Introduction
In January 2025, the National Institutes of Health (NIH) introduced a new NIH Intramural Research Program Access Planning Policy (“IRP Access Planning Policy” or “Policy”). An NIH web page provides links to several documents describing the policy:
https://osp.od.nih.gov/policies/innovation-and-translation#tab1/
The policy itself is set out in two documents: a 5-page document titled simply the “National Institutes of Health Intramural Research Program (IRP) Access Planning Policy,” and an 11-page document titled “NIH IRP Access Planning Policy: Implementation Guidance.”
- NIH IRP Access Planning Policy
- Implementation Guidance
There are also links to four other documents for additional context:
- NIH Guide Notice
- RFI on Draft NIH Intramural Research Program Program Policy: Promoting Equity Through Access Planning
- Compiled Public Comments in response to RFI
- Webinar on draft policy and RFI
The NIH Guide Notice, dated January 10, 2025, is the most complete, including in one document the policy, the implementation guidance and the overview of public comments.
NIH Intramural Research Program Access Planning Policy
Notice Number: NOT-OD-25-062
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-062.html
The NIH IRP Access Planning Policy document states that organizations applying to the NIH for certain certain commercial patent licenses relating to agencies intramural research program (research conducted by NIH employees), “are required to submit Access Plans outlining steps they intend to take to promote patient access to licensed products,” and “Once approved by NIH, those Access Plans will be incorporated into licenses granted by NIH as part of the licensee’s development plan.”
The Policy applies to commercial patent licenses for patents wholly owned by the
U.S. government that are related to the development of drugs, biologics (including vaccines), or devices.
Excluded from the scope of the policy are licenses when the expected use is not for a licensed product, such as a research tool. Importantly, the policy does not apply to patents invented and developed under NIH funding agreements with non-federal employees.
The decision to exclude the extramural NIH funding programs was seen as an effort to limit the opposition to the initiative from universities and other contractors, although the new program, if actually implemented by the new Trump team, will be seen by everyone as a test that could be the basis for a broader reach in the future.
The Policy applies to exclusive, co-exclusive, partially exclusive, and non-exclusive license applications and licenses.
Plan Elements
According to the Implementation Guidance, “access plans shall include, but not be limited to:
- A brief description of the licensed product(s);
- The anticipated patient population(s);
- Other products, tools, facilities, or unique resources that would be necessary for use of the product(s); and
- Strategies to promote patient access across criteria of affordability, availability, acceptability, and sustainability, to the extent such access can be advanced on terms that are commercially reasonable.”
Flexibility
The Policy and the Implementation Guidance make it clear that licensees will have considerable flexibility designing an access plan. The 11-page Implementation Guidance provides 41 non limiting examples of measures that might be included in an access plan. That said, the NIH will have to approve the access plan.
Transparency Provisions
The licensee will have to submit a non-confidential version of their Access Plan within 3 months of regulatory approval of a licensed product, that the NIH “may” publish or otherwise make available to third parties. There is no guarantee that the non-confidential version of their Access Plans will be made public, but the requirement to provide a non-confidential version suggests this may happen.
There is no provision at this point to give the public the opportunity to comment on the proposed access plans, before NIH approval of the plan.
Waiver
One of the controversies in the policy proposal was the possibility of a waiver. The published policy states that:
“License applicants and licensees may request a waiver or modification to the requirements of the IRP Access Planning Policy, in whole or in part, at any point during the application process or the duration of a license. NIH will evaluate those requests and may grant a waiver or modification upon a showing that access planning would not be commercially feasible and would hinder the overall benefit of access to the licensed product. The agency anticipates waivers would be very rare and only appropriate in exceptional circumstances.”
KEI has consistently supported the possibility of a waiver, but asked the NIH to require a public notice and comment on requests for a waiver. The NIH currently has a waiver for the US manufacturing preferences in the Bayh-Dole Act, and these waivers are available to the public through FOIA, but not published by the NIH, they are certainly not subject to public comment before they are granted.
The Public Comments on the Original Request for Information
The document titled “Compiled Public Comments on National Institutes of Health (NIH) Office of Science Policy (OSP): Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning” on the NIH web page is 88 pages long, and provides links to 48 comments from persons and organizations:
KEI made two submissions. One was 35 pages long. Another was a 5-page commentary and a spreadsheet of data, prepared by Claire Cassedy, of 114 comments KEI and collaborators had provided the NIH on previous notices for exclusive licenses.
Some other notable comments:
Health Advocates
KEI, two submissions, one 35 pages, one 5-page commentary and a spreadsheet of data.
Public Citizen on behalf of 25 organizations, 49 pages.
MSF, 23 pages.
UAEM, 16 pages.
Access to Medicine Foundation, 5 pages.
Patients For Affordable Drugs, 4 pages.
Bryce Robinson on behalf of 25 health groups, 3 pages.
Academics
Fred Ledley, Bentley University, 17 pages.
Julie Moonga, King’s College London, 2 pages.
Luis Gil Abinader, 21 pages.
Maya M. Durvasula, Lisa Larrimore Ouellette, and Bhaven N. Sampat, 9 pages.
Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (“MRCT Center”), 5 pages.
Program On Regulation, Therapeutics, And Law (PORTAL), 4 pages.
The Innovative Genomics Institute (IGI), 7 pages.
Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), 9 pages.
PDPs, Charities, donors
CEPI, 6 pages.
CIRM Access and Affordability Working Group, 5 pages.
DNDi, 9 pages.
GHIAA/MPP, 8 pages.
National Health Council, 6 pages.
Wellcome Trust, 4 pages.
Industry and Rights Holder Groups
Association of American Universities (AAU), 2 pages.
Association of Amicus Counsel, 6 pages
AUTM, 5 pages.
Bayh-Dole Coalition, 4 pages.
BIO, 7 pages.
California Life Sciences, 5 pages.
CEO Members of Business Roundtable, 2 pages.
COGR, 3 pages.
CSL Behring, 4 pages.
Intellectual Property Owners Association (IPO), 8 pages.
LST Strategies LLC., page 3
National Association of Manufacturers (NAM), 3 pages.
PhRMA, 12 pages.
Small Business Technology Council (www.SBTC.org), 1 page.
US Chamber of Commerce, 5 pages.
Other Commenters
Clifford Samuel and Claudio Lilienfeld, 3 pages.
KEI Comment on the NIH Policy
The NIH policy, published January 10, 2025, days before Donald Trump is inaugurated, is an important document, regardless of its reception by the incoming administration.
This is a significant document, even if ignored by Trump, because it provides a model that has made it to the top at the NIH. As drafted, how significant would it be? That will depend upon the implementation. The earlier NIH reasonable pricing policy was never implemented in a serious way.
The current NIH Director, Dr. Monica M. Bertagnolli, is serious, but everything will depend now on the new Director, whose views are not known. We are somewhat hopeful the Trump administration and the new NIH Director will be more open on the question of access and pricing conditions on US-funded inventions, but it’s really hard to know at this point. And obviously the access for non-US citizens seems at risk with the current White House. But that said, it’s an important policy.