In order to guarantee an ethical and rational use of the national plasma, Italy gives PDMPs that exceed national needs within specific agreements, programmes or projects of international cooperation. More than 28.000 vials of PDMPs have been exported since 2012, for scientific or humanitarian projects promoted by the Italian National Blood Centre and Regions.
In Italy, there is a surplus of some PDMPs and their intermediates, whose production is necessary to guarantee the extraction of albumin and immunoglobulins. This situation occurs also in other developed countries such as France, Netherlands, Australia and Canada, which adopt Programmes of national self-sufficiency of blood, blood components and PDMPs.
Since 2008, the Italian National Blood Centre set up a working group to manage these surpluses, involving the national Competent authorities such as the National Medicines Agency, the Ministry of the Health, the Regions through the Regional Blood Centres, Associations and Federations of Donors, Scientific Societies and Patient Associations. The main goals of the working group are to monitor the surplus situation, assess the areas of intervention and promote actions referring to interregional exchange.
Taking into account that some final or intermediate products such as the coagulation factors, which are in excess in Italy but deficient in other Countries of the world and included in the World Health Organization (WHO) essential medicines list, the Italian National Blood Centre promoted the development of new regulatory dispositions to allow the ethical and rational management of plasma and its products.
Two regulatory acts discipline the export of plasma, PDMPs and intermediates.
The Ministerial Decree of December 2, 2016 defines the rules to export the PDMPs exceeding the regional and national needs
The State – Regions Agreement of February 7, 2013 envisages that the Ministry of Health, in cooperation with the Italian National Blood Centre, the Regions, the Autonomous Provinces, the Ministry of Defence and the Ministry of Foreign Affairs, promotes the stipulation of specific agreements, programmes or projects aimed to export or transfer PDMPs or intermediate plasma-derived products, to support the organisation of the blood systems in the recipient countries as well as to train human resources and to support the implementation of capacity building programmes and haemophilia care networks.
Up to now, the countries involved in programmes of cooperation and humanitarian aid promoted and coordinated by the Italian National Blood Centre are Albania, Afghanistan, Armenia, Bolivia, Egypt, El Salvador, Kosovo, India, Palestine and Serbia.
Interventions are mainly focused on the donation of coagulation FVIII and FIX concentrates. Projects on Capacity building are about to be defined and implemented.
|Region||Country of destination||PDMPs||Number of phials|
|Veneto-AIP 1||Afghanistan||Factor VIII||700|
|Veneto-NAIP 2||India||Factor VIII||1.944|
No. of vials of exported PDMPs
Blood and plasma represent precious and limited resources characterised by a strong ethical value because resulting from the voluntary, responsible and unpaid donation.
The national system of plasma and plasma derived medicinal products is ruled by an extensive European and national legislation including both the laws regarding transfusion activities and the wider regulation attributable to the Community Code relating to medicinal products.
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Plasma Italia is an initiative promoted by the National Blood Centre and the Italian Institute of Health.
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