Boost For Transparency As EU Court Backs EMA's Approach To Disclosing Clinical Data
The EU General Court has dismissed three cases by pharmaceutical companies that wanted to prevent the European Medicines Agency from disclosing certain data about their marketed medicines on the grounds that it would harm their commercial interests. Firms now have a clearer idea of the standards they will need to meet to claim their information is commercially confidential.
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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.
Draft guidance states that "responsible parties" could be fined $10,000 for not submitting trial information to the federal data repository as required by law.
The EMA is halting its cherished transparency initiative on study data as it reckons with the fact that many of its employees will not be relocating to its new headquarters in Amsterdam. International collaboration, guidelines development and revision, and the agency's involvement in stakeholder meetings will all be cut back.