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4056

Question 4056 — human blood and organs

answeredFrance· National Assembly· FR

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11 November 2018

Summary

Ms. Valérie Thomas draws the attention of the Minister of Solidarity and Health to the full capacity of the National Agency for the Safety of Medicines and Health Products to guarantee the traceability of medicines derived from blood in the face of the potential distribution of products from paid donations abroad. The modern practice of blood donation is based on principles established by international and European texts as well as by the public health code. In Europe, Directive 2002/98/EC recalls that donation must be voluntary and respect the anonymity of the donor and the recipient. Above all, with the public health code, it clearly specifies that blood donation must be unpaid. This principle of voluntary and unpaid donation also applies to donations whose purpose is the production of medicines derived from blood. However, in spring 2017, several media relayed the information according to which several pharmaceutical groups would distribute in Europe and on the French market a drug derived from donated plasma whose donors, in the United States, would be remunerated. If the distribution on the European market of medicines derived from blood from paid donations were proven, this would seriously call into question compliance with French and European legislation as well as the traceability of medicines in Europe. In this climate of doubt, she would like to know whether strengthening controls on imports of medicines derived from blood, even on products coming from Member States of the European Union, would be considered. In the event that checks reveal this distribution, she would like to know what action the Government could take.

Machine translation from French. The official text remains authoritative.

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