Dáil Éireann Debate, Wednesday - 12 November 2025
967. Deputy Duncan Smith asked the Minister for Health if she will clarify Ireland's current position on the key issues of Bolar and Regulatory Data Protection/Market Protection with regard to the European General Pharmaceutical Legislation; and if she will make a statement on the matter. [61235/25]
View answerIn April 2023, the European Commission proposed an ambitious Revision of the EU General Pharmaceutical Legislation.
On the 4th June 2025, after two years of negotiations on the file, the Council of the European Union agreed their Mandate to enter into negotiations with the Parliament and the Commission.
The Council's mandate was agreed for both the proposal for a Directive on the Union code relating to medicinal products and a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency. This mandate was supported by 26 Member States, including Ireland.
Trilogue negotiations between the Institutions are now underway with a view to reaching political agreement on all elements of this important and complex legislative package later this year. Ireland is working intensively with the other Member States to ensure that the final text will provide Europe with a modernised regulatory system for medicines which is in the interests of patients and maintains a strong, innovative pharmaceutical sector in Europe.
The Deputy will appreciate that as negotiations are ongoing, it would be inappropriate at this time to comment on Ireland's position on any specific issue.
