Part 1: Controlling cost of health service medicines Section 6: Enforcement
Section 6 of the Act amends sections 265 (Enforcement) and section 266 (Controls: supplementary) of the NHS Act 2006.
	Subsection (3) of section 6 makes consequential amendments to section 265 of the NHS Act 2006, which sets out the enforcement mechanism for the control of the cost of health service medicines provisions of the NHS Act 2006. In particular, subsection (3) of section 6 ensures that the enforcement provisions of the NHS Act 2006 apply to the new provisions inserted into sections 261, 262 and 263. This includes the power to apply a penalty where there has been a breach of any of the provisions and the power to provide for any amount payable to the Secretary of State by virtue of new sections 261(8) (voluntary schemes) and new section 263(5A) (statutory schemes) to carry interest at a rate specified or referred to in the regulations.
	Subsection (4) of section 6 of the Act clarifies subsection (8) of section 265 of the NHS Act 2006 by inserting subsection (8A) into section 265. Subsection (8) of section 265 of the NHS Act 2006 provides that a prohibition or requirement under sections 261 to 264 may not be relied upon in any proceedings other than proceedings under sections 265. Subsection (8) was capable of being misconstrued in such a way that it might be said that the Secretary of State could not enforce payments that are due in a Court. New subsection (8A) in the Act makes clear that that is not the case. It explains that subsection (8) does not apply to any action by the Secretary of State to recover as a debt any amount required to be paid to the Secretary of State by virtue of any of sections 261 to 263 or by virtue of the enforcement provisions in section 265.
	Subsections (5) to (9) make consequential amendments to section 266 of the NHS Act 2006. Section 266 makes supplementary provisions for sections 261-265 which relate to the control of costs of health service medicines. Subsections (5) to (9) would ensure that the supplementary provisions of the NHS Act 2006 apply to new provisions inserted into sections 261 (voluntary schemes), section 262 (power to control prices) and 263 (statutory schemes) of the NHS Act 2006. This includes enabling the Secretary of State to exercise the new powers by making regulations or giving directions to a specific manufacturer or supplier, clarifying that the powers which relate to a direct limit of prices or profits, continue only to apply to provisions which directly limit prices or profits, and inserting new subsection (4A) so that the new power in subsection 263(1)(c) is exercisable only with a view to requiring payments to be made which would be reasonable in all the circumstances, bearing in mind the need for medicinal products to be available for the health service on reasonable terms as well as the costs of research and development.