- The European Commission and president-elect Jean-Claude Juncker has decided to cede all control over EU drug-related decisions -- including the European Medicines Agency (EMA) -- from the Directorate-General for Health and Consumers over to the Directorate-General for Enterprise and Industry and the pharmaceutical industry.
- Advocacy groups like Health Action International (HAI) warn that this move is not in the best interest of consumers and patients.
- Data transparency advocates expressed particular outrage at the decision, arguing that it will greatly set back the clinical trial sunshine movement.
Some onlookers contend that clinical trial transparency in the EU is now in jeopardy. The EMA has been largely spearheading the transparency movement, which has gotten significant pushback from many in the pharma industry who feel it is being pursued too aggressive and rapidly.
Many groups, including the HAI and the European Public Health Alliance, have characterized Juncker and the Commission's decision as bad for public health and the well-being of patients in the EU. Some cite the DG for Enterprise and Industry's prior failure to efficiently coordinate public health emergency responses during crises such as the H1N1 flu pandemic.
Organizations like HAI also noted the potential setbacks for transparency campaigns. “EMA had encountered significant opposition to its policy on public access to clinical trial data from the pharmaceutical industry in the last year," said the group in a statement. "Now, the strong opposition from the industry will be more loudly heard by the EMA, and will most likely jeopardise independent review and, ultimately, patient safety."