Medical Innovation Bill [HL]

Debate between Lord Kakkar and Lord Pannick

Friday 23rd January 2015 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I declare my interest as professor of surgery at University College London and as a member of the General Medical Council, although I do not speak for the council in this Chamber.

I thank the noble Lords, Lord Winston and Lord Saatchi, for having tabled this important amendment. It goes to the heart of good medical practice, of course, always to innovate—but always to innovate, first and foremost, with absolute regard to patient safety. The fact that the amendment will now appear in the Bill will provide absolute clarity on what is required to discharge that patient safety responsibility with regard to innovation, as described in the Bill, which is vitally important. I strongly support the amendment. Once again I thank the noble Lord, Lord Winston, for his contributions in the passage of the Bill and, in particular, for tabling this important amendment.

[Lord Pannick (CB)]

My Lords, I, too, welcome the amendment. It will further emphasise that, in order to be lawful, medical innovation must be responsible. The criterion of responsibility has been the essence of the law on this subject since the judgment of Mr Justice McNair in the Bolam case in 1957, when he said that a doctor,

“is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”.

That may provide some reassurance to the noble Baroness, Lady Gardner of Parkes, that the courts will easily understand what is involved in the amendment.

The amendment will reassure many of those concerned about patient safety. The words will further confirm what I understood to be the Minister’s statement in Committee that the Bill is not intended to alter the substance of the Bolam test but to provide a practical means by which innovative doctors can take steps in advance of carrying out the treatment.

Like the noble Lord, Lord Winston, I am less confident than the noble Lord, Lord Saatchi, that this Bill will have much, if any, beneficial effect. I am doubtful that the fear of litigation deters responsible innovation, but I have been reassured by the amendments that the Bill will certainly do no harm. I thank the noble Lord, Lord Saatchi, for the responsible manner in which he has responded to concerns about the Bill by welcoming amendments of this sort. I also thank Mr Daniel Greenberg, a former parliamentary draftsman, now an expert consultant, for the assistance that he has provided to many noble Lords, including myself, on the issues raised.

Mesothelioma Bill [HL]

Debate between Lord Kakkar and Lord Pannick

Wednesday 5th June 2013 Grand Committee

[Lord Kakkar]

My Lords, I support Amendment 31. In doing so, I declare my interest as professor of surgery at University College London, an institution that is actively involved in cancer research. We have heard about the importance of mesothelioma and the impact that it is going to have in the next 30 years with regard to the deaths of many tens of thousands of our fellow citizens. However, I wish to build on the comments of my noble friend Lord Walton of Detchant, who has spoken with considerable eloquence about the importance of research. This is a disease that is going to afflict many of our fellow citizens but there is no strategic defined national research initiative for it. That is quite striking, and it is a serious deficiency in the otherwise hugely successful and important approach that successive Governments have taken towards having a national research effort, conducted either through the work of the Medical Research Council or through the National Institute for Health Research.

We have heard about the important role that four insurance companies have played to date, providing some £1 million a year between them to support research in this area, supplemented by important charitable contributions. We cannot underestimate the importance of even this small contribution to having kick-started research and academic interest in this area. The meso-bank that we have heard of is a very important national initiative that will have global significance, because collecting tissue from patients afflicted with mesothelioma provides the opportunity for fundamental and translational research on those tissue samples to ensure that there is better understanding of the disease.

As we have heard, there is no opportunity at all to develop either better diagnostics or indeed treatments and cures for this particular form of malignant disease unless we understand fundamentally its biology. Collecting tissue using tissue banks and bio-banks is the basis of modern medical research, and it would not have been possible without the contribution of insurance companies and the work of the British Lung Foundation in having facilitated that. However, this work—these bio-banks, the meso-bank—needs to continue in future.

On that basis, large academic groups have started to focus on the question of mesothelioma. That would not have happened without the funds currently available. Scientists, academics and clinicians have come together, now in reasonable numbers, to focus on the question of mesothelioma as a result of recognising that funds to support their research would be available. If the signal cannot be sent in future that funding for research in this area will be available, regrettably, no research will be undertaken. That is the simple truth: without funding, research cannot be promoted and completed.

Interesting work is being undertaken at the Sanger Institute in Cambridge as a result of the limited funding currently available, which has allowed the first molecular characterisation of mesothelioma, providing a better understanding of genetic mutation and signalling pathway defects which could offer targets for future drug development. A disease in a similar situation to mesothelioma some years ago was melanoma, the malignant skin cancer. As a result of research focus and a better understanding of the molecular biology of melanoma, we can now offer patients biological therapies targeted specifically at the genetic and signalling defects that characterise their cancers, improving the outlook for certain patients with certain types of melanoma. It is surely possible to conceive that, with appropriate research funding, the same might be achieved for mesothelioma.

In addition to those two important areas—the meso-bank and genetic and molecular research into the nature of mesothelioma—the limited funds available for only a three-year period have also stimulated important research into better palliative care for patients with mesothelioma. Again, that is vital, because the median survival for that disease is only 12 months. Those few who respond to current chemotherapy have only an additional two months—eight weeks—of added median survival. For the vast majority, the reality of modern care is palliation of their disease, so research into appropriate palliation is vital, again supported by those limited funds.

I had some hesitation about the implications of the amendment more broadly but, having listened to the important contributions so far in Committee, it is clear that there is a potential route forward to pass an amendment that would stimulate the national research effort in this area. It would ensure that we are able to provide important funds either through having available in statute but not using—as, we have heard, is the case with the Gambling Act 2005—or having a tool available to apply to members of the compensation scheme. There is an important discussion to be had about how those funds would then be distributed to research-active organisations to ensure appropriate peer review, and that mechanisms from the National Institute for Health Research or one of the research charities could be used to facilitate it.

Without the emphasis in the Bill, it is likely that the early progress being made towards better understanding of the disease and, ultimately, providing treatment for it will be lost. That would be a great shame for the tens of thousands of our fellow citizens who will suffer from that terrible condition.

[Lord Pannick]

My Lords, I, too, support Amendment 31, for all the reasons powerfully advanced by the noble Lord, Lord Alton of Liverpool, and other noble Lords this afternoon. I should be very surprised if the Minister were to suggest that there is something inappropriate about a statutory levy on an industry to promote a valuable public purpose. It is not only in the Gambling Act 2005, there are other statutory examples that one could refer to. As long ago as 1963, Parliament decided that, under Section 24 of the Betting, Gaming and Lotteries Act, the levy board has a power to charge on all bookmakers involved in horserace betting, the levy to be spent for the purposes of improving the breeds of horses, the advancement or encouragement of veterinary science or education and the improvement of horseracing. So there is nothing novel about a statutory levy on a particular industry for a particular valuable purpose.

The noble Lord, Lord Alton, mentioned the Human Rights Act. The Minister has told us today that he cannot comment on whether he has had legal advice, but I would be astonished if his advice were that the Human Rights Act somehow stands in the way of a statutory levy on industry in this context. Parliament has a very broad discretion in the context of property rights, because that is what we are talking about, on the proper balance between individual interests and the public interest. It would be quite fanciful to suggest that there is a legal reason not to support an amendment such as Amendment 31, although I entirely accept that there may well be room for improvement in its drafting.