EFPIA Responds to EMA Policy on Publication and Access to Clinical-Trial Data

Published on: 

The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the European pharmaceutical industry, publicized its comments on the European Medicines Agency’s (EMA) draft policy on publication and access to clinical-trial data (Policy 0070).

“We are worried by a move towards greater transparency of clinical trials data that appears to be putting transparency-at whatever cost-ahead of public health interests,” said Director General of EFPIA, Richard Bergstrom, in an EFPIA press release. “While EFPIA values other voices and opinion in the conversation surrounding clinical trials data, we believe there are better alternatives than what the EMA is presenting. The EFPIA-PhRMA Joint Principles for Responsible Clinical Trial Data, formally announced July 24, 2013 and going into effect Jan. 1, 2014, outline a responsible transparency that safeguards patient privacy, respects the integrity of regulatory systems, and maintains incentives for investment in biomedical research. A transparency built on these pillars offers the protective measures for patients and research that ultimately will best serve patients and broader public health needs.”

EFPIA is concerned that the EMA approach will weaken safeguards intended to ensure the privacy of patients, undermine trust in the regulatory approval system governing biopharmaceutical products, introduce risks of misinterpretation and misuse of clinical data into the process, and weaken incentives for companies to invest in biomedical research by disclosing companies commercially confidential information. 


EMA released the draft policy in June, and stakeholders have until Sept. 30, 2013 to submit comments, EMA noted in a press release.