An ethics of anthropology-informed community engagement with COVID-19 clinical trials in Africa.

The COVID-19 pandemic has reinforced the critical role of ethics and community engagement in designing and conducting clinical research during infectious disease outbreaks where no vaccine or treatment already exists. In reviewing current practices across Africa, we distinguish between three distinct roles for community engagement in clinical research that are often conflated: 1) the importance of community engagement for identifying and honouring cultural sensitivities; 2) the importance of recognising the socio-political context in which the research is proposed; and 3) the importance of understanding what is in the interest of communities recruited to research according to their own views and values. By making these distinctions, we show that current practice of clinical research could draw on anthropology in ways which are sometimes unnecessary to solicit local cultural values, overlook the importance of socio-political contexts and wider societal structures within which it works, potentially serving to reinforce unjust political or social regimes, and threaten to cast doubt on the trustworthiness of the research. We argue that more discerning anthropological engagement as well as wider collaboration with other social scientists and those working in the humanities is urgently needed to improve the ethics of current biomedical and pharmaceutical research practice in Africa.

Assessing the implementation and influence of policies that support research and innovation systems for health: the cases of Mozambique, Senegal, and Tanzania.

BACKGROUND: Without good policies it will be difficult to provide guidance to research and innovation systems. However, policies need to be followed through and implemented to have the desired effect. We studied the policies and strategies in place to support research and innovation systems for health in Mozambique, Senegal, and Tanzania, and looked at the extent to which these policies and strategies have been implemented. METHODS: We reviewed documents and reports and conducted in-depth interviews with 16 key informants representing various actors of the national research for health systems. RESULTS: The results illustrate that there are various policies and strategies governing research and innovation for health in the three countries. However, implementation of these policies and strategies is generally rated as being poor. The reasons highlighted for this include lack of policy coherence, lack of enforcement and accountability mechanisms, and a lack of financing for implementing the policies. These contextual factors seem to be of such importance that even the increased stakeholder involvement and political leadership, as mentioned by the interviewees, cannot guarantee policy implementation. CONCLUSIONS: We conclude that due to the contextual realities of the study countries, there is need for greater focus on policy implementation than on developing additional policies. Government institutions should play a central role in all stages of the policy process, and should ensure implementation of defined policies. Strong mechanisms, including financing, that strengthen the position and role of government in policy coordination and the oversight of the policy process will help increase efficient and impactful implementation of research and innovation for health policies.

Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials.

BACKGROUND: This research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase IV clinical trials. METHODS: Two reviewers independently assessed CTRs of the International Committee of Medical Journal Editors (ICJME) and of World Health Organization (WHO) platforms. Each CTR was checked by two reviewers on availability of fields on brand name, manufacturer's name, approval status, approving authority, compliance with Good Manufacturing Practices, and quality testing. In case of discrepancy, consensus was sought between the two reviewers. RESULTS: Of 19 identified CTRs, 8 and 6 belonged to WHO and ICMJE, respectively, while 5 were equally part of both platforms. All CTRs had an 'intervention' field where data on IMPs and IMP comparators are captured. The Canadian CTR used 'drug name' rather than 'intervention'. The EU, Peruvian, and UK CTRs had fields for 'brand name'. However, only the EU CTR had fields for 'manufacturer's name', 'approval status', and 'approving authority'. None of the CTRs had fields on 'compliance with Good Manufacturing Practices' or 'quality testing'. CONCLUSION: This study demonstrates that none of the CTRs of ICMJE and WHO platforms has adequate fields to establish that the source of post-marketing IMPs is of assured quality. This is astonishing given the lengthy requirements in WHO and ICMJE guidelines. Considering the relation between IMP quality and safety of clinical trial participants, the gap of quality assurance fields should be bridged at CTRs concurrently to adjustments of WHO and ICMJE guidelines on CTRs. Specifically, IMP quality testing addressing issues on IMP appearance, impurities, microbial contamination, and dosing should be conducted and reported before, during, and after clinical trial conduct. Until adoption of these measures, the EU CTR should be preferred for registration of phase IV clinical trials conducted in countries lacking stringent regulatory capacities.

Health-industry linkages for local health: reframing policies for African health system strengthening.

The benefits of local production of pharmaceuticals in Africa for local access to medicines and to effective treatment remain contested. There is scepticism among health systems experts internationally that production of pharmaceuticals in sub-Saharan Africa (SSA) can provide competitive prices, quality and reliability of supply. Meanwhile low-income African populations continue to suffer poor access to a broad range of medicines, despite major international funding efforts. A current wave of pharmaceutical industry investment in SSA is associated with active African government promotion of pharmaceuticals as a key sector in industrialization strategies. We present evidence from interviews in 2013-15 and 2017 in East Africa that health system actors perceive these investments in local production as an opportunity to improve access to medicines and supplies. We then identify key policies that can ensure that local health systems benefit from the investments. We argue for a 'local health' policy perspective, framed by concepts of proximity and positionality, which works with local priorities and distinct policy time scales and identifies scope for incentive alignment to generate mutually beneficial health-industry linkages and strengthening of both sectors. We argue that this local health perspective represents a distinctive shift in policy framing: it is not necessarily in conflict with 'global health' frameworks but poses a challenge to some of its underlying assumptions.