Management of plasmapheresis in France.

According to French law, the collection of blood and the separation of plasma by apheresis may only be carried out in ETS licensed by the AFS. The major objective of the recent law is to reinforce and control the safety of blood transfusion and drugs. Plasma donation is based on ethical principles of anonymity, non remuneration and voluntary agreement of the donor. In 1994, the plasma requirements for fractionation were satisfied, with plasmapheresis covering 28%. Since fractionation of French plasma is performed solely by the LFB, the evolution of the use of immunopurified factor VIII will govern future plasmapheresis activity. The number of plasmapheresis donors could potentially be increased in this country, especially if immunopurified factor VIII can be prepared under licence by the LFB. Thus collaboration between public and private industry will be essential to enable France in the future: i) to produce immunopurified factor VIII from plasma collected in the ETS instead of importing the same product prepared abroad from foreign plasma, ii) to contribute to European self-sufficiency and iii) to develop the collection by plasmapheresis of specific plasma for the production of specific immunoglobulins.