Mr. Shaun Flanagan:

I may have confused the issue. I said that ultimately the decision-making process is formulated on the basis of the legislative process. On the issue of rare diseases process - which may be where the confusion relates to - there is a plan to change the rare disease process. Ultimately, however, the decision making around all drugs, including orphan drugs, is set by the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE cannot make different decisions for orphan drugs. It must be considered under the same criteria. That is by way of clarification.