The National Institutes of Health (NIH) Office of Science Policy (OSP) posted a Request for Information (RFI) on the Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning. The draft policy seeks, “to promote access to products stemming from taxpayer-funded inventions.” Through the RFI, the NIH will further develop this draft policy and accompanying license agreement language that “incorporates patient access in the commercialization process for NIH-owned inventions.”
Knowledge Ecology International (KEI) submitted two sets of comments to the Access Planning RFI, including:
- KEI Comments on NIH Proposal to Require License Holders to Provide Access Plans
- KEI Submission to the NIH, regarding previous proposals for terms in exclusive licenses on federally owned inventions
KEI Comments on NIH Proposal to Require License Holders to Provide Access Plans
KEI’s comments note that as the NIH seeks to enact obligations on companies to make products and services affordable and accessible, there will be considerable opposition, as in the past. This note provides some historical context for the negotiations, and makes several recommendations for the implementation. Historical measures reviewed include:
- Access and affordability measures from 1980 to 1995
- Legislative efforts to restore the reasonable pricing clause from 1996 to 1999
- 1999 requests to expand global access to federally-funded inventions
- The 2000 amendments to the Bayh-Dole Act
- Requests to address global access to NIH-funded inventions, 2000 to 2006
The full text of the comments are available as KEI Briefing Note 2024:7 KEI Comments on NIH Proposal to Require License Holders to Provide Access Plans
KEI Submission to the NIH, regarding previous proposals for terms in exclusive licenses on federally owned inventions
Beginning in 2015, KEI has engaged the NIH in its exclusive licensing practices, filing objections and calling for the NIH to include terms in its licenses that safeguard public access to resultant products. When the NIH offers a technology for licensing on an exclusive basis, it is required to provide a public comment period, as noticed in the Federal Register. While this comment period used to be longer, the NIH as a practice currently only allows the statutory minimum number of days (15) to comment on potential licenses. As of May 2024, KEI has commented on 114 NIH exclusive licenses.
KEI’s submission to the NIH RFI on Access Planning highlights access-promoting terms that KEI has previously and repeatedly suggested the NIH include in its license terms. Examples outlined include safeguards against price gouging, terms concerning global registration and affordability, limitations on geographic scope and exclusivity, transparency of price, sales/revenue, and R&D outlays, non-exclusive/Medicines Patent Pool licenses, implementation of World Health Assembly Resolution 72.8 on transparency, and more.
The full text of KEI’s submission is available here: Examples of Terms KEI Recommended for Inclusion in NIH Licenses – 22July2024
Attached to KEI’s submission was also a spreadsheet listing all instances KEI has commented on NIH licenses and offered suggested terms to safeguard patient access, including metadata on KEI’s term suggestions and the licenses themselves: KEI NIH Comments on Exclusive Licenses as of 22July2024 – Selected Metadata