Regenerative Medicine: S&T Committee Report

Baroness Sharp of Guildford Excerpts

Thursday 13th March 2014 Lords Chamber

[Baroness Sharp of Guildford (LD)]

My Lords, as a member of the committee, I thank the noble Lord, Lord Patel, for his excellent introduction to the debate. I repeat the thanks to the noble Lord, Lord Krebs, who cannot be with us today, who was an excellent chairman, and to Professor Fiona Watt, our specialist adviser.

Working on this report took me back to the 1980s when, in my position in the science policy research unit at the University of Sussex, I was an alien social scientist sitting in as a fly on the wall on an experiment in university/industry collaboration called the Protein Engineering Club, which was an attempt to assist the process of carrying science from the laboratory through to industrialisation and commercialisation. Then, as now with regenerative medicine, there were great hopes about what might be achieved. As we were working with proteins and antibodies, we hoped, for example, that regulation would get easier rather than more difficult because we were working with biological entities rather than chemical entities that were alien to the body.

There was also hope that the rise of the venture capital industry in the United States would rapidly spread to the United Kingdom—there was some indication that it was coming—and that this would lead to a wholesale change in the process of coping with, as they put it, the valley of the shadow of death—the process of financing commercialisation—with a wave of new firms that would be well funded, developed and built up, either contracting to or, as in many cases, being bought up by larger firms.

Looking back on it, the work that was done then has been very much the foundation of the current range of biotechnology medicines that are now coming on to the market, but it was 25 to 30 years ago. It has taken a very long time to get many of these medicines on to the market, and indeed some of them are still working their way on to it. The regulatory process, far from getting easier, has if anything become considerably more difficult and complex. The financing is no easier; venture capital waxes and wanes, largely with the macroeconomy. Big pharma itself has waxed and waned. The sort of work that was being done in the Protein Engineering Club has in many senses provided an underpinning for the technology for the two big British pharmaceutical companies, GlaxoSmithKline and AstraZeneca, in their current success. Nevertheless, there have been many ups and downs in the process.

The lesson that comes through clearly in the report is that there are great hopes for these new medicines but much hype. In paragraph 19, we talk about the possibility of regenerative medicine that may provide treatments for long-term, chronic diseases, such as Parkinson’s, cardiovascular disease and diabetes, but we also say:

“Many submissions to the inquiry offered a ‘health warning’, however, that public expectations must be managed as many of these treatments are relatively far from delivery to the wider public”.

As my noble friend Lord Willis said, regenerative medicine is not a short-term fix.

Our report identified the four main challenges to be overcome. Other noble Lords have spoken at some length about some of the issues. One is the science itself. As the noble Earl, Lord Selborne, said, it is moving under our feet. It is a highly innovative area where new ideas are bubbling up and being tested all the time. In no sense is the science stabilised. It is an extremely stimulating environment, but because things do not stand still, it is always a matter of the science moving forward and innovation having to adapt to the new developments that are taking place. The regulatory framework is increasingly complex—perhaps unnecessarily complex, as my noble friend Lord Willis suggested. We were hoping that an expert group could be set up which would manage to find some way to simplify it. Scale up—the shift from the laboratory to larger scale production—is also a considerable problem. There are always completely unforeseen difficulties in such processes. Cells do not behave on a larger scale as they do in a laboratory dish. Finally, there is the business model. It is very important that there should be patient capital. One is looking at 25 years, a whole generation, for such medicines to come on to the market. There has to be capital that is prepared to put its money down and wait for results.

On the whole it seems to me, as it does to others, that the processes the Government have put in place have been appropriate. As my noble friend Lord Willis said, the Government have played their cards well. They have designated regenerative medicine as one of the eight great technologies and have concentrated on the life sciences with the emphasis on investment in the research base, where we have a considerable comparative advantage. In November 2011, they produced their strategy for the life sciences, reinforcing what they call the “life sciences ecosystem”, and, in particular, bringing together R&D in the National Health Service and academic research supported by the research councils and seeking to exploit what other countries see as the UK’s unique advantage in having a unified health service as a platform for assessing the effectiveness of treatments.

Building on this, and into this, indeed, is the Technology Strategy Board. Its April 2012 report A Strategy for UK Regenerative Medicine dealt with the translation from research into commercialisation and concentrated in particular on the regulatory framework, manufacturing and industrial collaboration. Alongside the TSB initiatives is the Cell Therapy Catapult, which was originally a technology and innovation centre to help develop an emerging industry to be a precursor to what could be a £10 billion industry. The catapult is working on a five-year plan pulling academic and industry plans together and ensuring a voice for this new technology within government here and within Europe.

All of this is very positive, except when we come to what is happening in California. The California Institute for Regenerative Medicine—CIRM—has been raising $3 billion in 30-year bonds. The National Institutes of Health is spending $1.3 billion on regenerative medicine. In the UK, TSB is spending £16.25 million over the next three years; approximately £5.5 million a year. Catapult has core funding of £70 million over five years—£14 million a year core funding—and is hoping that the third sector will add another £10 million, and industry another £10 million, making somewhere in the region of £35 million a year. However, much of that is still a matter of hope, although both sectors are beginning to put more money into this area. Putting it all together, we are looking at something in the region of £70 million to £100 million a year for this sector, compared with the $3 billion that the Californians have raised through 30-year bonds.

Our recommendation 13 to the Government was that the ESRC and the Technology Strategy Board should do an evaluation of innovative funding models. The Government must, we said, put their money where their mouth is: we cannot expect the goose to lay golden eggs unless we feed it. The UK public spending and accounting framework is, to my mind, quite unduly risk-averse and focused on the short term in many senses. The centralisation of all capital funding via the Treasury cuts out intermediate authorities as raisers of capital. This compares with the United States, where states such as California, come in and can raise money for innovation. In Germany, the Länder, again, can go to the capital market and raise money for innovation and then work in conjunction with the Landesbank. There is no encouragement here by the Government of highlyconcentrated funding mechanisms at a regional level. The response of the Government to this recommendation was non-committal at best. They said:

“The TSB and Research Councils will respond to the recommendation to evaluate innovative funding models for late stage clinical development”.

Indeed, the TSB and the research councils welcomed the idea. The Government’s response continued:

“The Government is confident that regenerative medicine has enormous potential which is why we invest in the research base through the Research Councils and support commercialisation through the TSB. We cannot commit to adopting policy recommendations on regenerative medicine that might emerge from an Economic and Social Research Council … and TSB study … although we will consider any recommendations of such a study”.

As I say, that is non-committal at best. Unless we are prepared to think big in the way that California does, we shall end up—as we did in some senses with protein engineering—with positive but relatively little gains from this new technology while others grab the really big gains.

NHS: Association of Medical Research Charities Report

Baroness Sharp of Guildford Excerpts

Thursday 27th June 2013 Grand Committee

[Baroness Sharp of Guildford]

My Lords, I am speaking today substantially in place of my noble friend Lord Willis, who, as noble Lords may know, had a heart attack two or three weeks ago. He is making very good progress and, in fact, is hoping to be back before we go into recess. However, he was anxious that somebody from our Benches should speak on this subject. My noble friend, as chair of the Association of Medical Research Charities, played a very substantial part in helping to develop this Vision document. Before that, as the noble Earl knows very well, he played a seminal role in ensuring that the Health and Social Care Act 2012 incorporated clauses that put on the Secretary of State and others in the NHS the duty to promote,

“research on matters relevant to the health service”,

and,

“the use in the health service of evidence obtained from research”.

All are agreed that the Act is a major milestone which has helped to embed research within the body of the NHS.

In many senses, I think that this vision is a natural sequel to that achievement. The AMRC, working with member charities, has attempted to put flesh on the bones of phrases that were bandied around at the time of the Bill being discussed in this House—phrases such as, “placing research at the heart of the NHS”.

As the noble Lord, Lord Turnberg, mentioned, Our vision for Research in the NHS was written after wide consultation among professionals on the one hand and patients on the other, and it is built on three key concepts that emerged from that consultation. The first is involving patients: telling them about research being undertaken, how they can find out more about that research and how they can participate if they wish and it is relevant to their care. Secondly, there is involving staff so that they understand the benefits of research, are motivated to engage with it and know how to take part in it and use its findings. Lastly, there is ensuring that the NHS is open to and about its research, and develops among its staff a group of leaders who will champion research and help embed good researchers and good research practice into the NHS.

I have just three questions for the Minister. First, there is the matter of clinical trials. As I said, one key issue is the NHS being open to research, but there is concern that it is losing its share of global clinical trials. Back in the 1980s and 1990s, when I was doing more research on the pharmaceutical industry, the UK was a favoured location for clinical trials. Many multinational companies put their research laboratories here in the UK because of that. The Science and Technology Select Committee, of which I am a member, recently made a study of regenerative medicine. In the process of taking evidence for that, we learnt that despite the recognised quality of our research, it is no longer the case that we are among the leading countries doing clinical trials. One reason cited most frequently for this was the sheer complexity of procedures, especially the number of regulatory bodies involved. I noted in reading the report that this comes up yet again:

“40% of hospital doctors polled cited difficulties navigating regulatory processes as a barrier to them taking part in medical research in the last two years”.

I know that the UK Clinical Trials Gateway has been set up to simplify procedures, but can the Minister offer us any reassurance that the situation is likely to improve, and in particular that the Health Research Authority might in time become the one-stop shop that everybody is looking for?

My second question relates to co-operation between the NHS, universities and medical schools. Yesterday I attended the lecture given by my noble friend Lord Heseltine to the Industry and Parliament Trust, and I was amused when he talked about how, in the 1970s, the public sector—the Civil Service—and private sector industry were two separate worlds that worked in their own spaces and failed to recognise the benefits of working together in such areas as regeneration. In some senses, it seems that one hits the same problems between the NHS and the world of research, particularly university and medical school research:

“Our survey of almost 400 health professionals including 130 GPs found that around half knew something about the National Institute for Health Research and the NIHR Clinical Research Network … Awareness fell to around a quarter for Academic Health Science Centres, Biomedical Research Centres and Biomedical Research Units”.

Again, we know that a lot of effort is being made to bring together and develop these academic health science networks, linking up the local NHS organisations and universities. Nevertheless, that vision raises questions as to how these networks will share best practice. Can the Minister tell us a little more about how they will function?

Finally, I raise a question that was to a large extent raised by the noble Lord, Lord Turnberg. How can CCGs embed research throughout the NHS? There is considerable scepticism as to how far the CCGs will be able to do this. To help them, the report sets out on page 31 a research charter. How far does NHS England accept that charter and how much will it encourage CCGs to take note of and follow those procedures?

[Baroness Garden of Frognal]

My Lords, I apologise for intervening, but there are no spare minutes in this debate, so it would be helpful if Back-Benchers could keep their remarks to within the six minutes.

National Institute for Health and Clinical Excellence

Baroness Sharp of Guildford Excerpts

Wednesday 14th December 2011 Lords Chamber

[Earl Howe]

My Lords, I fully agree with the noble Lord, who puts the case very well. That is why NICE will be at the heart of our work to improve quality in the NHS. We are re-establishing it, as the noble Lord knows, in the Health and Social Care Bill, extending its role to social care and embedding the role of NICE quality standards in statute. Of course, it will still be there to provide independent advice to support clinicians in the way that we know it has over the last few years.

[Baroness Sharp of Guildford]

My Lords, the White Paper talks about establishing a NICE implementation collaborative. Could the Minister explain to the House precisely what is meant by this?

[Earl Howe]

My Lords, the NICE implementation collaborative is a collaboration between NICE and representatives or stakeholder groups, including the chief pharmaceutical officer, the main industry bodies, the NHS Confederation, the Clinical Commissioning Coalition, the Royal Colleges and, if Parliament approves, the NHS Commissioning Board. The idea is that its members are going to work together to identify where support is needed and to identify solutions for the NHS through the development of implementation guidance—in other words, to improve the uptake of new and innovative technologies in the NHS.

Life Sciences

Baroness Sharp of Guildford Excerpts

Tuesday 6th December 2011 Lords Chamber

[Earl Howe]

The noble Lord makes an extremely important point. He will know that the Government have already established a cancer drugs fund which is designed to enable patients to access drugs that their doctors feel they should receive but which the NHS will not otherwise fund. We are putting £200 million a year for the next three years—totalling £600 million, in other words—towards this fund. That fund is there for orphan medicines and for the treatment of rarer cancers as much as it is for more common cancer treatments. So, as a temporary device, that fund exists.

We have taken the view that the development of a value-based pricing structure for medicines should enable us to move to a situation where drugs are assessed for value in their broadest sense and priced accordingly. In that way, if the value is computed as being high for patients, the NHS will pay the corresponding price and the patient will be able to access that drug. I would, however, say that in the case of orphan medicines the work is at an early stage. It is clear that some orphan drugs are likely to be priced very high, and it is of course necessary to ensure that the value of those drugs as reflected in the price is one that the NHS is prepared to pay. As I say, we have work to do. I can update the noble Lord as time goes on in that area. However, I can tell him that this is very much within our sights.

[Baroness Sharp of Guildford]

My Lords, I should like to thank my noble friend for repeating the Statement and say how much I, like other noble Lords, welcome it. In so far as the new strategy being adopted gives earlier access to new drugs and new technologies for patients, it can only be a very good thing. I have a number of questions for the Minister.

Quite a few NHS hospital data are already available to researchers. One example is the link-up between Yale University and University College, London, where data on cardiac medicine are being mined and exchanged. With the NHS we have cohorts that can be followed through, which is not available in the United States. Am I right in thinking that the difference is that GP data as well as hospital data can now be mined in the same way, enabling cohorts to be followed? If so, and if we are developing these huge computerised databases, how confident can we be that they will not go the way of Connecting for Health, the £13 billion project that hit the ground well over six years behind schedule and which the coalition decided was no longer worth pursuing?

Finally, how confident can we be that these new proposals will change the trend in clinical trials? There has been a dramatic decrease in clinical trials in the UK, from something like 6 per cent of trials done in 2000 to only 1.4 per cent today. Part of the idea behind these new developments is to bring some clinical trials back to the UK. Can the Minister explain precisely how this is expected to be done, and how confident can we be that it will reverse this trend despite the advantage of the growing markets in the Far East, in particular, in attracting clinical trials?

[Earl Howe]

My Lords, my noble friend has asked some extremely pertinent questions. In answer to her first one, data from GP practices as well as data from hospitals are available today. However, the clinical practice research datalink, which is the new service for researchers being established under the umbrella of the Medicines and Healthcare products Regulatory Agency, will for the first time enable researchers to access very much larger banks of information on a population basis and to target their questions appropriately at the database. I do not see that there is any risk to the technological aspects of that system. The CPRD is using existing data structures in the NHS. It is not changing systems as Connecting for Health attempted to do and has done.

Will this make a difference to clinical trials in the UK? I believe that it is one ingredient of a package that will make the UK more attractive. On its own, perhaps it is not enough. When I recently visited Japan and spoke to pharmaceutical companies there they were extremely interested in this, but of course they take into account the wider picture. That has to include the fiscal environment, where we are introducing a patent box which will protect patents, at a very advantageous rate of tax, on intellectual property invented in this country. There are various incentives aside from that including the corporation tax rate, with ours being the lowest in the G7 in a few years’ time. Also, the establishment of the Health Research Authority is designed to streamline the ethical approvals for clinical trials. The establishment of the National Institute for Health Research also is designed to streamline the all-too-slow process that we have been used to over the past few years. We are determined that, across the piece, we must make this country and the NHS, in particular, the platform of choice for clinical trials in the world. I believe that this can be done, but of course it will not happen overnight.

NHS: Front-line and Specialised Services

Baroness Sharp of Guildford Excerpts

Thursday 13th January 2011 Lords Chamber

[Baroness Sharp of Guildford]

My Lords, I, too, thank the noble Lord, Lord Turnberg, for initiating this timely short debate, and I also look forward to the maiden speech of my noble friend Lady Jolly.

As most noble Lords will know, it is not usual for me to speak on National Health Service issues. I do not have the detailed knowledge that I have of the education system, but I retain an open mind about the proposed changes. I come from Surrey where we have not had a very happy experience with PCTs. Our PCT has had perennial financial problems of one sort or another. One area with which I have some concern is the future of community hospitals. The decisions they have made have been bad and incredibly vacillating, and have taken far too long. By contrast I have had good experience with my GP practice, and most of my friends are also extremely happy with their GPs. My own practice is very innovative and go-ahead, and I am pleased at the thought that it will have more power.

Of the reforms, I welcome very much the greater local accountability. We on the Liberal Democrat Benches have long argued for bringing together the responsibilities for health and social care, and a greater role for local authorities. The creation of the health and well-being boards will bring together, within the NHS, both the social care and the related children’s care and public health services. That is a very important step in helping to provide us with joined-up health services. I also welcome the focus on patients and their needs. I hope that it will not just be rhetoric. In most cases, patients defer to decisions made by their own GPs or by the consultants they see, but there is a danger that the whole system may be too dominated by professionals and the mentality that professionals know best what to do. It is, therefore, extremely important that we retain within the various boards lay membership at all levels—in the GP consortia and all the way up to the NHS commissioning board.

Lastly, I welcome the establishment of HealthWatch. I was quite involved at one point with our local community health council and I regretted very much its replacement 10 years back by what struck me as a relatively toothless link committee. I hope that HealthWatch, together with local scrutiny committees, will mean that there is a genuine watchdog for the patient in terms of quality and accountability.

I have five questions for the Minister. First, precisely what is the role and what will be the powers of the NHS commissioning board? Secondly, where within the system does NICE now fit? I am grateful for reassurances from the Minister at a meeting the other day that NICE will not be abolished, but indeed would be strengthened. However, it would be useful if those reassurances were on the record and he could tell the House how it will fit into the greater scheme of things. Thirdly, I do not understand the trail of accountability in the new system. Who will set the budget for the GP consortia and who will oversee their expenditures? What happens if they overspend? Who holds them to account? With the strategic health authorities now going, who will oversee hospital expenditures and hold them to account if they overspend? While I welcome the bringing together of local public health services with the community and children’s health services, will there be enough resources to meet needs given the cuts in local authority funding? Already instances of bed-blocking are reappearing. My noble friend John Shipley raised the issue of bed-blocking in Newcastle with the Minister the other day and there are other instances. As a school governor I have experience of children’s and adolescent mental health services and the lack of facilities to provide educational psychologists when they are needed to back up special educational needs provision in schools. Time and again, the NHS has failed to deliver on its responsibilities. How are we to get really effective linking-up between health and local government services?

Finally, the health and well-being boards will bring together public health and social care services, but one of the traditional problems of the NHS has been the divide between primary and secondary care. What incentives are there within the system to improve that relationship? In particular, there is the relationship between GP care and specialist care. Can the Minister tell us a little more about proposals there? I look forward to hearing the answers that the Minister will give us on those issues.

Queen's Speech

Baroness Sharp of Guildford Excerpts

Thursday 3rd June 2010 Lords Chamber

[Baroness Sharp of Guildford]

My Lords, I shall concentrate my remarks on education. The opening words of the gracious Speech state:

“My Government will seek to build a strong and fair society”.

As the noble Lord, Lord Hill, reminded us in his opening speech, that fair society depends a great deal on education. I was rather surprised at how well the coalition of the Liberal Democrats and the Conservatives managed to put their two education policies together. The noble Baroness, Lady Morgan, referred to the pupil premium. Some years ago, I travelled with Nick Clegg to Holland to look at the way in which the Dutch funded education. We found that disadvantaged children were given special extra funding which they carried with them as they moved from school to school. The pupil premium was based very much on the research work that we carried out on that expedition and I was delighted to see that it plays a substantial part in the policies which the coalition is putting forward.

I am also pleased at the emphasis that we are giving to rolling back bureaucracy. Both parties agree that schools and colleges—and universities, for that matter—are overwhelmed by bureaucracy. Last year a seminal report was produced by the Merits of Statutory Instruments Committee, which found that each year the average head received well over 700 pieces of paper comprising directives and guidance. That is roughly three for each working school day and is an impossible amount to manage. When I inquired of a local comprehensive school head how much time he allocated to interpreting the bureaucracy that he received from the centre to his staff and parents and governors who needed to know about it, he said that on average he thought it took him roughly half the week, which is an astonishing amount of time. The more that we can roll back that bureaucracy and allow our school leaders and teachers to give time to front-line services, the better it will be. It is important that we, as a Government, practise what we preach. It is too easy to talk with one breath of freeing up teachers from bureaucracy and then to declare with the next that they must use synthetic phonics to teach reading.

I confess that I am also somewhat worried at the thought of Ministers laying down the law on what the history curriculum should be, even if they call in eminent historians to advise them. We were very worried by what Stalin and Hitler did to the history curriculums of their countries. I am not suggesting that democratic Ministers would behave like that, but it is important to beware of too much political influence over the curriculum.

The flagship measure of this Government that we shall see within the next week is the Academies Bill. It will not surprise noble Lords on all sides of the House to hear that I have reservations about the Bill as it stands. However, I shall leave my thoughts on the proposals in that Bill until its Second Reading on Monday. I echo the point made by the noble Baroness, Lady Morris of Yardley. If we are looking to create a fair society, it is very important that we concentrate not on structures but on process. Taking the issue of process somewhat further, one aspect of lessening bureaucracy that is agreed is to change the role of Ofsted. The schools that consistently perform well will be inspected less often and, as the Minister mentioned, the Government are proposing to reduce the number of performance indicators. But in that case it is vital that we use the right measures of performance and it is difficult to know what they are, because any school's performance is also closely linked to its socio-economic profile. Our high-performing schools are predominantly in middle-class areas with middle-class intakes. Poorly performing schools serve disadvantaged populations. It is this gap in performance that both the coalition and the previous Government have sought to close, and will seek to close, so that there is genuine equality of opportunity.

It is no good just whipping the schools to produce better SATs and GCSE results. First we must find a way of compensating those coming from disadvantaged homes for the disadvantages that they suffer; hence the importance of programmes such as Sure Start, and the children's centres frequently associated with Sure Start, which combine education and parenting. Programmes such as Every Child a Reader are crucial because they provide one-to-one tutoring for six and seven year-olds who are having difficulty in mastering reading. At secondary school level, it is very important to find and provide a curriculum that excites and motivates those who at present are often turned off by the overacademic approach of GCSEs. Diplomas were supposed to be the answer to this problem, but I worry that, as currently developed, they are too much of a hybrid, satisfying neither the vocational nor the academic side of education. This is why I am very excited by the prospect of university technical high schools that the noble Lord, Lord Baker, spoke about. They would combine first-class vocational training with dedicated equipment and teachers, but keep open the door both to jobs and to higher education. That seems to be a much better way forward than shunting pupils around from school to college for the odd half day here and there.

Education remains the key to unlocking our potential. The UK must raise its game, both to maintain international competitiveness and to help to build a society that is fair and more at ease with itself. This is recognised within the coalition agreement by the priority given to education, and the ring-fencing of the schools budget. There are real savings to be gained from reducing bureaucracy and concentrating managerial resources on the central tasks of teaching and learning; but let us not waste these gains on fruitless restructuring. Rather, let us give our teachers and school leaders space and time to innovate and excel.