Robert Troy (Longford-Westmeath, Fianna Fail)
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924. To ask the Minister for Health when Ireland will be making its official response to the European Commission on the pharmaceutical review; if he will provide an indicative timeframe; and the consultation he is making with industry in Ireland. [24960/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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On the 26 April 2023, the European Commission’s proposal to revise the general pharmaceutical legislation was published - this is in the form of a Directive and a Regulation. The Minister for Health welcomed the publication of the legislation.

The objective of the revised framework is to impose safeguarding controls across the full spectrum of the supply chain, from “raw material” to a “medicine being placed in a patient’s hand”, with national and EU competences working synergistically to conserve patients’ best interests

The Department of Health is the lead department tasked with responding and engaging nationally as the EU commission proposal is negotiated by all 27 Member States. It should be noted that the legislative proposal is vast and complex and will need to be considered in full and with due regard in order to ensure that the national position is fully informed. Structured stakeholder engagement is a component of developing the national position as consideration of this proposal continues.

The Minister for Health established a 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 Department of Health recently conducted a Stakeholder Event where IPHA, Medicines for Ireland, IPPOSI and Rare Diseases Ireland attended and shared their initial views on the proposal - these contributions will also inform and be considered by the Department.

The Department of Health is also encouraging Stakeholders to submit their opinions on the legislative proposal and feedback can be submitted to the DOH at EUpharmastrategy@health.gov.ie.

The Department of Health understands that The European Commission is also conducting a Consultation exercise which is currently open until 17 July 2023, and is welcoming submissions from interested parties, details can be found on the EU website at: Revision of the EU general pharmaceuticals legislation (europa.eu)