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Rozhovor s hosťom mesiaca NOVEMBER 2012 s MUDr. Igorom Novákom, MPH


 | 8.11.2012 | komentárov: 306

Pozvanie byť hosťom mesiaca november prijal MUDr. Igor Novák, MPH. Vyštudoval lekársku fakultu UK v Bratislave. Promoval v roku 1990, potom pracoval 10 rokov ako detský anestéziológ a lekár na jednotke intenzívnej starostlivosti pre deti. Od roku 1999 pracuje vo farmaceutických spoločnostiach. Najprv pracoval na medicínskom oddelení, najskôr ako monitor klinických štúdií, následne ako riaditeľ medicínskeho oddelenia. Od roku 2009 ja zamestnaný v spoločnosti Novartis, kde pracuje ako vedúci oddelenia pre vonkajšie vzťahy a má na starosti aj cenotvorbu a je zodpovedný za vstup liekov spoločnosti na trh. Popri tom od roku 2009 je aj prezidentom Asociácie dodávateľov liekov a zdravotníckych pomôcok. Táto asociácia združujúca celý liekový reťazec (výrobcov, distribútorov, lekárnikov) existuje už 20 rokov a jej hlavným cieľom je transparentný a predvídateľný zdravotný systém s dôrazom na liekovú politiku. ADL chce byť dôveryhodným partnerom ministerstva zdravotníctva pri tvorbe zdravotníckej legislatívy. V súčasnosti je hlavnou úlohou ADL napomôcť zmenám v liekovej politike v prospech slovenského pacienta, tak aby sa na Slovensko dostávali lieky včas a aby bol adekvátne ohodnotený ich prínos, čo umožní aby boli aj cenovo dostupné. V rozhovore sme sa venovali otázkam klinického skúšania liekov, novelám liekových zákonov a vývoju nových liekov.

Obrazok MEDIUS: Pán doktor, pôsobíte vo farmaceutickom priemysle ako predseda Asociácie dodávateľov liekov a zdravotníckych pomôcok. Čo je predmetom činnosti asociácie?

Asociácia dodávateľov liekov a zdravotníckych pomôcok (ADL)  je záujmovým združením právnických osôb. V súčasnosti  je možné povedať, že zastrešujeme komplexný liekový reťazec na Slovensku, to znamená, farmaceutické spoločnosti, distribútorov liekov a zdravotníckych pomôcok, ale i majiteľov lekární. Spolu máme viac než 120 členov. Ako asociácia sa snažíme presadzovať oprávnené záujmy našich  členov a snažíme sa byť relevantným partnerom štátu, ale i takpovediac „svedomím“  ministerstva zdravotníctva v rámci legislatívneho procesu.

MEDIUS: Avizovali ste, že sa v úlohe hosťa mesiaca budete venovať téme súčasných problémov pri klinickom skúšaní  liekov. Skúste prosím laikovi opísať, aký je účel klinického skúšania liekov,  v akých krokoch prebieha, aké subjekty sa na ňom zúčastňujú?

Klinické skúšanie liekov je z pohľadu pacientov veľmi dôležité. Nové lieky umožňujú zlepšovať liečbu, zdravie, ale i životy pacientov. Na hľadaní a výskume nových liečiv sa v súčasnosti výrazne podieľajú farmaceutické spoločnosti, bez ktorých by nebolo možné výskum liekov realizovať. Ide o dlhodobé mimoriadne finančne náročné procesy, ktoré sprevádza  dôsledné, niekoľkoročné skúšanie v laboratóriách, po ktorých nasleduje tzv. klinické skúšanie. To je orientované dvoma základnými smermi. V prvom prípade ide o klinické skúšanie liekov pred ich samotnou registráciou, t.j. intervenčné klinické štúdie, v druhom prípade sa lieky sledujú pri použití v praxi,  čo označujeme ako neintervenčné  klinické skúšanie. V rámci intervenčného klinického skúšania sa všetky nové liečivá skúšajú  pod prísnym odborným dohľadom u vybraných zdravých jedincov, neskôr aj u pacientov s konkrétnym ochorením. Na Slovensku garantuje účinnosť a bezpečnosť liekov v obehu Štátny ústav pre kontrolu liečiv, ktorý definitívne určuje, ktorý liek sa u nás môže začať používať v praxi.  Ako problém vnímame zmeny v zákone č. 362/2011 Z.z. o liekoch a zdravotníckych pomôckach, kde nie je jednoznačne definované krytie nákladov v súvislosti s klinickým skúšaním a spôsob výmeny informácií so zdravotnými poisťovňami.  Podľa novely zákona majú zadávatelia klinických štúdií hradiť nielen náklady na skúšanie nových liečiv, čo je vo svete bežnou praxou, ale aj základnú liečbu, ktorú by pacient dostával aj keby nebol zaradený v klinickom skúšaní. Tú by ale podľa nášho názoru mali hradiť zdravotné poisťovne. A to už nehovorím o byrokratickom chaose rôznych hlásení, ktorý do klinického skúšania vniesla práve posledná zmena zákona. Následne mnohé spoločnosti pôsobiace v oblasti klinického skúšania pribrzdili, prípadne zredukovali svoje aktivity na Slovensku, čo v konečnom dôsledku má negatívny dopad na pacienta.  Ostatný návrh MZ SR prináša úpravu niektorých kritických bodov v tejto oblasti. MZ SR akceptovalo niektoré pripomienky ADL ale aj iných inštitúcií. Táto novela má vstúpiť do platnosti v januári 2013.

MEDIUS: Je známou skutočnosťou, že  nová „lieková legislatíva“, najmä zákon o liekoch a zdravotníckych pomôckach (zákon č. 362/2011 Z.z.) prijatý v minulom roku je vnímaný ako problematický. Ktoré ustanovenia konkrétne sú najviac kritizované a prečo?

Nielen zákon o liekoch a zdravotníckych pomôckach (zákon č. 362/2011 Z.z.) ale aj zákon o rozsahu a podmienkach úhrady liekov, zdravotníckych pomôcok a dietetických potravín na základe verejného zdravotného poistenia (zákon č. 363/2011 Z.z.) priniesol radikálne zmeny.  Ako asociácia sme otvorene komunikovali hneď niekoľko sporných súčastí oboch zákonov.  V prvom rade sme za neprijateľné považovali a stále považujeme zavedenie 2. najnižšej ceny liekov v rámci EÚ. Prax potvrdila, že na základe neprimeraného zníženia cien dochádza k reexportu liekov do zahraničia, ich nedostatku pre slovenských pacientov a podľa našich informácií stúpajú s tým súvisiace žiadosti o mimoriadne dovozy liekov, ktoré sú tak v konečnom dôsledku oveľa drahšie pre slovenskú ekonomiku. Za problematický  tiež považujeme nový spôsob rozhodovania o úhradách a cenách liekov. Kým v minulosti sa k rozhodnutiam MZ SR mohli vyjadrovať pacienti a odborné organizácie, od 1.12. 2011 sú účastníkmi konania len zdravotné poisťovne a farmaceutické spoločnosti. Správnym orgánom je ministerstvo zdravotníctva, ktoré však nie je viazané odporúčaním komisie a môže rozhodovať podľa vlastného uváženia nerešpektujúc návrhy komisie. V súvislosti s novelou sme tiež nesúhlasili a v tomto názore zotrvávame aj v otázke kontinuálneho vzdelávania zdravotníckych pracovníkov, kde sú farmaceutické spoločnosti doslova šikanované za to, že už viac než 20 rokov suplujú vlastnými prostriedkami štát. Ten na jednej strane trvá na priebežnom vzdelávaní zdravotníkov pod hrozbou sankcií vyplývajúcich zo zákona, na strane druhej, ale nerieši financovanie tohto vzdelávania príslušnými zdravotníckymi inštitúciami. Považujeme tento postoj za diskriminačný a reštrikčný, najmä, ak vezmeme do úvahy, že práve často krát kritizované farmaceutické a distribučné spoločnosti každý mesiac dotujú štátne zdravotnícke zariadenia, ktoré im často aj 400 dní po lehote splatnosti faktúr dlhujú platby za lieky a špeciálny zdravotný materiál.

MEDIUS: Aké dopady ste zaznamenali v priebehu uplynulých desiatich mesiacov na vývoj nových liekov (klinické skúšanie)?
 
Vzhľadom na reštriktívne opatrenia v zákone mnohé spoločnosti, ktoré financovali a realizovali klinické štúdie utlmili svoje aktivity v očakávaní ďalšieho vývoja. Pokračuje sa tak v otvorených štúdiách nové sa však takmer neotvárajú.

MEDIUS: Vplýva na vývoj nových liekov aj trend zvyšujúcej spotreby generík? Aká je situácia na Slovensku v porovnaní s inými európskymi krajinami?

Náklady na vývoj nových liekov neustále stúpajú a v súčasnosti sa pohybujú okolo 1 mld EUR na jednu novú molekulu. Preto je veľmi dôležité, aby lieková politika (a to nielen na Slovensku) bola nastavená tak, aby nové moderné lieky boli adekvátne ohodonotené, čo umožní ich dostupnosť pre slovenského pacienta. V súčasnosti sme často krát svedkami, že niektoré štáty v Európskej únii  už nie sú ochotné hradiť nákladnú liečbu pacientovi, čo sa stáva z pohľadu občanov konkrétnych štátov ako aj občanov EÚ diskriminačné. Farmaceutické spoločnosti sú si vedomé zložitosti súčasnej ekonomickej situácie a ponúkajú riešenia, ktoré na jednej strane umožňujú vstup nových moderných liekov, na strane druhej sa čiastočne spolupodieľajú na nákladoch za liečbu. Aby sa takéto riešenia mohli zrealizovať je veľmi dôležité, aby obe strany – platca i výrobca spolu úzko komunikovali a dôverovali si. Takýto stav u nás zatiaľ bohužiaľ neplatí, ale snažíme sa urobiť všetko pre to, aby sa vzájomná komunikácia zlepšila.  Čo sa týka generík, majú na trhu svoje miesto a po vypršaní patentovej ochrany, respektíve vypršaní ochrannej lehoty dát, prinášajú lacnejší ekvivalent originálnych liekov, čím šetria finančné zdroje v zdravotníctve a zároveň vytvárajú priestor pre nové originálne lieky.

MEDIUS: Ovplyvnila v tejto súvislosti  nejako rozloženie predaja liekov (originálnych liekov v pomere ku generikám) povinnosť lekárov uvádzať na recepte účinnú látku (liečivo) a len doporučene konkrétny názov lieku?

Predchádzajúcou vládou toľkokrát skloňovaná generická preskripcia nepriniesla výrazné zmeny v preskripčných zvyklostiach lekárov a ani v správaní pacientov.

MEDIUS: Aké zmeny v regulácii by ste z pozície organizácie zastupujúcej farmaceutické spoločnosti, distribútorov liekov a majiteľov lekární uvítali?

ADL spolu s ostatnými asociáciami, ktoré zastupujú liekový reťazec pripomienkovali aj súčasnú novelu oboch zákonov. Pre nás je kľúčová zmena pravidiel medzinárodného referencovania cien liekov. Už som spomínal, že 2. najnižšia cena v Európe spôsobuje problém s dostupnosťou niektorých liekov na Slovensku. V novele je návrh, aby lieky na Slovensku neboli drahšie ako je priemer 3 najnižších cien v EÚ. Táto regulácia nič neprináša, naopak, ceny na Slovensku budú v mnohých prípadoch ešte nižšie, čo s najväčšou pravdepodobnosťou znamená väčší vývoz liekov zo Slovenska do zahraničia. Náš návrh je, aby cena lieku na Slovensku bola stanovená ako 3. najnižšia v EÚ.

MEDIUS: Myslíte si, že pripravovaná novela dokáže zabezpečiť lepšie legislatívne prostredie pre klinické skúšanie?

Novela prináša pozitívne zmeny, ale ešte neprešla parlamentom a nebola schválená Národnou radou SR. V každom prípade, veríme v ďalšiu diskusiu s MZ SR. Už dnes je potrebné začať diskutovať na odbornej úrovní aj o  ďalších zlepšeniach, nielen v oblasti klinického skúšania. Predpokladáme, že vzhľadom na uzavretý návrh novely sa tieto zlepšenia stanú  súčasťou až ďalších legislatívnych návrhov a opatrení.

Rozhovor spracovala: Zuzana Zoláková



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