Pracovné rokovanie na ministerstve zdravotníctva k novelizácii "liekových" zákonov | Medicínske právo
              

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Pracovné rokovanie na ministerstve zdravotníctva k novelizácii "liekových" zákonov


 | 14.8.2012 | komentárov: 305

Na Ministerstve zdravotníctva sa minulý štvrtok uskutočnilo pracovné stretnutie so zástupcami zdravotných poisťovní, Slovenskej lekárskej spoločnosti (SLS), Slovenskej lekárskej komory (SLK), Slovenskej lekárnickej komory (SLeK), Farmaceutickej fakulty UK Bratislava, Asociácie dodávateľov liekov a zdravotníckych pomôcok (ADL), Slovenskej asociácie farmaceutických spoločností (SAFS), Asociácie zahraničných výrobcov generických liekov (GENAS) k novým návrhom noviel "liekových" zákonov.

Obrazok Návrhy noviel zákonov, ktorými sa menia zákony č. 362/2011 Z.z. a č.363/2011 Z.z. sú momentálne v medzirezortnom pripomienkovom konaní. Ide o druhý návrh novelizácie zákona o liekoch v tomto roku. Prvý návrh vypracovalo ministerstvo ešte pod vedením ministra Uhliarika v januári tohto roka. Cieľom nového návrhu je transponovať do slovenského právneho poriadku Smernicu Európskeho parlamentu a Rady 2012/84/EÚ, ktorou sa, pokiaľ ide o dohľad nad liekmi, mení a dopĺňa smernica 2001/83/ES, (touto smernicou sa ustanovuje zákonník Spoločenstva o humánnych liekoch). Pôvodný Uhliarikov návrh, ktorý nebol predložený NRSR, obmedzoval reklamu liekov, ktoré nie sú na predpis, ale obsahujú rovnaké liečivo alebo rovnakú kombináciu liečiv ako lieky na predpis, proti čomu sa ohradili výrobcovia.

Aktuálne predkladaná novela zákona č. 362/2011 Z.z. sa zameriava na prevenciu distribúcie falšovaných liekov, cieľom je zabrániť ich vstupu do legálneho distribučného reťazca prostredníctvom štátnej kontroly. Podľa dôvodovej správy „dochádza k alarmujúcemu nárastu liekov, ktoré sú falšované z hľadiska ich totožnosti, histórie či pôvodu. Tieto lieky obyčajne obsahujú podštandardné alebo falšované zložky alebo neobsahujú žiadne zložky alebo obsahujú zložky, vrátane účinných látok, v nesprávnej dávke, čo predstavuje nezanedbateľné riziko pre ľudské zdravie. Z minulej skúsenosti vyplýva, že takéto falšované lieky sa nedostávajú k pacientovi iba nelegálnou cestou, ale aj cez legálny dodávateľský reťazec“, pričom cieľom zákona je zaviesť opatrenia, ktoré budú reagovať na túto narastajúcu hrozbu.

Navrhovaná novela sa dotkne aj zákona o správnych poplatkoch zavedením poplatku za oznámenie vývozu humánneho lieku, za oznámenie sprostredkovania nákupu a predaja humánneho lieku a  za oznámenie výroby, dovozu a distribúcie účinnej látky; rovnako novelizuje aj zákon č. 147/2001 Z. z. o reklame a o zmene a doplnení niektorých zákonov v znení neskorších predpisov, najmä so zámerom zosúladenia s terminológiou zákona č. 362/2011 Z. z..
Na spôsobe  preskripcie liekov  by sa navrhovanou novelou nič meniť nemalo. Na receptoch sa bude naďalej uvádzať účinná látka, pričom lekár bude môcť na recepte uviesť aj obchodný názov odporúčaného lieku.


Autor: Zuzana Zoláková
Zdroj: health.gov.sk, návrh novely zákona o liekoch
Foto: coopersguns.com





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