Ukutshintsha iNkundla yokudlala yeeDrugs eziMpawu kunye neeGrikhi
Umthetho osayilwayo, obizwa ngokuba ngu-Hatch-Waxman Act, ophakanyiswe yiSenators u-Orrin Hatch kunye no-Henry A. Waxman, wavunywa ngo-1984. Le ntlawulo ibonakalise insimu yezobisi ngokubanzi, njengoko imise imimiselo karhulumente yezilwanyana zamanzi eMelika kwaye yenza Kulula ukuba iziyobisi zendalo zifike kwiimakethi.
Umthetho we-Hatch-Waxman: Indlela owawushintsha ngayo amayeza
Ukususela ekuvunyelweni koMthetho, inani leziyobisi eziqhelekileyo ezifumanekayo kubathengi liye landa kakhulu.
Izidakamizwa ezigqityiweyo zilahlekelwa ngaphezu kwe-40% yesabelo sabo semarike kubalingani babo obudala. Ngaphambi kokuba uMthetho we-Hatch-Waxman uvunyiwe, kuphela malunga ne-35% yegama lemveliso yegama lonyango kufuneka lineliswe ngumncintiswano wokudala; Kule mihla phantse zonke iziyobisi zijongene neikopiki zendalo.
Umthetho-mali we-Hatch-Waxman, owaziwa ngokusemthethweni njenge-Drug Price Competition kunye ne-Patent Term Restoration Act (uMthetho kaRhulumente 98-417), waletha utshintsho olulandelayo:
- Iziyobisi eziqhelekileyo azidingeki ukuba zibonakalise ukhuseleko kunye nokusebenza kwazo. Ngaphantsi kwebhiliki, abavelisi beziyobisi bezityalo badinga kuphela ukuhambisa iSicelo seMichiza esitsha esicacisiwe (ANDA) ukubonakalisa i-bioequivalence yemveliso kwisiza esichaziweyo. Le nkqubo yincinci kubakhiqizi, njengoko iindleko zokuqhuba izifundo zekliniki kunye nezingezizo zizonyango okanye ukubeka umxanduva kwimimiselo yokuphulwa komthetho ongeyena nxalenye ye-equation yabenzi beziyobisi.
- Iziyobisi eziqhelekileyo zinikezelwa ixesha elilodwa leentsuku ezingama-180. Ingaba isilwanyana sokuqala sokufaka i-ANDA, okanye iqela lokuqala leziyobisi, linikezelwa ngeli xesha.
- Abafaki ukufaka ii-ANDA banokwenza nje kuphela iziyobisi ezingenalo ilungelo lobunikazi.
- I-ANDA zinokufakwa kuphela xa i-patented drug patent iphela.
- Iziyobisi eziqhelekileyo azikwazi ukuya emarikeni ide i-patent yegama elidlulileyo liphelelwe yisikhathi.
- Imvume yokusetyenziswa kwezilwanyana ezinobumba akufuneki iphulwe okanye ingavumelekanga. (Ukuba i-patent iboniswa ukuba ayivumelekanga, i-FDA kufuneka ilinde iinyanga ezingama-30 ide ivume i-generic.)
- Ngenxa yokuba izidakamizwa zogqirha zilahlekelwa yininzi yengeniso yazo xa izidakamizwa eziqhelekileyo zenziwa, uMthetho ubanika iinketho zokwandiswa kweelungelo lomenzi, okwangoku ziphakathi kweminyaka emithathu.
Yintoni ekhokelela kwiNgqungquthela yoYilwayo?
Izimo ezahlukahlukeneyo zenze ukuba kubekho imfuneko yokuguqulwa kwamanani okuncintisana namaxabiso kunye neepententi. Imigaqo yeziyobisi zikaRhulumente ezivela ngo-1962 yenza kube nzima ukuba abenzi beziyobisi bezityalo bafumane iimveliso zabo kwimarike.
Ngaphambi kowe-1962, zonke iziyobisi zavunyelwa ukukhusela, kodwa kungekhona ukuphumelela. Nangona kunjalo, ngenxa yokulinda kwegosa lezokwelapha lase-United States lokutya kunye neDrug (iDA), uDkt. Frances Kelsey, inzululwazi yempilo yoluntu yayithintele xa iqinisekisa ukuba i-thalidomide yokudambisa yayingakaze ivunywe e-United States. Nangona i-thalidomide isetyenziswe kumazwe amaninzi kwaye yayikhokelela kubafazi abangenakubalwa ababeletha abantwana abaneziphene ezinzima kakhulu zokuzalwa, uDkt. Kelsey wathola ukuba akazange ahlolwe kwizilwanyana ezikhulelweyo. Emva koko, ngowe-1962, i-congress yongezelela imfuneko yokuba abenzi beziyobisi babefanele baqinisekise kwakhona ukusebenza kweemveliso zabo ngaphambi kokuba i-FDA ibenokwamkela ukuthengisa.
Olu tshintsho kwiimfuno kunye nemimiselo lwakhokelela kwiinkampani eziqhelekileyo ngokungazisebenzisi ixesha kunye nemali ukwenza izilingo zeklinikhi ukuya kwimarike emva kwe-1962.
Ukuvunyelwa koMthetho we-Hatch-Waxman Act ngo-1984 utshintshe iindlela zokulawula izidakamizwa eziqhelekileyo ukwenzela ukuba kube lula ukuzithengisa kwiimarike ngelixa libonakala likhuselekile kwaye liyimpumelelo.