Financial Times: EU Court stops regulator releasing drug trial data

2 May

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A few days ago Andrew Jack reported that the European Medicines Agency (EMA) has been blocked from releasing clinical trial data generated by AbbVie and InterMune, by the EU’s General Court, until a final ruling is given by the Court. The EMA website notes that these interim rulings were made as part of court cases brought by the two pharmaceutical companies.

The court  upheld requests from the two drug companies for a temporary stay in making public information on tests of their medicines in patients, stalling the agency’s policy of releasing data since 2010. The companies argued that such information is commercially sensitive and could undermine their competitive position and the incentives to conduct research.

A coalition of independent researchers, medical journals and academics had called for full release of clinical data to allow broader scrutiny of the safety and efficacy of medicines.

In a statement, the EMA said that it “regrets” the court’s decision, is considering whether to appeal, and will still consider releasing information similar to that contested by the two companies “on a case-by-case basis”.

The fight comes at a time of rising demands for transparency, with a campaign led by medical publications, including the British Medical Journal, concerned that too many drugs are approved and prescribed based on selective evidence that exaggerates benefits and downplays the risks of drugs.

This week, the British parliament’s science and technology committee begins hearings on whether pharmaceutical companies “cherry pick clinical trial data to promote their drugs and hide potential defects”.

Drug companies say that competitors developing similar drugs or generic companies trying to more rapidly produce cheaper copies could both exploit more openness, but the EMA said the “overwhelming majority” of freedom of information requests it had received for clinical trial data came not from independent researchers but drug companies, industry consultants and lawyers.

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