Print“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.”
Sanofi CEO Chris Viehbacher says that pressure by European regulators to release detailed clinical trials data on innovative therapies may drive his company to direct investments elsewhere.
Sanofi research and development dollars once invested in Europe might instead be invested in the United States or emerging markets, places where industry feels more welcome, Viehbacher says.
“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 Reuters.
Though Viehbacher spoke only for Sanofi, his comments likely reflect the concerns of at least some members of the European Federation of Pharmaceutical Industries and Associations. Viehbacher became the federation’s president on June 24.
The European Medicines Agency has released more than 1.9 million pages of clinical trials information requested under its three-year-old access-to-documents policy. But while Roche and GlaxoSmithKline have shared documents through the program, other companies have been reluctant to participate, expressing concerns that competitors would take advantage of the documents to mount new challenges. The EMA was set to release documents detailing trials of AbbVie’s rheumatoid arthritis drug Humira and InterMune’s Esbriet before the companies won a prohibition on the releases in The General Court of the European Union in May.
Viehbacher’s threat over the disclosures glosses over the fact that drugmakers are already cutting back in Europe as austerity measures put pressure on pricing. GlaxoSmithKline in February detailed its plans to downsize European operations. In March, AstraZeneca followed suit, and in June, Lundbeck said that it would trim jobs from its European operation.
Nevertheless, the European Medicines Agency appears to be gaining momentum in its push to proactively disclose trial data in response to what it calls “growing demand from external stakeholders for full transparency.” It is collecting comments to develop its final policy on publication and access through September 30.
June 28, 2013
http://www.burrillreport.com/article-viehbacher_threatens_to_cut_sanofi_rd_spending_in_europe.html
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