Brussels, 10/05/2010 (Agence Europe) - The European Ombudsman, Nikiforos Diamandouros, has called on the European Medicines Agency (EMEA) to reconsider its refusal to give access to documents related to a drug used to treat severe forms of acne. The complainant, an Irish citizen, had specifically asked for reports on suspected adverse reactions to the drug, such as reactions giving rise to suicidal tendencies. EMEA refused access, arguing that EU transparency rules do not apply to adverse reaction reports. Diamandouros did not share this view, but affirmed that EU transparency rules apply to all documents held by EMEA.
The Ombudsman said EMEA had argued that EU transparency rules (Regulation 1049/2001 on access to documents) do not apply to reports on suspected serious adverse reactions to drugs. The agency considers that revealing such reactions would not be beneficial to citizens as this could lead to the circulation of information that could prove misleading or unreliable. Following his investigation, Diamandouros concluded, on the other hand, that EU rules on access to documents apply to all documents held by EMEA. He said this does not mean that adverse reaction reports must automatically be accessible, given that certain exceptions contained in the transparency rules might apply. He therefore recommended that EMEA review its refusal to grant access to the adverse reaction reports. As regards EMEA's concerns about the circulation of data that could prove to be misleading or unreliable, the Ombudsman suggested that, as part of a proactive information policy, EMEA could provide additional explanations designed to render such data and their significance more readily understandable by the public. EMEA is invited to submit a detailed opinion by 31 July 2010. (O.J./transl.jl)