National Health Service Act 2006

129Regulations as to pharmaceutical servicesE+W

(1)Regulations must provide for securing that arrangements made by [F1NHS England] under section 126 will—

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

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

(2)The regulations must include provision—

(a)for the preparation and publication by [F1NHS England] of one or more lists of persons, other than medical practitioners and dental practitioners, who undertake to provide pharmaceutical services from premises in [F2England],

(b)that an application to [F1NHS England] 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,

[F3[F4may be granted only if] [F1NHS England] is satisfied as mentioned in subsection (2A), F5...] 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.

[F6(2ZA)[F1NHS England] may not include the Secretary of State, or such other persons as the regulations may prescribe, in a list prepared for the purposes of provision under subsection (2)(a).]

[F7(2ZB)Regulations under subsection (2)(a) may, in particular, require a list of persons to be prepared by reference to the area in which the premises from which the services are provided are situated (and regulations imposing that requirement must prescribe the description of area by reference to which the list is to be prepared).]

[F8(2A)[F1NHS England] is satisfied as mentioned in this subsection if, having regard to [F9the needs statement for the relevant area] and to any matters prescribed by the Secretary of State in the regulations, it is satisfied that [F10to grant the application would—

(a)meet a need in that area for the services or some of the services specified in the application, or

(b)secure improvements, or better access, to pharmaceutical services in that area.]

[F11(2B)In subsection (2A), “relevant area”, in relation to a needs statement, is the area of the Health and Wellbeing Board which includes the premises from which the application states that the applicant will undertake to provide services.]

(2C)In relation to cases where [F1NHS England] is satisfied as mentioned in subsection [F12(2A)], the regulations may make provision as to—

(a)the manner in which [F1NHS England] is to determine whether to grant the application,

(b)matters which [F1NHS England] must or must not take into account for the purpose of determining whether to grant the application.]

(3)The regulations may prescribe the extent to which the provision of LP services (within the meaning given by paragraph 1 of Schedule 12) must be taken into account in determining whether to grant an application for inclusion in a pharmaceutical list.

[F13(3A)The regulations may prescribe circumstances in which two or more applications referred to in subsection (2)(c)(i) or (ii) may be considered together by [F1NHS England].]

(4)The regulations may [F14make provision for [F1NHS England] to take into account prescribed matters in] the case where—

F15(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)[F16two or more applications referred to in subsection (2)(c)(i) or (ii)] are considered together by [F1NHS England], and

(c)[F1NHS England] would be satisfied as mentioned in [F17subsection (2A) F18...] in relation to each application taken on its own, but is not so satisfied in relation to all of them taken together.

[F19(4A)Regulations under subsection (4) may in particular make the provision mentioned in subsection (5), with or without modifications.]

(5)The provision mentioned in this subsection is provision for [F1NHS England], 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—

[F20(za)for the circumstances and manner in which [F1NHS England] may invite applications for inclusion in a pharmaceutical list,]

(a)that an application to [F1NHS England] may be granted in respect of some only of the services specified in it,

(b)that an application to [F1NHS England] relating to services of a prescribed description may be granted only if it appears to [F1NHS England] that the applicant has satisfied such conditions with regard to the provision of those services as may be prescribed,

(c)that an application to [F1NHS England] by a person who qualified to have his name registered [F21as 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 [F1NHS England] 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 F22...,

(d)that the inclusion of a person in a pharmaceutical list F23... [F24an application to [F1NHS England]] 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 [F1NHS England] in whose area those premises are situated,

(f)that [F1NHS England] may give its approval subject to conditions,

(g)as to other grounds on which [F25or circumstances in which] [F1NHS England] [F26—

(i)]may, or must, refuse to grant an application (including grounds corresponding to the conditions referred to in section 151(2), (3) or (4) as read with section 153)[F27,

(ii)may, or must, remove a person or an entry in respect of premises from a pharmaceutical list],

(h)as to information which must be supplied to [F1NHS England] by a person included, or seeking inclusion, in a pharmaceutical list (or by arrangement with him),

(i)for the supply to [F1NHS England] 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 [F28section 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 [F1NHS England] may defer a decision whether or not to grant an application,

(k)for the disclosure by [F1NHS England], 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 [F1NHS England] 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 [F1NHS England] to make the grant of an application subject to prescribed conditions.

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

(10)Before making regulations by virtue of subsection (6)(m), the Secretary of State must consult such organisations as he considers appropriate appearing to him to represent persons providing pharmaceutical services.

[F29(10A)[F1NHS England] must give reasons for decisions made by virtue of this section.

(10B)In this section a “needs statement” means the statement required by section 128A(1)(b) as most recently published by the relevant [F30Health and Wellbeing Board].]

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