Medical Innovation Bill [HL]

Baroness Masham of Ilton Excerpts

Friday 23rd January 2015 Lords Chamber

[Baroness Gardner of Parkes (Con)]

My Lords, I am slightly concerned about the wording of the amendment because I would not want it to become a way of dragging things on forever. How do you decide what is,

“a representative body of responsible medical opinion”?

To lay people such as myself, there seem to be heaps of medical bodies and I wonder how that would be determined. I would be interested to be satisfied on those points. The speech of the noble Lord, Lord Winston, was clear that he does not intend the amendment to represent any of those matters, but I would like someone who is more of an expert on the wording of these things to assure me that it would not be only a preventative technique.

[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.

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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.

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[Earl Howe]

I would not disagree with the noble Lord at all. I was about to say that on Report, my noble friend Lady Jolly suggested that there should be a registry and made a commitment to that effect. I would like to clarify that the Government are committed to exploring what may be useful in the data registry. The key here is to establish what could be workable and beneficial. The Government have heard a range of views on the topic of a data registry from those who argue, as many of your Lordships do, that this is essential to the Bill to others, including eminent clinicians, who argue that informal methods of sharing learning are more effective and that a compulsory registry would be overly burdensome.

With thanks to the contribution of your Lordships, the Government have started this conversation and are committed to continued engagement with relevant bodies. Any method of learning that should develop from the Bill must surely work for doctors to be of benefit to patients and the wider medical community. That is no simple task. It is crucial that any mechanism to encourage learning should be developed with a sufficiently light touch so that clinicians see it as facilitative of good practice, rather than burdensome and bureaucratic. It is also important to consider the costs of a method of learning and how this can be encouraged in the most cost-effective way. While I do not take issue with the end-point which noble Lords want to reach, I really believe that it is wise for us to remain open to all possibilities, rather than committing in legislation to an approach which may discourage doctors from innovating under the Bill and therefore not be of benefit to patients in the longer term.

This is a beguiling amendment and I understand the motivation behind it but I hope that noble Lords will join me in questioning the wisdom of having such an amendment in the Bill and accept instead our preferred approach: to continue to discuss this issue with relevant parties as the Bill progresses and, should the Bill pass, to engage with the medical community as to the best way to ensure that innovation can be translated into learning.

[Baroness Masham of Ilton]

Before the Minister sits down, to do research surely one needs data to see what benefits patients because these are new procedures that we are talking about.

[Earl Howe]

I would just say that the Bill is not to do with research but with innovative treatment, which is rather different. There is no question of the noble Lord, Lord Saatchi, promoting another form of clinical trial so while I accept the principle that the gathering of data is a very good idea, we must be clear that this is not for clinical research.