Medicines regulator wants to shake off UK ‘isolationist’ label with new alliance -Dlight News

Medicines regulator wants to shake off UK 'isolationist' label with new alliance

The chief executive of the UK’s medicines regulator is fighting back against perceptions that the country has become “isolationist” after Brexit, teaming up with other watchdogs around the world to ensure British patients don’t fall behind in queues to get new drugs.

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

Raine told the Financial Times that the merger was a “very significant global opportunity” and would help allay fears that Britain’s departure from the EU would mean losing some of the benefits of being part of its wider regulatory system. The EU and US markets give drugmakers access to potential patient populations of 450mn and 350mn respectively.

“There are occasions when, particularly in the sense of leaving the European Union, we are seen as a bit isolationist, or perhaps we want to be omnipotent on our own, [it’s important] That we are seen as true collaborators, because collaboration means previous success,” she said.

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

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

Drugmakers welcomed plans to give what the chancellor described as “quick, often close to automatic sign-off” for drugs 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, which governs trade relations with Northern Ireland, as a sign the UK is “returning to being the best in all worlds”. The so-called Windsor Framework brings Northern Ireland under the rules of the MHRA along with the rest of the UK. “It’s great that common sense . . . prevails,” she said.

Drugmakers have threatened to invest less in research and development in the UK, increasingly frustrated by pressure from the UK government to cap how much it spends on drugs, after a rapid rise in clawbacks they must pay the government to a total of 26.5 per cent. Income this year. They argue that it threatens to undermine the UK’s ambitions to become a life sciences superpower.

But Raine played down how the close relationship between the regulator and the NHS, which she called a “living incubator of innovation”, had contributed to the speedy approval of the Covid vaccine.

She said this collaboration, 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 am absolutely convinced that there is no other ecosystem with this capacity,” she added.

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