Dáil Éireann Debate, Thursday - 5 July 2018
213. Deputy John Brassil asked the Minister for Health the arrangements that have been made to address the safety of supply chain for medication post-Brexit; and if he will make a statement on the matter. [29757/18]
View answerThe continuity of medicines supply to the Irish market post-Brexit is an issue of significant concern and Ireland is exposed to risks in this regard in ways that other EU Member States are unlikely to be.
The framework for the regulation of medicines is complex and it isn't straightforward to address the various consequences of the UK leaving this system. However, ensuring the continued supply and availability of medicines to patients in Ireland post-Brexit is a key priority for the Department and the Health Products Regulatory Authority, as the competent authority for the regulation of medicines in Ireland.
The HPRA’s Brexit-related activities are focused on protecting the availability of medicines for Irish patients and the integrity of Ireland's medicines market. The authority established an internal working group which has developed plans for all possible outcomes and scenarios that may arise when the UK leaves the European Union. The HPRA continues to engage with the pharmaceutical companies who are the marketing authorisation holders of medicines in Ireland in order to quantify the scale of potential challenges and to offer the agency’s support in maintaining products on the Irish market.
The HPRA has also identified a number of risk mitigation measures, including maintaining joint labelling with the UK, where possible; expediting assessment of mutual recognition applications for critical medicines; authorising medicines via the new national authorisation procedure on the basis of public health need; identifying alternative EEA countries for parallel imports; and establishing increased collaboration and bilateral agreements with other MS. This work is considered essential to help protect medicines supply in Ireland.
The Department of Health is fully supportive of the HPRA's on-going work to prepare for Brexit, and to continue to deliver on its remit to protect and enhance public and animal health if the UK fully exits the current regulatory systems in March 2019.
The Department and HPRA also contribute to on-going review and discussion of mitigating actions at national and EU level, and working to ensure that legislative interpretations of the ‘pharmaceutical acquis’ consider fully the public health implications on European patients and that they are not be placed at a disadvantage through deprived access to medicines. In April, at a bilateral meeting with the Commission Brexit Preparedness Group, Department officials identified these risks and made Ireland’s public health concerns explicitly known.
As a significant purchaser of medicines, the HSE is an important stakeholder in this matter. The HSE is working on contingency plans in a number of areas in relation to Brexit, including measures required to maintain patient services and continuity of supplies. This includes liaison with the Pharmaceutical Industry and distributors in relation to medicines, in order to identify risk areas regarding supply and to ensure that contingency arrangements are in place.
