Decolonising global health: why the new Pandemic Agreement should have included the principle of subsidiarity.

The negotiations for the WHO Pandemic Agreement have brought attention to issues of racism and colonialism in global health. Although the agreement aims to promote global solidarity, it fails to address these deeply embedded problems. This Viewpoint argues that not including the principle of subsidiarity into Article 4 of the agreement as a pragmatic strategy was a missed opportunity to decolonise global health governance and promote global solidarity. Subsidiarity, as a structural principle, empowers local units to make decisions and address issues at their level, fostering collaboration, coordination, and cooperation. By integrating subsidiarity, the agreement could have ensured contextually appropriate responses, empowered local communities, and achieved justice in global health. This paper discusses the elements of subsidiarity-namely, agency and non-abandonment-and highlights the need to strike a balance between them. It also maps the principle of subsidiarity within the Pandemic Agreement, emphasising the importance of creating a practical framework for its implementation. By integrating subsidiarity into the agreement, a just and decolonialised approach to pandemic prevention and response could have been closer to being realised, promoting global solidarity and addressing health inequities.

Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research.

BACKGROUND: The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. METHODS: The GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was "Ethics of AI in Global Health Research". The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. RESULTS: We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. CONCLUSIONS: The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

Digital tools for youth health promotion: principles, policies and practices in sub-Saharan Africa.

Although digital health promotion (DHP) technologies for young people are increasingly available in low- and middle-income countries (LMICs), there has been insufficient research investigating whether existing ethical and policy frameworks are adequate to address the challenges and promote the technological opportunities in these settings. In an effort to fill this gap and as part of a larger research project, in November 2022, we conducted a workshop in Cape Town, South Africa, entitled 'Unlocking the Potential of Digital Health Promotion for Young People in Low- and Middle-Income Countries'. The workshop brought together 25 experts from the areas of digital health ethics, youth health and engagement, health policy and promotion and technology development, predominantly from sub-Saharan Africa (SSA), to explore their views on the ethics and governance and potential policy pathways of DHP for young people in LMICs. Using the World Café method, participants contributed their views on (i) the advantages and barriers associated with DHP for youth in LMICs, (ii) the availability and relevance of ethical and regulatory frameworks for DHP and (iii) the translation of ethical principles into policies and implementation practices required by these policies, within the context of SSA. Our thematic analysis of the ensuing discussion revealed a willingness to foster such technologies if they prove safe, do not exacerbate inequalities, put youth at the center and are subject to appropriate oversight. In addition, our work has led to the potential translation of fundamental ethical principles into the form of a policy roadmap for ethically aligned DHP for youth in SSA.

Proposed Principles for International Bioethics Conferencing: Anti-Discriminatory, Global, and Inclusive.

This paper opens a critical conversation about the ethics of international bioethics conferencing and proposes principles that commit to being anti-discriminatory, global, and inclusive. We launch this conversation in the Section, Case Study, with a case example involving the International Association of Bioethics' (IAB's) selection of Qatar to host the 2024 World Congress of Bioethics. IAB's choice of Qatar sparked controversy. We believe it also may reveal deeper issues of Islamophobia in bioethics. The Section, Principles for International Bioethics Conferencing, sets forth and defends proposed principles for international bioethics conferencing. The Section, Applying Principles to Site Selection applies the proposed principles to the case example. The Section, Applying Principles Beyond Site Selection addresses other applications of the proposed principles. The Section, Objections responds to objections. We close (in the Section, Conclusion) by calling for a wider discussion of our proposed principles. One-Sentence Capsule Summary: How should bioethicists navigate the ethics of global bioethics conferencing?

Preparing ethical review systems for emergencies: next steps.

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

The importance of getting the ethics right in a pandemic treaty.

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical-they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles.

Equitable global allocation of monkeypox vaccines.

With the world grappling with continued spread of monkeypox internationally, vaccines play a crucial role in mitigating the harms from infection and preventing spread. However, countries with the greatest need - particularly historically endemic countries with the highest monkeypox case-fatality rates - are not able to acquire scarce vaccines. This is unjust, and requires rectification through equitable allocation of vaccines globally. We propose applying the Fair Priority Model for such allocation, which emphasizes three key principles: 1) preventing harm; 2) prioritizing the disadvantaged; and 3) treating people with equal moral concern. Post-exposure prophylaxis (PEPV) has the most potential to mitigate harm, and so ensuring countries have sufficient supply for PEPV should be the first priority. And historically endemic countries, which face disadvantages that compound potential harms from monkeypox, should be the first recipients of such vaccines. Once sufficient supply is allocated for countries to apply PEPV, global allocation could move on to pre-exposure prophylaxis (PrEP), again prioritizing historically endemic countries first before distribution to the rest of the global community, based on projected number of cases and vulnerability to harm.

Rethinking solidarity towards equity in global health: African views.

When the COVID-19 pandemic first took the world by storm, the World Health Organization (WHO) issued a Solidarity Call to Action to realize equitable global access to COVID-19 health technologies through pooling of knowledge, intellectual property and data. At the dawn of 2022, 70% of rich countries' populations were vaccinated but only 4.6% of poor countries (Our World In Data, Coronavirus (COVID-19) vaccinations, 2022). Vaccine nationalism and rampant self-interest grew and our ineffective global response led to new variants of concern - like Omicron - emerging. Rather than abandon the idea of solidarity in global health, we believe that the international community must embrace it. Solidarity, with its emphasis on relationality and recognition of similarities, could offer fertile ground for building an ethical framework for an interconnected and interdependent world. Such a framework would be better than a framework that focuses principally on individual entitlements. To defend this view, we draw on African relational views of personhood and morality. When humans are conceived of as essentially relational beings, solidarity occupies a central role in moral behaviour. We argue that part of the reason appeals to solidarity have failed may be traced to an inadequate conceptualization of solidarity. For as long as solidarity remains a beautiful notion, practiced voluntarily by generous and kindhearted persons, in a transient manner to respond to specific challenges, it will never be able to offer an adequate framework for addressing inequities in global health in a systematic and permanent way. Drawing on this understanding of solidarity, we propose pathways to respond creatively to the risks we face to ensure equitable access to essential health for all.

Pandemic preparedness and response: beyond the Access to COVID-19 Tools Accelerator.

Nationalism has trumped solidarity, resulting in unnecessary loss of life and inequitable access to vaccines and therapeutics. Existing intellectual property (IP) regimens, trade secrets and data rights, under which pharmaceutical firms operate, have also posed obstacles to increasing manufacturing capacity, and ensuring adequate supply, affordable pricing, and equitable access to COVID-19 vaccines and other health products in low-income and middle- income countries. We propose: (1) Implementing alternative incentive and funding mechanisms to develop new scientific innovations to address infectious diseases with pandemic potential; (2) Voluntary and involuntary initiatives to overcome IP barriers including pooling IP, sharing data and vesting licences for resulting products in a globally agreed entity; (3) Transparent and accountable collective procurement to enable equitable distribution; (4) Investments in regionally distributed research and development (R&D) capacity and manufacturing, basic health systems to expand equitable access to essential health technologies, and non-discriminatory national distribution; (5) Commitment to strengthen national (and regional) initiatives in the areas of health system development, health research, drug and vaccine manufacturing and regulatory oversight and (6) Good governance of the pandemic prevention, preparedness and response accord. It is important to articulate principles for deals that include reasonable access conditions and transparency in negotiations. We argue for an equitable, transparent, accountable new global agreement to provide rewards for R&D but only on the condition that pharmaceutical companies share the IP rights necessary to produce and distribute them globally. Moreover, if countries commit to collective procurement and fair pricing of resulting products, we argue that we can greatly improve our ability to prepare for and respond to pandemic threats.

Towards a new model of global health justice: the case of COVID-19 vaccines.

This paper questions an exclusively state-centred framing of global health justice and proposes a multilateral alternative. Using the distribution of COVID-19 vaccines to illustrate, we bring to light a broad range of global actors up and down the chain of vaccine development who contribute to global vaccine inequities. Section 1 (Background) presents an overview of moments in which diverse global actors, each with their own priorities and aims, shaped subsequent vaccine distribution. Section 2 (Collective action failures) characterises collective action failures at each phase of vaccine development that contributed to global vaccine disparities. It identifies as critical the task of establishing upstream strategies to coordinate collective action at multiple stages across a range of actors. Section 3 (A Multilateral model of global health governance) takes up this task, identifying a convergence of interests among a range of stakeholders and proposing ways to realise them. Appealing to a responsibility to protect (R2P), a doctrine developed in response to human rights atrocities during the 1990s, we show how to operationalise R2P through a principle of subsidiarity and present ethical arguments in support of this approach.

The hermeneutics of recovery: Facilitating dialogue between African and Western mental health frameworks.

The widespread use of faith-based and traditional healing for mental disorders within African contexts is well known. However, normative responses tend to fall within two camps: on one hand, those oriented towards the biomedical model of psychiatry stress the abuses and superstition of such healing, whilst critics adopting a more 'local' perspective have fundamentally challenged the universalist claims of biomedical diagnostic categories and psychiatric treatments. What seemingly emerges is a dichotomy between those who endorse more 'universalist' or 'relativist' approaches as an analytical lens to the challenges of the diverse healing strands within African contexts. In this article, we draw upon the resources of philosophy and existing empirical work to challenge the notion that constructive dialogue cannot be had between seemingly incommensurable healing practices in global mental health. First, we suggest the need for much-needed conceptual clarity to explore the hermeneutics of meaning, practice, and understanding, in order to forge constructive normative pathways of dialogue between seemingly incommensurable values and conceptual schemas around mental disorder and healing. Second, we contextualise the complex motives to emphasise difference amongst health practitioners within a competitive healing economy. Finally, we appeal to the notion of recovery as discovery as a fruitful conceptual framework which incorporates dialogue, comparative evaluation, and cross-cultural enrichment across divergent conceptualisations of mental health.

Global sharing of COVID-19 therapies during a "New Normal".

This paper argues for global sharing of COVID-19 treatments during the COVID-19 pandemic and beyond based on principles of global solidarity. It starts by distinguishing two types of COVID-19 treatments and models sharing strategies for each in small-group scenarios, contrasting groups that are solidaristic with those composed of self-interest maximizers to show the appeal of solidaristic reasoning. It then extends the analysis, arguing that a similar logic should apply within and between nations. To further elaborate global solidarity, the paper distinguishes morally voluntary, sliding-scale, and mandatory versions. It argues for an all-hands-on-deck approach and gives examples to illustrate. The paper concludes that during the COVID-19 crisis, global solidarity is a core value, and global sharing of COVID-19 treatments should be considered a duty of justice, not of charity.

WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations.

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.