The Brexit Health Alliance called for post-Brexit cooperation between the European Union and the United Kingdom on medical device regulations to avoid disruption of international supply chains.
Brexit “could have serious implications for patients’ access to medicines and medical technologies,” according the alliance, whose members include the Academy of Medical Royal Colleges, the Association of British Healthcare Industries, the NHS Confederation, and other stakeholders.
The call comes as the U.K. and the EU negotiate over continuing relations post-Brexit. Regardless of whether they reach a “deal” or “no deal” on continuing relations, a lack of EU-U.K. cooperation on medical devices “could put public health at risk,” the alliance said.
BHA pointed to one reason a “no deal” could have a detrimental impact on supply chains — an estimated 50 percent of the assessment work for authorizing products to reach the EU market is done in the U.K. “There is already limited capacity in this area across Europe and any possible loss of capacity could clearly impact the availability of medical devices,” the alliance said.
The alliance also called for “aligning the U.K. as much as possible with the EU’s regulation of medicines and medical devices” in the interest of patient safety and public health.
With the EU’s new medical device and in vitro diagnostic regulations — being phased-in over the course of three and five years, respectively — there are unique challenges because of Brexit as it is unclear how they will be implemented in the U.K., especially if there is “no deal.”
The U.K. parliament’s European Union Committee issued a report in December stating, the closer the U.K. and the EU get to the deadline of March 29, 2019, “the more damaging a breakdown of negotiations, and a ‘no deal’ outcome, would be.”
Citing evidence submitted by devicemaker giant Johnson & Johnson, the committee said a “no deal” scenario “could potentially disrupt the supply of medicines, medical devices and other healthcare products from the EU to the U.K.”
BHA is not the only group expressing concerns over Brexit’s potential impacts. MedTech Europe issued a position paper in November recommending actions to mitigate harmful effects, which include recognizing U.K.-issued CE Marks until they expire, and avoiding lengthy delays for cross-border product supplies (IDDM, Nov. 20, 2017). — Ana Mulero