Medicines regulator seeks to shake off UK ‘isolationist’ label with new alliance

The chief executive of the UK’s medicines regulator is battling perceptions the country has become “isolationist” after Brexit, building an alliance with other watchdogs around the world to try to ensure British patients do not fall behind in the queue to access new drugs.

Dame June Raine, head of the Medicines and Healthcare products Regulatory Agency (MHRA), said she was working with counterparts in Australia, Canada, Singapore and Switzerland to create a regulatory partnership with access to a combined population of 160mn.

Raine told the Financial Times the alliance was a “very significant global opportunity” and would help address fears Britain’s departure from the EU would mean a loss of some of the advantages of being part of its larger regulatory system. The EU and US markets offer drugmakers access to potential patient populations of 450mn and 350mn, respectively.

“There’s occasions when, particularly in the sense of having left the EU, we’re seen as a little isolationist, or perhaps purely want to be omnipotent on our own, [it’s important] that we’re seen as being a true collaborator, because collaboration means earlier success,” she said.

Before Brexit, drugs for use in the UK were approved by the European Medicines Agency, the EU watchdog, and some manufacturers had privately suggested the need to submit an application solely for the relatively small British market might delay access to new treatments for patients.

The government sought to tackle the problem in the Budget last week, when it announced that the MHRA would be able to follow other “trusted” regulators, including the EMA and its US and Japanese counterparts, rather than always having to carry out its own assessments, freeing up time and resources to focus on more innovative products.

Drugmakers welcomed the plans to give what the chancellor described as “rapid, often near automatic sign-off” for drugs already approved elsewhere.

The MHRA was the first western regulator to license vaccines and drugs to treat Covid-19, an achievement Raine, speaking before the Budget, said would be a model for other transformative medicines rather than a “flash in the pan”.

She welcomed the new Brexit deal unveiled with the EU last month, governing trading relationships with Northern Ireland, as a sign that the UK was “moving back to be the best of all worlds”. The so-called Windsor framework brings Northern Ireland under the MHRA’s rules along with the rest of the UK. “It is great that common sense . . . has prevailed,” she said.

Drugmakers have threatened to invest less in research and development in the UK, increasingly frustrated at pressure by the UK government to restrict how much it spends on medicines, after a rapid rise in the clawback they must pay to the government to 26.5 per cent of total revenues this year. They argue it threatens to undermine the UK’s ambitions to become a life science superpower.

But Raine rejected this, pointing to how the close relationship between the regulator and the NHS, which she dubbed “a living incubator of innovation” had contributed to the rapid approval of the Covid vaccines.

She said this co-operation, along with the role played by the government’s Office for Life Sciences, formed a “jewel in the crown” that helped the UK move faster than other countries. “I’m absolutely certain that there is no other ecosystem that has this capability,” she added.