ADVOCATE-GENERAL : INDUSTRIALLY PREPARED PLASMA SUBJECT TO RULES ON MEDICINES.
The advocate-general of the EU Court of Justice proposes to make the processing, storage and distribution of plasma taken from whole blood and prepared industrially for use in blood transfusions - products like Octaplas - subject to Directive 2001/83 on medicines. His opinion, presented on 7 November in Case C-512/12, runs counter to current French practice, whereby the marketing of this type of plasma is governed by Directive 2002/98/EC on human blood and blood components, and therefore exclusively by the Etablissement francais du sang (EFS, French Blood Agency).
The dispute in the main proceedings pits Octapharma France SAS, specialised in the preparation and marketing of a plasma product called Octaplas against the Agence nationale du medicament et des produits de sante (ANSM, National Agency for Medicines and Health Product Safety) and the French Ministry for Social Affairs and Health, over an ANSM decision of 20 October 2010. The agency classified as a labile blood product (a therapeutic product made from blood) the industrially processed plasma known as "plasma SD," which includes Octaplas, used in blood transfusions. The French authorities consider that the marketing of industrially prepared human plasma is governed by the directive on quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components (Directive 2002/98/EC). Plasma SD is consequently administered and distributed exclusively by the EFS, in spite of the fact that Octapharma has marketed Octaplas as a medicine in some 30 countries around the world and in the Union (eg in Austria, Belgium, Germany and the UK).
In his opinion, Advocate-General Niilo Jaaskinen recommends that the court consider industrially prepared plasma from whole blood used for transfusions as a medicine with respect to its processing, storage and distribution, in line with the intention of the EU legislature. Directive 2002/98 on human blood and blood components, he explains, is "not relevant" for settlement of the dispute since "the case to hand does not concern the collection or testing of industrially prepared plasma". On the contrary, the directive on medicines, as amended in 2004, applies to plasma for which production involves an industrial process. The advocate-general also maintains that member states are no longer authorised to adopt stricter measures for this type of plasma than for medicinal products. Lastly, he suggests that the court should not suspend the temporal effects of its judgement, as requested by the French authorities on the ground that it would require important legislative modifications and administrative and practical adaptations.
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|Date:||Nov 15, 2013|
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