Case C-512/12, Octapharma France – on the regulation of plasma intended for transfusion [judgment 2014, ECLI:EU:C:2014:149]

Does plasma intended for transfusion fall within the Community’s legislation on medicinal products for human use in Directive 2001/83, and can the French state impose stricter standards of regulation?

Facts
In France, preparations involving blood or parts of blood are regulated by the Public Health Code. The Code requires the State to draw up a list of ‘labile blood products’ and their characteristics. It is a list drawn up by the French National Safety Agency for Medicines and Health Products, the ANSM (Agence nationale de sécurité du médicament et des produits de santé).

In 2010, the ANSM took a couple of decisions relating to labile blood products, and its list mentioned blood products containing ‘freshly-frozen, leukocyte-depleted, solvent/detergent-treated virus-deactivated plasma’.

These decisions were the subject of legal challenge brought by the claimant, Octapharma France. It pointed out that the ANSM had in effect lumped every type of plasma together and subsumed them all under the French rules on labile blood preparations. This approach was contrary to the one taken in the EC’s medicinal products Directives (Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27). Therefore, it contended that the ANSM’s decisions had no basis in law.

Further, Octapharma France stressed that Article 3 of the 2001 Directive, as amended by the 2004 Directive, makes an exception for plasma that has been prepared by a method involving an industrial process. Accordingly, it would have been in keeping with the aims of Directive 2001/83, for the ANSM to have made an exception for a ‘labile blood product’ that was prepared with freshly-frozen, leukocyte-depleted, solvent/detergent-treated virus-deactivated plasma. It submitted that the ANSM’s decisions contravened the EU’s legal principles of legitimate expectation and legal certainty.

Octapharma France also contended that the ANSM’s approach was contrary to EU law. It argued that since the Directive makes an exception for plasma prepared by a method involving an industrial process, this type of plasma actually falls within the scope of the Directive. Thus, it is a medicinal product for human use. Therefore, it is subject to the Directive’s rules governing the making, distribution, advertising, and supply to the public of medicines. As a medicinal product, it cannot be sold to the public without already having obtained a marketing authorisation. However, the French rules meant that labile blood products did not qualify as a medicinal product and thus marketing authorisations could not be issued. Indeed, under the strict French rules, plasma products could only be imported after having obtained the permission of the ANSM.

In its defence, the ANSM read Article 2(1) together with Article 4(2) of Directive 2002/98 (allowing Member States to take stricter measures where compatible with the EC Treaty). It ran the argument that the aims of Directive 2002/98 could be better realised if the quality and safety rules relating to the collection, testing, processing, storage, and distribution of blood (and components of blood with a human origin), were guaranteed in national legislation which subsumed all of the products intended for transfusion under the category of ‘labile blood products’ – and to do so irrespective of the way in which those products had been prepared. The ANSM added that under the Directive, national rules could be stricter than those applicable to medicines in order to protect the quality and safety of plasma intended for transfusion.

Questions Referred
According to the Curia website, the Conseil d’État has asked:

1. 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 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?

2. Must Article 4(2) of Directive 2002/98 be interpreted, where necessary in the light of Article 168 of the Treaty on the Functioning of the European Union, 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 scheme 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, 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?