Medical innovation under the microscope - the Saatchi Bill

Following the death of his wife in 2011 from ovarian cancer, Lord Saatchi introduced a Bill which would allow doctors to offer patients suffering from diseases or conditions that were not responding to conventional medicine, innovative treatments that had not necessarily been subjected to rigorous testing.
 
The underlying motivation for the Bill is the belief that many doctors are deterred from trying new procedures for fear of being sued for medical negligence. The arguments for and against the Medical Innovation Bill, more commonly referred to as the Saatchi Bill, are heated: proponents argue that doctors’ hands are tied by guidelines which are too prescriptive – even when tried and tested treatments are no longer working; while opponents believe that the current law does not stop doctors trying new procedures but does, more importantly, protect patients against irresponsible experimentation.
 
The Saatchi Bill – what it proposes
 
Jeanette Whyman, Head of Medical Negligence with Wright Hassall comments “On the face of it, it is perfectly understandable why Lord Saatchi has proposed this Bill. He lost his wife in painful circumstances and is strongly of the opinion that the medical profession is shackled by the fear of litigation making doctors unwilling to try remedies that might help in individual cases”. The Bill has proposed safeguards to ensure that the "doctor who acts alone and in a reckless way" is exposed as a maverick (that word plus the use of ‘quackery’ is used a great deal by both sides and reflects the emotional undertone of the debate).  One such safeguard is that any doctor proposing an innovative treatment must seek the agreement of a multi-disciplinary team with expertise in the relevant area and his / her Responsible Officer in order to proceed. By doing this, supporters of the Bill argue, doctors are applying the principle of the Bolam test (whereby they must, if accused of medical negligence, establish that they acted as any other responsible medical professional would have done under similar circumstances) in advance of the treatment rather than retrospectively. Lord Woolf, himself a supporter of the Bill, believes that it is not a ‘charter for risky experimentation’ but a genuine desire to improve the treatment for those for whom all else has failed.
 
Do we need the Saatchi Bill?
 
According to a long list of eminent organisations and individuals, the answer is no, or at least not in its current format. The Medical Defence Union (MDU), the NHS Litigation Authority, the Royal College of Physicians, Sir Robert Francis QC and Cancer Research UK, among many others, all refuted suggestions that fear of litigation was holding the medical profession back from innovating. Indeed, many of the comments received from the public consultation suggested that this Bill would actually protect maverick doctors who, having harmed a patient by trying an untested treatment, could avoid a claim for medical negligence by retreating behind this Bill which had essentially allowed the experimentation. Opponents of the Bill argue that the current law is able to differentiate between responsible medical practice and incompetence - which is not the same thing as stifling innovation - thus making further legislation unnecessary. They also make the point that many patients who are likely to consent to a new treatment are often desperate and thus vulnerable to persuasion by doctors willing ignore responsible medical opinion. Claims by supporters that it will help to further research into rarer cancers and diseases which, they maintain, are currently overlooked by larger research projects are also challenged by opponents. Cancer Research UK notes that research into effective treatments has to be scientifically robust if it is to benefit the majority. Experimentation on individuals will be of limited benefit although a project team at Oxford University has offered to store data from individual cases enabling them to map trends.
 
In short
 
The government, while supporting this Bill in principle, has acknowledged its shortcomings and has committed to incorporating amendments to overcome objections raised by opponents. However, judging by a recent announcement by Dan Poulter when he outlined the likely changes, the proposed legislation will offer nothing more than the current law. I think what this debate has helpfully highlighted is that doctors who do their job responsibly do not fear medical negligence claims and are not dissuaded from pursuing innovative treatments if they genuinely feel they will make a difference to the patient. This Bill, if it becomes law, could end up protecting doctors who actively harm patients by going out on a limb to carry out untried and untested remedies – which is the opposite effect of what it is trying to achieve. The Bill has now reached the Committee stage where it will be examined in detail against the backdrop of responses received from the public consultation which closed in April.
 
This article is courtesy of Jeanette Whyman, who heads up the team of Medical Negligence Solicitors with Wright Hassall.