Kukhishwe “Imithethonqubo Yokwengamela Nokuphathwa Kwamadivaysi Ezokwelapha” (ngemuva kwalokhu okuzobizwa ngokuthi “Imithethonqubo”) emisha, okuphawula isigaba esisha sokubuyekezwa kwemishini yezokwelapha yezwe lami kanye nezinguquko zokugunyazwa.“Imithetho Yokuqondisa Nokuphathwa Kwamadivayisi Ezokwelapha” yasungulwa ngo-2000, yabuyekezwa ngokuphelele ngo-2014, futhi yabuyekezwa kancane ngo-2017. Lokhu kubuyekezwa kubhekene nokuthuthuka ngokushesha kwemboni eminyakeni yamuva kanye nesimo esisha izinguquko ezijulile.Ikakhulukazi, iKomidi Eliphakathi Leqembu kanye noMkhandlu Wombuso wenze uchungechunge lwezinqumo ezinkulu kanye nokuthunyelwa ekuguqulweni kokubuyekezwa kwezidakamizwa nemishini yezokwelapha kanye nesistimu yokugunyazwa, futhi ihlanganise imiphumela yezinguquko ngemithetho nemithethonqubo.Kusukela ezingeni lesikhungo, sizophinde sikhuthaze ukusungulwa kwemishini yezokwelapha, sikhuthaze ukuthuthukiswa kwekhwalithi ephezulu yemboni, sikhuthaze amandla ezimakethe, futhi sihlangabezane nesidingo sabantu semishini yezokwelapha yezinga eliphezulu.
Amaphuzu avelele "Emitheshwana" emisha abonakaliswa ngokuyinhloko kulezi zici ezilandelayo:
1. Qhubeka nokukhuthaza ukuqamba okusha futhi ukhuthaze ukuthuthukiswa kwekhwalithi ephezulu yemboni yemishini yezokwelapha
Ukuqamba izinto ezintsha kungamandla okuqala aholayo ekuthuthukisweni.Kusukela kuNgqungquthela Kazwelonke ye-18 yeQembu LamaKhomanisi laseShayina, IKomidi Eliyinhloko Leqembu kanye noMkhandlu Wombuso banamathisele ukubaluleka okukhulu ekusungulweni kwezobuchwepheshe, basebenzisa isu lentuthuko eliqhutshwa into emisha, futhi basheshisa ukugqugquzelwa kokusungula izinto ezintsha ngokusungulwa kwezobuchwepheshe njengomgogodla.Kusukela ngo-2014, i-National Food and Drug Administration isize imishini yezokwelapha emisha engaphezu kwe-100 kanye nemishini yezokwelapha edingeka ngokushesha ukuze igunyazwe ngokushesha ukuze ifakwe ohlwini ngezinyathelo ezinjengokwakha isiteshi esiluhlaza ukuze sibuyekezwe kuqala kanye nokugunyazwa kwemishini yezokwelapha emisha.Isasasa lokusungula amabhizinisi liphezulu, futhi imboni ithuthuka ngokushesha.Ukuze kuqhutshekwe kusetshenziswe izimfuneko zeKomidi Elimaphakathi Leqembu kanye noMkhandlu Wombuso ukuze kuthuthukiswe ukulungiswa kanye nokuqanjwa okusha kwezobuchwepheshe embonini yezisetshenziswa zezokwelapha kanye nokuthuthukisa ukuncintisana kwemboni, lokhu kubuyekezwa kukhombisa umoya wokuqhubeka nokukhuthaza ukuqamba okusha nokukhuthaza ukuthuthukiswa kwezimboni. ngesisekelo sokuqinisekisa ukuphepha nokusebenza ngempumelelo kokusetshenziswa komphakathi kwezinto zokusebenza.“Imithethonqubo” emisha ibeka ukuthi umbuso ubumba izinhlelo nezinqubomgomo zemboni yemishini yezokwelapha, uhlanganise ukwakhiwa kwemishini yezokwelapha ezintweni eziza kuqala entuthukweni, usekele ukugqugquzelwa komtholampilo nokusetshenziswa kwemishini emisha yezokwelapha, uthuthukise amakhono azimele wokuqamba izinto ezintsha, ukhuthaze ukuthuthukiswa kwekhwalithi ephezulu kwezokwelapha. imboni yemishini, futhi izokwakha futhi ithuthukise okuthize Ukusebenzisa izinqubomgomo zokuhlela neziqondiso zezimboni zenkampani;ukuthuthukisa isistimu yokusungula idivayisi yezokwelapha, isekele ucwaningo oluyisisekelo kanye nocwaningo olusetshenziswayo, futhi inikeze ukusekelwa kumaphrojekthi wesayensi nezobuchwepheshe, ukuxhasa ngezimali, isikweletu, ukubhida nokuthenga, umshwalense wezokwelapha, njll.;ukusekela ukusungulwa kwamabhizinisi noma ukusungulwa ngokuhlanganyela kwezikhungo zocwaningo, futhi ukhuthaze Ibhizinisi lisebenzisana namanyuvesi kanye nezikhungo zezokwelapha ukwenza izinto ezintsha;incoma futhi iklomelise amayunithi nabantu ngabanye abenze umnikelo oncomekayo ocwaningweni nasekusungulweni kwezinto ezintsha zemishini yezokwelapha.Inhloso yale mithetho engenhla iwukuqhubekela phambili nokugqugquzela ubungqabavu bokusungula izinto ezintsha kwezenhlalo ngendlela ehlanganisa yonke indawo, kanye nokukhuthaza ukugxuma kwezwe lami lisuke ezweni elikhulu elikhiqiza izinto zezokwelapha liye emandleni okukhiqiza.
2. Hlanganisa imiphumela yezinguquko futhi uthuthukise izinga lokugadwa kwemishini yezokwelapha
Ngo-2015, uMkhandlu Wombuso wakhipha "Imibono Yokuguqula Ukubuyekezwa Nokuvumela Uhlelo Lwezidakamizwa kanye Namadivayisi Wezokwelapha", okuzwakala sengathi isimemo esicacile sokuguqulwa.Ngo-2017, Ihhovisi Elimaphakathi kanye NoMkhandlu Wombuso wakhipha "Imibono Yokujulisa Ukuguqulwa Kohlelo Lokubuyekeza Nokugunyazwa kanye Nokukhuthaza Ukuqamba Okusha Kwezidakamizwa Namadivayisi Ezokwelapha".I-State Food and Drug Administration yethule uchungechunge lwezinyathelo zokulungisa.Lokhu kubuyekezwa kuzoba yingxenye yesistimu yezinyathelo zokulawula esezivuthiwe futhi ezisebenzayo.Kuyisinyathelo esibalulekile ukuhlanganisa izimpumelelo ezikhona, ukwenza izibopho zokulawula, ukuthuthukisa amazinga okulawula, kanye nokusebenzela impilo yomphakathi.Njengokusebenzisa uhlelo lomnikazi welayisensi yokumaketha yezisetshenziswa zezokwelapha, ukuthuthukisa nokuhlanganisa ukwabiwa kwezinsiza zezimboni;ukusebenzisa uhlelo lokuhlonza oluyingqayizivele lwemishini yezokwelapha isinyathelo ngesinyathelo ukuze kuthuthukiswe ukulandeleka komkhiqizo;ukwengeza izimiso zokuvumela ukusetshenziswa okunwetshiwe komtholampilo ukuze kubonise ukuhlakanipha kokulawula.
3. Lungiselela izinqubo zokugunyaza futhi uthuthukise uhlelo lokubuyekeza nokugunyaza
Uhlelo oluhle luyisiqinisekiso sokuthuthukiswa kwekhwalithi ephezulu.Enqubweni yokubuyekeza "Imithetho" emisha, sihlaziye ngokucophelela izinkinga zesistimu ezijulile ezivezwe emsebenzini wokuqondisa wansuku zonke okunzima ukuzivumelanisa nezidingo zesimo esisha, ezifundwe ngokugcwele kokuhlangenwe nakho okuthuthukisiwe kokuqondisa kwamazwe ngamazwe, ukugqugquzela ukugada okuhlakaniphile, futhi yathuthukisa izinqubo zokuhlolwa nokugunyazwa futhi yathuthukisa uhlelo lokubuyekeza nokugunyaza.Thuthukisa izinga lokubuyekezwa kwemishini yezokwelapha yezwe lami kanye nesistimu yokugunyazwa, futhi uthuthukise ikhwalithi nokusebenza kahle kokubuyekezwa, ukubuyekezwa nokugunyazwa.Isibonelo, ukucacisa ubudlelwano phakathi kokuhlolwa komtholampilo kanye nezivivinyo zomtholampilo, kanye nokuqinisekisa ukuphepha nokusebenza komkhiqizo ngezindlela ezihlukene zokuhlola ngokuya ngokuvuthwa, ubungozi kanye nemiphumela yocwaningo olungeyona eyezempilo yomkhiqizo, ukwehlisa umthwalo wokuhlolwa kwezempilo ongadingekile;ukushintsha ukugunyazwa kwesilingo somtholampilo kube yimvume eshiwo, ukunciphisa isikhathi sokugunyaza;abafake izicelo zokubhalisa bavunyelwe ukuhambisa imibiko yokuzihlola yomkhiqizo ukuze kuqhutshekwe nokunciphisa izindleko ze-R&D;ukugunyazwa okunemibandela kuvunyelwe ezinsizeni zezokwelapha ezidingeka ngokushesha ezinjengokwelashwa kwezifo ezingavamile, ezisongela kakhulu ukuphila kanye nokusabela ezigamekweni zezempilo zomphakathi.Ukuhlangabezana nezidingo zeziguli ngaphansi kwezimo ezinqunyiwe;hlanganisa isipiliyoni sokuvimbela nokulawula ubhubhane olusha lwe-pneumonia ukuze kwandiswe ukusetshenziswa okuphuthumayo kwemishini yezokwelapha kanye nokuthuthukisa ikhono lokuphendula ezimweni eziphuthumayo ezinkulu zezempilo zomphakathi.
Okwesine, kusheshiswe ukwakhiwa kolwazi, futhi kwandise umfutho "wokuphathiswa, ukuphatha, kanye nenkonzo"
Uma kuqhathaniswa nokugadwa kwendabuko, ukugadwa kokwaziswa kunezinzuzo zejubane, ukunethezeka kanye nokufakwa okubanzi.Ukwakhiwa kolwazi kungomunye wemisebenzi ebalulekile yokuthuthukisa amakhono okugada namazinga esevisi.“Imithethonqubo” emisha iveze ukuthi umbuso uzoqinisa ukwakhiwa kokugadwa kwemishini yezokwelapha nolwazi, uthuthukise izinga lezinsizakalo zikahulumeni eziku-inthanethi, futhi uhlinzekele ukutholakala kwamalayisensi okuphatha nokufakwa kwemishini yezokwelapha kube lula.Ulwazi lwemishini yezokwelapha efayeliwe noma ebhalisiwe izodluliswa ngezindaba zikahulumeni eziku-inthanethi zomnyango olawula izidakamizwa woMkhandlu Wezwe.Inkundla imenyezelwa emphakathini.Ukuqaliswa kwalezi zinyathelo ezingenhla kuzothuthukisa ukusebenza kahle kokuqondisa futhi kunciphise izindleko zokubuyekeza nokugunyazwa kwabafake izicelo ababhalisiwe.Ngesikhathi esifanayo, umphakathi uzokwaziswa ngolwazi lwemikhiqizo esohlwini ngendlela eningilizayo, enembayo nangesikhathi esifanele, uqondise umphakathi ukuthi usebenzise izikhali, wamukele ukuqondiswa komphakathi, futhi uthuthukise ukubonakala kokuqondisa kukahulumeni.
5. Ukubambelela ekugadweni kwesayensi futhi kukhuthaze ukwenziwa kwesimanje kohlelo lokuqondisa kanye namakhono okugada
“Imithethonqubo” emisha yasho ngokucacile ukuthi ukugadwa nokuphathwa kwemishini yezokwelapha kufanele kulandele izimiso zokuqondisa kwesayensi.I-State Food and Drug Administration yethule uhlelo lwesayensi lokulawula izidakamizwa ngo-2019, luthembele kumanyuvesi asekhaya aziwayo kanye nezikhungo zocwaningo lwesayensi ukusungula izisekelo zocwaningo lwesayensi ezilawulayo, zisebenzisa ngokugcwele amandla omphakathi ukubhekana nezinkinga nezinkinga emsebenzini wokulawula. ngaphansi kwenkathi entsha kanye nesimo esisha.Izinselele, amathuluzi ocwaningo olusha, amazinga, nezindlela zokuthuthukisa umsebenzi wokuqondisa wesayensi, obheke phambili futhi oguquguqukayo.Iqoqo lokuqala lamaphrojekthi abalulekile ocwaningo lwemishini yezokwelapha eyenziwe yazuza imiphumela enezithelo, kanti iqoqo lesibili lamaphrojekthi abalulekile ocwaningo azokwethulwa maduze.Ngokuqinisa ucwaningo lwesayensi lokuqondisa nokuphatha, sizoqhubeka sisebenzisa umqondo wokuqondisa wesayensi ohlelweni nendlela, futhi sithuthukise izinga lesayensi, lezomthetho, lamazwe ngamazwe kanye nelesimanje lokuqondisa idivayisi yezokwelapha.
Umthombo we-athikili: Ministry of Justice
Isikhathi sokuthumela: Jun-11-2021