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Farmacijos sektorius Europos ekonomikoje sudaro svariA� dalA?: jame dirba daugiau nei 630 tA�kst. A?moniA?. VaistA? gamintojai yra ir svarbi mokslo dalis: A?io sektoriaus iA?laidos sudaro beveik penktadalA? ES moksliniA? tyrimA? ir technologijA? plA�tros iA?laidA?. Deja, Europos vaistA? gamintojams pastaruoju metu tenka itin arA?iai kovoti cipralex e pantoprazolo su JAV ir Azijos konkurentais. Blogiausia, kad daugeliu atveju konkurentai europieA?ius aplenkia. SusirA�pinA� esama padA�timi, Europos Parlamento nariai ketina pakeisti iki A?iol galiojanA?iA� vaistA? klinikiniA? tyrimA? tvarkA�. TreA?iadienA? jie balsavo uA? naujA� KlinikiniA? tyrimA? reglamentA�.

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Iki A?iol vaistus kurianA?ios A?monA�s, norA�damos atlikti klinikinius tyrimus Europoje, turA�davo gauti kiekvienos A?alies leidimA� atskirai. Europos Parlamentas balsavo uA? tai, kad A?monei reikA�tA? pateikti tik vienA� elektroninA? praA?ymA� atlikti klinikinius tyrimus nors ir visose ES A?alyse. a�zLigi A?iol A?monA�ms reikA�davo samdyti A?mones, kurie tvarkydavo dokumentus kiekvienoje A?alyje atskirai a�� nepamirA?kime, kad kiekvienoje A?alyje reikalavimai irgi skirtingi. A�iuo metu vidutiniA?kai leidimams atlikti klinikinius vaistA? tyrimus gauti Europoje reikia 1,5 metA?. Pakeitus tvarkA�, kai uA?teks vienos formos uA?pildymo ir bus pateikiamas bendras Europos SA�jungos A?aliA? kompetentingA? institucijA? vertinimas, procedA�rai atlikti uA?teks 2 mA�nesiA?a�?, a�� dA?iaugiasi Inovatyvios farmacijos pramonA�s asociacijos direktorius Leonas KalA�tinas.

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Paprastai vaistA? kA�rA�jai jA? tyrimA? A?alis renkasi pagal teisines aplinkybes, kainA�, tyrimo centrA? bei tyrA�jA? kvalifikacijA�, taip pat pagal tai, kiek toje A?alyje yra pacientA?, kuriems bus reikalingas naujas vaistas. Europos Parlamento nariai A?sitikinA�, kad klinikiniuose tyrimuose dalyvaujantys A?monA�s turA�tA? bA�ti apsaugoti vienodai visoje Europos SA�jungoje, todA�l A?pareigojo A?alis nares patvirtinti bendras taisykles.

Lietuvoje kasmet gaunama praA?ymA? atlikti apie 100 A?vairiA? vaistA? tyrimA?. Visi asmenys tyrimuose dalyvauja savo noru. Naujos klinikiniA? tyrimA? tvarkos rengime dalyvavA�s ValstybinA�s vaistA? kontrolA�s tarnybos VaistA? saugumo ir informacijos skyriaus vedA�jo pavaduotojas ArA�nas free levitra trial offer VaitkeviA?ius sako, kad kitas svarbus pokytis bus aktualus bA�tent naujA? vaistA? klinikiniA? tyrimA? dalyviams.

A.VaitkeviA?ius sako, kad siekiama nustatyti minimalios rizikos ribA�, kurios nebus galima perA?engti, jeigu norima, kad vaistus testuotA? nepilnameA?iai, nA�A?A?iosios ar kiti labiau paA?eidA?iami A?monA�s. Tai reiA?kia, kad esant didesnei rizikai tokie A?monA�s tyrimuose dalyvauti negalA�s. a�zNorint, kad klinikiniuose tyrimuose dalyvautA? vaikai, reikA�s gauti ne tik jA?, bet ampicillin 500 low prices for you ir tA�vA? ar globA�jA? raA?tiA?kus sutikimus, jiems taip pat raA?tu turA�s bA�ti pateikta visa informacija apie atliekamus tyrimusa�?, a�� pasakoja paA?nekovas.

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Iki A?iol ne visA? vaistA? klinikiniA? tyrimA? rezultatai pacientams bA�davo prieinami. Europos Parlamento narA� iA? JungtinA�s KaralystA�s Glenis Willmott (SocialistA? ir demokratA? aljanso frakcija) pastebi, kad apie pusA� klinikiniA? vaistA? tyrimA? rezultatA?, ypaA? neigiamA?, visuomenei nA�ra pristatomi. a�zLabai svarbu, kad mes A?inotume apie neigiamus rezultatus a�� kitaip tyrimai gali bA�ti atliekami nuolat, kol tampa vieA?ai A?inoma, kad kai kurie produktai yra neveiksmingi ar net pavojingia�?, a�� paA?ymi G.Willmott. Europarlamentarai A?pareigojo vaistA? gamintojus bendroje duomenA? bazA�je skelbti visA? klinikiniA? tyrimA? rezultatus. Taip jie taps prieinami visiems. Tuo tarpu reikalavimA? nesilaikanA?ios A?monA�s bus baudA?iamos piniginA�mis baudomis.

DA�l A?io teisA�s akto jau pasiektas neformalus europarlamentarA? susitarimas su ES vyriausybiA? atstovais. Prie to nemaA?ai prisidA�jo ir 2013 m. antroje pusA�je ES Tarybai pirmininkavusi Lietuva. Naujasis KlinikiniA? tyrimA? reglamentas A?sigalios po dvejA? metA? nuo jo paskelbimo. Tai reiA?kia, kad naujoji klinikiniA? tyrimA? tvarka Europoje pradA�s veikti maA?daug 2016 m. viduryje.

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Pasibaigus tam tikro vaisto patento galiojimui, vaistA? gamintojai gali gaminti tokius pat vaistus su savo prekA�s A?enklu. Kadangi gaminant tokius vaistA? analogus reikia gauti kur kas maA?au buy levothyroxine no rx in usa leidimA?, sutrumpA�ja biurokratinis procesas. Tai leidA?ia gerokai, kartais net perpus, atpiginti vaistus. Tokie medikamentai vadinami generiniais.

Europarlamentarai A?sitikinA�, kad generiniai vaistai turA�tA? lengviau patekti A? rinkA� nei dabar. A�iuo metu neretai net pusA� metA? vA�luojama nustatyti generiniA? vaistA? kainA� ir kompensavimo tvarkA�. Europos Parlamento nariai siA�lo numatyti fiksuotA� 60 dienA? terminA� A?ioms procedA�roms atlikti. Jie taip pat mano, kad ES A?aliA? institucijos, atsakingos uA? vaistA? kontrolA�, turA�tA? kasmet vieA?ai skelbti kompensuojamA? vaistA? bei jA? kainA? sA�raA?A�.

VaistA? gamintojA? asociacijos direktorius Albertas Bertulis tikisi, kad Europos Parlamento nariA? iniciatyva padA�s generiniams vaistams lengviau patekti A? rinkA�: a�zTai lemtA? daugiau iA?gelbA�tA? gyvybiA?. Kai kurie vaistai yra tokie brangA�s, kad pacientai jA? tiesiog negali nusipirkti. Jeigu rinkoje bA�tA? analogiA?kA? pigesniA? medikamentA?, visuomenA� taptA? sveikesnA�.a�?

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