Under current Italian legislation, the Italian National Blood Centre (CNS) is entrusted with the coordination and technical-scientific support for the production planning of plasma and plasma-derived medicinal products (PDMPs). In particular, the CNS has the task of providing guidance on the strategic objectives pursued by the transfusion system, including the attainment of regional and national self-sufficiency of labile blood components and PDMPs.
The self-sufficiency of PDMPs and of blood and blood components is one of the objectives of Law No. 219/2005 aimed at ensuring all citizens enjoy equal conditions of quality and safety in transfusion therapy. It is of national, supra-regional and supra-company interest that cannot be compartmentalised, for the achievement of which the cooperation of the Regions and local health authorities is required. The law identifies the annual National Self-sufficiency Programme (Art. 14) as the instrument for determining the factors that must be taken into account, such as historical consumption, real requirements, necessary production levels, resources, criteria for financing the system, the methods of compensation between the Regions, and the levels of import and export that may be necessary.
In addition, Legislative Decree No. 261 of 20th December 2007 (Article 26) requires that, by means of a specific decree, the Ministry of Health draw up a programme aimed at developing plasma collection in the Transfusion Services and Collection Units and promoting the rational and appropriate use of PDMPs.