In brief

The Italian Medicines Agency (AIFA) has summarized the distribution methods that can be applied in the event of shortages of drugs included in transparency lists. These measures can be implemented in order to guarantee pharmaceutical assistance at the regional level, avoid charges to citizens and optimize economic resources.

Key takeaways

In the event of shortages of drugs included in the transparency list of equivalent drugs, AIFA confirms to the Regions and Autonomous Provinces the possibility to choose for themselves the methods they deem most suitable among those typically used to cope with such circumstances. These include (i) the “safeguard clause,” which allows the Regions to take charge of the gap between the price of the drug to the public and the reference price identified in AIFA’s lists, (ii) the deletion of the drug from the transparency list at the regional level when it becomes unavailable in the relevant Region, and (iii) the implementation of Distribution on Account (DoA) or Direct Distribution (DD) Agreements.

Instead, with regard to new active substances to be included in the transparency list and/or cases of shortages of a drug, AIFA can carry out a check on the production capacity and the state of available stocks and can conduct monitoring activities to ensure the adequate supply of the drug to the National Health Service. On a residual basis, the three remedies described above, i.e., the “safeguard clause”, the deletion of the drug from the regional transparency list, and the implementation of DoA or DD Agreements, may also be used to deal with situations of supply difficulties during the early stages of the commercialization of a new drug.