EMA criticized for redaction of AbbVie’s data

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EMA criticized for redaction of AbbVie’s data

INICIO/Políticas y legislación | Posted 21/11/2014 0 Post your comment

The European Medicines Agency (EMA) has once again come under fire for the way it is implementing new European transparency rules for pharmaceuticals. The latest criticism of EMA concerns the way the agency is redacting clinical trials data.

New legislation approved by the European Parliament on 2 April 2014 aims to increase transparency with respect to clinical trials for drugs by making the results publicly available. The Clinical Trials Regulation, which is expected to take effect in 2016, will require the results of all new clinical trials to be published within a year of the trial ending [1].

In order to implement this new legislation EMA produced a policy document on publication of and access to clinical trial data. The initial document was criticized for only allowing data to be accessed in a ‘view on screen only’ mode, and for not allowing to download, save, edit, photograph, print, distribute or transfer the information [2]. However, after ‘user friendly’ amendments to the document, allowing the possibility to download, save, and print trial data for academic and non-commercial research purposes were made, the document was adopted at the agency’s Management Board meeting on 2 October 2014.

EMA plans to implement the policy in stages. From 1 January 2015, EMA will publish clinical reports for all newly approved medicines, but for ‘old’ medicines only new data submitted to EMA will be published.

In the latest turn of events, the European Ombudsman, Ms Emily O’Reilly, has expressed concern over the way EMA has redacted clinical study reports for AbbVie’s arthritis blockbuster Humira (adalimumab).

In a letter to EMA, dated 27 October 2014, the ombudsman agrees ‘that certain redactions may be justified to protect the personal data of patients’ or ‘may be considered to relate to the confidential business relationships of AbbVie’. However, Ms O’Reilly expresses her ‘doubts and concerns as regards to other redactions’. She then goes on to outline 16 cases where the rationale for redacting information from the clinical study reports is not clear and requires explanation from EMA.

Examples of redacted information include information on the rationale for dosage selection and determination of sample size.

The Ombudsman’s investigation into the redactions came after a complaint from an individual who had requested documents from EMA in early 2014. The agency has stated that it will provide ‘a detailed reply to the European Ombudsman’s queries in due course’.

Pharma companies sue EMA to block release of data

References
1. GaBI Online - Generics and Biosimilars Initiative. EMA criticized for change in data transparency plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 21]. Available from: www.gabionline.net/Policies-Legislation/EMA-criticized-for-change-in-data-transparency-plans
2. GaBI Online - Generics and Biosimilars Initiative. EMA changes transparency plans to increase access to data [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 21]. Available from: www.gabionline.net/Policies-Legislation/EMA-changes-transparency-plans-to-increase-access-to-data

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Source: EMA, European Ombudsman