EMA responds to European Ombudsman

News 12/11/2014

Stakeholder feedback and experience continue to shape EMA's understanding of commercially confidential information

The European Medicines Agency (EMA) has taken note of the European Ombudsman's recent remarks on the Agency's redaction of certain documents submitted by a pharmaceutical company. The Ombudsman is referring to an individual request for documents received and addressed by the Agency to the satisfaction of the requester in early 2014. A detailed reply to the European Ombudsman's queries shall follow in due course.

Comments from the Ombudsman and other interested parties are a welcome addition to the ongoing debate on the concept of commercially confidential information. It is, however, important to stress that EMA is responsible for ruling on any redactions of documents to be published. The Agency always takes its decisions based on a careful assessment of the specific request and in accordance with existing laws and internal implementing rules.

EMA has been applying its concept of commercially confidential information in relation to clinical study reports since the publication of its PDF icon access to documents policy in 2010 with the support of the medicines regulatory agencies of the European Union (EU) Member States.

Upon request, EMA releases clinical study reports for medicines that have been evaluated by the Agency. These reports are made available following the deletion of any information that might compromise personal data protection or be considered commercially confidential. This allows EMA to give widest-possible access to data while protecting the privacy of individuals and justified economic interests.

While the EU legislation provides ample guidance on the protection of personal data, there is no agreed or binding definition of commercially confidential information. Based on experience and stakeholder feedback, the Agency is continuously improving its understanding of what can and cannot be considered confidential.

In its recently adopted PDF icon policy on the publication of clinical study reports , the Agency clearly states that the overwhelming majority of data in clinical reports is not commercially confidential and can therefore be released to the public. In very few instances, some sections of the study reports may contain information that could be considered confidential. Companies can suggest possible redactions. These will be accepted by the Agency only if the information is not already in the public domain and if companies are able to justify that disclosure of the information in question would undermine their competitive position.


  • The European Ombudsman's letter to the EMA refers to two court cases initiated against the Agency in 2013 by AbbVie.

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