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By Seán McCárthaigh
EU medical authorities have been sharply criticised by the European Ombudsman over their refusal to give access to an Irish citizen who sought information on adverse reactions to the controversial anti-acne drug, Roaccutane.
The European Medicines Agency (EMEA) was yesterday instructed to supply the information to Dublin accountant, Liam Grant, as requested on the recommendation of the European Ombudsman, P Nikiforos Diamandouros.
The EU Ombudsman said the EMEA had failed to provide valid and adequate grounds for its refusal to make such information available.
"This constitutes an instance of maladministration," concluded Mr Diamandouros.
Mr Grant, who claims that his 20-year-old son, Liam, became depressed and died by suicide in 1997 after taking Roaccutane for a four-month period, had sought access to all reports on suspected adverse reactions to Roaccutane since 1982 relating to side effects on the central nervous system. In particular, he looked for information on possible links between the drug and suicidal tendencies.
However, the EMEA refused the request, arguing that EU transparency rules did not apply to reports on adverse reactions to medicines. The EMEA claimed the release of such information would not benefit citizens because it could result in the circulation of data which could prove either misleading or unreliable.
But the European Ombudsman, who investigated the matter following a formal complaint from the Irish citizen, said EU transparency rules applied to all documents held by the EMEA. He rejected the EMEA’s assertion that the request related to a "manifestly unreasonable number of documents". He also recommended that the EMEA could in future provide additional explanations about reports of adverse reactions to drugs in order to make their significance more readily understandable to the public.
The EMEA has been asked by the European Ombudsman to formally respond to his ruling by July 31.
In a statement yesterday, the EMEA said it noted the ombudsman’s recommendation to broaden access to documents it held. It pointed out that since the complaint was made by Mr Grant in April 2008 it has launched a major initiative designed to increase the transparency of its operations.
Roaccutane’s manufacturer Roche Pharmaceuticals withdrew the drug from the US market last year but said the decision was taken for business rather than safety reasons, although it has faced a large number of legal actions over its side effects.
The anti-acne drug has been linked to a number of adverse side effects, including depression, birth defects and bowel disease. In Ireland, it is understood that around 10 cases are pending against Roche from Irish users of the drug. The Supreme Court has already ruled against Roche in its attempt to prevent Mr Grant from suing the firm.
Yesterday, Mr Grant expressed delight at the European Ombudsman’s ruling and said it set a good precedent. "We should now have access to all reports making possible links between Roaccutane and suicides from 27 EU countries," said Mr Grant.
It is understood Mr Grant’s High Court action against Roche will be listed within the next 12 months.
This story appeared in the printed version of the Irish Examiner Tuesday, May 11, 2010
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