#Pharmaceuticals: Komisheni inokwenenzvera mitemo yezvivakwa

EU ine hwaro hwakasimba hwekodzero dzepfuma huripo hunochengetedza ruzivo rweEurope uye kuchengetedza indasitiri yemishonga yemhando yepamusoro yekuvandudza kugona. Kuvandudza hurongwa hwazvino uye kubvisa kukanganisa kukuru kwevagadziri veEU, Komisheni inokurudzira shanduko yakanangwa: iyo inonzi 'export kugadzira waiver' kune Supplementary Protection Certificates.

Supplementary Dziviriro Zvitupa (SPCs) inowedzera kuchengetedzwa kwepatent kune zvigadzirwa zvemishonga izvo zvinofanirwa kuongororwa kwenguva yakareba uye miedzo yekiriniki isati yawana mvumo yekushambadzira. Nekuda kwekuregererwa, mune ramangwana makambani akavakirwa muEU achave nekodzero yekugadzira generic kana biosimilar vhezheni yemushonga unodzivirirwa neSPC panguva yechitupa, kana ichiitwa chete nechinangwa chekuendesa kunze kwenyika kumusika usiri weEU uko. kudzivirira kwapera kana kumbovapo. Kuregererwa kunotsigira basa rekutanga reEurope mukutsvaga kwemishonga nekusimudzira.

Jobs, Growth Investment uye Competitiveness Mutevedzeri weMutungamiri Jyrki Katainen akati: "Europe iri uye inofanira kuramba iri mberi kwekutsvakurudza kwemishonga uye kugadzira. Mitemo yedu pamusoro pekuchengetedzwa kwezvinhu zvepfungwa zvemishonga inokurudzira hutsva nekugadzira. Isu takazvipira kune kodzero dzepakati uye kureba. yedziviriro iyi, iyo inoramba isina kuchinjwa.Tiri kupa hurongwa hwekugadzirisa zvakanaka hutongi hwemazuva ano kubvisa chipingamupinyi chemutemo changa chichitadzisa makambani edu kukwikwidza zvakaenzana pamisika yepasi rose apo makwikwi anotyisa.Tinoda kuve nechokwadi kuti yedu indasitiri yemishonga inokohwa zvakanakira makwikwi akadai."

Musika Wemukati, Indasitiri, Entrepreneurship uye SMEs Commissioner Elżbieta Bieńkowska akawedzera kuti: "Chikumbiro chanhasi chinobata chiyero pakati pezvakakosha kuti ive nechokwadi chekukwezva kweEurope kumakambani ekugadzira mishonga yemishonga uye nekukasira kubvumidza EU yakavakirwa generics uye biosimilar kukwikwidza pamisika yepasi rose. ichabatsira kugadzira kukura nemabasa epamusoro-soro muEU. Inogona kuunza € 1 bhiriyoni mambure ekuwedzera kutengesa pagore uye kusvika ku25,000 mabasa matsva mumakore 10. Ichanyanya kubatsira akawanda madiki uye epakati bhizinesi bhizinesi. Munguva yepakati, makwikwi akawanda achavandudza mukana wevarwere kuwana sarudzo yakakura yemishonga uye kuderedza mabhajeti eruzhinji.

Nekuregererwa, intellectual property (IP) kuchengetedzwa kwekugadzirwa kwemishonga muEurope kucharamba kwakasimba pasi rose. Mishonga inodzivirirwa neSPC inochengetedza musika wayo wakakwana muEU.

Chikumbiro ichi chinoperekedzwa nenhevedzano yezvidziviriro izvo zvinogadzira pachena uye kudzivirira IP-inotyora zvigadzirwa kupinda mumisika yenhengo dzenhengo. Zvinoenda pamwe chete mamwe maitiro eEU kudzivirira ruzivo rweEurope uye hutungamiriri hwekuvandudza uye kudzivirira varwere pamishonga yekunyepera. Inozadzisawo maitiro eEU ekuona kutengeserana kwakasununguka uye kwakaringana, kunoratidzwa nemisika yakavhurika, yevagadziri veEU.

Chikumbiro chinogadzirisa Regulation 469/2009 pachitupa chekuwedzera chekudzivirira chezvigadzirwa zvemishonga. Kana yangogamuchirwa neParamende yeEuropean neKanzuru, ichashanda zvakananga munhengo dzese dzeEU.

kumashure

EU uye misika yepasi rose yemishonga iri kuita shanduko huru. Kudiwa kwemishonga pasi rose kwawedzera zvakanyanya, kusvika pa €1 trillion muna 2017. Pamwe pacho, pane shanduko yekuenda kumusika wakakura unogara uchigoverwa wejenaric uye biosimilars. Sechinyakare EU yakaita basa rekutanga mukutsvagisa nebudiriro yemishonga, kusanganisira mishonga yemazuva ese uye biosimilars. Asi chinzvimbo ichi chehutungamiriri chiri munjodzi.

Supplementary protection certificates (SPCs) ikodzero yepfuma yakatanga kuunzwa muEU muna 1992 sekuwedzera kukodzero yemvumo. Pharmaceutical SPCs inotarisira kudzikamisa kurasikirwa kwekuchengetedzwa kwepatent kwemishonga kunoitika nekuda kwekuyedzwa kwenguva refu uye miedzo yekiriniki izvo zvigadzirwa izvi zvinoda tisati tawana mvumo yekushambadzira. Sangano reSPC rinogona kuwedzera kodzero yemvumo yemakore anopfuura mashanu.

Mitemo yeEU SPC ndiyo yakasimba kwazvo pasi rose. Kunyange vachivavarira kupa mubairo wekudyara mukuvandudza nekuchengetedza zvinhu zvehungwaru, maSPC anogona kuisa vagadziri veEU-based ejenarikisi uye biosimilar panjodzi neindasitiri isiri yeEU, nekudaro ichidzivirira humwe hunyanzvi uye kusikwa kwemabasa muEurope. Chokwadi, panguva yeSPC yekuchengetedzwa kwechigadzirwa muEU, vagadziri veEU-vanogadzira zvigadzirwa zvegeneric uye/kana biosimilar-zvine hukama havagone kugadzira chero chinangwa, kusanganisira kutumira kunze kwenyika kunze kwenyika dzeEU uko kudzivirira kweSPC kwapera kana kusipo. , nepo vagadziri vanogara munyika dzisiri dzeEU vanogona kudaro. Uku kukanganisa kukuru kwemakwikwi kunosanganisira njodzi yedelocalization yekugadzira uye kurasikirwa kwekudyara muEurope. Chitupa ichi zvakare chinoita kuti zvinyanye kuomera vagadziri veEU kuti vapinde mumusika weEU pakarepo mushure mekupera kwayo, zvichipihwa kuti havasi musimba rekuvaka simba rekugadzira kudzamara dziviriro yakapihwa nechitupa yapera.

Dziviriro zhinji dzeSPC dzinotanga kupera kubva muna 2020, sehuwandu hwakakosha hwezvigadzirwa zvemishonga zvichapinda munzvimbo yeruzhinji, sezvo patent kana SPC mazwi achapera. Iyi budiriro ichaburitsa yakakosha mikana yemusika mitsva yemageneric, uye yebiosimilars kunyanya. Pane chido chekukurumidzira chekugadzirisa murairo uripo kumamiriro ezvinhu aya, sezvo misika yezvigadzirwa zvemagetsi uye biosimilars iri kukwikwidza zvakanyanya uye iri kuramba ichikura uye sarudzo dzekudyara pamusoro penzvimbo yekugadzirwa dziri kuitwa pachine nguva.

Chikumbiro ichi chakaziviswa muKomisheni ye2015 Single Market Strategy, uye zvinotevera zvidzidzo zvakasiyana-siyana, ane kubvunzana kukuru uye Chisarudzo cheParamende yeEurope inotsigira kukosha kwekusuma pamberi pe2019 yeSPC yekugadzira waiver. 

More mashoko

FAQs pachikumbiro

Proposed Regulation

Kutanga Impact Ongororo muna Kukadzi 2017

Kubvunzurudza veruzhinji - 2017