Healthy Skepticism Library item: 17775

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Publication type: Journal Article

European Medicines Agency-more transparency needed
The Lancet 2010 May 22; 375:(9728):1753
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60785-4/fulltext

Abstract:

On May 10, 2010, the European Medicines Agency (EMA, formerly EMEA) published a draft recommendation from the European Ombudsman Nikiforos Diamandouros who called on EMA to reconsider its refusal to give access to documents relating to isotretinoin, which is used to treat severe acne. EMA protects and promotes Europe’s public health through assessment and supervision of medicines, which is mainly the collation and dissemination of information about adverse reactions to medicines throughout the European Union (EU). EMA receives information on suspected adverse reactions to drugs from competent authorities in EU member states, as well as from drug companies themselves.
A complaint had been submitted by Liam Grant from Dublin, Ireland, whose son had committed suicide in 1997. On April 22, 2008, Grant asked EMA for reports on suspected serious adverse reactions to the drug-those which might cause death or life-threatening illness, require admission to hospital or prolongation of hospital stay, or result in persistent or substantial disability or incapacity, congenital anomalies, or birth defects. These requests were refused by EMA, which argued that EU transparency rules did not apply to serious adverse reaction reports. EMA emphasised that their release would not benefit EU citizens because it could result in circulation of data that might prove to be misleading or unreliable.

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