Developing Pharmaceutical Legislation in the Federated States of Micronesia

Abstract

In the Federated States of Micronesia (FSM), pharmacies are largely unregulated, giving rise to a lack of quality control over medicines and potentially exposing the public to harmful consequences. A joint state and national response was to adopt the FSM Medicine Policy in 2012 which served as guidance for the pharmaceutical industry (DHSA 2012). A 2017 review of the sector found that a legislative and regulatory regime is urgently required to assure quality control and thus increase the public’s confidence in the medicines available (DHSA 2017). Assistance from the World Health Organization (WHO) and Australia was provided to collaborate with the Department of Health and Social Affairs for the purposes of creating the legislative framework. This In Brief provides an overview of the existing pharmaceutical legal regime and the legislative framework that has been proposed to replace it.