Dáil Éireann Debate, Tuesday - 31 January 2023
712. Deputy John Paul Phelan asked the Minister for Health if he will report on the work of his Department's cross-departmental agency group that was set up to monitor the European Commission's upcoming revision of pharmaceutical legislation; and if he will make a statement on the matter. [4542/23]
View answerThe Pharmaceutical Strategy for Europe, published on 25 November 2020 is the second major building block of the new EU Health Union, and is fundamentally about ensuring safe, affordable medicines for all citizens and patients.
The strategy has four key aims that are focussed on:
- ensuring access to affordable therapies for patients, and addressing unmet medical needs (in the areas of antimicrobial resistance and rare diseases, for example)
- supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines
- enhancing crisis preparedness and response mechanisms, establishing diversified and secure supply chains and addressing medicines shortages
- ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards
Significant progress has been made to date on the delivery of actions laid out in the Implementation Plan, with some of the mechanisms of delivery addressing more than one of the desired actions. (55 outlined actions both legislative and non-legislative which will operationally realise the objectives of the strategy). This includes ongoing work on the revision of the General Pharmaceutical Legislation, Orphan and Paediatric legislation, work to define/set criteria for unmet need, creation of the Health Emergency Response Authority, Structured Dialogue Initiative, and Clinical Trials Regulation.
I understand that the European Commission intends to publish its proposal to update the general pharmaceutical legislation in March. Ireland welcomes and eagerly anticipates the actions that will emanate from and underpin the delivery on the aims of the Pharmaceutical Strategy for Europe, which is premised essentially on ensuring access to safe, affordable effective medicines for all European patients. Once the legislative proposal and Impact Assessment are available my Department will be participating as appropriate in the deliberative process.
The Department of Health has established a Cross Departmental/Agency Group with key stakeholders, holding differing perspectives, which are shared so as to best inform national engagement as the implementation actions of the strategy progress. The Group has met on four occasions to date. Views are shared at these meetings, and the learnings gleaned utilised as appropriate by my officials as we respond in accordance with the obligations derived from our membership of the EU. I have also engaged directly with representative organisations in this context, and will engage further with key Stakeholders at a later stage as the implementation of the Strategy progresses.
