Shane Moynihan (Dublin Mid West, Fianna Fail)

It is great to hear about the progress that has been made in implementing the recommendations of the Mazars report on this subject that was published some years ago. That goes to the heart of the extra resourcing that the Minister spoke about. She is right; there needs to be a partnership between industry and the State to make sure that these applications are put through immediately and that the HSE can adjudicate on them accordingly. I am very encouraged to hear that the Department is considering other systems internationally, like the Belgian model. This model is particularly interesting because it shows a way in which timely access to these drugs that is not necessarily contingent on EMA approval can be provided. That is based on EU Regulation No. 726/2004. Article 83 of the regulation provides access to medications that are in late stage clinical development, expected to receive EU marketing authorisation and targeting patients with serious conditions. If we had those sorts of parameters for a scheme focused on early access to rare disease drugs, it would be a game-changer for many families that are afflicted with these conditions.

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