Ms Ann O'Connor:

I thank Deputy Healy for his question. The clinical trials carried out are controlled under a clinical trials directive which is transposed into Irish law by statutory instruments. If someone wants to do a clinical trial in Ireland, be it an academic body or a big manufacturing company, they can apply to the IMB. There is a period of 60 days allowed once we receive the application to assess it and come forward with either a positive or a negative outcome, and in the intervening period there would be some level of correspondence with the applicant to clarify questions. The trials can be divided into four phases, with phase one trials being the very early stage and the phase four trials being products on the market that are being further investigated. It is all controlled under a legal framework. Generally what we get on the applications are the protocols and the investigators' brochures. There is a system around it. The legislation on this area in Europe is being reviewed to change it to a regulation, which will mean there will be a uniform application of the legislation in Europe. In the clinical trials, we receive predominantly a large number of applications for cancer drugs, respiratory medicines and some cardiology products. We see these on an ongoing basis. We take them every month and deal with them in a 60-day timeframe.