This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.
Snakebites continue to be a public health concern in sub-Saharan Africa, where availability of appropriate medical treatment is rare, even though death and disability can be prevented with timely intervention. A challenge is the lack of sociopolitical studies to inform health policies. This study aimed to identify snakebite patient profiles, healthcare workers’ (HCWs) knowledge of snakebite, and facilities’ snakebite treatment capacity in Kenya, Uganda, and Zambia to inform interventions to improve access to appropriate treatment. The research comprised a cross-sectional key informant survey among HCWs from health facilities in Kenya (n = 145), Uganda (n = 144), and Zambia (n = 108). Data were collected between March 2018 and November 2019. Most of the HCWs suggested that the number of snakebite incidents was similar between the genders, that most patients were aged 21–30 years, and most people were bitten when farming or walking. Overall, only 12% of HCWs had received formal training in snakebite management. Only about 20% of HCWs in each country said their health facility had the medicines needed to treat snakebites, with antivenom available in 0–34% of facilities across the sectors and countries, and snakebites were not systematically recorded. This research shows that an integrative approach through policies to increase resource allocation for health system strengthening, including community education, HCW training, and improved access to snakebite treatment, is needed. Part of this approach should include regulations that ensure antivenoms available in health facilities meet quality control standards and that snakebites are accommodated into routine reporting systems to assess progress.
Context. Access to internationally controlled essential medicines is a problem worldwide. More than five billion people cannot access opioids for pain and palliative care or do not have access to surgical care or anesthetics, 25 million people living with epilepsy do not have access to their medicines, and 120,000 women die annually owing to postpartum hemorrhage. In Uganda, access to controlled medicines is also problematic, but a lack of data on factors that influence access exists.Objectives. The objective of this study was to identify the social, cultural, and regulatory barriers that influence access to internationally controlled essential medicines in Uganda.Methods. Semistructured interviews with 15 key stakeholders with knowledge on controlled medicines from relevant institutions in Uganda. Interviews were transcribed verbatim and analyzed using the Access to Medicines from a Health System Perspective framework.Results. Barriers in accessing controlled medicines were experienced owing to lack of prioritization, difficulties in finding the balance between access and control, deficiencies in the workings of the estimate and distribution system, lack of knowledge, inadequate human resources, expenses related to use and access, and stigma. It was believed that some abuse of specific controlled medicines occurred.Conclusion. The findings of this research indicate that to improve access to internationally controlled essential medicines in Uganda, health system strengthening is needed on multiple fronts. Active engagement and concerted efforts are needed from all stakeholders to ensure access and prevent abuse.
Background: Access to sexual and reproductive health services continues to be a public health concern in Kenya, Tanzania, Uganda and Zambia: use of modern contraceptives is low, and unmet family planning needs and maternal mortality remain high. This study is an assessment of the availability, affordability and stock-outs of essential sexual and reproductive health commodities (SRHC) in these countries to inform interventions to improve access.
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