The medicines regulator aims to shake off the UK’s ‘isolationist’ label with a new alliance

The chief executive of the UK’s medicines regulator is tackling the perception that the country has become “isolationist” after Brexit and building an alliance with other regulators around the world to ensure British patients are not left behind in the queue to access new medicines.

Dame June Raine, head of the Medicines and Healthcare Products Regulatory Agency (MHRA), said it was working with partners in Australia, Canada, Singapore and Switzerland to create a regulatory partnership that would reach a total population of 160 million.

Raine told the Financial Times that the alliance was a “very significant global opportunity” and would help address fears that Britain would leave the EU and lose the benefits of participating in its larger regulatory system. The EU and US markets offer pharmaceutical manufacturers access to a potential patient population of 450 million and 350 million, respectively.

“There are times when, especially in the sense that we’ve left the EU, we’re seen as a bit insular, or maybe we just want to be all-powerful on our own. [it’s important] that they see us as real collaborators, because collaboration means previous successes,” he said.

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Before Brexit, the drugs were approved for use in the UK by the European Medicines Agency, the EU’s watchdog, and some manufacturers have privately suggested that applying only for the relatively small UK market could delay patient access to new treatments.

The government sought to address the budget problem last week when it announced the MHRA would be able to follow other “trusted” regulators, including the EMA and its US and Japanese counterparts, instead of always having to carry out its own assessment. , freeing up time and resources to focus on more innovative products.

Drugmakers welcomed the plan, which the chancellor described as a “rapid, often almost automatic check-out” of drugs already approved elsewhere.

The MHRA was the first Western regulator to authorize vaccines and medicines for the treatment of Covid-19, an achievement Raine said in his Budget speech would serve as a model for other transformative medicines rather than a “flash in the pan”.

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He welcomed the new Brexit deal with the EU, revealed last month, governing trade relations with Northern Ireland, as a sign that the UK was “getting 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 MHRA rules. “That common sense is great. . . won,” he said.

Drugmakers have threatened to invest less in research and development in the UK, growing frustrated by pressure from the UK government to limit spending on drugs after a rapid rise in clawbacks to pay the government 26.5 per cent of total revenue. earnings this year. They argue that this could undermine the UK’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 he called a “living incubator of innovation”, had contributed to the rapid approval of Covid vaccines.

He said this collaboration, along with the role played by the government’s Life Sciences Office, formed a “crown jewel” 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.

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