In a letter to the director of the European Medicines Agency (EMA), three Members of European Parliament (MEPs) have expressed their concerns about vulnerable clinical trial participants in low- and middle-income countries. They urge the agency to be more transparent about its activities on protecting clinical trial participants and ethical testing of medicines in low- and middle-income countries. The letter refers to Wemos’ research report on unethical practices in clinical trials in African countries that was published earlier this year.
The letter follows the report that was adopted by the European Parliament in April this year. The MEPs want the EMA to deny access to the European market for medicines that have been tested unethically. The agency should perform more stringent checks on clinical trials conducted outside the EU, to guarantee that only medicines that have been tested ethically can enter the European market. The MEPs want to know how the EMA will do this, and whether EMA will deny medicines EU market access on the basis of unethical trials. It is unclear how EMA plans to annually report on its checks in low- and middle-income countries to the European Parliament, and how it will put pressure on companies that conduct trials that do not meet ethical guidelines. With their letter, the MEPs stress the importance of ethics, transparency and accountability in clinical trials. Wemos too acknowledges this and does not want medicines in the EU that have harmed clinical trial participants.
Unethical clinical trials
Wemos’ report revealed that clinical trials in Africa are not always conducted according to ethical guidelines. Clinical trial participants are therefore vulnerable and exposed to situations that could harm their health, or situations in which their rights are violated. Wemos thinks that EMA should have more stringent oversight of clinical trials in countries where participants are vulnerable. We also think that medicines must be tested according to ethical guidelines. Although this has been adopted in legislation, the law is not always enforced.
Wemos global health advocate Ella Weggen: ‘With this letter, MEPs have expressed their concerns about vulnerable clinical trial participants, and have shown that the European Parliament wants EMA to tackle unethical practices.’
Read the letter
Read more about what Wemos does on medicines
Photo: Roger Anis
