John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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234. To ask the Minister for Health when he intends to outline Ireland's national position in respect of the revision of the EU pharmaceutical strategy; if his Department intends to meet with representatives of the pharmaceutical industry; and if he will make a statement on the matter. [52267/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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

The Strategy identifies challenges and lays down high-level policy objectives to mitigate these, setting these out in a multi-year vision under a number of different work streams.  It is also cognisant of the challenges that were highlighted and intensified at the early stages of the pandemic and seeks to learn from these experiences, including access to medicines. 

I understand that 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. There is a delay in the timeline of the proposals related to the revision of the General Pharmaceutical legislation with these now expected in early 2023. 

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.

The current action being taken by the EU Commission to review the general pharmaceutical legislation, and the orphan and paediatric legislation is a welcome opportunity to introduce potential streamlining and rationalisation of the regulatory processes. New and innovative medicines will continue to be a key element of improving health outcomes, but it is equally important to ensure continued access to older, off-patent medicines, especially in smaller Member States. There is an opportunity, as part of the Strategy, to streamline and simplify our medicines legislation to minimise regulatory hurdles to placing products on smaller MS markets. The opportunity to potentially enhance market and patient access, through exploration of technological adaptive solutions, such as electronic product and patient information, and multi-country packs is welcome.

The Department of Health has established a Cross Departmental/Agency Group with key stakeholders, with differing perspectives so as to be best equipped and informed to react holistically from a national perspective as the implementation of the strategy progresses. The Group has already held three meetings with a fourth one planned in early December.  To ensure all views are heard the Department of Health will engage further with key Stakeholders at a later stage as the implementation of the Strategy progresses.