Clinical trials in Africa are not always conducted according to leading ethical guidelines. This puts clinical trial participants at risk of being physically harmed or having their rights violated. This is the main message of the report that Wemos has published today. Wemos therefore urges the European Medicines Agency (EMA) to be more stringent when evaluating unethical clinical trials and to be more transparent about how it aims to guarantee that trials are ethical.
The new publication is a summary of four country reports about clinical trials (Egypt, South Africa, Zimbabwe, and Kenya) that Wemos has published with partner organizations in the past. Last year, a pharmaceutical company provided judicial guidance to an Egyptian clinical trial participant to file a claim against our partner organization Public Eye. The reason for this was a newly published report on clinical trials in Egypt. This illustrates how the pharmaceutical industry is not reluctant to thwart organizations in conducting critical research. But in order to protect clinical trial participants, who are often vulnerable, and to expose unethical practices in trials, such research is all the more essential.
Violation of the Declaration of Helsinki
Although the four countries differ in terms of rules and regulations on clinical trials, most common diseases, and regulatory authorities, we found distinctive similarities that resulted in systemic problems. For example, we found that clinical trial participants were not always aware that they had signed up for a trial because trial researchers were not always transparent about this. Also, many participants agreed to participate in a trial because for most, it was the only way to get treatment, due to lack of access to health care in their country. But this meant that consent was not always voluntary or informed, a crucial aspect in ethical guidelines like the Declaration of Helsinki. Moreover, in case of physical harm due to a trial, receiving financial compensation was shown to be extremely difficult.
Wemos urges that checks on clinical trials in low- and middle-income countries be more stringent. The European Medicines Agency (EMA) should perform more checks in these countries. Also, we urge EMA to be more transparent about its research reports, and make them public. The European Parliament already made a case for this in April.
Read the report ‘Clinical trials in Africa’