When European politicians voted overwhelmingly in favor of a clinical research data sharing law last month, it looked like a big step forward for transparency campaigners. Yet just weeks later researchers have raised concerns that the European Medicines Agency (EMA) is already trying to lessen the impact of the legislation.
The concerns relate to draft terms of use the EMA shared with medical professionals, members of the biopharma industry and others this month. ScienceInsider has obtained a copy of the document, which places restrictions on who can access data and how they can use the information. The current draft would allow registered users to view clinical trial data on their computer screens but prohibit them from downloading, saving, editing, photographing, printing, distributing or transferring the information.
These restrictions would limit researchers' ability to reanalyze the results. Tom Jefferson and Peter Doshi, two of the people who pressured Roche ($RHHBY) to share its data on Tamiflu, called the EMA's draft policy "a stunning and surprising reversal." The European ombudsman and other researchers have also criticized the document, with the former calling for the EMA to explain the reasons and legal basis for what she views as a significant change of policy.
The EMA has denied that its draft policy sets back the transparency agenda, with spokesperson Martin Harvey-Allchurch saying the document is intended to facilitate access. In the Science article, Harvey-Allchurch is the lone defender of the terms, although no members of the biopharma industry are quoted. Having lobbied against the transparency law, some of the restrictions--such as the ability to redact novel statistical or other analytical methods--are likely to be welcomed by the industry.
- read the ScienceInsider article
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