Saatchi is right to promote medical innovation but his bill is wrong way to do itBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h531 (Published 04 February 2015) Cite this as: BMJ 2015;350:h531
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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
We see no need for and do not support the Medical Innovation Bill but agree with Michael Baum that the Bill has provided an opportunity for a wider debate about innovation in medical practice.
Since the Bill was first introduced to the House of Lords at the end of 2012, on the mistaken premise that doctors are being prevented from innovating because of the fear of litigation, we have been at pains to reassure doctors and their patients that this is not the case. Doctors have been positively encouraged to innovate for years and it happens all the time in medicine.
We have never known of a doctor being sued for using an innovative treatment, but we know doctors innovate all the time as we regularly advise MDU members about the medico-legal implications of using an innovative treatment or experimental drug regime.
The main problem we see with the Bill is that it will introduce delay and confusion to the process that is currently very clear and straightforward. Doctors can innovate without any fear of litigation, so long as they can show they acted in accordance with current legal and ethical principles governing clinical practice. This includes making sure the patient understands what they want to do and why, and agrees. We cannot support a Bill that will introduce additional and unnecessary steps to this process. It won’t benefit doctors or patients.
There is no need for additional legislation in this area and the Welsh assembly decided on 3 February the Bill is not necessary in Wales. We hope the English government will take note of this common sense approach.
Dr Michael Devlin
MDU head of professional standards and liaison
Competing interests: No competing interests