Ii-MEPs zamkele izindululo zazo zokuhlaziya umthetho we-EU woxubo-mayeza, ukukhuthaza ukusungula izinto ezintsha kunye nokomeleza ukhuseleko lonikezelo, ukufikeleleka kunye nokufikeleleka kwamayeza.
NgoLwesibini, i-Environment, iKomiti yezeMpilo yoLuntu kunye noKhuseleko loKutya yamkele isikhundla sayo kumyalelo omtsha (i-66 iivoti ezixhasayo, ezimbini ezichasene nezilithoba) kunye nommiselo (iivoti ezingama-67 ezixhasayo, ezintandathu ngokuchaseneyo kunye nezisixhenxe) ezibandakanya amayeza omntu. sebenzisa.
Idatha yokulawula kunye nokukhuselwa kweemarike: inkuthazo yokusungula izinto ezintsha
Ukuvuza izinto ezintsha, ii-MEPs zifuna ukwazisa ubuncinci bexesha lokhuseleko lwedatha (ngexesha apho ezinye iinkampani zingenako ukufikelela kwidatha yemveliso) yeminyaka esixhenxe enesiqingatha, ukongeza kwiminyaka emibini yokhuseleko lwentengiso (ngexesha apho imveliso yegeneric, hybrid okanye biosimilar ayinakho ukubakho. ithengisiwe), kulandela isigunyaziso sentengiso.
Iinkampani ezixuba amayeza ziya kuba selungelweni lamaxesha awongezelelweyo Ukukhuselwa kwedatha ukuba imveliso ethile ijongana nemfuno yonyango engafezekiyo (+12 iinyanga), ukuba uvavanyo lwezonyango oluthelekisayo lwenziwa kwimveliso (+6 iinyanga), kwaye ukuba isabelo esibalulekileyo sophando lwemveliso kunye nophuhliso lwenzeka kwi EU kwaye ubuncinci ngokuyinxenye ngentsebenziswano namaqumrhu ophando e-EU (+6 iinyanga). Ii-MEPs nazo zifuna i-cap kwixesha elidibeneyo lokukhusela idatha yeminyaka esibhozo nesiqingatha.
Ukongezwa kwexesha elinye (+12 iinyanga) kwiminyaka emibini ukhuseleko lwemarike ixesha linokunikezelwa ukuba inkampani ifumana isigunyaziso sokuthengisa kwisalathiso esongezelelweyo sonyango esibonelela ngeenzuzo ezibalulekileyo zeklinikhi xa kuthelekiswa nonyango olukhoyo.
Iziyobisi zeenkedama (amayeza aphuhliswe ukunyanga izifo ezinqabileyo) angazuza ukuya kuthi ga kwi-11 yeminyaka yobubodwa bemarike ukuba bajongana “nesidingo esikhulu sonyango esingafezekiswanga”.
Yandisa umlo wokuchasana ne-antimicrobial (AMR)
Ii-MEPs zigxininisa imfuno yokunyusa uphando kunye nophuhliso lwe inoveli antimicrobials, ngokukodwa ngamabhaso okungena kwimarike kunye neenkqubo zentlawulo yembuyekezo ebalaseleyo (umzekelo: inkxaso yemali ekwinqanaba lakwangoko ekuphunyezweni kweenjongo ezithile zeR&D phambi kokuvunywa kwemarike). Oku kuya kuncediswa yinkqubo yokuthengwa kwempahla edibeneyo esekelwe kwimodeli yobhaliso ngokuzithandela, ukukhuthaza utyalo-mali kwii-antimicrobials.
Bavumelana nokuqaliswa kwe "i-transferable data exlusivity voucher" ye-antimicrobial ephambili, ukubonelela ngeenyanga ezili-12 ezongezelelweyo zokukhusela idatha kwimveliso egunyazisiweyo. Ivawutsha ayikwazanga kusetyenziselwa imveliso esele ixhamle kukhuseleko lwedatha oluphezulu kwaye ingagqithiselwa kube kanye kuphela komnye umnikazi wesigunyaziso sentengiso.
Phakathi kwamanyathelo amatsha okukhuthaza ukusetyenziswa ngobulumko kwee-antimicrobials, ii-MEPs zifuna iimfuno ezingqongqo, ezifana nokukhawulela imimiselo kunye nokusabalalisa kwixabiso elifunekayo kunyango kunye nokunciphisa ixesha elimiselweyo.
Iimfuno ezomeleziweyo zovavanyo lomngcipheko wokusingqongileyo
Le mithetho mitsha iya kufuna ukuba iinkampani zingenise uvavanyo lomngcipheko wokusingqongileyo (ERA) xa zicela isigunyaziso sentengiso. Ukuqinisekisa ukuvavanywa okwaneleyo kwee-ERAs, ii-MEPs zifuna ukudalwa, ngaphakathi kwe-Arhente ye-European Medicines Agency, yeqela elitsha elisebenzayo lovavanyo lomngcipheko wokusingqongileyo. Ii-MEPs zigxininisa ukuba amanyathelo okunciphisa umngcipheko (athatyathwe ukuphepha kunye nokunciphisa ukukhutshwa emoyeni, emanzini kunye nomhlaba) kufuneka ajongane nawo wonke umjikelo wobomi bamayeza.
Ukwanda kokuzimela komzimba we-EU wezempilo kaxakeka
Ukujongana ngempumelelo nemingeni yempilo yoluntu kunye nokunyusa aseYurophu uphando, ii-MEPs zifuna iYurophu ULungelo lweMpilo oluNgxamisekileyo kunye neGunya lokuPhendula (i-HERA, okwangoku isebe leKhomishini) ukuba ibe yisakhiwo esahlukileyo phantsi kweZiko laseYurophu loKhuselo noLawulo lweZifo (ECDC). I-HERA kufuneka igxile kakhulu kumlo ochasene nezo zoyikiso zempilo zingxamisekileyo, kubandakanywa ukuxhathisa amayeza okulwa neentsholongwane kunye nokunqongophala kwamayeza.
Iinkcukacha ezithe vetshe malunga nezindululo ezithile ze-MEPs ziyafumaneka kule uxwebhu olungasemva.
kuchaphulo
Intatheli yomyalelo UPernille Weiss (EPP, DK) uthe: “Uhlaziyo lwemithetho ye-EU yonyango lubalulekile kwizigulana, kumashishini nakuluntu. Ivoti yanamhlanje linyathelo elisingise ekunikezeleni ngezixhobo zokujongana nemingeni yokhathalelo lwempilo yangoku neyexesha elizayo, ingakumbi kumtsalane wethu wentengiso kunye nofikelelo lwamayeza kumazwe e-EU. Siyathemba ukuba iBhunga liyawuqaphela umnqweno wethu kunye nokuzibophelela kwethu ekudaleni isikhokelo somthetho esomeleleyo, sibeka indawo yothethathethwano olukhawulezileyo. "
Intatheli yommiselo Tiemo Wölken (S&D, DE) uthe: “Olu hlaziyo luvula indlela yokujongana nemiceli mngeni ebalulekileyo efana nokunqongophala kwamayeza kunye nokunganyangeki kwe-antimicrobial. Siqinisa iziseko zoncedo lwethu lwezempilo kwaye someleza ukomelela kwethu ngokudibeneyo phambi kweentlekele zempilo ezizayo-inqanaba elibalulekileyo ekufuneni kwethu ukhathalelo lwempilo olufanelekileyo, olufikelelekayo kubo bonke abantu baseYurophu. Amanyathelo okuphucula ukufikelela kumayeza, ngeli lixa iindawo ezikhuthazayo kwiimfuno zonyango ezingafikelelwanga, ziyinxalenye ebalulekileyo yolu hlaziyo.”
Amanyathelo alandelayo
Ii-MEPs zicwangciselwe ukuba zixoxe kwaye zivotele uluvo lwePalamente ngexesha le-10-11 kuTshazimpuzi ka-2024. Ifayile iya kulandelwa yiPalamente entsha emva konyulo lwaseYurophu ngo-6-9 Juni.
imvelaphi
Ngomhla wama-26 kuTshazimpuzi ka-2023, iKomishoni yabeka phambili “iphakheji yamayeza” ukuhlaziya umthetho we-EU woxubo-mayeza. Ibandakanya izindululo entsha myalelo kunye entsha miselo, ezijolise ekwenzeni amayeza afumaneke ngakumbi, afikeleleke kwaye afikeleleke, ngelixa ixhasa ukukhuphisana kunye nomtsalane kwishishini le-EU loxubo-mayeza, ngemigangatho ephezulu yokusingqongileyo.
