Health and Social Care Bill

Baroness Warwick of Undercliffe Excerpts

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.