A need for the standardization of the pharmaceutical sector in Libya

Medicines are health technologies that can translate into tangible benefits for numerous acute as well as chronic health conditions. A nation's pharmaceutical sector needs to be appropriately structured and managed in order to ensure a safe, effective and quality supply of medicines to society. The process of medicines management involves the sequential management of five critical activity areas; namely; registration, selection, procurement, distribution and use. Formalized and standardized management of all five critical activity areas positively influences the availability, quality and affordability of medicines and ultimately increases the reliability and quality of the national healthcare system

Fear and rumours regarding placental biopsies in a malaria-in-pregnancy trial in Benin.

BACKGROUND: A multi-country, community-based trial on scheduled screening and treatment for malaria in pregnancy was conducted in Benin, The Gambia and Burkina Faso. Despite standardized procedures and outcomes, the study became subject to rumours and accusations of placenta being sold for mystical and financial gain by trial staff, leading to drop-out rates of 30% and the consequent halting of placental biopsy sampling in Benin. This paper explores the role of socio-cultural beliefs related to placenta and identified additional factors contributing these rumours. METHODS: A qualitative comparative emergent-theory design was used to assess social factors related to trial implementation and uptake in the three countries. Data from participant observation, informal conversations, group discussions and interviews were triangulated and analysed with NVivo Qualitative Analysis software. RESULTS: Despite similar sociocultural beliefs about the sacred nature of the placenta in all three study countries, these beliefs did not affect participation rates in Burkina Faso and The Gambia and placenta-related rumours only emerged in Benin. Therefore, the presence of beliefs is not a sufficient condition to have generated placenta-selling fears. The rumours in Benin reflected the confluence of placenta-related beliefs and factors related to the implementation of the trial (including a catalysing adverse event and miscommunication during the informed consent procedure). Furthermore, distinct socio-political factors contributed to the emergence of rumours, including the historical distrust in governmental organizations and the tense relationship between some of the actors involved in the trial. CONCLUSION: Transdisciplinary social science research designs should accompany the implementation of the trial. The integration of multiple stakeholders' knowledge and involvement is required to define and solve upcoming barriers

Challenges to international stem cell clinical trials in countries with diverging regulations

This chapter addresses challenges to the organization and conduct of international stem cell clinical trials in a context of regulatory pluralism. Multi-country clinical trial collaborations in stem cell medicine have the potential to speed up clinical developments and to widen access to new treatments among patients. However, the regulatory procedures through which the safety and efficacy of stem cell-based treatments are determined vary widely across countries. Internationally harmonized governance frameworks are not yet in place. In this chapter we show that this high level of regulatory variation and the absence of internationally binding standards for clinical stem cell research present important challenges to multi-country clinical trial collaborations. Four types of challenges will be highlighted. First is the need to inquire into and interact with regulatory procedures and law in multiple countries. Second, the interaction with medical authorities in multiple countries is resulting in a high level of organizational complexity. Third consists of delays, increased costs, and uncertainties that result from nonexistent, unclear, or still emerging regulatory arrangements in different countries. Fourth is that the high level of regulatory variation across countries necessitates far-reaching forms of scientific self-governance, training, and procedural adjustments in participating clinical trial sites. To illustrate this point, the chapter presents a case study of project-internal self-governance and capacity building in the context of a clinical trial infrastructure that is active across the contexts of China, Hong Kong, and the USA. The chapter concludes with a call for the creation of an international support structure that systematically addresses these problems. Five measures that may help to reduce existing difficulties will be introduced