The European Court of Justice has annulled interim injunctions against the European Medicines Agency (EMA) in its appeal against Abbvie and InterMune, who had sought to prevent the EMA releasing documents relating to specific clinical trials. The European Court of Justice now passes the case back to the European General Court, with the stipulation that AbbVie and InterMune must provide proof of the serious and irreparable harm the release of these documents will cause. Ben Goldacre, one of the founders of the AllTrials campaign said “We can only hope that the European Court will come to its senses, and recognise that it took a huge backwards step in forcing the EMA to hide these documents from doctors and researchers.”
Back in April 2013, the European Court issued interim injunctions against the European Medicines Agency (EMA) after the pharmaceutical companies AbbVie and InterMune challenged the Agency’s decisions to grant access to clinical study reports from clinical trials of drugs from each of those companies.
Recent research from IQWiG has shown that large quantities of vitally important information about the methods and results of clinical trials can only be found in the full Clinical Study Report.
Goldacre went on to say “This is an extraordinary and shameful case that has inflicted huge reputational damage on the pharmaceutical industry. While others have been moving forwards towards greater transparency, AbbVie and InterMune have actively sued the EMA, forcing them to withhold the very information that doctors, researchers and patients need to make informed decisions about which treatment is best.”