Tuesday, 25 February 2014

The Saatchi Bill - Why?

Lord Saatchi's Medical Innovation Bill should be of great interest to all medical practitioners and all who practise in clinical negligence. The Bill is now open for public consultation. Click on this link for a copy of the Bill.  It is very helpful to have had the publication of guidance to the Bill including a detailed advice given by Christopher Gibson QC, although that guidance appears to address a previous draft of the Bill. It begins: "How can an Act of Parliament Cure Cancer?" which gives you some idea of the claims Lord Saatchi has made about his proposed legislation.


A patient can sue a doctor in negligence where he or she has suffered harm as a result of conduct of the doctor which would not have been supported by any responsible body of practitioners in the same field, at the relevant time.

The Bill proposes a change to the law on clinical negligence, providing that it shall not be negligent for a doctor to depart from accepted practice, even in circumstances where no responsible body of medical opinion would support that departure, provided he takes that decision responsibly. Whilst this is intended to promote departures from accepted practice which are positive for innovation, there is no definition of innovation and so the Bill seems to apply to all treatment which departs from "the pre-existing range of accepted treatments" whether it adds to progress or not. Doctors' conduct is of course not only governed by the law of negligence, but more directly by professional obligations, employment contracts and regulations. The Bill has nothing to say about those restrictions on doctors' innovative treatments.

The conceit driving the Bill is that the common law of clinical negligence is impeding medical innovation.

The proposed solution is to protect doctors from being held accountable in law when they cause harm to patients by giving them treatment which no responsible body of their peers would condone. Surely there are better ways of promoting medical innovation.

For those who counter by saying that the Bill only allows non-negligent treatment, the obvious response is to ask why the Bill is needed: a patient cannot now recover compensation for non-negligent treatment, whether innovative or otherwise.

Whilst I have serious reservations about the Bill, I recognise that it is an important issue and you can read about the proponents' views here . For a powerfully expressed view in the Health Service Journal opposing the Bill see here.

You can respond to the consultation on the government's website here

As the Bill progresses through the Parliamentary process it is important that its contents and potential consequences are recognised. I have set out key elements of the draft Bill below.

I have previously posted on interviews Lord Saatchi had given in support of his Bill, suggesting that some of the claims he made about clinical negligence law were incorrect. In fact the Bill seems to take as its starting point that innovative treatment is that which departs from "the existing range of accepted treatments for a condition".

However, the Bill provides that decisions to depart from accepted treatments will not be negligent if they are taken responsibly. Thus the test of what is  responsibly taken decision becomes crucial. Is this a substantive requirement that the decision itself should be a responsible one, or merely a requirement that a responsible process is undertaken when reaching the decision? It appears to be the latter. If it were the former then the Bill would be circular. Hence, under the Bill, provided the doctor can establish that he or she believes that there are plausible reasons why the proposed treatment will be beneficial and has considered factors set out at 1(5) of the Bill and has gone through the processes at 1(6) and (7) of the Bill, then he or she will not have been negligent (subject to clause 1(8)). The decision made and treatment given are not, at this part of the Bill, scrutinised, only whether certain considerations and processes were taken into account in reaching the decision.

One of the general protections at clause 1(8) is that nothing in the Bill permits treatment which is other than for the purpose of the best interests of the patient. Thus a doctor who departs from accepted practice but does so responsibly may nevertheless be negligent if he does not act for the purpose of the patient's best interests. This cannot be intended to be an objective test of what in fact was in the best interests of the patient - that would defeat the purpose of the Bill which is to protect doctors who might face a negligence claim when the patient is harmed by their actions (without harm there could be no negligence claim). It appears to be a subjective test - was the rationale and intention of the treatment for the best interests of the patient, whatever the outcome or the actual likelihood of the outcome? Thus this is very little protection at all.

The other general protection is that the doctor must provide treatment with such consent from the patient as is required by law. In other words, the doctor must act in accordance with the current law.

My primary objection to the Bill is that it is unnecessary. Firstly, I am not aware of any evidence, other than anecdotal, that medical innovation by doctors is impeded by the existing common law rules of medical negligence. Yes, doctors might be intimidated by the threat of litigation generally. But when considering truly innovative treatment, I doubt very much whether the law of negligence is relevant to decision making, as opposed to the requirements of the GMC, ethics committees and other regulations. Secondly, if the Bill merely seeks to codify the common law position in relation to negligence, then it will make no substantive change. When analysed many of the provisions simply require doctors to abide by the law. Chirstopher Gibson QC advised that :

 "I have considered this formulation [of the Bill]  with care. It seems to me that there is nothing in this draft that effects a substantive change in the law. By definition the Bill is not concerned with standard treatment that conforms to standard practice: I have considered how a Court would consider treatment that was intended to be innovative and which departed from standard procedure, and it seems to me that this is an effective definition of how the task would be approached. I believe that it succeeds in the aim of setting out a framework and defining an approach that does not change the existing law."

Why then is it needed if it does not change the law? Surely it is not the purpose of legislation merely to provide reassurance to a group of individuals, here doctors, because they do not appreciate fully the current law. That is a problem for other policies to address, but not one requiring a change in the law. In any event the Medical Defence Union has now said that it sees no need for the Bill and has no evidence that fear of litigation discourages doctors from innovating.

My secondary concern is that if it does produce any change in substance, it will be a change for the worse from the patient's point of view. I once had a case where a patient with a malignant melanoma with a poor prognosis was given treatment with high dose interferon. The doctor departed from standard practice (which was governed by a clinical trial at the time) and the patient died because of that departure. We obtained expert evidence that no reasonable body of practitioners would have acted as the doctor acted and that the departure from the protocol caused the premature death of the patient. This Bill, if passed, would give doctors like that a potential defence.


         The Bill, if enacted, could provide a possible defence to negligence claims where none was intended. One man's "innovation" is another's eccentric experimentation. A doctor whose actions were not supported by any reasonable body of his or her peers, could defeat a claim in negligence by pleading the innovation defence even where the weight he/she gave to the listed considerations was unreasonable and the decision he/she came to was also unreasonable. Provided the doctor can persuasively contend that he or she took into account the considerations set out in the Bill, made a decision through an open process, obtained consent and that the purpose of the treatment was to further the patient's best interests, then he/she has a defence to what would otherwise be considered unacceptable practice by all reasonable bodies of doctors (negligent). I don't believe that changing the law to provide that defence is desirable in the interests of patients or innovation.


9 comments:

  1. "My primary objection to the Bill is that it is unnecessary. Firstly, I am not aware of any evidence, other than anecdotal, that medical innovation by doctors is impeded by the existing common law rules of medical negligence. ... Surely it is not the purpose of legislation merely to provide reassurance to a group of individuals, here doctors, because they do not appreciate fully the current law."

    Unclear law is bad law; and uncertain law is bad law. It is a key function of legislation to clarify the law and bring certainty to its application.

    How many "anecdotes" are needed of doctors being afraid to offer innovative treatments before "anecdotal evidence" becomes "real evidence"? The purpose of the Government's consultation is to record enough evidence from doctors, patients and others to demonstrate that the present lack of certainty and clarity in the law is obstructing innovation, so as to put it beyond doubt that the Bill is needed, and urgently.

    When the Bill is enacted, for the first time there will be a clear statutory set of criteria and procedures (non-exhaustive - so that the medical profession can continue to control and develop its best practice) that doctors can follow and be confident that their innovation will be treated as responsible innovation; and the existence of an authoritative set of statutory criteria and procedures will serve the equally important function of making it more difficult for irresponsible innovation to take place with impunity.

    Declaration of interest: The author of this comment is a member of Lord Saatchi's Bill team.

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    1. There are plenty of regulations and rules in existence which govern trial and introduction of new treatments. You may have a legitimate beef with those, but the Bill is directed not to the regulatory regime but to the law of negligence.The question therefore is not whether medical innovation which benefits patients should be encouraged - of course it should. The question is whether a law should be passed to prevent patients (or their families) from being compensated for harm caused to them by what would now be found to be negligent treatment. Is that necessary? Will the new law actually promote the kind of innovation which will benefit patients?

      The common law is not codified and to that extent I cannot claim it to be certain. However, the test of what is clinical negligence is clear as Mr Gibson QC advised. That fact that some doctors (how many?) do not understand it is not necessarily the fault of the law. In any event it is wishful thinking to believe that statutory law in this field will bring greater clarity let alone that it will encourage more innovation. I accept your point about "anecdotal" evidence. Your knowledge will be greater than mine on the evidence available - is the Bill supported by the BMA and the Royal Colleges or by Cancer Research UK?

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  2. Thanks Nigel. Yes, we have support from a range of medical and other institutions and charities, all of whom we hope will be responding positively and constructively to the consultation. We are very anxious to use the consultation as an opportunity to explore how, as Christopher Gibson QC concludes in the opinion that you quote above, the Bill can "have a positive effect on stimulating innovation in medical treatment", while, as you say, not permitting activity that would now be classed as negligent by reference to best medical practice. We will be running a number of events for lawyers and others during the consultation, and if you or any of your readers might be interested in attending an event, or would like to continue the discussion in another form, we would be delighted. I can be reached for that purpose at daniel@danielgreenberg.co.uk. Many thanks, Daniel.

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    1. I could not disagree more with Nigel's position. I have taken an important case to the High Court myself and I was surprised as a financial engineer to the subjectivity of the entire Duty of Care assessment of doctors. Despite being a victim of negligence I was able to look dispassionately at how doctors were essentially forced to work in a nebulous legal framework where mistakes were assessed by medico-legal experts which used 3 standards, 1) at the standard, 2) below the standard and 3) seriously below the standard. The lag of rigour in the assessments mean it is very easy to get paid for views which support or contradict the claim's being made on the same evidence which leads to the years required to establish a breach of duty of care in court proceedings. The patients suffer because primary and secondary is limited by mitigating exposure of a duty which they do not understand since it is so subjective and needlessly complex. The first casualty of court is innovation, since who can innovate the medico-legal industry and assessment of duty will punish doctors even if no worse an outcome could have been expected from being "at the standard". This principle of "at the standard" encourage doctors to be nothing more than that, see more patients, offer standard care and benefit from less litigation risk. That's great if you want to keep our medical care at the standard in perpetuity. I personally think barristers like Nigel are against a review of the practice since uncertainty in legal cases is quite lucrative. I think the Saatchi bill is a welcome piece of innovation in a legal system which badly needed to modernise so that patients and doctors can manage risk and healthcare.

      P.S. There is a parallel project which if integrated with the Saatchi bill would further support innovation, CareData which while passionately opposed on the basis of its current implementation if used to advise and record interactions been doctors and patients could reduce negligence or the appearance of negligence in the first place. Managing risk should be preventative exercise, interpreting actions in law after the fact is too late and I believe that a Duty of Care needs to be managed in real time, not in a court at enormous cost based on arbitrary assessments by medico-legal's and the outdated Bolam test. Doctor's should be assisted in real time with their duties so treatments and recommendations are known against confidence limits of their peers at the time, not later. Simple and easily to implement, preventative and easy to communicate to patients.

      I hope the government starts to join the dots.

      Alan



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    2. Caveat: Saatchi's Wife died I believe as a result of innovative cancer treatment not being used or so I am told which would explain his involvement and the cancer link and fear of litigation given his status. My comments above are in no way supportive of the legal approach taken by Saatchi but my issue with the way criticism was been taken by Nigel. Changes in law as recommended by Saatchi et al are not going to make this happen, improved risk management assessment supported by technology coupled with indisputable consent procedures which are reflected in law will.

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    3. Alan, You make some challenging and far-reaching comments. It is difficult to have absolute rules for determining when patients should receive compensation when they suffer avoidable injury at the hands of a healthcare professional. Somewhere between compensating all (but what is an avoidable injury?) or none, you have to have a system for determining who should be compensated - a line has to be drawn. The current law relies on assessing conduct in any one case by reference to standards considered acceptable by the medical profession. I do not think the current test is complex, but agree that in some cases the line between negligence and non-negligent conduct is far from clear - that is why judges are sometimes (albeit very rarely) called upon to decide whether the line has been crossed. If a doctor carries out radical or innovative treatment which is or would be supported by at least one body of responsible medical opinion, he/she is not negligent. I am not convinced that removing the right of redress to patients injured by doctors whose conduct no other doctor would support is the best way of promoting medical innovation. Thanks for your interest in the blog.

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    4. Nigel,

      The bill will not work since it looks too narrowly at the problems which might limit innovation in medicine, it reads like a HRA interpretation of medical negligence which would completely ride rough shod over the present legal system while providing little clarity on how the law should assess the claimant's claim in relation to the risks at the time.

      You say it is difficult to have absolute rules, but surely we can start being a bit more scientific about this to achieve the end of more accurate and more efficient claim assessment. Lord Saatchi et al IMHO should be looking at addressing the problems facing claimants and doctors in terms of assessing claims:-

      1. Bolam test is an outdate and exceptional unreliable test for a doctor in the 21st century and yet we are still constrained today by it, innovation in law is just as important as innovation in medical practice.

      2. Medico-Legal's are rarely independent, particularly from their peers and the assessment of a doctor's likely negligence based on a peer review is again a symptom of the legal profession not innovating. All data relating to treatment should be captured, biometric data coupled with the treatment and variation of the treatment would not only prove invaluable to doctors risk assessing their own treatments but could be used in courts to understand the risk the doctors treatment took in a more independent and transparent way.

      3. The consent process completely needs to be overhauled so that the risk data from (2) can be made available to patients in advance, and the treatment plan is informed choice. The current practice of signing consent on a piece of paper relying on a surgeons best intentions is simply not compatible with informed consent. Patients should be shown a series of outcomes and approve those actions in advance based on the statistics derived from other patients, in their age group etc, given their symptoms.

      Lawyers have an important place in protecting patients rights, I also believe compensation should be greater in claims made based on experience of running a support group for victims of NHS Negligence for 2 years. But also having been through the system, I realise that part of the problem is lawyers are not been given the data and tools while forced to work in an outmoded legal framework which the Lord Saatchi Bill provides little improvement on and will almost certainly never be implementable in it's current form.

      Best,

      Alan



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    5. Daniel,

      As discussed below the bill needs to improve not confuse the legal framework. The mistake in medical law appears to be that because individual scenarios are almost in medical care, medical law leaves the assessment to the courts and the legal framework is define in vague and often unhelpful terms. The solution is statistics, capturing data at source from real life treatment scenarios and referring to this within a legal framework which can focus on defining the risks in a more definite way. Your treatment of a innovating scenario in the Bill will almost certainly never get to statute since it will just be more confusing than the current system since it will lack the years of precedents to support it. If you want to preach innovation in medicine, maybe you should look at doing the same with the law .

      A

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    6. edit: should read "individual scenarios are almost infinite in variation"

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