Cazenave J P, Folléa G
Establissement de Transfusion Sanguine de Strasbourg, France.
Hematol Cell Ther. 1996 May;38 Suppl 1:S25-33.
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.
根据法国法律，采血和通过单采血浆术分离血浆只能在经法国卫生安全局许可的采血中心进行。近期这项法律的主要目标是加强和控制输血及药品的安全性。血浆捐献基于匿名、无报酬以及捐献者自愿同意的伦理原则。1994年，用于分馏的血浆需求得到满足，单采血浆术占比28%。由于法国血浆的分馏仅由法国血制品公司进行，免疫纯化因子VIII使用情况的变化将决定未来单采血浆术的活动。该国单采血浆术捐献者的数量可能会增加，特别是如果法国血制品公司能够获得许可制备免疫纯化因子VIII。因此，公私行业之间的合作对于法国未来实现以下目标至关重要：i）从采血中心采集的血浆中生产免疫纯化因子VIII，而非从国外进口由外国血浆制备的相同产品；ii）实现欧洲的自给自足；iii）通过单采血浆术采集特定血浆以生产特定免疫球蛋白。
