,i #aag? ,,congress #a/ ,session ,h4 ,r4 #dgaa ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,july #bg1 #bjba,mr4 ,joyce ( ,p5nsylvania 7= himself & ,mr4 ,banks7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,ways & ,means1 & 9 addition to ! ,committee on ,rules1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d ! ,bip>tisan ,congressional ,trade ,priorities & ,acc\ntability ,act ( #bjae to include pr9cipal negotiat+ objectives ( ! ,unit$ ,/ates relat+ to trade 9 ph>maceutical products1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,int]national ,ph>maceutical ,supply ,*a9 ,security ,agreem5t ,act ( #bjba4 #b4 ,pr9cipal negotiat+ objectives ( ! ,unit$ ,/ates relat+ to trade 9 cov]$ ph>maceutical products ,section #ajb7;b7 ( ! ,bip>tisan ,congressional ,trade ,priorities & ,acc\ntability ,act ( #bjae 7#ai ,u4,s4,c4 #dbja7;b77 is am5d$ by add+ at ! end ! foll[+3 7#bc7 ,trade 9 cov]$ ph>maceutical products 7,a7 ,9 g5]al ,) respect to an agreem5t relat+ to trade 9 cov]$ ph>maceutical products t is propos$ to be ent]$ into ) ! ,unit$ ,/ates & to :i* section #ajc7;b7 w apply1 ! pr9cipal negotiat+ objectives ( ! ,unit$ ,/ates are ! foll[+3 7i7 ,to ensure t a p>ty to ! agreem5t adopts & ma9ta9s measures to elim9ate ! imposition or reimposition ( t>iffs on imports ( su* products1 p>ticul>ly 9 ! ev5t ( a decl>$ em]g5cy4 7ii7 ,to ensure t a p>ty to ! agreem5t-- 7,i7 w r$uce or elim9ate regulatory & o!r te*nical b>ri]s 9 ! ph>maceutical sector2 7,,ii7 w promote exp$it$ approval ( facilities = ! production ( su* products be+ built by bus9ess ent]prises t op]ate "o or m su* facilities 9 ! t]ritory ( ! p>ty2 7,,iii7 w promote ! use ( good regulatory practices & /reaml9$ regulatory review & approval processes = ! production ( su* products 9 ! t]ritory ( ! p>ty2 7,,iv7 w elim9ate duplicat$ actions & o!r b>ri]s to r$uce ! "t = approvals ( bo? facilities & su* products2 & 7,v7 w exp& transp>5cy & coop]ation ) o!r p>ties & _! manufactur]s1 work+ collaboratively1 to ensure regulatory processes are /reaml9$ & h>moniz$ among o!r p>ties to ! maximum ext5t possible4 7iii7 ,to prohibit export re/ra9ts aga9/ p>ties to ! agreem5t1 p>ticul>ly 9 ! ev5t ( a decl>$ em]g5cy4 7iv7 ,) respect to use ( subsidies-- 7,i7 to enc\rage ! coord9at$ provision ( ^? types ( subsidies t are classifi$ "u ,_w ,trade ,organization rules z non-prohibit$1 su* z subsidies t are n cont+5t on exports or import-sub/itution1 to inc5tivize manufactur+ ( su* products1 includ+ ! provision ( grants1 loans1 tax inc5tives1 & gu>ante$ price & volume contracts2 7,,ii7 to explicitly p]mit1 among p>ties to ! agreem5t1 ! use ( production subsidies to build ph>maceutical manufactur+ capacity2 7,,iii7 to affirm t subsidies provid$ by p>ties are n int5d$ to be us$ prim>ily = export or to di/ort trade2 7,,iv7 to affirm p>ties' commitm5ts "u ! ,antidump+ ,agreem5t & ! ,agreem5t on ,subsidies & ,c\nt]vail+ ,measures1 includ+ ! recognition t dump+1 by :i* products ( "o c\ntry are introduc$ into ! comm]ce ( ano!r c\ntry at less ?an ! normal value ( ! products1 is to be condemn$ if x causes or ?reat5s mat]ial injury to an e/abli%$ indu/ry 9 ! t]ritory ( a contract+ p>ty or mat]ially ret>ds ! e/abli%m5t ( a dome/ic indu/ry2 & 7,v7 to enc\rage notification & consultation among p>ties z !y are consid]+ ph>maceutical manufactur+ subsidies to increase coord9ation & avoid creat+ conditions su* z ov]supply or m>ket ineffici5cies among ! p>ties4 7v7 ,) respect to gov]nm5t procurem5t-- 7,i7 to provide reciprocal access to gov]nm5t procurem5ts = su* products 9 p>ties to ! agreem5t2 7,,ii7 to increase coord9ation betwe5 p>ticipant c\ntries & facilitate ! involvem5t ( p>ticipant c\ntries' companies 9 bids to supply su* products2 & 7,,iii7 to ensure t any p>ticipant 9 ! agreem5t t is n already s designat$1 becomes designat$ = purposes ( section #cja ( ! ,trade ,agreem5ts ,act ( #aigi 7#ai ,u4,s4,c4 #beaa74 7vi7 ,) respect to trade 9 s]vices-- 7,i7 to obta9 fair1 op51 & transp>5t access to supply *a9 s]vices 9 ! m>kets ( p>ties to ! agreem5t1 su* z di/ribution1 logi/ics1 & transportation s]vices2 7,,ii7 to ensure any re/rictions or regulatory requirem5ts ma9ta9$ on su* s]vices are adopt$ & ma9ta9$ 9 a transp>5t & effici5t mann]2 & 7,,iii7 to require p>ties to e/abli% an int]nal process = id5tify+ re/rictions or regulatory requirem5ts t c\ld be waiv$ 9 ! ev5t ( a decl>$ em]g5cy4 7vii7 ,) respect to transp>5cy & trade facilitation-- 7,i7 to obta9 commitm5ts among p>ties to ! agreem5t to develop me*anisms = %>+ in=mation on ph>maceutical supply *a9 con/ra9ts & coord9ate approa*es ) p>ties to m9imize risks t c\ld lead to supply *a9 failures2 & 7,,ii7 to ! ext5t !y h n done s yet1 to obta9 commitm5ts f p>ties t !y w fully implem5t ! obligations "u ! ,_w ,trade ,organization's ,agreem5t on ,trade ,facilitation prior to ! date ! agreem5t ent]s into =ce4 7viii7 ,) respect to en=cem5t-- 7,i7 to ensure t b5efits "u ! agreem5t c only be obta9$ by p>ties t are fully meet+ _! obligations "u ! agreem5t2 7,,ii7 to ensure t p>ties w n br+ a dispute "u ano!r agreem5t = actions t are consi/5t ) ! agreem5t2 & 7,,iii7 to provide a dispute settlem5t me*anism comp>able to ! dispute settlem5t provisions ( ! ,agreem5t betwe5 ! ,unit$ ,/ates ( ,am]ica1 ! ,unit$ ,mexican ,/ates1 & ,canada4 7ix7 ,to m9imize ! ability ( p>ties to ! agreem5t to und]m9e ! effectiv5ess ( ! agreem5t by abus+ exceptions 9 ! agreem5t by includ+ additional proc$ural requirem5ts1 su* z notification ( int5t to rely on an exception at ! "t an inconsi/5t action is tak51 & limit+ ! duration t p>ticipants may rely on an exception4 7,b7 ,def9itions ,9 ?is p>agraph3 7i7 ,active ph>maceutical +r$i5t ,! t]m active ph>maceutical +r$i5t-- 7,i7 means any compon5t t is int5d$ to furni% ph>macological activity or o!r direct effect 9 ! diagnosis1 cure1 mitigation1 treatm5t1 or prev5tion ( a disease1 or to affect ! /ructure or any function ( ! body ( a human or animal2 & 7,,ii7 does n include-- 7aa7 int]m$iates us$ 9 ! syn!sis ( a drug product2 or 7bb7 compon5ts t may und]go *emical *ange 9 ! manufacture ( a drug product & be pres5t 9 a drug product 9 a modifi$ =m t is int5d$ to furni% su* activity or effect4 7ii7 ,agreem5t on ,subsidies & ,c\nt]vail+ ,measures ,! t]m ,agreem5t on ,subsidies & ,c\nt]vail+ ,measures means ! agreem5t ref]r$ to 9 section #aja7;d77#ab7 ( ! ,uruguay ,r\nd ,agreem5ts ,act 7#ai ,u4,s4,c4 #ceaa7;d77#ab774 7iii7 ,antidump+ ,agreem5t ,! t]m ,antidump+ ,agreem5t means ! ,agreem5t on ,implem5tation ( ,article ,,vi ( ! ,g5]al ,agreem5t on ,t>iffs & ,trade #aiid ref]r$ to 9 section #aja7;d77#g7 ( ! ,uruguay ,r\nd ,agreem5ts ,act 7#ai ,u4,s4,c4 #ceaa7;d77#g774 7iv7 ,biological product ,! t]m biological product has ! mean+ giv5 to su* t]m 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i774 7v7 ,cov]$ ph>maceutical product ,! t]m cov]$ ph>maceutical product means-- 7,i7 a drug 7includ+ a biological product72 or 7,,ii7 an active ph>maceutical +r$i5t4 4 #c4 ,reau?orization ( trade agreem5ts au?ority ,section #ajc ( ! ,bip>tisan ,congressional ,trade ,priorities & ,acc\ntability ,act ( #bjae 7#ai ,u4,s4,c4 #dbjb7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ ,july #a1 #bjah ea* place x appe>s & ins]t+ ,july #a1 #bjbc2 & 7,b7 by /rik+ ,july #a1 #bjba ea* place x appe>s & ins]t+ ,july #a1 #bjbf2 7#b7 9 subsection 7b7-- 7,a7 by /rik+ ,july #a1 #bjah ea* place x appe>s & ins]t+ ,july #a1 #bjbc2 & 7,b7 by /rik+ ,july #a1 #bjba ea* place x appe>s & ins]t+ ,july #a1 #bjbf2 & 7#c7 9 subsection 7c7-- 7,a7 by /rik+ ,july #a1 #bjah ea* place x appe>s & ins]t+ ,july #a1 #bjbc2 7,b7 by /rik+ ,june #cj1 #bjah & ins]t+ ,june #cj1 #bjbc2 7,c7 9 p>agraph 7#a77;,b71 by /rik+ ,july #a1 #bjba & ins]t+ ,july #a1 #bjbf2 7,d7 9 p>agraph 7#b71 by /rik+ ,april #a1 #bjah & ins]t+ ,april #a1 #bjbc2 & 7,e7 9 p>agraph 7#c71 by /rik+ ,june #a1 #bjah & ins]t+ ,june #a1 #bjbc4