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February 16, 2010

The Future of Bioethics Law and How It May Affect Medical Care

While many lawyers may not be familiar with the intricacies of bioethics, the study is a very important and substantive issue that directly affects the public as it relates to medical discoveries and health care costs. In a roundtable discussion sponsored by the _ Special Committee on Bioethics and the Law titled “Hot Topics in Bioethics,” experts William Allen, director, Program in Bioethics, Law and Medical Professionalism, University of Florida and Robyn Shapiro, partner at Drinker Biddle in the Health Practice Group, led and facilitated debate on current trends in the field, as well as legal and ethical issues.

One issue up for debate during the panel program was the yet-to-be-determined federal court decision in the case Association for Molecular Pathology v. U.S. Patent and Trademark Office. The fundamental question of the case is whether or not the patenting of genes is legal, in other words, can genes be separated from a DNA sequence in a manner that can be deemed, “new and useful” to the extent that a patent can be issued.

The dispute is over the patents on BRCA1 and BRCA 2 (pronounced bracka) that, while not the first human genes to be isolated and patented, raises fundamental ethical issues of our patent system vis-a-vis medical research and whether publicly funded research discoveries should be allowed to be patented.

Should patents be granted when doing so potentially risks the public good?  In the case of BRCA 1 and BRCA 2, doing so may restrict scientists other than the patented researchers from developing new cancer tests. Additionally, granting a patent in the BRCA case means that only one company, Myriad Genetics, who currently holds the patents to these genes, control all the testing related to those two strands of DNA.  These two strands are strongly correlated with breast and ovarian cancers, making it difficult for other  medical researchers to work simultaneously on finding a cure.

Another question is that, in theory, aren’t scientific discoveries initially based on previously published case studies done by hundreds of thousands of other scientists? Should only one or a few scientists get all the credit and, more importantly, all the money, for a discovery that was reached in part based on other scientists’ trial and error?

Further, if medical research is publicly funded—as much of it is government funded through the National Institutes of Health—should someone be able to privatize the discovery, ultimately allowing for the monopolization of a product needed to improve public health?

Another major issue discussed during the panel program was that of organ donation, and the rise in individuals and online groups selling and/or marketing their organs as gifts to non-family members.  Currently organ donation is run through the government, and the default choice is “not donating your organs.” But there is a massive disparity in supply and demand. Some 110 people a day are added to the organ donor list, so—as one can imagine—the wait can be long or a person on the list may never receive an organ at all.

Thus, there are concerns that there needs to be legislation outlawing the sale or donation of organs, and the bypassing of the United Network for Organ Sharing. By not using UNOS, organ donors may “cheat” or skip over those in need who have been waiting on the communal list for a long time. An alternative legislative change discussed that may help increase the number of organ donors is making the default choice of U.S. citizens as being organ donors, and make people actively opt-out, rather than the current opt-in, syste

These are just a few of many issues in bioethics that are gaining public attention and debate. To learn more about the ABA’s Special Committee on Bioethics email .