Genetic Exceptionalism and Paternalism Themes in new German Legislation
In April, the German Parliament approved the Human Genetic Examination Act. An English translation of the Act (pdf), which appears likely to be enacted, was recently posted to EuroGentest. (Special thanks to the PHG Foundation for locating the translation.) The Act is a clear example of what is known as “genetic exceptionalism”—the belief that genetic information is qualitatively different from other forms of personal or medical information—staking out a position near the paternalistic end of genetic regulation. Despite aspiring “to protect human dignity and ensure the individual right to self-determination via sufficient information,” the substance of the Act severely restricts individual freedom of action.
Strict Regulation of Genetic Examinations
The Act employs the terms “genetic examination” and “genetic analysis” in most of its provisions and defines these terms so broadly (§ 3) as to admit some uncertainty as to what would or would not constitute a genetic examination or genetic analysis. The vagueness of the definitions is mitigated to a degree by other defined terms that clarify that the Act’s provisions on genetic examinations and genetic analyses apply, in fact, to such examinations and analyses for medical purposes or for determining descent. The Act requires that “diagnostic” or “predictive” genetic examinations be ordered and interpreted by medical doctors having appropriate training and conducted only by institutions having the appropriate accreditation (§ 7). Such genetic examinations and genetic analyses may be conducted only upon the express, written and informed consent of the patient (§ 8).
In seeking informed consent (§ 9), doctors conducting a genetic examination must offer the patient counseling services (§ 10) that include an explanation of possible medical, psychological and social risks of conducting, or not conducting, a genetic examination. Patients also have a right to elect not to know the results. Consent may be withdrawn at any time, including orally, and a patient may require that the results of his or her genetic examination, including an tissue samples, be destroyed (§ 12, 13).
Prenatal genetic examinations (§ 15) are limited to identifying treatable medical conditions “according to the generally accepted status of science and technology.” However, no prenatal genetic testing is permitted for medical conditions or illness that do not “break out” until after the age of 18. What constitutes the “generally accepted status of science and technology” (§ 23) will be determined using guidelines supplied by the 13-member “Genetic Diagnostic Commission.”
With limited exceptions, the Act prohibits insurers (§ 18) and employers (§ 19) from demanding a genetic examination or the results of any previously conducted medical genetic examination. Insurers may request the results of previously conducted exams in the case of life, disability or pension insurance policies exceeding EUR 300,000 or that provide an annuity exceeding EUR 30,000 per year. The Act also provides an exception for occupational medical exams needed to assess genetic traits responsible for severe work-related health conditions (a provision that needs further regulatory clarification) (§ 20). The Act reinforces the prohibitions on requesting or obtaining genetic tests with a blanket prohibition on genetic discrimination by employers (§ 21). The Act contains an even more comprehensive prohibition (§ 4) providing that no person may be discriminated against or disadvantaged on account of genetic characteristics, or the genetic characteristics of a genetically related person, identified by a genetic examination. This latter prohibition is so broad as to be almost incomprehensible—taken at face value it seems to prohibit any genetic information from being used by any person in any detrimental fashion—and will require further elaboration by courts or regulators.
Direct-to-Consumer (DTC) Provisions
The requirement that any “diagnostic” or “predictive” genetic examinations be ordered and interpreted by medical doctors (§ 7), and the results disclosed to the individual only by the ordering physician (§11), means that any would-be providers of DTC genetic services will need to convince German regulatory authorities that they are supplying educational or informational products, and not clinical or medical services. One of the many uncertainties in reading the Act is whether whole-genome sequencing, which can yield both clinical and non-clinical information, would be prohibited unless ordered and interpreted by a medical doctor. Given the general tenor of the Act, prohibition seems likely.
Complicating matters further is a somewhat cryptic (either as written or as translated) provision of the Act (§ 6) that authorizes the Federal Health Ministry to restrict access to “genetic study materials” (an undefined term) for the conduct of genetic examinations to persons and institutions authorized to conduct such examinations. Possible restrictions could bar German residents from receiving or returning DTC sample collection kits or accessing information concerning genetic testing and genetic conditions directly from DTC companies such as 23andMe, Navigenics or Pathway Genomics.
Research and Other Exceptions
The Act does not apply to “genetic examinations and genetic analyses or the handling of genetic samples or genetic data conducted for research purposes.” Although the term “research purposes” is not defined, the exception (§ 2) appears to protect pure research and is reinforced by the fact that most substantive provisions of the Act apply to genetic testing for medical purposes. Similarly excepted are genetic analyses for authorized criminal procedures and in accordance with the Infection Protection Act.
Penalties, Future Regulations and Delayed Effectiveness
The Act contemplates that it will be fleshed out by future regulatory actions. It establishes a Genetics Diagnostics Commission that, in conjunction with the Robert Koch Institute (a German analog of the Center for Disease Control) will develop the regulations (§ 23). In addition, the Act becomes effective only in gradual steps (§ 27) that defer the effective date of most provisions until October 2009, 2010 or 2011. Interestingly, Section 6 of the Act, which authorizes the Federal Health Ministry to restrict access to “genetic study material” and appears targeted at DTC genetic testing services, is one of the few provisions given immediate effect. Depending on the violation, the Act provides for penalties of imprisonment up to two years and fines of up to 300,000 EUR per violation (§ 26).
An Extreme of the Spectrum
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?