EU Pharmaceutical Strategy and Revision of the General Pharmaceutical Legislation

The Pharmaceutical Strategy for Europe (‘the Strategy’), published in November 2020, is part of a package of measures put in place to build a strong European Health Union. The other measures include the establishment of the European Health Emergency Preparedness and Response Authority (HERA), the launch of the European Health Data Space, and Europe’s Beating Cancer Plan.

The Strategy is fundamentally about ensuring safe affordable and accessible medicines for all citizens and patients. It will also look to balance this patient-centred approach with support to enable the competitiveness and innovative potential of the European pharmaceutical industry. The Strategy is based on 4 pillars, which include a range of legislative and non-legislative actions – further information can be found on the European Commission website.

In April 2023, the European Commission published its proposals for a new Directive and a new Regulation to revise and replace the existing general pharmaceutical legislation.

The overall aim of these legislative proposals is to:

• make medicines more available, accessible, and affordable,
• support the competitiveness and innovative capacity of the EU’s pharmaceutical sector,
• promote higher environmental standards, and,
• combat antimicrobial resistance.

The Irish Government supports the Commission’s objectives in revising this legislation. It is important that the European Union strives to make medicines more available, accessible, and affordable, while supporting innovation, boosting the competitiveness of the Union’s pharmaceutical sector, promote higher environmental standards, and combat antimicrobial resistance.

The European Parliament adopted its position on the European Commission’s proposals in April 2024.

The Council of the European Union continues to deliberate on the Commission’s legislative proposals. Ireland continues to be actively engaged in and contribute to the deliberations of the Council of the European Union, with a view to securing a Council position in a timely manner, while giving due regard to the breadth and scope of legislative proposals.

The Department of Health is the lead Government Department in Ireland responsible for this proposed legislation.

To inform the national position, the Minister for Health established the Pharmaceutical Strategy Working Group (PSWG), which is chaired by his Department and through which the Department of Health continues to lead engagement across Government Departments and agencies, to ensure that the national position takes account of the full scope of stakeholder positions.

Following the publication of the European Commission’s legislative package in April 2023, the Department of Health hosted an initial stakeholder event to inform a preliminary national position on the European Commission’s legislative proposals.

The Department of Health has since held comprehensive multi-stakeholder engagements on targeted policy topics and continues to engage with all stakeholders in continuing to develop the Irish position.

The Department of Health has no further consultations planned at the time. Stakeholders should note however, that submissions to the Department of Health on this package of legislation can be made at any time, using the contact details below.

The Department of Health continues to welcome submissions from, and engagement with stakeholders on the European Commission’s proposed legislation.

Contact with the Department of Health on this package of legislation can be made via the following dedicated mailbox: EUpharmastrategy@health.gov.ie