Brussels, 08/11/2013 (Agence Europe) - The processing, conservation and distribution of industrial prepared plasma made from whole blood for blood transfusions (SD plasma) should be covered only by the EU directive on medicines (2001/83/EC) rather than the EU directive on quality and safety for the collection, control, processing, conservation and distribution of human blood (Directive 2002/98/EC), said European Court of Justice Advocate-General Niilo Jääskinen in conclusions issued on Thursday 7 November in Case C-512/12, and he asks the Court not to not to put a time limit on its ruling in this case.
Jääskinen asks the Court to respond as above to questions raised by the French Conseil d'État court, which has a case before it from French company Octapharma France, which makes the SD plasma Octaplas and which has appealed against a decision by the French medicines and healthcare products agency (ANSM) to classify SD plasma as a labile blood product, to be managed and marketed solely by the French state blood bank, EFS, which has the monopoly in France for organising blood donations. Arguing that the marketing of human plasma prepared industrially should be governed by Directive 2002/98/EC and noting that states are entitled to introduce more stringent health and safety rules than those laid down by the EU, the French authorities took their decision even though Octapharma sells Octaplas as a medicine (governed therefore by Directive 2001/83/EC) in two dozen countries in the EU and elsewhere. The French court asked the Court of Justice to decide which directive applies to industrially prepared blood plasma products used for blood transfusions.
The Advocate-General says this type of product should be solely governed by Directive 2001/83. It is clear from the 2004 amendment of the directive that it applies to plasma to which an industrial process is part of its production and the aim of the review of the directive was to ensure that plasma prepared using an industrial process is covered by the EU rules on medicines for human use, in other words Directive 2001/83. He says Directive 2002/98 does not apply here because this case does not concern the collection or control of industrially prepared plasma and he therefore says that member states are not allowed to introduce stricter measures for this plasma than apply to medicines. He therefore asks the Court of Justice to not give any time restrictions on the impact of the ruling that it issues in this case. (FG/transl.fl)