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.
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