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EFPIA says “indiscriminate” data transparency could be harmful

Comments come as European Parliament prepares to discuss clinical trial overhaul

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The ongoing debate concerning open data for clinical trials involving medicines took another turn yesterday, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) warning of the possible damage such an approach could have if not handled responsibly.

“There is a potential for significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way,” said the European trade body for the pharma industry in a statement.

The EFPIA's comments come at a crucial time for open trial data in Europe, with the European Parliament about to enter discussions to overhaul the region's Clinical Trials Directive, including plans for greater transparency on the results and recruitment status of studies.

Transparency in pharma has also hit the headlines recently, with Roche coming under heavy criticism from the British Medical Journal and the Cochrane Collaboration for its refusal to release all raw data related to its flu drug Tamiflu, despites concerns over its effectiveness.

This campaign has led the BMJ to say it will only publish trials that have full data accessible, while Cochrane researcher Peter Gøtzsche has called for doctors to boycott the use of Roche's products until all Tamiflu data is released.

In its statement, the EFPIA said it supported steps towards improved transparency, including measures to register all clinical trials conducted in patients on a public registry, although there should be consideration for both the company conducting the trial and the patients involved.

It said: “We believe it is both feasible and necessary to balance the needs of personal privacy and commercial confidentiality while providing the level of transparency needed to support public health decision-making. “

Particular concerns mentioned by the EFPIA included the potential for competing companies to access information about each other's medicines.

“[M]any products and new uses are not protected by patents but by regulatory data protection,” said the EFPIA. “It would be damaging to companies if competitors could circumvent this by printing all the data from the internet.”

The EFPIA's director general Richard Bergström also commented directly on the matter.

“[W]e recognise and take seriously our responsibility to lead in advancing transparency, and propose that this needs to be part of a comprehensive initiative involving all stakeholders,” he said.

15th November 2012

From: Research

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