Ukushintsha Inkundla Yokudlala Yezidakamizwa Ezifakiwe Nezizukulwane Ezijwayelekile
Umthethosivivinywa, manje owaziwa ngokuthi yi-Hatch-Waxman Act, ohlongozwa yiSenators Orrin Hatch noHenry A. Waxman, wamukelwa ngo-1984. Lo mthethosivivinywa waguqula insimu yezokwelapha ngokuyinhloko, njengoba isungula imithetho kahulumeni yezidakamizwa ezivamile e-United States futhi yenziwe kulula ukuthola izidakamizwa ezivamile ukungena emakethe.
Umthetho we-Hatch-Waxman: Indlela Washintsha ngayo Imithi
Kusukela ukuvunyelwa koMthetho, inani lemithi ejwayelekile etholakalayo kubathengi liye landa ngokukhululekile.
Izidakamizwa ezidakiwe zilahlekelwa ngaphezulu kwezingu-40% zesabelo sabo semakethe kubalingani babo obukhulu. Ngaphambi kokuba uMthetho we-Hatch-Waxman uvunyiwe, kuphela ama-35% wezidakamizwa zamagama wegama lomkhiqizo kwakudingeka aneliswe ngumncintiswano ojwayelekile; Namuhla zonke izidakamizwa zibhekene nama-copycats ajwayelekile.
I-Hatch-Waxman Bill, eyaziwa njenge-Drug Price Competition kanye ne-Patent Term Restoration Act (uMthetho kaZwelonke 98-417), yaletha izinguquko ezilandelayo:
- Izidakamizwa ezijwayelekile azidingeki ukufakazela ukuphepha nokusebenza kwazo. Ngaphansi komthethosivivinywa, abakhiqizi bezidakamizwa ezivamile bafuna ukuhambisa kuphela isicelo esibambile sokusetshenziswa kwezidakamizwa (ANDA) sokufaka isicelo se-bioquivalence yomkhiqizo wesidakamizwa sokuqala. Lena inqubo encane yabakhiqizi, njengoba izindleko zokuqhuba izifundo zemitholampilo noma ezingekho emtholampilo noma ukulimaza umonakalo wokulimala kwephula umthetho akuyona ingxenye ye-equation yabakhiqizi bezidakamizwa ezivamile.
- Izidakamizwa ezijwayelekile zinikezwa isikhathi sokuphela kwezikhathi ezingu-180. Noma ngabe izidakamizwa zokuqala zokufaka i-ANDA, noma iqembu lokuqala lezidakamizwa, zinikezwa lesi sikhathi.
- Abakhiqizi abafake ama-ANDA bangenza kuphela izidakamizwa ezingazange zenziwe amalungelo.
- Ama-ANDA angathunyelwa kuphela uma i-patent yomuthi we-branded iphelelwe yisikhathi.
- Izidakamizwa ezijwayelekile azikwazi ukuqhubeka emakethe kuze kube yilapho i-patent egunyaziwe iphelelwe yisikhathi.
- Izimvume zomuthi ezidakiwe akufanele ziphulwe noma zingavumelekile. (Uma i-patent iboniswa ukuthi ayivumelekile, i-FDA kumele ilinde izinyanga ezingu-30 ize ivume isizukulwane.)
- Ngenxa yokuthi izidakamizwa ezidakamizwa zilahlekelwa yimali engenayo kakhulu uma izidakamizwa ezijwayelekile ziqaliswa, lo Mthetho ubahlinzeka ngezinketho zokukhulisa i-patent, manje ezilinganiselwa eminyakeni emithathu.
Yini eyaholela ekusungulweni koMthethosivivinywa?
Izimo ezihlukahlukene zaholela ekudingeni izinguquko ekuncintisaneni kwamanani ezidakamizwa kanye nemigomo yegunya lobunikazi. Imithethonqubo yezidakamizwa zikahulumeni ezivela ngo-1962 yenza kwaba nzima kwabakhiqizi bezidakamizwa abavamile ukuthola imikhiqizo yabo emakethe.
Ngaphambi kuka-1962, zonke izidakamizwa zavunyelwa ukuphepha, kodwa hhayi ukuphumelela. Noma kunjalo, ngenxa yokuqapha kwesiphathimandla sezokwelapha se-US Food and Drug Administration (FDA), uDkt Frances Kelsey, inhlekelele yempilo yomphakathi yavinjelwa lapho eqinisekisa ukuthi i-sedative thalidomide ayingakaze yamukelwe e-United States. Nakuba i-thalidomide isetshenziswe emazweni amaningi futhi yayiholela kubesifazane abangenakubalwa ababeletha izingane ezineziphene ezinzima kakhulu zokuzalwa, uDkt. Kelsey wathola ukuthi akukaze kuhlolwe izilwane ezikhulelwe. Ngemva kwalokho, ngo-1962, inhlangano yanezela isidingo sokuthi abakhiqizi bezidakamizwa kufanele bafakaze nokuthi ukusebenza kwemikhiqizo yabo ngaphambi kokuba i-FDA ivumelane nabo ekuthengiseni.
Lolu shintsho ngezidingo kanye nemithethonqubo laholela ezinkampanini ezijwayelekile nje ukuthi zingasisebenzisi isikhathi kanye nemali zenza izivivinyo zokwelashwa ukuze zifike emakethe ngemuva kuka-1962.
Ukwamukelwa koMthetho weHatch-Waxman ngo-1984 kwashintsha imikhuba yokulawulwa kwezidakamizwa ezivamile ukuze kube lula ukuwazisa emakethe ngenkathi kubhekwa njengophephile futhi esebenzayo.