However you feel about the UK’s exit from the EU on 30th March 2019, there is no doubting that it will have a far-reaching and detailed impact on multiple areas of British industry.
Relying on global collaboration, funding, research and shared information, the ever-growing UK life science community is understandably concerned.
What has happened so far?
The value of the UK’s quoted healthcare sector grew by £40bn between 2015 and 2016 –and according to speakers at January 2017’s Future of Healthcare Investor Forum, hosted by the London Stock Exchange (LSE), uncertainty in global markets and political change was still not derailing investment in life sciences, which more than tripled on the year before.
Dr Eliot Forster, chairman of MedCity and chief executive of Immunocore, said, “The investments that were made into the whole sector over the past three years will begin to generate data and some of that will fail, but some will work and we will see growth there.”
Just over one year on, what do researchers and industry leaders think the biggest impacts of Brexit will be on the medical science community?
- Regulation changes
November 2017 saw the decision to move the European Medicines Agency (EMA) from its historic and current home in London to Amsterdam in the Netherlands. After leaving the EU, the UK will cease to be part of the EMA.With no precedent for a member state leaving the EU, it is unclear how other legal and regulatory environments may change business for the biopharmaceutical industry – but restrictions on the movement of people and materials is certain to make things more difficult.
Industry representatives recently named manufacturing supply issues as one of their biggest single concerns during the transition, according to the European Pharmaceutical Review.
- Research collaboration
Any restriction of movement between the UK and European countries is likely to make it more time consuming to conduct collaborative research and clinical trials.Clinical trials are currently authorised and monitored by national regulatory bodies, not the EMA, so sponsors must apply for authorisation in each country they wish to conduct a trial in.
But in 2018, the new EU Clinical Trials Regulation will streamline this process with one single application allowing access to all Member States – but the UK won’t benefit once it leaves. Will this see businesses skip over the UK in favour of less paperwork?
- Expensive exports
In economic terms, once the UK leaves the EU and EMA it will be considered a “third country”. This means any active substances or finished medicinal products manufactured in the UK will need to be tested to ensure they comply with EU Good Manufacturing Practice regulations, then imported into the EU by an authorised importer – unless the UK negotiates free trade of biopharmaceutical products within the EU.
While it is nearly impossible to predict every financial problem your business might face, you can help ease the worry with a dedicated Life Science insurance package, arranged by Safeguard’s expert team.
Get in touch on 08456 888 284 to talk to the team.