Published in The Times, 30th October 2014
Lord Saatchi’s Medical Innovation Bill completed its committee stage in the House of Lords last Friday. It has government support and so may become law before the end of this parliament next May. The bill could have a positive effect — though not as substantial as its supporters claim — and it contains (or will contain, with further amendments) sufficient protections to prevent it causing harm. It therefore deserves lukewarm support. The bill says that its purpose is “to encourage responsible innovation in medical treatment”. It provides that it is not negligent for a doctor to depart from the existing range of accepted medical treatments if the decision to do so is taken “responsibly”.
For the purposes of taking a responsible decision, the doctor must, in particular, obtain and take account of the views of one or more appropriately qualified doctors in relation to the proposed treatment, and consider the risks and benefits of that treatment, having regard to other available options.
This adds very little to the existing law. The common law test was stated by Mr Justice McNair in the Bolam case in 1957. A doctor is not guilty of negligence “if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”. In the Sidaway case in 1985, Lord Diplock emphasised that because the state of medical knowledge is not, and should not be, stagnant, the Bolam test does not require the doctor to follow the most orthodox approach: “there may be a number of different practices” that satisfy the test at any particular time.
The courts apply the Bolam criteria in a liberal manner in the interests of patients. Typical is the Judgment of Dame Elizabeth Butler-Sloss, as president of the family division, in the Simms case in 2002: she approved innovative treatment for two incapacitated patients suffering from brain disease. The treatment was “untried” with “no validation of the experimental work done in Japan”. But, she noted, there was responsible medical opinion in favour of trying the treatment. As she explained, the Bolam test should not be applied in such a way that “no innovative work such as the use of penicillin or performing heart transplant surgery would ever be attempted”.
In practice, doctors do already innovate in the interests of their patients, as Lords Winston and Turnberg, with their decades of medical experience, explained during the committee stage debate.
Lord Saatchi believes that the fear of litigation is holding back innovation in the treatment of cancer and other diseases and so a new statute would have a positive effect. But there is little evidence to suggest that the law, rather than lack of funding or excessive bureaucracy, is currently a problem in this context.
So this bill is itself not much of an innovation. Its main effect, as Earl Howe, the health minister, explained last Friday, would be to “bring forward the Bolam test to before treatment is carried out”, while preserving the common law rule for doctors who do not follow the procedures in the bill.
It is possible, though unlikely, that these new provisions will make a difference by encouraging otherwise timid doctors to innovate. It is a legitimate OBJECT of legislation to promote innovation, which is desperately needed in combating cancer. Parliament does not subscribe to the views of Sam Goldwyn, the film producer (as expressed in a pre-Twitter age): “messages should be delivered by Western Union”.
The crucial question, then, is whether the bill will offend against the basic principle of medical ethics recognised by Florence Nightingale as “the first requirement in a hospital”: it “should do the sick no harm”. The bill only applies to “responsible” innovation, which the law confines to reasonable treatment backed by a body of medical opinion. This excludes quacks. But there are important questions still to be decided at report stage.
At present, the bill applies to all medical treatment. But should the law be encouraging innovation in, for example, cosmetic surgery? A way forward would be to empower the secretary of state to prescribe excluded areas of treatment. A further defect is that the bill currently contains no requirement that those carrying out innovative treatment must record it on the patient’s notes or in a public register.
If we are to learn from the success, and more often regrettable failures, of medical trials, information needs to be recorded and shared. A third concern is that a bill which is said to be necessary to provide legal certainty for doctors in the interests of patients contains no provision safeguarding doctors who decline to innovate. The bill needs to state that a doctor is not obliged to innovate if he or she considers that to be contrary to the best interests of the patient.
The author is a practising barrister at Blackstone Chambers in the Temple, a Fellow of All Souls College, Oxford, and a crossbench peer in the House of Lords.