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Amsterdam, 27 May 2009 – Last week marked the celebration of International Clinical Trials' Day 2009. A worldwide coalition of health and human rights organizations united in the campaign FairDrugs.org called for the adequate protection of trial subjects in developing countries.
The campaign, led by the Wemos Foundation, centres on the Call for Ethical Clinical Trials in Developing Countries, and appeals to policymakers, legislators and pharmaceutical companies to respect the rights of trial subjects. Numerous organizations and individuals have already signed up, including independent investigative journalist Sonia Shah, the author of The Body Hunters: Testing New Drugs on the World's Poorest Patients. ‘For too long, clinical trials in poor countries have been conducted in the shadows, endangering the human rights and health of test subjects. I support the FairDrugs.org campaign because I believe civil society must be involved to ensure that all human experimentation is conducted to the highest ethical standards. Anyone who benefits from modern medications should, too’, says Sonia Shah.
The European Medicines Agency (EMEA) recently announced its intention to improve supervision of compliance with ethical guidelines in clinical trials conducted outside the European Union (EU). This is a positive development, according to Wemos' Annelies den Boer: 'We have been expressing our concern about the increasing number of medicines being tested on people in developing countries since 2006. We have called for thoroughgoing ethical evaluations before medicines are given EU market approval. EMEA now intends to actually do this.'
'We are especially interested in how EMEA will tackle the practical application of international ethical guidelines. We hope that the latest version of the Declaration of Helsinki will be used as the starting point and that EMEA will consult experts in developing countries for advice.' Den Boer points out that the registration authorities in EU member states will also need to take action. 'Political support is essential, both at European level and within member states, if the steps proposed by EMEA are to be implemented. We see our role as one of mobilizing support and creating momentum, for example by means of FairDrugs.org.'
On International Clinical Trials' Day 2009, coalition members wrote letters to public health ministers across Europe, calling for measures to prevent further abuses of trial subjects in developing countries. Sandhya Srinivasan, editor of the Indian Journal of Medical Ethics, visited Amsterdam to discuss the risks of carrying out clinical trials in developing countries. She joined Wemos and the Centre for Research on Multinational Corporations (SOMO) in considering ways in which the position of vulnerable test subjects can be improved.