Efforts are increasing to ensure that resource poor countries, which bear almost 90% of the global disease burden, have access to effective medicines.1 As a result, drug companies are facing increased pressure from governments, the World Health Organization, and patient lobby groups to remove legal and financial barriers to access.2 However, although these campaigns are necessary and clearly laudable, they are not accompanied by the development or upscaling of processes for monitoring drug safety. Although many drugs have been extensively used and studied in developed countries (thus informing global practice), their safety profile cannot necessarily be generalised to developing countries, where the incidence, pattern, and severity of adverse reactions may differ markedly because of local environmental and genetic influences.3

After the thalidomide disaster in the 1960s, most Western countries developed national pharmacovigilance systems.4 These systems use spontaneous reporting or other pharmacoepidemiological methods to systematically collect and analyse adverse events associated with the use of drugs, identify signals or emerging problems, and communicate how to minimise or prevent harm. Although these …