Genomic Medicine, the House of Lords, Science and Technology Committee publishes its report on the 2nd Session 2008-09 – 46 Recommendations

The House of Lords has publishes the “Science and Technology Committee 2nd Report of Session 2008–09 Genomic Medicine Volume I: Report”

Summary

Modern, effective healthcare rests upon centuries of scientific advances and innovation that have been shown in clinical trials and other studies to prevent, cure or alleviate human disease. Every so often, a scientific advance offers new opportunities for making real advances in medical care. From the evidence given to this inquiry, we believe that the sequencing of the human genome, and the knowledge and technological advances that accompanied this landmark achievement, represent such an advance.

The 2003 White Paper, Our inheritance our future, recognised the potential impact of genetics and the genome project on our lives and our healthcare, and the importance of preparing the National Health Service (NHS) to be able to respond to this new knowledge. In our inquiry, we have investigated these many aspects of genomic medicine, and make  recommendations to ensure that the challenges afforded by advances in genomic science are met and the opportunities exploited. If our recommendations are taken forward, we believe that the UK will benefit in terms both of wealth generation and of improved health of the population.

Recommendations:

1. We commend this strategic and co-ordinated approach to translational research and the work of OSCHR (Office for the strategic co-ordination of Helath research) in achieving this co-ordination.
2. we recommend that OSCHR should take the lead in developing a strategic vision for genomic medicine in the UK with a view to ensuring the effective translation of basic and clinical genomic research into clinical practice.
3. This strategic vision should form the basis of a new Government White Paper on genomic medicine which should outline:
   1. the measures the Department of Health will take in order to facilitate the translation of advances in genomic science into clinical practice;
   2. a roadmap for how such developments will be incorporated into the NHS; and
   3. proposals for a programme of sustained long-term funding to support such measures.
4. We recommend that the Government revises the UK implementation of the EU Clinical Trials Directive, in consultation with the research community, to make it less burdensome for researchers.
   1. If the European Commission decides in favour of a review of the EU Clinical Trials Directive in 2010, we urge the Government to participate fully in discussions in order to ensure that the revised Directive is less burdensome for researchers
5. We recommend that the proposed White Paper on genomic medicine and the Strategic Vision of the Office for the Strategic Co-ordination of Health Research should identify barriers to collaborative working between academia and the pharmaceutical and biotechnology industries, and ways of removing them and also address the need for incentives for collaboration so as to promote translational research in the UK.
6. We recommend that the National Institute for Health Research ringfence funding, through a specific Health Technology Assessment programme, for research into the clinical utility and validity of genetic and genomic tests within the NHS.
7. We therefore recommend that the Department of Health extends the remit of the National Institute for Health and Clinical Excellence to include a programme for evaluating the validity, utility and cost-benefits of all new genomic tests for common diseases, including pharmacogenetic tests.
8. We recommend that the Government support the re-classification of genetic tests to “medium risk” in the current review of the EU In Vitro Diagnostic Medical Devices Directive so as to ensure that all genomic tests on the market have been subject to pre-market review before their use either by the consumer directly or by the NHS and private healthcare services.
9. We recommend that the Government continue to work with the pharmaceutical industry to extend value-based pricing for the stratified use of medicines under the PPRS to reflect the value of drugs sold for stratified use and the increasing use of genetic tests to accompany such treatments.
10. we recommend further that, with regard to medicines for common diseases which are already in use in the NHS, the National Institute for Health Research should target funding to encourage the development of pharmacogenetic tests to stratify use of these medicines in order to improve their efficacy and to reduce the frequency of adverse reactions.
11. We recommend that the Department for Innovation, Universities and Skills address the issues relating to the management of intellectual property rights within the healthcare sector to improve incentives for stratifying uses of new and existing medicines and for development of pharmacogenetic tests necessary for stratification.
12. We therefore recommend that the Department of Health set out a national strategy on stratified uses of medicines (as part of the proposed White Paper on genomic medicine recommended in paragraph 3.12 of this report). The purpose underlying this strategy should be to streamline the co-development of stratified uses of medicines and of pharmacogenetic (or other) tests.
13. We recommend that genomic science is adopted as a key technology platform by the Technology Strategy Board, to drive forward commercial development and clinical application in this area over the next five years and to maintain the UK lead in genomic medicine.
14. We recommend that the Government should reconsider how they will prepare NHS commissioners and providers for the uptake of genomic medicine in the NHS. We also recommend that the National Institute for Health Research, as part of its remit, regularly monitors developments in genomic medicine and their implications for the
    NHS now and in the future.
15. We envisage that the proposed White Paper will address the operational changes needed as a result of bringing genetic aspects of treatments for common disorders into mainstream clinical specialities (including changes to commissioning arrangements, processes for providing genetic tests within the NHS and arrangements for NHS laboratories to conduct such tests).
16. We recommend that, on the basis of the monitoring activity of the National Institute for Health Research recommended in paragraph 4.6 above, the Secretary of State for Health should ensure that any necessary NHS operational changes, as a result of a shift in the provision of genomic services to mainstream medicine in the NHS, are implemented in the
    NHS. In order to facilitate the process the Secretary of State should identify whether the NHS is fit to handle such changes and also what new service models are needed if health professionals from other clinical specialties are to take routine responsibility for genomic aspects of healthcare (with referral to specialist genetics services only where necessary).
17. We recommend that the Department of Health should conduct a review with the aim of establishing appropriate commissioning structures for pharmacogenetic tests, tests for management of genetically complex diseases and tests for diagnosing single-gene subtypes of common diseases, as the use of such tests spreads further into the mainstream NHS.
18. We recommend that the Department of Health should conduct a review of current genetic test service provision within the NHS both for single-gene disorders and for single-gene subtypes of common disorders. This should aim to eliminate what are serious inconsistencies in the provision of genetic services across the NHS.
19. We recommend that the Department of Health should develop a national set of standards and tariff guidance for the commissioning of genetic tests, taking into account the recommendations from the second phase of the Carter Review of NHS Pathology Services that there should be tariff guidance for community-based and specialist pathology, particularly relating to DNA and RNA-based genetic tests.
20. We recommend that the Department of Health should commission the National Institute for Health and Clinical Excellence to issue guidance on the use of genetic tests by non-genetic specialties; and that the NHS should consider the expansion of the “red flag system” to alert healthcare workers to the need to conduct a specific test, in
    some cases a pharmacogenetic test, before deciding on treatment or prescription.
21. We recommend that the Government centralise laboratory services for molecular pathology, including genetic testing, in line with the recommendations of the second phase of the Carter Review of NHS Pathology Services. The aim should be to organise effective laboratory services for molecular pathology and genetics by bringing together the whole range of DNA and RNA-based tests for pathology and medical specialties to ensure that services are cost effective. This would have the potential to free up funds, for example, for the highly specialised technical equipment that is needed.
22. We recommend that the Government show leadership on leveraging sustainable funding to the European Bioinformatics Institute (EBI), through the European Research Infrastructure (ESFRI) instrument and through the UK Research Councils. This would reduce the dependence of the EBI on charitable and cyclical funding and allow further growth of the Institute commensurate with the recent growth in genomic databases and the value of the EBI to the UK science base.
23. We recommend the establishment of a new Institute of Biomedical
    Informatics to address the challenges of handling the linking of medical and genetic information in order to maximize the value of these two unique sources of information. Such an institute would bridge the knowledge, culture and communications gap that currently exists between the expertise in NHS IT systems and bioinformaticians working on genome research. The Institute would guide the NHS in the creation of NHS informatics platforms that will interface with databases containing personal genetic data and with publicly
24. We recommend that the Department of Health should establish a centre for national training in biomedical informatics (within the Institute of Biomedical Informatics) with the aim of providing training that bridges the gap between health records information technology and genome informatics, and ensuring the delivery of an expert workforce for the NHS. available genome databases.
25. We recommend that the Department of Health should implement a programme of modernisation of computing and information technology within the Regional Genetics Centres and laboratories, including an upgrade in computer hardware, software tools and communication bandwidth, in order to manage current needs of clinical and genome informatics in the Regional Centres.
26. We recommend in particular that the Human Genetics Commission should promote a wide-ranging debate on the ethical and social issues relating to genetic tests and gene
    associations for genetically complex diseases and how they contrast with genetic tests for single-gene disorders. The debate should aim to improve public understanding of genetic risk and predictive testing in common complex disorders.
27. We recommend further that the Department of Health should establish a comprehensive and regularly updated public information web site which would review the most recent science on the genetics of common diseases, to help the public to understand and interpret results of genetic tests.
28. When developing the “safe havens” for research, recommended by the Data Sharing Review report, we encourage the Department of Health to consider adapting the approach developed by UK Biobank for ensuring the protection of personal privacy as an exemplar.
29. We recommend that, the Government should seek to amend the Data Protection Act 1998 where possible so as to facilitate the conduct of non-personal research using genetic data.
30. We do not believe that at present there should be specific legislation against genetic discrimination, either in the workplace or generally. But rapid advances in genetic science mean that there is a continuing need to monitor the situation. This should be undertaken by a designated body, possibly the Human Genetics Commission.
31. We recommend therefore that the Government should negotiate with the Association of British Insurers a new clause in the Code of Practice, Moratorium and Concordat on
    Genetic Testing and Insurance that prevents insurers from asking for the results of genetic tests which were carried out while the Moratorium was in place.
32. We recommend that the Government, together with the Association of British Insurers, should establish a longer-term agreement about the use of genetic test results for insurance purposes. The moratorium is next due to be revised in 2011. This would provide a good opportunity to take this recommendation further.
33. Given that the Genetics and Insurance Committee is to be disbanded, we recommend further that the Government should put in place arrangements for monitoring the use of genetic tests for insurance purposes. These arrangements should be part of the longer-term agreement on the use of genetic testing in insurance envisaged in paragraph 6.48 above.
34. Further to our recommendation in paragraph 6.8 above, we recommend that the proposed Department of Health web site should set out the following:
    1. up-to-date information on the national or international accreditation schemes with which the “direct to consumer” test (DCT) laboratories are registered, including the laboratories’ registration status;
    2. the quality assurance schemes in which these laboratories participate; and
    3. the extent to which the DNA sequence variants used by DCTs for predicting risk of future disease have been validated in genomewide association studies, and shown in prospective trials to have utility for predictive genetic testing.
35. We recommend that the Royal Colleges of Pathologists, Physicians and General Practitioners, after consultation with other relevant bodies, should develop a joint national strategy for undergraduate and postgraduate education and training in genomic medicine, with a clear timetable for implementation.
36. We recommend that the General Medical Council should introduce training in genomic medicine as a core competency in the Certificate of Completion of Training of all junior doctors training in the medical and pathological specialties.
37. We recommend that general practitioners should be trained to be able to provide general advice to patients on the implications of the results of predictive tests for common diseases. Planning how this might be done should be part of the review by the Royal Colleges recommended in paragraph 7.16 above.
38. We recommend that the Postgraduate Deans of Medicine and Medical Education for England, together with the relevant Royal Colleges and the Postgraduate Medical Education and Training Board, reinstate the currently suspended training programme in genetic pathology with a view to reintroducing a viable programme for the intended small number of pathologists (perhaps up to five at any one time) training in this specialty. This training may need to be overseen by both pathologists and clinical geneticists and could lead
    to the possibility of dual accreditation in genetics and pathology.
39. We also recommend that the Department of Health should work with the Postgraduate Deans of Medicine and the relevant Royal Colleges to reinstate consultant posts in genetic pathology capable of absorbing a sustainable number of registrar training posts.
40. We recommend that genomic medicine is included as a clinical competency within continuing professional development (CPD) for clinicians in primary and secondary care, and that this is recognised by the Royal Colleges which monitor CPD.
41. We recommend that the Department of Health should reviewprovision of genetic counselling with regard to single-gene disorders, single–gene subtypes of common diseases and common diseases.
42. On the basis of the findings of the review, we recommend further that the Department should take steps to ensure that adequate provision for genetic counselling is made available within the Regional Genetic Centres and also outside the Centres. The review should take account of the increasing need to support non-specialist physicians in giving
    accurate and informed advice to patients, and their families, following diagnosis of a single-gene subtype of a common disease.
43. We recommend that the Department of Health reviews the National Genetics Education and Development Centre’s (NGEDC) role, to establish whether it has the appropriate structure and mechanisms in place to provide national leadership in training the general medical and nursing workforce in the practice of genomic medicine and the
    use of genetic testing in the context of common diseases. The aims of the review should be to establish a national programme of training in genomic medicine for the non-genetic medical and nursing specialties, either under the auspices of the NGEDC or another body.
44. We recommend that, as part of the current review of the healthcare scientific workforce, the Department of Health should consider how members of the current healthcare science workforce can be trained to enable them to use the new genomic technologies and, bearing in mind the recommendation at paragraph 7.47 below, how to develop
    bioinformatics skills in particular.
45. We support the Department of Health’s commitment to establish a Centre of Excellence for national planning and commissioning of workforce supply and demand. We recommend that the Centre is the appropriate body to provide advice to the NHS on what measures can be taken to address the pressing need to recruit bioinformatic
    expertise into the service.
46. We recommend therefore that the Centre should be asked also to evaluate the workforce planning implications of an expansion of genetic and genomic test services into mainstream specialties.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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