EMA to release closely held side-effect reports

European drug regulators are opening their drug-safety files for the first time. The European Medicines Agency says it will deliver side-effects reports on particular drugs to anyone who asks. That's an about-face from current EMA policies, which effectively stonewall requests for info.

The new transparency could escalate drug-liability litigation, giving patients data that could support their claims against drugmakers, as the Wall Street Journal reports. Indeed, the rule change was prompted by a lawsuit filed by Liam Grant, whose 19-year-old son committed suicide while taking the acne drug Roaccutane (Accutane). Grant asked EMA for side-effect reports on the drug, hoping they would strengthen his case against the drug's maker, Roche.

The EMA initially refused Grant's requests, but a report from a European Ombudsman chided the agency for doing so, saying that EMA wasn't following transparency regulations. "EMA's work has a direct impact on the health of European citizens," the Ombudsman wrote (as quoted by the WSJ). "It is therefore crucial to give the widest possible access to documents." The EMA will release documents to Grant within three weeks. More documents--relevant to more lawsuits--will follow.

- read the WSJ piece