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Genetic testing and insurance: opportunities and challenges for society
Forum
TRENDS in Molecular Medicine Vol.7 No.7 July 2001
323
Science & Society
Genetic testing and insurance: opportunities and challenges for society Elias Mossialos and Anna Dixon The increased availability of genetic tests poses new challenges to society. Here, we address the wider implications of genetic testing, with an emphasis on the markets for insurance. It also considers issues such as confidentiality, patient autonomy and fear of discrimination and the doctor–patient relationship.
The development of gene technology is likely to influence every aspect of modern society, redefining the scope of one’s ‘identity’ and changing the face of disease. Advances in human genetics bring challenges as well as opportunities. The controversy over genetics arises, not merely because of its infancy, but from its complexity and influence on religion, culture and other non-scientific areas1. As a result, many governments have attempted to regulate the use of genetic information (derived from genetic tests) in the hope that a balance can be struck between the public’s fear of discrimination or stigmatisation, the desire of the insurance industry to prevent fraud or financial instability, and the need of scientists to conduct research. Here we discuss the wider implications of genetic testing, with an emphasis on the markets for insurance. Information about our genetic make-up is not new and is not simply a product of recent scientific tests. For many people knowledge of their family history of disease has long presented clues to their own genetic inheritance. Indeed, such information has been used routinely by insurers as a means of assessing a person’s probability of making a claim. However, as tests become more numerous, cheaper and more accessible, many more people will have information about their genetic make-up (though not all available tests are of proven validity or accuracy)2. In the context of the insurance market such information raises a number of concerns, namely adverse selection and the risk this poses to the insurer and discrimination by insurers against those with high or certain probability of claiming3. http://tmm.trends.com
There has been much deliberation in the UK about the issue of genetics and insurance. The Department of Health’s Genetics and Insurance Committee (GAIC) has approved so far the use of genetic test results for Huntington’s Disease (HD) by life insurers. They are currently considering the use of genetic testing for early onset Alzheimer’s (for which there are currently two tests under scrutiny) and hereditary breast and ovarian cancer for a range of insurance products. GAIC’s remit is restricted to an examination of clinical and actuarial relevance of genetic testing for insurance purposes and it is the task of the Human Genetics Commission to determine what other regulatory provisions need to be put in place4.
Insurers claim that disclosure of existing test results by applicants is necessary to avoid exploitative insurance purchasing. Insurers fear that if applicants withhold information about their genetic status they might act fraudulently, and might insure themselves for excessively large sums of money. On the other hand, the requirement to disclose the results of genetic tests means people with an adverse test result are open to discrimination on the basis of genetic information and could face excessive premiums, significant exclusions or find it impossible to obtain insurance. Indeed there are already examples of people having been refused insurance on these grounds.
There is little evidence to support the insurers’view that patients with high risk over-insure in life insurance markets. It was argued that the insurance industry suffered in the 1980s, when individuals knowing they were HIV+ took out insurance cover that they would not normally have taken out, without disclosing their HIV status. However, as the 1997 report from the Human Genetics Advisory Commission (operational from December 1996 to December 1999) concluded5, ‘the insurance industry could currently withstand limited adverse selection that might occur as a result of non-disclosure of genetic test results for life insurance’. MacDonald estimated that if life insurance companies refrain from using genetic test results in underwriting, the industry will face additional costs but the magnitude of these costs will be nearer to 10% than say 100%6. Thomas estimated that a 10% increase would be indiscernible within the much larger variation that already exists between rates offered by different companies7. At the EU level, despite the introduction of legislation to harmonise the insurance market, there has been no binding legislation on genetics and insurance. The European Parliament in its 1992 Recommendation R (92) 3 on Genetic Testing and Screening for Health Care Purposes (which is not legally binding) states that insurers should not have the right to require genetic testing, or to enquire about results of previously performed tests, as a precondition for the conclusion or modification of an insurance contract. The lack of EU regulation means that it has been left to individual countries to enact legislation to limit the use of genetic information for the purposes of insurance. Belgium was the first country world-wide to prohibit the use of genetic test results – applicants are prohibited from submitting the results of genetic testing to insurers, whatever the results. The law also prohibits physicians from using genetic testing in medical examinations for insurance purposes. Use of genetic test results for the purposes of insurance is
324
Forum
prohibited in Austria, Denmark and Sweden. Through its Civil Code, France has enacted human rights regulation that limits the use of genetic tests to medical and scientific research purposes. By contrast, Germany requires by law that applicants to insurance companies disclose genetic test results. In the Netherlands, genetic information also includes family history information about hereditary diseases, and the use of this information is not permitted except where large amounts of coverage are being sought3. In the USA over the past decade, 28 states have passed laws that either restrict insurers’ use of certain genetic information or completely ban the use of genetic data for underwriting purposes. These laws sought to protect the interests of patients from the outset, by shaping industry norms and attitudes8. In an attempt to overcome the problems that bad risks will over-insure, several measures could be introduced to ensure cover for those with adverse genetic test results while protecting the insurers from fraudulent behaviour. The Netherlands has specified a value of life insurance up to which disclosure of genetic information is not required. A similar cut-off was defined in the UK decision, whereby insurers might require disclosure of HD genetic test results for the purposes of mortgage-related life insurance in excess of £100 000. Early in May 2001, insurers agreed to a new limit of £300 000 for life insurance, despite earlier resistance to such a change (see BBC Online, http://news.bbc.co.uk/hi/english/ health/newsid_1307000/1307175.stm). An alternative would be subsidisation of life insurance whereby modest premium increases would be levied on all subscribers to ensure cover for the small minority of people requiring special consideration. Another suggestion is the establishment of a reinsurance fund, through which the policies of individuals with a genetic predisposition are reinsured. The question arises as to whether such a fund should be also financed by the government. These somewhat cumbersome measures being debated arise from the insurer’s argument that adverse selection might occur. However, the wider social and ethical implications of genetic testing for insurance purposes should also be taken into account when deciding about the regulation of genetic information. A requirement to disclose genetic information has implications for http://tmm.trends.com
TRENDS in Molecular Medicine Vol.7 No.7 July 2001
confidentiality and patient autonomy and might deter individuals from having a test because of fear of discrimination. As such it could touch on privacy laws, discrimination legislation, public health, and the organisation of medical care. Patients will want guarantees that genetic information will not be disclosed. Moreover, a balance should be struck between the privacy of patients and the need of medical research to access data and the right of affected relatives to know that they might also be at risk. The growing use of genetic testing will require a re-examination of current health information management protocols to prevent the misuse of test results. Lack of such guarantees could create severe disincentives for genetic testing in general. Fears of discrimination or isolation, and now the recognition that insurance might not be available, have caused patients to forgo a test that would otherwise prove medically beneficial9. The impact of a deterrent effect can be devastating for patients, the research community and the area of preventive medicine. Alternatively, people might seek such tests outside the doctor–patient relationship. This could have severe implications for both the health of the patient and the provision of health services. The nature of genetic testing makes the establishment of one standard with regard to familial disclosure difficult and doctors could be torn between their duty to protect a patient’s confidentiality and informing family members about a potentially life threatening disease. Fear and unease could force patients to conceal their results from their physicians and families, posing dire consequences for early detection and prevention efforts. It is also widely held that the complexity surrounding genetic testing demonstrates a clear need for extensive pretest and post-test counselling10. The insurers’ view that genetic information is important to accurately assess the future risk of an individual making a claim also perpetuates a deterministic view of disease. In fact, defining the clinical utility of a genetic test is a rather complex task. Single genes can have several mutations occurring anywhere, all with varying levels of influence. Moreover, the time of onset is often unpredictable, further complicating early detection and prevention efforts using genetic test results. Furthermore, as Vineis et al. point out11, although rare and
highly-penetrant mutations in cancer genes could act with no interaction with external factors, gene–environment interactions are intrinsic to the mode of action of low-penetrant genes. It is important, therefore, for policy-makers and other stakeholders to recognise that in many cases the causality between a particular gene and its associative illness is somewhat weak. At the EU level, there is a clear need for further discussion of genetic testing and genetic information. This will need to take account of not only the implications for insurance but also the wider social and ethical dilemmas, such as confidentiality, discrimination, changes to the doctorpatient relationship and the impact on public health which the advances in genetic science pose. References 1 Kaufert, P.A. (2000) Health policy and the new genetics. Soc. Sci. Med. 51, 821–829 2 Holtzman, N.A. et al. (1997) Predictive genetic testing: from basic research to clinical practice. Science 24, 602–605 3 Murthy, A. et al. (2001) Genetic testing and insurance. J. R. Soc. Med. 94,57–60 4 Genetics and Insurance Committee (2000) Decision of the Genetics and Insurance Committee concerning the Application for approval to use Genetic Test Results for Life Insurance Risk assessment in Huntington’s Disease. London, Department of Health 5 Human Genetics Advisory Commission (1997) The implications of genetic testing for insurance. Human Genetics Advisory Commission, London 6 MacDonald, A.S. (1997) How will improved forecasts of individual lifetimes affect underwriting? Phil. Trans. R. Soc. Lond. B352, 1067–1075 7 Thomas, R.G. (2001) Comments regarding additional information requested from the insurance industry. Response to the Human Genetics Advisory Commission Public Consultation 8 Hall, M.A. and Rich, S.S. (2000) Laws restricting health insurers’ use of genetic information: impact on genetic discrimination. Am. J. Hum. Genet. 66, 293–307 9 House of Commons: Science and Technology Committee (2001) Genetics and Insurance. Fifth Report. London: The Stationery Office 10 British Medical Association (1998) Human Genetics: Choice and Responsibility. Oxford: Oxford University Press 11 Vineis, P. et al. (2001) Misconceptions about the use of genetic tests in populations. Lancet 357, 709–712
Elias Mossialos* Anna Dixon European Observatory on Health Care Systems, London School of Economics and Political Science, Houghton Street, London, UK WC2A 2AE. *e-mail: [email protected]
TRENDS in Molecular Medicine Vol.7 No.7 July 2001
323
Science & Society
Genetic testing and insurance: opportunities and challenges for society Elias Mossialos and Anna Dixon The increased availability of genetic tests poses new challenges to society. Here, we address the wider implications of genetic testing, with an emphasis on the markets for insurance. It also considers issues such as confidentiality, patient autonomy and fear of discrimination and the doctor–patient relationship.
The development of gene technology is likely to influence every aspect of modern society, redefining the scope of one’s ‘identity’ and changing the face of disease. Advances in human genetics bring challenges as well as opportunities. The controversy over genetics arises, not merely because of its infancy, but from its complexity and influence on religion, culture and other non-scientific areas1. As a result, many governments have attempted to regulate the use of genetic information (derived from genetic tests) in the hope that a balance can be struck between the public’s fear of discrimination or stigmatisation, the desire of the insurance industry to prevent fraud or financial instability, and the need of scientists to conduct research. Here we discuss the wider implications of genetic testing, with an emphasis on the markets for insurance. Information about our genetic make-up is not new and is not simply a product of recent scientific tests. For many people knowledge of their family history of disease has long presented clues to their own genetic inheritance. Indeed, such information has been used routinely by insurers as a means of assessing a person’s probability of making a claim. However, as tests become more numerous, cheaper and more accessible, many more people will have information about their genetic make-up (though not all available tests are of proven validity or accuracy)2. In the context of the insurance market such information raises a number of concerns, namely adverse selection and the risk this poses to the insurer and discrimination by insurers against those with high or certain probability of claiming3. http://tmm.trends.com
There has been much deliberation in the UK about the issue of genetics and insurance. The Department of Health’s Genetics and Insurance Committee (GAIC) has approved so far the use of genetic test results for Huntington’s Disease (HD) by life insurers. They are currently considering the use of genetic testing for early onset Alzheimer’s (for which there are currently two tests under scrutiny) and hereditary breast and ovarian cancer for a range of insurance products. GAIC’s remit is restricted to an examination of clinical and actuarial relevance of genetic testing for insurance purposes and it is the task of the Human Genetics Commission to determine what other regulatory provisions need to be put in place4.
Insurers claim that disclosure of existing test results by applicants is necessary to avoid exploitative insurance purchasing. Insurers fear that if applicants withhold information about their genetic status they might act fraudulently, and might insure themselves for excessively large sums of money. On the other hand, the requirement to disclose the results of genetic tests means people with an adverse test result are open to discrimination on the basis of genetic information and could face excessive premiums, significant exclusions or find it impossible to obtain insurance. Indeed there are already examples of people having been refused insurance on these grounds.
There is little evidence to support the insurers’view that patients with high risk over-insure in life insurance markets. It was argued that the insurance industry suffered in the 1980s, when individuals knowing they were HIV+ took out insurance cover that they would not normally have taken out, without disclosing their HIV status. However, as the 1997 report from the Human Genetics Advisory Commission (operational from December 1996 to December 1999) concluded5, ‘the insurance industry could currently withstand limited adverse selection that might occur as a result of non-disclosure of genetic test results for life insurance’. MacDonald estimated that if life insurance companies refrain from using genetic test results in underwriting, the industry will face additional costs but the magnitude of these costs will be nearer to 10% than say 100%6. Thomas estimated that a 10% increase would be indiscernible within the much larger variation that already exists between rates offered by different companies7. At the EU level, despite the introduction of legislation to harmonise the insurance market, there has been no binding legislation on genetics and insurance. The European Parliament in its 1992 Recommendation R (92) 3 on Genetic Testing and Screening for Health Care Purposes (which is not legally binding) states that insurers should not have the right to require genetic testing, or to enquire about results of previously performed tests, as a precondition for the conclusion or modification of an insurance contract. The lack of EU regulation means that it has been left to individual countries to enact legislation to limit the use of genetic information for the purposes of insurance. Belgium was the first country world-wide to prohibit the use of genetic test results – applicants are prohibited from submitting the results of genetic testing to insurers, whatever the results. The law also prohibits physicians from using genetic testing in medical examinations for insurance purposes. Use of genetic test results for the purposes of insurance is
324
Forum
prohibited in Austria, Denmark and Sweden. Through its Civil Code, France has enacted human rights regulation that limits the use of genetic tests to medical and scientific research purposes. By contrast, Germany requires by law that applicants to insurance companies disclose genetic test results. In the Netherlands, genetic information also includes family history information about hereditary diseases, and the use of this information is not permitted except where large amounts of coverage are being sought3. In the USA over the past decade, 28 states have passed laws that either restrict insurers’ use of certain genetic information or completely ban the use of genetic data for underwriting purposes. These laws sought to protect the interests of patients from the outset, by shaping industry norms and attitudes8. In an attempt to overcome the problems that bad risks will over-insure, several measures could be introduced to ensure cover for those with adverse genetic test results while protecting the insurers from fraudulent behaviour. The Netherlands has specified a value of life insurance up to which disclosure of genetic information is not required. A similar cut-off was defined in the UK decision, whereby insurers might require disclosure of HD genetic test results for the purposes of mortgage-related life insurance in excess of £100 000. Early in May 2001, insurers agreed to a new limit of £300 000 for life insurance, despite earlier resistance to such a change (see BBC Online, http://news.bbc.co.uk/hi/english/ health/newsid_1307000/1307175.stm). An alternative would be subsidisation of life insurance whereby modest premium increases would be levied on all subscribers to ensure cover for the small minority of people requiring special consideration. Another suggestion is the establishment of a reinsurance fund, through which the policies of individuals with a genetic predisposition are reinsured. The question arises as to whether such a fund should be also financed by the government. These somewhat cumbersome measures being debated arise from the insurer’s argument that adverse selection might occur. However, the wider social and ethical implications of genetic testing for insurance purposes should also be taken into account when deciding about the regulation of genetic information. A requirement to disclose genetic information has implications for http://tmm.trends.com
TRENDS in Molecular Medicine Vol.7 No.7 July 2001
confidentiality and patient autonomy and might deter individuals from having a test because of fear of discrimination. As such it could touch on privacy laws, discrimination legislation, public health, and the organisation of medical care. Patients will want guarantees that genetic information will not be disclosed. Moreover, a balance should be struck between the privacy of patients and the need of medical research to access data and the right of affected relatives to know that they might also be at risk. The growing use of genetic testing will require a re-examination of current health information management protocols to prevent the misuse of test results. Lack of such guarantees could create severe disincentives for genetic testing in general. Fears of discrimination or isolation, and now the recognition that insurance might not be available, have caused patients to forgo a test that would otherwise prove medically beneficial9. The impact of a deterrent effect can be devastating for patients, the research community and the area of preventive medicine. Alternatively, people might seek such tests outside the doctor–patient relationship. This could have severe implications for both the health of the patient and the provision of health services. The nature of genetic testing makes the establishment of one standard with regard to familial disclosure difficult and doctors could be torn between their duty to protect a patient’s confidentiality and informing family members about a potentially life threatening disease. Fear and unease could force patients to conceal their results from their physicians and families, posing dire consequences for early detection and prevention efforts. It is also widely held that the complexity surrounding genetic testing demonstrates a clear need for extensive pretest and post-test counselling10. The insurers’ view that genetic information is important to accurately assess the future risk of an individual making a claim also perpetuates a deterministic view of disease. In fact, defining the clinical utility of a genetic test is a rather complex task. Single genes can have several mutations occurring anywhere, all with varying levels of influence. Moreover, the time of onset is often unpredictable, further complicating early detection and prevention efforts using genetic test results. Furthermore, as Vineis et al. point out11, although rare and
highly-penetrant mutations in cancer genes could act with no interaction with external factors, gene–environment interactions are intrinsic to the mode of action of low-penetrant genes. It is important, therefore, for policy-makers and other stakeholders to recognise that in many cases the causality between a particular gene and its associative illness is somewhat weak. At the EU level, there is a clear need for further discussion of genetic testing and genetic information. This will need to take account of not only the implications for insurance but also the wider social and ethical dilemmas, such as confidentiality, discrimination, changes to the doctorpatient relationship and the impact on public health which the advances in genetic science pose. References 1 Kaufert, P.A. (2000) Health policy and the new genetics. Soc. Sci. Med. 51, 821–829 2 Holtzman, N.A. et al. (1997) Predictive genetic testing: from basic research to clinical practice. Science 24, 602–605 3 Murthy, A. et al. (2001) Genetic testing and insurance. J. R. Soc. Med. 94,57–60 4 Genetics and Insurance Committee (2000) Decision of the Genetics and Insurance Committee concerning the Application for approval to use Genetic Test Results for Life Insurance Risk assessment in Huntington’s Disease. London, Department of Health 5 Human Genetics Advisory Commission (1997) The implications of genetic testing for insurance. Human Genetics Advisory Commission, London 6 MacDonald, A.S. (1997) How will improved forecasts of individual lifetimes affect underwriting? Phil. Trans. R. Soc. Lond. B352, 1067–1075 7 Thomas, R.G. (2001) Comments regarding additional information requested from the insurance industry. Response to the Human Genetics Advisory Commission Public Consultation 8 Hall, M.A. and Rich, S.S. (2000) Laws restricting health insurers’ use of genetic information: impact on genetic discrimination. Am. J. Hum. Genet. 66, 293–307 9 House of Commons: Science and Technology Committee (2001) Genetics and Insurance. Fifth Report. London: The Stationery Office 10 British Medical Association (1998) Human Genetics: Choice and Responsibility. Oxford: Oxford University Press 11 Vineis, P. et al. (2001) Misconceptions about the use of genetic tests in populations. Lancet 357, 709–712
Elias Mossialos* Anna Dixon European Observatory on Health Care Systems, London School of Economics and Political Science, Houghton Street, London, UK WC2A 2AE. *e-mail: [email protected]