Ma MEPs adatengera malingaliro awo kuti akonzenso malamulo azamankhwala a EU, kuti alimbikitse ukadaulo komanso kupititsa patsogolo chitetezo chamankhwala, kupezeka komanso kugulidwa kwamankhwala.
Lachiwiri, Komiti Yoyang'anira Zachilengedwe, Zaumoyo ndi Zachitetezo cha Chakudya idatengera malingaliro ake pazachilangizo chatsopanocho (mavoti 66 mokomera, awiri otsutsana ndi asanu ndi anayi) ndi malamulo (mavoti 67 mokomera, asanu ndi mmodzi otsutsana ndi asanu ndi awiri) okhudza mankhwala amunthu. ntchito.
Deta yoyang'anira ndi chitetezo chamsika: zolimbikitsira zaukadaulo
Kuti apereke mphotho zatsopano, a MEP akufuna kukhazikitsa nthawi yocheperako yoteteza deta (panthawi yomwe makampani ena sangathe kupeza deta yazinthu) yazaka zisanu ndi ziwiri ndi theka, kuwonjezera pa zaka ziwiri zachitetezo chamsika (panthawi yomwe zinthu za generic, hybrid kapena biosimilar sizingakhalepo. kugulitsidwa), kutsatira chilolezo chotsatsa.
Makampani opanga mankhwala angakhale oyenera nthawi zina zowonjezera chitetezo cha deta ngati mankhwalawo akwaniritsa zofunikira zachipatala (+ miyezi 12), ngati mayesero ofananira a mankhwalawa achitidwa (+ miyezi 6), ndipo ngati gawo lalikulu la kafukufuku ndi chitukuko cha chinthucho chikuchitika mu EU ndipo mwina pang'ono mogwirizana ndi mabungwe ofufuza a EU (+ miyezi 6). MEPs amafunanso kapu pa nthawi yophatikizana yoteteza deta ya zaka zisanu ndi zitatu ndi theka.
Kuwonjezeka kamodzi (+ miyezi 12) kwa zaka ziwiri chitetezo cha msika nthawi ikhoza kuperekedwa ngati kampaniyo ipeza chilolezo chotsatsa kuti chiwonjezero chowonjezera chamankhwala chomwe chimapereka phindu lalikulu lachipatala poyerekeza ndi machiritso omwe alipo kale.
Mankhwala amasiye (mankhwala opangidwa kuti azichiza matenda osowa) angapindule mpaka zaka 11 za msika wokhazikika ngati atathana ndi "zosowa zachipatala zosakwanira".
Limbikitsani kulimbana ndi antimicrobial resistance (AMR)
MEPs amatsindika kufunika kolimbikitsa kafukufuku ndi chitukuko cha mankhwala antimicrobial atsopano, makamaka kudzera mu mphotho zolowa mumsika ndi njira zolipirira mphotho zazikulu (monga thandizo lazachuma losakhalitsa mukakwaniritsa zolinga zina za R&D msika usanavomerezedwe). Izi zitha kutsatiridwa ndi dongosolo logulira zinthu mwaufulu lachitsanzo, kulimbikitsa kugulitsa mankhwala opha tizilombo toyambitsa matenda.
Amagwirizana ndi kukhazikitsidwa kwa "transferable data exclusivity voucher" ya antimicrobial yofunika kwambiri, kupereka miyezi yowonjezereka ya 12 ya chitetezo cha deta kwa chinthu chovomerezeka. Voucher sikanatha kugwiritsidwa ntchito pazinthu zomwe zapindula kale ndi chitetezo chambiri chowongolera ndipo zitha kusamutsidwa kamodzi kokha kwa munthu wina wovomerezeka.
Mwa njira zatsopano zolimbikitsira kugwiritsa ntchito mwanzeru mankhwala oletsa tizilombo toyambitsa matenda, ma MEPs amafuna zofunikira zokhwima, monga kuletsa zolembedwa ndi kugawira ndalama zomwe zimafunikira pakuchiza ndikuchepetsa nthawi yomwe adauzidwa.
Zofunikira zolimbikitsa pakuwunika zoopsa zachilengedwe
Malamulo atsopanowa adzafuna kuti makampani apereke kafukufuku wokhudzana ndi ngozi (ERA) akapempha chilolezo chotsatsa. Kuti awonetsetse kuwunika kokwanira kwa ma ERA, a MEP akufuna kupangidwa, mkati mwa European Medicines Agency, kwa chipani chatsopano chowunikira zoopsa zachilengedwe. Ma MEPs amaumirira kuti njira zochepetsera chiopsezo (zomwe zimatengedwa kuti zipewe ndi kuchepetsa mpweya, madzi ndi nthaka) ziyenera kuthana ndi moyo wonse wamankhwala.
Kuchulukitsa kudziyimira pawokha kwa bungwe lazadzidzi la EU
Kuthana bwino ndi zovuta zaumoyo wa anthu komanso kulimbikitsa European kafukufuku, MEPs akufuna European Kukonzekera Zadzidzidzi Zaumoyo ndi Ulamuliro Woyankha (HERA, yomwe panopa ndi dipatimenti ya Commission) kuti ikhale yosiyana ndi European Center for Disease Prevention and Control (ECDC). HERA ikuyenera kuyang'ana kwambiri zankhondo yolimbana ndi ziwopsezo zomwe zikuyenera kuchitika mwachangu, kuphatikiza antimicrobial resistance ndi kusowa kwa mankhwala.
Zambiri pazamalingaliro enieni a MEPs zilipo mu izi chikalata chakumbuyo.
Quotes
Mtolankhani wa malangizo Pernille Weiss (EPP, DK) anati: "Kukonzanso malamulo a mankhwala a EU ndikofunika kwambiri kwa odwala, mafakitale ndi anthu. Voti yamasiku ano ndi gawo loti tipereke zida zothanirana ndi zovuta zachipatala zomwe zilipo komanso zamtsogolo, makamaka pakukopa kwathu msika komanso kupezeka kwamankhwala m'maiko onse a EU. Tikukhulupirira kuti Council izindikira zomwe tikufuna komanso kudzipereka kwathu kuti tikhazikitse malamulo okhazikika, ndikukhazikitsa njira zokambilana mwachangu. "
Rapporteur kwa malamulo Tiemo Wölken (S&D, DE) anati: “Kukonzansoku kumapereka njira yothanirana ndi mavuto akulu monga kusowa kwa mankhwala komanso kusamva maantimicrobial. Tikulimbitsa chitetezo chathu chaumoyo ndikulimbitsa mphamvu zathu zonse tisanakumane ndi zovuta zam'tsogolo zathanzi - chinthu chofunikira kwambiri pakufunafuna chithandizo chamankhwala chachilungamo, chopezeka kwa anthu onse aku Europe. Njira zopititsira patsogolo mwayi wopeza mankhwala, pomwe kulimbikitsa madera omwe akufunika kuchipatala omwe sanakwaniritsidwe, ndi mbali zofunika kwambiri pakusinthaku. "
Zotsatira zotsatira
A MEP akuyenera kukambilana ndikuvotera momwe Nyumba yamalamulo ikuyendera pa nthawi ya 10-11 April 2024. Fayiloyo idzatsatiridwa ndi Nyumba Yamalamulo yatsopano pambuyo pa zisankho zaku Europe pa 6-9 June.
Background
Pa 26 Epulo 2023, Commission idakhazikitsa "phukusi lamankhwala” kukonzanso malamulo a EU pazamankhwala. Zimaphatikizapo malingaliro atsopano malangizo ndi chatsopano lamulo, zomwe cholinga chake ndi kupanga mankhwala kukhalapo, kupezeka komanso kutsika mtengo, kwinaku akuthandizira kupikisana ndi kukopa kwa makampani opanga mankhwala a EU, ndi miyezo yapamwamba ya chilengedwe.
