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  • Italská farmaceutická politika se nedávno orientovala na dvoukoridorový přístup, kdy se vlastní regulace liší dle patentového postavení daného léčiva. Tato studie analyzuje italský regulační rámec a zaměřuje se na politiky vztažené k „nepatentovaným“ léčivům. V rámci studie byly prozkoumané tři hlavní regulační inovace: (1) generika, která se do Itálie dostala poprvé v roce 1996; (ii) systém referenčního stanovení cen (RP), ve kterém konzumenti platí část ceny velmi drahých produktů; (iii) právo lékárníka nahradit dané léčivo, což je podporováno systémem regresivních marží. Nedávno uskutečněné reformy již produkují určité užitečné výsledky, a to alespoň ve smyslu kompetitivního tlaku na těch „několik“ látek, u kterých končí patentová ochrana. Na druhé straně však je potřeba provést další zásah, aby tyto změny byly dlouhodobě udržitelné. (cs)
  • Italian pharmaceutical policy has recently moved towards a %22two lanes%22 approach, with regulation differing according to a drug's patent status. This study analyses the Italian regulatory framework, focusing on policies related to %22off-patent%22 drugs. Three main regulatory innovations have been examined: (i) generics, introduced in Italy for the first time in 1996; (ii) the reference pricing (RP) scheme, under which consumers pay part of the cost of high-priced products; (iii) pharmacists' right of substitution, supported by a regressive margins system. The recent reforms are already producing some worthwhile results, at least in terms of competitive pressure on the (few) substances that run out of patent protection. However, further intervention could be required to achieve long-term sustainability.
  • Italian pharmaceutical policy has recently moved towards a %22two lanes%22 approach, with regulation differing according to a drug's patent status. This study analyses the Italian regulatory framework, focusing on policies related to %22off-patent%22 drugs. Three main regulatory innovations have been examined: (i) generics, introduced in Italy for the first time in 1996; (ii) the reference pricing (RP) scheme, under which consumers pay part of the cost of high-priced products; (iii) pharmacists' right of substitution, supported by a regressive margins system. The recent reforms are already producing some worthwhile results, at least in terms of competitive pressure on the (few) substances that run out of patent protection. However, further intervention could be required to achieve long-term sustainability. (en)
Title
  • Pharmaceutical policy in Italy: towards a structural change?
  • Farmaceutická politika v Itálii: směřuje ke strukturální změně? (cs)
  • Pharmaceutical policy in Italy: towards a structural change? (en)
skos:prefLabel
  • Pharmaceutical policy in Italy: towards a structural change?
  • Farmaceutická politika v Itálii: směřuje ke strukturální změně? (cs)
  • Pharmaceutical policy in Italy: towards a structural change? (en)
skos:notation
  • RIV/00216208:11150/05:00004793!RIV08-MSM-11150___
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  • Pharmaceutical; policy; Italy; towards; structural; change (en)
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  • HR - Chorvatská republika
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  • Health Policy
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  • Krulichová, Iva
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