Louise O'Reilly (Dublin Fingal, Sinn Fein)
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260. To ask the Minister for Enterprise, Trade and Employment his views on the proposals from the European Commission to cut and modulate regulatory data protection intellectual property rights in the EU as part of the revision to the General Pharmaceutical Revision; his views on the potential impacts of these proposals on investment, innovation and employment in the life sciences sector in Ireland and the EU; and if he will make a statement on the matter. [29114/24]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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261. To ask the Minister for Enterprise, Trade and Employment his views on the decision of Ireland, at the EPSCO Council on 21 June, to indicate support for proposals to cut and modulate regulatory data protection intellectual property rights for pharmaceutical companies; his views on the potential impacts of this position on investment, innovation and employment in the life sciences sector in Ireland; and if he will make a statement on the matter. [29115/24]

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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263. To ask the Minister for Enterprise, Trade and Employment his views on proposals from the European Commission to cut and modulate regulatory data protection intellectual property rights in the European Union as part of the revision to the general pharmaceutical revision; his views, in particular, on the potential impacts of these proposals on investment, innovation and employment in the life sciences sector in Ireland and the EU; and if he will make a statement on the matter. [29171/24]

John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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264. To ask the Minister for Enterprise, Trade and Employment his views on the decision of Ireland, at the EPSCO Council on 21 June, to indicate support for proposals to cut and modulate regulatory data protection intellectual property rights for pharmaceutical companies; his views, in particular, on the potential impacts of this position on investment, innovation and employment in the life sciences sector in Ireland; and if he will make a statement on the matter. [29172/24]

Josepha Madigan (Dublin Rathdown, Fine Gael)
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268. To ask the Minister for Enterprise, Trade and Employment his views in relation to the proposals from the European Commission to cut and modulate regulatory data protection intellectual property rights in the European Union as part of the revision to the general pharmaceutical revision; his views, in particular, on the potential impacts of this proposal on investment, innovation and employment in the life sciences sector in Ireland and the EU; and if he will make a statement on the matter. [29263/24]

Josepha Madigan (Dublin Rathdown, Fine Gael)
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269. To ask the Minister for Enterprise, Trade and Employment his views on the decision of Ireland to support, at the EPSCO (Health) Council on 21 June, proposals from the European Commission to cut and modulate regulatory data protection intellectual property rights for pharmaceutical companies; his views, in particular, on the potential impacts of this position on investment, innovation and employment in the life sciences sector in Ireland; and if he will make a statement on the matter. [29264/24]

Peter Burke (Longford-Westmeath, Fine Gael)
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I propose to take Questions Nos. 260, 261, 263, 264, 268 and 269 together.

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.

The EU Proposal includes elements in relation to Regulatory Data Protection which is distinct from traditional intellectual property rights as it offers additional protection specifically targeted at the data required for regulatory approval and concerns the timelines regarding generic drug manufacturers accessing the clinical trial data of an original drug manufacturer during which a temporary market exclusivity for the original manufacturer exists.

From an enterprise perspective, industry concerns on this element of the overall package are clearly understood across Government and are taken into account when formulating the Irish contributions to the negotiations at EU level. Government remains very conscious of the importance of retaining a competitive pharmaceutical industry in the EU and in Ireland and the Government’s position on the EU Pharmaceutical Package remains that we are seeking to find the right balance to address three key objectives:

• Retention of a strong, innovative, pharmaceutical sector,
• Access to safe and effective medicines for patients, and
• Sustainability of national health systems.

The negotiations on the Pharmaceutical Package are complex and are likely to continue for a considerable period of time and the negotiations are continuing to evolve under the Hungarian Presidency. The outcome will be of vital importance to patients, national health systems and to our pharmaceutical industry for many years to come, and, therefore, Ireland will strive towards the best possible outcome that delivers a balanced and predictable approach and is faithful to all three of our key objectives, summarised above.

To date, there has been extensive engagement with stakeholders, including industry representatives and individual companies, as well as between relevant Government Departments and Agencies. This will continue as the negotiations proceed led by the Department of Health in close cooperation with my own Department.