The controversial argument for revising the Bayh-Dole Act — a law that for over thirty years has helped bring university technologies to market and the world — reached its biggest platform yet in the renowned New England Journal of Medicine (NEJM).
Howard Markel, MD, PhD, a distinguished professor of the history of medicine at the University of Michigan and director of the school’s Center for the History of Medicine, wrote the commentary “Patents, Profits, and the American People,” which was published on NJEM’s website August 29th. In it, Markel paints the Bayh-Dole Act as haphazardly constructed and out of touch with new and constantly changing concerns among the scientific community.
Markel lays out an interesting history of Bayh-Dole’s genesis as well as its rocky and somewhat inglorious road to passage by a lame duck Congress, before narrowly avoiding a pocket veto by Jimmy Carter as he exited the White House. “Nevertheless,” he notes, “his signature opened the floodgates to a river of money that has become more turbulent over time.”
“When the Bayh-Dole Act was written,” he writes, “its aim was primarily to stimulate economic growth by more efficiently mining the untapped scientific riches of hospitals, laboratories and universities. Much has changed since then.”
These changes, he argues, include mounting conflicts of interest and the dangers of profit-incentivized research, as well as the potential for blockage of research due to exclusively owned patents. The recent Supreme Court decision in the Myriad case, Markel asserts, illustrates critical questions over who should benefit from federally funded research that have arisen under the Act.
Though Markel offers no specific proposals, he contends that “[i]t’s time for Congress to recalibrate Bayh-Dole. Profits 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. All Americans should be able to share in the bounties of federally funded biomedical research.”
Markel’s argument is not the first time tech transfer professionals have heard vocal criticism of Bayh-Dole, which has long been staunchly defended by AUTM and its constituents. What is news, however, is the elevated platform which Markel’s argument for revisions have found in NJEM, arguably the world’s most respected and influential medical journal.