UK and EU inch toward regulatory cooperation after Brexit
- As the U.K. prepares to leave the European Union next March, a 26-page political declaration notes that the EU will "explore the possibility of cooperation of United Kingdom authorities with Union agencies" such as the European Medicines Agency, suggesting a possibility of continued alignment after next March for U.K. regulators.
- Even though the U.K. will no longer be an active member of the European Investment Bank, projects funded by the bank will continue to receive support until their completion. The political declaration also noted the U.K.'s "intention to explore options for a future relationship" with the bank.
- The latest draft version of the 585-page Brexit deal confirms the continued free movement of authorized products during the transition period, confirming freedom to operate for the sector during this time.
The Brexit clock continues to tick down: on March 29, 2019, the U.K. is set to leave the EU. Months of wrangling led to a deal accepted by Prime Minister Theresa May's cabinet, approved last month. This draft withdrawal agreement includes details on people, goods on the market, medicines regulation, intellectual property, state aid rules, the Irish border and access to EU databases.
It's far from a done deal: Parliament needs to give its OK, not a given by any means, and the remaining 27 member states in the EU also need to sign off.
Where the pharma, biotech and medtech industries are concerned, much has remained the same, according to a November webinar led by Steve Bates, CEO of the BioIndustry Association. The key change, however, is the beginning of the possibility of collaboration between agencies such as the European Chemicals Agency and most importantly the European Medicines Agency. The EU and U.K. will also continue to cooperate over health security as a "third country" over "prevention, detection, preparation for and response to established and emerging threats".
The U.K.'s political situation is currently a bit wobbly, with uncertainties over even which television channel will host a public debate involving May and opposition leader Jeremy Corbyn. The ruling Conservative party is split over the deal, with five ministers resigning in a short period of time, and there are calls for a Conservative leadership election, a "People's Vote" and even a general election.
The uncertainty lingers with just 116 days to go from the official exit date.
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