‘Red tape’ leaves UK patients at risk of missing out on breakthrough medicines

Eli Lilly - Mike Segar/Reuters
Eli Lilly – Mike Segar/Reuters

Patients risk missing out on breakthrough medicines because “red tape” is slowing down UK drug trials compared to the US and Germany, a pharmaceutical boss has warned.

In her first interview since taking over as the UK general manager for Eli Lilly, Laura Steele said that despite the “noise and ambition” around speeding up innovative drug trials and approvals, UK patients “face being left behind”.

The time between the approval of a clinical trial to the first dose of the drug being given to patients is more than eight months in the UK, compared to around four in Germany. The US has one of the shortest turnaround times – just 155 days.

Meanwhile, the number of phase three clinical trials started in the UK continues to fall behind global competitors. As of 2020, the UK ranked fifth in Europe behind Germany, Spain, Italy and France.

The number of people recruited to clinical trials in 2021/22 also decreased by 44 per cent compared to before the pandemic.

Last year, the Government launched a 10-year Life Sciences Vision as a “blueprint to accelerate the delivery of life-changing innovations to patients”.

But Ms Steele, who arrived in the UK from the US on the day the blueprint was published, said ministers were yet to “act” on the ambition.

‘You need to act now’

It comes amid reports that the Medicines and Healthcare Products Regulatory Agency (MHRA), the body responsible for medicine approvals, plans to cut up to 25 per cent of its staff. The news has caused concern among doctors that the approval of medicines could be delayed as a result of such substantial job losses.

Ms Steele said the Government had an ambition to be a “life science superpower” but the data showed that vision was not yet a reality.

“And so you need a plan – and most importantly you need to act now – to increase that to ensure that UK patients get the best care,” she said. “UK patients face being left behind in the race to approve and secure innovative treatments for some of the biggest health conditions affecting the population today, such as obesity, diabetes and Alzheimer’s.”

Her comments come after Lilly, which has been manufacturing medicines in the UK since the 1940s, secured approval for tirzepatide, a landmark weight loss drug for diabetes patients. Clinical trials found patients on the highest dose lost a fifth of their body weight on average.

There has already been “significant” uptake in the US, and the firm will now seek authorisation from the National Institute for Health and Care Excellence (Nice) to roll it out on the NHS.

New treatments don’t just ‘appear’

Separately, a final stage trial for Lilly’s donanemab, an immunotherapy drug for early-stage Alzheimer’s, is currently under way, with an early trial showing promising results.

Results from a similar drug, lecanemab, which were published last month, revealed that the progress of the disease and memory decline can be reduced.

But experts warned that UK officials have much to do to prepare to deliver the drug, provided it gets regulatory approval, to ensure that patients can access it.

“We’re on the brink of a tonne of innovation, not just for Lilly but across the industry,” said Ms Steele.

But she added that new treatments don’t just “appear” and “governments can’t just rest on their laurels and assume that industry will not look elsewhere if another country provides smoother approvals, lower costs and stronger infrastructure to roll out new treatments”.

Asked whether red tape at regulatory bodies was holding the UK back, she said: “Absolutely … If it takes too long, if the processes aren’t smooth enough and it doesn’t make commercial sense, then scientists researching the latest medical breakthroughs will not look to the UK as the best place to base themselves, which ultimately is bad news for patients here.”

A Department for Health and Social Care spokesman said efforts to tackle public health challenges facing the UK included “looking at new ways to speed up diagnosis and enhance treatments, delivering on our commitment to launch innovative new healthcare missions”.

Published by anthonyhayble

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