Medical Innovation Bill [HL]

Lord Turnberg Excerpts

Friday 27th June 2014 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, it is absolutely essential that we strive as hard as we can to find new cures and make them available as rapidly as possible. The principle behind this Bill is entirely in accord with that deeply felt need. I admire and respect the noble Lord, Lord Saatchi, for bringing the Bill forward in his persuasive and passionate speech. His motives are impeccable and he provided us with a valuable opportunity to debate this difficult issue.

Why has such strong opposition to the Bill been expressed by some significant bodies and respected individuals who cannot be easily dismissed? What does the General Medical Council have against it? We cannot really discard its fear of a rise in the number of cases of reckless and damaging practice. What do the Academy of Medical Sciences, the Wellcome Trust and Cancer Research UK have against it? CRUK says that the Bill is unnecessary because it can find no evidence that the doctors it supports are put off by a fear of litigation. What do the Patients Association and the charity Action against Medical Accidents have a problem with? Again, it is uncertainty about opening up patients to potentially damaging practices. Why is Sir Robert Francis still anxious about the Bill before us? A very respected medical litigation lawyer, he remains worried about the wording and safeguards in the Bill, and suggests that in any case it is unnecessary. These are significant anxieties from responsible people. At the very least they give us reason to be cautious about how we view the current Bill.

I hope your Lordships will forgive me if I spend a moment discussing the barriers to innovative practice. I fear that there are many. First, delays are imposed by an overly bureaucratic regulatory environment. The myriad regulatory bodies pose a major hurdle and there is much to do there. Then there are the funding issues. We still need much more money for research. There is the issue of affordability by hospital trusts and CCGs. Too often they find it difficult to provide the resources for very expensive treatments, even with the Cancer Drugs Fund, and because of that doctors are prevented from prescribing what they think their patients need.

Of course, we also have the natural conservatism of some doctors who seem unwilling to try anything new. However, the reasons for that seem more to do with a reluctance to try something of which they have had little experience rather than a fear of litigation. There is certainly need for guidance on good innovative practice, as described in the Association of Medical Research Charities publication, Our Vision for Research in the NHS. I declare my employment by the AMRC as a scientific adviser.

There are many targets at which we should aim if we are to improve access to novel treatments. Of course, the Bill is not designed to influence any of those. It is designed specifically to try to remove a fear of litigation by doctors wishing to use novel treatments. However that does not appear to be a problem in the major centres. For example, in the case of cancer treatments the Royal Marsden Hospital in London constantly tries novel treatments well before they have been approved or licensed. Oncologists working there say they do not need any help to innovate and are doing it all the time. They do the basic research, often with the involvement of the pharmaceutical industry, to produce new drugs and test them on their patients well before they have been approved and licensed.

Indeed, the whole personalised medicines agenda is one in which drugs are designed for very specific individual patients based on their own or their cancer’s genetic make-up. Clearly, the usual process of prolonged regulatory approval is inappropriate for these types of treatment. It is the case, too, that the majority of cancer patients are now in one type of clinical trial or another, where the possibility of litigation is not a barrier. Indeed, Mr Greenberg, Parliamentary Counsel, told me that the Bill is not intended for those situations.

Who is it intended for? Who might be put off trying something new on their patients for fear of litigation? Perhaps it might be an isolated doctor, outside one of the main specialist centres; a physician in private practice, general practice or a small district general hospital; or perhaps a surgeon wanting to try out a new procedure not tested elsewhere. These are the doctors we should certainly encourage to take up all the latest developments that have been shown to be effective at least somewhere or—preferably—refer patients desperate to try the latest possible treatment to a major centre that is trying them out in proper trials.

One can imagine the situation in which a new drug was being tried in America, Japan or Israel but not yet here and a doctor wanted to try it on his or her patient. Doctors can prescribe such drugs now on what is called a “named patient basis”, with all the safeguards of patient consent and a rational basis for the treatment to back them up. Certainly, better guidance on what doctors can and should do would be enormously helpful—the opportunity for debate that the Bill is giving us is invaluable in that regard—but the idea that someone working in isolation will come up with an entirely new treatment de novo seems inherently unlikely. Where will it have come from? What underlying research will have been done? What toxicity studies and tests will have been done to make it a reasonable option? Such innovation is far too risky.

Forgive me for going on for so long, but I wanted to explain why I have some difficulty with the Bill as it stands. Those working at the cutting edge of research and application of new treatments say that they do not need it; they have no fear of litigation. Those not working in the major specialised centres need better guidance, not a weakening of the law that might open opportunities for them to be more reckless than they are now.

I have read with interest and, I have to say, some confusion the legal opinions expressed by lawyers on both sides on the wording of the Bill. They have certainly made me realise why I am not a lawyer. I have also listened carefully to the wise words of the noble and learned Lord, Lord Mackay, but I also recognise that one has to be very cautious about accepting a Bill where there is room for disagreement among lawyers. Although the noble Lord, Lord Saatchi, for whom I have particular regard, has given us an extremely valuable opportunity to open up the whole subject of innovative practice—we certainly need that—and it may be possible to amend the Bill to make it more acceptable, we will have to look at that very carefully in this House. Meanwhile, I am sorry to say that I remain to be convinced that the Bill is the answer to the problem it seeks to solve.