EFPIA, representing the research-based pharmaceutical industry in Europe with a membership of 33 national associations and 40 pharmaceutical companies, has concerns about the EMA draft policy (0070) on publication and access to clinical trial data, saying it carries negative implications for public health in its failure to adequately protect the interests of patients and the research from which they benefit.
Richard Bergstrom, director general of EFPIA, said, “We are worried by a move toward greater transparency of clinical trials data that appears to be putting transparency—at whatever cost—ahead of public health interests. Our 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, announced July 24 and taking 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, according to EFPIA. 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 weaken safeguards intended to ensure the privacy of patients and other individuals identified in marketing authorization application (MA) dossiers; undermine the trust in the regulatory approval system governing biopharmaceutical products and 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 (CCI) without due consideration of the competing interests that may or may not justify disclosure.