National Health Service Act 2006

266 Controls: supplementary U.K.

(1) Any power conferred on the Secretary of State by sections 261(6) to (8) and 262 to 264 may be exercised by—

(a) making regulations, or

(b) giving directions to a specific manufacturer or supplier.

(2) Regulations under subsection (1)(a) may confer power for the Secretary of State to give directions to a specific manufacturer or supplier; and in this subsection “specific” means specified in the direction concerned.

(3) The powers to refuse approval under section 261(8)(a) or 263(6)(a) or to impose a limit under section 262(1)(a) or 263(1) are exercisable only with a view to limiting by reference to the prices or profits which would be reasonable in all the circumstances—

(a) the prices which may be charged for, or

(b) the profits which may accrue to any manufacturer or supplier in connection with,

the manufacture or supply for the purposes of the health service of health service medicines.

(4) In so exercising those powers (in the case of sections 262(1)(a) and 263(1) and (6)(a)) the Secretary of State and any other person must bear in mind, in particular—

(a) the need for medicinal products to be available for the health service on reasonable terms, and

(b) the costs of research and development.

(5) The powers conferred by sections 261 to 264 do not affect any other powers of the Secretary of State to control prices or profits.

(6) In this section and sections 261 to 265—

• “health service” includes the health services within the meaning of the National Health Service (Scotland) Act 1978 (c. 29) and the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I.14)),

• “health service medicine” means a medicinal product used to any extent for the purposes of the health service,

• “the industry body” means any body which appears to the Secretary of State appropriate to represent manufacturers and suppliers,

• “manufacture” includes assemble and “manufacturer” means any person who manufactures health service medicines,

• “medicinal product” has the meaning given by section 130 of the Medicines Act 1968 (c. 67),

• “supplier” means any person who supplies health service medicines,

and contravention of a provision includes a failure to comply with it, and supplying medicines includes selling them.