The European Ombudsman, who investigates complaints of maladministration in the institutions and bodies of the European Union, recently handed down its decision in a case against the European Medicines Agency (EMA). The complaint concerned the EMA’s refusal to disclose the identity of parties who request access to documents held by the EMA. In the past, the EMA had stated that the “identity and/or the name of the organisation of the requestor will be used for the sole purpose of processing the request and will not be disclosed to third parties”. Instead, third parties, including the owner of the document requested, would only be told the request came from a “pharmaceutical company” or “law firm”. Last week, the Ombudsmen confirmed that the EMA has changed its policy in light of its recommendations.

The complaint

In September 2015, the Ombudsman received a complaint from a pharmaceutical company regarding the EMA’s handling of an access to documents request under the EU Transparency Regulation (1049/2001). The complainant disagreed with the EMA’s refusal to disclose to the complainant the identity of an entity who had requested copies of the Periodic Safety Update Reports (PSURs) relating to one of the complainant’s products.

The EMA asserted, in its submissions to the Ombudsman, that its policy since July 2015 was not to disclose the identity of the requestor, so as to protect the commercial interests of the requestor. This policy was reflected in the information stated on the EMA’s website.

In its recommendation, the Ombudsman:

  • (i) noted that the EMA could not refuse to disclose information concerning the requestor on the basis of only an assumption that such disclosure would harm the commercial interests of the requestor; and
  • (ii) expressed serious doubts as to whether the disclosure of the identity of an entity requesting copies of PSURs would be “detailed, relevant [and] actionable” information that would put at risk the requestor’s commercial interests.

In view of the Ombudsman’s recommendation, the EMA changed its policy and the statements made on its website. Its amended policy is to consult with the requestor and, on the basis of that consultation, to then decide whether or not disclosure of the requestor’s identity will undermine their commercial interests such that the information may be withheld. The Ombudsman’s recent decision notes that the EMA has accepted and satisfactorily implemented its recommendation, and so the case is therefore now closed.

It is widely assumed that many, if not most, of the requests for access to documents made to the EMA are generated by competitors of the company who produced the requested document. After the Ombudsman’s recommendation, companies may consider more carefully whether or not to make requests for access to competitor documents held by the EMA, or whether to make such requests through a third party.