Brexit will undoubtedly be a major turning point for Britain and a time of great uncertainty – no more so than for pharma companies, as they await the fate of the regulations which have governed the UK industry and its products for so long.
At last month’s Tory party conference in Birmingham, Theresa May announced Britain will trigger Article 50 by March next year – in practice, this means that by 2019, we will no longer be a part of the European Union.
For pharma companies, Brexit brings with it its own unique threats and opportunities, the most pressing of which surrounds the future regulation of the industry. The life sciences sector is one of the most highly regulated industries, and a large proportion of this regulation comes from the EU.
The most straightforward solution would be for the Government to adopt EU laws, word for word, into UK law. Alternatively, Britain could remain part of the European Economic Area – as Norway and Iceland have done – allowing us to continue with EU centralised and decentralised procedures and ensuring all existing authorisations will continue to be valid.
But there is a possibility that the Government will decide against remaining in the EEA, leading to a divergence in the way the pharma sector in Britain is regulated compared to the rest of the EU.
Outside of the EEA, centralised authorisations will no longer be valid, leaving pharma companies with drugs that need to be resubmitted for approvals and causing a raft of headaches for company regulatory departments.
This is where things could get very complicated as the UK does not currently have the infrastructure in place for the authorisation and inspection of regulatory procedures, so any domestic regulatory body would need to be formed from scratch.
This replacement body would need to take on much of the work currently undertaken by the European Medicines Agency (EMA), which is based in London – for now. It has been speculated that the EMA will need to relocate post-Brexit to an EU member state, potentially disrupting approvals for drugs already under review in the short term. In the long term, an EMA move out of London could take with it the very talent we need to set up a comparable British medicines agency.
Any organisation established post-Brexit to take the place of EMA will have a lot of work to do upfront to get the industry onto a steady footing. It would need to negotiate its own agreements with other leading regulators to replace those agreed by EMA with the US, Canada and Japan. Pharmacovigilance and clinical trial procedures would also need to be reviewed and replacement policy written, communicated and implemented post-haste.
There is undoubtedly going to be some flux as the Government and the pharma industry finds its way in the post-Brexit reality. In the short term, it may inevitably have to adapt to new policies and procedures. The industry may have to work harder to attract investment, research funding and talent too. But what rises at the end of this process could be a stronger, more creative industry which remains the envy of Europe and the world. Switzerland alone is evidence enough that there can be life outside the EU for the life sciences sector.