Health policy
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Italian pharmaceutical policy has recently moved towards a "two lanes" approach, with regulation differing according to a drug's patent status. This study analyses the Italian regulatory framework, focusing on policies related to "off-patent" drugs. ⋯ 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.