Simon Coveney (Cork South Central, Fine Gael)
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On 26 April 2023 the European Commission published a proposal to revise and replace the existing general pharmaceutical legislation. The EU Pharmaceutical legislative package proposes a suite of measures with the purpose of assuring the quality and safety of medicines and ensuring their availability to health services across the EU. As such, the Department of Health is leading on this file in Ireland.

Ireland advocates for ensuring predictability, consistency, equity, sustainability, and transparency in the medicines legislative ecosystem across the EU. For my part, as Minister for Enterprise, Trade and Employment, I recognise the good jobs and strong economic growth this sector brings to Europe and so would wish that the EU is at the centre of developing such medicines to ensure that equitable and sustainable access to new and innovative medicines is achieved. In this regard, my colleague Minister Calleary confirmed the importance of regulatory predictability and the need to support the life sciences ecosystem at the EU Competitiveness Council on 25 September 2023.

To inform the national deliberation of this proposal, the Minister for Health formally established the Pharmaceutical Strategy Working Group (PSWG) in April 2023. This group, on which there is representation from my Department and our agencies, works with stakeholders to ensure the development of a national position that is fully informed and based on all available data. Accordingly, Government will continue to engage with stakeholders in shaping a national, cross-Government position on this important package.

More generally, I fully recognise the importance of the pharmaceutical sector in Ireland, and my Department will continually engage with key stakeholders throughout the course of the negotiations and will assess the impact of any further proposals made. In keeping with our ongoing focus on maintaining Ireland’s reputation as an exceptional place to do business, we will continue to advocate for measures that ensure predictability, consistency, equity, sustainability, and transparency in the medicines legislative ecosystem across the EU. To this end, and since the publication of the European Commission’s proposal, officials from my Department have been engaging with stakeholders, EU colleagues and colleagues in the Department of Health to examine the proposal and analyse the impact of the proposed measure for the Irish pharmaceutical sector.