Oireachtas Joint and Select Committees
Wednesday, 8 November 2017
Joint Oireachtas Committee on Health
Evaluating Orphan Drugs: Discussion (Resumed)
9:00 am
Professor Michael Barry:
In Germany there is no question they have the best access and faster access than any other country in Europe because they offer the free pricing. Orphan drugs are reimbursed automatically. It is the point that we were making. They have better access but it costs and that is the issue that we have. In relation to those drugs that are free priced the vast majority of them continue to be reimbursed under the German system. The other issue which a number of speakers raised was the European Medicines Agency, EMA, and when they approve a drug. It is a very important question. The EMA looks at the safety and the effectiveness of a medication. It does not look at the aspects that we look at or that similar agencies around Europe look at, in other words relating the effectiveness to the cost and the value for money proposition. That is not for the EMA. It does not do that. That is why sometimes one can see a divergence between what the EMA is saying and what agencies like ours say. There is a fundamental difference there.
On BioMarin, it took us eight months to assess that. I know it took a number of years but we spent eight months on it. On average we spend six months on a drug for a full assessment.
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