14 C
kweBrussels
Svondo, Kubvumbi 28, 2024
EuropeEU pharmaceutical policy: MEPs inotsigira shanduko yakazara

EU pharmaceutical policy: MEPs inotsigira shanduko yakazara

ZVINOTAURWA: Ruzivo uye maonero akaburitswa muzvinyorwa ndeaya anozvitaura uye ibasa ravo. Kuburitswa mu The European Times hazvirevi kungobvumira maonero, asi kodzero yekuataura.

DISCLAIMER TRANSLATIONS: Zvese zvinyorwa zviri pasaiti ino zvakaburitswa muChirungu. Shanduro dzakaturikirwa dzinoitwa kuburikidza nemaitiro ega ega anozivikanwa seneural shanduro. Kana usina chokwadi, gara uchitarisa kuchinyorwa chekutanga. Ndinotenda nekunzwisisa kwako.

MEPs vakatambira zvirevo zvavo zvekuvandudza mutemo wezvemishonga weEU, kukurudzira hunyanzvi uye kusimudzira kuchengetedzwa kwekuwanikwa, kuwanikwa uye kukwanisa kwemishonga.

NeChipiri, Dare reEnvironment, Public Health uye Food Safety Committee rakatora chinzvimbo charo pagwaro idzva (mavhoti makumi matanhatu nematanhatu, maviri achipokana uye mapfumbamwe akarambwa) uye mutemo (mavhoti makumi matanhatu nenomwe achitsigira, matanhatu achipokana uye manomwe abstention) anofukidza mishonga yevanhu. use.

Regulatory data uye kuchengetedzwa kwemusika: zvinokurudzira zvekuvandudza

Kupa mibairo yekuvandudza, MEPs vanoda kuunza nguva shoma yekudzivirira data (panguva iyo mamwe makambani haakwanise kuwana data yechigadzirwa) yemakore manomwe nehafu, mukuwedzera kumakore maviri ekuchengetedzwa kwemusika (panguva iyo generic, hybrid kana biosimilar zvigadzirwa hazvigone kuitwa. kutengeswa), zvichitevera mvumo yekushambadzira.

Makambani emishonga angakodzerwa kwedzimwe nguva dze data protection kana icho chigadzirwa chakatarisana nezvinodiwa zvekurapa zvisingaite (+12 mwedzi), kana kuenzanisa kuyedzwa kwekiriniki kuchiitirwa chigadzirwa (+6 mwedzi), uye kana chikamu chakakosha chekutsvagisa nekusimudzira kwechigadzirwa kuchiitika EU uye pamwe muchidimbu mukubatana neEU masangano ekutsvagisa (+6 mwedzi). MEPs zvakare inoda chivharo pane yakasanganiswa data kuchengetedza nguva yemakore masere nehafu.

Kuwedzerwa-nguva imwe chete (+12 mwedzi) yemakore maviri kuchengetedzwa kwemusika nguva inogona kupihwa kana kambani ikawana mvumo yekushambadzira yekuwedzera chiratidzo chekurapa icho chinopa zvakakosha mabhenefiti ekiriniki mukuenzanisa nearipo marapirwo.

Mishonga yenherera (mishonga yakagadziridzwa kurapa zvirwere zvisingawanzoitiki) yaizobatsirwa kubva kumakore gumi nerimwe ekutengeserana chete kana vakagadzirisa "chido chekurapa chisingawaniki".

Simudza kurwisa antimicrobial resistance (AMR)

MEPs inosimbisa kukosha kwekusimudzira kutsvagisa nekusimudzira kwe novel antimicrobials, kunyanya kuburikidza nemibairo yekupinda mumusika uye zvirongwa zvekubhadhara mibairo yakakosha (semuenzaniso tsigiro yezvemari yekutanga pakuzadzisa zvimwe zvinangwa zveR&D isati yapihwa mvumo yemusika). Izvi zvinotsigirwa nekunyoresa modhi-based voluntary joint procurement scheme, kukurudzira kudyara mumishonga inorwisa utachiona.

Vanobvumirana nekuunzwa kwe "transferable data exclusivity voucher" yepamberi antimicrobials, ichipa imwe yepamusoro 12 yekuwedzera mwedzi yekuchengetedzwa kwedata kune chigadzirwa chakabvumidzwa. Vhuti yaisagona kushandiswa kune chigadzirwa chakatobatsirikana kubva kune yakanyanya kudzora data kuchengetedzwa uye yaizochinjika kamwe chete kune mumwe mubati wemvumo yekushambadzira.

Pakati pematanho matsva ekusimudzira kushandiswa zvine hungwaru kwemishonga inorwisa utachiona, MEPs inoda zvakaomesesa zvinodikanwa, sekudzora zvakatemwa uye kupihwa kune huwandu hunodiwa pakurapwa uye kudzikisira nguva yavanenge vanyorerwa.

Zvido zvakasimbiswa zvekuongorora njodzi yezvakatipoteredza

Iyi mitemo mitsva inoda kuti makambani aendese ongororo yenjodzi yezvakatipoteredza (ERA) kana achikumbira mvumo yekushambadzira. Kuti ive nechokwadi chekuongororwa kwakakwana kweERAs, MEPs inoda kusikwa, mukati meEuropean Medicines Agency, yebato idzva re-ad-hoc rekuongorora njodzi yezvakatipoteredza. MEPs inosimbirira kuti matanho ekudzikisa njodzi (anotorwa kudzivirira uye kudzikisira kuburitsa kumhepo, mvura nevhu) inofanirwa kugadzirisa hupenyu hwese hwemishonga.

Kuwedzera kusununguka kweEU hutano emergency emergency

Kugadzirisa zvinobudirira matambudziko ehutano hweveruzhinji uye kuwedzera zvekuEurope tsvagiridzo, MEPs inoda iyo yeEurope Hutano Emergency Preparedness uye Response Authority (HERA, parizvino idhipatimendi reKomisheni) kuti ive yakaparadzana chimiro pasi peEuropean Center for Disease Prevention and Control (ECDC). HERA inofanira kunyanya kutarisisa kurwisa kutyisidzira kwehutano nekukurumidza, kusanganisa kusabatwa nemishonga inorwisa utachiona uye kushomeka kwemishonga.

Mamwe mashoko pamusoro peMEPs 'zvakananga zvikumbiro zviripo mune izvi gwaro rekumashure.

Quotes

Mutori wenhau wekuraira Pernille Weiss (EPP, DK) akati: "Kudzokororwa kwemitemo yemishonga yeEU kwakakosha kuvarwere, maindasitiri uye nzanga. Vhoti yanhasi inhanho yekuunza maturusi ekugadzirisa matambudziko aripo uye emangwana ehutano, kunyanya kukwezva kwemusika wedu uye kuwana mishonga munyika dzeEU. Tinovimba kuti Kanzuru inocherekedza chishuvo chedu nekuzvipira kwedu kugadzira bumbiro remitemo rakasimba, richigadzira mamiriro enhaurirano nekukurumidza. "

Mutori wenhau wemutemo Tiemo Wölken (S&D, DE) akati: “Ongororo iyi inovhura nzira yekugadzirisa matambudziko akanyanya sekushaikwa kwemishonga uye kusagadzikana kwemishonga inorwisa utachiona. Tiri kusimbisa hutano hwedu hwehutano uye kusimbisa kusimba kwedu pamwe chete pamberi pematambudziko ehutano emangwana - chiitiko chakakosha mukutsvaga kwedu kwehutano hwakanaka, hunowanikwa kune vose vekuEurope. Matanho ekuvandudza kuwanikwa kwemishonga, ukuwo achikurudzira nzvimbo dzezvido zvekurapa zvisina kuzadziswa, zvikamu zvakakosha zveshanduko iyi. "

Matanho anotevera

MEPs dzakarongerwa kukakavara nekuvhota pachinzvimbo cheParamende panguva ye10-11 Kubvumbi 2024 plenary session. Iyo faira ichateverwa neParamende nyowani mushure mesarudzo dzeEuropean pa6-9 Chikumi.

kumashure

Musi wa26 Kubvumbi 2023, Komisheni yakaisa "Pharmaceutical package” kudzokorora mutemo weEU wezvemishonga. Inosanganisira zvikumbiro zveimwe itsva Directive uye itsva chengetedzo, iyo inovavarira kuita kuti mishonga iwanikwe, iwanikwe uye inokwanisika, uku ichitsigira kukwikwidza uye kukwezva kweindasitiri yemishonga yeEU, ine mwero wepamusoro wezvakatipoteredza.

- Advertisement -

Zvinyorwa kubva kumunyori

- ZVIRI MUKATI -nzvimbo_img
- Advertisement -
- Advertisement -
- Advertisement -nzvimbo_img
- Advertisement -

Unofanira kuverenga

Zvinyorwa zvitsva

- Advertisement -