Professor Michael Barry:

Quite a number of other questions were asked. I will start with Translarna, also known as ataluren, for Duchenne muscular dystrophy, and the concept we are behind and an outlier. That is not what the evidence shows. The FDA, which authorises medications in the United States, concluded only two weeks ago that additional clinical trial data will be necessary at a minimum to indicate that the drug is effective in treating Duchenne muscular dystrophy. This is not us saying it, it is the FDA.

In the European Union, the European Medicines Agency, EMA, has granted conditional authorisation. The condition is that the company needs to carry out a further 18 month trial to demonstrate the efficacy of the drug. Those two stances illustrate the issue. As Mr. Hennessy said, it is not always about price as very often when we say no, it is because of the clinical data. The FDA was very clear that the clinical data in this case are not good enough and I agree with that assessment.

I do not know where Deputy O'Reilly's information in regard to the 22 European countries comes from but my information is that, as of last week, Translarna is not being reimbursed in Austria, Belgium, Finland, Norway, Portugal, Poland or Slovakia, there have been no applications for it in Croatia or Scotland, and it is currently being assessed in the Netherlands. Taking all that into consideration, I do not see us as being an outlier at all, and the evidence we have does not support that statement.

As regards the assessment of orphan drugs-----