Message from the Director
Genome Ethics & Public Policy
Huntington F. Willard, PhD
In October 1988, James Watson addressed a packed press conference and casually announced that 3% of the National Institutes of Health's budget for sequencing the human genome would be devoted to the study of ethical, legal and social implications (ELSI) of genome research. Recalling the episode, then-NIH Director Jim Wyngaarden (see interview this issue) told GenomeLIFE, "I had no clue that he was going to do this. That's not how we make policy at the NIH. But I think it was a stroke of genius."
"One of the most pressing needs in the realm of "genome policy" ... is to develop a coherent and practical understanding of the issues raised by genome-derived innovation and to resolve questions of access and commercial benefit."Now more than fifteen years later, the ELSI program has supported the study of any number of ethical concerns arising from human genetics and the Human Genome Project, ranging from privacy rights to genetic discrimination to uses of genetic testing. At least in the public's eye, such considerations of "genome ethics" are often blurred with more general bioethical (or perhaps biopolitical) concerns about cloning, stem cells, and even abortion.
Our own efforts in this direction are more expansive, implicit in the name of the IGSP's Center for Genome Ethics, Law and Policy. Lawyers and policy experts can be reflective and scholarly, but they are also about action.
One of the most pressing needs in the realm of "genome policy" – brought acutely to the forefront during the public-private genome war of 1999 to 2001 – is to develop a coherent and practical understanding of the issues raised by genome-derived innovation and to resolve questions of access and commercial benefit. Such a debate swirls around interpretations of U.S. (and worldwide) patent law, the Bayh-Dole Act of 1980, and determination of whether (or when) DNA-based discoveries meet the standards of inventions, which must be novel, useful and non-obvious to one of average skill in the art.
To some, the very possibility of DNA-based patents runs counter to a deeply held belief that the genome belongs to every man and woman and thus cannot, by definition or at least by assertion, be protected as intellectual "property". To others, this philosophical position must be tempered by practical considerations of the business world; how can one expect a biotechnology or pharmaceutical company to invest what could amount to hundreds of millions of dollars in development of new technology platforms, new diagnostic tests or new drugs without the protection of a monopoly afforded by current patent law?
In the spirit of full disclosure, I confess to being somewhat schizophrenic about this, as I've experienced both sides of this argument. In the late 1980's and early 1990's, we considered but then decided not to patent a variety of DNA probes from the human genome that we felt would be of diagnostic value to the medical community. Time has proven us right; the probes are widely used in prenatal and cancer diagnosis. I still believe we were right to publish the work quickly and to make the probes available freely. Others may disagree, however, as versions of these same probes are now marketed widely. Someone – not me and not my students – is making a lot of money.
On the other side of the debate, in 1997 we did decide to patent another discovery from our lab, methods to develop human artificial chromosomes. With this intellectual property protected, we were able to form a start-up company, which has benefited several parties: the postdocs in my lab who were largely responsible for the discovery, investors in the company, and the community through the creation of new jobs. But licensing the technology to the company (which I co-founded) has complicated our ability to share the technology freely and caused legitimate concerns about potential conflicts of interest that have had to be addressed, both by the institution and by me as a faculty member and mentor.
Even at his most extreme, I don't think what Sir John Sulston told us last month or advocates in this issue regarding the need for a scientific commons amounts to a demand for anything more than an honest accounting of our motives and biases. What is needed, and what Bob Cook-Deegan and his colleagues are pursuing in their Center for the Study of Public Genomics, is a scholarly assessment of the current state of affairs: Who has patented what? has it helped? How might it have hurt? Are there mechanisms that would ensure open access to data and discoveries while also encouraging the growth of elements within the for-profit sector? Or is the ideal of open thought inherently in conflict with the notion of proprietary thought? Can an institution develop a balanced policy that supports both?
Important questions all, and ones that Duke is favorably positioned to address at the intersection of the genome sciences and policy. It's what "Genome Life" is all about.
Huntington F. Willard
Director