Fresh Challenge To EMA's Access To Documents Policy Raises Hopes For Clarity
As the European Medicines Agency's policy on access to documents faces yet another legal challenge, the European Confederation of Pharmaceutical Entrepreneurs is hoping the verdict will demystify what constitutes commercially confidential information in a marketing authorization application.
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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.
The European Medicines Agency is keen to highlight its landmark policy on proactive publication of clinical data but it’s aware of the challenges involved in this and other transparency initiatives.
The European Medicines Agency is looking for a clear indication from the EU courts on whether its approach to transparency – as defined in its access to documents policy – is correct.