Facing High-Profile Criticism, EMA Defends Data Transparency Policy

Posted 13 February 2015 By Michael Mezher


Regulators are often faced with balancing commercially confidential information with the public’s right to access documents.

In a letter from European Ombudsman Emily O’Reilly late last year, the European Medicines Agency (EMA) was called out over how it handled that balance when responding to an "access to documents" request in 2013. Now the agency has responded to that letter, issuing a response to the ombudsman that both defends and apologizes for its handling of clinical study report (CSR) data.


The Ombudsman's letter concerned an "access to documents" request EMA received for three CSRs used in the marketing authorization for AbbVie’s arthritis drug Humira. After being notified of the request, AbbVie told EMA that the information in the CSRs was commercially confidential. EMA rejected AbbVie’s claim, but before the agency could release the CSRs AbbVie filed a lawsuit requesting EMA’s decision be annulled.

Before the case could proceed, AbbVie approached EMA with a proposal to redact portions of the CSRs. AbbVie withdrew the suit after reaching agreement with EMA on its proposed redactions to the CSRs. EMA claims it reviewed AbbVie’s reasoning and rejected certain redactions before releasing the redacted documents.

The Ombudsman’s Letter

The letter sent by the Ombudsman to EMA in October 2014 asked the regulator to justify why it redacted certain portions of three CSRs that were used to obtain market authorization for Humira.

Many of the redactions made to the CSRs raised doubts for the Ombudsman. In particular, O’Reilly questioned why portions of the CSRs related to determining the dosage, sample size and protocol were redacted. O’Reilly also inquired whether certain information truly related to ongoing developments by AbbVie, and asked whether certain redacted portions are now in the public domain.

EMA’s Response

In a letter signed by Andreas Pott, EMA's deputy executive director, the agency defended its handling of the redactions. EMA’s actions, the letter claims, were in line with both EU regulations and the agency’s policy.

EMA's response includes an annex that provides a detailed response to the 16 questions raised by the Ombudsman. In its defense, EMA claims that many of the redactions were made to protect AbbVie’s commercial interests related to the development of new dosages for Humira. The letter also admits that certain redactions should not have been made. EMA says this was an oversight due to the high volume of documents being reviewed.

Part of EMA’s defense is that the release of information from CSRs is a “dynamic process and evolves with time.” In line with that notion, EMA says that in subsequent access to document requests many of the previously redacted lines have been released.

EMA also argued that it would be too onerous to “describe at length the justification for the redaction of every single word” in a document, and said it is in the agency’s interest to consider the principles of “proportionality and good administration,” when releasing documents.

Transparency and Openness in the EU

Transparent access to information has long been a priority in the EU. The Treaty on European Union, the EU’s founding document, declares “transparency … strengthens the democratic nature of the institutions,” and requires the European Commission to determine ways of improving public access to information.

To facilitate the theme of transparency, the EU established the right to access documents in Article 15 of the Treaty on the Functioning of the European Union.

In 2001, the EU adoptedRegulation (EC) No. 1049/2001 to further define the conditions of Article 15. The regulation emphasized the importance of openness and established the grounds for both public and private interests to access documents held by the European Parliament, Council and Commission.

Article 73 of Regulation (EC) No. 726/2004 required EMA to “make available all documents that are publicly accessible,” under the provisions of Regulation (EC) No. 1049/2001.

More recently, the agency issued its 2010 Policy on access to documents (related to medicinal products for human and veterinary use). The policy details how EMA handles access to documents requests and explains the agency’s thinking on how it will balance commercial and public interests. The agency considers commercially confidential information to be “any information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information.” To protect commercially confidential information, EMA’s policy is to redact sensitive parts of documents, except in cases where there is “overriding public interest.”

Alongside its policy, EMA released an “output table,” to help clarify the types of documents the agency holds. The table lists the different documents generated or received by EMA and details their access status and whether they are subject to redaction prior to release.

New Policy on Publishing Clinical Trial Data

As of 1 January 2015, EMA is implementing its new policy on how it will release new clinical trial data to the public. The policy will cover clinical trial data submitted to EMA after 1 January 2015 for marketing authorization applications and post-authorization procedures.

The goal of the policy is to proactively release clinical trial data to the public while respecting the commercial interests of the data’s owners. In general, the agency says, “The information contained in clinical reports should not be considered [commercially confidential information].”

Companies will be responsible for proposing any redactions to CSRs, at which point EMA will review the proposed redactions before discussing whether the redactions meet the agency’s scrutiny.

EMA Letter

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Categories: Government affairs, News, Europe, EMA

Tags: European Ombudsman, Clinical Study Reports, Access to Documents, Transparency, Humira

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