Pharma firms way ahead in requesting access to EMA documents
This article was originally published in SRA
When the European Medicines Agency was drafting its policy on the proactive publication of clinical trial data, one concern expressed by the R&D industry was that the documents released might be of benefit to competitor companies, particularly if they contained commercially confidential information.
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The European Medicines Agency is facing excessive workload because of high volumes of access to document requests, and has decided not to process requests coming from outside of the EU.
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 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.