Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB998 Compare Versions

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11 II
22 119THCONGRESS
33 1
44 STSESSION S. 998
55 To authorize the President to enter into trade agreements for the reciprocal
66 elimination of duties or other import restrictions with respect to medical
77 goods to contribute to the national security and public health of the
88 United States, and for other purposes.
99 IN THE SENATE OF THE UNITED STATES
1010 MARCH12, 2025
1111 Mr. T
1212 ILLIS(for himself, Mr. COONS, Mr. CORNYN, and Mr. BENNET) intro-
1313 duced the following bill; which was read twice and referred to the Com-
1414 mittee on Finance
1515 A BILL
1616 To authorize the President to enter into trade agreements
1717 for the reciprocal elimination of duties or other import
1818 restrictions with respect to medical goods to contribute
1919 to the national security and public health of the United
2020 States, and for other purposes.
2121 Be it enacted by the Senate and House of Representa-1
2222 tives of the United States of America in Congress assembled, 2
2323 SECTION 1. SHORT TITLE. 3
2424 This Act may be cited as the ‘‘Medical Supply Chain 4
2525 Resiliency Act’’. 5
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2929 SEC. 2. FINDINGS; SENSE OF CONGRESS. 1
3030 (a) F
3131 INDINGS.—Congress makes the following find-2
3232 ings: 3
3333 (1) The COVID–19 pandemic created signifi-4
3434 cant demand pressures on the global medical supply 5
3535 chain. 6
3636 (2) According to a December 2020 report by 7
3737 the United States International Trade Commission, 8
3838 global demand significantly exceeded available sup-9
3939 ply of many goods critical for the response to the 10
4040 COVID–19 pandemic (in this section referred to as 11
4141 ‘‘COVID–19 critical goods’’). Health care providers 12
4242 in the United States faced difficulties in procuring 13
4343 such goods in sufficient quantities. Foreign export 14
4444 restrictions on finished drugs and active pharma-15
4545 ceutical ingredients may have contributed to stress 16
4646 on the supply of some critical COVID–19 treatment 17
4747 drugs (including anti-infective products), as well as 18
4848 hormone medications and vitamins. 19
4949 (3) According to the McKinsey Global Institute, 20
5050 during the 20 years preceding the date of the enact-21
5151 ment of this Act, pharmaceutical supply chains have 22
5252 become more globally dispersed and many generic 23
5353 small-molecule products have shifted to lower-cost 24
5454 production locations, some of which have been iden-25
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5858 tified as posing a threat to the national security of 1
5959 the United States. 2
6060 (4) According to the Organisation for Economic 3
6161 Co-operation and Development, while the United 4
6262 States is one of the largest exporters of COVID–19 5
6363 critical goods, it is also one of the largest importers 6
6464 of those goods. 7
6565 (5) The World Trade Organization has found 8
6666 that, while the United States, Germany, and the 9
6767 People’s Republic of China are all major producers 10
6868 and importers of COVID–19 critical goods, United 11
6969 States import partners are less diversified compared 12
7070 to Germany and the People’s Republic of China. In 13
7171 the United States, more than half of its imports of 14
7272 COVID–19 critical goods came from only 3 part-15
7373 ners—the People’s Republic of China (30.6 percent), 16
7474 Mexico (15.3 percent), and Malaysia (9.0 percent). 17
7575 (6) While some of the countries in which med-18
7676 ical supply manufacturing occurs are reliable sup-19
7777 pliers and allies to the United States, others have 20
7878 adopted or maintained policies that make United 21
7979 States supply less secure. 22
8080 (b) S
8181 ENSE OFCONGRESS.—It is the sense of Con-23
8282 gress that, given the threat to national security and public 24
8383 health that could arise if the United States is unable to 25
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8787 swiftly respond to significant demand surges for medical 1
8888 products in a future pandemic, it is critical that the 2
8989 United States diversify its trade relationships and 3
9090 prioritize partners that adopt and maintain reliable supply 4
9191 chain policies. 5
9292 SEC. 3. PURPOSES. 6
9393 The purposes of this Act are— 7
9494 (1) to improve overall medical supply chain re-8
9595 silience for the United States by establishing a 9
9696 framework to enhance medical supply chains with 10
9797 trusted trade partners; 11
9898 (2) to enhance supply chain security related to 12
9999 technology transfer and intellectual property protec-13
100100 tion; 14
101101 (3) to diversify and expand supplier networks to 15
102102 ensure a reliable supply of medical goods, especially 16
103103 in the event of emergency situations; 17
104104 (4) to eliminate unnecessary trade barriers and 18
105105 distortions that weaken or disrupt medical supply 19
106106 chains; 20
107107 (5) to expedite cross-border movement of crit-21
108108 ical medical goods; 22
109109 (6) to foster international collaboration, encour-23
110110 age new investments, promote cooperation and part-24
111111 nership in public and private research and develop-25
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115115 ment efforts, facilitate data flows for life science re-1
116116 search and development, and expand manufacturing 2
117117 capacities for medical devices and pharmaceutical 3
118118 goods; 4
119119 (7) to promote regulatory cooperation with re-5
120120 spect to manufacturing of medical goods; 6
121121 (8) to increase access to government procure-7
122122 ment markets for medical goods; 8
123123 (9) to encourage adoption of and adherence to 9
124124 good regulatory practices related to medical goods; 10
125125 (10) to enable greater transparency, regulatory 11
126126 harmonization, and reliance in authorization and li-12
127127 censing procedures for medical devices and pharma-13
128128 ceutical goods; 14
129129 (11) to facilitate trade in medical goods to the 15
130130 most efficient and practicable extent possible; and 16
131131 (12) to identify current production capacities, 17
132132 address potential weaknesses, and improve overall 18
133133 resilience. 19
134134 SEC. 4. DEFINITIONS. 20
135135 In this Act: 21
136136 (1) A
137137 PPROPRIATE COMMITTEES OF CON -22
138138 GRESS.—The term ‘‘appropriate committees of Con-23
139139 gress’’ means— 24
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143143 (A) the Committee on Finance of the Sen-1
144144 ate; and 2
145145 (B) the Committee on Ways and Means of 3
146146 the House of Representatives. 4
147147 (2) C
148148 OUNTRY.—The term ‘‘country’’ means— 5
149149 (A) any foreign country or territory, in-6
150150 cluding any overseas dependent territory or pos-7
151151 session of a foreign country; or 8
152152 (B) the Trust Territory of the Pacific Is-9
153153 lands. 10
154154 (3) M
155155 EDICAL DEVICE.—The term ‘‘medical de-11
156156 vice’’ means a device, as defined in section 201 of 12
157157 the Federal Food, Drug, and Cosmetic Act (21 13
158158 U.S.C. 321), that is intended for use in humans. 14
159159 (4) M
160160 EDICAL GOOD.—The term ‘‘medical good’’ 15
161161 means any medical device, pharmaceutical good, or 16
162162 input for such a device or good. 17
163163 (5) M
164164 EDICAL SUPPLY CHAIN.—The term ‘‘med-18
165165 ical supply chain’’ means any activities involving de-19
166166 sign, procurement, manufacturing, production, dis-20
167167 tribution, operation, or management related to med-21
168168 ical goods. 22
169169 (6) P
170170 HARMACEUTICAL GOOD .—The term ‘‘phar-23
171171 maceutical good’’ means a drug, as defined in sec-24
172172 tion 201 of the Federal Food, Drug, and Cosmetic 25
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176176 Act (21 U.S.C. 321), that is intended for use in hu-1
177177 mans. 2
178178 (7) T
179179 RADE REPRESENTATIVE .—The term 3
180180 ‘‘Trade Representative’’ means the United States 4
181181 Trade Representative. 5
182182 (8) T
183183 RUSTED TRADE PARTNER .—The term 6
184184 ‘‘trusted trade partner’’ means any country that has 7
185185 entered into an agreement with the United States 8
186186 under section 5. 9
187187 (9) T
188188 RUSTED TRADE PARTNER AGREEMENT .— 10
189189 The term ‘‘trusted trade partner agreement’’ means 11
190190 an agreement entered into under section 5. 12
191191 SEC. 5. AUTHORITY TO ENTER INTO TRUSTED TRADE PART-13
192192 NER AGREEMENTS. 14
193193 (a) I
194194 NGENERAL.—Whenever the President deter-15
195195 mines, based on the considerations set forth in subsection 16
196196 (b), that the reciprocal elimination of existing duties or 17
197197 other import restrictions of a country or countries and the 18
198198 United States with respect to medical goods would con-19
199199 tribute to the national security and public health of the 20
200200 United States, the President may, subject to the require-21
201201 ments under section 6— 22
202202 (1) negotiate, enter into, and enforce a trusted 23
203203 trade partner agreement with the country or coun-24
204204 tries; and 25
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208208 (2) proclaim such modification of any existing 1
209209 duty, such continuance of existing duty-free or excise 2
210210 treatment, or such additional duties, as the Presi-3
211211 dent determines to be required or appropriate to 4
212212 carry out any such trade agreement. 5
213213 (b) C
214214 ONSIDERATIONS.—In determining whether to 6
215215 enter into negotiations for a trusted trade partner agree-7
216216 ment with a country pursuant to subsection (a), the Presi-8
217217 dent shall take into account whether the government of 9
218218 the country has— 10
219219 (1) expressed a desire to enter into such an 11
220220 agreement; 12
221221 (2) demonstrated a commitment to contribute 13
222222 to global health security, including the national secu-14
223223 rity of the United States and the health of United 15
224224 States citizens, by maintaining open trade in medical 16
225225 goods during a public health emergency, including to 17
226226 enable research, development, and manufacturing of 18
227227 those goods; 19
228228 (3) adhered to and implemented the commit-20
229229 ments and obligations under existing free trade 21
230230 agreements to which that country and the United 22
231231 States are parties; 23
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235235 (4) implemented measures to reduce or elimi-1
236236 nate unnecessary trade barriers and distorting prac-2
237237 tices affecting medical goods; 3
238238 (5) maintained the rule of law by enacting and 4
239239 enforcing laws and regulations in a clear, publicized, 5
240240 transparent, and nondiscriminatory manner; 6
241241 (6) adopted and enforced laws that provide ade-7
242242 quate and effective protection of intellectual property 8
243243 rights reflecting a standard of protection similar to 9
244244 that found under United States law; and 10
245245 (7) agreed to recognize and promote good regu-11
246246 latory practices related to medical goods. 12
247247 (c) T
248248 RUSTEDTRADEPARTNERAGREEMENTS.—A 13
249249 trusted trade partner agreement may, with respect to 14
250250 medical goods, provide for— 15
251251 (1) reduction or elimination of duties, quotas, 16
252252 and other trade barriers that undermine the national 17
253253 security and public health of the United States by 18
254254 disincentivizing research, development, and manufac-19
255255 turing in the United States or in countries that are 20
256256 reliable suppliers of medical goods to the United 21
257257 States; 22
258258 (2) diversification and expansion of supplier 23
259259 networks to secure a reliable supply of medical 24
260260 goods; 25
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264264 (3) harmonization or convergence of regulatory 1
265265 procedures, regulatory reliance, inspection coopera-2
266266 tion, and adoption of international standards (such 3
267267 as to streamline post-approval changes) to expedite 4
268268 cross-border movement of medical goods; 5
269269 (4) increased access to government procurement 6
270270 markets for medical goods and, in the case of a mul-7
271271 tilateral agreement entered into under the auspices 8
272272 of the World Trade Organization, membership in the 9
273273 Agreement on Government Procurement of the 10
274274 World Trade Organization referred to in section 11
275275 101(d)(17) of the Uruguay Round Agreements Act 12
276276 (19 U.S.C. 3511(d)(17)); 13
277277 (5) adequate and effective protection of intellec-14
278278 tual property rights for medical goods reflecting a 15
279279 standard of protection similar to that found under 16
280280 United States law; 17
281281 (6) regulatory cooperation on manufacturing 18
282282 standards for medical goods; 19
283283 (7) a collaboration framework to promote public 20
284284 and private research and development efforts related 21
285285 to medical goods, including facilitation of data flows 22
286286 for life science research and development; 23
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290290 (8) adherence to good regulatory practices for 1
291291 sound, affordable, and efficient regulation of medical 2
292292 goods; 3
293293 (9) promotion of regulatory compatibility and 4
294294 cooperation to facilitate trade and investment related 5
295295 to medical goods and accelerate manufacturing of 6
296296 such goods during a public health emergency; and 7
297297 (10) exemption of parties to the agreement 8
298298 from trade-restrictive measures imposed with respect 9
299299 to medical goods during a public health emergency. 10
300300 (d) R
301301 EPORTREQUIRED.—Not later than 180 days 11
302302 after the date of the enactment of this Act, and every 180 12
303303 days thereafter, the President shall submit to Congress 13
304304 a report on the status of negotiations conducted under 14
305305 subsection (a) for trusted trade partner agreements. 15
306306 SEC. 6. CONGRESSIONAL OVERSIGHT, NOTICE, CONSULTA-16
307307 TIONS, ACCESS TO INFORMATION, AND RE-17
308308 VIEW. 18
309309 (a) N
310310 OTICE.—Not later than 60 days before initi-19
311311 ating negotiations with a trusted trade partner under sec-20
312312 tion 5(a) for a trusted trade partner agreement, the Presi-21
313313 dent shall submit to Congress written notice of the inten-22
314314 tion of the President to enter into the negotiations, which 23
315315 shall include the date negotiations will begin and the trust-24
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319319 ed trade partner with whom the President seeks to enter 1
320320 into the agreement. 2
321321 (b) C
322322 ONSULTATION WITHMEMBERS OF CON-3
323323 GRESS.— 4
324324 (1) C
325325 ONSULTATION DURING NEGOTIATIONS AND 5
326326 ACCESS TO INFORMATION .—In the course of negotia-6
327327 tions under section 5(a) for a trusted trade partner 7
328328 agreement, the Trade Representative shall— 8
329329 (A) meet upon request with the appro-9
330330 priate committees of Congress regarding negoti-10
331331 ating objectives, the status of negotiations in 11
332332 progress, and potential effects to the laws of 12
333333 the United States with respect to the agree-13
334334 ment; 14
335335 (B) upon request by the appropriate com-15
336336 mittees of Congress, provide access to pertinent 16
337337 documents relating to the negotiations; and 17
338338 (C) consult closely and on a timely basis 18
339339 with, and keep fully apprised of the negotia-19
340340 tions, the appropriate committees of Congress. 20
341341 (2) C
342342 ONSULTATION BEFORE ENTRY INTO 21
343343 AGREEMENT.—Before entering into a trusted trade 22
344344 partner agreement under section 5, the Trade Rep-23
345345 resentative shall consult with— 24
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349349 (A) the appropriate committees of Con-1
350350 gress; and 2
351351 (B) each other committee of the Senate 3
352352 and the House of Representatives, and each 4
353353 joint committee of Congress, that has jurisdic-5
354354 tion over legislation involving a subject matter 6
355355 that would be affected by the agreement. 7
356356 (c) C
357357 ONSULTATIONWITHFEDERALAGENCIES.—In 8
358358 the course of negotiations under section 5(a) for a trusted 9
359359 trade partner agreement, the Trade Representative shall 10
360360 inform and consult with any Federal agency having exper-11
361361 tise in the matters being negotiated, including the Depart-12
362362 ment of Health and Human Services. 13
363363 (d) L
364364 IMITATION ONACTION.—Any duty elimination 14
365365 or staged rate reduction provided for under section 5 may 15
366366 be proclaimed only if the President— 16
367367 (1) has obtained advice regarding the proposed 17
368368 action from the appropriate advisory committees es-18
369369 tablished under section 135 of the Trade Act of 19
370370 1974 (19 U.S.C. 2155) and the International Trade 20
371371 Commission; 21
372372 (2) has submitted to the appropriate commit-22
373373 tees of Congress a report that sets forth— 23
374374 (A) the action proposed to be proclaimed; 24
375375 (B) the reasons for such action; and 25
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379379 (C) the advice obtained under paragraph 1
380380 (1); and 2
381381 (3) has consulted with the appropriate commit-3
382382 tees of Congress regarding the proposed action dur-4
383383 ing the 60-day period on the date on which the 5
384384 President has met the requirements under para-6
385385 graphs (1) and (2). 7
386386 (e) R
387387 EPORT TOCONGRESS.—Not later than 60 days 8
388388 before the date on which the President enters into a trust-9
389389 ed trade partner agreement with a trusted trade partner 10
390390 under section 5, the President shall submit to Congress 11
391391 a report describing— 12
392392 (1) the nature and scope of the agreement; 13
393393 (2) the proposed duration of the agreement; 14
394394 (3) how and to what extent the agreement will 15
395395 achieve the applicable purposes, policies, priorities, 16
396396 and objectives of this Act; 17
397397 (4) whether sufficient evidence exists dem-18
398398 onstrating that— 19
399399 (A) the trusted trade partner satisfies the 20
400400 conditions under section 5(b); and 21
401401 (B) the reciprocal elimination of existing 22
402402 duties or other import restrictions of the trust-23
403403 ed trade partner or the United States with re-24
404404 spect to medical goods would contribute to the 25
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408408 national security and public health of the 1
409409 United States; and 2
410410 (5) the proposed implementation of the agree-3
411411 ment, including the general effect of the agreement 4
412412 on existing laws. 5
413413 (f) C
414414 ONGRESSIONAL RIGHTTOREVIEW ANDDIS-6
415415 APPROVE.— 7
416416 (1) I
417417 N GENERAL.—A trusted trade partner 8
418418 agreement shall not take effect until— 9
419419 (A) the proposed agreement has been sub-10
420420 mitted to Congress, together with the report re-11
421421 quired under subsection (e) with respect to that 12
422422 agreement; and 13
423423 (B) the review period required under para-14
424424 graph (2) following the date on which the pro-15
425425 posed agreement has been submitted to Con-16
426426 gress under subparagraph (A) has been ex-17
427427 hausted, during which period a joint resolution 18
428428 is not enacted under paragraph (4). 19
429429 (2) R
430430 EVIEW.— 20
431431 (A) I
432432 NITIAL REVIEW.—Unless extended 21
433433 under subparagraph (B) or (C), the review pe-22
434434 riod under this paragraph with respect to a 23
435435 trusted trade partner agreement is 30 days, 24
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439439 during which time Congress shall review the 1
440440 proposed agreement with respect to whether— 2
441441 (i) the President failed or refused to 3
442442 provide notice with respect to the agree-4
443443 ment in accordance with subsection (a); 5
444444 (ii) the President failed or refused to 6
445445 consult with respect to the agreement in 7
446446 accordance with subsections (b) and (c); 8
447447 (iii) the President failed or refused to 9
448448 submit to Congress a report with respect 10
449449 to the agreement in accordance with sub-11
450450 section (e); or 12
451451 (iv) the President failed or refused to 13
452452 demonstrate that the agreement would 14
453453 achieve the applicable purposes, policies, 15
454454 priorities, and objectives of this Act and 16
455455 contribute to the national security and 17
456456 public health of the United States. 18
457457 (B) F
458458 URTHER REVIEW.—If, during the 30- 19
459459 day period under subparagraph (A) with re-20
460460 spect to a trusted trade partner agreement, one 21
461461 House of Congress adopts a resolution stating 22
462462 that the House of Congress wishes to further 23
463463 review the proposed agreement, the review pe-24
464464 riod under this paragraph with respect to the 25
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468468 proposed agreement shall be extended by a pe-1
469469 riod of 60 days, during which time the appro-2
470470 priate committees of Congress shall engage the 3
471471 President with respect to the proposed agree-4
472472 ment and the failures or refusals of the Presi-5
473473 dent specified under subparagraph (A). 6
474474 (C) A
475475 DDITIONAL PERIOD.—If, during the 7
476476 60-day period under subparagraph (B) with re-8
477477 spect to a trusted trade partner agreement, one 9
478478 House of Congress adopts a resolution stating 10
479479 that the House of Congress wishes to further 11
480480 review the proposed agreement, the review pe-12
481481 riod under this paragraph with respect to the 13
482482 proposed agreement shall be further extended 14
483483 by a period of 30 days. 15
484484 (3) P
485485 ROCEDURES FOR CONSIDERING RESOLU -16
486486 TIONS.—A resolution under subparagraph (B) or 17
487487 (C) of paragraph (2)— 18
488488 (A) in the Senate— 19
489489 (i) may be introduced by any Member 20
490490 of the Senate; 21
491491 (ii) shall be referred to the Committee 22
492492 on Finance; and 23
493493 (iii) may not be amended; 24
494494 (B) in the House of Representatives— 25
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498498 (i) may be introduced by any Member 1
499499 of the House; 2
500500 (ii) shall be referred to the Committee 3
501501 on Ways and Means or the Committee on 4
502502 Rules; and 5
503503 (iii) may not be amended by either 6
504504 Committee; and 7
505505 (C) the vote on passage of the resolution 8
506506 shall occur immediately following the conclusion 9
507507 of the debate on the trusted trade partner 10
508508 agreement at issue and a single quorum call at 11
509509 the conclusion of the debate. 12
510510 (4) D
511511 ISAPPROVAL.—If, during the review period 13
512512 required under paragraph (2) with respect to a 14
513513 trusted trade partner agreement, a joint resolution 15
514514 is enacted stating that Congress does not favor the 16
515515 agreement, the agreement shall not take effect. 17
516516 SEC. 7. MONITORING AND ENFORCEMENT OF CONTINUED 18
517517 COMPLIANCE WITH TRUSTED TRADE PART-19
518518 NER AGREEMENTS. 20
519519 (a) M
520520 ONITORING.—The Trade Representative shall 21
521521 periodically monitor compliance by a trusted trade partner 22
522522 with the commitments and obligations of the partner 23
523523 under a trusted trade partner agreement. 24
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527527 (b) ACTIONS INRESPONSE TOFAILURETOCOM-1
528528 PLY.— 2
529529 (1) D
530530 ETERMINATION AND REPORT OF TRADE 3
531531 REPRESENTATIVE.—If the Trade Representative de-4
532532 termines that a trusted trade partner has failed to 5
533533 satisfactorily implement, maintain, and enforce the 6
534534 commitments and obligations of the partner under a 7
535535 trusted trade partner agreement, the Trade Rep-8
536536 resentative shall submit to the President a report 9
537537 setting forth— 10
538538 (A) the determination and the findings 11
539539 that support the determination; and 12
540540 (B) based on such findings, the rec-13
541541 ommendations of the Trade Representative for 14
542542 action or inaction under this subsection. 15
543543 (2) D
544544 ETERMINATION OF PRESIDENT .—Not 16
545545 later than 30 days after receiving a report under 17
546546 paragraph (1) with respect to a trusted trade part-18
547547 ner, the President shall— 19
548548 (A) determine whether the President con-20
549549 curs with the determination of the Trade Rep-21
550550 resentative set forth in the report; and 22
551551 (B) if the President concurs, determine 23
552552 whether— 24
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555555 •S 998 IS
556556 (i) to suspend, withdraw, or prevent 1
557557 the application of the trusted trade partner 2
558558 agreement with the trusted trade partner; 3
559559 (ii) to enter into a binding agreement 4
560560 with the partner that commits the part-5
561561 ner— 6
562562 (I) to eliminate any burden or re-7
563563 striction on the United States result-8
564564 ing from the failure of the partner to 9
565565 comply with the commitments and ob-10
566566 ligations of the partner under a trust-11
567567 ed trade partner agreement; and 12
568568 (II) to provide the United States 13
569569 with such compensatory trade benefits 14
570570 as are negotiated between the Trade 15
571571 Representative and the partner; or 16
572572 (iii) to take such other actions as the 17
573573 Trade Representative considers necessary 18
574574 to encourage the partner to adhere to the 19
575575 commitments and obligations of the part-20
576576 ner under a trusted trade partner agree-21
577577 ment, including suspending the exemption 22
578578 of the partner from trade-restrictive meas-23
579579 ures imposed with respect to medical goods 24
580580 during a public health emergency. 25
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583583 •S 998 IS
584584 (3) TIMELINE FOR ACTION .—If the President 1
585585 determines under paragraph (2)(B) to take action, 2
586586 the President shall implement that action by not 3
587587 later than the date that is 15 days after the day on 4
588588 which the President determines to take action under 5
589589 that paragraph. 6
590590 Æ
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