By Donald Zuhn —

In a perspective published
in the August 29 issue of the New England Journal of Medicine, Dr. Howard
Markel outlines the events leading up to the enactment of the Bayh-Dole Act and
states that "a review of [the Act's] origins and consequences supports the
idea that policies governing the fast-changing worlds of medicine and
biotechnology merit frequent reappraisal and reform."  In the article, entitled "Patents, Profits,
and the American People — The Bayh–Dole Act of 1980,"
Dr. Markel,
the George E. Wantz Distinguished Professor of the History of Medicine, and
Director for the Center for the History of Medicine at the University of
Michigan, notes that "Bayh–Dole's inspiration was not a perceived need to
transform the conduct of research but the economic doldrums of the 1970s."  Following a helpful summary of the history of
the Act, Dr. Markel explains that "[w]hen the Bayh–Dole Act was written,
its aim was primarily to stimulate economic growth by more efficiently mining
the untapped scientific riches of hospitals, laboratories, and universities."  He argues, however, that "[m]uch has changed since then."

While Dr. Markel provides
no proposed changes to the Act, he contends that "some of the most vexing
quandaries weren't fully addressed in the original legislation."  As for examples of such
"quandaries," he suggests that revised legislation should address several
questions:

Who should benefit from discoveries pertaining
to nature or the human body?  . . .  [W]hat conflicts of interest must be
identified and contained in order to protect patients?  How can scientific discovery proceed if all
innovations and research tools are patented and the discoverers control access
to them?

Dr. Markel (at left) concludes his article by
declaring that "[i]t's time for Congress to recalibrate Bayh–Dole,"
adding that "[p]rofits and patents can be powerful incentives for scientists,
businesspeople, and universities, but new and ongoing risks — including high
prices that limit access to lifesaving technologies, reduced sharing of
scientific data, marked shifts of focus from basic to applied research, and
conflicts of interests for doctors and academic medical centers — should be
mitigated or averted through revisions of the law."