Ta yaya bincike da bunƙasawa ga ƙwayoyi marayu ne aka ƙaddara
Mene ne miyagun ƙwayoyi marayu kuma menene Dokar Magunguna ta Orphan? Me ya sa bincike da ci gaba ga waɗannan kwayoyi mahimmanci ne kuma menene shingen?
Mene ne kwayar marayu? - Definition
Magunguna ne marayu ne magani (magungunan magani) wanda ya kasance wanda ya ɓoye saboda rashin kamfani don neman samfurin miyagun ƙwayoyi. Sau da yawa dalilin da cewa miyagun ƙwayoyi ba shi da amfani shi ne cewa akwai wasu mutane da yawa waɗanda za su sayi miyagun ƙwayoyi lokacin da suke da nauyin bincike da ci gaba da ake bukata don samar da magani.
A cikin kalmomi masu sauki, ƙwayoyin marayu sune wadanda kamfanonin ba sa tsammanin za su sami kudi mai yawa, kuma a maimakon haka sunyi kokari wajen maganin kwayoyi wanda zai kawo kudi.
Me yasa wasu kwayoyi sune "miyagun kwayoyi"
Magunguna da miyagun ƙwayoyi da masana'antun fasaha suna bincike da kuma bunkasa sababbin magunguna don magance yanayin kiwon lafiya, kuma sababbin magunguna sun zo kan kasuwa akai-akai. Mutanen da ke fama da cututtuka da cututtuka da yawa, a gefe guda, kada su ga irin wannan maganin likita ya kula da cutar su. Wannan shi ne saboda lambobin su ƙananan ne don haka kasuwa mai kyau ga sababbin kwayoyi don magance wadannan cututtuka (wanda ake kira "maƙwabciyar magunguna") ma ƙananan.
Wani mummunar cuta ya faru a kasa da mutane 200,000 a Amurka ko kasa da 5 a kowace 10,000 a cikin Tarayyar Turai. Ƙungiyoyin hukumomin gwamnati a Amurka da Tarayyar Turai sun dauki matakai don rage wannan rikici cikin ci gaban miyagun ƙwayoyi
Gudun hankula don ƙara haɓaka ƙwayoyin marayu
Ganin cewa an yi amfani da magungunan ƙwayoyi don rashin ciwo da yawa a Amurka kuma kamfanonin ƙwayoyi suna haifar da asarar kuɗi a magungunan ƙwayoyi don yanayin da ba su da kyau, Majalisar Dattijai ta Amurka ta ba da Dokar Magunguna a 1983.
Ofishin Jakadancin Amurka na Ƙarar Samfur marayu
Cibiyar Abinci da Drugura ta Amurka (FDA) tana da alhakin tabbatar da lafiyar da magunguna a kasuwa a Amurka.
FDA ta kafa Ofishin Ƙararren Ƙarƙashin Ƙarƙwara (OOPD) don taimakawa tare da ci gaba da magunguna (da sauran kayan kiwon lafiya don rashin lafiya), ciki har da bada tallafin bincike.
Magunguna marayu, kamar sauran magunguna, har yanzu za a samu lafiya da tasiri ta hanyar binciken da gwajin gwaji kafin FDA ta amince da su don sayarwa.
Dokar Drug ta Amurka ta 1983
Dokar Orphan Drug Act ta ba da dama ga sa kamfanoni su inganta kwayoyi (da sauran kayayyakin kiwon lafiya) don kananan kasuwanni na mutane masu fama da cututtuka (a Amurka, kashi 47 cikin 100 na rashin lafiya da yawa ya shafi mutane 25,000). Wadannan matakan sun hada da:
- Shaidun haraji na Tarayya don binciken da aka yi (kimanin kashi 50 cikin dari) don bunkasa magunguna.
- Abinda aka yi na tsawon shekara bakwai a kan tallace-tallace na miyagun ƙwayoyi don kamfanin farko don samun amincewa ta kasuwanci na FDA na wani magani. Wannan ya shafi kawai don amfani da miyagun ƙwayoyi. Za'a iya amincewa da wani aikace-aikacen da ke amfani da shi na FDA, kuma kamfanin zai mallaki haƙƙoƙin kasuwanci na musamman don miyagun ƙwayoyi don wannan amfani.
- Yarda da kudaden aikace-aikacen amincewa da miyagun kwayoyi da kuma kudaden kuɗi na FDA.
Kafin sakin Dokar Magunguna, wa] ansu 'ya'yan marayu sun kasance suna iya magance cututtukan cututtuka.
Tun da Dokar, an yarda da FDA fiye da 200 don sayarwa a Amurka
Ƙa'idar Dokar Magunguna ta Orphan a Amurka Pharmaceuticals
Tun da Dokar Magunguna ta Orphan ta kasance a cikin 1983, yana da alhakin ci gaban ƙwayoyi masu yawa. A 2012 an yi amfani da kwayoyi 378 wanda aka yarda ta hanyar wannan tsari, kuma lamarin ya ci gaba da hawan.
Misalin kwayoyi suna samuwa saboda Dokar Magunguna
Daga cikin kwayoyi da aka amince sun haɗa da waɗannan:
- Adonocorticotropic hormone (ACTH) don zalunta ƙwayoyin bashi
- Tetrabenzine don magance cututtukan da ke faruwa a mutanen da cutar Huntington ke
- Maganin maye gurbin Enzyme ga wadanda ke fama da cutar ta glycogen, cutar Pompe
Bincike na kasa da kasa da ƙaddamar da ƙwayoyi marayu
Kamar majalisar wakilai na Amurka, kungiyar tarayyar Turai (EU) ta amince da bukatar ƙara yawan bincike da ci gaba da magunguna.
Kwamitin a kan Magungunan Samurai
An kafa shi a shekarar 1995, hukumar kula da magunguna ta Turai (EMEA) tana da alhakin tabbatar da aminci da ingancin magunguna a kasuwa a cikin EU. Yana tattara dukkanin kimiyyar kimiyya na 'yan majalisa 25 na EU. A shekara ta 2000, an kafa kwamiti na ƙwararrun magunguna (COMP) don kula da ci gaba da magunguna a cikin EU.
Dokar kan Magungunan Samurai
Dokar kan Magungunan Abincin Marayu, wanda Majalisar Turai ta wuce, ta ba da dama ga ci gaba da magunguna (da sauran kayan kiwon lafiya don cututtuka) a cikin EU, ciki har da:
- Yarda da kudaden da suka danganci tsarin tallafin kasuwanci.
- Gidauniyar shekaru 10 da aka sanya a kan tallace-tallace na miyagun ƙwayoyi don kamfani na farko don samun amincewa ta hanyar sayar da magani a EMEA. Wannan ya shafi kawai don amfani da miyagun ƙwayoyi.
- Bayar da izinin sadaukarwar al'umma - hanya mai mahimmanci na izinin kasuwanci wanda ya kara wa dukan kasashe mambobin EU.
- Taimakon galihu, ma'anar samar da shawara na kimiyya ga kamfanonin ƙwayoyi game da gwaje-gwajen daban-daban da gwaji na gwajin da ake bukata don maganin miyagun ƙwayoyi.
Dokar kan Magungunan Magungunan Kwayoyi sunyi amfani da wannan sakamako mai amfani a cikin EU cewa Dokar Magunguna ta Orphan ta kasance a Amurka, daɗaɗaɗɗa karuwar ci gaba da sayar da magunguna don rashin lafiya.
Lashin Ƙasa a Dokar Magunguna
A lokacin da akwai jayayya da yawa game da Dokar Magunguna ta Orphan, tare da buƙatar maganin cututtuka da dama a gefe daya na sikelin, da kuma tambayoyi game da ci gaba a kan ɗayan. Abin godiya, wadannan ayyukan, a duka Amurka da Turai sun ba da sanarwa ga yawancin cututtuka da yawa, wanda, idan aka kara da juna, ba duka ba ne.
Sources:
Herder, M. Mene ne Manufar Dokar Magunguna? . PLoS Medicine . 2017. 14 (1): e1002191.
Murphy, S., Puwanant, A., da R. Griggs. Ra'ayin da ba'a da niyyar da aka yi wa marayu ya samo asali don rashin lafiya na rashin lafiya. Annals of Neurology . 2012. 72 (4): 481-490.
Cibiyar Abinci da Drug. Sanya wani abu marayu: Drugs and Biological Products. Updated 05/02/16. https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm