Better protection of clinical trial participants in low income countries?

On 13 September, SOMO, Wemos and partner Dr. Amar Jesani of the Indian Journal of Medical Ethics held a debate with Members of the European Parliament (MEPs) and European authorities. Topic: how to prevent that medicines being admitted to the European market have been tested unethically on trial participants in low income countries? SOMO and partners presented policy proposals for exercising the European responsibility for tackling this problem. European authorities and MEPs proved willing to take steps in this direction.

SOMO, Wemos and Indian partner Dr. Amar Jesani were invited to give presentations for MEPs during a lunchtime debate about the protection of vulnerable trial participants in low income countries. Fourteen MEPs showed up, a high score considering the always-crowded schedules of the people’s representatives. The agenda also included presentations by the European Medicine Agency, executive body in granting European-market access to medicines, and by the Health Directorate of the European Commission. After the debate SOMO and partners participated in the open meeting of the parliamentary working group on Bio-Ethics.

SOMO and partners had expected some opposition for their proposals to improve protection of the trial participants in low income countries, but this apprehension was unfounded. The authorities shared our thoughts on solutions and have already taken steps in the area of capacity building and cooperation with authorities in popular test countries. They also announced plans for increased transparency regarding the circumstances under which medicines that are allowed on the European market have been tested abroad. The availability of medicines for poor trial participants after the end of the trial transpired to be the most contested point in the proposals. It is not yet a cut and dried case that unethically tested medicines will actually be refused admission to the European market. Fortunately, the MEPs who were present shared the concerns of SOMO and partners, and we can therefore count on the authorities being monitored critically in the execution of their good intentions.

See: an overview of policy proposals presented by SOMO and partners