Mr. Muiris O'Connor:

Deputy Cullinane set out very well the dynamics at play at European level. There is a lot under way in terms of the EU pharmacy regulations being formulated and the pharmacy directives. There is a proposal from the Commission, as Deputy Cullinane said, to reduce the period of data exclusivity. It would go from eight years to six years, as the Deputy said, but the companies could buy them back with commitments that correspond with European policy objectives. We are speaking about an expectation that a product would be made available in all member states. A commitment to this market access would grant an extra two years' exclusivity. A commitment to clinical trials beyond launch, of which there are not half enough in terms of testing the efficacy of drugs in the real world, would buy six months' exclusivity in the proposals. There would also be some incentivisation of drugs that might not be greatly profitable but are vital, such as antibiotics that are capable of managing antimicrobial resistance and some paediatric drugs that might not have a large market.

As members know very well, we have a lot of interest in pharmaceuticals. We have a large and very vibrant pharmaceutical industry. The Department of Health shares the policy objectives of the Commission in ensuring affordability, access and relevant medicines. To navigate and develop the Irish position in a way that corresponds with all of these interests, we are part of an interdepartmental group that also involves the Departments of the Taoiseach and Enterprise, Trade and Employment. We bring our perspectives from each of these sectors and we formulate and develop the Irish position.

One of the things we really want, and what industry always says to us, is that whatever way it lands, we want it to land in an environment that is clear and has certainty for the industry to produce medicines and develop new medicines. Certainty is important. We do not want this bumbling on indefinitely. There are differences of opinion between the Parliament, the Commission and the Council. We have a nuanced position whereby we want it settled in a pragmatic way and we can get on with progressing the objectives of access while also protecting the competitiveness of the pharmaceutical industry in Ireland and in Europe more generally.