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.