,i #aaith ,,congress #ast ,session ,h4 ,r4 #bbac ,,in ,,the ,,house ,,of ,,representatives ,march #ah1 #bjbe,ms4 ,malliotakis 7for herself and ,mr4 ,schneider7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,rules1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,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 ,states1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medical ,supply ,chain ,resiliency ,act4 #b4 ,findings2 sense of ,congress 7a7 ,findings ,congress makes the following findings3 7#a7 ,the ,,covid-#ai pandemic created significant demand pressures on the global medical supply chain4 7#b7 ,according to a ,december #bjbj report by the ,united ,states ,international ,trade ,commission1 global demand significantly exceeded available supply of many goods critical for the response to the ,,covid-#ai pandemic 7in this section referred to as ,,covid-#ai critical goods74 ,health care providers in the ,united ,states faced difficulties in procuring such goods in sufficient quantities4 ,foreign export restrictions on finished drugs and active pharmaceutical ingredients may have contributed to stress on the supply of some critical ,,covid-#ai treatment drugs 7including anti-infective products71 as well as hormone medications and vitamins4 7#c7 ,according to the ,mc,kinsey ,global ,institute1 during the #bj years preceding the date of the enactment of this ,act1 pharmaceutical supply chains have become more globally dispersed and many generic small-molecule products have shifted to lower-cost production locations1 some of which have been identified as posing a threat to the national security of the ,united ,states4 7#d7 ,according to the ,organisation for ,economic ,co-operation and ,development1 while the ,united ,states is one of the largest exporters of ,,covid-#ai critical goods1 it is also one of the largest importers of those goods4 7#e7 ,the ,world ,trade ,organization has found that1 while the ,united ,states1 ,germany1 and the ,people's ,republic of ,china are all major producers and importers of ,,covid-#ai critical goods1 ,united ,states import partners are less diversified compared to ,germany and the ,people's ,republic of ,china4 ,in the ,united ,states1 more than half of its imports of ,,covid-#ai critical goods came from only #c partners--the ,people's ,republic of ,china 7#cj4f percent71 ,mexico 7#ae4c percent71 and ,malaysia 7#i4j percent74 7#f7 ,while some of the countries in which medical supply manufacturing occurs are reliable suppliers and allies to the ,united ,states1 others have adopted or maintained policies that make ,united ,states supply less secure4 7b7 ,sense of ,congress ,it is the sense of ,congress that1 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 pandemic1 it is critical that the ,united ,states diversify its trade relationships and prioritize partners that adopt and maintain reliable supply chain policies4 #c4 ,purposes ,the purposes of this ,act are-- 7#a7 to improve overall medical supply chain resilience for the ,united ,states by establishing a framework to enhance medical supply chains with trusted trade partners2 7#b7 to enhance supply chain security related to technology transfer and intellectual property protection2 7#c7 to diversify and expand supplier networks to ensure a reliable supply of medical goods1 especially in the event of emergency situations2 7#d7 to eliminate unnecessary trade barriers and distortions that weaken or disrupt medical supply chains2 7#e7 to expedite cross-border movement of critical medical goods2 7#f7 to foster international collaboration1 encourage new investments1 promote cooperation and partnership in public and private research and development efforts1 facilitate data flows for life science research and development1 and expand manufacturing capacities for medical devices and pharmaceutical goods2 7#g7 to promote regulatory cooperation with respect to manufacturing of medical goods2 7#h7 to increase access to government procurement markets for medical goods2 7#i7 to encourage adoption of and adherence to good regulatory practices related to medical goods2 7#aj7 to enable greater transparency1 regulatory harmonization1 and reliance in authorization and licensing procedures for medical devices and pharmaceutical goods2 7#aa7 to facilitate trade in medical goods to the most efficient and practicable extent possible2 and 7#ab7 to identify current production capacities1 address potential weaknesses1 and improve overall resilience4 #d4 ,definitions ,in this ,act3 7#a7 ,appropriate committees of ,congress ,the term appropriate committees of ,congress means-- 7,a7 the ,committee on ,finance of the ,senate2 and 7,b7 the ,committee on ,ways and ,means of the ,house of ,representatives4 7#b7 ,country ,the term country means-- 7,a7 any foreign country or territory1 including any overseas dependent territory or possession of a foreign country2 or 7,b7 the ,trust ,territory of the ,pacific ,islands4 7#c7 ,medical device ,the term medical device means a device1 as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba71 that is intended for use in humans4 7#d7 ,medical good ,the term medical good means any medical device1 pharmaceutical good1 or input for such a device or good4 7#e7 ,medical supply chain ,the term medical supply chain means any activities involving design1 procurement1 manufacturing1 production1 distribution1 operation1 or management related to medical goods4 7#f7 ,pharmaceutical good ,the term pharmaceutical good means a drug1 as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba71 that is intended for use in humans4 7#g7 ,trade ,representative ,the term ,trade ,representative means the ,united ,states ,trade ,representative4 7#h7 ,trusted trade partner ,the term trusted trade partner means any country that has entered into an agreement with the ,united ,states under section #e4 7#i7 ,trusted trade partner agreement ,the term trusted trade partner agreement means an agreement entered into under section #e4 #e4 ,authority to enter into trusted trade partner agreements 7a7 ,in general ,whenever the ,president determines1 based on the considerations set forth in subsection 7b71 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 ,states1 the ,president may1 subject to the requirements under section #f-- 7#a7 negotiate1 enter into1 and enforce a trusted trade partner agreement with the country or countries2 and 7#b7 proclaim such modification of any existing duty1 such continuance of existing duty-free or excise treatment1 or such additional duties1 as the ,president determines to be required or appropriate to carry out any such trade agreement4 7b7 ,considerations ,in determining whether to enter into negotiations for a trusted trade partner agreement with a country pursuant to subsection 7a71 the ,president shall take into account whether the government of the country has-- 7#a7 expressed a desire to enter into such an agreement2 7#b7 demonstrated a commitment to contribute to global health security1 including the national security of the ,united ,states and the health of ,united ,states citizens1 by maintaining open trade in medical goods during a public health emergency1 including to enable research1 development1 and manufacturing of those goods2 7#c7 adhered to and implemented the commitments and obligations under existing free trade agreements to which that country and the ,united ,states are parties2 7#d7 implemented measures to reduce or eliminate unnecessary trade barriers and distorting practices affecting medical goods2 7#e7 maintained the rule of law by enacting and enforcing laws and regulations in a clear1 publicized1 transparent1 and nondiscriminatory manner2 7#f7 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 law2 and 7#g7 agreed to recognize and promote good regulatory practices related to medical goods4 7c7 ,trusted trade partner agreements ,a trusted trade partner agreement may1 with respect to medical goods1 provide for-- 7#a7 reduction or elimination of duties1 quotas1 and other trade barriers that undermine the national security and public health of the ,united ,states by disincentivizing research1 development1 and manufacturing in the ,united ,states or in countries that are reliable suppliers of medical goods to the ,united ,states2 7#b7 diversification and expansion of supplier networks to secure a reliable supply of medical goods2 7#c7 harmonization or convergence of regulatory procedures1 regulatory reliance1 inspection cooperation1 and adoption of international standards 7such as to streamline post-approval changes7 to expedite cross-border movement of medical goods2 7#d7 increased access to government procurement markets for medical goods and1 in the case of a multilateral agreement entered into under the auspices of the ,world ,trade ,organization1 membership in the ,agreement on ,government ,procurement of the ,world ,trade ,organization referred to in section #aja7;d77#ag7 of the ,uruguay ,round ,agreements ,act 7#ai ,u4,s4,c4 #ceaa7;d77#ag772 7#e7 adequate and effective protection of intellectual property rights for medical goods reflecting a standard of protection similar to that found under ,united ,states law2 7#f7 regulatory cooperation on manufacturing standards for medical goods2 7#g7 a collaboration framework to promote public and private research and development efforts related to medical goods1 including facilitation of data flows for life science research and development2 7#h7 adherence to good regulatory practices for sound1 affordable1 and efficient regulation of medical goods2 7#i7 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 emergency2 and 7#aj7 exemption of parties to the agreement from trade-restrictive measures imposed with respect to medical goods during a public health emergency4 7d7 ,report required ,not later than #ahj days after the date of the enactment of this ,act1 and every #ahj days thereafter1 the ,president shall submit to ,congress a report on the status of negotiations conducted under subsection 7a7 for trusted trade partner agreements4 #f4 ,congressional oversight1 notice1 consultations1 access to information1 and review 7a7 ,notice ,not later than #fj days before initiating negotiations with a trusted trade partner under section #e7;a7 for a trusted trade partner agreement1 the ,president shall submit to ,congress written notice of the intention of the ,president to enter into the negotiations1 which shall include the date negotiations will begin and the trusted trade partner with whom the ,president seeks to enter into the agreement4 7b7 ,consultation with members of ,congress 7#a7 ,consultation during negotiations and access to information ,in the course of negotiations under section #e7;a7 for a trusted trade partner agreement1 the ,trade ,representative shall-- 7,a7 meet upon request with the appropriate committees of ,congress regarding negotiating objectives1 the status of negotiations in progress1 and potential effects to the laws of the ,united ,states with respect to the agreement2 7,b7 upon request by the appropriate committees of ,congress1 provide access to pertinent documents relating to the negotiations2 and 7,c7 consult closely and on a timely basis with1 and keep fully apprised of the negotiations1 the appropriate committees of ,congress4 7#b7 ,consultation before entry into agreement ,before entering into a trusted trade partner agreement under section #e1 the ,trade ,representative shall consult with-- 7,a7 the appropriate committees of ,congress2 and 7,b7 each other committee of the ,senate and the ,house of ,representatives1 and each joint committee of ,congress1 that has jurisdiction over legislation involving a subject matter that would be affected by the agreement4 7c7 ,consultation with ,federal agencies ,in the course of negotiations under section #e7;a7 for a trusted trade partner agreement1 the ,trade ,representative shall inform and consult with any ,federal agency having expertise in the matters being negotiated1 including the ,department of ,health and ,human ,services4 7d7 ,limitation on action ,any duty elimination or staged rate reduction provided for under section #e may be proclaimed only if the ,president-- 7#a7 has obtained advice regarding the proposed action from the appropriate advisory committees established under section #ace of the ,trade ,act of #aigd 7#ai ,u4,s4,c4 #baee7 and the ,international ,trade ,commission2 7#b7 has submitted to the appropriate committees of ,congress a report that sets forth-- 7,a7 the action proposed to be proclaimed2 7,b7 the reasons for such action2 and 7,c7 the advice obtained under paragraph 7#a72 and 7#c7 has consulted with the appropriate committees of ,congress regarding the proposed action during the #fj-;day period on the date on which the ,president has met the requirements under paragraphs 7#a7 and 7#b74 7e7 ,report to ,congress ,not later than #fj days before the date on which the ,president enters into a trusted trade partner agreement with a trusted trade partner under section #e1 the ,president shall submit to ,congress a report describing-- 7#a7 the nature and scope of the agreement2 7#b7 the proposed duration of the agreement2 7#c7 how and to what extent the agreement will achieve the applicable purposes1 policies1 priorities1 and objectives of this ,act2 7#d7 whether sufficient evidence exists demonstrating that-- 7,a7 the trusted trade partner satisfies the conditions under section #e7;b72 and 7,b7 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 ,states2 and 7#e7 the proposed implementation of the agreement1 including the general effect of the agreement on existing laws4 7f7 ,congressional right ,to review and disapprove 7#a7 ,in general ,a trusted trade partner agreement shall not take effect until-- 7,a7 the proposed agreement has been submitted to ,congress1 together with the report required under subsection 7e7 with respect to that agreement2 and 7,b7 the review period required under paragraph 7#b7 following the date on which the proposed agreement has been submitted to ,congress under subparagraph 7,a7 has been exhausted1 during which period a joint resolution is not enacted under paragraph 7#d74 7#b7 ,review 7,a7 ,initial review ,unless extended under subparagraph 7,b7 or 7,c71 the review period under this paragraph with respect to a trusted trade partner agreement is #cj days1 during which time ,congress shall review the proposed agreement with respect to whether-- 7i7 the ,president failed or refused to provide notice with respect to the agreement in accordance with subsection 7a72 7ii7 the ,president failed or refused to consult with respect to the agreement in accordance with subsections 7b7 and 7c72 7iii7 the ,president failed or refused to submit to ,congress a report with respect to the agreement in accordance with subsection 7e72 or 7iv7 the ,president failed or refused to demonstrate that the agreement would achieve the applicable purposes1 policies1 priorities1 and objectives of this ,act and contribute to the national security and public health of the ,united ,states4 7,b7 ,further review ,if1 during the #cj-;day period under subparagraph 7,a7 with respect to a trusted trade partner agreement1 one ,house of ,congress adopts a resolution stating that the ,house of ,congress wishes to further review the proposed agreement1 the review period under this paragraph with respect to the proposed agreement shall be extended by a period of #fj days1 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 7,a74 7,c7 ,additional period ,if1 during the #fj-;day period under subparagraph 7,b7 with respect to a trusted trade partner agreement1 one ,house of ,congress adopts a resolution stating that the ,house of ,congress wishes to further review the proposed agreement1 the review period under this paragraph with respect to the proposed agreement shall be further extended by a period of #cj days4 7#c7 ,procedures for considering resolutions ,a resolution under subparagraph 7,b7 or 7,c7 of paragraph 7#b7-- 7,a7 in the ,senate-- 7i7 may be introduced by any ,member of the ,senate2 7ii7 shall be referred to the ,committee on ,finance2 and 7iii7 may not be amended2 7,b7 in the ,house of ,representatives-- 7i7 may be introduced by any ,member of the ,house2 7ii7 shall be referred to the ,committee on ,ways and ,means or the ,committee on ,rules2 and 7iii7 may not be amended by either ,committee2 and 7,c7 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 debate4 7#d7 ,disapproval ,if1 during the review period required under paragraph 7#b7 with respect to a trusted trade partner agreement1 a joint resolution is enacted stating that ,congress does not favor the agreement1 the agreement shall not take effect4 #g4 ,monitoring and enforcement of continued compliance with trusted trade partner agreements 7a7 ,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 agreement4 7b7 ,actions in response to failure ,to comply 7#a7 ,determination and report of ,trade ,representative ,if the ,trade ,representative determines that a trusted trade partner has failed to satisfactorily implement1 maintain1 and enforce the commitments and obligations of the partner under a trusted trade partner agreement1 the ,trade ,representative shall submit to the ,president a report setting forth-- 7,a7 the determination and the findings that support the determination2 and 7,b7 based on such findings1 the recommendations of the ,trade ,representative for action or inaction under this subsection4 7#b7 ,determination of ,president ,not later than #cj days after receiving a report under paragraph 7#a7 with respect to a trusted trade partner1 the ,president shall-- 7,a7 determine whether the ,president concurs with the determination of the ,trade ,representative set forth in the report2 and 7,b7 if the ,president concurs1 determine whether-- 7i7 to suspend1 withdraw1 or prevent the application of the trusted trade partner agreement with the trusted trade partner2 7ii7 to enter into a binding agreement with the partner that commits the partner-- 7,i7 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 agreement2 and 7,,ii7 to provide the ,united ,states with such compensatory trade benefits as are negotiated between the ,trade ,representative and the partner2 or 7iii7 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 agreement1 including suspending the exemption of the partner from trade-restrictive measures imposed with respect to medical goods during a public health emergency4 7#c7 ,timeline for action ,if the ,president determines under paragraph 7#b77;,b7 to take action1 the ,president shall implement that action by not later than the date that is #ae days after the day on which the ,president determines to take action under that paragraph4