EU Opens Up Drug Data Secrets

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Reuter reports that the European Medicines Agency, EMA is opening up its data to allow independent researchers access to clinical trial data. This is a major step towards transparency in a thus far very secretive world of the USD $1 trillion global pharmaceutical market.

A conference is planned for November to discuss making data available in a more routine fashion, as well as more quickly.
The move comes while in many other fields similar pushes are made to release scientific data.

Although the move by EMA is not entirely voluntary (a ruling by the European Ombudsman saying commercial confidentiality of data is not in the public interest when it comes to medicines), transparency has been high on the agenda the new EMA executive director started last November.

Peter Gotzsche, of the non-profit Nordic Cochrane Centre in Denmark has been campaigning for access to the EMA data, and e.g. highlighted the need for transparency at the EC public hearing on access to scientific information last year in Luxembourg.

"It will make a huge difference to public health," he says. "The pharmaceutical industry routinely exaggerates the benefits of its drugs and plays down the harms or hides them. By getting access to material held by drug regulators we may discover that many drugs are less effective than we thought they were and also more harmful."