Health Policy, 18 (1991) 197-206

0 1991 Elsevier Science Publishers B.V./0168-8510191MI3.50 197

HPE 00420

Review

Genetic predictive testing and private insurances

Henriette D.C. Roscam Abbing Department of Health Law, University of Limburg, Maastricht, The Netherlands

Accepted 28 April 1991

Summary

Genetic information is a potential tool for selection of job applicants and of candidates for insurance. Social implications of genetic information may represent a threshold for the access to health care facilities. Some of the issues related to the use of predictive genetic information by private life and health insurance companies are discussed. They include the potential threat for the privacy of the individual and his relatives, the pressure to undergo genetic testing and the social consequences of the use of genetic information by private insurance companies. The justified financial interests of insurance companies and the interests of the individual to have his privacy protected and to be able to partake in social attainments have to be brought into balance. A ban on genetic testing in connection with access to insurances and a limitation to the use of existing genetic information have been suggested by the Dutch Health Council. This approach to the problem should be adopted throughout the European Communities, so that medical progress does not turn out to be against the interests of the consumer.

Private insurance; Genetic predisposition; Social function; Adverse selection

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Address for correspondence: Prof. Dr. H.D.C. Roscam Abbing, Department of Health Law, University of Limburg, P.O. Box 616, 6200 MD Maastricht, The Netherlands.

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Introduction

Medical know how and medical technology are expanding rapidly. The advances in medical science are undoubtedly beneficial to individuals and society. The outcome of the introduction of new techniques in health care is, however, not only positive. There is another side to the coin too. When diagnostic procedures outpace treatment possibilities, caution is particularly in place. Their application can be very intrusive, especially when predispositions for a fatal disease are involved. If treatment possibilities are not (yet) available, there is a reason not to introduce large scale screening programmes. In the field of genetics, for instance, present governmental health care policies are concentrating on individual testing and counselling, whenever forgoing offspring or abortion are the only answers to a given condition.

Whereas the introduction of diagnostic (predictive) procedures in health care requires specific attention for the individual’s legal position in case the disease is untreatable, their application outside the health care sector gives rise to even more complex issues. The discussions on HIV-testing have clearly demonstrated the difficulty to bring into balance justified interests of society or third parties with the necessary protection of individual rights and freedoms.

Genetics is one of the fields in which significant results are attained. Genetic diagnostic testing is becoming more and more reliable.

Knowledge about ones genetic constitution is also extremely sensitive. It is related to the genetic characteristics and to the genetic predisposition of a person. It reveals also information on relatives and it has implications for ones offspring.

The identification of a genetic predisposition without treatment options in health care creates serious problems of privacy, medical secrecy, the right to know, the right not to be informed and the like. Genetic information presents even more complex ethical, legal and social issues when used outside the health care setting. Genetic information is a potential tool for selection of job applicants and of candidates for an insurance. If genetic testing is used as an instrument for attribution of societal attainments, additional questions rise on the freedom to decide to undergo testing or to disclose information; discrimination hires around the comer. The often serious consequences of the use of predictive genetic information for a person’s societal functioning will also discourage people from seeking genetic advice and genetic counselling. Social implications thus represent a threshold for the access to health care facilities.

Little wonder that governments are looking for solutions to overcome the ethical, legal and social problems related to genetic information. Likewise, the European Community (EC) has expressed its concern about the possible misuse of genetic information. Therefore, the socalled ‘human genome research project’, which was approved by the Council of Ministers of the EC on the 29th of June 1990, also includes funds for studies on ethical, social and legal aspects of human genome analysis.

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Scope of the article

This article [I] discusses some of the issues related to the use of predictive genetic information without treatment outlook by insurance companies (life and health). Recent discussions on this subject in The Netherlands are reflected upon particularly. They may be held as an example for national policies to be followed in this respect, though it is recognized that national policies largely depend on the social and cultural setting of a country. The impact of the realisation of an internal market in the frame of the EC is also reflected upon.

Because there are some similarities between predictive genetic testing and HIV- testing, solutions suggested to avoid negative social consequences of HJV-testing are referred to also.

Despite the apparent differences between seropositivity and genetic predisposi- tion, they have at least one common demeanour: the same individual and social human rights issues are at stake. In that sense, policies adopted in respect to HJV- testing are a test case of how seriously society considers human rights. Such policies can set a precedence with bearings on genetics.

Human rights

The individual human rights issues involved with genetic testing (right to privacy and integrity, non-discrimination principle) are universal, though their appreciation can be influenced by the cultural context of a country. International human rights instruments are rather clear on their meaning. Jurisprudence of, for instance, the Human Rights Court in Strasbourg, established in the frame of the European Convention on the protection of human rights and fundamental freedoms (Council of Europe, 1948), clearly delineates the margins for their restriction.

The social human rights, on the other hand, are less clearly and precisely formulated in the human rights conventions (such as the European Social Charter, 1961 and the UN Covenant on economic, social and cultural rights, 1966). They serve as indicators, without specifying the circumstances under which the benefit is to be obtained. Hence, the social consequences of the use of genetic information vary from country to country.

Pertinent social rights are the right to work, the right to social security, the right to health care. Among the factors which influence the possible bearing of genetic information on social human rights in a country are the existence of a public health insurance system, the contribution of employers to insurance of their employees in case of a predominant private health insurance system, the necessary reliance upon life insurances by the free professions, the existence of a socalled social ‘safety network’ and the like.

The consequences for the individual of genetic information are more salient with private health insurances, [2] than in the case of a public health insurance system. The latter guarantees coverage, generally without admission conditions, whilst solidarity prevails. Private health insurances take into account individual

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risk factors; risk classification limits solidarity to certain groups; financial interests of insurers prevail. They are in fact not adequate for unusual epidemics or very expensive diseases. In those cases insolvency evidently cannot be solved through state insurance guarantee funds [3].

The U.S.A., for instance, is known for a predominant private health insurance market, with large contributions by employers, and for a comparably small social security and social policy coverage. The Netherlands, on the other hand, knows a predominantly public health insurance system (in the foreseeable future to cover the entire population), as well as a comparably high and broad social ‘safety net work’. Therefore, the use of genetic information in relation to health care insurance is much more topical in the U.S.A., than it is in The Netherlands. Regarding life- insurances, the issues are, however, comparable. Life insurances are always private insurances.

Social functions of private insurances

It is only a recent phenomenon to consider private insurance as a subject of social policy. The development of (predictive) medical tests has much contributed to recent discussions on social goals of private insurances. The more precise and accurate they become, the more difficulties one encounters to partake in social attainments. This is all the more serious when ones possibilities for social functioning depend on adequate private insurance coverage. This development may ultimately result in ‘have’ and ‘have nots’. However this may be, if no measures are taken, medical testing will in any case aggravate the problem of sharing financial responsibilities between private and public programmes [4].

The issue at stake is how to balance the financial interests of insurance companies on the one hand and their social responsibilities on the other hand. It is a generally accepted policy for private insurance companies to estimate their risks through medical examination. The pertinent question is where and when to draw the line. This question should also be answered against the background of individual and social human rights. What kinds of discrimination are essential and what kinds of underwriting practices are contrary to other (social) goals? When does the public interest outweigh the underwriting interests of insurers [5]? At what moment in the risk assessment process are the applicant’s rights to self-determination and privacy violated? Financial interests of private insurance companies are not unlimited. They become unjustified when they result in practices which are socially unacceptable. Coercion of the candidate may in some circumstances represent infraction on human rights. Hence, the increasing pressure on insurers to act in the public interest and the pressure on governments to use the law as an instrument to protect the public interest if voluntary measures regarding the use of genetic information on the side of the insurers do not suffice.

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Insurance, HIV-testing and genetic information

To some extent, the use of genetic information by insurance companies is comparable to their use of information on seropositivity in relation to AIDS.

Among the similarities are the following: like in the case of the majority of the genetic tests, the HIV antibody-test is predictive; it has a long latency period; there is sofar no cure available; and the disease is fatal. Differences are that HIV- infection is often contracted through personal behaviour. Genetic constitution is outside ones control.

In both instances individual rights (right to privacy, free informed consent to undergo testing, the right not to know, the non-discrimination principle) are at stake, though in case of genetics their impact is broader, because it always includes information on relatives.

In both instances, the use of information derived from testing by insurance companies can have serious consequences for the individual. This is the more pressing where such information is not sought after by the applicant for an insurance. In case of positive test results, the information thus obtained, can intrude upon a person’s privacy and ultimately disrupt his possibilities for normal social functioning: it may result in uninsurability and in refusal for employment. The consequences of the insurance practices will in any case prevent people from seeking medical advice or from participation in health research programmes.

In both cases insurance companies have a financial interest to counter adverse selection.

A difference is, that the AIDS epidemic is a new disease, whereas genetic disposition has always been there, though before not specified or recognised as such.

Thus, HIV-testing is performed by insurance companies in order to exclude inappropriate financial risks. Genetic information will enable insurance companies to improve and/or sharpen their risk classification, resulting in surcharging or denying coverage. Financial integrity of insurers (a condition imposed by law), as well as positive discrimination of persons at risk for a specific condition or disease (persons with other medical conditions, such as cancer, are likewise treated unfavourable) are the main arguments for the underwriting practice by insurance companies in the case of HIV-testing [6]. Their claim is their right to discriminate fairly [7].

Leaving aside the adverse selection issue, not using genetic information does not jeopardize the solvency of insurance companies: genetic risks have sofar - though implicitely - always been taken into account by insurers. Because in practice genetic risks have thus hitherto been part of solidarity, it is at least questionable whether not using genetic information for the underwriting practice would really be discriminatory (in the sense of positive discrimination) in relation to persons with other medical conditions.

Various options

In respect of HIV-testing practices, variety outruns uniformity. To give some examples: in New York State, since the Court of Appeals pronouncement of December 1990, private health insurance companies may test applicants for the AIDS-virus and reject those who are infected. California has a law prohibiting insurers from considering the result of a HIV-test. In some countries (like Finland and Western Germany), seropositives are excluded from life insurances. To prevent adverse selection, most countries (among which The Netherlands) accept the HIV- test, if the sum to be covered by a life-insurance exceeds a certain amount of money [8].

Unlike the case of HIV-testing, there is rather broad consensus that the use of genetic information by insurers should be limited. This applies in particular to the identification of genetic predisposition without treatment options. The main argument held in favour of a restrictive policy is that genetic testing has too far reaching consequences for the individual and his relatives to be socially acceptable.

Categorization of insurance risks on the basis of hereditary factors has not been usual in the past; this must remain the case in future. “The freedom to remain ignorant of genetic information concerning his future, or even not to allow such information to be collected, is central to his identity and must remain outside the sphere of business organization’s information interests” [9]. Acceptance of the use of genetic predictive testing and existing information in the frame of a private health insurance is unacceptable because of its consequences for the individual, unless an adequate public coverage scheme can be offered. Uninsurability for health care costs is contrary to the universally accepted social right to health care.

In the case of life insurance, the situation is different. A total ban on genetic information in connection with access to a life insurance is unrealistic, because it stimulates the adverse selection in case the candidate has knowledge of genetic data. Such a solution underlines the tendency of insurance companies towards individualisation and risk-diversification, thus undermining their social function even further and could result in an unjustified burden on taxpayers. It also faces numerous people with harmful knowledge and diverts them from useful health care services.

The Dutch solutions

To overcome the negative consequences for the individual, while respecting at the same time the justified interests of insurance companies, the Dutch Health Council, a scientific advisory body of the government, has suggested various alternatives [lo]. In respect to genetic testing they include: - testing is permitted, unless it may produce distressful information.

This option presents some difficulties, if only because the appreciation of distressful information is very subjective. - testing is prohibited, unless the insurance coverage requested exceeds a custom-

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ary and appropriate level. The advantage of this solution is that it limits adverse selection, for instance in case data of relatives are a serious indication for genetic disposition. A drawback is that there is a difficulty of setting an equitable ceiling. -testing is prohibited in all instances.

The advantage is that it meets optimally the interests of the individual. The drawback is that it does not prevent adverse-selection in the case of a serious indication for genetic disposition (family-history).

In respect to the use of existing genetic information the suggestions run as follows: -prohibition of asking for genetic information.

The advantage is that the privacy of the applicant is not intruded upon. The counter- argument is that non-genetic information can also be predictive and can violate privacy. Moreover, it leaves ample room for adverse-selection. - limitation of the disclosure requirement to less serious risks.

The advantage is once again the proportional privacy-protection of the individual. Among the disadvantages are that it hardly takes insurers interests into account and that the appreciation of seriousness is subjective. - limitation of the disclosure requirement to ‘certain’ risks.

The argument runs more or less as follows. In case the realisation of the risks are uncertain, it is somehow inappropriate to take them into account in the underwriting policies of the insurance companies. This option has been suggested in a report on gene technology drawn up by a research committee of the West German parliament [ll]. Among the difficulties of this option are: the definition of ‘certain’ and ‘uncertain’, a growing number of hitherto uncertain prognoses will become certain with advances in genetic testing and the like. - no limitation of the disclosure requirement, but no consequences for the insured

person, unless the risk is realised within a set period of time. This option leaves the risk for adverse selection intact. The setting of a time

period is, moreover, somehow arbitrary and discriminatory. - limitation of the disclosure requirement to a certain level of insurance.

The rationale is the same as indicated under the suggested testing option. The Dutch Health Council comes to the conclusion that there should be a total ban on genetic testing in connection with access to insurances. (In case a medical ex- amination incidently reveals genetic information the report suggests that insurance companies may take such information into account.) The use of already existing genetic information should be limited to situations where the requested coverage exceeds a certain financial limit, appropriate to the applicant’s social and financial circumstances. Arguments are that a requirement to undergo genetic testing in the case of an insurance contract does not leave any room for a personal, free decision to be informed about one’s genetic constitution, it would signify an excessive in- fringement of personnel self-determination, it may violate the privacy of relatives, it may create psychological drawbacks, insurance companies do not need specific protection because genetic conditions have always been present, adverse selection is sufficiently prevented, insurance candidates whose social functioning depends on

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adequate insurance coverage are in need of protection and the like. The solutions of the Dutch Health Council put a halt to the ongoing process of

individualisation and differentiation in connection with access to those insurances which somehow represent a social function. It stresses the solidarity aspect, which is part of an insurance scheme also, it excludes the likely effect of a medical exam- ination, namely to turn the candidate for an insurance into a patient (medicalisation of society), the duties of the candidate for an insurance are not disproportional to the goal to be attained, the privacy is protected, the negative consequences for the insurance companies are sufficiently countered, the free access to genetic testing and counselling as part of health care is secured, the participation in health research programmes on genetics is not unduly hindered and the like.

In a recent report on medical examination outside the health care sector, the Dutch medical association (Koninklijke Maatschappij voor de Geneeskunde, KNMG) comes to the same conclusions. The association is of the opinion that a medical doctor has a duty to prevent harm. Informed consent does not always suffice. In case of medical examination for insurance purposes, any medical doctor must be aware of the consequences of his diagnostic actions for the physical and physic integrity of his client. These put a limit to his medical actions, also in the case of informed consent. Societal consequences ought to be taken into account by the medical doctor. Like the Dutch Health Council, the medical association rejects predictive genetic testing in the frame of medical examination for insurance purposes. It accepts the use of existing predictive genetic information only in the case of a disproportionate coverage demand by the candidate of an insurance [ 121.

Implications at the level of the European Communities

So far, the association of life insurances and the Dutch government have agreed upon the course to be followed on basis of voluntariness: no genetic testing will take place in connection with access to insurances, existing genetic information ought only be disclosed when the insurance level is set above fl. 200,000.

In the frame of the European (EC) internal market, with its free circulation of goods, services and personnel, however, such a voluntary agreement does not bind insurance companies outside The Netherlands. The relevant EC Insurances- Directives’ are very strict on the limitations to the free circulation target of the EC. National limitations to insurance policies can be upheld only, if laid down by law, provided the conditions clearly serve the public interest and provided they do not constitute an indirect obstacle to the free trade objective. Consequently, the realisation of the EC internal market by the year 1992, necessitates specific action in order to reach the objectives of a reasonable and acceptable selection policy regarding insurance-admittance, as for instance set by the Dutch government in relation to genetic information. Preferably, such action is taken at the EC level,

‘79/267; 90/619 on life insurances; 73/239; 88f357 and a third one, which was approved in February 1991, for other insurance schemes.

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with a view to provide the consumer with the same level of protection throughout the EC. Moreover, it is likely that EC ruling is necessary also to safeguard its human genome research project. So far, discussions on limitation as meant here, have not yet started. This is, however, unavoidable in the context of the EC internal market.

Concluding remarks

The increasing possibilities for precise predictive diagnostic procedures are a tool for private health and life insurance companies to calculate their risks more precisely. Genetic predictive testing causes numerous negative consequences for the individual, as long as no treatment is available, particularly when the disease or condition is fatal. If no action is taken, there will be substantial drawbacks on individual and social human rights. The social function of life and health insurance schemes can not be disregarded anymore. The protection of individual and social human rights demands appropriate (legislative) efforts to achieve their objectives. This applies in particular to genetic information because it is a potential selection method for private (health and life) insurance companies. Whhin the European Communities the consumer can be protected adequately only, when common limits are set to possibilities for risk-selection by insurance companies. Also the EC has obligations in respect of individual and social human rights. For private health insurances this might imply a total ban on the use of genetic information as a selection instrument. The suggestions of the Dutch Health Council on the policies to be followed regarding life insurances represent a reasonable balanced solution which protects the interests of both parties. It deserves follow up not only by the Dutch government, but also at the EC level. The Dutch medical association has set an example in producing a report on the responsibilities and duties of medical doctors regarding medical examinations outside the health care setting. It constitutes a useful basis for further discussion among members of the medical profession at an international scale.

Only a common effort of all parties involved can guarantee that medical progress does not turn out to be against the interests of the consumer.

References

1 This article is inspired by two reports, namely a report of the Dutch Health Council “Genetics, science and society” (1989) and a research report on genetics and life insurances, Institute for health care, University of Maastricht (1990).

2 Paton, C.M., Medical testing and health insurance, BMJ, 298 (1989) 134-135. 3 Nelson, D.K., AIDS and life insurance, a look beyond the testing issue, AIDS and public policy

3, (1987) 27. 4 C.R. Paton O.C. 5 Hiam, P., Insurers, consumers and testing: the AIDS experience, Law, Medicine and Health Care,

15 (1987/88) 4, 212-222. 6 P. Hiam, O.C. 7 Bergkamp, L., Life insurance and HIV testing: insurance theory, discrimination and solutions.

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Medicine and Law, 8, (1989) 573. 8 Duynstee-Bijvoef W.E.M., Roscam Abbing H.D.C. and Nederveen van de Kragf C.J.M., Juridische

aspecten genetica en levensvetzekering, Rijksuniversiteit Limburg, Vakgrcep Gezondheidstecht, Maastricht, November 1990, nr. 14, Hst. 5.

9 European Parliament, Committee on Legal Affairs and Citizen’s Rights; the ethical and legal problems of genetic engineering, 24 July 1987, dot. PE115.268, 33.

10 Dutch Health Council, Genetics, science and society, The Hague, 1989. 11 Chances an den Deutschen Bundestag, Mtinchen, 1987. 12 KNMG, risicokeuringen in medisch perspectief, Utrecht, 1991.