European Court: No Patents on Human Embryonic Stem-Cell Products

The European Court of Justice ("ECJ") has held that scientists cannot patent products developed from any research which involves the destruction of the human embryo. The Court's full opinion is here. Greenpeace (!) began the case in 2004 by suing to block a Bonn researcher's patent on a technique for deriving neural cells from human embryonic stem cells. European law has banned patenting in connection with the "uses of human embryos for industrial or commercial purposes" since 1998, and German law includes similar language. The Greenpeace case turned on whether a blastocyst destroyed in creating a stem-cell line counts as an "embryo;" whether "industrial or commercial purposes" includes university-based research; and whether the European patent-exclusion law applies to research that is conducted significantly downstream from the act of embryonic destruction (for example, on stem cell lines produced many years ago, and purchased by German researchers from researchers in other countries). The German court's 2006 ruling in favor of Greenpeace was appealed to the German supreme court, who referred it to the ECJ for clarity on the meaning and application of the various terms. Earlier this year the ECJ's advocate-general recommended that the court uphold the patent ban, so yesterday's opinion was widely expected. The court held, first, that the term "embryo" includes any fertilized egg, any product of "research cloning" (in which an unfertilized egg has introduced into it a nucleus from a mature cell), and any parthenote (an unfertilized egg whose division and development have been artificially stimulated by researchers). (This last holding is surprising to me, since parthenotes aren't capable of developing into babies.) Next, the court held that scientific research is included within the legal restriction from patentability concerning the use of embryos "for industrial or commercial purposes". Finally, the court found that the patent restriction applies no matter how distant the research or patent is from the original act of embryonic destruction, and even if the patent itself makes no mention of embryos (referring, for example, only to particular cell-lines originally derived from embryos). There's a fine technical overview of the opinion here.

Upcoming Bioethicsy Stuff at Yale

Two things to put on the calendar: First, Hal Herzog (Psychology, Western Carolina University) will speak to our Animal Ethics Working Group at 1 p.m. on Thursday the 27th at the Bioethics Center; his topic will be "Moral Inconsistency, Psychology, and Animal Ethics." Second (though it's a day earlier, I'm just writing this backwards), our sister organization, Yale Medical Schoo'ls Program on Biomedical Ethics, will host a conference on Transplantation Ethics on Wednesday the 26th, 5 p.m., in the Beaumont Room of Yale Med's Sterling Hall, above the medical library. Speakers will be Robert Truog and Norm Fost. Should be wonderful!

French Parliament at Yale

Jean-Sebastien Vialatte and and Alain Claeys, members of the French Parliament, visited the Yale Interdisciplinary Center for Bioethics this week. They're in the US, visiting Boston, New York and Los Angeles (and Yale!) to find out what American scientists and bioethicists think about the ethics of neuroimaging. They came to us courtesy of Wendell Wallach, who runs our Technology and Ethics Working Group. (They'd originally hoped to meet with James Hughes and members of his Institute for Ethics and Emerging Technologies (IEET). James was out of the country, and graciously recommended they speak to Wendell, instead.) They arrived, together with a translator, a member of the Parliamentary office of Science and Technology, the Science and Technology rep from the French Consulate to the US, and at least two other staff, for a morning meeting with Wendell, myself, Carol Pollard and Mike Treder, Managing Director of the IEET. We had a wide-ranging and serious discussion about the ethics of imaging, the ethics of brain technologies more generally, the current political situation in the US around several bioethics issues from stem cell research to genetic medicine, the political status of the transhumanism movement, and more. All of which blew my mind, because I couldn't imagine the analogous US Congressional delegation to France, or anywhere else. To my admittedly rather amateur eye, our Congressional delegations to foreign destinations seem to be political events (chances to be seen and heard) rather than genuine investigations (chances to listen). Who in our Congress would actually ask, "I wonder what scientists and academics in France (or Germany or Sweden or Japan or the UK) think about this important issue?" And who, then, would actually go and ask, and listen?

This Year in Bioethics: Common Rule Edition

So, fall is (finally) in the air, and 2011 is winding down. It's not too early (is it?) to start thinking about what this year's top bioethics stories were. I think anybody's list has to start with the massive proposed changes to the Common Rule. Proposed changes include 1) beefing up data security standards in order to relieve IRBs from having to review protocols for informational risks; 2) eliminating continuing IRB review requirements for protocols past their active stages, and for all protocols originally subject only to expedited review; 3) expanding the category of exempt studies and reducing oversight of such studies; 4) permitting blanket prospective written consent for research on biospecimens; 5) expanding the category of studies subject only to expedited review, and streamlining of oversight for such studies; and 6) permitting single-IRB approval of protocols for multi-site studies. For a quick overview, look at this Emanuel/Menikoff article in NEJM. Here's the full text of the advance notice of proposed rulemaking. You can submit your own comments here, until October 26!

Another approach to organ donation...

Bioethics Hall of Fame: Paul Ramsey Edition

Over at blog.bioethics.net, Summer McGee has asked, "Who would you put in the bioethics hall of fame?"

So here's my first of many nominees: Paul Ramsey, author of Fabricated Man, Ethics at the Edges of Life, and The Patient as Person. He was one of the first-generation bioethicists who came, mostly, from moral theology backgrounds. Himself a Methodist, he is credited with having brought the Catholic doctrine of just war theory to the attention of mainstream Protestant ethicists. He is not, frankly, the easiest person to read; but his essays still repay careful attention, even when--or perhaps especially when--they wrestle with subjects about which most contemporary bioethicists have already reached consensus, e.g., cessation of life-sustaining treatment.

Bioethics Web Resource of the Week

And speaking of the Nuffield Council on Bioethics, why not name their collection of excellent, free, downloadable reports on a wide variety of bioethics issues as the first of my planned weekly "Bioethics Web Resources" posts? Here you'll find material on the bioethics of dementia, biofuels, the use of animals as research subjects, GM crops, personalized medicine, stem-cell research and more.

Nuffield on Bodily Donation

The Nuffield Council on Bioethics has posted a new report on donation of human bodies and body parts for medicine and research. It covers a wide range of topics: live and cadaveric organ donation for transplant, gamete donation for reproduction, use of healthy volunteers in first-in-human trials, blood and cord blood, tissue donation, and more. It's a huge and far-reaching report, and I haven't had time to read it deeply, yet, but it appears that the most controversial of its recommendations is to create a pilot program under which women would be paid for donating eggs for research.