Sanofi Chief Executive Officer Chris Viehbacher said a proposal by the European Medicines Agency to disclose more clinical-trial data threatens to undermine the competitiveness of the region’s drug industry.
Regulatory dossiers composed of millions of pages contain commercially confidential information that could be accessed by competitors in the U.S., China and India, Viehbacher said. Without a structured approach, such disclosure would be an unhelpful “data dump on the sidewalk,” he said.
“Do we want publicly supported research and development paid for by European taxpayers suddenly available to all and at a disadvantage to European companies?” Viehbacher, elected today as president of the European Federation of Pharmaceutical Industries and Associations, told reporters in Brussels. “We’re certainly open to doing things in a different way, but let’s do it intelligently.”
The EMA today released its draft policy on publication of clinical trial data, a step designed to improve transparency that affects all drugmakers seeking permission to sell their medicines in Europe -- not just local companies -- and has sparked industrywide debate.
While pharmaceutical companies want to share data to accelerate development of new medicines, they also must protect patient privacy and maintain incentives to conduct clinical trials in Europe, Viehbacher said. The commercially sensitive information includes know-how on patented manufacturing processes for biologics, which is “absolutely fundamental” to companies, he said.
AbbVie Inc. (ABBV:US), the drugmaker split off from Abbott Laboratories at the start of this year, and biotechnology company InterMune Inc. (ITMN:US) filed suits against the EMA earlier this year in a bid to block publication of clinical-trial data.
To address concerns raised by various stakeholders, the EMA has separated clinical data into three categories: commercially confidential information; open-access data that doesn’t contain patients’ personal information; and controlled-access data that will only be granted after the requester has fulfilled a number of requirements, including the signing of a data-sharing agreement, it said in a statement.
The draft policy will undergo a three-month public consultation, with a final policy to be issued by the end of the year, the EMA said.
EFPIA will publish its own position on the issue “any day now,” said Richard Bergstrom, director general of the industry association.
An unfavorable policy would further discourage drugmakers from investing in Europe, a region where governments are cutting prices and raising hurdles for reimbursement of new drugs in the face of austerity, according to Viehbacher.
“Europe is our most challenging region,” he said. As CEO of Sanofi (SAN), “our next euro of investment will go to the U.S. or emerging markets.”
Industrywide employment in Europe was unchanged at 700,000 in 2012 from a year earlier, according to EFPIA. Jobs in the region will remain little changed or decline over the next few years, Viehbacher said.
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