Reuters: Regulatory News: UPDATE 1-EU's drug data stance threatens investment -Sanofi CEO

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UPDATE 1-EU's drug data stance threatens investment -Sanofi CEO Jun 24th 2013, 13:58 Mon Jun 24, 2013 9:58am EDT * EMA decision to release drug data sparks controversy * Viehbacher says companies may decide to invest elsewhere * U.S. companies taking EU regulator to court By Ben Deighton BRUSSELS, June 24 (Reuters) - A decision by Europe's drug regulator to release detailed data on drugs once a medicine is approved could discourage critical investment in crisis-hit Europe, Sanofi's chief executive said. Chris Viehbacher, who took over as president of the European Federation of Pharmaceutical Industries and Associations (Efpia) on Monday, said companies would invest in regions where they felt welcome. "If you, on the other hand, say, 'you guys are bad actors, we want to cut your prices, we want to take your confidential data and share it with any one of your competitors', you don't get the same feeling of encouragement," he told reporters. His commments coincide with publication of a draft policy from the European Medicines Agency (EMA) on Monday that would see the regulator proactively release detailed clinical trial data on newly approved drugs from 2014. At present the EMA only gives out such data following a request. The controversy over clinical data transparency compounds a situation where drugmakers are already reluctant to invest in Europe because of a wave of austerity-driven cuts in drug prices. "If I was to say where would I put the next euro of investment, I would say either the next euro of investment would go to the United States or to emerging markets," Viehbacher said, speaking specifically as the head of France-based drugmaker Sanofi. 2 MILLION PAGES Since November 2010, EMA has released some 2 million pages of detailed information about drugs it has assessed - an approach it says reflects growing public demands for more openness to ensure that drugmakers cannot conceal adverse drug effects. The idea behind it is to make drug companies more transparent and help researchers pool information to fight disease better, while making the system proactive rather than reactive promises to take disclosure to a new level. The problem, Viehbacher said, was that the data included details on things such as manufacturing processes that could allow a competitor to step in. "The manufacturing process is often where the know-how of the company is, and this is particularly true of biological processes," he said. "If all of this stuff is laid out, then we could have competitors from any country, particularly outside of Europe, suddenly start looking at our manufacturing process and we could suddenly find ourselves with some non-European competitors." In April, U.S. companies AbbVie and InterMune used the courts to stop their clinical data being released, prompting the European regulator to appeal. The EMA's plans to release clinical trial data have been slammed as irresponsible by the Pharmaceutical Research and Manufacturers of America lobby group - the U.S. equivalent of Efpia - which fears it could harm business and undermine incentives for research. Still, some drug companies reckon the clamour for greater openness won't go away, given past drug safety scares. That has prompted Britain's GlaxoSmithKline to take a more conciliatory stance and decide to release a large amount of detailed data from its own clinical trials. Link this Share this Digg this Email Reprints

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