Health and Social Care Bill

Debate between Baroness Warwick of Undercliffe and Lord Patel

Wednesday 7th December 2011 Lords Chamber

[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.

[Baroness Warwick of Undercliffe]

My Lords, I declare an interest as chair of the Human Tissue Authority, whose work is affected by the review of arm’s-length bodies and is referred to in one of the amendments. The desire to streamline the governance and regulation arrangements to support high-quality research underlies both the Government’s intentions and the amendments relating to the new Health Research Authority. These are laudable aims which I certainly support and which the HTA also supports wholeheartedly. Researchers want to get on with their research, and from their perspective what is important is that they see a seamless end-to-end and proportionate process for regulation and governance. The HTA has always striven to do exactly that within its focused regulatory remit relating to research while ensuring that the interests of the public are protected. But transferring the HTA’s work in research to the new body, as Amendment 260A proposes, may undermine these aims. I want to focus my brief remarks on that point.

The Department of Health clearly has favoured an option to keep all the HTA’s functions together, including research, and will consult on that basis shortly. I believe this is to a large extent because of the HTA’s track record of collaborative working to ensure that the regulatory burden on researchers is minimised. I would be happy to provide a range of examples dealing with NRES, the MHRA, the HFEA, tissue banks and clinical pathology accreditation, but in the interests of brevity I certainly will not iterate them now. Suffice it to say that, in the absence of detail at this stage about how the HRA will operate, it would be premature to make decisions now in haste that we may live to regret later. However, I will briefly set out three reasons why I believe that the HTA’s research functions should not be part of the Health Research Authority.

Health and Social Care Bill

Debate between Baroness Warwick of Undercliffe and Lord Patel

Wednesday 9th November 2011 Lords Chamber

[Lord Patel]

I should also tell the noble Lord that his laparoscopic training is also historical because robots are used now.

I have brief comments, but I shall focus particularly on the amendment in the name of the noble Lord, Lord Warner, that refers to the need for informatics to be properly established to promote research in healthcare. One of the key areas in biomedical and clinical research in the UK is focused on translational research, as other noble Lords have said, to try to get research into clinical care.

Informatics plays a key role in our ability to do translational research. There are three domains of informatics in biomedical research—biomedical informatics, medical informatics and translational research informatics. Translational research informatics is about getting multidisciplinary research into clinical practice, with clinical trials being the first step to it. As we have heard, we have notable successes from our medical research into clinical translation. I say with hesitation that we think we are leaders in the world, but we are not quite the leaders—although we come pretty close. However, we can do better, and to do so we have to have what is required to promote research and its use into translation. Therefore, we will have to develop all three domains and incorporate what we already have—health information involving the medical records to which the noble Lord, Lord Warner, referred, and the development of electronic medical records. I know that other amendments address that issue. We should also be able to carry out statistical analysis.

The noble Lords, Lord Willis and Lord Warner, referred to the rapid sequencing of the genome—whole-genome sequencing—that will impact on the whole of medicine. Recent rapid developments in DNA sequencing technologies have dramatically cut the cost and the time required to sequence a human genome to a point that it will soon be easier and cheaper to sequence each patient’s genome and keep it in their notes. Every time they are diagnosed with or treated for a disease, a genome will be used to extract information. By combining that with our advancing understanding of genes and diseases, whole-genome sequencing is set to change the current clinical and public health practice by enabling more accurate, sophisticated and cost-effective genome testing.

Understanding the health impact of individual genomic variance presents a considerable challenge for analysis, interpretation and management of data. Managing that data will require bioinformatics to be established. The NHS should urgently develop clinical bioinformatics expertise and infrastructure to ensure clinical technical support for medical analysis and interpretation of genomic data. The amendment of the noble Lord, Lord Warner, that includes informatics is crucial in identifying that. If we are to succeed in applying the results of our research to patient care, we need to establish all these issues.

I should briefly mention Amendment 74 in my name. The noble Lord, Lord Willis, mentioned research in public health, as did the noble Lord, Lord Turnberg. My amendment relates to Clause 9 on,

“Duties as to improvement of public health”,

and the functions of local authorities and the Secretary of State as to improvement of public health. The amendment merely tries to,

“establish promotional research, and acting on research evidence into the causes of ill health”.

It is important that local authorities recognise that public health directors should be involved in research in the agenda that is being developed in the prevention of disease. Those are my brief comments.

[Baroness Warwick of Undercliffe]

My Lords, I was really pleased to see Clause 5 extend the duties of the Secretary of State with regard to research and its use. Clause 5 is a necessary acknowledgement of the extremely important role of medical and scientific research in ensuring that we deliver high-quality healthcare. The noble Lord, Lord Willis, and other noble Lords have spelt out graphically the dependence of improvements in treatments on research.

In his response to questions raised at Second Reading, the noble Earl, Lord Howe, repeated the Government’s assurance that a culture of research and innovation would be embedded in the structural changes to the NHS proposed in the Bill. It is a fine promise, but I am concerned as to whether the Bill in its current form is able to deliver this in practice. The lack of detail or clarity across the Bill about the role of and commitment to research in the reformed NHS has been noted by a number of noble Lords. For this reason, Clause 5 needs to be stronger and more explicit.

Embedding research across the complex NHS system requires proactive, top-down, leadership. Clause 5, as it currently stands, does not define how the Secretary of State would provide such leadership. Acknowledging that such research needs to be promoted stops short of an active commitment to promote research, or indeed of saying what that action would look like.