THE EUROPEAN Ombudsman has called on a medicines agency to reconsider its refusal to give a Dublin man access to documents relating to suspected adverse reactions caused by a drug used to treat severe forms of acne.
Liam Grant from Terenure, Dublin, asked the European Medicines Evaluation Agency for access to documents containing details of all suspected serious adverse reactions to Roaccutane in April 2008. The agency refused and he turned to the European Ombudsman. Following his investigation, ombudsman Nikiforos Diamandouros concluded that the EU rules on access to documents apply to all documents held by the agency.
Mr Grant claims his son Liam’s death by suicide in June 1997 was a side effect of his use of the drug Roaccutane. He is taking a case against Roche, the makers of the drug. Roche denies the claim.