Health and Social Care Bill

Lord Turnberg Excerpts

Wednesday 7th December 2011 Lords Chamber

The HTA will work closely with the Health Research Authority to provide the single point of access for researchers that retains all the strengths of its current systems and fully meets the requirements of the legislation. The HTA wants and expects to be judged on how it achieves that for the benefit of research.

[Lord Turnberg]

My Lords, I had a previous bite of this cherry when I spoke at some length in my prayer to take note of the statutory instrument to set up the Health Research Agency a few weeks ago, so I will not be long and will not repeat what I said on that occasion about the need for a research regulatory authority that was more than simply a home for the national research ethics committee. Highly important though that is, my message was that it was essential but not sufficient. If we are to get over the barriers to research posed by the regulatory processes that delay research approval, we must include more functions.

I was very taken by the Statement that the noble Earl repeated yesterday on the life sciences. It was a marvellous demonstration of the Government’s commitment to research and innovation—I could not have said more myself in many of its aspirations. However, if you were looking for a reason for us to have a fully functioning research regulatory authority, as set out in this group of amendments, you need look no further than that Statement. It points out quite clearly where the barriers to innovation lie—with excessive regulation, access to patient data and delays in taking up innovation into practice.

On regulation, the Statement says:

“Excessive regulation can mean that the uptake of new treatments and technology is slow. That is a challenge felt acutely by an industry that sometimes feels that the return is not there quickly enough to satisfy investors. It is felt even more acutely by patients”.—[Official Report, 6/12/11; col. 685.]

There it is; we need a more strongly established research regulatory authority. Let me give one example of where we are in danger of losing out. The NIHR—the National Institute for Health Research—sponsored the North West Exemplar programme to see whether it could engage both the pharmaceutical industry and the NHS in trying to get approval for multicentre clinical trials in a reasonably short time. This involved getting the strategic health authority in the north-west to convince the various hospital trusts in its area to approve the research as efficiently as possible. It has worked—their rate of research and development committee approvals are rapid and compare very favourably with the rest of Europe. They are certainly better than the rest of the UK.

However, there is a danger of that being lost when we lose the strategic health authorities. The driving force of the strategic health authorities will disappear shortly. That is another reason for a research regulatory authority to take on this leadership role: to drive this exemplar forward and spread its message more widely. We need it, therefore, not only for the National Research Ethics Service and the ethics committee on the use of data—a separate ethics committee—but for many of the other functions described so forcefully by the noble Lord, Lord Willis.

I heard exactly what the Minister said about the HTA and the HFEA, and what my noble friend Lady Warwick of Undercliffe said about the HTA. I accept that that should be looked at as a separate set of items. These amendments would allow that; I do not think that they are obviated. However, we need this critical role if we are to take advantage of our excellence in research and if we are to fulfil the Government’s ambitions, as set out yesterday in the Statement. The dangers are evident already, as we see the pharmaceutical industry withdrawing and moving elsewhere. If we are to draw it back, we must have something in the Bill that sets up a full—and fully empowered—health research authority. I hope that the amendment has some sympathy in the Government.

[Lord Warner]

My Lords, my name is on Amendment 258. I speak as a former Minister responsible for NHS R&D in the pharmaceutical industry in 2003 and 2004. We were having exactly the same discussions then. Since that time, the National Institute for Health Research has been set up, we have had the Cooksey review, OSCA has been set up, and we have had the review by the Academy of Medical Sciences. All these cases come back to the issue of a faster, smoother regulatory approval system. The same blockages that are being talked about now were being talked about five, six, seven years ago.

In that time the UK has lost large numbers of clinical trials. We continue to lose trials and we are going to lose more to south-east Asia. UK plc suffers while we continue with these present arrangements. I understand the Minister’s anxieties about this. However, at the end of the day it is difficult to see that a new authority would be in place, even with a very smooth passage, until at least a year later than if we went along with the amendment. We need to move faster on this.

I end with one question to the Minister. Have the Government actually talked to the big beasts in science research in this area—to the Wellcome Trust, the MRC, the Academy of Medical Sciences? Have they asked them directly whether they would you sooner have the Willis amendments or wait for a Bill in the next Session. I would like to know what their straight answer to the Minister would be on that particular question.