Health Research Authority (Establishment and Constitution) Order 2011

Lord Willis of Knaresborough Excerpts

Tuesday 15th November 2011 Grand Committee

[Lord Turnberg]

My Lords, this instrument is to set up the Health Research Authority as a special health authority. The main reason given for taking this step rather than the primary legislation route is because there is some urgency in finding a home for the national research ethics committees that will soon find themselves homeless when the strategic health authorities and the National Patient Safety Agency go out of business.

I can, of course, understand why it is necessary to go down this rapid secondary legislation route because even if the Health Research Authority were to find a place in the current Health and Social Care Bill, it would still be a couple of years before it would be fully enacted and we need something sooner. However, there remains the question of why it cannot be put into the Bill as well so that there can be a smooth transition from this temporary solution to a more permanent one. No doubt, we will be exploring that when we come to debate it later in the Bill.

The anxiety remains that we will have to wait a considerable amount of time before we see another round of primary legislation to set up a permanent agency. In our debates on the Bill yesterday, we heard about the doubts being expressed about when we will see further legislation. Can the Minister enlarge on the hint he gave in the debate last week that we might see something relevant to this in 2012?

It might be helpful if I said a few words about why the establishment of a health research authority or agency is so important. It comes directly from the recommendations in the Academy of Medical Sciences’s report A New Pathway for the Regulation and Governance of Health Research which the Government commissioned last year and which, to their credit, they have endorsed enthusiastically. The report described in great detail the current regulatory burden faced by clinical researchers and proposed a number of solutions, the most important of which was setting up this agency. It pointed out how the UK research effort is being undermined by an overly complex regulatory and governance environment and how this has caused a fall in the UK’s global share of patients in clinical trials of all types, as well as a marked increase in the time needed to navigate a very complex research approval process. Regulation has grown as new regulatory bodies have been set up, often in response to some scandal or other, and often with seemingly good reason, but without any consideration of the overall impact of yet another new hurdle and without any evidence whatever that they have improved the safety of patients or the public.

The problem is confounded by the delays and duplication in the governance arrangements within individual NHS trusts. They are now thought to be the single greatest barrier to health research, especially where several trusts are involved in multicentre trials, for example. There is a definite need for a regulatory pathway that allows us to cut through all this unnecessary and complex bureaucracy while at the same time ensuring the safety and interests of patients.

Now we have a research regulatory authority as an important government response, and we have to see how it is going to achieve all that is expected of it. First, the National Research Ethics Service, with its 80 or so local ethics committees, has done a marvellous job in the past few years in streamlining the ethics approval process. It has, for example, made it much easier for those engaged in multicentre research proposals to gain approval. Preserving its function has been vital, but unfortunately moving it by itself from one body to another will do no more than preserve the status quo. It simply moves it from one home to another, yet the research regulatory agency was expected to do so much more.

My questions for the noble Earl are: will the authority have any more responsibilities? For example, will it have any of the responsibilities currently undertaken by the ethics and confidentiality committee of the National Information Governance Board? That committee advises the Secretary of State on whether permission should be given to researchers wanting to use data about patients where it is not possible to gain consent. It is a very important safeguard for patients, but it means that researchers have to have two sets of ethical permission to do the research, one from a normal ethics committee and another from this committee, and that causes all sorts of delays. Can we expect some streamlining here? I see in the Explanatory Memorandum to this order that that might be on the horizon. If so, can the Minister give any further information on that and on when it might happen?

Then there is the problem posed by the delays caused by the local R&D committees in each of the NHS trusts. They can hold up research for months, especially if more than one trust is involved in multicentre research proposals. For example, Cancer Research UK said that the average time for a multicentre research grant to be approved was over 600 days. Can the noble Earl say whether the new authority will have any role in easing that problem, perhaps by ensuring that limits are set on the times that trusts can take in considering proposals? Will it, for example, be able to vet research proposals in such a way that it can save local R&D committees from each having to repeat much of the straightforward common areas of a proposal, leaving them to check on aspects of specific local importance? That would certainly help to speed up the process.

The excellent report from the academy outlines a whole range of other regulatory bodies and functions that could and should be rolled up into the new authority. I shall not go into them, save to recommend that noble Lords who have not read the report might find it of some interest.

A research regulatory authority or agency has enormous potential for good if we can get it right. If we do, all will benefit—the researchers, certainly, but most importantly the patients, who will access new treatments sooner and more efficiently. We will gain economically too, because we will regain something that we are already losing: the investment from the pharmaceutical industry, which is watching our debates with interest.

We owe a debt of gratitude to the Government for setting up this authority and removing the uncertainty surrounding the ethics committee, but much more needs doing. I look forward with interest to the response of the noble Earl, Lord Howe.

[Lord Willis of Knaresborough]

My Lords, first, I apologise to the noble Lord, Lord Turnberg, for arriving one minute into his speech; I did not realise that the earlier business would have been dispatched so summarily this afternoon. I am grateful to him for introducing the debate and giving us an opportunity to address the issues he raised ahead of discussions during the passage of the Health and Social Care Bill, to which there are clear amendments on some of these issues. Like him, I say to the Minister without hesitation that I welcome the establishment of this special health authority. He promised it in answer to questions some time after I had arrived in the House and saw the need to move on the academy’s report as quickly as possible, and I compliment him and the Government for moving so speedily; there is no issue about that.

The need to find a home for the National Research Ethics Service was important. There was haemorrhaging of staff and good will and, in terms of any research project, it is important that you have a stable, effective and well respected ethics service. We probably have the best research ethics service in the world. We welcome the appointment of Janet Wisely, the current chairman of NRES, as the new chief officer for the Health Research Authority; she is well respected and that level of continuity will serve us well.

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[Lord Willis of Knaresborough]

My Lords, I am delighted to continue. It is a punishment for coming a minute late that we have a Division half way through. While welcoming the special health authority, it is important to look at the order that has been referred to the Grand Committee. What we see, particularly under the heading “Functions of the Authority”, is the wonderful phrase in Article 3(1)(b),

“such other functions; as the Secretary of State may direct”.

What concerns me is that, while this organisation is set up as temporary, it could in fact simply continue indefinitely. There is no time limit on it.

As the noble Lord, Lord Owen, said in the debate yesterday, we have a real issue over the Government’s promises that there will be legislation. In reality, what we have been promised is a draft Bill in the next Session of Parliament, which will deal with research, education and training and any other such matters. As the noble Lord said yesterday, the Government will not be terribly enthusiastic about introducing another Bill. It will probably take us to 2013—or even beyond that—before a draft Bill is fully considered. That takes us right up to the end of this Parliament; perhaps to the final year or final Session of this fixed-term Parliament. Are we really saying that we are going to have a Bill of such importance and magnitude coming before Parliament at that stage? Quite frankly, I have my doubts despite the best intentions of the noble Earl, Lord Howe. If that is the case, we will see this temporary authority simply running on beyond the next election. Unless the Minister can give us a clear indication today of how long this organisation is going to stay in place, whether it has an end date and whether we will have actual, not draft, legislation, then I for one will continue to press the point.

Why do I say this is important? It is because it is not just the research ethics service that is in limbo. Several other organisations are in limbo as well. We have had the Public Bodies Bill. We have two organisations, the Human Tissue Authority and the Human Fertilisation and Embryology Authority, in limbo and running down their permanent staff. There is a real question about their future and significant elements of both may—I stress “may”—come into this new authority.

My first question is: when Article 3(1)(b) says,

“such other functions; as the Secretary of State may direct”,

is there a plan or an intention to take key elements out of the Human Tissue Authority and Human Fertilisation and Embryology Authority and move them into this organisation? The legislation is there for that to happen. It does not need any further primary legislation. Secondly, there is the issue of the Medicines and Healthcare Regulation Agency. What is going to happen to that? It is another organisation that is intricately involved with the research agenda and again there is an element of uncertainty about its future. Is there any intention to move parts of that into the new agency? Is that what we mean by “any other such functions”?

The other issue is the research and development permissions for each NHS trust. The noble Lord, Lord Turnberg, summed it up quite admirably. The main thrust of the Academy of Medical Sciences’s excellent report—which, to be fair, politicians on all sides of the House, including the Minister, have supported and agreed—is the key point that the noble Lord, Lord Turnberg, made. Recruiting people to trials can take over 600 days and while there is a commitment, quite rightly and importantly made last year by the Government, to go to a 70-day average period, how is that going to be driven? Paragraph 3(a)(i) refers to,

“the facilitation and promotion of research”.

Is that what this order actually means, and is it what the Minister means? When I asked him in a Question for Written Answer—I am sorry, but I do not have the reference; Hansard will find it—whether there was any requirement for legislation in order to ensure that NHS foundation trusts become actively involved as part of their duty to promote research and clinical trials, the clear response from the Minister was that there is no need for that because there is perfectly sufficient legislation at the moment for that to happen. I do not know how that is going to happen. If we are going to have an authority, other than the National Research Ethics Service, that simply treads water on every other aspect of research, we will be missing a trick because we could be two, three or four years away from having a permanent solution.

In conclusion, I ask the Minister what work the special health authority will do to prepare for new functions which may come down the line with the new Health Research Authority. What timescales does the Minister envisage for the establishment for the new Health Research Authority and for it becoming operational? Does he have a clear timeline that is not simply in terms of legislation? Indeed, what preliminary work will be done to pave the way for the new national research governance service, which was going to be swept into this organisation too? I think I can give the Minister eight out of 10 for making a commitment to the House. He has made a promise, and I thank him for that, but can we please now have some flesh on these bones as well so that we know what direction of travel we are heading in so that we can all get on the bus?

[Baroness Finlay of Llandaff]

My Lords, I would add my words of welcome to the principles of research which have been supported by the Government. I know that the Minister has done much personally to promote this. In welcoming the Health Research Authority as a special health authority, I also echo the words: “The problem is this: for how long and where will it lead to?”. The current regional ethics committees that are going will be covered in this, but they are only half the problem in relation to research. The other half is R&D committees in trusts. There is a separate committee for every trust and people who want to undertake multi-centre research have to take their research through them. If you are researching into rare diseases, you may have to go through every trust in the country in order to be able to recruit enough patients to enter into whatever study you are conducting. That could be 100 or so different committees. It means that researchers have to sign up at every trust. Each trust behaves quite differently. Some speed research through in about two weeks, but others become extremely fussy. Unfortunately, that fussiness often focuses on things like the patient information sheet. The committees will spend time requesting redrafts of that sheet, but the redraft may be rejected by another trust. Researchers end up going around in circles for months on end in what is in fact a pretty futile activity.

That is because the original research ethics committee which looked at the proposal will have to go through everything, including the consent form, the patient information sheet and so on. The committee also has to look at the protocol of the study itself and the science behind it. If the science is bad, that is really when the research programme should be stopped in its tracks. That is the role of the ethics committee, and if it does its job properly, it could centralise all these other factors and look at them.

Apart from the duplication taking time for researchers, it is duplication across the whole country with people doing exactly the same job and coming to slightly different, but often not very consequentially different, conclusions. There is duplication at many levels. One could say that if something is good enough for the research ethics committee, it really should be good enough across the board. If it is not, there is a question about the research ethics committee and the way it functions, and it needs to be looked at again because it is not up to scratch.

There are quite a few things that I hope can be centralised, and it will be helpful if the Minister will clarify what will and will not be centralised. For example, will checks on the principal investigator’s qualifications to undertake the research be centralised? Will the protocol of a study and the science behind it be scrutinised with patient information sheets and patient consent forms? Will there be a way of informing the trust that that has been done adequately and does not have to be done again? At a local level, of course the trust has to look to see whether it has the right research facilities and the right infrastructure. That is not usually about the nature of the research but more about whether it is in a position to participate. That is a feasibility check at a local level. That could be done very quickly, but it needs a different mindset. I am concerned that with the push to autonomy for all the different trusts, a trust can say, “No, we’re not going to play ball with this. We want to have our own processes and do our own research ethics rather than participate at a national level”, which might strengthen its R&D committee processes.

An issue not being addressed in this order is indemnity for research. Are there plans to establish an all-England research risk pool or some kind of centralised and co-ordinated indemnity so that we free research processes and stop risk-averse behaviour at local level? Sometimes, risk aversion, which is an inappropriate interpretation of risk, is making some of these committees particularly nitpicking in their processes. I recognise that that might need primary or secondary legislation, but I urge the Minister to take away the amendments that we have tabled to the Health and Social Care Bill and think very carefully about them because they would solve quite a large part of this problem. They would not solve it all, but this order is an interim measure, and it cannot last for years because the gaps will widen and we will then carry on losing research from our shores. We are all aware of the urgent need to turn that traffic around and to bring pharmaceutical and all other types of research back because it is a strength and an economic earner for this country if we can get it right. The infrastructure is critical.