The National Institutes of Health (NIH) has implemented a new policy requiring organizations seeking commercial licenses for NIH-owned patents to submit detailed plans on how they will promote patient access to any resulting drugs, biologics, or medical devices. This policy, effective October 1, 2025, aims to ensure that medical products developed from NIH-owned inventions are accessible to the public.
Under the Intramural Research Program (IRP) Access Planning Policy, applicants must provide an “Access Plan” as part of their license application. This plan should outline strategies to promote patient access across four key criteria: affordability, availability, acceptability, and sustainability. The policy applies to licenses granted by NIH for patents wholly owned by the U.S. government and encompasses exclusive, co-exclusive, partially exclusive, and non-exclusive licenses. ([osp.od.nih.gov](https://osp.od.nih.gov/nih-intramural-access-planning-policy-set-to-take-effect-additional-guidance-available/?utm_source=openai))
NIH defines patient access broadly, including considerations such as pricing strategies, distribution plans, and measures to ensure that underserved communities benefit from new medical products. For instance, applicants might commit to pricing products at the lowest sustainable level or aligning prices with those in other developed countries. ([techtransfer.nih.gov](https://www.techtransfer.nih.gov/policy/access-policy/faqs?utm_source=openai))
Once approved, these Access Plans will be incorporated into the licensing agreements. Licensees are also required to provide updates on their progress and, within three months after FDA approval of the licensed product (or a foreign equivalent), submit a non-confidential version of their Access Plan that NIH may publish or share with third parties. ([techtransfer.nih.gov](https://www.techtransfer.nih.gov/policy/access-policy/faqs?utm_source=openai))
While the policy has been lauded for its intent to promote equitable access, it has also faced criticism. Some industry stakeholders express concern that the additional requirements could deter companies from entering into licensing agreements with NIH, potentially hindering the development and commercialization of new medical products. ([ipwatchdog.com](https://ipwatchdog.com/2025/10/02/trump-administration-adopts-innovation-killing-biden-nih-licensing-guidelines/id%3D192786/?utm_source=openai))
NIH has indicated that waivers or modifications to the Access Plan requirements may be granted in exceptional circumstances where access planning would not be commercially feasible and could hinder the overall benefit of access to the licensed product. However, such waivers are expected to be rare. ([techtransfer.nih.gov](https://www.techtransfer.nih.gov/policy/access-policy/faqs?utm_source=openai))
This policy reflects NIH’s commitment to ensuring that publicly funded research translates into medical products that are accessible to all, particularly underserved communities. As the policy takes effect, its impact on licensing practices and the broader biomedical innovation landscape will be closely monitored by both industry and public health stakeholders.