UK Regulator Seeks to Reassure Pharma as Brexit Nears

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced yesterday that it will not make any sudden changes to the nation’s regulatory framework following the country’s exit from the European Union.

In an update to pharmaceutical companies on preparations for the so-called Brexit, MHRA reassured industry that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the [United Kingdom] and the [European Union] with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.”

MHRA also notes that it is seeking to negotiate an “implementation period” that would allow the United Kingdom and the European Union to allow access to “…one another’s markets to continue on current terms throughout this period, and for it to be based on the existing structure of EU rules and regulations” during the transition, as well as a “close working relationship” with EU regulators after the transition is complete.

However, the agency acknowledged the fact that it is possible that no agreement will be reached to allow the United Kingdom to have a continued relationship with the European Medicines Agency (EMA). In the event of such a “no-deal” outcome, the MHRA plans to convert the existing EU legislative framework into UK law at the time of exit so that there will be no sudden changes to UK regulation. Yet changes will follow, suggests MHRA, saying that its “pragmatic” adjustments to regulatory requirements would be rolled out with adequate notice to ensure that companies have enough time to implement the changes.

The Association of the British Pharmaceutical Industry (ABPI) responded to the MHRA update by noting that it shares the government’s hope for a strong working relationship with the EMA post-Brexit, but noted that industry needs more detail about MHRA’s plans for a no-deal scenario.

“For patients and the public there are very real consequences of failing to get this right, and we will continue to work with our members, regulators, governments and the [European Commission] to mitigate these risks. The complex issues surrounding medicines regulation and supply chain need to be front and [center] in the second phase of talks,” wrote ABPI in a statement.

The UK Bioindustry Association (BIA) also voiced its hopes for a continued partnership with the EMA; the organization’s head of regulatory affairs, Christiane Abouzeid, PhD, said in a statement, “The BIA has long advocated for retaining ongoing UK regulatory cooperation with the European Union on medicines to ensure minimal disruption to patient access in both the [United Kingdom] and [European Union].”