A step ahead of controversial transparency rules, Sanofi commits to open access

Sanofi CEO Chris Viehbacher

Sanofi is starting the New Year with a resolution to join the open-access movement. But it's keeping the vaults firmly closed on any past data--this is one resolution that applies only to future drug approvals.

Like GlaxoSmithKline ($GSK), and to a certain extent, Roche ($RHHBY) and Pfizer ($PFE) before it, Sanofi ($SNY) says it will provide data, documents and reports on studies used to back up U.S. and European applications on drugs approved after the first day of this year. And it will work with regulators to provide simple explanations of individual results to the subjects involved in their clinical studies.

Pfizer was the first big company to lay out plans to open up results to individual trial subjects. Just weeks ago the pharma giant also made a commitment to make it easier for qualified independent researchers to look over clinical data.

It's probably no coincidence that Sanofi's move to open up on new drugs coincides with the joint principles on data sharing adopted by the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America, which also went into effect Jan. 1. The EFPIA--currently led by Sanofi CEO Chris Viehbacher--and PhRMA have been scrambling to come up with an industry solution to a regulatory problem. The industry groups have been waging open warfare against a proposal by the European Medicines Agency to force data disclosure in a way that is likely to shed far more light on data than the industry would like to see. From some of the companies' perspectives, the EMA is trying to open the door to confidential product information, and they are determined to stop it.

The EMA has had to delay its final policy on transparency until March while the European Union moves ahead on its own sunshine rules.

"Sanofi has a history of contributing in this collective effort of sharing clinical trial data and results with researchers and patients with initiatives such as Project Data Sphere, an independent initiative of the Life Sciences Consortium of the CEO Roundtable on Cancer, the Coalition Against Major Diseases, and Prize4Life," said Viehbacher in a statement. "Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers. Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers. The private sector has taken a lead on this which I would hope academic researchers will follow."

- here's the release

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