Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee

Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee

March 22, 2024, Pink Sheet

Adem Koyuncu’s commentary was included in an article from the Pink Sheet exploring a German bill that endeavors to make the country more attractive for clinical research. The bill would streamline the system governing ethics committees and reorganize the competencies of the two main German regulators.

Adem shared his insight on the bill, saying it could reduce bureaucracy and bring more simplicity to the processes for authorizing clinical studies. He also raised the concern that the regulator reorganization will lead to confusion and a “loss of energy.” Adem further pointed out that there could be a risk of conflicts of interest if the new Federal Ethics Committee operated under the Federal Institute for Drugs and Medical Devices, or BfArM, the medical regulatory body in Germany. “If there are differing views on certain points, ethics committee staff may feel tempted to take the BfArM position rather than contradict it.”