Health (Pricing and Supply of Medical Goods) Act 2013

19.

Action to be taken by Executive where it makes decision under section 18.

19.— (1) The Executive shall, as soon as is practicable after making a relevant decision (but, in any case, not later than 14 days after making the relevant decision), give notice in writing of the relevant decision, together with its reasons for the relevant decision, to the supplier of the item or listed item the subject of the relevant decision.

(2) Where the Executive has made a relevant decision based on any expert opinions or recommendations, it shall attach copies of all such opinions and recommendations to the notice concerned under subsection (1) to be given to the supplier of the item or listed item the subject of the relevant decision.

(3) The Executive may—

( a) in the case of a relevant decision which falls within paragraph (a) or (e) of the definition of “relevant decision” in subsection (8), specify a date, or the occurrence of an event, from which the relevant decision shall take effect, and

( b) in the case of a relevant decision which falls within paragraph (d) of that definition, specify a date, being a date after the expiration of the period of 28 days immediately following the Executive’s compliance with subsection (1) in respect of the relevant decision, from which the relevant decision shall take effect.

(4) The Executive shall not make a relevant decision except in accordance with the criteria specified in Schedule 3 that apply to the item or listed item the subject of the relevant decision.

(5) The Executive shall, in making a relevant decision, have regard to any Health Technology Assessment guidelines published by the Health Information and Quality Authority that appear to the Executive to be relevant to the relevant decision.

(6) Where the Executive determines a deemed application under section 18(2)

( a) the deemed listed item the subject of the deemed application shall cease to be a deemed listed item, and

( b) a deemed condition attached to the listing of the deemed listed item shall cease to be a deemed condition,

immediately upon the supplier of the item being given notice under subsection (1) of the relevant decision concerned or, if subsection (3) applies in the case of that relevant decision, immediately upon the relevant decision taking effect.

(7) Part 2 of Schedule 1 shall have effect where the Executive proposes to make a relevant decision.

(8) In this section and Part 2 of Schedule 1 “relevant decision” means a decision of the Executive—

( a) under section 18(2)(a) to add an item to the Reimbursement List, whether or not subject to conditions,

( b) under section 18(2)(a) , as read with section 18(4) or (5), to retain a listed item on the Reimbursement List, whether or not subject to conditions,

( c) under section 18(2)(b) to refuse to add an item to the Reimbursement List,

( d) under section 18(2)(b) , as read with section 18(4) or (5), to remove a listed item from the Reimbursement List, or

( e) under section 18(6) , (7) or (8) to remove a listed item from the Reimbursement List.