Beddelista Goobta Ciyaarta ee Calaamadeysan iyo Daroogada Guud
Sharciga, oo hadda loo yaqaan Xeer Hatch-Waxman, oo ay soo jeedisay Senators H. Orin Hatch iyo Henry A. Waxman, ayaa la ansixiyey 1984-kii. Sharciga ayaa bedelay daawada dawooyinka, taas oo ku saleeysay dawladaha dawooyinka guud ee dawooyinka guud ee Maraykanka waxay u sahlan tahay daawooyinka caamka ah inay galaan suuqa.
Sharciga Hatch-Waxman: Sida Loo Beddelay Farmasiyada
Tan iyo markii la ansaxiyey sharciga, tirada daawooyinka guud ee loo heli karo macaamiisha ayaa kor u kacay.
Daroogooyinka calaamadaysan waxay badiyaa ka lumiyaan in ka badan 40% saamigooda suuqgooda inay u dhigmaan shaqsiyaadka guud. Kahor Xeerkii Hatch-Waxman la ansixiyay, kaliya 35% oo ka mid ah daroogada magaca caanka ah waa inay kaqeyb qaataan tartame caan ah; Maanta waxaa ku dhawaad dhammaan daawooyinka ay la kulmaan copycat generic.
Biilka Hatch-Waxman, oo si rasmi ah loo yaqaan "Competition Price Competition and Patent Term Restoration Act" (Sharciga Dadweynaha 98-417), wuxuu keeney isbedeladan soo socda:
- Daawooyinka caadiga ah uma baahna inay caddeeyaan nabadgelyadooda iyo waxtarkooda. Sida ku xusan sharciga, shirkadaha daroogada wadaaga ah waxay u baahan yihiin oo kaliya inay soo gudbiyaan Codsi Cusub oo Cusbooneysiin ah (ANDA) si ay u caddeeyaan midabkooda u qalmid la'aanta daroogada asalka ah . Tani waa nidaam raqiis ah oo loogu talagalay soo saarayaasha, sida kharashka ku baxa daraasad kiliinikada iyo kuwa aan kiliinikada ahayn ama masuuliyada halista ah ee waxyeellada xadgudubka ee patent-ka ah ma aha qayb ka mid ah isla'egta loo isticmaalo daroogooyinka caadiga ah.
- Daawooyinka guud waxaa la siiyaa mudo 180-maalmood ah oo gaar ah. Midkood daroogada ugu horeysa ee lagu diiwaan geliyo IA, ama kooxdii hore ee daroogada, ayaa la siiyaa waqtigan.
- Warshadaha xereeynaya IYO waxay kaliya u sameyn karaan daawooyinka aan la shaacin.
- IYO waa la soo rogi karaa oo keliya markii la soo daayo daroogada daroogada ee sumadaysan.
- Daawooyinka caadiga ah ma sii socon karaan ilaa suuqa ilaa ay dhacdo in patent-kii calaamad u dhacay.
- Sharciyeyaasha maandooriyaha ee brand-ka ah waa in aan la xad-gudbin ama la xaqiijin ansax. (Haddii shati u qoran yahay in la ansaxiyo, FDA waa inay sugto 30 bilood ilaa ay oggolaato guud ahaan.)
- Sababtoo ah daroogada calaamadeysan ayaa waayaya inta badan dakhligooda marka daawooyinka guud la soo saaro, Sharcigu wuxuu ku siinayaa fursado dheeraad ah oo la xidhiidha patent-ka, taas oo hadda celcelis ahaan saddex sano ah.
Maxaa Loo Diiday Hirgelinta Sharciga?
Xaalado kala duwan waxay keeneen baahida loo qabo isbedelka tartanka qiimaha daroogada iyo shuruudaha patentka. Qawaaniinta dawladaha dawladaha ee sannadkii 1962, waxay adkeeyeen dawladaha daroogada wadaaga ah inay soo saaraan alaabtooda suuqa.
Ka hor 1962, daroogooyinka oo dhan ayaa loo ansixiyey amniga, laakiin maaha wax ku ool ah. Hase yeeshe, sababo la xiriira feejignaanta sarkaal caafimaad oo Mareykan ah, Dr Frances Kelsey, ayaa ka hortagay musiibada caafimaadka dadweynaha markii ay hubisay in daawada thalidomide ee seddexda ahi aanay waligood ogolaaneyn Maraykanka. Inkasta oo thalidomide loo adeegsan jiray dalal badan oo u horseeday dumar aan tiro lahayn oo dhalanaya carruurta qaba cillado halis daran, Dr. Kelsey ayaa ogaaday in aan waligood laga baarin xayawaanka uurka leh. Kadib, ka dib, 1962, shirku wuxuu ku daray shuruudaha in shirkadaha daroogada ay sidoo kale cadeynayaan wax ku oolnimada alaabtooda ka hor inta aysan FDA u oggolaanin suuqgeynta.
Isbedelkan shuruudaha iyo xeerarka waxay keeneen shirkado caan ah oo aan si fudud u isticmaalin wakhtiga iyo lacagaha ay sameeyaan tijaabooyinka kiliiniga si ay u helaan suuqa kadib 1962.
Oggolaanshaha Sharciga Hatch-Waxman ee 1984-kii ayaa wax ka beddelay hab-dhaqanka guud ee dawooyinka guud si loo sahlo in lagu soo bandhigo suuqyada iyadoo weli loo arko inay tahay mid ammaan ah oo hufan.