Medical Supply Chain Resiliency Act
This bill authorizes actions to facilitate trade in medical goods (i.e., medical devices, pharmaceutical goods, or inputs for such devices or goods).
Specifically, the bill authorizes the President to (1) negotiate, enter into, and enforce a trusted trade partner agreement with a country or countries with respect to medical goods; and (2) proclaim a modification of any existing duty, a continuance of existing duty-free or excise treatment, or additional duties to carry out the trade agreement. These actions may only be taken if the President determines, based on specified considerations, that the reciprocal elimination of existing duties or other import restrictions with respect to medical goods would contribute to U.S. national security and public health.
A trusted trade partner agreement may include certain provisions, such as those to (1) reduce or eliminate duties, quotas, or other trade barriers; (2) diversify and expand supplier networks to secure a reliable supply of medical goods; and (3) harmonize regulatory procedures.
Not later than 60 days before initiating negotiations with a trusted trade partner, the President must submit written notice to Congress. The bill requires congressional consultation and review of these trade agreements. A trade agreement shall not take effect if, during the required review period, Congress enacts a joint resolution of disapproval.
The Office of the U.S. Trade Representative must monitor compliance by a trusted trade partner with the trade agreement's commitments and obligations. Further, the President may take certain actions in response to a failure to comply.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2115 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 2115
To authorize the President to enter into trade agreements for the
reciprocal elimination of duties or other import restrictions with
respect to medical goods to contribute to the national security and
public health of the United States, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 22, 2023
Mr. Carper (for himself and Mr. Tillis) introduced the following bill;
which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To authorize the President to enter into trade agreements for the
reciprocal elimination of duties or other import restrictions with
respect to medical goods to contribute to the national security and
public health of the United States, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medical Supply Chain Resiliency
Act''.
SEC. 2. FINDINGS; SENSE OF CONGRESS.
(a) Findings.--Congress makes the following findings:
(1) The COVID-19 pandemic created significant demand
pressures on the global medical supply chain.
(2) According to a December 2020 report by the United
States International Trade Commission, global demand
significantly exceeded available supply of many goods critical
for the response to the COVID-19 pandemic (in this section
referred to as ``COVID-19 critical goods''). Health care
providers in the United States faced difficulties in procuring
such goods in sufficient quantities. Foreign export
restrictions on finished drugs and active pharmaceutical
ingredients may have contributed to stress on the supply of
some critical COVID-19 treatment drugs (including anti-
infective products), as well as hormone medications and
vitamins.
(3) According to the McKinsey Global Institute, during the
20 years preceding the date of the enactment of this Act,
pharmaceutical supply chains have become more globally
dispersed and many generic small-molecule products have shifted
to lower-cost production locations, some of which have been
identified as posing a threat to the national security of the
United States.
(4) According to the Organisation for Economic Co-operation
and Development, while the United States is one of the largest
exporters of COVID-19 critical goods, it is also one of the
largest importers of those goods.
(5) The World Trade Organization has found that, while the
United States, Germany, and the People's Republic of China are
all major producers and importers of COVID-19 critical goods,
United States import partners are less diversified compared to
Germany and the People's Republic of China. In the United
States, more than half of its imports of COVID-19 critical
goods came from only 3 partners--the People's Republic of China
(30.6 percent), Mexico (15.3 percent), and Malaysia (9.0
percent).
(6) While some of the countries in which medical supply
manufacturing occurs are reliable suppliers and allies to the
United States, others have adopted or maintained policies that
make United States supply less secure.
(b) Sense of Congress.--It is the sense of Congress that, given the
threat to national security and public health that could arise if the
United States is unable to swiftly respond to significant demand surges
for medical products in a future pandemic, it is critical that the
United States diversify its trade relationships and prioritize partners
that adopt and maintain reliable supply chain policies.
SEC. 3. PURPOSES.
The purposes of this Act are--
(1) to improve overall medical supply chain resilience for
the United States by establishing a framework to enhance
medical supply chains with trusted trade partners;
(2) to enhance supply chain security related to technology
transfer and intellectual property protection;
(3) to diversify and expand supplier networks to ensure a
reliable supply of medical goods, especially in the event of
emergency situations;
(4) to eliminate unnecessary trade barriers and distortions
that weaken or disrupt medical supply chains;
(5) to expedite cross-border movement of critical medical
goods;
(6) to foster international collaboration, encourage new
investments, promote cooperation and partnership in public and
private research and development efforts, facilitate data flows
for life science research and development, and expand
manufacturing capacities for medical devices and pharmaceutical
goods;
(7) to promote regulatory cooperation with respect to
manufacturing of medical goods;
(8) to increase access to government procurement markets
for medical goods;
(9) to encourage adoption of and adherence to good
regulatory practices related to medical goods;
(10) to enable greater transparency, regulatory
harmonization, and reliance in authorization and licensing
procedures for medical devices and pharmaceutical goods;
(11) to facilitate trade in medical goods to the most
efficient and practicable extent possible; and
(12) to identify current production capacities, address
potential weaknesses, and improve overall resilience.
SEC. 4. DEFINITIONS.
In this Act:
(1) Appropriate committees of congress.--The term
``appropriate committees of Congress'' means--
(A) the Committee on Finance of the Senate; and
(B) the Committee on Ways and Means of the House of
Representatives.
(2) Country.--The term ``country'' means--
(A) any foreign country or territory, including any
overseas dependent territory or possession of a foreign
country; or
(B) the Trust Territory of the Pacific Islands.
(3) Medical device.--The term ``medical device'' means a
device, as defined in section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321), that is intended for use in
humans.
(4) Medical good.--The term ``medical good'' means any
medical device, pharmaceutical good, or input for such a device
or good.
(5) Medical supply chain.--The term ``medical supply
chain'' means any activities involving design, procurement,
manufacturing, production, distribution, operation, or
management related to medical goods.
(6) Pharmaceutical good.--The term ``pharmaceutical good''
means a drug, as defined in section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321), that is intended for
use in humans.
(7) Trade representative.--The term ``Trade
Representative'' means the United States Trade Representative.
(8) Trusted trade partner.--The term ``trusted trade
partner'' means any country that has entered into an agreement
with the United States under section 5.
(9) Trusted trade partner agreement.--The term ``trusted
trade partner agreement'' means an agreement entered into under
section 5.
SEC. 5. AUTHORITY TO ENTER INTO TRUSTED TRADE PARTNER AGREEMENTS.
(a) In General.--Whenever the President determines, based on the
considerations set forth in subsection (b), that the reciprocal
elimination of existing duties or other import restrictions of a
country or countries and the United States with respect to medical
goods would contribute to the national security and public health of
the United States, the President may, subject to the requirements under
section 6--
(1) negotiate, enter into, and enforce a trusted trade
partner agreement with the country or countries; and
(2) proclaim such modification of any existing duty, such
continuance of existing duty-free or excise treatment, or such
additional duties, as the President determines to be required
or appropriate to carry out any such trade agreement.
(b) Considerations.--In determining whether to enter into
negotiations for a trusted trade partner agreement with a country
pursuant to subsection (a), the President shall take into account
whether the government of the country has--
(1) expressed a desire to be enter into such an agreement;
(2) demonstrated a commitment to contribute to global
health security, including the national security of the United
States and the health of United States citizens, by maintaining
open trade in medical goods during a public health emergency,
including to enable research, development, and manufacturing of
those goods;
(3) adhered to and implemented the commitments and
obligations under existing free trade agreements to which that
country and the United States are parties;
(4) implemented measures to reduce or eliminate unnecessary
trade barriers and distorting practices affecting medical
goods;
(5) maintained the rule of law by enacting and enforcing
laws and regulations in a clear, publicized, transparent, and
nondiscriminatory manner;
(6) adopted and enforced laws that provide adequate and
effective protection of intellectual property rights reflecting
a standard of protection similar to that found under United
States law; and
(7) agreed to recognize and promote good regulatory
practices related to medical goods.
(c) Trusted Trade Partner Agreements.--A trusted trade partner
agreement may, with respect to medical goods, provide for--
(1) reduction or elimination of duties, quotas, and other
trade barriers that undermine the national security and public
health of the United States by disincentivizing research,
development, and manufacturing in the United States or in
countries that are reliable suppliers of medical goods to the
United States;
(2) diversification and expansion of supplier networks to
secure a reliable supply of medical goods;
(3) harmonization or convergence of regulatory procedures,
regulatory reliance, inspection cooperation, and adoption of
international standards (such as to streamline post-approval
changes) to expedite cross-border movement of medical goods;
(4) increased access to government procurement markets for
medical goods and, in the case of a multilateral agreement
entered into under the auspices of the World Trade
Organization, membership in the Agreement on Government
Procurement of the World Trade Organization referred to in
section 101(d)(17) of the Uruguay Round Agreements Act (19
U.S.C. 3511(d)(17));
(5) adequate and effective protection of intellectual
property rights for medical goods reflecting a standard of
protection similar to that found under United States law;
(6) regulatory cooperation on manufacturing standards for
medical goods;
(7) a collaboration framework to promote public and private
research and development efforts related to medical goods,
including facilitation of data flows for life science research
and development;
(8) adherence to good regulatory practices for sound,
affordable, and efficient regulation of medical goods;
(9) promotion of regulatory compatibility and cooperation
to facilitate trade and investment related to medical goods and
accelerate manufacturing of such goods during a public health
emergency; and
(10) exemption of parties to the agreement from trade-
restrictive measures imposed with respect to medical goods
during a public health emergency.
(d) Report Required.--Not later than 180 days after the date of the
enactment of this Act, and every 180 days thereafter, the President
shall submit to Congress a report on the status of negotiations
conducted under subsection (a) for trusted trade partner agreements.
SEC. 6. CONGRESSIONAL OVERSIGHT, NOTICE, CONSULTATIONS, ACCESS TO
INFORMATION, AND REVIEW.
(a) Notice.--Not later than 60 days before initiating negotiations
with a trusted trade partner under section 5(a) for a trusted trade
partner agreement, the President shall submit to Congress written
notice of the intention of the President to enter into the
negotiations, which shall include the date negotiations will begin and
the trusted trade partner with whom the President seeks to enter into
the agreement.
(b) Consultation With Members of Congress.--
(1) Consultation during negotiations and access to
information.--In the course of negotiations under section 5(a)
for a trusted trade partner agreement, the Trade Representative
shall--
(A) meet upon request with the appropriate
committees of Congress regarding negotiating
objectives, the status of negotiations in progress, and
potential effects to the laws of the United States with
respect to the agreement;
(B) upon request by the appropriate committees of
Congress, provide access to pertinent documents
relating to the negotiations; and
(C) consult closely and on a timely basis with, and
keep fully apprised of the negotiations, the
appropriate committees of Congress.
(2) Consultation before entry into agreement.--Before
entering into a trusted trade partner agreement under section
5, the Trade Representative shall consult with--
(A) the appropriate committees of Congress; and
(B) each other committee of the Senate and the
House of Representatives, and each joint committee of
Congress, that has jurisdiction over legislation
involving a subject matter that would be affected by
the agreement.
(c) Consultation With Federal Agencies.--In the course of
negotiations under section 5(a) for a trusted trade partner agreement,
the Trade Representative shall inform and consult with any Federal
agency having expertise in the matters being negotiated, including the
Department of Health and Human Services.
(d) Limitation on Action.--Any duty elimination or staged rate
reduction provided for under section 5 may be proclaimed only if the
President--
(1) has obtained advice regarding the proposed action from
the appropriate advisory committees established under section
135 of the Trade Act of 1974 (19 U.S.C. 2155) and the
International Trade Commission;
(2) has submitted to the appropriate committees of Congress
a report that sets forth--
(A) the action proposed to be proclaimed;
(B) the reasons for such action; and
(C) the advice obtained under paragraph (1); and
(3) has consulted with the appropriate committees of
Congress regarding the proposed action during the 60-day period
on the date on which the President has met the requirements
under paragraphs (1) and (2).
(e) Report to Congress.--Not later than 60 days before the date on
which the President enters into a trusted trade partner agreement with
a trusted trade partner under section 5, the President shall submit to
Congress a report describing--
(1) the nature and scope of the agreement;
(2) the proposed duration of the agreement;
(3) how and to what extent the agreement will achieve the
applicable purposes, policies, priorities, and objectives of
this Act;
(4) whether sufficient evidence exists demonstrating that--
(A) the trusted trade partner satisfies the
conditions under section 5(b); and
(B) the reciprocal elimination of existing duties
or other import restrictions of the trusted trade
partner or the United States with respect to medical
goods would contribute to the national security and
public health of the United States; and
(5) the proposed implementation of the agreement, including
the general effect of the agreement on existing laws.
(f) Congressional Right To Review and Disapprove.--
(1) In general.--A trusted trade partner agreement shall
not take effect until--
(A) the proposed agreement has been submitted to
Congress, together with the report required under
subsection (e) with respect to that agreement; and
(B) the review period required under paragraph (2)
following the date on which the proposed agreement has
been submitted to Congress under subparagraph (A) has
been exhausted, during which period a joint resolution
is not enacted under paragraph (4).
(2) Review.--
(A) Initial review.--Unless extended under
subparagraph (B) or (C), the review period under this
paragraph with respect to a trusted trade partner
agreement is 30 days, during which time Congress shall
review the proposed agreement with respect to whether--
(i) the President failed or refused to
provide notice with respect to the agreement in
accordance with subsection (a);
(ii) the President failed or refused to
consult with respect to the agreement in
accordance with subsections (b) and (c);
(iii) the President failed or refused to
submit to Congress a report with respect to the
agreement in accordance with subsection (e); or
(iv) the President failed or refused to
demonstrate that the agreement would achieve
the applicable purposes, policies, priorities,
and objectives of this Act and contribute to
the national security and public health of the
United States.
(B) Further review.--If, during the 30-day period
under subparagraph (A) with respect to a trusted trade
partner agreement, one House of Congress adopts a
resolution stating that the House of Congress wishes to
further review the proposed agreement, the review
period under this paragraph with respect to the
proposed agreement shall be extended by a period of 60
days, during which time the appropriate committees of
Congress shall engage the President with respect to the
proposed agreement and the failures or refusals of the
President specified under subparagraph (A).
(C) Additional period.--If, during the 60-day
period under subparagraph (B) with respect to a trusted
trade partner agreement, one House of Congress adopts a
resolution stating that the House of Congress wishes to
further review the proposed agreement, the review
period under this paragraph with respect to the
proposed agreement shall be further extended by a
period of 30 days.
(3) Procedures for considering resolutions.--A resolution
under subparagraph (B) or (C) of paragraph (2)--
(A) in the Senate--
(i) may be introduced by any Member of the
Senate;
(ii) shall be referred to the Committee on
Finance; and
(iii) may not be amended;
(B) in the House of Representatives--
(i) may be introduced by any Member of the
House;
(ii) shall be referred to the Committee on
Ways and Means or the Committee on Rules; and
(iii) may not be amended by either
Committee; and
(C) the vote on passage of the resolution shall
occur immediately following the conclusion of the
debate on the trusted trade partner agreement at issue
and a single quorum call at the conclusion of the
debate.
(4) Disapproval.--If, during the review period required
under paragraph (2) with respect to a trusted trade partner
agreement, a joint resolution is enacted stating that Congress
does not favor the agreement, the agreement shall not take
effect.
SEC. 7. MONITORING AND ENFORCEMENT OF CONTINUED COMPLIANCE WITH TRUSTED
TRADE PARTNER AGREEMENTS.
(a) Monitoring.--The Trade Representative shall periodically
monitor compliance by a trusted trade partner with the commitments and
obligations of the partner under a trusted trade partner agreement.
(b) Actions in Response to Failure To Comply.--
(1) Determination and report of trade representative.--If
the Trade Representative determines that a trusted trade
partner has failed to satisfactorily implement, maintain, and
enforce the commitments and obligations of the partner under a
trusted trade partner agreement, the Trade Representative shall
submit to the President a report setting forth--
(A) the determination and the findings that support
the determination; and
(B) based on such findings, the recommendations of
the Trade Representative for action or inaction under
this subsection.
(2) Determination of president.--Not later than 30 days
after receiving a report under paragraph (1) with respect to a
trusted trade partner, the President shall--
(A) determine whether the President concurs with
the determination of the Trade Representative set forth
in the report; and
(B) if the President concurs, determine whether--
(i) to suspend, withdraw, or prevent the
application of the trusted trade partner
agreement with the trusted trade partner;
(ii) to enter into a binding agreement with
the partner that commits the partner--
(I) to eliminate any burden or
restriction on the United States
resulting from the failure of the
partner to comply with the commitments
and obligations of the partner under a
trusted trade partner agreement; and
(II) to provide the United States
with such compensatory trade benefits
as are negotiated between the Trade
Representative and the partner; or
(iii) to take such other actions as the
Trade Representative considers necessary to
encourage the partner to adhere to the
commitments and obligations of the partner
under a trusted trade partner agreement,
including suspending the exemption of the
partner from trade-restrictive measures imposed
with respect to medical goods during a public
health emergency.
(3) Timeline for action.--If the President determines under
paragraph (2)(B) to take action, the President shall implement
that action by not later than the date that is 15 days after
the day on which the President determines to take action under
that paragraph.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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