On Wednesday March 22nd, the budgetary control committee (CONT) of the European Parliament voted in favour of an amendment on the European Medicines Agency (EMA). This states that EMA must report its activities on protecting clinical trial participants and guaranteeing that trials are conducted according to ethical guidelines. Wemos contributed to this amendment with several MEPs.
The EMA has promised to perform extra checks on clinical trials outside the European Union before drugs are authorized for the European market. Although Wemos has contacted EMA several times about its obligations, it still remains unclear how the organization guarantees that trials are conducted ethically. We hope that this amendment in EMA’s discharge procedure – which is annually approved by the European Parliament – will better protect clinical trial participants.
‘It is great that this amendment has been accepted. 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. This amendment enables us to control and monitor this,’ says Bart Staes (MEP Green).
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.
The vulnerability of trial participants
For years now, Wemos has been working on ethical testing of medicines intended for the European market, focusing on the rights of those in low- and middle-income countries who participate in clinical trials. Our research in this area points 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, it is often difficult to get post-trial access to treatment or compensation.
Read more about our work on Medicines
Read our report on clinical trials in Egypt