JusticeItaly Official institution
Italy issues health ministry rules implementing its 2021 rare-disease law
Italy's Ministry of Health has issued a regulation, Decree No. 198 dated 5 August 2026, to carry out a 2021 law on rare diseases. That law covers care for rare diseases and support for research into and production of orphan drugs, which are medicines developed for conditions affecting very few people. The excerpt shows only the title, so the specific rules it sets are not visible here.
What does it mean?
This decree sets out the detailed rules for a 2021 Italian law meant to help people with rare diseases and to encourage the making of medicines for those conditions. The text shown here is only the title, so the exact details of what changes are not included.
Who is affected?
People living with rare diseases, and companies and researchers working on orphan drugs.