The Italian national plasma and plasma-derived medicines system is based on a comprehensive set of EU and national regulations, including both the laws on transfusion activities and the broader regulations established under Directive 2001/83/EC (Community Code for Medicinal Products) and the guidelines issued by the European Medicines Agency (EMA).
Self-sufficiency of plasma, plasma-derived medicinal products, blood and blood components, is one of the objectives of Law no. 219/2005 219/2005 the aim of which is to ensure all citizens have equal access to transfusion therapies that are safe, reliable and of good quality.
The objective of self-sufficiency is a supra-regional, supra-industrial, indivisible national goal, the achievement of which requires the cooperation of the regions and health authorities.
A law in force assigns a crucial role to voluntary blood donor associations and federations, which contribute to the institutional purposes of the Italian National Health Service through the promotion and advancement of organised blood donation and donor protection.
National Plasma and Plasma-derived Products Programme. Pursuant to Legislative Decree no. 261 of 20th December 2007 261which transposed European Directive 2002/98/EC into Italian law,the Italian Minister of Health, in agreement with the Regions and Autonomous Provinces and in accordance with the indications issued by the Technical Health Committee – Transfusion Section of the Italian National Blood Centre (CNS), outlined a programme aimed at furthering plasma collection at the Transfusion Services (TSs) and the Blood Collection Units (BCUs), and at promoting the rational and appropriate use of plasma-derived medicinal products (PDMPs).
With Ministerial Decree of 2nd December 2016, the first Programme in Italy to contain the principles and strategic objectives to pursue in order to achieve self-sufficiency in plasma and PDMPs in the five-year period 2016-2020 was published.
The plasma-derivation system. The Regions, individually or in pools, send the plasma collected at the Transfusion Services (TSs) and the associative Blood Collection Units (BCUs) to the authorised and affiliated companies specified in Ministerial Decree of 5th December 2014.The finished products, obtained through third party industrial processing or toll-fractionation agreements, are then returned to the Regions.
In compliance with the model convention scheme set out in Ministerial Decree of 12th April 2012subsequently updated in the Ministerial Decree of 19th December 2022,the industrial production of PDMPs is defined in an agreement between the Regions and the manufacturers to ensure that the PDMPs produced meet the required quality standard and quantity requirement. The Regions retain the full ownership of the plasma sent for fractionation and of all the pharmaceutical specialities (PDMPs) deriving from it.
Contracts between the regions and the companies awarded the tender must cover the production of at least albumin, polyvalent immunoglobulins for intravenous use (IVIg), and coagulation factor VIII concentrates. They must also include pre-processing services such as plasma collection and storage, and post-production services such as batch release, storage and delivery of finished products. Plasma for fractionation, PDMPs and certain intermediates can be exchanged between regions at the national tariffs first specified in the State-Regions Agreement of 20th October 2015 and subsequently updated in the State-Regions Agreement of 17th June 2021.
Quality and safety of plasma. Whether obtained through the separation of whole blood or by means of apheresis, plasma can be used in clinical settings or sent for industrial processing as raw material for the production of PDMPs. The quality and safety requirements are defined in the Ministry of Health Decree of 2nd November 2015,, which takes into account the requirements of the which takes into account the terms of Directive 2002/98/EC and the implementing Technical Directives.
Legislative Decree no. 19 of 19th March 2018, “Implementation of Commission Directive (EU) 2016/1214 of 25th July 2016 amending Directive 2005/62/EC as regards standards and specifications of the quality system for blood transfusion services”, ensures that donor Associations and Federations that run blood transfusion services and collection units apply Good Practice Guidelines (GPGs) in the implementation of the standards and specifications established for the quality system.
Plasma as a raw material for the production of PDMPs is also subject to the requirements of Directive 2001/83/EC (Community Code for Medicinal Products), the guidelines of the European Medicines Agency (EMA), and the recommendations of Italian authorities.
For Italian regulations, please consult this link.