Regulatory Focus™ > News Articles > 2 > EU Court Backs EMA in Trio of Transparency Cases

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Posted 06 February 2018 | By Michael Mezher 

EU Court Backs EMA in Trio of Transparency Cases


The EU General Court on Tuesday sided with the European Medicines Agency (EMA) in three cases that challenged the agency's authority to release documents under EU transparency regulations.

The rulings mark the first time the Court of Justice of the European Union (CJEU) has ruled on an issue related to EMA's application of Regulation (EC) No 1049/2001, also known as the Transparency Regulation.

"We are very pleased that the General Court affirmed that the information contained in these documents cannot be considered commercially confidential in its entirety," said Stefano Marino, EMA's head of legal department, who said the ruling is an endorsement of the agency's implementation of the Transparency Regulation.

In each of the three cases, Pari Pharma v EMA, PTC Therapeutics International v EMA and MSD Animal Health Innovation and Intervet International v EMA, the plaintiffs challenged EMA's authority to release certain documents related to their products under the Transparency Regulation and EMA's 2010 access to documents policy (Policy 0043).

Between 2015 and 2016, the court issued interim orders in all three cases suspending EMA's decision to release additional documents requested by third parties.

While appealing the three interim orders, EMA maintained that the documents, while potentially containing some "residual commercially confidential information" that should be redacted, did not qualify for blanket protection from disclosure. EMA has also held that the cases did not impact its policy to proactively release clinical study reports for all trials submitted to the agency.


The documents included similarity and superiority reports in the Pari Pharma case, a clinical study report related to PTC's muscular dystrophy treatment Translarna (ataluren) and toxicology study reports for Intervet's Bravecto (fluralaner), a veterinary drug used to treat flea and tick infestation in cats and dogs.

However, in all three judgements, the court dismissed the applicants' claims, clearing EMA's decision to release the documents.

The court also found that in all three cases, the drugmakers failed to present any evidence demonstrating that the information EMA sought to release was commercially confidential in nature and thus protected from release to third parties.

"Based on the guidance issued today by the General Court, the agency will continue to diligently assess each individual request for access to documents," EMA says.



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