Medical Innovation Bill [HL]

Lord Kakkar Excerpts

Friday 23rd January 2015 Lords Chamber

[Baroness Masham of Ilton (CB)]

My Lords, having tabled an amendment to the Bill on patient safety, I am happy to support the amendment.

[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.

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[Baroness Masham of Ilton (CB)]

My Lords, I am very pleased to support this amendment, to which I have added my name. Within the rare disease community, there is significant unmet medical need, and research and innovation are seen as the means through which new therapies for currently untreatable conditions will be developed. For this to make a difference to patients, the barriers to medical research and the adaption and integration of research and innovation into the NHS need to be addressed. Therefore, it is vital to ensure that registries are created to enable the collection and exploitation of real-world patient data and to promote the sharing of research findings and best practice.

The Royal College of Pathologists says that, unfortunately, this Bill, allowing the results of new tests and treatments to go unrecorded, will hinder its work and medical science more widely. Without the mandatory recording of results of such treatments, unexpected adverse outcomes and irresponsible activity will be harder to detect and prevent.

All results of innovative treatments should be centrally recorded, reported and publicly accessible. This must include both positive and negative outcomes and feedback from patients. Without the mandatory recording of results, the public benefits of medical innovation will not be achieved and the advantages to future patients will be lost.

I am pleased that the noble Lord, Lord Saatchi, is supporting this amendment. I hope that the Government will, too. I would like to ask whether patients from both the NHS and the private sector are covered by the Bill. In my view, all patients who wish it should be able to benefit from innovation as long as it is fully explained to them and is felt to be as safe as possible.

There are many splendid trusts which support medical research. I hope that if this Bill becomes an Act they may find it possible to help fund the register.

[Lord Kakkar]

My Lords, I remind noble Lords of my interests, stated earlier, as professor of surgery at University College and as a member of the GMC, but I do not speak for the council in this Chamber.

I thank the noble Lord, Lord Hunt of Kings Heath, for once again bringing this issue to your Lordships’ House. It is critically important, and probably one of its most vital elements is that there is the opportunity for registration of innovative interventions and therapies.

Clearly, providing transparency and the opportunity for sharing the outcomes of such innovations rapidly and broadly across clinical communities in this country and internationally is of so much importance. It will allow colleagues to understand what has been achieved and not achieved; it will allow those with other ideas to build on knowledge gained from experience to date; and it will ensure that through transparency we have the best opportunity to ensure the greatest patient protection. I am very grateful to the noble Lord, Lord Saatchi, for having considered this issue carefully and having come to the place where he has put his name to the amendment and supports it. I hope that Her Majesty’s Government will be able to consider this issue. The measure enjoys substantial support and will be a vital contribution to this long journey with regard to innovation, ensuring that we can do the best for patients as rapidly as possible without undermining the very best practice and the ability to share knowledge, and ultimately ensuring that this Bill enhances patient safety.

[Lord Giddens (Lab)]

My Lords, I strongly support this amendment and hope the Government will take it seriously because we are talking here about not innovation but scientific innovation. Science is a collective enterprise. It depends on the accumulation of evidence. It is crucial that that be recognised formally somewhere in the Bill, with this embodied as part of the advancement of scientific progress more generally.