MEDIA ADVISORY: Andrew W. Torrance, professor of law, will deliver his keynote address, “Tempest Tossed: Genomics Amidst Legal Storms,” at noon CST in Ottawa, Ontario. He will be available for phone interviews on any aspect of law and genes, genomics or personalized medicine after 3 p.m. All of Torrance’s articles are available for free download here.
LAWRENCE – An organization sponsored by the Canadian government is looking to a University of Kansas School of Law professor for guidance on federal genomics policy.
Andrew W. Torrance, professor of law, has been invited to deliver the keynote address Tuesday at “Where Genomics, Public Policy and Society Meet,” a conference sponsored by Genome Canada, a government-sponsored organization that helps to set genetics policy in that country.
As a biotechnology, innovation and patent law expert with a doctorate in genetics from Harvard University, Torrance is uniquely positioned to address this intersection of science and public policy.
Although it took a decade and more than $3 billion to sequence the first complete human genome, technology has advanced to the point that it’s now possible to sequence a genome in about a week for around $1,000.
“Obviously, it’s a double-edged sword,” Torrance said. “The more we know about our genes, the more we might be inspired by the potential abilities, or depressed by the potential limitations or diseases, such knowledge might predict. Do you really want to know if your genes indicate you are at risk for devastating conditions like early-onset Alzheimer’s or incurable cancers? Do you really want to know how tall, fast or cheerful your child’s genes predict he or she could potentially be? Such intimate knowledge could have a powerful effect on one’s views of the future. Furthermore, without a proper understanding of genetics and probability, it is uniquely prone to misinterpretation and misuse.”
The bioethical concerns are myriad, Torrance said, but the technology is surging forward. Companies such as 23andMe and Navigenics offer a mail-order saliva kit, an initial report and a Web-based subscription service to keep up with new DNA discoveries as they become available.
In his keynote address, Torrance will discuss how the law is attempting to grapple with genomics; how to encourage research while also ensuring that the research is used for socially positive goals; how to encourage and incentivize more innovation in the field of genomics through mechanisms like the patent system, open innovation, technology transfer and drug regulation; and how to ensure that, to the extent possible, government agencies like the Food and Drug Administration ensure quality control and patient safety.
“If you’re going to get a report about your genome, you want to be sure it’s an accurate report accompanied with thoughtful and meaningful interpretive guidelines,” Torrance said. “You can imagine how devastating it would be to get an inaccurate report suggesting that you will likely suffer a deadly illness, but then, later, to find out that this devastating and life-changing news was simply the result of machine malfunction, patient misinterpretation or reporting error.”
Genome Canada asked Torrance to share his insights into innovation policy in the United States and Europe, including lessons learned that could help Canada overcome some of its own challenges. That picture is still rapidly evolving. For example, the U.S. Supreme Court will soon decide one or more cases that could determine whether genes, genomes and personalized medicine inventions are patentable, and the FDA has recently trained its sights on the “medical” services and advice already being offered by companies like 23andMe and Navigenics.
“This has powerful implications for the genomics industry,” Torrance said. “Organizations like the American Civil Liberties Union have argued passionately that no one should be able to patent something as fundamental as a gene. However, if there were no patent protection for genes, it is unclear how companies could justify investing in newer, faster and cheaper technologies for sequencing, analyzing and producing drugs with genes.
“In addition, if genomics is going to fulfill its promise of helping to create a more personalized and precise future for medicine, the FDA will have to choose deftly how to regulate the field of genomics so as to assure patient safety while simultaneously encouraging breakthrough innovations. I can’t think of a more exciting time to be a legal scholar studying this field.”