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European drug agency wins victory over drug companies that wanted to withhold data

BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k604 (Published 07 February 2018) Cite this as: BMJ 2018;360:k604
  1. Nigel Hawkes
  1. London

The European Medicines Agency (EMA) has won an important court ruling backing its policy of open data.

In an eagerly awaited judgment, the European Court of Justice backed data transparency and rejected claims by companies fearful that competitors may exploit the data.

The case arose from challenges to the EMA’s transparency rules, introduced in 2010, which established the principle that all documents underlying a successful application for a drug licence should be made accessible.

Three separate challenges were made: by the German company Pari Pharma, over its orphan drug Vantobra (tobramycin in a nebuliser solution) for treating pulmonary infections in patients with cystic …

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