EMA Loses Key Round In Court Battle For Flagship Transparency Policy
EU Advocate General says clinical trial data are presumptively confidential
The European Medicines Agency may be forced to re-examine whether clinical trial data should be regarded as presumptively confidential under its access to documents policy.
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The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.
A number of transparency supporters have issued an open letter ahead of an EU court judgment on the European Medicines Agency’s access to documents policy.
A recent event in Brussels organized by the European Public Health Alliance found that cross-country initiatives on pricing and calls for more R&D and clinical trial transparency are gathering momentum in Europe, but there is still some way to go to address the imbalances in the system. The Pink Sheet spoke to EPHA's Yannis Natsis about the issues raised at the organization's fourth forum on medicines access.