Minutes of the First Meeting of the Genetics Green Paper
Held on Thursday, 12 July at 2.30 pm
Adam House, 7-10 Adam Street, London, WC2N 6AA
Lord Leslie Turnberg (Chair) - former President of the Royal College of Physicians
Prof Martin Bobrow - Professor of Medical Genetics, Cambridge
Prof John Burn - Professor of Clinical Genetics, University of Newcastle Upon Tyne; Director Northern Genetics Service
Dr Paul Debenham - Head of Life Sciences and Forensics, LGC
Joanie Dimavicius - Chair of Genetic Interest Group
Penny Guilbert - Nurse Counsellor, Nottingham City Hospital; member of the Joint Colleges Working Party on Confidentiality and Consent [check]
Delyth Morgan - Chief Executive, Breakthrough Breast Cancer
Baroness Onora O'Neill - International bioethicist; former Chair of the Nuffield Council on Bioethics; Principal of Newnham College, Cambridge
Dr Nigel Starey - GP; Director of the Centre for Primary Care, University of Derby
Dr Ron Zimmern - Director, Public Health Genetics Unit, Cambridge; Chair of the HTA diagnostic and screening panel
Liz Woodeson - Head of Genetics and Assisted Conception Branch, Department of Health
Tony Taylor - Head of Genetics Unit, Department of Health
Dianne Kennard - Team Leader, NHS aspects of genetics, Department of Health
Angela Piearce - Team member, NHS aspects of genetics, Department of Health
Simon Stockwell - Scotland Office
Welcome and introductions
1.1 The Chair welcomed members to the first meeting of the genetics Green Paper advisory panel. Apologies had been received from Peter Farndon, David King and Crispin Kirkman.
Terms of reference
2.1 The Chair explained that the panel will not produce a report, and the timescales preclude much original work, but a record of discussions will be taken by the secretariat. The panel should feel free to think openly and widely. Views expressed in meetings will be treated as confidential. Members are there in an individual capacity and will not be expected to ask for views from their organisations unless specifically asked to do so. The views of members will be used to inform the production of the Green Paper, but no guarantees can be given that the panel's views will be adopted. Members agreed that the membership of the panel could be put on the Department of Health website.
2.2 A number of bodies have already been established to give advice on genetic issues, such as the Genetics Commissioning Advisory Group (GenCAG) and the Human Genetics Commission (HGC). These groups could usefully feed into the work of the panel, but the panel has a distinct and separate role. It will only exist for a few months with a specific remit to feed in views on the Green Paper. Members of HGC might be invited to talk to the panel.
2.3 The focus of the Green Paper will be on getting the NHS in the best position to take advantage of advances in human genetics, ensuring that the public is taken on board and doesn't feel threatened. Some elements may require legislation in order to help underpin public confidence, but the steer from the Secretary of State indicates that the focus should be on providing ammunition that will help the NHS prepare itself. The timing of advances in genetics is very hard to predict, but members should feel free to think beyond the immediate future. Members should also feel free to think beyond existing structures, for example in knowledge management.
2.4 It will also be important to consider developments in other government departments, Europe and the rest of the world, and to acknowledge the impact of wider developments on activity in the UK, for example the fact that people will be able to order tests over the internet. Particular lessons can be learnt from experiences in the US. It may be that the UK will want to adopt a position which sets it apart from other European countries: Germany in particular can appear to have a negative approach to genetic advances, and this is proving influential in Europe.
Themes and content for the Green Paper: draft storyboard
3.1 The Chair suggested that, as a framework for discussions, the panel should consider the potential benefits of genetic advances, likely timescales, potential anxieties, and recommendations to the NHS. This was agreed as a reasonable approach. The Green Paper needs to strike a balance between being upbeat about the potential benefits of genetic advances, while at the same time recognising potential areas of concern.
3.2 The panel agreed that the chapters may not be in the right order at present. Public understanding / appreciation should be nearer the front given its importance. Readers may also be more engaged if the Green Paper starts by tackling more individual and personal matters. People need to understand that genetics affects everyone. At the same time, the Green Paper should not veer towards "geneticising" the whole of life. Public understanding of risk will be fundamental to the understanding of genetics. There is a need to increase public interest in genetics and to be open and honest about what is and is not involved. People need to take personal responsibility for their own health and well being. At present, people associate the word "genetics" with worry, although they are often in favour of specific activities which are not labelled as "genetic", eg prenatal testing for Downs. The Green Paper could set out examples of the way in which the NHS has integrated advances in genetics in order to improve health care, eg within the blood transfusion service and phenylketonuria (PKU) testing. The BBC is launching a targeted learning initiative which should be running by the time the Green Paper is launched, and there are questions about the inclusion of genetics within education, at school and onwards. There is a need to be clear about what is meant by genetics - whether it refers to genetics as inheritance, or genetics as the basis of human biology. The public often doesn't understand the difference.
3.3 The chapter on R&D and industry should be later in order to avoid giving the impression that commercial considerations are at the forefront. In may be helpful to readers for an early chapter to set out the existing genetic services and regulation. This could be followed by a projection of possible future developments.
3.4 There is an issue about whether the Green Paper should cover the whole of the UK or England only.
3.5 It was agreed that the Green Paper should be written in a way that is accessible to an intelligent lay audience.
Chapter 1: Introduction
3.6 The introduction should say something about projected timescales. At the same time, it should acknowledge that this is an unpredictable field: panel members need to consider how to deal with advances that could happen in the knowledge that they may not happen.
Chapter 2: R&D and industry
3.7 This chapter needs to cover not just scientific R&D, but also research into health service provision and the social sciences. The role of, and relationship with, industry will need to be covered, and in an unbiased way: what they can offer the NHS and vice versa. Much research would not be done without private sector involvement, and the Green Paper should talk of "partners" in the private sector. The UK also has a great deal to offer the biotech industry, in particular a national patient base and the framework of the NHS.
3.8 The rationale behind the development of Knowledge Parks is to bring together various different aspects of genetics. More information on them will be available soon when the tender document is made public.
Chapter 3: Impact of genetic technologies on the NHS
3.9 It was agreed that it would be helpful to include a snapshot of what genetic services are like at present. This would set the scene for setting out a vision of what service provision could be like in the future.
3.10 The Green Paper could consider the series of processes needed in the NHS in order to bring genetic advances into practice, eg procedures for consent and how research ethics committees handle genetic issues. The roles of NEQAS / NIBSC / NICE also need to be considered, and the imbalance between the regulatory requirements for drugs and for tests. The relevance of pharmacogenetics (and any regulatory structures) to older drugs also needs to be thought through.
3.11 Most of the genetic conditions that are strongly predictive but untreatable are already known. Tests that are developed in future are likely to be much less predictive. There is a question about whether tests should be carried out if they only identify a slight increase in risk and are of limited clinical utility. However, industry is unlikely to develop tests unless they are useful. Those consulted by the Genetic Interest Group (GIG) thought it should be the prerogative of those with serious genetic conditions to decide if they wanted to be tested, irrespective of whether anything could be done about their condition.
3.12 It would be helpful to include positive case studies, eg designing drugs specifically for abnormal gene targets. At the same time, the Green Paper should make clear that some advances in genetics may take a long time to develop.
3.13 The Green Paper should also consider issues of professional awareness, capacity and funding. The existing system of primary care has some big advantages, for example its knowledge of family history, and the provision of information via computers and the Electronic Library for Health will be very helpful. However, there is still a knowledge gap about genetics in primary care, and it can be difficult for doctors to put over all the necessary information to patients in short consultations. There were some effective examples of mechanisms used to cascade knowledge and change out into healthcare, and these approaches (such as those used for cancer) should be redeployed.
3.14 The use of genetics "champions" could be an effective way of raising awareness of genetics among health professionals. Jon Emery and Rhydian Hapgood have written about genetics in primary care and the Royal College of General Practitioners genetics subgroup is having a workshop in September.
Chapter 4: Enabling the NHS to make best use of genetic technologies
3.15 The panel thought that the points raised in the storyboard plan for this chapter were not necessarily in the right order. In particular, material on existing services and patient / public involvement should be earlier.
3.16 There was a discussion about the likely future configuration of genetics services. Some things, eg blood grouping and tumour-typing, are dispersed out into other parts of the service. Other components of the testing service might remain within a specialist genetics service or become part of pathology. At present, there are 23 Regional Genetics Centres, which will be more formally linked in future, and there will be two National Reference Laboratories. There is a question of how many laboratories are needed to do genetic testing for the NHS. One laboratory could have sufficient capacity, but some believe that it is important to maintain the clinical and laboratory interface in order to maintain skills. Work is currently underway on the genetic testing network, but it is within the scope of the panel to comment on how it thinks genetic testing could be best organised in the future.
3.17 Informatics will also need to be considered, including the taking and recording of family histories, consent and confidentiality, and later the linking of genomic DNA information with health information.
3.18 The Green Paper will need to acknowledge the benefits of intellectual property rights in stimulating research and even in generating income for public sector bodies, but also the public concerns about intellectual property rights being a sign of commercialisation.
Chapter 5: Ethical and societal issues
3.19 The Green Paper should address public concern about the storage of genetic information. People are concerned about security and the non-medical uses to which genetic data might be put. The difficulties in this area were highlighted by the House of Lords Select Committee report on genetic databases. It is an area in which the HGC takes a strong interest. The ICRF familial cancer record is an example of how a genetic database can be handled, with the possibility of downloading non-attributable data, and different levels of consent.
3.20 The use of genetic tests in employment is another area of potential public concern, although it is rare at the moment. The Human Genetics Advisory Commission (HGAC) produced a report on employment and genetic data in 1999, in which it recommended further discussion and regulation.
3.21 The HGC has published interim recommendations regarding genetic testing and insurance and aims to publish a final report by the end of the year. It was agreed that there was therefore no need for the panel to address this issue. A survey carried out for GIG found that this was not an issue of particular concern amongst members. The only area in which people with genetic conditions experienced difficulty in getting insurance was travel insurance. There was a danger of creating a problem by focusing on the issue.
4.1 For the next meeting, panel members were invited to submit r�sum�s of up to 3-6 pages, or issues summarised in bullet point form, on areas of particular interest to them which they would like to see covered in the Green Paper. These papers will be kept confidential. It would be very helpful if members could also think of examples and case studies which could be included in the Green Paper to help to make it accessible. Papers should be sent to Angela Piearce at the Department of Health by Friday 17 August.
Date of next meeting
5.1 The next meeting will be held on Tuesday 4 September at 2pm.
Any other business
6.1 A one day international conference, opened by the Secretary of State, will be used to inform the development of the Green Paper. The most likely date is 16 January 2002.