Mr. Finian Judge:

The first thing I would say is that the Act has only been in place since 2013. The Minister has stood over the robustness of that Act on numerous occasions. Since the committee's report calling for a review of the entire Act was published, and because the Act contains so many different provisions, we have concentrated on addressing the recommendations regarding the reimbursement process because it was that element of the Act the committee focused on in its report. Obviously, if, down the line, the Minister decides that there should be a review of the 2013 Act, it is in his gift to decide to bring forward proposals on that Act. I am letting the committee know that, since the publication of its report, we have, with the NCPE, been concentrating on what were essentially process issues which the committee pointed out in its report. As my colleagues have said today, the HSE has done a lot in terms of the process to address any barriers that the committee pointed out in its report, or any areas where orphan drugs may have a problem in the process. I think the big development is Professor Barry's new committee which, more or less, adds another layer to the process because of the special situation around orphan drugs.