Trial subjects, wherever they live, are entitled to clinical trials that are conducted in accordance with the ethical principles for medical research involving human subjects laid down in the most recent version of the Declaration of Helsinki.
As purchasers of drugs tested in developing countries, EU Member States have a responsibility towards the people on whom these drugs have been tested.
European Commission Directive 2003/63/EC already states that clinical trials conducted outside the European Community will only be taken into account during the assessment of a drug application if they have been carried out in accordance with ethical principles such as the Declaration of Helsinki.
Research indicates that the European Medicines Agency and equivalent national bodies are not carrying out the ethical checks required by Directive 2003/63/EC.1
As a result, drugs that have not been tested according to ethical standards are entering the EU market.2
We call on the European Commission and EU Member States to:
Ensure the European Medicines Agency and national medicines agencies perform the required ethical checks and ensure they have access to the required information such as Good Clinical Practice audit reports;
Apply sanctions against pharmaceutical companies and other sponsors of clinical trials that engage in unethical drug testing;
Oblige pharmaceutical companies and other sponsors of clinical trials to register all relevant information in a publicly accessible register according to the guidelines set out by the World Health Organization’s International Clinical Trial Registry Platform.
We commend the European Commission and EU Member States for supporting capacity building related to clinical trials in developing countries. They should continue to provide the resources needed to ensure that the regulatory bodies and ethical review committees in developing countries are able to function and that health workers are trained to carry out clinical trials to required standards.
We call on the European Medicines Agency and the national medicines agencies to:
Develop tools to better assess the ethical aspects of clinical trials, in consultation with experts from developing countries;
Routinely seek access to information on the ethical aspects of trials from pharmaceutical companies.
We call on governments of the countries in which clinical trials are being carried out to:
Ensure that trial sponsors adhere to the ethical principles laid down in the Declaration of Helsinki;
Strengthen their own regulatory bodies and ethical review committees to achieve this objective.
We call on pharmaceutical companies and other trial sponsors to:
Demonstrate that any clinical trials undertaken in developing countries are conducted in an ethical manner, including those trials which are outsourced to a Contract Research Organization (CRO);
Make drugs available and affordable to the population from which the trial participants were drawn.