Care Bill [HL]

Lord Turnberg Excerpts

Monday 10th June 2013 Lords Chamber

[Lord Ribeiro]

My Lords, following the disruption of medical education that followed on from the MTAS debacle in 2007, one of the outcomes, which was a positive one, was the development of schools of surgery—a concept that we took on from the anaesthetists. This required personnel from the Royal College of Surgeons and the deaneries to take responsibility for the delivery and planning of training and education. However, this was very much confined to trainees. There was no requirement to extend it to consultants in terms of CPD.

However, we all know that health education does not end with certification; it is a continuum that occurs throughout one’s career as a professional doctor. It is a requirement to keep up to date. It is a requirement by the GMC to ensure that one knows what is happening within the wider medical field. One of the problems for doctors is having the time to go away and attend courses to improve one’s CPD. The amendment of the noble Lord, Lord Patel, places an obligation on HEE and the LETBs to support CPD and, in doing so, to allow the release of NHS staff, as he quite rightly said, to attend courses and educational programmes. It is also important to provide consultants and medical personnel of all disciplines with the opportunity to work in the wider NHS. It has been one of the basic tenets of the NHS that contributions in the wider NHS benefit not only the NHS but the participants, who learn a lot more about its workings. That, too, can improve and enhance one’s continuing development.

In that context, I welcome the suggestion made today several times by speakers—certainly by the noble Lord, Lord Hunt of Kings Heath, in that he made reference to the Francis report. One thing that came out of the Francis report was a clear statement that he would recommend that the GMC and the royal colleges work together in providing visits to educational centres. That was stopped some time ago. I think that there is a real opportunity to reintroduce that and I hope that the Minister, in responding, will address that issue. Here again is an opportunity, because in the past lessons were learnt by consultants visiting hospitals and looking at the education provision.

The very presence of peer groups in a hospital often helps to raise standards. Therefore, not only would CPD provide another training opportunity for those who participate but it would improve local education provision. The quality assurance of the training it would provide would ensure that, in the long term, patients benefited from such visits. For that, if nothing else, I support the amendment of the noble Lord, Lord Patel. We need to include something on continuing professional development because the whole emphasis of HEE is very much on training and trainees and it has very little to do with those who continue right through to retirement.

[Lord Turnberg]

My Lords, I, too, strongly support the amendment of the noble Lord, Lord Patel. Like him, I am concerned and rather surprised that there is no mention in the Bill about the need for trusts and other providers to support their staff in continuing professional development. We really cannot afford to have any staff working in front-line clinical services not keeping up to date when we know that clinical practice changes rapidly from month to month.

New tests, new diagnostic methods and new treatments are coming along fast and furious. Unless members of staff are given the time and facilities to keep abreast of all of those, we will get poorer and more out-of-date care. As the noble Lord, Lord Patel, said, it is unfortunately the case that when health budgets are stretched, as they almost always are, CPD budgets are the first to go. Time off to attend courses or to engage in appraisals disappears quickly, as everyone in the service is rushed off their feet.

It is in just those circumstances that a stand should be made. The amendment of the noble Lord, Lord Patel, makes it clear that the LETBs must include the need for employers to allow the time for CPD development of their staff. How else will doctors, for example, be able to comply with the mandatory requirement of the GMC to revalidate at regular intervals? We have struggled both long and hard to get revalidation mandated and we cannot afford to see it eroded now at the same time as the responsibility for funding CPD is falling to employers. LETBs must be given the teeth to insist that time and support for CPD are included in their educational contracts with trusts.

[Baroness Emerton]

My Lords, I support the amendment but I also support what the noble Lord, Lord Patel, said, about CPD being extended to other healthcare professionals. One thing that has emerged as a barometer from the questionnaires is that, often, the culture of an organisation is affected by the fact that there has been no appraisal system and no continuing professional education built into the programme for other healthcare professionals—nurses, physiotherapists and radiographers. There is an important issue here: all staff delivering care need to have regular appraisals and regular updating of their continuing professional education.

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I hope that the noble Lord, Lord Patel, will accept what I have said as at least some measure of reassurance, if not a full measure, that Health Education England and local education and training boards will work closely with healthcare providers to ensure that in planning education and training, there is adequate provision of continuing professional development of healthcare workers.

[Lord Turnberg]

I am sorry to interrupt again. I think the noble Earl said that we should leave it to the local providers to decide what or how much CPD individuals should have. We know, however, that at the moment local providers are very variable in how far they are willing to go along that route. The problem is that leaving it where it is certainly does not give any great confidence that CPD will be uniformly available in the service. Hence the amendment of the noble Lord, Lord Patel, which tries to give a little force and pressure to local providers so that they could indeed be sure that CPD was being provided. The noble Earl is full of good intentions, quite rightly, but we need a little more than that.

[Earl Howe]

I probably expressed the position less than well because I was seeking to indicate that CPD is inescapable. There are a whole host of reasons why providers and the LETBs cannot avoid a focus on continuing professional development. Equally, we do not want to prescribe any kind of ring-fenced budget for CPD, for the reasons we debated earlier: we are clear that we must leave it to LETBs to exercise autonomy in the way that they work out their local education and training plans. They will have to prioritise, inevitably, in certain cases and from year to year. It may be that they will have to make hard choices. The great thing about Health Education England is that, as a non-departmental public body separate from NHS England, it will have a dedicated budget which cannot be eroded by those who might wish to siphon money off to patient care, for example. I hope that, in that sense, the noble Lord, Lord Turnberg, can take some comfort. We are very clear that the prescription is there and that local providers cannot avoid addressing the needs of their employees for CPD, but at the same time we do not want to dictate to them how much to spend on this in any one year.

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[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.

[Baroness Wheeler]

My Lords, I support Amendments 58 and 63. It is right for my noble friends Lord Warner and Lord Turnberg and the noble Lord, Lord Patel, to press the Government on this important issue. As we have heard, the Joint Committee proposed including the promotion of transparency in research and ensuring full publication of the results of research—consistent with the preservation of patient confidentiality—in the Bill and we strongly support this.

This is our first opportunity to welcome the establishment of the Health Research Authority as a statutory body and we do so wholeheartedly. We recognise the vital importance of research and innovation to the NHS, the very real progress that is being made in these areas and the scale and pace of change in medical science. The HRA’s objectives not only promote and protect the interests of patients and the public in health and social care research but ensure that it is ethical and safe research, which inspires the public confidence that my noble friend Lord Turnberg spoke about.



Alongside other bodies, the HRA has a key role in promoting transparency, and we acknowledge that its recent guidance on how it will undertake this role sets out important measures that will go some way towards underlining that it takes its duty seriously. These include: gaining approval from research ethics committees before clinical trials can go ahead; a new timescale for registrations; the commitment to work with research funders and sponsors to set the standards for the publication and dissemination of research outcomes; taking steps to facilitate further analysis of detailed data; and plans to look at how patient consent forms can be amended to provide early consent and understanding on how data will be used, as well as how the HRA will be informed of the outcome of study findings.

There is no doubt that the HRA is committed to working with others to overcome barriers to transparency and create a culture of openness. The amendment and Amendment 63, which provide for the publication of research findings “fairly and frankly” and transparency in the reporting of clinical trials, would enshrine the HRA’s commitment in statute, and ensure that clinical research benefits patients and that the findings are available for others to learn and benefit from. As we have heard from my noble friend Lord Turnberg, the advice of the Association of Medical Research Charities to its members to ensure that there is a requirement to publish in the terms and conditions of all their research awards has played an important role in providing greater transparency and would be reinforced by greater HRA authority in this matter.

Finally, like other noble Lords, I received a valuable briefing from the National Advisory Council to the Thalidomide Trust on the need for transparency and a change in the law for the disclosure of clinical and healthy volunteer trial data in relation to the drugs available on the market. The briefing states:

“Adverse effects caused by drugs that are designed to lead to a health improvement can be difficult to prove, and easy for the pharmaceutical companies to dismiss ... At the core of the problem is the fact that the safety assessments of a drug, undertaken in clinical trials done prior to the drug’s launch, remain hidden once the drug is on the market. A patient experiencing adverse effects therefore has no access to data that could be used to prove their claim … the onus is on patients to prove it was a drug that harmed them rather than the company that already holds that evidence”.

The Thalidomide Trust proposes changes to the informed consent form to allow sharing of anonymised data and making data from clinical trials available and accessible to the public once a drug has been released on the market. The trust acknowledges that this is a difficult issue. Have the Government had any discussions with the trust on this matter? I should be grateful if the noble Earl would comment on this, either today or in a written response.