EMA Plans Public Access to Side-Effects Data

Jul 19, 2011

The European Medicines Agency (EMA) has detailed plans for granting public access to information concerning the potential side effects of medicines. Members of the public will be able to access data in the EudraVigilance database—EMA’s central repository for reports of suspected adverse reactions related to authorized medicines in the European Economic Area, as well as those being studied in clinical trials.

According to a statement, EMA will begin producing monthly reports by the end of this year that summarize information held in the database for all medicines authorized centrally. By the end of 2012, this will be extended to searchable reports for all medicines, and, subject to available funding, by 2015 EMA will further improve the search and data–output functions, and give the pharmaceutical industry access to tools that enable the detection and analysis of signals of adverse reactions.

In addition, EMA said it will consider providing access to data for research purposes, but this will be on a case-by-case basis. Information on the potential side effects of veterinary medicines will also be available.

The access policy was developed as part of EMA’s ongoing plan to increase levels of transparency, for which it has been criticized on several occasions. In May 2010, for instance, the European Ombudsman intervened when EMA refused to grant access to documents regarding the suspected side effects of an antiacne drug. Earlier this year, an article was also published in the British Medical Journal that described the difficulties that authors experienced when trying to obtain access to unpublished trial reports from EMA concerning certain antiobesity drugs.

According to EMA, the new access policy has “been developed to contribute to public health protection, to facilitate the implementation of the European transparency initiatives and to comply with EU personal data protection legislation.”