I-US Pharmaceuticals Ngokukhethekile Ivikelekile Emncintiswaneni
Bambalwa bangaphikisana neqiniso lokuthi imithi ye-HIV iyabiza. Eqinisweni, ngokusho kwamaCenters for Disease Control and Prevention (CDC), umuntu ophila negciwane lesandulela ngculazi oqala ukwelashwa kuqala uzobhekana nezindleko zokuphila okungenani amaRandi ayizigidi ezingama-250,000, futhi yizo kuphela amaphilisi abo kuphela. Izindleko azikwazi neze ukumangazwa ngokuthi inqubo ejwayelekile yezinyanga ezintathu, njenge- Triumeq , inenani lentengo engaphezu kuka-$ 2,600 ngenyanga.
Okunye ukuhlanganiswa kuhle kakhulu kwalokho .
Naphezu kwalokhu, awuvame ukuzwa okuningi endleleni yokukhala komphakathi ngokumelene nentengo yalezi zidakamizwa. Futhi lokhu kungenxa yokuthi abaningi bathola izidakamizwa zabo ze-HIV ezikhokhelwa, okungenani ngezingxenye, kusuka kumshuwalense noma izinsizakalo ezihlukahlukene zikahulumeni nezizimele.
Ngokuphefumula okufanayo, abanye bayazibuza ukuthi izidakamizwa zokulwa nezidambisigciwane zingathwala kanjani amanani entengo eningi e-US uma sizwa ukuthi izinguqulo ezivamile azikhona nje kuphela ngaphandle kwezwe kodwa zibiza cishe amaphesenti angu-2000 ngaphansi kwalokho esikukhokha lapha.
Izizathu zokungabikho kwemithi ejwayelekile ye-HIV e-US ngesikhathi esisodwa zilula futhi zidideka, ezibandakanya isayensi, ezombusazwe, nokuhle, inzuzo endala. Ngokuhlukanisa lezi zindaba ezihlangene, singenza ngcono izinselelo ezibhekene nabathengi abane-HIV kanye nomkhakha wezempilo.
Lapho Ukuthuthukiswa Kwezesayensi Kuvuselela Ukuthuthukiswa Kwezidakamizwa Zama-Generic
Ngokuvamile, uma i-patent yesidakamizwa iphelelwa yisikhathi (ngokuvamile iminyaka engu-20 ngemuva kokuba i-patent ifike kuqala), ilungelo lokukopisha lelo dakamizwa lizovulelwa kunoma ubani okhetha ukwenza i-generic version.
Umgomo we-generic ukuncintisana nomkhiqizo wangempela ngentengo, nabadlali abaningi bakha ukuncintisana okukhulu futhi, kaningi kunalokho, izindleko eziphansi.
Pho kungani singaboni lokhu ngemithi ye-HIV? Phela, amalungelo obunikazi olwahlu olude lwama-antiretrovirals asiphelelwe yisikhathi noma azophelelwa yisikhathi, kufaka phakathi izidakamizwa zangaphambili "eziphezulu" njenge- Sustiva (efavirenz) ne-tenofovir (TDF).
Kodwa uma uhlola ukubhaliswa kwe-Food and Drug Administration (FDA), ukufometha okujwayelekile kuvele kuhanjiswe futhi kuvunyelwe ama-adjenti ayisithupha ezidakamizwa. Kulezi, ingxenye yesithathu isetshenziselwa ukwelashwa kwe-HIV e-US (stavudine ne-didanosine), kuyilapho bonke ababili (Abacavir ne-lamivudine) behluleka.
Futhi kukhona enye yezinselele ezibhekene nabakhiqizi abakhiqiza endaweni ye-HIV: Isayensi yokuguquguquka esheshayo ingenza ezinye izidakamizwa zezidakamizwa zingasebenzi.
Ukunciphisa Ukunciphisa Kunciphisa Ukuncintisana Kokukhiqiza
Thatha, isibonelo, i-Rescriptor (delavirdine) ne-Aptivus (tipranavir), imishanguzo emibili ye-HIV enezikhwama eziphelelwe yisikhathi ngo-2013 no-2015, ngokulandelana. Nakuba zombili zisasetshenziselwa ukwelashwa kwe-HIV, ezinye, izidakamizwa ezitshela izizukulwane (ikakhulukazi integrase inhibitors) zinikezwe isimo esikhethiwe. Lezi zidakamizwa, okwamanje, ziye zahliswa kwesinye isimo.
Ngenxa yalokho, i-Rescriptor ne-Aptivus izovame ukusetshenziswa kangcono njengokuthi "ukuwa emuva" uma ezinye izinkinga zihluleka. Lokhu kuphela kunciphisa ukugqugquzela abakhiqizi ukuba bafinyelele ekukhiqizeni okukhiqizayo uma kunesiqiniseko esincane sokuthengisa kwevolumu.
Ngendlela efanayo, ngenkathi isidakamizwa esifana ne-TDF sisesezindaweni ezisetshenzisiwe kakhulu emhlabeni, inguqulo ethuthukisiwe-ebizwa ngokuthi i- tenofovir alafenamide (TAF) -yafakwa ngo-2016 njengoba nje i-patent ye-TDF isethelwe.
Kungenzeka ukuthi ugobe? Akukona ngempela, kunikezwe ukuthi ifomu elisha linikeza imiphumela emincane kakhulu emiphakathini kanye namazinga aphezulu okugxiliswa kwegazi (okusho ukuthi izidakamizwa zihlala ohlelweni lwakho isikhathi eside). Ekugcineni, i-TAF iyisidakamizwa esiphezulu esizokwehlisa ngokufanele i-TDF, ikakhulukazi kumathebhulethi amasha.
Ngakho-ke, lokho kusho ukuthi ngeke sibone amafomu ajwayelekile we-TDF noma kunini? Abaningi bakholelwa ukuthi sizokwenza. Ngisho nalapho ebhekene nesidingo esicindezelayo, i-generic TDF isenendawo endaweni yamanje ye-HIV futhi ingase ilandelwe ngokucindezela ngabashuwalense kanye nabanye abahlinzeki abafuna ukunciphisa izindleko zemithi . Futhi, ekugcineni, ukuncintisana okuvamile kunamakethe, ukwehlisa amanani kuzohamba.
Yilokho okuye kwaba njalo nge-generic version ye- Epzicom , inketho ezimbili-in-eyodwa equkethe abacavir ne-lamivudine. Ngombili izingxenye zezidakamizwa zisatshenziselwa ukwelapha okuqala, abakhiqizi abane baye baphuma kwi-bandwagon generic futhi baye bakwazi ukunikeza imali engamaphesenti angama-70 ngaphandle kwegama lomkhiqizo.
Abakhiqizi be-HIV Abadakamizwa Bavikelekile Kusuka Kwezingcindezi Zama-Generic Price
Abakhiqizi bezidakamizwa be-HIV base-US basesimweni esiyingqayizivele sokucindezelwa okuncintisana okuvela ezinkampanini ezivamile ezingahle zibe zihamba ngezithende zabo.
Okokuqala, ukuthenga komthengi ngezinketho ezilodwa zamaphilisi kuye kwenza amaphilisi amancane kakhulu akhangele kunoma yikuphi ukwelapha okuqhubekayo. Akumangalisi ukuthi amalungelo obunikazi amaningi kulezi amaphilisi ezinhlanganisela azungeze ekupheleni kwempilo yabo, ezinye ezifana neTruvada (TDF plus emtricitabine) kuphela ngenxa yokuphela ngo-2021.
Ngakho-ke ngisho noma izingxenye zomuthi ngamunye zitholakala kubakhiqizi abakhiqizi, umthengi uzovame ukukhetha ithebhulethi yegama legama lomkhiqizo (ngaphandle uma, noma kunjalo, umshwalense uyabaphoqa ukuba benze okuhlukile).
Kodwa, ngisho nangaphandle kwenkinga yemfuno yabathengi, inkundla yokudlala e-US isikhathi eside isetshenziselwe ukuqondiswa komkhiqizi wezidakamizwa ezingezona ojwayelekile we-HIV. Lokhu kubangelwa kakhulu ukuthi uhulumeni wase-United States ungumthengi oyedwa owodwa wezidambisigciwane namuhla.
Nge- Programmed Assistance Programme Aid Assistance Program (ADAP) , ohulumeni basekhaya baqondiswa ukuthenga izidakamizwa ze-HIV ngokuqondile kwabathengisi. Amanani asetshenziswa ohlelweni lwe-Federal 340B lweDrug Pricing Program, elithengisa inani lentengo elijwayelekile ngamaphi amaphesenti angu-60 kuya ku-70. Ngemuva kokufaka imali emabhalweni, izidakamizwa zamagama ezidakamizwa cishe ziphela njalo zithengeka kunomlingani wazo ojwayelekile.
Esinye isici sokuvikela imithi yindlela yokuhlinzeka ngayo ukwelashwa. Ngokungafani nomshuwalense wezempilo wangasese, ukhetho lwe-ADAP lwezokwelapha luqondiswa kuphela ngeziqondiso ezikhishwe uMnyango WezeMpilo Nezinsizakalo Zabantu , okwamanje zibeka amaphilisi okuhlanganiswa wonke-in-eyodwa-zona kanye izidakamizwa ezivikelwe amalungelo-ilungelo lokukhetha ukwelashwa kokuqala .
Ekugcineni, akuyona "ukuhlanganiswa" okushayela lezi ziqondiso. Sekuyisikhathi eside ukuhlolwa kubonisa ukuthi abantu abaphethe ukwelashwa okulodwa kwepilisi kungenzeka ukuthi bahlale benamathela uma kuqhathaniswa nalabo abaphatha amaphilisi amaningana. Lokhu, kubuye kube yizinga eliphakeme lokunciphisa i-viral, okusho ukuthi igciwane alikwazi ukuphindaphindiwe futhi awukwazi kakhulu ukuthuthukisa ukumelana nezidakamizwa.
Okulungile noma cha, lezi zinqubomgomo azikwazi ukusiza kodwa zithande umkhiqizi ongeyena ojwayelekile, okwenza kube nzima nakakhulu izinkampani eziyinhloko ukuncintisana kunoma yini ngaphandle kwezinga elincane.
Ukuze baqhubeke bevikela isikhundla sabo samakethe, cishe bonke abakhiqizi bamagama abanikazi bavumelene ukunikeza usizo lwezezimali kulabo abangakwazi ukukhokhela izidakamizwa zabo, noma ngendlela yokukhokhelwa ngokukhokha noma ukuxhaswa kwalabo abangafanelanga umshwalense. Kuyinto abakhiqizi abahlinzeka ngemikhiqizo abacindezelekile ukufanisa.
Kodwa, njengoba kubalulekile njengalezi zincithakalo, azikali ukubhekana nezindleko eziphezulu zezidakamizwa ze-HIV uma kuqhathaniswa nemithi efanayo ekhona ngaphandle kwe-US
Izinselele zezinkokhelo ezisemaphandleni Izinkomba zokuCwaninga nokuThuthukiswa
I-pharma enkulu yokuthengiswa kwemithi ye-pharma yinkampani yomhlaba wonke eqhubeka ngaphesheya kwemingcele yase-US. Akugcini nje ukubeka lezi zinkampani ezinkampanini ezimakethe eziphuthumayo lapho izifo, njenge-HIV, zivame ukuba nethuba lokugcina ezinye izilawuli phezu kwamalungelo engqondo yemikhiqizo yazo.
Lokhu kuyiqiniso ikakhulukazi emazweni afana ne-India, imithetho yakhe evumela ukukhiqizwa kwezidakamizwa ezibalulekile ze-HIV kungakhathaliseki ukuthi i-patent. Ngenxa yalokho, iNdiya namuhla ngumhlinzeki omkhulu wezidambisigciwane ezikhiqizayo emazweni asathuthuka, izidakamizwa ezingekho nje kuphela ezakhiweni zamakhemikhali kodwa zivunyelwe ngabanye yi-FDA.
Ngalokhu, umuntu angathenga inguqulo yesi-Atripla cishe ngama-dollar angama-50 ku-counter yokuthengisa eNingizimu Afrika, ngenkathi ebhekene nenani eliphelele lama $ 2,500 kuma-Walgreens noma i-CVS yangakini.
Isimboni sezokwelapha sekuyisikhathi eside sigcizelele ukuthi lokhu ukungalingani kuwumphumela wezindleko ezinkulu kakhulu zocwaningo nentuthuko (i-R & D), okungenakuthatha iminyaka kuphela kodwa kufinyelela kumabhiliyoni amaRandi. Phezu kwalokho, isimangalo esifanele sinikezwe inqwaba yeR & D yokuqala e-US phakathi nendawo yezolimo ze-biopharma kanye nezikhungo zophando.
Ngokwemithetho ye-patent ekhonjisiwe, i-pharmas iphikisana, amazwe afana ne-India angenza kalula inzuzo kuma-generic aphansi kakhulu njengoba engabhekene no-R & D utshalomali. Amantombazane ama-pharmaceutical, ngokuphambene, akanalo ukunethezeka okunjalo, futhi, ngokuzenzakalelayo, namakhasimende abo akwenzeki.
Kodwa-ke, ukukhathazeka ukuthi amaphesenti angama-80 ezithako ezidakamizwa ezenziwe e-US kanye namaphesenti angu-40 azo zonke izidakamizwa ezedlule zivela emazweni afana ne-India ne-China, ngokusho kwe-FDA. Futhi, naphezu kwezinsolo zokuthi iNdiya yenza ukubulawa ngokuhlukunyezwa kwamalungelo obunikazi, inzuzo yonyaka yembonini yezokwelapha yaseNdiya ibhekisela kumaphesenti amabili kuphela emali yezindleko zomhlaba jikelele.
Ngaphezu kwalokho, imishanguzo eminingi yaseMelika imiswe kahle embonini yama generic yaseNdiya, kuhlanganise neMylan yasePennsylvania, okwathi ngonyaka ka-2007 wathenga ubuningi bomnikazi weMatrix Laboratories, umkhiqizi ophezulu waseNdiya wezithako ezisebenzayo zokwelapha (API) ezisetshenziselwa izidakamizwa ezivamile. Ukuthengwa kwasiza i-Mylan ukuba yilokho okwamanje inkampani yesine yezidakamizwa ezinkulu kunawo wonke emhlabeni.
Ngokufanayo, i-GlaxoSmithKline (GSK) yezidakamizwa zomhlaba wonke, kuze kube yamuva, iqhaza elikhulu ku-Aspen Pharmacare, imithi e-South Africa esekelwe kulo mkhakha ohlala emkhiqizweni ohamba phambili wezidakamizwa ze-HIV. Ubuhlobo, okwakhiwa ngo-2009, buvumela i-GSK ukuba ilayisenise ibhasikidi lezidakamizwa ze-HIV ku-Aspen, kufaka phakathi ithebhulethi ye-powerhouse ngaleso sikhathi, i-Combivir. Lokhu kwavumela i-GSK ukuthi ihlanganyele ezinzuzweni ekuthengiseni izidakamizwa zabo ezijwayelekile ze-HIV e-Afrika ngenkathi igcina inani eliphakeme letikiti elifanayo, izinguqulo ezingezona ezivamile e-US
Ngo-2016, i-GSK ithengise ingxenye yayo yamaphesenti angu-16 e-Aspen Pharmacare ngenzuzo ebikiwe ye $ 1.9 billion. Lokhu kuhambisana nokuphela kwe-Combivir ngalowo nyaka ofanayo.
Kwakungabonakali ukuphikiswa ngabameli, abaphikisana ngokuthi imikhuba enjalo iyabandlulula. Ngakolunye uhlangothi, inkampani yaseMelika efana ne-Mylan ingakwazi ukukhiqiza izidakamizwa ezishibhile, ezikhiqizayo ze-HIV emazwe asathuthuka ezingenakuzithengisa e-US Ngakolunye uhlangothi, inqwaba enkulu yezwe njenge GSK ingaba "nekhekhe layo futhi idle," futhi ukuvimbela abathengi baseMelika ukuthi bathole ukuthi yiziphi izidakamizwa zabo ezivunywa yi-FDA, izidakamizwa ezijwayelekile ze-HIV.
Yini Engingayenza Ngomthengi?
Ukudayiswa kwemingcele yezidakamizwa ezivela kwamanye amazwe kuya eU.S. kubhekene nokuphikisana okukhulu, kepha omunye wabasebenzisi baseMelika baqhubeka bephendukela. I-Canada iyisibonelo esihle, ivuselela ukugxekwa kulabo abathi ama pharmacies ase- intanethi adumile asetshenziselwa ukungenisa ngokungemthetho kwemithi engavumelekile eya e-US
Ukugxeka kunesiqingatha-kwesokudla nengxenye-hhayi. Ngokuqondene nemali engenayo yangempela, umbiko we-pharmacy waseCanada ku-intanethi uthengisa okungaphezulu kwamaRandi ayizigidi ezingu-80 ngonyaka, inombolo engabhekwa njengengozi uma kuqhathaniswa ne-$ 425 billion ezidayiswayo ku-US ngonyaka ka-2015.
Phakathi naleso sikhathi, umthetho ngokuphathelene nokungeniswa kwezidakamizwa ungenye indaba futhi enye engaba yinto ephikisanayo.
Ngokomthetho we-FDA, akuvumelekile ukuthi abantu bangenise noma yikuphi izidakamizwa e-US ukuze basebenzise ngokwabo ngaphandle uma behambisana nezimo ezikhethekile ezilandelayo:
- Isidakamizwa sisetshenziselwa isimo esibucayi lapho ukwelashwa kungatholakali khona e-US
- Akuzange kube nokukhuthazwa kwezohwebo kwedakamizwa kubasebenzisi base-US.
- Lesi sidakamizwa asisho umonakalo wezempilo ongenangqondo kumsebenzisi.
- Umuntu ongenisa izidakamizwa uqinisekisa ngokubhaliwe ukuthi uzisebenzise yena ngokwakhe, futhi unikeza ulwazi lokuthintana nodokotela ocacisa noma uqinisekisa ukuthi umkhiqizo uwukuqhutshelwa kokwelashwa okuqalwe kwelinye izwe.
- Lo muntu akafaki okungaphezulu kokunikezwa kwezinyanga ezintathu.
Lokhu kugxila kunoma ngubani omunye ngaphandle kokufika kwamanye amazwe noma labo abanesifo esingathí sina, esingenakugula ukungenisa imithi.
I-conundrum-ke ukuthi imithetho yayisekelwe ekuzicabangeni ukuthi i-FDA, ngamazwi abo, "ayikwazi ukuqinisekisa ukuphepha nokusebenza kwezidakamizwa ezingavumelekile." Iqiniso lokuthi iningi lemithi ejwayelekile yegciwane lesandulela ngculazi elisetshenziswe emazweni asathuthuka i-FDA-ivunyiwe ayizange ihambisane ne-agency noma abameli be-US ekushintsheni imithetho yamanje.
Ingabe lokhu kusho ukuthi abathengi abanesandulela ngculaza e-US banekamelo elincane lokuzithengisa izidambisigciwane ezivela phesheya? Cishe akunjalo, njengoba kunendlela eminingi yokuthuthukisa ukutholakala kwalabo abanesifo, kuhlanganise nezinhlelo zosizo lwe-copay (CAPS) nezinhlelo zokusiza abagulayo (PAPs) ezixhaswe ngabakhiqizi bezidakamizwa ze-HIV.
Futhi lokho, mhlawumbe, kuyinhloko enkulu kunazo zonke. Ngisho nalapho abantu bekwazi ukuthola izidakamizwa eziphansi zamahhala nge-CAPs nama-PAP, izidakamizwa zisakwazi ukuzuza kakhulu.
Ngokusho kwe-non-profit AIDS Healthcare Foundation (AHF), lezi zinhlelo ezihlonishwa kakhulu ngeke zibhekwe njengesihe esinikezwa ukuthi abakhiqizi bangafaka izicelo zokunciphisa intela ngokuphindwe kabili izindleko zokukhiqiza izidakamizwa ezinikeziwe ngenkathi begcina amanani aphezulu ukuze asuse ngokuphelele i-ADAP etholakalayo izimali. Ngenxa yalokho, ama-CAPs nama-PAP awazuzisi kuphela ezinkampanini ezidakamizwa kodwa ezizuzisa kakhulu.
Lokhu kungashintsha njengoba izidakamizwa eziningi zifinyelela kosuku lokuphelelwa yisikhathi se-patent, okubandakanya ukubamba iqhaza okukhulu ekukhiqizeni izidakamizwa ezivamile. Kuze kube yileso sikhathi, abathengi abaningi base-US kuzodingeka bathembele emigqeni yamanje yamasevisi-ADAPs, ama-CAPs, ama-PAP, umshuwalense-ukunciphisa umthwalo ophezulu wezidakamizwa zabo ezibiza nge-HIV.
> Imithombo:
> I- Wire Business. "Usizo Lokubhekana Neziguli - I-AIDS Drug Company 'I-Charity' Izinhlelo Ziphumelelanga Iziguli, Kodwa Zinikezela Izigidi Ezimayini Zentela, kusho i-AHF." Ishicilelwe ku-Agasti 2, 2011.
> Farnham, P .; I-Gopalappa, iC .; Isihlengo, S .; et al. "Ukubuyekezwa Kwezindleko Zesikhathi Zokuphila Zokunakekelwa Nezinga Lokuphila Lokulinganiselwa Kwabantu Abathintekayo Nge-HIV e-United States: Ukuhamba Ngesikhathi Esizayo Nokuthola Ukuhlolwa Okuqala Nokungena Ekunakekelweni." I-Journal ye-Immune Deficiency Deficiency Syndromes. Okthoba 2013: 64: 183-189.
> London Stock Exchange. "I-GlaxoSmithKline iqedela ukuthengiswa kwamasheya ase-Aspen asele." ILondon, eNgilandi; imibhalo yokulawula 1740L; Ngo-September 29, 2016.
> Izikhungo Zikazwelonke Zempilo (NIH). "Imihlahlandlela yokusetshenziswa kwama-antiretroviral Agents kuma-HIV nabangu-1 abathintekayo abathintekayo ne-Adolescents - Isithasiselo B: Izidakamizwa Zezidakamizwa (Amanani AseNyanga Aphakanyiswa Ngayo Imithi Ye-Antiretroviral Drugs)." I-Rockville, e-Maryland; April 2016.
> Ukuphathwa Kwezokudla Nezidakamizwa zase-US (FDA). "Ukwakhiwa kwamakhemikhali e-antiretroviral asetshenziselwa ukwelashwa kwe-HIV." I-Silver Spring, e-Maryland; Februwari 4, 2014.