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


Memorandum submitted by the Genetics and Insurance Committee

  In December 1997, following a period of public consultation, the Human Genetics Advisory Commission published a report entitled `The Implications of Genetic Testing for Insurance'. This 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 Government response to this report was published on 5 November 1998. Paragraph 16 of the Government response states that:

    "The Government believes that genetic test results should only be taken into account by insurers in making underwriting decisions where the relevance of the test results to the risk assessment relating to particular types of insurance product has been demonstrated. We welcome the ABI's commitment to this principle in its Code of Practice. The Government also agrees with the HGAC that an effective mechanism should be established to evaluate the reliability and actuarial evidence relating to the use of specific genetic test results by insurers. Any such mechanism should involve people with sufficient expertise and independence to meet concerns about the interpretation of these test results. The mechanism should be permanent and be used to evaluate all new genetic tests as they are developed. The Government intends to consult with the industry, HGAC and ACGT on how this mechanism can be put in place within a period of three months. The membership of the mechanism should include members of the ACGT with the necessary expertise and representatives of the insurance industry and the actuarial profession."

  The establishment of the Genetics and Insurance Committee (GAIC) in April 1999 fulfilled the Government's commitment to establish an independent review body.

  John Durant, the first Chairman of GAIC, was appointed from among the members of the Advisory Committee on Genetic Testing. Other members have been nominated by the Association of British Insurers, the Chief Medical Officer, the Faculty and Institute of Actuaries and the Genetic Interest Group.

 (i)   How the GAIC interprets its role in the regulatory system. Please could you clarify whether you consider purely the scientific accuracy of tests or also the wider implications of testing.

  The Genetics and Insurance Committee has a very specific remit to evaluate the scientific and actuarial relevance of genetic tests proposed for use by the insurance industry in setting insurance premiums. The terms of reference of GAIC are:

    —  to develop and publish criteria for the evaluation of specific genetic tests, their application to particular conditions and their reliability and relevance to particular types of insurance;

    —  to evaluate particular tests against those criteria and promulgate is findings; and

    —  to report to Health, Treasury and Department of Trade and Industry Ministers, on proposals received by GAIC from insurance providers and the subsequent level of compliance by the industry with the recommendations of GAIC.

  The Committee's terms of reference do not include consideration of the wider ethical and social issues around the principle of the use of genetic test results by insurers. However, the members of GAIC have been very mindful of the wider context in which they are working. In assessing tests they have been concerned to protect the rights of the individual who has disclosed a genetic test result as well as the rights of insurers.

  The Committee is aware of the role of the Human Genetics Commission in considering the wider picture on genetics and insurance. As well as being Chairman of GAIC, Professor Durant was also a member of the Human Genetics Commission and ensured that the Commission was aware of GAIC's work. He referred to the Commission the wider issues raised in GAIC's consultation on its criteria for assessment of tests. GAIC has also been working very closely with the HGC in its current consideration of genetics and insurance.

 (ii)   The work you are currently undertaking, especially in relation to the verification of genetic tests for use by insurers.

  GAIC's first task was to draw up the procedure to be followed before deciding whether results of specific genetic tests can continue to be used for insurance purposes, the criteria for making such decisions and guidelines for insurance providers wishing to submit information on genetic tests that were to be used for insurance purposes.

  The Committee spent several meetings in 1999 drafting and refining questions and guidance notes for applicants. These take the form of an application form of 11 questions 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.

  The draft application form and accompanying notes were subject to a wide public consultation in February 2000 and the final version was published in June 2000. A copy of the GAIC 'Notes to accompany applications to GAIC for approval to use genetic test results for insurance risk assessment' is enclosed.[5]

  Once this week was completed, the Committee was ready to consider applications for assessment of genetic tests and, in particular, the ten tests for seven genetic conditions currently used by the insurance industry and covered by the Association for British Insurers' Code of Practice on Genetic Testing.

  The procedure which is used to review applications to GAIC by the insurance industry is as follows:

    1.  The Secretariat will acknowledge all applications within seven days.

    2.  They will then be subject to an initial 14 day review by the Committee and Secretariat. If necessary, the applicant may be asked to submit additional information and clarification at this stage.

    3.  The application will then be sent out to outside reviewers from a panel to be appointed by GAIC. This will provide an expert review of the genetics (by a clinical geneticist and/or a population geneticist / epidemiologist) and the actuarial evidence (by an actuary nominated by the Faculty and Institute of Actuaries).

    4.  A copy of the application will also be sent for comment to the appropriate patient support group(s) for the condition under discussion.

    5.  The application and reviewers' comments will be assessed by the GAIC at a meeting and a decision made. Interested observers will be permitted to attend the meeting by arrangement with the Secretariat.

    6.  GAIC's advice on the use of the genetic test by insurers will be forwarded to Ministers. The applicant should be notified of the decision of the Committee within 14 days of the meeting.

  All applications are treated in confidence during the assessment process but, when determined, both the test of the application and details of the decision and reasons for it will be published by GAIC on its website.

  The ABI has submitted applications for the following conditions:

    —  Huntingdon's Disease

    —  Early onset Alzheimer's Disease (PSI and APP genes)*

    —  Hereditary breast/ovarian cancer (BRCAI and BRCA2 genes)*

    —  *awaiting initial review

  For each condition, separate applications have been made covering life insurance, critical illness insurance, income protection insurance and long-term care insurance (not breast/ovarian cancer).

  ABI members had also been using test results for a further four conditions, for which applications have not been submitted to GAIC, as follows:

    —  Myotonic dystrophy

    —  Familial adenomatous polyposis

    —  Multiple endocrine neoplasia

    —  Hereditary motor and sensory neuropathy

  In accordance with their agreement with GAIC, the ABI has indicated its willingness to advise its members to cease to use results from these tests and to re-underwrite any individuals who may have been disadvantaged by the disclosure of a test result for one of these conditions since November 1998, when the ABI Code of Practice was introduced. A similar undertaking has been given in respect of any tests in current use for which GAIC approval is refused.

  GAIC has commenced its review of the applications submitted and announced its first decision in October 2000, namely that the reliability and relevance of the genetic test for Huntingdon's Disease is sufficient for insurance companies to use the result when assessing applications for life insurance. Review of the remaining applications is ongoing and will be completed in the next six to nine months.

  GAIC will also have a monitoring role in the future to assess usage of genetic test results by insurers and compliance with the terms of GAIC's decisions.

(iii)   The scientific evidence that GAIC bases its decision upon

  GAIC recognises that there are three conditions that need to be met before a test can be deemed to be suitable for use when assessing insurance proposals:

    —  Is the test technically reliable? Does it accurately detect the specific changes sought for the named condition? This is the technical relevance of the test.

    —  Does a positive result in the test have any implications for the health of the individual? This is the clinical relevance of the test.

    —  Do the health implications make any difference to the likelihood of a claim under the proposed insurance product? This is the actuarial relevance of the test.

  Only where all three of these conditions are satisfied can a test be approved by GAIC for consideration by the insurance industry in setting premiums for insurance.

  Full details of the evidence to be submitted and the review procedure are given in the answer to (ii) above and in the attached "Notes to accompany applications to GAIC for approval to use genetic test results for insurance risk assessment".

(iv)   What future developments you expect in the use of genetic tests by the insurance industry and, in particular, whether the GAIC anticipates companies using tests for diseases that are not single gene defects, or where there are non-genetic influences (for example, heart disease).

  The tests that have been used by the insurance industry and have been the subject of the initial applications to GAIC have all been for genetic conditions caused by changes in a single gene that are very likely to lead to serious ill health or disability and that are therefore most relevant to the setting of premiums for life and health insurance.

  GAIC has stated that, at this stage, genetic tests that do not accurately predict ill health (including tests that are low penetrance or multi-factorial) and those that are predictive of less serious conditions will not be candidates for GAIC consideration. 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 sufficient to make a case for use of the genetic tests by insurers. It is possible that in the future there will be applications for multi-gene defects and defects where there are significant environmental influences. GAIC's assessment criteria should ensure that approval to use the results of such tests is only given in circumstances where a test result does have implications for the health of the individual and these health implications do make a difference to the likelihood of claim under the insurance product.

22 January 2001

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