ISpain isizisungule njengenye yezindawo izikhungo ezinkulu zaseYurophu zocwaningo lwezokwelaphaISpain izibeke phambili kwi-European Union kokubili enanini lezivivinyo ezigunyaziwe kanye nobubanzi bezindawo zokwelapha ezihlanganisiwe. Lobu buholi abuyona inhlanhla, kodwa umphumela wesu eliqhubeke iminyaka engaphezu kweyishumi, elihlanganisa uhlelo lokulawula oluqinile, amandla enethiwekhi yezibhedlela, kanye nokubandakanyeka kweziguli kanye nochwepheshe bezempilo.
Ngokusho kwedatha yakamuva evela ku- Irejista YaseSpain Yezifundo Zemitholampilo (REec)Iphethwe yi-Spanish Agency for Medicines and Health Products (AEMPS), kwagunyazwa izivivinyo zemitholampilo ezingu-962 eSpain ngo-2025. Lesi sibalo siqinisekisa ukuthambekela okukhulayo okugcinwe iminyaka engaphezu kweyishumi futhi siqinisa indima ye-AEMPS njenge i-ejensi yokulawula ehamba phambili eYurophu kanye nesilinganiso samazwe ngamazweLokhu kuhumusha ukufinyelela kwangaphambi kwesikhathi kweziguli zaseSpain ekwelashweni okusha, njengalezo Kuzokhiqizwa umuthi omusha eSpain..
ISpain, izwe laseYurophu elisebenza kakhulu ezivivinyweni zemitholampilo
Ukuguquguquka kwesistimu yocwaningo lwezokwelapha yaseSpain kwabonakala lapho ISpain idlule iJalimane njengezwe laseYurophu eliqalise izivivinyo eziningi zezokwelaphaNgokusho kombiko othi "Ukuhlola I-Clinical Trials Ecosystem eYurophu," olungiselelwe yi-IQVIA ye-EFPIA kanye ne-Vaccines Europe, iSpain ivelele njengesibonelo sokusebenza kahle esimweni lapho iYurophu iyonke yayilahlekelwa khona yi-United States kanye ne-China.
Umbiko uxhumanise lokhu kugxuma no ukusetshenziswa kwasekuqaleni koMthethonqubo Wezilingo Zomtholampilo waseYurophu (i-CTR)okuyinto iSpain eyaqala ukuyisebenzisa ngendlela yokuqala ngo-2016. Lokhu kulindela imithetho, kanye nendawo esebenzayo yokubambisana komphakathi kanye nezizimele, kuye kwayivumela ukuthi ihehe ukugeleza okwandayo kwezifundo zamazwe ngamazwe futhi ihlanganise izwe njenge umlingani okhethwayo embonini yezemithi kanye nabagqugquzeli bezemfundo.
Ngesikhathi esifanayo, ukutshalwa kwezimali ocwaningweni lwezokwelapha kuqhubekile nokukhula. Phakathi kuka-2012 no-2022, ukusetshenziswa kwemali okuhlobene nalezi zifundo kukhuphuke kusuka ku-479 kuya ku- 834 million eurongokukhula okumaphakathi konyaka okucishe kube ngu-6%. Lokhu kwanda okuqhubekayo kwezinsizakusebenza zomnotho kuqinisa amandla ezibhedlela namaqembu ocwaningo okuhlanganyela kumaphrojekthi ayinkimbinkimbi kakhulu.
I-AEMPS igcizelele ukuthi iSpain ayigqami nje kuphela ngobuningi bezivivinyo, kodwa futhi nangobuningi bezilingo. ukuhlukahluka kokwelapha kanye nezinga lobuchwepheshe lwezifundo. I-Oncology, izifo ezingavamile, izindlela zokwelapha ezithuthukisiwe kanye nemithi emisha sekuyizinsika zemodeli ehlanganisa ubuhle bezokwelapha, isivinini sokulawula kanye nenethiwekhi yezempilo ehileleke kakhulu ekwakhiweni kobufakazi besayensi.
Izivivinyo zemitholampilo ezingu-962 ngo-2025: ubuholi obuhlanganisiwe
Idatha esemthethweni ye-REEc iqinisekisa ukuthi ngo-2025 i-AEMPS yagunyaza Izivivinyo zemitholampilo ezingu-962 eSpainLokhu kuqinisa isikhundla sezwe njengelisebenza kakhulu kwi-European Union kule ndawo. Lesi sibalo sigcina ukuthambekela kokukhula okuqhubekayo iminyaka engaphezu kweyishumiukuhlanganisa imodeli eye yabonakala izinzile, inokuncintisana futhi iyakhanga kubathuthukisi bamazwe ngamazwe.
Inhlangano elawulayo yaseSpain igcizelela ukuthi lokhu kuthuthuka kuvumele i-Ejensi ukuthi izibeke njenge- Igunya laseYurophu elinenani eliphakeme kakhulu lezimvume zokuhlolwa kwezokwelapha futhi ingenye yezindawo ezinethonya kakhulu emhlabeni jikelele. Lesi sikhundla siqinisa indima yaseSpain njengesango lemithi emisha kanye nobuchwepheshe bezokunakekelwa kwempilo, okunomthelela oqondile ekufinyeleleni kweziguli kusenesikhathi ekwelashweni okuseqophelweni eliphezulu.
Ezingeni laseYurophu, i-AEMPS ayigcini ngokucubungula amafayela: uhola izinhlelo ezibalulekile zomphakathi ocwaningweni lwezokwelapha futhi iyingxenye yeqembu eliyinhloko lezinhlangano ezibeka uhlelo lokulawula. Indima yayo esebenzayo ivumela ukuthi ithonye ukuthuthukiswa kwezinqubo ezisheshayo nezihambisanayo phakathi kwamazwe ahlukene angamalungu, into ebaluleke kakhulu ezivivinyweni zamazwe ngamazwe.
Kumavivinyo angu-962 agunyazwe ngo-2025, ingxenye ebaluleke kakhulu yizifundo zamazwe ngamazwe. Ngokukhethekile, Izivivinyo zemitholampilo zamazwe ngamazwe ezingama-758 Bahlanganisa nokubamba iqhaza kwezikhungo zaseSpain, okubeka izwe esimweni esihlelekile uma kukhulunywa qasha iziguli futhi unikeze idatha eqinile ekuthuthukisweni kwemithi emisha. Leli khono lokuheha abacwaningi liqinisa isithombe seSpain njengendawo ethembekile nephumelelayo yocwaningo.
I-AEMPS ngokwayo iqokomisa ukuthi leli nani lezifundo, kuhlanganiswe nokuzinza kokulawula kanye nesivinini sokuhlola, lenze iSpain yaba Isikhungo saseYurophu sezivivinyo zemitholampiloIzwe lihlanganisa ulwazi lokulawula, izinsiza zokunakekelwa kwempilo, kanye nesiko elikhulayo lokubamba iqhaza ocwaningweni, izinto ezilivumela ukuthi lincintisane ngokulinganayo nezinye izikhungo ezinkulu zomhlaba.
I-Oncology, izifo ezingavamile kanye nokwelashwa okuthuthukile, enkabeni yemephu
Ukusatshalaliswa kwezilingo ezigunyaziwe ngo-2025 kukhombisa ukugqama okucacile kwe i-oncology njengendawo eyinhloko yokwelaphaNgalowo nyaka, i-Spanish Agency for Medicines and Health Products (AEMPS) yavuma izivivinyo eziphathelene nomdlavuza ezingu-378, ezimele cishe u-40% wazo zonke izifundo ezivunyelwe eSpain. Ngalezi zibalo, iSpain ibalwa njengezwe laseYurophu eline- inani elikhulu lamaphrojekthi ocwaningo lomdlavuza aqhubekayo, ngesilinganiso esikhulu uma kuqhathaniswa namanye amazwe angamalungu.
La maphrojekthi athuthukiswe ku- izibhedlela esezibe yizilinganiso zaseYurophu Ekubhekaneni nomdlavuza, kunamaqembu akhethekile ahlukahlukene kanye nenhlangano egxile ekuhlanganiseni ucwaningo emisebenzini yezokwelapha. Ukubamba iqhaza ezivivinyweni kunikeza iziguli eziningi ithuba lokufinyelela ukwelashwa okusathuthuka obekungathatha isikhathi eside ukuthi kutholakale.
Ngemva kwe-oncology, ezinye izindawo zokwelapha zivelele ngokuba khona okukhulu enanini eliphelele lezivivinyo ezigunyaziwe. izinkinga zesistimu yomzimba Zimelela u-10,5% wezifundo, izinkinga zesimiso sezinzwa ngu-6,9%, izifo zenhliziyo nemithambo yegazi ngu-6,2%, kanye nezinkinga zendlela yokuphefumula ngu-4,4%. Lokhu kusatshalaliswa kubonisa isithakazelo esikhulayo ezifweni ezingamahlalakhona neziyinkimbinkimbi ezidinga izinketho ezintsha zokwelapha.
Esinye sezibalo ezihlaba umxhwele kakhulu yilesi esibhekisela ku- izifo ezingandileCishe ama-22,5% ezivivinyo zemitholampilo ezenziwa eSpain ngo-2025 agxile kulezi zinhlobo zezifo, ebezicwaningwa kancane ngenxa yokusabalala kwazo okuphansi. Ukubamba iqhaza kwezikhungo zaseSpain kulo mkhakha kuqinisa ukuzibophezela emaqenjini eziguli, iminyaka eminingi, ebenokufinyelela okulinganiselwe kokusungula izinto ezintsha.
Ngesikhathi esifanayo, iSpain isalokhu iphakathi kweqembu eliphambili laseYurophu ocwaningweni nge imithi yokwelapha ethuthukisiweLe nsimu ihlanganisa ukwelashwa kobunjiniyela bezakhi zofuzo, amaseli, kanye nezicubu. Ngo-2025, kwagunyazwa izivivinyo zemitholampilo ezingu-40 kulesi sigaba, zisekelwa yi- ubuchwepheshe babahloli be-AEMPS kanye nezinhlaka ezikhethekile kakhulu ezibhedlela ezihamba phambili, ezikwazi ukuphatha nokuqapha lezi zindlela zokwelapha eziyinkimbinkimbi nazo zonke iziqinisekiso ezidingekayo.
Izigaba zokuqala kanye nokuzibophezela ekuqanjweni kwezokwelapha
Isibonakaliso esibalulekile sokulinganisa izinga lokusungula izinto ezintsha ezweni ocwaningweni lwezokwelapha yinani la izivivinyo ezigabeni zokuqala zokuthuthukiswaikakhulukazi izivivinyo zesigaba I kanye nesigaba I/II. Lezi zifundo zisesigabeni sokuqala sokuhlolwa kwabantu futhi zibangela ingxenye enkulu yocwaningo ngemithi emisha kanye nezindlela zokusebenza.
ESpain, ukuthuthuka kule ndawo kube kuhle ngokusobala. Ngo-2015, kwavunyelwana Izilingo zesigaba I kanye nesigaba I/II eziyi-156Lokhu kumele cishe u-19% wazo zonke izifundo. Eminyakeni eyishumi kamuva, inani lenyuke laya ezivivinyweni zokuqala ezingu-244, ezibalelwa cishe ku-25% wabo bonke abagunyaziwe ngo-2025. Lokhu kwanda kubonisa i- intshisekelo yabathuthukisi ekutholeni intuthuko yokuqala ezweni lethu, uphawu lokuqiniseka emandleni okulawula kanye nesayensi alolu hlelo.
I-AEMPS ibeke phambili ukuhlolwa kwale misebenzi, iqaphela ukuthi izigaba zokuqala zibalulekile ukuheha utshalomali olunenani eliphezulu kanye nokubeka iSpain phambili ekusungulweni kwemithi. Ukuhlanganiswa kwezikhathi zokuphendula ezincintisanayo, ubuchwepheshe bezobuchwepheshe, kanye nohlaka olucacile lokulawula kube ngenye yezinto ezichaza lokhu kukhula.
Kulesi simo, ukuqiniswa kwamayunithi okuhlolwa kwezokwelapha ezibhedlela nasezikhungweni zocwaningo kudlale indima ebalulekile. Ukuthuthukiswa kobungcweti kwala maqembu, ngamaphrofayili anikezelwe ku- ukuphathwa, ukuqapha kanye nokuxhumanisa izifundoKusivumele ukuthi sithole inani elikhulu lamaphrojekthi ngaphandle kokulahlekelwa yikhwalithi noma ukuphepha.
Ngaphezu kwezivivinyo zesigaba sokuqala, iSpain iyaqhubeka nokuba khona okukhulu ezivivinyweni zeSigaba II nesesi-III, lapho ukusebenza kahle nokuphepha kuqinisekiswa khona kubantu abaningi. Lokhu kuqhubeka phakathi kwezigaba zokuqala nezesibili kwenza kube lula ukuthuthuka kwentuthuko eminingi eqala ezweni lethu. baqede ingxenye ebalulekile yokuqeqeshwa kwabo kwezokwelapha ngaphakathi kwenethiwekhi efanayo yezikhungo, okuqinisa ulwazi oluqoqwe ngamathimba ocwaningo.
Intshisekelo kwezokwelapha ezintsha, njengemikhiqizo yezokwelapha ethuthukisiwe noma ukwelashwa okuqondiswe ezinhlosweni ezithile zama-molecule, kunezela kulokhu. izivivinyo zokuqala, izindlela zokwelapha ezisezingeni eliphezulu, kanye nesisekelo esiqinile sezifundo zesigaba esilandelayo Kudala uhlelo olukhangayo kakhulu lwezinkampani namaqembu ocwaningo afuna izindawo ezivuthiwe lapho angahlola khona intuthuko yawo.
Inethiwekhi eqinile yesibhedlela, iziguli ezibandakanyekayo, kanye nokusebenzisana komphakathi nezizimele
Enye yezinsika zobuholi beSpain ocwaningweni lwezokwelapha ukuthi ibanzi inethiwekhi yezibhedlela nezikhungo zokunakekelwa kwempilo ezihilelekile ekwenzeni izivivinyo. Eminyakeni emihlanu edlule, izikhungo ezicishe zibe yi-1.000 ezahlukene ziye zahlanganyela ocwaningweni lwezokwelapha, okubonisa ukuba khona kwendawo ebanzi kanye nokuhlanganiswa okuqhubekayo kocwaningo emisebenzini yezokwelapha yansuku zonke.
Ukubamba iqhaza kweziguli kungenye into ephawulekayo. ISpain iphakathi kwamazwe aseYurophu ane- amazinga okuqashwa athuthukisiwe ezivivinyweni zemitholampiloLokhu kungenxa kakhulu yokwethembana komphakathi kochwepheshe bezempilo kanye nohlelo lwezempilo lomphakathi. Le mpendulo enhle yenza kube lula ukuthi izifundo zifinyelele inani elidingekayo labahlanganyeli ngaphakathi kwezikhathi zokuncintisana, okuyisici esibalulekile kubaxhasi bamazwe ngamazwe.
Ukubambisana phakathi kwemikhakha kahulumeni neyangasese sekungenye yamandla emodeli yaseSpain. Ukuba khona kwe izivumelwano ezizinzile phakathi kwezibhedlela, amanyuvesi, izikhungo zocwaningo kanye nezinkampani zemithi Ivumela ukwabelana ngezinsizakusebenza, ulwazi kanye nezakhiwo, okwandisa ukuncintisana kweSpain uma kuqhathaniswa namanye amazwe aseYurophu uma kukhulunywa ngokuheha amaphrojekthi.
Amakomidi ocwaningo lokuziphatha nawo adlala indima ebalulekile. ukusebenzisana okuseduze ne-AEMPS kanye namaqembu ocwaningoNgemihlangano evamile kanye nezinhlelo zokuqapha eziqhubekayo, kusiza ukuqinisekisa ukuthi izifundo zenziwa ngeziqinisekiso eziphelele zokuziphatha kanye nokuvikelwa kwabahlanganyeli, kuyilapho kugwema ukubambezeleka okungadingekile ezinqubweni zokubuyekeza.
Uma zizonke, lezi zinto zivumele iSpain ukuthi ibhekwe njengendawo lapho ucwaningo lwezokwelapha lukhona khona kuhlanganiswe ekuhleleni izinsizakalo zezempilohhayi njengomsebenzi ongaphansi. Lokhu kuhlanganiswa kukhuthaza ochwepheshe ukuthi babone izivivinyo zemitholampilo njengengxenye yomkhuba wabo ojwayelekile futhi kunikeza iziguli izinketho ezengeziwe zokuzifinyelela lapho kufaneleka.
Uhlaka lokulawula olusheshayo: ukusheshisa, ubuholi baseYurophu kanye nokuguqulwa kwedijithali
Indima ye-AEMPS njenge injini yokulawula yocwaningo lwezokwelapha Lokhu kube yinto ebalulekile ekwenzeni iSpain ikwazi ukugcina isikhundla sayo sokuhola. Eminyakeni yamuva nje, i-Ejensi iqinise izinyathelo zokunciphisa izikhathi zokuhlola, ukwandisa ukusebenza kahle, nokunikeza indawo yokuncintisana ngaphandle kokubeka engcupheni ukuphepha noma ukuqina kwesayensi.
Phakathi kwezinhlelo ezifanele kakhulu, okulandelayo kuyagqama: ukunwetshwa kwezinqubo zokuhlola ezisheshayo noma ezisheshayo kuya ezivivinyweni zezokwelapha zikazwelonke ezindaweni ezifana ne-oncology kanye nezifo ezingavamile. Lezi zindlela zivumela ukwehla okukhulu kwezikhathi zokugunyazwa, ngezinhloso ezithi, kwezinye izimo, zibe cishe izinsuku ezingama-26. Isibonelo, ucwaningo lokuqala ngaphansi kwalolu hlelo, olwaziwa ngokuthi i-EMBOLD futhi oluxhaswe yi-GSK, seluvele lugunyaziwe.
Ngaphezu kwalokho, i-Agency ikhuthaze inqubo yokuqala yokusheshisa yamazwe ngamazwe e-EU, eyaziwa ngokuthi i-FAST-EUNgaphakathi kohlaka lwe-Heads of Medicines Agencies (HMA) Network, eholwa nguMqondisi we-Spanish Agency for Medicines and Health Products (AEMPS), uMarÃa Jesús Lamas, lobu buholi baseYurophu buqinisa indima yeSpain njengomdlali oholayo ekuhlanganiseni izivivinyo phakathi kwamazwe angamalungu.
Ukuguqulwa kwedijithali kungenye indlela ebalulekile. Ukuhlanganiswa okugcwele kwi-CTIS (Uhlelo Lolwazi Lwezivivinyo Zemitholampilo)Lapho isikhathi sokuguquka kwe-European Clinical Trials Regulation sesiqediwe, le nkundla ikhulise ukucaca futhi yenza lula ukuphathwa kwezifundo ngasikhathi sinye emazweni amaningana. Le nkundla ehlanganisiwe inciphisa imithwalo yokuphatha futhi yenza kube lula ngabaxhasi ukuqapha amaphrojekthi abo kulo lonke i-European Union.
I-AEMPS iphinde yaqinisa indima yayo yokuqeqesha nokusekela, ngokuhlela Izikhathi zolwazi ezihloselwe abacwaningi, abagqugquzeli kanye neziguli, kufaka phakathi ukugomela i-pertussis komamaLezi zingxoxo zichaza izinguquko zomthetho, amathuba anikezwa uhlaka olusha lwaseYurophu, kanye nendima ebalulekile edlalwa abahlanganyeli ezivivinyweni, ngokunaka kakhulu ukuvikelwa kwamalungelo abo kanye nekhwalithi yolwazi abalutholayo.
Konke lokhu kusekelwe ku-a umthethonqubo oguquguqukayo noguquguqukayo, ngokusekelwe eziqondisweni ezivuselelwa njalo - okubizwa ngokuthi "iziqondiso zokuphila" - ezivumela izinqubo ukuthi zilungiswe ukuze zivumelane neqiniso elishintshayo lokusungula izinto ezintsha kwezokwelapha, zihlale zigcina amazinga okuphepha nokusebenza kahle adingwa yimithethonqubo yemithi yocwaningo.
Iqoqo ledatha nezilinganiso ezichazwe lidweba isithombe lapho iSpain izibonakalise khona njenge- Umholi waseYurophu ocwaningweni lwezokwelaphaUkuhlanganisa umthamo wesilingo, ukuhlukahluka kokwelapha, amandla okusungula izinto ezintsha, kanye nokuguquguquka kokulawula, ukuxhumanisa phakathi kwe-Spanish Agency for Medicines and Health Products (AEMPS), inethiwekhi yezibhedlela, amakomidi okuziphatha, imboni, kanye neziguli kuye kwenza kwaba nokwenzeka ukudalwa kwendalo eqinile nekhangayo. Kule ndlela yokuphila, izivivinyo zemitholampilo sezibe yingxenye ejwayelekile yomkhuba wezempilo kanye nomshayeli oyinhloko wokuletha ukwelashwa okusha kakhulu okuthuthukiswa eYurophu nasemhlabeni jikelele ohlelweni lwezempilo yomphakathi.
