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Publication of European Commission’s Proposal to Reform Pharmaceutical Legislation

The Minister for Health Stephen Donnelly and the Minister for Enterprise, Trade and Employment Simon Coveney have formally welcomed the publication of the European Commission’s proposal to reform the general pharmaceutical legislation on medicines for human use.

This proposal is fundamentally about ensuring safe, affordable medicines for all and seeks to achieve a balance between a patient-centred approach along with measures to support the competitiveness and innovative potential of the European pharmaceutical industry.

The commitment to revise the legislation is one of the key actions emanating from the Pharmaceutical Strategy for Europe and is described as a once in a lifetime opportunity. The objective of the proposed revised framework will impose safeguarding controls across the full spectrum of the supply chain, from raw material to a medicine being placed in a patient’s hand, with national and EU competences working synergistically to conserve patients’ best interests.

Ministers Donnelly and Coveney recognise the importance for the EU of ensuring that the right environment for research and innovation is in place, as part of any new legislative proposal. The importance of balancing the need for affordable and accessible medicinal products in parallel with the creation of an environment that fosters innovation and competitiveness in the EU is appreciated and supported by both Ministers.

Access to new and innovative medicines is a core element of improving health outcomes for patients. It is equally important to ensure continued access to older, off-patent medicines, especially in smaller Member States, such as Ireland. The proposal offers the opportunity to small Member States to potentially enhance market and patient access, through exploration of the use of technological adaptive solutions, such as electronic product and patient information, and multi-country packs.

Minister Donnelly said, “my department is chairing a Working Group which will operate to support Ireland’s response to the proposal from a national perspective. I welcome the publication of the EU Commission’s legislative proposal, which seeks to ensure a fit for purpose medicines regulatory framework is put in place, to ensure that patients in the EU can have trust and confidence in the safety, efficacy and quality of the medicines they take. I look forward to working with EU partners in the negotiations to realise this.”

The Minister appreciates the commitment and work conducted by the Group to date and is confident through further deliberations will assist in informing the national position.

Minister Coveney said, “I welcome the publication of the legislative package today and look forward to working with colleagues across Government on this important opportunity. Good regulation at EU level is key to enabling collaboration and incentivising the research and development of new medicines and treatments.”

“Companies in Ireland are at the forefront of developing innovative treatments and investing in costly research, development and innovation. In that regard, we will work hand-in-glove with the Department of Health to ensure that the EU and Ireland optimise our competitiveness and remain the destination of choice to locate patent-generating and patent reliant business activities, while also ensuring that patients across Europe can access innovative treatment options.”


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