What is the name of the process that insurance companies use to determine whether or not an applicant is insurable?

European Institutions

European Union, Resolution on the Ethical and Legal Problems of Genetic Engineering of the European Parliament (March 16, 1989, n. R89, 2, n. R89, 14) (http://europa.eu.int)

Two principles refer to insurance: Principle 19: ‘Insurance companies have no right to demand that genetic testing be carried out before or after the conclusion of an insurance contract nor to demand to be informed of the results of any such tests which have already been carried out and that genetic analysis should not be made a requirement for the conclusion of an insurance contract’. Principle 20: ‘The insurer has no right to be notified by the policyholder of all the genetic data known to the latter’

The Resolution has no legal authority; it sensitizes people to the arisen problems of the developments in genetics.

Council of Europe, Recommendation on genetic testing and screening for health-care purposes of the European Committee of Ministers (1992, n. R92, 3) (http://www.coe.fr/cm/ta/rec/1992/92r3.htm)

Principle 7 refers to insurance: ‘Insurers should not have the right to require genetic testing or to inquire about results of previously performed tests, as a pre-condition for the conclusion or modification of an insurance contract’.

All members of the Council of Europe adopted this Recommendation, except the Netherlands.

European Union, The Data Protection Directive, 1995 (http://www.privacy.org/pi/intl_orgs/ec/eudp.html)

In 1995 the Council and Parliament of the European Union adopted the Directive 95/46/EC in order to harmonize the protection of data privacy in the EU. The Directive was implemented in national laws and regulations by October 24, 1998. The Directive was designed to establish minimum standards for the processing and use of personal data throughout the EU, for two reasons: (1) to ensure that the Member States protect the ‘fundamental right’ to privacy with respect to the processing of personal data, and (2) to prevent Member States from restricting the ‘free flow of personal data’ among Member States on grounds of privacy protection.

Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (April 1997, DIR/JUR 96, 14) (http://www.coe.fr/fr/txtjur/164fr.htm)

Three articles refer to insurance. Article 11: ‘Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited’. Article 12: ‘Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counseling’. Article 26: ‘No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others’. These restrictions may not be placed on Articles 11, 13, 14, 16, 17, 19, 20 and 21.

Council of Europe, Recommendation on the Protection of Medical Data of the European Committee of Ministers (1997, n. 97, 5) (www.coe.fr/cm/ta/rec/1997/97r5.html)

Article 4.7 states that ‘Genetic data collected and processed for preventive treatment, diagnosis or treatment of the data subject or for scientific research should only be used for these purposes or to allow the data subject to take a free and informed decision on these matters’. Article 4.9 stipulates that for purposes other than those provided for in Principles 4.7, ‘the collection and processing of genetic data should, in principle, only be permitted for health reasons and in particular to avoid any serious prejudice to the health of the data subject or third parties. However, the collection and processing of genetic data in order to predict illness may be allowed for in cases of overriding interest and subject to appropriate safeguards defined by law’.

European Union, The Data Protection Act of the European Committee of Ministers, 1998 (europa.eu.int/comm/dg03/publicat/)

The Data Protection Act 1998 implements the EU Data Protection Directive and provides a system of general protection and security for personal data which covers, amongst other things, medical data.

European Union, Charter of Fundamental Rights of the European Union (December 18, 2000) (http://www.europarl.eu.int/charter/default_en.htm)

Article 21 of the Charter apply to insurance and states that ‘any discrimination based on any ground such as sex, race, color, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation shall be prohibited’.

European Countries

Austria

The Gene Technology Act (1994) (http://www.gentechnik.gv.at/gentechnik/B1_orientierung/gen_10084.html)

This Act regulates work with genetically modified organisms, the release and marketing of genetically modified organisms, and the use of genetic testing and gene therapy in humans. Section 67 stipulates that it is forbidden for insurers and employers including their representatives and collaborators to obtain, request, accept or in any other way make use of the results of genetic analyses on their employees, candidates, policyholders, or insurance applicants. In practice, the state insurance system does not refuse cover to any applicant, but the private insurance companies are able to refuse to grant cover or only grant it at the cost of an increased premium.

Belgium

Law on terrestrial insurance contracts, 1992

Article 95 prohibits the use of genetic testing that enables to predict the future state of health while Article 5 states that ‘genetic data may not be declared’. Applicants are prohibited from subletting the results of genetic testing to insurers, whether these results are positive or negative.

Denmark

Danish Council of Ethics, Protection of Sensitive Personal Information – A Report, Copenhagen, 1992 (www.etiskraad.dk/english/publications.htm)

The Council recommends very strict control on the use of medical records and medico-biological banks. The Council recommends that the individual is given full control of the gathering and use of ‘person-sensitive’ data and biological material. The Council also recommends legislation to secure individual autonomy, integrity and the right to know about and control the use of person sensitive data.

Danish Council of Ethics, Genetic Testing in Appointments. Copenhagen, 1993

Law No. 286 of 24 April 1996 on the Use of Health Information on the Labor Market (Intl. Dig. Hlth. Legis., 47, 1996:371-72)

This Act strictly limits employers' rights to ask potential employees for health information including information based on genetic testing.

Act No. 413 of 10 July 1997, Act to Amend the Insurance Agreement Act and Act on the Supervision of Company Pension Funds (http://www.forsikringenshus.dk/htmm/eng/annualr.htm)

The way insurers used to get health information when the law was passed is not prohibited and this means that the insurer is allowed to ask for information on blood samples e.g. HIV test. Insurers may only ask for HIV test and family history when the sum insured is high and over a certain level.

Estonia

Estonian Parliament, Human Gene Research Act, 2001 (http://www.genomics.ee/genome/act1312.html)

This Act has been enacted to protect persons from misuse of genetic data and from discrimination based on interpretation of the structure of their DNA and the genetic risks arising therefrom.

Article 25 on Prohibition on discrimination states that (1) ‘It is prohibited to restrict the rights and opportunities of a person or to confer advantages on a person on the basis of the structure of the person's DNA and the genetic risks resulting therefrom; (2) It is prohibited to discriminate against a person on the basis of the person being or not being a gene donor’.

Article 26 is devoted to discrimination in employment relationships: (1) ‘Employers are prohibited from collecting genetic data on employees or job applicants and from requiring employees or job applicants to provide tissue samples or descriptions of DNA; (2) Employers are prohibited from imposing discriminatory working and wages conditions for people with different genetic risks’.

Article 27 is devoted to discrimination in insurance relationships: (1) ‘Insurers are prohibited from collecting genetic data on insured persons or persons applying for insurance cover and from requiring insured persons or persons applying for insurance cover to provide tissues samples or descriptions of DNA; (2) Insurers are prohibited from establishing different insurance conditions for people with genetic risks and from establishing preferential tarif rates and determining insured events restrictively’.

Under Article 31, the Criminal Code is amended as follows: ‘unlawful restriction of the rights of a person or conferral of unlawful preferences on a person based on the genetic risks of the person is punishable by a fine, detention or up to one year imprisonment’.

Finland

By law, policyholders are obliged to give correct and complete answers to questions posed by insurance companies before policies are approved. In principles, such questions include those about genetic tests. However, the Finnish Insurance Companies have adopted a policy of not asking questions about genetic tests in connection with their risk assessment. Nor do they make use of such information if they obtain the results of genetic tests undergone by their customers. Nor, in their risk assessment, do they pose questions or use information on the state of health of applicants' relatives (Federation of Finnish Insurance Companies, 1999).

About the occupational aspects, there is a law on the privacy in occupational life that is under preparation. The proposal states that genetic tests in occupational settings can be used only with a permission of The National Board of Medical Legal Affairs and that permission could be attained only if the test is for protecting the individuals health.

France

Law of December 1989 related to the protection of persons against discrimination on the basis of their state of health or of their handicap, J. O. of January 3, 1990

Law n. 94-653 of July 29, 1994 on respect for the human body (Article 16-10 of the Civil Code) (http://www.cnrs.fr/SDV/loirespectcorps.html)

According to the Article 16-10, ‘the genetic study of an individual's characteristics can only be carried out for medical purposes or scientific research’.

Article 226-26 of the Code pénal states that ‘the use of information about an individual which has been obtained by studying his genetic characteristics other than for medical purposes for scientific research is punishable with one year's imprisonment and a fine of FRF 100 000’.

Law n. 94-654 of July 29th regarding the donation and use of elements and products of the human body, medically assisted procreation and prenatal diagnostic (http://www.cnrs.fr/SDV/loirespectcorps.html)

Article L1131-1 states that the Genetic characteristics of a person or his identification through the use of genetic prints, when not performed for a judiciary procedure can only be done for medical or scientific goals after having obtained that person's consent.

In 1994, the French Federation of Insurance Companies (http://www.ffsa.com/pub/pub.htm) announced that for a period of 5 years, which coincided with the 5-years period upon expiry of which the law n. 94-653 of July 29, 1994 was to be revised, its members would not use genetic information to determine applicants' insurability. This moratorium has been extended for another period of 5 years (2004).

National Consultative Ethics Committee, Opinion and Recommendations on Genetics and Medicine: from Prediction to Prevention, Reports, Paris, 1995 (http://www.ccne-ethique.org/english/avis/)

The report recommends prohibiting insurers from using genetic information, even if that information is voluntarily provided by applicants.

Decree n. 2000-548 date June 15, 2000 Predictive Medicine, Genetic Identification and Genetic Research (http://www.legifrance.gouv.fr)

This decree states that the examination of genetic characteristics of a person, when not done for a judiciary procedure can only be performed for medical purposes or scientific research after having obtained the consent of that person.

Germany

Contractual liberty allows insurers to ask applicants to undergo tests that are relevant for the determination of risks. According to the medical committee within the German insurance federation, paragraph 16 of the German insurance contract law states that an insured is already bound to give information regarding all particulars known to him which could be important for the acceptance of a risk. This includes the results of a genetic test. However, a moratorium exists since 1988, according to which insurers neither make genetic tests a prerequisite for insurance contracts nor do they ask for the results of genetic tests performed in the past. This moratorium has been renewed in 1999 by the German insurers' association (Lauth & Schmidtke 1999).

Regarding genetic testing in the workplace, there is a requirement to obtain genetic knowledge for certain occupations at pre-employment stage. This consists of traditional questions, such as those about family history. Genetic testing designed to analyze genes in relation to employment is not undertaken. Because of the dynamic character of molecular genetics and the fact that future developments can hardly be predicted there is general agreement that legal regulations are not suitable for the regulation of genetic testing (Karlic & Horak 1998).

Enquette-Kommission des Deutschen Bundestages, Chancen und risiken der Gentechnologie, Dokumentation des Berichts an den Deutschen Bundestag, Frankfurt, 1987

This document recommended a new criminal offence where an employer discriminates against an employee on the basis of the results of his genetic test. In most instances the report did not recommend that legislation be enacted but rather that these matters be supervised by authoritative professional bodies (McGleenan 1999).

The German insurers' roof organization, Moratorium on genetic tests, 1988

This moratorium states that insurers neither make genetic tests a prerequisite for insurance contracts nor do they ask for the results of genetic tests performed in the past.

Greece

To date, there is no legislation concerning practice in genetics. Insurance companies have agreed to a voluntary code of conduct and do not ask for genetic testing prior to insuring patients.

Iceland

There is no legislation dealing specifically with the issue of genetic discrimination in life insurance and employment. However, discrimination based on genetic characteristics might be prevented by the following regulation and Act.

Ministry of Health and Social Security, Government Regulation No 32/2000 on a Health Sector Database (2000)

According to Article 14, ‘providing information on individuals from the Health Sector Database is prohibited. Only statistical information involving groups of individual may be provided’.

Ministry of Health and Social Security, Act on the Rights of Patients No 74/1997 (1997)

Article 1 stipulates that ‘It is prohibited to discriminate against patients on grounds of gender, religion, beliefs, nationality, race, skin color, financial status, family relation or status in other respect’.

Ireland

Irish Insurance Federation, Code of practice on genetic testing, 2001

1. Applicants must not be required to undergo a genetic test in order to obtain insurance

2. Disclosure of the result of a genetic test will not be required in new applications for life cover unless the sum assured on the new application exceeds £300 000 or the total of the sum assured on the new application and other policies, if any, taken out with any insurer between 1st April 2001 and 31st December 2005 exceeds £300 000.

Italy

Law n. 675, 31 December 1996, D.P.R. n. 318, 28 July 1999, on Medical Information Privacy

There is no specific legislation on the use of genetic information by insurers and employers in Italy, but the Law n. 675 states the privacy of all medical information.

The Italian Committee on Bioethics, Orientamenti bioetici per i test genetici, 19 November 1999 (http://www.palazzochigi.it/bioetica/orientamenti%20biomedici.htm)

These recommendations state that genetic information must be treated as the general medical information and therefore it is forbidden to give this information to insurers or employers without consent.

Luxembourg

Insurance Contracts Act of 27th July 1997

This law stipulates that the prohibition on the use of genetic test by insurers is of public matter and cannot be bypassed, even with the consent of the insurance applicant.

Norway

Act Relating to the Application of Biotechnology in Medicine, Law n. 56 of 5 August 1994 (http://www.helsetilsynet.no/htil/avd2/bio_act.htm)

Chapter 6 states that genetic testing can only be performed for medical diagnosis and/or therapeutic purposes. (…) It is forbidden to request, receive, possess or use information resulting from a genetic test on any person. It is also prohibited to ask whether such a test has been carried out previously.

Chapter 8 stipulates that anyone violating this law will be punished with an economic fine or will be sentenced to prison for three months.

Norwegian Biotechnology Advisory Board, Genetic Testing: When & Why? Oslo, March 1996.

Norwegian Biotechnology Advisory Board, The Use of Genetic Information about Healthy People by Insurance Companies. Oslo, April 1997.

Portugal

The Ratification of the ‘Convention for the Protection of Human Rights and Dignity of the Human Being and the additional protocol on the prohibition of cloning human beings’ was published in January 2001.

Act No 10/95 related to the Protection of Personal Information

Spain

The Spanish Constitution of 1978

The Spanish Constitution forbids any kind of discrimination on grounds of any personal or social circumstance or condition. This prohibition should be concerned for employers as well as for insurers, if they try to refuse to contract with some applicants being carriers of genetic susceptibility for certain diseases (Karlic & Horak 1998).

The Organic Law regulating the automated processing of personal data of 29 October 1992

This law provides special measures of protection for personal health data (articles 7.3 and 8).

Labor Risk Preventive Act of 8 November 1995

Article 25 ‘Protection of the specially sensitive workers to determined risks’ stipulates that employers will guarantee the protection of the workers who will be specially sensitive to the risk derived from work. This article does not refer to the situations of susceptibility to known genetic predisposition or to future monogenic illnesses also known without any type of symptom at the moment of entering the work post (Karlic & Horak 1998). There is no provision for applicants to a job.

The Organic Law regulating the automated processing and protection of personal data of 13 December 1999

This law includes automated data and any type of personal data.

Sweden

Law 114 of March 1991 on the Use of Certain Gene Technologies within the Context of General Medical Examinations (1993)

This law examines the use of certain genetic technology in medical screening. There must be a permission from the National Board of Health and Welfare. Authorization from this body is required before DNA testing can be carried out. This requirement extends to the use of genetic screening techniques for diagnostic purposes.

The use of information about an individual which has been obtained by studying his genetic characteristics other than for medical purposes is prohibited.

Genetic discrimination can be subject to penalties in the form of fines or prison sentences up to a maximum of 6 months.

The Agreement between the Swedish State and the Swedish Insurance Federation concerning genetic testing, 1999

According to this agreement, insurance companies have undertaken not to start requiring insurance applicants to undergo genetic investigations, nor – as a condition of individual life and health policies up to an inflation-indexed once-only lump sum – to ask them to submit the findings of previous genetic tests, if any. The state is entitled to cancel the agreement with immediate effect if any insurance company disregards what the Insurance Federation has undertaken. This agreement is valid to the year 2002.

Switzerland

The Federal Code of Obligations

The federal Code of Obligations stipulates the nullity of any contract against the law or against common morality (art. 20). Read in connection with article 27 II of the Civil Code which protects the individual against excessive commitments, this article speaks for the nullity of a contractual clause in an insurance contract which would release the applicant physician altogether from his obligation of confidentiality. Article 321 of the federal Criminal Code punishes the professionals who reveal confidential information.

Article 328b of the Code of Obligations stipulates that employers may only use data regarding the employee if they concern the employment relationship or if they are necessary to carry out the employment contract. This rule concerns existing or imminent diseases, thus excluding presymptomatic investigations (Karlic & Horak 1998).

The Swiss Federal Constitution, 1992

Article 119 (introduced in 1992 as article 24novies, old numbering) paragraph 2 states that the genetic heritage of an individual may be analyzed, registered or divulged only with his consent or on the basis of a legal prescription.

The Swiss Academy of Medical Sciences, Medical-ethical Guidelines for Genetic Investigations in Humans, Approved by the Senate of the Swiss Academy of Medical Sciences on 3rd June 1993 (http://www.samw.ch/e/richtlinien/richtlinien_fs.html)

Paragraph 3.7 states that ‘medical doctors may make the medico-genetic findings available to third parties only with the consent of the person investigated or of his legal representative, and only after the implications of such disclosure of information have been explained to them’.

Paragraph 3.8 states that ‘genetic investigations must not be carried out for the purpose of assessing the suitability of a person for certain activities or work, unless the investigation is performed in order to detect factors which, if present, would render a particular activity a considerable risk to the health of the individual or for other persons’.

Paragraph 3.9 recommends ‘particular reservations when the results of a requested genetic investigation are to be used in connection with the taking out or the revision of an insurance policy. The results are to be communicated exclusively to the person investigated or his legal representative, after the implications of the passing on of such information to third parties have been explained to them’.

The Swiss Academy of Medical Sciences guidelines about genetic investigations in humans have been included into the Code of Deontology of the Swiss Medical Association and apply directly to all the physicians who are members of the Association. These guidelines are not legally binding, unless cantonal legislation gives them binding force.

Bill regarding Genetic Investigations in Humans, 1998 (http://www.admin.ch/cp/d/)

This bill has not yet been debated in Parliament. Section 3 stipulates that when establishing an employment relationship, or during employment, the industrial doctor may order a presymptomatic investigation only if all of the following conditions are met (Art. 19 § 1): The workplace represents a risk for an industrial disease or a serious damage to the environment or an extraordinary risk of accidents or health hazard for third parties. Safety measures according to the law are not sufficient to eliminate this risk. The workplace is put under the regulation of preventive industrial medicine by order of the competent authority or by law. The specific risk for the employee or the imminent and serious risk for third parties or the environment cannot be evaluated in another way. A federal panel for genetic investigations has pronounced the method safe and reliable on detecting a risk. The employee agrees to the investigation. The employee shall inform the industrial doctor, on the latter's initiative, of the results of former presymptomatic investigations relevant to the ability to perform the specific work (Art. 19 § 2).

Section 4 stipulates that insurers are not allowed to demand a presymptomatic or prenatal investigation as a condition of insurance (Art. 22 § 1). As for the results of former investigations, the Bill differentiates: As a rule, insurers are not allowed to ask for or use the results of former presymptomatic or prenatal investigations or investigations for family planning (Art. 22 § 2). The competent federal authority, however, can make an exception in the case of non-compulsory insurance (Art. 23 § 2). The applicant is obliged to answer the medical examiner's questions on the results of a former presymptomatic investigation, if this investigation is reliable and if the scientific value of the result for calculating the premium is shown (Art. 23 § 2). The applicant may inform the insurer of the results of former presymptomatic or prenatal investigations in order to demonstrate that he has wrongly been classified in a high-risk group (Art. 23 § 1). The competence to specify which genetic information can be requested by insurers must rest in the hands of a federal authority (Art. 24 § 1). The questions must be relevant to evaluating the insured risk (Art. 24 § 2).

The Netherlands

Verzekeraars verlengen moratorium erfelijkheidsonderzoek, December 1990 (1995)

The moratorium, originally for 5 years, became indefinite in 1995. Insurers must abstain from using existing genetic test results for life applications up to NLG 300 000 and for disability applications up to NLG 60 000. Insurers must abstain from requesting genetic tests for all applications.

Medical Examination Act, 1 January 1998

The basic principle of the Act is that individuals must have unimpeded access to socially important facilities such as work and certain insurances; employers and insurers may not discriminate people with some blemish. The legislature was of the opinion that in a number of cases this principle could only be achieved by a prohibition of the medical examination. The Medical Examination Act prohibits employers and insurers from requiring medical tests that could indicate that the applicant may be suffering from a severe incurable disease. Regarding genetic testing, when carrying out a medical examination for taking out or changing insurance, insurers may not ask an insured whether the prospective insured has any hereditary, serious, untreatable disease, unless the illness has already manifested itself in the prospective insured. Insurers may not ask whether any blood relatives have any hereditary, serious, untreatable diseases, not even if the illness has already manifested itself or the blood relative has died from it. Finally, insurers may not ask about the results of previous genetic tests among blood relatives or the prospective insured himself. However, these prohibitions apply only for life policies below NLG 300 000 and for disability policies below NLG 60 000 (Goedvolk 1999).

United Kingdom

In May 2001, the Human Genetics Commission (HGC) recommended a three-year moratorium on the use of genetic information by insurers, except in respect of policies over £500 000 in value. In the case of these high-value policies, the HGC says insurers should be permitted to use only the results of tests approved by the Genetics and Insurance Committee (GAIC). GAIC has so far approved only tests for Huntington's disease in respect of life insurance, but a small number of additional tests is currently under consideration. The HGC recommends that the moratorium on the use of genetic information in insurance should be enforced by legislation. The HGC recommendation follows a report by the House of Commons Select Committee on Science and Technology on Genetics and Insurance (April 2001), which found that the current system of self-regulation by the insurance industry was not satisfactory. On the same day that the HGC released its recommendations, the Association of British Insurers announced that its members would no longer request results of genetic tests in respect of applications for any type of insurance up to a value of £300 000. For policies above this value, only the results of tests approved by GAIC would be used. The ABI also announced in a joint statement with the UK Forum for Genetics and Insurance and the British Society for Human Genetics, that the results of a genetic test taken as part of a research project, rather than in the context of a clinical consultation, need not be declared to insurers.

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.

House of Commons Select Committee on Science and Technology, Human Genetics: the science and its consequences, 3rd report, HMSO, London, 1995 (http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmselect/cmsctech/489/48902.htm)

The House of Commons Select Committee in its report on human genetics recommended that the insurance industry should find ways to avoid a conflict between their interests and the medical interests in genetic testing. The Association of British Insurers subsequently issued a Code of Practice on Genetic Testing (see below) and the Government appointed the HGAC, who took on insurance as one of their first projects.

Government Response to the Third Report of the House of Commons Select Committee on Science and Technology, Human Genetics: The science and its consequences, Department of Trade and Industry, 1996 (http://www.parliament.the-stationery-office.co.uk/pa/cm/cmsctech.htm)

Association of British Insurers, Code of Practice on Genetic Testing, November 1997 (revised August 1999) (http://www.abi.org.uk)

In its Code of Practice, the ABI undertakes not to require applicants to take any genetic test. In addition, genetic test results are disregarded when setting premiums for life insurance policies up to a value of £100 000 that are linked to new mortage applications. Insurers may not ask for the results of tests taken by other family members, nor offer individuals lower-than-standard premiums on the basis of genetic test results, nor disclose test results to any other party without the individual's consent. In the interim before further applications are put to GAIC, ABI member companies may continue to require disclosure of the results of certain tests that had been identified by its Genetics Adviser as at November 1998. These are tests for myotonic dystrophy, multiple endocrine neoplasia, hereditary motor and sensory neuropathy, familial Alzheimer's disease, familial adenomatous polyposis, and BRCA1/2-associated familial breast cancer. If any of these tests are subsequently rejected by GAIC, the insurance companies will refund any extra premiums paid by applicants on the basis of their results, or contact them to offer them insurance if it had been refused.

Human Genetics Advisory Committee, The implications of genetic testing for insurance, November 1997 (www.dti.gov.uk/hgac/papers/papers_b.htm)

The HGAC report made a number of recommendations of which the three most important were that insurers should not be allowed to use any genetic tests results unless they had satisfied an independent body that there was a good factual actuarial basis for using these results; that there should be a transparent, open and independent appeals process; and that there should be a moratorium on all testing for 2 years while these arrangements were being put in place.

Department of Trade and Industry, Genetic Testing and Insurance, Government formal response to the HGAC report, 5 November 1998 (www.hgc.gov.uk/about_regulatory.htm)

The British Government accepted all of the HGAC recommendations apart from the moratorium. While not agreeing to the moratorium, they suggested that the insurance industry should immediately stop using test results, until the Genetics and Insurance Committee (GAIC), had validated them. In November 1998, the British Government set up the Genetics and Insurance Committee, a nonstatutory, advisory body 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.

British Society for Human Genetics, Statement on Genetics and Life Insurance, 1998 (http://www.bshg.org.uk/insuranc.htm)

This statement recognizes that insurers need to protect themselves against an unacceptable degree of anti-selection. It endorses the recognition of the ABI stating that applicants must not be asked to undergo a genetic test in order to obtain any type of insurance. Genotypes present in more than 5% of the population should not be disclosed or considered for any life insurance. Cover up to an agreed sum should be available for all life insurance purposes without any genotype disclosure. If an insurer requires disclosure of any genetic test results, that requirement should be restricted to results where published and actuarially validated data allow evidence-based underwriting. Finally, insurers should recognize and counter the fear of undue discrimination (BSHG 1998).

The BSHG statement will be reviewed not later than summer 2003.

Human Genetics Advisory Committee, The implications of genetic testing for employment, June 1999 (www.dti.gov.uk/hgac/papers/papers_f/f_03.htm)

The HGAC report does not recommend a total ban on the testing of employees for genes that might predispose them to various conditions. The report suggests that employers could be allowed to ask for tests to detect a potentially dangerous illness, in the way that pilots are currently tested. In effect, testing should only be for the employees' benefit and not for the benefit of shareholders. The Commission also said that genetic tests should not play a part in recruitment. The Commission concluded that an individual's right not to know his or her genetic pre-dispositions should be upheld. 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. Finally, the report recommends that testing be covered by the principles of data protection.

The Government's response to the HGAC report has now been published. This accepts all the main findings of the HGAC report and agrees that this issue should be kept under review. It asks the Human Genetics Commission to include this issue in the Commission's wider study of the uses of genetic information and to provide advice to Ministers in due course.

Genetic tests and future need for long-term care in the UK, A report of a work group of the Continuing Care Conference Genetic Tests and Long-term Care Study Group, July 1999 (with update published January 2000) http://www.medinfo.cam.ac.uk/phgu/info_database/Policy/cccreport.asp)

The group's report concentrates mainly on Alzheimer's disease, for which an actuarial model is presented to predict the costs of long-term care depending on levels of risk as predicted by apoE genotype. The report also contains information about the genetic and environmental basis of other adult-onset conditions including cancers, diabetes, ischaemic heart disease and stroke, osteoarthritis, rheumatoid arthritis and some psychiatric conditions, and preventive options.

The Genetics and Insurance Committee, 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, October 2000 (http://www.doh.gov.uk/genetics/gaichuntington.htm)

The Genetics and Insurance Committee (GAIC) was asked to examine the actuarial evidence for using individual genetic tests. The insurance industry, through the main trade body the Association of British Insurers, has agreed to abide by GAIC decisions. If GAIC decides that the evidence on the reliability and relevance of a particular test is insufficient to justify its use, the Association have agreed to stop using them and retrospectively reassess affected individual insurance premiums. The broader social and ethical issues surrounding the use of genetic tests in insurance and employment have been referred to the new Human Genetics Commission.

An application for approval of two genetic tests for Huntington's Disease was submitted to GAIC by the Association of British Insurers (ABI) in July 2000. The application was sent to a clinical geneticist and an independent actuary for expert review and also to support groups for Huntington's Disease and to the Genetic Interest Group (GIG) for their comments. At their meeting in September, GAIC considered the application, in the presence of observers from the ABI, GIG and Huntington's Disease Association.

The committee recognizes that this complex subject is an important issue to the public, industry and government alike. GAIC will work closely with the new Human Genetics Commission when they begin their inquiry into the use of genetic data including in insurance and employment.

House of Commons Select Committee on Science and Technology, 5th report, Genetics and Insurance, HMSO, London, 2001 (http://www.publications.parliament.uk/pa/cm200001/cmselect/cmsctech/174/17404.htm)

The House of Commons Select Committee in its report on genetics and insurance recommends a two-year moratorium on the use of positive genetic test results by insurers, to allow time for further research on the actuarial relevance of test results.

UK Forum on Genetics and Insurance, Association of British Insurers, British Society for Human Genetics, Joint statement on Genetics and Insurance, 24 April 2001 (http://www.ukfgi.org.uk/joint%20statement%20abi,%20bshg,%20ukfgi%2024%2004%2001.htm)

The UK Forum on Genetics and Insurance said that ‘it would continue to work to ensure the use of genetic information is handled appropriately by all parties’. The Association of British Insurers said that ‘results from genetic testing arising from research projects will not be used for underwriting policies. Also, if someone already has an insurance policy it will not be affected by the policyholder participating in a research project concerned with genetic testing’. The British Society for Human Genetics ‘welcomes the ABI's confirmation that research genetic tests will not affect any insurance proposal and do not need to be declared in any insurance application. This removes one source of anxiety for people asked to take part in genetic research, and should help avoid the risk that research will be hampered because of people's worries about insurance’.

Human Genetics Commission, The use of genetic information in insurance: Interim recommendations of the Human Genetics Commission, May 2001 (http://www.hgc.gov.uk/business_publications_statement_01may.htm)

In the HGC's view the moratorium should embrace the following features: ‘No insurance company should require disclosure of adverse results of any genetic tests, or use such results in determining the availability or terms of all classes of insurance. The moratorium should last for a period of not less than three years. This will allow time for a full review of regulatory options and afford the opportunity to collect data which is not currently available. The moratorium should continue if the issues have not been resolved satisfactorily within this period. (…) An exception should be made for policies greater than £500 000. This will address concerns about adverse selection, the process by which persons having a known risk set out to acquire substantial insurance cover. (…) We recommend this upper financial limit on the basis of the industry's own tables and information as a protection from significant financial loss. Only genetic tests approved by the Genetics and Insurance Committee (GAIC) should be taken into account for these high-value policies'.

Association of British Insurers, Insurers Confirm Decision To Extend Moratorium On Use Of Genetic Test Results, 1 May 2001 (http://www.abi.org.uk/HOTTOPIC/nr415.asp)

‘The (industry's) existing Code includes a moratorium on the use of test results in respect of life insurance linked to a mortgage of up to £100 000. Following very careful consideration within the industry, we propose to extend this moratorium to cover all classes of insurance up to £300 000. This will have the effect of excluding genetic test results from underwriting other than for a very small number of high value policies. The House of Commons Select Committee on Science and Technology called for a 2-year moratorium. The advantage of this will be to provide a period of stability while new and more permanent arrangements can be put in place. We continue to be keen to work with you and the Government to bring this about’.

Government Response to the Report from the House of Commons Science and Technology Committee: Genetics and Insurance, (October 2001) (http://www.doh.gov.uk/genetics/gaicgovrespoct2001.pdf)

International Organizations

The World Medical Association, World Medical Association Declaration on the Human Genome Project (September 1992, doc. 17.S/1) (www.wma.net/e/policy/17-s-1_e.html)

In its Declaration of the Human Genome Project, the World Medical Association considers that ‘Medical secrecy should be kept and information should not be passed on to a third party without consent. (…) The disclosure of information to a third party or the accessibility to personal genetic data should be allowed only with the patient's informed consent’.

UNESCO, The Universal Declaration on the Human Genome and Human Rights, (November1997) (http://www.unesco.org/ibc/uk/genome/project/index.html)

Article 6 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’. And according to article 7, ‘genetic data associated with an identifiable person and stored or processed for the purposes of research or any other purpose must be held confidential in the conditions foreseen set by law’.

The World Medical Association, Proposed international guidelines on ethical issues in medical genetics and genetics (1998) (http://www.live.who.ch/ncd/hgn/hgnethic.htm)

‘Genetic data should not be given out to insurance companies, employers, schools or governments, other than after the full informed consent of the person tested. In some countries it may be possible or necessary to protect both confidentiality and non-discrimination through legal means’

HUGO, Statement on the DNA Sampling Control and Access (February 1998) (http://www.gene.ucl.ac.uk/hugo/conduct.htm)

Unless authorized by law, there should be no disclosure to institutional third parties – such as employers, insurers, schools, and government agencies because of possible discrimination – of participation in research, nor of research results identifying individuals or families. Like other medical information, there should be no disclosure of genetic information without appropriate consent.

The World Health Organization, Cloning in Human Health, (1stApril 1999) (http://www.who.int/gb/EB_WHA/PDF/WHA53/ea15.pdf)

Article 8 stipulates that ‘Genetic information should not be used as the basis for refusing employment or insurance. Exceptions would have to be legally defined’.

Appendix B

Contributions

This document was reviewed by the ESHG Public and Professional Policy Committee (PPPC). Members of the PPPC are:

Ségolène Aymé (Paris, France) Chair

Martin Bobrow (Cambridge, UK)

Jean-Jacques Cassiman (Leuven, Belgium)

Domenico Coviello (Modena, Italy)

Gerry Evers-Kiebooms (Leuven, Belgium)

Peter Farndon (Birmingham, UK)

Helena Kääriäinen (Helsinki, Finland)

Ulf Kristoffersson (Lund, Sweden)

Marcus Pembrey (London, UK)

Sandy Raeburn (Nottingham, UK)

Joerg Schmidtke (Hannover, Germany)

Leo ten Kate (Amsterdam, The Netherlands)

Lisbeth Tranebjaerg (Tromso, Norway) Secretary

The first draft of this document was sent out to a wide range of people and organizations for consultation. It was reviewed critically by the following consultants:

Australia

Agnes Bankier, Institute Royal Children's Hospital, Parkville Victoria

Austria

Gertrud Hauser, Institute of Histology & Embryology, University Vienna, Vienna

Belgium

Herman Nys, Center for Bio-medical Ethics and Law, Catholic University Leuven

Myriam Welkenhuysen, Psychogenetics Unit, Centre for Human Genetics, Leuven

Cyprus

Kyproula Christodoulou, The Cyprus Institute of Neurology and Genetics, Nicosia

Denmark

Jane Emke, Danish Insurance Association, Copenhagen

Lene Koch, Institut of Public Health, University of Copenhagen, Copenhagen

Eastern Countries

Vladislav Baranov, Institute of Obstetrics and Gyneaecology, Russian Academy of Medical Sciences, St. Petersburg, Russia

Georges Kosztolanyi, National Institute of Hygiene, Department of human Genetics and Teratology, Budapest, Hungary

Maria Kucerova, Genetics Department, Thomayer University Hospital, Prague, Czech Republic

Astrida Krumina, Department of Medical Biology and Genetics, Medical Academy of Latvia, Riga, Latvia

Finland

Kaija Holli, Tampere University Central Hospital, Tampere

Pekka Koivisto, Retro Life Assurance Company Ltd, Helsinki

Veikko Launis, Department of Philosophy, University of Turku, Turku

Nina Meincke, Medical Law Project, University of Helsinki, Helsinki

Minna Poyhonen, The Family Federation of Finland, Department of Medical Genetics, Helsinki

Riitta Salonen, Department of obstetrics and Gynecology, Helsinki University Central Hospital, Helsinki

France

Yves-Jean Bignon, Department of Oncology and Genetics, Jean Perrin Centre, Clermont-Ferrand

François Ewald, French Federation of Insurance Companies, Paris

François Eisenger, Institut Paoli Calmettes, Marseille

Josué Feingold, Laboratoire d'Anthropologie Biologique - Paris XII University, Paris

André Klarsfeld, Centre National de la Recherche Scientifique, Institut Alfred Fessard, Gif-sur-Yvette

Dominique Stoppa-Lyonnet, Department of Oncology and Genetics, Curie Institute, Paris

Germany

Achim Regenauer, Munich Reinsurance Company, Munich

Ireland

David Barton, National Centre for Medical Genetics, Ous Lady's Hospital for Sick Children, Dublin

Tony McGleenan, Faculty of Law, Queen's University, Belfast

Peter Whittaker, Biology, National University of Ireland, Maynooth

Israel

Ariella Oppenheim, Hebrew University-Hadassah Medical School, Jerusalem

Italy

Bruno Dallapiccola, Medicina Sperireniato, La Spapienza University, Roma

Giovanni Neri, Instituto di Genetica Umana, Universita Cattolica, Roma

Norway

Kare Berg, Institute of Medical Genetics, University of Oslo, Oslo

Erik Rosaeg, Scandinavian Institute of Maritime Law, University of Oslo, Oslo

Portugal

Maria Cristina Rosamond Pinto, Department of Human Genetics, Faculdty of Medicine, Lisboa

Heloisa Santos, Department of Medical Genetics, De Santa Maria Hospital, Lisboa

Yorge Sequeiros, UmiGENE, IBMC, University of Porto, Porto

Spain

Maria Ramos, Department of Genetics, Virgen Del Camino Hospital, Pamplona

Sweden

Goran Flood, Swedish Skandia Life, Stockholm

Jan Wahlström, Department of clinical Genetics, Sahlgrenska University Hospital/East, Göteborg

Switzerland

Suzanne Braga, FMH medizinische Genetik, Bern

André Chuffart, Swiss Re Life & Health, Zurich

Christian Kind, Ostschweizer Kinderspital, St Gallen

Olivier Guillot, Institut de droit de la santé, Neuchatel University, Neuchatel

United Kingdom

Peter Brett, Peridontology, Eastman Dental Institute, London

Jerry Brown, Swiss Re Life & Health Limited, London

Ruth Chadwick, Center for Professional Ethics, University of Central Lancashire, Preston

David Cook, The Whitfield Institute, Oxford

Stephen Diacon, Centre for Risk and Insurance Studies, University of Nottingham, Nottingham

Robert Dingwall, Genetics and Society Unit, University of Nottingham, Nottingham

Bethalee Jones, Association of British Insurance, London

Beryl Keeley, Genetics Science Policy, Department of Health, London

Alastair Kent, Genetic Interest Group, London

Doris Littlejohn, Central Office of Industrial Tribunals, Glasgow

Angus MacDonald, Department of Actuarial Mathematics & Statistics, Heriot-Watt university, Edinburgh

David Muiry, Swiss Re Life & Health Ltd, International Financial Center, London

D. Paul, British United Provident Association Ltd, BUPA House, London

Andrew Read, Department of Medical Genetics, St Marys Hospital, Manchester

Virginia Warren, Group Medical, UPA, London

Pamela Watson, Genetics & Society Unit, University of Nottingham, Nottingham

United States of America

Dorothy Wertz, The Eunice Kennedt Shiver Center for Mental Retardation, Waltham, MA

This document forms part of a BIOTECH program financed by the Commission of the European Communities (CEE BIO4–CT98–0550).

All rights reserved. No part of this document may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcoping, or by any information storage and retrieval system, without permission in writing from the copyright holder.

© Copyright 2002 by ESHG/PPPC