Introduction

Genetic information or genetic test results can be used to prevent the onset of diseases, or to assure early detection and treatment, or to make reproductive decisions. This information can also be used for nonmedical purposes, such as insurance and employment purposes. Insurers might wish to use a genetic test result for underwriting, just as other medical or family history data. Employers might wish to ensure that an individual does not have a genetic risk which might affect his ability to work or which might lead to problems of safety to the individual or to others. Applicants might wish to voluntarily disclose their genetic status in order to pay cheaper premiums; or applicants who are prone to disease might wish to seek out the companies with the best benefits. The impact of the use of genetic information for nonmedical purposes justify special attention. The issues which could arise need to be very carefully assessed. Being denied insurance or charged higher premiums on the basis of genetic traits could have serious consequences and could affect individuals, families, or groups who may be already disadvantaged. The choices of the present may affect future generations.

A number of international and national committees have developed recommendations for policy-makers to protect individuals against genetic discrimination. The UNESCO Universal Declaration on the Human Genome and Human Rights (1997) states that ‘no one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity’. The 1997 Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Applications of Biology and Medicine specifies in Article 11: ‘Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited’. At the national level, the approaches used vary greatly.Footnote 1 In respect to insurance, three solutions are usually proposed: (1) prohibition of any use of genetic information by insurers outright; (2) legislation prohibiting this below a certain amount of coverage; and (3) moratoria; the adoption of moratoria on the use of genetic information has been a widespread response of the insurance industry throughout Europe. Among the countries where there is no regulation, bills have been presented or states that have ratified the 1997 Council of Europe's Convention are bound by it.

Despite the desire to protect individuals against genetic discrimination and consequently to restrict the use of genetic information for nonmedical purposes, it seems necessary to find a balance between the interests of insurers, those of applicants, as well as those of other policy holders. This appears especially relevant and sensitive under health-care systems and welfare sectors with increasing budgetary restrictions.

The present paper aims to examine the professional and scientific views on the social, ethical, and legal issues that impact on Genetic Information and Testing in Insurance and Employment in Europe. For this purpose, many aspects have been considered, such as the concerns of medical geneticists (II), of the insurers (III), of the employers (IV) and of the public (V), as well as the regulatory frameworks (VI) and unresolved issues (VII).

Methods

The method used for analyzing the professional and scientific views on the social, ethical, and legal issues that impact on genetic information and testing in insurance and employment in Europe was primarily the review of the technical, social, economical, and ethical aspects of advances in genetics and the concerns of parties who are involved, that is, the insurers, the employers, and the public. The existing guidelines and legislation on this topic were also reported. Then, the method was to examine the issues debated by these parties in Europe, as well as the results of discussions held during an international workshop. This workshop was organized by the European Society of Human Genetics Public and Professional Policy Committee in Manchester, United Kingdom, February 25–27, 2000.

The purpose of the workshop was to identify, from a professional viewpoint, the most important/pressing/burning ethical issues raised by genetic information and testing in insurance and employment in Europe. The formal workshop presentations covered the following themes: the fundamentals of genetics, of insurance, family histories, actuarial relevance and genetic testing and employment issues. Small multidisciplinary groups were convened to take these discussions further, in particular to consider the specific issues involved in employment, life insurance, private medical insurance, long-term care and critical illness insurance, and total permanent disability and income replacement insurance. Their initial task was to explore the insurance needs and rights in the countries represented and to consider the extent to which these needs were currently being met. Following the small group sessions, conclusions were fed back to the whole group where there were opportunities for further discussion.

A group of 47 experts from 14 European countries was invited. These experts were representatives of the seven following sectors:

  1. 1)

    Medical Genetics

  2. 2)

    Human Genetics Societies

  3. 3)

    Ethical, Legal and Social Issues

  4. 4)

    Support Groups

  5. 5)

    Biotechnology/Pharmaceutics

  6. 6)

    Insurance/Employment

  7. 7)

    European Union Institutions

A first background document was discussed during the workshop. A second document, including discussions of the workshop, was sent for comments to representatives of the human genetic societies and European experts in the fields of insurance and genetics, as well as to all ESHG members. This document was also put on the ESHG website (www.eshg.org) for public consultation and discussion. The final document was approved by the ESHG board.

Concerns of medical geneticists

Complexity of genetic tests

Genetic tests are available for two forms of genetic diseases: monogenic and multifactorial diseases. Monogenic disorders are rare but highly penetrant; the genetic test will indicate whether a person has or will get the disease. Presymptomatic testing identifies healthy individuals who may have inherited a gene for a late-onset disease and if so will develop the disease if they live long enough. Multifactorial diseases are frequent and most likely triggered by specific combinations of functional DNA polymorphisms interacting with the environment in ways that are subject to behavioral changes. Susceptibility testing identifies healthy individuals who may have inherited a gene that puts them at increased risk of developing a multifactorial disease, although these individuals may never develop the disease in question. In these situations, the most that the genetic test can do is to show a propensity to a disease.1,2

Genetic testing classifies people into those who have the mutant gene and those who do not have it. Now, a mutant gene is not a disease. Genetic disorders show different degrees of severity and diverge with respect to the age of onset. Some genetic disorders affect people with near-certainty but others not. Predictions are therefore complicated by these phenomena.

Finally, our ability to identify individuals at risk for genetic diseases often exceeds our ability to prevent or treat the diseases.3,4 This has been described as the ‘therapeutic gap’ and as a reason for tension between policy-makers and health professionals.5 The use of computerized medical data banks within large companies could exacerbate this problem, genetic information becoming not only a medical fact but also a disease.6,7

We are forced to note that genetic tests present some limits, including the possibility of uninformative results, the inability to predict the exact age of onset or the severity of symptoms and, in the case of multifactorial diseases, the inability to predict if the individuals will develop the disease in question. In fact, genetic tests cannot account adequately for the external factors, which can be as important as inborn characteristics.3,6,8 Tests using genetic markers linked to a disease gene (as opposed to testing directly for disease-causing mutations) are not totally reliable since they provide only statistical probabilities based on the presumption that people have inherited genes with the identified markers. In other respects, a clear distinction must be drawn between genetic tests carried out in a research setting (aimed at establishing new genetic tests or developing quality control of tests) and those carried out in clinical practice. Research projects can be experimental and the results of the tests can be uncertain.

Calling ethical principles into question

Different arguments suggest that there is something special about genetics, and yet ethical principles in medical genetics are the same in medicine, even if this has been questioned. These principles are: respect for the autonomy of persons, beneficence, non-maleficence, and justice. At present, in regard to medical genetics, these principles are not applied with equal force around Europe. The principle of nonmaleficence which aims at avoiding and preventing harm to persons, is called into question if genetic information is used for discrimination or favoritism in insurance and employment. The principle of justice, which may consist in distributing benefits and burdens fairly and with equity, varies depending on whether healthcare is founded on the principle of social solidarity or on the basis of mutuality. Although the market for private health insurance in Europe is small and in some countries nonexistent, the possible use of genetic information in insurance and employment has gradually generated debate and increasingly causes concern.9,10,11,12,13,14,15

Furthermore, medical geneticists' concerns extend beyond the traditional ethical guidelines in medicine. For instance, genetic testing for insurance and employment purposes could disturb family relations. Family cooperation is often necessary to detect genetic problems, but genetic information may affect an entire family rather than only one individual, and the choices of the present may affect future generations. Genetic information links the members not only of families but also of whole communities. Genetic disorders are often over-represented in ethnic groups and intensive genetic research on some populations could exaggerate the presence of problems.6,16,17

Concerns of the insurers

Genetic information through family history was already used by some insurance companies before anyone considered genetic testing, and individuals were covered or denied coverage or charged higher premiums according to family history. Nevertheless, the progress made in predicting diseases alters the information available with regard to the risk of disease. Genetic information contains more certainty than information traditionally gathered by insurers to investigate the existence of diseases running in the family.6,18 This may have important consequences for insurance industry.

Goal of insurers

The insurers' goal is to maximize their profits. This is usually reached with an increased number of people under coverage. In this regard, developments in medical science have resulted in an increase of life insurance sales.19 In other respects, everyone carries some potentially abnormal genes and insurers will not wish to deny coverage to a significant segment of the population. However, the insurance industry would like to use genetic information as just part of the (predictive) information that they should be able to use less for deciding to accept a private, voluntary application, than for setting the premium level according to the individuals' risk, and for avoiding the possibility of adverse selection.

Underwriting

Underwriting is the method used to classify people according to their risk. Insurers classify the risk by asking questions and through medical investigation. The questions sometimes cover the medical histories of family members. Depending on the case and the amount of coverage involved, medical questions might be followed by medical tests or complete medical examinations.20,21

In the underwriting process, the expectations of individuals in relation to longevity and health are quantified and expressed as statistical probabilities. Insurers can predict that the overall mortality rate of a specific group of people, classified in the same substandard risk category, will be higher than the mortality rate in the general population.7 Usually, underwriting leads to classification in three groups: standard, substandard, and uninsurable. Individuals in the first group have few problems getting insurance. Individuals in the second group must pay higher than average premiums, based on the risk they represent. Individuals in the third group are excluded because the cost of their coverage is unquantifiable or would exceed any reasonable premium.

Experience shows that the assessment of substandard risks due to genetic information is proved fair since the observed mortality is very close to what had been expected. Requesting genetic tests from insurance applicants could then constitute another source of information for insurers. This would permit to classify individuals more accurately in various categories of risk, or to assess risk premiums more accurately. Genetic testing would enhance equity by allowing a precise calculation of which people are really in the same situation and which are not.6,18 The concept of equity in insurance means that people who have similar health or similar life expectancies should pay equal premiums and those who have worse health or lower life expectancies should pay more.

To date, insurers do not require applicants to submit to genetic testing. In some countries, this is due to legal barriers which prohibit insurers from asking for genetic tests. This is also due to the lack of information on the predictive value of certain tests and on the costs of diseases.1,6,22 But that does not mean that insurers are not using genetic information. Insurers can currently make genetic inferences from routine and well-accepted questions on family history. Insurers can use genetic information available in medical files; the registered information in medical files is usually more accurate and complete than what is known by the insurance applicants.15 Since genetics is integrated in medical practice, insurers will have access more and more to genetic information. This will allow insurers, among other things, to know whether applicants have neglected to mention that they are carriers of genetic disorders or that these run in the family.

Adverse selection

Adverse selection occurs when people have undergone testing and conceal positive test results from insurers.16 If the insured person does not disclose information which the insurer needs to know, then this disrupts the equilibrium of the relationship and the possibility of adverse selection arises. Insurers require symmetry of information. If insurers are prohibited from having access to pertinent information at the time of underwriting or when the policy is renewed, the applicants could use genetic information to abuse the insurance system, taking advantage of private knowledge of the risks they are submitting for coverage.19 The consequences of a lack of symmetry in information between insurers and applicants or insured persons could force insurers to adjust premiums. In this way, in the Netherlands, after the Medical Examination Act has been in force (1998), insurers have taken measures to prevent the risk of adverse selection by implementing premium increases in advance, by prescribing a maximization of the pension pay-out or basing payments on a maximum salary, or by including an option to increase the premium in the policy.23 Dutch insurers have also introduced waiting times for existing illnesses when issuing the insurance. This means that if, within a term stipulated in the waiting time, the insured becomes disabled or dies as a result of an illness that he had when he took out the insurance, no payment will be made. This measure does not apply for life insurance. Sweden (1999) has the same policy. In the United Kingdom (2000), the Genetics and Insurance Committee stated that the reliability and relevance of the genetic test for Huntington's Disease was sufficient for insurance companies to use the result when assessing applications for life insurance. But in October 2001 the UK government reached an agreement with the Association of British Insurers (ABI) to institute a 5-year moratorium on the use of genetic tests results up to a certain value.

Concerns of the employers

Concerns of employers and of insurers are similar. The main difference between life insurers and employers is that for employers, sickness represents a greater financial risk than death, while for health insurers, the opposite is usually the case.

Goal of employers

It is in employers' interests to have a healthy workforce. Some employers provide facilities to encourage the staff to achieve a good health, like regular medical check-ups and sport. It has been argued that if it could be demonstrated that genetic screening would encourage more healthy lifestyles, it would be possible to envisage that employers would fund such screening for their staff.23,24

Employers are particularly interested in the health of the employees for jobs where there is a substantial investment in training or for very senior positions. Different sources of information can be used to assess whether an individual has a risk of either sickness or death: medical examination, medical history, family history, age, lifestyle. Genetic testing might confirm the risk of developing a genetic disease, for which some jobs could make the person unacceptable.23,25 What would also change is that some employees would move from 50 to 0% chance and they would have opportunities which are currently denied them.

For most jobs, employers do not insist on intensive health testing of prospective employees, because the extent of the employers' investment in new employees is not great enough to warrant such expense.23 The prospective employees are simply asked to make a declaration about their state of health.

Constraints imposed on employers

The costs of any health investigation by employers are significant: if employers investigate every prospective employee, they will have to pay the investigation costs for all of them, but in only a few will the investigation show anything at all. The decision for employers, where there is a known health risk, is whether the value that employees will give to the firm justifies the risk.21,23

Many employers provide a range of health insurance coverage for their employees: sick pay, permanent health insurance, spouse's pension, retirement pensions, health-care benefits. Most employees are covered without having to provide any information about their health. But in recent years there has been some trend towards flexible remuneration packages, under which employees get some measure of choice as to which employees benefits they take. Where employees have a choice, some measure of individual underwriting is required.21,23

Although the use of genetic information might conceivably be of some benefit for employers, it runs counter to the fundamental rights of workers to nondiscrimination for health reasons and those relating to protection of privacy. For instance in France, such rights which have been reinforced by the laws on bioethics in 1994, are proclaimed in several articles in the labor and penal codes. In those countries that do not have specific regulations prohibiting or limiting employer access to, and use of, genetic information, existing antidiscrimination and privacy legislation may provide individuals with some protection.

Concerns of the public

Right to underwrite

People are becoming aware that they are exposed to global risks, such as rising unemployment, collapse of pension funds, funding problems of welfare programs, and are therefore vulnerable. In this context of cost-shifting, public funding for insurance may be threatened, while community rating in commercial insurance may happen, as for instance with private medical insurance cover in Ireland.

Private insurance is based on mutuality and consequently discriminates in setting premiums. Mutual insurance refers to the notion of forming a risk pool in which each of the members participate according to the risk they represent to the pool. The cost of the insured risk is distributed between the members of the pool, each paying its own part.26 Individuals assessed as representing a higher perceived risk may pay more, and some may be denied cover, although the great majority are treated as standard risks.13,25,27,28

Duty of disclosure

The duty of disclosure, which is established by legislation, states that the insurance applicants must declare everything relevant to their risk's appreciation and their classification.6 If the applicants have neglected to mention that they are carriers of genetic disorders or that these run in the family, this could be invoked to prove that the applicants have made a false declaration and that the contract is invalid.

The duty of disclosure raises many questions: (1) Are genetic test results always relevant for insurers? Applicants who test positive for genetic mutations in a context of research might not have health problems that are relevant for insurance purposes; (2) How relevant is it, when people neglect to inform their insurer about medical problems or conceal health information from them, if their death has nothing to do with the missing information? (3) Insurers may have access to confidential information that applicants do not want to know, thus infringing on their right not to know. (4) The duty of disclosure may also generate social pressure on a would-be applicant to have a genetic test and disclose a negative result to show that their family history does not put them at increase risk.

Fear of discrimination

The fear of genetic discrimination by insurers or employers may tip the scales against somebody seeking testing to obtain improved medical management and reassurance.29 This fear has been observed among people with a family history of Huntington disease who requested presymptomatic gene identification: people attempted to avoid insurance or employment discrimination by withholding the decision to seek testing from their primary care providers.29 People may also be encouraged not to share the result with their general practitioner for fear of disclosure to insurance companies.30 Genetic testing could then cause insurance applicants and their relatives to be rated up or denied insurance and lead to social exclusion, especially since genetic information would not only be used for insurance purposes but also employment purposes. The practice of some clinicians to advise people to buy insurance before having a predictive DNA-test highlights the current perception that people at high genetic risk of late-onset disease face the additional social disadvantage of higher premiums or application rejection.31

Regulatory frameworks

In regard to the above, two principles govern the use of genetic information and testing in insurance and employment; firstly, no one should be subjected to discrimination based on genetic characteristics; secondly, the disclosure of information to a third party or accessibility to personal genetic data should be allowed only with the individual's informed consent. These principles can be found in all international and regional texts. There is a general consensus that applicants should not undergo genetic testing as a condition of obtaining insurance.

On the contrary, national texts (legislation and recommendations) vary greatly. Three solutions are usually proposed: (1) Prohibition of any use of genetic information by insurers outright; such as Austria, Belgium, Denmark, Estonia, France, Luxembourg, and Norway. In Belgium, a notable feature of the legislation is that it prohibits the use of genetic information even in circumstances where it is to the benefit of the applicant. The rationale is to protect privacy. (2) Legislation prohibiting this below a certain amount of coverage, like in Sweden, the Netherlands, and the United Kingdom. In the United Kingdom, the government also set up the Genetics and Insurance Committee (1998) whose role is to assess the actuarial validity of genetic tests that insurance companies would like to be able to take into account in setting insurance premiums. And 3) Moratoria; Moratoria are either indefinite (Finland, Germany), or for a limited number of years (France, Switzerland), or still limited to insurance policies which do not surpass a certain value (Sweden, The Netherlands, the United Kingdom).

Among the countries where there is no regulation, bills have been presented, like in Iceland and Switzerland, or states that have ratified the European Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine are bound by it. The Council of Europe's Convention on Biomedicine upholds that the rights and dignity of humans should be respected with regard to the application of biology and medicine and have primary over the goals of science or society.

Table 1 shows the current responses to the use of genetic information by insurers in Europe (dated the 1st January 2003).

Table 1
Full size table

The ceiling system (ie ‘no questions’ asked below a certain amount) of regulation is a policy response that mitigates the problems associated with genetics and insurance. This approach protects the insurance industry against the dangers of adverse selection and, for the applicants, it permits the acquisition of social goods such as healthcare or housing. It is assumed that the risk of adverse selection only truly comes into play with large amounts of capital. This is the case in the Netherlands where insurance companies are prohibited by the Medical Examinations Act from seeking disclosure of the results of any genetic test where the amount being sought is less than 300.000 00 guilders. Although it is not a legislative decision, in the United Kingdom, the Association of British Insurers (2001) announced that its members would no longer request results of genetic tests in respect of applications for any type of insurance up to a certain value.

A system of regulation combined with a pragmatic board of examination of ongoing scientifically validated tests, like in the United Kingdom, is also another policy option. The advantage of this approach is that in an area of rapidly developing technology, a responsive system of procedural regulation can react to changing circumstances.11 Until the moratorium, GAIC had approved only tests for Huntington's disease in respect of life insurance, but a small number of additional tests was under consideration.

A further policy option is the use of moratoria. The adoption of moratoria on the use of genetic information has been a widespread response of the insurance industry throughout Europe. The rationale is that the consequences of the use of genetic information and testing on health and medical research can be studied. This practice affords the insurance industry time to formulate an alternative policy strategy. However, since moratoria are voluntary, they may only survive for as long as there are no commercial advantages to be gained in using genetic information. For instance, in October 2001 the UK government reached an agreement with ABI to institute a 5-year moratorium on the use of genetic tests results in assessing applications for life insurance policies up to a value of £500 000, and for critical illness, long-term care and income protection policies up to a value of £300 000. For an amount over those limits ABI will be able to use genetic tests results if they have been approved by GAIC. These limits will be reviewed after 3 years.

In the context of employment, there has been some public anxiety that employers may use personal genetic information to discriminate improperly against employees who are seen to be at risk of a particular illness or condition. Yet, it should not be forgotten that employers are bound to protect the health and welfare of their employees. Some countries (Austria, Estonia, France) have adopted legislation which prohibits genetic testing by employers. In other countries, such as Switzerland and the Netherlands, genetic tests can only be used by employers where there is an unambiguous health requirement for the job, or where the protection of the employee's health in the workplace calls for such a test. In the United Kingdom, where there is no legislative prohibition on the use of genetic information in employment, discrimination on the basis of an existing disability of genetic origin would be prevented by the Disability Discrimination Act 1995, but there is currently no specific legislation to prevent discrimination against asymptomatic employees.

Finally, in both insurance and employment unless genetic information becomes increasingly normalized (eg blood pressure, cholesterol, etc), the ‘consent’ of the individual to access to the medical record will limit participation in genetic testing and research, if such ‘consented-to’ access has more negative economic consequences than access to other medical information. However, the Association of British Insurers (2001) in a joint statement with the British Society for Human Genetics and the UK Forum for Genetics and Insurance, announced that the results of a genetic test taken as part of a research project need not be declared to insurers.

Issues

The following discussion has been largely inspired by the workshop organized by the European Society of Human Genetics Public and Professional Policy Committee in February 2000 in Manchester (UK) (see Methods). This discussion has then allowed the ESHG: PPPC to issue recommendations on genetic information and testing in insurance and employment (www.eshg.org).

Need for definition

Insurance contracts laws state that the contract must be written up in utmost good faith otherwise the contract may be void. This means that the applicant is under an obligation to reply honestly, without withholding information. But if the definition of what can be considered genetic information is not clear, how can an applicant reply honestly and how can an insurer ask specific questions which are relevant to risk assessment? There is a need then for clear definitions of terms used in genetics, insurance and employment, so that different professions and their clients have a common understanding of the issues. A genetic test is a test of anything that is, or potentially can be, inherited according to mendelian laws. This covers not only DNA, RNA, and chromosome analysis, but also protein truncation test and clinical examination of a patient for a mendelian condition that is diagnosable in that way.30 But does the test result have predictive value for the subject or family members? If the answer is no, there are no special features. If it is predictive for the subject but not the family, it is ethically similar to several other medical tests. Only if there are also implications for the family is there a special case. It is also important to distinguish between research and clinical genetic tests. A lot of people's worries concern tests for disease susceptibility, and these are almost always part of research, but only clinically validated tests should be considered for insurance purposes. Legislation without a precise definition of these terms may confuse insurers and applicants when underwriting or renewing an insurance policy.

Risk pooling and underwriting

A common objection is that classifying policyholders according to risk is an objectionable practice because it amounts to discrimination.32 The insurance industry argues that it is not engaged in discrimination but in differentiation. It differentiates between risk categories rather than between individuals. To date, legislators have reacted to the claim that since an increased use of genetic information will mean that some people will be refused insurance premiums, this amounts to an unjustified form of discrimination. This could then lead to the conclusion that legislation should be passed to limit the use of genetic information by insurers.

Another objection has to do with the distinction which arise between an industry based on equity and one that is based on equality. The insurance industry does not claim to be based on equality – as a social insurance system would – but rather the principles of equity, mutuality, and actuarial fairness produce a system whereby the individual consumer pays a premium which seeks to reflect the risk which she/he brings to that mutuality or risk pool. However, genetic testing skews the fairness principle because (1) some will be aware of their risk status whereas others will not and (2) because the risks associated with particular genotypes are not voluntarily assumed by individuals, but are rather the result of the luck of the draw. It has been argued that if the principle of equity in insurance is replaced by the principle of equality, this could signal the end of the involvement of the insurance industry in certain sectors of the market, notably life insurance and perhaps medical expenditure insurance. If legislators decide to intervene in this area and alter the balance of the insurance industry, efforts might be directed at finding an alternative method of producing the social benefits currently provided by the insurance industry.33

Adverse selection

More and more, people might be able to undergo confidential genetic testing and hide their results.6,32 Genetic testing will be readily available in doctors' offices and free-standing commercial laboratories. Those who will know that they are at high risk might start buying substantial amounts of insurance and insurance companies would be overwhelmed by claims. Insurers are concerned that many individuals could attempt to use genetic test results to create an estate when none would have existed prior to testing and for many people, the temptation to buy insurance under these circumstances could be irresistible.34 Those opposed to sharing genetic information with insurers argue that antiselection will be a rare event. A recent study assessing the potential for adverse selection in the life insurance market when tested individuals know their genetic test results but insurers do not, shows that women who test positive for the BRCA1 gene mutation do not capitalize on their informational advantage by purchasing more life insurance than those women who have not undergone genetic testing.35

There is an element of speculation involved in the possibility of adverse selection due to the information provided by genetic tests. Only about 5% of diseases are caused by a single gene. Most are caused by interactions between many genes that are subtle and difficult to determine. Consequently, only individuals with mutations for late onset untreatable diseases will be able to deceive the industry. The number of such diseases will probably also be reduced as treatments will be available for these diseases.

There is controversy about the ruling by insurance companies that genetic test results have to be disclosed by people seeking new policies. For monogenic disorders, the effect of any anti-selection by an individual exploiting knowledge of his undisclosed genotype depends largely on the size of the sum for which his life is insured7 while for multifactorial diseases, it is difficult to establish genotype-specific predictive empirical risk figures. Therefore, there should be no role for genetic data concerning multifactorial diseases in underwriting decisions.33 Although insurance companies may vary in the stringency with which they scrutinize medical record or use research data to determine insurability, one denial may have far-reaching effects on the individual's opportunities from other insurers. Critics fear that people could be deterred from taking tests whose outcome may be vital for determining their need for prophylactic treatment, or from participating in research involving genetic testing. They are also concerned that the duty of disclosure may infringe on individuals' privacy and violate their right not to know.12,36

Predictive genetic information in insurance

There is an issue surrounding the boundary between predictive genetic information and other health-relevant data. A person's sex is genetic information predictive of health outcomes, but being overt and covered by its own anti-discrimination legislation would not normally be included within ‘genetic information’ for insurance purposes.

Family history is also predictive genetic information, although it is recognized that the self-reported family history may be inaccurate. There is a need to resolve inconsistencies in current attitudes and policies on use of family history in relation to the use of genetic test results. If the ceiling for life insurance cover, without use of genetic information is intended to allow all healthy people to obtain this basic cover without disclosure of their genetic risk of late onset disease, then it is illogical to still take family history into account.7 Most of the high risks relevant to life insurance that are contained in genetic test results are revealed by an accurate family history. Thus it would be of little benefit to the genetically disadvantaged if a company agreed to forego the use of genetic test results, but would still require family history information.

In other respects, it is difficult to predict the extent to which genetic tests might become relevant for health prediction in multifactorial diseases, and even more difficult to predict the extent of their influence and timing of such advances in knowledge. A predictive DNA test cannot be regarded as a diagnostic test but rather as a prognostic factor because, at the time the genetic test is performed, there is not yet a disease established. However, one can compare how many tested persons have a positive result and how many a negative result and how many will develop a certain disease during a period. The final result is a likelihood of disease and not a predictive value which can then be expressed as a relative risk. Therefore, as with all genetic information used in an insurance context, sound knowledge of the real predictive value of the information needs to be accrued and validated before being put into practice. It is important that insurance applicants should be clearly aware of the limits of genetic information that is required and utilized by the insurance industry in relation to these complex diseases.

Types of insurance product affected by predictive medicine

Some argue that genetic test results will not affect all types of insurance product in the same manner. Genetic test results may almost exclusively affect individuals insurance as members of groups usually not individually underwritten.19 In the same way, genetic test results may only concern individuals applying for high levels of coverage, for which a medical examination is usually requested,20 or for personally purchased insurance in general.37

It is recommended that insurance product which should be exposed to restrictive legislation are those which are perceived as necessary to guarantee a service considered as a basic need, such as health and social insurance.19,38 There is a clear case for a solidarity-based system for basic needs, with optional extras being provided through a system based on mutuality. Insurance with respect to basic needs has often been compulsory (state or private). There is an issue as to how much ‘solidarity for basic needs’ can be incorporated into private, voluntary insurance without serious threat to the industry (through adverse selection for example). If it is considered that a substantial solidarity element can be provided by the private sector, the questions arise as to who should finance this solidarity and whether guidelines or legislation are required to regulate this insurance.

Requesting genetic tests

In the future, could applicants be asked to undergo a genetic test in order to obtain any type of insurance? Insurers may therefore have access to information that applicants do not want to know. Furthermore, requesting genetic tests from insurance applicants could create problems if counseling services are missing and if social pressure increases on those affected by genetic disorders.

Some published works indicate that despite the significant scientific progress, there are currently not sufficient grounds for requiring individuals to undergo genetic testing and to disclose genetic test results to insurers. This is because the current state of knowledge about patterns of genetic test results does not generally support good predictions of the incidence, timing and severity of disease or of time of death.3,31 Further research is needed in order to yield useful information. Well-described conditions such as Huntington disease have yielded such information, but this has been gathered over periods of several years. Nevertheless, in the United Kingdom for instance, there had been public disquiet following the ABI report and personal experience had shown increased anxiety regarding testing in Huntington disease clinics.12 Some of the public found that negative genetic test results could be used to their advantage in lowering already high premiums.12

In employment

At least two types of employment discrimination based on genetic testing have been identified.26,39 First, an employer may not hire someone who is likely to develop a genetic disease. An at-risk individual may be viewed as someone who would frequently be absent from work, would be less productive than others, or might require more healthcare services. Second, an employer may not permit an individual to work in an area in which he would be exposed to a toxic chemical if that individual is known to have a susceptibility to its toxic effects. It might be proved easier to test for genetic susceptibility than to remove whatever environmental health hazards there are in the work place. Genetic testing in this situation may increase productivity by reducing absenteeism caused by illness linked to susceptibilities to occupational hazards. However, it has been argued that, at least for multifactorial diseases, there is no scientific evidence yet to link unexpressed genetic factors and the ability to perform a job function.40 The Human Genetics Advisory Committee (1999) said that individuals should not have to disclose the results of previous genetic tests without clear evidence that the information was needed to assess whether they could do the job safely. Also, genetic tests are unlikely to identify susceptibility to disease with any precision as it might be aggravated by the workplace environment.27 Now even if genetic testing in the workplace may lead to individuals with an increased susceptibility to the effects of workplace toxins being banned from working in these areas,26,41 prevention of most genetically determined defects that may lead to illness and disability seems an unattainable goal. Consequently, it has been argued that genetic testing by employers should be limited to screening individuals at-risk for developing diseases that may result from certain exposures that exist in the workplace; employment decisions should not be based on genetic factors.42,43,44 However, there is a range of ethical issues with which the occupational health professional may be confronted as genetic technology advances.44,45 Genetic testing could be used to improve preventive medicine but also to reduce the costs of sickness in the workplace.23

Finally, as for insurance, the fear of employment discrimination through employers access to medical files might discourage at-risk individuals from undergoing medically indicated genetic testing.2,46

Education

The fear of genetic discrimination by insurers and employers has spread throughout society.4,33,45 It is likely that many people who might benefit from such testing will be reluctant to be tested unless laws are in place to protect them. However, a law is not enough to provide a comprehensive solution to genetic discrimination in insurance. One cannot be certain in the present economic context, that pressure might not be put upon applicants for an insurance contract in order to obtain genetic information about them. Nor can one exclude the possibility that the candidates themselves might wish to produce the information spontaneously if it were in their favor. Education is needed. Insurance decisions are sometimes made by inexperienced people, or because of a lack of knowledge about particular genetic conditions. Educational programs on the basic principles of genetics and insurance will have to be developed to improve the insurance coverage. This is important especially since the funding problems of most welfare programs lead many governments to shift a portion of the State's financial burden onto private insurers, particularly in relation to medical costs and the costs of long term care.

Conclusion

Insurers and employers are told that unreliable genetic tests must be ignored. Ultimately, objections to the use of genetic information will be subsumed by economic and scientific realities: individually underwritten insurance cannot be sold without risk classification, and some of the medical information needed to classify risks will be genetic.36 It will become increasingly difficult to distinguish genetic from nongenetic diseases, genetic information from nongenetic information, or to talk of medical and genetic tests as separate categories.

However, in attempting to develop practice fair to both insured and insurer, it is widely accepted that there is a need for clarification of the best means for determining the extent of increased genetic risk of late onset disease, so that there is demonstrable evidence of validity and consistency in the use of any genetic information in underwriting. It is accepted that in time when more reliable actuarial data are available for single gene disorders, genetic test results may be used but it is felt strongly that for multifactorial diseases the results should not be used. Most susceptibility genes are already shared by many people currently insured at standard rates. The unfolding of such results would stratify society in an unacceptable way.

Clear definitions of the terms used in genetics and insurance are revised for the transparency of the process by which genetic information is incorporated into insurance decisions, and for ensuring that genetic information is not used to the detriment of other family members. There is a broad consensus that insurance or employment considerations should not unduly influence the uptake of appropriate clinical care, which may increasingly involve genetic tests. There is also a broad consensus that applicants should not be asked to undergo genetic tests, in order to obtain insurance or employment.

At present, the fear of genetic discrimination remains intense; perhaps because there are very little data to support or refute that discrimination is actually taking place. How to reassure people and protect them? Can a law provide a solution to the problems of insurance, employment and genetics? There are diverging approaches among the various states which have sought to establish binding norms. The legislative activities in several countries show a growing consensus on the need to define the use of genetic information for insurance purposes. Some restrictions on the use of genetic information may be found and be compatible with the continued existence of the insurance industry, such as a ceiling below which no genetic information (genetic test results or family history) has to be disclosed. A valid explanation for selecting a particular ceiling also needs to be provided and should relate to the point where basic economic security (basic house purchase, necessary provision for dependants, and protection for the self-employed) gives way to personal investment. As to genetic testing by employers, it should stay limited to screening individuals at risk for developing diseases that may result from certain exposures that exist in the workplace.