Genetics and insurance in the UK

1. Genetics and insurance in the UK Dr Mark BaleDeputy Director of Scientific Development and Bioethics Department of Health UK

2. UK background • National Insurance systems account for majority of healthcare insurance, small private health insurance market • Large private life and health insurance market • Life insurance (often mortgage linked) • Critical illness • Income protection • Based on mutuality requires a proposer's accurate disclosure of relevant information and a fair actuarial assessment. • Insurance contracts on this basis are said to reflect the utmost good faith (uberrima fides) • Debate of ‘fairness’ prompted by AIDS/HIV testing in mid-1980’s • Human Genome Project and ELSI debate extended this to genetic information • Insurers expected disclosure; clinicians and patients experienced over-emphasis on predictive nature of genetic tests • Parliament and advisory groups recognised need for independent scrutiny of material relevance of genetic test results

3. Historical context • Mid-1990 debate about disclosure of genetic test results • 1999 Genetics and Insurance Committee • Industry-backed Code of Practice • 2000 GAIC approved HD for life insurance • 2001 Parliamentary debates and recommendations from HGC • 2001 5-year Moratorium announced, with stronger GAIC • 2005 extended Moratorium plus Concordat • 2007 Government consultation on Single Equality Bill • 2008 Operational review of concordat

4. Genetics and Insurance Committee • Independent committee, chaired by Prof. David Johns, including genetics experts, insurers and patient representatives. • Evaluates specific proposals from insurers to use genetic tests for particular types of insurance; • Reports to Ministers on compliance by the industry with the recommendations of GAIC; • Provides independent wide ranging oversight of how insurers are using genetic tests, including compliance with the concordat and moratorium • Considers complaints from insurance applicants about the way an insurance company has dealt with their application.

5. GAIC process • Genetic test: “A test to detect the presence or absence of, or change in, a particular gene or chromosome” • The genetic test should be predictive of, or associated with, significant health effects relevant to life and/or health insurance; • The definition includes an indirect test for a gene product or other specific metabolite that is indicative of a specific genetic change in a particular family; • The definition does not include diagnosis based on non-genetic clinical examinations. • The three relevance criteria: • Scientific Relevance: Does the test accurately measure the genetic information? • Clinical Relevance: Does a positive result in the test have likely future adverse implications for the health of the individual? • Actuarial Relevance: Does a positive result justify increased premiums? • Only where all three of these conditions are satisfied can a predictive genetic test be approved by GAIC for consideration by the insurance industry in setting premiums for insurance

6. The moratorium • Since 2001, insurance industry and Government agreed that no insurer will require disclosure of predisposition genetic tests for sums insured of: • <£500,000 for life insurance • <£300,000 for critical illness insurance • <£30,000/yr for income protection insurance.97% of policies are below these limits • For policies over these limits, insurers can only use GAIC approved predictive tests • To date only approved predictive tests for Huntington’s disease, for use in determining premiums for life insurance policies over £500,000.

7. Concordat and Moratorium • Original moratorium extended in 2005 until November 2011 • Additional industry and policy issues also negotiated since 2001 • Industry codes and complaints mechanisms overhauled • Concordat sets out the terms of these agreements in a single place

8. Scope of the concordat Background • Acknowledges concerns that some might be deterred from taking predictive genetic tests, if they fear that insurance companies may discriminate against them unfairly on the basis of the test results. • States that the relationship between medical data and insurance underwriting should be proportionate and based on sound evidence. • Accepts that unless otherwise agreed, insurance companies should have access to all relevant information to enable them to assess and price risk fairly in the interest of all their customers. Principles • Insurers should not treat customers who have an adverse predictive test result less favourably without justification • The technical, clinical and actuarial relevance should be subject to independent oversight Predictive test results • Insurers will not use predictive genetic tests results to underwrite travel insurance, private medical insurance, or any other one-off or annual policy, or for long term care policies. • “10 Commitments” on the information to be sought from customers • If a predictive test result is disclosed by mistake it will be ignored • If a customer discloses a test result that is in their favour, individual companies will publish their policies on how that will be used

9. “10 commitments” • Customers will not be asked to: • undergo a predictive genetic test as a condition of obtaining insurance; • disclose a family member’s test results; • disclose any predictive or diagnostic genetic test results acquired as part of clinical research; • disclose any predictive genetic test results that are made available after their policy has started, for as long as that policy is in force. • Customers taking tests before the moratorium will be treated the same way as those taking tests now • Insurers can seek access to medical family history and diagnostic tests, with consent to confirm information disclosed, but not to predictive genetic test results • Customers can be asked to disclose results of GAIC-approved tests for policies over the moratorium limits • Insurers will: • abide by stringent procedures for seeking access to medical records; • for handling such information and; • destroy medical evidence when it is no longer required

10. Remaining concerns • What happens after 2011 - “Test now, buy later”? • What genetic tests will GAIC approve next? • Financial levels – house price inflation • Scope – what about family medical history, non-DNA predictive tests • Rising trends in number of genetic tests • Impact of future screening technologies for complex chronic diseases • Private genetic testing services and medical record • ‘Fit’ with other discrimination legislation

11. Actions • Operational review of concordat and moratorium by end 2008 • Will work with GAIC, HGC the industry, patient groups, and other stakeholders on trends in genetic testing and ethical issues • Discuss ways of improving insurance access for people with genetic diseases. • GAIC not expecting any applications before 2009 • Breast & ovarian cancer (BRCA1 & BRCA2 genes) • Huntington’s (HD gene) for critical illness and income protection insurance • Green Paper on single equality bill advocated not legislating on ‘genetic discrimination’. • HGC and GAIC (among others) disagreed and recommended including legal provisions against unfair discrimination on basis of genetic features • Government policy decision expected early 2008

12. Further information • Concordat:http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4105905 • GAIC:www.advisorybodies.doh.gov.uk/genetics/gaic/ • GAIC Secretariatmb-gaic@dh.gsi.gov.uk • Human Genetics Commission: www.hgc.gov.uk • Association of British Insurers leaflet: http://www.abi.org.uk/Public/Consumer/Codes/InsGenTestsFinal.pdf