Reklama liekov na vedeckých medicínskych kongresoch: áno, či nie? | Medicínske právo
              

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Reklama liekov na vedeckých medicínskych kongresoch: áno, či nie?


 | 25.10.2012 | komentárov: 361

Reklama liekov je v slovenskom právnom poriadku upravená v troch právnych predpisoch: zákone č. 308/2000 Z. z. o vysielaní a retransmisii a o zmene zákona č. 195/2000 Z. z. o telekomunikáciách, zákone č. 147/2001 Z. z. o reklame a o zmene a doplnení niektorých zákonov v znení neskorších predpisov (ďalej len „zákon o reklame“) a zákone č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov v znení zákona č. 244/2012 Z. z. (ďalej len „zákon o liekoch“). Požiadavky na reklamu liekov ustanovené v § 8 zákona o reklame boli doň transponované z hlavy VIII Smernice 2001/83/ES, ktorou sa ustanovuje zákonník spoločenstva o humánnych liekoch. V tejto súvislosti je dôležité poukázať na rozdiel medzi reklamou a inými formami komunikovania o lieku (napr. Dear Health Care Provider Letters, reprinty odborných článkov, štúdie atď.), pričom rozhodujúcim pre ich odlíšenie je účel tejto komunikácie.

Obrazok V ďalšom texte sa budem zaoberať iba reklamou liekov.

Zákon o liekoch v § 60 ods. 1 písm. v) zakazuje držiteľovi registrácie humánneho lieku priamo alebo prostredníctvom tretej osoby financovať, sponzorovať, alebo inak priamo alebo nepriamo podporovať podujatie zdravotníckemu pracovníkovi alebo účasť zdravotníckeho pracovníka na podujatí, okrem podujatí určených výhradne na odborné alebo vedecké účely alebo ďalšie vzdelávanie zdravotníckych pracovníkov. V tejto súvislosti sa objavil v časti verejnosti názor, že na takomto podujatí nie je možné šíriť reklamu liekov, pretože to odporuje účelu a charakteru podujatia, ktorým má byť výlučne získavanie odborných poznatkov.

Organizovanie odborných kongresov alebo ich  sponzorovanie  farmaceutickou spoločnosťou vrátane preplácania cestovných náhrad a nákladov na ubytovanie, sa považuje za dôležitý spôsob informovania o lieku a predstavuje pre farmaceutickú spoločnosť aj mimoriadnu príležitosť osloviť na jednom mieste mnohých zdravotníckych pracovníkov.
Obsah a rozsah údajov v reklame liekov determinuje jej adresát – v našom prípade lekár alebo lekárnik. § 8 v odseku 10 zákona o reklame ustanovuje, že reklama liekov určená odborníkom musí obsahovať o. i. základné údaje  o lieku v zhode so súhrnom charakteristických vlastnosti a zároveň je v odseku 11 tohto  paragrafu ustanovené,  že dokumentácia týkajúca sa lieku, ktorá sa odovzdáva odbornej verejnosti pri propagácii lieku, musí obsahovať presné a aktuálne údaje, ktoré sú overiteľné a dostatočne úplné, aby príjemcovi – odborníkovi – bolo umožnené urobiť si vlastný názor na terapeutickú hodnotu propagovaného lieku.  Z týchto ustanovení vyplýva, že samotný obsah reklamy je pomerne prísne regulovaný a v prípade, že reklama je v súlade s platnou právnou úpravou, ide o časť komplexu informácií, ktoré odborník nevyhnutne potrebuje pre poskytovanie zdravotnej starostlivosti. Je však potrebné si uvedomiť, že reklama liekov pre odborníkov má jeden atribút, ktorý nemusí spĺňať žiadna iná reklama, ani tá, určená laikom, a to úplnosť. Takáto reklama teda nemôže obsahovať a ani neobsahuje iba pozitíva lieku (napr. indikácie, údaje o účinnosti), ale aj jeho negatíva (napr. vedľajšie účinky). Miera úplnosti údajov v reklame musí byť dostatočná na to, aby si odborník mohol urobiť na liek vlastný názor a zároveň je potrebné reflektovať fakt, že ide o odborníka v danej oblasti.

Reklamná komunikácia výrobcu odbornej verejnosti špecifikuje liek komplexne. Vďaka faktu, že jej obsahom nie sú len prínosy liekov, ale aj ich riziká,  má reklama spravidla odlišný obsah a formu  v porovnaní s reklamou iných produktov. V tomto svetle reklama liekov prestáva mať výlučne komerčný a propagačný charakter a stáva sa jedným zo zdrojov informácií a svojím charakterom a účelom sa stáva súladnou s účelom a cieľom odborných podujatí. Takýto záver podporuje aj znenie odseku 47 úvodných ustanovení citovanej smernice, ktorý deklaruje, že reklama liekov prispieva k informovanosti odborníkov. Nahliadanie na reklamu liekov iba optikou držiteľov rozhodnutí o registrácii liekov ako súťažiteľov, nie je v tomto prípade správne a odôvodnené. Liek je produktom sui generis, ktorého predpisovanie a používanie je rovnako prísne regulované a mať presné a aktuálne informácie o ňom je pre odborníka nevyhnutnosťou.  Dôležité tiež je, že pojem reklama liekov je v § 8 ods. 1 zákona o reklame pomerne široko koncipovaný a zahŕňa akékoľvek propagačné aktivity, ktoré smerujú k uplatneniu lieku na trhu (podpora predpisovania, vydávania, predaja alebo spotreby liekov), pričom negatívne vymedzenie reklamy v § 8 ods. 3 je pomerne striktné a teda nie je dosť dobre možné odkázať na poskytovanie informácií v ich nereklamnej podobe.

Obmedzením, resp. nemožnosťou poskytnúť takého informácie na uvádzaných podujatiach, by podľa môjho názoru prišlo práve k zníženiu odbornej úrovne podujatia a samotný účel týchto podujatí by nemusel byť vôbec naplnený.

AUTOR: Mgr. Eva Siminská, pôsobí v Štátnom ústave pre kontrolu liečiv (ŠÚKL)




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