Mutsara unopisa pamusoro pemvumo yekupihwa mushonga mutsva

Pakatanga COVID-19 pasi rose muna 2020, Spain yakarohwa zvakanyanya, neavhareji yekufa kwemazana masere pazuva pane imwe nguva.

Sezvingatarisirwa, zvakawira kumakambani emishonga kugadzira zvigadziriso zvinogona kurapa chirwere ichi kana kudzikisa mhedzisiro yacho kuvarwere. Mazhinji emakambani aya akatarisa mumishonga yakagadziridzwa zvimwe zvirwere uye mamiriro ekuongorora kushanda kwavo pakoronavirus iyi.

Izvi ndizvo zvakatsvakwa naPharmaMar, kambani inozivikanwa pasi rose yeoncology, neAplidin, mushonga wakagadzirirwa kudzokororwa/refractory Multiple Myeloma (MM), wanga uchiongororwa kurapwa kwevakuru vane COVID-19 yaida kuti varapwe muchipatara. 

Kuvimbika kwekambani kwakavakirwa pane akati wandei akabudirira in-vitro zvidzidzo zvakaitwa pasi rese. Sekureva kweFarmaMar data, simba reAplidin kurwisa coronavirus rakapetwa kanopfuura chiuru kune mamwe madhiragi.

Mushonga uyu wakatarisana nekukunda matambudziko akateedzana pawakaiswa mumvumo kuSpain Agency of Medicines and Medicinal Products (AEMPS) uye wakazopihwa mvumo yekuenderera mberi nemiedzo yekiriniki yemushonga.

Zvakadaro, European Medicines Agency (EMA), inoonekwa seEU yakaenzana neFDA muU.S uye dare rinotarisira kubvumidzwa kwemishonga mitsva, yakaramba mvumo. Hakasi kekutanga kuti Aplidin nemamwe madhiragi anovimbisa, ane humbowo hunobudirira aive pasi pezvipingamupinyi.

Kunyatsotarisisa maitirwo emvumo yemusika kunoita kuti kambani iyi ifungidzire kuti, “vezvematongerwo enyika” vangangodaro vakaita basa mukugadzira “zvimhingamupinyi” pakuita sarudzo - fungidziro yakarambwa zvakasimba neEMA.

Myeloma Patients Europe, sangano reNGO remasangano evarwere anodarika makumi mana muEurope yose, ratumira tsamba kuna sachigaro weKomiti yeMedicinal Products for Human Use (CHMP), komiti yeEMA inoona nezvemishonga yevanhu, ichiratidza “kunetsekana kwakanyanya” kuti mushonga uyu unovimbisa hauzombofa wakatenderwa.

Apo Aplidin yakaiswa pamberi pemvumo yemusika muna 2016, tariro yaive yakakwirira kuti yaizobvumidzwa. Pane kudaro, mushonga uyu wakatarisana nekurambwa kwakati wandei kubva kuEMA inotungamira PharmaMed kubvunza kuti nei? Yakabvunza kuti: Kurambwa kwe Aplidin kwakaruramiswa sei? Pangava ne“masimba ezvamatongerwe enyika ane simba” ari kutamba achifarira mimwe mishonga nemakambani kupfuura mamwe here? Kusvika papi, rinobvunzawo kuti, nzira yemvumo yemusika inoenderana nezvinodiwa nevarwere - vese mutengi nevanobatwa mumamiriro ezvinhu aya - vane shungu yekuwana mishonga inoponesa hupenyu?

Kambani iyi inoti pane "humbowo hunomanikidza" kutsigira kubvumidzwa kwemushonga uye, inodaro, kuti EMA inongoita kunge "yakatsunga" kunonoka kupihwa mvumo.

Nekuda kwekuramba kweEMA kwaAplidin, nyaya yakaendeswa kuEU General Court uye PharmaMar akakumbira kujekeswa kwemaitiro ebvunzo akashandiswa panguva yemvumo yekushambadzira pamberi peEMA.

Chiitiko chekambani iyi chakanangana nekukanganisa kwainonzi kwakaitwa pakupihwa mvumo kwemusika kuEMA, zvichinzi zvakarerekera pakubatwa kwavo neCHMP pamwe nekusarurwa kwavanoti kubva kunhengo dzakasiyana dzeEMA. Zvose izvi zvakarambwa neEMA asi kuramba kweEMA mushonga wePharmaMar's Aplidin kwave kubvunzwa, kwete nekuti kwabvumidzwa kurapwa myeloma muAustralia.

Muna Gumiguru 2022, iyo European Count yakawana ichifarira PharmaMar, ichivhura magonhi ekugamuchirwa kweAplidin semushonga wekutengesa. Iyo kambani inoti maitiro eEMA kune Aplidin "ezvematongerwo enyika" uye "mhedzisiro yekumanikidzwa nedzimwe hurumende nemakambani anokwikwidza".

Kazhinji, maererano nePharmaMar, nyaya yacho inomutsa mibvunzo yakananga: Hurumende kana makambani akazvimirira “anokanganisa” maitirwo esarudzo eEMA here? Nzira dziripo dzinoshanda zvakakwana kudzivirira kupokana kwezvido here? Sei mamwe madhiragi asingashande zvakanaka achinzi ari kuwana mvumo, asi mamwe achirambwa? Sei masangano anodzora achinzi anoda kutsigira mamwe makambani kupfuura mamwe?

Chimwe chipingamupinyi pakupinzwa kwemishonga mitsva pamusika chinooneka kana tichifunga kuti nyika dzenhengo dzeEU idzo dzinofanirwa kudzosera masangano ekurapa chero mishonga yakapihwa, zvinonziwo, ndidzo dziri kuita ongororo yeEMA.

Muna 2020, General Court yeEuropean Union yakagamuchira chikumbiro ichi, zvizere, ichidzima mutongo weEuropean Commission. Mukuongorora kwaro nyaya iyi, Dare Gurusa rakatarisa kunonzi kurerekera kwaigona kuitika mumaitiro akatungamira mukutambirwa kwemutongo waipikisa neKomisheni. Zvakanyanya, zvakatarisa nyaya, iyo inopokana, yekuti dzimwe nyanzvi dzakadomwa neEMA dzakashandirwa nechipatara cheyunivhesiti uye vaiita mabasa akanangana nekugadzira mishonga inopikisana neAplidin.

Sarudzo yacho inoti: "maitiro akatungamira mukugamuchirwa kwechisarudzo chakapikiswa haana kupa vimbiso yakakwana yekusabvisa chero kusava nechokwadi kuri pamutemo pamusoro pekurerekera kunobvira."

PharmaMar inosimbirira kuti EU neEuropean Ombudsman vanofanirwa kuongorora zvese zviri pamutemo uye zvisina kurongwa kutaurirana pakati pevakuru veEMA neNyika dzenhengo dzinotora chikamu mukukwidza nyaya, pamwe neindasitiri yemishonga yenyika idzi. Iyo kambani inotenda kuti vazhinji cancer uye varwere veCovid-19 vangadai vakabatsirwa neAplidin - zvechokwadi, vachiri kutarisira kuti ichabvumidzwa "mukupedzisira". Zvichakadaro, rave kuda kuti paferefetwa nezve chero “kumanikidza” kungave kwakaunzwa panyaya iyi.

Mutauriri weEMA akapa chirevo chine simba chinoti, “Hatigone kutaura nezvezviri kuitika mumatare edzimhosva pamusoro peAplidin.

“Asi idzi imhosva dzisina musoro uye tinoona zvakakosha kururamisa rekodhi.

“Chekutanga, tinoda kutaura kuti komiti yedu yemishonga yevanhu (CHMP) inoshanda chete nezvikonzero zvesainzi dzakaomarara uye hunyanzvi hwakazvimirira. Inosanganisira nhengo dzinobva kunhengo dzese dzeEU pamwe neEEA-EFTA States.

"Kuongororwa kweCHMP kwakavakirwa pakunyatsoongorora humbowo huripo pamhando, kushanda kwayo uye kuchengetedzeka kwemushonga uye iri pasi pekuongororwa kwevezera uye kuita sarudzo pamwe chete. Pachikumbiro chega chega chemushonga mutsva, nhengo dzekomiti mbiri - dzinozivikanwa semutauriri uye mubatsiri - kubva kunyika dzakasiyana dzinogadzwa kuti dzitungamire ongororo uye kuita ongororo yesainzi yemushonga dzakazvimirira kubva kune mumwe nemumwe. Iyo CHMP zvakare inogadza mumwe kana vanopfuura vezera vanoongorora kubva pakati penhengo dzeCHMP. Basa ravo nderekutarisa nzira iyo ongororo mbiri dzinoitwa uye kuona kuti gakava resainzi rakajeka, rakajeka uye rakasimba. Kurudziro yekupedzisira, inomiririra huwandu hwekuongorora kwekomiti uye maonero pane data, inogadzirwa.

“Kwemakore akawanda ikozvino, EMA yange iri pamberi mukubuda pachena panyaya yekuongororwa kwemishonga. Iyo Agency inoona kuti kubuda pachena kwakakosha mukusimbisa kuvimba muzvisarudzo zvekutonga.

"Kujeka kune veruzhinji kunosimbiswa nekuburitswa kwemishumo yekuongorora yeCHMP pawebhusaiti yedu yekambani. Tinogashira maonero ekunze uye mhinduro pamaonero edu esainzi, uye mukupindura zvakataurwa kana mibvunzo chinangwa chekupa tsananguro dzakabatanidzwa, dzakajeka pazvinzvimbo zvedu pamwe nekubuda pachena zvizere pakuita kwedu nevanobata.

"Panyaya yeAplidin, panguva yekuongororwa kwepakutanga, takabudisa rondedzero yekuongorora yakadzama iyo yakatsanangura zvakajeka kufunga kweCHMP pauchapupu hunoenderana nekubatsirwa kwemushonga uyu mukurapa myeloma yakawanda uye njodzi dzinogona kuitika dzekuchengetedza. Ruzhinji rweCHMP rwaive nemafungiro ekuti mabhenefiti eAplidin haana kudarika njodzi dzayo uye akakurudzira kuti irambwe mvumo yekushambadzira.

Kana iyo itsva CHMP pfungwa paAplidin ichave yakagadzirira, ichaburitswa sezvakaita yapfuura.

"Izvi zvakati, tinoramba zvakasimba chero mhosva yekutadza uye yekumanikidza kwezvematongerwo enyika pakuongorora kweCHMP kunotungamira kune kurudziro kuEuropean Commission, kwete chete mumhosva yeAplidin asi kune chero chimwe chigadzirwa. Tiri kutyira kuti panzvimbo pacho panogona kunge paine kuedza nemaune kuvhiringa danho rinogara richiitwa rekutonga, iro riri kuitwa zvizere zvichitevedza zvinodiwa nemutemo.”

Inoenderera mberi ichiti: “Nyika mbiri dziri nhengo dzeEU dzakapikisa mutongo wedare reGeneral Court panyaya yeAplidin, uye kuti imwe nhengo yechitatu yapindira munyaya yadzo, kunze kweEMA. Sekuona kwevamhan’ari, mutongo wekutanga unotadza zviri pamutemo uye unofanira kusendeka parutivi kana kugadziriswa. Ruzivo urwu rwuri paruzhinji.”

Goverana ichi chinyorwa: