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.