Brexit contingency plans revealed

Contingency plans set out by the UK government outlining how medicines and medical devices would be regulated and tested in the event of a ‘no deal’ exit by Britain from the European Union (EU) at the end of March 2019 have been welcomed by the Proprietary Association of Great Britain (PAGB).

Last week, the UK government published a series of “technical notices” explaining what would change in the drug regulatory arena in the event of a no-deal Brexit, and what stakeholders needed to do to prepare.

According to the notices, the Medicines and Healthcare products Regulatory Agency (MHRA) would take over the functions currently performed by the European Medicines Agency (EMA) for medicines on the UK market. For medical devices, the UK would continue to recognise devices approved for the EU and CE-marked, the government said, adding that the country would also comply with “all key elements” of the new medical devices legislation.

PAGB chief executive officer, John Smith, said this clarification from the government gave its members “a greater degree of certainty on which to base their contingency planning”, and “some reassurance as to how important regulatory processes and procedures will operate in the UK in the event of a no deal exit”.

PAGB concerns addressed

A “number of concerns” raised by the PAGB and its member companies had been addressed by the notices, Smith pointed out.

In a position paper published earlier this year, the PAGB had warned that in the “worst case scenario” of a no deal Brexit, imported OTC medicines and self-care medical devices might be held up at the UK border “for up to five days in the immediate aftermath of withdrawal” (OTC bulletin, 10 August 2018, page 14).

The government said that it was working with “relevant pharmaceutical companies to ensure that UK stockpiles of medicines are adequate to cope with any potential delays at the border that may arise in the short term”.

As part of its ‘Medicines Supply Contingency Planning Programme’, the government said it had written to pharmaceutical companies asking them to ensure that they had a “minimum of six weeks additional supply” of prescription and pharmacy-only medicines “above their business as usual operational buffer stocks” by 29 March 2019.

With regards to regulation in a no deal scenario, the government maintained that while that the “UK’s participation in the European regulatory network would cease”, the MHRA would “take on the functions currently undertaken by the EU for medicines on the UK market”.

However, it promised that the MHRA would “take a streamlined approach” to medicines and medical devices regulation that placed “no greater burden on industry” and which would ensure that “patients can access new and innovative medicines at the same time as EU patients”.