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8.23 pm

Lord Colwyn: My Lords, I, too, thank the noble Lord, Lord Patel, for his effective chairing of this committee. I thank Professor Tim Aitman for his

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professional guidance and acknowledge the hard work of Christine Salmon Percival, Rachel Newton, Elisa Rubio, Cathleen Schulte and Cerise Burnett-Stuart. I also congratulate the noble Lord, Lord Winston, a member of our committee, on his guest appearance on the Front Bench.

This report has been described as a,

I have been almost overwhelmed by the hundreds of documents and complexity of the information, but I am proud to have been associated with this inquiry into genomic medicine.

Ethical questions now need public discussion. I realise that any reference to "Government response" refers to the previous Administration and very much look forward to hearing my noble friend the Minister's views on behalf of the new Government.

It seems likely that, in a few years, many babies will have their genetic code mapped at birth. One reading taken from a tiny drop of blood, as with the test for cystic fibrosis, will produce the single unit of heredity responsible for how we develop, grow, live and die. This will herald a new approach to medicine, where conditions such as diabetes and heart disease can be predicted and prevented. By examining inherited genetic variants, it is possible to identify raised risks of many conditions. Those at high risk can be screened more regularly and given advice and drugs to lower their chances of becoming ill.

This personalised medicine signals an enormous advance, revealing who is at risk, who will respond best to particular drugs and who will suffer the side effects of various treatments. These findings could lead to, for example, a genetic test of breast cancers to help doctors choose the right treatment for an individual patient, avoiding the current trial-and-error approach that in some cases exposes patients to the toxic side effects of a cancer drug that is destined to be ineffective.

The risks and social challenges posed by genetic tests and other health services sold direct to consumers have prompted various inquiries into personalised medicine. While DNA screens, personal MRI scans and internet advice services that bypass GPs have the potential to empower patients and encourage people to take greater responsibility for their health, they also have drawbacks. Genetic profiling services which screen DNA variations for links to disease traits are marketed as a way of identifying health risks that might be reduced by lifestyle changes or medical treatment. Companies sell products over the internet for a wide range of fees and many require no genetic counselling or medical supervision. Some tests have been criticised for delivering potentially misleading, unreliable or inconsistent results. There is not yet any evidence of real health benefits. The Select Committee made recommendations on the evaluation and regulation of genomic tests within and outside the NHS. The Government response to this, and to Peter Furness's advice that the evaluation of diagnostic tests is inherently more complex and difficult than for therapeutic interventions, is vague.



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The health service needs increasingly to involve the expertise of its laboratory scientists to turn a growing understanding of the human genome into better patient care. Training for NHS scientists should provide a broader grounding in genetics and equip scientists to be able to advise hospital doctors on which DNA tests might be appropriate and how to interpret the results. As part of this process, scientists may attend consultations between doctors and patients. They may play a key role, explaining to patients what the results are showing and working together as a team.

There were plans to trial a pilot scheme in the West Midlands last October before consideration of a national scheme. It was designed to help the NHS adapt to the rapid advances in genetics which could change the way that medicine is practised. As noble Lords will have heard, it is predicted that it may be possible to sequence a patient's genome for £1,000 or less in the next two or three years, which may help doctors to provide care tailored to individual genetic profiles. The Select Committee believes that these developments require urgent reforms to NHS training and infrastructure.

Last year, there were many examples of the benefits of genetic screening tests. The first baby was born who had been screened to ensure that it was free of the breast cancer gene carried by a parent. At least 8 per cent of breast cancer cases are caused by specific genetic mutations. Identifying the rogue genes, BRCA1 and BRCA2, before the onset of disease will give people the chance to lead a lifestyle that minimises the chances of disease taking hold. Women with these defective genes are seven times more likely to develop breast cancer than those without the mutations. Faulty genes are responsible for between 5 per cent and 10 per cent of the 44,000 cases of breast cancer that occur in Britain each year.

As the noble Baroness, Lady Finlay, said, more personalised care has been promised following the discovery of a genetic signature that can determine whether breast cancer is likely to respond to common treatment. This allows doctors to predict which types of chemotherapy are most likely to benefit patients, sparing them some of the more toxic and unpleasant regimes that are unlikely to work.

The complete genetic codes of various cancers are being mapped. This information will transform treatment of the disease and has been described as the most significant milestone in cancer research in more than a decade. It is predicted that by 2020 all cancer patients will have their tumours analysed to find the genetic defects that cause them, with the information being used to select the appropriate treatments.

The Government agreed with the committee's recommendation that the Department of Health, via NICE, instigate a programme for the evaluation of validity, utility and cost benefits of all new genomic tests for common diseases, including pharmacogenetic tests.

A genetic screening test could more than double the chances of pregnancy for women who undergo fertility treatment. A trial last year found that two out of three women having IVF became pregnant if their embryos were checked for abnormalities before being implanted,

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compared with less than one-third when the test was not used. The technique known as comparative genomic hybridisation checks chromosomes in the developing embryo and ensures that only those embryos with the best chance of becoming a healthy baby are used in fertility treatment.

The role of genetics in insurance has emerged as a controversial issue, with the development of increasingly reliable tests for DNA mutations and variations that are linked to disease. The possibility of an ability to sequence entire genomes at a reasonable cost within a few years and the widespread use of this test could open a new personalised approach to medicine in which diseases can be predicted and prevented, but the same data could be used by insurers to raise premiums for those whose genomes suggest an increased risk of illness, which could be a disincentive for taking tests.

The Association of British Insurers has placed a moratorium on genetic testing until 2014, with a revision due in 2011, the only exception being the Huntington's predictive test whereby companies can demand test results for life policies worth more than £500,000 and health cover above £300,000. Privacy campaigners and some scientists have called for this to be hardened into legislation along the lines of the Genetic Information Nondiscrimination Act passed by the US in 2008. One issue that the Government response did not address was the committee's recommendation that Government should negotiate with the ABI a new clause in the code of practice, moratorium and concordat on genetic testing and insurance that prevents insurers asking for the results of genetic tests which were carried out while the moratorium was in place. The committee said,

Some insurers have suggested that customers who take personal DNA tests may pay lower premiums because the results encourage a healthier lifestyle and that people who take genetic screening are likely to act on the results and therefore present a much better risk profile. Insurers may reflect this in premiums regardless of whether results are disclosed.

Currently, genetic susceptibility has reached a stage where only careful experimentation will provide the information needed to show whether testing should become part of the accepted standard of care. There is a danger of widespread testing without sufficient background information and the development of a market where products are not related to public health priorities and without benefit to the individuals and populations in greatest need.

In conclusion, having successfully managed to cut my speech from 28 minutes to l4-and now to 10-I thank the many experts and organisations who gave evidence to this fascinating inquiry. I think that it has made a significant contribution to improved health in the future. I hope that my noble friend will be able to indicate how this can be taken forward.

8.33 pm

Lord Warner: My Lords, I begin by saying what a privilege it was to serve on this inquiry, which was so skilfully chaired by the noble Lord, Lord Patel. We

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owe him a great deal of gratitude for ensuring the presence of scientific stars of a positive World Cup standard, who appeared before us to give evidence that helped to inform our report. I also look forward to the appearance of my noble friend Lord Winston on the Front Bench. I wish only that the Labour Party had thought of the idea of guest spokesmen on the Front Bench when I was a Minister. I thank Tim Aitman and wish him a happy birthday and thank all the clerks' office staff for the work that they put in.

This was an important report for the NHS and patients. It is based on extensive evidence-gathering. As a committee, we were fully seized of the state of the public finances, and we went to some trouble not to produce a wish-list of things to please scientists and damage the Government's finances further. We have been hard-headed in the recommendations we have made, with a strong focus on things that will benefit patients. What is, however, clear is that in the world of genomic medicine things will not stand still but will change at a rapid pace whatever a UK Government do about this report. It looks as though linking therapies for identifiable individuals with common diseases is progressing very rapidly, and we cannot ignore, as the noble Lord, Lord Taverne, said, the speed of that progress.

The UK has traditionally been a world leader in the field of genetics and we were told consistently that it has punched above its weight in genomic research. That was reflected in the 2003 White Paper that I was involved in as the responsible Health Minister. The world moves on, with many advances overseas, especially in the US and China, but the UK still has a major advantage if we choose to use it wisely-a National Health Service, with universal population coverage and health data. This provides a strong scope for population-based approaches to early diagnosis of diseases and targeted personal drug therapies. Moreover, the cost of burgeoning genetic knowledge is falling rapidly, as the noble Lord, Lord Patel, described so well.

The pace of change presents serious challenges to government and the NHS. To be honest, I found the previous Government's response to our report disappointing and, if I may say so, in some respects slightly complacent. I note that respected bodies such as the Wellcome Trust, and others, were also disappointed in that response. Too much of it looked back to what the Government had done rather than forward to what the Government and the NHS needed to do, given the pace of change. I can see that there could be a case for setting up a Human Genomics Strategy Group, which seems to be the cornerstone of the previous Government's response, but my fear is that this will be a poorly resourced talking shop with no clear mission statement and without the authority to drive change. For me, the unwillingness to produce a new White Paper that looks ahead for five to 10 years and sets out a new agenda for genomics within an NHS context is a sign of the Department of Health's reluctance to define and drive a new agenda through a HGSG or alternative machinery. After so many years around government, I have developed an expertise in recognising bureaucratic inertia, which is what this could be interpreted as. So my first question to the Minister is whether he and his colleagues in the new

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Government are willing to revisit the issue of producing a forward-looking White Paper and creating a more sharply defined machinery for driving forward a new agenda in this area. That would be totally consistent with the efficiency and quality agenda for the NHS that the new Government wish to produce.

I shall confine myself to a few specific issues on the other points in the report around the translation of this new knowledge into patient benefit. The NHS in my experience has a mixed track record in translating discoveries from the lab to the bedside. There are four of these translation aspects in the report that I have concerns about. The first is extending the remit of NICE to evaluate validity, utility and cost-benefits of genomic tests for common diseases. The noble Baroness, Lady Finlay, has spoken in more detail about this critical area. We thought that it was best to place this responsibility on an existing, respected body, and I think that that was the right thing to do. However, as a former Minister responsible for NICE, I know how many new duties have been piled upon it. Can we be confident that NICE will have the resources, including the specialised expertise, to take on this demanding new role, and when can we expect to see this new role featuring substantively in NICE's work programme?

My second area of concern relates to pathology, on which the noble Earl, Lord Selborne, has spoken. We deliberately proposed centralising laboratory services for molecular pathology as a way of making the efficiency savings that would fund much of the new equipment that will be required and on the basis of evidence given to us, particularly in relation to Oxford from Sir John Bell.

Amalgamation also goes with the flow of the two reports on NHS pathology services by my noble friend Lord Carter of Coles, who, if I may put it this way, I unleashed on these services when I was a Minister nearly five years ago. However, never underestimate the capacity of parts of the NHS to resist change. As the committee indicated in its report, implementation of the Carter proposals has been painfully slow, given the scale of the possible savings that the noble Earl, Lord Selborne, described. The previous Government's response on this issue was hardly galvanising, even though they sort of accepted our recommendation. Their proposal was that SHA medical directors were to lead work on pathology service redesign to bring together pathology and genetics laboratories. I certainly would not have bet the farm on this achieving change quickly in the face of longstanding resistance from many local consultant pathologists, but if SHAs are to be abolished in 2012, I would expect even less to happen between now and then.

Will the Minister have another look at this whole area, including the Carter recommendations, and come up with a more convincing plan that is also likely to deliver substantial savings and improve services? I remind him that when I was a Minister setting up the Carter review, we were thinking then in terms of 20 per cent savings on the cost of the pathology services by consolidation and amalgamation.

My third area of concern is commissioning, where the previous Government rejected the committee's recommendation that changes were needed in the commissioning of genetic tests because of the inconsistency across the NHS in the provision of

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genetic tests and genetic testing for subtypes of common diseases. The noble Lord, Lord Patel, has already referred to the risk of a postcode lottery with regard to the availability of these tests. The then Government wanted to rely on the web portal NHS evidence to inform commissioners, and on the current commissioning arrangements. The respected PHG Foundation has sided with the committee after expert workshops looked at this issue among others. In a report published last month, the foundation said that the DoH,

and that, in effect, these make it difficult to realise cost savings throughout the healthcare economy. Given that the new Government have in mind new approaches to commissioning, this would seem a good opportunity to revisit the concerns over the commissioning of genetic tests that others have raised. Will the Minister be prepared to do this?

My final point relates to issue of medical bioinformatics, which is critical to success in this area, as other noble Lords have mentioned. All the evidence that we received suggested that a shortage of bioinformatics personnel and kit was likely to be one of the greatest impediments that the NHS would face in using the new genetic knowledge. I am pleased that the previous Government accepted that more secure funding for the European Bioinformatics Institute was needed. We hope that this will not be a victim of cuts. However, I have grave doubts about whether the DoH is doing enough to provide sufficient bioinformatics capability to the NHS through its Modernising Scientific Careers programme, which seems to be its process of choice. That is why we recommended the establishment of an institute of biomedical informatics. I encourage the Minister to get his colleagues to look again at this proposal, particularly drawing on the potential for savings, as a number of us have said, from consolidation in the pathology area.

I recognise that there is a lot of detail in these questions and that the Minister may well need to take further advice. We should say to him, though, that the Science and Technology Committee-I hope-will continue to keep a beady eye on this area and progress in it.

8.44 pm

Lord Kakkar: My Lords, I, too, congratulate my noble friend Lord Patel and members of the Science and Technology Committee on this excellent report. I was not a Member of your Lordships' House when the report was first published but I have had the opportunity to speak to my noble friend about its recommendations, and I agree with my noble friend Lord Sutherland of Houndwood that the implications of the report will be read throughout the world. It is a thorough, thoughtful and authoritative piece of work, and I am sure that many other Governments and authorities will wish to consider its recommendations as they consider an issue that will affect the provision of healthcare throughout the world.

The advances in genomic medicine that we have heard about in this debate are profound and, as we have heard, are starting to affect clinical practice today

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in the management of common diseases. There is no doubt as we move forward that the research that is being undertaken in this country and in other parts of the world will start to resonate, in terms of both what is available for our patients and what our patients and the general public hear about. This will drive patient and public expectation. We have heard that genetic testing and new diagnostic strategies will be available, not only through mechanisms provided through the National Health Service and other care institutions, but, as we have heard, will be available independent of healthcare institutions and systems. This will pose a considerable challenge for medical practice. Medical practitioners will be keen to do the very best for their patients and respond to their inquiries, but they will not be able to do that if they are not trained and educated in the new science of genomic medicine.

I shall concentrate on the issue of the recommendations in chapter 7 of the report-those related to education, training and workforce planning. If we do not get this right, many of the potential advantages and benefits that we could potentially provide to society will be lost in the medium term, and in fact there will be opportunities for misunderstanding as the available science is misunderstood and clinical practitioners are not able to respond.

Some important areas have been identified in the report regarding the question of primary education, subsequent training and continuing professional development. With regard to undergraduate medical education, the General Medical Council, in its publication Tomorrow's Doctors, which was updated in 2009, has recognised the importance of including a requirement for the teaching of genetics in the curriculums offered by higher education institutions in the United Kingdom offering primary medical qualifications. There is no doubt that these will be adopted because the recommendations in Tomorrow's Doctors will have to be applied by 2011-12, so we can feel certain that new generations of medical students moving into the next stage of their training will have knowledge about this important new science and will therefore be ready in their subsequent training to learn how to apply it.

We need to be certain that those training programmes both for primary and secondary care across the disciplines and sub-specialties have a requirement to ensure a core competency in the understanding of genomic medicine as it applies to that specific discipline. That has been agreed in terms of the Government's response, but we need to make certain that it is applied. The coming together of the General Medical Council and the Postgraduate Medical Education and Training Board certainly suggests an opportunity for that to happen. I hope that the noble Earl will confirm that this will remain an area of focus so that the training we provide ensures the opportunity for practitioners to be able to respond not only to knowledge currently available but knowledge that will become available in the near and medium-term future. As we have heard in this debate, so much research is taking place in this particular area that advances will come thick and fast.

Then there is the issue of current practitioners-a very large proportion of the workforce-who were educated and undertook their training prior to the

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whole emergence of the field of genomic medicine. They will be seeing patients and members of the general public with the results of tests and inquiries about the implications of genetic and genomic medicine on their own health day in and day out, but they have not been trained to date. We need mechanisms for continuing professional development that ensure that as advances become available, and are being considered by our healthcare systems, they can be readily made available to practitioners so that they are able to respond to inquiries from their patients. That will be hugely important because large numbers of doctors and other healthcare professionals will be confronted with these challenges. We need to make sure that we have considered this and that we have appropriate mechanisms available to ensure that continuing professional development also provides opportunities as we go forward.

If we do not do that, the advances that come from all the excellent research and technology that we have heard about will not be readily available to patients as soon as we would hope. That will cause anxiety and unhappiness. It will miss opportunities in terms of protecting people and providing early opportunities for diagnosis and better treatment outcomes. Therefore, I urge the Government to look at this whole area of training and education in terms of taking forward the excellent recommendations in this report.


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