Medical Innovation Bill [HL]

Lord Brennan Excerpts

Friday 27th June 2014 Lords Chamber

[Lord Brennan (Lab)]

My Lords, everybody in the House admires the determination of the noble Lord, Lord Saatchi, in advancing the Bill. I am sure that noble Lords all agree that we should improve and enhance responsible medical innovation. However, the question to answer is not that, but whether the Bill performs a significant part of that objective. I speak as a practising barrister who has done medical negligence over the years on both sides, and as a trustee of the International Centre for Circulatory Health at St Mary’s Hospital, which regularly finances cutting-edge research into circulatory health.

Let us test the Bill against the objectives. First, is it necessary? Secondly, are there dangers? And thirdly, how does it fit in to an overall framework for improving medical innovation in this country?

First, is the Bill necessary? This point has nothing to do with litigation. It is highly unusual, and I cannot at present think of another example of a statute that gives legal immunity to a profession in certain circumstances. The Bolam test, as it is called after the case that decided it—which was explained by the noble and learned Lord, Lord Mackay—applies to all professions, not just to medicine. Therefore to give such an immunity by statute is highly unusual. The first and obvious question is: is it necessary? Is the present law lacking? I beg to differ from the noble and learned Lord, Lord Mackay, whom I respect as a most distinguished lawyer, for the following reasons.

The Bolam test—whether the practice accords with a responsible body of opinion—was developed in another case, called Bolitho, in which I appeared in one of the sides of the argument in the House of Lords, which said that that test had to be refined. If there are different bodies of responsible opinion, the test is not a numerical one—whether there are in existence such opinions—but looks at the logical basis to them. Can they be justified in risk-benefit analysis as being in the best interest of the patient and in accordance with a reasonable standard of care? That is an efficient test because it is not numerical; you can hypothesise on a specialised sector of medicine where there might be only two practitioners, or even just one, in a very specialised kind of operation, for example. The test would not fail because of numbers but would be applied on the basis of risk benefit and the logic of serious sustainable practice.

I therefore venture to suggest that the majority of lawyers and judges in this country at the moment would say that the present test was adequate and that it has not hindered the advance of a variety of medicine but has supported it. The noble and learned Baroness, Lady Butler-Sloss, in her then role as President of the Family Division, decided a case where the operation to be carried out on a patient who did not have capacity was pretty well unique. She determined that case on the Bolam test—was it logical and in the best interests of the patient? This has nothing to do with litigation but is to do with principled conduct of professional practice in this country. I am not aware of any evidence of a substantial kind that litigation is affecting doctors’ ability and desire to introduce innovative treatment.

The next question is: are there dangers? The Bill does not distinguish between private and public medicine. Its text almost presupposes public medicine as the paradigm. It refers to any condition, as the noble Lord, Lord Colwyn, pointed out, at any stage of that condition. The risk is obvious. Some practitioners, small groups in a private practice, or the private sector of a medical practice will know that they are going to be legally immune, or will feel confident that they are, and will take advantage of this. It is self-evident. We know, historically, how vulnerable patients will do anything; even with pretty average clinicians, when they have no great confidence in them, some people will do anything in medical terms. That is a danger, and this Bill does not embrace sufficient protections to meet that danger.

Noble Lords should remember the MMR scandal, where the proposed treatment of the rebels led by the medical man who produced the paper, was, “Let’s have a treatment that involves no treatment—don’t give the MMR jab”. We cannot assume that, in this modern world, everybody will act responsibly. There is a risk of medical quackery, and the Bill is not presently sufficient to meet it.

Finally, what about the bigger picture? It is dangerous to conflate the words “doctor”, “patient” and “treatment” as the basis for a test of medical innovation, because it does not take into account the supply chain of medical innovation—the inventors, universities, medical scientists and the big medical companies in pharmacology, or whatever, all of which are inventing. That passes on into clinical trials—and, as the noble Baroness, Lady O’Neill, pointed out, they need serious attention—and into the medical marketplace, where doctors learn about it and apply the treatment. They are the end point in a long process. This Bill does not take that process into account but concentrates particularly on the doctors’ decision. I suggest to the House that that is inappropriate. If we want to do something about medical innovation—I refer to the contribution of the noble Lord, Lord Turnberg—we must look at bureaucracy and regulation and other impediments. With the challenge of cancer and diabetes, with which my trust is concerned, there is much more to be done. We should not allow this Bill to detract from the fact that those major illnesses require a major campaign or programme—call it what you will—by society in general and the state in particular. I am deeply concerned about this Bill, but it could be the vehicle for a much greater attempt to improve medical innovation.