Access to toxicity study reports and protection of commercial interests

By Kevin Munungu


Gerard Hogan, Advocate General at the Court of Justice of the European Union (“CJEU”) recently delivered an opinion in the pending case between MSD Animal Health Innovation (“MSD”), Intervet international (“Intervet”) and the European Medicines Agency (“EMA”). In his opinion, due to their commercial value toxicity study reports are covered by a general presumption of confidentiality and their disclosure may only be granted under very strict conditions. 

Accordingly, Advocate General Hogan recommends the annulment of the General Court’s previous judgment, which ruled in favour of the widest possible access to such reports. Although the Advocate General’s opinions are not binding this position illustrates the ongoing contest before the CJEU on one of the major topics for the life-science industry. 

View the full article in our BioTalk blog.