National Health Service Act 2006 (c. 41)

(The document as of February, 2008)

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(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 Primary Care Trust 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 Primary Care Trust,

(b) that an application to a Primary Care Trust 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 Primary Care Trust 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 12) 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 Primary Care Trust, and

(c) the Primary Care Trust 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 Primary Care Trust, 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 Primary Care Trust may be granted in respect of some only of the services specified in it,

(b) that an application to a Primary Care Trust relating to services of a prescribed description may be granted only if it appears to the Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust,

(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 Primary Care Trust in whose area those premises are situated,

(f) that that Primary Care Trust may give its approval subject to conditions,

(g) as to other grounds on which a Primary Care Trust 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),

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

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

(k) for the disclosure by a Primary Care Trust, 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 Primary Care Trust 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 Primary Care Trust 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.

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

130 Regulations under section 129: appeals, etc

(1) Regulations under section 129 must include provision conferring on such persons as may be prescribed rights of appeal from decisions made by virtue of that section.

(2) If regulations made by virtue of section 129(6)(g) provide that a Primary Care Trust may refuse to grant an application, they must also provide for an appeal (by way of redetermination) to the FHSAA against the decision of the Primary Care Trust.

(3) Regulations under section 129 must be so framed as to preclude--

(a) a person included in a pharmaceutical list, and

(b) an employee of such a person,

from taking part in the decision whether an application such as is mentioned in section 129(2)(c) should be granted or an appeal against such a decision brought by virtue of subsection (1) of this section should be allowed.

131 Power to charge

(1) The Secretary of State may give directions to a Primary Care Trust requiring it to charge a fee in cases or descriptions of case specified in the directions to persons who make an application referred to in section 129(2)(c)(i) or (ii).

(2) The Secretary of State may in the directions--

(a) specify the fee himself, or

(b) require the Primary Care Trust to determine the amount of the fee in accordance with any requirements set out in the directions.

(3) Before determining the amount of the fee-

(a) in a subsection (2)(a) case, the Secretary of State must consult such organisations as he considers appropriate that appear to him to represent persons providing pharmaceutical services and such organisations as he considers appropriate that appear to him to represent Primary Care Trusts,

(b) in a subsection (2)(b) case, the Primary Care Trust must undertake any consultation required by the directions.

(4) The Secretary of State must publish in such manner as he considers appropriate any directions he gives under this section.

(5) In a subsection (2)(b) case, the Primary Care Trust must publish in such manner as it considers appropriate the fee which it determines.

132 Persons authorised to provide pharmaceutical services

(1) Except as may be provided for by or under regulations, no arrangements may be made by a Primary Care Trust with a medical practitioner or dental practitioner under which he is required or agrees to provide pharmaceutical services to any person to whom he is rendering primary medical services or primary dental services.

(2) Except as may be provided for by or under regulations, no arrangements for the dispensing of medicines may be made under this Chapter with persons other than persons who--

(a) are registered pharmacists or persons lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 (c. 67), and

(b) undertake that all medicines supplied by them under the arrangements will be dispensed either by or under the supervision of a registered pharmacist.

(3) Regulations must provide for the preparation and publication by each Primary Care Trust of one or more lists of medical practitioners who undertake to provide drugs, medicines or listed appliances (within the meaning given by section 126) under arrangements with the Primary Care Trust.

(4) The regulations may, in particular, include provision--

(a) as to grounds on which a Primary Care Trust may, or must, refuse to grant an application for inclusion in a list of medical practitioners referred to in subsection (3) (including grounds corresponding to the conditions referred to in section 151(2), (3) or (4) as read with section 153(2)),

(b) as to information which must be supplied to a Primary Care Trust by a medical practitioner included, or seeking inclusion, in such a list (or by arrangement with him),

(c) for the supply to a Primary Care Trust by a medical practitioner who is included, or seeking inclusion, in such a 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,

(d) for grounds on which a Primary Care Trust may defer a decision whether or not to grant an application for inclusion in such a list,

(e) for the disclosure by a Primary Care Trust to prescribed persons or persons of prescribed descriptions, of information of a prescribed description about applicants for inclusion in such a list, and refusals by the Primary Care Trust to grant such applications,

(f) as to criteria to be applied in making decisions under the regulations.

(5) If regulations made by virtue of subsection (4)(a) provide that a Primary Care Trust may refuse to grant an application for inclusion in such a list, they must also provide for an appeal (by way of redetermination) to the FHSAA against the decision of the Primary Care Trust.

(6) The regulations must include provision for the removal of an entry from a list in prescribed circumstances.

(7) No arrangements for the provision of--

(a) pharmaceutical services falling within section 126(3)(e), or

(b) additional pharmaceutical services provided in accordance with a direction under section 127,

may be made with persons other than those who are registered pharmacists or are of a prescribed description.

(8) Where--

(a) arrangements for the provision of pharmaceutical services have been made with a registered pharmacist, and

(b) a suspension order or an interim suspension order is made with respect to him,

he may not provide pharmaceutical services in person during the period of suspension.

(9) "Suspension order" and "interim suspension order" have the same meaning as in the Pharmacy Act 1954 (c. 61).

133 Inadequate provision of pharmaceutical services

(1) Subsection (2) applies if the Secretary of State is satisfied, after such inquiry as he considers appropriate, that--

(a) as respects the area, or part of the area, of a Primary Care Trust, the persons whose names are included in any pharmaceutical list are not such as to secure the adequate provision of pharmaceutical services in that area or part, or

(b) for any other reason any considerable number of persons in any such area or part are not receiving satisfactory services under the arrangements in force under this Chapter.

(2) Where this subsection applies, the Secretary of State--

(a) may authorise the Primary Care Trust to make such other arrangements as he may approve, or may himself make such other arrangements, and

(b) may dispense with any of the requirements of regulations made under this Part (other than Chapters 2 to 4) so far as appears to him necessary to meet exceptional circumstances and enable such arrangements to be made.

Chapter 2 Local pharmaceutical services: pilot schemes

134 Pilot schemes

(1) Primary Care Trusts may establish pilot schemes.

(2) In this Act, a "pilot scheme" means one or more agreements--

(a) made by a Primary Care Trust in accordance with this Chapter,

(b) under which local pharmaceutical services will be provided (otherwise than by the Primary Care Trust), and

(3) A pilot scheme may include arrangements--

(a) for the provision of services which are not local pharmaceutical services, but which may be provided under this Act, other than under Chapter 1 of this Part, and whether or not of the kind usually provided by pharmacies,

(b) for the provision of training and education (including training and education for persons who are, or may become, involved in the provision of local pharmaceutical services).

(4) A pilot scheme may not combine arrangements for the provision of local pharmaceutical services with arrangements for the provision of primary medical services or primary dental services.

(5) In determining the arrangements it needs to make in order to comply with section 126, a Primary Care Trust may take into account arrangements under a pilot scheme made by it.

(6) The functions of an NHS trust and an NHS foundation trust include power to provide any services to which a pilot scheme applies.

(7) In this Chapter--

"local pharmaceutical services" means such services of a kind which may be provided under section 126, or by virtue of section 127 (other than practitioner dispensing services) as may be prescribed for the purposes of this Chapter, and
"piloted services" means services provided under a pilot scheme (including any services to which the scheme applies as a result of subsection (3)).

(8) "Practitioner dispensing services" means the provision of drugs, medicines or listed appliances (within the meaning given by section 126) by a medical practitioner or dental practitioner to a patient of his pursuant to arrangements made by virtue of section 132(1).

135 Making pilot schemes

Schedule 11 makes provision with respect to making pilot schemes, including provision with respect to the procedure to be followed.

136 Designation of priority neighbourhoods or premises

(1) The Secretary of State may make regulations allowing a Primary Care Trust to designate--

(a) neighbourhoods,

(b) premises, or

for the purposes of this section.

(2) The regulations may, in particular, make provision--

(a) as to the circumstances in which, and the neighbourhoods or premises in relation to which, designations may be made or maintained,

(b) allowing a Primary Care Trust 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 Secretary of State gives a direction to that effect, or

(ii) in prescribed circumstances.

(3) "Pharmaceutical list applications" means applications for inclusion in a pharmaceutical list.

137 Reviews of pilot schemes

(1) At least one review of the operation of each pilot scheme must be conducted by the Secretary of State.

(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 Secretary of State must give--

(a) the Primary Care Trust 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 Secretary of State.

138 Variation and termination of pilot schemes

(1) The Secretary of State may give directions authorising Primary Care Trusts 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 Secretary of State may by directions require a pilot scheme to be varied by the Primary Care Trust concerned in accordance with the directions.

(3) If satisfied that a pilot scheme is (for any reason) unsatisfactory, the Secretary of State may give directions to the Primary Care Trust concerned requiring it to bring the scheme to an end in accordance with the terms of the directions.

139 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 Secretary of State 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 Secretary of State may grant an application.

(5) If an application is granted, the Secretary of State 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 9.

(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 9(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 9(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 Secretary of State 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 Secretary of State considers appropriate.

140 Funding of preparatory work

(1) Provision may be made by regulations for Primary Care Trusts 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 Primary Care Trust 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 Primary Care Trust 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.

141 Application of this Act

This Act has effect in relation to piloted services--

(a) subject to any provision of, or made under, this Chapter, section 145 (application of enactments) or section 178 (charges for local pharmaceutical services), but

(b) otherwise as if those services were provided as a result of the delegation by the Secretary of State of his functions (by directions given under section 7).

142 Premises from which piloted services may be provided

The Secretary of State 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.

143 Control of entry regulations

The power to make regulations under section 129 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

144 Local pharmaceutical services schemes

Schedule 12 makes provision with respect to the provision of local pharmaceutical services in accordance with schemes made by Primary Care Trusts.

Chapter 4 Local pharmaceutical services: miscellaneous

Application of enactments

145 Application of enactments

(1) The Secretary of State 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 92 arrangements or section 107 arrangements, or

(b) persons who provide or perform services under section 92 or section 107.

(2) The regulations may, in particular, provide for the application of any such enactment with such modifications, if any, as the Secretary of State considers 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.

Performance of local pharmaceutical services

146 Persons performing local pharmaceutical services

(1) Regulations may provide that a health care professional of a prescribed description may not perform any local pharmaceutical service for which a Primary Care Trust is responsible unless he is included in a list maintained under the regulations by a Primary Care Trust.

(2) For the purposes of this section--

(a) "health care professional" means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17),

(b) a Primary Care Trust is responsible for a local pharmaceutical service if it secures its provision by or under any enactment.

(3) Regulations under this section may make provision in relation to lists under this section and in particular as to--

(a) the preparation, maintenance and publication of a list,

(b) eligibility for inclusion in a list,

(c) applications for inclusion (including provision as to the Primary Care Trust to which an application must be made, and for the procedure for applications and the documents to be supplied on application),

(d) the grounds on which an application for inclusion may or must be granted or refused,

(e) requirements with which a person included in a list must comply (including the declaration of financial interests and gifts and other benefits),

(f) suspension or removal from a list (including provision for the grounds for, and consequences of, suspension or removal),

(g) circumstances in which a person included in a list may not withdraw from it,

(h) payments to be made in respect of a person suspended from a list (including provision for the amount of the payment, or the method of calculating the payment, to be determined by the Secretary of State or a person appointed by him),

(i) the criteria to be applied in making decisions under the regulations,

(j) appeals against decisions made by a Primary Care Trust under the regulations, and

(k) disclosure of information about applicants for inclusion, grants or refusals of applications or suspensions or removals,

and may make any provision corresponding to anything in sections 151 to 159.

(4) Regulations under this section may, in particular, also provide for--

(a) a person's inclusion in a list to be subject to conditions determined by a Primary Care Trust,

(b) a Primary Care Trust to vary the conditions or impose different ones,

(d) the review by a Primary Care Trust of decisions made by it by virtue of the regulations.

(5) The imposition of such conditions must be with a view to--

(a) preventing any prejudice to the efficiency of the services to which a list relates, or

(b) preventing fraud.

(6) Regulations making provision as to the matters referred to in subsection (3)(k) may in particular authorise the disclosure of information--

(a) by a Primary Care Trust to the Secretary of State, and

(b) by the Secretary of State to a Primary Care Trust.

Assistance and support

147 Assistance and support: local pharmaceutical services

(1) A Primary Care Trust may provide assistance or support to any person providing local pharmaceutical services.

(2) Assistance or support provided by a Primary Care Trust under subsection (1) is provided on such terms, including terms as to payment, as the Primary Care Trust considers appropriate.

(3) "Assistance" includes financial assistance.

Chapter 5 Conditional inclusion in pharmaceutical lists, and supplementary lists

148 Conditional inclusion in pharmaceutical lists

(1) Regulations may provide--

(a) that if a person is included in a pharmaceutical list he is subject, while he remains included in the list, to conditions determined by the Primary Care Trust in whose list he is included,

(b) for the Primary Care Trust 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 Primary Care Trust 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 151(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 Primary Care Trust is investigating whether there are grounds for exercising their power to remove him, or after the Primary Care Trust 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 Primary Care Trust makes any decision as to his removal from the list, and

(iii) requiring him to be given notice of the decision of the Primary Care Trust and the reasons for it and of his right of appeal under subsection (4).

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