Open Medicine EU

Intermune have withdrawn one part of their legal challenge to EMA’s disclosure of documents concerning the medicine Esbriet. This needs careful explaining.

The cases started when Intermune took legal action to stop disclosure by the EMA of documents relating to the medicine. They also applied for and received an interim order prohibiting disclosure until the full hearing of the case – not unusual in such cases. After an appeal by EMA the application for the interim order was to be re-heard by the court.

Now Intermune have withdrawn their application for interim measures, but their main case still stands.

So, we have a strange situation here. Intermune want the court to block disclosure, but are not asking for a ban on disclosure before the full hearing of the court. The medicines agency is no longer subject to a court order banning disclosure.

It is difficult to see what all of this means. Will the medicines agency now disclose the documents – for example if a new applicant applies for access to them? Was the company comforted by the potential new limits on disclosure introduced recently by EMA? If the company is not looking for interim measures, why is it continuing with the full case? Was there some understanding between the company and EMA about (non)disclosure before the full hearing of the case?

And so, the evolution of public policy on transparency of clinical trial results continues to be shrouded in mystery.

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