Plasma is the liquid component of blood that can be obtained following the collection of blood from a donor either by separation of whole blood or by the production of blood components by apheresis. Plasma collected in Italy comes from voluntary, periodic, responsible, anonymous and unpaid donations. Through industrial separation and fractionation processes, it is the raw material used for the production of plasma-derived medicinal products (PDMPs), some of which are true “life-saving” drugs.
Italy currently ranks first in Europe for the quantity of plasma collected and sent to pharmaceutical companies authorised for industrial processing. Ownership of the raw material plasma as well as its derivatives is public. The Regions, individually or in associated forms, deliver the plasma collected by the Transfusion Services in their territory to companies authorised to industrially process the plasma for the production of PDMPs. The contract with the companies, which act as service providers, is considered a “third party processing” arrangement for the production of these medicines.
Procurement is implemented through a tender procedure in accordance with the regulations in force. Current contracts between the regions and the contract awardees envisage the production of at least the following PDMPs: Albumin, IVIG, FVIII, FIX, CCP, and AT. They 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.