BioPharma, Policy

Report: British drugmakers worry about damage to competitiveness after possible Brexit deal

In what was reported as an "unprecedented backlash," trade groups representing U.K. drugmakers - as well as four other industries - for the first time expressed concerns about a possible Brexit deal, having previously been more concerned about a possible no-deal Brexit.

In what has been called an “unprecedented backlash,” British drugmakers, along with other manufacturing industries, are warning the government of U.K. Prime Minister Boris Johnson that his plans for trade arrangements after a possible deal for the country’s withdrawal from the European Union could hurt their ability to compete, according to a news report.

Citing extracts of a letter sent to two cabinet ministers, the BBC reported Friday that representatives of five key industries – pharmaceuticals, as well as the chemical, food and drink, automotive and aerospace industries – had for the first time raised concerns about a possible deal around the withdrawal, popularly known as Brexit. They had previously been concerned mainly about the possibility of a no-deal Brexit.

Of particular worry is that the government may not participate in specific E.U. regulatory institutions after a Brexit deal, the BBC reported, noting that the industries had mostly supported the deal negotiated by the previous prime minister, Theresa May. The groups warned of damage from regulatory divergence and pointed to the importance of regulatory alignment across Europe.

The letter was sent to Brexit Secretary Steve Barclay and Michael Gove, the Cabinet Office minister by the Association of the British Pharmaceutical Industry and trade groups representing the other industries. Brexit is expected to take place on Oct. 31.

The European Medicines Agency, which is the counterpart of the Food and Drug Administration for the European Union and the European Economic Area countries of Norway, Iceland and Liechtenstein, had previously been headquartered in London, but relocated to Amsterdam earlier this year as a consequence of Brexit.

In the event of a no-deal Brexit, the UK’s Medical and Healthcare products Regulatory Agency would take over the functions currently handled by the EMA. However, all products that currently have EMA approval will automatically have MHRA approval when Brexit takes place, though companies will have the ability for a short period to opt out of having a U.K. marketing authorization.

Although Switzerland is part of the European Free Trade Association – along with the aforementioned EEA countries – it also has its own regulatory agency, Swissmedic. However, Swissmedic has provisions that allow for a lighter-touch approach to approving drugs that already have approval from agencies with established regulatory structures, like the EMA, FDA and Health Canada.

Photo: Ian Forsyth, Getty Images

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