With this post the GLR introduces a new Contributing Writer, Jonathan Webber. Jonathan is a web editor at Robinson, Bradshaw & Hinson, the law firm that sponsors the GLR. His duties include copy-editing the GLR. That exposure, together with his background in anthropology—he came to RBH with a degree in anthropology and experience as both a field archaeologist and cultural educator for a state park system—has sparked his interest in some of the cultural and ethical issues that genomics raises. In this first post he brings his perspective to bear on the implications of 23andMe’s “designer babies” patent, and we look forward to more of his insight in the future.
By the way, some readers may detect a growing anthropological conspiracy: I’m an anthropologist, as is Contributing Editor Jen Wagner, and now Jonathan. Yes, we’re taking over.
The September 24, 2013 grant of a patent to 23andMe for “gamete donor selection based on genetic calculations” has stirred another round of controversy about “designer babies.” Predictably, the press and blogosphere lit up with condemnations of both 23andMe and the United States Patent and Trademark Office. Karen Kaplan of the Los Angeles Times writes that the patent itself is “even more repulsive than the idea of using DNA tests to help people create designer babies.” Dov Fox of the University of San Diego School of Law suggests that “Congress should consider amending the patent law to appoint ‘ethics representatives’ to the PTO.” Sigrid Sterckx, et al., writing in Genetics in Medicine, note that the PTO did not “question whether techniques for facilitating the ‘design’ of future human babies were appropriate subject matter for a patent.”
So, while some ire has been and will be directed at 23andMe itself, commentators are also raising larger questions about patent eligibility and the patent application process.
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The World Medical Association published revisions to the Declaration of Helsinki (DoH) in JAMA on October 19, 2013. As noted previously on the Genomics Law Report, the DoH was adopted in 1964 and is considered a foundational guiding document for ethical medical research. The DoH has been revised six times previously, and these are the first revisions since 2008. The revised DoH was announced following the Working Group’s public consultation from April to June 2013 on the text of proposed changes, though the Working Group has apparently spent at least two years contemplating revisions and consulting with experts. In the United States, the DoH has been an important foundational document promoting the creation of institutional review boards (IRBs) but has had relatively little practical influence since it was effectively abandoned by the administration of former President George W. Bush. Nonetheless, the DoH continues to exert significant influence over international ethical standards.
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