The role of government agencies and other actors in influencing access to medicines in three East African countries.

The WHO Model List of Essential Medicines (MLEM) has since 1977 helped prioritize and ensure availability of medicines especially in low- and middle-income countries. The MLEM consists mainly of generic medicines, though recent trends point towards listing expensive on-patent medicines and increasing global support for medicines against non-communicable diseases. However, the implications of such changes for national essential medicines list (NEML) updates for access to essential medicines has received relatively little attention. This study examined how government agencies and other actors in Kenya, Uganda and Tanzania participate in and influence the NEML update process and subsequent availability of prioritized medicines; and the alignment of these processes to WHO guidance. A mixed study design was used, with qualitative documentary review, key informant interviews and thematic data analysis. Results show that NEML updating processes were similar amongst the three countries and aligned to WHO guidelines, albeit conducted irregularly, with tendency to reprioritization during procurement stages, and were not always accompanied by revision of clinical guidelines. Variations were noted in the inclusion of medicines against cancer and hepatitis C, and the utilization of health technology assessment (HTA). For medicines against diseases with high global engagement, such as HIV/AIDS and TB, national stakeholders had more limited inputs in prioritization and funding. Furthermore, national actors were not influenced by the pharmaceutical industry during the NEML update process, nor were any conflicting agendas identified between health, trade and industrial policies. Hence, the study suggests that more attention should be paid to the combination of HTAs and NEMLs, particularly as countries work towards universal health coverage, in addition to heightened awareness of how global disease-specific initiatives may confound national implementation of the NEML. The study concludes with a call to strengthen country-level policy and procedural coherence around the process of prioritizing and ensuring availability of essential medicines.

The politics of global immunization initiatives: can we learn from research on global environmental issues?

The number of institutions, representing different groups of stakeholders and organizations, aiming to coordinate global health policy is on the rise. Yet, as each have distinct interests and priorities, the political dimension becomes an important factor in understanding how institutions work, and how the coordination at the global level affects implementation in countries. This is already a topic for research on global environmental cooperation, inciting the question if one can transfer their analytical framework to the health field. This paper combines a presentation of lessons from research on environmental regimes with a review of global immunization policies and initiatives in order to explore that possibility. The paper describes cooperation on vaccines and immunization according the concepts of institutions and regimes, as defined by international relations research. This description emphasizes efforts to fulfill transnational agreements on objectives, the different ways stakeholders organize and the dynamics of such arrangements. An account of the research practice on global environmental cooperation leads to a discussion of how one could adapt the analytical framework. The paper makes the case for the development of a research program, where the analytical approach is modified to account for the interaction between technology production and public-led institutions. The conclusion proposes a number of entry points to research that have already yielded policy-relevant knowledge in the environmental field. These include the formation of new institutions, the contribution of institutional design to effective implementation, and the interplay between vaccine initiatives and other global institutions.

A new approach to global health institutions? A case study of new vaccine introduction and the formation of the GAVI Alliance.

There is an emerging research agenda to analyse empirically the forces driving changes in global health governance. This study applies analytical tools from international relations research to explain the formation of international health regimes. The study utilizes two explanatory perspectives: individual leadership, and the interests of key non-state actors in the formation process, using the case of the formation of the Global Alliance for Vaccines and Immunization (GAVI) from 1995 to 1999. The case study is based on material from interviews with key actors, an archival review of documents from the Children's Vaccine Initiative (CVI), and published literature. Findings show that the regime formation process was initiated by individuals who were primarily affiliated to scientific communities and who led to the World Bank and the Gates Foundation becoming champions of a new coordinating mechanism for new vaccine introduction. Negotiations in the regime formation process were between a small group of founding agencies with divergent interests regarding immunization priorities. The case also sheds light on the authority of the WHO and the resources of the Gates Foundation in driving the process towards the final structure of the alliance. The paper discusses the potential contribution of the international relations approach compared to policy research as a way of understanding the institutional dynamics of global health, particularly in respect of relations between countries and non-state actors.