§ 6.10 p.m.
§ Lord Oxburgh rose to move, That this House takes note of the report of the Science and Technology Committee, Human Genetic Databases: challenges and opportunities (4th Report, Session 2000–2001, HL Paper 57).
1026 The noble Lord said: My Lords. I beg to move the Motion standing in my name on the Order Paper. Our committee decided to undertake the inquiry because it believed the subject to be of great importance and technically complex. It decided to do so when it did because it appeared that parts of our work could usefully complement that of the Human Genetics Commission. The work of that commission extends far beyond ours and we address a number of matters which fall outside its immediate remit. However, there is an important area of overlap where science, medicine, ethics and the law are inextricably interwoven.
Throughout our work we have kept in touch with the commission and I am glad to acknowledge a most constructive interaction between the two bodies. I look forward today to the contribution of the noble Baroness, Lady Kennedy of The Shaws, bringing the House up to date with the commission's latest thinking. I am also delighted that the noble Lord, Lord May, has chosen this occasion for his maiden speech. We look forward to hearing that and the contributions of other noble Lords.
The committee is most grateful to those who gave up their time to give evidence and instructed us in the complexities and implications of the fast-moving field of molecular genetics. However, the fact that the report was completed not only to a very high standard but in record time because of the impending dissolution of Parliament is due to the exceptional efforts of three people: first, our outstanding special adviser, Professor Paul Elliott of the Imperial College School of Medicine; secondly, Dr Adam Heathfield, our special assistant; and, finally, Mr Roger Morgan, our clerk. All burnt an amount of midnight oil that went far beyond the call of duty and the committee is most grateful to them.
We are also most grateful to the Government for their published reply to our report. It is gratifying to find a high degree of agreement on such an important matter.
Human genetic databases are simply organised collections of genetic data relating to particular individuals, or organised collections of human tissue that could be used to provide such data. Each of us has imprinted in the chemistry of our cells a unique genetic code that contains elements inherited from both our parents. Although the codes of all human beings are similar and distinct from those of other animals, there remain minute differences between individuals that allow us to develop as distinct individuals with different body types, different personalities and different resistance to disease. How we exploit or indeed suffer from the different genetic potential that each of us has depends on what we eat, on how we live and on our external environment.
It is the highly personal nature of these data and their growing potential to reveal some of our most intimate details that makes them sensitive and suggests that human genetic databases might he in need of regulation.
1027 In practice, genetic databases are of interest to three distinct groups for rather different reasons: first, the Home Office and security agencies; secondly, the insurance industry; and, thirdly, health practitioners and researchers. I shall deal with the first two rather briefly.
I shall deal first with the Home Office. Minute samples of human tissue—perhaps a hair or fragment of fingernail—can provide genetic data about the person from whom it came. Matches can then be sought against the police database that contains the data of people convicted of particular crimes, or with data collected from a small group of suspects for the purpose.
Even if no match is found, it may be possible to deduce some personal characteristics of the person from whom a sample came. It is already possible to specify whether it is a man or a woman and, in future, it is likely that it will be possible to specify racial type and the colour of hair and eyes.
That is clearly a very important forensic tool. Equally clearly, there are civil liberty considerations related to the protection and use of the police database. We were a little uneasy that adequate safeguards do not appear to be in place both to protect the interests of individuals and to protect the police from unjustified complaints concerning that database.
Turning now to insurance, I must remind the House that this use of genetic data has been the subject of a valuable recent report from the Select Committee on Science and Technology in another place. We would not dissent from the findings of that report.
Until late last year, some insurance companies expected insurance applicants to disclose any available personal genetic data on the ground that it was relevant to insurance risk. However, the industry recently announced a welcome five-year moratorium on this practice.
The concern is that people may choose not to undergo genetic testing that could be important for their health if it could make them a poorer insurance risk. In fact, personal genetic data contain little information pertinent to insurance risk that is not already available from family histories, disclosure of which is readily accepted.
The main substance of our report concerns the use of genetic databases for therapy and biomedical research. I must, however, at this point digress to emphasise that, regardless of their practical applications, genetic databases are the essential tools for research at one of the most exciting and fundamental frontiers of human knowledge—the nature of life itself—and merit support for the same reasons that we support pure research in other areas, such as astronomy and particle physics. The difference is that this is one of the rare occasions when the advance of pure science walks closely hand in hand with its practical application. It is also one of the rare occasions when one may justly claim that, along with the United States, the UK research community is a world leader.
1028 So why is there a problem? The problem is that making sense of the genetic data, which is acquired by detailed and careful analysis of tissue samples, depends crucially on linking those data to individual medical records. The usual method is to compare the genetic data of many individuals who display a particular medical condition and to search for elements of the genetic code that they have in common and are absent in others. Such studies obviously require that genetic data be associated with individual medical histories, individual by individual. However, current legislation (the Data Protection Act) requires that sensitive personal data be used only for the purposes for which permission was given at the time the data were originally collected; and that is the nub of the problem.
Collection of medical history begins at birth and continues over a person's whole lifetime. It was impossible to anticipate when such data began to be collected decades earlier what the focus or requirements of future research might be. Equally, it is impracticable to find and seek the permission of many thousands of individuals every time a new experiment is contemplated
Smaller-scale experiments, such as the Avon Longitudinal Study, are indeed possible under present arrangements but national and international studies, which are increasingly important, would not be feasible.
In looking for ways around this problem we believed that a balance had to be struck. On the one hand, society should respect the desires of individuals both to preserve their privacy and to withhold consent for the use of their personal data in research of which they disapprove. On the other hand, the case histories and personal data of earlier generations are the practical basis of today's medical knowledge. We felt that there is a general moral obligation on us all to do for succeeding generations what our forefathers have done for us.
Naturally this dilemma is not unique to the UK. Drawing on our observations of practice in other countries, we proposed a solution based on the concept of "the trusted third party". The idea was that, on a one-off basis, everyone should be invited to agree—or not—that, as long as their personal privacy was protected, their medical data could be used for medical research that was approved by the "trusted third party".
We proposed that the "trusted third party" should be an independent non-governmental medical data panel containing lay people, medical, legal and ethics professionals, as well as representatives of government departments. It would be their duty to pronounce on the acceptability of research proposals in the light of what they judged to be public sentiment of the time. We saw the independence of such a body as essential, perhaps ensured by having its members nominated by different social and professional constituencies.
The proposal appears to a significant extent to have been overtaken by events. The Health and Social Care Act 2001 established a Patient Information Advisory 1029 Group that appears to carry some or all of the responsibilities that we foresaw for our medical data panel, albeit in a rather different way.
To avoid any confusion, will the Minister be good enough to confirm that the new group will be able to pronounce on all requests for access to personal medical data for biomedical research, regardless of whether they originate within or outside the NHS? Furthermore, will the group recognise that it is in the nature of research that a successful and therefore beneficial outcome cannot be guaranteed at the outset? Otherwise it would not be research. Finally, will the new group have the resources and the procedures required to deal with applications speedily and effectively?
In a commendable effort to move the research forward and to circumvent some of these problems, three major medical bodies have come together to fund jointly an experiment of truly gigantic proportions. The Wellcome Trust, the Medical Research Council and the NHS plan to enrol a cadre of 500,000 volunteers for genetic testing, who have agreed from the outset that their medical records may be used for research. This should help the UK to maintain its already commanding position in the field. But it will take time to establish and there will also be projects for which a different patient sample is required. It therefore remains urgent that the problem of existing data and patient records be addressed.
What benefits will such research bring, and when? Broadly, there are three areas currently in prospect. First, because the genetic basis of some diseases, currently untreatable, will be understood, it will be possible to design new drugs to target them. Even existing drugs may be used more effectively because genetic differences mean that the same condition in different patients may need to be treated differently. It will also help to avoid prescribing drugs that will do no good, or even harm.
Secondly, it will be possible to advise individuals that by living in a particular way they will reduce their chances of suffering particular illnesses.
Thirdly, and further into the future, it may be possible to repair genetic defects, whether they are inherited or are the result of subsequent damage.
These benefits will come gradually because the field is still in its infancy, but it is not unreasonable to expect that practical benefits will begin to flow within the next 10 years.
As well as humanitarian benefits, the advances will bring commercial opportunities. The design of new drugs that will be effective in individuals with a known genetic make-up will form a major part of the future business of pharmaceutical companies. That raises important questions that could merit an inquiry in their own right; namely, what aspects of such research should be patentable? Our committee did not explore those questions in full detail, but if a commercial company is to invest in R & D, it must be able to look forward to a period when it sees a return on its investment.
1030 On the other hand, the fundamental mapping of the basic human genetic code is human physiology that most people agree should remain in the public domain. It is, however, primarily the workings of the code that need to be understood for useful therapeutic intervention and it is this that is both in its infancy and of the most commercial interest. In my view, it will be easier to see a fair way of protecting legitimate intellectual property in this area when the science itself is better understood.
Before we get that far, however, other hurdles need to be overcome. It is easy to think that the challenges are all for biomedicine. That is far from the case. Our current success in genomics may come to nothing if the enormous challenges for computer science are not tackled as well. Here the UK position is less encouraging. The challenges are of two kinds. First, there is the need to develop computational methods to deal with prodigious amounts of heterogeneous data in ways that are quite novel. Although we have some excellent research groups in the UK, this country as a whole is not an international leader in these disciplines. Secondly, it is not clear that the UK will be able to find sufficient trained people to support the computational needs of the work. Our committee saw a major need both for computational research and for trained people. Unless the issues are addressed through the research councils and the university funding councils, UK genomics efforts could founder.
Before concluding, I shall say a few words about the NHS. With patient records extending back over 50 years for more than 50 million people, this should be a gold mine for health researchers. In fact, partly because computerisation has come in so late, so patchily and with such a diversity of incompatible systems, and partly because use of the NHS number, which should be our unique health record identifier, is honoured more in the breach than in the observance, this potential is unlikely ever to be fully realised. We are aware that things are changing and that there is a shortage of resources, but progress has been glacially slow. It does seem, however, that things are rather better in Scotland than in England.
I have attempted to sketch some of the highlights of our report and to set the scene for our debate. Many of the important matters that the committee touched on will, I have no doubt, be taken forward by the Human Genetics Commission. However, it is essential to emphasise that exceptionally the UK is poised to make groundbreaking advances in fundamental biomedical science that will carry with them improvements in health and important commercial opportunities. However, those opportunities will be realised if, and only if, we have a responsive and sympathetic regulatory environment for handling medical data, a fair and effective way of handling intellectual property and a properly supported computational infrastructure. I commend the report to the House.
Moved, That this House takes note of the report of the Science and Technology Committee, Human Genetic Databases: challenges and opportunities (4th Report, Session 2000–2001, HL Paper 57).1031
§ 6.30 p.m.
§ Lord Rea
My Lords, it is quite daunting to follow a wide-ranging and superb speech such as we have heard from our chairman, the noble Lord, Lord Oxburgh. It was a great pleasure to serve under his chairmanship on the committee, where he carried out his duties with good humour and great skill. I hope that in your Lordships' House in the future a proportion of seats will continue to be given to Cross-Benchers such as the noble Lord, Lord Oxburgh.
I, too, pay tribute to our excellent specialist adviser, Professor Elliott, our specialist assistant, Adam Heathfield, our Clerk, Roger Morgan, and his staff for making life easier for us, despite us being sometimes quite elusive.
Of the five Science and Technology Committees on which I have served, I found this one much the most conceptually difficult—not because of the complexity of genetics itself but in understanding how the prodigious quantities of data are handled and the tricky ethical issues involved.
The Sanger human genome research centre at Hinxton, which we visited, deposits 50 million base pairs of genetic data every 24 hours. Using the full power of its computer resources, which are huge, it would take about a week to sequence the genome of only one individual. Senior staff at the Sanger centre were concerned that the highly qualified IT staff that will be needed for future development are in short supply. I understand that the noble Lord, Lord Flowers, will address this issue later.
Of course, most genomic data held on a database consists of only a fraction of a total genome of an individual. For conditions dependent on the expression of a single or small number of genes, comparatively small databases may be sufficient for research purposes. But the inheritance or susceptibility of most common diseases is polygenic—dependent on quite large numbers of genes—and so large numbers of individuals are needed to detect the genetic differences, as the noble Lord, Lord Oxburgh, pointed out.
Professor John Bell, who is Professor of Clinical Medicine at Oxford, put it this way in evidence to us. He said:The ability to use genetic factors diagnostically will be … to put people into risk groups where they are either at a higher or a lower risk of developing particular outcomes. That is a terribly important difference. In my view, the public—and, indeed, some of the medical profession—have got confused over the clear distinction between single gene disorders … and common diseases where you are really looking at epidemiological-like risk factors of which genes are one. That is not to say that they will not be useful, because one of the great challenges in health care is to try and stratify people into those at high, medium or low risk of different diseases".He was referring, of course, to diseases such as cancer, in its various forms, coronary heart disease and so on. This approach is also relevant to responses to certain drugs, a matter described more fully by the noble Lord, Lord Oxburgh.
That is why it is necessary to recruit and follow up large numbers of people who are representative of the population as a whole, who have different lifestyles 1032 and who are exposed to different environmental and socio-economic influences. If, at the same time, we have access to tissue or blood samples giving genetic information on the individuals in this population and follow their health status over the years, it should prove possible to identify the genetic profile of, for instance, smokers who succumb to lung cancer compared with those who also smoke but do not get lung cancer. This would make it possible to identify and target vulnerable individuals before their cancer develops. Some may say that that would be a bad thing because it would give the green light to other smokers. I doubt if it would work that way. Perhaps liability to coronary heart disease would have been a better example.
It is often suggested, more in hope than experience—again as described by the noble Lord, Lord Oxburgh—that because the National Health Service holds health information on almost everyone in the country, particularly those on GP lists, we could have a ready-made, vast database. The reality of course, as the noble Lord, Lord Oxburgh, indicated, is very different. The basic problems are twofold. First, the data recorded by each trust and each GP practice is incomplete, inconsistent, often out of date and therefore inaccurate, particularly in relation to addresses and post codes and so on, which are very important as indicators of the environment to which people are exposed.
Secondly, the systems of recording the data are many and various and not necessarily compatible. In the GP field, of which I have some experience, software firms were encouraged by the previous Government to compete in selling their programmes to GPs. In any case, these systems were mostly set up to help GPs in their own practices with, for example, repeat prescriptions, appointments systems and so on, and not for record linkage. Similarly, each trust developed its own system. The Department of Health is now having to mount special, expensive exercises to enable the transfer of patient data from practice to practice, practice to hospital and hospital to hospital.
In its response, the Department of Health put on a very brave face about what is happening. I know that the department is fully aware of the enormous benefits to be gained from an integrated system for the administration of the National Health Service alone, but important epidemiological research benefits would also follow.
As the Government's response indicates, increasing amounts of money are being allocated to IT by the department. As an indication of the importance it gives to this issue, four out of the 15 pages of its response refer to IT. I recognise that it is a huge task, but I am a little concerned that the approach being adopted may be too bureaucratic.
For instance, the four pages to which I referred contain references to the titles of 14 separate new National Health Service organisations or initiatives. I attempted to find out more about two of these—Information for Health, a 1998 document, and Building the Information Core, a 2001 initiative—on the web. 1033 When I searched for them, I came up with the answer, "not scanned". I hope and trust that these initiatives, and the rest of the department's IT strategy, are more accessible to those directly involved.
I know that information technology is one of my noble friend's particular areas of responsibility. I am sure that he will have a suitable riposte to my remarks. But there is a target date of 2005 for the achievement of the department's internal objectives on IT and I hope that he will be able to use global warming to speed up the glacial pace mentioned by the noble Lord, Lord Oxburgh.
In the meantime, there is a pressing need to harness a sufficiently large population to carry out the population-based research described earlier by the noble Lord, Lord Oxburgh. The MRC/Wellcome/NHS collection will help to fulfil this need. An important reason for setting up the collection is that each subject will have been given full details of the scheme and will be allowed to opt out if they so wish. Other existing large population databases, such as the General Practice Research Database (GPRD), would not have this opportunity, as well as there being other disadvantages.
Finally, I should like to touch on the ethics of secondary use for research of data originally assembled for another purpose or as part of a routine medical record. It is difficult to be brief in such a complex area, so I shall jump several stages of the argument and go straight to the report's recommendation for the setting up of a medical data panel,to provide a single clear process for approving projects".In their response the Government say that Section 60 of the Health and Social Care Act 2001 would fulfil this function better through the Patient Information Advisory Group which it sets up. It will have statutory status and will be able to advise on regulations. These are certainly important points.
However, information reaching me from the first meeting of the PIAG suggests that a form of bureaucracy may be creeping in in that a number of decisions were put off. But that is only one meeting and it is early days yet. However, I suggest that there may still be a role for our medical data panel to clarify, amalgamate and present the requests of researchers to the PIAG in a more convincing way.
I believe that I have spoken for too long already. I am sure that noble Lords are impatiently waiting to hear the maiden speech of the noble Lord, Lord May. I hope that my noble friend and his department will continue to refer to the report and will listen to and act on the more erudite speeches which are to follow.
§ 6.41 p.m.
§ Lord Wade of Chorlton
My Lords, I do not know whether what I wish to say will form one of the erudite speeches, but I shall give my non-scientific view of the matter. I thank the chairman, the noble Lord, Lord Oxburgh, for doing a marvellous job. I was enormously impressed throughout the inquiry by his 1034 breadth of intellect and his enormous ability to bring some expert knowledge to every aspect of what to me was a very complicated issue indeed. I am most grateful to him for helping me to grasp something which I never believed I would understand. I am also very grateful to him for giving a much more scientific explanation of the report. I can only give noble Lords the non-scientific result of my sitting through what I considered to be a most fascinating period of several months when we took evidence from experts in the field and on all aspects of it.
I would like to concentrate on what appeared to me to be the highlights of the proceedings. As has already been said, our scientific adviser was Professor Paul Elliott. At the first meeting we received a presentation from him concerning the main issues that we were likely to come across in hearing the evidence. What impressed me about his presentation was the very important environmental issues and their impact on the genetic influences. The implication was the enormous amount of extra information that one needs in a database. It was not just genetic information, but the environmental implications that went with it. That point will arise later when I refer to the need to understand one's genetic make-up and the environment in which one lives.
The presentation also added significantly to the amount of information that has to be included in a database. Our attention was drawn very early on to the enormous computerised resources that would be needed to store all that information not only in a databank, but in a way in which it could easily be understood and used later on. I shall come to that point later. That was the first main issue, which for me was an important part of the inquiry.
As has already been stated, the background to a great deal of the evidence was the proposed United Kingdom population medical collection of 500,000 people, how that would work, how the information would be collected, saved and protected when collected, and how it could be used later on in a significant way. That drew me to one of the main and fascinating issues which emerged from the inquiry.
All the information is enormously important to the individual. It can be used by others against the interests of the individual. It is the individual's private information and we consider that such information is private. Yet for the population as a whole to gain any benefit from that information at some stage it has to be used. I was interested in Professor Bell's evidence to us. He emphasised that there was little purpose in having a data collection of 500,000 individuals unless one could draw on it in future.
To me it is not just a question of drawing on it in the light of what we already know, but also in the light of issues which are beyond our comprehension at the moment. We do not know what new ideas and possibilities will unfold as a result of the genetic information which is now being collected and understood more and more. How can we persuade an individual to give up the information and put it into a databank on the basis that it may well be used in a 1035 manner about which we have no idea at the moment, but in the hope and the knowledge that it will bring benefit to many people although not all?
We pondered this matter a great deal, as was mentioned by the two previous speakers. We came to a view about the setting up of the panel. The noble Lord, Lord Oxburgh, has explained the Government's response. I believe that they accept the principle of having an independent group look at these matters, although they are already covered by existing structures. No doubt the Minister will refer to that.
The noble Baroness, Lady O'Neill, is in her place. We were most grateful to the noble Baroness and others for giving evidence on this matter which we found fascinating. But it was not completely consistent. Some believed that there was greater responsibility as regards the benefit to society as a whole, whereas others felt that the powers and rights of the individual probably came first. But it was not a fixed feast. In that regard fascinating evidence was received from a number of people that at no stage can one say that this particular point is the balance between the rights of the individual against those of the majority: it moves in relation to public opinion. How does one define and encapsulate it? We still have to ponder that question.
Although we have, and can still, draw attention to known specific benefits that can come from genetic research, we have not yet seen it all. I believe that until people understand more about what can be done and the benefits, which not everyone will recognise as benefits, we shall return to the issue time and time again. In my view there is no better place for these matters to he pondered than in the House of Lords where we can bring such a wide range of knowledge, experience and skills to try to find a consensus on how these matters change. It may be that the best panel to deal with these issues is the House of Lords itself under the chairmanship of the noble Lord, Lord Oxburgh.
There is another point which I found quite fascinating. I shall read a part of the evidence which was received from Professor Sir George Radda. He said,but perhaps in the longer term what is important is that it—the genetic database and genetic information—is going to lead us to a completely new understanding of the nature of disease and its progression. Not only will we have new drug targets, but we will also have a new approach to medicine, thinking about preventing heart disease much more than treatment, informing the public about in what way they can avoid the interaction between bad environment and their genetic makeup. That is not going to happen in the next five years … but in the next ten or fifteen years I think we are going to have a tremendous amount of new information on those sorts of environmental gene interactionsI believe that returns to the point of how we can relate these issues of genetic knowledge, environmental knowledge and future health. It is a question of tying together a system that allows us to trace the future health of an individual whose genetic basis and make-up we know. Then, we can begin to bring out the enormous advantages referred to by Professor Radda.
1036 Bringing all these resources to bear will not be the job of government alone, although government must ensure the computer power and the skilled operators—who are in extremely short supply; it was drawn to our attention that every time a suitably able person is found to deal with the computerisation of these matters, he or she is whipped away to a job in the City or to some other higher-paid job. Government must be aware that, if we are to achieve these things, the provision of highly skilled people is be a vital factor. There will have to be a commercial element; and it is important that it should be allowed free knowledge and free expression. It is important that there should also be sufficient flexibility in the regulatory system which is bound to be involved in such issues to allow the commercial world to grow these opportunities for the benefit of all.
Perhaps I may conclude by quoting from the final part of a recent interview with Mr Bill Heseltine, founder and chief executive officer of Human Genome Sciences in the United States. He says:I can imagine a world in which we level the genetic playing field so almost everyone can live to between 120 and 125 years, and where most accidental damage can be repaired. But that should be shared by all people, not just a few. That is health Utopia".That is the kind of ambition that many people have.
Twenty years ago, I learnt that I was a diabetic. I was told then that if I wanted to live very long I must not eat any more fatty food and must take plenty of exercise. I took not the slightest notice of that advice. Even if people were told when they were young that a certain lifestyle would make all the difference to them and they could live to be 125, I do not believe it would make the slightest difference to their behaviour. Although we shall have the knowledge, it does not necessarily follow that we shall all live longer.
But there will be advantages for many people. There is great potential for opening up new health opportunities in areas of the world where few such opportunities presently exist—the kinds of areas in which the noble Lord, Lord Patel, is involved. As a nation—together with the Government and the commercial world—we must embrace and support these advances in every possible way.
§ 6.53 p.m.
§ Lord May of Oxford
My Lords, at the outset, I want to thank the many people who have helped to induct me into the workings of this House—especially the staff, who have been unfailingly thoughtful and willing. On a personal note, as your Lordships may have guessed, I am a joint Australian/British citizen, and a relative newcomer at that. I like to think of myself as part of the UK academic brain gain in 1988.
The Select Committee report on Human Genetic Databases: challenges and opportunities is a most thorough and altogether excellent account of the issues. I want to comment on a couple of its detailed recommendations.
I begin, however, by saying that as you read this report, and consider the range of biomedical advances it envisions, you might blanche at the possible cost 1037 implications for the National Health Service. There are many, however—and I am one of them—who think, to the contrary, that as medicine becomes more based on genetic and molecular understanding, it might at the same time become more oriented to prevention and less oriented to heroic intervention. This could, at least in some areas, reduce rather than increase costs—just as the advent of polio vaccines reduced the costs of iron lungs, along with reducing suffering.
Turning to the report's recommendations, I wholeheartedly underline the succinct summary in paragraph 11. It says that past achievements have resulted in the UK being in a unique position in the field of genetics. Nevertheless,To succeed, we must … ensure that we have a regulatory regime that is sympathetic to the work, but which offers individuals the privacy they have a right to expect".In particular, I warmly commend the Population Biomedical Collection, as proposed jointly by the Medical Research Council, the Wellcome Trust and the Department of Health. This project aims to take advantage of the some of the unique aspects of the comprehensively embracing nature and history of the UK National Health Service. However, I agree with the statement in the report that, in order to do this successfully, three things must be done:
First, as my noble friend Lord Oxburgh said, the unpredictability of future secondary uses of the database—and such unpredictability is the only certainty—requires that a medical data panel be created along the lines proposed.
Secondly, the adoption and implementation of uniform protocols and standards for medical records is long overdue. I realise that this is easier said than done, but done it should and must be. In parenthesis, my noble friend Lord Oxburgh said that it is already being done somewhat better in Scotland. I hope that he will sympathise when I say that, as a Celt, with a father born in Carrickfergus and a mother whose maiden name was McCredie, I simply say: "Of course".
Thirdly, attaining the benefits foreseen in the report will require substantial investment, particularly in people with skills which are often more conventionally thought of as lying in the physical sciences rather than the biological sciences—information technology; statistics; computing science; mathematical aspects of the genetics of populations, as distinct from a focus on the detailed genetic constitution of individuals. This is indeed the century of biology, but physicists and engineers will continue to play a crucial role in creating the enabling instrumentation and analysis. We forget that at our peril.
The report says many other important things. However, I want briefly to widen the discussion from human genomes to those of other creatures. More and more, we are learning to reconstruct the evolutionary tree of life, from the evidence contained in the genetic make-up of other organisms. There are many surprises. We humans are less genetically distant from other animals, and even from plants, than was 1038 previously thought. For example, almost half the genes found in bananas are also found in us—a fact which I sometimes think is more evident in some of my acquaintances than in others!
There are potential practical implications here. For instance, of roughly 300 genes known to be associated with diseases in humans, almost 200 are also found in the genome of the fruit-fly. This raises the possibility of future alternatives in some particular kinds of biomedical research involving non-human animals. But much more important, I think, are the ethical implications for how we see ourselves as part of a larger web of life on earth.
In conclusion, the issues raised in this Select Committee report—hugely important though they are—are ultimately but a shadow of things to come. The century just ended saw more advances in our understanding of the external world than in all previous human history. We have used that understanding to make life better in both the developed and the developing world. However, we are only just beginning to realise, and grapple with, the unintended adverse consequences of our well-intended actions: climate change and diminishing biological diversity are two examples.
In the century just begun, however, our understanding begins to reach beyond the external world, down into the molecular machinery of life itself. The doors opened by this understanding will increasingly raise ethical and other questions, compared to which today's excellent report is a whispered preamble. We need to ask what kind of world we want to create with the possibilities that science offers, subject to the constraints that science clarifies, rather than just letting things happen. So today's report, wise though its recommendations are, is even more interesting and even more important for the questions of tomorrow which we here foreshadow.
§ 7.2 p.m.
§ Lord Turnberg
My Lords, what a pleasure and a privilege it is to have heard such a marvellous maiden speech. The noble Lord, Lord May, is a very distinguished scientist, as was pretty obvious from the way that he spoke this evening. Of course, he is president of the Royal Society, in which position he has the role of representing the scientific view at large; and he did so this evening in an exemplary way. It was a fascinating speech to which, if I did not, unfortunately, have to intrude, in a way, in order to give my own speech, I could have continued to listen for a very long time. If noble Lords were worried that the introduction of people's Peers might somehow lower the tone of your Lordships' House, I believe that such fears have been allayed tonight. It is obvious that the noble Lord will contribute greatly to our deliberations.
I, too, should like to pay tribute to the noble Lord, Lord Oxburgh, who chaired our committee so gently, so wisely and so carefully. Indeed, it was a great pleasure to work with him. I also commend our specialist adviser, Paul Elliott, and the secretariat that gave us such excellent support.
1039 I shall focus my remarks on the two parallel concerns that have been mentioned by other speakers. These formed the essence of our deliberations: the need to protect the rights and interests of individuals from whom genetic data may be obtained, and, at the same time, to be able to use those data for the good of society as a whole and for other individuals within it. It may be thought that this requires a choice to be made, or a balance to be struck, between two conflicting aims: between society and the individual. But, in this case, I believe that it is vital for us to keep both. It is quite possible to achieve both provided that we do not become side-tracked by extreme cases, and instead take the reasonable, rational approach that I believe our report took.
Perhaps I may elaborate a little on the latter. In general, patients are very happy to be given treatment for their ills. They may, or may not, realise that they are virtually all heavily dependent on research that has been carried out with the help of previous patients. Further, they have been largely unconcerned hitherto that information about their own case might be used for research that is aimed at helping future patients—providing that they themselves are not harmed, disadvantaged or embarrassed in any way. This give and take has worked remarkably well, even though it may have been largely achieved below the level of consciousness of many.
I believe that individuals do have a moral responsibility to society to allow information about themselves to contribute to the pool of knowledge that can lead to improvements in the care of others, provided that they are not harmed or embarrassed in any way. I do not use the words "moral responsibility" lightly; such matters have be considered along with the rights of the individual.
It is worth considering what are the potentially undesirable outcomes of access to this information about patients. These largely involve access to information by those who might use it against the best interests of the patient—insurance companies are often quoted in that respect, as are employers, and a wider public where codes of confidentiality do not exist.
I have looked long and hard for evidence of patients being inconvenienced in any of these ways by this give and take in which patients accept both the treatment in the NHS and a tacit responsibility to contribute to the health of others. As far as concerns the use of data, I have not really found any such evidence in practice. However, when we come to genetic information new fears are raised because genetic data have the additional capacity to predict the future; that is, future susceptibility to the risk of getting a disease which is not yet apparent in an individual, and, perhaps equally importantly, has some predictive capacity for susceptibility in close relatives—that is, people not directly tested.
But even here, as has been suggested by others, we should not ascribe to genetic tests an accuracy that they do not have, and probably never will have. In fact, with the small number of exceptions of rare genetic 1040 diseases, prediction by DNA analysis for the vast majority of illnesses is not much better than simply asking patients about what illnesses have occurred in their close relatives. Both family history and DNA tests can give an idea of the risk of developing a disease but, with the rare exceptions such as Huntington's disease, are not nearly as clear cut as some would have us believe.
It was at least in part for that type of reasoning that the committee recommended that there is no real need to seek additional legal provisions over and above those provided by the Data Protection Act and the common law. In most instances, we can rely on these and two safeguards that are extremely valuable; namely, the principles of anonymity and of consent. Where anonymity can be guaranteed, you c staid argue that consent is unnecessary. That is certainly the case as regards the Data Protection Act. But this does not take account of the possibility that an individual may wish to object to certain lines of research being pursued with data—even anonymous data—derived from him. So consent is clearly desirable.
If anonymity and consent was all that there was to it, there would be few problems. But, unfortunately, neither anonymity nor consent—or "fully informed consent", as some would have it—is always possible. On the one hand, many types of research using genetic data cannot be carried out unless one knows from which patients the data have been derived. Does a particular DNA pattern lead to a risk of developing a certain disease? That can be determined only if you follow named patients over time. So anonymity is problematic.
On the other hand, consent is not always possible either. As we have heard, in many instances the type of research that will be done at some time in the future is not known when the data are collected. That is the case for the large cohort study being set up by the MRC, Wellcome and the NHS. It will probably provide for the possibility of much future research, the nature of which we cannot possibly predict. How can individuals give informed consent to research that cannot be predicted? Furthermore, by the time that such research is performed, many of the individuals will be untraceable or dead, so it will be impossible to go back to them to obtain new consent.
That is why an alternative route had to be found. The committee proposed the establishment of an independent guardian of such data—the medical data panel—which would examine research proposals to ensure that the data that it was protecting were used only for legitimate research and that the patient's interests were taken into account. The idea was based on a Danish model which has been shown to work very well, at least in that country.
Unfortunately, in their response the Government did not accept the proposal and pointed instead to two other types of committee, which they thought would be adequate for the purpose—the research ethics committees and the Patient Information Advisory Group, set up under the Section 60 of the Health and Social Care Act 2001. I believe that in this rare instance 1041 the Government are wrong. First, research ethics committees are heavily overburdened with a large number of different types of research proposals. The committees are largely made up of volunteers from a variety of backgrounds. While they do a marvellous job, they cannot be expected to have all the necessary expertise to take on that additional role. There is already evidence that the conclusions that ethics committees are reaching about such research proposals differ markedly around the country. Local and multi-centre research ethics committees need help. That could be provided by a medical data panel that had a specific remit, the necessary knowledge and the expertise to command the confidence of the public while facilitating the pursuit of important research.
Section 60 of the Health and Social Care Act has appeared since our report. I am afraid that the incredibly bureaucratic system involved seems intent only on delaying or preventing research rather than facilitating it. Its working so far gives little confidence that it will be capable of changing the image that it already unfortunately conveys of being the enemy of research. I believe that there is even more need now for an independent medical data panel that works on common-sense principles and can advise on important matters openly and transparently. I hope that my noble friend the Minister will at least agree to leave open the possibility of looking again at the proposal. I cannot believe that it would not have wide support.
Once again, I thank the noble Lord, Lord Oxburgh, for leading us so wisely and gently through the morass.
§ 7.13 p.m.
My Lords, I, too, take this opportunity to congratulate my noble friend Lord May of Oxford on his brilliant maiden speech. I look forward to hearing him on many other occasions. I also take this opportunity to thank our chairman, the noble Lord, Lord Oxburgh, for providing such excellent chairmanship.
This is one of the key reports that will help shape the development of healthcare in this country. I welcome the fact that the Government's response was positive on the whole. Human genetic databases have the potential to identify genes involved in the development of progressive diseases. Such information should increase understanding of the biological mechanisms of disease and indicate ways in which a disease might be prevented or treated.
The Medical Research Council has already provided grant support for a number of genetic databases focused on specific diseases, including diabetes, cardiovascular disease, asthma and Alzheimer's disease. Those databases are being developed in partnership with charities and patient groups. Plans are well advanced for the creation of a large prospective cohort—BioBank UK—that will collect medical and lifestyle information on about 500,000 people aged between 45 and 69, as well as DNA samples. Data collected through BioBank UK will act as a national resource for studies of the 1042 interaction between genetic, environmental and lifestyle factors in the development of the common multi-factorial diseases of adult life. The importance of the public ownership of that national resource is underlined by the experience with the private sector genetic database initiative in Iceland. That cannot be over-emphasised.
It is clear that, while the setting up of a national genetic database is at an early stage of developing protocols for the collection of samples and data, the cost involved in that process and subsequently in the ability to identify individuals in the databank throughout their lives and link genetic information with health information for individuals or groups of individuals will require a long-term commitment of resources. As it cannot be possible at this stage to identify all the costs and as the eventual cost will also depend on other initiatives, such as our ability to collect patient health data electronically, can the Minister comment on the Government's commitment to supporting the cost of BioBank UK and to future costs? Is he able to comment on the current status of the initiative on the electronic collection of reliable patient information?
The report's recommendation for a national identification number given at birth or at registration as a citizen is important. There is some doubt that that is currently widely used, that general practitioners are informed of the hospital number or that it is used widely in communications. It has been suggested that the system seems to work better in Scotland. As someone who works in Scotland, I can tell your Lordships that it does, but not as well as you might think.
It is important that there is public ownership of the national resource of a population-based genetic databank. Experience in other countries, not only in Iceland, has shown that commercial ownership is unacceptable to the public and has run into other difficulties.
Having said that, if the potential benefits of such a databank are to be realised fully, particularly in the development of treatments for diseases, it has to be possible for industry, particularly bio-industry, to have appropriate controlled access to the data, including for genetic research and especially for pre-competitive research. Clearly, access to such data must be made known to the public, particularly to the individuals who are participating in the databank. Commercial organisations should not have ownership of the database itself.
The issue of consent has already been alluded to. The initial process of giving consent to opt in to the databank, following relevant and appropriate information, is absolutely right. However, the subsequent consent to further research requires clarification. The recommendations in the report are right. They protect the rights of individuals, while also allowing the use of the information for secondary research purposes.
That leads me to the issue of the medical data panel. As has been said, that recommendation has been superseded by the establishment of the Patient 1043 Information Advisory Group under the Health and Social Care Act 2001. We should wait and see how the group works in practice. There is no reason why it should not do all that the medical data panel would have done. If it does not work, the case for replacing it will be even stronger.
None the less, there may be a need for an independent oversight body for a genetic data bank—to establish policy on access to samples and databases, to protect participants and the public interest, and to ensure confidentiality and data security. Perhaps that role should be performed, without legislation, by the Medical Research Council and the Wellcome Trust. Other genetic databases also should come under the remit of that body.
The report also points out the need for training in computing science, bio-information and genetic science. Although I am pleased to note that the Medical Research Council has increased the number of awards for training PhDs and post-doctoral scientists, more is needed. I also believe that universities have a role to play in establishing training not only for scientists, but for genetic counsellors. If we are to meet the population's future needs in genetic information and decision making, we shall need more genetic counsellors. Establishment of genetic databases and the knowledge that will follow from other research in genomics will lead to a need for the appropriate provision of genetic services.
I also believe—although it is not directly relevant to this report—that the issue of genetic services needs to be addressed now. I wonder whether the Minister will tell us what plans the Government have on genetic services.
Based on the available evidence, I believe that there is a further need for the General Medical Council to clarify its guidance to doctors on prior consent before passing patient information to disease registries or for audit purposes. The current guidance seems to produce constraints. At another meeting, evidence was presented showing that that is causing problems.
Much public anxiety about genetic information centres on its use and control. This report, and the Government's response to it, should go a long way to reassuring the public on the issue.
§ 7.22 p.m.
§ Lord Jenkin of Roding
My Lords, it was daunting enough for a layman to take part in this inquiry, but to follow the President of the Royal Society and two extremely distinguished medical men only makes the problem more difficult, especially as I feel that it is sometimes dangerous for laymen to intrude.
Perhaps, however, I have a couple of justifications. Some noble Lords may remember that, at the end of 1998, having already debated the NHS's 50-year record, we debated a Motion moved by my noble friend Lady Cumberlege on looking ahead to the next 50 years. Looking back on that debate, I was rather pleased to find that my own contribution to it concentrated entirely on the advantages that were to flow from the genome revolution. Nothing that we 1044 heard in Committee cast any doubt on the somewhat starry vision that I sought to express in 1998. We have heard today that we are still only at the threshold of realising not only what can be done because of the science, but the consequent ethical considerations—which were described in an outstanding maiden speech by the noble Lord, Lord May of Oxford. We can now see the possibilities of harnessing the new science for better prevention, diagnosis and treatment of illness.
At this stage in the debate, I should like to concentrate on one particular aspect of the report and the Government's response to it. The report acknowledges, right at the beginning, at paragraphs 2.4 and 2.5, that the inquiry started when the Select Committee visited the laboratories of SmithKline Beecham, in Harlow. In a presentation there, its then research director, Dr George Poste, a most distinguished member of the pharmaceutical industry, pointed to the key role of human genetic databases. He went on to say that, in Britain, the NHS should constitute a uniquely valuable source of information.
At the time, I suggested to the noble Lord, Lord Winston, the then Select Committee chairman, that the Select Committee should examine that possibility. Happily, we did. The investigation turned out to be both challenging and fascinating. I fully endorse the remarks that have been made by other noble Lords about our chairman, our specialist adviser and those who helped us to draft the report.
I return to George Poste's point: the NHS should have the capacity to be an enormously valuable source of data for the purposes that we are discussing now. The Select Committee made various recommendations to that effect. However, it was not only Dr Poste who made that point; we heard a good deal of evidence from various sources that harnessing that NHS data, in the form of computerised genetic information, was an essential precursor to maximising the benefits to patients and to public health. I shall give only two examples, both of which are drawn from a fascinating seminar that was arranged for us at Imperial College, where we heard from some of those who are engaged in compiling, using and analysing databases.
First, Professor Ian Purves, professor of health informatics at the University of Newcastle, said:large-scale projects to interpret the impact of genetics on disease would need good quality primary health care information about a large number of patients: computerised records were the obvious way of producing such data".Secondly, we had what I might describe as an electric presentation by Professor Carole Goble, of the department of computer science at the University of Manchester. She describedthe challenges created by attempting to link (or fuse) the extremely large databases that were increasingly common in genetics research".Professor Goble went on to describe the differences between the various sources of information within the NHS. As much of the information had been compiled for a very wide variety of purposes, and because of the use of different terminologies, there was bound to be what she called this inherent "semantic heterogeneity" 1045 which limits the ability of computers to do the huge amount of analysis that our report consistently recognises will have to be done. Additionally, as Professor Goble said, "intelligent input" will continue to be needed, with the clear implication that, without common standards, full value cannot be gathered from the databases.
Those concerns, which were echoed by many of our witnesses, led us to make some key recommendations, although I shall draw attention to only three of them. In paragraph 5.28, we said:GP databases need to be made compatible with one another and held in a way that allows the computer retrieval of the wealth of clinical information they contain … Achieving this will require an NHS-wide standard protocol for data capture and retrieval, and that will need to be in place much sooner.The noble Lord, Lord May, said that universal protocols were long overdue. One does not doubt that the Government have a great task before them.
Paragraph 6.23 of our report states:We recommend that the Government should review the strategy for instituting electronic patient records throughout the NHS, to include clinical information contained in GP, hospital and other health records. Delivering a fully functioning national system … will require firmness of purpose to drive forward the development of robust and standardised systems".The third recommendation to which I draw attention relates to the use of the NHS patient number. We stated,we recommend that the Government should urgently make use of the NHS number mandatory as a common identifier".One has to ask: how did the Government's response measure up to those three demanding but entirely necessary requirements? They are very clear, and essential if we are to realise the aim of using NHS data as recommended by Dr Poste.
I have to say that I do not find the Government's responses to those three recommendations in the least convincing. In their response to the first recommendation, which was about compatible GP databases, we were treated to a description of a quite different problem—the question of the use of the NHSnet. Well, we have a parliamentary net, and most of us are now familiar with its use. With the greatest of respect to Ministers, that has nothing to do with standardised patient information.
The Government's response went on to describe various other measures that were being taken to strengthen GPs' ability to use computers, with the emphasis, quite reasonably, being on measures that will improve the delivery of care. However, measures that are devised to improve the delivery of care and all that goes with that are not by themselves going to begin to meet the requirements involving the use of standardised records to realise the benefits of the genomic revolution.
We called for an,NHS-wide standard protocol for data capture and retrieval".Is the Minister really going to argue that the Government's response to the first recommendation, about records, will achieve the NHS-wide standard protocol for which we asked? If so, how? And if not, why not? 1046 I turn to the second of our three recommendations, which called for a,strategy for instituting electronic patient records throughout the NHS",and for "standardised systems". And the Government's response? That refers to the development of,electronic patient records to support many aspects of its"—that is, the NHS Plan's—"vision". It also referred to "Lifelong electronic health records", "Round-the-clock … access", "seamless care", "public access", and,effective use of NHS resources".Those are all no doubt highly relevant to the proper functioning of the NHS but they bear very little relation to the requirement for the standardised data for which we called. It is even more disturbing that the department that drew up the response to this recommendation has not recognised that what it has described has fallen so far short of what the Select Committee asked for.
I turn to the third recommendation, which was about making use of the NHS number mandatory as a common identifier. It is interesting to hear that it does not work in Scotland quite as well as we had been told. The Government say in their response that the NHS number is,a requirement of NHS Information Technology Standards".Yes, some efforts have been made to increase its use. And yes, there is now a system—the NSTS system—for tracing NHS numbers. Again, however, that bears absolutely no relation to the recommendation. The response is totally silent on our recommendation that the number should be made mandatory throughout the NHS. The Government do not even tell us why it should not be made mandatory; that is simply left in the air. I find that an inadequate response to a very straightforward and essential recommendation.
My final point has not been raised by other noble Lords. I was fascinated to read in The Times this morning an account of the interview with the Secretary of State for Health. We seem to be heading for a very different kind of health service. A sub-headline in the article quoted the Secretary of State as saying:We must redefine the NHS from a centrally run monopoly. It is time to let go".He is also quoted as saying:The job of government should not be to run the system but to oversee it. We want greater community ownership and less state ownership, leading to greater diversity and plurality in local services".Many of us say, "Hear, hear", to that. Some of my honourable friends in another place have been making powerful speeches along exactly those lines. Now we have it from the Secretary of State himself. He went on to say that one cannot run the NHS from the Secretary of State's office in Richmond House. I was conscious that I could not do so from the Elephant and Castle. One simply cannot do so. Yet the structure seems to suggest that one can.
The point that I wish to make is that there is nothing in that more diverse NHS that Mr Milburn now seems to be offering the country—we shall certainly need to 1047 see the details—that would preclude the NHS from adopting the IT standards that we have been discussing and for which the Select Committee called. He may not have had IT standards in mind, but Mr Milburn said:All this will be held together by a common set of values about care being largely free at the point of delivery and a common set of standards".It is perfectly possible to reconcile the more diverse NHS that Mr Milburn is advocating and the unified—standardised—information service for which the Select Committee called. The Government's response to the Select Committee's three recommendations falls far short of what will be required to enable the doctors, scientists, informatics technologists and all the others to begin to realise the potential that the new branch of science can offer to people. Nothing need inhibit the common standards for which we have called.
I return to George Poste. It was his vision that the NHS is such a source of information that sparked us off. I find it very disappointing that the first reaction to our report, in which we called for that, falls far short of what is required. I do not detect the clear purpose or robust resolution for which we called, and I find that disappointing.
§ 7.39 p.m.
§ Lord Flowers
My Lords, I found the chairmanship of the noble Lord, Lord Oxburgh, agreeable and stimulating. He is to be congratulated on having extracted from us an excellent report on such an important subject and on having introduced it so clearly to the House this evening.
It was good to hear the remarkable maiden speech of my noble friend Lord May of Oxford. He speaks with the awesome authority of the Royal Society and has much to contribute to your Lordships' House.
It was pointed out in 1999 by a working group of the National Institutes of Health in the United States that during the latter half of the 20th century two scientific fields stood out for their speed of progress and their evident implications for society. One was biomedical science; the other was computation.
Our report dealt with the developing convergence—to use a popular word—of biomedical research and computing science in the construction of genetic databases. That convergence looks set to dominate much of biomedicine for decades to come and to require continuing developments in the techniques of computing science.
Most of our report, of course, was concerned with the biomedical content of genetic databases and with their regulation to address public concern about their use. From that point of view, our most important recommendation, made in paragraph 7.56 and explained by the noble Lord, Lord Oxburgh, was that databases as such did not require separate regulation. In so far as the privacy of personal data is concerned, as the noble Lord, Lord Turnberg, said, the Data Protection Act 1998, together with the common law, is a sufficient basis on which to provide adequate regulation.
1048 Since that was written, however, I have become more acutely aware than I was that the need in genetic research repeatedly to copy, combine and edit data from one database to another may make it difficult, if not impossible, to ascribe ownership to the data. It seems to me that that point will need to be looked at closely in the interpretation of the Act.
However, those issues are being addressed today by several noble Lords who are well qualified to deal with them, and I am not. Instead, I want to say a few words about one particular recommendation that occurs in paragraph 5.27 of our report. I shall paraphrase it because it is rather long. It states:We recommend that the Government [and other relevant bodies] should give high priority to funding training and supporting research in the areas of bioinformatics, statistical genetics and the computing science underlying database management".In other words, we recommend that those bodies—the Government included—should give close attention to the convergence of which I have just spoken between biomedical research and computing science.
Of course, when any new interdisciplinary subject emerges, one starts by assembling teams of researchers containing representatives of the relevant disciplines. Thus, in genetic database research the teams contain computing scientists as well as biomedical experts. But that is not enough. As the NIH working group, to which I have already referred, said:What is needed is a higher level of competence in mathematics and computer science among biologists themselves".It goes on to make as its first recommendation the creation of a number of centres of excellence in "biomedical computing", which, as well as getting on with the job, would play a major role in educating practitioners of the new discipline.
A scientist who wishes to seek out a gene that may be responsible for the onset of some disease—for example, breast cancer—will wish to assemble a database that he or she hopes will show the pattern being sought. The data that is involved may come from a new experiment or, much more likely, as I have already mentioned, from reinterpreting data already entered into other databases assembled for other purposes. As the noble Lord, Lord Jenkin of Roding, said, Professor Carole Goble of the University of Manchester, of which, I should declare, I was Chancellor at the time, described to us the difficulties of linking together extremely large databases of quite different natures—annotated DNA sequences and clinical trial data, to mention but two.
The DNA from one human being amounts to the equivalent of about 3 billion characters of text, which can easily be stored on a small computer such as the one that I have on my desk at home. The same applies to many other noble Lords. However, building databases that account for genetic variation, in which we must store the DNA sequences from a possibly very large number of individuals together with much other information, poses serious problems for data management, organisation and storage—many orders of magnitude more than I have available at home. 1049 Searching the combined data for significant variations presents new challenges for the designers of computer software.
Obviously great computer power must be, and is, available in the major centres of genetic research. But in order to harness that computer power, a number of powerful algorithms must also be available. These are the building blocks of the software that instructs the computer how best to go about its allotted task. In the case of genetic databases, the algorithms are pieces of computer software specialised so as to encapsulate the biomedical hypotheses being tested. They constitute the bridge between data and understanding.
Clearly such algorithms, which are the core of computer software, allowing the efficient assembly of a new database, possibly from disparate parts, and the scanning of such a database for desired patterns, should be devised by someone steeped in biology as well as in mathematics and computing science.
To be a little more explicit, the development of algorithms and the design of databases are core problems requiring much research in mathematics and statistics and, of course, in computing science itself. But the tools provided by computing scientists will be useful only if we have people available who understand both fields. That is why we need training as well as research in the new field.
I could give other examples of convergence, but I shall end, if I may, with a question to the Minister. I know from the government response that funds are supposed to be available for bioinformatics. But is he satisfied that adequate policies have been made for the training of specialists in biomedical computing equivalent to those being made by the National Institutes of Health in Washington? I am bound to say that the evidence that we received from bodies such as the research councils did not convince me that his answer should be "yes".
§ 7.49 p.m.
§ Baroness Kennedy of The Shaws
My Lords, I start by adding my garland to the many laurels already received by the noble Lord, Lord May, on his very fine maiden speech. He is a great advocate for science and, indeed, a great advertisement for the benefits of immigration. It is good to see him here in this House.
The noble Lord reminded me that recently I was at an international forum where I heard the Foreign Minister of Israel, Shimon Peres, speak. He said that it is not philosophers who change the world; it is scientists. But then scientists have to persuade the philosophers that they have got it wrong. Having heard the noble Lord, Lord May, speak on a number of occasions, I can tell your Lordships that there is no end to his powers of persuasion. I know that this House will be greatly enriched by his presence in our many philosophical discussions of genetic issues.
I have just returned from India, where the Prime Minister launched for the British Council a festival of science. That was a glorious event, which brought together many eminent scientists from Britain and 1050 India. We had there our own Nobel Laureate, Sir Paul Nurse; Sir Walter Bodmer; Professor David King, The Chief Scientific Advisor; and Professor Richard Sykes from Imperial College. There was a whole range of truly wonderful scientists from Britain. The event was greeted with huge enthusiasm. I think that we would all agree that that confirms the esteemed place of British science in the world. There was also great interest in the Human Genetics Commission, which I chair. While greeting the benefits and advances that are coming with genetic science, the world also shares many of the concerns that the public have about some of the challenges that go hand in hand with that.
There is an avid desire to know how Britain will meet those challenges. The way that I always respond is to say that all sources of wisdom are to be welcomed and embraced. Indeed, that was the response of my commission when the Science and Technology Committee said that it would look into genetic databases and asked what we felt about that. We greatly encouraged the committee to have such an investigation. Indeed, it has proved to be as helpful as we imagined. The Human Genetics Commission thoroughly welcomes the report. In particular, we thank the noble Lord, Lord Oxburgh, and his colleagues for their complete treatment of this complex matter.
This may be a complex matter, but it is one which affects people in an immediate sense. In the commission we undertook a large-scale public survey of attitudes towards personal genetic information. We found—this was not a result which surprised us—that people are concerned about how information on their DNA will be stored and used. For that reason it is vital that any regime of controls around that sort of database should be strong, clearly understandable and capable of securing public trust. There are several reasons why that is so. Some are reasons of principle. Human rights considerations require respect for the privacy of the individual. At the core of this is the right to keep personal medical information, including genetic information, private. That is nothing new, It goes right back to Hippocrates and has long been recognised as a cornerstone of ethical medical practice. We must not allow that principle to be weakened.
Apart from such reasons for taking the security and confidentiality of genetic data seriously, there are practical and pragmatic considerations to be borne in mind. Genetic knowledge has made immense strides. We all know that we are on the verge of great medical breakthroughs. Continued research is vital. That will require the co-operation and trust of large numbers of people. The setting up of genetic databases is an important part of that research, as other noble Lords have explained. How we regulate those databases will have an effect on their success. The stakes are high.
How are we to achieve that public trust? If we are called upon to identify the absolutely central principles which must govern genetic databases, I believe they would be, first, as others have said, that the principle of consent must be centre stage. That requires open explanation and voluntary agreement. Your Lordships have heard from the noble Lord, Lord 1051 Patel, about the proposed population database known as BioBank UK. The commission is discussing with those responsible for that database how the overall research protocol will embody respect for the principle of informed consent.
Secondly, there must be what we call the principle of minimalism. Here, others may differ from the general consensus of the commission. Personal data must be used only for those purposes which have been agreed to by the person who provided it. That means that in general, databases set up for one purpose should not be used for quite different purposes. Again, there is a lot at stake here. If the public were to think that genetic data stored in medical research databases might be accessed for police purposes or for establishing paternity, we can be pretty sure that a lot of people would be unwilling to participate. We must work out ways of ensuring that the integrity of research databases is fully respected and that people's trust in them is not betrayed. The recommendation of a panel to oversee databases is one that we support.
Those are the general points. I shall now say a few words about particulars. First, your Lordships debated the issue of forensic DNA databases during the passage of the Criminal Justice and Police Bill. In the course of that debate I raised certain doubts about changes to the conditions governing the taking of DNA samples from those suspected of having committed a criminal offence. As noble Lords are aware, I am a criminal lawyer. I expressed concern at the fact that the samples of those who are subsequently acquitted, or who are not even charged—for example, those who volunteer samples for elimination purposes such as the husbands of the victims of rape or persons in a village who volunteer their samples when a child has been killed—may none the less have their samples retained on a national DNA database. Those protestations did not have the desired effect, or at least not the effect that I desired. I do not want to rake over them. However, in allowing those data to be retained in respect of innocent persons, we are out of step with every other comparable jurisdiction which uses such databases. I am not happy about that.
But the law has now changed. We need to ensure that the independent body which the committee recommended should be established to oversee that the national DNA database is set up. I note with satisfaction that the Government have said that they will give consideration to the need for independent oversight. There is an important point here, which I want to emphasise. Two things are stored. The first is identifying information which consists of a series of numbers forming the basis of the so-called DNA fingerprint. The second is the sample of cells from which that information is obtained. Both of those are retained; one in a computer and one in a fridge.
It is important that there is independent oversight of both of those. That means that not only will there be supervision of matters such as access to the DNA fingerprints in the computer and over who has that access, but also there will be control of anything that is done to the samples; that is, the cells which are stored in individual containers. Representations have been 1052 made to us at the commission that there is no real justification for keeping the samples. The answer given by those who keep them is that there could be, for example, a breakdown in the computer. But the question of whether they need to be retained is one which should not be forgotten.
There may be some who take the view that the state does not have the right to retain the tissue of individuals who are innocent in the eyes of the law. We should be careful to remember all the anguish and embarrassment experienced over the retention of organs and tissues within the National Health Service. People feel strongly about their tissue, and are entitled to those feelings. We should be conscious of the ways in which we can undermine the trust that needs to exist between citizens and the state.
The other particular aspect of the report about which I should like to speak is the question of how we ensure that the law adequately protects the security of genetic data. The committee has placed its trust in that regard in the Data Protection Act, which sets out the conditions under which data is stored in this country. In general, the data protection legislation provides valuable protection against wrongful disclosure of personal information. However, there are respects in which the protection may be considered to be on the weak side. In particular, the wrongful disclosure of such data is not an offence. We have had submissions to the commission that that should be reviewed. Indeed, the commission is currently looking closely at the issue of whether there should be created a criminal offence of wrongful disclosure or misuse of genetic information. After our considerations we shall make recommendations to the Government within the next few months.
Finally, the report has been most timely. Not only has it helped us on the commission to address these issues, but it has been very closely looked at by others engaged in work involving genetic databases. Its influence will be far-reaching. I want to thank the noble Lord, Lord Oxburgh, and his colleagues on the committee for this very important work.
When the Prime Minister was in India at the launch of the science festival, he spoke about the extraordinary strides that are being made. He quoted Gandhi and said that there should not be politics without principle. He also said that there should not be science without values. I think that we all would agree with that.
§ 8 p.m.
§ Baroness Walmsley
My Lords, may I first compliment the noble Lord, Lord Oxburgh, and all the members of Sub-Committee II on the quality and clear-sightedness of their report on human genetic databases. Although I am a member of the Select Committee, I was not a member of the sub-committee that conducted this interesting and worthwhile inquiry. But I have read it and the Government's response with a great deal of interest.
It strikes me that many of the report's recommendations are of value, not only in addressing the issues that arise specifically in relation to genetic 1053 databases but also much other research into human disease, as well as cost efficiency in the NHS, tracking down wrongdoing and many other issues. This multiplies the value of the report several-fold.
Perhaps I may also compliment the noble Lord, Lord May of Oxford, on his fascinating maiden speech. I am sure that the Minister fervently hopes that his crystal ball gazing about possible savings to the NHS from this work can be achieved. He opened our eyes to future possibilities in a way that was both inspiring and terrifying in terms of the Pandora's box of ethical dilemmas which we are soon to face, far beyond those so ably addressed in the report.
I personally have already benefited from the wisdom of the noble Lord, Lord May, in my capacity as chairman of Sub-Committee I and our current inquiry into systematic biology and biodiversity. Therefore, it gives me particular pleasure to welcome him to this House. I know that we shall have many future opportunities to be grateful for his knowledge and expertise.
I turn now to some of the issues raised by the report. I comment first on the recommendations about electronic NHS patient records in paragraph 6.23. That is a matter about which the noble Lord, Lord Oxburgh, was somewhat critical of the Government in his speech. I believe that investment in this area will have untold benefits in the future. Not only will a fully functioning national system by 2005 enable a wide range of research to be carried out more quickly and efficiently, but I can envisage a situation where appalling cases, such as that of the mass murderer Dr Harold Shipman, could be prevented from happening in the future. If we had had a centralised easily accessible electronic database system with built-in alerts, morbidity trends such as Dr Shipman's caseload contained, which were missed over many years, could have been picked up and a number of tragic deaths avoided.
The hardware, software, systems development, training and oversight of such a national system present an enormous undertaking, but the benefits overwhelmingly justify that. Is the Minister able to update the House about progress in the matter? Perhaps he can address the concerns of the noble Lord, Lord Rea, and others about it being overly bureaucratic. I also agree with the noble Lord, Lord Jenkin of Roding, in regretting the Government's rejection of the recommendation of the need for a unified system.
Much of the Select Committee's deliberations concerned the matter of patient privacy, ethics and consent. There have been a number of high profile cases about which the tabloid press have gone to town in a way which I do not regard as being universally helpful, although, to be fair, they raised some very important issues. Sadly, however, their tendency sometimes to go over the top can get in the way of real progress by frightening people unnecessarily. However, I particularly welcome the provisions in the 1054 Health and Social Care Act 2001 which set up a Patient Information Advisory Group. Can the Minister update us about how it is getting on in its early days?
The suggested procedure for informing patients laid down by the committee in its report has been welcomed by the Government. It is however very important that the operation of this procedure is carried out by staff who have had adequate training and with the utmost sensitivity, since some of the issues involved are highly emotive.
The establishment of the UK Population Biomedical Collection is one of the most exciting research initiatives under way in this country. The committee had something to say about the consultation which needs to take place, particularly about the remit of the oversight committee. It is vital that the oversight of this project is done in a way that does not get in the way of the science but which at the same time protects the rights of the volunteers who take part with regard to secondary usage. It is a balancing act that needs, as do so many issues covered by the report, the wisdom of Solomon. I wish it a fair wind.
I turn to the recommendation about an independent body having oversight of the workings of the National DNA Database. In the Government's response they claim that safeguards are already in place. However, we now have an anomalous situation as regards the retention of DNA samples taken from innocent people in the course of an investigation. Those who volunteer to give samples in order that they can be eliminated from an inquiry can insist that these be destroyed when they have served their purpose. However, those from whom samples are taken because they are under some suspicion cannot so elect, even though they are subsequently proved to have had nothing to do with the offence. That strikes me as totally wrong and an affront to human rights.
In the debate on the Criminal Justice and Police Bill the noble Baroness, Lady Kennedy of The Shaws, and my noble friend Lord Phillips of Sudbury put the case against this strongly. The noble Baroness has done so again today. In an audit of the National DNA Database, over 50,000 samples were found to have been retained illegally by the police from suspects who had subsequently been cleared and whose samples should have been destroyed. Instead of putting this illegality right, the Government moved the goalposts and legalised the police behaviour—a matter of great regret to my noble friends and I. This is the kind of abuse which an independent body, as recommended by the Select Committee, overseeing the National DNA Database should be in a position to prevent in future.
In their response the Government say that they recognise the importance of having a system in which people have confidence. However, the Government do not accept the need for such an independent body. From these Benches we do not feel that the justification they give in their response holds water. Can the Minister offer any more convincing justification in his response to the debate today?
1055 I now turn to the patenting of genes. Here I believe that the committee's report strikes exactly the right balance. The principle should be to enable adequate reward to come to those who invest time, money and brainpower in gene research but to avoid a straitjacket that would hinder future research. Patent rights should be granted only when a significant gene function has been established. That does not need to preclude further research based on that gene. I hope that the Government will continue to work within Europe to ensure that the existing balance remains in the interests of future research.
Current safeguards should prevent patents being used in an anti-competitive manner. This is a rapidly developing area. I urge the Government to keep a close eye on it. The stakes are high and the regulators need to be one step ahead, not one step behind, those who would seek to stifle competition and the advancement of science for personal gain. The Select Committee urges the Government to do that in paragraph 8.31. It is one of the most important recommendations of this fine report.
§ 8.9 p.m.
§ Lord McColl of Dulwich
My Lords, much of what I had planned to say has already been said, so I shall not repeat it. In particular, our splendid chairman the noble Lord, Lord Oxburgh, has expressed so succinctly the essence of our report. I should like to pay tribute to his excellent chairmanship, expertise and humour.
We are also grateful to the advisers and especially to our clerk, Roger Morgan, whose industry and courtesy, good humour and frankness were of great help to us.
I also congratulate the noble Lord, Lord May of Oxford, on his outstanding maiden speech.
As our chairman has said, genetic databases will unlock the health benefits of the human genome project and reveal how much of our health is determined by the genes we inherit and how much by the way we live—and, even more important, what can be done about it.
Incidentally, as more and more is discovered in the genetic field, perhaps that will make people more sympathetic to those with congenitally determined diseases, many of which are rare but others are quite common. For instance, who would have thought that patients with pityriasis capitis, which as noble Lords will recognise, is Latin and Greek for dandruff, would be congenitally predisposed to this fungal infection, which can be kept under control by using the appropriate anti-fungal agent.
Some adverse reactions to certain drugs may be genetically determined, and it will prove of great benefit to patients if that is known beforehand. The noble Lord, Lord Rea, mentioned smoking. There is now solid research evidence that half of chronic smokers take on average 20 years off their life. I hope that funds will not be spent to find out how to identify the other half who do not take 20 years off their life. Surely, nothing should be done to encourage smoking.
1056 Much has been written about the problems raised by the complex subject of human databases, and we had the benefit of advice from many different sources. Paul Martin provided a good analysis of how technological and scientific change in the field of genetics demands new governance arrangements. He stated that he doubted,whether the existing governance system of medical research in the UK is adequate to respond to recent changes. In particular the system is marked by the absence of a clear policy framework, it is underdeveloped with respect to genetics and suffers from lack of agency; as a consequence there is a strong case for both the reform of these arrangements and the creation of new institutions specifically designed for the task of governing genetic research and the emerging market in genetic data. Without such measures there is a danger that declining public confidence in the conduct of medical research and growing fears about the misuse of genetic data will have a damaging impact on the development of new health technologies".Several speakers have already stressed that general practitioners are the key players in the management and delivery of health. Their data input is vital in obtaining an overall picture of health needs and provision. As we pointed out at paragraph 5.14 our report, and as the noble Lord, Lord Jenkin of Roding, emphasised, substantial parts of the information in GP records is wrong or incomplete. In some cases, there were errors in 25 per cent of the postcodes alone. Sir John Pattison said that a system of holding each person's data in electronic health records in the National Health Service would not be fully implemented nationally until the year 2005 at the earliest.
Perhaps I may wholeheartedly support the chairman and all those who have made a plea for the right scale of funding in the field. Of course that will be essential but what is even more important is that those who will be working in it have the appropriate expertise. Computer experts have already been mentioned. I wonder whether the government would especially ensure that the computer experts are actually at the cutting edge of the subject. It must be most difficult for civil servants working in a government department for any length of time to continue to have the kind of computer expertise which is essential.
It is disappointing that the Government have not accepted our recommendation that a new medical data panel be set up. As the noble Lord, Lord Turnberg, stressed, that would have gone a long way to deal with public concern about confidentiality in health records, genetic makeup and the enormous amount of genetic data that will inevitably accumulate. There is genuine concern that the increasing amount of data will bring to light new and unforeseen situations, the solution to which would have been greatly helped had the government accepted and agreed to our recommendation.
In their reply, the Government argue that confidentiality of patient information is already adequately protected under Section 60 of the Health and Social Care Act 2001. They suggest that such a medical data panel would have a much wider remit than just the use of genetic data bases. They point out 1057 that Section 60 of the Health and Social Care Act 2001 provides powers to require patient-identifiable data to be used for specific medical purposes, and that that is restricted to where there is a benefit to patient care or public health.
As the noble Lord, Lord Oxburgh, mentioned, one of the problems with research is that it is difficult to be absolutely sure that a piece of research will be of benefit to patient care. As the noble Lord, Lord May of Oxford, emphasised, the results of much research are unpredictable. To put it another way, research and prophecy are two separate subjects.
In their response, the Government mentioned that they have asked Sir Gareth Roberts to undertake a review of the supply of skilled scientists and engineers in the UK, and that the report be available next spring. Knowing how long these committees and working parties can take, will the Government consider asking for the report to be ready within six months? There is an enormous urgency to the matter.
In conclusion, I hope that the Minister will be able to reassure us that there will be adequate funding and staffing for this great project. I make a special plea for the Government to avoid the ever-present temptation to swamp the proposed committees with people who have often been described as congenital snag-hunters.
§ 8.18 p.m.
§ Lord Hunt of Kings Heath
My Lords, the opportunity arising from the use of human genetic databases can hardly be overstated. As we have heard, they can be crucial tools in developing a full understanding of the effects of genes and their variations. Armed with such knowledge, we could see a revolution in healthcare. The noble Lord, Lord Oxburgh, spelt out many of the potential benefits, as did my noble friend Lord Rea. But with such potential comes a number of real challenges about the use of such databases including information about individuals and their health, and, as the noble Lord suggested, embraces many questions surrounding science, education, health, the law and ethics.
The Select Committee has undertaken an invaluable job in setting out the scope of the key issues that need to be tackled. We are extremely grateful to the noble Lord, Lord Oxburgh, and his committee for producing such a clear and lucid report on such a complex subject—in, as the noble Lord, Lord Wade of Chorlton, suggested, double quick time.
My noble friend Lord Rea, in an attempt to take us down the route of a discussion on House of Lords reform, testified to the quality of expertise available to your Lordships. If the forecast mentioned by the noble Lord, Lord Wade, is correct and we all live to be 125, some of the calculations that have been made as regards when most of us will die and when elected representatives will assume a higher proportion of the membership of your Lordships' House will be fatally flawed and gross underestimates.
The maiden speech of the noble Lord, Lord May, was outstanding. He certainly represents an academic brain gain to this country and to your Lordships' 1058 House. I was fascinated to hear his description of the human tree of life and the interconnection between bananas, fruit fly and humans. He postulated that in the future that may provide alternatives for research in relation to non-human animals. The issue of animal research has been debated a number of times in your Lordships' House. At the current state of knowledge, I believe that properly regulated animal research is crucially important to medical research in this country.
The report made a number of important recommendations to which the Government formally replied in their published response. I welcome the kind comments of the noble Lords, Lord Oxburgh and Lord Patel. I very much agree that the UK has a major role to play in the development and use of human genetic databases and disease registers. The noble Lord, Lord Oxburgh, referred to ground-breaking advances. My noble friend Lady Kennedy referred to the crucial role of science in the UK in ensuring that we make the most of those developments.
The Government are well aware of our responsibility to ensure that the UK continues to take a leadership role. Tomorrow my right honourable friend the Secretary of State for Health will host a major conference on genetics which will outline measures to ensure that the UK is well placed to take advantage of advances in genetics. He will also refer to the Government's proposed Green Paper on genetics which will be guided by an advisory group ably chaired by my noble friend Lord Turnberg.
Integral to this matter are human genetic databases. They make it possible for personal genetic information to be linked to the wide range of other information that is already available to us. It will soon be possible to link genetic make-up with susceptibility to disease. Most are agreed that that heralds a new way of looking at disease in terms of cause, progress and treatment. I was intrigued by the suggestion of the noble Lord, Lord May, that ultimately that could lead to a reduction in NHS costs. Of course, Nye Bevan thought that in 1948, but so far we have not seen any sign of it. I say to the noble Lord that it is better not to tell that to the Treasury until we have absolute proof that that will be the case.
The inquiry report also indicates how genetic databases can be used for other purposes. My noble friend Lady Kennedy referred to the national DNA database, as did the noble Baroness, Lady Walmsley. During the passage of the Criminal Justice and Police Bill the Government gave an undertaking to review the need for independent oversight of forensic DNA samples. I shall, of course, ensure that the comments of both noble Baronesses are fully considered as part of that review.
The inquiry report refers to the many databases that already exist. Most of those databases have been created for specific purposes; for example, to study a specific disease from a pathological, epidemiological or public health perspective. The power and utility of those databases are not in doubt, but I suggest that they lack the ability to be able effectively to study the 1059 complex interactions between individuals' genotypes, the environment in which they live and the lifestyle which they choose to adopt which together determine susceptibility to disease indication or acquisition.
Those studies need access to different sorts of genetic databases that are longitudinal in nature, collect data in a prospective manner and are able to make associations that are not always obvious. Those considerations led to the proposal to establish the initiative now known as BioBank UK. I was particularly interested to hear the remarks of the noble Lord, Lord Wade, in that regard. An expert group has developed the detailed protocol for the study which has now been submitted for peer review.
The noble Lord, Lord Patel, asked me about funding. Funding decisions by the sponsors, my department, the Medical Research Council and the Wellcome Trust are expected in April. The noble Lord will not expect me to comment further on that tonight but I acknowledge the importance of his comments on funding. We remain committed to the principles of BioBank UK, which we regard as an extremely important strategic initiative which we believe the UK is uniquely able to undertake.
Of course, we cannot neglect concerns that have been raised about the study, particularly as regards consent, confidentiality and the security of samples and data. The joint sponsors take those matters seriously and propose to create an independent monitoring body with functions not dissimilar to those of the medical data panel proposed in the inquiry report. As my noble friend Lady Kennedy so ably described, the Human Genetics Commission provides the Government with strategic advice on such developments. We are always anxious to listen to that advice.
The current proposal is that the monitoring body I mentioned should be established as a company limited by guarantee so that it can provide independent oversight free from the influence of sponsors and government. Appointments to the board of directors will need to remain open and transparent to assure the independence of that organisation. Advice from the Human Genetics Commission on the appointments mechanisms will be welcome.
Much has been said about the role of the NHS in collecting and supplying clinical data. The inquiry makes a number of helpful recommendations in that area. I do not pretend that the delivery of information systems does not set a formidable challenge for the National Health Service. Anyone who looks at the history of information technology within the NHS over the past 20 years will discover that it has been characterised by a series of failures and of resources ill spent. Frankly, its whole history of information technology reveals that it has been handled poorly.
However, I say to the noble Lord, Lord Jenkin of Roding, who was particularly critical of the Government's response, that I believe that we have turned the corner. The information strategy that was developed two or three years ago is fully accepted within the National Health Service. I believe that there 1060 has been a sea change in attitudes among people in the National Health Service who are committed to providing effective information systems. The need for national standards is clear. However, we also have to recognise that difficulties exist, particularly in primary care, where in the past IT systems were not put in place with a clear understanding of the standards that should apply and where requirements for the accreditation of systems have perhaps not kept pace with the need for a more considered national approach. However, we are making progress. We have established four boards that will oversee the development of standards in several key areas. There is increased recognition that, although it may not be possible to have an all-singing, all-dancing uniform information system, we can draw together what we have to make sure that communication across systems is much more effective. More resources are going to the National Health Service to allow for greater expenditure on IT.
That must be matched by local determination. As part of the process of agreeing franchise plans for the new strategic health authorities, we will examine closely the proposals that they make for information systems. We will want to see whether enough investment is being put in place and, in the large areas covered by each strategic health authority—with populations of anything up to 2 million—we will want to ensure that the whole health community is committed to a much more integrated approach.
I am sure that the noble Lord, Lord McColl of Dulwich, has suffered more than most over the years from inadequacies in the information system. I agree with him about the need for high calibre staff. In some cases, we have very good staff employed within the NHS, but we should look to private sector partners to provide the required skills.
The noble Lord, Lord McColl of Dulwich, rightly singled out the importance of GPs, generally and with regard to information. The noble Lord, Lord Jenkin of Roding, thought that our protestations of success for the NHS Net were a little wide of the mark, but we must recognise that, although there are problems with the number of different systems that GPs have brought into the NHS, many GPs are at the cutting edge of using information. We must embrace that.
I agreed with the remarks made by the noble Lord, Lord Jenkin of Roding, in the context of the speech made by my right honourable friend the Secretary of State today. I always suspected that it was not possible to micro-manage the NHS from Whitehall; after three years in the Department of Health, I know that it is not possible. That is why I welcome the statement made by the Secretary of State today. He is absolutely right that, in a more diverse National Health Service, information can often be a unifying factor. We will redouble our efforts to ensure that the kind of progress that the committee wishes to see will happen.
Data protection and confidentiality are important matters. We have debated them on several occasions in your Lordships' House. As a result of the Section 60 order, we have created a group that will be able to deal 1061 with the issues raised by the committee in its report. I listened carefully to the comments and potential criticisms that some noble Lords made about how the advisory group will operate.
I accept the comments made by my noble friends, Lord Rea and Lord Turnberg, that we must ensure that the advisory group operates in as unbureaucratic a way as possible. The Department of Health has put forward proposals for what is described as broad class support for activity—primary research activity—in which the likelihood of detriment to patients is small, the infringement of privacy is minimal, and necessary and appropriate safeguards are in place. Those proposals were developed with the help of key interests, including the Medical Research Council, and should provide a basis in law for the great majority of referral proposals that would otherwise prove difficult to get under way.
We cannot get away from the fact that there will be a certain amount of bureaucracy or administration. We will work hard to minimise that. As the noble Lord, Lord Patel, suggested, it is early days; we must see how it works in practice. However, I can confirm to the noble Lord, Lord Oxburgh, that the power provided by Section 60 extends to all those who may seek to undertake research using patient information. It is not limited to the National Health Service. I accept that a successful outcome cannot be guaranteed for research. That should in no way constrain properly conducted research. Nor should the Data Protection Act or any foreseeable use of the Section 60 mechanism have that effect.
Several comments were made about the remit of research ethics committees. My noble friend, Lord Turnberg, expressed particular concern. Research ethics committees are bound to follow Department of Health guidance, which is available in the Red Book. A new version, entitled Government arrangements for NHS Research Committees, was published in July 2001. It will come into force in April 2002. The Red Book helpfully clarifies the roles and responsibilities of research ethics committees and allows for the provision of a single, clear process for obtaining ethical approval for the secondary use of health and related data. I accept that local and multi-centre research ethics committees are overburdened, but procedures are being streamlined through the central office of research ethics committees. I can assure my noble friend that we will keep that matter under close review.
Although it has not been mentioned particularly in our debate tonight, the committee raised some concern about the patenting of gene sequences. The Government were asked to monitor patenting practices in genetics. As indicated in our response, we are in broad agreement with the findings of the committee, and we will continue to monitor developments in that important area.
The noble Lords, Lord Flowers, Lord May of Oxford, Lord Oxburgh and Lord Rea, raised several important questions about the availability of people skilled in this area. We accept the thrust of the 1062 arguments put forward by the committee. There is no doubt that there are skill shortages in bio-informatics, statistical genetics and computing science. We accept the relevant recommendation. The noble Lord, Lord McColl of Dulwich, referred to the review being undertaken by Sir Gareth Roberts of the supply of skilled scientists and engineers in the United Kingdom. I can reassure him that "next year" was next year in 2001. We expect the report in spring 2002. The review will focus on the high-level scientific and technical skills possessed by postgraduates and well qualified graduates. I understand the noble Lord's concern for speed; the Government share that concern. It will be to our everlasting advantage if we tackle skill shortages in such a crucial area once and for all.
The noble Lord, Lord Patel, challenged me to describe in some detail the Government's overall plans for genetic services. I have already referred to the speech that my right honourable friend the Secretary of State will make tomorrow. It will take the matter forward. We look forward to a Green Paper on genetics. A national network of genetic testing is being developed, with the aim of improving the quality and equity of access to genetic services for patients and their families in the United Kingdom. We are also committed to the creation of two genetic reference laboratories and to improvements to the commissioning process for genetic services through the Genetics Commissioning Advisory Group.
The noble Lord, Lord Oxburgh, referred briefly to the discussions and agreements that have been reached in relation to insurance. I do not believe that I need go into that further, but I want to take this opportunity to welcome the agreement and the terms of a new five-year moratorium.
In conclusion, I again thank the noble Lord, Lord Oxburgh, and his committee for what I believe on any count is an excellent report. It will, I am sure, continue to influence the thinking of government and other decision makers in this country. It is essential that we harness advances in human genetics in a way that is ethically based, commands the confidence of the public and, above all, brings to the people of this country the many advantages which I believe such research can give. Once again I thank noble Lords for the quality of the report and the quality of the debate.
§ 8.41 p.m.
§ Lord Oxburgh
My Lords, we have had an excellent debate and have heard some excellent speeches. I, too, congratulate my noble friend Lord May on an exceptional, eloquent, clear and insightful maiden speech, delivered with rare authority. It will be some time before we hear its like again.
There are several points on which it is worth briefly touching in conclusion. Perhaps for the purposes of clarity one should emphasise that the way in which criminal genetic databases and those set up for medical purposes are used are quite different. It was our intention that the medical data panel should have oversight only of the latter.
1063 The medical data panel would, if functioning as we intended, oversee both genetic data and general medical data. It is essential for the practical operation of research that the same body oversees both matters; otherwise the hurdles for those contemplating research work would become ridiculous.
I am most grateful to the Minister for his assurances relating to the Patient Information Advisory Group and for the other assurances that he has been able to give us. None the less, I believe that certain unease 1064 remains about the advisory group. It lacks independence of government and the moral legitimacy that a panel such as we proposed would carry. That is a pity. I understand that the group has had its first meeting and we must watch carefully how it operates. I look forward to learning the detail, of the independent supervisory body to which the Minister referred. I commend the Motion to the House.
On Question, Motion agreed to.
House adjourned at sixteen minutes before nine o'clock.