Plasma and PDMPs are regulated by a comprehensive European and national legislation, including laws concerning transfusion activities as well as Directive 2001/83/CE (Community code relating to medicinal products for human use) and the guidelines by the European Medicines Agency (EMA).

Self-sufficiency of plasma, PDMPs, blood and blood components represents one of the areas tackled by the Law n. 219/2005 which aims at granting equal access to quality and safety of transfusion therapies to all citizens. Self-sufficiency is a national supra- local and supra-regional goal; its achievement also depends on the contribution by Regions and Healthcare Authorities likewise. The 219/2005 Law acknoledges a vital role to the Associations and Federations of voluntary blood donors. As a matter of fact, they undoubtedly contribute to achieving the National Health Service goals through the promotion and development of timely blood donations and donor protection.

National Plasma and PDMP Programme. As provided for under the Legislative Decree No. 261 of December 20, 2007, the Ministry of Health, in agreement with the Regions and the Autonomous Provinces, as well as in accordance with the provisions issued by the Italian National Blood Centre, outlines a programme aiming at furthering the development of plasma collection and the promotion of the most rational and appropriate use of PDMPs.
The Ministerial Decree 2 December 2016 covers the first programme ever published in Italy to pursue national plasma and PDMP self-sufficiency. It holds the principles and strategic objectives at national and regional level to be achieved in the 2016–2020 time frame.

National Plasma and PDMP system. The Regions, independently or in consortia, provide the manufacturers identified in the Ministerial Decree of December 5, 2014, with the plasma collected at the Blood Establishments and Collection Units. The Regions receive the final products back in compliance with specific toll-fractionation agreements and contracts.

As stated in the Ministerial Decree of April 12, 2012, the production of PDMPs is defined in a quantitative and qualitative production plan agreed between the Regions and the manufactures. The Regions are entitled to the full ownership of plasma and of all pharmaceutical specialties (PDMPS) deriving from it.

Toll-fractionation contracts must consider the production of at least albumin, polyvalent immunoglobulins for intravenous administration (IVIg), and coagulation factor VIII concentrates. Furthermore, they must include also services of both pre-processing (collection, plasma storage, etc.) and post-production (batch release, storage and delivery of final products, etc.). Plasma for fractionation, PDMPs and intermediates can be exchanged amongst Regions in accordance with national tariffs as first defined in the 20th of October 2015 State-Regions Agreement and then updated in the 17th of June, 2021 State-Regions Agreement.

Quality and safety of plasma. Plasma, either obtained by the separation of whole blood or through apheresis, 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 specified in Ministerial Decree of November 2nd , 2015, which implements the Directive 2002/98/CE requirements technical guidelines.

The legislative Decree No. 19 of March 19 2018, “Implementation of Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality systems standards and specifications for blood establishments”, ensures the fulfilment of the Good Practice Guidelines (GPGs) by blood transfusion services and collection units run by donor Associations and Federations in the implementation of the standards and specifications regarding 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 provisions issued by the national authorities.