{"id":3593,"date":"2023-05-15T14:59:08","date_gmt":"2023-05-15T13:59:08","guid":{"rendered":"https:\/\/www.hhpartners.eu\/?page_id=3593"},"modified":"2023-05-15T14:59:09","modified_gmt":"2023-05-15T13:59:09","slug":"novela-v-oblasti-inovativnych-liekov","status":"publish","type":"page","link":"https:\/\/www.hhpartners.eu\/en\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/","title":{"rendered":"Novela v oblasti inovat\u00edvnych liekov"},"content":{"rendered":"\n<p>V&nbsp;lete minul\u00e9ho roka nadobudla \u00fa\u010dinnos\u0165 novela z\u00e1kona o&nbsp;podmienkach a&nbsp;rozsahu \u00fahrady liekov (z. \u010d. 363\/2011 Z. z.), ktorej cie\u013eom bolo spr\u00edstupni\u0165 inovat\u00edvne lieky, resp. lieky, ktor\u00e9 maj\u00fa tzv. \u201eorphan status\u201c pacientom, ktor\u00ed ich potrebuj\u00fa. Lieky, zaradzovan\u00e9 do tejto skupiny liekov s\u00fa zv\u00e4\u010d\u0161a ur\u010den\u00e9 na lie\u010dbu raritn\u00fdch ochoren\u00ed a&nbsp;pre pacientov, ktor\u00ed ich potrebuj\u00fa, znamenaj\u00fa posledn\u00fa \u0161ancu na z\u00e1chranu.<\/p>\n\n\n\n<p>Novela priniesla v&nbsp;oblasti inovat\u00edvnych liekov, teda liekov, ktor\u00e9 s\u00fa uhr\u00e1dzan\u00e9 vo v\u00fdnimkovom re\u017eime, viacero k\u013e\u00fa\u010dov\u00fdch zmien. \u00da\u010dinnos\u0165ou novely sa zmenil mechanizmus v\u00fdpo\u010dtu prahovej hodnoty pre pos\u00fadenie n\u00e1kladovej efekt\u00edvnosti liekov. Pred prijat\u00edm novely bola hranica n\u00e1kladovej efekt\u00edvnosti na z\u00e1klade QALY naviazan\u00e1 na priemern\u00fa mesa\u010dn\u00fa mzdu. Novelou Slovensko prist\u00fapilo k&nbsp;rovnak\u00e9mu princ\u00edpu ako ostatn\u00e9 krajiny E\u00da, ktor\u00e9 mali a&nbsp;maj\u00fa ekonomick\u00fd parameter QALY naviazan\u00fd na hrub\u00fd dom\u00e1ci produkt (HDP). Pri posudzovan\u00ed liekov sa prizer\u00e1 aj na aspekt medic\u00ednskej potreby a&nbsp;vytvoril sa priestor aj na posudzovanie soci\u00e1lnych dopadov pri rozhodovan\u00ed o&nbsp;vstupe lieku na slovensk\u00fd trh s&nbsp;liekmi.<\/p>\n\n\n\n<p>Po novom dohody s&nbsp;v\u00fdrobcami uzatv\u00e1ra \u0161t\u00e1t. V&nbsp;pr\u00edpade, ak lieky nesplnia ekonomick\u00e9 podmienky pre ich zaradenie do syst\u00e9mu verejn\u00fdch \u00fahrad, na trh m\u00f4\u017eu vst\u00fapi\u0165, ak farmaceutick\u00e9 firmy pon\u00faknu z\u013eavnen\u00e9 ceny za lieky a&nbsp;dohodn\u00fa sa na podmienkach vstupu so \u0161t\u00e1tom. Nov\u00e9 lieky tak maj\u00fa vytvoren\u00fd jednoduch\u0161\u00ed, r\u00fdchlej\u0161\u00ed a&nbsp;lacnej\u0161\u00ed vstup do syst\u00e9mu, \u010do v&nbsp;zna\u010dnej miere benefituje pacientov trpiacich raritn\u00fdmi ochorenia, nako\u013eko takto upraven\u00fd syst\u00e9m napom\u00e1ha v\u00fdrobcom jednoduch\u0161ie vst\u00fapi\u0165 na slovensk\u00fd liekov\u00fd trh.<\/p>\n\n\n\n<p>Novela z\u00e1kona o&nbsp;podmienkach a&nbsp;rozsahu \u00fahrad liekov zlep\u0161uje podmienky pre vstup preuk\u00e1zate\u013ene \u00fa\u010dinn\u00fdch inovat\u00edvnych liekov na n\u00e1\u0161 trh a&nbsp;odstra\u0148uje rozdiely v&nbsp;pr\u00edstupe pacientov k&nbsp;lie\u010dbe t\u00fdmito liekmi, ale zabezpe\u010duje aj to, \u017ee vynakladanie finan\u010dn\u00fdch prostriedkov v&nbsp;tomto smere bude efekt\u00edvne a&nbsp;\u00fa\u010deln\u00e9.<\/p>\n\n\n\n<p>Ak v\u00e1s t\u00e1to t\u00e9ma zaujala, bli\u017e\u0161ie inform\u00e1cie sa dozviete na <a href=\"https:\/\/www.medipravnik.sk\/pravne-clanky\/podcast-173-viete-ako-funguje-vybavenie-ziadosti-o-vynimku-povieme-vam-ako-na-to-1550\/\">tomto<\/a> linku.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>V&nbsp;lete minul\u00e9ho roka nadobudla \u00fa\u010dinnos\u0165 novela z\u00e1kona o&nbsp;podmienkach a&nbsp;rozsahu \u00fahrady liekov (z. \u010d. 363\/2011 Z. z.), ktorej cie\u013eom bolo spr\u00edstupni\u0165 inovat\u00edvne lieky, resp. lieky, ktor\u00e9 maj\u00fa tzv. \u201eorphan status\u201c pacientom, ktor\u00ed ich potrebuj\u00fa. Lieky, zaradzovan\u00e9 do tejto skupiny liekov s\u00fa zv\u00e4\u010d\u0161a ur\u010den\u00e9 na lie\u010dbu raritn\u00fdch ochoren\u00ed a&nbsp;pre pacientov, ktor\u00ed ich potrebuj\u00fa, znamenaj\u00fa posledn\u00fa \u0161ancu na [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":279,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v18.5.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Novela v oblasti inovat\u00edvnych liekov - h&amp;h PARTNERS<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novela v oblasti inovat\u00edvnych liekov - h&amp;h PARTNERS\" \/>\n<meta property=\"og:description\" content=\"V&nbsp;lete minul\u00e9ho roka nadobudla \u00fa\u010dinnos\u0165 novela z\u00e1kona o&nbsp;podmienkach a&nbsp;rozsahu \u00fahrady liekov (z. \u010d. 363\/2011 Z. z.), ktorej cie\u013eom bolo spr\u00edstupni\u0165 inovat\u00edvne lieky, resp. lieky, ktor\u00e9 maj\u00fa tzv. \u201eorphan status\u201c pacientom, ktor\u00ed ich potrebuj\u00fa. Lieky, zaradzovan\u00e9 do tejto skupiny liekov s\u00fa zv\u00e4\u010d\u0161a ur\u010den\u00e9 na lie\u010dbu raritn\u00fdch ochoren\u00ed a&nbsp;pre pacientov, ktor\u00ed ich potrebuj\u00fa, znamenaj\u00fa posledn\u00fa \u0161ancu na [...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/\" \/>\n<meta property=\"og:site_name\" content=\"h&amp;h PARTNERS\" \/>\n<meta property=\"article:modified_time\" content=\"2023-05-15T13:59:09+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.hhpartners.eu\/en\/#website\",\"url\":\"https:\/\/www.hhpartners.eu\/en\/\",\"name\":\"h&amp;h PARTNERS\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.hhpartners.eu\/en\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-GB\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/#webpage\",\"url\":\"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/\",\"name\":\"Novela v oblasti inovat\u00edvnych liekov - h&amp;h PARTNERS\",\"isPartOf\":{\"@id\":\"https:\/\/www.hhpartners.eu\/en\/#website\"},\"datePublished\":\"2023-05-15T13:59:08+00:00\",\"dateModified\":\"2023-05-15T13:59:09+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/#breadcrumb\"},\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Domovsk\u00e1 str\u00e1nka\",\"item\":\"https:\/\/www.hhpartners.eu\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Aktuality\",\"item\":\"https:\/\/www.hhpartners.eu\/aktuality\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Pr\u00e1vne novinky\",\"item\":\"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Novela v oblasti inovat\u00edvnych liekov\"}]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Novela v oblasti inovat\u00edvnych liekov - h&amp;h PARTNERS","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.hhpartners.eu\/aktuality\/pravne-novinky\/novela-v-oblasti-inovativnych-liekov\/","og_locale":"en_GB","og_type":"article","og_title":"Novela v oblasti inovat\u00edvnych liekov - h&amp;h PARTNERS","og_description":"V&nbsp;lete minul\u00e9ho roka nadobudla \u00fa\u010dinnos\u0165 novela z\u00e1kona o&nbsp;podmienkach a&nbsp;rozsahu \u00fahrady liekov (z. \u010d. 363\/2011 Z. z.), ktorej cie\u013eom bolo spr\u00edstupni\u0165 inovat\u00edvne lieky, resp. lieky, ktor\u00e9 maj\u00fa tzv. \u201eorphan status\u201c pacientom, ktor\u00ed ich potrebuj\u00fa. 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