House of Lords - Explanatory Note
Health And Social Care Bill - continued          House of Lords

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Personal medical services and personal dental services

Clause 33: PMS and PDS lists

162. Clause 33 introduces new arrangements further extending the Health Authority list system to include those practitioners who may perform personal medical services "PMS" and personal dental services "PDS".

163. Subsection (1) inserts new section 28DA into the 1977 Act. Subsection (1) of that section provides powers to make regulations providing for the preparation and publication by each Health Authority of lists of medical and dental practitioners who may perform PMS and PDS. Subsection (2) of the new section provides that such a list is to be referred to as a "services lists".

164. Section 28DA(3) sets out provisions which (among others) may be included in regulations about services lists. Paragraph (a) provides powers to prescribe the Health Authority to which an application for inclusion in a services list should be made.

165. Paragraph (a) provides powers to prescribe the Health Authority to which an application for inclusion in a services list should be made.

166. Under paragraph (b), the regulations may make provision for the procedure for applying for inclusion in a list. This may include details of the information to be supplied to the Health Authority, either directly by or arranged by an applicant, in order for that Authority to assess the applicant's suitability.

167. Paragraph (c) enables provision to be made about the grounds on which a Health Authority may or must refuse an application for inclusion in a list. This includes reasons of unsuitability or on other grounds. For example, regulations might make special provision for cases in which an applicant has previously been included in or removed from a list by another Health Authority, or disqualified previously by the NHS Tribunal. Regulations might also require a Health Authority to refuse entry to a list where, for example, the applicant has a conviction for murder. Provision may be made under paragraph (e) as to the grounds on which a Health Authority may, or must, suspend or remove a person from a services list and the procedure for doing so.

168. Provision may be made under paragraph (f) about payments to be made to or in respect of suspended practitioners. Applicants for inclusion in a list and practitioners already included, may, under paragraph (g), be required to supply the Health Authority with criminal conviction or criminal record certificates. Under paragraph (k), regulations may provide for the disclosure by Health Authorities to prescribed persons or persons of prescribed descriptions of specified information about applicants applying for inclusion in a services list as well as refusals of such applications and suspensions and removals of practitioners from a services list.

169. Paragraph (h) provides that regulations may make provision to prevent a person withdrawing from a Health Authority services list (for example, during any period a practitioner is under investigation which might result in removal or during any period awaiting removal from a list).

170. Section 28DA(4) provides for regulations to make provision for a person's inclusion in a list to be subject to conditions determined by the Health Authority. The Health Authority may vary these conditions or impose different ones. The regulations will also set out the consequences of a practitioner failing to comply with a condition, which could include removal from the list. They may also provide for the Health Authority to review their decisions to conditionally include a person in the list.

171. Regulations under section 28DA(5) may require that no person may deliver PMS or PDS unless they are included in either a medical or dental list, a supplementary list or a services list.

172. Section 28DA(6) allows provision to be made about services lists which corresponds to provision which may be made about principal lists under sections 49F to 49N.

173. Section 28DA(7) provides that any regulations providing for the removal of a person from a services list or a refusal to include him in one (other than a compulsory removal or refusal) must also provide for an appeal, by re-determination, to the FHSAA against the Health Authority's decision.

174. If the regulations make provision under section 28DA(4), they must provide for an appeal, by re-determination, to the FHSAA against any Health Authority decision to impose conditions on a person's inclusion in a services list; to vary a condition, to remove a person from a list for failing to comply with a condition or any review of an earlier decision.

175. Subsection (2) inserts a new section 8ZA into the National Health Service (Primary Care) Act 1997 introducing similar provisions in relation to PMS and PDS pilot schemes.

The Family Health Services Appeal Authority

Clause 34: The Family Health Services Appeal Authority

176. The NHS Plan set out the Government's intention to abolish the NHS Tribunal, to devolve the power to suspend or remove practitioners from a Health Authority list to Health Authorities. Practitioners will have a right of appeal to the Family Health Services Appeal Authority (FHSAA) against any decision to remove them a list. Clause 23 of this Bill abolishes the NHS Tribunal. The intention is to rationalise the functions carried out by the existing Family Health Services Appeal Authority and the NHS Tribunal into one body. In effect the Family Health Services Appeal Authority created by the Bill will take over the functions of the Tribunal, adapted to take account of the new powers of Health Authorities to suspend or remove practitioners. The existing Family Health Services Appeal Authority is a special Health Authority. Clause 34 provides for the creation of the new Authority as an independent body.

177. Subsection (1) of clause 34 inserts a new section 49S into the 1977 Act which sets up the Family Health Services Appeal Authority (FHSAA). Subsection (2) provides for the authority to be constituted in accordance with new Schedule 9A. Subsection (3) provides for the functions of the FHSAA to be conferred on it by the 1977 Act or by any other enactment. Subsection (4) provides a power for the Secretary of State to direct the FHSAA to exercise any of his functions relating to the determination of appeals (for example, such functions currently exercised by the existing Family Health Services Appeal Authority). Subsection (5) provides that such directions must be given by regulations or in writing. Subsection (6) permits the Secretary of State to make available to the FHSAA any facilities (or premises) provided by him or a Special Health Authority or NHS trust as well as the services of any staff employed by him or by a Special Health Authority or NHS trust.

178. Subsection (4) (of clause 34) inserts Schedule 9A into the 1977 Act. Paragraphs 1 to 6 set out the constitution and membership of the FHSAA. The FHSAA will consist of a President, one or more Deputy Presidents, and a number of other members, all to be appointed by the Lord Chancellor. The number of other members will be determined by the Lord Chancellor after consulting the Secretary of State. The membership must include people with a lay background as well as those with relevant professional expertise.

179. Paragraph 7 provides for the FHSAA to determine its own procedure, subject to the requirements of paragraphs 8 to 18 of the Schedule. Paragraph 8 provides that the functions of FHSAA are exercised by panels consisting one or more members chosen by the President (who may include himself). Paragraph 9 requires that at least one member of a panel (or in the case of a one member panel, that member) must have a seven year legal qualification. Paragraph 10 provides that a three member panel exercising functions under section 49M or 49N of the 1977 Act, as inserted by clause 32, must comprise one legal member, one professional member and one other.

180. Paragraph 11 requires that where a panel has more than one member, the President shall nominate one of the members to act as chairman; for decisions to be taken by a majority of votes, and if there is a tie for the Chairman to have a second vote as a casting vote.

181. The FHSAA will be required to give notice of a panel's decision and the reasons for it to each party to the proceedings; to publish each decision of a panel, and to send a copy of any such decision, and, where necessary, any information as appears to be relevant, to prescribed persons or persons of prescribed descriptions.

182. Paragraphs 15 to 18 provide for the Lord Chancellor to make rules regarding the composition of the panels and the procedure to be followed. Paragraph 19 provides for the publication of an annual written report about the FHSAA's activities. Paragraph 20 provides that the President must arrange for appropriate training for himself and the other members of the FHSAA.

183. Paragraph 19 provides for the publication of an annual written report about the FHSAA's activities. Paragraph 20 provides that the President must arrange for appropriate training for himself and the other members of the FHSAA.

PART 2 PHARMACEUTICAL SERVICES

Chapter 1: Local Pharmaceutical Services

184. Chapter I of Part II provides for new arrangements under which community pharmacy and related services may be provided on a piloted basis. At present, pharmaceutical services, including the dispensing of NHS prescriptions, are provided by community pharmacies, appliance contractors and dispensing doctors under arrangements made with Health Authorities in accordance with Part II of the NHS Act 1977, and in particular regulations made under sections 41 and 42 of that Act. These arrangements are referred to below as "Part II pharmaceutical services".

185. The new arrangements will be known as Local Pharmaceutical Services and will provide an alternative legal framework for the provision of pharmaceutical services, under locally agreed contracts. Local Pharmaceutical Services will first be provided under pilot schemes, which are intended to develop and demonstrate innovative ways of providing high quality, cost-effective services to patients. They will be similar to Personal Medical Services and Personal Dental Services pilot schemes, established under the NHS (Primary Care Act) 1997. Many of the provisions in this Part of the Bill (and in particular Clauses 38 to 41) are modelled on the equivalent provisions in that Act.

Preparation and making of pilot schemes

Clause 35: Pilot Schemes

186. Clause 35 deals with the general nature of Local Pharmaceutical Services pilot schemes. Subsection (2) provides that a pilot scheme may consist of one or more agreements between a Health Authority and any other person or persons (other than another Health Authority) under which Local Pharmaceutical Services are to be provided. The Health Authority may not itself provide Local Pharmaceutical Services.

187. Unlike Personal Medical and Dental Services pilots, provision of Local Pharmaceutical Services is not to be restricted to particular classes of person (although nothing in these provisions will alter restrictions in the Medicines Act 1968 and other legislation on who may supply medicines). The parties to pilot schemes may therefore include, amongst others, individual pharmacists, retail pharmacy businesses and dispensing appliance contractors. They may also include NHS trusts and Primary Care Trusts, and subsection (7) provides that NHS trusts and Primary Care Trusts have the necessary powers to provide services under a pilot scheme.

188. Subsection (8) defines Local Pharmaceutical Services as such services prescribed in regulations which are of a kind that may be provided under sections 41 or 41A of the NHS Act 1977 (that is, Part II pharmaceutical services.) However, subsection (9) means that Local Pharmaceutical Services may not include the dispensing of drugs, medicines and appliances by doctors or dentists to their own patients.

189. Under section 41 of the NHS Act 1977, Health Authorities have a duty to arrange Part II pharmaceutical services for their area. Since Local Pharmaceutical Services pilot schemes will be providing similar services, subsection (6) permits Health Authorities to take into account such schemes in determining how to meet their duty under section 41.

190. Subsection (3) provides that a pilot scheme may also include health services which are not Local Pharmaceutical Services, but which may be provided under Part I of the NHS Act 1977. This could include, for example, diagnostic testing, therapeutic monitoring and health education. It need not be restricted to services normally associated with pharmacies. So it could, for example, include the provision of chiropody or similar services. Pilot schemes may also include the provision of training and education. However, subsection (4) provides that schemes may not combine arrangements for Local Pharmaceutical Services with those for Personal Medical or Dental Services.

191. Subsection (5) defines piloted services as services provided under a pilot scheme, which therefore include not only Local Pharmaceutical Services but any other services included within a scheme.

Clause 36: Making of Pilot Schemes

192. Clause 36 introduces Schedule 2, which makes provision about the making of pilot schemes. In particular, that Schedule provides that pilot schemes may only be established with the approval of the Secretary of State or, in relation to Wales, the National Assembly for Wales.

Clause 37: Designation of priority neighbourhoods or premises

193. Clause 37 permits the Secretary of State or National Assembly for Wales to make regulations allowing Health Authorities to designate neighbourhoods, particular premises, or particular descriptions of premises for the purposes of Local Pharmaceutical Services pilot schemes. Under subsection (2) the regulations may, in particular, make provisions about which such places Health Authorities may designate and in what circumstances. The regulations may allow Health Authorities to defer applications to provide Part II Pharmaceutical Services relating to designated places. To avoid designations being prolonged inappropriately, regulations may also deal with the cancellation of designations, and may permit the Secretary of State or the National Assembly for Wales to direct that a designation be cancelled.

Reviews, variation and termination of pilot schemes

Clause 38: Reviews of Pilot Schemes

194. Clause 38 deals with the review of pilot schemes. Subsection (1) requires that each pilot scheme be reviewed at least once by the Secretary of State or National Assembly for Wales, and subsection (2) requires that this be done within three years of services first being provided under the scheme. Subsection (3) requires the Secretary of State or National Assembly for Wales to give the relevant Health Authority and the people providing services under each scheme an opportunity to comment as part of the review, but otherwise subsection (4) allows the procedure for the review to be at the discretion of the Secretary of State or National Assembly for Wales.

Clause 39: Variation and Termination of Pilot Schemes

195. Clause 39 deals with the variation and termination of pilot schemes. In particular subsection (1) permits the Secretary of State or National Assembly for Wales to issue directions to Health Authorities giving them a general authority to vary pilot schemes in specified circumstances and subject to specified conditions. The Secretary of State or National Assembly for Wales may also issue directions under subsection (2) to require Health Authorities to vary particular schemes. If for any reason the Secretary of State or National Assembly for Wales is satisfied that a pilot scheme is unsatisfactory, subsection (3) permits them to issue directions requiring the Health Authority concerned to bring the scheme to an end.

NHS contracts and Financial provision

Clause 40: NHS Contracts

196. Under Clause 40, persons providing pilot services may apply to become a health service body. The effect of such an application being granted is that the contracts entered into between the Health Authority and the health service body will be NHS contracts within the meaning of the National Health Service and Community Care Act 1990, rather than legal contracts.

197. Where a pilot scheme involves a single individual or body corporate, subsection (1) provides for that individual or body to apply to become a health service body. Where a pilot scheme involves more than one person, subsection (2) permits all the people involved to apply collectively. In both cases, applications must be made in accordance with regulations under subsection (3). Regulations under subsection (4) may provide for applications to be granted except in specified cases. If an application is granted, subsection (5) requires the Secretary of State or National Assembly for Wales to specify when it is to come into effect.

198. From a specified day following grant of an application, the applicant or applicants are to be treated as health service bodies for the purposes of section 4 of the 1990 Act. Subsection (7) provides that where an application has been granted to pilot scheme providers collectively, it is the providers in that scheme at any given time who are to be considered the health service body, even if they have changed since the original application. Regulations under subsection (9) may provide for people to cease to be health services bodies in specified circumstances.

199. Subsections (10) and (11) require the Secretary of State and National Assembly for Wales to maintain and keep up to date a list of pilot scheme providers who have been awarded health services body status, and to publish it in such manner as they consider appropriate.

200. Subsection (6) has the effect that contracts between pilot scheme providers which have been granted the status of health service bodies and other health services bodies (including other pilot scheme providers) are to be treated as NHS contracts if they are for the provision of goods or services in connection with the scheme.

201. NHS contracts are not normally enforceable in the Courts. Instead, any disputes can be put to the Secretary of State or National Assembly for Wales for resolution. However, because most pilot scheme providers will be rather different to other health service bodies, subsection (8) provides that the County Court may enforce directions issued as a result of that dispute resolution procedure in favour of, or against a pilot scheme provider.

Clause 41: Funding of preparatory work

202. Clause 41 deals with financial support for people developing proposals for pilot schemes and preparing to provide services under them. Subsection (1) provides that regulations may make provision for Health Authorities to give people financial assistance in respect of preparatory work, as defined by subsection (2). Subsection (3) sets out matters which may in particular be included in those regulations.

Clause 42: Charges for the provision of piloted services

203. Clause 42 deals with charges. The Government's policy is that arrangements for prescription charges under Local Pharmaceutical Services will be the same as those which apply in relation to Part II Pharmaceutical Services. People who are exempt, or who otherwise are not required to pay prescription charges, will receive free prescriptions whether they use a pilot scheme provider or a Part II provider. Similarly, there will be no difference in the level of prescription charges, or in the cost of pre-payment certificates. Such certificates will be valid for both services interchangeably. To that end, subsection (1) provides that regulations may be made about the making and recovery of charges for Local Pharmaceutical Services. Subsection (2) specifies matters which may in particular be included in regulations, including the application to Local Pharmaceutical Services of sections 122A and 122B of the 1977 Act, which deal with the recovery of certain charges and the imposition of penalty charges in certain cases. Subsection (3) requires the regulations to secure that any charges in respect of Local Pharmaceutical Services will be the same as those which would apply had the service been provided under Part II of the 1977 Act.

General

Clause 43: Effect of the 1977 Act

204. Clause 43 makes general provision about the status of the functions of the Secretary of State, National Assembly for Wales and Health Authorities in respect of Local Pharmaceutical Services pilot schemes. In particular, subsection (2) provides that, unless otherwise specified, the 1977 Act applies to services provided under pilot schemes as if the Secretary of State or National Assembly for Wales had directed a Health Authority to arrange those services on his behalf. One effect of this is that Health Authorities may, subject to directions from the Secretary of State or National Assembly for Wales under section 17A of the 1977 Act, delegate their functions in respect of pilot schemes to a Primary Care Trust. (For that reason, references in these explanatory notes to Health Authorities should be read to include Primary Care Trusts unless the context demands otherwise).

Clause 44 Premises from which pilot services may be provided

205. Clause 44 deals with the relationship between pilot schemes and pharmaceutical services provided under Part II of the NHS Act 1977. Clause 44(a) permits regulations to be made preventing the provision of pilot scheme services from the same premises as pharmaceutical services under Part II of the NHS Act 1977, except as provided in the regulations. Clause 44(b) permits regulations to make provision about the inclusion, re-inclusion, removal and modification of entries in pharmaceutical lists held under Part II of that Act. It is envisaged that such regulations may be used to establish arrangements for determining whether, and to what extent, pilot scheme providers are to have a preferential right to return (or transfer) to Part II services in respect of particular premises on ceasing to provide services under a pilot scheme.

Clause 45: Control of Entry Regulations

206. Section 42 of the 1977 Act requires regulations to be made about (amongst other things) the preparation and publication by Health Authorities of lists of people who have undertaken to provide Part II Pharmaceutical Services. Except as provided for in those regulations, applications by people wishing to join such a list (or to change the services or premises in respect of which they are already entered in the list) are granted only if the Health Authority is satisfied that it is necessary or desirable to do so in order to secure in the neighbourhood in question the provision of adequate pharmaceutical services by people on the list.

207. Clause 45 provides that regulations under section 42 of the 1977 Act may include provision about the extent which services provided under Local Pharmaceutical Services pilot schemes are to be taken into account when determining such applications.

Assessing the result of pilot schemes

Clause 46: Assessing pilot schemes

208. Clause 46 provides that the Secretary of State or National Assembly for Wales may not bring into effect Clause 47 (which deals with the provision of Local Pharmaceutical Services otherwise than under pilot schemes) unless they are satisfied that pilot schemes have shown that the continued provision of Local Pharmaceutical Services would be in the interests of the health service (or any part of it). The Secretary of State or National Assembly for Wales must have regard, in particular to the results of reviews of pilot schemes required under Clause 33.

Provision for local pharmaceutical schemes

Clause 47: Provision for LPS schemes

209. Clause 47 makes provision for Local Pharmaceutical Services schemes which are not pilot schemes by inserting a new section 28J and a new Schedule 8A into the NHS Act 1977. The new Schedule 8A is set out in Schedule 3 to this Bill. Subsection (3) inserts a new subsection 42(2A) in the 1977 Act, which has the same effect in relation to Local Pharmaceutical Services schemes which are not pilot schemes, as Clause 45 has in relation to pilot schemes.

Corresponding provision and application of enactment's

Clause 48: Corresponding provision and application of enactment's

210. Clause 48 provides a power to make regulations in relation to local pharmaceutical services (or the people involved in providing them) whose provisions correspond to equivalent statutory provision in relation to personal medical or dental services (or the people involved in providing them). The provisions may be applied with such modifications as are considered appropriate.

Schedule 2: Pilot Schemes

211. This Schedule deals with arrangements for establishing Local Pharmaceutical Services pilot schemes (see explanatory notes to Chapter I of Part II of the Bill and in particular Clause 36).

212. Paragraph 1 provides that a pilot scheme may be established on a Health Authority's own initiative or on the request of a person wishing to participate in a scheme. A request from a prospective participant must be made in writing and must conform to any requirements set out in regulations.

213. Paragraph 2 deals with the preparation of proposals for pilot schemes both for preliminary and final approval. Before establishing a pilot scheme Health Authorities are to be required to prepare proposals for submission to the Secretary of State or National Assembly for Wales, who may issue directions about the issues to be dealt with and the information to be included in such proposals. They may also issue directions requiring Health Authorities to consult on proposals before submitting them (and any such requirement would be in addition to any other obligation to consult imposed by or under any other legislation).

214. In some cases, it may be that Health Authorities will be required to include with proposals a recommendation about whether it should, or should not, be approved. The Secretary of State or National Assembly for Wales is therefore to be able to issue directions specifying the factors that Health Authorities should take into account in making any recommendation and the form in which the recommendation is to be made. Like other directions under this paragraph, such directions may be general, or particular to specific schemes.

215. Health Authorities are not generally to be required to submit proposals at the request of potential participants. However, sub-paragraph (5) will allow the Secretary of State and National Assembly for Wales to direct Health Authorities to submit summaries of such requests, prepared and presented in accordance with the directions, and to specify circumstances in which Health Authorities must submit proposals for consideration.

216. Paragraph 3 deals with approval. The Secretary of State or National Assembly for Wales will not be able to approve a proposal unless satisfied that there are adequate arrangements for participants (other than the Health Authority) to withdraw. Otherwise, they may approve proposals as submitted, or with modifications, or reject them. They must notify the relevant Health Authority of their decision and the Health Authority must notify the other participants without delay.

217. Paragraph 4 will permit a Health Authority to apply for preliminary approval for a scheme, before it has identified who the participants are to be. This could be used, for example, by a Health Authority wishing to establish services in an area that is not adequately served either by Local Pharmaceutical Services or Part II Pharmaceutical Services. It could first obtain preliminary approval for a scheme, and then invite bids from people to become the pilot scheme provider. As with full proposals, the Secretary of State and National Assembly for Wales will be required either to approve preliminary approvals as they stand or subject to modifications, or else reject them. If the preliminary proposal is approved, Health Authorities may be required to prepare full proposals in accordance with directions from the Secretary of State or National Assembly for Wales. Preliminary approval will not guarantee final approval of the scheme.

218. Paragraph 5 requires Health Authorities to include in their proposals for pilot schemes and assessment of the likely effect of the schemes on other services. Those other services are pharmaceutical services provided under Part II of the NHS Act 1977, local pharmaceutical services provided under other pilot schemes, general medical services and personal medical services. Where necessary, the Health Authority making the proposals must consult any other Health Authority whose area may be affected, and that Health Authority must provide an assessment of the effects on services in its area.

219. Paragraph 6 permits the Secretary of State and National Assembly for Wales to issue guidance about the criteria they are likely to apply when considering both full and preliminary proposals.

220. Paragraph 7 deals with the establishment of schemes once approved. It will require Health Authorities to implement proposals that have been approved, in accordance with directions from the Secretary of State or National Assembly for Wales. The Health Authority may not withdraw from the scheme before it is established, but any of the other parties may at any time. A pilot scheme may only differ from the proposals as approved if the Secretary of State or National Assembly for Wales agree the particular change, or if the change falls within the scope of any directions they have issued permitting variations. As soon as possible after implementing a scheme, Health Authorities will be required to publish details of the scheme, in accordance with any directions issued by the Secretary of State or National Assembly for Wales.

 
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Prepared: 21 February 2001