H.R. 2213 — Medical Supply Chain Resiliency Act

This section states congressional findings regarding vulnerabilities in the U.S. medical supply chain exposed by the COVID-19 pandemic, including shortages of critical goods, foreign export restrictions, global dispersion of pharmaceutical production to lower-cost locations, and U.S. import reliance on three countries (China at 30.6 percent, Mexico at 15.3 percent, and Malaysia at 9.0 percent). It expresses the sense of Congress that the United States should diversify its trade relationships and prioritize partners with reliable supply chain policies to mitigate national security and public health risks in future pandemics.

This section declares the purposes of the Act, which include improving U.S. medical supply chain resilience through trusted trade partners; enhancing 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 capacity expansion; promoting regulatory cooperation and good practices; increasing government procurement access; enabling transparency and harmonization in device and pharmaceutical authorizations; facilitating efficient trade; and identifying production capacities and weaknesses.

This section defines terms for purposes of the Act, including: (1) appropriate committees of Congress as the Senate Committee on Finance and the House Committee on Ways and Means; (2) country as any foreign country or territory (including overseas dependent territories or possessions) or the Trust Territory of the Pacific Islands; (3) medical device as a device, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), intended for use in humans; (4) medical good as any medical device, pharmaceutical good, or input for such a device or good; (5) medical supply chain as activities involving design, procurement, manufacturing, production, distribution, operation, or management related to medical goods; (6) pharmaceutical good as a drug, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), intended for use in humans; (7) Trade Representative as the United States Trade Representative; (8) trusted trade partner as any country that has entered into an agreement with the United States under section 5; and (9) trusted trade partner agreement as an agreement entered into under section 5.

This section authorizes the President, upon determining that reciprocal elimination of duties or import restrictions on medical goods with one or more countries would contribute to U.S. national security and public health—based on specified considerations (e.g., the country's commitment to open trade in medical goods during public health emergencies, adherence to existing free trade agreements, rule of law, intellectual property protections, and good regulatory practices)—to negotiate, enter into, and enforce trusted trade partner agreements and to proclaim corresponding modifications to duties or other treatments. Such agreements may provide for reciprocal reductions or eliminations of duties, quotas, and other barriers on medical goods; supplier diversification; regulatory harmonization and cooperation (including adoption of international standards); expanded government procurement access (including potential WTO Agreement on Government Procurement membership); intellectual property protections; research collaboration; good regulatory practices; and exemptions from trade-restrictive measures during public health emergencies. (Thus, these agreements aim to secure reliable medical goods supplies, incentivize U.S. and allied manufacturing, and facilitate rapid response to health crises.) This section also requires the President to report to Congress on negotiation status not later than 180 days after enactment and every 180 days thereafter.

This section establishes congressional oversight, notice, consultation, information access, and review procedures for trusted trade partner agreements under section 5 of the Act. Specifically, it requires (1) written notice to Congress 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, plus pre-agreement consultations with jurisdictionally relevant committees; (3) consultations with relevant federal agencies (e.g., Department of Health and Human Services); (4) prior to proclaiming any duty eliminations, advice from advisory committees under 19 U.S.C. 2155 and the International Trade Commission, a report to committees on the action and advice, and 60-day consultations with committees; (5) a report to Congress at least 60 days before agreement entry detailing the agreement's nature, scope, duration, alignment with Act purposes, evidence of partner eligibility 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, then by 30 more days) before the agreement takes effect, during which Congress may enact a joint resolution of disapproval for specified procedural failures or failure to advance Act purposes, national security, or public health.

This section requires the U.S. Trade Representative (USTR) to periodically monitor each trusted trade partner's compliance with commitments and obligations under a trusted trade partner agreement. If USTR determines noncompliance, it must report to the President with findings and recommendations; the President then has 30 days to concur and, if concurring, select and implement (within 15 days) a response including (1) suspending, withdrawing, or preventing application of the agreement; (2) entering a binding compensatory agreement; or (3) other actions such as suspending the partner's exemption from trade-restrictive measures on medical goods during a public health emergency.