Re-blogged with permission from The Medical Innovation Bill – In a Nutshell by Nigel Poole QC
The Medical Innovation Bill has passed to the House of Commons from the House of Lords.
The purpose of the bill is to promote responsible medical innovation.
The means by which innovation is promoted in the bill is by seeking to reduce or remove the threat of medical negligence litigation against doctors who innovate. Medical negligence litigation is the means by which patients who have suffered injury as a result of negligent medical treatment, can obtain compensation for their avoidable pain, suffering and consequent financial losses. The bill does not change the law of consent. The bill does not address regulations governing the trial and introduction of new treatments, nor the funding of research or the commissioning of new treatments by the NHS.
1. “Medical innovation” is not defined in the bill but section 1(2) provides that a doctor who meets the requirements later set out in the bill shall not be negligent if he departs from the existing range of accepted treatments. The bill does not seek to define when a treatment is to be considered as “accepted”.
2. Apart from cosmetic surgery, the bill applies to all doctors registered with the GMC, all patients, all conditions and all treatments.
3. The requirements which a doctor has to meet under the bill, in order to avoid a finding of negligence, include a requirement that he should obtain an opinion about the proposed treatment from an appropriately qualified doctor and take that opinion into account in a way in which any responsible doctor would do.
4. The doctor must comply with any professional requirement to register the treatment, but there is in fact no such professional requirement.
5. If a doctor makes out the Saatchi Defence then he cannot be found to have been negligent by the court, even if he would have been found negligent under the common law. Thus, in some cases, patients or their families who would now be entitled to compensation for injury or death caused by negligent treatment will no longer be so entitled.
6. The MDU and MPS, bodies which defend doctors in medical negligence claims, have opposed the bill. They have said that the law of medical negligence is clear and is not an obstacle to responsible medical innovation.
7. The bill is opposed by the Patients’ Association, National Voices and AvMA, as being “unnecessary and dangerous”.
8. The BMA, the Academy of Royal Medical Colleges, Cancer Research UK, the Medical Research Council, the Wellcome Trust, Parkinsons UK, the Lancet Oncology, and the British Heart Foundation have all publicly opposed the bill.
9. The Welsh Assembly has voted unanimously to reject the bill and to oppose its application in Wales.
10. Leading members of the All Party Parliamentary Group on Cancer, the Chair of the APPG on Pancreatic Cancer and the Chair of the Health Select Committee have publicly opposed the bill.