FAQs - IRP Access Planning Policy

General

Policy Scope

Drafting Access Plans

Amending Access Plans

Confidentiality

 

 

General

Why is NIH requiring access plans for certain licenses?

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. NIH recognizes that decisions around, e.g., product design and formulation, clinical trial design, and distribution channels can have profound impacts on who gets access to a final product. The IRP Access Planning Policy seeks to promote a general cultural awareness around incorporating accessibility throughout the R&D process. And it serves as a lever to hold the agency and our private-sector partners accountable to the American public while preserving flexibility for incentivizing the translation of research when public funds are used.

What is an access plan?

Access planning is intended to promote and prioritize patient access by shaping product development and commercialization through a lens that. In general, it involves incorporating patient access considerations, at a high-level, in agreements related to biomedical research and development. In these plans, organizations outline steps they intend to take to promote access to products they are developing. The parties commit to revisit access considerations as product development progresses. The initial plans and agreement terms are intentionally flexible and not prescriptive, while access commitments and strategies can become more specific as products get closer to market.

For the purposes of the NIH IRP Access Planning Policy, 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. The access plan is submitted as part of the plan required by 35 U.S.C. 209 and 37 CFR part 404.5.

Who can I contact with questions about the Policy?

For general questions about the IRP Access Planning Policy, please contact: nihott@mail.nih.gov. If you are interested in a specific licensing opportunity (for example, one of the technologies advertised on the NIH Technology Transfer website), contact the appropriate licensing contact. You may also work with personnel at the various NIH Technology Transfer Offices and other NIH Institutes & Centers, listed on the HHS Tech Transfer Offices & Contacts page.  

Policy Scope

Who does the IRP Access Planning Policy apply to? Do I need to submit an access plan?

The IRP Access Planning Policy applies to entities seeking a commercial patent license from NIH if: 

  • The applicant is applying for a license that would authorize the commercialization of drugs, biologics (including vaccines), or devices for the prevention, diagnosis, or treatment of human disease;
  • The license would be granted by an NIH Institute or Center (IC); and
  • The license would grant rights under patents wholly owned by the U.S. government.
    • The Policy applies to licenses granted by NIH for domestic and foreign patents or pending patent applications.
  • The Policy applies to exclusive, co-exclusive, partially exclusive, and non-exclusive license applications and licenses.

The Policy does not apply to, e.g.:

  • Licenses and applications that are unrelated to the development of drugs, biologics (including vaccines), or devices for the prevention, diagnosis, or treatment of human disease.
    • 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).
  • Internal use, commercial evaluation, or licenses for unpatented materials or software.
    • More information on types of NIH licenses is available on the Licensing FAQs page.
  • Patents owned or co-owned by external third parties (i.e., patents co-owned by parties external to the U.S. government, like universities or companies, are not within the scope of this Policy).
  • Patents that are owned by NIH grantees or contractors (e.g., patents developed under NIH funding agreements are not within the scope of this Policy).

The Does the IRP Access Planning Policy apply to my license page provides more information about the Policy’s scope.

If I applied for a patent license or signed a license agreement with NIH before October 1, 2025, do I need to submit an access plan?

No. Access plans are only required for patent license applications submitted to NIH on or after October 1, 2025.

Can I request a waiver? When will NIH grant a waiver?

License applicants and licensees may request a waiver or modification to the requirements of the IRP Access Planning Policy, in whole or in part, at any point during the application process or the duration of a license. NIH will evaluate those requests and may grant a waiver or modification upon a showing that access planning 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. For example:

  • A waiver may be appropriate if the access planning requirement creates a substantial risk that product development will fail altogether. This may be the case 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.
  • A waiver may be appropriate if the access planning requirement will negatively impact the long-term viability of the licensed product in the market. This may be the case where there is a risk of later drug shortages or inadequate product quality.

Drafting Access Plans

What is the difference between an “access plan” and the other plans that are part of a license application or agreement (e.g., a “development plan” or a “commercial development plan”)?

The access plan is part of the plan required by 35 U.S.C. 209 and 37 CFR part 404.5. 

NIH’s license application asks applicants to include a “Development Plan,” and the model license agreements include a “Commercial Development Plan,” at Appendix E. Among other things—these provide detailed and specific plans for the development of an invention. They can include research and development plans to be employed (including all relevant preclinical, clinical, regulatory, manufacturing, and marketing stages) and other supporting information. 

In each of these broader plans, license applicants and licensees should include a separate, dedicated subsection for the access plan. It may be appropriate to cross-reference relevant information from other places (for example, if a license applicant describes an anticipated patient population in the R&D portion of its plan, it can reference that in the access portion of the plan instead of repeating it). 

Where can I find examples or strategies and information that might be appropriate to include in an access plan?

The NIH IRP Access Planning Policy: Implementation Guidance includes a Section E. Points to Consider & Potential Strategies to Include when Drafting an Access Plan, with a non-limiting list of strategies licensees may consider using to promote patient access. These are possible options, and NIH encourages license applicants and licensees to craft their own strategies that make sense for their products. Access plans may also describe choices that were already made which would tend to bolster access. NIH does not seek to second-guess good faith efforts to improve access. NIH will publish updated guidance and additional resources, including sample access plans, on the IRP Access Planning Policy page.

How many access strategies are required in an access plan – is one enough?

Access plans shall include 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. There is no set requirement as to the number of access strategies license applicants or licensees should propose. In some cases, it may be difficult to advance all four criteria with one strategy, and multiple strategies will be the best approach; in other cases, it may be easier to address all criteria with a single strategy. NIH will evaluate whether license applicants address all four criteria required by the Policy, not by any set number of strategies or any set length.

I am working on very early-stage R&D. How will NIH evaluate my access plan, given uncertainty about the final product?

NIH recognizes the substantial uncertainty associated with biomedical product development, particularly for early-stage technologies, and will take stage of development into account when evaluating access plans. At the same time, early planning for patient access can deliver the best, most comprehensive solutions—as choices on product design, formulation, clinical trial design, and other aspects of product development shape access in critical ways. Licensees and license applicants are encouraged to identify strategies that make sense for them and their products, including the stage of a technology’s development. 

When evaluating whether access plans are reasonable and fulfill the Policy’s requirements, NIH will take a holistic approach and consider many factors including: the commercial readiness of the invention, the relevant contributions of the parties, the nature of its patented technology, how that technology factors into the licensed product, the scope of the license, and the relative contribution of the public and private sector to the product’s ultimate development.

NIH also expects that licensees’ access plans may change as development progresses and they learn more about their product and associated access challenges. Licensees may also discover something new or unexpected, revealing compelling reasons to pivot in product development and/or access planning. NIH will work closely with licensees to monitor progress. When appropriate, approved access plans may be modified, to support successful commercial development and implementation of access strategies as products reach later stages of development. NIH does not intend access plans to lock licensees into a single direction when there are other, more promising paths to pursue.

Please see Section E. Points to Consider & Potential Strategies to Include when Drafting an Access Plan in the NIH IRP Access Planning Policy: Implementation Guidance for additional assistance in drafting access plans.

What license application should I fill out? 

Applicants interested in licensing patents from NIH should fill out the “NIH License Application.” If you are applying for a license that will be within the scope of the IRP Access Planning Policy, you will need to submit an access plan as part of your application. Please be sure to complete section VIII of the license application. 

Please see Section II of the Policy, this description of the Policy’s scope, and the prior question “Who does the Access Planning Policy apply to?” for more information on which license applications require access plans. 

Amending Access Plans

Am I allowed to change my access plan over time?

Yes, NIH invites license applicants and licensees to propose changes to access plans at any point. This Policy is intended to be flexible, both to accommodate public health needs and to catalyze opportunities across a variety of emerging biotechnologies. NIH will reasonably consider requests to change access plans and will work with licensees to modify or amend access plans, as warranted. 

Indeed, we anticipate it will be necessary to update access plans periodically, as licensees learn more about their products and the market. Licensees may also discover something new or unexpected, revealing compelling reasons to pivot in product development and/or to amend an access plan. NIH does not intend access plans to lock licensees into a single direction when there are more promising paths to pursue. Licensee’s periodic progress reports may be an opportune time to propose changes to an access plan. 

NIH anticipates that licensees will be most likely to initiate requests to change an access plan, but NIH staff may also propose modifications or amendments for consideration. Examples of some progress-dependent changes might include:

  • A company developing an oncology treatment may start out by testing against multiple indications, but through the course of R&D may narrow on a single indication. This will give a more concrete understanding of the specific patient population, and allow for more tailored, concrete access strategies.
  • When a company finalizes a drug formulation, that will reveal information about the relevant supply chains and distribution channels, and that information may point to different, additional, or more specific access strategies.

For existing license agreements, submit requests to update an access plan to the NIH Office of Technology Transfer on the License Notices/Reports page. For license applications, changes can be discussed with the appropriate NIH Technology Transfer Office(s), listed on the HHS Tech Transfer Offices & Contacts page.

If I am unable to execute the access strategies I proposed in my license application for reasons outside my control, will NIH revoke my license?

NIH seeks to approach access planning with flexibility and in collaboration with licensees. If you are unable to execute on one or more portions of your access plan, or if one or more portions of your plan are no longer feasible, you should identify these challenges, for example in your annual progress report or by contacting the NIH Office of Technology Transfer on the License Notices/Reports page. NIH will work to negotiate with licensees in good faith to modify or amend access plans, as warranted. 

Additionally, you may request waiver or modification to the requirements of the IRP Access Planning Policy, in whole or in part, at any point during the application process or the duration of a license. NIH will evaluate those requests and may grant a waiver or modification upon a showing that access planning would not be commercially feasible and would hinder the overall benefit of access to the licensed product.

If a licensee fails to provide progress reports or fails to negotiate access plan modifications in good faith, NIH will first notify the licensee of any concerns and allow the licensee to take appropriate corrective action, likely through, but not limited to, amending your access plan or negotiating other modifications with NIH.

NIH will only consider further actions if compliance issues remain unaddressed. Any such actions will be taken as specified in the license.

Confidentiality

Who will be able to see the access plan I submit?

NIH will maintain access plans as confidential, along with other license information and reports, as permitted by applicable law. 

However, licensees will generally be required to submit a non-confidential summary of their access plan within 3 months after FDA approval (or a foreign equivalent). NIH may publish or otherwise make the non-confidential summary of the access plan available to third parties.

While the Freedom of Information Act (FOIA) provides individuals with a right to access records in the possession of the federal government, the government may withhold information pursuant to the nine exemptions and three exclusions contained in the Act. For more information, please go to the NIH FOIA website.