Will NIH’s Newly-Proposed Policy Improve Patient Access?

On May 22, 2024, the U.S. National Institutes of Health (NIH) announced it was soliciting feedback on a proposed policy (the Policy)¹ that would require licensees of NIH internally-developed inventions to include, in the parties’ license agreement, plans for expanding patient access to products incorporating those inventions.

Background of the Proposal

Last year, NIH hosted a workshop²  to discuss potential policies that could promote access to NIH-funded inventions. One of the concepts discussed at the workshop was “access planning,” which NIH describes as the incorporation of patient access considerations into agreements relating to biomedical research and development. NIH notes in the Policy that it views patient access—encompassing product affordability, availability, acceptability, and sustainability—as being of “paramount importance” in determining whether U.S. taxpayers receive a sufficient return on NIH’s investment in biomedical research.

Scope of the Proposal

At the highest level, NIH funding is broadly divided between NIH’s Intramural Research Program (IRP), i.e., research conducted by NIH employees at NIH federal laboratories, and NIH’s Extramural Research Program (ERP), i.e., research conducted by scientists at universities and other institutions using NIH grant and other funding. The Policy is directed solely towards the IRP, whose work generally is funded solely through NIH’s budget. According to NIH, approximately 1,200 principal investigators and more than 4,000 postdoctoral fellows conduct research under the IRP, making it “the largest biomedical research institution on earth.”³

As a general matter, the Policy would “require that licensees that succeed in bringing certain products toward market submit a plan outlining steps they intend to take to promote patient access to those products” (each such licensee, a Licensee, and each such plan, as further described below, an Access Plan). However, the Policy clarifies that its application would be specifically limited to:

• inventions made by investigators in the IRP that are solely owned by the agency;⁴
• patent licenses—regardless of exclusivity (e.g., exclusive, non-exclusive, etc.)—that permit the licensee to commercialize drugs, biologics, vaccines, or devices covered by the inventions for the prevention, diagnosis, or treatment of human disease.

The Policy includes the following detailed definition of an Access Plan:

Licensee’s plan, and incorporating the plan(s) of its sublicensee(s), as applicable, that describes Licensee’s strategy to support broad access to Licensed Product(s) for the U.S. population, as well as 

(a) through the lens of promoting equity for underserved communities such as 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, as defined by Executive Order 13985⁵ and/or 

(b) populations in low-and middle-income countries, as defined using the World Bank classification system.

At a minimum, each Access Plan would be required to include: (i) a brief description of the Licensed Product(s); (ii) the Licensed Product(s)’ anticipated patient population(s); (iii) other products, tools, facilities, or unique resources that would be necessary for the Licensed Product(s)’ use; and (iv) strategy(ies) to mitigate access challenges across the above-mentioned criteria (i.e., affordability, availability, acceptability, and sustainability).

The Policy would impose the following obligations on Licensees:

• Provide Access Plan prior to Pivotal Trials. Licensees would be required to provide NIH with an Access Plan within three months of a Licensed Product entering a first pivotal clinical trial. If the Access Plan includes proprietary information, Licensees would also be required to provide NIH, upon its request, with a non-confidential version or statement of the plan that NIH may publish or otherwise make available to third parties.
• Meet with NIH upon Request and Consider NIH Suggestions. If requested by NIH, Licensees would be required to meet with NIH at least annually to review its progress under, and consider in good faith any reasonable modifications proposed by NIH to, the Access Plan.

The Policy provides that Licensees’ foregoing obligations would not apply where the NIH has approved Licensees’ request for a waiver or modification, which NIH would be required to consider in good faith.

Initial Observations and Looking Ahead

Recognizing the Policy is in the early stages of the rulemaking process, we note the following:

• The Access Plan requirements do not appear to vary depending on the stage of development at which the relevant license is granted. However, the Policy states that NIH would “employ a tiered approach” on that basis, requiring more “specific, tailored access-oriented provisions” for late-stage inventions and a “more flexible” approach for early-stage inventions. It will be interesting to see if the Policy is revised to include optionality on this point.
• The Policy aims to promote access throughout the world, not only in the U.S. While the Policy states that access is important in “providing a return on [U.S.] taxpayers’ investment in biomedical research,” the Access Plan is defined to require Licensees to also consider “populations in low-and middle-income countries.” Although companies typically seek to commercialize products on a global basis, it is possible that stakeholders who comment on the Policy may object to this component of the Access Plan as going beyond the scope of NIH’s interests.
• Licensees would largely retain discretion over the content of Access Plans. Although NIH would have the right to review and comment on Access Plans on an annual basis, there is no firm requirement for Licensees to actually incorporate NIH’s comments—instead, they would only need to be considered in good faith. As a result, NIH’s control over the contents of the plans would likely be fairly limited.
• NIH’s request to publicly disclose Access Plans would potentially have unintended consequences. As noted above, if an Access Plan includes proprietary information, Licensees may be required to provide a non-confidential version or statement regarding the plan that NIH may publicly disclose. We expect companies engaged in developing and commercializing Licensed Products may seek to remove NIH’s publication right. Indeed, they may view even the “non-confidential” version of the plan as requiring the disclosure of proprietary commercialization strategies that apply beyond the relevant Licensed Product—for example, to all products developed by a given Licensee for the same indication as the Licensed Product. We think that, if the final Policy retains NIH’s publication right, it is possible Licensees will seek to avoid including any meaningful details in the Access Plans given the potential that they could be made publicly available to competitors.

In light of the above, it will be very interesting to see how the Policy evolves as feedback is submitted. The comment period is scheduled to close on July 22, 2024.⁶

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(1) “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;” see here. 

(2) “Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer;” see here.

(3) https://irp.nih.gov/about-us/what-is-the-irp.

(4) NIH states that the treatment of jointly­-owned IP would be considered at a later date.

(5) “Executive Order On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government;” see here.

(6) “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;” see here.