Kuchinja Munda Unobatsira Kutengeswa uye Zvirwere Zvinodhaka
Mutemo uyu, unozivikanwa seHatch-Waxman Act, wakasarudzwa neSenators Orrin Hatch naHenry A. Waxman, wakatenderwa muna 1984. Mutemo uyu wakashandura mushonga wemishonga zvikuru, sezvo wakagadza mitemo yehurumende yemishonga inowanzo muUnited States uye yakaitwa Zviri nyore kuti zvinodhaka zvinowanzopinda mumusika.
Hatch-Waxman Mutemo: Maitiro Aakachinja Mishonga
Kubvira kugamuchirwa kweMutemo, nhamba yemishonga inowanika inowanikwa kune vatengi yakawedzera zvishoma nezvishoma.
Zvinhu zvinoshandiswa zvinodhaka zvinowanzorasika zvinodarika 40% zvemugove wavo wemusika kune vamwe vavo vanoita zvekare. Pamberi peHatch-Waxman Act yakagamuchirwa, chete 35% yezita remishonga yemishonga inofanira kugutsikana nemupikisano wechizvarwa; Mazuva ano madhigiriro ose anotarisana nemakopikiti akawanda.
Hatch-Waxman Bill, inonzi inozivikanwa seDrug Price Competition uye Patent Term Restoration Act (Mutemo 98-417), yakaunza zvinotevera kuchinja:
- Generic drugs haichadi kuratidza kuchengetedza kwavo uye kubudirira. Pasi pemutemo, vatori vezvinodhaka zvinokonzerwa chete zvinoda kuendesa Bhuku Rakarefu reDrug Application (ANDA) kuti varatidze bioquivalence yemuiti yavo kune chinonzi chirwere chinonzi branded . Iyi inodhura hurongwa hwevanogadzirisa, sezvo mari yekuitisa kuchipatara uye kwete-kuchipatara kana kuti kuisa mungozi kwekuvhiringidza kwepamutemo kwepamutemo haisi chikamu chekuenzanisa kwevanhu vanoita zvinodhaka zvinodhaka.
- Generic drugs inopiwa mazuva 180 ega ega. Zvichida mushonga wekutanga wokuisa ANDA, kana boka rokutanga remishonga, rinopiwa nguva iyi.
- Vagadziri vanyorera ANDAs vanogona kungoita izvozvi pamishonga isina kubhadhara.
- IAA inogona kungoiswa chete kana chiratidzo chechirwere chechirwere chekare chakapera.
- Mishonga yemagetsi haigone kuendesa kumusika kusvikira chinonzi breed patent chapera.
- Kutengeswa kwechirwere chepaiti chepaiti haufaniri kunge chakaputswa kana kuti chisina kuonekwa chisina kuwanikwa. (Kana chibvumirano chinoratidzika chisina kukodzera, FDA inofanira kumirira mwedzi makumi matatu kusvikira ichibvumirana nemaitiro.)
- Nemhaka yokuti mabhizimisi aya anorasikirwa nemari yakawanda yemari yavo apo mishonga yemishonga inowanikwa, Mutemo unovapa vane maitiro ekuwedzera epa patent, ayo zvino avereji anenge makore matatu.
Chii chakaita kuti kuve nokutanga kweBill?
Mamiriro akasiyana-siyana akaunza kudikanwa kwekugadziriswa mumakwikwi emakwikwi emakwikwi uye maitiro epamutemo Hurumende mitemo yezvinodhaka inotangira kubva muna 1962 yakaita kuti zvive nyore kuti vashandisi vezvinodhaka vese vawane zvinodhaka pamusika.
Kusati kwa1962, mishonga yose yakabvumirwa kuchengetedzwa, asi kwete kubudirira. Asi, nekuda kwekuchenjerera kweU.S. Food and Drug Administration (FDA) mushonga wezvehutano, Dr. Frances Kelsey, dambudziko rehutano rehutano rakarambidzwa paakaona kuti sedative thalidomide yakanga isina kumbobvumirwa muUnited States. Kunyange zvazvo thalidomide yakanga iri kushandiswa munyika dzakawanda uye yakanga iri kutungamirira kune vakadzi vasingaverengeki vachizvara vana vane urema hwakakomba kwazvo, Dr. Kelsey akawana kuti yakanga isati yaongororwa pamhuka dzine mimba. Mushure maizvozvi, muna 1962, congress yakawedzera chido chekuti vatengesi vezvinodhaka vaifanirawo kuratidza kubudirira kwezvigadzirwa zvavo vasati vava FDA vanovabvumira kuti vatengese.
Kuchinja uku mumitemo nemitemo kwakatungamirira kumakambani anowanzoga asingashandisi nguva nemari vachiita mishonga yekliniki kuti vasvike kumisika shure-1962.
Kugamuchirwa kweHatch-Waxman Act muna 1984 kwakashandura mitemo yezvinodhaka zvinowanzoita kuti zvive nyore kuvataurira kuti vatengese vachiri kuonekwa sevakachengeteka uye vanobudirira.