Zmena legislatívy pre chýbajúce lieky | Medicínske právo
              

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Zmena legislatívy pre chýbajúce lieky


 | 12.7.2016 | komentárov: 322

Ministerstvo zdravotníctva pripravuje novelu zákona č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov (ďalej len zákon o liekoch), ktorá prináša niekoľko opatrení na zamedzenie exportu liekov do krajín západnej Európy.

Obrazok

Novela zákona o liekoch reaguje na súčasný stav liekov na Slovensku, pri ktorom sa väčšina liekov vyváža do zahraničia čo vedie k ich nedostatku. Novela má preto upraviť podmienky vývozu liekov do zahraničia, pri ktorom lieky hradené z verejného zdravotného poistenia
budú môcť vyvážať len ich výrobcovia a nie distribučné firmy.

Súčasná právna úprava síce pripúšťa obmedzenie vývozu lieku Štátnym ústavom pre kontrolu liečiv v prípade nedostatku na domácom trhu, avšak takéto opatrenie je považované za nežiaduce z pohľadu Európskej komisie, ktorá voči Slovensku začala v tejto veci právne
konanie. Preto v dôsledku uvedených okolností, nová legislatíva zo zákazom vývozu už nepočíta, a kritizované ustanovenie nahrádza nové, podľa ktorého budú môcť lieky vyvážať len ich výrobcovia. Distribučné firmy budú podobne ako výrobcovia povinné dodávať lieky
len do lekární a pokiaľ ich budú chcieť dodať inej distribučnej firme, budú tak môcť urobiť len vtedy, ak lieky skončia v lekárni.

Nová právna úprava sa prirodzene bude týkať aj lekárni. Lekárne po novom už nebudú môcť receptové lieky odpredať komukoľvek a spätný predaj lieku bude možný iba tomu držiteľovi povolenia na veľkodistribúciu humánnych liekov, od ktorého lekáreň liek nakúpila. Pričom si
lekárne budú môcť v prípade potreby tiež vymieňať lieky medzi sebou.

Právny predpis má v prípade súhlasného stanoviska vlády, parlamentu a prezidenta platiť od januára 2017. A za jeho nedodržanie bude môcť ministerstvo zdravotníctva udeliť pokutu 100.000 eur, a v niektorých prípadoch až jeden milión eur. Distribučné firmy či lekárne tiež
môžu prísť pre nedodržiavanie o povolenia na prevádzku.


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