Care Bill [HL]

Debate between Lord Turnberg and Lord Warner

Monday 10th June 2013 Lords Chamber

[Lord Warner]

My Lords, I suspect that the amendment has a similar purpose to Amendment 63, in the names of the noble Lords, Lord Turnberg and Lord Patel. The purpose is to ensure that in exercising its functions the HRA not only promotes the interests of research participants and those of the wider public in facilitating research but, in doing so, has to ensure that the publication of research findings takes place fairly and frankly. I tabled the amendment because there was concern in the Joint Select Committee, of which I was a member, about whether those responsible for conducting research were tempted on occasion to shield from public view the downside findings of a piece of research, for commercial or even professional, reputational reasons.

The Joint Committee’s discussions of that issue are set out in paragraphs 328 to 336 of its report to the Government. There was a lot of support in principle for greater transparency around research findings, and particularly clinical trials data, but there was some ambivalence in the discussions of witnesses in front of us, including the Minister, about prescribing this requirement in primary legislation. Tucked away in the discussion was a concern that this kind of approach would cause pharmaceutical companies to take clinical trials away from the UK. That was the implication, I think, of some of the remarks passed to the Joint Committee, which rightly in my view took a more robust view. In paragraph 335 of its report, it recommended that the Bill should be amended,

“so that promoting transparency in research and ensuring full publication of the results of research, consistently with preservation of patient confidentiality, becomes a statutory objective of the HRA”.

That is what my amendment aims to do.

My views on this issue have been shaped over time, but particularly by my experience as the Department of Health Minister responsible for the pharmaceutical industry and its regulation as well as for NHS R&D. In those roles, I did my bit to promote that industry and secure UK jobs in it, and I know the arguments about securing clinical trials. However, they have to be balanced with other considerations, when deliberate concealment of adverse research data has taken place. This is in nobody’s interests, including those of the company where it has taken place, because eventually it usually gets found out.

To illustrate my concerns, I want to detain the House a little longer with a brief account of what came up in my time as a Minister, when there was concealment. “Panorama” revealed, in 2003, what was happening with an anti-depressant called Seroxat, which was being given to about half a million people a year. Some of the people taking higher doses of the drug experienced suicidal feelings, and there were a number of cases of younger patients committing suicide. There was widespread concern among patient groups, and the MHRA had to launch a review, which included a small subset of younger patients under 18, for whom Seroxat was not licensed but for whom it was being prescribed by doctors. At that time, about 8,000 young people a year were being prescribed this drug, and the Committee on Safety of Medicines advised me that children taking this drug were more likely to self-harm or have suicidal thoughts. That finding was not then available to the regulators, but the public fuss caused by the media caused the company—and I want to mention it; it was GSK—to end up passing the information in its files to the regulators in the UK, Europe and the US. I took the view, in 2004, that there was a respectable case for prosecuting GSK, because it had failed to inform the MHRA in a timely fashion of the information on adverse reactions in juveniles.

The whole affair limped on after my time as a Minister and became the largest investigation of its kind. Over 1 million pages of evidence were scrutinised, with GSK challenging matters all the way. Matters were only concluded in March 2008 when the decision was taken not to prosecute GSK, which received a slap on the wrist. The then MHRA chief executive said in a press release:

“I remain concerned that GSK could and should have reported this information earlier than they did”.

This case—and there are others which I know of—illustrates why we should put in the Bill a clear requirement that research information is put into the public arena in a timely way when there is a downside as well as when there is an upside so that people can have a fuller picture of what is actually going on. If noble Lords want a fuller account of the Seroxat saga, they can find it in my book, A Suitable Case for Treatment, which is available in the Library. I beg to move.

[Lord Turnberg]

My Lords, the point of Amendment 63, which is in my name, is the need for the HRA to emphasise transparency in the reporting of clinical trials because patients and the public must have confidence that research in which they have been involved will be used in the best way to spread the message for the good of other sufferers. They have to know that results, whether negative or positive, are published. As my noble friend Lord Warner has said, it is particularly important if they are negative, for at least two reasons. First, it is to stop the unnecessary, wasteful repetition of the research by others who are unaware that it has already been done. Equally important is to prevent a bias in reports towards research that shows only that a new drug works when other, unpublished, research shows that it does not. This is particularly important when we consider what is called meta-analysis, whereby an analysis is made of all relevant published reports, brought together to provide a large database on whether a drug works or does not. If only the positive results are reported, we have a biased result at the end, which could result in all sorts of problems.

Open access to research data provides researchers with a much better picture of their field than if research results are held too closely to the chest, perhaps by researchers jealous of their findings or by drug companies fearful of rivals gaining an advantage. It is heartening to know that GSK seems to have learnt the lesson: it is the first pharmaceutical company to lead the way in transparency. Members of the Association of Medical Research Charities make it a condition of their grants that results are published. We are pushing on an open door and we just need the HRA to have some capacity to ensure transparency in NHS research.

Health and Social Care Bill

Debate between Lord Turnberg and Lord Warner

Monday 27th February 2012 Lords Chamber

[Lord Turnberg]

My Lords, my name is attached to two amendments in the group, Amendments 57 and 99. I shall speak very briefly. They are both about ensuring that, first, the commissioning board can put itself in the best possible position to develop its plans by having available to it all the advice that it can get. When the board makes its decisions it has to be able to show and demonstrate that it has reached those decisions on the best evidence possible. That is what the amendment tries to do. The same argument, only even more so, can be applied to CCGs. That is Amendment 99. They will certainly need all the help that they can get, and Amendment 99 gives them the opportunity to get the support that they need. I hope that those two amendments can be supported, at least.

[Lord Warner]

My Lords, I have added my name to Amendment 66 from the noble Lord, Lord Patel. Given all the hard work that has gone into trying to improve knowledge about medical and other areas, to improve patient safety, it seems extraordinary that in this Bill there is a provision to enable the national Commissioning Board to be able to charge for information about patient safety defects that have come to its attention. That seems pretty bizarre, but no doubt there is some explanation in Richmond House that would convince me. I look forward eagerly to knowing what it is.

Health and Social Care Bill

Debate between Lord Turnberg and Lord Warner

Wednesday 7th December 2011 Lords Chamber

[Lord Warner]

My Lords, we come now to Clause 53 and the proposed abolition of the Health Protection Agency. I shall speak to Amendment 257ZA in this group, but in doing so I should make clear that I do not support the abolition of the Health Protection Agency, and I have every sympathy with the Front-Bench amendment that Clause 53 should not stand part of the Bill. I should not be unhappy if I lost my amendment because the clause itself was removed.

However, if the Government are going to proceed with this casual vandalism against an internationally respected organisation, I would hope that we could secure some damage limitation, which is what this amendment attempts to do. I will leave it to my co-signatories of this amendment, who have much more scientific and clinical expertise than me, to explain why we need to protect the independent scientific and research expertise of the Health Protection Agency in any new organisational form that there is for it.

As the Minister who helped to shape the Health Protection Agency in its present form by bringing together a wider range of scientists in one organisation, I want to put on record that it has acknowledged the importance of that and the improvement in the cross-fertilisation of ideas that has come about because we brought a wider range of scientists into the organisation.

I should also make clear that when confronted with crises involving areas of great public concern—I cite as examples the great concern in 2003 and 2004 about the growth in healthcare-acquired infections, and, later on, the Litvinenko affair and the concerns about polonium-210—the independent scientific advice from the arm’s-length Health Protection Agency was absolutely vital to giving the public confidence in how we were moving forward and dealing with those issues. It was the people from the Health Protection Agency, particularly during the Litvinenko affair, who were able to stand up in public and give scientific reassurance in that area. It is that independence of scientific expertise that I am very anxious we should preserve in the move to abolish the Health Protection Agency.

Amendment 257ZA would ensure that if the functions of the Health Protection Agency are to be transferred to the Secretary of State and the Department of Health, there should be a distinct executive agency with its own chief executive as accounting officer, and a management board with an independent chairman and at least three non-executives with expertise in its functions, selected by the department’s chief scientific adviser. The amendment would also ensure that staff had the freedom to secure and discharge external research contracts.

These changes will help to retain high calibre staff over time, and indeed the scientific reputation of what is currently the Health Protection Agency, in its new guise. I believe that they have the support of the staff of the HPA and reassure them about scientific independence and the ability to carry on seeking research contracts.

We need this reassurance in the Bill, not just warm words, however well intentioned the Minister is. I beg to move.

[Lord Turnberg]

My Lords, my name is also attached to Amendment 257ZA. I also do not like the idea that the HPA is to be abolished, so I hope my amendment is not necessary, which it will not be if the proposal that the clause should not stand part of the Bill is agreed.

I have, of course, extolled the virtues of the HPA on a number of occasions in your Lordships’ House. You could say that I would do that, wouldn’t I?, having been the chairman of the predecessor of the HPA, the Public Health Laboratory Service, but it is certainly true to say that it is the envy of the world, and I am not the only one who says that. The Centers for Disease Control and Prevention in Atlanta, in the United States, are a very well funded counterpart with which we collaborated very strongly, and even they recognised this excellence and envied the fact that we, unlike them, had a network of laboratories across the country primed and ready to detect outbreaks of infection wherever they occurred. Those laboratories were linked into a central laboratory at Colindale, where highly specialised tests could be carried out when needed for unusual infections and where epidemiologists could link up outbreaks in one area of the country with outbreaks in another, so that it was possible to track the speed and spread of infections and prevent them developing into epidemics.

The fact that the HPA is hardly ever in the news is testament to its success in protecting the population. If your Lordships think that because it is so good there is now less need for such surveillance, let me point to the fact that just one set of infections—those responsible for food poisoning—remain a considerable health hazard, and gives rise to about 1 million cases per annum in the UK. Although it is usually fairly mild and often not reported, some cases, such as those due to E. coli, can be very severe indeed, and in the particularly vulnerable can be fatal. Food poisoning is, unfortunately, not showing any signs of decreasing, so the need for constant vigilance is high and the role of the HPA remains absolutely vital.

The amendment sets out two of the planks needed for the agency to contribute to its key roles. The first is the degree of independence that it needs to be able to give advice not only to those out in the field who need to act but very specifically to the Secretary of State and the Government. The HPA must not be seen to be simply the mouthpiece of government. It must have the independence that is so necessary to its credibility. It has stood it in good stead over the years. Its advice is respected and accepted, and we should not lose that now.

The other element of the amendment is the need to be able to undertake research. If the agency is to keep ahead of ever-changing bacteria and viruses, which seem to mutate every week, and to be able to develop new ways of rapid detection, it needs access to research funds. For example, it has excellent high quality researchers, two of whom have recently been elected to the fellowship of the Academy of Medical Sciences, which is a demonstration of their esteem. Over the years it has been fortunate to have access to research funds from the Department of Health, and I understand that that will continue. That, of course, has been of enormous value, but the agency has also attracted research funds in fairly large amounts from external grant funders, and this is funding won in open competition. There is a fear that as an authority that is rather more closely identified with the Department of Health, access to those external funds will be denied to it.

The amendment makes the clear case that the agency must continue to have access to these funds in order for it to function at the highest level. I hope that the Minister will accept the case and look sympathetically at the amendment.

Health and Social Care Bill

Debate between Lord Turnberg and Lord Warner

Wednesday 7th December 2011 Lords Chamber

[Lord Turnberg]

My Lords, I had a previous bite of this cherry when I spoke at some length in my prayer to take note of the statutory instrument to set up the Health Research Agency a few weeks ago, so I will not be long and will not repeat what I said on that occasion about the need for a research regulatory authority that was more than simply a home for the national research ethics committee. Highly important though that is, my message was that it was essential but not sufficient. If we are to get over the barriers to research posed by the regulatory processes that delay research approval, we must include more functions.

I was very taken by the Statement that the noble Earl repeated yesterday on the life sciences. It was a marvellous demonstration of the Government’s commitment to research and innovation—I could not have said more myself in many of its aspirations. However, if you were looking for a reason for us to have a fully functioning research regulatory authority, as set out in this group of amendments, you need look no further than that Statement. It points out quite clearly where the barriers to innovation lie—with excessive regulation, access to patient data and delays in taking up innovation into practice.

On regulation, the Statement says:

“Excessive regulation can mean that the uptake of new treatments and technology is slow. That is a challenge felt acutely by an industry that sometimes feels that the return is not there quickly enough to satisfy investors. It is felt even more acutely by patients”.—[Official Report, 6/12/11; col. 685.]

There it is; we need a more strongly established research regulatory authority. Let me give one example of where we are in danger of losing out. The NIHR—the National Institute for Health Research—sponsored the North West Exemplar programme to see whether it could engage both the pharmaceutical industry and the NHS in trying to get approval for multicentre clinical trials in a reasonably short time. This involved getting the strategic health authority in the north-west to convince the various hospital trusts in its area to approve the research as efficiently as possible. It has worked—their rate of research and development committee approvals are rapid and compare very favourably with the rest of Europe. They are certainly better than the rest of the UK.

However, there is a danger of that being lost when we lose the strategic health authorities. The driving force of the strategic health authorities will disappear shortly. That is another reason for a research regulatory authority to take on this leadership role: to drive this exemplar forward and spread its message more widely. We need it, therefore, not only for the National Research Ethics Service and the ethics committee on the use of data—a separate ethics committee—but for many of the other functions described so forcefully by the noble Lord, Lord Willis.

I heard exactly what the Minister said about the HTA and the HFEA, and what my noble friend Lady Warwick of Undercliffe said about the HTA. I accept that that should be looked at as a separate set of items. These amendments would allow that; I do not think that they are obviated. However, we need this critical role if we are to take advantage of our excellence in research and if we are to fulfil the Government’s ambitions, as set out yesterday in the Statement. The dangers are evident already, as we see the pharmaceutical industry withdrawing and moving elsewhere. If we are to draw it back, we must have something in the Bill that sets up a full—and fully empowered—health research authority. I hope that the amendment has some sympathy in the Government.

[Lord Warner]

My Lords, my name is on Amendment 258. I speak as a former Minister responsible for NHS R&D in the pharmaceutical industry in 2003 and 2004. We were having exactly the same discussions then. Since that time, the National Institute for Health Research has been set up, we have had the Cooksey review, OSCA has been set up, and we have had the review by the Academy of Medical Sciences. All these cases come back to the issue of a faster, smoother regulatory approval system. The same blockages that are being talked about now were being talked about five, six, seven years ago.

In that time the UK has lost large numbers of clinical trials. We continue to lose trials and we are going to lose more to south-east Asia. UK plc suffers while we continue with these present arrangements. I understand the Minister’s anxieties about this. However, at the end of the day it is difficult to see that a new authority would be in place, even with a very smooth passage, until at least a year later than if we went along with the amendment. We need to move faster on this.

I end with one question to the Minister. Have the Government actually talked to the big beasts in science research in this area—to the Wellcome Trust, the MRC, the Academy of Medical Sciences? Have they asked them directly whether they would you sooner have the Willis amendments or wait for a Bill in the next Session. I would like to know what their straight answer to the Minister would be on that particular question.

Health and Social Care Bill

Debate between Lord Turnberg and Lord Warner

Monday 14th November 2011 Lords Chamber

[Lord Turnberg]

My Lords, I rise to lend my support for this amendment. I speak here as a trustee of the Wolfson Foundation, which has a programme of support for hospices and care homes and over the years has given many millions of pounds, largely for capital projects. VAT is a constant source of unhappiness to the trustees, and, in fact, they have reached the conclusion that they will no longer pay VAT for capital projects. This means, of course, that the hospices and care homes themselves will have to find that money, which is unfortunate. Therefore, I hope that the Minister will take this amendment seriously.

[Lord Warner]

My Lords, I support the amendment and I do so from a background of having been the chairman of the National Council for Voluntary Organisations and a trustee of a number of organisations that have supplied services to the NHS and local government. This is indeed a very long-running sore; it is a source of grievance. It often goes with another grievance—one which is not germane to this debate but which I might as well mention, because it explains why voluntary organisations are sometimes reluctant to provide some services for public authorities. That is a kind of meanness, almost, on the part of many public bodies about meeting the administrative costs—the management costs—of local authorities. If one takes the two together—a meanness about meeting management costs and being treated unfairly on VAT—this is a barrier to entry.

I fully support the points made by the noble Baroness, Lady Finlay. As the Minister knows, I have probably made myself a little unpopular on these Benches through my support for the idea of competition on a level playing field. I have a later amendment which raises the issue of barriers to entry. This is a barrier to entry. It is stopping voluntary organisations participating fully on the basis of a level playing field as a qualified provider. Therefore, in terms of the Government’s own philosophy in the area of competition, they would do well to listen to these arguments and remove this barrier to entry.