UK lags EU in authorizing new drugs after Brexit

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The UK has fallen behind the EU in the race to attract innovative drugs for use in the country in the first year after Brexit, researchers have found.

An audit of approvals issued by the UK medicines regulator conducted by Imperial College London found that only 35 so-called new medicines were approved for use in the UK in 2021, compared to 40 in the EU and 52 in the states -United.

Industry experts said the small size of the UK market, now that it was regulated independently from the EU, coupled with the complexity of dealing with the NHS, were likely key factors behind the shortfall.

James Barlow, professor of healthcare innovation at Imperial College Business School and co-author of the research, said the finding raised questions about whether the UK could maintain its appeal for longer-term international drugmakers.

“The problem is that the UK is a smaller market and Brexit creates another layer of bureaucracy. The real question is what will things look like in five or ten years. Will we see a cumulative accumulation of drugs that have not been authorized in the UK, but elsewhere? ” he said.

After Brexit, the UK left the European Medicines Agency (EMA), the umbrella organization that regulates medicines across the bloc, opting instead to use its own regulator, the Medicines Regulatory Agency. and health products (MHRA).

The UK accounts for 2.4% of global healthcare spending, compared to 22% for the EU, making it less economical for some international pharmaceutical companies to complete paperwork for the UK only.

Last July, the UK government announced a 10-year life sciences strategy in which it said that after Brexit the MHRA would be an “independent and sovereign regulator with great agility” which would focus on getting drugs to patients “in the safest and fastest way possible”. .

New treatments are defined as medicines that contain new active substances. Of the five that were approved in the EU before the UK, two of the drugmakers said they waited for EMA approval before submitting an application to the UK regulator.

They added that the MHRA then asked for more information about their candidacy. One was approved in recent weeks, 10 months after it was made available in the EU.

Another drugmaker said it had not sought UK approval because it did not believe the NHS would pay for the drug, even though it is covered in Italy, Germany and Canada.

Steve Bates, chief executive of the UK’s BioIndustry Association, said the Imperial Journal was a “wake-up call” for the UK to look into incentives to bring a new drug into the country.

He added that France and Germany have programs in place to encourage the early adoption of innovative therapies. He said the whole ecosystem, including the NHS and the regulator, needed to take action.

“We need to make sure we bring together all the elements of the UK supply to ensure that NHS patients are not left behind compared to other parts of the world,” he said.

David Watson, executive director of economic, health and trade policy at the British Pharmaceutical Industry Association, said it was an “open question” whether the UK could overcome the challenges industry and health authorities by working as closely as they do. to fight against Covid-19.

The MHRA said Imperial’s analysis focused only on new drug approvals, but added that Britain’s early access to medicines system had given ‘hundreds of patients’ access to treatments that had not yet received a license.

He added: “The Covid-19 pandemic – during which we were the first regulator in the world to approve Covid-19 vaccines made by BioNTech/Pfizer and AstraZeneca – has shown that we are an innovative and agile regulator.

The Imperial study acknowledged that such programs had shown “early promise”, but said the analysis indicated an “emerging risk of delays in the authorization of new drugs compared to the EU”.

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