Malpractices in clinical trials are still common. In October, three Members of the European Parliament requested the European Medicines Agency to address these issues. The agency’s reply to the letter still leaves Wemos concerned.
In a letter to the director of the European Medicines Agency (EMA), three Members of the European Parliament (MEPs) expressed their concerns about vulnerable trial subjects in low- and middle-income countries. They asked EMA to be more transparent about its activities on protecting trial subjects and ethical testing of medicines in low and middle-income countries. The letter referred to our research report on unethical practices in clinical trials in African countries which we published earlier this year.
In his letter, EMA Director Rasi states that EMA is actively working on capacity building in the countries where we conducted our research, and that the Good Clinical Practices Inspectors Working Group will review our report. We hope that this will prompt them to take actual measures to strengthen existing guidelines. The three MEPs also requested that the reflection paper, which Rasi also refers to in his reply, be given a more binding status. Rasi did not comment on this specific request.
Not transparent enough
The report of the European Parliament (Budget Control Committee) of April 2017 stated that EMA must annually report to the European Parliament. In their letter, the MEPs also asked for more transparency on medicines that have been rejected due to ethical violations. The reply includes a detailed explanation of what EMA does when it comes to capacity building and that the agency even rejects certain medicines in case of ethical malpractices.
While we think this is certainly a positive development, we still wish for more transparency, as we want insight in the agency’s inspection reports. We need to know which companies are responsible for the unethical testing of certain medicines. Only then will we be able to hold these companies accountable, and will they be pressured to conduct their clinical trials in a more ethical manner.
Read the letter from the three MEPs to Professor Rasi
Read Professor Rasi’s reply to the three MEPs
Read more about our work on Medicines
Photo: Roger Anis
