Medical Innovation Bill [HL]

Baroness O'Neill of Bengarve Excerpts

Friday 12th December 2014 Lords Chamber

[Baroness O'Neill of Bengarve (CB)]

My Lords, I am not certain whether the noble Lord, Lord Turnberg, makes things easier by suggesting in Amendment 3 that one should move from views to support, for two reasons. One is that we have a later amendment that refers to views and the recording of them. The other is that I would have thought it would be important to record the spectrum of views concerned, not just the support—the negative views as well as the positive. So I have my doubts about Amendment 3.

[Lord Mackay of Clashfern]

My Lords, I think that we would all take the view that the last thing we want to do in any sort of legislation is endanger patient safety. However, I suggest that the honourable Honor Smith was not acting under my noble friend Lord Saatchi’s Bill; she was acting, I take it, under the law that existed at that time. Therefore, even in the best regulated circles, with no provision for innovation, something can happen. No doubt the lady thought that she was doing the right thing when she did it, but it turned out ultimately that that was not so.

With regard to the Bill, the ultimate test of the defence is whether it is in the best interests of the patient. In taking account of views from qualified people in the area, that is an important factor. It is necessary that a doctor who is going to use this treatment should be able to satisfy the court that, in the light of the available evidence at the time when the decision was taken, this decision was in the best interests of the patient. Therefore, endangering a patient strikes me as something that is already covered quite clearly by that requirement. The mention of danger must be an important aspect of the best interests of the patient, surely.

On Amendment 2 from the noble Lord, Lord Winston, he talks about the body of medical opinion. The cases that I know of talk about “a” body; lawyers certainly do not often agree one with another and I think that sometimes doctors do not agree either. Someone therefore has to make a choice from time to time.

It is perfectly clear that we all want to prevent patients from being put in danger. I have seen and listened to the programmes by the noble Lord, Lord Winston, about the injection of stem cells into people for money in different parts of the world without the promised success ensuing from that. I am sure that there is a danger in that area. Indeed, there are dangers in many areas. However, the problem for the doctor—and I am glad in a way that this responsibility is not the kind of responsibility that one has to carry generally in other professions—is that it is the life of the patient that may well be in question. Therefore, in taking an innovative step it is essential that the views which are available in relation to the matter and which are reasonably readily available to the doctor making the decision to use the treatment are taken fully into account. That is what this Bill is trying to do.

The Bill is set out as providing for responsible innovation. One of the fundamental elements of responsibility must be the patient’s safety. While I entirely agree with the view that that is an important issue, I believe that the Bill safeguards that so far as possible. The experience to which the noble Lord, Lord Walton, referred is an example of what can happen. On the other hand, you cannot make certain; nothing is infallible. I believe that from that point of view this is as good as we can achieve.

--- Later in debate ---

[Baroness Jolly]

I have said that the Government are very supportive of a registry. Of course, patients would want to know what does and does not work, as would all doctors. I have said that I will take this issue back and discuss it with the noble Earl, Lord Howe.

[Baroness O'Neill of Bengarve]

My Lords, in so doing, it would be valuable if the Minister could go back to the central theme of today’s debate, which is patient safety, not the protection of doctors from clinical negligence claims. If we are focused on patient safety, any failure to collect valuable information, whether positive or negative, would compromise patient safety—not perhaps the safety of that individual patient at that moment but patient safety generally. The collection of data here is of fundamental importance. I cannot see the reasons why it should not be compulsory.

[Lord Mackay of Clashfern]

Do I understand that the position that the Government are taking is a technical one on the scope of this Private Member’s Bill and that it would be improper in a Private Member’s Bill to set up a register that would go beyond the scope of this Bill as to the innovations that it covers? The idea is to set up a register that would be wider in its scope than the mere innovations that take place under this Bill, assuming that it becomes an Act. Is that the difficulty?

Medical Innovation Bill [HL]

Baroness O'Neill of Bengarve Excerpts

Friday 27th June 2014 Lords Chamber

[Baroness O'Neill of Bengarve (CB)]

My Lords, I declare an interest in that I am on the board of the Medical Research Council and chair its ethics, regulation and public involvement committee. Nothing that I say is said in the name of the Medical Research Council, but I believe that it will be compatible with the views that it holds.

I have great sympathy with the purpose of the Bill and agree that we need to ensure that, where permitted, those providing innovative treatments under safeguards should be required to complete and to make available the relevant data for the benefit of others with like conditions. I was therefore very encouraged to hear about the initiative for the registration of innovations, which may make a difference. That benefit may be knowledge of cure or improvement, but, equally, it may be knowledge that protects against treatment that would either exacerbate or not benefit—benefits go two ways in this.

However, I want briefly to point to some wider issues that lie in the background of this discussion. The days of the blockbuster drug may be drawing to a close. We are seeing the emergence of many more narrowly targeted drugs that meet the needs of smaller numbers of patients. This is the promise, but also the problem, of stratified medicine. It raises problems for the classical model of the randomised controlled trial. Such trials are expensive and take a long time. Where a drug or innovation may benefit quite small patient populations, it may be difficult to recruit a cohort of trial participants with the relevant condition. Where a market is likely to remain small, it may not be feasible for any pharma company to take the financial risk. We therefore have strong reasons to think about possible ways of making legitimate clinical trials more feasible and more flexible, while protecting patients and always acting within their consent.

I want to point to one particular sort of research for which we need to make room, and that is participant-led research. In participant-led research, those who suffer from a condition agree to make their data available for analysis. That analysis may reveal that some form of treatment benefits or harms. It is marvellously cheap as a way of doing it. As an example, I would cite the ALS lithium study conducted by users of the online platform, PatientsLikeMe. It was initiated by two advanced-stage patients from Brazil and the US who were users of the platform and who died before the conclusion of the study. A group of 149 ALS patients on the platform took lithium in order to test the findings of a small earlier study into its effects on disease progression and symptom alleviation. The PatientsLikeMe ALS study was completed over a period of eight months—note how short that was—and was published in Nature Biotechnology. It found that lithium had no effect, which was subsequently confirmed by standard clinical trials, but the innovative approach to establishing a result was much faster.

Participant-led research faces some difficulties. It may not be eligible for ethical review, not because one cannot consider the ethics of the matter but because there is, believe it or not, no principal investigator—so how does one do the ethics review? It may not be eligible for publication in medical journals; for example, because it has not been subject to ethical review. I do not think that such research should be subjected to less rigorous ethical or scientific review than other research, but nor do I think that it should be obstructed because it does not conform to the precise assumptions of the classical randomised control trial. Is the Department of Health considering a wider review of the fitness-for-purpose of present ways of regulating clinical trials so that they might be extended to cover a greater range of innovative research and innovation proposals?

Queen’s Speech

Baroness O'Neill of Bengarve Excerpts

Wednesday 11th June 2014 Lords Chamber

[Baroness O'Neill of Bengarve (CB)]

My Lords, ostensibly, few constitutional Bills were listed in the gracious Speech. Apart from the Wales Bill and the recall of Members of Parliament Bill, no others appear obviously constitutional and yet we all know that this year may mark momentous constitutional changes.

I am one of those fortunate people with an Irish, a Scots, a Welsh and an English grandparent. I am a person of the UK. Three of my four grandparents were in uniform in the First World War—the fourth had very young children and was not. Looking ahead, if the majority who will be eligible to vote and do vote in the Scottish referendum vote yes, much will change. For those of us with multiple allegiances this is deeply painful. It is, in effect, like being told that that the family is to be broken up, while being denied voice or vote.

I want to ask the Government about what may prove a deep lacuna in the preparation for the possibility of a yes vote. I say this in spite of having read and profited from the report from the Constitution Committee of your Lordships’ House. Those fortunate enough to be resident in Scotland, whether Scots or not, will have voice and vote, but who will speak for the rest of the UK? I appreciate the Government’s reasons for not, as the phrase goes, pre-negotiating for something that may not arise, and the report endorses the Government’s position on that point. However, neither government policy nor the report has provided any clarity about who will speak for those UK citizens not resident in Scotland. The Government of Scotland will speak for those resident there and the assumption appears to be that the Government of the UK will speak for those resident in England, Northern Ireland and Wales. This proposal may be convenient, but I believe that it is flawed.

Until the date of independence, whenever that might be, the Government of the UK will remain the Government of Scotland, together with the Government in Edinburgh with their already extensive competences. This is not disputed: it is after all the context of the referendum. Consequently, during the period of any negotiation, the Government of the UK must maintain responsibility for Scotland. I do not think we can expect the Government of the UK to, so to speak, sit on both sides of the negotiating table. At the stage of negotiation, the Government of the UK will not be, as the report helpfully puts it, the Government of “the continuator state”—they will remain the Government of the UK as constituted at present. Only after independence and the constitution of Scotland as a successor state will the Government of the UK become the Government of a continuator state.

It is therefore important to think now about the way in which the interests of those who will, if things proceed to separation, later be citizens of the continuator state are to be represented in any negotiation. There will be difficult matters to be negotiated: the allocation of the national debt; the allocation of oil and gas reserves, which is different from other allocations of fixed assets; the provision and protection of pensions, to say nothing about banking; the provisions for those who study outside the jurisdiction where they have grown up; and the eligibility of researchers resident in Scotland to apply for UK research funding, which means so much for the excellent universities of Scotland.

The report from the Constitution Committee addresses a number of political issues that will arise in any transition, including how to determine the date of exit of Scottish MPs from this Parliament and whether to end the service of Scots judges on the Supreme Court. However, there remains the most basic question of who speaks for whom. Who speaks for England, Northern Ireland and Wales? How do we ensure that those who are to negotiate are not compromised by conflicts of interest because they remain representatives of the Government of the UK as constituted at present?

I should declare a further interest here, in that the outcome of these negotiations is a very particular concern, indeed an anxious concern, to everyone from Northern Ireland, with its close cultural and other ties to Scotland and its still-fragile peace process.

Financial Services (Banking Reform) Bill

Baroness O'Neill of Bengarve Excerpts

Wednesday 27th November 2013 Lords Chamber

[Lord Eatwell]

I am very grateful to the noble Lord for his comments. I had overlooked that point. Once the House has accepted this amendment, we can move on, perhaps at Third Reading, to add the elements that the noble Lord suggests.

[Baroness O'Neill of Bengarve (CB)]

My Lords, before the noble Lord sits down again, I offer another friendly thought—I hope. I have it in mind because the Netherlands has reintroduced a bankers’ oath analogous to an oath for physicians. As part of that move, we should note that the relationship with the persons who are here designated as customers should, indeed, properly be that of a client. This is a professional service and the fiduciary duties are in place precisely because this is a relationship not to a customer from whom one might make money but to a client to whom one owes a service.

[Lord Eatwell]

I am grateful to the noble Baroness. I am sure that her suggestion and, indeed, the example of the Netherlands might well be followed here.