Select Committee on Science and Technology Appendices to the Minutes of Evidence


Memorandum submitted by the Department of Health

  1.  This memorandum is provided by the Department of Health on behalf of health and science ministers in reply to the letter dated 11 January sent by Geoffrey Farrar, Clerk to the House of Commons Science and Technology Committee, to the Office of Science and Technology. This letter requested information on the significant issues surrounding the use of genetic test results by insurance companies.

  2.  The Government is aware of the sensitivity of this issue and the widespread public concern that individuals should not be disadvantaged by their genetic inheritance. The Government is concerned to prevent unfair discrimination as a result of genetic developments.

  3.  The Human Genetics Advisory Commission (HGAC) produced a report entitled "The Implications of Genetic Testing for Insurance" in November 1998. The HGAC report recommended the establishment of a mechanism to evaluate the scientific and actuarial evidence presented in support of the use of specific genetic tests for insurance products. The HGAC also recommended that a moratorium on use of genetic tests should be put in place for at least two years.

  4.  The Government accepted the first recommendation and has subsequently established the Genetics and Insurance Committee (GAIC). GAIC has a remit to develop a procedure and criteria for the assessment of genetic tests currently being used in insurance risk assessment and to evaluate each test against the criteria agreed.

  5.  The Government carefully considered the recommendation to introduce a two-year moratorium. Since this would have required the introduction of primary legislation, the Government explored with the Association of British Insurers (ABI) the possibility of a temporary moratorium on the use of tests until they had been considered by GAIC. The ABI was not prepared to accept this. The ABI did, however, agree that it should advise its members not to use any tests which were not submitted to GAIC by the end of December 2000, and that it would advise its members to abide by GAIC's decisions, so that tests that were judged unreliable by GAIC would be withdrawn. The Association also agreed to advise its members to re-underwrite any individuals who may have been disadvantaged by the disclosure of a test result for any such conditions, since November 1998.

  6.  The current position is that family records are used in medical assessments to establish whether individuals have a genetic predisposition to a particular disease and, if they do, this information is taken into account in establishing premiums. In addition, most ABI members ask for the results of the genetic tests for Huntington's Disease, early onset Alzheimer's Disease (PSI and APP genes), hereditary breast/ovarian cancer (BRCA1 and BRCA2 genes), myotonic dystrophy, familial adenomatous polyposis, multiple endocrine neoplasia and hereditary motor and sensory neuropathy if they have been taken by people seeking insurance.

  7.  By the end of December, the ABI had only put forward tests for three conditions. We understand that the ABI will not advise its members to cease using the tests relating to all other conditions.

  8.  The result of the GAIC procedure is to rule out the use of tests for which there is no actuarial basis, while a deeper examination takes place of the wider social and ethical issues involved in the use of all genetic tests. The HGC is currently considering these issues.

 (i)   How does the current regulatory system operate, and what future developments are planned?

  GAIC was established in 1999. It is a multidisciplinary committee including actuarial and genetic expertise and representatives of relevant patient groups. GAIC has published evaluation criteria covering the details of the genetic condition being tested for, the accuracy and reliability of the tests used to detect it and the relevance of the test results to decisions about insurance underwriting. Over the next few months, GAIC will consider applications relating to three conditions currently covered by the Association of British Insurers' Code of Practice on Genetic Testing. These are Huntington's Disease, the early-onset form of Alzheimer's Disease and hereditary breast/ovarian cancer. The intention is to complete the review of these applications by September 2001. In the future, if another test should be proposed for use in insurance risk assessment then assessment by GAIC would be required before insurers could start to use results of the test.

  The insurance industry, through the main trade body the Association of British Insurers (ABI), has agreed to abide by GAIC decisions. If GAIC decides that the evidence on the reliability and relevance of a particular test is insufficient to justify its use, the Association will advise its members to cease to use results of that test and to retrospectively reassess affected individual insurance premiums. The ABI Code of Practice on Genetic Testing states that individuals should not be asked to take a test before being offered insurance but, where individuals have already been tested as part of their medical care, then insurance companies can ask for that information.

  Complementary to the work of GAIC is the work of the Human Genetics Commission in looking at the wider social and ethical issues related to the use of genetic test results by insurers. The Commission was created in 1999 to provide the Government with strategic advice on the big picture of human genetics. The Human Genetics Commission has included the wider social and ethical issues involved in the use of genetic data in insurance in their ongoing public consultation on the storage, protection and use of personal genetic data, "Whose hands on your genes?"

  The Commission has also been specifically asked to consider the wider social and ethical aspects of genetic testing and insurance, taking the wok of the Genetics and Insurance Committee (GAIC) into consideration.

  HGC will hold an information-gathering day on genetics and insurance on 9 February 2001. The Commission will hear presentations from all sides of the debate; particularly academic insurance experts, the insurance industry, patient support groups and clinical geneticists. The intention will be to allow an informal discussion session with these and wider interests, such as those responsible for data protection financial services and consumer protection. In common with all full HGC meetings, the meeting will be open to the public.

  It is intended that a report from the information-gathering day, together with relevant responses to the consultation, will be discussed at the HCG's main meeting on 2 March. The Commission will then discuss what additional work will be necessary on insurance and what form their report and recommendation to Ministers on this may take.

 (ii)   What is the Government's policy toward the use of genetic test results for this purpose, and what are the reasons underlying this policy?

  The Government's policy in the short-term is to prevent the use of genetic tests which are not clinically and actuarially relevant while at the same time a major review of the medical, social, ethical and financial implications of the use of genetic tests is made by the HGC.

 (iii)   What scientific advice has the Government based its decisions upon, and what measures have been take to ensure its reliability?

  The Government receives advice from both the Human Genetics Commission and the Genetics and Insurance Committee. Each has a responsibility to provide Ministers with advice under their terms of reference. The roles of the two bodies are very different, and their membership is intended to reflect these differences. The role of the Human Genetics Commission in relation to insurance is to advise the Government on its overall policy. In doing so, it obviously has to take account of social and ethical issues. The role of the Genetics and Insurance Committee is essentially to decide the technical question of whether or not a test is a reliable indicator of disease for actuarial purposes.

  GAIC makes its decision on a specific genetic test based on the following:

    —  the information included in the application;

    —  reviews of the application provided by independent clinical geneticist and actuarial experts; and

    —  comments received from relevant patient groups who are sent a copy of the application to review.

  Full details of the basis on which GAIC makes its decisions are included in the response form GAIC and are not repeated here.

 (iv)   What is the Government's view of insurers using results from diseases which are not single gene defects, or where there are non-genetic influences (for example, heart disease) when assessing risk?

  At the moment, any genetic tests which insurers have not submitted to GAIC for approval should not be used. None of these tests have been submitted to GAIC. For most genetic polymorphisms and multi-factorial conditions, the current level of understanding of the relative importance of genetic and other factors for predisposition to disease and excess insurance risk is likely to be insufficient to make a case that the test is actuarially and clinically relevant. Genetic tests that are not single gene defects or do not accurately predict ill health (that are low penetrance or multi-factorial) and those that are predictive of less serious conditions which do not lead to serious ill health or disability should therefore not be used by insurers in risk assessment at this time.

 (v)   What consideration has been given to the potential effect on UK research of insurance companies using genetic test results?

  The Government is aware of the potential threat to research if volunteers withhold consent due to concerns about the possible effects of their participation on their subsequent ability to gain insurance. Such use of research information by insurers, if it occurred, could be considered to be an unfair use of genetic data. The Government is very concerned that individuals should not be unfairly disadvantaged by their voluntary participation in research. The ABI's Code of Practice on Genetic Testing states that only tests which have been assessed by GAIC may be used in insurance risk assessment.

  This concern is especially important in relation to the proposed MRC/Wellcome database and agreement has been sought with the ABI to include a specific reassurance on insurance in the information given to participants on this project. The ABI has informally indicated that any test carried out for research purposes (including those for conditions assessed by GAIC) should not be used by insurers. On this basis, there should be no threat to potential volunteers.

 (vi)   What are the roles of the various government departments in this area?

  HGC is responsible to health and science ministers. GAIC reports to health, science and treasury ministers. The secretariats for both bodies are based in the Department of Health Genetics Unit; the HGC Secretariat is a joint DH/OST body.

  The role of the Department of Health in sponsoring these bodies is part of the department's general responsibility to contribute to improving and protecting the health and social well-being of the people of England and in reducing inequalities.

  The role of the Office of Science and Technology in sponsoring these bodies is part of its general responsibilities for trans-departmental scientific and technological issues and for the Government's guidelines on scientific advice and policy making.

  The role of the Treasury in sponsoring GAIC relates to its general responsibilities for financial services issues in the UK and its objective of securing an efficient market in financial services and banking with fair and effective supervision.

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