EMA States Position on Confidential Information

November 13, 2014
The Pharm Exec staff
Pharmaceutical Executive

In response to a letter the European Medicines Agency received from the European Ombudsman on Oct. 27, 2014, the agency is clarifying its policy on commercially confidential information.

In response to a letter the European Medicines Agency received from the European Ombudsman on Oct. 27, 2014, the agency is clarifying its policy on commercially confidential information. EMA states in its response that the agency is responsible for ruling on redactions of published documents and bases its decisions in accordance with laws and internal rules.

The European Ombudsman’s letter to EMA addresses a particular request for public access to documents where information has been redacted. The Ombudsman asks EMA to clarify why certain information had been deleted from the reports, saying that some redacted information does not appear to be confidential.

EMA’s access to documents policy was published in 2010 with the support of European Union member states. When requested, the agency will release clinical study reports of drugs evaluated by EMA with any potentially commercial confidential information redacted. The agency states that this policy allows for the widest-possible access to data while protecting privacy and economic interests.

According to EMA, “while 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.”

The agency points to the policy on the publication of clinical study reports, where it 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.”

Source: European Medicines Agency