The Brexit referendum of June 2016 seems a long time ago now, but Britain is yet to fully understand the consequences of what our exit from the European Union will mean and the ramifications it will have on our businesses and manufacturing sectors. The pharma industry is one such sector that is destined to be affected greatly. Just last summer, the European Medicines Agency (EMA) and the European Commission jointly published regulatory guidance that said drugs made in Britain will be treated as imports by the EU in the event of a “hard” Brexit and that the life sciences sector will face a series of new regulatory obligations as a result.
The paper is a stark reminder of the potential disruption that UK-based companies could face if Britain and the EU struggle to reach agreements on the regulation of various areas in the economy. However, in reality, many issues are still up in the air after only a few rounds of negotiation talks. This issue has rightly thrust the regulation of the pharmaceutical sector in the UK into the spotlight as a key point to be negotiated in the run-up to Brexit. But with so many “known unknowns,” what can companies operating in the industry do to prepare? And does technology now have an even more important role to play in weathering the Brexit storm?