Germany’s Human Genetic Examination Act exists at a paternalistic extreme of the spectrum with respect to the regulation of genetic services and information, sharing that space with the similarly restrictive Norwegian Biotechnology in Human Medicine Act (pdf), both of which seem influenced by the Council of Europe’s Convention on Human Rights and Biomedicine. Elsewhere on the spectrum, the most comprehensive piece of U.S. federal genetic legislation, the Genetic Information Nondiscrimination Act (GINA), restricts use of genetic information by insurers and employers but leaves individuals free to use genetic testing services as they choose. Similarly, in the United Kingdom, the recent and widely-discussed House of Lords Report on Genomic Medicine advises the DTC genetic testing industry to adopt a voluntary code of conduct for assessing the clinical utility of its services and the need for associated genetic counseling.
The German Act, on the other hand, adopts an extremely protective, even fearful, view of genetic information as something so dangerous and private that the generation and disclosure of genomic data must be mediated solely through specially trained physicians, accompanied by psychological and social counseling, and subject to destruction of the data at any time upon the request of the subject individual. In addition to tightly regulating the doctor/patient relationship, the Act appears intended to outlaw (or at least highly restrict) DTC genetic testing services. One of the laudable purposes of the act, “to protect human dignity and to ensure the individual right to self-determination via sufficient information,” is belied by provisions of the Act that restrict the ability of individuals to access their own genetic information directly.
Assuming the legislation is enacted, there will be plenty of international observers tracking the consequences of Germany’s attempt to tightly control its citizens’ access to and use of their genetic information. Will DTC companies cease sending spit kits to German residents? Will German citizens seek genetic testing in less restrictive climes? Will Germany’s example prompt other countries to follow a similar policy of genetic exceptionalism enforced by paternalistic regulation?