The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.
The Act specifies the criteria to be applied in the making of reimbursement decisions, which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.
In reaching its decision, the HSE will examine all the relevant evidence and will take into account such expert opinions and recommendations that are appropriate, including from the National Centre for Pharmacoeconomics (NCPE). This ensures that reimbursement decisions are made on objective scientific and economic grounds.
In 2016, a new Framework Agreement was made with the Irish Pharmaceutical Healthcare Association on the supply and pricing of medicines. The terms of the Agreement are aligned with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.
As the Deputy will be aware, the pipeline for new medicines is growing significantly and this poses affordability challenges for the health service in Ireland as it does in many other countries.
I want to maximise the potential for patients in Ireland to have timely access to these new innovative drugs, and it was in that context that I sought a new dialogue with industry on how we can secure access to new innovative drugs at affordable and sustainable prices.
My Department will be progressing this agenda in the coming months.