Key Dates

Related Announcements

May 21, 2024 - Notice of Availability: Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning.  See Notice NOT-OD-24-125

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

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-owned patents. 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 treatment.¹ 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 devices.² 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 products.³ 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 on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning) that are described in the Implementation Guidance. 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 contractors.⁴ 

Section III. Phase-In

The IRP Access Planning Policy applies to license applications submitted to NIH on or after June 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 parties.⁵

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 equity 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.

NIH IRP Access Planning Policy: Implementation Guidance

These additional materials will assist license applicants and licensees as they work with NIH to fulfill the requirements of this Policy.

Section A. Access Plans

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 equity 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.

For the purpose of this Policy, the term “underserved communities” has the definition used in Executive Order 13985.⁶ It refers to populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life, and may include 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.

Plan Elements:

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 may request additional or specific information be addressed in an Access Plan. Section E outlines points license applicants and licensees may consider in drafting an access plan and summarizes a range of strategies that may be appropriate to include.

Plan Assessment & Criteria:

NIH will consider Access Plans in their entirety and review (1) to ensure that each required element has been included and (2) to assess the reasonableness of those plan elements, considering the commercial readiness of the invention and the characteristics of the anticipated product(s). In general, NIH will approve Access Plans that describe appropriate strategies across criteria of affordability, availability, acceptability, and sustainability.

• Availability. To be available, a product must exist, be manufactured, authorized for sale, and distributed in the applicable region. In evaluating an Access Plan, NIH will consider whether it proposes strategies that would tend to support product availability for the applicable patient populations.
• Affordability. Affordability implicates factors such as pricing structure, insurance, reimbursement, coverage decisions, and payment models. NIH also recognizes its licensees are often private sector organizations affected by commercial market factors. In evaluating an Access Plan, NIH will consider whether the plan proposes strategies that would tend to support product affordability for the applicable patient populations and relevant stakeholders.
• Acceptability. An acceptable product was developed and/or is delivered in a manner that resonates with end users and is tolerated for the duration of use. There must also be effective systems for safely delivering the product to patients. In evaluating an Access Plan, NIH will consider whether it proposes strategies that would tend to promote product acceptability.
• Sustainability. Access is not static, and future patients are likely to need access to products on the market today. Licensees will need to consider predictable and stable approaches for enabling and maintaining the above elements of access (whether those approaches involve the licensees, themselves, or another party). In evaluating an Access Plan, NIH will consider whether it proposes strategies that would tend to promote sustainable patient access.

NIH will also consider the relevant contributions of the parties in evaluating an Access Plan. For example, NIH will consider the nature of its patented technology, how that technology factors into the licensed product, the scope of the license, and the relative contributions of the public and private sector to the product’s ultimate development. NIH will work closely with licensees to monitor progress and modify approved Access Plans, when appropriate and in concert with the licensee, to support successful commercial development and implementation of access strategies.

Section B. Waivers

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. 

Section C. Submitting and Updating Access Plans

Initial Access Plan Submission:

Organizations applying to NIH for licenses within the scope of this Policy are required to submit an Access Plan as a component of their license application. Once approved by NIH, those plans will be incorporated into the licenses granted by NIH.

Updating Access Plans & Reporting on Progress:

Licensees are expected to address progress on their approved Access Plan in the periodic progress reports required by their license agreements.⁷ If there are no updates, then licensees can state that nothing has changed about their Access Plan. Licensees may also request changes to their approved Access Plans, which NIH will reasonably consider.

Licensees are generally expected to submit a non-confidential version of their Access Plan within 3 months after FDA approval (or a foreign equivalent) that NIH may publish or otherwise make available to third parties. At a minimum, these updated plans should address items that were included in the initial, approved Access Plans the licensees submitted with their license applications. But at the point of regulatory approval, licensees will know more about their products and the patient populations, and that additional clarity and certainty would be reflected in more tailored, concrete access planning. 

How to submit:

License applications, including Access Plans, should be submitted to the appropriate Licensing and Patenting Manager at the relevant NIH Institute or Center.

License related reports, notices, and requests (including progress reports, requests to update an Access Plan, and requests for waivers or modifications) should be provided to the NIH Office of Technology Transfer: https://www.techtransfer.nih.gov/royalties/license-notices-reports.

Section D. Compliance and Enforcement

NIH anticipates that the best public health outcomes will emerge when it can approach access planning with flexibility and in collaboration with partners and licensees. NIH will not consider license applications that fall within the scope of this Policy unless those applications include an Access Plan, and the agency will not grant licenses within the scope of this Policy without an NIH approved Access Plan. While NIH expects licensees will submit acceptable Access Plans in a timely manner, it also anticipates negotiating with licensees in good faith to modify or amend Access Plans, as warranted.

In general, if a licensee does not comply with the terms of the license implementing this Policy, NIH may take one or more enforcement actions depending on the severity or duration of non-compliance. NIH will undertake any such action in accordance with applicable statutes, regulations, and policies.

If a licensee fails to provide progress reports or updated Access Plans as required by a license, or if it refuses to negotiate modifications to an Access Plan in good faith, NIH may take one or more enforcement actions. 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 Access Plans or negotiating other modifications with NIH.

If compliance issues remain unaddressed, NIH may consider further enforcement action, pending corrective action, including but 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.

Any such enforcement actions will be taken as specified in the license. In such case, NIH may also decline to negotiate amendments or extensions of the license or enter into new licenses with the licensee.

The agency will also take into account the normal course of relevant commercial development programs in deciding whether and how to proceed when enforcing the IRP Access Planning Policy. It will consider sound and reasonable business practices and judgement and the agency will consult the progress reports submitted by the licensee.

Section E. Points to Consider & Potential Strategies to Include when Drafting an Access Plan

These points to consider are intended to provide license applicants and licensees with assistance in developing Access Plans.

1. Product Description:

In describing the licensed product(s), license applicants and licensees may include information such as:

• The product type and the intended indication and/or intended use of the product.
• Any plans for developing the patented invention into other products or seeking approval, clearance, de novo classification, or authorization for additional indications.
• Design specifications, including whether the product is being designed primarily for use or administration in a certain setting (e.g., hospital, community).
• Whether the product will be tailored, for example, to have different formulations or dosages across countries, regions, or patient populations.
• A proposed target product profile (TPP), which is a planning tool that can streamline the product development process. It emphasizes starting the process with a clear end goal, and it offers a structured approach to crucial details including intended use, target populations, and safety/efficacy-related characteristics. It includes both minimal and preferred product attributes and gives innovators a defined framework to evaluate their product as it moves through the development process. A TPP is designed to be consulted and updated throughout the process.⁸
• If an Access Plan is being updated after a licensed product has been authorized by a regulatory authority: a summary of the product’s label information, e.g., indications and usage, dosage and administration, dosage forms and strengths.

2. Patient Population:

Access Plans should describe strategies to support broad patient access for the U.S. population, and can include, as applicable, strategies through the lens of promoting equity 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. License applicants and licensees know the most about the products they are developing, and they are in the best position to identify the applicable patient populations that could benefit from access planning. Access Plans should focus on those populations. For example:

• If there is no demonstrable public health need for the licensed products in a given country or region, for example, if a disease is largely absent from that region, then the licensee can note that limitation.
• If the licensee will not be able to offer the licensed products in a given country or region, for example, if the region is outside the license’s field of use, then the access plan can note that limitation.  

NIH encourages licensees to discuss the applicable patient populations with the agency periodically, so that the parties can resolve any potential concerns as the licensee learns more about the product and market.

In describing the anticipated patient population in an Access Plan, license applicants and licensees may include information such as:

• The estimated size of the intended patient population and the projected growth/reduction of relevant markets during the duration of the license.
• Whether the licensee plans to develop the patented technology to meet the needs of other patient populations, e.g., develop products for a pediatric population.
• Other populations that may also benefit from the licensed product, for which the licensee has no current plans to pursue product development, authorization, or launch.
• Regions or countries where the licensee plans to seek regulatory authorization.
• If an Access Plan is being updated after a licensed product has been authorized by a regulatory authority: a summary of information about the patient population that is included on the product’s label, e.g., indications and usage or use in specific populations.

3. Other Necessary Products, Tools, Facilities, or Unique Resources:

NIH recognizes that many aspects of access are outside a licensee’s control. That is why Access Plans should discuss any other products, tools, facilities, or unique resources that would be necessary for use of the licensed product(s). For example, access to a given product might hinge on other healthcare infrastructure, like proximity to a specialized hospital. Or a patient might need access to a certain diagnostic before receiving a treatment, but access to that diagnostic might be outside the licensee’s control. NIH does not expect licensees to resolve all external challenges to patient access. Instead, license applicants and licensees may summarize these other, external features in their Access Plans, and they may consider how to approach mitigation where applicable.

In describing these features in an Access Plan, license applicants and licensees may include information such as:

• Aspects of patient access that are outside the licensee’s control, including barriers to equitable access.
• Unique obstacles to product deployment, such as supply chain challenges, distribution channels, or manufacturing needs that could make it difficult to reach certain populations.
• Any unique considerations related to healthcare system capacity.
• Where the licensed product will be administered, or where licensees will encounter or receive it. 

4. Strategies to Promote Patient Access:

Access-oriented thinking spans the product development lifecycle. 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 can have profound impact on which patients get access to which products.⁹ NIH likewise recognizes it is difficult to predict what strategies will truly improve patient access,¹⁰ even after a product is on the market. NIH does not seek to second-guess licensees’ good faith efforts to improve access.

Strategies for license applicants and licensees to consider may include, but are not limited to, the following. These are suggested options, and license applicants and licensees are encouraged to identify strategies that make sense for them and their products. When drafting Access Plans, license applicants and licensees may also describe choices already made that would tend to bolster access.

By way of non-limiting example:

Partnering with public health, non-profit, or patient advocacy organizations. Examples could include:

• Establishing product development partnerships during R&D, regulatory authorization, or sales and marketing within and/or beyond the U.S.
• Selling products to organizations that treat underserved populations (e.g., Federally Qualified Health Centers).
• Collaborating on health technology assessments for the licensed products, to reduce duplication of efforts and related costs and to support healthcare decision-making with transparent and accountable evidence about the products.
• Partnering with ministries of health, clinicians, and patient/community-based organizations for service delivery, where appropriate.
• Licensing intellectual property to public health patent pools (e.g., Medicines Patent Pool, WHO HTAP) ¹¹
• Preparing tailored, culturally sensitive educational materials for a range of domestic and global patient populations.
• Establishing post-trial and/or early access guarantee programs for clinical trial participants.
• Licensees may choose to submit letters of support from their partners, if appropriate.

Addressing accessibility as a design objective. Examples could include:

• Strategically making access-oriented product development choices (e.g., single dose) or business choices (e.g., pricing structures).
• Conducting patient interviews, needs assessments, and/or health technology assessments early in development.
• Evaluating the appropriateness of a product (such as delivery method and cold-chain requirements) for the applicable patient populations.
• Committing to develop products that can be best delivered in settings that expand access (e.g., developing products that can be delivered in home settings, if that is what patients need).
• Designing appropriately inclusive clinical trials to mitigate gaps in knowledge that impede access.
• Conducting additional studies to understand barriers to and drivers for adoption in applicable patient populations and commit to product development choices or subsequent R&D to overcome those barriers.
• Conducting late phase (IIIb/IV) clinical trials to assess acceptability, feasibility, knowledge, attitudes, and practices on diseases and the licensed product, to support product introduction at a community level in more patient populations. 
• Committing to invest in R&D that could support cheaper or more robust innovation, competition, delivery, etc. (e.g., swapping from batch to continuous manufacturing).

Committing to sublicense relevant intellectual property and know-how. Examples could include:

• Committing to license all intellectual property and know-how needed to make a product if the licensee exits a market and/or committing to surviving rights/technology transfer in case of license termination.
• Sublicensing to manufacturers in additional regions or countries on voluntary and mutually agreed to terms, especially in areas where the licensee does not intend to market or sell products.
• Agreeing to sublicense relevant intellectual property on a low- or no-royalty basis, on voluntary and mutually agreed to terms.
• Providing forecasts to regulatory agencies and NIH on product availability for appropriate sublicensing as necessary to avoid disruptions in distribution.
• Forgoing patent protection for certain subsequent inventions.
• Committing to humanitarian sublicenses, for example, in the event of unmet global health demand, inaccessible product distribution in humanitarian settings, or if the licensee is unwilling or unable to improve technological appropriateness.
• Implementing a non-assert declaration, by pledging not to enforce certain patent rights in certain regions/countries and allowing generic or biosimilar versions of a product.

Entering purchasing partnerships or commitments. Examples could include:

• Committing to supply product in each given market(s) for a designated duration.
• Agreeing to sell a designated volume of product to the U.S. government or another designated entity on a cost-plus basis.
• Agreeing to coordinate and set aside a portion of manufactured product for donation or sale to a partner organization on a cost-plus basis.
• Ensuring that donations comply with WHO Guidelines for Medical Donations.¹²
• Producing or manufacturing the licensed products in locations near the applicable patient populations, with the goal to reduce cost and subsequent price.
• Agreeing to scale-up production when new or prescribed patient needs arise.
• Entering licensed products into government run prescription programs.

Submitting additional plans related to commercialization and distribution. Examples could include:

• Proposing product development timelines to develop suitable products that meet a population's unique needs (e.g., additional formulations).
• Committing to seek regulatory authorization for additional indications.
• Using Collaborative Registration Procedures (CRP) or WHO’s pre-qualification program to increase the speed and efficiency of registration in global markets.
• Agreeing to file with regulatory organizations, including for emergency use (e.g., WHO Emergency Use Listing).
• Investing in manufacturing innovations that can reduce prices and expand access.

Promoting equitable access and affordability in product deployment. Examples could include:

• Optimizing dose, formulation, and manufacturing processes to reduce cost of goods and the prices patients pay.
• Committing to keep prices in the U.S. equal to those in other developed countries.
• Not raising prices at rates outpacing inflation.
• Pricing products at the lowest sustainable level or connecting product prices to marginal production costs.
• Agreeing to locally-affordable pricing strategies or non-profit pricing models in certain populations or regions.
• Committing to price reductions once preset sales, revenue, or profit thresholds are reached.

Access plans may also address research outputs or other benefit sharing, including public access to publications, data sharing, or community-led or international collaboration in research. Such commitments might supplement, but not replace, patient-focused strategies.

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 on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning on May 21, 2024 (89 FR 45003, comment period closing on July 22, 2024). NIH received 48 responses to that Request for Information (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 equity 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 equity 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. The final Policy adopts a definition of “underserved communities” from Executive Order 139856.

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.

[6] Exec. Order No. 13985, 86 Fed. Reg. 7009 (Jan. 25, 2021).

[7] Licensees generally have an obligation to provide the NIH Office of Technology Transfer (OTT) with periodic reports. NIH’s model patent licenses include a section on “Reports on Progress, Benchmarks, Sales, and Payments.” See, e.g., 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). 

[8] For more information on TPPs, see, e.g., Creating a Target Product Profile for New Drug Products, NIH’S SEED, https://seed.nih.gov/sites/default/files/2023-12/Creating-Target-Profile-for-New-Drug-Products.pdf (last visited Dec. 30, 2024); Q8(R2) Pharmaceutical Development, U.S. FOOD AND DRUG ADMINISTRATION (Nov. 2009), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-development.

[9] For example, a single-dose treatment may be more accessible and affordable for many patients, compared to a multi-dose regimen. And reliance on cold chain could make it difficult to reach patients in some parts of the country and the world.

[10] For example, in some circumstances, subcutaneous administration of a drug may be better than intravenous. But for patients with insurance who lack easy access to a pharmacy but can go to a physician’s office for an infusion, then intravenous infusions may be the more accessible option.

[11] See, e.g., Medicines Patent Pool, https://medicinespatentpool.org/ (last visited Dec. 30, 2024); WHO Health Technology Access Pool, WORLD HEALTH ORGANIZATION, https://www.who.int/initiatives/who-health-technology-access-pool (last visited Dec. 30, 2024). 

[12] Donations of Medicines and Medical Devices, WORLD HEALTH ORGANIZATION, https://www.who.int/teams/health-product-and-policy-standards/medicines-selection-ip-and-affordability/donations (last visited Dec. 30, 2024). 

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy

[email protected]