James Browne
Question:1188. Deputy James Browne asked the Minister for Health the procedure for approval of new drugs for reimbursement by the HSE; and if he will make a statement on the matter. [38277/17]
View answerMonday, 11 September 2017
Questions (1188)
Written answers
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria to be applied in decisions on the reimbursement of medicines. The Act does not confer any powers on the Minister for Health in this regard and the HSE does not require the approval or consent of the Minister or Government when making a decision.
A new Framework Agreement on the Supply and Pricing of Medicines 2016-2020 was signed on 20 July 2016. This Framework Agreement incorporates the statutory requirements of the 2013 Act for reimbursement decisions on new medicines. In addition as set out in section 6.1 of the agreement the addition of new medicines to the Reimbursement List will be made in accordance with the relevant provisions of the Health (Pricing and Supply of Medical Goods) Act 2013 and by reference to Schedule 1, the Principle and Processes for the Assessment of New Medicines in Ireland. A copy of this agreement is available at http://www.ipha.ie/alist/ipha-hse-agreement.aspx.