Kusintha Munda wa Masewera kwa Mankhwala Ogulitsa ndi Ochibadwa
Ndalamayi, yomwe tsopano imadziwika kuti Hatch-Waxman Act, yomwe inakambidwa ndi a Senators Hatch ndi Henry A. Waxman, inavomerezedwa mu 1984. Lamuloli linasintha munda wa mankhwala kwambiri, chifukwa unakhazikitsa malamulo a boma a mankhwala ochiritsira ku United States ndipo Zimakhala zosavuta kuti mankhwala osokoneza bongo alowe mumsika.
Hatch-Waxman Act: Mmene Zinasinthira Mankhwala
Popeza kuvomerezedwa kwa lamuloli, chiwerengero cha mankhwala omwe amapezeka kwa ogula chawonjezeka mwachangu.
Mankhwala ogulitsidwa amawononga kwambiri magawo 40 peresenti ya gawo lawo la msika kwa anzawo obadwa nawo. Asanavomereze Hatch-Waxman Act, pafupifupi 35 peresenti ya mankhwala osokoneza bongo anali okhutira ndi mpikisano wachibadwa; Masiku ano pafupifupi mankhwala onse akuyang'aniridwa ndi makopi a generic.
Bill Hatch-Waxman, yomwe imadziwika kuti Drug Price Competition ndi Patent Term Restoration Act (Public Law 98-417), inabweretsa zotsatirazi:
- Mankhwala osokoneza bongo sayenera kutsimikizira kuti ali otetezeka komanso ogwira ntchito. Pansi pa msonkhanowu, opanga mankhwala osokoneza bongo amafunika kungopereka mankhwala osokoneza bongo atsopano (ANDA) osindikizira kuti asonyeze bioquivalence ya mankhwala awo pachiyambi. Iyi ndi njira yotsika mtengo yopanga opanga mankhwala, monga mtengo wochitira maphunziro a zachipatala ndi osakhala kuchipatala kapena kuika chiopsezo chowopsya kwa kuwonongeka kwa chilolezo siko gawo la equation kwa opanga mankhwala opanga mankhwala.
- Mankhwala ochiritsira amaperekedwa kwa masiku 180 okha. Mwina mankhwala oyamba opangira ANDA, kapena gulu loyamba la mankhwala, amapatsidwa nthawiyi.
- Olemba mafayilo a ANDA akhoza kungochita izi kwa mankhwala omwe sanavomerezedwe.
- ANDAs ingangotumizidwa kokha pamene chilolezo cha mankhwala osokoneza bongo chitatha.
- Mankhwala osokoneza bongo sangathe kupita ku msika mpaka patent ya patentho itatha.
- Zogwiritsira ntchito mankhwala osokoneza bongo siziyenera kuphwanyidwa kapena zosatsimikiziridwa zosayenera. (Ngati chiwonetsero chovomerezeka chikuwonetsedwa kukhala chosayenera, a FDA ayenera kuyembekezera miyezi 30 kufikira atavomerezera zachibadwa.)
- Chifukwa mankhwala osokoneza bongo amataya ndalama zochuluka zedi pamene mankhwala ochiritsira akuyambitsidwa, Chilamulocho chimapereka iwo zosankha zowonjezera za patent, zomwe tsopano zakhala pafupi zaka zitatu.
Nchiyani Chinayambitsa Kuyamba kwa Bill?
Mkhalidwe wosiyanasiyana unayambitsa kufunika kwa kusintha kwa mpikisano wa mtengo wamagetsi ndi zovomerezeka. Malamulo a mankhwala a boma omwe amachokera mu 1962 anapangitsa zovuta kuti opanga mankhwala osokoneza bongo apange mankhwala awo pamsika.
Pambuyo pa 1962, mankhwala onse adavomerezedwa kuti atetezeke, koma osati mogwira mtima. Komabe, chifukwa cha chipatala cha United States cha Food and Drug Administration (FDA), Dr Frances Kelsey, vuto la thanzi la anthu lidalepheretsedwa pamene anaonetsetsa kuti sedative thalidomide sichivomerezedwe ku United States. Ngakhale kuti thalidomide inali kugwiritsidwa ntchito m'mayiko ambiri ndipo inali yopititsa kwa amayi ambirimbiri kubereka ana okhala ndi zilema zobadwa kwambiri, Dr. Kelsey anapeza kuti sanayesedwepo pa zinyama. Pambuyo pake, mu 1962, congress inaonjezeranso kuti opanga mankhwala ayenera kutsimikiziranso kuti ntchito zawo zisanayambe kugwiritsidwa ntchito mpaka FDA isavomereze.
Kusintha kumeneku mwazimene zimapangitsa makampani enieni kuti asagwiritse ntchito nthawi ndi ndalama kuchita mayesero a kuchipatala kuti afike kumsika pambuyo pa 1962.
Chivomerezo cha Hatch-Waxman Act chaka cha 1984 chinasintha malamulo oyendetsera mankhwala osokoneza bongo kuti athe kuwalimbikitsa kuti agulitse pamene akuonedwa ngati otetezeka komanso ogwira ntchito.