Germany Struggles to Find Balance in Promoting, Regulating Genetic Technologies
Last fall we reported on the passage of the Human Genetic Examination Act by the German Bundestag. We characterized the Gendiagnostikgesetz (GenDG), as the act is known in Germany, as “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.”
The GenDG (pdf) took effect early this year and, until recently, little news of its impact on German law, policy or business has made its way across the Atlantic. Last week, however, several prestigious German scientific academies released a report entitled “Predictive Genetic Diagnostics as an Instrument of Disease Prevention.” The “Academy Group,” as the report’s authors refer to themselves, consists of the Leopoldina, the Berlin-Brandenburg Academy of Sciences and Humanities and the German Academy of Science and Engineering Acatech. Astoundingly, according to a recent editorial in the journal Nature, the report is the first from the group in its 350 year existence.
The Importance of Balance in Evaluating DTC Genomics
Earlier this week the New York Times published a generally alarmist and one-sided piece (“Buyer Beware of Home DNA Tests”) advising consumers to steer clear of direct-to-consumer (DTC) genetic testing and genomic services providers. The Times piece advises consumers to opt instead for a certified medical geneticist or genetic counselor even as it acknowledges, in the next paragraph, “a relative shortage of genetic counselors to clarify the significance of test results, and the fact that most practicing physicians lack the knowledge and training in genetics to interpret them properly.”
There’s no need for me to dissect and evaluate the arguments against DTC genomics made in the article. That task has been ably carried out by Daniel MacArthur, Blaine Bettinger and Jens McCabe. And it’s worth mentioning that the Times’ DTC genomics coverage has been relatively rich and varied (see, e.g., the now infamous “spit party” coverage, 23andMe co-founder Anne Wojicki’s Q&A on the Freakonomics blog or Steven Pinker’s excellent piece in the Times magazine, “My Genome, My Self”).
I do want to weigh in, however, on the potential consequence of the paternalistic medical establishment viewpoint that is advanced in the Times article, which paints DTC genomics as an industry lacking in analytic validity, clinical validity, clinical utility and (in what was a new concept for me) “ethical validity.” In failing to acknowledge any of the benefits provided by DTC genomics (which MacArthur, Bettinger and McCabe all highlight), the Times article invites readers (including legislators) to plausibly conclude that a legitimate solution might be simplyto restrict the business of genomic interpretation to traditional medical professionals. This is, in fact, exactly what Germany is proposing to do on a national level, but this type of genetic paternalism—largely a byproduct of a genetic exceptionalism perspective—is an extreme position, with most legislators taking a more measured approach, at least to date.
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).
