Notice for the OJ
SEQ CHAPTER \h \r 1
Action brought on 14 January 2004 by Sandoz GmbH against the Commission of the European Communities
(Case T-15/04)
Language of the case: English
An action against the Commission of the European Communities was brought before the Court of First Instance of the European Communities on 14 January 2004 by Sandoz GmbH, Kundl, (Austria), represented by C. Thomas and N. Dagg, Solicitors, and B. Oosting, lawyer.
The applicant claims that the Court should:
annul the Commission decision, notified to the applicant by letter dated 14 November 2003, not to proceed with the decision for a marketing authorisation of Omnitrop under Article 10(1)(a)(ii) of Directive 2001/83 and to send the CPMP opinion of 26 June 2003 back to the EMEA;
order the Commission to pay the applicants costs.
Pleas in law and main arguments:
The context of the contested Decision was an application for marketing authorisation made to the European Agency for the Evaluation of Medicinal Products in 2001, in accordance with scientific advice from the Committee for Proprietary Medicinal Products (CPMP), which issued a favourable Opinion in June 2003. However, the Commission decided not to proceed with a decision on the authorisation of the medicinal product in question, OMNITROP, under Article 10(1)(a)(ii) and Annex I of the Directive 2001/83 of the European Parliament and Council of 6 November 2001, on the Community Code relating to medicinal products for human use1, on the basis that the performance of "comparability studies" implied that the legal conditions for the application of the procedure were not met. Hence, the dispute between the applicant and the Commission relates to the interpretation of Article 10(1)(a)(ii) and Annex I of this Directive, which govern "bibliographical applications" based on the well-established medicinal use of the product concerned.
The applicant considers in this respect that the defendant's position conflicts with the clear wording of the applicable legislation. It would also conflict with the scientific view of the body established to provide the Community with expertise in these matters, the CPMP.
Accordingly, the applicant submits, as a single plea, the infringement of Article 10(1)(a)(ii) and Annex I, mainly indent d) of Sections I of its Parts 3 and 4, for the following grounds:
- Annex I to Directive 2001/83 expressly requires the CPMP to make a judgment on whether two products are similar, and this necessarily requires the applicant to support its explanations with comparability studies.
- The rules established by the Scotia judgment2, as invoked, in the Commission's Decision, have previously been reversed by the Commission's own legislation.
- The Commission has publicly rejected the "extremely rigid" approach of the Scotia judgment and called for a "flexible" approach to Article 10(1)(a)(ii) of the Directive 2001/83.
- The principles governing comparability exercises have been established by the Communty's centre of expertise on biotechnology-derived products (the EMEA) and the exercise will always be carried out under the EMEA's supervision.
- The scientific rigour of comparability exercises is clear from the CPMP's 2001 Note for Guidance and from the CPMP's review of OMNITROP.
- The use of comparability studies is therefore fully consistent with the objective of safeguarding public health, and certainly does not represent any relaxation of health protection standards.
- The CPMP consistently opposed the use of the essential similarity route.
____________1 - OJEC L 3, of 28..200, p. 67,2 - Case C-440/93 [1995] ECR I-851.