In order to ensure an ethical and rational use of national plasma, Italy exports plasma-derived medicinal products (PDMPs) in excess of national requirements within the framework of specific international cooperation agreements, programmes or projects. Since 2012, more than 28,000 bottles of PDMPs have been exported as part of scientific and humanitarian projects promoted by the Italian National Blood Centre (CNS) and the Regions.
In Italy, as in other countries with advanced economies such as France, the Netherlands, Australia and Canada, where national self-sufficiency programmes for blood components and PDMPs are adopted, a surplus of certain PDMPs or their intermediates, which are necessary to guarantee the extraction of albumin and immunoglobulins, is produced. In 2008, the CNS set up a working group for the management of the aforementioned surplus production. The WG involved the competent authorities in the field, the AIFA, the Italian Ministry of Health, the Regions through the Regional Blood Coordination Centres, donor Associations and Federations, Scientific Societies and Patients’ Associations, and was mandated to monitor the situation, assess the relative areas of intervention and propose actions to put in place interregional compensation initiatives. As mentioned above, Italy produces a surplus of certain finished and intermediate blood products, such as coagulation factors, while there is a shortage of them in other countries. As these products are included in the World Health Organisation’s list of essential medicines, the CNS has promoted the development of new legislative instruments to enable the transfusion system to manage its plasma and PDMPs ethically and rationally.
With the Ministerial Decree of 12th April 2012, amended by the Ministerial Decree of 2nd December 2016 (IT Text), the modalities for the export of blood products in excess of regional and national requirements were defined. Subsequently, with the State-Regions Agreement of 7th February 2013, the Ministry of Health (through the CNS), the Regions and Autonomous Provinces, the Ministry of Defence and the Ministry of Foreign Affairs, each with its respective responsibilities, committed themselves to promoting specific agreements, programmes or projects regarding the export or transfer of PDMPs or plasma processing intermediates. Support for the organisation of the transfusion systems of the recipient countries, training and education of human resources, as well as support for the setting up and implementation of healthcare networks for patients suffering from haemophilia and congenital haemorrhagic diseases (CHD), were also envisaged.
The countries involved to date in the cooperation programmes promoted and coordinated by the CNS are Albania, Afghanistan, Armenia, Bolivia, Egypt, El Salvador, Kosovo, India, Palestine and Serbia. The interventions have mainly entailed the donation of coagulation Factor VIII and Factor IX concentrates (indicated in the treatment and prophylaxis of haemophilia A and B). Training and capacity building projects are also being defined and implemented.
More information on humanitarian projects can be found at the following link