August 11, 2010 / 3:16 PM / 9 years ago

EU agency allows access to drug side effects data

LONDON (Reuters) - The European Medicines Agency has agreed to provide access to studies about drug side effects, following criticism over data secrecy from the European Ombudsman.

The move could help people hoping to take legal action against drugmakers and highlights the pressure on healthcare regulators to make more information about drug safety available to the public.

A spokeswoman for the agency said on Wednesday that the London-based watchdog would release the information requested about Roche’s acne drug Accutane by an Irish citizen whose son committed suicide “within the next few weeks.”

The EMA had argued that European transparency rules did not apply to serious adverse reaction reports, given the need to protect patient confidentiality.

But, in a change of heart, the organization has now agreed to release such reports, after first deleting personal data that would allow identification of individual patients.

The agency said the same principle would be applied to other requests for access to individual drug reaction reports.

Accutane, or Roaccutane, which Roche said last year it would stop selling because of generic competition, has had a controversial history since its launch in 1982.

While powerful at clearing acne, the drug has been linked to birth defects if taken during pregnancy and has also been suspected of causing mental side effects, although Roche has vigorously defended personal injury claims in this area.

Reporting by Ben Hirschler; Editing by Louise Heavens

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