Commentary on Sections Part 2: Pharmaceutical Services Schedule 2: Pilot Schemes
187.This Schedule deals with arrangements for establishing Local Pharmaceutical Services pilot schemes (see explanatory notes to Chapter 1 of Part 2 of the Act and in particular section 29).
188.Paragraph 1 provides that a pilot scheme may be established on a Health Authority’s own initiative or at 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.
189.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).
190.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.
191.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.
192.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.
193.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 2 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.
194.Paragraph 5 requires Health Authorities to include in their proposals for pilot schemes an assessment of the likely effect of the schemes on other services. Those other services are pharmaceutical services provided under Part 2 of the 1977 Act, 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.
195.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.
196.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.