Xa Ifika Kumachiza, Ngaba "Ufumana Oko Uhlawula"?
Umbuzo onzima kunayo yonke oye wahlangana nayo kwivenkile ukususela okokuqala ucele "iphepha okanye iplastiki?" Wena usekhomishini ukuzalisa umyalelo wakho kwaye umepmistiki uphendukela kuwe ukuba abuze, "Ngaba i-generic version yalungile?" Unomdla ngokunyanisekileyo ukhetho lwakho: izidakamizwa zendalo zibiza ixabiso elincinci, kodwa ngaba zifana nelo gama igama legama ?
Ngaba kufuneka ufumane i-generic kwaye ulondoloze amabhaksi ambalwa?
Impendulo yinto ephazamisayo "mhlawumbi." Kwiimeko ezininzi, iziyobisi zendalo zibhekwa zikhuselekile ngenxa yenkqubo yokuvavanya esetyenziswa yi-Food and Drug Administration (FDA).
Amalungelo eMithi
Iinkampani zamachiza zizisa imali eninzi ekuphuhliseni amayeza abo. Ukuze uhlawule ezo ndleko, ezinokuthi zibe ngamakhulu ezigidi zeedola, urhulumente wase-US unikezela ilungelo lobunikazi okanye ubodwa kwiziyobisi.
Ilungelo lobunikazi lichazwa ngokuthi "ilungelo lokukhupha abanye ngaphandle kokwenza, ukusebenzisa, ukuthengisa okanye ukuthengisa." Ngamanye amagama, akukho nkampani yonyango inokudala isilwanyana esifanayo kwiibhubhoratri zayo kwaye ithengise. Iipenteko zingapheli iminyaka engama-20, kodwa i-patent nganye ihlukile. I-patent inokukhutshwa nanini na ngexesha ngexesha lokuvunywa kweziyobisi. Ngoko ke, isilwanyana sinokubakho ilungelo lobunikazi, kodwa asikavunywa yi-FDA ukuba isebenzise kwizigulane.
Ukusetyenziswa kweziyobisi kuphela
Ilungelo elifanayo elibizwa ngokuba yedwa lingabuye linikezelwe kwinkampani yezobisi kwiyeza zabo ezintsha. Ubungcali buchazwa nje ngokuba "amalungelo okuthengisa okuthe ngqo anikezelwa yi-FDA ngokuvunywa kweziyobisi." Idalwe ukubetha ibhalansi phakathi kokudalwa kwesilwanyana esitsha kunye nokuthengisa ngokubanzi, ubunakho kuphela okanye abuhambisani ne patent.
Ubungakanani bodwa buxhomekeke kuhlobo lwesigqirha esinikezelwa ngalo, kwaye lunokuthi lube luphi na oluphakathi kweminyaka emi-3 ukuya kweyesi-7. Xa ilungelo lobunikazi kunye nokuphela luphelelwe yisikhathi, ezinye iinkampani zonyango ziyakwazi ukuphinda ziphinde ziphinde zithengise zona phantsi kwegama elihlukile. Oku kuvula imarike yokhuphiswano kwaye iqhuba iindleko ze-generics phantsi.
Izidakamizwa zamaGrikhi kunye neBoeoequivalency
Izidakamizwa eziqhelekileyo kufuneka zibe nezithako ezifanayo njengegama, kodwa izithako ezingasebenziyo ziyahluka. Izithako ezingasebenziyo zingabandakanya imibala, izilondolozo okanye ezinye iifom. Nangona kunjalo, ngenxa yokuba i-generic inezithako ezingafaniyo ezifanayo, ayinakuthathwa ngokuzenzekelayo ngokulinganayo.
Ikhamphani yezobisi efuna ukuthengisa iimveliso zabo zonyango kufuneka inikele ubungqina be-bioequivalency kwi-FDA. Ukuze ube yi-bioequivalent, izithako ezisebenzayo kwisicikirho sohlobo kufuneka zifakwe kwizinga elifanayo kunye nesixa esifanayo negama legama lomenzi. I-generic ayifanele ukuba yenze into efanayo negama lomenzi wegama, kodwa kufuneka iwele phantsi kwezikhokelo ezithile ezibekwe yi-FDA. Ezi zikhokelo zingahlukahluka kwiziyobisi ukuya kwiziyobisi.
Ukuze uqiniseke ukuba isilwanyana esiyilwayo esiye sinikwe senziwe njenge-bioequivalent negama legama, jonga kunye nekhemistiki yakho.
I-pharmist yakho inokufikelela kwiinkcukacha ngezidakamizwa ezivela kwi-FDA ye-Orange Book. Incwadi ye-Orange iqulethe uludwe lwezilwanyana kunye nesimo sabo se-bioequivalency. Ingxelo yekhompyutheni ikhengiswa ngumxube osebenzayo kunye negama elifanelekileyo (igama).
Njani kwaye nini ukukhetha i-Generic
Ukuba ugqirha wakho ubhale isigqirha sesilwanyana esisebenzisa igama lophawu lobisi, ikhemistri kufuneka izalise le nkunkuma ethile. I-pharmist ingabiza ugqirha wakho kwaye uthethe ngokufaka indawo yohlobo lwesiza. Okanye, ungathetha nogqirha wakho malunga nezidakamizwa kunye nezigulane xa umyalelo ubhaliwe.
Ukuba uyamangaliswa kwikalathisi yezilwanyana kunye nombuzo malunga negama lomenzi okanye uhlobo olutsha, biza i-ofisi yakho ugqirha. Ugqirha oye wachaza isilwanyana kuwe uya kukwazi ukuba unokufumana iziphumo ezifunayo nge-generic.
Imithombo:
US Food and Drug Administration. "Ziziphi izidakamizwa eziqhelekileyo?" FDA.gov 16 Oktobha 2008.
US Food and Drug Administration. "Imibuzo Ebuzwa Ngokuphindaphindiweyo malunga nePentents and Exclusivity." FDA.gov 28 uMbasa 2006.