Briefng paper: Protection of Clinical Trial Participants in Countries Outside the EU

Background and purpose

Medicines intended for the European market are increasingly tested on clinical trial participants outside the EU in low and middle income countries. Over the past years, SOMO and Wemos have collected extensive evidence of violations of ethical principles and guidelines in such trials. In this briefing paper SOMO and Wemos provide the European Parliament, the European Commission and the European Medicines Agency (EMA) with policy recommendations to take their responsibility and address this problem.

About the authors

SOMO is an independent, non­profit research and network organisation that promotes sustainable and fair global economic development and the elimination of the structural causes of poverty, environmental problems, exploitation and inequality.

Wemos is an independent, non­profit organisation that advocates for the right to health of people in developing countries.

Background documents

Relevant publications are available from www.somo.nl and www.wemos.nl:

  • The Globalization of Clinical Trials. Testimonies from Human Subjects (Wemos, 2010)

  • Putting Contract Research Organisations on the Radar (SOMO and partners, 2011)

  • Clinical Trials in Developing Countries: How to Protect People Against Unethical Practices? (SOMO, 2009)

  • Ethics for Drug Testing in Low and Middle Income Countries (SOMO, 2008)

  • A Bitter Pill. The risks of carrying out clinical drug trials in developing countries (Wemos, 2008)

Problem description

Clinical trials that test medicines for use in the European Union (EU) increasingly take place in low and middle income countries. Most trial participants in these countries are poor, have limited access to health care and have low medical literacy, all factors that limit their autonomy to participate in the clinical trial. Unfortunately, the bodies responsible for protecting the rights and safety of these vulnerable partici­ pants, such as national drug regulatory authorities and ethics committees, often do not function properly.

However, this is not the only concern. The ongoing frag­ mentation of the trial implementation process through (sub) contracting to so called contract research organisations (CROs) raises concerns over the ability of sponsors, regula­ tory agencies and ethics committees to supervise the implementation of clinical trials. Another point of concern is that most of the trial participants will never obtain access to the medicines they have helped to develop because of their exorbitant costs. Finally, the integrity of the data collected has been questioned: cases have been documented where participants claimed they had participated in several clinical trials at the same time to generate more income. This means the data is unreliable and may pose risks to patients in the EU.

Many cases of violations of ethical principles and guidelines have been reported (see Background documents). Directive 2003/63/EC states that medicines can only be considered for EU marketing authorisation if they have been tested according to ethical guidelines. In practice however the Directive is not implemented, since marketing applications are not screened with regard to their compliance with the Declaration of Helsinki, which formulates the most stringent ethical guidelines.

As medicines intended for the European market are increas­ ingly tested on clinical trial participants outside the EU in low and middle income countries, European institutions have a moral and legal responsibility to protect their rights. Therefore, Wemos and SOMO are calling upon the European Parliament, the European Commission and the European Medicines Agency (EMA) to take measures at the following three levels:

  1. Vigorously pursue the integration of ethical principles into EMA procedures,
  2. Increase transparency and
  3. Strengthen capacity in low and middle income countries.
Posted in Pharma.

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