Health (Pricing and Supply of Medical Goods) Act 2013

PART 5

Reference Pricing

24.

Reference price for listed items which fall within group of interchangeable medicinal products.

24.— (1) Subject to subsections (3) to (5) and section 25 and without prejudice to the generality of section 21(3) , the Executive may set a price (in this Act referred to as the “reference price”) for a relevant group of interchangeable medicinal products in relation only to the listed items which fall within the group.

(2) Subject to section 25 , the Executive shall review the reference price (if any) set for a relevant group of interchangeable medicinal products at least once a year but not more than once every 3 months and may, following any such review, set a new reference price for the relevant group of interchangeable medicinal products.

(3) The Executive shall, when setting a reference price for, or reviewing a reference price set for, a relevant group of interchangeable medicinal products take into account—

( a) the ability of suppliers of the relevant listed items to meet patient demand for the relevant listed items,

( b) the value for money afforded by the relevant listed items,

( c) the equivalent relevant prices (if practicably available) of the relevant listed items in all other Member States where one or more than one of the relevant listed items is marketed,

( d) the relevant prices of therapeutically similar listed items,

( e) the resources available to the Executive, and

( f) the terms of any agreement in place (whether entered into before, on or after the commencement of this section) between the Executive and any representative body of the suppliers of drugs, medicines or medical or surgical appliances where the agreement relates, whether directly or indirectly, to the price of one or more of those items.

(4) The Executive may use a competitive process to set the reference price for a relevant group of interchangeable medicinal products.

(5) Where a reference price has been set for a relevant group of interchangeable medicinal products, nothing in this section shall be construed to require the supplier of a relevant listed item to supply the relevant listed item at the reference price.

(6) When the Executive sets a reference price for a relevant group of interchangeable medicinal products, it shall, not later than 4 weeks before the reference price takes effect, give notice in writing of the reference price to community pharmacy contractors.

(7) Section 59(2) of the Act of 1970 applies to the following expenditure:

( a) expenditure on a relevant listed item if, and only if, the relevant listed item is priced at or below the reference price;

( b) expenditure on a relevant listed item which is priced above the reference price if, and only if, the medicinal product is the subject of a clinical exemption; and

( c) expenditure on a relevant listed item which is priced above the reference price but only up to the reference price.