SCHEDULES

Section 135

SCHEDULE 11E+WPilot schemes

How pilot schemes may be initiatedE+W

1(1)A pilot scheme may be made—E+W

(a)on the initiative of [F1NHS England], or

(b)in response to a request made by a person wishing to participate in the scheme.

(2)The request referred to in sub-paragraph (1)(b) must—

(a)be made in writing, and

(b)comply with such requirements (if any) as may be prescribed.

Preliminary steps to be takenE+W

2(1)Before making a pilot scheme, [F1NHS England] must prepare proposals for the scheme and submit them to the Secretary of State.E+W

(2)But proposals may be submitted by [F1NHS England] only with the agreement of the other proposed participants.

(3)In preparing proposals for a pilot scheme, [F1NHS England] must comply with any directions given to it by the Secretary of State as to—

(a)the matters to be dealt with, and information to be included, in the proposals, and

(b)the procedure to be followed by [F1NHS England].

(4)Before submitting proposals for a pilot scheme, [F1NHS England] must (in addition to complying with any requirements about consultation imposed by or under any other enactment) comply with any directions given to it by the Secretary of State about the extent to which, and manner in which, it must consult on the proposals.

(5)The Secretary of State may give directions—

(a)requiring [F1NHS England] to submit proposals to him,

(b)as to the matters to which [F1NHS England] must have regard in making any recommendation to the Secretary of State when submitting proposals for a pilot scheme,

(c)as to the form in which any such recommendation must be made,

(d)requiring [F1NHS England] to provide the Secretary of State with summaries (prepared and presented in the manner specified in the directions) of all requests received by [F2it] during the period specified in the directions.

(6)A direction under this paragraph may be given so as to apply—

(a)generally in circumstances specified in the direction, or

(b)in relation to a particular case.

ApprovalE+W

3(1)If proposals for a pilot scheme are submitted under paragraph 2, the Secretary of State must—E+W

(a)approve them as submitted,

(b)make such modifications as he considers appropriate and approve them as modified, or

(c)reject them.

(2)The Secretary of State may not approve proposals for a pilot scheme unless satisfied that they include satisfactory provision for any participant other than [F1NHS England] to withdraw from the scheme if he wishes to do so.

(3)When the Secretary of State makes a decision under this paragraph—

(a)he must notify [F1NHS England] of the decision, and

(b)[F1NHS England] must, without delay, notify the other participants in the proposed scheme.

Preliminary approvalE+W

4(1)This paragraph applies if [F1NHS England] proposes to make a pilot scheme but has not determined who the participants, or who all of the participants, will be.E+W

(2)[F1NHS England] may apply to the Secretary of State for preliminary approval to be given to its proposals.

(3)If such an application is made, the Secretary of State must—

(a)give preliminary approval to the proposals as submitted,

(b)make such modifications as he considers appropriate and give preliminary approval to them as modified, or

(c)reject them.

(4)If [F1NHS England] is given preliminary approval, it must take such steps, with a view to obtaining final approval for the proposed pilot scheme, as the Secretary of State may direct.

(5)The fact that the Secretary of State has given preliminary approval to proposals for a pilot scheme does not affect his right to refuse to approve the completed proposals when they are submitted under paragraph 2.

(6)Sub-paragraphs (3) to (6) of paragraph 2 apply in relation to an application for preliminary approval of proposals under this paragraph as they apply in relation to proposals under that paragraph.

Effect of proposals on existing servicesE+W

5(1)Proposals for a pilot scheme submitted under paragraph 2, or included in an application for preliminary approval of proposals under paragraph 4, must include—E+W

(a)an assessment by [F1NHS England] of the likely effect of the implementation of the proposals in [F3the area concerned] on the services mentioned in sub-paragraph (2),

(b)any assessment [F4prepared under sub-paragraph (3)].

(2)The services are—

(a)pharmaceutical services,

(b)local pharmaceutical services provided under existing pilot schemes or LPS schemes,

(c)primary medical services.

(3)If it appears to [F1NHS England] that the proposals would, if implemented, affect any of the services mentioned in sub-paragraph (2) provided in [F5another area], it must [F6prepare an assessment of the likely effect on those services of the implementation of] the proposals before submitting them under paragraph 2 or including them in an application for preliminary approval under paragraph 4.

F7(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

GuidanceE+W

6E+WThe Secretary of State may issue guidance about the criteria by reference to which, as a general rule, powers under paragraph 3 or 4 are likely to be exercised.

Making a schemeE+W

7(1)If the Secretary of State approves proposals for a pilot scheme under paragraph 3 and notifies [F1NHS England] in accordance with that paragraph, [F8[F1NHS England] must] implement the proposals in accordance with directions given by the Secretary of State.E+W

(2)A proposed participant in a pilot scheme (other than [F1NHS England]) may withdraw at any time before the proposals relating to him are implemented.

(3)A pilot scheme, as implemented, may differ from the proposals for the scheme approved by the Secretary of State only if he agrees to the variation or—

(a)directions given by him (either under sub-paragraph (1) or generally) authorise variations that satisfy specified requirements, and

(b)the variation satisfies those requirements.

(4)As soon as is reasonably practicable after implementing proposals for a pilot scheme, [F1NHS England] must (in accordance with any directions given to it by the Secretary of State) publish details of the scheme.