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1404

Question 1404 — human blood and organs

answeredFrance· National Assembly· FR

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9 October 2017

Summary

Mr. Ian Boucard draws the attention of the Minister of Solidarity and Health to the traceability of plasma in France in the composition of blood-derived medicines (MDS). By a judgment of March 13, 2014, the Court of Justice of the European Union (CJEU) indicated that plasma treated with a detergent solvent must be considered as a simple medicine since it undergoes this transformation process. However, this classification by the Court of justice of the European Plasma Union leaves the door open to the fears founded and expressed by the French Blood Establishment (EFS), blood donor associations and volunteer networks in the field. The transfusion ethics to which the EFS is deeply attached, and regulated by article L. 1221-3 of the public health code, is thus mistreated by this authorization to place on the market a product derived of an industrial process. This process opens the way to the trade in substances derived from the human body and further slows down blood donations in France. This marketing also calls into question the French model based on an ethical donation which respects the four principles of volunteering, anonymity, voluntary service and non-profit. He therefore wishes to know the Government's intentions to preserve transfusion ethics. and its wish to insert or not the notion of traceability in the PLFSS 2018.

Machine translation from French. The official text remains authoritative.

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