Medicine shortages and unavailability
The shortage and unavailability phenomena and monitoring activities
The temporary lack of supply on the national market of medicines essential for the treatment of certain diseases is monitored by AIFA on the basis of an ad hoc procedure.
‘shortage’ refers to the situation where a medicinal product is not available throughout the country, as the marketing authorisation holder (MAH) cannot temporarily ensure an appropriate and continuous supply.
A shortage on the market can be determined by several factors, including, for example, the unavailability of the active substance, manufacturing problems, regulatory framework, unforeseen increase in the demand for a particular medicinal product, or health emergencies in the countries of production.
The actual shortage of a medicinal product must be distinguished from its momentary unavailability caused by distortions of distribution dynamics.
European legislation does not contain a harmonised definition of the terms ‘shortage’ and ‘unavailability’ of medicines. The two phenomena refer in fact to two situations of different nature:
- shortages related to manufacturer-related issues are generally due to production difficulties, but may also be related to the decision to suspend the marketing of ‘older’ or low-cost medicines with limited profitability.
- the unavailability generated by market distortions can be attributed to the phenomenon of parallel trade, which exploits the price differences of medicines on the different markets.
For alerts concerning shortages of medicinal products transmitted by MAHs, AIFA shall:
- ascertain the effectiveness and extent of the shortage;
- assess the specific criticalities by verifying:
- the type of shortage (periodic, recurrent, chronic or new reporting);
- the availability of similar products on the Italian or foreign market or the uniqueness of the medicine;
- contact the MAH of the medicinal product, of analogues and the other parties involved (producers, intermediaries, distributors, importers, health facilities and authorities, etc.)
Based on the performed assessment, AIFA shall take the necessary measures:
- issuance of import authorisation for the medicinal product subjected to shortage;
- issuance of import clearence (nulla osta) for individual health structures requesting it;
- other specific measures (e.g. determinations, rationalisation of use for certain categories of patients, etc.)
List of medicine shortages
AIFA periodically updates and publishes on the institutional portal a list of the medicinal products temporarily subjected to shortages, containing the following information:
- trade name of the medicinal product, active substance, pharmaceutical form, packaging and name of the MAH;
- date of commencement and presumed conclusion of the shortage;
- whether or not there is a therapeutic alternative;
- reasons which led to the shortage;
- suggestions and/or measures taken by AIFA.
This list is compiled from information provided by MAHs and on the basis of the alerts received and verified by AIFA’s competent Office.
In addition, the list of medicinal products temporarily subjected to shortages for which AIFA issued an import authorisation to health structures for analogous products authorised abroad or has issued an import determination to the MAH, is published as an extract from the above list.
Finally, AIFA publishes since 2018 a list of determinations by which MAH of medicines under shortage have been authorised to import analogous medicines from abroad.