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Dáil
‹ An tOrd Gnó - Order of Business

Rare diseases and orphan drugs

Summary

Pádraig O'Sullivan raised delays in reimbursement for orphan drugs and cited a new Bill on pricing and supply of medical goods. The Taoiseach welcomed the initiative and said he would seek an update from the Minister for Health.

I would like to raise the issue of rare diseases and orphan drugs. This is an issue which the Taoiseach would have a lot of experience of, having served as Minister for Health and given his engagement with the Orkambi case. Today, Senator Malcolm Byrne, Senator Fiona O'Loughlin and I launched our Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021, which is essentially a replication of former Deputy John Brassil’s work in the previous Dáil. The Taoiseach is well aware of the issue that, on average, people are waiting up to 1,000 days to get an orphan drug approved for reimbursement. It is generally acknowledged that the process is not working, is not fit for purpose and needs to be looked at. I ask that this legislation would be given priority in the months ahead.

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I thank the Deputy for his initiative in bringing forward this legislation. The whole area of rare diseases and orphan drugs is an important one, and there has been significant investment in research at European Union level under the Horizon programmes. There is a need here in terms of our pricing frameworks to facilitate the research and development that goes into orphan drugs in particular, which are very important for rare diseases but ordinarily would not command the necessary critical mass to facilitate the kind of investment that goes into conventional drugs. This legislation will facilitate a very important debate on this but also follow-through from Government. We will work with the Deputy and Senators Byrne and O’Loughlin on this initiative.

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