Nūhou

I kēia manawa, aia ma mua o 10,000 mau mea lapaʻau ma ka honua holoʻokoʻa. 1 Pono nā ʻāina e kau mua i ka palekana o ka maʻi a hōʻoia i ka loaʻa ʻana o nā mea lapaʻau kiʻekiʻe, palekana a maikaʻi hoʻi. 2,3 Ke hoʻomau nei ka mākeke lāʻau lapaʻau ʻAmelika Latin i ka ulu nui o ka ulu makahiki. Pono nā ʻāina ʻAmelika Latin a me Karipiano e hoʻokomo ma mua o 90% o nā lāʻau lapaʻau no ka mea ʻo ka hana kūloko a me ka hāʻawi ʻana i nā lāʻau lapaʻau ma lalo o 10% o kā lākou noi.
ʻO Argentina ka lua o ka ʻāina nui loa ma Latin America ma hope o Brazil. Me ka heluna kanaka ma kahi o 49 miliona, ʻo ia ka ʻehā o ka ʻāina nui loa ma ka ʻāina4, a ʻo ke kolu o ka hoʻokele waiwai nui ma hope o Brazil a me Mekiko, me kahi huahana ʻāina nui (GNP) ma kahi o US $450 biliona. ʻO ka loaʻa kālā o kēlā me kēia kapita o Argentina he US $22,140, ​​kekahi o nā mea kiʻekiʻe loa ma Latin America. 5
Ke manaʻo nei kēia ʻatikala e wehewehe i ka hiki o ka ʻōnaehana mālama ola o Argentina a me kāna pūnaewele haukapila. Eia kekahi, ke kālailai nei i ka hui, nā hana, a me nā hiʻohiʻona hoʻoponopono o ke kahua hoʻoponopono lāʻau lapaʻau o Argentine a me kona pilina me Mercado Común del Sur (Mercosur). ʻO ka mea hope loa, e noʻonoʻo ana i nā kūlana macroeconomic a me ka nohona ma Argentina, hōʻuluʻulu ia i nā manawa ʻoihana a me nā pilikia i hōʻike ʻia i kēia manawa e ka mākeke lako Argentine.
Ua hoʻokaʻawale ʻia ka ʻōnaehana olakino o Argentina i ʻekolu mau subsystem: ka lehulehu, ka palekana a me ka pilikino. Aia ka ʻoihana aupuni i nā ʻoihana aupuni a me nā panalāʻau, a me kahi pūnaewele o nā halemai aupuni a me nā keʻena olakino, e hāʻawi ana i nā lawelawe lapaʻau manuahi i kēlā me kēia mea e pono ai ka mālama olakino manuahi, ʻo ia hoʻi nā poʻe i kūpono ʻole no ka mālama ola a ʻaʻole hiki ke uku. Hāʻawi ka loaʻa kālā i nā kālā no ka subsystem mālama ola lehulehu, a loaʻa nā uku maʻamau mai ka subsystem mālama ola e hāʻawi i nā lawelawe i kona mau hui.
Pono ka ʻōnaehana mālama ola kino, e kau ʻia ma luna o "obra sociales" (nā papahana olakino hui, OS), e hōʻoia a hāʻawi i nā lawelawe mālama ola i nā limahana a me ko lākou ʻohana. Hāʻawi nā haʻawina mai nā limahana a me kā lākou mau mea hana i ka hapa nui o nā OS, a hana lākou ma o nā ʻaelike me nā mea kūʻai pilikino.
Aia i loko o ka subsystem pilikino nā limahana mālama ola kino a me nā keʻena mālama ola kino e mālama i nā maʻi loaʻa kālā kiʻekiʻe, nā mea kōkua OS, a me nā mea ʻinikua pilikino. Aia pū kēia subsystem i nā hui ʻinikua manawaleʻa i kapa ʻia ʻo "prepaid drug". Ma o nā uku hoʻolimalima, hāʻawi nā kānaka, nā ʻohana a me nā mea hana i nā kālā no nā hui ʻinikua lapaʻau i uku mua ʻia. 7 ʻO nā halemai aupuni o ʻArgentine he 51% o ka nui o nā halemai (ma kahi o 2,300), ʻo ka pae ʻelima ma waena o nā ʻāina ʻAmelika Latin me ka nui o nā halemai lehulehu. ʻO ka lakio o nā moena o ka haukapila he 5.0 moena no 1,000 mau kānaka, ʻoi aku ka kiʻekiʻe ma mua o ka awelika o 4.7 ma nā ʻāina o ka Organization for Economic Co-operation and Development (OECD). Eia kekahi, ʻo Argentina kekahi o nā kauka kiʻekiʻe loa o ka honua, me 4.2 no 1,000 mau kānaka, ʻoi aku ma mua o ka OECD 3.5 a me ka awelika o Kelemania (4.0), Sepania a me United Kingdom (3.0) a me nā ʻāina ʻē aʻe o ʻEulopa. 8
Ua helu ka Pan American Health Organization (PAHO) i ka Argentine National Food, Drug and Medical Technology Administration (ANMAT) ma ke ʻano he ʻāpana hoʻoponopono ʻehā, ʻo ia ka mea hiki ke hoʻohālikelike ʻia me ka US FDA. ʻO ANMAT ke kuleana no ka nānā ʻana a me ka hōʻoia ʻana i ka pono, palekana a me ka maikaʻi o nā lāʻau lapaʻau, nā meaʻai a me nā mea lapaʻau. Hoʻohana ʻo ANMAT i kahi ʻōnaehana hoʻohālikelike e like me ka mea i hoʻohana ʻia ma ka European Union a me Kanada e nānā i ka ʻae ʻana, ka hoʻopaʻa inoa ʻana, ka nānā ʻana, ka nānā ʻana a me nā ʻano kālā o nā mea lapaʻau a puni ka ʻāina. Hoʻohana ʻo ANMAT i ka hoʻohālikelike ʻana i ka pilikia, kahi e māhele ʻia ai nā mea lapaʻau i ʻehā mau ʻāpana e pili ana i nā pilikia kūpono: Class I-lowest risk; Papa II-pilikia waena; Papa III-pilikia kiʻekiʻe; a me ka Papa IV-pilikia loa. Pono nā mea hana haole e kūʻai aku i nā lāʻau lapaʻau ma Argentina e koho i kahi ʻelele kūloko e waiho i nā palapala i koi ʻia no ke kaʻina hoʻopaʻa inoa. ʻO ka pauma infusion, ka pauma syringe a me ka pauma meaʻai (puʻu hānai) ma ke ʻano he lāʻau lapaʻau calss IIb, pono e hoʻouna ʻia i New MDR e 2024
Wahi a nā kānāwai hoʻopaʻa inoa o nā mea lapaʻau pili, pono nā mea hana i kahi keʻena kūloko a i ʻole ka mea hoʻolaha i hoʻopaʻa inoa ʻia me ke Kuhina Ola ʻo ʻAmelika e hoʻokō me nā Best Manufacturing Practices (BPM). No nā lāʻau lapaʻau Class III a me Class IV, pono nā mea hana e hoʻouna i nā hopena hoʻokolohua lapaʻau e hōʻoia i ka palekana a me ka pono o ka hāmeʻa. He 110 mau lā hana ʻo ANMAT e loiloi i ka palapala a hoʻopuka i ka mana kūpono; no nā lāʻau lapaʻau Papa I a me Papa II, he 15 mau lā hana a ANMAT e loiloi a ʻae ʻia. He ʻelima makahiki ka hoʻopaʻa inoa ʻana o kahi lāʻau lapaʻau, a hiki i ka mea hana ke hoʻonui iā ia i 30 mau lā ma mua o ka pau ʻana. Aia kahi papa inoa maʻalahi no ka hoʻololi ʻana i nā palapala hoʻopaʻa inoa ANMAT o nā huahana III a me IV, a hāʻawi ʻia kahi pane i loko o 15 mau lā hana ma o ka haʻi ʻana o ka hoʻokō. Pono ka mea hana e hāʻawi i ka moʻolelo piha o ke kūʻai mua ʻana o ka mea hana ma nā ʻāina ʻē aʻe. 10
ʻOiai ʻo ʻAmelika kahi ʻāpana o Mercado Común del Sur (Mercosur)-he wahi kālepa i haku ʻia ʻo Argentina, Brazil, Paraguay a me Uruguay-ua ʻauhau ʻia nā mea lapaʻau āpau i lawe ʻia e like me ka Mercosur Common External Tariff (CET). Aia ka auhau mai 0% a 16%. I ka hihia o nā lāʻau lapaʻau i hoʻihoʻi hou ʻia, ʻo ka helu ʻauhau mai 0% a 24%. 10
He hopena nui ka maʻi maʻi COVID-19 ma Argentina. 12, 13, 14, 15, 16 I ka makahiki 2020, ua hāʻule ka waiwai o ka ʻāina i ka 9.9%, ʻo ka emi nui loa i 10 mau makahiki. ʻOiai ʻo kēia, e hōʻike mau ana ka hoʻokele waiwai i ka makahiki 2021 i nā imbalances macroeconomic koʻikoʻi: ʻoiai ke kaohi ʻana o ke kumukūʻai o ke aupuni, ʻoi aku ka nui o ka piʻi ʻana o ka makahiki ma 2020 e like me 36%. 6 ʻOiai ke kiʻekiʻe o ka inflation rate a me ka hāʻule ʻana o ka hoʻokele waiwai, ua hoʻonui nā halemai Argentine i kā lākou kūʻai ʻana i nā lāʻau lapaʻau maʻamau a koʻikoʻi loa i 2020. ʻO ka piʻi ʻana o ke kūʻai ʻana i nā mea lapaʻau kūikawā ma 2020 mai 2019: 17
I ka manawa like mai 2019 a 2020, ua hoʻonui ʻia ke kūʻai ʻana i nā lāʻau lapaʻau maʻamau i nā haukapila o Argentine: 17
ʻO ka mea mahalo, ke hoʻohālikelike ʻia me 2019, e hoʻonui ʻia nā ʻano mea lapaʻau nui ma Argentina i 2020, ʻoi aku hoʻi i ka makahiki i hoʻopau ʻia ai nā kaʻina hana e koi ai i kēia mau mea hana ma muli o COVID-19. Hōʻike ka wānana no 2023 e piʻi aʻe ka nui o ka ulu ʻana o ka makahiki (CAGR) o kēia mau lāʻau lapaʻau: 17
He ʻāina ʻo Argentina me kahi ʻōnaehana olakino hui pū ʻia, me nā lawelawe mālama ola kino a me ka lehulehu. Hāʻawi kāna mākeke lāʻau lapaʻau i nā manawa ʻoihana maikaʻi loa no ka mea pono ʻo Argentina e lawe mai i nā huahana olakino āpau. ʻOiai ke kaohi ʻana i ke kālā, ka piʻi kiʻekiʻe a me ka haʻahaʻa haʻahaʻa haʻahaʻa o nā haole, 18 ke koi kiʻekiʻe o kēia manawa no nā lāʻau lapaʻau maʻamau a me nā mea lapaʻau kūikawā i lawe ʻia mai, nā papa manawa hoʻoponopono kūpono, ka hoʻomaʻamaʻa haʻawina kiʻekiʻe o nā limahana mālama ola ʻo Argentine, a me nā hiki o ka haukapila maikaʻi loa o ka ʻāina. ʻO kahi huakaʻi maikaʻi no nā mea hana lāʻau lapaʻau e makemake e hoʻonui i ko lākou wāwae ma Latin America.
1. Organización Panamericana de la Salud. Regulación de dispositivos médicos [Internet]. 2021 [i ʻōlelo ʻia mai Mei 17, 2021]. Loaʻa mai: https://www3.paho.org/hq/index.php?option=com_content&view=article&id=3418:2010-medical-devices-regulation&Itemid=41722&lang=es
2. 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 Caribe [COVID-19]. //repositorio. //repositorio. cepal.org/bitstream/handle/11362/45510/1/S2000309_es.pdf
3. Organización Panamericana de la salud. Dispositivos médicos [Internet]. 2021 [i ʻōlelo ʻia mai Mei 17, 2021]. Loaʻa mai: https://www.paho.org/es/temas/dispositivos-medicos
4. Datos macro. ʻAmelika: Economía y demografía [Internet]. 2021 [i ʻōlelo ʻia mai Mei 17, 2021]. Loaʻa mai: https://datosmacro.expansion.com/paises/argentina
5. Heluhelu. Producto interno bruto por país en América Latina y el Caribe en 2020 [Internet]. 2020. Loaʻa mai kēia URL: https://es.statista.com/estadisticas/1065726/pib-por-paises-america-latina-y-caribe/
6. ʻO ka World Bank. ʻO ka waihona kālā honua o Argentina [Internet]. 2021. Loaʻa mai kēia pūnaewele pūnaewele: https://www.worldbank.org/en/country/argentina/overview
7. Belló M, Becerril-Montekio VM. Systema de salud de Argentina. Salud Publica Mex [Internet]. 2011; 53: 96-109. Loaʻa mai: http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0036-36342011000800006
8. ʻO Corpart G. Latinoamérica es uno de los mercados hospitalarios másrobustos del mundo. ʻIkepili Ola honua [Internet]. 2018; loaʻa mai: https://globalhealthintelligence.com/es/analisis-de-ghi/latinoamerica-es-uno-de-los-mercados-hospitalarios-mas-robustos-del-mundo/
9. Kuhina Argentine Anmat. ANMAT elegida por OMS como sede for concluir el desarrollo de la herramienta de evaluación de sistemasregulationios [Internet]. 2018. Loaʻa mai: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf
10. RegDesk. He hiʻohiʻona o nā hoʻoponopono lāʻau lapaʻau o Argentina [Internet]. 2019. Loaʻa mai: https://www.regdesk.co/an-overview-of-medical-device-regulations-in-argentina/
11. Luna Hooponopono o ke Komite enehana Mahiai. Productos médicos: normativas sobre habilitaciones, registro y trazabilidad [Internet]. 2021 [i ʻōlelo ʻia mai Mei 18, 2021]. Loaʻa mai: http://www.cofybcf.org.ar/noticia_anterior.php?n=1805
12. Ortiz-Barrios M, Gul M, López-Meza P, Yucesan M, Navarro-Jiménez E. E loiloi i ka hoʻomākaukau ʻana i ka pōʻino o ka haukapila ma o ke ʻano hoʻoholo hoʻoholo i nā mea he nui: E lawe i nā halemai Turkish ma ke ʻano he laʻana. Int J Hoemi Poino [Internet]. Iulai 2020; 101748. Loaʻa mai: https://linkinghub.elsevier.com/retrieve/pii/S221242092030354X doi: 10.1016/j.ijdrr.2020.101748
13. Clemente-Suárez VJ, Navarro-Jiménez E, Jimenez M, Hormeño-Holgado A, Martinez-Gonzalez MB, Benitez-Agudelo JC, a pēlā aku. Hoʻomau [Internet]. Malaki 15 2021; 13(6):3221. Loaʻa mai: https://www.mdpi.com/2071-1050/13/6/3221 doi: 10.3390/su13063221
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15. ʻO Romo A, Ojeda-Galaviz C. Tango no COVID-19 e koi aku i ʻoi aku ma mua o ʻelua: ka nānā ʻana i ka pane maʻi maʻi mua ma Argentina (Ianuali 2020 a ʻApelila 2020). Int J Environ Res Public Health [Internet]. Kekemapa 24, 2020; 18(1):73. Loaʻa mai: https://www.mdpi.com/1660-4601/18/1/73 doi: 10.3390/ijerph18010073
16. Bolaño-Ortiz TR, Puliafito SE, Berná-Peña LL, Pascual-Flores RM, Urquiza J, Camargo-Caicedo Y. Nā hoʻololi i nā hoʻokuʻu ʻana o ka lewa a me ko lākou hopena hoʻokele waiwai i ka wā o ka laka maʻi maʻi COVID-19 ma Argentina. Hoʻomau [Internet]. ʻOkakopa 19, 2020; 12(20): 8661. Loaʻa mai: https://www.mdpi.com/2071-1050/12/20/8661 doi: 10.3390/su12208661
17. Corpart G. En Argentina en 2020, se dispararon las cantidades deequipos médicos especializados [Internet]. 2021 [i ʻōlelo ʻia mai Mei 17, 2021]. Loaʻa mai: https://globalhealthintelligence.com/es/analisis-de-ghi/en-argentina-en-2020-se-dispararon-las-cantidades-de-equipos-medicos-especializados/
18. Otaola J, Bianchi W. Ua emi iho ka emi o ka waiwai o Argentina ma ka hapaha eha; ʻo ke kolu o ka makahiki ka emi ʻana o ka waiwai. Reuters [Pūnaewele]. 2021; Loaʻa mai: https://www.reuters.com/article/us-argentina-economy-gdp-idUSKBN2BF1DT
ʻO Julio G. Martinez-Clark ka mea hoʻokumu a me ka Luna Nui o ka bioaccess, kahi hui kūkākūkā e pili ana i ka mākeke e hana pū ana me nā hui lāʻau lapaʻau e kōkua iā lākou e hana i nā hoʻokolohua lapaʻau kūpono a kūʻai aku i kā lākou mau mea hou ma Latin America. ʻO Julio hoʻi ka mea hoʻokipa o ka podcast LATAM Medtech Leaders: nā kamaʻilio pule me nā alakaʻi Medtech kūleʻa ma Latin America. He lālā ʻo ia o ka papa ʻōlelo aʻoaʻo o ke kula nui o Stetson University's disruptive innovation program. Loaʻa iā ia ke kēkelē laepua ma ka ʻenekinia uila a me ke kēkelē laepua ma ka hoʻokele ʻoihana.