Regenerative Medicine: S&T Committee Report

Lord Hunt of Kings Heath Excerpts

Thursday 13th March 2014 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I very much welcome the debate and I congratulate the noble Lord, Lord Patel, on securing it and commend him, the noble Lord, Lord Krebs, and the committee members for the quality of the report itself. I declare my interests as chair of an NHS foundation trust, president of GS1 and consultant and trainer with Cumberlege Connections.

This subject is of considerable interest to me. I am sure that the noble Earl, Lord Howe, will remember our great debate on the order allowing the extension of embryonic stem cell research over 10 years ago, when your Lordships’ House debated the matter for over seven hours. We agreed to it subject to the establishment of a Select Committee. I think that we played our part in laying some of the foundations for the progress that has subsequently been made.

The report itself is a powerful one. It very helpfully points out the many strengths the UK has in regenerative medicine—strengths we always hoped we would be able to take advantage of—but it also points out some of the issues around private investment, regulation, translation and how we are to take forward developments that look particularly promising as far as patient treatments are concerned.

Overall I welcome the Government’s response, which has been positive. However, it leaves four specific questions, which I will put to the noble Earl. They concern: regulation; the funding of research and development; and manufacturing capacity. I will then look a little further down the line towards the role of the National Health Service and the uptake of such new medicines and developments.

Both the noble Lords, Lord Willis and Lord Turnberg, spoke particularly eloquently about the issue of regulations and the problem we may have because of the number of regulatory bodies involved in regulation. The committee itself wanted to give a stronger role to the HRA; that is an important point on which we look forward to a perhaps more considered response from the Government. However, I was particularly interested in the point raised by my noble friend Lord Turnberg about the issue of clinical trials and the approach of the MHRA as compared to regulators in Japan and the US. That is the issue in Japan, for example. My noble friend cited that approval can be based around phase 2 trials and that what is needed is the adoption of what my noble friend called an adaptive licensing system. I am well aware of that issue.

I believe that the MHRA is a very good agency that does very good work. However, I am not yet convinced that it sufficiently recognises the urgency of making changes to its own approach. I understand that this is difficult, and I have no doubt that it has to work within the context of European directives in that area. However, can the noble Earl give us some assurance that the MHRA and the other regulatory bodies recognise that this country has a big stake in regenerative medicine? We cannot allow overbureaucratic regulatory procedures to get in the way of that.

I know that we have debated regulation on many occasions, and I wonder whether the noble Earl might consider taking a more proactive role himself—because I think he has responsibility in this area—to knock heads together between the different regulatory bodies. We have huge potential here; it would be a very great pity to lose it because our regulatory bodies were not able to keep up with the science.

Can the noble Earl respond to the issue of research investment? We will never be able to match the kind of investment that the US makes. However, we have clearly shown that we can produce very good results with investment at UK levels. Hearing the sums—the noble Baroness, Lady Sharp, very helpfully went through them—I think that they are pitiful compared to the kind of sums that need to be invested. I would like to hear some more about how the Government think that they, the medical charities and other sources can increase our effort in this area.

Manufacturing capacity has been raised as an issue. I welcome the Regenerative Medicine Expert Group, but I saw no reference in the work streams to the issue of manufacturing capacity. Can the noble Earl say a little more about how the Government think they ought to be able to encourage more manufacturing capacity in the UK?

Finally, I will ask the noble Earl about uptake by the National Health Service, which again is an issue that we have debated and which will become a big problem in the future. We know that the NHS, wonderful though it is, is very conservative as regards uptake of new medicines and treatments. The reason NICE was created was to encourage the NHS to do better. Yet in a recent report, as regards technology appraisals, which clinical commissioning groups are by law duty-bound to fund, it is clear that the take-up varies 20-fold for some important new technologies in England. We cannot allow the caution of the NHS over the uptake of new medicines to get in the way of making the most of regenerative medicines. I would be interested in the Minister’s view of how we can get the NHS to play a much stronger role.

The Regenerative Medicine Expert Group is very much to be welcomed. All of us respect highly Sir Mike Rawlins, who is an excellent choice as chairman, and I note that the group is expected to conclude its work by the end of 2014. It would be very helpful to the House if the Minister could be clear with us that the Government will take the report seriously and, on the back of it, will be prepared to reconsider some of the points that they have made in answer to the excellent report of your Lordships’ House.