Notice2024-11188
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
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Published
May 22, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
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<title>Federal Register, Volume 89 Issue 100 (Wednesday, May 22, 2024)</title>
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[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45003-45005]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://Https://osp.od.nih.gov/comment-form-draft-nih-intramural-research-program-policy-promoting-equity-through-access-planning/">Https://osp.od.nih.gov/comment-form-draft-nih-intramural-research-program-policy-promoting-equity-through-access-planning/</a>. 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
<a href="/cdn-cgi/l/email-protection#b0e3d3d9d5ded3d5e0dfdcd9d3c9f0dfd49eded9d89ed7dfc6"><span class="__cf_email__" data-cfemail="98cbfbf1fdf6fbfdc8f7f4f1fbe1d8f7fcb6f6f1f0b6fff7ee">[email protected]</span></a>.
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, <a href="https://www.techtransfer.nih.gov/reportsstats/hhs-license-based-vaccines-therapeutics">https://www.techtransfer.nih.gov/reportsstats/hhs-license-based-vaccines-therapeutics</a> (last visited May 2, 2024).
\2\ Public Health & Economic Impact Study, NATIONAL INSTITUTES
OF HEALTH TECHNOLOGY TRANSFER (May 2023), <a href="https://www.techtransfer.nih.gov/reports/public-health-and-economic-impact-study">https://www.techtransfer.nih.gov/reports/public-health-and-economic-impact-study</a>.
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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 (<a href="https://osp.od.nih.gov/events/workshop-on-transforming-discoveries-into-products-maximizing-nihs-levers-to-catalyze-technology-transfer/">https://osp.od.nih.gov/events/workshop-on-transforming-discoveries-into-products-maximizing-nihs-levers-to-catalyze-technology-transfer/</a>), 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:
<bullet> 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).
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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?
<bullet> 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?
<bullet> 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?
<bullet> 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
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