- EU Court Suspends EMA Decision to Grant Access to Drug Data
- September 24, 2015 | Authors: Edgar Asebey; Maureen Bennett; Christian B. Fulda; Colleen M. Heisey; Cristiana Spontoni
- Law Firms: Jones Day - Miami Office ; Jones Day - Boston Office ; Jones Day - Munich Office ; Jones Day - Washington Office ; Jones Day - Brussels Office
- On September 1, 2015, the European General Court granted an interim order in favor of Pari Pharma, temporarily suspending the operation of a decision by the European Medicines Agency ("EMA") to allow Novartis Europharm to gain access to reports on Pari Pharma's drug Vantobra under the agency's new transparency regulation. Such reports were prepared for and supported Vantobra's marketing authorizing application.
Novartis was originally granted "orphan" designation for its cystic fibrosis treatment TOBI Podhaler. However, Pari was able to obtain market clearance for its rival product, in part by proving its treatment was clinically superior due to greater safety in a substantial portion of the target population. Novartis subsequently made a request under Regulation 1049/2001 ("Transparency Regulation") for access to the Similarity Report and Superiority Report between the two products. The EMA issued a decision granting Novartis access to the requested reports on the basis that such documents did not contain "commercial confidential information."
Pari appealed the EMA decision on the basis that it violates the Transparency Regulation and thus violates the applicant's fundamental rights and freedoms with respect to private life and confidentiality under article 7 of the Charter of Fundamental Rights of the European Union ("Charter") and article 8 of the Convention for the Protection of Human Rights, among other things. Pari argues that disclosure would allow any competitor to simply use the data for the purpose of obtaining marketing authorization for its own tobramycin product without any additional investment, thereby undermining Pari's commercial interest, and that there is no overriding public interest in disclosure of the documents. The court's order temporarily suspends the EMA's decision, while the main case is pending. This case is the latest in a series of cases brought by pharmaceutical companies challenging the EMA's policy on access to documents.