Brexit: What Does It Mean for Life Sciences?

Approximately two weeks ago, citizens of the UK voted to leave the EU, so-called “Brexit,” by a vote of 53.4 percent to 46.6 percent. If you are like me, you are fascinated by the outcome of the Brexit vote. I have consumed news stories, podcasts, and social media all reporting on the implications of this vote – financial meltdown, voter regret, political fallout, concerns about overly strong currencies, cheap trips to England, the dissolution of the UK, and intergenerational family rifts…I have been reading it all.

What has been a smaller part of the story, however, is what the Brexit means for the life sciences industry. Below are some key takeaways from the recent news coverage:

  1. The European Medicines Agency may have to relocate its headquarters and its oversight may no longer extend to the UK. At issue here is the EMA’s ability to grant a single marketing authorization across the EU. IF the UK is not part of the EU, companies will face an additional regulatory burden and may look for licensing/market access in Europe before launching medicines in the UK. There are also questions about the ability of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to adequately fill the role of the country’s primary regulatory body.brexit-1478082_960_720
  2. Efforts to harmonize regulatory review and approval processes between the FDA and EMA could be hampered, and the FDA may have to take up additional harmonization efforts with the MHRA. This could lead to longer review and approval times across the continent for both medicines and devices.
  3. Firms located in the UK could lose a fair amount their grant funding. This has caused some uncertainty for the future of innovation in the UK, in terms of disruption to existing research, as well as the ability to fund future research and attract talent and future investment.
  4. The EU may struggle to continue negotiations for international free trade deals while simultaneously dealing with the UK departure. That could not only put trade deals like the Transatlantic Trade and Investment Partnership (TTIP) on hold, but it also means a host of separate trade deals may need to be negotiated with the UK itself. The affect here will be felt on patent protection, data exclusivity, and market exclusivity provisions for pharmaceuticals and biologics. Again, this could lead to uncertainty around future innovation and potentially delay review/approval of some drugs in foreign markets.

Overall, industry representatives caution that we need to “Keep Calm” at this point, as it could take years for the departure to actually occur. Finally, although UK citizens did vote to leave the EU, there is some hope that the impact of the Brexit on the life sciences could be mitigated. The EU and UK governments, with support from the industry, could negotiate an agreement that keeps the infrastructure substantively in place, particularly as it affects research collaborations and regulatory alignment.

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