EMA plans adverse event reports for the public

pharmafile | July 12, 2011 | News story | Research and Development, Sales and Marketing EMA, adverse events, patient information 

The EMA will start producing monthly adverse event reports for the public as part of its plans to open up access to drug information.

The European regulator, which was heavily criticised last year over its lack of transparency, will release safety reports for all centrally authorised medicinal products by the end of 2011.

They will initially feature summarised information from the EMA’s EudraVigilance database, but will be extended to searchable reports for all medicines by the end of 2012.

The EMA also plans to give pharma access to new tools to allow the detection and analysis of signals on adverse reactions to human medicines by 2015, subject to having the budget for it.

The Agency said in a statement it would also “consider providing access to data for research purposes on a case-by-case basis, in line with its objective of protecting public health”.

The EMA agreed to give greater access to documents on medicines after heavy criticism last year from the European Ombudsman.

In May 2010, the European Ombudsman, led by P. Nikiforos Diamandouros, investigated complaints about EU bodies, including the EMA.

In one case, the ombudsman focused on an Irish patient who in 2008 had his request for information on the adverse drug reactions for Roche’s acne medicine Roaccutane turned down by the regulator.

At the time Diamandouros called on the EMA to give access to the relevant documents, especially those on the reactions seen in Roaccutane, in the name of patient safety.

In June he went further, saying the body should grant access to blocked clinical study reports and trial protocols for three anti-obesity drugs, after new safety concerns about the drugs’ link to suicidal thoughts and depression were found.

The EMA had long argued that it could not disclose such documents because of the risk to confidentiality and that the publication of such documents could result in people seeing data that was “misleading or unreliable”.

• More information on the EudraVigilance access policy for medicines for human use (pdf)

Brett Wells

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