Regulatory Focus™ > News Articles > 2020 > 1 > EU Court of Justice Rules in Favor of EMA in Transparency Case

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Posted 22 January 2020 | By Zachary Brennan 

EU Court of Justice Rules in Favor of EMA in Transparency Case

The Court of Justice of the EU on Wednesday ruled that the European Medicines Agency (EMA) acted lawfully when it released certain toxicology reports and a clinical study report from two sponsors that wanted to keep that information confidential.

The cases centered around New Jersey-based PTC Therapeutics and MSD Animal Health (part of Merck), which claimed that EMA’s disclosure of a clinical study report, in the case of PTC, and five toxicology reports from MSD Animal Health would undermine their commercial interests.

But the Court of Justice concluded, siding with the General Court ruling from February 2018, that the passages in the reports at issue “did not constitute information capable of falling within the exception relating to the protection of commercial interests.”

In the PTC case, the Court of Justice found that it had not provided EMA, prior to the agency’s decision, with explanations concerning the nature, purpose and scope of the data at issue and did not precisely identify which passages of the reports could undermine its commercial interests if disclosed.

For MSD Animal Health, the court similarly noted that the firm had not provided necessary explanations before the General Court or specifically and precisely identified the passages in the reports at issue which could undermine their commercial interests in the event of disclosure. Indeed, the General Court noted that the companies failed to give any concrete evidence of how the release of the contested documents would undermine their commercial interests.

The Court of Justice also rejected both companies’ pleas that the reports at issue were covered by a general presumption of confidentiality, noting that the EMA was not obliged to apply such a presumption and that the

EMA had specifically examined the reports and redacted certain passages.
In addition to the rejections, the court also said the companies have to pay EMA’s legal fees. The court previously ruled against EMA.

And back in July 2018, EMA began publishing redacted clinical trial information.

Court of Justice of the European Union


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