The Health Products Regulatory Authority (the "HPRA") has provided an insight into its preparations for the possibility of Brexit taking full effect in 2019. In a recent statement, the HPRA outlined its efforts to ensure continued delivery of its regulatory responsibilities in the event of a hard Brexit. The HPRA, formerly known as the Irish Medicines Board, is the state agency tasked with regulating medicines (human and veterinary), medical devices and other health products. Meanwhile, Ireland is bidding to be the new, post-Brexit home of the European Medicines Agency (the "EMA").
Key Strategic Aims of the HPRA
The HPRA's statement identifies the agency's key strategic aims should the United Kingdom proceed to exit the existing regulatory system. The aims include:
- Protecting the availability of medicines for Irish patients and the integrity of the Irish medicines market.
- Maintaining strong working relationships with the HPRA's counterparts in the United Kingdom.
- Recognising the particular challenges facing Irish agriculture and the impact of Brexit on the availability of veterinary medicines in Ireland.
- Elevating the HPRA's role within the European regulatory network by:
- boosting its contribution to the assessment of both centralised and decentralised marketing authorisation applications;
- increasing the agency's availability to carry out site inspections; and
- expanding its role in relation to medical devices.
Preparing for Brexit
The HPRA has established an internal working group to ensure that it is fully prepared for the UK’s withdrawal from the European Union. A number of surveys have been initiated to identify products for which Brexit may cause an interruption to supply or availability. The HPRA aims to proactively address any potential interruptions. Support for marketing authorisation holders has been promised and the HPRA has committed to being available to meet and discuss issues as they arise.
Medicines Assessment Readiness
Perhaps most significantly, the HPRA has confirmed that it is ready to assume a greater role in EU regulatory activities post-Brexit. Having identified a need for increased resources in order to meet its post-Brexit objectives, the HPRA says it has obtained the backing of the relevant government departments.
For its part, the European Medicines Agency has initiated discussions with national authorities about distributing the medicines assessment workload currently undertaken by the United Kingdom. The HPRA already plays a significant role in the European medicines regulatory network. Its commitment to increasing its contribution to medicines assessments, and its readiness to assume a greater share of the regulatory workload, is welcome news for pharmaceutical businesses looking to increase their focus on Ireland.
Future of the European Medicines Agency
In June, the Heads of the 27 Member States remaining in the European Union endorsed a procedure for deciding on relocation of the EMA's headquarters. Final submissions from interested parties, which will include Ireland, are due by 31 July 2017 with voting by the Member States to follow in November 2017. While up to 21 Member States will bid to host the new headquarters, Ireland is already putting forward a strong case for a seamless transition of EMA activities to Dublin. Further information on Ireland's bid is available at www.emadublin.ie.