[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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