Legalize / United Kingdom / Public General Act

National Health Service (Wales) Act 2006

Type Public General Act

Publication 2006-11-08

Last updated 2026-03-28

State In force

Department Statute Law Database

Source legislation.gov.uk

articles Not indexed

Reform history JSON API

(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—

(za) as to circumstances in which the Local Health Board may invite applications for inclusion in a pharmaceutical list,

(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 as a pharmacist in the Register maintained under article 19 of the Pharmacy Order 2010 by virtue of a qualification in pharmacy awarded in an EEA State other than the United Kingdom, or in Switzerland, 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,

(fa) about the timescale for dealing with an application,

(g) as to other grounds on which or circumstances in 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 113A of that Act, an enhanced criminal record certificate under section 113B of that Act or up-date information within the meaning given by section 116A 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.

(n) as to circumstances in which a Local Health Board may, or must, remove a person or an entry in respect of premises from the pharmaceutical list for breach of a term or condition of arrangements made with the Local Health Board for the provision of pharmaceutical services.

(6A) The regulations, if they make provision within subsection (6)(n), must specify that a person or entry is not to be removed by a Local Health Board unless—

(a) the Local Health Board has given notice under section 106A (notice in relation to breach of arrangements) in respect of the breach, and

(b) the person in respect of whom the notice was given has failed to comply with a requirement of that notice.

(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.

(10A) The regulations may make provision for a Local Health Board to give reasons for decisions made by virtue of this section.

(11) In this Act a “pharmaceutical list” means a list published in accordance with regulations made under subsection (2)(a).

Regulations under section 83: appeals, etc

84

(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 on grounds corresponding to the conditions referred to in section 107(2), (3) or (4) as read with section 109, they must also provide for an appeal... to the First-tier Tribunal 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.

(4) If regulations made under section 83 include provision for a Local Health Board to remove a person or an entry in respect of premises from a pharmaceutical list, the regulations must also make provision —

(a) requiring the Local Health Board to give notice of its intention to remove the person or entry (including provision requiring the notice to give reasons for the intended removal);

(b) about making representations.

Power to charge

85

(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.

Persons authorised to provide pharmaceutical services

86

(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 113A of that Act, an enhanced criminal record certificate under section 113B of that Act or up-date information within the meaning given by section 116A 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 First-tier Tribunal 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) his registration is suspended by virtue of any direction or order under the Pharmacy Order 2010,

he may not provide pharmaceutical services in person during the period of suspension.

(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inadequate provision of pharmaceutical services

87

(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

Remuneration for persons providing pharmaceutical services

88

(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.

(8A) Regulations may impose requirements in relation to remuneration in respect of any of the following—

(a) drugs or medicines used for vaccinating or immunising people against disease,

(b) anything used in connection with the supply or administration of drugs or medicines within paragraph (a),

(c) drugs or medicines, not within paragraph (a), that are used for preventing or treating a disease that, at the time the regulations are made, the Welsh Ministers consider to be a pandemic disease or at risk of becoming a pandemic disease,

(d) anything used in connection with the supply or administration of drugs or medicines within paragraph (c), or

(e) a product which is a special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (S.I. 2012/1916).

(8B) Such regulations may, for example, require determining authorities to ensure—

(a) that remuneration is to be calculated by reference to the outcome of prescribed procedures, or

(b) that determinations do not provide for or permit remuneration to be paid in prescribed circumstances.

(8C) Procedures prescribed by virtue of subsection (8B)(a) may include the person to whom remuneration is payable, a health service body or a determining authority—

(a) carrying out inquiries to ensure that remuneration is reasonable, or

(b) estimating an amount of remuneration that is reasonable (whether or not the estimated amount corresponds exactly to expenses in respect of which remuneration is to be paid).

(8D) Circumstances prescribed by virtue of subsection (8B)(b) may include circumstances in which anything within subsection (8A)(a) to (e) is made available to persons who provide pharmaceutical services under this Part—

(a) by a health service body, or

(b) under an arrangement for the supply of that thing, to which a health service body is a party.

(8E) In subsections (8A) to (8D)—

“health service body” has the meaning given by section 7(4);

(8F) Where regulations include provision made in reliance on subsection (8A)(c) or (d) and the Welsh Ministers consider that the disease to which it relates is no longer a pandemic disease or at risk of becoming a pandemic disease, the Welsh Ministers must revoke that provision within such period as the Welsh Ministers consider reasonable (taking into account, in particular, the need for any transitional arrangements).

(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.

Section 88: supplementary

89

(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,

(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,

(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

(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

Use of accommodation: provision of pharmaceutical services

91

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

Pilot schemes

92

(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

(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).

Making pilot schemes

93

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

Designation of priority neighbourhoods or premises

94

(1) The Welsh Ministers may make regulations allowing a Local Health Board to designate—

(a) neighbourhoods,

(b) premises, or

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,

(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.

Reviews of pilot schemes

95

(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.

Variation and termination of pilot schemes

96

(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.

NHS contracts and the provision of piloted services

97

(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 the 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.

Funding of preparatory work

98

(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.

Application of this Act

99

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).

Premises from which piloted services may be provided

100

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.

Control of entry regulations

101

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

Local pharmaceutical services schemes

102

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

Application of enactments

103

(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

Conditional inclusion in ophthalmic and pharmaceutical lists

104

(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,

(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 First-tier Tribunal against the decision of the Local Health Board—

(a) to impose conditions, or any particular condition,

(b) to vary a condition,

(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 First-tier Tribunal 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.

Supplementary lists

105

(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 113A of that Act, an enhanced criminal record certificate under section 113B of that Act or up-date information within the meaning given by section 116A 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,

(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 First-tier Tribunal 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 First-tier Tribunal against the decision of the Local Health Board—

(a) to impose conditions, or any particular condition,

(b) to vary a condition,

(d) on any review of an earlier such decision of the Local Health Board.

Further provision about regulations under section 105

106

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

(a) an ophthalmic list,

(b) a pharmaceutical list, or

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,

(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f) a list corresponding to a list mentioned in any of paragraphs (a) to (d) prepared by NHS England under or by virtue of the National Health Service Act 2006,

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

Disqualification of practitioners

107

(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 purposes of this subsection which appears to the Welsh Ministers to be a health or medical scheme paid for out of public funds.

(8) Detriment to a health scheme includes detriment to any patient of, or person working in, that scheme or any person liable to pay charges for services provided under that scheme.

(9) In this Chapter a “practitioner” means a person included in an ophthalmic list or a pharmaceutical list.

Contingent removal

108

(1) In an efficiency case or a fraud case, the Local Health Board may, instead of deciding to remove a practitioner from its list, decide to remove him contingently.

(2) If it so decides, it must impose such conditions as it may decide on his inclusion in the list with a view to—

(a) removing any prejudice to the efficiency of the services in question (in an efficiency case), or

(b) preventing further acts or omissions within section 107(3)(a) (in a fraud case).

(3) If the Local Health Board determines that the practitioner has failed to comply with a condition, it may decide to—

(a) vary the conditions, or impose different conditions, or

(b) remove him from its list.

(4) The Local Health Board may decide to vary the terms of service of the person concerned for the purpose of or in connection with the imposition of any conditions by virtue of this section.

Fraud and unsuitability cases: supplementary

109

(1) Where the practitioner is a body corporate, the body corporate must be treated for the purposes of this Chapter as meeting a condition referred to in section 107(3) or (4)—

(a) in the case of an optometrist not referred to in paragraph (b), if any director meets that condition (whether or not he first did so when he was a director), and

(b) in the case of a body corporate providing pharmaceutical services or an optometrist which is a limited liability partnership, if any one of the body of persons controlling the body meets that condition (whether or not he first did so when he was such a person).

(2) A practitioner must be treated for the purposes of this Chapter as meeting the condition referred to in section 107(3) if—

(a) another person, because of an act or omission of his occurring in the course of providing any services mentioned in section 107(1) on the practitioner's behalf, meets that condition, and

(b) the practitioner failed to take all such steps as were reasonable to prevent acts or omissions within section 107(3)(a) occurring in the course of the provision of those services on his behalf.

Suspension

110

(1) If the Local Health Board is satisfied that it is necessary to do so for the protection of members of the public or is otherwise in the public interest, it may suspend a practitioner from its list—

(a) while it decides whether or not to exercise its powers under section 107 or 108 (other than in circumstances falling within paragraph (b)), or

(b) while it waits for a decision affecting the practitioner of a court or of a body which regulates—

(i) the practitioner's profession,

(ii) the profession of a person providing any of the services mentioned in section 107(1) on the practitioner's behalf, or

(iii) if the practitioner is a body corporate, the profession of one of its directors, or one of the body of persons controlling it or (if it is a limited liability partnership) one of its members,

or one of that regulatory body's committees.

(2) The references in subsection (1)(b) to a court or regulatory body are to a court or such a body anywhere in the world.

(3) In a case falling within subsection (1)(a), the Local Health Board must specify the length of the period of suspension.

(4) In a case falling within subsection (1)(b), the Local Health Board may specify that the practitioner remains suspended after the decision referred to there for an additional period which the Local Health Board must specify.

(5) In either case—

(a) before that period expires it may extend, or further extend, the suspension for a further specified period, or

(b) if that period has expired, it may impose a further suspension, for a period which it must specify.

(6) The period of suspension (in a subsection (1)(a) case) or the additional period (in a subsection (1)(b) case), including in both cases the period of any further suspension imposed under subsection (5)(b), may not exceed six months in aggregate, except—

(a) in prescribed circumstances, when it may not extend beyond any prescribed event (which may be the expiry of a prescribed period),

(b) if, on the application of the Local Health Board, the First-tier Tribunal orders accordingly before the expiry of the period of suspension, or

(c) if the Local Health Board has applied under paragraph (b) before the expiry of the period of suspension, but the First-tier Tribunal has not made an order by the time it expires, in which case it continues until the FHSAA has made an order.

(7) If the First-tier Tribunal does so order, it must specify—

(a) the date on which the period of suspension will end, or

(b) an event beyond which it will not continue.

(8) The First-tier Tribunal may, on the application of the Local Health Board, make a further order (complying with subsection (7)) at any time while the period of suspension pursuant to the earlier order is still continuing.

(9) The Welsh Ministers may make regulations providing for payments to practitioners who are suspended.

(10) Those regulations may include provision for the amount of the payments, or the method of calculating the amount, to be determined by the Welsh Ministers or by another person appointed for the purpose by them.

Suspension pending appeal

111

(1) This section applies if the Local Health Board decides to remove a practitioner from a list under section 107.

(2) In such a case it may also decide to suspend the practitioner from the list pending any appeal by him, if it is satisfied that it is necessary to do so for the protection of members of the public or is otherwise in the public interest.

(3) If it does suspend the practitioner under this section, the suspension has effect from the date when the Local Health Board gave him notice of the suspension.

(4) The suspension has effect until its revocation under subsection (5) or (6) or, if later, until the expiry of the period of 28 days referred to in section 114(1), or, if the practitioner appeals under section 114, until the First-tier Tribunal has disposed of the appeal.

(5) The Local Health Board may revoke a suspension imposed under this section.

(6) If the practitioner appeals under section 114 against the decision of the Local Health Board to remove him from the list, the First-tier Tribunal may also revoke a suspension imposed on him under this section.

(7) Subsections (9) and (10) of section 110 apply for the purposes of this section as they apply for the purposes of that.

Effect of suspension

112

While a practitioner is suspended (whether under section 110 or under section 111) he must be treated as not being included in the list from which he has been suspended even though his name appears in it.

Review of decisions

113

(1) The Local Health Board may, and (except in prescribed cases) if requested in writing to do so by the practitioner must, review a contingent removal or a suspension (other than a contingent removal or a suspension imposed by, or a suspension continuing pursuant to, an order of the First-tier Tribunal, or a suspension imposed under section 111).

(2) The practitioner may not request a review before the expiry of the period of—

(a) three months beginning with the date of the decision of the Local Health Board to suspend or contingently remove him, or (as appropriate),

(b) six months beginning with the date of its decision on the previous review.

(3) On such a review, the Local Health Board may—

(a) confirm the contingent removal or the suspension,

(b) in the case of a suspension, terminate it,

(c) in the case of a contingent removal, vary the conditions, impose different conditions, revoke the contingent removal, or remove the practitioner from the list.

Appeals

114

(1) A practitioner may appeal to the First-tier Tribunal against a decision of a Local Health Board mentioned in subsection (2) . . . .

(2) The Local Health Board decisions in question are—

(a) to remove the practitioner from a list (under section 107 or 108(3) or under subsection (5)(b) of this section),

(b) to remove him contingently (under section 108),

(c) to impose any particular condition under section 108, or to vary any condition or to impose any different condition under that section,

(d) to vary his terms of service (under section 108(4)),

(e) any decision on a review of a contingent removal under section 113.

(3) The appeal must be by way of redetermination of the decision of the Local Health Board.

(4) On an appeal, the First-tier Tribunal may make any decision which the Local Health Board could have made.

(5) If the First-tier Tribunal decides to remove the practitioner contingently—

(a) the Local Health Board and the practitioner may each apply to the FHSAA for the conditions imposed on the practitioner to be varied, for different conditions to be imposed, or for the contingent removal to be revoked, and

(b) the Local Health Board may remove him from its list if it determines that he has failed to comply with a condition.

(6) The Local Health Board may not remove a person from a list, or impose a contingent removal—

(a) until the expiry of the period of 28 days referred to in subsection (1), or

(b) if the practitioner appeals within that period, until the First-tier Tribunal has disposed of the appeal.

(7) Regulations may provide for payments by Local Health Boards to practitioners who are removed from lists pursuant to decisions of the First-tier Tribunal under this section, but whose appeals against those decisions are successful.

(8) Regulations under subsection (7) may include provision for the amount of the payments, or the method of calculating the amount, to be determined by the Welsh Ministers or by another person appointed for the purpose by them.

National disqualification

115

(1) If the First-tier Tribunal removes the practitioner from a list, it may also decide to disqualify him from inclusion in—

(a) the pharmaceutical lists and ophthalmic lists prepared by each Local Health Board,

(b) the supplementary lists prepared by each Local Health Board,

(d) the lists corresponding to the lists under section 49 prepared by each Local Health Board by virtue of regulations made under section 103,

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f) the lists corresponding to the lists mentioned in paragraphs (a) to (d) prepared by NHS England under or by virtue of the National Health Service Act 2006,

or only from inclusion in one or more descriptions of such lists prepared by each Local Health Board and NHS England ..., the description being specified by the First-tier Tribunal in its decision.

(2) A decision by the First-tier Tribunal to do what is mentioned in subsection (1) is referred to in this section as the imposition of a national disqualification.

(3) The First-tier Tribunal may also impose a national disqualification on a practitioner if it dismisses an appeal by him against the refusal by a Local Health Board to include him in such a list.

(4) The Local Health Board may apply to the First-tier Tribunal for a national disqualification to be imposed on a person after the Local Health Board has—

(a) removed him from a list prepared by it of any of the kinds referred to in subsection (1)(a) to (d), or

(b) refused to include him in such a list.

(5) Any such application must be made before the end of the period of three months beginning with the date of the removal or of the Local Health Board's refusal.

(6) If the First-tier Tribunal imposes a national disqualification on a person—

(a) no Local Health Board ...or NHS England may include him in a list of any of the kinds prepared by it from which he has been disqualified from inclusion, and

(b) if he is included, and NHS England, in such a list, each Local Health Board... in whose list he is included must remove him from it.

(7) The First-tier Tribunal may at the request of the person upon whom it has been imposed review a national disqualification, and on a review may confirm it or revoke it.

(8) Subject to subsection (9), the person may not request such a review before the end of the period of—

(a) two years beginning with the date on which the national disqualification was imposed, or

(b) one year beginning with the date of the First-tier Tribunal's decision on the last such review.

(9) The Welsh Ministers may provide in regulations for subsection (8) to have effect in prescribed circumstances as if the reference there to “two years” or “one year” were a reference to a different period specified in the regulations.

Notification of decisions

116

Regulations may require a Local Health Board to notify prescribed persons, or persons of prescribed descriptions, of any decision it makes under this Chapter, and of any information relevant to the decision which it considers appropriate to include in the notification.

Withdrawal from lists

117

Regulations may provide for circumstances in which a practitioner—

(a) whom a Local Health Board is investigating in order to see whether there are grounds for exercising its powers under section 107, 108 or 110,

(b) whom a Local Health Board has decided to remove from a list under section 107 or 108, or contingently remove under section 108, but who has not yet been removed or contingently removed, or

may not withdraw from a list in which he is included.

Regulations about decisions under this Chapter

118

(1) Any decision by a Local Health Board referred to in this Chapter must be reached in accordance with regulations about such decisions.

(2) The regulations must include provision—

(a) requiring the practitioner to be given notice of any allegation against him,

(b) giving him the opportunity of putting his case at a hearing before a Local Health Board makes any decision affecting him under this Chapter,

(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 which he may have.

(3) The regulations may, in particular, make provision as to criteria which the Local Health Board must apply when making decisions in unsuitability cases.

Corresponding provisions in Scotland and Northern Ireland

119

(1) This section applies where it appears to the Welsh Ministers that there is provision in Scotland or Northern Ireland under which a person may be dealt with in any way which corresponds (whether or not exactly) with a way in which a person may be dealt with under this Chapter.

(2) A decision in Scotland or Northern Ireland to deal with such a person in such a way is referred to in this section as a “corresponding decision”.

(3) If this section applies, the Welsh Ministers may make regulations providing for the effect to be given in Wales to a corresponding decision.

(4) That effect need not be the same as the effect of the decision in the place where it was made.

(5) The regulations may not provide for a corresponding decision to be reviewed or revoked in Wales.

Chapter 3 — Indemnity Cover

Indemnity cover

120

(1) The Secretary of State may make regulations for the purpose of securing that, in prescribed circumstances, prescribed persons included in a pharmaceutical list or an ophthalmic list hold approved indemnity cover.

(2) The regulations may, in particular, make provision as to the consequences of a failure to hold approved indemnity cover, including provision—

(a) for securing that a person must not be added to a pharmaceutical list or an ophthalmic list unless he holds approved indemnity cover,

(b) for the removal from such a list prepared by a Local Health Board of a person who does not within a prescribed period after the making of a request by the Local Health Board in the prescribed manner satisfy the Local Health Board that he holds approved indemnity cover.

(3) For the purposes of this section—

“approved body” means a person or persons approved in relation to indemnity cover of any description, after such consultation as may be prescribed, by the Secretary of State or by such other person as may be prescribed,

“approved indemnity cover” means indemnity cover made—on prescribed terms, andwith an approved body,

“indemnity cover”, in relation to a person included in a pharmaceutical list or an ophthalmic list (or a person who proposes to provide pharmaceutical services or general ophthalmic services), means a contract of insurance or other arrangement made for the purpose of indemnifying him, and any person prescribed in relation to him, to any prescribed extent against any liability which—arises out of the provision of pharmaceutical services or general ophthalmic services in accordance with arrangements made by him with a Local Health Board, andis incurred by him or any such person in respect of the death or personal injury of a person,

“personal injury” means any disease or impairment of a person's physical or mental condition and includes the prolongation of any disease or such impairment,

and a person holds approved indemnity cover if he has entered into a contract or arrangement which constitutes approved indemnity cover.

(4) The regulations may provide that a person of any description who has entered into a contract or arrangement which is—

(a) in a form identified in accordance with the regulations in relation to persons of that description, and

(b) made with a person or persons so identified,

must be treated as holding approved indemnity cover for the purposes of the regulations.

(5) Regulations under this section have effect as if made under the National Health Service Act 2006 (c. 41) (and accordingly, section 272 of that Act applies to any such regulations).

Part 9 — Charging

Power to charge generally

Charges for drugs, medicines or appliances, or pharmaceutical services

121

(1) Regulations may provide for the making and recovery in such manner as may be prescribed of such charges as may be prescribed in respect of—

(a) the supply under this Act (otherwise than under Part 6 or Chapter 1 of Part 7) of drugs, medicines or appliances (including the replacement and repair of those appliances), and

(b) such of the pharmaceutical services referred to in Chapter 1 of Part 7 as may be prescribed.

(2) Regulations under this section may in particular make provision in relation to the supply of contraceptive substances and appliances under paragraph 8 of Schedule 1.

(3) This section does not apply in relation to the provision of any relevant dental service (within the meaning of section 125).

Exemptions from general charging

122

(1) No charge may be made under regulations under section 121(1) in respect of—

(a) the supply of any drug, medicine or appliance for a patient who is resident in hospital,

(b) the supply of any drug or medicine for the treatment of sexually transmitted disease (otherwise than in the provision of primary medical services),

(c) the supply of any appliance (otherwise than in pursuance of paragraph 8(d) of Schedule 1) for a person who is under 16 years of age or is under 19 years of age and receiving qualifying full-time education, or

(d) the replacement or repair of any appliance in consequence of a defect in the appliance as supplied.

(2) In subsection (1)(c) “qualifying full-time education” means full-time instruction at a recognised educational establishment or by other means accepted as comparable by the Welsh Ministers.

(3) For the purposes of subsection (2)—

(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.

Pre-payment certificates

123

(1) Regulations under section 121(1) may provide for the grant, on payment of such sums as may be prescribed, of a pre-payment certificate.

(2) A pre-payment certificate is a certificate which confers on the person to whom it is granted exemption from charges otherwise chargeable under the regulations in respect of drugs, medicines and appliances supplied during such period as may be prescribed.

(3) Different sums may be prescribed in relation to different periods.

Charges in respect of non-residents

124

(1) Regulations may provide for the making and recovery, in such manner as may be prescribed, of such charges as the Welsh Ministers may determine in respect of the services mentioned in subsection (2).

(2) The services are such services as may be prescribed which are—

(a) provided under this Act, and

(b) provided in respect of such persons not ordinarily resident in Great Britain as may be prescribed.

(3) Regulations under this section may provide that the charges may be made only in such cases as may be determined in accordance with the regulations.

(4) The Welsh Ministers may calculate charges under this section on any basis that they consider to be the appropriate commercial basis.

Charging for dental services

Dental charging

125

(1) Regulations may provide for the making and recovery, in such manner as may be prescribed, of charges for relevant dental services.

(2) Regulations under subsection (1) may in particular include provision—

(a) specifying the amount, or maximum amount, of any charge (or aggregate charge in respect of the provision for two or more relevant dental services),

(b) for calculating the amount of any charge,

(d) for any charge not to be payable in cases of a prescribed description,

(e) for power to direct that a charge is not payable in any particular case,

(f) for the repayment of any charge (including provision as to the persons by whom, and manner in which, repayments must be made).

(3) Regulations under subsection (1) may provide for sums which would otherwise be payable by a Local Health Board or Special Health Authority to persons providing relevant dental services to be reduced by the amount of the charges authorised by the regulations.

(4) In this section and section 126 “relevant dental services” means—

(a) dental treatment provided—

(i) under section 56(2),

(ii) under a general dental services contract, or

(iii) in accordance with section 64 arrangements, and

(b) the supply of dentures and other dental appliances under this Act.

(5) Any reference in this section or 126 to the supply of an appliance includes a reference to its repair, adjustment, refitting or replacement and, in the case of dentures, to their being relined or having additions made to them.

Exemptions from dental charging

126

(1) No charge may be made under regulations under section 125(1) in respect of a relevant dental service provided for any person who at the prescribed time—

(a) was under 18,

(b) was under 19 and receiving qualifying full-time education,

(d) had given birth to a child within the previous 12 months.

(2) No charge may be made under regulations under section 125(1) in respect of—

(a) the repair or replacement of any appliance,

(b) any appliance supplied to a patient who is resident in a hospital,

(3) Subsections (1) and (2)(a) do not apply in relation to—

(a) the repair or replacement of any appliance of a prescribed description,

(b) the repair or replacement of any appliance where it is determined in the prescribed manner—

(i) in any case, that the repair or replacement was necessitated by an act or omission of the person supplied, or

(ii) in a case where the person supplied was under the age of 16, that the repair or replacement was necessitated by an act or omission, occurring while that person was under that age, of a person having charge of him.

(4) Subsection (2)(b) does not apply where an appliance is supplied—

(a) under section 56(2),

(b) under a general dental services contract, or

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