May 14, 2014
The European Medicines Agency (EMA) has confirmed that AbbVie has withdrawn both its court cases brought against the Agency on access to clinical-trial data, although the case brought by InterMune is ongoing (read the OrphaNews article from June 6, 2013). AbbVie requested EMA to consider an entirely new set of redacted documents along with justification for the redaction proposed by the company. EMA responded positively affirming that the redaction proposed by AbbVie was limited and compatible with EMA’s practices. This led to AbbVie accepting the new set of documents and thus dropping the case.
In related news, as the new Clinical Trials Regulation was overwhelmingly voted in favor of releasing clinical trial data in the European Parliament on April 2, 2014 (read the OrphaNews article), the European Medicines Agency has also announced its move towards increased transparency by maneuvering the release of clinical trial reports. The Agency will be providing targeted discussions on how they will set the principles for the possible redaction of the clinical study reports to be published. These discussions will decide the criteria for redacting commercially sensitive material and provide clarifications on consultations with the clinical trial data-owners on this redaction. The Agency will liaise shortly with organisations representing patients, academia, pharmaceutical industry, as well as European Union (EU) institutions.