Dáil Éireann Debate, Thursday - 22 June 2023
388. Deputy John Paul Phelan asked the Minister for Health if he will outline Ireland's national position in respect of the European Commission's proposed pharmaceutical strategy; and if he will make a statement on the matter. [30431/23]
View answerOn 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 complex and will need to be considered comprehensively 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.
Ireland (IE) supports the policy objectives of the proposal and welcomes the commitment to optimise the EU regulatory framework to improve supply chain resilience and to address the risks of medicine shortages. We are also supportive of the commitments to enhancing environmental protection and counter antimicrobial resistance as well as the measures aimed at addressing unmet need and rare diseases.
As a smaller Member State, IE particularly welcomes measures aimed at improving access to medicines. Patients and health systems need access to new, innovative treatments, as well as older (off patent) products, generics, and biosimilars. Proposals relating to adaptive clinical trials and the promotion of real-world evidence are particularly welcomed, given the importance of the ongoing assessment of the effectiveness of new medicines in promoting positive health outcomes
IE advocates for ensuring predictability, consistency, equity, sustainability, and transparency in the medicines legislative ecosystem across the EU. IE believes that the proposed reduction of the baseline RDP and its further modulation needs to be critically analysed. We need to support the competitiveness of the EU pharma ecosystem, while achieving and maintaining the critical balance between access and innovation.
Overall, IE acknowledges that this proposal is a component part of a suite of complex and complementary legislative instruments and policies that seek to deliver on the primary goals of the Pharmaceutical Strategy. These include the HTA Regulation, the Cross Border Directive, extension of the EMA mandate (Regulation EU 123 of 2022), the establishment of HERA and others.
