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Budú zdravotnícke pomôcky v EÚ pod väčším dohľadom?


 | 25.10.2013 | komentárov: 284

Zákonodarcovia Európskeho parlamentu sa tento týždeň chystajú v Bruseli schváliť legislatívu, ktorá môže vystaviť Vaše zdravie zvýšenému riziku. Tak znie slogan iniciatívy „Don’t lose the 3“, ktorá sa snaží upozorniť na negatívne dôsledky pripravovaných legislatívnych zmien upravujúcich proces výroby zdravotníckych pomôcok a ich uvádzania na trh.

Obrazok Podľa tejto iniciatívy, pacienti v Európe majú oproti ich „kolegom“ z iných krajín ako sú USA, Japonsko či Čína výhodu v tom, že oblasť výroby a licencovania zdravotníckych pomôcok pri ich uvedení na trh nie je regulovaná jednou centrálnou autorizačnou inštitúciou tak ako je tomu v spomínaných krajinách. To spôsobuje konkurenčnú výhodu 3-5 rokov (odtiaľ názov Don’t lose the 3), o ktoré sa dostane zdravotnícka pomôcka k európskym pacientom skôr, keďže decentralizovaný systém autorizačných orgánov je oveľa pružnejší. Výrobcovia zdravotníckych pomôcok si v súčasnosti môžu slobodne zvoliť autorizačnú osobu, ktorá posúdi ich „výrobok“ a udelí, resp. neudelí mu licenciu potrebnú pre uvedenie zdravotníckej pomôcky na trh. Poslanci sa však obávajú, že pokiaľ má výrobca slobodnú voľbu zvoliť si ktorúkoľvek autorizačnú osobu, táto osoba bude náchylnejšia na vydávanie licencií, keďže ich nevydávaním by sa oberala o svojich potenciálnych budúcich zákazníkov, a tým pádom aj o svoj zisk. V parlamente pripravované zmeny by však mali do tohto systému, kde pôsobí približne 80 autorizačných autorít, priniesť zásadné zmeny.

Tou najmarkantnejšou má byť prechod od systému množstva národných autorizačných orgánov pôsobiacich naprieč celou EÚ, ktoré prakticky nikto nereguluje, k systému notifikovaných osôb, ktoré bude jednotlivo určovať Európska lieková agentúra (EMA). Takéto notifikované osoby by mali potom, podľa návrhu poslancov, schvaľovať určité presne vymedzené pomôcky, ktoré v sebe nesú najvyššie riziko pre pacienta. Celý proces výroby zdravotníckych pomôcok (aspoň tých najviac rizikových), ich testovania, schvaľovania a uvádzania na trh sa teda dostane pod väčšiu kontrolu Bruselu, čo má v konečnou dôsledku predstavovať väčšiu ochranu zdravia pacientov v EÚ. Zároveň sa vytvorí aj výbor pre posudzovanie zdravotníckych pomôcok (ACMD) s cieľom zabezpečiť hodnotenie v jednotlivých prípadoch, ak jeho členovia považujú za potrebné požiadať o preskúmanie klinických údajov. ACMD formálne zabezpečuje Komisia prostredníctvom sekretariátu a organizáciou bezproblémového fungovania. ACMD by mali tvoriť najlepší špecialisti z rôznych medicínskych odborov, podľa kategórií alebo podskupín, ktoré môžu byť predmetom zmien, najmä so zreteľom na technický pokrok.

Súčasťou ACMD by mali byť aj zástupcovia pacientov a Európskej agentúry pre lieky (EMA), ktorí by sa mali podieľať na jednotlivých hodnoteniach. Tu však zákonodarcovia narazili na spomínaný odpor iniciatívy „Don’t lose the 3“, za ktorou stojí Eucomed – organizácia zastrešujúca 25.000 európskych výrobcov zdravotníckych pomôcok, vyrábajúcich a predávajúcich pomôcky ako sú napr. náhrady srdcových chlopní, prsné implantáty a pod. Všetci výrobcovia sa totiž obávajú, že navrhované zmeny legislatívy môžu výrazne ovplyvniť ich podnikanie v tejto oblasti. Vo svojej lobby výrobcovia vytiahli jeden, no o to zásadnejší, argument v prospech zachovania súčasného stavu. Tým argumentom je čas. Čas, o ktorý by sa malo schvaľovanie, potenciálne nových zdravotníckych pomôcok, predĺžiť. A tento čas hrá, ako to svorne tvrdia výrobcovia, proti pacientovi. Pacient bude tým, ktorý na navrhované zmeny najviac doplatí, keďže sa včas nemusí dostať k novej pomôcke, ktorá by mu mohla zachrániť život.

Pre porovnanie, v roku 2012 zverejnil americký úrad pre potraviny a liečivá (FDA) zoznam obsahujúci názvy 12 „najnebezpečnejších a najneúčinnejších“ zdravotníckych pomôcok, ktorým aj vďaka prísnejšiemu systému licencovania v USA nebola udelená licencia. Všetky tieto zdravotnícke pomôcky sú v Európe voľne dostupné a pacienti ich môžu používať.
Rozprava a hlasovanie Európskeho parlamentu o návrhu nariadenia Európskeho parlamentu a Rady o zdravotníckych pomôckach a ktorým sa mení smernica 2001/83/ES, nariadenie (ES) č. 178/2002 a nariadenie (ES) č. 1223/2009 sa očakáva v utorok 22. októbra 2013 v doobedňajších hodinách.

AUTOR: Tomáš Pázmány


Zdroj: http://www.spiegel.de/international/europe/medical-device-makers-lobby-against-tighter-eu-licensing-rules-a-928191.html
            http://www.europarl.europa.eu

FOTO: freedigitalphotos.net




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