Ethics for Drug Testing in Low and Middle Income Countries : Considerations for European Market Authorisation

In this report SOMO links clinical trials carried out on people in low and middle income countries to medicines that are currently available on the European market. The number of clinical trials off-shored to countries like China, India, Russia and Argentina has experienced enormous growth in the last five years. However, trial subjects in these countries are more vulnerable and their rights are less secured than in high income countries. Conditions such as poverty, illiteracy, poor health systems and inadequate research ethics committees result in international ethical standards not being met. Current EU legislation requires that results from unethical clinical trials that have not been conducted in accordance with the Declaration of Helsinki not be accepted for marketing authorisation. With three case studies on recently approved drugs in the EU (Abilify, Olmetec, and Seroquel), SOMO demonstrates that this principle is being violated. European authorities devote little to no attention to the ethical aspects of the clinical trials submitted, and they accept unethical trials as well as trials of poor quality. Transparency about clinical trials in low and middle income countries is insufficient, both with regard to the amount of trials covered in public databases and with regard to the amount of information on ethical considerations. In addition, national medicine authorities fail to promptly publish public assessment reports on medicines approved for the EU market as is legally required