Ivana Bacik (Dublin Bay South, Labour)
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619. To ask the Minister for Health further to Parliamentary Question No. 953 of 30 September 2025, the reason Ireland has not advocated deletion of Article 1 paragraph 10(a). [53296/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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In 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.

The wording in Article 1(10)(a) of the Commission’s proposal maintains the text in the current Directive. The Council’s agreed mandate in June did not propose any change to the wording contained in the Commission’s proposal.

The European Parliament adopted its position in April 2023, proposing hundreds of amendments to the texts, including the deletion of Article 1(10)(a) of the Directive.

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.