Is plasma from whole blood which is prepared by a method involving an industrial process and which is intended for transfusions capable of having the provisions of Directive [2001/83, as amended by Directive 2004/27] and those of [Directive 2002/98] applied to it simultaneously, as regards not only its collection and testing, but also its processing, storage and distribution; for that purpose may the rule laid down [in Article 2(2) of Directive 2001/83, as amended by Directive 2004/27] be interpreted as meaning that the Community legislation on medicinal products alone applies to a product which falls simultaneously within the scope of another piece of Community legislation only where that latter is less strict than the legislation on medicinal products?

Directive 2001/83, as amended by Directive 2004/27, and Directive 2002/98 must be interpreted as meaning that plasma from whole blood prepared by an industrial process and intended for transfusions comes within the scope of Directive 2002/98 for collection and testing, and within the scope of Directive 2001/83 for processing, storage, and distribution, provided it meets the definition of a medicinal product.

Must the provisions [of Article 4(2) of Directive 2002/98] be interpreted, where necessary in the light of Article 168 [TFEU], as allowing the maintenance or introduction of national provisions which, because they submit plasma which is prepared by a method involving an industrial process to a stricter regime than that to which medicinal products are subject, provide justification for setting aside the application of all or part of the provisions of Directive [2001/83, as amended by Directive 2004/27], in particular those which make the marketing of medicinal products subject to the sole condition of the prior grant of a marketing authorisation and, in the affirmative, under what conditions and to what extent?

Article 4(2) of Directive 2002/98, read in the light of Article 168 TFEU, allows the maintenance or introduction of national provisions that make plasma prepared by an industrial process subject to a more rigorous regime than medicinal products solely with respect to its collection and testing.

Plasma prepared industrially for transfusions is regulated by both Directives 2001/83 and 2002/98 under specific conditions.

European Court of Justice (First Chamber) · 13 maart 2014 · Judgment · Preliminary ruling

‛Approximation of laws — Directive 2001/83/EC — Directive 2002/98/EC — Scope — Labile blood product — Plasma prepared by means of an industrial process — Simultaneous or exclusive application of the directives — Option for a Member State to provide for a more rigorous regime for plasma than for medicinal products’

Rechtsvraag

Whether plasma from whole blood prepared by an industrial process and intended for transfusions falls under the scope of Directive 2001/83/EC as amended by Directive 2004/27/EC, Directive 2002/98/EC, or both simultaneously, and whether national provisions can impose a more rigorous regime than that for medicinal products.

Regel

Article 2(2), Directive 2001/83/EC (DIR 2001/83) (In cases of doubt, the provisions of this Directive shall apply where a product may fall within the definition of a medicinal product and within the definition of a product covered by other Community legislation)
Article 4(2), Directive 2002/98/EC (DIR 2002/98) (Allows Member States to maintain or introduce more stringent protective measures for blood and blood components)
Article 168 TFEU (Ensures a high level of human health protection and allows Member States to maintain more stringent protective measures)

Conclusie

The Court concluded that plasma from whole blood prepared by an industrial process and intended for transfusions falls under Directive 2002/98/EC for its collection and testing, and under Directive 2001/83/EC for its processing, storage, and distribution, provided it satisfies the definition of a medicinal product. Additionally, Member States are allowed to impose more stringent protective measures than those for medicinal products, but only concerning the collection and testing of such plasma.

Tijdlijn

20-10-2010 The Agency issued a decision setting out the list and fixing the characteristics of labile blood products, including plasma prepared by means of an industrial process such as plasma SD.
28-03-2011 The Agency implicitly dismissed Octapharma's administrative appeal against the decision of 20 October 2010.
30-05-2011 Octapharma filed an action for annulment before the Conseil d’État against the decision of 20 October 2010 and the implicit decision of 28 March 2011.
26-10-2012 The Conseil d’État decided to refer questions to the Court of Justice of the European Union for a preliminary ruling.
13-11-2012 The Court of Justice received the request for a preliminary ruling from the Conseil d’État.
10-07-2013 The Court held a hearing to consider the observations submitted by the parties involved.
07-11-2013 The Advocate General delivered his opinion regarding the case.
13-03-2014 The Court issued its judgment, stating that plasma from whole blood prepared by an industrial process and intended for transfusions falls within the scope of Directive 2002/98 for collection and testing, and Directive 2001/83 for processing, storage, and distribution, provided it meets the definition of a medicinal product.