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2018, vol. 57, br. 4, str. 43-51
Dostupnost lekova za retke bolesti - komparativna analiza legislativnih zahteva između Srbije, Hrvatske i Makedonije
aUniverzitet u Beogradu, Farmaceutski fakultet, Katedra za socijalnu farmaciju i farmaceutsko zakonodavstvo
bMedical University of Sofia, Faculty of Pharmacy, Department of Social Pharmacy, Sofia, Bulgaria
cRepublic Fund for Health Insurance, Niš

e-adresadusica.krajnovic@pharmacy.bg.ac.rs
Projekat:
Retke bolesti: molekularna patofiziologija, dijagnostički i terapijski modaliteti i socijalni, etički i pravni aspekti (MPNTR - 41004)
Biomarkeri oštećenja i disfunkcije organa (MPNTR - 175036)

Ključne reči: orfan lekovi (OMP); priuštivost; dostupnost; retke bolesti; legislativni zahtevi
Sažetak
Dostupnost lekova za retke bolesti (orfan lekovi, u EU regulativi koristi se izraz na engleskom Orphan medicinal products, OMP) igra važnu ulogu u tome da li će bolesnici sa retkim bolestima imati pristup efikasnoj i adekvatnoj terapiji. Ciljevi ovog rada su da se identifikuju razlike u pristupu bolesnika orfan lekovima u tri odabrane zemlje: Srbiji, Hrvatskoj i Makedoniji. Pristup orfan lekovima definisana je kao: tržišna pristupačnost (dostupnost) i priuštivost (finansijska pristupačnost). Analizirali smo legislativne zahteve u procesu stavljanja leka u promet i uradili komparaciju među posmatranim zemljama. Retrospektivnom studijom preseka poredili smo nacionalne liste lekova posmatranih zemalja i Listu orfan lekova u EU, za period od šest meseci (maj-oktobar 2014.). Od ukupno 179 OMP, koliko ih je u tom periodu bilo sa dozvolom za stavljanje u promet u EU, u Srbiji je bilo registrovano 59 (32,96%), u Makedoniji 52 (29,05%), dok su u Hrvatskoj učlanjenjem u EU svi registrovani lekovi postali tržišno dostupni. Međutim, dozvola za stavljanje u promet nije i garancija da bolesnik ima pristup datom leku, pa je samo 39,11% lekova sa dozvolom za stavljanje u promet bilo na listi lekova koje se refundiraju u Hrvatskoj (70 OMP). Broj lekova kojima bolesnici imaju pristup preko nacionalnih fondova zdravstvenog osiguranja u Srbiji i Makedoniji su manji (32 OMP i 20OMP, respektivno), što čini da je priuštivost lekova u Srbiji tek 17,88% , a u Makedoniji 11,17% od liste orfan lekova u EU. Broj lekova, fizička i finansijska pristupačnost u analiziranim zemljama nije ista, dok je u Hrvatskoj bolesnicima dostupan najveći broj registrovanih lekova, u Srbiji se više od polovine registrovanih OMP može refundirati o trošku RFZO. Makedonija zbog manjeg broja stanovnika ima manji broj obolelih od RB, što rezultira manjim brojem OMP.
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O članku

jezik rada: engleski
vrsta rada: izvorni naučni članak
DOI: 10.5633/amm.2018.0406
objavljen u SCIndeksu: 24.01.2019.
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