U.K. Human Genetics Commission Proposes Principles for DTC Genetic Testing Services

Paper FlyingLast month, the Human Genetics Commission, the U.K. government’s genetics advisory body, issued for public comment a “Common Framework of Principles” for direct-to-consumer (DTC) genetic testing services. The Principles are derived from earlier reports by the Commission (Genes Direct (2003) (pdf) and More Genes Direct (2007) (pdf)) and seek to:

…promote high standards and consistency in the provision of direct-to-consumer genetic tests among commercial providers at an international level in order to protect the interests of people seeking genetic tests and their families.

The Principles, which are ambitious in scope and detailed in their recommendations, represent an important next step in the ongoing debate over the appropriate level of oversight for the emerging DTC genetic testing industry.

Published in draft form, the Principles provide ample room for analysis, and companies and consumers are invited to provide responses and comments until December 6th, 2009.

In this post we take a close look at the draft Principles and summarize the core values and goals that appear to underlie these recommendations.


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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Informed Consent, International Developments, International News

Genetic Exceptionalism and Paternalism Themes in new German Legislation

ReichstagIn 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).


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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Informed Consent, International Developments, Pending Regulation, Privacy

Is the ACCP’s Call for Greater Governmental Regulation of DTC Genetics Premature?

ReformAnother player has entered the debate over direct-to-consumer (DTC) genetic testing and come down on the side of greater regulation. In a position statement authored by Barbara Ameer and Norberto Krivoy (pdf), the American College of Clinical Pharmacology (ACCP) proposes greater regulation of laboratory genetic tests generally, DTC advertising of genetic tests, and communication to consumers of genetic test results.

The ACCP’s position paper faults a number of features of the current regime: (i) the FDA does not require premarket review of laboratory-developed tests; (ii) even if conducted in CLIA certified laboratories, the clinical validity of laboratory-developed tests (which includes most DTC genetic testing) is not regulated; (iii) there is no regulatory oversight system for advertising of DTC genetic tests; and (iv) the communication of DTC test results is not mediated through a trained clinician. The ACCP fears that consumers are insufficiently protected in the current unregulated environment, with the result that “at a population level, these collective [negative] experiences may give future genetic testing a poor reputation, and it consequently may not be trusted by consumers.” The ACCP further cautions that the “inequitable regulatory policy regarding laboratory-developed tests [may stifle] innovation in the creation of validated genetic tests.” The position paper does not state, or offer any data suggesting, that any such stigma currently attaches to genetic testing or that innovation is being stifled.


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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Pending Regulation

U.K. House of Lords Issues Report on Genomic Medicine

houses-of-parliamentOn July 7, the Science and Technology Committee of the United Kingdom’s House of Lords issued its report on genomic medicine (pdf).  The Report is optimistic about the potential long-term benefits of translating advances in genetics into substantial improvements in medical care but determines that the National Health Service (NHS) is not currently equipped to take advantage of this scientific revolution.  The Report identifies existing institutional deficiencies and makes a variety of recommendations for improving the U.K.’s current system.

The following first summarizes key features and recommendations of the Report and then considers how the Report may influence legislative and regulatory developments in the United States, as well as in the U.K.

Part I: Recommendations for Genomic Medicine

At a hefty but still manageable 126 pages, the full Report is recommended reading for those interested in the field of genomic medicine in any country with a developed healthcare system.  But for the sake of convenience, some of the highlights of the Report are summarized below.


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Filed under Bioinformatics/IT, Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Society, International Developments