Dáil Éireann Debate, Tuesday - 13 June 2023
471. Deputy Jim O'Callaghan asked the Minister for Enterprise, Trade and Employment what assessments are taking place within his Department regarding the impact of the EU pharmaceutical strategy review on the Irish pharmaceutical sector; and if he will make a statement on the matter. [28488/23]
View answerOn 26 April, 2023 the European Commission published a proposal to revise and replace the existing general pharmaceutical legislation. The EU Pharmaceutical legislative package proposes a suite of measures with the purpose of assuring the quality and safety of medicines and ensuring their availability to health services across the EU. As such, consideration of the proposal is being led by Health Ministries at EU level, including for Ireland.
Since its publication, officials from my Department have been engaging with colleagues in the Department of Health to examine the proposal and analyse the impact of the proposed measure for the Irish pharmaceutical sector. We understand that regulation must ensure patient safety while acting as an enabler of bringing new products to market with certainty and predictability at its core. We are committed to collaborating across Government in analysing the proposal and working with all stakeholders to ensure this assessment is fully informed and based on all available data.
To inform the national deliberation of this proposal, the Minister for Health formally established the Pharmaceutical Strategy Working Group (PSWG) in April 2023 which is chaired by his Department and on which there is representation from my Department and our agencies. The PSWG will continue to meet at regular intervals to consider the Commission’s proposal in full. An initial structured stakeholder engagement exercise took place on 8th May at which key representative stakeholders were invited to share their perspectives. Government will continue to engage on the views of stakeholders in progressing the Pharmaceutical Strategy for Europe and in shaping a national, cross-Government position on this important package. For example, as Minister for Enterprise Trade and Employment, I am clear that a well-functioning intellectual property system is key in incentivising R&D of novel medicines and enabling the balance to facilitate equitable and adequate access to medicines alongside industry’s incentives to undertake long-term and expensive research and innovation costs. For new and innovative medicines, the goal of ensuring equitable and sustainable access must be balanced with the EU being at the centre of developing such medicines, supporting the good jobs and strong economic growth this sector brings to Europe.
I fully recognise the importance of the pharmaceutical sector in Ireland, and my Department will continually engage with key stakeholders throughout the course of the negotiations and will assess the impact of any interventions made. In keeping with our ongoing focus on maintaining Ireland’s reputation as an exceptional place to do business, we will continue to advocate for measures that ensure predictability, consistency, equity, sustainability, and transparency in the medicines legislative ecosystem across the EU.
