The AAMC and four other higher education associations sent a joint letter July 27 to Health and Human Services Secretary Xavier Becerra opposing a proposal to use provisions under the 1980 Bayh-Dole Act in an attempt to reduce drug prices. The associations, which were joined in their comments by the Bayh-Dole Coalition, an advocacy group, were responding in part to a June 23 letter by Sen. Elizabeth Warren (D-Mass.) and more than one hundred other Democratic lawmakers urging Becerra to “march in” and relicense or otherwise take control of patented drugs developed through federal research grants.
In their letter, the AAMC and other organizations expressed their shared concerns for the affordability of drugs but argued that the proposal to use march-in or other Bayh-Dole provisions in this manner would not be an effective or comprehensive solution to drug pricing. Moreover, the letter argues that exercising the government use license and/or march-in rights over the end price of a product would disincentivize industry from licensing university inventions in the future and would harm the system of innovation that the Bayh-Dole Act, which permits medical schools and universities to patent inventions arising from federal research, has created.
The AAMC has advocated on this issue for more than two decades, when march-in proposals were first raised over high prices for certain HIV medications and patients petitioned the National Institutes of Health (NIH) to exercise the government’s option. As cited in the joint letter, neither the NIH nor any other federal agency has ever granted such petitions over the commercial price of a product. The legislative history of the Bayh-Dole Act, and statements by Sens. Birch Bayh (D-Ind.) and Robert Dole (R-Kan.) themselves, specify that the provisions were never intended as a means for price control. Other organizations have also raised these arguments to Becerra.
The higher education associations concluded: “In addition to an ineffective mechanism to reduce drug prices, such an action would significantly undermine university innovation and the benefits it delivers to the American people, and indeed, as in the case of COVID-19 vaccines, the entire global community.”