Health and Social Care (Safety and Quality) Bill

Debate between Lord Turnberg and Lord Hunt of Kings Heath

Friday 13th March 2015 Lords Chamber

[Lord Turnberg]

My Lords, I listened extremely carefully to what the noble Earl has just said and I am grateful to him for clarifying what a registered person is—I think that it is the word “person” that gets very personal here. I remain somewhat concerned about whether legislation to stop avoidable harm is a feasible proposition.

[Lord Hunt of Kings Heath]

Perhaps I may say to my noble friend that I think that the noble Lord, Lord Ribeiro, should wind up first and then he should come back.

Medical Innovation Bill [HL]

Debate between Lord Turnberg and Lord Hunt of Kings Heath

Friday 24th October 2014 Lords Chamber

[Lord Turnberg]

As we have heard, my Lords, there is a degree of uncertainty surrounding certain aspects of the Bill that we have been trying to clarify. It is on that account that I have tabled Amendment 31, which sets out the need for a code of practice in which the Secretary of State describes in somewhat more detail what the Bill is about and how it should be enacted. I hope that it will be helpful to have that in the Bill.

[Lord Hunt of Kings Heath (Lab)]

My Lords, this has been a fascinating debate, both in Committee and at Second Reading. We are all very grateful to the noble Lord, Lord Saatchi, for listening carefully and bringing the amendments that he has today, and for agreeing to a roundtable discussion between Committee and Report, which is a very constructive response to some of the issues that have been raised.

I say at once that I am absolutely with the noble Lord on the need to encourage innovation in our NHS, but the more that I have listened to the debate, the more convinced I am that it is not so much a question of the law but more one of actual practice within our NHS. I am afraid that we have to face up to the fact that there is a culture of regulatory processes and funding procedures that often get in the way of introducing innovation. For me, the Act that the Bill will become will be a signal to the NHS.

The noble Lord, Lord Blencathra, raised some interesting points about some of the problems that we have at the moment. He talked about off-label medicines. The Minister responded by saying that the Government are committed to innovation and gave a number of examples, which were welcome, but the point that I would put to him is that we now have a situation where NICE produces technology appraisals of new innovative procedures and drugs that clinical commissioning groups are essentially breaking the law by not implementing. He knows that they are under a requirement to fund the use of those procedures and medicines within three months of the technology appraisal being issued, yet we know from research by patient groups that the actual implementation is patchy. We could do an awful lot in relation to innovation if we insisted that people locally did what they were required to do.

My second point relates to the drug budget, an issue that the noble Lord raised. A few months ago the Government concluded an extremely interesting agreement with the branded drug companies, so that for five years the cost of branded drugs in England, apart from modest rises in inflation, will be fully met by the pharmaceutical industry. This is a very good agreement and one that I very much welcome. We still hear people in the NHS saying that they cannot afford the new drugs, yet the industry has promised to pay back any increase in the cost of those drugs over what they are paying now plus a modest increase in inflation. Here is a wonderful opportunity at last for the NHS to move quickly in widely adopting new medicines, but somewhere in the system someone is stopping it. I have read the NHS England five-year plan and it says nothing about the introduction of innovative new medicines.

I am sorry that this is a little outside the noble Lord’s Bill and I hope that he will forgive me, but this is about innovation. I am genuinely puzzled, and we will come back to this point, about why the Government did not rush to insist that the NHS took advantage of the agreement. In fact very few people in the NHS know about the agreement. My concern is that the rebates that the drug industry is going to give will be used for other purposes, which would be a very big mistake.

I hope that the Minister will agree to the amendment; I strongly advise him to do so, or at least to consider it. It is clear from the speeches that have been made that there is some confusion about the circumstances in which the noble Lord’s provisions are going to be made. Earlier in our debates, the noble Earl essentially said that doctors would have a choice when it came to whether, in relation to a given medical treatment, they would use this Bill’s provisions or rely on the traditional approach, the Bolam test. The noble and learned Lord, Lord Woolf, said that they are not alternatives and, in the circumstances raised by one noble Lord where there was not time to get the advice of the clinicians that is provided for in the noble Lord’s Bill, you would rely on the Bolam test. I am only a lay person, but I suspect that there is a risk of doctors not catching the nuance of that distinction. It is clear from the various letters that we have had from many of the medical bodies that there is some concern about this. I know that the noble Lord will speak and I strongly endorse his amendment on the regulation-making power, but I strongly advise the Government to agree to issuing guidance to the medical profession in this regard. There is a danger of some confusion and such guidance would be useful. If the noble Lord is not able to accept this amendment today, perhaps he will give it some further consideration.

Health: Polypill

Debate between Lord Turnberg and Lord Hunt of Kings Heath

Monday 7th July 2014 Lords Chamber

[Lord Turnberg]

Those are very good points. The doses used in polypills are very low, in fact—20 milligrams of simvastatin, when the normal dose is 40 to 80 milligrams. The other drugs in the polypill are half doses. The point is that, if you have raised LDL cholesterol or raised blood pressure, you should certainly be on the treatments; they have been shown to be effective. It is people who do not have raised cholesterol or raised blood pressure who we are aiming to treat—or to prevent their diseases—so it is a different situation. The point about safety is important. It is clear that we need and should have proper clinical trials of those doses, but the impact of such doses, from what we know about them in this combination, is that they are likely to be safe in the vast majority of cases. What we do not know is the number who will get side-effects.

[Lord Hunt of Kings Heath (Lab)]

My noble friend, and other noble Lords, mentioned the importance of clinical trials, which I am sure is absolutely right. Is not the problem here that in fact no pharmaceutical company will conduct a clinical trial because all the drugs used in combination in the polypill are off-patent, so there can be no protection of that research by any company taking it forward? So there is, if you like, a block here, although people can see the potential benefits. Rightly, noble Lords are asking for clinical research, but there is no possibility of that happening unless the Government take a hand themselves, which is why the debate on antibiotics is interesting. They are completely separate subjects, but the Government had to step in there because, at the moment, the market simply cannot respond to the issue.

[Lord Turnberg]

I agree entirely. I think that it will be difficult for the drug firms themselves to conduct trials because these are generics and they are manufactured by a number of companies. The only way forward, I suspect, if we are to have a clinical trial, is through NHS funding—that sort of trial. My final remark is that I very much look forward to the noble Earl’s response.

Health Research Authority (Amendment) Regulations 2012

Debate between Lord Turnberg and Lord Hunt of Kings Heath

Wednesday 13th June 2012 Grand Committee

[Lord Hunt of Kings Heath]

My Lords, I should start by declaring interests as the chair of a foundation trust, as a consultant in the health service and as a trainer with Cumberlege Connections Ltd.

As well as moving this Motion, I shall also speak to my second Motion, which also relates to the Health Research Authority.

On the face of it, the regulations and order are unexceptionable and they passed through the Secondary Legislation Scrutiny Committee without comment. They provide for the board to be reconstituted with independent non-executives and an independent chair.

The responsibility that falls to the members of the authority is indeed weighty. The noble Earl, Lord Howe, has a long-standing record of commitment to health research, which is considerably reassuring to all those with an interest in this area. I have no doubt at all that health research is as important to the economy of this country as it is to the quality of patient experience and outcome. Indeed, embraced with the high quality of life sciences in the UK, it is crucial that we prioritise health research to the fullest extent possible. Certainly my experience in chairing the Pharmaceutical Industry Competitiveness Task Force some years ago convinced me of the essential link between the health of the person, the health of the NHS and the health of the economy, and that is why I think it is so important for the National Health Service to support health research. Our debates during the passage of the Health and Social Care Bill indicated the strength of support for research and for the Secretary of State’s responsibility for it to Parliament.

The HRA has been set up to protect and promote the interests of patients and the public in health research. The aim is to lead to the creation of a unified approval process and to promote consistent and proportionate standards of compliance and inspection. The HRA has a number of functions, including being the appointing authority for research ethics committees in England, and it provides the National Research Ethics Service. Also, by agreement with the devolved Administrations, it supports a UK-wide system for ethical review in the UK. It has an important ongoing programme of work and it also provides the integrated research application system through which applications for regulatory and governance approvals of health research are made in the UK. It also agrees plans to provide a platform for the unified approval process from the IRAS, as it is known.

I turn to the details of the regulations and order. I ask the noble Earl whether it is intended that the non-executives should be a majority on the board. I should also like to ask him about the Government’s intention regarding the publication of draft clauses to establish the HRA as a non-departmental public body. I do not know whether he can give any indication at all about the timing of and commitment to the eventual legislation that has been promised. Will he also comment on the Government’s approach to, and policies for, enhancing health research in the UK?

How are we to ensure that we make the most of the excellence of our life sciences? Can the Minister give some reassurance about the priority to be given to research by the NHS Commissioning Board? Does he believe that academic medicine is given sufficient support by the National Health Service? Is he confident that the HRA has the capacity to streamline research application processes? That point has been made to me by a number of organisations that have been interested in the order and in our debate.

The noble Earl will be aware of the continuous debate over probably the past decade about the bureaucracy involved in the application processes and a feeling that the UK has lost its competitive edge because of that. I know that the previous Government and this one have continued to do work in this area and I wonder whether he can report any further progress. I should like him to comment on whether he believes that the UK will be able to maintain a competitive edge in research in the years to come and whether he believes that the intention is to maximise large-scale patient recruitment.

Alongside that is the importance of site selection and the question of whether it is going to be easier for applicants in the future to conduct multi-centre research. My understanding is that one of the problems is that applications for multi-centre research have to go to the individual institutions concerned, which can sometimes hold up approval. My understanding is that there is going to be a concerted attempt to speed up that process. Again, if the noble Earl could give some comfort there, it would be much appreciated.

It is also important that the National Health Service recognises the importance of its role in supporting, developing and encouraging research. That is partly to do with the appointment of academic clinicians within the National Health Service, partly about a willingness to accept that it is important for clinicians to take part in research and also about the importance of ensuring that individual bodies in the NHS have good processes for offering opportunities for clinical trials. Any positive messages that the noble Earl could give on that would be appreciated.

On the private sector, if the Government are to develop a market in the NHS, what obligation will there be on private companies to maintain and support research if they win contracts to provide services to patients? I attended the launch of the Clinical Practice Research Datalink, at which the noble Earl spoke and which I thought was very impressive. How does he think this will link to the work of the Health Research Authority? I was very taken with the potential to use such a wide database of anonymised information, which the NHS can provide. The issue that arose from that debate and that launch is whether we are really able to make the most of the opportunity that is being given.

My final point brings me to value-based pricing. My understanding is that the Government still intend to introduce value-based pricing. I express again to the noble Earl my reservations about the impact of that on flexibility within the pharmaceutical industry and the pricing structure, which might then have an impact on their willingness to invest in R&D in this country. The Department of Health, I understand, is still a sponsor of the pharmaceutical industry. It is, of course, always torn; there is always a tension between the cost of drugs to the NHS and sponsorship of the industry. I hope that we are not going to see short-term decisions taken in relation to the cost of drugs at the expense of long-term investment in R&D in this country. Value-based pricing is a quite complex and technical subject, but it is important that there is transparency about the decisions that lie behind a move to value-based pricing and its likely impact on the UK as a whole, and not just the cost of drugs to the NHS. I beg to move.

[Lord Turnberg]

My Lords, the development of the Health Research Authority has been extremely welcome and the research community is very grateful that we have it; it has a number of very important roles in relation to the research ethics committees.

My questions relate to the extension of those functions as it plays out, because, of course, the Academy of Medical Sciences report expected this to apply to rather more than just the ethics committee; they relate to what is planned for it as it moves along. In particular, when is it likely that the ethical approval for the use of patient data—not anonymised data but unanonymised data, if there is such a word—which are currently with the Secretary of State, will come under the jurisdiction of the new authority? My noble friend Lord Hunt referred to the major hurdle that is put in the way of research and which takes time: the problem of getting approval from several health authorities or trusts. At that level, it is unclear whether the Health Research Authority will have any power over that process. I would like to hear more about what is intended for the future, now that we have it set up. I know that there are intentions and I would like to hear more about them.