Medical Innovation 'Saatchi' Bill passes through Lords committee stage

The Medical Innovation Bill has been proposed by Lord Saatchi as a way to encourage doctors to innovate responsibly when prescribing medical treatments without a fear of being held as having acted negligently should those treatments fail. The Bill has received the backing of the UK government.

However, a number of research bodies have expressed concern with the plans (3-page / 321KB PDF). They have claimed the Bill could lead to patient harm and act as a disincentive to participation in clinical trials.

Under the latest draft of the Bill, doctors could not be held negligent if they decide to "depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly".

The proposals outline what doctors must do to be held as having taken a responsible decision to innovate. The Bill would prohibit doctors from proscribing unlicensed drugs or other alternative treatments for conditions for the purposes of research.

To be said to be innovating responsibly and avoid negligence claims, a doctor would have to consult with "one or more appropriately qualified doctors" with expertise and experience in the treatment of the condition suffered by the patient which they propose to treat using drugs not normally proscribed for those conditions.

The doctor would have to "take full account" of those views "in a way in which any responsible doctor would be expected to take account of such views", obtain necessary patient consents and consider a number of other issues before proceeding with their intended alternative treatment plan to be protected from negligence claims.

According to the Bill, doctors would need to consider "any opinions or requests expressed by or in relation to the patient" as well as weigh up both the risks and benefits that "are, or can reasonably be expected to be, associated with the proposed treatment" in comparison with the risks and benefits of progressing with traditional treatments for the condition or not carrying out any treatments at all.

Doctors would also be required to consider "any other matter that it is necessary for [them] to consider in order to reach a clinical judgement" and ensure that the decisions they take are accountable and transparent.

Among the new amendments added to the Bill during the Lords committee stage was a new section that clarifies that doctors that fail to follow the procedures outlined for qualifying for the proposed new 'responsible innovation' process can still defend against negligence claims if their decision to depart from traditional treatment methods is "supported by a responsible body of medical opinion".

"A departure from the existing range of accepted medical treatments for a condition is not negligent merely because the decision to depart from that range of treatments was taken otherwise than in accordance with [the responsible innovation process]," according to the draft Bill.

The Wellcome Trust, Medical Research Council and British Heart Foundation are among research groups that have criticised the Bill, however.

In a statement they said that the Bill as currently drafted could put patients at risk of possible harm stemming from "receiving treatments for which the evidence base is not fully established". The bodies questioned whether there was sufficient evidence to support the aims of the Bill and said that rather than clarifying the legal position, the law governing clinical negligence would subject to "a degree of ambiguity" if the Bill was introduced.

"We believe the best way to assess the efficacy and safety of treatments is through robust research studies with appropriate clinical monitoring and collection of data and other evidence, on a rigorous statistical basis and with appropriate ethical approval(s)," the research groups said. "We support amendments to strengthen these provisions. It is not currently clear how the Bill would be enacted to allow the monitoring, assessment and follow up of innovative treatments, and to ensure that it does not conflict with existing law or regulation."

"We are also concerned that the Bill may discourage patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis, leading to a failure to develop the robust evidence of efficacy necessary to support wider adoption of innovations in the NHS," they said.

The research bodies said that the Bill does not address "other important barriers to medical innovation", such as constraints on budgets, regulatory complexity around clinical trials, as well as "the lack of financial incentives, clinical engagement and training for the development, adoption and diffusion of innovative approaches and treatments".