Ethical testing of medicines outside the EU

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Dear European Medicines Agency,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

Wemos and partners have studied clinical trials in fragile settings for almost 10 years now. This has resulted in many reports:


- The Globalization of Clinical Trials: Testimonies from Human Subjects

- Examples of unethical trials SOMO briefing paper on ethics in clinical trials

- Ethics for Drugs Testing in Low and Middle Income Countries

- Protection of Clinical Trial Participants in Countries Outside the EU

- The Clinical Trials Industry in South Africa: Ethics, Rules and Realities

- THE CLINICAL TRIALS INDUSTRY IN KENYA: Realities, Risks and Challenges

- CLINICAL TRIALS REALITIES IN ZIMBABWE: Dealing with Possible Unethical Research

All reports point to the same conclusions:

Clinical trials in low and middle income settings are vulnerable because they have limited access to health care and therefor see themselves forced to participate in clinical trials and disregard the risks of receiving experimental treatment.

When clinical trial participant experience physical harm during a clinical trial it is extremely difficult for them to get access to compensation or care.

The vulnerability of clinical trial participants should be balanced by extra vigilant authorities such as local ethical review board and national monitoring to assess whether the risks do not outweigh the potential benefits for trial participants. Our investigations show that in most low and middle income settings bodies charged with overseeing clinical trials and protecting the rights and safety of clinical trials participants do not function properly often due to lack of resources or proper regulations.

This makes checks and balances at EU level all the more relevant. European law provides us with a hook to assess whether medicines that have been tested outside the EU, have been tested in accordance with GCP and ethical guidelines. Directive 2003/63/EC states that medicines can only be considered for EU marketing authorisation if they have been tested according to ethical guidelines.

The EMA has its responsibility in this document: Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU Regulatory Authorities

The EMA promised to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation.

However to date it is unclear what EMA does exactly. MEPs have submitted written questions to get more clarity. For example MEP’s Rivasi and Sargentini have asked Parliamentary questions on the implementation by the EMA of the reflection paper pertaining to the protection of the rights of clinical trial participants:
In its answers the commission and EMA mention their capacity building activities and inspections however the activities described in the reflection paper are much broader and comprehensive.

We would like to get more information about the exact execution of the promises of the EMA. We would like to receive documents of the checks in low and middle income countries, and get insights in the documents how they did this and how often and what were the consequences of non compliance.

Yours faithfully,

Ella Weggen
[email address]

PF-15, Agence européenne des médicaments

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The European Medicines Agency

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