Oireachtas Joint and Select Committees

Wednesday, 22 June 2022

Joint Oireachtas Committee on Health

Rare Diseases: Discussion (Resumed)

Mr. Shaun Flanagan:

Ireland joined the BeNeLuxA initiative several years ago. Last year was the first time there was a successful medicine taken from the start of the assessment process through to reimbursement. The medicine in question is Zolgensma, for spinal muscular atrophy. In that assessment, Ireland took the lead on the health technology assessment side. The National Centre for Pharmacoeconomics, led by Michael Barry, did the assessment for the three countries. Arising from that assessment, the three countries agreed to go into a joint negotiation process. That process went reasonably well. Within it, there were several matters that had to be ironed out. When one gets into these things, it is amazing how different systems can be. For example, the Irish negotiators had to deal with the fact that the HSE would have to pay 23% VAT on Zolgensma. It can be matters as simple as that. One of the other countries does not pay VAT on medicines. Within the negotiations, that had an impact on how the deal had to be configured so that it worked for everybody. One of the great learnings from the process was that when one is in those joint negotiations, one has the assurance that at least two other countries are getting the same deal as the country one is representing. One's country is doing no worse and no better than those three countries. As the Deputy stated, there is the additional population benefit of negotiating for well in excess of 20 million people - probably 30 million people - across the three countries, rather than just 5 million people, or the small number of people within the population of 5 million who will benefit.

From the perspective of the HSE, we are committed to the BeNeLuxA process. This week, several of the team are engaged in meetings with BeNeLuxA colleagues to try to make progress on that. As part of the BeNeLuxA process, we are very close to the first major output from it in the area of horizon scanning. A new horizon scanning process will be in place that will enable all the countries involved to benefit from shared information in respect of what is coming down the road in terms of the medicines and health technology assessments for which we have to plan and the expertise we have to get in place to be able to do those health technology assessments. Obviously, there is the benefit now that where there is agreement, we can rely on the expertise within three countries.

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