The trade and security deal the UK Government struck with the EU is a bare-bones deal for tariff-free trade in goods. For many other business sectors that are not covered by the trade deal it means a no-deal outcome creating significant frictions and less EU market access from 1 January. Below we explore what it means for the Pharmaceutical & Medical industry.
Snapshot:
A vital industry with many global market leaders, who are aligned to the EU market. Expect significant disruption and price increases for at least two years.
Overview:
Industry leaders expect that Brexit will cause at least two years of disruption for the UK pharma industry. It is expected that the trade deal will not include a Mutual Recognition Agreement (MRA) between the UK and the EU for medicinal products, despite pleas from the Association of the British Pharmaceutical Industry and the European Federation of Pharmaceutical Industries & Associations.
Pharma companies have been proactive and put contingency plans in place to manage the disruption caused by leaving the EU. However, significant uncertainties remain in areas such as product testing and certification. It needs to be established urgently that product testing and certification for UK products entering the EU can continue with as little impact as possible. As it stands, the Medicines and Healthcare products Regulatory Agency have stated that they will continue to recognise EU testing and certification. However, the EU will not recognise the new UK systems.
Clinical trials are the other area of uncertainty. The UK is currently the most popular location for clinical trials, but it is likely this will change if the UK is no longer part of the EU regulatory system. It remains to be seen whether the UK will adopt the new EU clinical trial regulation, which aims to harmonise trials throughout the EU and ultimately make the EU more attractive for such trials. This will also have an impact on trials already underway in the UK. Finally, all medical devices currently receive the EU CE mark on approval. Again, depending on the trade outcome, UK companies may need additional approvals should they wish to receive the CE mark moving forward.
Would you like to know more?
If you would like to learn more about how Brexit may impact you, please visit our Practical Guidance: Brexit hub here.
And if you have any questions or would like to discuss your specific circumstances, please get in touch with your usual Blick Rothenberg contact or one of the partners on this page.