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Genetic testing legislation in Western Europe—a fluctuating regulatory target

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Abstract

Rapid developments of biomedical science have initiated different fora to take stand on the protection of human rights and human dignity. In front of the new genomic era with the completion of the Human Genome Project in 2003, a plethora of instruments addressing human genetic testing emerged, some looking suspiciously like legal acts. The notion of genetic exceptionalism was characteristic to the normative reactions in the legal acts, but it can be questioned how justified this is. Despite the critique on genetic exceptionalism, it is argued that in certain situations detection of a serious genetic anomaly may cause extra anxiety in a person tested, if the knowledge has a great significance also to family members. Regulative needs should depend on the context and purpose of the test. This review examines the legal framework governing the use of genetic tests in the clinical setting in Western Europe. Five countries have enacted genetic specific laws, and three have comprehensive provisions pertaining genetic testing in their biomedical legislation. Central provisions cover informed consent, autonomy and integrity of the person tested, further uses of tests results, quality requirements of the personnel and facilities involved. Moreover, contemporary challenges related to whole genome sequencing, direct-to-consumer genetic tests and insurance are briefly discussed.

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Notes

  1. For an overview on US legislation, see Hudson 2011

  2. See www.unesco.org/bioethics

  3. For a timely list of ratifications, see www.coe.int/bioethics

  4. www.gentechnik.gv.at

  5. An English translation is at http://www.eurogentest.org/professionals/ethical_and_legal/

  6. Comparative law is a specific legal academic discipline that studies differences of legal systems, legal orders and laws of different countries. It aspires to go further into the local legal culture and history to be able to understand and explain normative structures and solutions in a given country.

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Conflict of interest

The author declares that she has no conflict of interest.

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Authors and Affiliations

  1. Faculty of Law, Institute for Health and Welfare (THL) and University of Helsinki, Helsinki, Finland

    Sirpa Soini

  2. University of Helsinki, Helsinki, Finland

    Sirpa Soini

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  1. Sirpa Soini
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Correspondence to Sirpa Soini.

Additional information

Western Europe, in this text, comprises the Nordic countries and German and French-speaking countries, as well as Spain and Portugal. The UK does not have specific genetic legislation. The choice of countries is based on language (Nordic, German, Latin, and English).

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Soini, S. Genetic testing legislation in Western Europe—a fluctuating regulatory target. J Community Genet 3, 143–153 (2012). https://doi.org/10.1007/s12687-012-0078-0

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