While “eighty percent of the world’s population lives in developing countries, where both healthcare and research related to healthcare are severely constrained by limited financial and human resources and by the lack of appropriate infrastructure..., ...an increasing amount of research related to health care is being supported in developing countries by governments, government agencies and voluntary organisations in developed countries, in addition to international bodies... and multinational pharmaceutical companies” (Nuffield Council on Bioethics, The ethics of research related to health care in developing countries, London, 2002, p. 6).
Since the 1990’s the number of research conducted in developing countries by external sponsors has significantly grown (from 271 in 1990 to 4,458 in 1999 according a report made by the FDA, DHHS Office of the Inspector General, The globalization of clinical trials. A growing challenge in protecting human subjects, Office of Evaluation and Inspections, Boston, 2001) mainly in Latin America and Eastern European countries. If some forms of sponsorship may be regarded as altruistic, others are simply driven by interests which are not primarily those of the developing countries.
The social, cultural, economic and legal contexts of developing countries, which differ from those in the developed countries, may therefore create some risks of greater vulnerability for the indigenous populations that are involved in clinical research as it was highlighted by the international controversy about a series of clinical trials into the prevention of mother-to-child transmission of HIV in 1997 (Lurie P, Wolfe SM, Unethical trials of interventions to reduce perinatal transmission of the HIV in developing countries…