In response to harsh criticism that important side effect information was being kept hidden from the public, the European Medicines Agency has agreed to make adverse events available, and the move is likely to result in additional complaints filed by consumers.

The change in policy comes after EMA ombdusman Nikiforos Diamandouros chastised the agency twice in recent months for refusing to release documents containing suspected adverse reactions caused by the Accutane acne med and then two diet pills, Acomplis, which was withdrawn by Sanofi-Aventis, and orlistat, which is sold as Xenical by Roche and as Alli, an over-the-counter med marketed by GlaxoSmithKline (back story here and here).

“EMEA plays a crucial role in the approval and monitoring of medicines placed on the market,” he said in a statement at the time. “Since its work has a direct impact on the health of European citizens, it is of utmost importance for EMEA to give the widest possible access to documents and also to pursue a pro-active information policy for the benefit of citizens.” He released another statement today commending the EMA for its “constructive approach.”

For its part, the EMA had argued EU transparency rules don’t apply to suspected serious adverse reaction reports and their release wouldn’t benefit citizens because circulating such data could be misleading or unreliable. Diamandorous agreed such reports don’t have to be automatically available, but exceptions may be warranted.

Now, an EMA spokeswoman writes us to say adverse events reports will be given to a man from Ireland who is suing Roche over alleged links between Accutane and suicide (back story), but the EMA “will be deleting personal data that would allow identification of the patient concerned. These principles will be applied on any future requests for access to individual drug reaction reports,” she writes.