Colm Burke (Cork North-Central, Fine Gael)
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120. To ask the Minister for Foreign Affairs and Trade for an update on the European Union’s plans to improve the competitiveness of the region for the bio-pharmaceutical sector, in view of recent policy developments in the United States; and if he will make a statement on the matter. [57792/25]

Colm Burke (Cork North-Central, Fine Gael)
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121. To ask the Minister for Foreign Affairs and Trade the co-ordination taking place within the European Union to improve the competitiveness of the European Union, in order to ensure Ireland can remain a world leader in life sciences; and if he will make a statement on the matter. [57793/25]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 120 and 121 together.

Ireland is committed to engaging intensively with EU Member States and the European Commission in delivering on our shared ambition to increase Ireland's and the EU's competitiveness.

The importance of delivering on the competitiveness ambitions of the EU and the streamlining and simplification of EU regulation was a key focus of the latest meeting of the European Council in October 2025. During these discussions, the Taoiseach called for the early publication of the Single Market Roadmap to 2028 and increased ambition to complete the Single Market as a key driver of competitiveness.

Concerning life sciences and bio-pharmaceuticals specifically, there are a number of proposals underway at EU level which will shore up European competitiveness in these sectors, which are of particular interest for Ireland.

The Critical Medicines Act, which was launched in March 2025, will strengthen the resilience of our supply chains.

The Pharma Package proposes revisions to the EU’s pharmaceutical regulation and aims to increase the competitiveness of the biopharmaceutical industry. It is also currently under discussion among Member States with a view to agreement with the European Parliament by the end of this year.

A European Biotechnology Act is also expected to be published by the European Commission in 2026. This will set out a series of measures to accelerate the transition of innovative biotechnologies from laboratory to factory and to the market.

In July 2025, the European Commission launched a new European Life Sciences Strategy, aiming to make Europe the world leader for life sciences by 2030. This plans to optimise the ecosystem for research and innovation, enable rapid market access for life science and bio-pharmaceutical innovations and boost uptake and use of innovation.

In terms of EU-US trade, the European Commission continues to engage with the US. Ireland and the EU’s position remains that we will continue to respond in a substantive, calm and measured way, with the focus now on the implementation of the EU-US Joint Statement.

Given the new international trading reality, the European Commission is also seeking to advance its wider trade diversification agenda with new reliable global partners, which will assist EU companies in expanding into new markets. Concluding and completing new trade agreements has the potential to present opportunities for Ireland’s bio-pharmaceutical and life sciences sectors, but we will continue to work with EU partners to ensure that sectors important to Ireland, such as agriculture, are also protected.

Throughout my co-ordination with the EU on these topics, I have conveyed our sensitivities and interests regarding the life sciences and bio-pharmaceuticals sector. I believe our EU partners understand strategic importance of Ireland’s strength in these areas for the competitiveness of the Union as a whole.

Our stance has been that Ireland and the EU must continue to control what is controllable in order to ensure that sectors such as bio-pharmaceuticals and life sciences remain as competitive as possible.