By Martin Banks - 11th August 2010
I commend EMA's constructive approach in this important case
Nikiforos Diamandouros
European ombudsman Nikiforos Diamandouros has welcomed the announcement of the European Medicines Agency (EMA) that it will release documents related to a drug used to treat severe forms of acne.
The move comes after an Irish citizen complained to the Strasbourg-based official after he was refused access to the documents.
The complainant, who has not been named, had asked for the release of reports in April 2008 concerning suspected adverse reactions to the drug.
His son had committed suicide after taking the drug.
The EMA, which approves and monitors medicines placed on the EU market with a view to protecting public health, initially refused access, saying EU transparency rules do not apply to adverse reaction reports.
It argued that the EU rules on access to documents did not apply to reports concerning suspected serious adverse reactions to drugs.
The Greek-born ombudsman did not agree and called on the EMA to reconsider its refusal to give access to the documents.
The London-based EMA has now accepted his recommendation and announced on Wednesday that it will release the reports.
Responding to the decision, Diamandouros said, "I commend EMA's constructive approach in this important case.
"EMA's work has a direct impact on the health of European citizens. It is, therefore, crucial to give the widest possible access to documents and to pursue a pro-active information policy for the benefit of citizens."
The ombudsman also suggested 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.
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