EU Clinical Trial Transparency Under Fire

The EMA is concerned clinical trial transparency in the European Union may suffer if a recent court ruling is allowed to stand.

In two separate rulings in February 2018, the EU Court of Justice found in favor of the agency in the cases Pari Pharma v. EMA and PTC Therapeutics International v. EMA. The pharma companies claimed that their trial results should be considered trade secrets and not subject to EMA’s transparency rules. EMA argued that sharing clinical trial data is in the public interest and does not violate sponsors’ commercial interests.

The court ruled against the drugmakers, reinforcing the EMA clinical trial transparency policy. On appeal, however, a judge sided with the pharma companies and ruled they did not have to share their trial results.

Although the judge’s rulings are not binding without approval from the full Court of Justice, the EMA warned that allowing the appeals ruling to stand would set a precedent against data-sharing and collaboration and require the agency to rewrite its transparency policies.