US Pharmaceuticals ekhuselekileyo ekukhuselweni kwiNcintiswano
Bambalwa banokuphikisana nenyaniso yokuba izidakamizwa ze-HIV zibiza. Enyanisweni, ngokwamaziko okuLawula nokuLawula (i-CDC), umntu ophila ne-HIV oqala unyango kuqala uya kujongana neendleko zokuphila ezimalunga nama-250,000, kwaye zizo kuphela izipilisi zabo. Iindleko akunakwenzeka kumangaliswe ukuba inqanaba elingu-ezintathu ngeyodwa , njengo Triumeq , inexabiso elithe xaxa elingaphezu kwama-$ 2,600 ngenyanga.
Olunye udibaniso lungaphezulu kwelo .
Nangona kunjalo, awuvami ukuva kakhulu endleleni yokukhala kwesizwe ngokumalunga nexabiso leziyobisi. Kwaye kungenxa yokuba abaninzi banokufumana iziyobisi zabo ze-HIV ezihlawulwe, ubuncinane inxalenye, kwi-inshurensi okanye inkxaso-mali eyahlukeneyo karhulumente kunye neyodwa.
Ngomoya ofanayo, abanye bacelwa ngokucacileyo ukuba izidakamizwa ze-antiretroviral zingayithwala njani iteksi ephezulu e-US xa siva ukuba iinguqulelo zesi-generic azifumaneki nje phesheya ngaphandle kweendleko ezimalunga nama-2000 eepesenti ngaphantsi koko sihlawula apha.
Izizathu zokungabikho kwezidakamizwa ze-HIV kwi-US ngokukhawuleza zilula kwaye zidideka, ezibandakanya isayensi, ezopolitiko, kunye nokuhle, inzuzo engumdala. Ngokuhlukanisa le miba edibeneyo, sinokwenza ngcono ingxaki yemingeni ejongene nabathengi abane-HIV kunye noshishino lononophelo lwezempilo.
Xa ukuqhubela phambili kweeNzululwazi kuQinisekisa ukuPhuhliswa kweeMveliso eziDala
Ukuthetha ngokuqhelekileyo, xa i-patent yesilwanyana iphela (ngokuqhelekileyo kwiminyaka engama-20 emva kokuba i-patent ifike kuqala), ilungelo lokukopisha eso sigqirha siya kuvulwa kunoma ubani okhetha ukudala inguqu yesiqhelo.
Injongo yesizukulwana kukukhuphisana nemveliso yokuqala kwintengo, kunye nabadlali abaninzi abakhuphisana nokuncintisana okukhulu kwaye, ngokuphindaphindiweyo kuninzi, iindleko eziphantsi.
Ngoko kutheni singakuboni oku ngeziyobisi zeHIV? Emva koko, amaphepha abenzi beliluhlu olude lwe-antiretrovirals liye laphelelwa yisikhathi okanye liza kuphelelwa yisikhathi, kubandakanywa nezidakamizwa zangaphambili "njenge-superstar" njengeSusvava (efavirenz) kunye ne-tenofovir (TDF).
Kodwa xa uhlolisisa ukubhaliswa kwe-Food and Drug Administration (i-FDA), ukufometha kwezinto eziqhelekileyo kuye kwafakwa kuphela kwaye kuvunywe iinqununu zamachiza ezithandathu. Kule ndawo, isithathu sisetyenziswa rhoqo kunyango lwe-HIV e-US (stavudine kunye ne-didanosine), ngelixa zonke ezimbini (abacavir kunye ne-lamivudine) ziwa phantsi.
Kwaye kukho enye yeengxaki ezijongene nabenzi bokuvelisa kwisithuba se-HIV: Ukutshintsha ngokukhawuleza kwenzululwazi kunokwenza ezinye iifayili zonyango zingasebenzi.
Ukunciphisa Ukufuna Ukunciphisa Umncintiswano wamaGeneric
Thatha, umzekelo, i-Rescriptor (delavirdine) kunye ne-Aptivus (tipranavir), imichiza emibili ye-HIV enesifo sayo sephepha eliphelelwe lixesha ngo-2013 no-2015, ngokulandelana. Nangona zombini zombini zisasetyenziselwa unyango lwe-HIV, ezinye, izidakamizwa eziza kutsalwa (ngokukodwa i-integrase inhibitors) zinikezelwe isikhundla. Ezi zi yobisi, okwangoku, zichithwe kwimeko ethile.
Ngenxa yoko, i-Rescriptor ne-Aptivus iya kusetyenziswa ngokuphindaphindiweyo ngokuthi "ukuwa" xa ezinye iyeza ziphumelela. Oku kuphela kunciphisa i-incentive kubakhiqizi ukuba bagxume kwimveliso yesiqhelo xa kukho isiqinisekiso esincinci sokuthengiswa kwevolumu.
Ngokufanayo, ngelixa i-TDF iphakathi kwezona zisetyenziswa kakhulu kwihlabathi, inguqu ephucukileyo-ebizwa ngokuthi i- tenofovir alafenamide (TAF) -yaqaliswa ngo-2016 njengoko i-patent ye-TDF isetyenziselwe ukuphela kwayo.
Uceba? Hayi ngokwenene, kunikezelwa ukuba ifom entsha inika imiphumo embalwa yecala kunye nemilinganiselo ye-concentration ye-blood-static-state (ebonisa ukuba izilwanyana zihlala kwindlela yakho ixesha elide). Ekugqibeleni, i-TAF yisisisi esilungileyo esilungisa ngokufanelekileyo iTDF, ngokukodwa kwiipilisi ezidibeneyo ezintsha.
Ngoko, ngaba oko kuthetha ukuba asiyi kubona iifom zendalo zeTDF nanini na? Uninzi lukholelwa ukuba siya. Ngaphandle kwimeko yokunciphisa imfuno, i-TDF generic isenendawo kwi-regimen yangoku ye-HIV kwaye ingamkelwa ngenyameko ngabaxhasi-mali kunye nabanye ababoneleli abafuna ukunciphisa iindleko zonyango . Kwaye, ekugqibeleni, ukukhuphisana kwama-generic kukho kwiimarike, ixabiso eliphantsi liya kuhamba.
Ngokuqinisekileyo kuye kwimeko ye-generic version ye- Epzicom , inketho ezimbini ngeyodwa ene-abacavir kunye ne-lamivudine. Ngamacandelo omabini amachiza atshayelwa unyango lokuqala, abavelisi abane baye baphuma kwi-bandwagon ye-generic kwaye baye bakwazi ukunikela imali engama-70 kwipesenti yegama legama lomtshini.
Abakhi bezobisi be-HIV baxhaswe kwii-Generic Price Pressures
Abenzi beziyobisi be-HIV base-US basesimweni esicacileyo sokunyanzeliswa komncinci okhuphiswano oluvela kwiinkampani eziqhelekileyo ezinokuthi zibe zihamba kwizithende zabo.
Okokuqala, umthengi ufuna iipilisi enye yeepilisi yenza iipilisi zamanye zikhangeleke nakakhulu nakweyiphi na kodwa emva kwexesha. Akumangalisi ukuba iipatentshi ezininzi zeepilisi ezihlanganisiweyo azikho ngaphaya kokuphela kokuphila kwazo, ezinye zifana neTruvada (TDF kunye ne-emtricitabine) kuphela ngenxa yokuphela kwe-2021.
Ngoko nangona izixhobo zonyango zifumaneka kubenzi bokuvelisa, umthengi uya kufaka amanqaku e-brand combination tablet (ngaphandle kokuba, ngokuqinisekileyo, i-insurer iyabangela ukuba benze njalo).
Kodwa, nangapha ngaphaya kombandela weemfuno zabathengi, inkundla yokudlala ngokukhuphisana e-US sele iqhutywe ingqamene kwindlela yokuvelisa umenzi weziyobisi ze-HIV. Oku kubangelwe inxalenye enkulu kwinyaniso yokuba urhulumente wase-US nguye oyena mthengi omkhulu wezilwelisi ze-antiretroviral namhlanje.
Ngokusetyenziswa kweNkqubo yoNcedo lweAIDS ye-AIDS (ADAP) , oorhulumente baseburhulumenteni bajoliswe ekuthengeni iziyobisi ze-HIV ngqo kwiivenkile. Amanani asetyenziswa kwiNkqubo ye-340B yeProducative Pricing Programme, ehlawula ixabiso lentengo ngokubanzi ukusuka kwimizuzu engama-60 ukuya kuma-70. Emva kokufaka imali kwizaphulelo, igama legama elibizo liphantse liphela lingabi nancinci kunelihlobo lomenzi.
Enye into yokukhusela imithi yindlela yokwaziswa ngayo unyango. Ngokungafani ne-inshorensi yempilo yabucala, i-ADAP yokukhetha unyango ijoliswe kuphela kwizikhokelo ezikhutshwe yiSebe lezeMpilo kunye neenkonzo zeNtlalo , okwangoku zibeka zonke iipilisi ezidibeneyo-zona kanye izidakamizwa ezikhuselweyo ngamalungelo abenzi-njengokhetho olukhethiweyo kunyango lokuqala .
Ekugqibeleni, "ayikho" ukuqhuba le miyalelo. Izifundo sele zibonise ukuba abantu abakwiyeza elilodwa lonyango banokuthi bahlale bexhasana ngokumalunga nalabo bathabatha iipilisi eziliqela. Le nto iguqulela kumazinga aphezulu okunciphisa intsholongwane, oku kuthetha ukuba intsholongwane ayikwazi ukuphindaphinda kwaye awukwazi kakhulu ukuvelisa ukungaxhatshazwa kweziyobisi.
Eyona nto okanye ayikho, le migaqo ayikwazi ukunceda kodwa iyakuthanda umenzi ongeyena-generic, okwenza kube nzima nakakhulu kwiinkampani zenkampani ukukhuphisana nantoni na ngaphandle kwezinga eliphezulu.
Ukuqhubela phambili ukukhusela isikhundla sabo semarike, phantse bonke abavelisi begama lomntu bavumelene ukubonelela ngenkxaso-mali kwabo bangenako ukufumana iziyobisi zabo, nokuba ngabahlobo lwe -pay-pay aid okanye inkxaso yenkxaso kwabo bangenako ukufumana i-inshorensi. Ngumnikelo wokuvelisa abenzi bokuvelisa unzima ukuxhatshazwa.
Kodwa, njengento ebalulekileyo njengalezi zikhuthazo, abasayi kujongana neendleko eziphezulu ze-ARV xa kuthelekiswa namachiza afanayo afumaneka ngaphandle kwe-US
I-Overseas Price Price Challenges Research and Development Claims
Inkampani enkulu yokuthengisa i-pharma yinkampani yehlabathi jikelele eqhubeka ngaphaya kwemida yase-US. Akugcini nje ukubeka ezi nkampani kwiintengiso zemveliso apho izifo, ezifana ne-HIV, zixhaphaza, zibavulela ithuba lokugcina ulawulo olulodwa kumalungelo abo engqondo.
Oku kuyinyani ngokukhethekileyo kumazwe afana ne-Indiya, apho imithetho yayo ivumela ukuveliswa kwezidakamizwa ezibalulekileyo ze-HIV kungakhathaliseki ilungelo lobunikazi. Ngenxa yoko, iIndiya namhlanje ngumthengisi omkhulu we-antiretrovirals kumazwe aphuhlisayo, iziyobisi ezingekho nje ngekhemikhali ezifana neyokuqala kodwa zivunywe ngabanye yi-FDA.
Ngaloo ndlela, umntu angathenga i- Atripla inguqu ye- generic malunga ne-$ 50 kwi-counter yokuthengisa eMzantsi Afrika, ngelixa ejongene nentengo epheleleyo ye-$ 2,500 kwiiWalgreens okanye kwi-CVS.
Icandelo lezobisi liye laqhubeka lifuna ukuba le nkunkuma ingenxa yendleko ephezulu kakhulu yophando kunye nophuhliso (R & D), ezingenakuthatha iminyaka kuphela kodwa zifike kwiibhiliyoni zeedola. Ekubeni, ibango elifanelekileyo linikezelwa ubuninzi be-R & D yokuqala e-US phakathi kwendawo ye-biopharma kunye nezixhobo zophando.
Ngokwemithetho esemthethweni ye-patent, i-pharmas ithi, amazwe anjengamaNdiya angenza inzuzo ngokulula kwi-generic-cost generics kuba bengenelinyanzeliso lwe-R & D. Iimpawu ezinkulu zezobisi, ngokuchaseneyo, abanalo i-luxury, kwaye, ngokungagqibekanga, abathengi babo.
Ingqungquthela ukuba i-80 ekhulwini yezithako ezenziwe ngamachiza ase-US kunye neepesenti ezingama-40 zazo zonke izidakamizwa ezigqityiweyo zivela kumazwe afana neIndiya kunye neChina, ngokwe-FDA. Kwaye, nangona amabango athi iIndiya yenza ukubulawa ngokunyusa amalungelo abenzi, i-annual return for the shishini le-Indian mveliso limela ama-2 nje ekhulwini kwi-indleko yehlabathi jikelele.
Ngaphezu koko, ezininzi iimveliso zakwaMerika zixhomekeke kumashishini ase-Indiya, kuquka ne-Pennsylvania-based Mylan, leyo ngo-2007 bathenga ubunini bomnini weMatrix Laboratories, umvelisi ophezulu waseIndiya wezityalo ezisebenzayo (i-API) ezisetyenziswa kwiziyobisi eziqhelekileyo. Ukuthenga kwandinceda i-Mylan ibe yiyiphi enye yezona zine nkampani enkulu yezilwanyana ezinkulu emhlabeni jikelele.
Ngokufanayo, i-GlaxoSmithKline (GSK) yegciwane lehlabathi jikelele, kude kube kutshanje, inxaxheba enkulu e-Aspen Pharmacare, i-Pharmaceutical yaseMzantsi Afrika esekelwe enye yelizwekazi eliphambili elivelisa izidakamizwa ze-HIV. Ubudlelwane, okwakhiwa ngo-2009, buvumele i-GSK ukuba ilayisenisi ye-HIV ye-HIV e-Aspen, kubandakanywa i-tablet ye-powerhouse efanayo, i-Combivir. Oku kwavumela i-GSK ukuba ihlanganyele kwingeniso ekuthengiseni izidakamizwa zabo ze-HIV e-Afrika ngelixa zigcina ixabiso eliphezulu letikiti ezifanayo, ezingezona ziguquko kwi-US.
Ngo-2016, i-GSK yathengise ipesenti zayo ezingama-16 kwi-Aspen Pharmacare ngenzuzo ebiziweyo eyi-1.9 billion yezigidi. Oku kuhambelana nokuphela kwe-Combivir ngaloo nyaka.
Kwakungenangqondo ukuphoswa ngabameli, abavakalisa ukuba izenzo ezinjalo zibandlulula. Ngakolunye uhlangothi, inkampani yaseMelika efana ne-Mylan inokuvelisa ixabiso elincinci, i-HIV egazini kwilizwe eliphuhlisayo elingenakuyithengisa e-US Ngolunye uhlangothi, i-giant multinational like GSK inokuthi "inokwakheka kwayo kunye nayo" ukuthintela abathengi baseMelika ukuba bafikelele kwizinto ezizenzekelayo zabo ze-FDA-ezivunyiweyo, iziyobisi zentsholongwane kaGawulayo.
Yintoni Ndingayenza NjengeMboleki?
Ukuthengiswa kwemida-mida yezilwanyana zamachiza okuvela kwamanye amazwe ukuya eU.S. uhlala umbandela omkhulu, kodwa omnye umthengi waseMerika uyaqhubeka ephendukela. IKhanada ngumzekelo oyintloko, ukugxekwa kwabo bafuna ukuba ama- pharmacy adumile e-intanethi azuzisa ukungenisa ngokungekho mthethweni kwezidakamizwa ezingavumelekanga kwi-US
Izigxeko zi-half-right and half-not. Ngokweengeniso zengeniso-mali, ingxelo ye-pharmacy yaseCanada e-intanethi engathengi imali engaphezu kwezigidi ezingama-80 ngonyaka, inani elingenakubonwa njengengozi xa kuthelekiswa ne-$ 425 yezigidigidi kwiirhwebo ezibikwe e-US ngo-2015.
Okwangoku, umthetho malunga nokungeniswa kwamachiza ngenye into ebalulekileyo kwaye enye inokuba yinto ephikisanayo.
Ngokomthetho we-FDA, akukho mthethweni ukuba umntu angenise nayiphi na into e-US ukuba ayisebenzise ngokwakhe ngaphandle kokuba ahambisane nezi meko ezizodwa:
- Isilwanyana sisetyenziselwa imeko ebalulekileyo apho unyango alufumaneki e-US
- Akuzange kubekho ukukhuthazwa kwezorhwebo kweziyobisi kubasebenzisi base-US.
- Isilwanyana asibonakali umngcipheko wempilo kumsebenzisi.
- Umntu ongenisa izidakamizwa uqinisekisa ngokubhaliweyo ukuba usetyenziso lwakhe, kwaye unikezela ngolwazi lokuqhagamshelana noogqirha okanye uqinisekise ukuba umkhiqizo ukuqhubeka unyango oqalwe kwelinye ilizwe.
- Umntu akangenisi ngaphezu kweenyanga ezintathu zokubonelela.
Le miba ebaluleke kakhulu ngaphandle kwababemi basanda kufika okanye abo banesifo esibi, esingenasifo sokungenisa iimyeza.
I-conundrum, ngokuqinisekileyo, kukuba imithetho yayisekelwe ekucingeni ukuba i-FDA, ngamazwi abo, "ayikwazi ukuqinisekisa ukhuseleko kunye nokusebenza kweziyobisi ezingavumelekanga." Inyaniso yokuba ininzi yezidakamizwa zentsholongwane kaGawulayo ezisetyenziswa kumazwe asathuthukayo avunyelwe i-FDA ayizange ifake i-arhente okanye abameli be-US ngokuguqula imithetho yangoku.
Ngaba oku kuthetha ukuba abathengi abanentsholongwane ye-HIV e-US banamagumbi athile xa beza ekungeniseni izidakamizwa ze-antiretroviral ezivela phesheya? Mhlawumbi akunjalo, ngenxa yokuba kukho iindlela ezininzi zokuphucula ukufikeleleka kwabo banesifo, kubandakanywa iinkqubo zonyango lwe-copay (ii-CAPs) kunye neenkqubo zokuncedisa isigulane (PAPs) ezixhaswa ngemali ngabenzi beziyobisi be-HIV.
Kwaye, mhlawumbi, yiyona nto inkulu kunayo yonke into. Ngaphandle kokuba abantu bekwazi ukufikelela kwiimali eziphantsi kweendleko eziphantsi kweCAPs kunye ne-PAPs, amayeza ayaqhubeka nokufumana inzuzo enkulu.
Ngokwe-Non-profit Foundation Foundation (AHF), ezi nkqubo ezixutywayo kakhulu akunakucingwa ukuba zintando ezinikezelwayo ukuba abavelisi banokubanjiswa kweerhafu ngokuphindwe kabini kwindleko yokuvelisa izidakamizwa ngexesha lokulondoloza amaxabiso aphezulu ukucima yonke i-ADAP ekhoyo. mali. Ngaloo ndlela, i-CAPs nee-PAP azizuzisi nje kwiinkampani zonyango kodwa zizuzisa ngokukodwa.
Oku kungatshintshwa njengendlela yokusetyenziswa kweziyobisi ngaphezulu komhla wokuphelelwa ngumenzi we-patent, ukukhuthaza inxaxheba enkulu kwi-generic product production. Kuze kube ngoko, abaninzi abathengi baseMelika baza kufuneka bathembele kwizigaba ezikhoyo zamancedo-ADAPs, ii-CAPs, ii-PAPs, i-inshurensi-ukunciphisa umthwalo ophezulu weziyobisi zabo zeHIV.
> Imithombo:
> I- Wire Wire. Inkxaso Yonyango I-Scam - AIDS I-Drug Company 'I-Charity' Inkqubo Yehluleka Izigulane, Kodwa Ibonelela Izigidi Kwiingxowa Zentlawulo kwiShishini, i-AHF ithi " Ishicilelwe ngo-Agasti 2, 2011.
> Farnham, P .; Gopalappa, C .; Isihlengo, iS .; okqhubekayo. "Ukuhlaziywa kweeNkcitho zoLondolozo lweMpilo kunye noLungiso lwezoBomi kubantu abachaphazelekayo kwi-HIV e-United States: Ixesha elifutshane kunye nokuxilongwa kwangaphambili kunye nokungena kwiNkathalo." I-Journal ye-Immune Deficiency Syndromes. Oktobha 2013: 64: 183-189.
> London Stock Exchange. "I-GlaxoSmithKline igqiba ukuthengiswa kwezabelo zeAspen ezisele." ELondon, eNgilani; maxwebhu 1740L; NgoSeptemba 29, 2016.
> IiNational Institutes of Health (NIH). "Izikhokelo zokusetyenziswa kwee-Antiretroviral Agents kwi-HIV-1-Abadala abakhulelweyo kunye nabantwana abakwi-Adolescent - Isihlomelo B: Iinkcukacha zeDrug Rockville, Maryland; Epreli 2016.
> Ulawulo lweZiko lokuTya kunye neDrug (FDA). "Iifom ye-generic ye-antiretroviral yezilwanyana ezisetyenziswayo kunyango lwe-HIV." Silver Spring, eMaryn; Fe bruwari 4, 2014.