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National Health Service Act 2006

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261Powers relating to voluntary schemesU.K.

(1)The powers under this section may be exercised where there is in existence a scheme (referred to in this section and sections 262 [F1, 263 and 264A] as a “voluntary scheme”) made by the Secretary of State and the industry body for [F2one or more of the following purposes]

(a)limiting the prices which may be charged by any manufacturer or supplier to whom the scheme relates for the supply of any health service medicines, F3...

(b)limiting the profits which may accrue to any manufacturer or supplier to whom the scheme relates in connection with the manufacture or supply of any health service medicines,

[F4(c)providing for any manufacturer or supplier to whom the scheme relates to pay to the Secretary of State an amount calculated by reference to sales or estimated sales of any health service medicines (whether on the basis of net prices, average selling prices or otherwise).]

(2)For the purposes of this section and sections 262 and 263, a voluntary scheme must be treated as applying to a manufacturer or supplier to whom it relates if—

(a)he has consented to the scheme being so treated (and has not withdrawn that consent), and

(b)no notice is in force in his case under subsection (4).

(3)For the purposes of this section a voluntary scheme has effect, in relation to a manufacturer or supplier to whom it applies, with any additions or modifications made by him and the Secretary of State.

(4)If any acts or omissions of any manufacturer or supplier to whom a voluntary scheme applies (a “scheme member”) have shown that, in the scheme member's case, the scheme is ineffective for [F5any] of the purposes mentioned in subsection (1), the Secretary of State may by a written notice given to the scheme member determine that the scheme does not apply to him.

(5)A notice under subsection (4) must give the Secretary of State's reasons for giving the notice, and the Secretary of State may not give a notice under that subsection until he has given the scheme member an opportunity to make representations about the acts or omissions in question.

(6)Consent under subsection (2)(a) must be given, or withdrawn, in the manner required by the Secretary of State.

F6(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8)The Secretary of State may—

(a)prohibit any manufacturer or supplier to whom a voluntary scheme applies from increasing any price charged by him for the supply of any health service medicine covered by the scheme without the approval of the Secretary of State, and

(b)provide for any amount representing any increase in contravention of that prohibition in the sums charged by that person for that medicine, so far as the increase is attributable to supplies to the health service, to be paid to the Secretary of State within a specified period.

[F7(9)The Secretary of State may provide for any amount payable in accordance with a voluntary scheme by any manufacturer or supplier to whom the scheme applies to be paid to the Secretary of State within a specified period.

(10)Neither of the following affects any liability of a manufacturer or supplier to pay amounts to the Secretary of State arising during a period when a health service medicine was covered by a voluntary scheme treated as applying to the person or the taking of any action in relation to any such liability—

(a)the withdrawal of consent by the person to the scheme being treated as applying to the person;

(b)the giving of notice to the person under subsection (4).]

Textual Amendments

Commencement Information

I1S. 261(8) in force at 7.8.2017 immediately after 1999 c. 8, s. 33(8) comes into force by S.I. 2017/810, art. 2(a)

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