Regenerative Medicine: S&T Committee Report

Earl of Selborne Excerpts

Thursday 13th March 2014 Lords Chamber

[The Earl of Selborne (Con)]

My Lords, the whole House will be grateful to the noble Lord, Lord Patel, who speaks with great authority on the subject and was a fellow member of the committee. He speaks as a very distinguished professor in this area; I speak as a layman, but one who learnt a lot during the course of this inquiry into a fascinating area of very fast-moving technology and science.

This is a highly appropriate subject for a Select Committee report. Where science moves so fast, the regulatory framework will inevitably lag behind and it is a challenge for Administrations to ensure that there is the appropriate regulatory framework and fiscal support for what everyone will recognise has enormous potential. The technology has enormous potential in the longer term to produce new treatments for the plethora of diseases mentioned in paragraph 18 of the report, which lists Parkinson’s disease, cardiovascular disease and diabetes. I am sure that many people will wish to add to that list.

In the shorter term, a number of treatments can be seen coming over the horizon or are indeed almost available. One example, in paragraph 15, is a therapy which seeks to reverse the damage caused by a stroke. Given an ageing population—which is common to pretty well every developed economy—given that healthcare as practised at present with the tools available to us is forecast to require ever larger proportions of our economic resources and given the international interest, let alone our own national interest, in novel and innovative treatments that may have great economic and social benefits, there will be enormous rewards to those countries that put in place successful policies to promote these opportunities.

As the noble Lord, Lord Patel, reminded us, we have a strong science base at present and we need alongside it a suitable regulatory framework which gives confidence to patients, investors and, of course, the scientists and those conducting trials. We will need to ensure that public funds can complement funding from other sources, such as charities and commercial interests. We will have to negotiate the so-called valley of death, which is the difficulty, so often experienced in this country, in commercialising research findings. That is being addressed by the Cell Therapy Catapult, about which more anon. We will have to ensure that we make best use of those advantages derived from the National Health Service. The noble Lord, Lord Patel, reminded us that we have the great advantage of access to much valuable data on a scale not available to some of our competitors.

The Government have identified regenerative medicine as one of their eight great transforming technologies. Other reports, as well as our own, have alerted the Government to the critical importance of identifying barriers to development. The Government’s own report of July 2011, Taking Stock of Regenerative Medicine in the United Kingdom identified,

“steep technological, regulatory and strategic barriers to realising regenerative medicine’s significant potential”.

Our report emphasised the frustration that some scientists and clinicians have experienced negotiating the various regulatory hurdles. The Government response recognised the need for regulatory simplification in the long term and help to get through the existing minefield—perhaps I should call it labyrinth—in the shorter term. The establishment of the Regenerative Medicine Expert Group, tasked with developing a regenerative medicine delivery readiness strategy and action plan, is certainly a positive response to the report and is to be welcomed. However, at the risk of seeming grudging in my praise for the Government’s response, I draw attention to the rapidly changing international competition for recognition as a global leader. We refer in our report to the high level of investment in the United States and to the rapid progress in countries such as China and India.

Since we published our report, Japan passed legislation in November last year that revised its pharmaceutical affairs law, with the intention of establishing Japan as a global leader in regenerative medicine while continuing to protect patient safety and confidence. Last month at the World Economic Forum in Davos, the Japanese Prime Minister made it clear that this legislation redefines the regulatory framework and gives the opportunity for new therapies to move more rapidly from an early-stage clinical trial towards conditional approval, which enables the product to be brought to market and therefore to obtain reimbursement for the product in an accelerated manner. In the light of such responses from our competitors, it may well prove necessary to look more fundamentally at our own regulatory framework, as indeed we recommended.

On pages 42 and 43 we say that we will revisit the regulatory aspect of the inquiry to ensure that progress has been made. I am absolutely sure that it will be essential to monitor progress, although we all hope that the Regenerative Medicine Expert Group can facilitate simplification without, at least for the present, the need for further legislation.

I want to say a word in support of the catapult centres in general and the Cell Therapy Catapult centre in particular. For years we have complained in this country that we allow others to reap the rewards of commercialising scientific research. The previous Administration are to be congratulated on asking Hermann Hauser to make recommendations on how we should address this long-standing problem. He concluded that what was missing from the United Kingdom’s innovation landscape was a network of centres working at the commercialisation stage of technology, matching scientific research to industrial needs. His recommendation was that we should follow the model of the Fraunhofer institutes in Germany.

One of the seven new catapult centres is the Cell Therapy Catapult established in 2012 through the Technology Strategy Board and is designed to create a world leading cell therapy industry in the United Kingdom through innovation and collaboration. It is early days and we do not yet know how successful the centre will be—we will not know, probably, for a decade or so—but meanwhile we should allow the centre to build up its dedicated cell therapy teams, bringing together scientists, investors, manufacturing interests, regulatory experts and other interested parties from around the world. We must resist all temptation to interfere or change—it will need a good long period for bedding down—but it must be a highly appropriate subject for a catapult centre.

What is now needed is continuity of funding and support from us all. This catapult centre is exactly what is needed if we are going to emerge in the next decade as a global leader in this exciting sector.