[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45003-45005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institutes of Health (NIH) Office of Science Policy 
(OSP): Request for Information on Draft NIH Intramural Research Program 
Policy: Promoting Equity Through Access Planning

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is proposing to 
develop and implement a new policy within its Intramural Research 
Program (IRP) to promote access to products stemming from taxpayer-
funded inventions. NIH seeks input on this draft policy and 
accompanying draft license agreement language that incorporates patient 
access in the commercialization process for NIH-owned inventions.

DATES: To ensure consideration, comments must be submitted in writing 
by July 22, 2024.

ADDRESSES: Comments may be submitted electronically to Https://osp.od.nih.gov/comment-form-draft-nih-intramural-research-program-policy-promoting-equity-through-access-planning/. Responses to this 
request for information are voluntary and may be submitted anonymously. 
You may voluntarily include your name and contact information with your 
response. Other than your name and contact information, please do not 
include in the response any personally identifiable information or any 
information that you do not wish to make public. Proprietary, 
classified, confidential, or sensitive information should not be 
included in your response. After the Office of Science Policy (OSP) has 
finished reviewing the responses, the responses may be posted to the 
OSP website without redaction.

FOR FURTHER INFORMATION CONTACT: Abby Rives, Director of the Technology 
Transfer and Innovation Policy, at (301) 496-9838 or 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    As the world's largest public funder of biomedical research, NIH 
seeks to drive effective partnerships that foster a shared commitment 
to transforming

[[Page 45004]]

knowledge into improved health for all. These investments are critical 
to the health of our scientific enterprise, both in terms of supporting 
research discoveries and by fueling U.S. leadership in the bioeconomy. 
Indeed, NIH-owned inventions have provided the foundation for new 
vaccines, drugs, and medical devices.\1\ A recent report estimated that 
technology licensed from the IRP supported an average of 74,500 jobs 
and contributed an average of over $13 billion to U.S. GDP each year 
over the last two decades.\2\
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    \1\ HHS License-Based Vaccines & Therapeutics, NATIONAL 
INSTITUTES OF HEALTH TECHNOLOGY TRANSFER, https://www.techtransfer.nih.gov/reportsstats/hhs-license-based-vaccines-therapeutics (last visited May 2, 2024).
    \2\ Public Health & Economic Impact Study, NATIONAL INSTITUTES 
OF HEALTH TECHNOLOGY TRANSFER (May 2023), https://www.techtransfer.nih.gov/reports/public-health-and-economic-impact-study.
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    NIH recognizes that all too often, however, patients across the 
country and across the globe may be unable to access products they 
need--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 
take. For example, millions of adults skip medications due to high 
costs, and the rising cost of prescription drugs puts many of these 
products out of reach. Thus, NIH is exploring how it might leverage 
partnerships to further enhance health through the biomedical research 
it funds.
    In 2023, NIH hosted a workshop in support of this agenda, 
Transforming Discoveries into Products: Maximizing NIH's Levers to 
Catalyze Technology Transfer (https://osp.od.nih.gov/events/workshop-on-transforming-discoveries-into-products-maximizing-nihs-levers-to-catalyze-technology-transfer/), to discuss policies and practices that 
shape biomedical innovation and promote access to NIH-funded 
discoveries. At this workshop, NIH heard from participants with 
experience using ``access planning'' as a means to prospectively 
address downstream access challenges. Access planning involves 
incorporating patient access considerations, at a high level, in 
agreements related to biomedical research and development. The parties 
commit to revisit access considerations as product development 
progresses, but the initial agreement terms are intentionally flexible 
and not prescriptive.
    NIH is proposing a new policy within the NIH IRP (see Appendix), to 
require that licensees that succeed in bringing certain products toward 
market submit a plan outlining steps they intend to take to promote 
patient access to those products. This new IRP policy makes it clear 
that access, defined broadly to include product affordability, 
availability, acceptability, and sustainability, is of paramount 
importance in providing a return on taxpayers' investment in biomedical 
research. This new policy would apply to patent licenses for the 
commercialization of drugs, biologics, vaccines, or devices. NIH would 
also employ a tiered approach, where licenses granted for late-stage 
inventions that are closer to market launch would include more 
specific, tailored access-oriented provisions, while licenses granted 
for early-stage inventions would be more flexible to reflect the higher 
uncertainty associated with technologies that lead to drugs, biologics, 
vaccines, or devices. Importantly, a final policy approach should be 
reasonable and not seek to force licensees into access obligations that 
obstruct commercial development or damage the viability and 
sustainability of a product in the market, while also balancing the 
need to promote access through reforms to various policies. The agency 
is proposing a flexible approach that allows appropriately tailored, 
commercially reasonable strategies to promote patient access across a 
range of technologies. This RFI is in relation to the licensing of 
government-owned inventions in accordance with 35 U.S.C. 207 and 37 CFR 
part 404.

Request for Information

    NIH seeks information from all interested individuals and 
communities, including, but not limited 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. While comments are 
welcome on all elements of this proposal, input would be most welcome 
on the specific issues identified below:
    1. Promoting meaningful access approaches. NIH intends to provide 
additional guidance to licensees on examples of acceptable, 
commercially reasonable approaches for promoting access. NIH is seeking 
input on the 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.
    2. Promoting transparency in the biomedical research enterprise and 
return on investment. The process of bringing a new product through 
research and development, to market, and into the hands of patients is 
long, fraught with challenges, and expensive. NIH is interested in 
hearing from potential partners on how access plans could incorporate 
transparent cost accounting measures to assist NIH in driving down 
costs associated with innovation and making clearer what costs are 
incurred along the way and how those affect product costs.
    3. Providing flexibility while achieving clear policy objectives. 
NIH recognizes that its licensees, their partners, and the public will 
need confidence around what this policy requires and the standards that 
would be used to evaluate plans. The agency is seeking input on how to 
maintain flexibility for licensees to pursue their specific product 
development and commercialization needs while simultaneously promoting 
certainty and transparency on access efforts and policy enforcement.
    4. Helping licensees achieve access goals. NIH is interested in 
hearing ideas about how it may be able to help licensees deliver 
patient access to products that stem from these agreements. Licensees 
could include such information in access plans or at earlier stages of 
product development. NIH invites input on additional steps it could 
take or ways to leverage existing U.S. Government programs and 
resources to assist in this endeavor.
    5. Establishing licensee obligations depending on the stage of 
technology development. Generally, as a product moves closer to market, 
the odds of successful commercialization improve, and NIH's proposed 
policy would take this into account. If the agency has advanced 
products to the point of a first pivotal clinical trials (e.g., Phase 
III or the equivalent)--licenses covering those products would include 
specific, tailored access-oriented provisions that should be clear and 
understandable. NIH is seeking further input on specific provisions 
that would meet these objectives.
    6. Assessing policy impact. NIH is seeking input on how to assess 
compliance with the proposed policy and potential metrics for assessing 
its impact.

Appendix: Proposed Aspects of Draft NIH IRP Policy Promoting Equity 
Through Access Planning

I. Policy Scope

    NIH is proposing a new policy that would apply to inventions 
made by investigators in the NIH Intramural Research Program (IRP) 
and owned by the agency. This policy would

[[Page 45005]]

apply to commercial patent licenses that authorize commercialization 
of drugs, biologics, vaccines, or devices for the prevention, 
diagnosis, or treatment of human disease and would include 
exclusive, co-exclusive, partially exclusive, and non-exclusive 
licenses. Third-party IP (i.e., patents solely owned by NIH's 
collaborators and partners) would be outside the scope of this 
policy. Application of the proposed policy to jointly-owned IP will 
be considered at a later date.

II. Policy Requirements

    NIH proposes adding the following language to NIH IRP model 
license agreements within the scope of the policy:
    ``Access Plan'' means Licensee's plan, and incorporating the 
plan(s) of its sublicensee(s), as applicable, that describes 
Licensee's strategy to support broad access to Licensed Product(s) 
for the U.S. population, as well as (a) through the lens of 
promoting equity for underserved communities such as 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, as defined by Executive Order 13985 and/or (b) 
populations in low- and middle-income countries, as defined using 
the World Bank classification system.
    The Access Plan 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 Licensed Product; 
and one or more strategies to mitigate access challenges across 
criteria including affordability, availability, acceptability, and 
sustainability. To the extent such Access Plan includes proprietary 
information [to be defined], upon NIH's request Licensee will also 
provide a non-confidential version or statement of such Access Plan 
that NIH may publish or otherwise make available to third parties.
    Within 3 months of a Licensed Product entering a first pivotal 
clinical trial (a Phase III trial or the equivalent), Licensee will 
provide NIH with an Access Plan (as defined), unless a written 
waiver or modification is obtained in advance from NIH. NIH agrees 
to consider such requests for waivers or modifications in good 
faith.
    Within 30 days of NIH's request (no more often than once 
annually), Licensee agrees to confer with NIH to review Licensee's 
progress, and to consider in good faith any reasonable modifications 
suggested by NIH with respect to the Access Plan.

III. Access Plans

    Each product will be different, and patient populations and 
access challenges will vary by product. Access planning presents an 
opportunity for NIH and its licensees to proactively mitigate access 
challenges and devise tailored strategies to expand the reach, and 
benefit, of products. Accordingly, NIH proposes developing guidance 
for acceptable access plans.
    Potential strategies for licensees to consider would include, 
but not be limited to, one or more of the following:
     Partnering with public health, non-profit, or patient 
advocacy organizations. Examples could include partnerships during 
research and development, regulatory approval, or sales and 
marketing; selling product to organizations that treat underserved 
populations (e.g., Federally Qualified Health Centers); or licensing 
intellectual property to public health patent pools (e.g., Medicines 
Patent Pool).
     Addressing accessibility as a design objective. 
Examples could include conducting patient interviews or needs 
assessments early in development or strategically making product 
development choices (e.g., single dose) or business choices (e.g., 
pricing structures) to promote patient access.
     Committing to sublicense relevant intellectual property 
and know-how. Examples could include sublicensing to manufacturers 
in additional countries or world regions on voluntary and mutually 
agreed to terms; committing to license all intellectual property and 
know-how needed to make a product if the licensee exits a market; or 
agreeing to sublicense relevant intellectual property on a low- or 
no-royalty basis.
     Entering purchasing partnerships or commitments. 
Examples could include committing to supply product in a given 
market(s) for a designated duration; agreeing to coordinate and set 
aside a portion of manufactured product for donation or sale to a 
partner organization on a cost-plus basis; or agreeing to sell a 
designated volume of product to the U.S. Government or another 
designated entity on a cost-plus basis.
     Submitting additional commercialization plans targeted 
to other markets. Examples could include offering product 
development timelines to develop formulations that meet a 
population's unique needs or committing to a plan for developing 
suitable products for additional users.
     Promoting equitable access and affordability in product 
development and deployment. Examples could include committing to 
keep prices in the U.S. equal to those in other developed countries; 
not raising costs above inflation; preparing tailored, culturally 
sensitive educational materials for a range of domestic and global 
patient populations.
    Access plans might include requests for additional support or 
facilitation to advance access goals. For example, licensees might 
seek connections to preclinical or clinical trial resources NIH 
offers, help in developing their access plans, or connections to 
partner organizations well-versed in access considerations relevant 
to the technology in question.
    Access plans might 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 elements proposed above.
    NIH also proposes to include a process for licensees to request 
a waiver or modification of the access planning provision, in whole 
or in part. The agency would consider such requests on a case-by-
case basis and evaluate them according to criteria that would be 
identified in the guidance for access plans.

IV. Assessing Efforts To Address Access

    NIH recognizes that myriad factors affect access to emerging 
biomedical technologies, such as:
     Affordability. For example, can patients afford the 
intended product(s), taking into account factors such as pricing 
structure, insurance, reimbursement, coverage decisions, payment 
models, and/or international price comparators?
     Availability. For example, are products in existence, 
able to be manufactured, widely available on the market, and 
approved for sale and distributed across geographical regions?
     Acceptability. For example, are products developed and/
or delivered in a manner that resonates with end users and is 
tolerated for the duration of use? Are there effective systems for 
safely delivering the product?
     Sustainability. For example, are there predictable and 
stable infrastructure at local levels for enabling and maintaining 
the above elements of access?
    NIH does not expect licensees to address each issue but instead 
address elements of patient access that are relevant to the specific 
product in question to expand access.

    Dated: May 16, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-11188 Filed 5-21-24; 8:45 am]
BILLING CODE 4140-01-P