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Medical innovation by law

Lars Bevanger, ManchesterOctober 29, 2014

A new law proposed by Lord Saatchi in the UK would protect doctors who use unlicensed drugs on terminal patients. Supporters say it encourages innovation. Critics warn it leaves patients unprotected.

Lord Maurice Saatchi, British politician Politiker aus Großbritannien Archiv 2013
Lord Maurice Saatchi, who proposed the Medical Innovation Bill, lost his wife to cancerImage: Getty Images/WPA Pool/Olivia Harris

The Medical Innovation Bill, which recently secured UK government backing, aims to make it easier for clinicians to use experimental drugs on terminally ill patients who no longer respond to treatment with licensed medication.

"The Bill makes it secure for a doctor to innovate, it takes away the threat of legal action if it goes wrong with a terminal patient," says Dominic Nutt, who runs the PR campaign to gather backing for the Bill.

"It is simply a way to protect doctors who wish to work with patients who are perhaps terminally ill to allow them to try treatments that are outside the standard medical procedures as laid down by the National Health Service," says Nutt. "That in turn should build a culture of innovation for doctors and patients. Ultimately that will help push forward medical science and medical knowledge."

Fighting cancer and Ebola

The proposed law is also known as the Saatchi Bill - named after advertising magnate and Conservative Lord Maurice Saatchi, who came up with the proposal after loosing his wife to ovarian cancer in 2011.

Dr Ian Hampson, St Mary's Hospital Manchester
Dr Ian Hampson supports the Bill. He and his wife Lynne moved their research to Kenya to get around current regulationImage: Lars Bevanger

The Bill's supporters say protecting doctors from litigation would lead to far more innovation and speed up the discovery of new treatments for diseases such as cancer - and Ebola.

Cancer Research UK, a charity, says it can take 10 to 15 years or more to complete all three of the required phases of clinical trials before a drug can be licensed for use.

Many terminally ill patients, who are not responding to already approved medication cannot - or will not want to - wait that long.

Outsourcing to Kenya

"This is not something we could have done in the UK due to the associated costs and red tape," says Dr Ian Hampson at Manchester's St Mary's Hospital.

He and his wife, Lynne, moved their medical test lab to the Kenyatta National Hospital in Nairobi, Kenya, when they needed to run trials in humans for a potential new treatment of cervical cancer.

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"The Saatchi Bill, I think, will give clinicians more freedom where situations demand it, to be more experimental, to be more adventurous, to be more accepting of new treatments," says Dr Hampson. "We had the idea for this new treatment ten years ago, and we only just managed to actually get it trialed in people."

Others point to the success, albeit limited, of using unlicensed medication on some Ebola patients as another reason for making it easier to reach out for experimental drugs in extreme circumstances.

Fierce opposition

Yet many medics and legal experts are fiercely opposed to the Medical Innovation Bill.

"The first problem with the Bill is that, despite what you might have heard, there is no evidence at all that innovation is being stifled by a fear of litigation," says Jose Miola, a professor of medical law at the University of Leicester. "The Medical Defense Union is not aware of one single case of medical innovation leading to a doctor being sued."

Jose Miola, professor of medical law, University of Leicester
Jose Miola says there is no proof that "fear of litigation" is stopping innovationImage: privat

"The Bill doesn't provide access to any new drugs, it doesn't allow doctors to use any more unlicensed drugs than they can already use. It's actually trying to solve a problem that doesn't exist," Miola says.

"All that the Bill does is provide what is essentially a blanket immunity for doctors who innovate. A doctor who is fundamentally misinformed or has made a fundamental mistake - in theory, the Bill protects that doctor. This means there is no mechanism for redress for the patient."

The Medical Innovation Bill got the backing of Prime Minister David Cameron's centre-right government earlier this month.

Before it can become law, it needs the backing of the UK's upper house of parliament, the Lords, before being presented for a vote in the Commons.