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Abstract 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.

Background What constitutes state`s global power to shape access to medicines? How was it distributed between states and how did this change from 2000 to 2019? In this comparative case study, we explored the powers of China, India and the United States, and discuss whether our findings from the pre-pandemic era were reflected in the global COVID-19 response related to pharmaceuticals. We used an analytical framework from the international relations literature on structural power, and assessed the following power structures after adapting them to the context of access to medicines: finance, production, financial protection, knowledge, trade and official development assistance. Results We found that from 2000 to 2019 there had been a power-shift towards China and India in terms of finance and production of pharmaceuticals, and that in particular China had increased its powers regarding knowledge and financial protection and reimbursement. The United States remained powerful in terms of finance and knowledge. The data on trade and official development assistance indicate an increasingly powerful China also within these structures. During the COVID-19 pandemic, we found that the patterns from previous decades were continued in terms of cutting-edge innovation coming out of the United States. Trade restrictions from the United States and India contrasted our findings as well as the limited effective aid from the United States. Building on our findings on structural powers, we argue that both structural power and political decisions shaped access to medical technologies during the COVID-19 pandemic. We also examined the roles and positions of the three states regarding developments in global health governance on the COVAX mechanism, the TRIPS Agreement waiver and the pandemic accord in this context. Conclusion From 2000-2019, China and India increased their structural powers to shape global access to medical technologies. The recent COVID-19 pandemic demonstrated that both structural power and political decisions shaped global access to COVID-19 technologies.

Background: The formation of the Coalition for Epidemic Preparedness Innovations (CEPI) sheds light on how conditions for global collaboration are created and sustained. This is a multi-stakeholder initiative whose objective is to be a global financing and coordination mechanism that supports the development of vaccines against epidemic infectious disease. Methods: The paper reports from an empirical study that documented and analysed CEPI’s formation from idea in mid-2015 to its formal launch in January 2017, using a qualitative approach and analytical perspectives from international relations and the governance of socio-technical systems to explain decisions and outcomes. Results: The accomplishment of forming CEPI in only 15 months was possible due to a substantial operational capacity among founding partners for groundwork and coordinating parallel processes, multiple individuals in leadership roles as well the flexibility offered by an interim phase. Findings also suggest that key alignments needed to be found between diverging positions on collective action for technology development, revealing the complexity and dynamics of interests among actors. The study further identifies key institutional conditions that interests clustered around, which CEPI needed manage in order to become operational. Conclusions: The study concludes that while successful in developing a new nexus between global public health, vaccine innovation and pandemic response, CEPI was in 2017 still in the process of defining the nature of its authority within that landscape. Finally, the CEPI formation process bears significance for the global coordinated response to the coronavirus (COVID-19) pandemic in 2020. As features of the CEPI formation represent persistent challenges in global health collaboration, the study offers both a backdrop and lessons learned.