Mr. John Hennessy:

I do not agree with Senator Colm Burke and his conclusion because very considerable progress has been made on generic substitution. It is constrained as Mr. Shaun Flanagan mentioned. Products have to be declared interchangeable in order for generic substitution to apply. Anybody who regularly purchases some commonly prescribed drugs and medicines will have seen the vast change that has occurred in the cost over the past three years.

On the point about the international dimension, which was mentioned by Senators Colm Burke and Mullen, the Minister, Deputy Harris, and the Department of Health have been making considerable progress on this with colleagues within the European Union. The size of the Irish population and the jurisdiction are factors and perhaps opportunities of scale can be achieved by collaborating with other smaller States. It is at preliminary stages.

Progress is being made and this clearly represents an opportunity for smaller states with smaller populations. This is probably still in its early stages, however. Part of that agenda would presumably facilitate the adaption of certain European standards. There might also be possible economies of scale with regard to assessments, as these could be carried out on a collaborative rather than an individual basis with each member state.

I will ask Professor Barry to come in at this point to talk about some of issues around rare diseases and the rare disease plan, with particular regard to the time involved in assessing and processing applications for new drugs.