On April 27th, the European Parliament voted in favour of a report which contained an amendment on the European Medicines Agency (EMA). The report states that the EMA must annually report its actions to ensure that drugs intended for the European market are tested ethically in lower- and middle-income countries. This way, clinical trial participants can be better protected. Wemos contributed to this report with several MEPs.
While the EMA has promised to perform extra checks on clinical trials conducted outside the EU before they are authorized for the European market, it remains unclear how the agency guarantees that trials are conducted ethically. Wemos has contacted EMA several times about its obligations, but to no avail. Therefore, we hope this amendment will ensure better protection of clinical trial participants.
Special vulnerabilities and ethical conduct
The amended report stresses the importance of ethical guidelines and the fact that clinical trials performed outside the EU have special vulnerabilities. The EMA should thus be committed to its obligations and yearly report on its actions to protect those who participate in such trials:
‘Reminds the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines, and reminds the Agency of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation(1) ; therefore, due to the special vulnerabilities of those tests, asks the Agency to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically in lower and middle income countries, in accordance with the law.’
Bart Staes (MEP Green) believes this amendment will make the EMA more transparent. ‘This will make EMA more transparent, as it will give us more insight in its activities regarding ethical clinical trials. Medicines that are intended for the EU should not harm clinical trial participants in low-income countries.’
Guidelines and responsibilities
The EMA is responsible for protecting clinical trial participants. Directive 2003/63/EC states that drugs tested in low- and middle-income countries can only be considered for EU marketing authorization if they have been tested according to guidelines, like the Good Clinical Practice or Declaration of Helsinki Guidelines. These guidelines safeguard the protection and health of trial participants. For example, participation must be solely voluntary, and post-trial access to treatment must be guaranteed.
Clinical trial participants are vulnerable
Wemos and partners have studied clinical trials in fragile settings for almost 10 years now. Our research points amongst others to the following conclusions:
- Due to limited access to healthcare, clinical trials are often the only way for participants in low- and middle-income countries to get treatment. But this means that they are in fact participating involuntarily – they have no other choice. And often, the risks of participating in a trial are neglected. This makes them vulnerable.
- When a trial participant is physically harmed as a result of the trial, they lack the way to compensation.
- It is often difficult to get post-trial access to treatment due to the fact that the medicine is either unavailable on the national market or available at such a high price that the majority of the population cannot afford it.
Photo: Roger Anis