CJEU - C 104/13 / Judgment

Olainfarm AS v Latvijas Republikas Veselības ministrija and Zāļu valsts aģentūra
Deciding body type
Court of Justice of the European Union
Deciding body
COURT (Fifth Chamber)
Type
Decision
Decision date
23/10/2014
ECLI (European case law identifier)
ECLI:EU:C:2014:2316
  • CJEU - C 104/13 / Judgment
    Key facts of the case:
     
    (Reference for a preliminary ruling — Approximation of laws — Industrial policy — Directive 2001/83/EC — Medicinal products for human use — Article 6 — Marketing authorisation — Article 8(3)(i) — Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials — Derogations relating to pre-clinical tests and clinical trials — Article 10 — Generic medicinal products — Concept of ‘reference medicinal product’ — Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product — Article 10a — Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years — Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10a as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product)
     
    Results (sanctions) and key consequences of the case:
     
    41. Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable. 
     
    On those grounds, the Court (Fifth Chamber) hereby rules:
    1. The concept of ‘reference medicinal product’ within the meaning of Article 10(2)(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007, must be interpreted as encompassing a medicinal product for which the marketing authorisation was granted on the basis of Article 10a of the directive.
    2. On a proper construction of Article 10 of Directive 2001/83, as amended by Regulation No 1394/2007, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, the holder of a marketing authorisation for a medicinal product used as a reference product in an application for a marketing authorisation under Article 10 of the directive for a generic product of another manufacturer has the right to a judicial remedy enabling him to challenge the decision of the competent authority which granted the marketing authorisation for the generic product, provided that that holder is seeking judicial protection of a right conferred on him by Article 10. Such a judicial remedy exists, inter alia, where the holder demands that his medicinal product is not to be used for the purpose of obtaining, under Article 10, a marketing authorisation for another medicinal product in relation to which his own product cannot be regarded as a reference product within the meaning of Article 10(2)(a) of the directive.
  • Paragraphs referring to EU Charter

     

    35. However, Article 47 of the Charter of Fundamental Rights of the European Union (‘the Charter’) provides that any person whose rights guaranteed by the law of the European Union are violated has the right to an effective remedy before a tribunal.

    36. Accordingly, the first question is to be understood as raising, in essence, the issue whether Article 10 of Directive 2001/83, read in conjunction with Article 47 of the Charter, is to be interpreted as conferring on the holder of a MA for a medicinal product used as the reference product in an application under Article 10 for a MA for a generic product of another manufacturer the right to a judicial remedy enabling that holder to challenge the decision of the competent authority which granted a MA for the generic product.

    37. It should be observed that Article 10 of Directive 2001/83 lays down the conditions under which the holder of a MA for a medicinal product is required to accept that the manufacturer of another medicinal product is entitled to refer to the results of pre-clinical tests and clinical trials contained in the dossier relating to the application for the MA for the former product, rather than perform those tests or trials himself, for the purpose of obtaining a MA for the other medicinal product. It is apparent that that provision confers a concomitant right on the holder of the MA for the former medicinal product to demand that the rights attaching to him by virtue of those conditions are observed.

    38. Thus, without prejudice to the law relating to the protection of industrial and commercial property, the holder of a MA for a medicinal product has the right to demand, pursuant to the second and fifth subparagraphs of Article 10(1) of Directive 2001/83, that that medicinal product is not to be used as a reference product for the purpose of authorising the placing on the market of a medicinal product of another manufacturer until a period of 8 years has elapsed from the date on which that MA was granted, or to demand that a medicinal product authorised to be placed on the market on the basis of Article 10 is not to be marketed until a period of 10 years — which may be extended, where appropriate, to 11 — has elapsed from the date on which that MA was granted. Similarly, that holder may demand that his medicinal product is not to be used for the purpose of obtaining, under Article 10, a MA for another medicinal product in relation to which his own product cannot be regarded as a reference product within the meaning of Article 10(2)(a), as contended by Olainfarm before the referring court, or for a product which does not fulfil the requirement, laid down in Article 10(2)(b) of the directive, that it should be similar to the reference product in terms of its composition in active substances and pharmaceutical form.

    39. It should therefore be recognised that the holder of a MA for a medicinal product used as a reference product in an application for a MA under Article 10 of Directive 2001/83 is, by virtue of that provision, read in conjunction with Article 47 of the Charter, entitled to judicial protection in so far as concerns respect for his rights.

    40. In the light of the foregoing considerations, the answer to Question 1 is that, on a proper construction of Article 10 of Directive 2001/83, read in conjunction with Article 47 of the Charter, the holder of a MA for a medicinal product used as a reference product in an application for a MA under Article 10 of the directive for a generic product of another manufacturer has the right to a judicial remedy enabling him to challenge the decision of the competent authority which granted the MA for the generic product, provided that that holder is seeking judicial protection of a right conferred on him by Article 10. Such a judicial remedy exists, inter alia, where the holder demands that his medicinal product is not to be used for the purpose of obtaining, under Article 10, a MA for another medicinal product in relation to which his own product cannot be regarded as a reference product within the meaning of Article 10(2)(a) of the directive.