The Italian healthcare system is decentralised, divided into 3 levels: national, regional and local. Pricing and reimbursement of drugs are mainly decided at the national level but it is up to the individual regions whether they add the drug to their formularies or not.
Italy has one of the highest number of regulatory hurdles to overcome which slows down access of pharmaceuticals to the market. As a result, fewer drugs were registered in Italy which had launched in other EU countries. However, there are certain classes of drugs such as orphan drugs which can be brought to market sooner such as through the Early Access Programme (EAP).
For a more detailed breakdown of Italy’s healthcare economy and pharmaceutical industry, refer to our Italy section on MAP Europe.
Please see our Italy specific news section for all the latest market access updates.