The Access to Medical Treatments (Innovation) bill aims to protect doctors from “fear of legal action” when trying out new or unusual treatments. It was first proposed by Lord Saatchi, who argued that radical treatments were being denied to desperately ill patients because doctors feared being sued. But the so-called “Saatchi bill” is a Trojan Horse that will put patients at risk and could impede the very innovation it seeks to promote.
“Society has become more litigious,” says the Saatchi website. “An unintended consequence of existing law is to act as a deterrent to medical innovation.” Chris Heaton-Harris MP, who has taken on the second version of the bill in this parliamentary session, has repeated this argument. But the bill (both its old and new incarnation) has been flawed from the outset, as its objective is based on a problem that doesn’t exist: that doctors are not innovating for fear of being found negligent if a treatment goes wrong. But is there any evidence to support this?
The overwhelming (although not unanimous) response to a Department of Health consultation on the original bill was that innovation was not being deterred by a fear of litigation. Despite supporting the second bill even George Freeman MP, under-secretary of state for life sciences, admitted that “organisational, cultural and financial barriers are higher concerns”.
The Medical Defence Union – which knows a thing or two about clinical negligence – has said there is no evidence that doctors are avoiding innovation because of a fear of litigation (as has Cancer Research UK). On the contrary, its members contact it for advice on how best to go about innovating. More than 100 leading oncologists wrote to The Times to say it was not a deterrent. Heaton-Harris himself chose to introduce his bill by acknowledging that:
Not a day goes by without those practising medicine in our national health service innovating. Talk to any doctor, and especially any surgeon … and they will show how they have been innovative and, in being innovative, how they have helped those they are trying to treat. The levels of innovation are, without doubt, inspiring.
The history of innovation in the NHS includes antibiotics, vaccines, modern nursing, IVF, CT scanners as well as discoveries about the blood and DNA. Innovation is clearly not under threat from the fear of litigation. And analysis of the current legal framework reinforces the view that if there are any clinicians who are afraid to innovate because of a fear of litigation, this stems from a fundamental misunderstanding of the law.
The Bolam and Bolitho tests
The current legal framework for establishing whether treatment – innovative or conventional – has been negligent is formed of two parts. The first from the 1957 Bolam case, where it was held that “a medical professional 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”.
Another safeguard was added by the Bolitho case, where a requirement was added that a course of action, even if supported by a responsible body of medical professionals, must also be capable of “withstanding logical analysis”. In practice, this provides a pragmatic balance between ensuring patients can have redress if treated negligently, and providing a supportive legal environment for innovation.
The existing Bolam and Bolitho tests support responsible innovation, and herein lies the danger of the bill.
The current wording of the bill that “a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion” seems to mirror the Bolam test. But any reassurance is specious – elsewhere it says that it isn’t negligent for a doctor to depart from the existing range of accepted medical treatments “if the decision to do so is taken responsibly,” including asking at least one “appropriately qualified” doctor whether the treatment in question would be supported by a responsible body of medical opinion.
As Heidi Alexander MP pointed out in the parliamentary debate, this relies heavily on the other doctor’s subjective interpretation, rather than (as Bolam would provide) it actually being supported by a body of medical opinion. There is nothing in the wording of the bill to suggest that the other doctor’s opinion necessarily has to be listened to. The threshold for whether a decision would be supported by the medical community is therefore considerably lowered, introducing a risk that patients who are harmed by irresponsible care masquerading as innovation will have reduced routes for redress.
Unfortunately, this is not the only way in which the current law is potentially affected. Although the bill seems to make some effort – however flawed – to accommodate the Bolam test, no equivalent effort has been made to incorporate the Bolitho test – that a treatment must also withstand logical analysis. This is tantamount to saying that any doctor innovating with no logical basis for their actions is exempt from a negligence claim, no matter the harm caused by the decision – as long as a lower threshold for the Bolam test has been met.
At the heart of the bill is a fundamental logical problem. The drafters say doctors are “not negligent” provided a specific process is followed in advance, but it still suggests that negligence law could apply after the treatment, which makes a distinction between the decision to try a new treatment and the actual performance of the treatment itself. Surely any clinician put off by a risk of being found negligent for deciding to try something new – a complicated new surgical technique, for example – will still be put off if the bill leaves them liable for any mistake made in applying that unfamiliar treatment or technique. If the bill recognises the importance of patients being safeguarded after treatment, then it seems fundamentally inconsistent not to apply this principle to a treatment decision itself.
Instead of clarifying the law of clinical negligence in order to promote innovation, there is a danger that legislation of this nature will foster confusion and generate more litigation, which – ironically – could impede the innovation it seeks to unleash.
Database already possible
What of the merits of a database? The bill proposes that a database of innovative medical treatments be created that can be shared with others. Heaton-Harris maintains this will guard against the quackery that some fear will be a consequence of its passage. But even if there was consensus about this being a good thing, this is still no reason to pass the bill. The secretary of state for health already has the power to establish such a database under the Health and Social Care Act 2012. To be effective it would have to be compulsory to submit to; far from cutting the Gordian Knot of red tape, it would more likely tighten it.
The Academy of Medical Royal Colleges, which also rejected the bill, was also particularly baffled by the spurious distinction between innovation (the purpose of the bill), and research (specifically excluded in the bill). “Innovation without research isn’t innovation, it’s more often just advertising,” it said.
To his credit, Heaton-Harris undertook to consult, listen, and take advice. He should now listen to the doctors who say they aren’t put off innovation because of a fear of litigation. And to the Greater Medical Council, whose guidance already clearly tells doctors that they can use innovative treatments in the same way that they use conventional treatments, underpinned by with good clinical decision-making and patient consent. Most importantly, he should listen to the Patients Association who have condemned the bill as an “ill-judged, dangerous and unnecessary attempt at legislation in this area.”