Gene Therapy

HL Deb 12 January 1995 vol 560 cc346-63

6.58 p.m.

Lord Colwyn

rose to ask Her Majesty's Government what plans they have for further initiatives in gene therapy that will help protect the United Kingdom's ability to contribute to new treatments and maintain its pre-eminence in medical research.

The noble Lord said: My Lords, I am most grateful to the Government for giving me this opportunity to discuss the current situation in gene therapy. I have re-read the debate in this House on 11 th May last year when the noble Lord, Lord Kennet, drew our attention to the problems and ethical considerations of genetic manipulation. He mentioned briefly the involvement of the pharmacological industry and it is this aspect I wish to address. I should declare that I am a director of a pharmaceutical company whose work on drug delivery and diagnostics will inevitably influence and be influenced by advances in gene therapy. I am also president of the Huntington's Disease Association.

The multi-billion dollar biotechnological industry has made significant advances in the past 20 years. By the 1980s it had developed to the point where genetic changes could be made to cells in the human body via a variety of delivery vehicles which allowed the insertion of DNA directly into the cell. The appeal of biotechnology today is the concept and possible reality of gene therapy assisting in the quest for total disease management.

September 1994 marked the fourth anniversary of the first therapeutic gene therapy procedure performed in humans and today the recipients are thriving. The progress of genetic therapy is remarkable. There are currently 63 ongoing trials in the US alone. There is worldwide interest in gene therapy among patients, the public and politicians. There is acceptance that the clinical strategies and regulatory framework are in place and that the complex ethical considerations are being addressed. If there were ever any doubt about the ability of gene therapy to change the medical and financial foundations of the healthcare system one need only have been witness to the unprecedented interest generated from within some of the major healthcare corporations in 1994. Pharmaceutical companies such as Merck and Co., Schering and Plough, Rhone Poulenc Rorer, Glaxo, SmithKline Beecham, Pfizer Inc. and Hoffman LaRoche have realised that they need to be involved now if they want to be associated with the realisation that gene therapy offers the opportunity to cure disease at its origin while improving the quality of life, reducing health costs and developing new preventive practices.

Gene therapy offers access to new clinical markets and global opportunities. Some financial forecasts predict a market size of between 2.8 billion and 5.8 billion dollars by 2000, growing to 50 billion dollars by 2010. However, success will depend on having the correct blend of core competencies and technologies to complete the cellular puzzle. Once each of those core technologies has been developed and incorporated into one system specific for a particular disease, gene therapy will have the ability to influence the treatment of most of the major diseases that affect us today. For example, cystic fibrosis is the most common genetic defect in Caucasians and is under serious frontal attack from the scientific community worldwide.

CF gene therapy studies are but one excellent example of how quickly development takes place in gene therapy and may go some way towards explaining the unprecedented number of collaborative agreements entered into recently by major pharmaceutical companies. This brings to light the need for a concentrated gene therapy effort within the UK. Recent substantial investment in the gene therapy technology by governments and major pharmaceutical companies around the world must now encourage the British Government to set in place a structure and foundation, outside that already in place, that not only attracts core competencies and technologies to the UK but ensures that they remain in the UK for the benefit of all British citizens.

The White Paper Realising Our Potential concluded: The United Kingdom must continue to play an active part in international scientific and technological activity at all levels whether this involves individual scientists, companies or Government. As the newly-emergent nations begin to contribute to extending the knowledge base on which the technologies of the future will depend, this country's world share of total scientific research will inevitably be reduced". With certain exceptions the UK has been slow to pick up on commercial opportunities in biotechnology development and there is still much technology in laboratories throughout the UK that has not been adequately supported or exploited.

It seems to me that the admirable conclusion of the White Paper is being ignored. This country's world share of total scientific research has already been reduced and the "brain drain" of core competencies and technologies is increasingly evident. We cannot expect to remain competitive, let alone maintain world class scientific researchers and technologies when other countries have already realised the commercial potential of gene therapy and in doing so have committed extraordinary numbers of scientific staff and financial resources to its successful development.

The Medical Research Council strategy for gene therapy is being advanced through two related programmes; first, the human genome mapping project, and, secondly, the initiative on the genetic approach to human health. Such strategies are commendable but they are not long-term solutions to the dilemmas facing UK gene therapy today. The UK cannot afford to await the outcomes of under-funded research programmes and training initiatives while other countries provide extraordinary amounts of finance for research programmes being undertaken by an already established base. The UK must become more commercially oriented so as to drive the projects to commercial success. In order to achieve that the UK Government, together with industry, must be encouraged to commit more funding to programmes to bring them into line with the USA, the rest of Europe and other newly emerging nations. Currently, the MRC allocates some £21 million for development and inheritance programmes, a portion of those funds being used to exploit the potential for clinical research and industrial application arising from rapid development in gene therapy.

Pharmaceutical companies are entering into alliances with gene therapy companies to focus on specific diseases. Recently Rhone Poulenc Rorer has aligned itself with a number of companies and could potentially spend 1 billion dollars by 2000. The alliance includes a mix of American and French partners as well as private companies and public institutions. That strategy ensures that all the requisite technologies are housed under one umbrella for the ultimate benefit of the company.

Gene mapping was initiated in the USA. In 1988–89 funding amounted to £41.3 million. The operating budget for 1992 was £110 million and for 1993 £113.8 million. Outside Europe and the USA, Japan is the only other country to have a human genome programme with a budget of £20 million or more for 1992. Other countries with smaller programmes include Canada, the Soviet Union, South Korea, New Zealand and Australia.

Singapore is another recent entrant into the field of biotechnology. Its government have launched a number of initiatives and made funding and investment available to biotechnological companies, ensuring that scientists from around the world will be attracted to work in Singapore.

Gene therapy is still in its infancy in this country, but, as illustrated by the rapid development of gene therapy for the treatment of CF, there is sufficient preliminary data within the industry to suggest that it is a powerful technology for the treatment of disease. We must strive to see that difficulties are overcome and that the combined efforts of scientific institutions, pharmaceutical and biotechnological companies, government and industry ensure that the technologies remain in the UK.

Initiatives by the MRC have seen the establishment of the clinical research initiative with centres at Nottingham, Glasgow, Edinburgh and Cardiff, in addition to the recently established clinical sciences centre. The MRC was also fundamentally responsible for the development of the Sanger centre and for the establishment of the European Bioinformatics Institute at Hixton Park, Cambridge. The technology transfer group brings researchers together with industrialists and venture capitalists by increasing the scientific community's awareness of research opportunities and the MRC collaborative centre has been allowed increased flexibility to enable it to start up new companies to pursue scientific knowledge derived by the MRC. The MRC has therefore undertaken many initiatives in the area of gene therapy and continues to implement the recommendations of the White Paper by bringing science and industry closer together. But can it truly develop the UK's international competitiveness with its limited financial resources and wide charter?

In the MRC's 1994 Scientific Strategy, the secretary of the council, Dai Rees, stated: While I would naturally wish for more funding, constraints on public expenditure are a fact of life and we must make the best of what we are given from the public purse and increase our income from other sources whenever we can". That is an intolerable situation, implying that the MRC must strive to compete internationally while being tied down by lack of funds.

A report commissioned by the Office of Science and Technology to "identify areas in human genome research important for investment in the UK to benefit both basic science and commercial opportunity" concluded: There is an urgent need to investigate the ways in which the setting up of venture capital funded companies for gene discovery can be facilitated. Such companies should be able to access and exploit genetic and physical mapping technology in the UK or exploit it by another mechanism that leverages all appropriate technology".

As matters stand, the MRC cannot possibly be expected to fund all areas of research. At present the MRC is not, and will never be, in a position to provide a co-ordinated approach to gene therapy in the UK. If the UK wishes to remain competitive at an international level it must successfully and immediately put in place a co-ordinated network, together with a financial plan, that will ensure the UK becomes and remains competitive by maintaining and attracting key scientists and technologies.

In Canada, the networks of centres of excellence have been established by the federal government through the Natural Sciences and Engineering Research Council of Canada. Being an important part of Canada's science base, the centres bring together researchers from across the country in co-ordinated fashion to exchange ideas and knowledge, to facilitate the transfer of technology to industry, and to develop new approaches to new problems.

As an example, Neuroscience Inc.—a co-ordinated affiliation of five universities and individual investigators—has formed a partnership with MDS Ventures to allow investors to participate in the growth and development of neuroscience businesses and enterprises in Canada and internationally. Joint financing by the government and the institutions raised approximately 75 million Canadian dollars. This kind of initiative should be a pointer to the UK Government that there are a number of other bodies, both private and public, which are co-ordinating and funding different research and development areas by bringing them together in a co-ordinated fashion in order to gain a competitive advantage.

I hope that my noble friend the Minister will see that the US, France, Canada, Japan and Singapore have all realised the need for an appropriately funded and co-ordinated approach to the problems that face the development of gene therapy today. Those countries have been quick to recognise and back programmes that have potentially enormous returns for money invested.

I conclude by making a few suggestions as to how the UK could align itself with the rest of the world with respect to gene therapy. The UK has a history of leading the pharmaceutical and biopharmaceutical industries with products in the top 20 selling pharmaceuticals and potential blockbuster products and technologies under development. Very significant export earnings have been derived and a co-ordinated gene therapy approach could produce similar benefits.

The importance of biotechnology investment in the UK was recently reiterated by the establishment of the inward investment team, designed to encourage US and Japanese companies to invest in the UK. However, as the UK already has a network of world recognised scientists and technologies, we should also be actively encouraging domestic investment to ensure that scientists and technologies remain within British control and are brought together in a co-ordinated fashion, supported by comparative global funding. That strategy will ensure that the application of these technologies leads to the successful development of important gene therapy products within the UK, eventually impacting on the wealth of the nation and the health of its citizens.

The UK must establish a multi-layered highly co-ordinated organisation to draw on all the expertise and current research that is available and being undertaken. Scientists and technologies must be maintained and kept in the UK and potential partners must have access to them and show a willingness to share developments and experience in order to emphasise the commercialisation of findings. The attraction for the partners is the recognition that commercial success will be achieved by collaborating with others.

Fundamental support led by government in a drive towards successful gene therapy application will ensure that greater investment is attracted from industry. World-recognised scientists and their technologies will simply not remain in, or be attracted to, the UK unless they have suitable domestic financial support—either private or public—together with first-class facilities to ensure that they can fully develop technologies to a commercially exploitable stage.

I apologise for rushing through my speech. When I arrived an hour ago I had to cut out more than half of my 35-minute speech. I am grateful to all noble Lords who are to take part in the debate. I look forward to hearing what they have to say, in particular my noble friend the Minister. I am grateful to her for being here tonight to answer my Question.

7.13 p.m.

Lord Kennet

My Lords, before addressing what the noble Lord said, and this Question, perhaps I may draw a distinction between somatic gene therapy and germline therapy. The former cures sick people and is an extension of ordinary Hippocratic procedures. As regards human relations, it has been familiar for thousands of years. It involves ordinary doctors doing ordinary things with new understandings and new technologies. Germline therapy on the other hand alters the heredity of a given strain of human beings in permanency. There is a consensus—and we may be grateful for it—that somatic therapy has no ethical obstacle in its way; that it is to be welcomed and worked for by all concerned as hard and as fast as they can. On the other hand, there is a consensus that germline therapy should not be contemplated for a long time; until there has been further time to examine the ethical and even ontological content of such a procedure.

It struck me that a great deal of what was said by the noble Lord, Lord Colwyn, was familiar. The technology is new and it is hard for this country to catch up and keep up with it. That is partly because we are not as big as some of the other countries and because during the past 15 years governments have prided themselves on not hindering companies, but not helping them either.

I believe that the noble Lord is right in saying that in this area, as in others, there would be a case for more government intervention, a government point of contact and a government ring-holding, in order to help corporations to agree on what they can do together and to reach civilised disagreement on what they want to compete over. They are all familiar concepts. The Government do not do enough.

However, I believe that in this area that would be exceptionally difficult. In this country genetic technology is not developed by a number of British corporations which are registered here, have all their shareholders here and sell all their products here. It is among the most internationalised of all the hi-tech industrial enterprises one can think of. The role of a British government in helping British corporations and those portions of, for instance, American-owned corporations which function in Britain needs to be compared with the potential role of other governments doing the same thing in other countries.

The noble Lord gave certain figures that looked hazy and implied that more was being spent per capita by the French taxpayers, possibly even the Singaporean taxpayers, than is paid by the British taxpayers to help these things come about. If that can be established, there is certainly a case for Britain to do as well as or better than our commercial competitors.

I wish to raise a particular aspect, which is patenting. I never know whether to say "paytent" or "pattent". I believe that I am old enough to say "paytent" but perhaps I should adopt the more recent American pronunciation "pattent". Noble Lords who are interested will remember that a year or two ago a fearful situation developed in which an American corporation started to claim, and made progress towards obtaining, a patent on healthy human genes in living human bodies. That would have had the effect that anyone anywhere who wished to correct a defect in gene X in a certain position on a certain sequence in the chromosome, whatever means or technique they used, would have to pay a royalty to the company which first identified the position and coding purpose of the gene.

That was taken to the American Patent Office, which initially smiled on it to such an extent that our own Medical Research Council, backed by the Government, had to take up a defensive position and say in effect, "If you do this we shall do it too, and therefore we cannot proclaim in an unqualified manner that we think it is an absurd, a faintly monstrous idea to patent living cells in living bodies walking about the world. In this the Americans, with us regretfully going along behind, differed sharply with most of the continental countries, which under French conceptual leadership instantly took up an absolute position against any such notion.

When the time came for decision the American Patent Office said, "No, you can't do that. It is absurd. You are supposed to patent inventions, and you certainly didn't invent those genes walking about the world in all those human bodies".

There has since been a renewed attempt by American interests to obtain an American patent. It has been made in particular by corporations which come forward and say, "You had better give the patent to us, otherwise our employees who did the work and made the discovery will leave us and leave the country, and go to work somewhere else where they can get a patent". If I understand rightly, the American Patent Office is now facing that problem and wondering what to do. Once again, it is possible that they will agree to issue patents to many different applicants who have discovered the position and function of many different genes in the human body.

If that were to happen, the question is: what would the British Government do about it? Would they be forced to go back into the position they tentatively occupied a year or two ago of saying, "Well, we've got to do it too"? Or would they stand with the French Government, and with the European Commission, and say, "Let the heavens fall, but we will not permit such an absurdity in our country"? It may be hard to answer that now, but it is an interesting question.

Equally, what financial effect do our Government expect the patenting of healthy genes in the manner that I have described to have on the therapies when they become available? It could be quite crippling, and it would certainly be very broad. Another scenario is the following; what about patenting the means of carrying a healthy gene from a healthy person to an unhealthy person? As noble Lords will know, the way that one corrects an unhealthy gene is by flooding it with healthy genes from the same position on a healthy chromosome in another individual. It is obviously legitimate for an inventor or company to patent a means of carrying a healthy gene from one individual to another. But it is not very difficult to find those means; the difficulty is to find what gene does what. Still, in the future there is no doubt a legitimate field for this sort of patenting of somatic gene therapy, even if it is a rather smaller one.

How in the view of the Government, will the development of patents in this field impose an unacceptable financial burden on our health service and, indeed, on the provision of medical treatment, whether public or private, in this or in other countries of the world?

7.22 p.m.

Viscount Craigavon

My Lords, I am grateful to the noble Lord, Lord Colwyn, for his formidable and wide-ranging speech and review of the field. I should like to emphasise concerns in two areas; namely, the need for an appropriate regulatory framework and the problems surrounding patents. Having just listened to the most interesting speech made by the noble Lord, Lord Kennet, I realise that it is extremely difficult in such a very short debate to make a very meaningful contribution on the subject of patents. However, I shall try to do so.

It is my impression that things are moving so fast in the field that it will not be enough in the future to react on a case by case basis. Given the considerable disagreements and complications of patenting and the fact that so much is now at stake, I do not believe that even the well-managed market place will be a suitable forum from which to expect an acceptable outcome—acceptable that is, in part, to the public, which in this field may at present have exaggerated hopes, fears and expectations.

Part of the process of reassurance and education can really only be achieved by the presumption of open and flexible discussion and decision-making, whenever possible. The Select Committee on Science and Technology in another place is providing an excellent forum for the expression of views and a snapshot of current opinion; but it will probably be another year at best before the Government's reaction to that committee is published. Things are moving so fast that major action should not wait until then.

It is already a year since the authoritative Nuffield Council on Bioethics in its report "Genetic Screening, Ethical Issues" recommended that a central co-ordinating body be established. The MRC's excellent gene therapy advisory committee can give advice, co-ordinate data and research and also create policies; but it is not a regulatory body that can provide an enforceable framework of minimum standards and best practice, against which developments can be measured and shaped.

I know that the organisation called the Genetic Interest Group supports the creation of such a regulatory body. The group is an influential umbrella organisation of over 100 charities, voluntary organisations and support groups for various genetic conditions trying to co-ordinate common action.

Perhaps I may offer a relatively minor recent instance of the sort of problems that are arising. About a month ago, according to an account in the Independent newspaper, a firm was launching a postal service test for the cystic fibrosis gene. That was not a cure, but was to indicate if the subject was a carrier. A counselling service was to be provided by telephone. According to the article, the Department of Health was not told in advance about the new service and so, naturally, a spokesman for it could not give a very useful reaction or recommendation to the development. Someone was then quoted on behalf of the firm saying that, in many ways, the test could have been offered over the past three years, concluding that the block has been lack of mechanisms within the NHS. Even if that article is not completely accurate, it highlights just the sort of problems that are capable of arising.

Perhaps I may take that example a little further. What happens if another firm offers a similar but cheaper test, but without the counselling? Will the original firm be compelled to drop the counselling in order to survive? What happens if another firm offers a very much cheaper test which later turns out to have an unacceptable rate of false positives?

How and when are we at least going to set minimum standards, and how will they be enforced? I hope that the answer is, "as soon as possible". If the regulatory authority has to be as comprehensive as the HFEA (the Human Fertilisation and Embryology Authority), so be it. Given the very much wider subject matter, it is desirable that it should be more proactive and encouraging. Part of the need for such a body is to reassure the public at this stage that a sensible and responsive body is in place, with habits of openness.

Perhaps I may now turn to the patent aspects. I shall start with a small but completely different example from the same article in the Independent of 9th December of last year, which reads: The gene for a human hormone which eases labour during childbirth is now the property of a research institute at Melbourne University. The first objection to the patenting of a human gene was rejected yesterday by the Munich-based European Patent Office. A board upheld the university's patent on the gene, in the face of objections by the Greens in the European Parliament that it was ethically unacceptable". I have no further information on that particular case. But that, again, is an example of the sort of situation that is arising.

One of the most valuable aspects of patents is in creating certainty and, as far as possible these days, international certainty. Presumably on the subject of gene patenting we are trying to proceed in step with our European partners. It appears to me that conflicting interests are already becoming so entrenched, and so much is at stake, that it will become more impossible to unscramble things into any form of sense the longer the situation is unresolved. It is said that these gene patenting issues have already created a climate of mutual distrust among scientists.

Perhaps I may give a last example of a discovery, announced last September by an American university, of one of the most eagerly awaited genes for breast cancer, apparently the first gene for a lethal disease affecting large numbers of people. It should be said that it is responsible for only 5 per cent. of breast cancer. Pre-existing arrangements, despite the American university and some small British involvement, have led to a large American pharmaceutical company becoming, quite legally, the beneficiary of the patent—this to the considerable dismay and disapproval of publicly-funded scientists. The diagnostic test may not be ready for two years, but it has been estimated in the specialist media that the cost per test might be as much as £600. All sorts of questions arise, not least the affordability of such tests to the NHS. That is just the beginning.

As against that exploitable gene patent, there are many so called "orphan" diseases which may benefit from gene therapy but which are so numerically small that it will never be commercially worth while to follow down that path. They need some sort of regulatory encouragement.

As far as patents are concerned, I hope that the Government, and in particular the Department of Health, can give a lead on this and announce that they are prepared to argue—as it is perfectly respectable to do—that the human genome is not to be regarded as a patentable invention but a natural phenomenon and that an unreasonable monopoly will not be created.

I hope the department will accept that it is more convincing now, rather than later, to warn hopeful biotech companies that the sort of excessive monopoly pricing that is associated with drug patenting will not be accepted in gene therapy. This is the sort of area that an effective regulatory body could be created to control. I hope that the department could also take a lead in offering that as an international example.

7.31 p.m.

Baroness Hooper

My Lords, I also congratulate my noble friend on his Question and on the way in which he introduced it. He has the advantage of understanding many of the medical implications of these very complex issues which are so difficult for the average layman to understand and grasp. I also agree with his emphasis on the need for unrelenting effort in the research field in order that the United Kingdom can maintain its pre-eminence in this area, and also with the necessary follow-up on commercial development. In this context, I welcome the joint initiative by the health and industry departments to which my noble friend referred, which is known as "Prescribe UK" and which was launched last December. It aims to encourage pharmaceutical and biotech inward investment in the United Kingdom. That reminds us that the United Kingdom is among the world's leaders in invention and scientific exports and that we have a strong science base.

I also welcome the announcement about the establishment of a new national forum which is to be chaired by Professor Michael Peckham, the NHS director of research and development, and which is intended to bring together major funders of health research including the MRC, charities, universities and industry.

My interest in this subject dates from the well informed discussions we had in your Lordships' House on the Human Fertilisation and Embryology Bill a few years ago in which I was very much involved. However, I must also declare an interest in that I am now a director of SmithKline Beecham, a company which is doing vital research into the application of genomics to drug discovery and diagnostics development.

Within the time constraints of this short debate I should like to concentrate my remarks on the implications that this rapidly developing technology will have in the area of medical ethics and human rights protection. This has already been touched upon, but there is no doubt that these scientific advances will revolutionise healthcare and offer disturbing as well as exciting new choices for everyone concerned. I therefore wish to urge the Government to ensure that in any work they support and encourage they will insist upon the highest ethical standards being maintained, and that they should give consideration to the regulatory framework as the noble Viscount, Lord Craigavon, also insisted. Indeed, it might well be appropriate to reconvene the Warnock Committee or create a successor to it in order to keep hand in hand with the scientific progress the consideration of the human and social issues.

I would be glad to hear the views of my noble friend the Minister on that matter and indeed on the Nuffield Foundation recommendations. It is by no means too soon for that given that, for example, prospective genetic profiling for disease risk already has the necessary testing procedures in place and commercial development is proceeding rapidly.

It is interesting to note in the international field that the Council of Europe is tackling the issue with a draft bio-ethics convention which will be debated by the parliamentary assembly at our next plenary session at the beginning of next month. I was also interested to note that at the forthcoming International Parliamentary Union international conference to be held at the end of March one of the topics to be discussed is bio-ethics and its implications worldwide for human rights protection. I feel sure that there are a number of other international and learned bodies giving consideration to that issue and that we in this country will not lag behind.

In conclusion I repeat that these are indeed exciting vistas for the future of medicine and that here in the United Kingdom we have the opportunity to be at the forefront of development and that it is an opportunity we should not lose. Yet in conquering this new world of genetic knowledge, as we can already define ethical, legal, social and economic issues of stunning complexity, we ignore these issues at our peril.

7.35 p.m.

Baroness Jay of Paddington

My Lords, I, too, should like to thank the noble Lord, Lord Colwyn, for introducing this interesting subject this evening in his Question. I congratulate him particularly in making a précis of his speech in such an authoritative way that he conveyed much information in half the time he had expected to take. I am also grateful to my noble friend Lord Kennet for identifying the subject of our debate so precisely this evening and for concentrating our attention simply on somatic genes. As was also emphasised by the noble Baroness, Lady Hooper, we should consider those matters particularly in relation to conquering disease. I think we are all aware of the pre-eminence of the UK in this particular area. I shall just mention one field which is of particular interest to me—the noble Baroness, Lady Hooper, touched on this—and that is the whole area of in vitro fertilisation and embryo therapy. Without trespassing into the difficult ethical ground which some of us considered earlier last year with regard to some of the amendments to the criminal justice Bill—which is now the criminal justice Act—and some of the other more difficult subjects we embarked on then, I should say that the whole question of pre-implantation embryo selection has been one of the most important areas where this country has led genetic development.

I emphasise that some of the developments in which we have led the world have focused more on the abilities of our scientists than on the technology that they have used. In introducing this debate, the noble Lord—and other speakers—referred to cystic fibrosis as one of the particular triumphs. The noble Lord, Lord Colwyn, in passing—perhaps his remarks were slightly contracted as regards this matter—referred to the brain drain of some of our scientists who are involved in this field.

I believe the Government must be conscious of the need to preserve our pre-eminence in this field. Over the past six months there has been great concern that some of the scientists who are working most prominently in these fields have left. I draw particular attention to Professor Bob Williamson of St. Mary's Hospital, Paddington, who was at the forefront of the development of the work of identifying the cystic fibrosis gene. He is one of those who has decided to leave this country. Some publicity was devoted to this. I cannot forbear but to mention to the Minister one of the reasons which Bob Williamson was quoted as giving for leaving. He said that he could no longer work in a pure scientific atmosphere which depended on co-operation—that is precisely the kind of co-operation to which several noble Lords have referred this evening—in what he described as the competitive and bureaucratic nightmare of the new health service. That is obviously a particular viewpoint; but I must say that I, from a lay position, support that viewpoint. However, there is a more general anxiety among the medical establishment about the lack of clinical geneticists to develop some of the work which is being done in the laboratory.

The Medical Research Council, in recent evidence to the Science and Technology Committee in another place—to which the noble Viscount, Lord Craigavon, referred—said that: the number of clinical geneticists in the UK is very small and this is a matter of considerable concern". That is an issue which needs to be addressed at a national level. The whole area of manpower and pre-eminence in scientific excellence, and particularly in relation to individual scientists, is a further question upon which I should like the Minister's comments when she replies.

As has been said, we have been slow to pick up on some of the biotechnologies which have been developed. That is something about which we should be very concerned. I shall be very interested to hear the Minister's response to the collaborative arrangements suggested by the noble Lord who introduced the Question between commercial companies and research funding councils such as the Medical Research Council and the Government themselves. Clearly, from what has been said, underfunding of work in this field, particularly in comparison with some of our international competitors, is one of the concerns about which those who have looked at the subject in detail feel most strongly.

I was particularly interested that the noble Lord, Lord Colwyn, suggested that this form of underfunding was a particular threat in the area of long-term solutions to some of the problems being addressed.

I should also like to support the suggestion which came from both the noble Viscount, Lord Craigavon, and the noble Baroness, Lady Hooper, and which has been mentioned previously in your Lordships House, about the need for developing a further regulatory body beyond those which now exist and perhaps, as the noble Viscount, Lord Craigavon, suggested, depending on the somewhat controversial it must be admitted but nonetheless practically very successful example of the Human Fertilisation and Embryo Authority. If something in that field could be expanded and developed, it might be of great national importance.

I am aware that this is a very closely timed debate and that the Minister must be given time to respond in some detail to all the various points which were made by the noble Lord, Lord Colwyn. All I would say in conclusion is that on 11th May last year your Lordships had an interesting debate, introduced on that occasion by my noble friend Lord Kennet, about the whole area of human genetic manipulation in which there was agreement on all sides of the House that our record in this country on this subject is extremely good. There was also a concern that we need to develop a more succinct and precise national strategy so that we could have co-ordinated investment both in people and in technologies to see that our pre-eminence continues. I very much hope that when the Minister replies she will be able to give some indication that that will happen.

7.42 p.m.

The Parliamentary Under-Secretary of State, Department of Health (Baroness Cumberlege)

My Lords, I too am grateful to my noble friend Lord Colwyn for drawing to the attention of your Lordships' House one of the most interesting and exciting areas of medical research. It is an area in which this country makes a significant contribution. As my noble friend indicated, genetic research has the potential to produce a quantum change in the practice of medicine. Our hope is that by building on the links between developments in basic science, NHS research and development and best clinical practice that research will bring major advances to the diagnosis and, eventually, to the treatment of a wide range of serious diseases for the benefit of the NHS and its patients.

My noble friend Lady Hooper and the noble Viscount, Lord Craigavon, were right to highlight the ethical aspects of this work. In order to ensure that the Government had the very best advice, in 1992 the Clothier Committee was set up to consider the ethics of gene therapy and to examine not only its potentials but some of the dilemmas it presents. I believe that as my very distinguished predecessor, my noble friend was instrumental in setting up that committee.

Like the noble Lord, Lord Kennet—surely one of the clearest and most knowledgeable people on this subject—the committee took the view that somatic gene therapy, which only alters the patient's individual body cells, does not in itself raise new ethical challenges. As such we feel that it should be regarded as research and should be subject to the already accepted ethical codes. However, modification of the germ line—changing the genes which are transmitted to future generations—was not considered acceptable. I am grateful to the noble Lord for drawing the distinction so clearly and explaining the significance between the two.

Later that year, the Government announced their agreement in principle to the main recommendations of the Clothier Report. This led, after public and professional consultation, to the establishment in 1993 of the gene therapy advisory committee under the chairmanship of Professor Dame June Lloyd. Three members of that committee are ethicists, so the field is well covered, and one is a lawyer. The committee's remit is to consider all aspects of gene therapy research. It does that by carrying out a case-by-case review of individual protocols.

I understand the reservations that have been expressed tonight and that there are those who want that committee to have a stronger statutory base. However, we believe that it is working well. As a committee it works closely with the Medicines Control Agency which has responsibility for overseeing all clinical trials in patients.

In such a rapidly evolving field it is important to have a system which is flexible enough to accommodate rapid changes in research and clinical practice. The gene therapy advisory committee is therefore a non-statutory body. However, it has been made clear to researchers that no study involving human subjects should proceed without prior approval from the committee.

Last year a number of clinical trials began which the Government hope will result in successful clinical interventions. A total of 10 protocols were approved. These are exciting developments since they deal with severely disabling conditions such as cystic fibrosis—mentioned by my noble friend Lord Colwyn—three forms of cancer and severe immune deficiency. Protocols are still under review for breast cancer and a form of leukaemia.

The main responsibility for government-funded research into human genetics lies with the Medical Research Council. The MRC spends around £12 million a year on the human genome project, whose main aim is to link specific diseases to the gene responsible. This important project is too large for any one organisation, and requires national and international collaboration. Apart from the MRC, support for genome research in the UK is also provided by the Biotechnology and Biological Sciences Research Council, the Wellcome Trust and the Imperial Cancer Research Fund as well as other charities, such as the Cancer Research Campaign. The UK has also been particularly successful in attracting funds from the EC human genome analysis programme, which was mentioned by my noble friend Lady Hooper.

Taking this work together, the UK has a thoroughly credible national genome programme. This is borne out by a bibliometric analysis conducted in 1990 which showed that apart from the USA—which spends approximately 10 times as much as this country—the UK leads the world. This lead is the result of the very good UK basic science, allied to the clinical environment provided by the NHS. It is a combination which has attracted leading scientists to our country from other parts of the world.

As my noble friend Lord Colwyn mentioned, the Government's White Paper Realising our Potential strongly promotes a UK science base which is linked to wealth creation. That link, which noble Lords have highlighted this evening, is crucial. The Department of Health's research and development strategy is also a step forward in developing a rational response to anticipating developments.

Two years ago the MRC set up a second major programme of genetic research to complement work on the human genome mapping project. That programme is called the genetic approach to human health and is designed to take the fruits of genome research into health care. Initiatives include work to improve understanding of the gene products which are responsible for dysfunction, the development of new screening tests, better methods of genetic counselling and the development of somatic gene therapy.

The potential for gene therapy in treating disease is being actively pursued by MRC groups in Edinburgh, London and Birmingham. Those multi-disciplinary groups have the expertise to bring laboratory-based research through to a defined clinical goal.

The MRC also has an industrial advisory group to identify opportunities for collaborative research, and as clinical trials are further expanded, the MRC will work through this group and with the pharmaceutical industry to encourage a further scaling up of materials needed for clinical trials.

My noble friend Lord Colwyn mentioned the need to raise venture capital. The MRC has set up three new companies to exploit genetic research including Therexsys, the UK's first company dedicated to gene therapy.

There is a need for skilled researchers. To meet that need the council funds researchers to visit overseas laboratories in order to learn new techniques and supports a small number of Ph.D students in that area.

Perhaps I may address the general issue that has been raised not only by my noble friend but by the noble Baroness, Lady Jay. I refer to the question of the brain drain. I think that that catchphrase is now obsolete and that in fact we ought to recast it as the "brain gain". In the past 14 years far more academic staff have moved to this country than have left it. In 1993 there was a net inflow of staff at all levels of academic posts with the exception of that of a reader/senior lecturer where there was a small net outflow. Flows in and out are very small. However, an independent report by the science and engineering policy studies unit entitled The Migration of Scientists and Engineers, confirms the indications from an earlier study and from university statistics that the brain drain is not a cause for concern.

Lord Kennet

My Lords, perhaps I may interrupt the noble Baroness to ask for clarification of those figures. First, are those figures for all scientific research or for all medical research, or just for genetic research? Secondly, do they take any account of where those people are coming from? If the outflow is all to the United States, and the inflow is all from Tanzania, it is not so interesting.

Baroness Cumberlege

My Lords, very high calibre scientists are attracted to this country. This report covered a wider area than simply geneticists. It covered engineers and other scientists. I shall certainly send a copy to the noble Lord if he would like to have a look at it. I believe that there is a common belief in this country that scientists are leaving in droves and that we attract very few. That is not the case. In the past two years the director of the British Postgraduate Medical Foundation reported that we have attracted more world-class scientists from as far afield as Australia and the United States than we have lost. Therefore we are quite convinced that there is a brain gain.

The MRC has set up a gene therapy co-ordinating committee to oversee national activities, to develop policy with other sponsors and industry, to advise the community on issues pertinent to gene therapy, and to assist in the co-ordination of data from clinical trials. That committee includes nominated representatives from major research centres, industry and the medical research charities, from the health departments and the Medicines Control Agency.

The Department of Health keeps in close touch with MRC developments in genetic research through the concordat between the department and the MRC. Under that arrangement there is regular contact about all aspects of work including genetics. I believe that the post of Professor Michael Peckham, the Director of Research and Development, was very skilfully negotiated by my noble friend Lady Hooper through your Lordships' House. It was a suggestion by your Lordships. It has proved to be a very successful post. I think that many of the fears that have been expressed tonight are not founded, because Professor Peckham's whole responsibility is to co-ordinate research within the country. I believe that he does that extremely well.

Professor Peckham commissioned a genetics research advisory group under the chairmanship of Professor Martin Bobrow, Professor of Paediatric Research at Guy's Hospital to provide an informed view of the possible implications of genetic research for the NHS over the next five to 10 years. Its report is due to be published shortly.

The report discusses anticipated advances in areas such as diagnosis and screening, gene therapy, and genetic techniques and laboratory services. The report also considers the impact of those advances on genetic services in the NHS, including the importance of adequate provision for counselling, and the implications of genetic testing as it becomes more available in general practice.

My noble friend Lord Colwyn has acknowledged the potential contribution of genetic research to human health and the wider implications that it has in social and economic terms. The report reflects that view and the view of the Government's White Paper, Realising our Potential, which emphasises that advances in research and development should benefit quality of life and contribute to wealth creation. Advances in genetic research offer the prospect of considerable gain, not only for the NHS and its patients but also, as has been highlighted tonight, for the British pharmaceutical and healthcare industries, with the attendant benefits of employment, exports and national income. Those prospects are being currently explored by a number of initiatives arising from the White Paper including the technology foresight programme which will be published in the spring.

Currently the main impact of genetic research is on inherited diseases such as cystic fibrosis, muscular dystrophy, haemophilia and Huntington's disease. It is our hope that an increasing programme of work on the genetics of common diseases will enable progress to be made in tackling disorders such as diabetes, hypertension, asthma, coronary artery disease and several forms of cancer. The Department of Health's research and development strategy is currently exploring a range of practical and ethical aspects of genetic research. Last July the NHS research and development programme published its priorities for cancer which gave a high priority to such work.

The noble Lords, Lord Kennet and Lord Craigavon, raised the issue of the patenting of genes and the implications of that for research. The Government's view is that information discovered on the structure of genomes should be freely available to researchers in the field. Lack of access would delay progress in research. However, that should not preclude industry from obtaining patents on novel inventions derived from gene analysis and other genome work. Without such protection there would be no incentive for industry to invest the large sums of money required to bring such inventions to the market to the benefit of patient care.

The noble Lord, Lord Craigavon, also raised the point of commercial genetic screening tests. That is a matter wider than we anticipated this evening. I shall be delighted to write to him on that subject.

In conclusion, the United Kingdom enjoys a worldwide reputation in the field of genetic research. Through the work I have described your Lordships will have had a feel for the way our country is taking forward this work into an exciting area of medical research with potential benefits for the nation's health and wealth. The first clinical trials are already under way and results from the research groups are encouraging, suggesting that further trials are not far off.

Through MRC funding, the essential support of many of the research charities, and the work of the NHS research and development programme, the Government are confident that the system of oversight for UK gene therapy research will encourage and above all assist researchers making progress to the target of achieving real and lasting benefits for patients. The mechanisms that I have described will allow the development of that important field of medical research to proceed in a climate of public, parliamentary and professional reassurance. The future looks bright.

Baroness Miller of Hendon

My Lords, I beg to move that we adjourn during pleasure for two minutes until eight o'clock.

Moved accordingly, and, on Question, Motion agreed to.

[The Sitting was suspended from 7.58 to 8 p.m.]