James O'Connor (Cork East, Fianna Fail)
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63. To ask the Minister for Enterprise, Trade and Employment to provide an update on the efforts of the Government to highlight the potential economic impacts of ongoing revisions to the EU's general pharmaceutical legislation; whether concerns around the proposed reduction in the regulatory data protection baseline have been specifically highlighted; and if he will make a statement on the matter. [33187/25]

Peter Burke (Longford-Westmeath, Fine Gael)
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The Department of Health is the lead Department responsible for the negotiations of the EU Pharmaceutical Strategy and Revision of the General Pharmaceutical Legislation. In 2023, to ensure a whole-of-government view, the then Minister for Health established a cross-Government and cross-agency group – the Pharmaceutical Strategy Working Group (PSWG) - of which my Department is a member.

In April 2023, as part of the Pharmaceutical Strategy, the European Commission published proposals to revise the general pharmaceutical legislation known as the EU Pharma Package. The general pharmaceutical legislation encompasses the regulation of the authorisation, manufacturing distribution, marketing, and monitoring of medicines. It essentially creates the framework that imposes controls from “raw material” to a “medicine being placed in a patient’s hand”. As part of the proposal to revise the general pharmaceutical legislation the Commission carried out and published a comprehensive Impact Assessment of the proposals.

The EU Pharma Package contains a draft Directive and Regulation which has been the subject of contentious negotiations at EU level for the past 18 months. The Pharma Package reached a significant milestone in the negotiation of the file on 4th June last when the Council of the European Union agreed their Mandate for negotiations with European Parliament.

The Mandate agreed by Council is now publicly available at the following links: data.consilium.europa.eu/doc/document/ST-9286-2025-INIT/en/pdf and data.consilium.europa.eu/doc/document/ST-9285-2025-INIT/en/pdf. The Mandate contains compromise positions on some of the most sensitive and contentious parts of the Pharma Package, including Regulatory Data Protection period (RDP), and the proposal got the support of all MS apart from Malta which abstained. The Council will now start negotiations with the European Parliament.

Ireland welcomed this significant milestone as this was the first revision of the legislation in 20 years. Moreover, the outcome of these negotiations will be of vital importance to patients, national health systems and to the pharmaceutical industry for many years to come. Throughout the negotiations, Ireland has sought a balanced compromise which supports a strong, competitive Pharmaceutical Industry in Europe while, at the same time, provides access to safe and innovative medicines which are affordable for health systems and individual patients.

Ireland considers getting agreement on the EU pharmaceutical package a priority to give certainty and stability in the regulatory landscape across Europe. Given the vital importance of this package, Ireland commits to working intensively with our EU partners to conclude this package.

Paul Gogarty (Dublin Mid West, Independent)
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64. To ask the Minister for Enterprise, Trade and Employment if he will outline Ireland’s position in the ongoing Council negotiations on the Corporate Sustainability Due Diligence Directive (CSDDD) and related Omnibus proposals (COM 80 and COM 81); the specific steps the Government is taking at Council level to ensure that a risk-based approach to supply chain due diligence is retained in the final directive; and if he will make a statement on the matter. [33197/25]

Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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In the context of optimising the competitiveness of EU companies in the evolving global trading environment and ensuring proportionality, I am supportive in principle of initiatives to simplify the reporting requirements and reduce costs on companies, and most especially SMEs.

I would welcome agreement of the proposed changes in the Omnibus proposal on sustainability at the earliest opportunity in order to give business the legal certainty that it needs. However this does not mean losing sight of the objectives of the Corporate Sustainability Due Diligence Directive (CSDDD) but rather giving careful consideration to the proposals for change.

European Commission document COM (2025) 80, or the so-called ‘Stop the Clock’ Directive, which postpones the dates for certain corporate sustainability reporting and due diligence requirements has been agreed by the co-legislators and will be transposed in Ireland before the 31 December 2025 deadline.

Commission document COM (2025) 81 is the so-called ‘Content’ Directive and includes a number of proposed legislative changes to the CSDDD. The omnibus proposal retains the requirement for in-scope companies to conduct risk-based human rights and environmental due diligence of their own operations, those of their subsidiaries and their direct business partners. Companies will also be required to conduct in-depth assessments where plausible information suggests the existence or possibility of adverse impacts arising from the operations of their indirect business partners.

Consideration of the proposed changes is ongoing at EU level and my Department is continuing to assess the implications as discussions progress.