National Health Service (Wales) Act 2006

83 Regulations as to pharmaceutical services

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

(a) enable persons for whom drugs, medicines or appliances mentioned in that section are ordered as there mentioned to receive them from persons with whom such arrangements have been made, and

(b) ensure the provision of services prescribed under subsection (3)(e) of that section by persons with whom such arrangements have been made.

(2) The regulations must include provision—

(a) for the preparation and publication by a Local Health Board of one or more lists of persons, other than medical practitioners and dental practitioners, who undertake to provide pharmaceutical services from premises in the area of the Local Health Board,

(b) that an application to a Local Health Board for inclusion in a pharmaceutical list must be made in the prescribed manner and must state—

(i) the services which the applicant will undertake to provide and, if they consist of or include the supply of appliances, which appliances he will undertake to supply, and

(ii) the premises from which he will undertake to provide those services,

(c) that, except in prescribed cases (which may, in particular, include cases of applications for the provision only of services falling within subsection (7)—

(i) an application for inclusion in a pharmaceutical list by a person not already included, and

(ii) an application by a person already included in a pharmaceutical list for inclusion also in respect of services or premises other than those already listed in relation to him,

may be granted only if the Local Health Board is satisfied, in accordance with the regulations, that it is necessary or expedient to grant the application in order to secure in the neighbourhood in which the premises are located the adequate provision by persons included in the list of the services, or some of the services, specified in the application, and

(d) for the removal of an entry in respect of premises from a pharmaceutical list if it has been determined in the prescribed manner that the person to whom the entry relates—

(i) has never provided from those premises, or

(ii) has ceased to provide from them,

the services, or any of the services, which he is listed as undertaking to provide from them.

(3) The regulations may prescribe the extent to which the provision of LP services (within the meaning given by paragraph 1 of Schedule 7) must be taken into account in determining whether to grant an application for inclusion in a pharmaceutical list.

(4) The regulations may include the provision mentioned in subsection (5) for the case where—

(a) two or more applications referred to in subsection (2)(c)(i) or (ii) relate to the same neighbourhood,

(b) they are considered together by the Local Health Board, and

(c) the Local Health Board would be satisfied as mentioned in subsection (2)(c) in relation to each application taken on its own, but is not so satisfied in relation to all of them taken together.

(5) The provision mentioned in this subsection is provision for the Local Health Board, in determining which application (or applications) to grant, to take into account any proposals specified in the applications in relation to the sale or supply at the premises in question, otherwise than by way of pharmaceutical services or in accordance with a private prescription, of—

(a) drugs and medicines, and

(b) other products for, or advice in relation to, the prevention, diagnosis, monitoring or treatment of illness or handicap, or the promotion or protection of health.

(6) The regulations may include provision—

(a) that an application to a Local Health Board may be granted in respect of some only of the services specified in it,

(b) that an application to a Local Health Board relating to services of a prescribed description may be granted only if it appears to the Local Health Board that the applicant has satisfied such conditions with regard to the provision of those services as may be prescribed,

(c) that an application to a Local Health Board by a person who qualified to have his name registered under the Pharmacy Act 1954 (c. 61) by virtue of section 4A of that Act (qualification by European diploma) may not be granted unless the applicant satisfies the Local Health Board that he has the knowledge of English which, in the interest of himself and persons making use of the services to which the application relates, is necessary for the provision of pharmaceutical services in the area of the Local Health Board,

(d) that the inclusion of a person in a pharmaceutical list in pursuance of such an application may be for a fixed period,

(e) that, where the premises from which an application states that the applicant will undertake to provide services are in an area of a prescribed description, the applicant may not be included in the pharmaceutical list unless his inclusion is approved by reference to prescribed criteria by the Local Health Board in whose area those premises are situated,

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

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

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

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

(i) who is included, or seeking inclusion, in a pharmaceutical list, or

(ii) who is a member of the body of persons controlling a body corporate included, or seeking inclusion, in a pharmaceutical list,

of a criminal conviction certificate under section 112 of the Police Act 1997 (c. 50), a criminal record certificate under section 113 of that Act or an enhanced criminal record certificate under section 115 of that Act,

(j) for grounds on which a Local Health Board may defer a decision whether or not to grant an application,

(k) for the disclosure by a Local Health Board, to prescribed persons or persons of prescribed descriptions, of information of a prescribed description about applicants for inclusion in a pharmaceutical list, and refusals by the Local Health Board to grant such applications,

(l) as to criteria to be applied in making decisions under the regulations (other than decisions required by virtue of paragraph (e)),

(m) as to the making of declarations about—

(i) financial interests,

(ii) gifts above a prescribed value, and

(iii) other benefits received.

(7) A service falls within this subsection if the means of providing it is such that the person receiving it does so otherwise than at the premises from which it is provided.

(8) The regulations may, in respect of services falling within subsection (7), include provision—

(a) requiring persons to be approved for the purposes of providing such services, or

(b) requiring the Local Health Board to make the grant of an application subject to prescribed conditions.

(9) The approval mentioned in subsection (8)(a) is approval by the Welsh Ministers or such other person as may be specified in the regulations, in accordance with criteria to be specified in or determined under the regulations (whether by the Welsh Ministers or by another person so specified).

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

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