Stop the Saatchi Bill

Driven by an extraordinary two-year PR campaign on social media and a supportive newspaper partner, this all started as Lord Saatchi’s Medical Innovation Bill, metamorphosed through several versions, and was resurrected under a new name by Chris Heaton-Harris, before finally clearing its last hurdle in the Lords this week to become the Access to Medical Treatments (Innovation) Act.
Pretty much the only thing they share is the word 'Innovation' in the title.

One day, it may be possible for politicians to ask the people who actually work in the medical field: what are the problems you face, and how can we help you overcome them?

One day, politicians may actually listen to the answers they receive, and thus try to tackle genuine problems rather than imagined ones.

One day, politicians, medics, researchers, lawyers, patient groups, charities, and the public, may work together to overcome the barriers to the development and provision of new treatments.

But it is not this day.

Read more: Not this day

The Medical Anecdote Bill

MP Dr Sarah Wollaston was able to instigate an Adjournment Debate in the House of Commons yesterday on the Medical Innovation Bill.

The former GP gave an excellent summary of the very many serious concerns many informed doctors, researchers, lawyers and others have that the Bill will be a disaster for patients and research. She was ably assisted by former research scientist Dr Julian Huppert who clearly also understood the real issues with the Bill and its implication for patient safety and innovation.

Together, they raised many questions and it was left to the Parliamentary Under-Secretary of State for Business, Innovation and Skills, George Freeman, to answer. Unfortunately, many questions remained unanswered.

The whole debate can watched here, starting at 16:34:50:

(Go to Parliament TV for other viewing options.)

A full transcript can be found in Hansard, but here are some key extracts:

Dr Sarah Wollaston:

Like books, one should never judge a Bill by its cover. Later this week, the Medical Innovation Bill reaches Report stage in the House of Lords, but I would like to demonstrate that 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.

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 Julian Huppert:

I thank my hon. Friend for giving way and for securing this debate on an important subject. It is a shame that more people are not in the Chamber to discuss it. There are some very real concerns. Does she agree that people who are terminally ill may be desperate for treatment, and that simply makes them prey to people who may be unethical, who may be trying to push the envelope, and who may be doing things that would harm them but that sound quite good?

Does she agree that this is not just about cancer? We have already had homeopathic doctors, who may practise medicine as well as homeopathy, claiming that they have powerful treatments for Ebola that the World Health Organisation will not let them work on. The Bill would open the door for all sorts of quacks who will do serious harm in the name of medical innovation.

Dr Sarah Wollaston:

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. The MPS briefing says:

“Fundamentally, current law allows doctors acting responsibly to innovate, and this Bill is unnecessary. The time has come for the debate to shift towards improving education about the present law, rather than confusing the law through a new piece of legislation.”

That is another point that is worth bearing in mind.

Far from promoting medical innovation, the Bill could undermine recruitment to genuine clinical trials. If someone had been persuaded by the likes of the doctors in the letter that I read out that there was a miraculous treatment for their terminal cancer, why would they wish to be enrolled in a clinical trial and be part of a randomised trial? If they could circumvent that and go along to a private clinic, why would they do that? Medical research does not just answer the question about whether a treatment works; it also helps answer the question whether a therapy or procedure has serious side effects. 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.

The accusation sometimes made is, “Aren’t clinical trials just experimenting on people?” Far from it. There seems to be a benefit for everyone taking part in a clinical trial, even those who are not receiving a treatment that turns out to be more effective. 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. I would like the Minister to address that point when he responds.

That is a fundamental flaw in the Bill.

Where will the evidence be of benefit from those “innovative treatments”? Will the Minister look carefully at that, and be clear in responding? 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.

Richard Francis QC, one of our most respected national authorities on patient safety, opposes the legislation. I think that we ought to reflect carefully on his words:

“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.”

Those are very serious words indeed. 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.

There is a powerful lobby in favour of this legislation that purports that those who oppose it are somehow dinosaurs.

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.

All excellent points and many more were made by Dr Huppert.

Some key points from Freeman’s reply:

I would be interested to see the Bill once it has completed its passage through another place and ensure that it contains adequate provision for evidence-based medicine, and that, by encouraging innovation, we are not in any way encouraging medicine that is not supported by the best evidence available.

I stress that the Bill has not been given Government time. We are supportive of its principles, but it is very important that when it leaves the House of Lords, where it will have been subject to extensive scrutiny by very eminent medical and legal opinion, it comes to us in a format, even if not every single point is unanimously supported, that has the very strong support of our most senior lawyers and medics.

I want to close by highlighting the fact that the Bill has generated substantial interest, both in Parliament and outside. In many ways, if those concerns can be reflected in high-quality scrutiny and the tabling of amendments, we should be able to demonstrate that democracy works and end up with a Bill that both achieves the aims of Lord Saatchi and reassures those with concerns. I want to be clear that, as the Bill completes its passage in the House of Lords, I hope it returns to this House in a form that the vast majority of medical opinion and respectable bodies in the medical field feel able to support. It is not our intention to have a Bill that undermines public or patient trust in research medicine.

We are concerned that although some of the answers Freeman gave were helpful, we were not convinced that he either fully understood the Bill or fully understand some of the very many serious concerns raised in the debate, in the consultation or elsewhere.

We would urge you to watch the short debate or read the full transcript.