Search for:

In brief

The bill on the “Annual Market and Competition 2021” (“Competition Bill“), approved by the senate on 30 May 2022 and currently under examination by the Chamber of Deputies, provides for the amendment of Article 15 of Law No. 219/2005, governing the Italian transfusion system and the production of blood-derived medicines.

Key takeaways

  • The most relevant change provided for by the Competition Bill refers to the possibility for companies manufacturing blood-derived medicines to use processing, fractioning and production plants located in EU member states or in third countries that are party to mutual recognition agreements with the EU, in whose territory the plasma is collected exclusively from unpaid voluntary donors.
  • In other words, pursuant to the aforementioned provision, plasma collected by Italian blood establishments could also be processed by companies operating in countries where, although there is a mixed blood donation system (i.e., unpaid-reimbursed), donors are not remunerated. The current provision of Article 15 of Law No. 219/2005 provides that the plasma collected in Italy can only be processed in EU member states where the plasma is not provided for profit.
  • Finally, the Competition Bill provides that batches of drugs derived from national plasma must undergo state control according to EU procedures in a laboratory of the General European Official Medicines Control Laboratories Network before they can be provided to regions.

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Write A Comment