Colm Burke (Fine Gael)
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I thank the witnesses for their presentations. My apologies for being late. I had to be in the Seanad. The problem I am encountering is that the pharmaceutical companies are expressing their frustration to us with the process here. In our report on orphan drugs we referred to what occurred in Scotland. It was having the same problem and it set up a new process for dealing with it. With regard to co-ordination with other member states, have we examined, for argument's sake, aligning ourselves with another member state as regards the processes, rather than acting independently? I realise that we rely on the European Medicines Agency and what is happening at European level, but we still seem to have a totally separate process. Many of the pharmaceutical companies that are based here spend a huge amount of money on research and development, but when they come through process here they find it frustrating. I was talking to a representative of one company recently that had invested €149 million here. After making that investment, the company found that dealing with the process was very tedious and difficult compared with other member states. The report we produced set out a number of recommendations and I note the witnesses are suggesting a change in legislation. Can we do something to fast track the decision making process here and make it as efficient as possible? If companies get a negative answer that is fine, but at least they know they are getting an answer. Instead it appears to be review after review. Can we examine that issue?