The opposition to the Medical Innovation Bill has been overwhelming in its volume, consistency and expert authorship, notably receiving negative feedback from patients’ groups and charities too. It passed its third reading in the Lords recently despite this widespread opposition and is scheduled for a second reading in the House of Commons later this month.
As an issue of high public importance affecting all patients, MPs in the Commons would be wise to listen to the concerns and take a read of the consultation responses and subsequent statements of alarm by leading experts. If that’s too much hard work, it is at the very least wise to listen to the words of other Members of the House; those who have taken the time to consider this matter deeply, appraise the evidence and speak on the Bill with an opinion informed by a life’s career in medicine and scientific research.
‘Like books, one should never judge a Bill by its cover’ opened Dr Sarah Wollaston, GP, Conservative MP for Totnes and Chair of the Health Select Committee in the adjournment debate that she scheduled in the Commons on the Medical Innovation Bill.
‘it is fundamentally flawed in its premise, it is unnecessary, it removes essential protections for patients, and it increases the risks of their exposure to maverick doctors. I believe it will undermine not only patients’ safety but medical innovation and so will have precisely the opposite effect to that intended.’
‘Under current law, a doctor is negligent if he or she acts in a way which no responsible body of medical opinion would support, or which is irrational or illogical—the so-called Bolam test, as refined in the case of Bolitho. The Bill would rewrite the law on clinical negligence and a doctor whose decision to treat would not be supported by any responsible body of medical opinion, or was illogical or irrational, would be able to call on a new Saatchi defence if they fulfilled the procedural requirements of the Bill. That is important: the Bill’s protection of doctors applies if the procedural requirements are met.’…
‘There is no requirement for the second doctor to have seen the patient or even read their notes, and no requirement for them to be independent. They could be working at the same private clinic. It is of little reassurance that the treating doctor must “take full account of the views” of the second doctor if the second doctor is in collusion with the first in that treatment, which may be unreasonable.
If the Bill is passed, we will put patient safety at risk and we will no doubt have to return to amend the legislation subsequently.’
Dr Wollaston continued, providing a compelling example of the terrifying and misguided Saatchi-future from a letter she had received, one of countless, indeed limitless, that would be given ‘carte blanche’ if the Bill is passed into law. She touched upon further problems including media portrayals of treatment, and the Bill working as a legal circumvention of the Cancer Act 1939.
These ‘very real concerns’ were echoed by Dr Julian Huppert, who put his PhD to good use in his career as a research scientist and fellow at Cambridge. He expressed concern for ‘people who…may be desperate for treatment’ and at risk of unethical practice, or unknown iatrogenic harms, noting
‘This is not just about cancer treatment but about a wide range of surgical treatments and therapies for any number of conditions.’
‘If the Bill is about reducing medical litigation so that doctors are free to undertake innovative treatments, why do those who are involved in medical litigation say that there is no need for it? The Medical Defence Union, the Medical Protection Society, even the NHS Litigation Authority, are clear that the law, with the Bolam and Bolitho tests, is well established. They feel that the Bill could increase uncertainty.’
If the Bill is passed and undermines enrolment in clinical trials, we will be doing a grave disservice to medical innovation, and it will be to our great shame to have done so.That is a fundamental flaw in the Bill. There is also a fundamental flaw in the premise that separate anecdotal treatments can progress medical research. Interestingly, clause 1(5) states: “Nothing in this section permits a doctor to carry out treatment for the purposes of research”. In other words, it specifically precludes the treatments being linked in any way, so we will learn nothing from these treatments.Lord Saatchi’s premise is that his Bill will advance medical knowledge, but there is no evidence that it will advance medical knowledge an inch because we will not be able to answer that fundamental question about whether there are unintended harms from the treatments or any long-term benefits. The history of medicine is littered with good intentions and innovations that seemed like a good idea but turned out to have disastrous side effects. There is an assumption that all innovation must be good innovation, but much innovation can be dangerous.’
Dr Huppert continued ‘Professor Sir Mike Richards, who is one of the country’s foremost and respected experts in cancer… does not think the Bill will protect patients. We need to listen to the opinion of those who have serious concerns about such Bills.’
‘The list of bodies opposed to the Medical Innovation Bill is very long—the Academy for Healthcare Science, the Academy of Medical Royal Colleges, the Academy of Medical Sciences, the Medical Research Council, the Wellcome Trust, Action Against Medical Accidents, the Association of Medical Research Charities, the Association of Personal Injury Lawyers, the British Medical Association, the British Pharmacological Society, Cancer Research UK, the Good Thinking Society, Healthwatch, the Medical Protection Society, the Medical Defence Union, the Motor Neurone Disease Association, the National Institute for Health and Care Excellence, the NHS Health Research Authority and the NHS Litigation Authority.’
Remarking that Sir Robert Francis QC, ‘one of our most respected national authorities on patient safety’ opposes the legislation, Dr Wollaston urged careful reflection on ‘very serious words indeed’.
‘If there is misunderstanding then it should be corrected by guidance, not by legislation which exposes vulnerable patients to unjustified risk and deprives them of remedies when mistreated by those who have no acceptable justification for what they have done. The legislation is also opposed by the Royal College of General Practitioners, the Royal College of Physicians, the Royal College of Psychiatrists and the Royal College of Radiologists. That is an important list. Were we to title the Bill correctly, it would be called the medical anecdote Bill. We should be saying that it makes provision in relation to anecdotal treatments in medical treatment. If we titled it correctly, there would be no question whatsoever of its having Government support. I urge the Minister in the strongest terms please not to give the Bill Government backing. To do so, I think, would be to our great shame. We would undoubtedly have to return to amend it. It would put patients at risk, and it would put recruitment to clinical trials and genuine innovation at risk.’
Dr Wollaston restated that ‘a doctor who uses such innovative treatments within the NHS is protected under existing law …we do not need new legislation to make them available to patients’ and later, responding to George Freeman MP’s advocacy for the Bill on the basis of learning along the way, she asked:
‘Does the Minister accept that that cannot happen under the Bill, and that those things will remain a series of unlinking anecdotes? In medical science and for the safety of patients no one will be able to track whether there were unintended consequences or benefits, and it will not advance the cause of medical innovation whatsoever.’
Michael Ellis MP should consider these learned words carefully in his attempt to popularise the Bill and ensure a rapid passage through the Commons. While he’s considering them, he may wish to revise his explanatory notes and ensure press coverage accurately represents the Bill’s contents.
While ‘curing cancer’ may be thought of as a vote-winner for the election, MPs should be aware that rushing ill considered legislation to gain popularity points does not make them a good representative of their constituency’s interests. Legislation that entirely transforms the law of negligence, that alters clinical practice, doctors’ regulation and removes or diminishes and obstructs access to justice for vulnerable people, doesn’t serve the electorate, but does serve the short-term self interest of some MPs.
They must listen to Dr Wollaston, Dr Huppert, Sir Robert Francis QC, Cancer Research UK and many more. This Bill is not necessary, will not achieve its stated aims and on the contrary may be extremely harmful and damaging. It is not appropriate for the Bill to advance, and anything playing with lives, quality of life and diminishing legal and personal rights requires consultation and careful consideration as patients, doctors and all the public should be able to expect from a rational, responsible Parliament.