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US pharma firm seeks to stop EU agency releasing drug data

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Published 11 March 2013

The European Medicines Agency, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny, a move that is creating tensions with drugmakers worried about preserving business confidentiality.

AbbVie, a pharmaceutical company has sought an injunction to block Europe's medicines regulator from releasing "confidential" and "commercially-sensitive" information on its blockbuster rheumatoid arthritis drug, a spokeswoman for the U.S. drugmaker confirmed on Sunday.

The Chicago-based company had taken legal action against the European Medicines Agency to stop it from releasing data on the effects in individual patients in clinical trials for its drug Humira, the Financial Times reported earlier on Sunday.

Sales of the drug, by far the company's biggest product, jumped 17% last year to $9.27 billion (€7.13 bn).

The European Medicines Agency, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny, a move that will let independent researchers trawl through millions of pages of clinical trial information.

It is blow for the pharmaceutical industry, which guards its commercial secrets fiercely and has not before been required to share its data with outside researchers.

The EU’s rules on clinical trials are currently being reviewed. The aim is to make it easier for drug companies and researchers to carry out cross-border clinical trials, in a bid to cut costs and red tape.

>> Want to express your opinion on the EU's clinical trials directive review? Please log in to our special WikiDossier page (Beta phase).

EurActiv.com with Reuters

COMMENTS

  • Super iniative from EMA. Of course the drug companies will object violently, using their pet pretext of protecting their copyrights and data. While there may be some truth to that I think the major reason for their reluctance, even dread, for disclosing their research data is due to the fact that it will show that their drugs don't work better than placebo, have unreported and glossed over adverse effects, or even worse, that they have fudged their test results.

    By :
    Carsten Lundmark
    - Posted on :
    11/03/2013

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