[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88637-88639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected] 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 www.regulations.gov. In this instance, business 
confidential submissions will also be accepted. Note that relevant 
comments submitted to regulations.gov 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 regulations.gov.

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: 
https://inb.who.int/home/inb-process. 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:
     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.
     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.
     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: https://apps.who.int/gb/inb/pdf_files/inb7/A_INB7_3-en.pdf.
    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

     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''?
     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?
     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''?
     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?
     What is the appropriate role for WHO in facilitating the 
R&D process in areas focusing on infectious diseases?
     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

     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''?
     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.''
     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

     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''?
     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''?
     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?
     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

     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?
     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?
     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?
     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?
     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?
     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

     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]
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