A new draft Brexit agreement announced last week would provide an almost two-year transition period whereby U.K. and European device companies will continue as they have under EU rules.
Although the proposed deal is short on details, the fact that a draft agreement is in place is providing some hope that relief that the details for a future trading relationship will eventually be hammered out.
Under the draft plan, a transition period will be in place until December 2020; however there would be no UK participation in EU institutions or EU bodies, and the UK would have no role as a leading authority — meaning it would “not have a role as rapporteur or reference Member State,” the European Medicines Agency said.
The UK will remain subject to obligations of international agreements concluded by the EU and its notified bodies will remain intact during the transition period.
But the EMA warned that industry “should not rely on the transition period as there is currently no certainty that it will apply.” The agency said the transition is subject to the withdrawal agreement, and outstanding points being negotiated are not expected to be agreed and ratified until 2019.
“The EC urges all industry stakeholders to prepare now for the consequences of the UK becoming a ‘third country’ on March 30, 2019,” the EMA said.
Brexit “could have serious implications for patients’ access to medicines and medical technologies,” according to the Brexit Health Alliance (BHA), whose members include the Academy of Medical Royal Colleges, the Association of British Healthcare Industries, the NHS Confederation, and other stakeholders.
A lack of EU-UK cooperation on medical devices “could put public health at risk,” the alliance said.
BHA warned that the UK leaving the EU without a formal withdrawal agreement 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 UK. “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.