Notice2023-28341
Notice and Request for Comments on the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response
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Published
December 22, 2023
Issuing agencies
Health and Human Services Department
Abstract
This Request for Comment seeks information from stakeholders, broadly defined, on concepts currently under consideration by parties negotiating a World Health Organization (WHO) Pandemic Preparedness Agreement. It seeks information on how stakeholders' efforts to facilitate response efforts, including the rapid creation and equitable deployment of safe and effective vaccines, diagnostic tests, and treatments, can be advanced or hindered by concepts and commitments under consideration by the negotiating parties as reflected in current negotiating text.
Full Text
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<title>Federal Register, Volume 88 Issue 245 (Friday, December 22, 2023)</title>
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[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88637-88639]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28341]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Notice and Request for Comments on the Implications of Access and
Benefit Sharing (ABS) Commitments/Regimes and Other Proposed
Commitments Being Considered Under a WHO Convention, Agreement or Other
International Instrument on Pandemic Prevention, Preparedness and
Response
AGENCY: Office for Global Affairs, Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: This Request for Comment seeks information from stakeholders,
broadly defined, on concepts currently under consideration by parties
negotiating a World Health Organization (WHO) Pandemic Preparedness
Agreement. It seeks information on how stakeholders' efforts to
facilitate response efforts, including the rapid creation and equitable
deployment of safe and effective vaccines, diagnostic tests, and
treatments, can be advanced or hindered by concepts and commitments
under consideration by the negotiating parties as reflected in current
negotiating text.
DATES: To be assured consideration, written comments must be received
by 5 p.m. Eastern time on January 22, 2024. Written comments should be
emailed to <a href="/cdn-cgi/l/email-protection#8ec1c9cfa0dcddd8decee6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="4b040c0a6519181d1b0b232338652c243d">[email protected]</span></a> with the subject line ``Written Comment Re:
Implications of Access and Benefit Sharing (ABS) Commitments/Regimes
and Other Proposed Commitments in the WHO Pandemic Agreement'' by
January 22, 2024. Comments received after that date will be considered
to the extent practicable.
The Department's policy is to make all comments received from
members of the public available for public viewing on the Federal
eRulemaking Portal at <a href="http://www.regulations.gov">www.regulations.gov</a>. In this instance, business
confidential submissions will also be accepted. Note that relevant
comments submitted to <a href="http://regulations.gov">regulations.gov</a> will be posted without editing
and will be available to the public; therefore, business-confidential
information should be clearly identified as such and an accompanying
redacted version should be submitted for posting on <a href="http://regulations.gov">regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Susan Kim, Office for Global Affairs,
Office of the Secretary, HHS, Room (639H) Hubert H. Humphrey Building,
200 Independence Avenue SW, Washington, DC 20201, (202) 235-3537.
SUPPLEMENTARY INFORMATION:
Background: In December 2021, WHO's Member States decided at a
Special Session of the World Health Assembly to establish an
intergovernmental negotiating body (INB), representing all regions of
the world, to draft and negotiate a WHO convention, agreement, or other
international instrument on pandemic prevention, preparedness, and
response. More information about the INB process can be found here:
<a href="https://inb.who.int/home/inb-process">https://inb.who.int/home/inb-process</a>. The INB currently intends to
submit its outcome to the Seventy-seventh World Health Assembly in May
2024.
The United States has expressed support for the development of an
international instrument to protect the world from pandemic health
threats now and in the future, and in a more rapid and equitable
manner.
The United States is seeking the following key outcomes in the
negotiations:
<bullet> Enhance the capacity of countries around the world to
prevent, prepare for, and respond to pandemic emergencies and provide
clear, credible, consistent information to their citizens.
<bullet> Ensure that all countries share data and laboratory
samples from emerging outbreaks quickly, safely, and transparently to
facilitate response efforts and inform public health decision making
regarding effective disease control measures, including the rapid
creation of safe and effective vaccines, diagnostic tests, and
treatments.
<bullet> Support more equitable and timely access to, and delivery
of, vaccines, diagnostic tests, treatments, and other mitigation
measures to quickly contain outbreaks, reduce illness and death, and
minimize impacts on the economic and national security of people around
the world.
Purpose: The U.S. Department of Health and Human Services (HHS) and
the Department of State are charged with co-leading the U.S. delegation
to the Intergovernmental Negotiating Body (INB) to draft and negotiate
a WHO convention, agreement or other international instrument on
pandemic prevention, preparedness, and response.
This Request for Comments procedure is designed to seek input from
stakeholders and subject matter experts to help inform the U.S.
government negotiating position, including new approaches, proposals,
or concerns with the current version of the negotiating text.
The most recent Negotiating Text of the WHO Pandemic Agreement
(Negotiating Text) can be found here: <a href="https://apps.who.int/gb/inb/pdf_files/inb7/A_INB7_3-en.pdf">https://apps.who.int/gb/inb/pdf_files/inb7/A_INB7_3-en.pdf</a>.
Representatives from HHS, State and the Department of Commerce will
review written submissions and share them, as appropriate, with staff
from other Federal Agencies to inform U.S. Government policy and our
international engagements on these issues. U.S. officials may contact
individuals making submissions for further information or explanation.
Respondent information. Please note the following information is
not required but will assist us in contextualizing responses. If
possible, in your submission, please include institution or
organization name and type; for foreign-based entities, please
[[Page 88638]]
specify country/ies in which the institution or organization is
headquartered; if your institution or organization is a potential
provider of pandemic-related products or services, please specify the
types of products or services with which you are commonly associated or
seeking to develop. All personal identifying information (for example,
name and address) voluntarily submitted by the commenter may be
publicly accessible.
Specific topics and questions: Stakeholders are invited to provide
comments on any and all issues raised by the negotiating text,
including potential vehicles and means for implementation of
commitments to which the U.S. may subscribe. To the extent commenters
choose to comment on specific provisions of the negotiating text, it is
helpful to reference any articles or sub-articles being addressed.
In addition, stakeholders are invited to respond to any or all of
the following questions.\1\ Unless otherwise indicated, quotations are
from the relevant article of the Proposal for negotiating text.
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\1\ The content or phrasing of questions in this Request for
Comment should not be taken to indicate that the U.S. is favoring or
preparing to accept commitments and/or not engage in further
negotiation over them. Rather, we are seeking to learn more about
stakeholder positions on these pivotal questions to further refine
the U.S. delegation's negotiating stance.
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Article 9, Research and Development
<bullet> What approaches or incentives might be provided to
governments, research institutions, or the private sector to encourage
participation of relevant stakeholders to, as proposed in the
Negotiating Text, ``accelerate innovative research and development,
including community-led and cross-sector collaboration, for addressing
emerging and re-emerging pathogens with pandemic potential''?
<bullet> What voluntary steps could Research & Development (R&D)
stakeholders take that would build capacities and promote more
inclusive research collaborations and participation from basic science
through advanced development and clinical research, addressing the
global calls for equity and inclusion?
<bullet> What national policies might be developed that (as
proposed in the Negotiating Text), ``support the transparent, public
sharing of clinical trial protocols and results conducted either within
their territories or through partnerships with other Parties, such as
through open access publications''?
<bullet> What are respective pros and cons of, the following
proposed language in the Negotiating Text: ``in accordance with
national laws and considering the extent of public funding provided,
publish[ing] the terms of government-funded research and development
agreements for pandemic-related products, including information on: (a)
research inputs, processes and outputs, including scientific
publications and data repositories, with data shared and stored
securely in alignment with findability, accessibility, interoperability
and reusability principles; (b) the pricing of end-products, or pricing
policies for end-products; (c) licensing to enable the development,
manufacturing and distribution of pandemic-related products, especially
in developing countries; and (d) terms regarding affordable, equitable
and timely access to pandemic-related products during a pandemic''? In
your view, are there alternative recommended actions or commitments
that could be considered?
<bullet> What is the appropriate role for WHO in facilitating the
R&D process in areas focusing on infectious diseases?
<bullet> Are there provisions that could reasonably be included in
government-funded research or advanced development agreements, or
policies related to licensing of government-owned and/or government-
funded technology that would promote global access to pandemic-related
products, without disincentivizing innovation or partnering with the
U.S. government around research and development?
Article 10, Sustainable Production
<bullet> What approaches or incentives might be used to encourage
manufacturers and others ``to grant, subject to any existing licensing
restrictions, on mutually agreed terms, non-exclusive, royalty-free
licenses to any manufacturers, particularly from developing countries,
to use their intellectual property and other protected substances,
products, technology, know-how, information and knowledge used in the
process of pandemic-related product development and production, in
particular for pre-pandemic and pandemic diagnostics, vaccines and
therapeutics for use in agreed developing countries''?
<bullet> How helpful or harmful would the following proposed
obligations for governments be for public health, business, and
innovation interests generally:
[cir] ``(a) encourage research and development institutes and
manufacturers, in particular those receiving significant public
financing, to waive or manage, for a limited duration, royalties on the
use of their technology for the production of pandemic-related
products;
[cir] (b) promote the publication, by private rights holders, of
the terms of licensing agreements or technology transfer agreements for
pandemic-related products; and
[cir] (c) promote the voluntary licensing and transfer of
technology and related know-how for pandemic-related products by
private rights holders with established regional or global technology
transfer hubs or other multilateral mechanisms or networks.''
<bullet> How can we work to promote a globally sustainable medical
countermeasures (MCM) manufacturing system, including leveraging
regional approaches to production and maintaining readiness of
facilities between pandemic emergencies?
Article 11, Transfer of Technology and Know-How
<bullet> What measures could be taken, or incentives provided, to
``strengthen existing, and develop innovative, multilateral mechanisms
[under WHO], including through the pooling of knowledge, intellectual
property and data, that promote the transfer of technology and know-how
for the production of pandemic-related products, on mutually agreed
terms as appropriate, to manufacturers, particularly in developing
countries''?
<bullet> What measures could be taken, or incentives provided, to
``make available non-exclusive licensing of government-owned
technologies, on mutually agreed terms as appropriate, for the
development and manufacturing of pandemic-related products, and publish
the terms of these licenses''?
<bullet> In your view, is there a lack of transparency concerning
information regarding pandemic-related products, their technological
specifications, and manufacturing details? If so, could the
establishment of a new mechanism at the WHO effectively address this
lack of transparency?
<bullet> What net impacts, positive or negative, would you envision
arising from commitments presently outlined in Article 11.3, including:
[cir] ``(a) commit to agree upon, within the framework of relevant
institutions, time-bound waivers of intellectual property rights to
accelerate or scale up the manufacturing of pandemic-related products
to the extent necessary to increase the availability and adequacy of
affordable pandemic-related products;
[cir] (b) encourage all holders of patents related to the
production of pandemic-related products to waive or manage, as
appropriate, for a limited duration, the
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payment of royalties by developing country manufacturers on the use,
during the pandemic, of their technology for the production of
pandemic-related products, and shall require, as appropriate, those
that have received public financing for the development of pandemic-
related products to do so; and
[cir] (c) encourage manufacturers within its jurisdiction to share
undisclosed information, in accordance with paragraph 2 of Article 39
of the Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Agreement, with qualified third-party manufacturers when the
withholding of such information prevents or hinders urgent manufacture
by qualified third parties of a pharmaceutical product that is
necessary to respond to the pandemic''?
Article 12, Access and Benefit Sharing
<bullet> A key negotiating objective of the United States has been
to ensure that all countries share pathogen samples and associated
data, including genetic sequence data, from emerging outbreaks quickly
and transparently to facilitate response efforts, including the rapid
creation of safe and effective vaccines, diagnostic tests, and
treatments.
[cir] What sample and data access impediments have you encountered
in the past or what impediments would you envision based on the
proposed Pathogen Access and Benefit Sharing (PABS) System in the
Negotiating Text that might thwart or delay research efforts?
[ssquf] Does implementation of Nagoya Protocol requirements impede
the rapid development or deployment of vaccines, diagnostic test, and
treatments? Explain.
[cir] How important is a commitment by negotiating parties to
provide parties with the access to pathogen samples and data that are
needed to contribute to rapid creation of safe and effective vaccines,
diagnostic tests, and treatments?
[cir] Are alternative strategies for ``access'' to samples and data
available and how do they compare in terms of effectiveness and
efficiency?
[cir] How might such commitments impact researchers and
institutions?
<bullet> The Article 12 negotiating text proposes that sanctioned
use of the WHO PABS System would be recognized as a specialized
international access and benefit-sharing instrument within the meaning
of paragraph 4 of Article 4 of the Nagoya Protocol; such recognition
would provide for the exemption of the pathogens covered under the PABS
System from additional access and benefit sharing requirements.
[cir] How valuable would such an ``exemption'' be to U.S.
stakeholders? What pathogens would benefit from exemption status?
[cir] What additional incentives might be needed to encourage
participation in an ABS system exempt from Nagoya Protocol
requirements?
<bullet> The Article 12 negotiating text envisions parties agreeing
to set aside certain percentages of pandemic-related products (proposed
in the current negotiating text as a minimum of 20%) and facilitating
their exportability.
[cir] What, from your perspective, are the pros and cons of such a
requirement?
[cir] Would such a requirement advance or hinder rapid research and
development efforts?
<bullet> The Article 12 negotiating text further envisions required
monetary contributions from recipients of shared samples or data,
including researchers and manufacturers, for privileges of access. What
in your view is the monetary value of access that would be provided in
terms of an annual or percentage-based contribution from your
organization? How would requiring monetary contributions from academic,
government, or other non-profit research institutions impact, positive
or negative, research?
<bullet> The Article 12 negotiating text specifies other benefits
that should be considered for provision to developing countries,
including ``(i) encouraging manufacturers from developed countries to
collaborate with manufacturers from developing countries . . . to
transfer technology and know-how and strengthen capacities for the
timely scale-up of production of pandemic-related products; (ii)
tiered-pricing or other cost-related arrangements, such as no loss/no
profit loss arrangements, for purchase of pandemic-related products . .
.; and (iii) encouraging of laboratories . . . to actively seek the
participation of scientists from developing countries in scientific
projects associated with research on WHO PABS Materials.''
[cir] How helpful would these additional measures be in advancing
the rapid creation and/or production scale-up of safe and effective
vaccines, diagnostic tests, and treatments? What are the risks or
potential negative impacts could come from including such provisions?
[cir] What incentives might be provided to stakeholders to
encourage/assure participation in such voluntary measures?
<bullet> What provisions might companies, academic research
institutions, and other industry stakeholders look for when assessing
voluntary participation in such a proposed Access and Benefit Sharing
system? What samples/data are needed the most and how could such a
system improve access to needed resources? What provisions are missing
that would incentivize broad participation in the system that Member
States should consider?
Article 13, Global Supply Chain and Logistics (SCL) Network
<bullet> The WHO SCL Network proposed in Article 13 envisions
performing a range of functions ordinarily left to individual
governments, institutions, or organizations.
[cir] What functions of Access to COVID-19 Tools-Accelerator (ACT-
A) should or should not be institutionalized?
[cir] Should the U.S. consider incentives to encourage U.S.
stakeholders' participation in such an effort and what would compelling
incentives be?
Susan Kim,
Principal Deputy Assistant Secretary, Office for Global Affairs.
[FR Doc. 2023-28341 Filed 12-20-23; 4:15 pm]
BILLING CODE 4150-38-P
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