I was reminded of this on reading Lord Saatchi's proposed amendments to his Medical Innovation Bill. He has tabled these after discussions with the government and Sir Bruce Keogh, the Chief Medical Officer. You can read the amendments and commentary on them from the Saatchi Bill team here.
In the House of Lords debate on the second reading of the bill Lord Saatchi said unequivocally that he would accept (unpublished) government amendments.
"I believe that the result of his work will be, as my noble friend summarised briefly, that the Government will themselves propose amendments to the Bill in the Public Bill Committee in the House of Commons. I hope that that may be an appropriate point for other amendments to be tabled, following the Government’s example in the Public Bill Committee in the House of Commons.
I give the House this undertaking. I and Michael Ellis, the MP for Northampton North, who will propose the Bill in the House of Commons, undertake here and now to adopt the government amendments that my noble friend and the Department of Health will put forward and to take them forward in our name in the House of Commons"
So far the government has not tabled any amendments itself, so these may be the last word on amendments by those who support the bill. If the government was to table its own amendments now, will Lord Saatchi withdraw his own amendments given his undertaking?
What is the effect of these amendments? In short, it is not altogether clear! One small amendment seems designed to widen the ambit of the bill considerably. On the other hand the wholesale changes to clause 1(3) would produce a bill which dismantles the Bolam/Bolitho test with one hand and reconstructs it with the other.
I commend an article by Professor Miola on the Stop the Saatchi Bill Website. I do not want to repeat the points he has made but wish to add to them as follows.
1." Innovation" and "innovative treatment" are still not defined. Treatment is still defined by the bill as including management and inaction.This bill is still not targeted at treatment which is new, which is for the terminally ill, or which is for conditions for which so-called "standard" treatments are ineffective. It would apply for example to a doctor whose treatment was outdated and was given for a broken leg. But the amendments introduce a new term. Previously it applied to departures from a range of accepted "treatment". Now it applies where a doctor departs from "the existing range of accepted medical treatments for a condition". The insertion of the word "medical"raises a whole new set of questions. "Medical treatment" as defined in a mental health context by s145 of the Mental Health Act 1983 as amended includes nursing care, psychological therapy and rehabilitation. Although "medical" is often used to distinguish treatment from "surgical", presumably there was no intention to exclude surgical treatment from the ambit of the bill? Would "medical treatment" include alternative management and treatments such as acupuncture or homoeopathy?
2. The second amendment is to leave out the word "decision" from clause 1(2) with the effect that the immunity for negligence is to apply to departures rather than decisions to depart from the range of accepted treatments. I must confess I gave that little attention when I first saw it but the explanatory notes say that the intention of the amendment is that the protection of the bill should apply to the decision to treat and "what the doctor does to put the decision into effect." I had previously drawn at least a little comfort from the fact that the bill only applied to treatment decisions not to performance. It seems that this small amendment is designed to provide immunity from a negligence claim for delivery of the treatment itself. So, if a doctor is negligent in the dosage of an innovative form of radiotherapy, he is to be provided with immunity. I am not sure that that is how the consolidated bill reads, but his is potentially highly significant and surely cannot be allowed to pass.
3. With the aim of "protecting" patients from irresponsible treatment decisions the amendments jettison previous requirements for an MDT meeting and notification of an authorised officer, and replace them with new procedural requirements . It has been claimed on many occasions that the bill will require the doctor to secure agreement to his proposed treatment. The amendments do not impose that requirement. The doctor would comply with the requirements by obtaining the views of one doctor who has "appropriate" experience and expertise in dealing with patients with the condition in question, and taking those views into account - the doctor does not have to agree with the other's views.
4. However there is a new requirement which requires careful scrutiny: the doctor providing the treatment must take "full account of the views" of the other doctor "and do so in a way in which any responsible doctor would be expected to take account of such views."
This bill has no purpose unless it provides an immunity for a doctor who provides medical treatment which no responsible body of doctors would support. Thus the bill now supposes that a doctor can take into account views on the proposed treatment in a way in which any responsible doctor would do, and yet still give the treatment which no responsible body of doctors would give. Thus there is now a new Bolam test: not in relation to the treatment given, but in relation to taking into account the views of another doctor.
This bill is intended to provide certainty and clarity to doctors but if, as claimed by Lord Saatchi, doctors are riddled with uncertainty about whether their treatment would pass the Bolam test when examined by the court several years later, how will a doctor know if his taking into account the views of another doctor, will pass a similar test when examined by the court several years later?
5. The following considerations would be relevant as to whether the doctor has acted in a way any responsible doctor would have acted when taking into account another doctor's views on proposed treatment?
- were the other doctor's views sought in relation to the particular patient or generally in relation to the proposed treatment - were they generic views or specific?
- what information did the other doctor have? Was it in writing? Had he examined the patient?
- did the other doctor discuss the case and options with the patient?
- did the other doctor support or oppose the proposed treatment decision?
- was the other doctor's opinion given in writing or orally? What were the specifics of his or her view?
- was the other doctor's opinion rational?
- was the other doctor's opinion one which would be supported by any responsible body of medical opinion, or not so supported?
- is the other doctor wholly independent? Is he or she in the same hospital team, the same private clinic?
- does the other doctor have any financial or professional interest in the decision to treat the patient in the way proposed?
- is the other doctor in a position of authority over the treating doctor or vice versa?
- is the other doctor expert not only in the condition but in the mode of treatment proposed?
- what was the time between the other doctor giving his views and the treatment being given - what has happened of relevance in that time?
- was it or ought it to have been evident that the views of experts in more than one field had to be taken into account (e.g. surgery, oncology and radiology)?
- was the doctor making the decision senior or junior, more experienced or less experienced than the doctor whose views were sought?
- were the other doctor's views communicated to the patient before the patient's consent was obtained?
- if the other doctor's views were against giving the treatment but the treatment was nevertheless given, what reasons did the treating doctor have for not accepting the other's advice, and were those reasons rational and justified?
- would any responsible body of doctors have so treated the patient having taken into account the views of the other doctor?
Will this consolidated bill lead to more or to less litigation in the future? As I have previously warned, I am sure it will lead to more.
So the Saatchi Bill has come almost full circle. Lord Saatchi thought that the Bolam test was preventing a cure for cancer. In its latest manifestation his bill actually introduces a new Bolam test as to how the doctor arrived at his decision to treat.
Isn't life for doctors wishing to innovate much simpler under the present law than it would be under the Saatchi Bill?
The medical establishment, along with patients' bodies and research bodies, spoke loudly and clearly in response to the government's consultation - this bill is unnecessary and unwanted. Once it looks at these amendments I would expect its opposition to become even more loud and more clear.