At present, Romania does not collect plasma for fractionation and does not send for fractionation human plasma recovered from whole blood. This despite the fact that data presented either by officials of the national transfusion system or by independent experts, show that Romania annually destroys over 50,000 liters of plasma.
Moreover, according to the latest audit carried out by European experts from DG SANTE in 2017, none of the 40 transfusion centers within the national transfusion system complies with European legislation on Transfusion safety and quality, so it is not authorized according to European legislation. Under these conditions, the plasma recovered from the blood collected from Romanian donors cannot be processed in factories in the European Union.
In order to be authorized according to the European legislation on Transfusion safety and quality, public transfusion centers in Romania require major investments in space (buildings), equipment, IT infrastructure, staff training. Unfortunately, so far no coherent plan has been presented to bring the national transfusion system into line with European legislation on Transfusion safety and quality, including the necessary funding.
Under these conditions, as of March 2020, a total of 26 transfusion centers out of the 40 existing nationwide have benefited from the support of a private company, which provided free plasmapheresis equipment and consumables for the collection of convalescent plasma needed by patients infected with SARS-COV-2.
In addition to the equipment and consumables provided, that company provided a training program for plasma collection center staff, and supported donation promotion campaigns.
Thus, a large part of these centers managed to collect sufficient quantities of convalescent plasma, which could be offered for the treatment of Romanian patients infected with SARS-COV-2.
Thus was born the idea of the “Donam Plasma” Association and the project “Plasma for Romania – the first 10 plasmapheresis centers”
The long-term solution to ensure sufficient quantities of plasma for fractionation is to modernize the legislation in order to allow private plasmapheresis centers to operate.
However, until these changes are accepted by all health system actors and implemented, the current legal framework allows the development of plasmapheresis centers in partnership with public transfusion centers, even if those plasmapheresis centers are funded, developed and operated by non-governmental non-profit organizations.
Thus, in two years at most, Romania will start collecting and fractionating human plasma to ensure the access of Romanian patients to essential medicines at risk of discontinuity, especially immunoglobulin. In 5 years at most, Romania could have 10 authorized plasmapheresis centers and registered PMF, with a total collection capacity of approximately 200,000 liters per year. Thus, the 10 plasmapheresis centers will be able to provide the necessary plasma for the manufacture of a sufficient amount of immunoglobulin to cover the minimum needs of Romanian patients.