Monday, 31 March 2014

Re-writing the Bolam Test

The consultation on Lord Saatchi's Medical Innovation Bill is open until the end of April. I have previously posted on the Bill. Against my better judgement I am returning to the issue here. The reason why is that there have been, as yet,  few public comments from representative bodies of  doctors and patients (other than the MDU which is not supportive of the Bill)  and, to my surprise, little noise from clinical negligence lawyers. Meanwhile the public is busy responding to the Bill having been told that it will lead to a cure for cancer (see my previous posts). It will be unsurprising therefore if the response is largely positive!

The government's view can be predicted from the way it has introduced the consultation:

"We want to make sure doctors are not held back if they want to use pioneering treatments to offer a lifeline to dying patients..."

What kind of evil person would want to hold back pioneering treatment and deprive dying patients of a lifeline?

Well, sorry, but I do oppose this Bill. In my opinion the existing law of clinical negligence does not hinder innovation. The claims made for the Bill are far-fetched. The Bill is unnecessary but, more worryingly, it will remove reasonable and proportionate patient safeguards.

The present law

A doctor who provides treatment or management of a patient which a responsible body of fellow practitioners would support is not negligent, even if most other practitioners would not support it. A doctor is only negligent if no responsible body of fellow practitioners would support their treatment or management. If that negligent treatment or management harms the patient then the patient will be entitled to compensation for their injuries.

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.

The Bill
Clauses 1(1) and (2) of the Bill seek to change the law on clinical negligence by providing that a doctor is not negligent if he treats or manages a patient in a manner which no responsible body of medical opinion would support, provided the decision so to treat or manage the patient is "taken responsibly".

A decision is taken responsibly under the Bill if the doctor bases it on certain considerations and makes it by an open process. By clause 1(7) factors which "may be taken into account" in determining whether the process of decision making was open include:

(a) whether the doctor has discussed the proposed treatment with the patient and given the patient the explanation that the doctor would in the circumstances be expected to give of the doctor’s reasons for carrying out the treatment,
(b) whether the decision has been made within a multi-disciplinary team, and
(c) whether the doctor has given notification in advance to the doctor’s responsible officer (if any).

Proponents of the Bill have claimed that it requires that a "panel of senior doctors" will have to approve the proposed treatment. As can be seen, that is not so. Clause 1(7) sets out factors which may, not must, be taken into account and 1(7)(b) does not require the approval of a panel of senior doctors. The MDT might not include any other doctors at all. Clause 1(7)(c) requires only notification to not approval of a responsible officer.

Patient Protection
Over emphasis on patient protection might in principle thwart other desirable goals but I do not believe that depriving patients of compensation when they are harmed by doctors who act in a way which no responsible body of practitioners would support is the right way to promote innovation.

Take the hypothetical case of a maverick doctor who genuinely believes that vitamin x capsules can cure bowel cancer. He sets up a clinic with a  nurse and a nutritionist with whom he consults before giving treatment. In fact his capsules are ineffective but do cause severe liver problems in some patients. Those patients sue for negligence. No other doctors would support the treatment. Under the current law those patients would have a remedy. If this Bill is enacted the doctor would have a defence. And if he has a defence in law, how could the GMC seek to intervene to prevent such conduct?

You can respond to the consultation here 


  1. An interesting issue Nigel; not one that is presently under consideration in Australia but I have put a link to your post from my blog. Regards, Bill Madden

  2. Nigel,

    Once again well done for this magnificent blog.

    The Saatchi Innovation Bill is nonsense in its current form since while claiming the current system it is undermining innovation it is itself by failing to:-

    1) Manage the risk in real time ensuring that patients are fully aware of the risks and are bought into the various steps of a procedure and treatment before passing the point of no return. If there are decisions to be made based on future unknowns patients should know what they are and have already signed off on them;

    2) Simplify the legal assessment of a Duty of Care by capturing high quality data on treatment approaches vs outcomes so that negligence becomes not subjective based on who pays for the medico legal but truly independent;

    3) Provide irrefutable facts to a court using real time video capture of patient and medical interaction secured to medical records and only accessible for court purposes would revolutionise negligence claims by simplifying them, reducing court time and court costs.

    When I criticised you before Nigel I was too focussed on your response to changes in negligence and not enough on the Bill itself, Bolam needs to be rewritten but not with this ill thought out legislation based on the individual experience on a single but important individual.

    Alan Edwards

  3. Well said Nigel. As you know the Bolam test itself is a poor safeguard. This bill makes matters worse with all due respect to Lord Saatchi.

  4. This will result in every quack and charlaton across the World setting up shop in Harley Street. It will make our pre-Simon Singh libel laws look reasonable. There needs to be a strong response from the medical professional bodies. There won't be one from the public as it is presented. They want to be able to choose an unproven "cure" for their loved one who is desperately ill.

  5. This bill will allow every quack and charlaton to set up shop in Harley St. It will make our pre-Simon Singh libel laws look sensible. There must be a strong response from the professional bodies. Why is it silent in the press? Teesside SitP

  6. You have really raised a very important point concerning the doctors practice. I hope that
    gmc for doctors will take steps to improve the existing conditions