Dáil Éireann Debate, Tuesday - 7 November 2023
1293. Deputy Pádraig O'Sullivan asked the Minister for Health if he will provide an update on the work being carried out by his Department on the proposed pharmaceutical legislation revision being delivered under the European Pharmaceutical Strategy; and if he will make a statement on the matter. [48490/23]
View answerBackground
In November 2020, the EU Commission put forward a Pharmaceutical Strategy for Europe. This Strategy 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 this comprehensive Strategy, the EU Commission proposed an ambitious revision of the EU pharmaceutical legislation, with a view to achieving 5 main objectives:
1. Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines,
2. Enhance security of supply and ensure medicines are always available to patients, regardless of where they live in the EU,
3. Offer an attractive, innovation- and competitiveness friendly environment for research, development, and production of medicines in Europe,
4. Make medicines more environmentally sustainable,
5. Address antimicrobial resistance (AMR) through a One Health approach, encompassing human health, animal health and the environment.
Revision of the general pharmaceutical legislation
On April 26th , 2023, the EU Commission published its proposals to revise the general pharmaceutical legislation. This took the form of one EU Directive and one EU Regulation. This is the first full revision of the pharmaceutical legislation in over 20 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 legislative 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 ( the ‘3 A’s and 3C’s’.)
National Approach
The Department of Health (DoH) is the lead Government Department that has been tasked with negotiating this proposed legislation at EU level on behalf of Ireland. In developing the national position, the DoH has been and is engaging nationally and at EU level and will continue to as the proposal is negotiated by EU-27 and progresses through the ordinary legislative procedure (OLP.)
To inform the national position, in April 2023, the Minister for Health established a cross-Government and cross-agency working group; the ‘Pharmaceutical Strategy Working Group (PSWG)’ to support and inform the development of Ireland’s response to the legislative proposals from a national perspective and facilitate this position to be informed by a whole of government view.
The PSWG continues to meet on a regular basis to consider the Commission’s proposal in full and in detail in preparation for the negotiation of this package at EU level and to inform the negotiation mandate of IE, which of course will be kept under review as the file is reviewed and goes through the OLP.
Stakeholder Engagement
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 IE preliminary position on the Commission’s proposal. Stakeholders that presented to the PSWG.
The DoH continues to listen to and consider the views and positions of all stakeholders in developing and informing the national position on the proposed legislation.
The DoH encourages stakeholders to submit their opinions, views and positions on the legislative proposals to the DoH for consideration by it and the PSWG - such positions and submissions can be made to the DoH via the dedicated mailbox; EUpharmastrategy@health.gov.ie .
