Europees Geneesmiddelenbureau onthult geheime informatie over bijverschijnselen van geneesmiddelen (en)
The European Medicines Agency (EMA i) has reversed its long-held stance on releasing studies on drug side effects after pressure from the European Ombudsman.
The London-based agency, which evaluates drugs in the EU, on Wednesday (11 August) said that it would issue data on anti-acne medication Roaccutane produced by pharma giant Roche in the coming weeks.
An Irish man, whose son committed suicide after taking Roaccutane, is currently suing Roche over the drug, which has been linked to behavioural problems and birth defects.
The EMA position had long been that in order to protect patient confidentiality, a 2001 EU transparency law did not apply to "adverse reaction reports."
In April this year, the European Ombudsman, Nikiforos Diamandouros, warned the agency that it was not adhering to EU regulations and "must react to requests for access to documents."
The agency has since decided to put out side-effect reports once personal data has been removed and will do so voluntarily without the need for citizens to make requests.
Drug companies will be watching the development closely as it potentially could make it easier for citizens to launch lawsuits against them.
In 1997, the 19-year-old son of Liam Grant, an Irishman, killed himself. The father holds Roaccutane, a powerful anti-acne remedy, responsible for the tragedy and is involved in legal action against Roche.
He had sought access to the adverse reaction reports for the drug in order to help his case against the firm.