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The second political point-with a small "p"-is not quite as direct to the Minister, but a request to him to carry a message back. A measure of the impact of the report of the Science and Technology Select Committee is to be found, first, in this volume of evidence, and, secondly, in the subsequent reports from those who gave evidence in the first place in response to the Government's reply. This is a measure of the impact of the importance of this committee. It is an impact which goes far beyond this Chamber. Will the Minister draw this to the attention of those who are charged with making proposals for the reform of the House of Lords? An elected House, which would have no room for the calibre of scientific expertise and wider scientific engagement which this committee attracts, would be a much impoverished House. That point needs to be before those who are to think about the future shape of this House.

However, perhaps I may slightly deviate from my noble friend Lord Patel, who expressed his disappointment eloquently on the government response. That was a relative disappointment: I simply have to add that if noble Lords had seen some of the government responses that I have seen over the years, this is pretty good. At least there are some proposals which suggest that the previous Government were interested in moving forward in this area, which are to be welcomed. The fact that there is a good, considered government response, although it does not agree on all points, is a civilised way of advancing debate on this important and complex topic. I shall come to this issue shortly.

As other speakers have indicated, I should like to say a word first on the broader context which we inhabit. In scientific terms, the context is one of significant scientific advance in this country and elsewhere. There are fruits to be cropped here of huge significance; namely, medically, the health of the nation, commercially for the economic health of the nation and so on. These advances give us the capacity over time to extend the range of medical treatments and the good health of the nation. It should be noted that most of the advances proposed in this report are potentially part of that holy grail of preventive medicine-that after which we all seek and strive, but to which we seldom pay sufficient attention. Preventive medicine is to be preferred to the

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rather more expensive remedial alternative. Again, this report gives a direction of travel if we are to make the most of that. That is the scientific context.

The economic context is well expressed in the perhaps ill judged joke-"Sorry there's no money left". However, the truth of this is evident to all of us-we are in times of severe financial constraint. That constraint allows various responses. One response is special pleading on our part and I have no doubt that there will be a fair bit of that. There will be special pleading to say that this is important, and it is, but that is not the direction I wish to follow now. A second response is to cut and slash percentagewise across the board, which would be ill considered in this area. Let us be strategic in our thinking.

There are other responses, but the third, on which I want to focus, is that this constraint gives us an opportunity to consider future strategies in some detail. I hesitate to go so far as to say that this is the silver lining in the financial clouds, which would be rather overoptimistic, but there is the possibility of taking time for careful, calm and deliberative thought. We can be sure, for example, that no ambitious Minister will be ready to make his or her name with a promise of high-profile, short-term spending which has not been properly evidenced or evaluated, as we had before the election with suggestions around the House for spending on the long-term care of groups within the community-political stunts that did not bear discussion. We are absolved from the likelihood of that because of the financial picture within which we live. A time of financial retrenchment is a time when the backroom engine should be devoted to long-term planning and priority setting. It is not necessarily a time to say, "Let's not discuss this, we can't afford it". It is a time to think through to the future when we hope we will be in better times.

In this spirit I warmly welcome the previous Government's pre-election proposal to create a human genomics strategy group. I know that we wanted a White Paper-it would be good to have that too-but I see the potential value of such a group. Does this proposal have the support of the coalition Government? If not, why not? Perhaps I may be optimistic. If it does, might we first work on the remit and the membership of such a strategy group? There could be a very good starting point in asking the group chaired by my noble friend Lord Patel to give advice to the Government on what such a remit should be. It is not easy and completely obvious how best we should advance on this. My view is that the remit should not simply be confined to questions of a scientific, medical and technical nature-they should be central but not exclusive. I shall supplement my own suggestions on these issues by referring to the work of Generation Scotland, whose advisory board I have the privilege of chairing. Generation Scotland has a significant presence at my noble friend Lord Patel's university, Dundee. It works in consort with the other Scottish universities with medical schools-Aberdeen, Edinburgh and Glasgow-and alongside the National Health Service for Scotland.

The intention is to build a database, which is complementary to the UK Biobank, but different in important respects. Largely through general practices in Dundee, Aberdeen and Glasgow, so far more than

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15,000 families-I stress "families"-have been recruited to this study, which amounts to more than 70,000 individuals. Through genetic screening a picture is being built up of the correlation between family genetic inheritance and the medical histories of those families. It puts on to an evidential scientific basis the information that, informally and tentatively, a GP tries to piece together by asking when your parents died and, if you know, why they died. This is a scientific approach to providing data that will correlate genetic inheritance with perceived and actual illness patterns within families. The potential benefits are huge both for knowledge and for treatment.

So much for the example now happening in Scotland, and I draw on that, but what is its relevance to the proposed human genomic strategy group? One central conclusion I have drawn is that the oversight of such matters requires more than technical and scientific expertise. Certainly these are both central and essential, but a whole penumbra of related questions arise that may require much more than simply expertise in the scientific and technical context. They are issues of commercial exploitation-already referred to-of data sharing; of ethical principles and informed consent in relation to data sharing; and issues around the future shape of healthcare and the appropriate training and manpower needs that will arise as a result. There is a temptation to shunt all of these off to specialist committees, but it is too early to do that. A human genomic strategy group should be charged with recommendations not simply for the short term-tomorrow-but for the next decade and the decade after that. The issues of science, healthcare, commercial exploitation, ethics and regulation all bear on each other and would benefit, at least initially, from being considered in the round rather than by competing specialist committees that can easily become policy silos. In passing, I have to say that the sceptic in me does not think that there is such a thing as, for example, an ethical expert. There are experts who can aid ethical discussion, but ethics is a matter for the wider community and should not be shunted off to be considered by a separate body absent from those who know about the technology.

That is why I believe that the human genomic strategy board, if it is set up, would have important work to do and why its remit and membership should be a matter of careful discussion and decision-making. Since we cannot afford initially to commit hugely significant sums of money, we have the opportunity for thoughtfulness through this mechanism. I look forward to the Government's response to this suggestion.

8.02 pm

The Lord Bishop of Newcastle: My Lords, I, too, am pleased to have the chance to contribute to this debate and I want to thank the noble Lord, Lord Patel, and his colleagues for the excellent work set out in this report. I am pleased to be here not only because of the importance of the rapid advances in genomic medicine in recent years, but also because it enables me to pay tribute to some of the groundbreaking work that is being undertaken in my home city of Newcastle upon Tyne at the university, in the Centre for Life and in our NHS hospitals.



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The links between genetic make-up and the diseases that afflict us are clearly established and I for one, as a non-specialist, am becoming much more aware of the possibilities that advances in molecular genetics seem to offer for the understanding, prevention and treatment of a wide range of complex diseases. I am aware of the advances that are being made so rapidly despite the very considerable complexities involved. I am also aware of Professor Sir John Burn and his work in identifying people with the gene that causes an inherited form of colorectal cancer, and of the clinical trials to test aspirin and a form of starch as inhibitors of the disease. That opens up the possibility of using simple food additives to prevent the development of that particular type of cancer.

Another area of research in Newcastle has been into a degenerative brain disease which it was previously assumed was a form of Parkinson's or Huntingdon's disease. Only by studying in great detail the individual genetic make-up of a large family was it possible to determine the cause of the disease and identify the genetic markers for it. Other research at the Centre for Life in Newcastle has involved the use of highly sophisticated genetic analyses of a large number of families to identify how genetic variability between individuals contributes to the risk of developing cardiovascular disease both in childhood and adulthood. None of those would have been possible without the DNA technologies that have been developed in the past 20 years, and I cannot help but wonder what the next 20 years will bring.

The advances in our understanding have been little short of extraordinary in the first years of this century, and rightly these advances have given rise to much excitement and enthusiasm. But they also give rise to a number of important issues which are addressed in this helpful report, so I will make a few points about some of the recommendations. First, I turn to the recommendation that the Office for the Strategic Coordination of Health Research should be tasked to,

That is a really good recommendation, but in the current climate of the culling of quangos, it is necessary to ensure that this body or any other is adequately funded for that purpose. Money spent on getting the strategic vision right is likely to save many times that amount in both waste and application in the absence of such a strategy.

The report also recognises the variety of stakeholders and institutions that are already active in the field of genomic research. It is essential for the public good that we,

and the NHS-

The first part of that task will be much more easily achieved than the second, but barriers to collaboration will have to be overcome. The recommendations that identify the changes required to incorporate genomic medicine into mainstream NHS are good, but they,

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too, inevitably will require an increase in personnel and resources if we are to obtain the best possible outcomes.

For genomic medicine to achieve optimum effect, it is important that a large database is established which is reflective of the population of the United Kingdom. Individuals agreeing to their genetic information being stored and used for research purposes must, of course, give their informed consent. Since, however, the potential uses to which their genetic information may be put are impossible to identify, unless the consent agreement is restricted to immediate and specific research, that raises a number of key questions. How informed is an individual's consent if he or she does not know how the information is to be used? Is it right to ask for broad or blanket consent unless the individual is aware of the range of possible research projects? For example, information may be used to help research into cancer treatment, but it may also be used to aid antenatal diagnosis of disease that may provide the basis for an abortion. While some people may not have a problem with this, others most certainly will. And yet, at the same time, to restrict consent to certain types of research programmes may be overly prescriptive and impractical to police. We need a fuller debate in this area.

The report goes on to suggest that it is not necessary to introduce legislation to ban genetic discrimination. I remain to be convinced about this because if discrimination is rightly banned on the grounds of race, gender, disability or sexual orientation, then why not here? It would be possible for an employer to seek genetic information on current or future employees and then to make employment decisions based on that information. Can that be right? For people who have, for example, the gene for familial colorectal cancer or a gene which contributes to the likelihood of developing cardiovascular disease, this could lead to employers not wanting to employ-or certainly not wanting to invest in the training of-people who have those genes. Each of the genes would give a different risk of developing the disease and, in one case, there is a lifestyle contributory factor too. Would an employer be able to distinguish between some of the subtleties and the nuances? Surely it is too complex an area not to regulate through legislation.

Similarly, the recommendation that companies supplying direct-to-consumer tests should self-regulate rather than be subject to statutory regulation is highly questionable. Self-regulation has already been found wanting in other areas of public life; what leads us to think that commercial companies would be any good at it here? The potential for misinformation is too great to be left to companies, whose main aim, after all, is to make a profit.

When the first draft of the human genome was published in 2000, President Clinton described it as,

and Prime Minister Tony Blair hailed it as a,

While of course, as we have heard, some genetic sequencing still remains to be completed, the past 10 years suggest that Clinton and Blair were not overengaging in hype. That is why I welcome the

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report. Although I am not sure about all the recommendations within it, it is an important step as we embark on the next stage of the exciting developments in genomic medicine.

8.12 pm

Baroness Finlay of Llandaff: My Lords, I was fortunate enough to be co-opted on to the inquiry and it has been a great privilege to work alongside so many people from a scientific background, many of whom sit on our Cross Benches. I congratulate my noble friend Lord Patel on his chairing of the committee and on his splendid introduction today.

I wish to speak about stratified or personalised medicine, the area of genomic medicine predicted to hold great potential for healthcare in the near term. It entails matching treatments to specific patients using clinical biomarkers to target treatments effectively by taking account of patient susceptibility to particular drugs or to adverse drug reactions. The Royal College of Pathologists told us that it anticipates that DNA and RNA-based diagnostic approaches,

However, doing the test is not enough; it is the clinical context that is crucial. Therefore any thoughts that over-the-counter tests could move things out of the clinical arena are misplaced. Tests can be misleading at best-but they can be worse than that if they are not conducted in a proper clinical context.

My noble friend Lord Patel has already spoken about the cancer treatments that have emerged indicating a likelihood of a response to drugs, particularly Herceptin and Iressa in breast and lung cancer respectively. It is worth noting that such testing has increased about threefold in the past two years.

However, there are problems surrounding, in general, the translation of research on pharmacogenetic tests into applications. At present there is little incentive for the pharmaceutical industry to develop the genomic tests because the business model relies on the consumption of a product-a rather blockbuster approach-to ensure a return on the substantial R&D investment which is needed to bring a drug to the market. However, stratified medicine targets a much smaller patient group and requires the development of accompanying tests, and these tests must be developed in parallel with the therapy itself.

Professor Sir John Bell suggested that,

One reason for this was that diagnostic companies could not be relied on,

This was because,

We therefore recommended flexible pricing models for therapies that rely on the use of pharmacogenetic tests, the protection of intellectual property and the

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concurrent development and authorisation processes for therapies and diagnostic tests that will assess the clinical utility and validity of genetic and genomic tests within the NHS.

The previous Government's response stated that the Department of Health had commissioned NICE to develop and manage a single evaluation pathway specifically for diagnostic technologies, with a pilot scheme due to report this summer. A new committee within NICE should ensure health technology assessments look at the clinical utility and validity of diagnostic tests. Can the Minister assure us that these developments are still on course? Can he clarify how the proposed value-based pricing system will allow targeted treatments to be more available, even if at a local level commissioning decisions do not support the necessary infrastructure? There may be a potential tension here between central promises and local sovereignty in decision-making.

This is particularly important when evaluating diagnostic tests. These are inherently more complex to evaluate and yet the funds for doing so are relatively trivial. Commissioners do not know when to invest in expensive testing equipment if its utility and validity has not been assessed, and so silo budgeting acts as a barrier to capital investments, leading to a postcode lottery in diagnostics. Decisions need to be made at a national strategic level, not locally, and it is essential that clinical genetics departments are supported. They should be linked and pivotal to informing studies into the whole commissioning process. Can the Minister confirm that the Department for Business, Innovation and Skills is working with the Department of Health to ensure that intellectual property systems and management of intellectual property rights support diagnostic test development, evaluation and rollout as we recommended?

The research community is collaborating to realise the potential of the NHS for the benefit of all. The network of hospitals in the NHS is ideally placed to link with research bodies. Indeed, the funding bodies are doing just that. This year Cancer Research UK will begin to establish a network of NHS centres using similar genetic techniques to guide treatment decisions. It will be the precursor to treating every NHS cancer patient in a similar way, perhaps in as little as five years. However, other genetic tests have not been integrated properly into healthcare. Our committee heard of the patchiness of testing, as has already been alluded to, for conditions such as diabetes.

There is a lack of clarity over funding streams for the use of such tests as part of treatments within non-genetic specialties, and there are inconsistencies in the ordering of such tests during consultations. As I have said, doing the test alone is not enough; it is the clinical context that is key. Genetic testing is usually in the genetics department's budget and so is not necessarily more widely available. The cost of testing is increased if the patient has to be referred to be seen in genetics rather than a treating clinician taking responsibility for the whole process. Meanwhile, genetics departments are increasingly taken up with the delineation of single gene disorders as a subset of common complex disorders, and with the co-ordination of care for those with single gene, multi-system complex disease. Genetics departments are already facing potential overload.



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To ensure better use of drugs we need a red flag system of automated warnings rolled out to ensure that appropriate tests happen routinely. This will result in a cost saving through stopping inappropriate prescribing and inappropriate testing and avoid adverse reactions.

The area that concerns me most of all is the failure of the Human Tissue Act to promote single gene testing for single gene sudden death disorders that mean that many young lives are lost. For more than 20 years we have been able to perform gene testing in the family and make an early diagnosis in the family of a risk of sudden cardiac death. NICE recommended the testing but at a clinical level it is not readily available.

One problem is that there is no clear definition at post-mortem of "retention" for tissue samples, so, whether or not anything is seen macroscopically, samples are not always sent for DNA testing. If the family is not integrally linked into the process, samples can fall between pathology, genetics and the coroners system, and a diagnostic opportunity for others in the family can be lost. Will the Minister assure me that we will look urgently at this matter so that all patients who die of suspected sudden cardiac death will have tissue removed post-mortem for comprehensive DNA analysis? That will be linked to genetic support. Such testing should be for multiple genes, because it will save lives.

The UK Genetic Testing Network is meant to be undertaking a review of service provision within the NHS to inform a consistent approach for single-gene disorders and single-gene subtypes of common disorders. Does the Minister know when we can expect the Government's comprehensive assessment of this? I realise that it is difficult for a Government who have only just taken over something already in progress.

An extension of genomic medicine is epigenetics; that is, changes in the gene expression caused by mechanisms other than a change in the underlying DNA. The molecular basis of these changes is related to the packaging proteins known collectively as chromatin. The changes are not encoded in the genome sequence so are not generally passed from generation to generation. We are seeing ever more examples of underlying genetic links, such as the link with addiction, where it seems that the serotonin and dopamine in the brain's reward systems may be linked in some people when other factors come into play with developing addictions. However, it does not mean that everybody with that piece of genetic code will necessarily become an addict.

Understanding these developments provides a "fantastic window" on different types of common diseases, but genetic counselling and genetic support are key if we are going to use any advances appropriately. I must declare an interest: I am at Cardiff University, which has one of only two established MSc courses in genetic counselling in the UK. It is well on its way to becoming an independent discipline.

We need to ensure that genetic testing and services are supported today to ensure that developments are used to best advantage when they appear tomorrow.


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