Father granted files on adverse effects of drug

AN Irish father who believes his son took his own life as a result of taking the drug Roaccutane has welcomed a decision by the European Medicines Agency (EMA) to hand over information on adverse reactions to the anti-acne medicine from across the EU.

Liam Grant, a Dublin-based accountant, is expected to receive details about adverse reactions to the drug filed in all 27 EU member states from the EMA.

“It’s great news as it will complement similar reports we already have from the US and UK,” said Mr Grant.

The information is likely to be used in a forthcoming High Court action Mr Grant is taking against the drug’s manufacturer, Roche Pharmaceuticals.

The EU Ombudsman, Nikiforos Diamandouros, yesterday announced that the EMA had agreed to release documents to Mr Grant concerning Roaccutane.

It followed his earlier recommendation that the London-based organisation, which approves and monitors medicines placed on the EU market, should release such information after the EMA had initially refused a request made by Mr Grant in 2008 for the documentation.

The EMA had argued that EU transparency rules did not apply to reports of adverse reactions to medicines and that their release would not benefit EU citizens as such data could prove misleading or unreliable. It also maintained that the request related to an “unreasonable number of documents”.

However, the EMA was criticised by the EU Ombudsman for failing to provide valid and adequate grounds for its refusal to allow Mr Grant access to the requested documents. He claimed the EMA’s decision had constituted maladministration.

Mr Diamandouros yesterday commended the EMA’s constructive approach in what he described as “an important case”.

“The 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 EU Ombudsman said.

Mr Diamandouros has also suggested to the EMA that it could provide additional clarifications to make it easier for the public to understand data and its significance as part of a proactive information policy.

Mr Grant claims his 20-year-old son, a UCD engineering student also called Liam, became depressed and died by suicide in June 1997 after taking Roaccutane over a four-month period.

Roche Pharmaceuticals withdrew Roaccutane from the US market last year but insisted the decision was taken for business rather than safety reasons, although it is facing a large number of legal actions over its side effects on both sides of the Atlantic. Roaccutane is still used on a prescription-only basis in many parts of Europe, despite being linked to a number of adverse side-effects including depression, birth defects and bowel disease.

Around 10 cases are pending against Roche in the Irish courts.

The Supreme Court has already ruled against Roche in its attempt to prevent Mr Grant, who has already spent over €1m of his own money pursuing the case, from suing the pharmaceutical giant.

The case is due to come up before the High Court in October relating to the discovery of documents.

Earlier this week, the Irish Medicines Board issued a safety notice concerning Roaccutane in which it warned the drug could cause serious and potentially life threatening skin conditions including erythema multiforme, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.


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