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

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

Patients are at risk of missing out on innovative medicines because ‘Red tape’ is slowing down UK drug trials compared to the United States and Germany, a chief pharmacist warned.

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

The time between the approval of a clinical trial and the administration of the first dose of the drug to patients is more than eight months in the UK, compared to around four in Germany. The United States has one of the shortest response times: just 155 days.

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

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

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

But Ms Steele, who arrived in the UK from the US on the day the plan was published, said ministers still had to “act” on the ambition.

‘You have to act now’

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

Ms Steele said the government had ambitions to be a “life sciences superpower” but the data showed that vision was not yet a reality.

“So you need a plan, and most importantly you need to act now, to augment that and ensure UK patients receive the best care,” he said. “UK patients face being left behind in the race to approve and secure innovative treatments for some of the major health conditions plaguing the population today, including obesity, diabetes and Alzheimer’s.”

His comments come after Lilly, which has made medicines in the UK since the 1940s, won approval for tirzepatide, a landmark weight-loss drug. for diabetic patients. Clinical trials found that patients on the highest dose lost one-fifth of their body weight on average.

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

New treatments don’t just ‘appear’

Separately, an end-stage trial is currently underway for Lilly’s donanemab, an immunotherapy drug for early-stage Alzheimer’s, with a preliminary trial showing promising results.

Results from a similar drug, lecanemab, which were published last month, revealed that disease progression and memory are decreased can be reduced.

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

“We are on the brink of a ton of innovation, not just for Lilly but for the entire industry,” said Ms. Steele.

But he added that new treatments don’t just “appear” and that “governments can’t just rest on their laurels and assume that the industry won’t look elsewhere if another country provides smoother approvals, lower costs and a stronger infrastructure for implement new treatments. .

Asked if red tape in regulatory bodies was holding the UK back, he said: “Absolutely… If it takes too long, if the processes aren’t smooth enough and it doesn’t make business sense, then scientists looking into the latest medical advances don’t look to the UK as the best place to settle, which is ultimately bad news for patients here.”

A spokesman for the Department of Health and Social Care said efforts to address the public health challenges facing the UK include “seeking new ways to speed up diagnosis and improve treatments, delivering on our commitment to launch innovative new healthcare missions.” “.

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