 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).

(9) A Local Health Board 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 (8)(a) as the Local Health Board 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, or arrangements under section 71, entered into by those persons with the Local Health Board.

(10) A committee recognised under this section must apportion the amount determined by it under subsection (8)(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.

(11) The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.

Provision of accommodation by the Welsh Ministers

55 Use of accommodation: provision of primary medical services

If the Welsh Ministers consider that any accommodation provided by them by virtue of this Act is suitable for use in connection with the provision of primary medical services, they may make the accommodation available on such terms as they consider appropriate to persons providing those services.

Part 5 Dental services

Duty of Local Health Boards in relation to primary dental services

56 Primary dental services

(1) Each Local Health Board 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 Local Health Board may (in addition to any other power conferred on it) provide primary dental services itself (whether within or outside its area).

(3) Each Local Health Board 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 Local Health Board must co-operate with each other Local Health Board and each Primary Care Trust in the discharge of their respective functions relating to the provision of primary dental services under this Act and the National Health Service Act 2006 (c. 41).

(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

57 General dental services contracts: introductory

(1) A Local Health Board 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 Local Health Board 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 Local Health Board.

58 Requirement 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.

59 Persons eligible to enter into GDS contracts

(1) A Local Health Board 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 50 employee, section 64 employee, section 92 employee, section 107 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 Act 2006 (c. 41), or

(iv) an individual falling within section 51(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 50 employee”, “section 64 employee”, “section 92 employee”, “section 107 employee”, “section 17C employee” and “Article 15B employee” have the meaning given by section 65.

60 GDS contracts: payments

(1) The Welsh Ministers 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 Local Health Board 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 Welsh Ministers—

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

(b) may consult such other persons as they consider appropriate.

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

61 GDS 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 Local Health Board 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.

62 GDS 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 Welsh Ministers, and

(b) for the Welsh Ministers, or a person appointed by them, 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 7, in circumstances where he or they so elect.

(4) Regulations under subsection (3) may include provision as to the application of section 7 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 7(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

63 Persons 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 Local Health Board is responsible unless he is included in a list maintained under the regulations by a Local Health Board.

(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 Local Health Board 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 Local Health Board 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 Welsh Ministers or a person appointed by them),

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

(j) appeals against decisions made by a Local Health Board 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 107 to 115.

(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 Local Health Board,

(b) a Local Health Board 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 Local Health Board 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 Local Health Board to the Welsh Ministers, and

(b) by the Welsh Ministers to a Local Health Board.

Other arrangements for the provision of primary dental services

64 Arrangements by Local Health Boards for the provision of primary dental services

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

(2) An agreement must be in accordance with regulations under section 66.

(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 Part 6 (general ophthalmic services) or Chapter 1 or 2 of Part 7 (pharmaceutical services and local pharmaceutical services under pilot schemes).

(6) Regulations may provide—

(a) for functions which are exercisable by a Local Health Board in relation to an agreement to be exercisable on behalf of the Local Health Boards 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 Health Board by a Local Health Board.

(7) In this Act, arrangements for the provision of services made under this section are called “section 64 arrangements”.

65 Persons with whom agreements may be made under section 64

(1) A Local Health Board may make an agreement under section 64 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 an English general medical services contract or an English general dental services contract,

(ii) in accordance with section 64 arrangements, section 50 arrangements, section 92 arrangements, section 107 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 64 employee, a section 50 employee, a section 92 employee, a section 107 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,

• “English general dental services contract” means a contract under section 100(2) of the National Health Service Act 2006 (c. 41),

• “English general medical services contract” means a contract under section 84(2) of that Act,

• “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 an English general medical services contract or an English 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), or

  (b)

  a body corporate which, in accordance with the provisions of Part 4 of the Dentists Act 1984 (c. 24), is entitled to carry on the business of dentistry,

• “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 92 arrangements” means arrangements for the provision of services made under section 92 of the National Health Service Act 2006 (c. 41),

• “section 107 arrangements” means arrangements for the provision of services made under section 107 of that Act,

• “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 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 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,

• “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.

66 Regulations about section 64 arrangements

(1) The Welsh Ministers may make regulations about the provision of services in accordance with section 64 arrangements.

(2) The regulations must include provision for participants other than Local Health Boards to withdraw from section 64 arrangements if they wish to do so.

(3) The regulations may, in particular—

(a) provide that section 64 arrangements may be made only in prescribed circumstances,

(b) provide that section 64 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 64 arrangements,

(d) impose conditions (including conditions as to qualifications and experience) to be satisfied by persons performing services in accordance with section 64 arrangements,

(e) require details of section 64 arrangements to be published,

(f) make provision with respect to the variation and termination of section 64 arrangements,

(g) provide for parties to section 64 arrangements to be treated, in such circumstances and to such extent as may be prescribed, as health service bodies for the purposes of section 7,

(h) provide for directions, as to payments, made under section 7(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 Welsh Ministers.

(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 Local Health Board, 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 64 arrangements and who so requests.

(7) The regulations may also include provision for the resolution of disputes as to to the terms of any proposed section 64 arrangements, and in particular may make provision—

(a) for the referral of the terms of the proposed arrangements to the Welsh Ministers, and

(b) for the Welsh Ministers or a person appointed by them 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 64 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 64 arrangements.

Dental public health

67 Dental public health

(1) A Local Health Board has such functions in relation to dental public health in Wales as may be prescribed.

(2) The Welsh Ministers have such functions in relation to dental public health in Wales as may be prescribed.

(3) The functions of a Local Health Board under this section may be discharged—

(a) by the Local Health Board itself,

(b) by the Local Health Board and one or more other Local Health Boards acting jointly, or

(c) by any other person or body in accordance with arrangements made by the Local Health Board.

Assistance and support

68 Assistance and support: primary dental services

(1) A Local Health Board 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 64 arrangements.

(2) Assistance or support provided by a Local Health Board under subsection (1) is provided on such terms, including terms as to payment, as the Local Health Board considers appropriate.

(3) “Assistance” includes financial assistance.

Local Dental Committees

69 Local Dental Committees

(1) A Local Health Board may recognise a committee formed for its area, or for its area and that of one or more other Local Health Boards, 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 56(2),

(ii) in accordance with section 64 arrangements, or

(iii) under a general dental services contract, and

(b) who has notified the Local Health Board 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 Local Health Board, 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) A committee recognised under this section has such other functions as may be prescribed.

(8) 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).

(9) A Local Health Board 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 (8)(a) as the Local Health Board 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 Board.

(10) A committee recognised under this section must apportion the amount determined by it under subsection (8)(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.

(11) The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.

Provision of accommodation by the Welsh Ministers

70 Use of accommodation: provision of primary dental services

If the Welsh Ministers consider that any accommodation provided by them by virtue of this Act is suitable for use in connection with the provision of primary dental services, they may make the accommodation available on such terms as they consider appropriate to persons providing those services.

Part 6 Ophthalmic services

General ophthalmic services

71 Arrangements for general ophthalmic services

(1) Each Local Health Board must, in accordance with regulations, arrange as respects its area—

(a) with medical practitioners having the prescribed qualifications, and

(b) with optometrists,

for securing sight tests by them of the persons mentioned in subsection (2).

(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, or

(c) a person of such other description as may be prescribed.

(3) In subsection (2)—

• “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, and

• “qualifying full-time education” means full-time instruction at a recognised educational establishment or by other means accepted as comparable by the Welsh Ministers.

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

(a) “recognised educational establishment” means an establishment recognised by the Welsh Ministers 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.

(5) 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.

(6) Descriptions of persons may be prescribed for the purposes of subsection (1) 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, and

(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.

(7) Regulations which refer to an Act of Parliament or an instrument made under an Act of Parliament may direct that the reference is to 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.

(8) Regulations may provide that a person—

(a) whose sight is tested by a person who provides general ophthalmic services, and

(b) who is shown during the test or within a prescribed time after it to fall within subsection (1),

must be taken for the purposes of the test to have fallen within subsection (1) immediately before the test.

(9) For the purposes of subsection (8), the test must be treated as a sight test under this Act—

(a) for the purposes of any arrangements under this section,

(b) for the purposes of remuneration in respect of the test, and

(c) for any such other purpose as may be prescribed.

(10) Regulations must define the services for the provision of which arrangements under this section must be made, and the services so defined are in this Act referred to as “general ophthalmic services”.

72 Regulations as to general ophthalmic services

(1) Regulations may provide as to the arrangements to be made under section 71, and must include provision—

(a) for the preparation and publication by each Local Health Board of a list of medical practitioners and a list of optometrists who undertake to provide general ophthalmic services for persons in the area of the Local Health Board,

(b) for conferring a right on any medical practitioner having the prescribed qualifications, and on any optometrist, who wishes to be included in an ophthalmic list, to be included,

(c) for conferring on any person a right to choose in accordance with the prescribed procedure the medical practitioner or optometrist by whom his sight will be tested, or from whom any prescription for the supply of optical appliances will be obtained,

(d) for the removal from an ophthalmic list for any area of the name of any person in whose case it has been determined in such manner as may be prescribed that he has never provided, or has ceased to provide, general ophthalmic services for persons in that area.

(2) Subsection (1)(b) is subject to subsections (3) and (4) and Part 8.

(3) The regulations may, in particular, make provision in relation to—

(a) grounds on which a Local Health Board may, or must, refuse to include a medical practitioner or an optometrist in an ophthalmic list (including grounds corresponding to the conditions referred to in section 107(2), (3) and (4) as read with section 109),

(b) information which must be supplied to a Local Health Board by a person included or seeking inclusion in an ophthalmic list (or by arrangement with him),

(c) the supply to a Local Health Board by an individual—

(i) who is included, or seeking inclusion, in an ophthalmic list, or

(ii) who is a director of a body corporate or who is a member of a limited liability partnership 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) grounds on which a Local Health Board may defer a decision whether or not to include a person in an ophthalmic list,

(e) the disclosure by a Local Health Board, to prescribed persons or persons of prescribed descriptions, of information of a prescribed description about applicants for inclusion in an ophthalmic list, and refusals by the Local Health Board to include them, and

(f) criteria to be applied in making decisions under the regulations.

(4) If regulations made by virtue of subsection (3)(a) provide that a Local Health Board may refuse to include a person in an ophthalmic list, they must also provide for an appeal (by way of redetermination) to the FHSAA against the decision of the Local Health Board.

(5) The regulations may include provision as to the making of declarations about—

(a) financial interests,

(b) gifts above a prescribed value, and

(c) other benefits received.

(6) Before making regulations by virtue of subsection (5), the Welsh Ministers must consult such organisations as they consider appropriate appearing to them to represent persons providing general ophthalmic services.

(7) In this Act an “ophthalmic list” means a list published in accordance with regulations made under subsection (1)(a).

73 Medical practitioners with qualifications prescribed under section 71

The power conferred by section 71 to prescribe the qualifications to be possessed by any medical practitioner includes a power to—

(a) prescribe a requirement that the practitioner must show to the satisfaction of a committee recognised by the Welsh Ministers for the purpose that he possesses such qualifications, including qualifications as to experience, as may be mentioned in the regulations, and

(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 Welsh Ministers, and to provide for any matter for which it appears to the Welsh Ministers to be requisite or expedient to provide in consequence of the conferring of that right.

74 Exercise of choice of practitioner

Regulations may provide that, where a right is conferred to choose the person by whom general ophthalmic services will be provided under this Part, that right must, in the case of prescribed persons, be exercised on their behalf by other prescribed persons.

75 Inadequate provision of ophthalmic services

(1) Subsection (2) applies if the Welsh Ministers are satisfied, after such inquiry as they consider appropriate, that—

(a) as respects the area, or part of the area, of a Local Health Board, the persons whose names are included in any ophthalmic list are not such as to secure the adequate provision of general ophthalmic 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 Part.

(2) Where this subsection applies, the Welsh Ministers—

(a) may authorise the Local Health Board to make such other arrangements as the Welsh Ministers may approve, or may themselves make such other arrangements, and

(b) may dispense with any of the requirements of regulations made under this Part or Part 8 so far as appears to the Welsh Ministers necessary to meet exceptional circumstances and enable such arrangements to be made.

Remuneration

76 Remuneration for persons providing general ophthalmic services

(1) The remuneration to be paid to persons who provide general ophthalmic 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 77 determining authorities are—

(a) the Welsh Ministers, and

(b) so far as authorised by the Welsh Ministers to exercise the functions of determining authorities, any Local Health Board or other person appointed by them 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 77, 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 77 to a determination is to a determination of remuneration under this section.

77 Section 76: supplementary

(1) Before a determination is made by the Welsh Ministers which relates to all persons who provide general ophthalmic services or a category of such services, they—

(a) must consult a body appearing to them to be representative of persons to whose remuneration the determination would relate, and

(b) may consult such other persons as they consider 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 76 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 general ophthalmic services or of any category of general ophthalmic 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 general ophthalmic services or the category of general ophthalmic services to which the determination will relate,

(e) the desirability of promoting general ophthalmic services which are—

(i) economic and efficient, and

(ii) of an appropriate standard.

(11) If the determination is of remuneration for a category of general ophthalmic services, the reference in subsection (10)(a) to a category of general ophthalmic services is a reference to the same category of general ophthalmic services or to any other category of general ophthalmic services falling within the same description.

Local Optical Committees

78 Local Optical Committees

(1) A Local Health Board may recognise a committee formed for its area, or for its area and that of one or more other Local Health Boards, which it is satisfied is representative of the optometrists providing general ophthalmic services in that area.

(2) A committee recognised under this section is called the Local Optical Committee for the area for which it is formed.

(3) Any such committee may delegate any of its functions, with or without restrictions or conditions, to sub-committees composed of members of that committee.

(4) Regulations may require a Local Health Board, in the exercise of functions under this Part, to consult committees recognised by it under this section on such occasions and to such extent as may be prescribed.

(5) Subsection (4) does not affect any other power to require a Local Health Board to consult committees recognised by it under this section.

(6) A committee recognised under this section has such other functions as may be prescribed.

(7) A Local Health Board 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 as may be determined by the Local Health Board.

(8) Any sums so allotted must be out of the moneys available to the Local Health Board for the remuneration of persons of whom the committee is representative under this section.

(9) The amount of any such sums must be deducted from the remuneration of those persons in such manner as may be determined by the Local Health Board.

(10) The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.

Provision of accommodation by the Welsh Ministers

79 Use of accommodation: provision of general ophthalmic services

If the Welsh Ministers consider that any accommodation provided by them by virtue of this Act is suitable for use in connection with the provision of general ophthalmic services, they may make the accommodation available on such terms as they consider appropriate to persons providing those services.

Part 7 Pharmaceutical services and local pharmaceutical services

Chapter 1 Pharmaceutical services

Provision of pharmaceutical services

80 Arrangements for pharmaceutical services

(1) Each Local Health Board must, in accordance with regulations, make the arrangements mentioned in subsection (3).

(2) The Welsh Ministers must make regulations for the purpose of subsection (1).

(3) The arrangements are arrangements as respects the area of the Local Health Board 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 Welsh Ministers 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 Welsh Ministers 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 Welsh Ministers consider 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 Local Health Board 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 Local Health Board makes arrangements under subsection (1) wishes to provide services to persons outside the area of the Local Health Board 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 81, 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 Welsh Ministers 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)).

81 Arrangements for additional pharmaceutical services

(1) The Welsh Ministers may—

(a) give directions to a Local Health Board 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 Local Health Board authorise it to arrange for such provision if it wishes to do so.

(2) Directions under this section may require or authorise a Local Health Board 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 Local Health Board).

(3) The Welsh Ministers must publish any directions under this section in the Drug Tariff or in such other manner as they consider appropriate.

(4) In this section—

• ”additional pharmaceutical services”, in relation to directions, means the services (of a kind that do not fall within section 80) 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.

82 Terms and conditions, etc

(1) Directions under section 81 may require the Local Health Board 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 (c. 29).

(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 Local Health Board 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 Local Health Board must publish, in such manner as the Welsh Ministers may direct, such details of the arrangements as they 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 129(2)(a) of the National Health Service Act 2006 (c. 41), or

(b) Article 63(2A)(a) of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)).

83 Regulations as to pharmaceutical services

(1) Regulations must provide for securing that arrangements made by a Local Health Board under section 80 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 Local Health Board 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 Local Health Board,

(b) that an application to a Local Health Board 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 Local Health Board 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 7) 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 Local Health Board, and

(c) the Local Health Board 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 Local Health Board, 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 Local Health Board may be granted in respect of some only of the services specified in it,

(b) that an application to a Local Health Board relating to services of a prescribed description may be granted only if it appears to the Local Health Board 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 Local Health Board 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 Local Health Board 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 Local Health Board,

(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 Local Health Board in whose area those premises are situated,

(f) that that Local Health Board may give its approval subject to conditions,

(g) as to other grounds on which a Local Health Board may, or must, refuse to grant an application (including grounds corresponding to the conditions referred to in section 107(2), (3) or (4) as read with section 109),

(h) as to information which must be supplied to a Local Health Board by a person included, or seeking inclusion, in a pharmaceutical list (or by arrangement with him),

(i) for the supply to a Local Health Board 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 Local Health Board may defer a decision whether or not to grant an application,

(k) for the disclosure by a Local Health Board, 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 Local Health Board 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 Local Health Board to make the grant of an application subject to prescribed conditions.

(9) The approval mentioned in subsection (8)(a) is approval by the Welsh Ministers 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 Welsh Ministers or by another person so specified).

(10) Before making regulations by virtue of subsection (6)(m), the Welsh Ministers must consult such organisations as they consider appropriate appearing to them 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).

84 Regulations under section 83: appeals, etc

(1) Regulations under section 83 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 83(6)(g) provide that a Local Health Board 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 Local Health Board.

(3) Regulations under section 83 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 83(2)(c) should be granted or an appeal against such a decision brought by virtue of subsection (1) of this section should be allowed.

85 Power to charge

(1) The Welsh Ministers may give directions to a Local Health Board 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 83(2)(c)(i) or (ii).

(2) The Welsh Ministers may in the directions—

(a) specify the fee themselves, or

(b) require the Local Health Board 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 Welsh Ministers must consult such organisations as they consider appropriate that appear to them to represent persons providing pharmaceutical services and such organisations as they consider appropriate that appear to them to represent Local Health Boards,

(b) in a subsection (2)(b) case, the Local Health Board must undertake any consultation required by the directions.

(4) The Welsh Ministers must publish in such manner as they consider appropriate any directions they give under this section.

(5) In a subsection (2)(b) case, the Local Health Board must publish in such manner as it considers appropriate the fee which it determines.

86 Persons authorised to provide pharmaceutical services

(1) Except as may be provided for by or under regulations, no arrangements may be made by a Local Health Board 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 Local Health Board of one or more lists of medical practitioners who undertake to provide drugs, medicines or listed appliances (within the meaning given by section 80) under arrangements with the Local Health Board.

(4) The regulations may, in particular, include provision—

(a) as to grounds on which a Local Health Board 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 107(2), (3) or (4) as read with section 109(2)),

(b) as to information which must be supplied to a Local Health Board by a medical practitioner included, or seeking inclusion, in such a list (or by arrangement with him),

(c) for the supply to a Local Health Board 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 Local Health Board may defer a decision whether or not to grant an application for inclusion in such a list,

(e) for the disclosure by a Local Health Board 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 Local Health Board 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 Local Health Board 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 Local Health Board.

(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 80(3)(e), or

(b) additional pharmaceutical services provided in accordance with a direction under section 81,

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).

87 Inadequate provision of pharmaceutical services

(1) Subsection (2) applies if the Welsh Ministers are satisfied, after such inquiry as they consider appropriate, that—

(a) as respects the area, or part of the area, of a Local Health Board, 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 Welsh Ministers—

(a) may authorise the Local Health Board to make such other arrangements as the Welsh Ministers may approve, or may themselves make such other arrangements, and

(b) may dispense with any of the requirements of regulations made under this Chapter or Part 8 so far as appears to the Welsh Ministers necessary to meet exceptional circumstances and enable such arrangements to be made.

Remuneration

88 Remuneration 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 89 determining authorities are—

(a) the Welsh Ministers, and

(b) so far as authorised by the Welsh Ministers to exercise the functions of determining authorities, any Local Health Board or other person appointed by them 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 89, 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 89 to a determination is to a determination of remuneration under this section.

89 Section 88: supplementary

(1) Before a determination is made by the Welsh Ministers which relates to all persons who provide pharmaceutical services, or a category of such services, they—

(a) must consult a body appearing to them to be representative of persons to whose remuneration the determination would relate, and

(b) may consult such other persons as they consider 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 88 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.

Local Pharmaceutical Committees

90 Local Pharmaceutical Committees

(1) A Local Health Board may recognise a committee formed for its area, or for its area and that of one or more other Local Health Boards, which it is satisfied is representative of the persons providing pharmaceutical services from premises in that area.

(2) A committee recognised under this section is called the Local Pharmaceutical Committee for the area for which it is formed.

(3) Any such committee may delegate any of its functions, with or without restrictions or conditions, to sub-committees composed of members of that committee.

(4) Regulations may require a Local Health Board, in the exercise of functions under this Chapter, to consult committees recognised by it under this section on such occasions and to such extent as may be prescribed.

(5) Subsection (4) does not affect any other power to require a Local Health Board to consult committees recognised by it under this section.

(6) A committee recognised under this section has such other functions as may be prescribed.

(7) A Local Health Board 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 as may be determined by the Local Health Board.

(8) Any sums so allotted must be out of the moneys available to the Local Health Board for the remuneration of persons of whom the committee is representative under this section.

(9) The amount of any such sums must be deducted from the remuneration of those persons in such manner as may be determined by the Local Health Board.

(10) The administrative expenses of a committee include the travelling and subsistence allowances payable to its members.

Provision of accommodation by the Welsh Ministers

91 Use of accommodation: provision of pharmaceutical services

If the Welsh Ministers consider that any accommodation provided by them by virtue of this Act is suitable for use in connection with the provision of pharmaceutical services, they may make the accommodation available on such terms as they consider appropriate to persons providing those services.

Chapter 2 Local pharmaceutical services: pilot schemes

92 Pilot schemes

(1) Local Health Boards may establish pilot schemes.

(2) In this Act, a “pilot scheme” means one or more agreements—

(a) made by a Local Health Board in accordance with this Chapter,

(b) under which local pharmaceutical services will be provided (otherwise than by the Local Health Board), and

(c) the parties to which do not include any other Local Health Board.

(3) A pilot scheme may include arrangements—

(a) for the provision of services, other than general ophthalmic services, which are not local pharmaceutical services, but which may be provided under this Act, other than under Part 6 or 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 80, a Local Health Board 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 80, or by virtue of section 81 (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 80) by a medical practitioner or dental practitioner to a patient of his pursuant to arrangements made by virtue of section 86(1).

93 Making pilot schemes

Schedule 6 makes provision with respect to making pilot schemes, including provision with respect to the procedure to be followed.

94 Designation of priority neighbourhoods or premises

(1) The Welsh Ministers may make regulations allowing a Local Health Board 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 Local Health Board 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 Welsh Ministers give a direction to that effect, or

(ii) in prescribed circumstances.

(3) “Pharmaceutical list applications” means applications for inclusion in a pharmaceutical list.

95 Reviews of pilot schemes

(1) At least one review of the operation of each pilot scheme must be conducted by the Welsh Ministers.

(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 Welsh Ministers must give—

(a) the Local Health Board 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 Welsh Ministers.

96 Variation and termination of pilot schemes

(1) The Welsh Ministers may give directions authorising Local Health Boards 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 Welsh Ministers may by directions require a pilot scheme to be varied by the Local Health Board concerned in accordance with the directions.

(3) If satisfied that a pilot scheme is (for any reason) unsatisfactory, the Welsh Ministers may give directions to the Local Health Board concerned requiring it to bring the scheme to an end in accordance with the terms of the directions.

97 NHS 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 Welsh Ministers 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 Welsh Ministers may grant an application.

(5) If an application is granted, the Welsh Ministers 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 7.

(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 7(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 7(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 Welsh Ministers 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 Welsh Ministers consider appropriate.

98 Funding of preparatory work

(1) Provision may be made by regulations for Local Health Boards 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 Local Health Board 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 Local Health Board 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.

99 Application of this Act

This Act has effect in relation to piloted services subject to any provision of, or made under, this Chapter, section 103 (application of enactments) or section 127 (charges for local pharmaceutical services).

100 Premises from which piloted services may be provided

The Welsh Ministers 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.

101 Control of entry regulations

The power to make regulations under section 83 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 3 Local pharmaceutical services: LPS schemes

102 Local pharmaceutical services schemes

Schedule 7 makes provision with respect to the provision of local pharmaceutical services in accordance with schemes made by Local Health Boards.

Chapter 4 Local pharmaceutical services: application of enactments

103 Application of enactments

(1) The Welsh Ministers 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 50 arrangements or section 64 arrangements, or

(b) persons who provide or perform services under section 50 or section 64.

(2) The regulations may, in particular, provide for the application of any such enactment with such modifications, if any, as the Welsh Ministers consider 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.

Part 8 Qualifications to practice

Chapter 1 Conditional inclusion and supplementary lists

104 Conditional inclusion in ophthalmic and pharmaceutical lists

(1) Regulations may provide—

(a) that if a person is included in an ophthalmic list or a pharmaceutical list he is subject, while he remains included in the list, to conditions determined by the Local Health Board in whose list he is included,

(b) for the Local Health Board 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 Local Health Board 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 Local Health Board 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 107(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 Local Health Board is investigating whether there are grounds for exercising their power to remove him, or after the Local Health Board 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 Local Health Board makes any decision as to his removal from the list, and

(iii) requiring him to be given notice of the decision of the Local Health Board 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 Local Health Board—

(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 Local Health Board,

(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 Local Health Board.

(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 Local Health Board, to prescribed persons or persons of prescribed descriptions, of information of a prescribed description—

(a) about persons whose inclusion in an ophthalmic or pharmaceutical list is subject to conditions imposed under this section, and

(b) about the removal of such persons from such a 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.

105 Supplementary lists

(1) The Welsh Ministers may make regulations providing for the preparation and publication by each Local Health Board of one or more lists of persons approved by the Local Health Board for the purpose of assisting in the provision of general ophthalmic services and pharmaceutical services.

(2) Such a list is referred to in this section, section 106 and section 115 as a “supplementary list”.

(3) The regulations may, in particular, include provision as to—

(a) the Local Health Board 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 Local Health Board (whether by the applicant or by arrangement with him),

(c) grounds on which the Local Health Board 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 Local Health Board 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 Welsh Ministers or by another person appointed for the purpose by the Welsh Ministers),

(g) the supply to the Local Health Board 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 Local Health Boards under the regulations,

(k) the disclosure by a Local Health Board, 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 Local Health Board,

(b) the Local Health Board 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 Local Health Board 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 107(3)(a).

(6) Regulations made by virtue of subsection (3)(e) may (but need not) make provision corresponding to anything in sections 107 to 115.

(7) If the regulations provide under subsection (3)(e) or (4) that a Local Health Board 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 Local Health Board make any decision as to his suspension or removal, and

(c) requiring him to be given notice of the decision of the Local Health Board 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 Local Health Board 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 Local Health Board.

(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 Local Health Board—

(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 Local Health Board.

106 Further provision about regulations under section 105

(1) Regulations under section 105 may require a person (“A”) included in—

(a) an ophthalmic list,

(b) a pharmaceutical list, or

(c) a list under section 86(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 49 or 63,

(d) a list corresponding to a list under section 49 or section 63 and prepared by a Local Health Board by virtue of regulations made under section 103,

(e) a list corresponding to a list mentioned in any of paragraphs (a) to (d) prepared by a Primary Care Trust under or by virtue of the National Health Service Act 2006 (c. 41),

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 Local Health Board, but

(b) may, in particular, require that both A and B be included in lists prepared by Local Health Boards.

Chapter 2 Disqualification

107 Disqualification of practitioners

(1) If it appears to a Local Health Board that any of the conditions set out in subsections (2) to (4) is established in relation to a person included in an ophthalmic list or 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 Local Health Board must remove the practitioner from the list in prescribed circumstances.

(6) The Local Health Board 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 Act 2006 (c. 41) 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 pu