The Life Sciences sector is one of the most highly regulated industry sectors. A substantial proportion of that regulation originates with the EU, much in the form of Regulations. Although the UK has now voted to leave the EU, the vast majority of all these rules are uncontroversial and there will be no obstacle to the UK Government simply enacting those that form part of EU law verbatim into UK law. In many cases even this may not be necessary if the UK rejoins the European Economic Area via EFTA.
However, if the form that Brexit takes removes the UK from direct effect of EU legislation in this area, the UK Government will have to decide, in the longer term, whether to continue to align UK law with that of Europe, or to make its own decisions, which will lead to some divergence. Brexit in this form will add significantly to the administrative overhead for life sciences companies, since regulatory procedures (eg marketing authorisation applications, clinical trial authorisations, pharmacovigilance etc) which are currently undertaken in a harmonised EU environment will need to be duplicated in the UK. And this burden will increase if there is divergence between UK and EU law.
The necessary relocation of the European Medicines Agency, and the significant increase in the workload of the MHRA, are likely to lead to inconvenience and disruption in the short term. More significant will be the end of the UK’s membership of the European Centre for Disease Control and Prevention: although it is to be expected that the MHRA will be fully engaged with its activities, anyone with experience of large organisations will know that cooperation within a group or department is much easier to achieve than across departmental or group boundaries.
Areas where there is potential for significant debate over the extent to which the UK should simply adopt current EU law include “8+2+1” data exclusivity, the territorial scope of exhaustion of rights (that is, where parallel imports may come from) and the details of transparency and the publication of clinical trials.
The European Union is a major coordinator and funder of pharmaceutical research. Following the UK’s departure from the EU, UK companies will no longer be eligible to participate or to apply for funding. Multi-national companies will not be affected (save to the extent that they have to relocate research centres to qualifying countries), but UK medical research charities will be significantly affected.
The major impact on most ordinary members of the public will be that they will no longer be able to use the European Health Insurance Card to access free medical assistance when travelling in EU countries.
This document (and any information accessed through links in this document) is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.