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Freedom for doctors to innovate should not leave drugs companies exposed to legal claims, says expert

New laws that would give medical practitioners greater freedom to prescribe innovative treatments for patients should not leave pharmaceutical companies unduly exposed to legal claims, an expert has said.

Litigation expert Manoj Vaghela of Pinsent Masons, the law firm behind Out-Law.com, welcomed the "potential health benefits" that could derived from the passing of the new Medical Innovation Bill which has been drafted, but warned about the potential impact it could have on drugs companies.

The Medical Innovation Bill (3-page / 74KB PDF), which the Department of Health has just launched a consultation on, is intended to "encourage responsible innovation in medical treatment".

The Department of Health's consultation (48-page / 372KB PDF) explains that the existing legal position means doctors can prescribe innovative treatments currently where they have "support from a responsible body of medical opinion". However, it said that doctors may be fearful of straying from standard treatments, even where they know they will deliver "poor outcomes", where no such body of medical opinion exists to support the proscribing of alternative, innovative treatments, because of the risk of being held to have acted negligently if things go wrong.

Under the proposed new Bill, doctors would be able to "depart from the existing range of accepted medical treatments for a condition" without having to fear that their actions could be deemed negligent, as long as their decision to do so is a responsible one. The circumstances that would allow doctors to take this action are where they believe the treatment they propose to proscribe is either not backed by "a responsible body of medical opinion" or it is unclear whether there has been or would be such support for the proposed treatment.

The Bill contains a definition of what constitutes a 'responsible decision'. Doctors must believe there are "plausible reasons" why their proposed treatment "might be effective" and must consider factors such as the "relative risks" of the treatment and its "like success rates", as well as the "likely consequences" of both carrying out and not carrying out those treatments.

In addition, the opinions of patients and appropriate colleagues must also be taken into account by doctors as well as "any other matter that appears to the doctor to be appropriate to take into account in order to reach a clinical judgement".

A responsible decision is one which is taken "in accordance with a process which is accountable, transparent and allows full consideration by the doctor of all relevant matters", according to the Bill. No alternative or experimental treatments may be prescribed without "consent that is otherwise required by law" or for research or any other purposes aside from that that serves the "patient's best interests".

"The proposals have the potential to significantly enhance health care, by giving doctors more freedom to prescribe innovative new treatments in the hope of delivering a cure, or at least a better quality of life, to seriously ill patients," Vaghela said."However, the legal protections for doctors under the Bill are not extended to drugs manufacturers. They may find themselves at risk of being sued where their products were prescribed by doctors in accordance with the new rules but where the treatment fails or causes additional problems for patients."

"The creation of a new compensation fund, similar to the National Vaccine Injury Compensation Program that exists in the US and other similar schemes worldwide, alongside the Bill would give patients a less expensive and time consuming means by which to claim redress than they would encounter if trying to sue drugs companies and would reduce the threat those companies face of being held liable for the actions of doctors they have no control over," he added.

The Department of Health's consultation is open until 25 April.

"We are keen to hear views, especially from doctors, on whether medical innovation is being unduly constrained by the possibility of litigation," the consultation said. "We also want to hear from patients whose experience suggests that the possibility of litigation has been a factor in their doctor’s attitude to possible innovation."

Health Secretary Jeremy Hunt added: "We want to make sure doctors are not held back if they want to use pioneering treatments to offer a lifeline to dying patients. Innovation has always been at the heart of the NHS and is essential for improving treatments and finding new cures."

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