Health (Pricing and Supply of Medical Goods) Act 2013

Chapter 3

Setting of relevant prices for items and listed items

21.

Relevant prices of items and listed items.

21.— (1) Subject to subsections (2) and (3), the relevant price, immediately before the commencement of section 17 , of a deemed listed item shall, on and from that commencement, continue to be the relevant price of the deemed listed item.

(2) The Executive shall, when considering the proposed relevant price by the supplier of an item, take into account—

( a) the equivalent relevant prices (if practicably available) of the item in all other Member States where the item is marketed,

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

( c) the potential therapeutic benefits of the item for patients likely to use the item if it were to become a listed item,

( d) the potential budget impact of the item if it were to become a listed item,

( e) the ability of suppliers of the item to meet patient demand for the item if it were to become a listed item,

( f) the resources available to the Executive, and

( g) 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 medicinal or surgical appliances where the agreement relates, whether directly or indirectly, to the price of the item.

(3) Subject to section 22 , the Executive may review and alter the relevant price of a listed item (including a deemed listed item) to take into account any change in any of the matters referred to in subsection (2) subsequent to the last time that the relevant price was set for those purposes.

(4) The Executive may use a competitive process to determine the relevant price of an item or a listed item.