NIH’s Access Planning Policy for Patent Licenses: Part 1
Beginning Oct. 1, 2025, all applicants for commercial licenses of patents owned by the U.S. National Institutes of Health (NIH) are required to submit an Access Plan outlining how they will promote patient access to the resulting products.
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Beginning Oct. 1, 2025, all applicants for commercial licenses of patents owned by the U.S. National Institutes of Health (NIH) are required to submit an Access Plan outlining how they will promote patient access to the resulting products.
The NIH Access Planning Policy could represent a significant step toward ensuring the affordability of biomedical products for underserved communities. Yet questions remain regarding the implementation and effectiveness of this Policy.
Part 1 of this two-part post describes the background and terms of the Policy; and Part 2 explores several key issues it raises.
NIH Intramural Research and Patents
The (NIH) is the largest public funder of biomedical research in the world. In 2024, NIH distributed more than $37 billion to universities and other “extramural” biomedical research institutions in the form of research grants, R&D contracts, training grants and facilities support.
NIH also maintains its own laboratories that conduct “intramural” research at a cost of more than $5 billion in 2024. While the size of NIH’s intramural research program is far smaller than that of its combined extramural researchers, it is nevertheless a significant biomedical research operation.
In 2024, NIH filed 235 patent applications covering the inventions and discoveries made by its intramural researchers. Like most nonprofit research institutions, NIH does not seek to commercialize the results of its research directly, but instead licenses the corresponding patents to the private sector. In 2024, NIH entered into 38 commercial patent licensing agreements and earned approximately $211 million in royalty income. According to NIH, “more than 1,000 products have been brought to market based on NIH licenses, including 39 vaccines and therapeutics approved by the [Food & Drug Administration] [FDA]”.
The Challenge of Patient Access
A perennial issue in government-funded research is whether there should be some constraint on the pricing of the resulting products. This issue has arisen primarily with respect to patented drugs based on NIH grant-funded (extramural) research. Since the Bayh-Dole Act of 1980, numerous petitions have been filedrequesting NIH exercise its statutory “march-in” rights to procure lower prices for drugs resulting from extramural research.
Similar concerns exist with respect to patented technologies developed by NIH’s intramural researchers. In response to public criticism of the high price of the drug AZT, in 1989 NIH required that cooperative R&D agreements (CRADAs) between NIH and private parties include a clause requiring that there be a “reasonable relationship between the pricing of a licensed product, the public investment in that product, and the health and safety needs of the public.” However, NIH revoked this requirement in 1995 as a result of industry pressure.
Development of the NIH Access Planning Policy
Public concern over the pricing of vaccines and therapeutics based on NIH intramural research reemerged during the COVID-19 pandemic. In July 2023, NIH hosted a public workshop to discuss technology transfer from NIH laboratories, and patient access to the products of NIH research was raised as an important issue. The next year, NIH published a draft Access Planning policy that would require applicants for NIH patent licenses to submit a plan to promote patient access to products based on the patented technology. NIH received 48 public responses to the draft policy from nonprofit research organizations, professional associations, academic institutions, industry, and others, and assessed that more than half of the responses supported the policy proposal.
On Jan. 10, 2025, during the final weeks of the Biden Administration, NIH issued a final Intramural Research Program Access Planning Policy, which was scheduled to become effective on June 1, 2025. However, NIH rescinded that policy on July 24, 2025, “to facilitate alignment with the Administration’s priorities” and replaced it with a new Intramural Research Program Access Planning Policy, along with implementation guidance. The Access Planning Policy became effective on Oct. 1, 2025.
Requirements of the Access Planning Policy
The stated purpose of the Access Planning Policy is to “expand equitable patient access to products that emerge from NIH’s own patent licenses.” It requires that every applicant for a license of an NIH-owned patent submit an Access Plan describing its “strategy to support broad access to a licensed product for the U.S. population.” NIH will not consider a license application unless it includes an Access Plan and will not grant a license until the applicant’s Access Plan is approved. Once approved, the terms of the Access Plan will be incorporated into the licensing agreement entered into by NIH and the applicant.
Applicability
The Access Planning Policy applies to exclusive, co-exclusive and non-exclusive licenses, and covers all licenses “that would authorize the commercialization of drugs, biologics (including vaccines), or devices for the prevention, diagnosis, or treatment of human disease.” The policy does not apply to licenses for the production or sale of reagents used for research purposes only.
Content
Access Plans are required to include “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.”
The intended beneficiaries of equitable access under an Access Plan are “underserved communities in the U.S.” as well as “populations in low- and lower-middle-income countries, as defined using the World Bank classification system.” Interestingly, while the international component of this provision is defined by reference to World Bank classifications, “underserved communities in the U.S.” is not defined. The rescinded January 2025 version of the Policy referenced a since-withdrawn Biden Administration Executive Order (No. 13985, Jan. 20, 2021) that included within this category “Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.” The elimination of this expansive definition in the current Policy suggests a narrower interpretation will be applied.
Pricing
In evaluating Access Plans, NIH will consider a range of factors including, most importantly, affordability, which includes “pricing structure, insurance, reimbursement, coverage decisions, and payment models.” Among the approaches suggested by NIH for promoting equitable access and affordability are: “optimizing dose, formulation, and manufacturing processes to reduce cost of goods …; committing to keep prices in the U.S. equal to those in other developed countries; not raising prices at rates outpacing inflation; pricing products at the lowest sustainable level or connecting product prices to marginal production costs; agreeing to locally-affordable pricing strategies or non-profit pricing models in certain populations or regions; [and] Committing to price reductions once preset sales, revenue, or profit thresholds are reached.”
Waiver
The Access Planning Policy provides that NIH may (very rarely and under “exceptional circumstances”) waive some or all of the requirements of the Policy if the applicant shows that “access planning, in whole or in part, would not be commercially feasible and would hinder the overall benefit of access to the licensed product.” For example, NIH states waivers may be appropriate “if the market for the product is very small (e.g., population affected by a rare disease) or where there is heightened scientific uncertainty involved with further R&D on the patented technology” and “where there is a risk of later drug shortages or inadequate product quality.”
Enforcement
Unlike prior NIH access policies criticized as merely hortatory or aspirational (see Rai & Eisenberg (2003, 306-10), Contreras (2017, 31-32)), the implementation guidance for the Access Planning Policy (Sec. D) lists specific actions NIH may take in response to a licensee’s failure to comply with its access commitments. These include limiting licensed fields of use, revoking license exclusivity, imposing additional royalties and terminating the license in whole or in part.
