Part 7Pharmaceutical services and local pharmaceutical services

Chapter 1Provision of pharmaceutical services

C1129C2C3C4C5C6C7C8Regulations as to pharmaceutical services

C21

Regulations must provide for securing that arrangements made by F8a Primary Care TrustF8the Board 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 F9a Primary Care TrustF9the Board of one or more lists of persons, other than medical practitioners and dental practitioners, who undertake to provide pharmaceutical services from premises in F10the area of the Primary Care TrustF10England,

b

that an application to F24a Primary Care TrustF24the 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,

F33must be granted if the Primary Care Trust is satisfied as mentioned in subsection (2A), and may otherwise be granted only if the Primary Care Trust is satisfied as mentioned in subsection (2B), 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.

F282A

The Primary Care Trust is satisfied as mentioned in this subsection if, having regard to its needs statement and to any matters prescribed by the Secretary of State in the regulations, it is satisfied that it is necessary to grant the application in order to meet a need in its area for the services or some of the services specified in the application.

2B

The Primary Care Trust is satisfied as mentioned in this subsection if, having regard to its needs statement and to any matters prescribed by the Secretary of State in the regulations, it is satisfied that to grant the application would secure improvements, or better access, to pharmaceutical services in its area.

2C

In relation to cases where the Primary Care Trust is satisfied as mentioned in subsection (2B), the regulations may make provision as to—

a

the manner in which the Primary Care Trust is to determine whether to grant the application,

b

matters which the Primary Care Trust must or must not take into account for the purpose of determining whether to grant the application.

F22ZA

The Board 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).

F32ZB

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).

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.

F293A

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 the Primary Care Trust.

4

The regulations may F34make provision for the Primary Care Trust to take into account prescribed matters in the case where—

F35a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b

F36two or more applications referred to in subsection (2)(c)(i) or (ii) are considered together by F7the Primary Care TrustF7the Board, and

c

F7the Primary Care TrustF7the Board would be satisfied as mentioned in F37subsection (2A) or (2B) in relation to each application taken on its own, but is not so satisfied in relation to all of them taken together.

F304A

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 F23the Primary Care TrustF23the 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—

F32za

for the circumstances and manner in which a Primary Care Trust may invite applications for inclusion in a pharmaceutical list,

a

that an application to F22a Primary Care TrustF22the Board may be granted in respect of some only of the services specified in it,

b

that an application to F21a Primary Care TrustF21the Board relating to services of a prescribed description may be granted only if it appears to F20the Primary Care TrustF20the 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 F4a Primary Care TrustF4the Board by a person who qualified to have his name registered F1as 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 F5the Primary Care TrustF5the 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 F6in the area of the Primary Care Trust,

d

that the inclusion of a person in a pharmaceutical list F39... F38an application to a Primary Care Trust 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 F19the Primary Care TrustF19the Board in whose area those premises are situated,

f

that F18that Primary Care TrustF18the Board may give its approval subject to conditions,

g

as to other grounds on which F25or circumstances in whichF17a Primary Care TrustF17the BoardF26—

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 F16a Primary Care TrustF16the Board by a person included, or seeking inclusion, in a pharmaceutical list (or by arrangement with him),

i

for the supply to F15a Primary Care TrustF15the 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 F14a Primary Care TrustF14the Board may defer a decision whether or not to grant an application,

k

for the disclosure by F13a Primary Care TrustF13the 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 F12the Primary Care TrustF12the 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 F11the Primary Care TrustF11the Board 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.

F3110A

Primary Care Trusts 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 Primary Care Trust.

11

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