About the IRP Access Planning Policy

All NIH activities are driven by the principle that our work is not finished when we deliver scientific discoveries; our work is finished when all people are living long and healthy lives. To advance this aim, NIH’s Intramural Research Program (IRP) Access Planning Policy seeks to improve access to medical products developed from NIH-owned inventions.

The IRP Access Planning Policy applies to certain NIH-owned inventions and research conducted by NIH’s own scientists within its Intramural Research Program—the internal research arm of the agency. Under the policy, outside organizations submitting license applications to NIH on or after October 1, 2025, are required to provide a plan describing the steps they will take to promote patient access to any resulting new drugs, biologics (including vaccines), or devices. The policy only applies to licenses that would authorize the development of those patient-facing products and NIH defines patient access broadly to include affordability, availability, acceptability, and sustainability. Upon approval by NIH, access plans will be incorporated into commercial patent licenses granted by NIH.

Overall, this policy emphasizes the importance of proactive planning for patient access in the commercialization process for NIH-owned inventions.

For more historical background on the policy, visit Office of Science Policy.