The Medical Innovation Bill, promoted by Lord Saatchi, proposes legal protection for doctors who try novel treatments for patients for whom standard treatments are no longer effective. The Bill is currently undergoing further scrutiny in the House of Lords.
Although Medical Protection welcomes the debate the Bill has ignited – including a commitment to work with Oxford University to develop a method of data collection and sharing for innovative treatments – we have concerns about the Bill’s ability to fulfil its stated aims.
We believe it may potentially inhibit responsible innovation whilst also giving false reassurance to some doctors.
An unnecessary change
Medical Protection has extensive experience of issues of clinical negligence and advising doctors on ethical and medicolegal matters, and we are not aware that a fear of clinical negligence claims is preventing doctors from being innovative.
The law currently allows doctors acting responsibly to innovate – the Bill itself recognises this as it explicitly preserves the current legal tests for standards of care, as well as the current law on consent. This means that any doctor acting with the support of a responsible body of their peers and the informed consent of their patient, would not be guilty of negligence under the current law.
"The law currently allows doctors acting responsibly to innovate"
Potential risks
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The Bill will confuse rather than clarify the law. Information accompanying the Bill states: “There is a distinct lack of understanding of the current legal standards test and the case law around medical negligence.” Whether or not that is the case, creating a law targeted at medical innovation will lead doctors to believe that one law exists for medical innovation and another for established treatments. If there is a lack of understanding of the current legal standards, it is not an argument for statute to further complicate matters; it is an argument for greater education and understanding about the existing legal position.
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The Bill will prevent proper assessment of potential innovations and thus hold back innovation. This Bill could create a mechanism allowing doctors to bypass research and development processes necessary to properly evaluate all treatments. There would be a reluctance to undertake full clinical trials on innovative treatments doctors had used under this Bill that had failed on one, maybe two, occasions – thereby delaying or even preventing the introduction of good treatments.
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The brief attached to the Bill claims the Bill will “empower patients to demand that every possible route should be tried”. There are two issues arising out of this statement. First, the sad reality of most cases where the Bill might apply is that there is seldom time to try all possible treatments, nor is there likely to be funding for this, and the use of one may in some circumstances preclude the use of another. Second, not every possible route will meet the legal standard. The combined effect of these issues may lead to a breakdown in the doctor–patient relationship, where the doctor is simply not able to deliver on expectations.
Dr Nick Clements, editor-in-chief of Casebook, said: “The Bill is unnecessary. Current law already allows doctors acting responsibly to innovate without fear of clinical negligence claims, provided they have the support of a responsible body of their peers and the patient’s informed consent. The Bill could give false reassurance to doctors over their legal position and could undermine clinical trials therefore disrupting medical research.
“A full review should look at whether responsible medical innovation is being held back. If this is the case, contributing factors need to be looked at, and only then should well thought through recommendations be put forward.”
"The Bill could give false reassurance to doctors over their legal position and could undermine clinical trials"
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