Colm Burke (Cork North Central, Fine Gael)
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722. To ask the Minister for Health the Government’s position on the European Union Pharmaceutical Strategy; and if he will make a statement on the matter. [4590/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Pharmaceutical Strategy for Europe, launched by the Commission on the 25 November 2020, is a patient-centred strategy that aims to ensure the quality and safety of medicines, while boosting the sector’s global competitiveness.  It aims to ensure access, and address medicines shortages, ensure sustainable need-driven patient-centered innovation, and ensure affordability of medicines for patients and health systems sustainability. The Department of Health contributed to and shaped the development of the Strategy through its representation at Pharmaceutical Committee meetings, the Directors of Pharmaceutical Policy meetings and in workshops hosted virtually by the Commission during its genesis.

The strategy is now at an implementation stage and a wide spectrum of actions covering different policy areas have been identified to contribute to its realisation. The Pharmaceutical Committee will be a key mechanism to drive the execution of a number of actions in the coming years. My officials participate in meetings of this committee. These actions include amongst others, attention to issues around unmet medical needs, affordability of medicines for patients and health systems’ sustainability, a sound and flexible regulatory system, access to medicines, antimicrobial resistance, providing a fertile environment for Europe’s industry, enabling innovation and digital transformation, enhancing Europe’s crisis response mechanisms and securing supply of medicines and avoiding shortages.

The Commission has recently launched a study to support the evaluation and impact assessment for the revision of the EU general pharmaceutical legislation, one of the key identified actions required to implement the Strategy.  It is expected that the outcome of this study will provide data, analysis and evidence to the Commission to evaluate the effects of the comprehensive revision of the general pharmaceutical legislation adopted in 2004, and to assess the impacts of possible future changes to the legislative framework. 

Ireland continues to watch and participate with interest in, the progression of the work activities underpinning the evolution of the aims of Pharmaceutical Strategy for Europe, and wishes to acknowledge the ongoing work being done by the Commission to date on this initiative.