Stephen Donnelly (Wicklow, Fianna Fail)
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In November 2020, the Commission put forward a Pharmaceutical Strategy for Europe which aims to create a future-proof and patient-centred pharmaceutical environment in which the EU industry can innovate, flourish, and continue to be a global leader. As a key part of the EU’s comprehensive response to these challenges, the Commission proposed an ambitious revision of the EU pharmaceutical legislation.

On the 26 April 2023 the EU Commission published its proposal to revise the general pharmaceutical legislation - this is in the form of a Directive and a Regulation. This is the first full revision of the pharmaceutical legislation in over twenty years and is significant to all stakeholders involved in the medicines’ ecosystem.

The general pharmaceutical legislation encompasses the regulation of the authorisation, manufacturing distribution, marketing, and monitoring of medicines. It provides for cooperation, roles, and division of responsibilities between the Commission and EU Member States.

The aim of the pharmaceutical revision is described as ensuring access to affordable, available medicines, while maintaining the competitiveness of the EU pharma industry sector, combating antimicrobial resistance, and providing for compliance measures which reinforce environmental protections.

National Approach;

Department of Health Role

The Department of Health is the lead Government department in Ireland tasked with responding and engaging nationally and at EU level, as the proposal is negotiated by all EU-27 and progresses through the ordinary legislative process.

The Minister for Health established the Cross Government and Cross Agency Pharmaceutical Strategy Working Group (PSWG) to support the development of Ireland’s response to the proposal from a national perspective and facilitate this position to be informed by a whole of government view.

The PSWG continues to meet to discuss this package regularly and is actively involved in considering the detail of the proposed package of legislative measures, ensuring a well informed and balanced Irish position on the package.

Engagement activities

An initial structured stakeholder engagement exercise took place on 8th May 2023 at which key representative stakeholders were invited to share their perspectives to inform the Irish preliminary position on the Commission’s proposal.

The Belgian Presidency have commenced the detailed discussion of the proposed package at Council, and will focus on the policy topic of shortages / security of supply and incentives. In anticipation of this the Department conducted a consultation exercise with external stakeholders at the end of Dec 2023 to help to inform the national position on the policy topic of shortages / security of supply and to feed into the Irish negotiation mandate.

Next Steps

The Department of Health will conduct a consultation with Stakeholders on the policy topic incentives in the coming weeks and again this will help inform the national position and assist in the deliberations at an EU level. Information about this will be available on the Department's website shortly.

Ireland will continue to listen to the views of stakeholders in progressing the Pharmaceutical Strategy for Europe. The Department is also encouraging stakeholders to submit their opinions on the legislative proposal and feedback can be submitted to the Department at EUpharmastrategy@health.gov.ie.