, EMA ; les deux ne s'entendant pas sur l'étendue des éléments pouvant être considérés comme confidentiels. L'EMA annonça sa décision de publier

, Merck demanda une injonction pour empêcher l'EMA de divulguer les rapports

, L'injonction fut accordée

, Merck mettait en avant 5 arguments : 1. que les rapports étaient protégés au titre de l'Article 4(2) et (3) du règlement n°1049/2001 en raison de la présomption de confidentialité

, que les rapports étaient confidentiels dans leur intégralité selon l'article 4(2° du règlement n°1049/2001 parce qu'ils dévoilent des savoir faires, des aptitudes aux essais cliniques et la stratégie innovante de Merck dans la façon de mener des essais cliniques

, que les intérêts respectifs n'ont pas fait l'objet d'un juste équilibre

, que si l'EMA avait réalisé un juste équilibre entre les intérêts respectifs la décision aurait été en faveur de Merck

C. La and . Débouta, Merck et condamna Merck à payer les frais de l'EMA en plus des siens. Pari Pharma v EMA, pp.235-250

, Pari pharma avait obtenu une AMM pour Vantobra®, un produit bénéficiant de la désignation de médicament orphelin

T. Vantobra®.-l'-;-le and . Podhaler, EMA a accordé l'accès au rapport d'évaluation du CHMP sur la supériorité clinique et la similarité de Vantobra® et un produit existant

, Pari Pharma a obtenu une injonction pour s'opposer à la divulgation. Paris Pharma a demandé réparation de son préjudice et l'annulation de la décision de l'EMA

, Pari Pharma mettait en avant 5 arguments : 1. Qu'il existe une présomption générale de confidentialité des rapports du CHMP dans le contexte d'une procédure de demande d'AMM selon les règlements n°726, 2004.

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