The chief executive of Britain’s medicines regulator is fighting the perception that the country has become “isolationist” after Brexit, building alliances with other watchdogs around the world to try not to let British patients fall behind in the queue to access new medicines.
The head of the Medicines and Healthcare Products Regulatory Agency (MHRA), Dame June Wren, said she was working with counterparts in Australia, Canada, Singapore and Switzerland to create a regulatory partnership to reach a combined population of 160 million.
Wren told the Financial Times the alliance was a “hugely important global opportunity” and would help address fears Britain’s exit from the EU would mean it would lose some of the benefits of being part of a larger regulatory system. The EU and US markets give drugmakers access to potential patient populations of 450mn and 350mn respectively.
“There are occasions when, especially in the sense of leaving the EU, we are seen as a bit isolationist, or perhaps we want to be omnipotent in our own right, [it’s important] That we see as a true colleague, because cooperation is the first success,” she said.
Before Brexit, the drugs were approved for use in the UK by the European Medicines Agency, the EU watchdog, and some manufacturers privately suggested that applications should only be submitted because the relatively small British market could delay access to new treatments for patients.
The government sought to address the problem in the budget last week, when it announced that the MHRA would be able to follow other “credible” regulators, including the EMA and its American and Japanese counterparts, instead of always carrying out its own assessments. , freeing up time and resources to focus on more innovative products.
Drugmakers welcomed the plan, which the chancellor described as “rapid, often near 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 which Raine, speaking ahead of the Budget, said would be a model for other transformative medicines rather than a “flash in the pan”.
He welcomed the new Brexit deal unveiled with the EU last month, which governs its trading relationship with Northern Ireland, as a sign that Britain is “going back to being the best in the world”. The so-called Windsor Framework brings Northern Ireland together with the rest of the UK under the rules of the MHRA. “It’s common sense that’s great … has prevailed,” she said.
Drugmakers have threatened to invest less in research and development in the UK, increasingly frustrated by pressure on the UK government to cap how much it spends on drugs, after a sharp rise in clawbacks they owe the government a total of 26.5 per cent. revenue this year. They argue that this threatens to undermine Britain’s ambitions to become a life sciences superpower.
But Raine rejected this, pointing to how the close relationship between the regulator and the NHS, which she called a “living incubator of innovation”, had contributed to the rapid acceptance of Covid vaccines.
She said this collaboration, along with the role played by the government’s Office for Life Sciences, formed the “jewel in the crown” that helped the UK move faster than other countries. “I am absolutely certain that there is no other ecosystem that has this capability,” he added.
