EFPIA response to EMA consultation on the publication and access to clinical-trial data
05.09.13
Brussels - (September 5, 2013) - Representing the research-based pharmaceutical industry in Europe, EFPIA and its member companies welcome efforts towards greater transparency of clinical trials data. However EFPIA has serious concerns about the EMA draft policy (Policy 0070 on publication and access to clinical trial data), which carries negative implications for public health in its failure to adequately protect the interests of patients and the research they benefit from. In the interests of sharing its concerns with all relevant stakeholders as well as the general public who will be impacted by these measures, EFPIA is today making publicly available its comments on the EMA submission.
Director General of EFPIA, Richard Bergstrom, stated: “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. Our detailed response to the EMA draft policy speaks to this concern. 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 and going into effect January 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’s response to the EMA draft policy focuses on three primary concerns, specifically that the EMA approach, as it stands, will:
1. Weaken safeguards intended to ensure the privacy of patients and other individuals identified in
marketing authorization application (MA) dossiers;
2. Undermine the trust in the regulatory approval system governing biopharmaceutical products and
introduce risks of misinterpretation and misuse of clinical data into the process;
3. Weaken incentives for companies to invest in biomedical research by disclosing companies" commercially confidential information (CCI), without due consideration of the competing interests that may or may not justify disclosure.
The specific points addressed by EFPIA in its response to the EMA draft policy, and an Executive Summary overview, are available on the EFPIA website, as well as its dedicated transparency platform. The EMA public consultation remains open for comments until September 30.