The evolution of the regulatory framework for the plasma and plasma-derived medicinal products system in Italy.

In Italy, the plasma system is a part of the Blood System (BS) that is run under a thoroughly public governance scheme. The Italian National Blood Centre (NBC) (Centro Nazionale Sangue, http://www.centronazionalesangue.it) is designated as the Italian blood and blood product competent authority operating on behalf of the Ministry of Health (Ministero della Salute, MoH, http://www.salute.gov.it). It coordinates and supervises the 21 Regional Blood Transfusion Centres, with the aim of guaranteeing homogeneous standards of quality and safety across the 310 blood establishments (BEs) and 352 donor association collection units (with 1,867 collection points) (source: Italian Blood Information System, SISTRA database1). In 2012, the number of voluntary non-remunerated donors of whole blood and blood components amounted to approximately 1,739,712. The BS relied on 1,739,712 voluntary non-remunerated donors of whole blood and blood components: 1,443,770 (83%) repeat donors and 295,942 first-time donors2. Based on a national definition, 666,479 of the repeated donors are considered “frequent donors” that means they donated at least once a year, every year, in the previous 5 years. There were 240,218 apheresis donors (13.8% of total). In the same year, 3,191,026 donations (53.7 donations per 1,000 population) were collected. Of the 7,224,409 blood components produced in 2012, 2,666,726 were red blood cell units (44.9 units per 1,000 population). Those transfused were 2,529,803 (42.6 units per 1,000 population). Every day, 8,719 blood components were transfused involving totally approximately 650.000 recipients (source: Italian Blood Information System, SISTRA database). In 2012, the volume of plasma sent to industry for fractionation was approximately 772,590 kilograms (source: Kedrion Biopharma SpA). In February 2011, the MoH convened a panel of experts from the national competent authorities in the field of blood and blood products: the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA, http://www.agenziafarmaco.gov.it), the National Institute of Health (Istituto Superiore di Sanita, ISS, http://www.iss.it), the NBC and the MoH. The mission of the panel was to review and implement the current legislation and define proposals for regulations to comply with European directives and guidelines. Furthermore, efforts had to be put into the harmonisation of existing legislation, particularly for those aspects which were lacking and/or were not implemented: the production of plasma-derived medicinal products (PMPs) from Italian plasma, the opening up of the toll fractionation market to other contractors and the import/export of plasma and its products. The proposals, after approval of the State-Regions Conference, upon advice of the National Blood Technical Board and auditing of the Plasma Fractionators Association (Gruppo Emoderivati di Farmindustria), were signed by the Minister of Health on April 12th, 20123–6. The aim of this paper is to describe the main features of the Italian regulatory framework of the plasma system in the light of the recent changes of legislation, in particular related to the opening up of the toll fractionation market.