Dáil Éireann Debate, Wednesday - 18 June 2025
63. Deputy James O'Connor asked the Minister for Enterprise, Tourism 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]
Amharc ar fhreagraThe 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.
