An Inexhaustively Incomplete (But Completely Exhausting) List of Saatchi Bill Comments

10th May 2014

Here’s a list of comments I’ve pulled from the responses various professional bodies and patient organisations have made to the Medical Innovation Bill – the so-called Saatchi Bill.

You may be forgiven for thinking it’s a bit rich, me complaining that the Saatchi Bill campaign is cherry-picking its evidence, and yet here I am cherry-picking quotes. The difference is that in each case I provide you a link to the source document. You can check for yourself whether I am misrepresenting or taking comments out of context.

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The comments
  • We have been unable to find evidence that fear of medical litigation is currently a barrier to innovation in cancer. (Cancer Research UK)
  • The RCP does not have significant evidence (anecdotal or through case examples) from our members and fellows, nor we understand do two medical protection organisations, that litigation or potential litigation is a substantial or primary deterrent to clinicians’ use of innovative treatment. (Royal College of Physicians)
  • However, at present, we do not believe the wording of the Bill achieves [the aims of the bill]. In particular, we have a concern that it could protect doctors deviating in a harmful way from standard practice. (Royal College of Surgeons)
  • A doctor should not be allowed to simply disregard a body of clinical opinion or colleagues in their multi-disciplinary team. (Royal College of Surgeons)
  • If the doctor considers that the proposed treatment would not have the support of a responsible body of medical opinion, as outlined in clause 1(3), and would therefore not satisfy the Bolam test if challenged in court, then the overwhelming likelihood is that the treatment will not be of value and there is a significant risk that it may be harmful. (Royal College of Radiologists)
  • Relaxation of these governance mechanisms, which this Bill proposes, risks exposing vulnerable and desperate patients to false hope, futile and potentially harmful (and expensive) treatments. (Royal College of Radiologists)
  • In our view the draft Bill should not become law. Fundamentally, we do not believe this legislation is needed. We do not feel that doctors are constrained as regards innovation and we believe that the current structures provide the appropriate checks and balances. (Royal College of Radiologists)
  • This goes some way beyond the Bolam test for medical negligence […]where the test is that a ‘medical man’ needs to act in conformity with a ‘responsible body of medical opinion,’ in other words, NOT in the manner of 1 (3) (a) and (b) of the Bill (The Royal College of Psychiatrists)
  • The Academy and medical Royal Colleges are not persuaded that the Bill will achieve its stated purposes and we are concerned that it could have unintended adverse consequences. (The Academy of Medical Royal Colleges)
  • We have not seen any evidence that suggests litigation or the possibility of litigation is deterring clinicians from innovative practice and, anecdotally, that is not the experience of members. (The Academy of Medical Royal Colleges)
  • However, there are serious concerns that the provisions in the Bill, which in effect obviate the Bolam judgement principle of having to seek support from peers gives undue weight to the unmediated judgement of an individual clinician. This could easily lead to innovation that is not responsible or in the best interests of patients.
  • It seems to give licence to be selective in the opinions which the doctor seeks and ignore views which do not accord with the doctors own opinion. If this is what is actually intended we do believe it is completely inappropriate. (The Academy of Medical Royal Colleges)
  • Individual medical Royal Colleges will have their own views but the overall general opinion of the Academy is that we do not believe the Bill should become law. (The Academy of Medical Royal Colleges)
  • A worrying element of this Bill is that it restricts the duty to consultation to ‘opinions expressed by colleagues whose opinions appear to the doctor to be appropriate to take into account.’ (Academy for Healthcare Science)
  • The Bill is concerned with medical innovation yet does not itself deal with the conduct of research. We feel that innovation and research are intimately linked since innovation requires an evidence base if it is to be put into practice, which is unachievable using data obtained from a single patient (or a small number of patients). (Academy of Medical Sciences, Medical Research Council and Wellcome Trust)
  • The BMA strongly believes that this Bill should not become law and, for the reasons outlined in this response, does not believe that primary legislation which focuses on redefining clinical negligence is the best mechanism to promote or encourage responsible innovation, should there be a need to do so, when other more suitable alternative approaches exist. The draft Bill is therefore unnecessary, risks removing important protections for patients and could encourage reckless practice, with attendant risks for patient safety. (The British Medical Association)
  • We have no evidence to suggest that the threat of litigation is a barrier to the provision of innovative treatment of this kind and we strongly question the necessity and desirability of introducing statute to clarify or change the law in this area. (The British Medical Association)
  • Clause 1(5e) requires doctors to consider the “opinions or requests expressed by colleagues whose opinions appear to the doctor to be appropriate to take into account”. The BMA has a number of concerns with this clause. As it only requires a doctor to “consider” such views it raises the possibility that he or she could ignore the views of colleagues who might vehemently disagree that the proposed course of action was justified. It also allows doctors to consult whomever they believe to be appropriate, which could in reality just be colleagues who agree with their viewpoint, arguably making the process redundant and offering no protection to patients. As footnote 9 in the consultation document acknowledges, there is no requirement that these colleagues are medical colleagues. This could mean that a doctor could ask any colleague for their opinion, irrespective of their training, impartiality or relationship with the doctor, and meet this requirement in the Bill. (The British Medical Association)
  • The BMA strongly believes that the draft Bill should not become law and, for the reasons outlined in this response, does not believe that primary legislation which focuses on redefining clinical negligence is the best mechanism to promote or encourage responsible innovation. (The British Medical Association)
  • We have been unable to find evidence that fear of medical litigation is currently a barrier to innovation in cancer. (Cancer Research UK)
  • The MDU does not have any experience or evidence to suggest that doctors are deterred from innovating by the fear of litigation. (Medical Defence Union)
  • No. The draft Bill should not become law. The current legal and ethical requirements upon doctors already provide adequate safeguards for patients and for doctors. (Medical Defence Union)
  • It is the bedrock of medical ethics that treatments must be both safe and efficacious, and these principles serve well to strike a balance that allows scientifically proven new treatments to be promoted without making it easy to exploit vulnerable people with a serious illness. We fear that the provisions of this Bill could undermine this position, and unintentionally open the door to the exploitation of people with MND. (Motor Neurone Disease Association)
  • Even if our fears were to prove unfounded, we must also observe that the Bill would not remedy the problem it is aimed at, for such a problem does not exist: uncertainty around the law or fear of litigation do not, as far as we can see,dissuade doctors from trying new treatments. (Motor Neurone Disease Association)
  • To pretend that this gives patients any protection from naked quackery would be misguided (Dr. Margaret McCartney)
  • The proposal of this Bill proceeds from a fundamental misunderstanding of the effect of the current law of medical negligence. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • If there is misunderstanding then it should be corrected by guidance, not by legislation which exposes vulnerable patients to unjustified risks and deprives them of remedies when mistreated by those who have no acceptable justification for what they have done. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • The scope of the Bill is uncertain and potentially far wider than the concerns expressed by Lord Saatchi. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • It is not difficult to imagine how such a freedom might be abused. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • There is an alarming lack of accountability or scrutiny or other safeguard built into the Bill.   It explicitly frees the doctor to offer treatment which has no support from responsible medical opinion. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • There does not appear to by anything to stop the Bill applying to treatment and practices believed to be dangerous to patients and which are not innovative, but which have been tried, tests, and found wanting. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • While the Bill excludes   “treatment for the purposes of research” from its ambit, it is far from clear that it protects patients from being induced to accept treatment which is untested but the experience of which will benefit the manufacturers. The learning from the use of innovative treatment will often benefit inventors as well as patients, but this Bill effectively passes the risk entirely to the patient and lifts it from the promoter of the treatment. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • It increases the risk to vulnerable patients of mavericks with irrational or unjustifiable grounds for proposing a treatment and those with commercial interests in promoting dubious treatments. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • The assessment suggests there will be a reduction in medical negligence claims. On the contrary there is likely to be protracted and complex litigation about the meaning of this Bill. (Robert Francis QC, author of the two Mid-Staffordshire NHS Foundation Trust enquiries)
  • As things stand the Patients Association would oppose this Bill (The Patients Association)
  • We are however concerned that legislation which aims to clarify and encourage good practice in terms of when medical innovation is responsible could have the opposite effect as well as unintentionally weaken the principles which we regard as fundamental to safe, effective patient care. We take the view, therefore, that legislation is both unnecessary and undesirable. (General Medical Council)
  • It suggests that doctors should take account of the opinions of ‘those doctors who they wish to’, and places on them no obligation to take account of the opinions of doctors who have relevant clinical expertise in the area. As currently drafted, this addition removes an important safeguard for patients by removing a key requirement of responsible practice. (General Medical Council)
  •  The current law does not mandate adherence to a standard treatment as Lord Saatchi has claimed. It allows innovative treatment provided a responsible body of medical opinion would support it. (Nigel Poole QC)
  • the Bill would have serious unintended consequences for patient safety and access to justice for patients harmed by clinical negligence. (AVMA)

 

I understand that at least two other patient groups – AvMA and HealthWatch UK– have also come out against the bill, though I haven’t seen their written responses yet.

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3 Responses to “An Inexhaustively Incomplete (But Completely Exhausting) List of Saatchi Bill Comments”

Trackbacks/Pingbacks

  1. Why there is no legal or medical justification for the Saatchi bill – BMJ | - May 27, 2014

    […] this dangerous ill-thought through concept and take stock of the consultation responses, their comments and their recommendations for something to ‘back’ that would be of real benefit to […]

  2. Ministry of Truth » Blog Archive » What Saatchi Doesn’t Tell You - June 4, 2014

    […] negligence claims but the reality is that this is some considerable way from the truth given what a wide range of professional bodies and patient organisations had to say in response to a recent Department of Health […]

  3. The overwhelming expert response against the Saatchi Bill must not be ignored | - June 4, 2014

    […] is like a runaway train about to wreak havoc on those least expecting it further down the track.– overwhelmingly negative from an exceptionally long list of expert bodiesfrom charities, from patient groups, health groups, […]

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