Nūhou

I kēia manawa, aia ma mua o 10,000 mau mea lapaʻau ma ka honua holoʻokoʻa. 1 Pono nā ʻāina e kau i ka palekana o ka mea maʻi ma mua a hōʻoia i ke komo ʻana i nā mea lapaʻau kiʻekiʻe, palekana a pono hoʻi. 2,3 Ke hoʻomau nei ka ulu ʻana o ka mākeke mea lapaʻau ʻAmelika Latina i ka ulu nui ʻana o ka makahiki. Pono nā ʻāina ʻAmelika Latina a me Karipiano e lawe mai ma mua o 90% o nā mea lapaʻau no ka mea ʻo ka hana kūloko a me ka hoʻolako ʻana i nā mea lapaʻau he emi ma mua o 10% o kā lākou koi holoʻokoʻa.
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 ʻāina ʻehā o ka heluna kanaka nui loa ma ka ʻāina4, a ʻo ke kolu o ka hoʻokele waiwai nui loa ma hope o Brazil a me Mekiko, me ka huina waiwai aupuni (GNP) ma kahi o US$450 biliona. ʻO ka loaʻa kālā makahiki o Argentina no kēlā me kēia kanaka he US$22,140, ​​ʻo ia kekahi o nā mea kiʻekiʻe loa ma Latin America.5
ʻO ka pahuhopu o kēia ʻatikala e wehewehe i ka hiki o ka ʻōnaehana mālama ola kino o Argentina a me kāna pūnaewele haukapila. Eia kekahi, kālailai ia i ka hoʻonohonoho ʻana, nā hana, a me nā ʻano hoʻoponopono o ke kahua hoʻoponopono hāmeʻa lapaʻau Argentina 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 kūpono ʻoihana a me nā pilikia i hōʻike ʻia e ka mākeke lako Argentina i kēia manawa.
Ua māhele ʻia ka ʻōnaehana mālama ola kino o Argentina i ʻekolu mau ʻōnaehana liʻiliʻi: lehulehu, palekana kaiāulu a pilikino. Hoʻokomo pū ka ʻāpana aupuni i nā keʻena aupuni a me nā panalāʻau, a me kahi pūnaewele o nā haukapila aupuni a me nā kikowaena olakino, e hāʻawi ana i nā lawelawe lapaʻau manuahi i kekahi mea e pono ai ka mālama ola kino manuahi, ʻo ia hoʻi ka poʻe i kūpono ʻole no ka palekana kaiāulu a ʻaʻole hiki ke uku. Hāʻawi ka loaʻa kālā i nā kālā no ka ʻōnaehana mālama ola kino lehulehu, a loaʻa iā ia nā uku maʻamau mai ka ʻōnaehana palekana kaiāulu e hāʻawi i nā lawelawe i kona mau lālā.
He mea koi ʻia ka ʻōnaehana palekana pili kanaka, e kālele ana ma luna o "obra sociales" (nā hoʻolālā olakino hui, OS), e hōʻoiaʻiʻo ana a me ka hāʻawi ʻana i nā lawelawe mālama ola kino i nā limahana a me ko lākou mau ʻohana. ʻO nā hāʻawi mai nā limahana a me kā lākou mau mea hana ke kālā no ka hapa nui o nā OS, a hana lākou ma o nā ʻaelike me nā mea kūʻai aku pilikino.
ʻO ka ʻōnaehana pilikino e komo pū ana me nā loea olakino a me nā ʻoihana olakino e mālama ana i nā maʻi me ka loaʻa kālā kiʻekiʻe, nā mea pōmaikaʻi OS, a me nā mea paʻa ʻinikua pilikino. Hoʻokomo pū kēia ʻōnaehana i nā ʻoihana ʻinikua manawaleʻa i kapa ʻia ʻo nā ʻoihana ʻinikua "lāʻau lapaʻau i uku mua ʻia". Ma o nā uku ʻinikua, hāʻawi nā kānaka, nā ʻohana a me nā mea hana i nā kālā no nā ʻoihana ʻinikua lapaʻau i uku mua ʻia. 7 ʻO nā haukapila aupuni o Argentina he 51% o kona huina o nā haukapila (ma kahi o 2,300), ʻo ia ka lima ma waena o nā ʻāina ʻAmelika Latina me ka hapa nui o nā haukapila lehulehu. ʻO ka lakio o nā moena haukapila he 5.0 moena no 1,000 mau kamaʻāina, 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 ʻāpana kiʻekiʻe loa o nā kauka ma ka honua, me 4.2 no 1,000 mau kamaʻāina, ʻoi aku ka nui 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 ʻEulopa ʻē aʻe. 8
Ua helu ka Pan American Health Organization (PAHO) i ka Argentine National Food, Drug and Medical Technology Administration (ANMAT) ma ke ʻano he keʻena hoʻoponopono ʻehā pae, ʻo ia hoʻi hiki ke hoʻohālikelike ʻia me ka US FDA. ʻO ANMAT ke kuleana no ka nānā ʻana a me ka hōʻoia ʻana i ka pono, ka palekana a me ke kiʻekiʻe o nā lāʻau lapaʻau, nā meaʻai a me nā mea lapaʻau. Hoʻohana ʻo ANMAT i kahi ʻōnaehana hoʻokaʻawale pilikia e like me ka mea i hoʻohana ʻia ma ka ʻAhahui ʻEulopa 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 ma ka ʻāina holoʻokoʻa. Hoʻohana ʻo ANMAT i kahi hoʻokaʻawale pilikia, kahi i māhele ʻia ai nā mea lapaʻau i ʻehā mau māhele e pili ana i nā pilikia hiki: Papa I-ka pilikia haʻahaʻa loa; Papa II-ka pilikia waena; Papa III-ka pilikia kiʻekiʻe; a me Papa IV-ka pilikia kiʻekiʻe loa. Pono kekahi mea hana haole e makemake ana e kūʻai aku i nā mea lapaʻau ma Argentina e koho i kahi ʻelele kūloko e waiho i nā palapala e pono ai no ke kaʻina hana hoʻopaʻa inoa. ʻO ka pamu infusion, ka pamu syringe a me ka pamu meaʻai (pamu hānai) e like me nā lako lapaʻau IIb, pono e hoʻouna i loko o New MDR ma 2024.
Wahi a nā lula hoʻopaʻa inoa hāmeʻa lapaʻau e pili ana, pono i nā mea hana ke loaʻa kahi keʻena kūloko a mea hoʻolaha paha i hoʻopaʻa inoa ʻia me ke Kuhina Ola o Argentina e hoʻokō me nā Hana Hana Hana Maikaʻi Loa (BPM). No nā hāmeʻa lapaʻau Papa III a me Papa IV, pono nā mea hana e waiho i nā hopena hoʻāʻo lapaʻau e hōʻoia i ka palekana a me ka pono o ka hāmeʻa. He 110 mau lā hana ko ANMAT e loiloi i ka palapala a hoʻopuka i ka ʻae like; no nā hāmeʻa lapaʻau Papa I a me Papa II, he 15 mau lā hana ko ANMAT e loiloi a ʻāpono. He kūpono ke kau inoa ʻana o kahi hāmeʻa lapaʻau no ʻelima mau makahiki, a hiki i ka mea hana ke hoʻohou iā ia i 30 mau lā ma mua o ka pau ʻana. Aia kahi ʻano hoʻopaʻa inoa maʻalahi no nā hoʻololi i nā palapala hōʻoia hoʻopaʻa inoa ANMAT o nā huahana mahele III a me IV, a hāʻawi ʻia kahi pane i loko o 15 mau lā hana ma o ka hoʻolaha ʻana o ka hoʻokō. Pono nō hoʻi ka mea hana e hāʻawi i kahi mōʻaukala piha o nā kūʻai aku ma mua o ka hāmeʻa ma nā ʻāina ʻē aʻe. 10
ʻOiai ʻo Argentina kekahi ʻāpana o Mercado Común del Sur (Mercosur) - he wahi kālepa i haku ʻia me Argentina, Brazil, Paraguay a me Uruguay - ua ʻauhau ʻia nā mea lapaʻau i lawe ʻia mai e like me ka Mercosur Common External Tariff (CET). Loaʻa ka helu ʻauhau mai 0% a 16%. I ke ʻano o nā mea lapaʻau i hoʻoponopono hou ʻia i lawe ʻia mai, loaʻa ka helu ʻauhau mai 0% a 24%. 10
Ua nui ka hopena o ka maʻi ahulau COVID-19 ma Argentina. 12, 13, 14, 15, 16 I ka makahiki 2020, ua hāʻule ka huina o ka huahana aupuni o ka ʻāina ma 9.9%, ʻo ia ka emi nui loa i loko o 10 mau makahiki. ʻOiai naʻe kēia, e hōʻike mau ana ka hoʻokele waiwai kūloko i ka makahiki 2021 i nā kaulike ʻole macroeconomic koʻikoʻi: ʻoiai nā kaohi kumukūʻai o ke aupuni, e mau ana ka nui o ke kumukūʻai makahiki i ka makahiki 2020 i ka 36%. 6 ʻOiai ke kiʻekiʻe o ka nui o ke kumukūʻai a me ka emi ʻana o ka hoʻokele waiwai, ua hoʻonui nā haukapila Argentina i kā lākou kūʻai ʻana i nā lako lapaʻau kumu a me nā lako lapaʻau kūikawā i ka makahiki 2020. ʻO ka piʻi ʻana o ke kūʻai ʻana i nā lako lapaʻau kūikawā i ka makahiki 2020 mai ka makahiki 2019: 17
I loko o ka manawa like mai 2019 a 2020, ua piʻi aʻe ke kūʻai ʻana i nā lako lapaʻau maʻamau ma nā haukapila o Argentina: 17
ʻO ka mea hoihoi, i hoʻohālikelike ʻia me 2019, e piʻi aʻe ana kekahi mau ʻano lako lapaʻau pipiʻi ma Argentina i ka makahiki 2020, ʻoi aku hoʻi i ka makahiki i hoʻopau ʻia ai a hoʻopanee ʻia paha nā kaʻina hana ʻoki e pono ai kēia mau lako ma muli o COVID-19. Hōʻike ka wānana no 2023 e piʻi aʻe ka nui o ka ulu makahiki (CAGR) o nā lako lapaʻau ʻoihana ma lalo nei:17
He ʻāina ʻo Argentina me kahi ʻōnaehana lapaʻau i hui pū ʻia, me nā mea lawelawe mālama ola kino lehulehu a pilikino i hoʻoponopono ʻia e ka mokuʻāina. Hāʻawi kāna mākeke lako lapaʻau i nā manawa kūpono ʻoihana maikaʻi loa no ka mea pono ʻo Argentina e lawe mai i ka aneane o nā huahana lapaʻau āpau. ʻOiai ke kāohi ʻana i ke kālā paʻa, ke kumukūʻai kiʻekiʻe a me ka hoʻopukapuka haole haʻahaʻa,18 ke koi kiʻekiʻe o kēia manawa no nā lako lapaʻau kumu a me nā mea kūikawā i lawe ʻia mai, nā papa manawa ʻae ʻia e nā mea hoʻoponopono kūpono, ke aʻo hoʻonaʻauao kiʻekiʻe o nā loea mālama ola kino Argentina, a me nā hiki haukapila maikaʻi loa o ka ʻāina. ʻO kēia ka mea e hoʻolilo ai iā Argentina i wahi hoihoi no nā mea hana lako lapaʻau e makemake ana e hoʻonui i ko lākou kapuaʻi 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 retricciones 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.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 Panakō Honua. ʻO ka Panakō Honua o Argentina [Pūnaewele]. 2021. Loaʻa mai ka pūnaewele ma lalo nei: 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 ʻike holoʻokoʻa o nā lula no nā mea lapaʻau o Argentina [Pūnaewele]. 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. ʻO Ortiz-Barrios M, Gul M, López-Meza P, Yucesan M, Navarro-Jiménez E. E loiloi i ka mākaukau no nā pōpilikia haukapila ma o kahi ʻano hoʻoholo multi-criteria: E lawe i nā haukapila Turkish ma ke ʻano he laʻana. Int J Disaster Risk Reduction [Pūnaewele]. 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, etc. Ka hopena o ka maʻi ahulau COVID-19 i ke olakino noʻonoʻo lehulehu: he wehewehe moʻolelo ākea. Hoʻomau [Pūnaewele]. Malaki 15 2021; 13(6):3221. Loaʻa mai: https://www.mdpi.com/2071-1050/13/6/3221 doi: 10.3390/su13063221
14. Clemente-Suárez VJ, Hormeno-Holgado AJ, Jiménez M, Agudelo JCB, Jiménez EN, Perez-Palencia N, etc. Nā dinamika palekana o ka heluna kanaka ma muli o ka hopena hui i ka maʻi ahulau COVID-19. Lāʻau pale [Pūnaewele]. Mei 2020; loaʻa mai: https://www.mdpi.com/2076-393X/8/2/236 doi: 10.3390/vaccines8020236
15. Romo A, Ojeda-Galaviz C. Pono ʻo Tango no COVID-19 ma mua o ʻelua: ka nānā ʻana i ka pane mua ʻana i ka maʻi ahulau ma Argentina (Ianuali 2020 a ʻApelila 2020). Int J Environ Res Public Health [Pūnaewele]. Dekemaba 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. ʻOtaola J, Bianchi W. Ua emi ka emi ʻana o ka hoʻokele waiwai o Argentina i ka hapaha ʻehā; ʻo ka emi ʻana o ka hoʻokele waiwai ka makahiki ʻekolu. Reuters [Pūnaewele]. 2021; Loaʻa mai: https://www.reuters.com/article/us-argentina-economy-gdp-idUSKBN2BF1DT
ʻO Julio G. Martinez-Clark ka mea nāna i hoʻokumu a me ka Luna Nui o bioaccess, kahi hui kūkākūkā komo mākeke e hana pū ana me nā ʻoihana hāmeʻa lapaʻau e kōkua iā lākou e hana i nā hoʻokolohua lapaʻau mua a kūʻai aku i kā lākou mau hana hou ma Latin America. ʻO Julio kekahi ka mea hoʻokipa o ka podcast LATAM Medtech Leaders: nā kamaʻilio pule me nā alakaʻi Medtech holomua ma Latin America. He lālā ʻo ia o ka papa aʻoaʻo o ka papahana hana hou hoʻopilikia alakaʻi o ke Kulanui ʻo Stetson. Loaʻa iā ia ke kēkelē laepua ma ka ʻenekinia uila a me ke kēkelē laeoʻo ma ka hoʻokele ʻoihana.