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.
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- European Medicnes Agency
- Commission: Clinical trials
- Parliament legislative file: Clinical trials on medicinal products for human use