Given the highly regulated nature of the Pharmaceutical and Life Sciences sector, it’s no surprise that the separation of the UK from the EU could have major ramifications for the industry. For many organisations in the sector, the future arrangements for regulation of medicines and medical devices post-Brexit is the main concern in their preparations for operating Beyond Brexit.
Historically, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has been a major contributor to, and thought-leader for, the European Medicines Agency (EMA). However, as the EMA moves to Amsterdam and the UK falls outside the jurisdiction of the EMA, the MHRA and the UK life sciences sector will need to clarify their future role in Europe and the world. The prime minister has proposed an option for the UK to have associate membership of the EMA. The details and implications of this need to be worked out and agreed with European counterparts to determine what will remain the same, and what will be different. If such a deal isn’t secured, then the MHRA will need to identify how to operate as an independent regulator, with patients’ interests and the future of the UK Pharmaceuticals and Life Sciences sector in mind.
Today, many companies are focussed on ensuring business continuity in the face of Brexit and the uncertainty surrounding the details of the eventual UK and EU trade deal. For those preparing for the eventualities of a “no deal” scenario, of major concern is transferring all European Marketing Authorisations (MAs) held by UK entities, which were approved through the centralised procedure, to an EU-based entity before the end of the transition period (Dec 2020), as MAs held in the UK will not be valid for EU trade without an appropriate deal in place. Whilst such a deal may be secured in the future, the time required to transfer licences means that companies can not afford to wait for this to materialise. As such, we have seen that the majority of companies have begun to move their EU MAs out of the UK.
In addition to transferring licences, companies are also relocating key EU roles where they are currently based in the UK (Qualified Persons, Qualified Persons responsible for PharmacoVigilance and Responsible Persons) to satisfy EU residency requirements. Some companies are also transferring additional Regulatory Affairs and Pharmacovigiliance personnel to maintain a meaningful footprint in the EU. Of course, these roles will also be needed to manage product on the UK market when the UK becomes a third country to the EU.
Sometime in the near future, companies may need to apply for a UK MA (separate to EU MA) in order to continue sales in the UK. There is currently no specific Brexit guidance provided by the MHRA, though the national procedure remains available. The MHRA have said of Brexit that
“where possible, we would be making use of the information we already have to complete administrative tasks for continuity of work and licences”
suggesting that holders of EU centralised licences will be able to quickly obtain UK licences; though this is not yet clear. However, it is clear that neither side would wish to put patient safety at risk, so pragmatic approaches to continue permissibility of EU approved products in the UK are likely.
Transferring licensing and staff, though a bureaucratic burden, are activities focused on maintaining “business as usual”. The fundamental impact on Pharma and Life Sciences companies in the UK will be felt if regulatory divergence from the EU impacts decisions to invest locally through clinical trials and other R&D initiatives, and the UK’s place in the order of launch sequencing; this will be the subject of our next article.