All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including development, testing, and manufacturing; fair distribution; sustainability; and accountability. All parties' obligations should be coordinated and mutually consistent. For (...) instance, companies should not be obligated to provide host countries with additional booster shots at the expense of fulfilling bilateral contracts with countries in which there are surges. Finally, any satisfactory approach should include mechanisms for assurance that all parties are honouring their obligations. This assurance enables countries, pharmaceutical companies, global organisations, and others to verify compliance with the chosen approach and protect ethically compliant stakeholders from being unfairly exploited by unethical behaviour of others. (shrink)

Countermeasures for mpox (formerly known as monkeypox), primarily vaccines, have been in limited supply in many countries during outbreaks. Equitable allocation of scarce resources during public health emergencies is a complex challenge. Identifying the objectives and core values for the allocation of mpox countermeasures, using those values to provide guidance for priority groups and prioritisation tiers, and optimising allocation implementation are important. The fundamental values for the allocation of mpox countermeasures are: preventing death and illness; reducing the association between death (...) or illness and unjust disparities; prioritising those who prevent harm or mitigate disparities; recognising contributions to combating an outbreak; and treating similar individuals similarly. Ethically and equitably marshalling available countermeasures requires articulating these fundamental objectives, identifying priority tiers, and recognising trade-offs between prioritising the people at the highest risk of infection and the people at the highest risk of harm if infected. These five values can provide guidance on preferable priority categories for a more ethically sound response and suggest methods for optimising allocation of countermeasures for mpox and other diseases for which countermeasures are in short supply. Properly marshalling available countermeasures will be crucial for future effective and equitable national responses to outbreaks. (shrink)

The goal of achieving Universal Health Coverage (UHC) can generally be realized only in stages. Moreover, resource, capacity and political constraints mean governments often face difficult trade-offs on the path to UHC. In a 2014 report, Making fair choices on the path to UHC, the WHO Consultative Group on Equity and Universal Health Coverage articulated principles for making such trade-offs in an equitable manner. We present three case studies which illustrate how these principles can guide practical decision-making. These case studies (...) show how progressive realization of the right to health can be effectively guided by priority-setting principles, including generating the greatest total health gain, priority for the worse off, and financial risk protection. They also demonstrate the value of a fair and accountable process of priority setting. (shrink)

La cobertura universal de salud está en el centro de la acción actual para fortalecer los sistemas de salud y mejorar el nivel y la distribución de la salud y los servicios de salud. Este documento es el informe fi nal del Grupo Consultivo de la OMS sobre la Equidad y Cobertura Universal de Salud. Aquí se abordan los temas clave de la justicia (fairness) y la equidad que surgen en el camino hacia la cobertura universal de salud. Por lo (...) tanto, el informe es pertinente para cada agente que infl uye en ese camino y en particular para los gobiernos, ya que se encargan de supervisar y guiar el progreso hacia la cobertura universal de salud. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research to improve emergency (...) care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)

El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera ética, fortalecer la ética de la investigación en salud, particularmente en países de ingresos bajos y medios, y promover colaboración entre países (...) del norte y del sur.a Los participantes en el GFBR provenientes de Latinoamérica incluyeron a eticistas, investigadores, miembros de comités de ética y representantes de autoridades sanitarias provenientes de Argentina, Brasil, Chile, Colombia, Ecuador, El Salvador, Guatemala, Honduras, Panamá, Perú, Nicaragua y la República Dominicana. Una legítima preocupación por la protección de las mujeres embarazadas y sus embriones o fetos ha llevado a la mayoría de los países de la Región de las Américas a limitar la realización de estudios con mujeres embarazadas exclusivamente a aquellos estudios específicos sobre el embarazo, y a requerir la exclusión sistemática de las mujeres embarazadas o de las mujeres que quedan embarazadas en el curso del estudio. Ciertamente, a lo largo de la historia de la ética de la investigación, se ha creído erróneamente que proteger a una población es sinónimo de excluirla de los estudios. Se sabe ahora que proceder así implica exponer a riesgos mucho mayores a la población que se busca proteger. El embarazo implica cambios fisiológicos sustantivos e impacta profundamente la manera como el cuerpo metaboliza los medicamentos. Sin embargo, por evitar hacer investigación con mujeres embarazadas, no se ha producido la evidencia científica necesaria para tomar decisiones sobre tratamientos e intervenciones preventivas con dosis eficaces y seguras para ellas y sus embriones o fetos. A manera de ilustración, en el 2001 había en los Estados Unidos apenas más de una docena de medicamentos aprobados para uso en el embarazo (1) y en el 2011 la Food and Drug Administration (FDA) aprobó por primera vez en 15 años un medicamento para su uso en el embarazo (2). Como consecuencia de no haber producido la evidencia necesaria, se pone en riesgo la salud de las mujeres embarazadas cada vez que se les da atención médica. Las mujeres embarazadas se enferman y las mujeres enfermas se embarazan, y no se sabe si los medicamentos que se les da son eficaces o siquiera seguros para ellas y sus embriones o fetos. (shrink)

This report from the WHO Consultative Group on Equity and Universal Health Coverage offers advice on how to make progress fairly towards universal health coverage.