Notice for the OJ
Action brought on 4 February 2003 by Merck Sharp & Dohme Limited and 19 other applicants against the Commission of the European Communities and the European Agency for the Evaluation of Medicinal Products ("EMEA")
(Case T-41/03)
Language of the case: English
An action against the Commission of the European Communities and the European Agency for the Evaluation of Medicinal Products ("EMEA") was brought before the Court of First Instance of the European Communities on 4 February 2003 by Merck Sharp & Dohme Limited, Hoddeston, United Kingdom, Merck Sharp & Dohme BV, Haarlem, Netherlands, Laboratoires Merck Sharp & Dohme-Chibret, Paris, France, MSD Sharp & Dohme GmbH, Haar, Germany, Merck Sharp & Dohme (Italia) SpA., Rome, Italy, Merck Sharp & Dohme, LDA. Paço de Arcos, Portugal, Merck Sharp & Dohme de Espana S.A., Madrid, Spain, Merck Sharp & Dohme Ges.m.b.H., Wien, Austria, Merck & Co. Inc., Whitehouse Station, USA, Dieckmann Arzneimittel GmbH, Haar, Germany, Neopharmed SpA, Rome, Italy, Istituto Gentili SpA., Pisa, Italy, Laboratórios Químico-Farmacêuticos Chibret, LDA., Paço de Arcos, Portugal, Laboratoires Sanofi, Synthelabo France, Paris, France, Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim, Germany, VIANEX S.A., Nea Erythrea, Greece, Sigma-Tau Industrie Farmaceutiche Riunite SpA., Rome, Italy, Mediolanum SpA., Milano, Italy, BIOHORM S.A. (Groupo Uriach), Barcelona, Spain, and LACER S.A., Barcelona, Spain, represented by Dr Georg M. Berrisch and Mr Peter Bogaert, Lawyers.
The applicant claims that the Court should:
listnum "WP List 1" \l 1annul the Contested Decision
listnum "WP List 2" \l 1order the Commission to pay the applicants' costs
Pleas in law and main arguments:
The Applicants in the present case are all Marketing Authorisation Holders (MAH) for the product ZOCORD, which, containing the active ingredient simvastatin, is a lipid-lowering medicine reducing levels of toal cholesterol, LDL-C (low density lipoprotein cholesterol), Apo B (Apolipoprotein B) and triglycerides in the blood It also increases the amount of HDL-C (High density lipoprotein cholesterol) in the blood.
They challenge the decision of the European Agency for the Evaluation of Medicinal Products to initiate a referral procedure under Article 30 of Directive 2001/83/EC of the European Parliament and the Council, of 6 November 2001, of the Community code relating to medicinal products for human use (the Directive),
1 in relation to the aforementioned product.
The Applicants sumit that the contested Decision violates Article 30 of the Directive on the following grounds:
- There are no divergent decisions following decisions in accordance with Article 8, 10(1) and 11 of the Directive.
- The contested Decision is a decision to harmonise the summary of product characteristics (SPC) for ZOCORD and associated trade names, and the single proposal of the referral procedure for ZOCORD is to develop and impose the EU-wide harmonised SPC. The Article 30 procedure, however, does not allow for the adoption of a harmonised SPC.
- Before the mutual recognition procedure took effect, pharmaceutical companies were under no obligation to submit identical marketing authorisation applications to different Member States. Applicants could, for example, request approval of different therapeutic uses or presentations, often to take account of differences in national medical practices and customs. Such differences in applications unavoidably result in differences in the approvals, but do not qualify as "divergent decisions" for the purposes of Article 30. Hence, differences between national approvals resulting from different applications are not covered by Article 30.
- The referral covers the entire content of the SPC. This goes beyond the permissible scope of an Article 30 referral, which must be limited to a "clearly identified question", according to Article 30, second indent, of the Directive.
- It has not been demonstrated that the contested Decision is based on public health grounds.
____________1 - OJEC L 311, of 28.11.2001, p. 67.