National Health Service (Wales) Act 2006 (c. 42)

(The document as of February, 2008)

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(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.

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,

(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,

(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,

(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,

(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

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) 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 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 a pharmaceutical list.

108 Contingent removal

(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.

109 Fraud and unsuitability cases: supplementary

(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.

110 Suspension

(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 FHSAA 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 FHSAA has not made an order by the time it expires, in which case it continues until the FHSAA has made an order.

(7) If the FHSAA does so order, it must specify--

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

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

(8) The FHSAA may, on the application of the 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.

111 Suspension pending appeal

(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 FHSAA 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 FHSAA 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.

112 Effect of suspension

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.

113 Review of decisions

(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 FHSAA, 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.

114 Appeals

(1) A practitioner may appeal to the FHSAA against a decision of a Local Health Board mentioned in subsection (2) by giving notice in writing to the FHSAA within the period of 28 days beginning with the date on which the Local Health Board gave him notice of the decision.

(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 FHSAA may make any decision which the Local Health Board could have made.

(5) If the FHSAA 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 FHSAA 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 FHSAA under this section, but whose appeals against those decisions are successful.

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

115 National disqualification

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

(a) the pharmaceutical lists 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,

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