Oireachtas Joint and Select Committees

Wednesday, 21 November 2018

Joint Oireachtas Committee on Health

Evaluating Orphan Drugs: Discussion (Resumed)

9:00 am

Mr. Shaun Flanagan:

For the record, in that period of 11 months there were six or seven meetings with the pharmaceutical company about commercial negotiations. The commercial negotiations have finished and, to the best of our knowledge, the company has made it clear it has made its best offer and it will not move any further. The drugs group has considered the drug. In committee meetings like this, it is difficult to explain the complexity. There is not one decision to be made but rather three separate decisions: SMA type 1, SMA type 2 and SMA type 3. There is considerable variation in the level of evidence for each of those. As has been communicated, the drugs group strongly want access for type 1 on the basis of the evidence, which is robust. It made an offer to Biogen but the offer was not acceptable. Biogen made a counter offer to the State but that offer for type 1 has not been acceptable to date. On type 2 and type 3, it is a far more challenging issue because the evidence is far less robust.

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