In this time of COVID-19 emergency, one often hears about 'Compassionate Use'.

DM 7/9/2017 regulates the free supply by pharmaceutical companies of:

• medicines not yet authorised, in clinical trials and produced in pharmaceutical factories;
• medicines with a marketing authorisation for other than authorised indications;
• medicines authorised but not yet available in the country.
  
  

If the company is willing, free provision may be made for the treatment of patients with serious diseases, rare diseases and tumours or life-threatening conditions for whom there are no viable therapeutic alternatives available or who cannot be included in a clinical trial

The DM also defines:

• the role and activities of AIFA
• who and how can apply
  
  

For more information:

Ministerial Decree of 7 September 2017 - Regulation of the therapeutic use of medicinal products

AIFA Question and Answer Document

On the AIFA website, the detailed documentation and the list of active Compassionate Use programmes