Wednesday, 1 May 2013

Interim injunctions to stop EMA from releasing non-clinical and clinical data

As we mentioned last month the Court of Justice was asked by two major pharmaceutical companies AbbVie (case T-44/13, T-29/13) and InterMune (T-73/13) to issue injunctions against the European Medicines Agency (EMA) to stop EMA from releasing certain non-clinical and clinical trial data until a final ruling is given by the Court on validity of such disclosure. The EMA's 2010 access-to-documents policy allowed it to release some of the information as part of marketing-authorisation applications. The EMA is considering whether to appeal the interim decision (EMA receives interim decisions of the General Court of the EU on access to clinical and non-clinical information). 

This is just a small part of a bigger battle to define the concept of 'commercially confidential information' in the EU. While the EMA and its supporters (over 30 statements of support have been given to the EMA from an impressive group of representatives of medical journals, scientific organisations, patient advocacy groups, academic institutions, research centres etc. - see a join letter of support) claim that transparency and openness of such information is not
only desirable but even required in order to enable proper scrutiny of EMA's recommendations on medicines. Lack of common access to that information may prevent effective monitoring of health claims and may endanger consumers' health.

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