New bill aims to embolden doctors to practise innovative medicine

BMJ 2012; 345 doi: (Published 04 December 2012) Cite this as: BMJ 2012;345:e8271
  1. Clare Dyer
  1. 1BMJ

A private member’s bill aiming to shield UK doctors who provide innovative treatment from the fear of being sued for negligence has been introduced in the House of Lords by a peer whose wife died from a rare cancer.

Maurice Saatchi’s wife, the poet and novelist Josephine Hart, died in June 2011 from primary peritoneal cancer. Saatchi believes that doctors are falling back on standard treatments through fear of litigation, and he hopes that the bill would help by “safely shifting the balance from therapeutic conservatism to therapeutic innovation.”

Pressures on legislators’ time means that the Medical Innovation Bill is unlikely to get a second reading in this session of parliament, but if it doesn’t, Saatchi plans to reintroduce it in the next parliamentary session.

“Fear of litigation for medical negligence is a deterrent to innovation in cancer treatment,” he said. “The bill will codify into law what constitutes best practice in relation to responsible medical innovation. It will clarify what counts as responsible innovation and clearly contrast that with reckless experimentation which puts patients’ lives at risk. It will provide certainty to the courts and doctors about the difference between the two.”

The short bill, which has been drafted by parliamentary counsel, sets out a series of steps doctors should go through before trying non-standard treatment. One possible outcome is that the bill gathers support and is attached to a government health bill.

The peer, who made his fortune in advertising, found his wife’s treatment “medieval, degrading, and ineffective.” He added, “The survival rate is zero, and the mortality rate is 100%. These figures are the same as they were 40 years ago. That is because the drugs, the procedures, and the operations are exactly the same as they were 40 years ago.”

Alan Ashworth, chief executive of the Institute of Cancer Research, said, “I fully support Lord Saatchi’s bill, which highlights an important issue. If we are to improve outcomes for cancer patients it is essential that clinicians are free to innovate as long as appropriate safeguards are in place. This is particularly true for new therapies, which are being developed at an ever increasing pace.”

Hani Gabra, professor of oncology at Imperial College School of Medicine, said, “How do you offer patients potentially innovative treatment before very long clinical trials have done? [The bill] broadly seeks to support patients and doctors and give confidence to the public that it’s done within some sort of reasonable quality control framework.” His main concern was that it should not generate extra bureaucracy where informal processes already exist.

James Badenoch QC, an expert in clinical negligence law, said that the bill would codify the principles that judges would probably apply in any event but thought that it might allow doctors “to be a bit bolder than they would otherwise be.”

A Department of Health spokesperson said, “There is nothing to stop doctors considering novel and innovative treatments to help their patients, but what is crucial is that patients are involved in the decision making process and are fully informed of the risks and benefits of any treatment.

“We don’t think the current system presents a barrier to doctors doing the best for their patients. But if anything specific is highlighted [in the bill], of course we will consider it.”


Cite this as: BMJ 2012;345:e8271