I propose to take Questions Nos. 397 to 401, inclusive, and 403 together.
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 2013 Act requires the HSE to have regard to both the clinical benefits and cost effectiveness but it does not include provision for a different rule set when assessing orphan drugs. However, both the National Centre of Pharmacoeconomics (NCPE) and HSE are mindful of the differences and challenges in terms of patient numbers when assessing this type of medicine.
This rigorous assessment process ensures that treatments that are clinical and cost effective are reimbursed. In circumstances where a company has failed to demonstrate the clinical benefit to support the price that they are seeking for the drug, the HSE reaches a decision not to reimburse the medicine.
In February I received the Report on Evaluating Orphan Drugs from the Joint Committee on Health. Currently my Department is examining the Committee's Report and its recommendations. The report raises some significant policy issues which require careful consideration by my Department, the HSE and the National Centre for Pharmacoeconomics. This process is underway and once completed I will be in a position to report back to the Joint Committee.