According to a news source, European Medicines Agency (EMA) Director Guido Rasi intends to appeal interim rulings recently issued by the European Union’s (EU’s) General Court to stop the agency from releasing to third parties information on AbbVie and InterMune’s clinical trials. AbbVie, Inc. v. EMA, Case T-44/13 (Gen. Ct., decided April 25, 2013); InterMune UK Ltd. v. EMA, Case T-73/13 R (Gen. Ct., decided April 25, 2013).
The court refused to decide, as a matter of first impression, whether EMA’s new disclosure policy infringes the drug makers’ right to professional secrecy, noting that it “requires an in-depth examination in the context of the main proceedings,” but upheld the applications for interim measures because the drug companies had made a prima facie case.
Rasi claims that transparency is critical to combat a growing level of public distrust of the pharmaceutical industry. Since the end of 2010, EMA has apparently released nearly 2 million pages of detailed clinical trial information in response to requests. AbbVie and InterMune reportedly resisted a request for their data because competitors were evidently among those seeking it. They contend that commercially confidential information in their EMA filings would benefit competitors. See Reuters, April 30, 2013.