The European Medicines Agency (EMA) Aug. 10 announced that it will release documents related to a drug used to treat severe forms of acne, following the guidance of the European Ombudsman, P. Nikiforos Diamandouros.
An Irish citizen sought reports concerning suspected adverse reactions to the drug, but EMA initially refused access, arguing that EU transparency rules do not apply to adverse reaction reports.
Following his investigation into the Irish citizen’s complaint, the ombudsman concluded that the EU rules on access to documents apply to all documents held by EMA. The ombudsman recommended that EMA to reconsider its refusal to give access to the documents and welcomed the change of heart in an Aug. 11 news release. The ombudsman also said that “as part of a proactive information policy, EMA could provide additional clarifications to make it easier for the public to understand such data and their significance.”
The ombudsman’s full recommendation is available at:
http://www.ombudsman.europa.eu/cases/draftrecommendation.faces/en/4810/html.bookmark
A European Observer article on the situation is here.
Filed under: IFTI Watch