S. 998 — Medical Supply Chain Resiliency Act

This section states congressional findings regarding vulnerabilities in the global medical supply chain for COVID-19 critical goods exposed by the pandemic, including U.S. reliance on a limited number of import partners (e.g., China at 30.6 percent, Mexico at 15.3 percent, and Malaysia at 9.0 percent of imports) and risks from foreign export restrictions and dispersed pharmaceutical production. It expresses the sense of Congress that the United States should diversify its trade relationships and prioritize partners with reliable supply chain policies to enhance national security and public health preparedness for future pandemics.

This section states the purposes of the Act, including improving U.S. medical supply chain resilience through enhanced frameworks with trusted trade partners; bolstering supply chain security for technology transfer and intellectual property; diversifying supplier networks; eliminating trade barriers; expediting cross-border movement of critical medical goods; fostering international collaboration, research and development, data flows, and manufacturing expansion; promoting regulatory cooperation; increasing access to government procurement; encouraging good regulatory practices; enabling transparency, harmonization, and reliance in authorization procedures; facilitating efficient trade; and identifying production capacities to address weaknesses.

This section defines nine terms for purposes of the Act: (1) appropriate committees of Congress, meaning the Senate Committee on Finance and House Committee on Ways and Means; (2) country, meaning any foreign country or territory (including overseas dependent territories or possessions) or the Trust Territory of the Pacific Islands; (3) medical device, meaning 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, meaning any medical device, pharmaceutical good, or input for such a device or good; (5) medical supply chain, meaning activities involving design, procurement, manufacturing, production, distribution, operation, or management related to medical goods; (6) pharmaceutical good, meaning 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, meaning the United States Trade Representative; (8) trusted trade partner, meaning any country that has entered into an agreement with the United States under section 5; and (9) trusted trade partner agreement, meaning an agreement entered into under section 5.

This section authorizes the President, subject to section 6, to negotiate, enter into, and enforce trusted trade partner agreements with one or more countries—upon determining, based on specified considerations, that reciprocal elimination of duties or other import restrictions on medical goods would promote U.S. national security and public health—and to proclaim related modifications to duties or duty-free treatment. The considerations include the foreign government's commitment to open trade in medical goods during public health emergencies, adherence to existing U.S. free trade agreements, reduction of trade barriers on medical goods, maintenance of the rule of law, protection of intellectual property rights comparable to U.S. standards, and promotion of good regulatory practices. Such agreements may provide for (1) reductions or eliminations of duties, quotas, and other barriers on medical goods; (2) supplier network diversification; (3) regulatory harmonization and cooperation; (4) expanded government procurement access, including potential membership in the WTO Agreement on Government Procurement; (5) intellectual property protections comparable to U.S. standards; (6) manufacturing standards cooperation; (7) research and development collaboration; (8) good regulatory practices; (9) regulatory compatibility to facilitate trade and investment; and (10) exemptions from trade-restrictive measures during public health emergencies. This section requires the President to submit to Congress a report on negotiation status not later than 180 days after enactment and every 180 days thereafter.

This section establishes congressional oversight procedures for trusted trade partner agreements under section 5, including (1) a requirement for the President to provide Congress written notice at least 60 days before initiating negotiations identifying the start date and partner; (2) consultations by the Trade Representative during negotiations with congressional committees on objectives, status, effects on U.S. law, and access to documents, and before agreement entry with jurisdictional committees; (3) Trade Representative consultations with relevant federal agencies (e.g., Department of Health and Human Services); (4) prior to any duty elimination or reduction proclamation, obtaining advice from advisory committees under 19 U.S.C. 2155 and the International Trade Commission, submitting a report to congressional committees on the proposed action and advice received, and consulting during a 60-day period; (5) a report to Congress at least 60 days before agreement entry describing the agreement's nature, scope, duration, consistency with the Act's purposes, evidence of partner qualifications and national security/public health benefits, and implementation effects; and (6) a congressional review period of 30 days (extendable by 60 days upon one chamber's resolution and further by 30 days) before the agreement takes effect, during which Congress may enact a joint resolution of disapproval based on procedural failures or inconsistency with the Act's purposes, national security, or public health.

This section directs the U.S. Trade Representative to periodically monitor a trusted trade partner's compliance with commitments under a trusted trade partner agreement and, upon determining noncompliance, to submit a report to the President with findings and recommended actions. Not later than 30 days after receiving the report, the President must determine whether to concur and, if so, whether (1) to suspend, withdraw, or prevent application of the agreement; (2) to enter a binding agreement for the partner to eliminate resulting U.S. burdens and provide negotiated compensatory trade benefits; or (3) to take other actions, including suspending the partner's exemption from trade-restrictive measures on medical goods during a public health emergency; any selected action must be implemented not later than 15 days after the President's determination.