[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7757-7759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02466]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 332-596]


COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS 
Agreement Flexibilities

AGENCY: United States International Trade Commission.

ACTION: Notice of investigation and scheduling of a public hearing.

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SUMMARY: Following receipt on December 16, 2022, of a request from the 
U.S. Trade Representative (USTR), under the Tariff Act of 1930, the 
U.S. International Trade Commission (Commission) instituted 
Investigation No. 332-596, COVID-19 Diagnostics and Therapeutics: 
Supply, Demand, and TRIPS Agreement Flexibilities. The USTR requested 
that the Commission conduct an investigation and prepare a report that 
analyzes the universe of existing COVID-19 diagnostics and therapeutics 
in relation to the World Trade Organization (WTO) Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS Agreement)--
including the range of definitions for diagnostics and therapeutics; 
diagnostics and therapeutics covered by patents and those in 
development; an overview of production, distribution, and demand; 
information on market segmentation of global demand and consumption; 
and other information relevant to the discussion of TRIPS Agreement 
flexibilities.

DATES: 
    March 15, 2023: Deadline for filing requests to appear at the 
public hearing.
    March 17, 2023: Deadline for filing prehearing briefs and 
statements.
    March 22, 2023: Deadline for filing electronic copies of oral 
hearing statements.
    March 29-30, 2023: Public hearing.
    April 12, 2023: Deadline for filing posthearing briefs and 
statements.
    May 5, 2023: Deadline for filing all other written submissions.
    October 17, 2023: Transmittal of Commission report to the USTR.

ADDRESSES: All Commission offices, including the Commission's hearing 
rooms, are located in the U.S. International Trade Commission Building, 
500 E Street SW, Washington, DC. All written submissions should be 
addressed to the Secretary, U.S. International Trade Commission, 500 E 
Street SW, Washington, DC 20436. The public record for this 
investigation may be viewed on the Commission's electronic docket 
(EDIS) at https://edis.usitc.gov.

FOR FURTHER INFORMATION CONTACT: Project Leader Philip Stone (202-205-
3424 or [email protected]) or Deputy Project Leader Dixie Downing 
(202-205-3164 or [email protected]) for information specific to 
this investigation. For information on the legal aspects of this 
investigation, contact Brian Allen (202-205-3034 or 
[email protected]) or William Gearhart (202-205-3091 or 
[email protected]) of the Commission's Office of the General 
Counsel. The media should contact Jennifer Andberg, Office of External 
Relations (202-205-3404 or [email protected]). Hearing-
impaired individuals are advised that information on this matter can be 
obtained by contacting the Commission's TDD terminal on 202-205-1810. 
General information concerning the Commission may be obtained by 
accessing its internet address (https://www.usitc.gov). Persons with 
mobility impairments who will need special assistance in gaining access 
to the Commission should contact the Office of the Secretary at 202-
205-2000.

SUPPLEMENTARY INFORMATION: 
    Background: As requested in the letter received from the USTR on 
December 16, 2022, the Commission has instituted an investigation under 
section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)) that 
analyzes the universe of existing COVID-19 diagnostics and therapeutics 
in relation to the TRIPS Agreement. Specifically, the USTR has 
requested that the Commission prepare a report that:
     Identifies the range of definitions for ``diagnostics'' 
and ``therapeutics'' in the medical field.
     Identifies and defines the universe of existing COVID-19 
diagnostics and therapeutics covered by patents as well as COVID-19 
diagnostics and therapeutics in development.
     Provides a broad overview of relevant COVID-19 diagnostics 
and therapeutics, including a description of the products and any 
intellectual property protections, and containing, to the extent 
practicable and where data are available:
    [cir] An overview of production and distribution, including key 
components, the production processes, key producing countries, major 
firms, operational costs, a description of the supply chain, and the 
level of geographic diversification within the supply chain;
    [cir] An overview of demand, including key demand factors, an 
assessment of where unmet demand exists, supply accumulation and 
distribution, and the impact of the relationship between testing and 
demand for treatment, if any exists;
    [cir] Information on market segmentation of global demand and 
consumption, which may be delineated by low-income countries (LICs), 
lower middle-income countries (LMICs), upper middle-income countries 
(UMICs), and high-income countries (HICs);
    [cir] Information on availability and pricing (or manufacturing 
costs in the cases where goods are donated) for COVID-19 diagnostics 
and therapeutics, if available; and
    [cir] Global trade data for COVID-19 diagnostics and therapeutics 
or diagnostics and therapeutics in general if specific data are not 
available.
     Catalogs, to the extent practicable based on available 
information and a critical review of the literature:
    [cir] The reasons for market segmentation and barriers to a more 
diverse geographical distribution of the global manufacturing 
industries for COVID-19 diagnostics and therapeutics;
    [cir] The relationship between patent protection and innovation in 
the health sector and between patent protection and access to medicine 
in LICs, LMICs, UMICs, and HICs;
    [cir] Actions taken by WTO Members to use or attempt to use 
compulsory

[[Page 7758]]

licenses for the production, importation, or exportation of 
pharmaceutical products and the outcomes of those actions, including 
the effect on product access, innovation, and global health;
    [cir] A description of any alternatives to compulsory licensing 
available to WTO Members, such as voluntary licenses, including through 
the Medicines Patent Pool (MPP); multilateral programs, including the 
GlobalFund and United Nations Children's Fund (UNICEF); government-to-
government programs; and private-sector donations; and
    [cir] The effect, or lack thereof, of the MPP on access to COVID-19 
diagnostics and therapeutics.
    The USTR explicitly asked that the Commission solicit input on the 
above issues from a wide variety of participants, including foreign 
governments, non-governmental health advocates, organizations such as 
the MPP and Foundation for Innovative New Diagnostics (FIND), and 
manufacturers of diagnostics and therapeutics. The USTR stated that 
input on the following would be particularly salient:
     How the TRIPS Agreement promotes innovation in and/or 
limits access to COVID-19 diagnostics and therapeutics;
     Successes and challenges in using existing TRIPS 
flexibilities;
     The extent to which products not yet on the market, or new 
uses for existing products, could be affected by an extension of the 
Ministerial Decision to diagnostics and therapeutics;
     Whether and how existing TRIPS rules and flexibilities can 
be deployed to improve access to medicines;
     To what extent further clarifications of existing TRIPS 
flexibilities would be useful in improving access to medicines;
     The relationship between intellectual property protection 
and corporate research and development expenditures, taking into 
account other expenditures, such as share buybacks, dividends, and 
marketing;
     The relevance, if any, of the fact that diagnostic and 
therapeutic products used with respect to COVID-19 may also have 
application to other diseases; and
     The location of jobs associated with the manufacturing of 
diagnostics and therapeutics, including in the United States.
    As requested by the USTR, the Commission will deliver the report on 
October 17, 2023. Since the USTR has indicated that USTR intends to 
make this report available to the public in its entirety, the 
Commission will not include confidential business or national security 
classified information in its report. However, as detailed below, 
participants may submit confidential information to the Commission to 
inform its understanding of these issues, and such information will be 
protected in accordance with the Commission's Rules of Practice and 
Procedure. Participants are strongly encouraged to provide any 
supporting data and information along with their views.
    Public Hearing: A public hearing in connection with this 
investigation will be held beginning at 9:30 a.m., March 29, 2023, and 
continuing, if necessary, on March 30, 2023, in the Main Hearing Room 
of the U.S. International Trade Commission, 500 E Street SW, Washington 
DC 20436. The hearing can also be accessed remotely using the WebEx 
videoconference platform. A link to the hearing will be posted on the 
Commission's website at https://www.usitc.gov/calendarpad/calendar.html.
    Requests to appear at the hearing should be filed with the 
Secretary to the Commission no later than 5:15 p.m., March 15, 2023, in 
accordance with the requirements in the ``Written Submissions'' section 
below. Any requests to appear as a witness via videoconference must be 
included with your request to appear. Requests to appear as a witness 
via videoconference must include a statement explaining why the witness 
cannot appear in person; the Chairman, or other person designated to 
conduct the investigation, may at their discretion for good cause 
shown, grant such requests. Requests to appear as a witness via 
videoconference due to illness or a positive COVID-19 test result may 
be submitted by 3 p.m. the business day prior to the hearing. All 
prehearing briefs and statements should be filed no later than 5:15 
p.m., March 17, 2023. To facilitate the hearing, including the 
preparation of an accurate written public transcript of the hearing, 
oral testimony to be presented at the hearing must be submitted to the 
Commission electronically no later than noon, March 22, 2023. All 
posthearing briefs and statements should be filed no later than 5:15 
p.m., April 12, 2023. Posthearing briefs and statements should address 
matters raised at the hearing. For a description of the different types 
of written briefs and statements, see the ``Definitions'' section 
below.
    In the event that, as of the close of business on March 15, 2023, 
no witnesses are scheduled to appear at the hearing, the hearing will 
be canceled. Any person interested in attending the hearing as an 
observer or nonparticipant should check the Commission website as 
indicated above for information concerning whether the hearing will be 
held.
    Written submissions: In lieu of or in addition to participating in 
the hearing, interested parties are invited to file written submissions 
concerning this investigation. All written submissions should be 
addressed to the Secretary, and should be received no later than 5:15 
p.m., May 5, 2023. All written submissions must conform to the 
provisions of section 201.8 of the Commission's Rules of Practice and 
Procedure (19 CFR 201.8), as temporarily amended by 85 FR 15798 (March 
19, 2020). Under that rule waiver, the Office of the Secretary will 
accept only electronic filings at this time. Filings must be made 
through the Commission's Electronic Document Information System (EDIS, 
https://edis.usitc.gov). No in-person paper-based filings or paper 
copies of any electronic filings will be accepted until further notice. 
Persons with questions regarding electronic filing should contact the 
Office of the Secretary, Docket Services Division (202-205-1802), or 
consult the Commission's Handbook on Filing Procedures.
    Definitions of types of documents that may be filed; Requirements: 
In addition to requests to appear at the hearing, this notice provides 
for the possible filing of four types of documents: prehearing briefs, 
oral hearing statements, posthearing briefs, and other written 
submissions.
    (1) Prehearing briefs refers to written materials relevant to the 
investigation and submitted in advance of the hearing, and includes 
written views on matters that are the subject of the investigation, 
supporting materials, and any other written materials that you consider 
will help the Commission in understanding your views. You should file a 
prehearing brief particularly if you plan to testify at the hearing on 
behalf of an industry group, company, or other organization, and wish 
to provide detailed views or information that will support or 
supplement your testimony.
    (2) Oral hearing statements (testimony) refers to the actual oral 
statement that you intend to present at the hearing. Do not include any 
confidential business information (CBI) in that statement. If you plan 
to testify, you must file a copy of your oral statement by the date 
specified in this notice. This statement will allow Commissioners to 
understand your position in advance of the hearing and will also assist 
the court reporter in preparing an accurate transcript of the hearing 
(e.g., names spelled correctly).

[[Page 7759]]

    (3) Posthearing briefs refers to submissions filed after the 
hearing by persons who appeared at the hearing. Such briefs: (a) should 
be limited to matters that arose during the hearing; (b) should respond 
to any Commissioner and staff questions addressed to you at the 
hearing; (c) should clarify, amplify, or correct any statements you 
made at the hearing; and (d) may, at your option, address or rebut 
statements made by other participants in the hearing.
    (4) Other written submissions refers to any other written 
submissions that interested persons wish to make, regardless of whether 
they appeared at the hearing, and may include new information or 
updates of information previously provided.
    In accordance with the provisions of section 201.8 of the 
Commission's Rules of Practice and Procedure (19 CFR 201.8) the 
document must identify on its cover (1) the investigation number and 
title and the type of document filed (i.e., prehearing brief, oral 
statement of (name), posthearing brief, or written submission), (2) the 
name and signature of the person filing it, (3) the name of the 
organization that the submission is filed on behalf of, and (4) whether 
it contains CBI. If it contains CBI, it must comply with the marking 
and other requirements set out below in this notice relating to CBI. 
Submitters of written documents (other than oral hearing statements) 
are encouraged to include a short summary of their position or interest 
at the beginning of the document, and a table of contents when the 
document addresses multiple issues.
    Confidential business information: Any submissions that contain CBI 
must also conform to the requirements of section 201.6 of the 
Commission's Rules of Practice and Procedure (19 CFR 201.6). Section 
201.6 of the rules requires that the cover of the document and the 
individual pages be clearly marked as to whether they are the 
``confidential'' or ``nonconfidential'' version, and that the CBI is 
clearly identified by means of brackets. All written submissions, 
except for CBI, will be made available for inspection by interested 
parties.
    As requested by the USTR, the Commission will not include any CBI 
in its report. However, all information, including CBI, submitted in 
this investigation may be disclosed to and used: (i) by the Commission, 
its employees and Offices, and contract personnel (a) for developing or 
maintaining the records of this or a related proceeding, or (b) in 
internal investigations, audits, reviews, and evaluations relating to 
the programs, personnel, and operations of the Commission, including 
under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and 
contract personnel for cybersecurity purposes. The Commission will not 
otherwise disclose any CBI in a way that would reveal the operations of 
the firm supplying the information.
    Summaries of written submissions: Persons wishing to have a summary 
of their position included in the report should include a summary with 
their written submission on or before May 5, 2023, and should mark the 
summary as having been provided for that purpose. The summary should be 
clearly marked as ``summary for inclusion in the report'' at the top of 
the page. The summary may not exceed 500 words and should not include 
any CBI. The summary will be published as provided if it meets these 
requirements and is germane to the subject matter of the investigation. 
The Commission will list the name of the organization furnishing the 
summary and will include a link where the written submission can be 
found.

    By order of the Commission.

    Issued: February 1, 2023.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2023-02466 Filed 2-3-23; 8:45 am]
BILLING CODE 7020-02-P