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Saatchi is right to promote medical innovation but his bill is wrong way to do it

BMJ 2015; 350 doi: (Published 04 February 2015) Cite this as: BMJ 2015;350:h531

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Re: Saatchi is right to promote medical innovation but his bill is wrong way to do it

We the share concerns regarding the Medical Innovation Bill expressed by virtually every major medical, medical protection, patient and research organisation: that it is unnecessary, misunderstands the law, jeopardises patient safety and undermines clinical trials. But we would also point to another, hitherto under-examined problem with the Bill, which is that it is structurally incoherent to the point of it being impossible for it to function, even on its own terms.

The Bill rests on two central pillars: peace of mind for doctors and safeguards for patients. In relation to the former, this is purportedly achieved by bringing the question of liability forward so that it is determined before treatment. Its fundamental philosophy is that if it can move the determination of potential liability forward then doctors can innovate safe in the knowledge that they cannot be sued or disciplined later. Thus, the Bill describes the process that the doctor must undertake in order for the proposed innovative treatment to be labelled ‘responsible’ and the doctor to be safe as a consequence. This includes “obtaining the views” of at least one other doctor (s.1(3)(a)), taking “full account” of those views in a way that reasonable doctors would do (s.1(3)(b), obtaining patient consent (s.1(3)(c)), considering the patient’s views (s.1(3)(d)(i)) and risks and benefits of the proposed treatment (s.1(3)(d)(ii)). If this process is complied with, the doctor is supposed to be reassured that she is not liable in negligence and need not fear litigation or professional sanction.

At the same time, patients are supposed to be protected, and the second central pillar is that of patient safety. It is claimed that common law provisions allowing the courts to review decisions are not affected. However, it is impossible to have both protection from litigation and protection for the patient. Put bluntly, if liability is determined before treatment, there is no mechanism available to a court to assess the content of the decision afterwards. Conversely, if it is possible to assess the content of the decision, the intended release from the fear of litigation is impossible.

The Bill, as currently drafted, must therefore choose between patient safeguards and freeing doctors from the fear of litigation. Even on its own terms, it cannot have both. Given this, it would be entirely inappropriate for MPs to nod the Bill through without scrutiny. The flaw in its construction makes it fundamentally unworkable.

Competing interests: No competing interests

11 February 2015
Jose Miola
Professor of Medical Law
David Hills
University of Leicester
School of Law, University of Leicester, University Road, Leicester, LE1 7RH