§ Motion made, and Question proposed, That this House do now adjourn.—[Derek Twigg.]
12.27 am§ Dr. Ian Gibson (Norwich, North)The research proposal called Biobank seeks to make available the DNA of 500,000 volunteers to researchers in the United Kingdom who want to investigate disease processes. It represents the concerted effort of the Medical Research Council, the Wellcome Trust and the Department of Health to apply the knowledge gained through the human genome project to concrete insights into human health and illness.
The discussion about Biobank resembles many other debates about science in general. On one side of the controversy are the enthusiasts who get carried away by their admiration for and excitement about new scientific findings. I guess that I would put myself on that side of the argument. On the other side of the divide are those who often get immensely worried about the implications that this new knowledge has for society. Hearing the word "genetics" makes them think of exploitation, commercialisation and discrimination.
It is worth while reminding ourselves of the words of my right hon. Friend the Prime Minister in his much-reviewed recent "science speech". He said:
Science is just knowledge. And knowledge can be used by evil people for evil ends. Science doesn't replace moral judgment. It just extends the context of knowledge within which moral judgments are made. It allows us to do more, but it doesn't tell us whether doing more is right or wrong.I take issue with some of the assumptions that were expressed in his speech—his blurring of science and business and his misconception of the crisis of trust—but his general insistence that scientific knowledge is not good or bad per se is spot on and right.Biobank is an example of what the Prime Minister was referring to. It will help us to increase knowledge and we, as politicians, must make sure that the framework is right for the use of this knowledge. We have to make sure that "evil people"—in the Prime Minister's terminology—cannot use it for "evil ends" or that—this is more likely—well-meaning, decent people do not end up doing damaging things because they have not done enough to think through the consequences of their actions.
The debate should be about a framework to safeguard the proper and secure use of all the new knowledge that Biobank generates. I am sure the Minister will clarify some of the thinking on the issues that I raise. I think that the Department of Health is considering them, but nothing has been decided. We need public and parliamentary dialogue on what the Department is thinking. It is putting much money into Biobank and will recruit its volunteers through GP surgeries. The findings based in Biobank will have profound implications for the national health service, and thus for the Department and all of us.
The project needs to be conducted and organised by experts, but such an important and unprecedented step must not be taken without parliamentary scrutiny and a wider public debate. Scientific knowledge, and the knowledge generated through Biobank is one example of that, is not gained in a vacuum. The insights that scientists have, and even more so their application, depend on the 366 institutional framework and the regulatory regime under which science takes place. We need to get the framework right to achieve the benefits from Biobank that we all hope for and to prevent abuses and negative consequences.
I do not have time to go through all the detailed discussions, so I shall tackle one or two of the major issues. Once Biobank is launched, GPs will recruit 500,000 volunteers aged between 45 and 69. That group has been chosen because people in it are most likely to come down with serious and/or chronic diseases. The problem with the sample is, however, that those people and their bodies are already the outcome of a complicated interaction between genetic make-up and environmental factors. If Biobank is really about investigating the genetic versus the environmental impact on health outcomes, the chosen sample will lead to dubious methodology.
The problem with taking on an older group is that we have to rely on their recollection of what risk factors they might have been exposed to. It seems dubious methodology to ask 50-year-olds what they had for dinner in their childhood or whether their mums were overweight when they were young. Similarly, relying on patient records can be difficult, especially with older records. For example, the viral infection someone had as a child might not be included in a patient's record. Some epidemiologists believe that Biobank should have tried to recruit newborns, which would lead to more problems of consent and confidentiality.
Sampling adults and using their genetic information vis à vis their patchy recollections of past behaviour and exposure to environmental risks will make it difficult to disentangle genetic and environmental factors, which will have important implications for the findings of Biobank. I think it will skew towards over-emphasising the genetic influence on disease processes because it is the only thing on which Biobank will provide hard data. Biobank will facilitate a comparison between detailed genetic data and crude environmental information, and genetic factors will probably seem more important for disease processes as their influence can be shown more clearly. That bias will have important consequences for public health policies.
If the data that flow from Biobank over-emphasise the genetic influence on health outcomes, then public health policy might over-emphasise individualised rather than population-based approaches to public health. The World Health Organisation said:
It is vital that the more conventional approaches of epidemiology and public health … continue to be pursued with vigour. This is particularly important as there are still major uncertainties about the predictive role and cost of genomics for controlling common diseases.Let us take the example of obesity. Nearly two thirds of men and more than half the women in England are overweight or obese, and obesity is continuing to rise faster here than in most other European countries. At the current rate of increase, more than one in four adults will be obese by 2010 and they will be at a higher risk of a range of major health problems, including heart disease and adult-onset diabetes. That is obviously not due to an increase in the genes responsible for obesity, but unhealthy diets and lack of exercise, problems that the Government are tackling. Too much emphasis on susceptibility genes for obesity could lead to the underlying causes of the epidemic being ignored and to the growing sale of diet or anti-cholesterol pills to the genetically susceptible instead.367 The data that flow from Biobank need to be balanced with a clear commitment to population-based public health approaches and a strong emphasis on tackling health inequalities; otherwise the genetic tests that flow from Biobank research will increase, not decrease, health inequalities. That would make most of us less, not more, healthy.
We hear that there is a crisis too in the public trust in scientific knowledge and expertise. Indeed, the Prime Minister picked up on that point in his dramatic speech. The success of research, and in particular of Biobank, greatly depends on that public trust. Trust can only stem from knowledge, transparency and democratic control. That is why it is so important that we publicly discuss and make decisions on the many legal and political implications of Biobank before we run into the first major controversy. If we have learned one thing from any of the past science scare stories, it is that we must disengage the conflict and disagreement about the direction and use of research.
We must address questions of consent, for example. What do volunteers participating in Biobank consent to? Does their consent embrace any type of research? Should the use of Biobank be limited to research into serious disease processes? Should the participants have a say in what they want their DNA sample to be used for?
There is, of course, the pressing problem of confidentiality. Is it wise to leave the collecting, encoding and researching of DNA samples in the hands of those who are keen on doing research? Should the encoding of data to render them anonymous be done by an independent third party? What about conflicting interests? Do not we need to make sure that those who approach possible volunteers do not have an interest in the research, and that those who do the research do not turn out to have commercial interests in the application of these biosciences?
That leads me to commercialisation. The founders of Biobank make it clear that no one will have exclusive access to the material stored at Biobank. But what about the findings published through the research? Will companies be able to apply for patents? Do volunteers know that their DNA might lead to a patent? Several models could be used. Companies could be charged for using Biobank and then they could keep whatever money they might make on the basis of Biobank; or companies could not be charged, or they could be charged less, and Biobank would get a share of whatever profits are generated on the basis of its resources. If Biobank got a share of people's profits, it might lose its independence and have a vested interest in a certain type of commercially targeted research.
Either way, private companies will certainly try to capitalise on the knowledge established through Biobank. The likely outcome of the research, at least in some cases, will be the development of drugs or tests for individuals with certain genetic problems. Again, that has public health and cost implications. The NHS has to decide whether to make those new technologies available.
The current set-up of Biobank means that the NHS will be bounced into focusing on new health technologies rather than on public health messages that might come from such a large-scale study. The notion of knowledge transfer must not only apply to commercially applicable bits of genetic information, but must be used in a 368 politically intelligent way. Knowledge established through Biobank must lead not only to patents and drugs, but to better health policies.
To address all those problems, we need to establish a solid and trusted framework of regulation, control and ownership of Biobank. So far we have learned from the three funding partners of Biobank—the MRC, the Wellcome Trust and the Department of Health—that there will be an independent oversight body that will steer and control the use of Biobank as a resource for researchers in the UK. I cannot stress enough how important it is that we get that structure right.
One thing has to be clear from the outset: we will not be able to establish trust behind closed doors. The discussions about the design of Biobank have to come out of the closet and into the open. We need an open-ended, democratic debate about how to conduct this research and about how to make it safe. That may include strict rules about what to do when things go wrong. What if a leak occurs and highly personal data end up in places where they should not? We need methods of redress and clear accountability structures. We may also need legal protection against genetic discrimination. That may be particularly important if Biobank is a pilot project for a national genetic database or an NHS-wide patient records system.
The participants in Biobank should have a high degree of ownership over the project. There could be participants' panels, probably at each of the regional centres. The panels should be independent of parties that have an interest in performing the research, and of the funding bodies for Biobank. They could make decisions about general guidelines and individual research proposals, and investigate consent procedures and secure the confidentiality of all those concerned. There should be an overall majority of so-called lay people, or at least people without vested interests, on that oversight body.
To some extent, that would mean that the Wellcome Trust and other bodies that finance the research would have to let go. If that happened, Biobank could become a model for regulation and participation in medical research. So far, the Department of Health has not come clean about those issues, but if we do not get the framework right, there will be no benefit to science, the project could be harmed, and the relationship between science and the public could be ruined even further. We can do better than that, and I hope that the Minister will not duck the issues. He must start to engage with Parliament and the wider public and tell us how we will take forward what I believe will be an exciting piece of research.
§ The Minister of State, Department of Health (Mr. John Hutton)I am grateful to my hon. Friend the Member for Norwich, North (Dr. Gibson) for giving me the opportunity to confirm the Government's commitment to the UK Biobank project and answer the important points that he has raised during this short debate. He has extensive knowledge of the issues raised by the research project, and he has demonstrated that expertise very ably and effectively tonight.
My hon. Friend has asked specific questions and thrown down the gauntlet to the Department of Health and the Government over the conduct of the project, which, 369 as he says, has tremendous potential to benefit millions of people in this country and elsewhere. I strongly agree with his overall argument about openness and transparency: that is precisely how we want to conduct the project. I agree absolutely that Biobank must be used intelligently and in a politically intelligent way: it will be. Furthermore, I agree that, in general terms, science must be the servant of society and never its master. That dictum clearly applies to Biobank and its potential.
My hon. Friend has accurately explained many of the details of the project and I do not intend to go over them again. Biobank is a flagship project for the UK. As I am sure he understands, it will take time and significant investment before the potential benefits are realised, but I have absolutely no doubt that the project is in a crucial area of research that holds out the prospect of real advances in medical science. Many devastating disorders including heart disease, cancer, diabetes and Alzheimer's disease are caused by complex interactions between genes, environment and lifestyle. Information from the Biobank study could ultimately lead to improved diagnosis, treatment and prevention strategies for those disorders, thus benefiting millions of people in the UK and around the world.
The UK Biobank project is to be jointly funded by the Department of Health, the Medical Research Council and the Wellcome Trust. The initial cost of the project will be £45 million, of which more than half will be provided by the Government. Biobank is a major scientific research programme. For the reasons spelled out by my hon. Friend, it is probably one of the most exciting and potentially significant projects to be commenced in the UK for many years.
The project itself has been through a long planning process which started in 1998; the final funding decisions were taken in April this year. I accept that the process has been lengthy, but that is in large part due to the number of necessary consultations undertaken with both the scientific community who will use the resource and the general public. I understand from his arguments that my hon. Friend is generally in favour of such consultation. I hope that the process followed will help to establish a consensus on the future direction of the project. Such a consensus is important and will be of genuine benefit to the research project as a whole. None the less, concerns have rightly and properly been expressed about the project by several organisations, as well as by my hon. Friend tonight. I assure him that the Government will continue to work positively to address those concerns.
My hon. Friend raised concerns about the project design and methodology, and in particular about the selection criteria for volunteers. He asked that a clear framework for the project should be worked out in consultation with all the experts. I can tell him that that has been done. A committee of experts under the chairmanship of Professor Tom Meade produced the final project protocol, which was made widely available to the scientific community for it to comment on during its development. The protocol was then extensively and independently reviewed by a number of international experts—not politicians—some of whom were from abroad, but all of whom had no prior involvement in the development of the protocol. That peer group judged the 370 protocol to be strong and scientifically sound. The protocol has been published on the Medical Research Council website at www.mrc.ac.uk
My hon. Friend asked for clear leadership from the Department of Health in taking the project forward. I can certainly confirm that that will be provided. The Department of Health has been actively engaged in the creation of the UK Biobank and in shaping its programme. We will also maintain general management oversight of the project as one of its key hinders.
There are at least two areas in which we have a major interest. They relate to the concerns already mentioned by my hon. Friend regarding the need to protect people who provide DNA samples and to maintain the public's confidence in the project itself. As he said, recruitment to the Biobank will be co-ordinated mainly through GP practices and, as he knows, it will be entirely voluntary. Participants will be free to withdraw from the study at any time. If a person wants to withdraw from the research programme, all their personal information and samples will be removed from the database.
I should like to make one point very clear to my hon. Friend. The Biobank will be used for research purposes only. Any data released to research workers will be properly anonymised and free of any identifiable markers. The Biobank will operate according to the relevant ethical and legal guidelines regarding the use of human tissue, biological samples and genetic information. It will also operate in accordance with the Human Rights Act 1998, the Data Protection Act 1998 and the Council of Europe's recommendations on the protection of medical data.
Those are important safeguards, but security and confidentiality of data are key issues that are rightly a matter of continuing concern. The Human Genetics Commission, the Government's independent advisory body on human genetics, has rightly taken a close interest in the project and has indicated that it will continue to do so. We welcome its continued involvement. As my hon. Friend will be aware, the commission has recently undertaken an investigation into the use of personal genetic information and how security and confidentiality of data held within databases can be properly maintained. It recommended that genetic research databases that are established for health research should not be used for any purpose other than that research, and also that that should be put beyond doubt, by legislation if necessary. The Government are considering very carefully the implications of that recommendation and will respond later this year.
Providing independent oversight of the project by a trusted third party offers a further way not only of providing protection for people taking part in the study, but of gaining the public's trust in the project. An organisation that has a clear legal identity will be needed to achieve that. The current thinking is that that should be provided through the creation of a new limited company with a power of veto over the research conducted using the Biobank resource that is enshrined in its articles of association and incorporation. I agree with my hon. Friend that the chairman of the board will need to be someone who can command the public's full trust and confidence. It is planned to appoint the chairman and all other board members in a transparent way using the full Nolan procedures and principles.
371 My hon. Friend asked about the role of the proposed monitoring body. It will be responsible for the development, application and monitoring of policies on access to data and samples, in accordance with the consent obtained from the participants. It will also be responsible for ensuring that the samples and data are all held securely and that all procedures to protect confidentiality are strictly adhered to. It will not provide ethical review of the initiative or its constituent projects, as that will be done through the system provided by multi-centre research ethics committees. Equally, it will not scrutinise the scientific quality of the research that is being undertaken, as that will be the remit of a separate scientific management committee. The monitoring body will exist solely to represent and protect the interests of the participants and the general public. We perceive its independence, authority and credibility as crucial to the success of the Biobank. We place the highest importance on that success.
The more general management of the project will involve creating a separate organisation responsible for establishing and using the database. Like the monitoring body, that organisation will need to have a separate legal identity and will again be incorporated as a company limited by guarantee. It will control the operation of the regionally distributed groups that will be recruited to collect the baseline dataset from participants and carry out the initial processing of blood samples.
The ability efficiently to link a participant's medical records with genetic and lifestyle data is clearly an important part of the study. That will necessitate developing both the infrastructure and the methodology needed to obtain access to NHS records. I acknowledge that that will be a significant challenge, and we do not underestimate it.
The information technology requirements for the UK Biobank will need to be fully integrated into the overall NHS information systems that are being developed. The method for doing that has not been finalised but the Biobank project offers an opportunity to pilot new methodologies whereby valuable clinical data held by the NHS in patient records can be utilised effectively to support wider, essential public health research.
My hon. Friend asked for a full public and parliamentary debate to discuss the issues raised by the UK Biobank project. As he would acknowledge, that is a matter for others to determine, but of course it is proper for Parliament to consider the issue. Ministers and officials in the Department of Health would want to play a full and positive role in such a process. However, two public consultation exercises on the project have already taken place. One was conducted in 2000 by Cragg Ross 372 Dawson, and the other earlier this year by People Science and Policy Ltd. Again, I refer my hon. Friend to the Medical Research Council's website, where those documents have been published. I am sure that he has already seen them. I assure him that other consultations will be held as the project develops.
The project's success ultimately depends on the good will of the participants. That can be achieved only if there are opportunities, such as tonight, openly to debate the project and the many issues that it raises. As I said, my Department will continue to encourage that.
The benefits of the UK Biobank need to be set out clearly and unequivocally to ensure that public acceptability and confidence in the study is maintained. We need to be especially clear that it is not a big brother exercise. Nothing could be further from the truth. The study will help facilitate the translation of the new genetic knowledge into new ways of preventing and treating common illnesses. As my hon. Friend said, the benefits to individuals and society are clear. They are potentially enormous. We therefore have a precious opportunity to advance our understanding of illness and disease, and we must take full advantage of it. We intend to do that. We shall not squander that unique opportunity.
As I said earlier, we are considering a long-term research project, and there will be no instant results. Participants will gift their samples and data for the benefit of future generations, not necessarily their own.
We know that the research supported via the Biobank project will help us better to understand the causes of many common diseases that have such a devastating effect on our society. They include cancer, heart disease and stroke. That will lead, in turn, to the development of better, more effective, treatments and, more important, to the identification of methods of prevention. There is enormous potential to improve the health and quality of life of every member of our society. That is why we must rise to the challenges and the opportunities before us.
In summary, the Government welcome the creation of the UK Biobank and are committed to its success. I believe that adequate safeguards are being built into the project to ensure the maintenance of public trust and confidence. There will be further debate and consultation on the project as it develops, and adequate independent oversight from the start. As I said, it is an important flagship project, which will establish the UK as a world leader in translating advances in genetic research into real benefits for health.
§ Question put and agreed to.
§ Adjourned accordingly at seven minutes to One o'clock.