Jerry Buttimer (Cork South Central, Fine Gael) | Oireachtas source

Should the IMB have a role in respect of price setting?

There are various attitudes to that internationally. Typically, pricing is not within the remit of the medicines regulator. The regulator is asked to focus on the safety of patients and the quality of the medicines. I understand two equivalent agencies in Europe have a role in this area: the agency in Denmark and the agency in Italy, which has a small role. Most agencies are like ours in that this role is done by somebody else. The regulator is set up to access the safety, quality and efficacy of medicines and deal with the manufacturing sites, distribution and so on.

On the question of the independence of the regulator as an independent agency versus the Department, although I note Deputy Ciara Conway who raised this issue has left the room, that is a philosophical policy debate. It has happened across all the developed world that medicines regulation has been moved to independent stand-alone agencies, the argument being that they can develop, have resources and run their business and that lets Departments deal with policy issues and the regulator deal with regulatory issues. There is nothing we are doing that could not be done within the Department if the necessary staff were in place and there was a legal basis to provide for that but the model I outlined is the one that exists across the developed world.

Deputy Healy asked specifically about our role in clinical trials. On the question of the use of blood from patients with haemochromatosis, I do not know the answer to that. I do not have that information to hand but I will be happy to provide it by e-mail. I will ask Ms Ann O'Connor to deal with the topic of clinical trials and our role in how that is operated.