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Okwangoku, kukho izixhobo zonyango ezingaphezu kwe-10,000 kwihlabathi liphela.Amazwe e-1 kufuneka abeke ukhuseleko lwesigulane kuqala kwaye aqinisekise ukufikelela kumgangatho ophezulu, izixhobo zonyango ezikhuselekileyo nezisebenzayo.2,3 Imarike yezixhobo zonyango zaseLatin America iyaqhubeka nokukhula ngesantya esibalulekileyo sokukhula konyaka.Amazwe aseLatin America kunye neCaribbean kufuneka angenise ngaphezu kwe-90% yezixhobo zonyango ngenxa yokuba imveliso yendawo kunye nokunikezelwa kwezixhobo zonyango zenza i-akhawunti engaphantsi kwe-10% yemfuno yazo iyonke.
IArgentina lilizwe lesibini ngobukhulu kwiLatin America emva kweBrazil.Ngabemi abamalunga nezigidi ezingama-49, lilizwe lesine elinabantu abaninzi kulo mmandla, kwaye lilizwe lesithathu ngobukhulu emva kweBrazil neMexico, elinemveliso yesizwe (GNP) emalunga nama-450 eebhiliyoni zeedola zaseMelika.Umvuzo wonyaka waseArgentina ngomntu ngamnye yi-US$22,140, ​​enye yeyona iphakamileyo kwiLatin America.5
Eli nqaku lijolise ekuchazeni umthamo wenkqubo yezempilo yaseArgentina kunye nothungelwano lwesibhedlele sayo.Ukongeza, ihlalutya umbutho, imisebenzi, kunye neempawu zolawulo lwesakhelo solawulo lwesixhobo sonyango sase-Argentina kunye nobudlelwane bayo noMercado Común del Sur (Mercosur).Ekugqibeleni, ngokuqwalasela iimeko ze-macroeconomic kunye nezentlalo e-Argentina, ishwankathela amathuba oshishino kunye nemingeni ekhoyo ngoku imelwe yimarike yezixhobo zase-Argentina.
Inkqubo yokhathalelo lwempilo yaseArgentina yahlulwe yazinkqubo ezingaphantsi ezintathu: zikawonke-wonke, ukhuseleko loluntu kunye nolwabucala.Icandelo likarhulumente libandakanya isebe lesizwe kunye nephondo, kunye nothungelwano lwezibhedlele zikarhulumente kunye namaziko ezempilo, ukubonelela ngeenkonzo zonyango zasimahla kuye nabani na ofuna unyango lwasimahla, ngokusisiseko abantu abangafanelanga ukufumana ukhuseleko loluntu kwaye abanako ukuhlawula.Ingeniso yemali ibonelela ngemali yenkqubo yokhathalelo lwempilo yoluntu, kwaye ifumana iintlawulo rhoqo kwi-subsystem yokhuseleko loluntu ukubonelela ngeenkonzo kumahlakani ayo.
Inkqubo engaphantsi yokhuseleko loluntu inyanzelekile, igxile kwi-"obra sociales" (izicwangciso zezempilo zeqela, i-OS), ukuqinisekisa nokubonelela ngeenkonzo zokhathalelo lwempilo kubasebenzi kunye neentsapho zabo.Iminikelo evela kubasebenzi kunye nabaqeshi babo ixhasa uninzi lwee-OS, kwaye basebenza ngezivumelwano nabathengisi babucala.
Inkqubo yabucala yabucala ibandakanya abaqeqeshi bezempilo kunye namaziko okhathalelo lwempilo anyanga abaguli abanemivuzo ephezulu, abaxhamli be-OS, kunye nabanini beinshorensi yabucala.Le subsystem ikwabandakanya iinkampani zeinshorensi ngokuzithandela ezibizwa ngokuba ziinkampani zeinshorensi “zechiza elihlawulelwayo”.Ngokusebenzisa izavenge zeinshorensi, abantu ngabanye, iintsapho nabaqeshi babonelela ngemali kwiinkampani zeinshorensi yezonyango ezihlawulelwa kwangaphambili.Izibhedlele zikawonke-wonke ze-7 zase-Argentina zithatha i-51% yenani elipheleleyo lezibhedlele (malunga ne-2,300), indawo yesihlanu phakathi kwamazwe aseLatin America anezona zibhedlele zikarhulumente.Umlinganiselo weebhedi zesibhedlele ziibhedi eziyi-5.0 kubemi abayi-1,000, nto leyo engaphezulu nangaphezulu komyinge we-4.7 kumazwe oMbutho weNtsebenziswano yoQoqosho noPhuhliso (OECD).Ukongeza, i-Argentina inomlinganiselo ophezulu woogqirha emhlabeni, kunye ne-4.2 kubemi abayi-1,000, idlula i-OECD 3.5 kunye nomyinge waseJamani (4.0), eSpain nase-United Kingdom (3.0) kunye namanye amazwe aseYurophu.8
I-Pan American Health Organisation (PAHO) idwelise i-Argentine National Food, Drug and Medical Technology Administration (ANMAT) njenge-arhente yokulawula yamanqanaba amane, oku kuthetha ukuba inokuthelekiswa ne-US FDA.I-ANMAT inoxanduva lokongamela nokuqinisekisa ukusebenza kakuhle, ukhuseleko kunye nomgangatho ophezulu wamayeza, ukutya nezixhobo zonyango.I-ANMAT isebenzisa inkqubo yokuhlela esekelwe kumngcipheko efana naleyo isetyenziswa kwiManyano yaseYurophu naseKhanada ukongamela ukugunyaziswa, ukubhaliswa, ukongamela, ukubeka iliso kunye nemiba yezemali yezixhobo zonyango kwilizwe lonke.I-ANMAT isebenzisa ulwahlulo olusekelwe kumngcipheko, apho izixhobo zonyango zihlulwe zibe ziindidi ezine ezisekelwe kwimingcipheko enokubakho: I-Class I-lowest risk;Udidi II-umngcipheko ophakathi;Udidi III-umngcipheko ophezulu;kunye neClass IV-ingozi ephezulu kakhulu.Nawuphi na umenzi wangaphandle onqwenela ukuthengisa izixhobo zonyango eArgentina kufuneka atyumbe ummeli wendawo ukuba angenise amaxwebhu afunekayo kwinkqubo yokubhalisa.Impompo yokufakelwa, impompo yesirinji kunye nempompo yesondlo (impompo yokutya) njengesixhobo sonyango se-calss IIb, kufuneka idluliselwe kwi-MDR eNtsha ngo-2024.
Ngokwemigaqo esebenzayo yobhaliso lwezixhobo zonyango, abavelisi kufuneka babe ne-ofisi yasekuhlaleni okanye umsasazi obhalisiweyo kuMphathiswa wezeMpilo wase-Argentina ukuze ahambelane neMisebenzi yoMveliso eGqwesileyo (BPM).KwiKlasi ye-III kunye neKlasi IV yezixhobo zonyango, abavelisi kufuneka bangenise iziphumo zovavanyo lweklinikhi ukubonisa ukhuseleko kunye nokusebenza kwesixhobo.I-ANMAT ineentsuku zokusebenza ezili-110 zokuvavanya uxwebhu kwaye ikhuphe isigunyaziso esihambelanayo;kwiKlasi I kunye neClass II izixhobo zonyango, i-ANMAT ineentsuku zokusebenza ze-15 zokuvavanya kunye nokuvuma.Ukubhaliswa kwesixhobo sonyango sisebenza iminyaka emihlanu, kwaye umenzi unokusihlaziya iintsuku ezingama-30 ngaphambi kokuba siphelelwe lixesha.Kukho indlela elula yokubhalisa yokulungiswa kwezatifikethi zobhaliso ze-ANMAT zodidi III kunye nemveliso ye-IV, kwaye impendulo inikezelwa kwiintsuku zokusebenza ezili-15 ngokubhengezwa kokuthotyelwa.Umvelisi kufuneka anikezele ngembali epheleleyo yeentengiso zangaphambili zesixhobo kwamanye amazwe.10
Ekubeni iArgentina iyinxalenye yeMercado Común del Sur (Mercosur)-indawo yorhwebo eyenziwe yiArgentina, Brazil, Paraguay kunye neUruguay-zonke izixhobo zonyango ezithunyelwa ngaphandle zirhafiswa ngokuhambelana neMercosur Common External Tariff (CET).Izinga lerhafu liqala kwi-0% ukuya kwi-16%.Kwimeko yezixhobo zonyango ezihlaziyiweyo ezivela kumazwe angaphandle, izinga lerhafu lisuka kwi-0% ukuya kwi-24%.10
Ubhubhani we-COVID-19 ube nempembelelo enkulu eArgentina.I-12, 13, 14, 15, 16 Ngo-2020, imveliso yelizwe epheleleyo yelizwe yehle nge-9.9%, ukwehla okukhulu kwiminyaka eyi-10.Ngaphandle koku, uqoqosho lwasekhaya ngo-2021 lusabonisa ukungalingani okukhulu kwezoqoqosho: nangona urhulumente elawula amaxabiso, isantya sokunyuka kwamaxabiso ngonyaka ngo-2020 sisazakuba phezulu ukuya kuma-36%.6 Nangona izinga eliphezulu lokunyuka kwamaxabiso kunye nokuhla kwezoqoqosho, izibhedlele zase-Argentina ziye zandisa ukuthengwa kwazo kwezixhobo zonyango ezisisiseko kunye nezikhethekileyo kwi-2020. Ukunyuka kokuthengwa kwezixhobo zonyango ezikhethekileyo kwi-2020 ukusuka kwi-2019 yile: 17
Ngexesha elifanayo ukusuka ngo-2019 ukuya ku-2020, ukuthengwa kwezixhobo zonyango ezisisiseko kwizibhedlele zase-Argentina kuye kwanda: 17
Okubangela umdla kukuba, xa kuthelekiswa no-2019, kuya kubakho ukonyuka kweentlobo ezininzi zezixhobo zonyango e-Argentina ngo-2020, ngakumbi kulo nyaka apho iinkqubo zotyando ezifuna ezi zixhobo ziye zarhoxiswa okanye zamiswa ngenxa ye-COVID-19.Uqikelelo lwengqikelelo luka-2023 lubonisa ukuba isantya sokukhula konyaka (CAGR) kwezi zixhobo zonyango zilandelayo ziya kunyuka:17
I-Argentina lilizwe elinenkqubo yonyango exubeneyo, kunye nabanikezeli benkonzo yezempilo elawulwa ngurhulumente kunye nababucala.Imakethi yesixhobo sayo sonyango ibonelela ngamathuba abalaseleyo eshishini kuba iArgentina idinga ukungenisa phantse zonke iimveliso zonyango.Ngaphandle kolawulo olungqongqo lwemali, ukunyuka kwamaxabiso kunye notyalo-mali oluphantsi lwangaphandle, i-18 imfuno ephezulu yangoku yezixhobo zonyango ezisisiseko kunye nezikhethekileyo, iithayimthebhile zokuvunywa okufanelekileyo, uqeqesho olukwinqanaba eliphezulu lezemfundo labasebenzi bezempilo base-Argentina, kunye nezakhono ezibalaseleyo zesibhedlele. indawo enomtsalane kubavelisi bezixhobo zonyango abanqwenela ukwandisa unyawo lwabo eLatin America.
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2. I-Comisión Económica para América Latina y el Caribe (CEPAL. Las restricciones a la exportación de productos médicos dificultan los esfuerzos por contener la enfermedad porcoronavirus (COVID-19) en América Latina y el Caribekorio]. cepal.org/bitstream/handle/11362/45510/1/S2000309_es.pdf
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6. IBhanki yehlabathi.IBhanki yeHlabathi yaseArgentina [i-Intanethi].2021. Ifumaneka kule webhusayithi ilandelayo: https://www.worldbank.org/en/country/argentina/overview
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9. UMphathiswa waseArgentina u-Anmat.I-ANMAT elegida por OMS como sede para concluir el desarrollo de la herramienta de evaluación de sistemasregulationios [Internet].2018. Ifumaneka apha: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf
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UJulio G. Martinez-Clark ungumseki kunye ne-CEO ye-bioaccess, inkampani yokubonisana nokufikelela kwimarike esebenza kunye neenkampani zezixhobo zonyango ukubanceda ukuba baqhube iimvavanyo zeklinikhi ezinokwenzeka kwangaphambili kunye nokuthengisa izinto zabo ezintsha eLatin America.UJulio ukwangumamkeli we-LATAM Medtech Leaders podcast: iincoko zeveki kunye neenkokeli eziphumeleleyo zeMedtech eLatin America.Ulilungu lebhodi yabacebisi yeYunivesithi yaseStetson eyona nkqubo iphambili ephazamisana nenguqulelo.Unesidanga se-bachelor kubunjineli be-elektroniki kunye nesidanga se-master kulawulo lweshishini.


Ixesha lokuposa: Sep-06-2021