Genetic testing legislation in Western Europe-a fluctuating regulatory target.

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.