Health and Social Care Bill

Lord Walton of Detchant Excerpts

Wednesday 7th December 2011 Lords Chamber

I hope that my noble friend in his reply, and other noble Lords who will speak to these amendments, will accept that this is a one-and-only chance for us to do something momentous in this House. I trust that the Minister will give full support. I beg to move.

[Lord Walton of Detchant]

My Lords, I give very warm support to these amendments, which were so expertly introduced by the noble Lord, Lord Willis. As he said, the report of the Academy of Medical Sciences, after a long period of study and a committee chaired by Sir Michael Rawlins, made a number of important proposals, which the Government, in principle, accepted.

This takes the matter very much further. Following last night’s very exciting and far-sighted Statement by the Government about the developments in research and their sponsorship of translational research, the need to translate the discoveries of basic medical science into practical developments in patient care, the crucial importance of making access available to the NHS database to enable clinical trials to be carried out, and the crucial importance of more rapid access to new medicines and so on through the NHS, it is crucial to recognise that all those proposals are very important. These amendments would carry that forward.

It is also important that the Health Research Agency, which has already been established, is as yet an inadequate vehicle to further the developments to which the noble Lord, Lord Willis, referred in great detail. It is essential to recognise that to carry forward the developments envisaged in the Government’s Statement last night on translational research on the governance of clinical trials and the overall governance of research as a whole in the NHS, something like these amendments must be put in the Bill.

I want to comment briefly on the proposals set out in one of the amendments, to the effect that it would be sensible to remove from the Human Tissue Authority and the Human Fertilisation and Embryology Authority their research components and that these would much more happily settle in the newly defined Health Research Authority. There is a lot of sense in that, because the research carried out by these organisations is important, and it is research that is in many ways crucial to the development envisaged in these amendments.

However, it is important to recognise too that the Human Tissue Authority in its present existence has a major responsibility for regulation—regulating the departments, for instance, in which anatomical work is carried out, and regulating departments of pathology and other teaching functions which are absolutely vital. Similarly, the Human Fertilisation and Embryology Authority is not primarily concerned with research but also has major licensing functions, in licensing organisations in which work under the Human Fertilisation and Embryology Act can be carried out.

I understand that there has been a proposal by the Government that the functions of the HTA and the HFEA might be transferred to the Care Quality Commission. I would only comment, as John McEnroe said, that you cannot be serious. The Government cannot really be serious. This is not an organisation which is set up to handle that type of information. It is crucial to recognise that the Care Quality Commission has very specific responsibilities. It has taken on the responsibilities of three previous bodies, which were involved in looking at healthcare, social care and psychiatric care. It is carrying a major load—

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

Will the noble Lord give way? I am sure the noble Lord will know that through this Bill we cannot transfer the functions of either the HTA or the HFEA to any body at all. Indeed, that was the substance of my undertakings to this House under the Public Bodies Bill debate—that we would defer consideration of those matters until a later Bill. This Bill simply covers the reform of the health service, obviously, and my noble friend has sought to introduce an amendment to set up the Health Research Authority as a statutory body. But I gave an undertaking to this House that I take very seriously: that the consultation process on the transfer of functions from the HTA and the HFEA has to take place. It would be premature for this Bill to cover that matter. For that reason alone, I urge noble Lords to be very cautious about my noble friend’s amendment, about which, nevertheless, I will say some warm words.

I wanted to specifically cover that matter, as I notice the noble Baroness, Lady Warwick, looks as if she wants to rise to her feet. I can understand why, because it is important for the Committee to understand that the matters to which the noble Lord has just referred are matters which we will reach in due course, rather than today.

[Lord Walton of Detchant]

I am very grateful to the noble Earl for clarifying the position, but it is important that in the longer term we shall have to learn more about the future of those two very important authorities. In the mean time, the crucial importance of these amendments is to clarify in the Bill the responsibilities of this new organisation which is going to be responsible for regulating research in the UK, and which will streamline and improve the present mechanisms for research approval in many different situations. Therefore, I strongly support these amendments.

[Lord Patel]

My Lords, I hesitated to rise last time because I saw the Minister getting up, and I thought he was about to make a pronouncement to stop the debate because he had a solution to it all, but I realise now that was not the case.

I strongly support the amendment of the noble Lord, Lord Willis. I have my name attached to it. It is crucial that we hear more than just the setting up of the authority, as the Government have announced a few days ago, to take charge of the National Research Ethics Service. I was part of that organisation until I finished my time in the National Patient Safety Agency and was responsible for setting up much of its work, so I take the blame for its shortcomings, if there were any.

The issue we are discussing is why there is a need to set up the Health Research Authority with wider functions than those of NRES. The report produced by the Academy of Medical Sciences identifies serious issues which are important if we are going to deliver on the life sciences strategy announced yesterday and on which I have highly commended the Government; it is excellent. But if we are to deliver on it, we need to streamline the regulatory processes that currently are so cumbersome. For instance, an NHS research and development permission is required at every NHS site where the research is to take place, and the review by the Academy of Medical Sciences confirms that this is perceived to be by far the greatest barrier within the regulation and governance framework. The current process for obtaining research permissions across multiple NHS sites is inefficient and inconsistent. Local negotiation about research contracts and costings is a further source of delay, together with a lack of agreed timelines within which approval decisions are made. Governance arrangements are therefore very important, and the noble Lord, Lord Willis, told us that the report has highlighted that there should be a governance board as part of the Health Research Authority.

The noble Lord gave some examples of delays which had been highlighted by respondents, including in kidney research, stroke research and multiple clinical trials involved in heart research. The solution is to set up an authority which can provide a national research governance service as a part of it. Clinical trials are another example. The noble Lord mentioned how our global share of clinical trials has fallen dramatically. This is particularly related to the fact that it is cumbersome to conduct clinical trials in the UK. To address the challenges identified around clinical trials, improvements are clearly necessary at both the European and the UK level. I know that discussions are going on and that the department is involved in a revision of UK clinical trials, and I hope that they will come to some fruition. The noble Lord also said that the relationship between the new Health Research Agency and the Medicines and Healthcare Regulatory Agency will be crucial in improving the current system. That is an important point, because it was the relationship between the MHRA and clinical trials that at times caused problems.

The problem is that the existing regulation and governance pathways, which evolved in a piecemeal manner over several years, have now become dysfunctional. Although new regulatory bodies and checks have been introduced with good intentions, the sum effect is a fragmented process characterised by multiple layers of bureaucracy and uncertainty in the interpretation of individual pieces of legislation and guidance. This has produced a lack of trust in the system along with duplication and overlap of responsibilities. There is no evidence that these measures have enhanced the safety and well-being of either patients or the public, so the answer lies in now creating a Health Research Authority with multiple functions in order to go forward.