UK lags behind EU in authorising new medicines after Brexit

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

An audit of approvals issued by the UK’s medicines regulator conducted by Imperial College London found that only 35 so-called novel medicines were approved for use in the UK in 2021 compared with 40 in the EU and 52 in the US.

Industry experts said the smaller 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 to be key factors explaining the shortfall.

James Barlow, professor of healthcare innovation at Imperial College Business School who co-authored the research, said the finding raised questions about whether the UK could maintain its attractiveness to international drugmakers in the longer term.

“The problem is that the UK is a smaller market and Brexit creates another layer of bureaucracy. The real question is how things will look in five or 10 years’ time. Will we see a cumulative build up of drugs that haven’t been licensed in the UK, but have elsewhere?” he said.

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

The UK accounts for 2.4 per cent of global healthcare spending, compared with 22 per cent for the EU, making it less economical for some international drug companies to complete paperwork for just the UK.

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

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

They added that the MHRA then asked for more information on their application. One has been approved in recent weeks, 10 months after it became available in the EU.

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

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

He added that France and Germany had been rolling out programmes to encourage early adoption of innovative therapies. He said the entire ecosystem, including the NHS and the regulator, needed to take action.

“We need to make sure that we are putting together all the pieces of the UK offer to ensure NHS patients aren’t at the back of the queue compared to other parts of the world,” he said.

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

The MHRA said that Imperial’s analysis focused only on authorisations of new medicines, but added that the UK’s own Early Access to Medicines Scheme had given “hundreds of patients” access to treatments that had not yet received licences.

It added: “The Covid-19 pandemic — during which we were the first regulator in the world to approve the 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 schemes had shown “early promise”, but said the analysis pointed to an “emerging risk of delays in authorisation of novel medicines compared to the EU”.