Mr. John Hennessy:

I will start and I will rely on my colleagues to chip in on particular issues. I will start with the questions asked by Senator Colm Burke. I will ask Professor Barry to comment further on the question on the German system.

If I understood the question on a specific drug, the particular product to which the Senator referred has been in process for some time but notifications are due to issue to the company in the coming weeks as it is coming to the end of its assessment process. More information will be available on it in the next week or so.

The third question related to orphan drugs and the process involved. Deputy O'Connell mentioned that as well in terms of what the committee can do. The issue for us is that the legislation that is in place, which guides our approach at the moment is the 2013 Act, and it does not make separate provision for orphan conditions but obviously there are features that apply to orphan situations that need to be taken into account. It is perhaps an area the committee might wish to consider from a policy and even a legislative point of view.

The point about compassionate access is a good one. The Helsinki protocol is in place for patients on clinical trials and compassionate access. In fairness, when the trials conclude, most pharmaceutical companies manage the patients that are on those programmes very well. When companies say they are closing down a trial or compassionate access, most companies mean they are not taking on new patients but they manage the existing patients in a responsible manner. Obviously some companies take a different approach and wish to conclude their compassionate access programmes. That is something of which we do not approve in terms of the manner in which that is done. Conversations are ongoing with a number of companies in that regard as well. The Helsinki protocol does set out very clearly the arrangements to be put in place at the outset for the management of patients at the end of trials.