Life Sciences Newsletter - June - July - August 2019 (Slovak)

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Spoločnosti podnikajúce v oblasti life sciences pravidelne čelia novým výzvam súvisiacim s aktuálnymi zmenami legislatívy. Pripravili sme pre Vás špeciálne číslo letného Life Sciences Newslettra, v ktorom prinášame stručný prehľad vybraných právnych, regulačných a mediálnych noviniek za posledné kalendárne mesiace z oblasti life sciences prijatých v Slovenskej republike a v Európskej únii. Ku každému príspevku je pripojený link, ktorý Vás presmeruje k podrobnejším informáciám.

Právne novinky

Slovenská republika

Návrh zákona, ktorým sa mení a dopĺňa zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov v znení neskorších predpisov a ktorým sa menia a dopĺňajú niektoré zákony

Ministerstvo zdravotníctva Slovenskej republiky predložilo rozsiahlu novelu zákona o liekoch, ktorou reaguje na prijatú európsku legislatívu. Značnú časť návrhu predmetného zákona tvorí zriadenie etickej komisie Ministerstva zdravotníctva Slovenskej republiky pre klinické skúšanie a pre štúdie výkonu diagnostických zdravotníckych pomôcok in vitro. Etické komisie tak po novom majú posudzovať etické aspekty žiadosti o povolenie klinického skúšania zdravotníckej pomôcky, ako aj štúdie výkonu diagnostickej zdravotníckej pomôcky in vitro. Etická komisia bude v pôsobnosti Ministerstva zdravotníctva Slovenskej republiky a návrh zákona počíta aj s rozšírením funkčnosti národného portálu klinického skúšania.

Predmetom návrhu zákona sú ďalej opatrenia na zabránenie reexportu humánnych liekov zaradených do zoznamu kategorizovaných liekov, resp. na zabezpečenie ich dostupnosti pre pacientov v Slovenskej republike. Návrh zákona taktiež: (i) uvádza nové zákonné definície niektorých pojmov (napr. transfúzny liek, výdaj, atď.), (ii) ustanovuje novú oznamovaciu povinnosťou v prípade stiahnutia lieku nariadeného v inom členskom štáte, (iii) precizuje podmienky internetového výdaja liekov, (iv) ustanovuje zákaz uzatvárať podľa Obchodného zákonníka zmluvu o uložení vecí alebo zmluvu o poskytnutí finančného obratového bonusu pre držiteľov povolenia na poskytovanie lekárenskej starostlivosti, atď.

Predpokladaná účinnosť zmien je stanovená na 1. januára 2020, s výnimkou niektorých ustanovení, ktorých účinnosť je posunutá na 26. mája 2020 a 26. mája 2022.

Legislatívny proces budeme podrobne sledovať a v ďalších vydaniach Life Sciences Newslettra budeme informovať o prípadných zmenách a o finálne schválenej podobe novely.

Zdroj: slov-lex.sk

Návrh zákona, ktorým sa mení a dopĺňa zákon č. 363/2011 Z. z. o rozsahu a podmienkach úhrady liekov, zdravotníckych pomôcok a dietetických potravín na základe verejného zdravotného poistenia a o zmene a doplnení niektorých zákonov v znení neskorších predpisov

Ministerstvo zdravotníctva Slovenskej republiky predložilo novelu zákona o úhrade liekov. Cieľom predkladaného návrhu zákona je precizovať definíciu základného pojmu európskej referenčnej ceny lieku, umožniť aplikovať zmeny v Zozname zdravotníckych pomôcok na mieru a upraviť podmienky, pri ktorých môže byť pomer úhrady zdravotnej poisťovne a doplatku poistenca za liek, zdravotnícku pomôcku alebo dietetickú potravinu, zmenený v záujme udržania stability systému verejného zdravotného poistenia.

Cieľom návrhu zákona je tiež zlepšenie pravidiel pri porovnávaní cien rovnakého lieku v iných európskych krajinách. Doteraz sa pri tzv. referencovaní porovnávali iba ceny identických veľkostí balenia lieku. Podľa novej úpravy bude možné prepočítať cenu na rovnakú veľkosť balenia. Ministerstvo zdravotníctvo Slovenskej republiky hovorí o potenciálnej úspore v dôsledku novej úpravy vo výške 6,5 mil. eur.

Ak navrhované zmeny schváli vláda a parlament, upravené ceny pre niektoré lieky, ktoré budú podliehať novému referencovaniu, očakáva Ministerstvo zdravotníctva Slovenskej republiky už od júna 2020.

Zdroj: slov-lex.sk

Vyhláška Ministerstva zdravotníctva Slovenskej republiky, ktorou sa mení vyhláška č. 435/2011 Z. z. o spôsobe určenia štandardnej dávky liečiva a maximálnej výšky úhrady zdravotnej poisťovne za štandardnú dávku liečiva

Ministerstvo zdravotníctva Slovenskej republiky prijalo zmeny vo vyhláške, ktorou sa určujú ŠDL a maximálne úhrady zdravotných poisťovní za tieto ŠDL, a to vo forme vytvorenia nových úhradových skupín pre jednotlivé lieky. Uvedená zmena je súčasťou tzv. šetriaceho balíka z dielne Ministerstva zdravotníctva Slovenskej republiky, ktorým sa snaží lepšie regulovať výdavky zo zdravotného poistenia využívané na úhradu liekov pre pacientov.

Zdroj: slov-lex.sk

Vyhláška Ministerstva zdravotníctva Slovenskej republiky, ktorou sa ustanovuje zoznam humánnych liekov so špecifickými podmienkami výroby a dodania do 60 dní a zoznam individuálne pripravovaných humánnych liekov so špecifickými podmienkami výroby a dodania do 30 dní

Zdroj: slov-lex.sk

Európska Únia

Nariadenie Európskeho parlamentu a Rady (EÚ) 2019/933 z 20. mája 2019, ktorým sa mení nariadenie (ES) č. 469/2009 o dodatkovom ochrannom osvedčení pre liečivá

Vzhľadom na zásadný nárast výroby generických, najmä biologicky podobných liekov a výroby ich aktívnych zložiek, a to predovšetkým v krajinách mimo EÚ, v ktorých neexistuje alebo sa už skončila tzv. patentová ochrana (alebo dodatková ochrana), má nariadenie za cieľ udeliť niektoré výnimky z tejto ochrany. Uvoľniť sa majú najmä pravidlá výroby generických liekov na účel ich uskladnenia na vymedzené obdobie pred skončením platnosti ochrany a pravidlá výroby generických liekov za účelom ich vývozu mimo krajín EÚ, kde neexistuje alebo už skončila tzv. patentová ochrana. Uvedenými opatreniami tak má by zabezpečené, aby nebola ohrozená životaschopnosť výrobcov generických a biologicky podobných liekov usadených v EÚ, čo by malo následky pre celú základňu farmaceutického priemyslu v EÚ. 

Zdroj: eur-lex.europa.eu

Regulačné novinky

Slovenská republika

Stiahnutie lieku ENDIEX z trhu

Zdroj: sukl.sk

Gilenya (fingolimod) – nová kontraindikácia u gravidných žien a u žien vo fertilnom veku, ktoré nepoužívajú účinnú antikoncepciu

Zdroj: sukl.sk

Stiahnutie lieku CONOXIA, stlačený medicinálny plyn z trhu

Zdroj: sukl.sk

Obnovenie výroby očných liekov v Unimed Pharma

Zdroj: sukl.sk

Stiahnutie lieku Elotrace z trhu

Zdroj: sukl.sk

Dohoda EU-US Mutual Recognition Agreement o uznávaní inšpekcií správnej výrobnej praxe

Zdroj: sukl.sk

Stiahnutie lieku Adrenalin Bradex z trhu

Zdroj: sukl.sk

Štátny ústav pre kontrolu liečiv nariadil stiahnutie lieku Egilok 25 mg až z úrovne pacientov

Zdroj: sukl.sk

Očkovací kalendár na Slovensku sa bude upravovať

Zdroj: health.gov.sk

ŠÚKL informuje o falšovanom balení lieku Xarelto zachytenom v Anglicku - Aktualizácia

Zdroj: sukl.sk

Zoznam zdravotníckych pomôcok a špeciálneho zdravotníckeho materiálu s úradne určenou cenou od 1.9.2019 - 30.11.2019

Zdroj: health.gov.sk

Zoznam kategorizovaných liekov 1.10.2019 – 31.10.2019

Zdroj: health.gov.sk

Zoznam liekov s úradne určenou cenou 1.10.2019 – 31.10.2019

Zdroj: health.gov.sk

Zoznam zdravotníckych pomôcok a špeciálneho zdravotníckeho materiálu s úradne určenou cenou od 1.9.2019 - 30.11.2019

Zdroj: health.gov.sk

Zoznam dietetických potravín s úradne určenou cenou 1.09.2019 – 30.11.2019

Zdroj: health.gov.sk

Zoznam kategorizovaných liekov 1.9.2019 – 30.9.2019

Zdroj: health.gov.sk

Zoznam liekov s úradne určenou cenou 1.9.2019 – 30.9.2019

Zdroj: health.gov.sk

Európska Únia

Európsky úrad pre boj proti podvodom (OLAF) zverejnil Výročnú správu o činnosti za rok 2018

Zdroj: health.gov.sk

 

New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases

Zdroj: ema.europa.eu

Names of liposomal medicines to be changed to avoid medication errors

Zdroj: ema.europa.eu

Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy

Zdroj: ema.europa.eu

First ‘histology-independent’ treatment for solid tumours with a specific gene mutation

Zdroj: ema.europa.eu

PRAC recommends new measures to avoid dosing errors with methotrexate

Zdroj: ema.europa.eu

Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections

Zdroj: ema.europa.eu

New treatment for children with type 2 diabetes

Zdroj: ema.europa.eu

Mediálne novinky

Slovenská republika

Purdue Pharma údajne núka miliardy, aby vyrovnala žaloby pre opiátovú epidémiu

Zdroj: ekonomika.sme.sk

V Bratislave je prvý lekárenský automat na Slovensku

Zdroj: ekonomika.sme.sk

Unimed Pharma obnoví výrobu očných liekov

Zdroj: ekonomika.sme.sk

Lekárnici vyriešili spor o zmluvy so štátnou poisťovňou

Zdroj: ekonomika.sme.sk

Lacnejšiu alternatívu lieku odmietne v lekárni pätina Slovákov

Zdroj: ekonomika.sme.sk

Poisťovne vrátia ľuďom za lieky viac ako päť miliónov

Zdroj: ekonomika.sme.sk

VšZP chce kúpiť liečivá pre krv a krvotvorné orgány

Zdroj: ekonomika.sme.sk

Kalavská dva mesiace vie, aké nežiaduce účinky mal na pacientov liek z Kuby, zatiaľ ich však tají

Zdroj: dennikn.sk

Svet

Well Pharmacy stockpiles for Brexit

Zdroj: thetimes.co.uk

Four-in-one pill prevents third of heart problems

Zdroj: bbc.com

Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakvi

Zdroj: reuters.com

Canada makes drug price crackdown official over industry opposition

Zdroj: reuters.com

Bayer in frame to win first EU nod for high-precision cancer drug

Zdroj: reuters.com

Roche's Tecentriq recommended for EU approval to treat lung cancer form

Zdroj: reuters.com

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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