Plasma and plasma-derived medicinal product self-sufficiency: the Italian case.

Abstract

According to the World Health Organization, “self-sufficiency in safe blood and blood products based on voluntary non-remunerated blood donation (VNRBD) means that the national needs of patients for safe blood and blood products, as assessed within the framework of the National Health Service (NHS), are met in a timely manner, that patients have equitable access to transfusion services and blood products, and that these products are obtained from VNRBD of national, and where needed, of regional origin, such as from neighbouring countries”1. In Italy, the achievement of self-sufficiency of plasma-derived medicinal products (PMPs), as well as blood components, is a goal of the blood system “aimed at guaranteeing equal conditions of quality and safety of transfusion therapy to all citizens”, as set out by the main regulatory reference2. Self-sufficiency is recognised as a role of “national, supra-regional, supra-local indivisible interest of the National Health Service” whose achievement is entrusted to the contributions of the regional health authorities. In order to attain this strategic goal, the Ministry of Health is responsible for defining an annual national programme for self-sufficiency aimed at identifying historical usages, real demand, necessary production levels, resources, funding system criteria, interregional PMP exchanges, import and export levels3–5. Moreover, according to current legislative provisions6,7, a special decree must be adopted for defining the “program for the development of plasma collection in blood services and blood collection units, as well as the promotion of an appropriate and rational use of plasma-derived medicinal products”. In addition, national plasma derives from voluntary, periodic, responsible, anonymous and non-remunerated donations2. Regions and Autonomous Provinces (APs) (henceforth referred to as “Regions”), individually or in association, send the plasma collected by blood establishments (BE) to Kedrion Biopharma (Kedrion SpA, Castelvecchio Pascoli, Lucca, Italy), which, at the moment, is the only manufacturer authorised under a toll fractionation agreement. The latter has the capacity to produce at least the following PMPs: human albumin solution (albumin), polyvalent immunoglobulin (for intravascular administration, IVIG), plasma-derived factor VIII concentrates (pdFVIII), plasma-derived factor IX concentrates (pdFIX), prothrombin complex concentrates (PCCs), and antithrombin (AT). However, Regions remain owners of the plasma sent for fractionation, as well as of PMPs manufactured and of the residual raw material, including discards. Therefore, self-sufficiency strongly depends on the capacity of regional health systems and the national blood system to ensure the satisfaction of patients’ needs using all products obtained by the manufacturing of national plasma within the toll fractionation agreements between Regions and fractionators thus reducing supplies from the pharmaceutical market8–10. However, also the appropriate clinical use of plasma11 and of PMPs plays a key role in self-sufficiency. The aim of the present paper is to address the issue of PMPs self-sufficiency in Italy in 2011.