Reexporty: Zákaz vývozu liekov, ktoré by nám mohli chýbať | Medicínske právo


Reexporty: Zákaz vývozu liekov, ktoré by nám mohli chýbať

 | 1.8.2013 | komentárov: 289

Štátny ústav pre kontrolu liečiv (ďalej len "ŠUKL") vydal rozhodnutia, ktorými zakázal vývoz troch druhov liekov. Konkrétne ide o Inspra 25 mg, Clexane 2000 a Azilect.

Obrazok Liek Inspra sa používa pri liečbe srdcových chorôb. Clexane sa používa ako prevencia venóznej tromboembolickej choroby aj pri liečbe angíny pectoris a infarktu myokardu. Vývoz tohto lieku bol už v máji analyzovaný ústavom, avšak v tom čase podľa odborníkov jeho dostupnosť, vzhľadom na možnosti alternatívnej liečby, nebola ohrozená. Liek Azilect je indikovaný na liečbu Parkinsonovej choroby. Zákaz vývozu sa týka obdobia prelomu mesiacov jún a júl 2013. Rozhodnutia nadobudli právoplatnosť v dňoch 12. – 25. júla 2013.

Novela zákona č. 362/2011 Z. z.  o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov (ďalej len "zákon o liekoch"), ktorá umožňuje ŠUKL zakázať vývoz liekov je pritom účinná len od januára 2013. Za toto krátke obdobie ŠUKL využil túto možnosť už dvakrát. Prvýkrát to bolo v máji, keď nepovolil vývoz lieku Lyrica.  Podľa zákona o liekoch má ŠUKL túto možnosť v prípade, ak by vývoz lieku mohol spôsobiť ohrozenie dostupnosti lieku alebo zdravotnej starostlivosti na Slovensku. Distribútor lieku je povinný 30 dní pred začatím vývozu oznámiť množstvo lieku, ktoré plánuje vyviesť štátnemu ústavu. Dostupnosť lieku posudzuje ŠUKL pravidelne podľa množstva dovozu a ohláseného množstva vývozu lieku a tiež podľa hlásení Národného centra zdravotníckych informácií o spotrebe liekov. Týmto postupom tak zabezpečí bezpečnosť a dostupnosť liekov a zdravotnej starostlivosti pre slovenských pacientov.

Spracovala: Veronika Miková


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