For more on KEI’s work on COVID-19, see keionline.org/coronavirus.
On March 23, 2020, Knowledge Ecology International (KEI) sent a letter to Speaker Nancy Pelosi regarding a provision in the current draft of the Senate version of the coronavirus funding bill (H.R. 748) that would eliminate accountability in government research and development (R&D) agreements. The draft bill proposes to expand the authority of the Biomedical Advanced Research and Development Authority (BARDA) to use “Other Transaction Authority” (OTA) for R&D funding agreements. Agencies such as the Department of Health and Human Services have asserted that OTA agreements are not subject to the Bayh-Dole Act, and expanding OTA would take away safeguards that are critical to protecting to the public’s investments in biomedical R&D.
KEI’s letter asks Congress to ensure that the public’s investment in biomedical R&D is protected by stipulating that any funding agreements related to the coronavirus pandemic are subject to the public interest protections in the Bayh-Dole Act. This includes, but is not limited to, the government’s royalty-free right in federally-funded inventions, march-in authority, and contactors’ obligation to make patented inventions available to the public on reasonable terms.
A copy of KEI’s letter to Speaker Pelosi is available here: KEI Letter to Speaker Pelosi Regarding OTA
Examples of existing OTA contracts involving HHS:
HHSO100201700018C, an expanded agreement between HHS and Johnson and Johnson related to the development of a coronavirus vaccine.
Expanded agreement between HHS and Regeneron Pharmaceuticals, Inc. “to develop new treatments combating the novel coronavirus, 2019-nCoV[.]”