National Health Service Act 2006

129 Regulations as to pharmaceutical services E+W

(1) Regulations must provide for securing that arrangements made by [F1 a Primary Care Trust][F1 the 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 [F2 a Primary Care Trust][F2 the Board] of one or more lists of persons, other than medical practitioners and dental practitioners, who undertake to provide pharmaceutical services from premises in [F3 the area of the Primary Care Trust][F3 England],

(b) that an application to [F4 a Primary Care Trust][F4 the 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,

[F5 must 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.

[F6 (2A) 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.]

[F7 (2ZA) 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).]

[F8 (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).]

(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.

[F9 (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 the Primary Care Trust.]

(4) The regulations may [F10 make provision for the Primary Care Trust to take into account prescribed matters in] the case where—

F11 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) [F12 two or more applications referred to in subsection (2)(c)(i) or (ii)] are considered together by [F13 the Primary Care Trust][F13 the Board], and

(c) [F13 the Primary Care Trust][F13 the Board] would be satisfied as mentioned in [F14 subsection (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.

[F15 (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 [F16 the Primary Care Trust][F16 the 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—

[F17 (za) 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 [F18 a Primary Care Trust][F18 the Board] may be granted in respect of some only of the services specified in it,

(b) that an application to [F19 a Primary Care Trust][F19 the Board] relating to services of a prescribed description may be granted only if it appears to [F20 the Primary Care Trust][F20 the 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 [F21 a Primary Care Trust][F21 the Board] by a person who qualified to have his name registered [F22 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 [F23 the Primary Care Trust][F23 the 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 [F24 in the area of the Primary Care Trust],

(d) that the inclusion of a person in a pharmaceutical list F25 ... [F26 an 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 [F27 the Primary Care Trust][F27 the Board] in whose area those premises are situated,

(f) that [F28 that Primary Care Trust][F28 the Board] may give its approval subject to conditions,

(g) as to other grounds on which [F29 or circumstances in which] [F30 a Primary Care Trust][F30 the Board] [F31 —

(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)[F32 ,

(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 [F33 a Primary Care Trust][F33 the Board] by a person included, or seeking inclusion, in a pharmaceutical list (or by arrangement with him),

(i) for the supply to [F34 a Primary Care Trust][F34 the 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 [F35 a Primary Care Trust][F35 the Board] may defer a decision whether or not to grant an application,

(k) for the disclosure by [F36 a Primary Care Trust][F36 the 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 [F37 the Primary Care Trust][F37 the 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 [F38 the Primary Care Trust][F38 the 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.

[F39 (10A) 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).

Textual Amendments

F1 Words in s. 129(1) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(2)

F2 Words in s. 129(2)(a) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(3)(a)(i)

F3 Words in s. 129(2)(a) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(3)(a)(ii)

F4 Words in s. 129(2)(b) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(3)(b)

F5 Words in s. 129(2)(c) substituted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(2), 40(1); S.I. 2012/1902, art. 2(a)

F6 S. 129(2A)-(2C) inserted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(3), 40(1); S.I. 2012/1902, art. 2(a)

F7 S. 129(2ZA) inserted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), ss. 207(3), 306(1)(d)(4)

F8 S. 129(2ZB) inserted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(4)

F9 S. 129(3A) inserted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(4), 40(1); S.I. 2012/1902, art. 2(a)

F10 Words in s. 129(4) substituted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(5)(a), 40(1); S.I. 2012/1902, art. 2(a)

F11 S. 129(4)(a) repealed (1.9.2012) by Health Act 2009 (c. 21), ss. 26(5)(b), 40(1), Sch. 6; S.I. 2012/1902, art. 2(a)

F12 Words in s. 129(4)(b) substituted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(5)(c), 40(1); S.I. 2012/1902, art. 2(a)

F13 Words in s. 129(4) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(6)

F14 Words in s. 129(4)(c) substituted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(5)(d), 40(1); S.I. 2012/1902, art. 2(a)

F15 S. 129(4A) inserted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(6), 40(1); S.I. 2012/1902, art. 2(a)

F16 Words in s. 129(5) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(6)

F17 S. 129(6)(za) inserted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(7), 40(1); S.I. 2012/1902, art. 2(a)

F18 Words in s. 129(6)(a) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(a)

F19 Words in s. 129(6)(b) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(a)

F20 Words in s. 129(6)(b) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(b)

F21 Words in s. 129(6)(c) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(a)

F22 Words in s. 129(6)(c) substituted (27.9.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(5), Sch. 4 para. 13(2); S.I. 2010/1621, art. 2(1), Sch.

F23 Words in s. 129(6)(c) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(8)(a)

F24 Words in s. 129(6)(c) omitted (27.3.2012 for specified purposes) by virtue of Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(8)(b)

F25 Words in s. 129(6)(d) repealed (1.9.2012) by virtue of Health Act 2009 (c. 21), s. 40(1), Sch. 6; S.I. 2012/1902, art. 2(f)

F26 Words in s. 129(6)(d) substituted (1.9.2012) by Health Act 2009 (c. 21), ss. 27, 40(1); S.I. 2012/1902, art. 2(b)

F27 Words in s. 129(6)(e) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(b)

F28 Words in s. 129(6)(f) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(c)

F29 Words in s. 129(6)(g) inserted (27.3.2012 for specified purposes, 1.7.2012 in so far as not already in force) by Health and Social Care Act 2012 (c. 7), ss. 207(8)(a), 306(1)(d)(4); S.I. 2012/1319, art. 2(3)

F30 Words in s. 129(6)(g) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(a)

F31 Words in s. 129(6)(g) inserted (27.3.2012 for specified purposes, 1.7.2012 in so far as not already in force) by Health and Social Care Act 2012 (c. 7), ss. 207(8)(b), 306(1)(d)(4); S.I. 2012/1319, art. 2(3)

F32 S. 129(6)(g)(ii) inserted (27.3.2012 for specified purposes, 1.7.2012 in so far as not already in force) by Health and Social Care Act 2012 (c. 7), ss. 207(8)(c), 306(1)(d)(4); S.I. 2012/1319, art. 2(3)

F33 Words in s. 129(6)(h) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(a)

F34 Words in s. 129(6)(i) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(a)

F35 Words in s. 129(6)(j) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(a)

F36 Words in s. 129(6)(k) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(a)

F37 Words in s. 129(6)(k) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(7)(b)

F38 Words in s. 129(8) substituted (27.3.2012 for specified purposes) by Health and Social Care Act 2012 (c. 7), s. 306(1)(d)(4), Sch. 4 para. 66(6)

F39 S. 129(10A)(10B) inserted (1.9.2012) by Health Act 2009 (c. 21), ss. 26(8), 40(1); S.I. 2012/1902, art. 2(a)

Modifications etc. (not altering text)

C1 S. 129(2A)(2B) excluded (E.) (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), regs. 1, 23

C2 S. 129(2A)(2B) excluded (E.) (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), regs. 1, 24(1)(2)

C3 S. 129(2A)(2B) excluded (E.) (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), regs. 1, 25(1)

C4 S. 129(2A)(2B) excluded (E.) (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), regs. 1, 26(1)(2)

C5 S. 129(2A)(2B) excluded (E.) (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), regs. 1, 27(1)

C6 S. 129(2A)(2B) excluded (E.) (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), regs. 1, 28(1)

C7 S. 129(2A)(2B) excluded (E.) (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), regs. 1, 29(1)

C8 S. 129 modified (temp.) (1.3.2007) by National Health Service (Consequential Provisions) Act 2006 (c. 43), s. 8(2), Sch. 3 para. 6 (with Sch. 3 Pt. 1)