UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE
To be published as HC 104-ii

House of COMMONS

Oral EVIDENCE

TAKEN BEFORE the

SCIENCE AND TECHNOLOGY Committee

CLINICAL TRIALS

Monday 3 June 2013

RT HON DAVID willetts MP and RT HON EARL HOWE

Evidence heard in Public Questions 176 - 225

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Oral Evidence

Taken before the Science and Technology Committee

on Monday 3 June 2013

Members present:

Andrew Miller (Chair)

Stephen Metcalfe

Stephen Mosley

Pamela Nash

Graham Stringer

Roger Williams

________________

Examination of Witnesses

Witnesses: Rt Hon David Willetts MP, Minister of State for Universities and Science, Department for Business, Innovation and Skills, and Rt Hon Earl Howe, Parliamentary Under-Secretary of State for Quality, Department of Health, gave evidence.

Q176Chair: Gentlemen, can I welcome you to the session? We are coming to the end of our evidence sessions in our inquiry into clinical trials. It has been a fascinating exercise, and we hope that this afternoon can shed light on some of the issues that have cropped up during our inquiry. Earl Howe, if I could start off on a broad issue, as a rough proportion how much of your time do you spend on health research issues? You have an incredibly wide brief that goes well beyond the limitations of this inquiry. How much time do you spend on it?

Earl Howe: I regard research as a very important part of my portfolio. In terms of my time, it includes a number of tasks: PQs, correspondence, meetings and briefing visits. For example, last week I was at Addenbrooke’s looking at their neurological research. It is a little difficult to answer what proportion of my time it takes up. I am available when required to ensure that I give sufficient attention to it. The time given to any part of my portfolio inevitably varies. In the round, innovation, life sciences and medicines collectively take up a good deal of my time, and research bears upon all those things very closely. If you were to pin me down to how many hours a week or days a month, I would probably have to come back to you on that, but it would be several hours a week.

Q177Chair: Thank you for that, and I appreciate that measuring something like this is not an exact science.

Mr Willetts, you have a specific responsibility for life sciences, in that you obviously spill over into the work of the Department of Health. If you were sitting in the Cabinet just now, tell us a secret. What more would you be asking the Department of Health to do in terms of its research effort?

Mr Willetts: That is a very ingenious question. I would say let us do more of what has emerged since the life sciences strategy, which is that clearly we need to work together. I have appreciated an excellent working relationship with Earl Howe as well as with Jeremy Hunt and his predecessor. For example, I have noticed that, when talking to the life sciences industry wearing my BIS and science hat, and Earl Howe with his responsibilities for the health service, and we meet them jointly, as we are now doing, they very much appreciate the fact that there are two Ministers with rather different responsibilities working together. A few weeks ago we had a very successful visit to Switzerland, calling on Roche, Novartis and other companies. They said there were very few other Governments where they would see at the same time in the same meeting the Minister responsible for health care and the Minister responsible for science with a shared agenda. We could do even more of that.

Q178Chair: How much more?

Mr Willetts: Earl Howe must talk from the Department of Health’s perspective, but from our perspective in BIS, we are keen to strengthen our science base and as a result to see more companies choosing Britain as the place to do their R and D and invest. We have some major life science companies with a very significant presence here already, such as GSK or AstraZeneca. There are other major life sciences companies that, to be honest, I would like to see doing rather more in the UK. Our active strategy has meant that already, even as the industry goes through this big restructuring, the levels of overall investment in life sciences in the UK have been maintained. I would like to see us do even better and persuade some of the other life sciences companies, which currently may not be quite so active here, that we have such a joined-up approach embodied in our life sciences strategy and that Britain is a place where they would like to do more of their clinical trials and R and D.

Q179Stephen Mosley: More specifically, what are you doing to try to achieve that?

Mr Willetts: The life sciences strategy was published in December 2011. We did a one-year-on update with further new ambitions, such as the sequencing of 100,000 genomes. We now feel that we have a sufficiently clear overall strategy that we do take it abroad. As I said, the visit to Switzerland was a good example. With my responsibilities for strategic relationship management, I am regularly meeting the major life sciences companies that are active in the UK, and I make it a priority on overseas trade missions to call on them in the US and elsewhere.

Earl Howe: In having those conversations, we are able to say that we have done quite a bit already to make the climate in this country much more benign and attractive to them. For example, we have followed through very diligently the recommendations of the report by the Academy of Medical Sciences in 2010, including setting up the Health Research Authority, which was one of its major recommendations. I think that by common consent the HRA has got off to a very good start indeed. There are things like the Patent Box, which David Willetts’ Department has championed, and measures taken by the National Institute for Health Research, such as the 70-day benchmark for commencing a clinical trial once approved. There are various things that send the right signals, I believe, to companies in the sense that you have just mentioned.

Q180Stephen Mosley: Earl Howe, I am interested in the 70-day benchmark that you mention. Do you have the statistics for how many NHS trusts are meeting that benchmark?

Earl Howe: I did anticipate that you might ask me this. Unfortunately, the advice I have received is that we do not yet have robust data. I am told that the data collection is "maturing", it having been piloted last year. We will be in a position to give a precise answer to your question later this year. I am sorry I do not have robust figures.

Q181Stephen Mosley: I assume that you remember "The Plan for Growth" in 2011, which committed the Government to publishing these figures by 2012.

Earl Howe: The NIHR included the clinical trial initiation benchmark in new contracts with NHS trusts from 1 April 2012. Currently, 41 new contracts have been established, and in the period between April last year and April this year it introduced a data submission process, which is now being tested. From July this year, NHS providers are requested to publish their performance regarding the benchmark on their websites, and the NIHR will be monitoring the extent to which they do that.

Q182Stephen Mosley: Do you think the 70-day target will be achievable?

Earl Howe: Yes, I do, but, if I were candid, it may take a little time before we see majority compliance with it, and that is partly because some trusts are working on older-type contracts and have not signed up to this yet. When contracts are renewed over the coming years they will include the new benchmark as a stipulation, but inevitably it will be a gradual process of implementation.

Q183Stephen Mosley: We have heard that one of the main barriers to starting a clinical trial in the UK is the process by which researchers sometimes have to get multiple permissions from each individual NHS trust. I am aware that options for resolving this issue are being examined by the HRA in a feasibility study run in collaboration with the Department of Health. Do you have any indications of how that work is continuing and when it is likely to report?

Earl Howe: The Health Research Authority is looking at ways to speed up the whole research journey and it is running a feasibility study, including a number of pilots, to test the effect of rationalising and combining NHS study-wide review with elements of the Research Ethics Committee review into a single HRA assessment. It is very much on the case in that regard. The HRA, however, has brought together the functions relating to Research Ethics Committees and is developing a unified approval process for research, which has been very warmly welcomed as an idea. That builds on the current IRAS system-integrated research application system-and will bring together the bodies involved in approving and advising on research behind the scene: in other words, Research Ethics Committees, trusts, the MHRA, the National Information Governance Board and so on. While we cannot expect overnight results, there is cause to hope that in the HRA we have a body that sees it as its job to streamline the processes.

Q184Stephen Mosley: Do you have any time scales for when you hope that will be implemented?

Earl Howe: I may have to take advice and come back to you on exactly what the milestones are in that regard, and I am happy to do that.

Q185Pamela Nash: Following on Mr Mosley’s last question, is there evidence of any setback to this progress with the new organisation of the NHS when so much power has been devolved?

Earl Howe: No, there is not. There are a number of statistics that I believe give us cause for optimism, in that the trends are heading in the right direction. For example, over 99% of NHS trusts actively recruited patients on to clinical research network studies last year. That is a big improvement. There was a 7% increase on the previous year in terms of the number of participants recruited: 630,000. The number of new trials-phases one to four-in the NIHR clinical research network has more than doubled over the past five years. The work of the NIHR in particular has already shown dividends in that sense.

Q186Pamela Nash: Mr Willetts, the strategy for life sciences two years ago contained a pledge to relaunch the Clinical Trials Gateway. Can you update us on the progress of that? Can you share with the Committee what the Department has invested in this project in terms of staffing and finances?

Mr Willetts: The Clinical Trials Gateway might be more for Earl Howe.

Earl Howe: It is. The Clinical Trials Gateway, which has recently been updated and renewed and is in the process of being improved still further, is an initiative of the NIHR. It is designed to enable members of the public and NHS patients to access information on clinical trials that may be relevant to them. We are aware that knowledge of the gateway is less than we would like. I understand that the NIHR is taking various steps to promote the existence of the gateway, as indeed the NHS itself must do. In the NHS constitution there is now a duty to promote the existence of clinical trials, so there is an onus on the system itself to do this. One of the refinements that the gateway is looking to achieve is a more geographic focus to it so that, if you are living in a certain part of the country, you can find out what trials are going on nearby, but there is no doubt that it is another initiative that has the potential to involve more patients in trials.

Q187Pamela Nash: Can you tell us a bit more about how the gateway is being promoted? I am particularly interested in how it is promoted to healthy people and not someone who might have a specific illness.

Earl Howe: The NIHR has ensured that all parts of the NHS are made aware of the gateway’s existence so that, at relevant opportunities, clinicians and others are encouraged to draw attention to it when they have a patient sitting in front of them. I cannot be more specific than that. I know there has been an information campaign by the NIHR through the NHS. I can supply you with precise details, if you would like me to.

Q188Pamela Nash: That would be helpful to the Committee. It is a concern to me that, if the Minister doesn’t know, how the public is supposed to know what is going on and how the gateway has been promoted.

Earl Howe: I do know that the NIHR has made it its job to promulgate the existence of the gateway but with limited success so far, and it is continuing to promote it. If you are asking me about the precise mechanisms with which it has done that, I will need to come back to you.

Q189Chair: Before you move on, can I push you a little harder on this? I raised this point with a previous witness having come across, in one hospital, an issue surrounding a clinical trial that was brought to the attention of patients. The first the patient was told about it was in a document that started off by saying, "This is the procedure you follow if you want to opt out." That is not a terribly good way of encouraging people to participate and have confidence in clinical trials, is it? Would you agree with me and the previous witness that we should proactively encourage trusts not to adopt that kind of procedure?

Earl Howe: I most certainly do. I think it was with that very thought in mind that the NIHR, through Dame Sally Davies, last month launched the campaign "It’s OK to Ask". The whole point of that campaign, which incidentally was launched on 20 May, International Clinical Trials Day, was to raise awareness among patients and patient groups about the role of research in the NHS; the role of patients in research; that it is okay to ask your doctor about clinical research and, at the same time, to encourage clinicians and those working in the clinical environment-for example, people working in care homes-to think positively about research in the context of those they look after, and how they might channel interest that patients express positively. There were badges and space on various websites devoted to this. Being proactive is very much part of this, and it links to your question about the Clinical Trials Gateway, which was part of the publicity campaign.

Q190Pamela Nash: I have a final question on the gateway, and you may want to write to us about this later. I was interested to know whether in the promotions you are looking at examples of best practice elsewhere. From the evidence we have received, Cancer Research UK, for instance, has its own trials database that receives eight times as much traffic as the Clinical Trials Gateway. Is this something you are aware of? Are they speaking to other people in the sector?

Earl Howe: In terms of improving the profile of the Clinical Trials Gateway.

Pamela Nash: Yes.

Earl Howe: I will have to come back to you on that.

Q191Roger Williams: To move on to the NICE guidelines, we have been told in evidence that, while people have high regard for them, when drugs are developed, for instance, for cancer care, the period between referral and the time the guideline appears can be up to two years. Are you satisfied with that timeline, and is there anything that could be done to speed up the process?

Earl Howe: How long it takes depends on the type of work that NICE is doing. With some of its single technology appraisals, the timelines are much shorter. One has to acknowledge that over the last few years NICE has significantly accelerated the rate at which it is able to produce results. If it were the case that it took two years for NICE to do everything, I would not be satisfied. I do not believe that is so. It takes that kind of time scale for certain sorts of work. Don’t forget that NICE is now engaged in a range of work. It is engaged in producing a library of about 180 quality standards to inform commissioning; it is engaged, as it has been for many years, in clinical guidelines, and the methods guide that it publishes explains in detail how it approaches the evidence base and so on. It is quite a complex process, and it does take 18 to 24 months to produce a clinical guideline. Technology appraisal guidance, on the other hand, can take the form of either a single technology appraisal or multiple technology appraisals. Single technology appraisal takes around a year; the development of multiple technology appraisals takes around two years, but the reasons for the difference are hopefully obvious.

Q192Roger Williams: You will be able to understand that, as Members of Parliament, we have constituents who have heard that drugs are available but they cannot be prescribed through the national health service and the huge concern that causes.

Earl Howe: There is a common misconception among the public about this. Merely because NICE has not pronounced on a drug does not mean to say it is not available on the NHS. If a drug is licensed, it is available on the NHS providing that commissioners are prepared to pay for it, but, even if a drug is not licensed, an individual clinician on their own responsibility can prescribe it for an individual patient. There is no barrier in this sense if there is a medicine from which a clinician thinks a patient would benefit.

Q193Roger Williams: Once NICE has produced a guideline, sometimes that needs to be looked at again. What is the process that triggers that?

Earl Howe: NICE routinely reviews clinical guidelines every three or four years to consider whether they should be updated and can take into account any new evidence. It also has processes in place to bring forward updates if significant new evidence emerges before the scheduled review point. The general answer is that it is flexible and responsive in this regard, and it is as consultative as it possibly can be.

Q194Roger Williams: It is sometimes said that the evidence NICE looks at is slanted in such a way that it looks at evidence that is very positive because some of the negative work that has been done might never have been published. Do you understand that, and do you think that is a problem?

Earl Howe: I do not think that is a problem. If you talk to the pharmaceutical industry, it would say that NICE is altogether too negative. If you look at the percentage of drugs that NICE approves in one shape or form, it is around 80%. The answer is that NICE guidance and technology appraisals are based on a thorough assessment of the best and latest available evidence. It looks very carefully at clinical trials data in the case of drugs; it consults widely in the development of guidance; and it consults stakeholders on the methods and processes that it uses to develop its guidance. If you talk to NICE, I am sure it would hotly repudiate the suggestion that it is biased on one side or another to look at negative as opposed to positive data. I think it wants to be as even-handed as it can.

Q195Roger Williams: I was not suggesting it is biased but that the information at its disposal and its use may be biased.

Earl Howe: I beg your pardon. No is the answer; I do not get that impression. There was one particular case recently, which you will be aware of, where the suggestion was made that NICE was not made aware of negative data when it should have been. That was on Tamiflu. I think you will be getting a memorandum from the NAO on that issue. Am I aware of any cases where important data on clinical trials were not released either to NICE or the MHRA? I am not aware of any cases where that has happened. That particular issue is in my brief, so officials have looked into that.

Q196Chair: Mr Willetts, what do the pharmaceutical companies say to you about the NICE processes?

Mr Willetts: They are looking at it from their perspective of course. Sometimes they argue that the hurdles to get NICE acceptance in the UK are rather too high. This very much supports what Earl Howe was saying. In many ways, they see NICE as a particularly stringent process.

Q197Chair: Who is right?

Mr Willetts: These are deep waters. NICE is a great advance, and it is right to have this type of appraisal. I can remember, as doubtless you can, the days before NICE. It is right to have that national framework. In terms of the life sciences strategy and our responsibilities in BIS, sometimes the NHS is slow to take up and prescribe drugs even after they have passed the NICE guidelines, and in some ways the industry would be a bit more relaxed or a bit more accepting of NICE if they felt, even after NICE approval, it was then going to be reliably prescribed. Earl Howe is the expert on this, but sometimes the speed of getting something into a formulary and it being used in an individual hospital seems quite slow, even after NICE approval.

Q198Pamela Nash: The current Prime Minister famously said that this Government would be the most transparent ever. How do clinical trials fit into this, and what does the Department feel is the correct level of transparency for clinical trials?

Earl Howe: The Government support the principle of disclosure in relation to clinical trials data. In our judgment, very little of the information that is submitted to the MHRA could be regarded as commercially or personally confidential at the clinical trial stage. The MHRA, from where I sit, has done quite a lot of work to ensure that information about clinical trials that it receives is put in the public domain. It publishes public assessment reports following the approval of new medicines. It began publishing summaries of product characteristics of all UK-approved medicines on its website last year, and those summaries are a distillation of the safety and efficacy data. It is considering what more it could do.

In terms of the principle, I can couple David’s Department with my own on this. We are squarely signed up to the principle of transparency, but there are important considerations around it, the chief of which has to be the need to ensure that individual patient confidentiality is respected. I do not think anyone seriously contests that, but there are ways in which we and the pharmaceutical industry see a way through this, namely, the safe havens idea for parking information with a trusted intermediary.

In talking through the issues around transparency and clinical trials, one has to separate out distinct elements of what we are talking about. The first stage is the registration of the clinical trial where clearly there is no problem about transparency. There are clinical trials registries and so on to make that information accessible. The Clinical Trials Gateway is a good case in point. It has to be said that none of the current registries is very user-friendly. We are looking at how to improve that aspect.

Then there is publication of the outcomes of clinical trials. The NIHR and MRC both require all clinical trials outcomes to be published. That is going to be monitored through Researchfish, which is a software program sponsored by BIS. Then there is publication of protocols and analyses, and, there, we think that the aims of transparency can be achieved through defining what measures should be made available, but not necessarily mandating, for reasons which I can go into if you like, that the entire clinical study report-the CSR-should be made publicly available. There are good reasons why that would not be a proportionate thing to do, but to make available the central metrics is important. We then get on to access to individual participant data where the idea of the safe haven comes in. I hope that has given you a sense that we are working on a number of fronts to achieve that. I can perhaps go into that further, if you would like me to.

Q199Pamela Nash: Before you go into that further, are you referring only to future trials, or is the publication of data and information of previous trials being considered by the Department?

Earl Howe: Certainly we are talking about future clinical trials, but we are also encouraging the industry to make available past data-and to some extent they are doing that, although I am afraid I do not have the stats here. We know that GSK in particular is addressing this issue quite energetically, but, if you ask me about the precise extent to which past data have already been published, I apologise that I do not have that data in front of me.

Q200Pamela Nash: You mentioned GSK voluntarily tackling this at the moment. Do you think it is appropriate or realistic that the Government would force companies to produce previous data from trials?

Earl Howe: We have to define what data we expect and want them to publish. All this is the subject of discussion at EU level at the moment in the context of the revision of the Clinical Trials Directive-in other words, the creation of a clinical trials regulation. Instead of having a directive, the proposal is that there will be a regulation. Discussions are going on almost as we speak about the level of granularity that will be required in this regulation for publication. It is not yet clear. It is a fast-moving scene. I am told that at the end of last week the European Parliament’s Environment, Public Health and Food Safety Committee voted in favour of laying down the content of the clinical trials summary in legislation and making it compulsory for the summaries to be accompanied by a summary understandable to a lay person. The committee added to the draft regulation that a clinical study report submitted in support of a marketing authorisation should be made available through the EU portal within 30 days. We are now getting down to an interesting point in the discussion and level of detail. We are supportive of the way things are going. As you know, the process at European level takes its time to work through, but things are looking quite promising.

Q201Chair: To follow up that point, what role have you been taking in these discussions at European level?

Earl Howe: None, because they are being led by the Medicines and Healthcare Products Regulatory Agency, but I have been receiving briefs on what they are proposing to do.

Q202Chair: Have they taken a lead role, or are they responding to other European initiatives?

Earl Howe: Sparing their blushes, the MHRA has been very much at the forefront in all of these discussions and has influenced the EU Commission very heavily on the direction of travel it has taken throughout these negotiations. I think it deserves a lot of credit.

Q203Chair: When some parliamentary colleagues come back and seek to blame Europe for changes, the correct answer is that the MHRA has been taking a lead role in these discussions.

Earl Howe: In these discussions. Looking back to when the current Clinical Trials Directive was in gestation and implemented, there was a general lack of perception across Europe about the extent to which we were shooting ourselves in the foot by making Europe a less attractive place in which to conduct clinical trials. We have learned those lessons over the last few years, so the present activity at European level is designed to get us back to where all member states want to be, which is to make Europe a more attractive platform for research. The various elements of the Commission’s proposal are ones I can supply you with, if you wish.

Q204Pamela Nash: Mr Willetts, in the discussions about the transparency of clinical trials, in your role have you heard any concerns from the life sciences sector? Does this give you any concern about how it could affect growth in that area in the UK?

Mr Willetts: No. I think they understand that the Government overall are committed to transparency. There are some tricky policy issues. Patient confidentiality is a very important principle. Delivering it in practice and what the arrangements are so as to maintain patient trust is not at all straightforward. The safe haven option that has emerged in several contexts is very productive, and they see it as a useful step forward.

Q205Stephen Metcalfe: Earlier you mentioned Tamiflu, of which I understand we have a significant stockpile. Could you run us through what evidence is used or how the Government assess the evidence before they make a commitment to stockpile such a drug?

Earl Howe: The answer is twofold. Tamiflu is a licensed medicine and is assessed for safety, quality and efficacy by the MHRA in order to achieve marketing authorisation, so there is information there. NICE was also tasked to assess Tamiflu, and the balance of cost-benefit came out favourably. It is very much, as it often is for clinicians, to look to NICE’s assessment for a steer in this regard, if you like.

Q206Stephen Metcalfe: I can understand how the drug itself is assessed and its efficacy is evaluated, but how did the Government come to build up a stockpile covering 80% of the population, and how was that process driven? That is a slightly different thing from working out the effectiveness of the drug.

Earl Howe: Of course. This decision was taken before the current Government took office. I have to say that I am not aware of the basis on which the previous Government made that assessment.

Q207Stephen Metcalfe: That is fair enough. Presumably, you have not had a similar circumstance since, where you have been through the process to evaluate how decisions are made.

Earl Howe: I stand to be corrected, but I think that process is ongoing because the stocks of Tamiflu that were built up need replacement. It will be Dame Sally Davies’s office, the CMO’s office and Public Health England that will be involved in that decision.

Q208Stephen Metcalfe: The decision about whether it is still effective or the decision about the level at which to maintain the stockpile.

Earl Howe: The decision on what level of stockpile there should be.

Q209Stephen Metcalfe: Will that come across your desk?

Earl Howe: It is unlikely to be a decision for me. I believe this will fall more in the domain of my colleague Anna Soubry, the Minister for Public Health.

Q210Stephen Metcalfe: At the time the original decisions were being taken there was some conflict, as I understand it, between the Cabinet Office and the Scientific Pandemic Influenza Advisory Committee, and they came to different conclusions about how effective Tamiflu was. Why was that? Why did that happen?

Earl Howe: I have nothing in my brief about this because I came prepared for clinical trials rather than stockpiles of Tamiflu. My understanding is that NICE’s initial appraisal of the cost-benefit of Tamiflu was somewhat equivocal in terms of its clinical and cost-effectiveness. It then revised its opinion in a more positive way. That may have been the origin of any differences of view that you refer to.

Q211Stephen Metcalfe: Let’s get back to clinical trials. The Government are a major customer of drug companies. Do they use their buying power or influence with those companies to try to improve the transparency of commercially funded drugs trials?

Earl Howe: You are right to say that the Government are an important customer. The NHS is an important customer for drug companies, although in terms of their global sales we are a very small player indeed. It is arguable that anything we might do in terms of negotiating prices would have much effect in getting companies to invest in clinical trials. The considerations that companies look at mainly when taking those decisions are around the science base in the country concerned, taxation and perhaps a whole range of other factors that are unrelated to the extent to which the products are bought in that country. If you speak to the pharmaceutical companies, you may hear them say that the pricing arrangements do have an influence on their decision making. I cannot speak for them, but, if one looks at it analytically, the two issues are distinct.

Q212Stephen Metcalfe: I think we touched on the involvement in the European Medicines Agency’s clinical trials advisory groups. We were told or led to believe that no one from the Department of Health, MHRA, the Health Research Authority or NICE took part in those advisory groups, but I think you said earlier that was not the case.

Earl Howe: My understanding is that, as regards the discussions at EU Commission level, the MHRA has played a prominent role. I have no notes to tell you who served on the advisory groups and whether we had adequate representation, but I can certainly find out that information for you.

Q213Stephen Metcalfe: That would be very useful, because I was going to ask you why, if that is accurate, we did not take part in those advisory groups. Perhaps you could expand on that, if there was some reason behind that.

Earl Howe: We should not forget that, in Sir Kent Woods, we have somebody who is British as chair of the EMA, and he does a very fine job, but at a lower level on the advisory groups or at a more operational level I will need to come back to you.

Stephen Metcalfe: That is fine.

Q214Chair: Our understanding is that 15 Governments were represented in the advisory groups but nobody from the UK. It would be helpful to know what the facts are.

Earl Howe: I will find out and let you know.

Q215Stephen Metcalfe: One of those advisory groups was looking at what the EMA’s new clinical trials transparency policy should be. Do you have a view on what that policy should be?

Earl Howe: Yes. As I mentioned in answer to an earlier question, there are various distinct elements in the various stages of a clinical trial that we can isolate in answering that question, starting with registration and moving right through to availability of individual patient data. Aside from the qualification David referred to about patient confidentiality and privacy-which is an important issue because, unless one preserves that, one does not retain the confidence of patients-we are pleased by the tenor and direction of travel of the Commission in putting together its proposals on transparency in the context of the Clinical Trials Directive.

It is not just up to the MHRA or indeed Government here. The onus is also on those who own the data to lead the way, and in this respect we welcome what has already happened among a number of companies. I mentioned earlier GSK, which has done good work in this area, as has the ABPI on behalf of the industry with its transparency toolkit that it is now developing. We must not forget that, regardless of what we as a Government believe in terms of promoting transparency, which we do, nevertheless we operate in a European-wide system where an increasing number of medicines are being licensed at EU level by the EMA. We welcome the approach that the EMA is taking to releasing data. In our judgment, it seems to be a proportionate approach, and it is important that any solution is agreed at an international level. We have supported the work of the EMA in developing the EudraCT database to provide a public registry of all trials of medicines in the EU. That has been the case since 2004, when the Clinical Trials Directive was introduced. It is being further developed to allow the publication of results summaries later this year. We are aware of current legal challenges to the EMA position on the disclosure of clinical trial information, but, in line with the Prime Minister’s commitment, there needs to be more transparency in clinical trials data. We are wholeheartedly in favour of that, and we are committed to ensuring that this process moves forward.

Q216Stephen Metcalfe: I am sure you are aware that the European Parliament’s Environment, Public Health and Food Safety Committee last week approved the draft EU Clinical Trials Regulations.

Earl Howe: Yes.

Q217Stephen Metcalfe: On that basis, were you happy that they passed that?

Earl Howe: They have reached what seems to us to be a sensible and proportionate decision on this.

Q218Stephen Metcalfe: Is there anything else you would have liked to see, or any changes or differences?

Earl Howe: No. We were concerned at one point that they were going to insist on the publication of CSRs for every single clinical trial. There are some clinical trials that are not related to interventional medicines. Some are related to the surgical procedures for inserting hip replacements, where it would be unduly burdensome to require publication of a fully fledged CSR. We think that publication of summaries is the right level.

Q219Chair: On a slightly broader, philosophical point, what role do you think the Government have to play in ensuring that people have access to research that they fund both as taxpayers and as donors to charity?

Mr Willetts: The basic principle is pretty clear. We would usually expect that publicly funded research should be made publicly available. That is a policy we are implementing with research findings and, increasingly, though there are some rather tricky technical issues, with the data underpinning those findings. As you know, open data is one of the Government’s key commitments.

Earl Howe: It is a requirement that the results of any clinical trial or research, as far as I am aware, funded by either the MRC or the NIHR should be put in the public domain.

Q220Chair: When you say "any", does that include noncommercial players?

Earl Howe: When it comes to academic trials-

Q221Chair: Academic or charitable sector trials that might be funded through public funds.

Earl Howe: If there is an element of public funding, my understanding is that the contract requires publication of the result.

Q222Chair: Is this what is meant by the Government’s recommendation to register non-commercial clinical trials?

Earl Howe: No. The registration of a trial is putting in the public domain the fact that the trial is happening, whereas your question was much more about the results of the trial, was it not?

Q223Chair: The second would not come without the first, would it?

Earl Howe: Of course.

Q224Chair: I have registered that I am going to conduct a trial. I am now conducting the trial in a non-commercial environment. Does the register cover that work?

Earl Howe: Yes. All trials need to be registered, whatever their nature. Research Ethics Committees consider the proposals the applicant puts forward for the registration and publication of the research involved; the dissemination of the findings including, incidentally, to those people who took part in the study; and, if tissue is involved, making available any data or tissue collected for the research. Since April this year, the Health Research Authority has been undertaking checks of applicants to Research Ethics Committees and the reports that they publish to see whether they have registered and published as they declared they would to the Research Ethics Committees.

Q225Chair: You would expect compliance to be 100%.

Earl Howe: We would expect compliance to be 100%, given that these people have undertaken to do this. We would certainly expect that they fulfil their undertaking.

Chair: Gentlemen, thank you very much for your time this afternoon.

Prepared 11th June 2013