Key Dates

Related Announcements

• July 24, 2025 –NIH Intramural Research Program Access Planning Policy Implementation Guidance. See Notice NOT-OD-25-137
• January 10, 2025 – NIH Intramural Research Program Access Planning Policy. See Notice NOT-OD-25-062 - Rescinded

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

The purpose of this Notice is to reissue the NIH Intramural Research Program Access Planning Policy, initially issued under NOT-OD-25-062, to facilitate alignment with the Administration’s priorities. In addition, the guidance that was released with the original Policy is being issued as its own separate Guide Notice. The updated Policy and guidance include minor revisions to the text and removes references to Executive Orders that have been rescinded since the original publication. 

Background

The National Institutes of Health (NIH) is issuing this Intramural Research Program (IRP) Access Planning Policy, to expand equitable patient access to products that emerge from NIH’s own patent licenses. Under this Policy, organizations applying to NIH for certain commercial patent licenses are required to submit Access Plans to NIH outlining steps they intend to take to promote patient access to those licensed products. Once approved by NIH, Access Plans will be incorporated into the licenses granted by NIH. This Policy will apply to license applications and licenses granted by the NIH IRP for patents wholly owned by the government. Overall, the Policy emphasizes the importance of proactive planning for patient access in the distribution and commercialization process for NIH-owned inventions.

NIH IRP Access Planning Policy 

Section I. Background & Purpose 

As the world’s largest public funder of biomedical research, NIH seeks to drive effective partnerships that foster a shared commitment to transforming knowledge into improved health for all. The agency’s Intramural Research Program (IRP) Access Planning Policy is designed to further leverage NIH patent licenses to enhance health and expand patient access to emerging biomedical technologies.  

Study after study has shown how NIH-funded and conducted research catalyzes the development of new products and services for disease prevention, diagnosis, and treatment¹. Indeed, NIH has a decades-long history of licensing inventions made by government scientists in its Intramural Research Program (IRP)—inventions that have provided the foundation for new vaccines, drugs, and medical devices². And partnerships are central to this success. NIH does not develop, distribute, or commercialize technologies itself; it relies on partners, including licensees, to turn inventions into new products and services that can directly impact people’s lives. NIH also recognizes that all too often patients across the country and across the globe may be unable to access products they need—for example, a treatment for their disease may not yet exist, or it might exist but be out of reach because it is too expensive or difficult to administer. With that in mind, under the NIH IRP Access Planning Policy (“IRP Access Planning Policy” or “Policy”), organizations applying to the NIH IRP for certain commercial patent licenses are required to submit Access Plans outlining steps they intend to take to promote patient access to licensed products³. Once approved by NIH, those Access Plans will be incorporated into licenses granted by NIH as part of the licensee’s development plan. 

NIH intends this Policy to be flexible, both to accommodate public health needs and to catalyze opportunities across a variety of emerging biomedical technologies. Each of NIH’s patent licenses are unique and can potentially support the development of a broad range of drugs, biologics (including vaccines), and devices. A flexible Policy allows NIH and its licensees to pursue tailored strategies to expand the reach, and benefit, of products. 

Flexibility is also warranted given the uncertainty associated with product development and patient access. Licensees may discover something new or unexpected in the R&D process, revealing compelling reasons to pivot in product development. NIH does not intend Access Plans to lock licensees into a single direction when there are other more promising paths to pursue.   

NIH sought public input on development of this Policy, including strategies for developing appropriate Access Plans and for promoting access under the IRP Access Planning Policy (see Request for Information) that are described in the Implementation Guidance (NOT-OD-25-137). NIH will continue to work with stakeholders and communities to develop additional materials as needed to promote effective implementation of the IRP Access Planning Policy. 

Section II. Scope 

Under the IRP Access Planning Policy, an organization applying to NIH for a commercial patent license is required to submit an Access Plan—as part of the plan required by 35 U.S.C. 209 and 37 CFR part 404.5—if the applicant is seeking a license that would authorize the commercialization of drugs, biologics (including vaccines), or devices for the prevention, diagnosis, or treatment of human disease. The Policy applies to commercial patent licenses (hereinafter referred to as licenses) granted by the NIH IRP, for patents wholly owned by the U.S. government, e.g., inventions made by investigators in the NIH IRP. The Policy applies to exclusive, co-exclusive, partially exclusive, and non-exclusive license applications and licenses.  

The IRP Access Planning Policy does not apply to licenses and applications that are unrelated to the development of drugs, biologics (including vaccines), or devices. For example, NIH does not require Access Plans for license applications that are limited to the sale of reagents for research purposes only (with no clinical or therapeutic scope). The IRP Access Planning Policy also does not apply to patents owned by third parties (i.e., parties external to the U.S. government), and it does not apply to patents that are developed under NIH funding agreements and owned by NIH grantees or contractors⁴. 

Section III. Phase-In 

The IRP Access Planning Policy applies to license applications submitted to NIH on or after October 1, 2025.  

Section IV. Requirements 

Organizations applying to NIH for licenses within the scope of this Policy are required to:

• Submit an Access Plan as part of their license application, for NIH review and approval;
• Commit to provide updates on progress and, as appropriate, reassess the approved Access Plan as product development progresses; and
• Submit a non-confidential version of their Access Plan within 3 months after FDA approval of the licensed product (or a foreign equivalent) that NIH may publish or otherwise make available to third parties⁵.

An Access Plan refers to a license applicant or licensee’s strategy to support broad access to a licensed product for the U.S. population, and it can include, as applicable, strategies through the lens of promoting equitable access for underserved communities in the U.S. and for populations in low- and lower-middle-income countries, as defined using the World Bank classification system. 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. 

NIH will not consider license applications that fall within the scope of the IRP Access Planning Policy unless those applications include an Access Plan. The agency will not grant licenses within the scope of the Policy without an NIH approved Access Plan. Once approved by NIH, these Access Plans will be incorporated into licenses granted by NIH as part of the licensee’s development plan. 

Section V. Waivers 

NIH may waive the requirements of the IRP Access Planning Policy upon a showing by a licensee or license applicant 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. The agency anticipates waivers would be very rare and only appropriate in exceptional circumstances. 

Overview of Public Comments

NIH considered all feedback received from the public in the development of the IRP Access Planning Policy. The agency released its Request for Information (RFI) on May 21, 2024 (89 FR 45003, comment period closing on July 22, 2024). NIH received 48 responses to the RFI, and the comments are publicly available. While some respondents did not self-report their affiliation, those that did included respondents from nonprofit research organizations, professional organization associations, academic institutions, industry, and others. A discussion of the public comments on topics and how they were addressed follows below.

In general, more than half of the RFI respondents were supportive of the Policy proposal. Common remarks from respondents, regardless of their position on the policy, centered on requests for NIH to provide additional clarity in the final Policy. NIH was encouraged to provide additional details on topics such as access plan requirements, plan evaluation, waivers, and consequences. By addressing these parameters in the final Policy and Implementation Guidance, NIH can communicate clear expectations and standards to patients and patient advocates, small business firms, technology transfer and licensing professionals, investigators, public health organizations, investors, industry partners, healthcare providers, universities, research institutions, and other members of the public, seeking to resolve potential implementation uncertainty around the final Policy. Furthermore, many respondents expressed understanding that some barriers to access are outside of the scope of what this Policy can address and/or outside of the scope of what NIH’s licensees can change.

In addition to the thoughtful commentary and suggestions about the IRP Access Planning Policy, NIH received comments on a variety of notable alternatives that might promote patient access but are outside the scope of this particular Policy. For example, some commenters suggested changes to NIH licensing agreements or further investment in clinical trials, while others addressed topics outside NIH’s authority. Those responses remain pertinent to the landscape of patient access and will be considered in other venues for action.

Discussion of Public Comments submitted in response to RFI on the IRP Access Planning Policy

Clarifying Expectations for Promoting Meaningful Access Approaches

Policy Proposal: The Policy proposal did not articulate a minimum requirement for what constitutes an acceptable Access Plan proposal. Rather, NIH recognized that “licensees, their partners, and the public will need confidence around what this policy requires and the standards that would be used to evaluate plans,” and the agency sought input through the RFI. NIH also asked for input on how to maintain flexibility while also promoting certainty and transparency on access efforts and policy enforcement.

Public Comments: Many comments discussed the need for certainty, so that interested parties can understand how the agency will evaluate access plans and what is required to comply with the Policy. Several respondents offered suggestions for how NIH could evaluate access plans. Many of those comments acknowledged that not all strategies to promote access are created equal, while others emphasized how strategies to promote access will vary depending on details of the technology and the license in question. Suggestions included: asking licensees to address affordability, availability, acceptability, and sustainability in each plan; mandating “must have” access strategies; applying different standards depending on the nature and maturity of the NIH invention; developing flexible standards that can be adapted; and periodic review of the Policy to update evaluation criteria, best practices, and case studies/examples. Some respondents also suggested NIH define strategies that are not “commercially reasonable” for improving access or otherwise provide examples of inadequate access plans.

Final Policy: The final Policy and associated Implementation Guidance state that Access Plans should 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 the criteria of affordability, availability, acceptability, and sustainability to the extent such access can be advanced on terms that are commercially reasonable. NIH will review Access Plans, in their entirety, to ensure each of these elements is included and to evaluate the reasonableness of the plan, considering, e.g., the nature of the patented technology, how the technology is used in the development of a product, and the contributions of the public and private sector. The agency will use criteria of availability, affordability, acceptability, and sustainability to assess plans. Furthermore, NIH will not lock licensees into a plan that may no longer serve the direction of the product’s development. Instead, NIH intends to work closely with licensees to monitor progress and modify approved Access Plans, as appropriate, to support successful commercial development and implementation of access strategies.

Expectations for Domestic and Global Access Planning

Policy Proposal: The Policy proposal suggested that Access Plans describe strategies to support broad access for the U.S. population, as well as to promote equitable access for underserved U.S. communities and/or populations in in low- and middle-income countries, as defined using the World Bank classification system.

Public Comments: Many comments called for access plans to address both domestic and global populations, and suggested NIH replace “and/or” with “and.” Other comments suggested the Policy’s scope be limited, to only cover products that would likely be used in resource-poor settings or if a technology is specifically addressing the health needs of an underserved population. There were related concerns raised about how some medical technologies may only be relevant in certain regions, and how there are some global territories where NIH has no patent rights. In light of these facts, some respondents suggested that either (1) NIH designate on a case-by-case basis in the license if the access plan will need to focus on domestic, global, or both populations, or (2) NIH incorporate a blanket expectation in the final Policy that access plans cover both domestic and global populations and also include a formal process for licensees to seek waivers when there is no demonstrable public health need for a given global, regional, or domestic population. 

Final Policy: The final Policy and associated Implementation Guidance require Access Plans to describe strategies to support broad access to a licensed product for the U.S. population, and it can include, as applicable, strategies through the lens of promoting equitable access in underserved communities in the U.S. and for populations in low- and lower-middle-income countries, as defined using the World Bank classification system. 

Timing of Submission of Access Plans

Policy Proposal: The Policy proposal recommended the submission of Access Plans within 3 months of a licensed product entering a first pivotal clinical trial (a Phase III clinical trial or the equivalent).

Public Comments: NIH received many comments about the timing of plan submission, with some respondents expressing concern that the Policy proposal’s recommended due date would be too early in the development lifecycle and others expressing concern that the proposed date was too late. Respondents who favored earlier submission of access plans frequently argued it would promote a more comprehensive and integrated approach to patient access, since decisions that can shape patient access such as product formulation and clinical trial design are made before pivotal clinical trials. Respondents who favored later submission of access plans often noted that substantial uncertainty surrounds products even when they enter pivotal clinical trials—features like the approved indication(s) of use, product labelling, market dynamics, and eventual demographics of the patient population are still unknown—which may make it difficult to develop a concrete access plan.

Many respondents also acknowledged that product development is dynamic, and they discussed how licensees could update their access plans as licensed products move closer to market and the parties learn more about the products’ features. Several respondents also discussed high failure rates for biomedical products, even in Phase III trials, and expressed concern about the burden of preparing access plans for products that never make it to market. 

Final Policy: The final Policy states, “[o]rganizations applying to NIH for licenses within the scope of this Policy are required to [s]ubmit an Access Plan as a part of their license application.” The Policy and associated Implementation Guidance go on to discuss how, once approved by NIH, those plans will be incorporated into the licenses granted by NIH. Licensees will be expected to provide progress reports in accordance with their license agreements and will be able to make updates/changes to their Access Plan as warranted, pending NIH approval. Ultimately, three months after FDA approval of the licensed product (or a foreign equivalent), the licensee will provide NIH with a non-confidential version of the Access Plan that reflects the product at that stage of development, which NIH may publish or otherwise make available.

Promoting Transparency Through Sharing of Access Efforts

Policy Proposal: The Policy proposal suggested that, upon NIH request, licensees would provide non-confidential versions or statements of Access Plans, to “the extent such Access Plan[s] include[] proprietary information,” and that NIH may publish or share those versions with third parties. 

Public Comments: Several respondents supported the publication of access plans, noting that publication of non-confidential material would boost public confidence in NIH’s patient access efforts and be a driver for licensees to comply with the Policy—to avoid bad publicity from poor plans or a failure to deliver on commitments. Some respondents also suggested NIH publish aggregate data on, e.g., licensing, approved access plans, waivers, and return on investment.

On the other hand, some comments cautioned that public posting of access plans could have unintended, negative consequences, like creating undue scrutiny of plans and/or licensees. Respondents who did not support sharing of access plans also had concerns that licensees would need to include confidential business material in public plans, which may also hinge on the definition of proprietary information (which was not included in the Policy proposal). At least one respondent also mentioned the potential for larger companies to utilize public access plans to harass smaller competitors by arguing their access plans are inadequate. 

Final Policy: The final Policy and associated Implementation Guidance maintain the expectation for a licensee to submit a non-confidential version of the Access Plan which NIH may publish or otherwise make available. But the final Policy has an updated timeline, delaying submission of that non-confidential plan to within three months after FDA approval of the licensed product (or a foreign equivalent). Prior to this stage, Access Plans will remain confidential, along with other license information and reports kept confidential, by law. 

Enforcement Options/Consequences for Policy Non-Compliance

Policy Proposal: The RFI welcomed feedback on all aspects of the Policy proposal, however there were specific issues that NIH invited respondents to address in their comments, including Policy enforcement. To that end, the Policy proposal did not elaborate on any enforcement options or consequences; rather, NIH sought input to incorporate into the final Policy.

Public Comments: Many respondents that were in favor of the Policy proposal urged that the final Policy have “teeth,” and some suggested that NIH should have recourse to address deficiencies in access plans as a first course of action rather than defaulting to terminate licenses. Comments proposed ideas for Policy enforcement, short of termination, including: changing royalty rates; converting exclusive licenses to non-exclusive; limiting eligibility for further NIH partnerships, funding, or licenses; and developing a default access plan NIH could use as backup. The agency also received comments that recommended sanctions in the case of bad faith actors or token access plans. Other comments emphasized concerns that NIH would terminate licenses in unpredictable ways under an access planning policy. Some also noted the uncertainty inherent in biomedical product development and discouraged NIH from pursuing excessive consequences, such as license termination, due to factors out of the licensee’s control.

Final Policy: The final Policy and associated Implementation Guidance reflect how NIH anticipates the best public health outcomes will be possible when the agency can approach access planning flexibly and in collaboration with partners and licensees. If compliance concerns emerge, NIH will first notify the licensee and work with them to take appropriate action.

In general, NIH will not consider license applications that fall within the scope of the Policy unless the applicant includes an Access Plan, and the agency will not grant such licenses unless it has ultimately approved the proposed plan. If a licensee fails to comply with the terms of the license implementing this Policy, NIH may request appropriate corrective action, such as amending an Access Plan or negotiating other modifications. NIH expects timely submission of Access Plans and amendments and will conduct good faith negotiation with licensees, as warranted. However, if compliance issues remain unaddressed, NIH may consider one or more actions, in accordance with applicable statutes, regulations, and policies, and depending on the severity or duration of non-compliance. Enforcement actions could include, but are not limited to, removing indications or geographic scope from the licensed fields of use or otherwise limiting the licensed fields of use, disallowing incentives, wholly or partly removing exclusivity, terminating the license in whole or in part, or requiring the licensee to pay an additional royalty. The agency will also take into account the normal course of relevant commercial development in deciding whether and how to proceed when enforcing the Policy.

Promoting Meaningful Access Approaches

Policy Proposal: In the Policy proposal, NIH explained its intention to “provide additional guidance to licensees on examples of acceptable, commercially reasonable approaches for promoting access,” and it asked the public for input on a range of “activities that could be considered and strategies to mitigate access challenges and expand the reach, and benefit, of drugs, biologics, vaccines, and devices stemming from NIH inventions.” The Policy proposal also listed a few exemplary strategies that licensees might consider for inclusion in an Access Plan.

Public Comments: Many respondents suggested strategies to promote access that may be aggregated into the following categories: partnering with public health, non-profit, or patient advocacy organizations; addressing accessibility as a design objective; committing to sublicense relevant intellectual property and know-how; entering purchasing partnerships or commitments; submitting additional commercialization-related plans; and promoting equitable access and affordability in product deployment.

Final Policy: The final Policy and associated Implementation Guidance list potential strategies, many of which were identified by respondents, that might be incorporated into Access Plans. This list is intended to serve as a reference upon which licensees may draw inspiration. It is a non-limiting list of examples, and not an exhaustive or compulsory list of strategies to promote patient access. In addition to these strategies, license applicants and licensees are welcome to propose other creative strategies tailored to their products. 

Incorporating Access Planning Incentives

Policy Proposal: The Policy proposal acknowledged that access planning will be an additional specified requirement for licensees, and it invited input on, e.g., leveraging existing federal programs and resources to help licensees achieve access goals. While the Policy proposal did not suggest specific incentives, it did solicit feedback on what NIH could do to best help licensees deliver patient access to products that stem from these agreements. 

Public Comments: Many comments, regardless of their position on the Policy proposal, acknowledged that requiring access planning could deter licensees from partnering with NIH and several discussed how NIH could counter that risk by making licensing opportunities more attractive. Respondents proposed a variety of possible incentives including, but not limited to, additional NIH funding towards de-risking technology prior to licensing, lower royalty rates, additional access or eligibility for NIH resources or opportunities, technical assistance, and connections to or benefits from other HHS agencies (e.g., FDA, CMS). 

Final Policy: NIH already employs several of these approaches, and the agency will continue to discuss those possibilities with licensees. NIH also plans to explore additional incentives, benefits, or programs it might offer to encourage and assist licensees in fulfilling access goals. 

Footnotes

[1] See, e.g., Public Health & Economic Impact Study, NIH Technology Transfer (May 2023), https://www.techtransfer.nih.gov/reports/public-health-and-economic-impact-study.

[2] See, e.g., Impact of NIH Research: Improving Health, NIH (Apr. 10, 2023), https://www.nih.gov/about-nih/what-we-do/impact-nih-research/improving-health (discussing selected examples).

[3] NIH’s model patent licenses define “licensed products” as “tangible materials, which in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.” Model Exclusive Patent License Agreement, NIH TECHNOLOGY TRANSFER, https://www.techtransfer.nih.gov/sites/default/files/NIH_Patent_License_Exclusive_model_102015_rev092024.pdf (last visited Dec. 30, 2024). 

[4] In most cases, NIH funding recipients can retain title to inventions that are conceived or first reduced to practice under a funding agreement. There are exceptions, for example, if the grantee or contractor decides it does not want to file for patents then NIH has the right to obtain title to those inventions. See, e.g., PHS Technology Transfer Policies and Procedures Manual Chapter No. 602, NIH Technology Transfer (Sept. 20, 2012), https://www.techtransfer.nih.gov/sites/default/files/documents/policy/pdfs/602-policy.pdf. In those cases, if the U.S. government wholly owns a patent and licenses it, then the Access Planning Policy would still apply.

[5] For ease of reference, in this Policy, when “FDA approval” (and similar terms) are used in discussing drugs, biologics, or devices, the terms refer to FDA permitting the marketing of a product via approval, clearance, de novo classification, or authorization.

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy

[email protected]