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Codes of medical ethics (codes) are part of a longstanding tradition in which physicians publicly state their core values and commitments to patients, peers, and the public. However, codes are not static. Using the historical evolution of the Canadian Medical Association's Code of Ethics as an illustrative case, we argue that codes are living, socio-historically situated documents that comprise a mix of prescriptive and aspirational content. Reflecting their socio-historical situation, we can expect the upheaval of the COVID-19 pandemic to prompt calls to revise codes. Indeed, Alex John London has argued in favour of specific modifications to the World Medical Association's International Code of Medical Ethics (which has since been revised) in light of moral and scientific failures that occurred during the COVID-19 pandemic. Responding to London, we address the more general question: should codes be modified to reflect lessons drawn from the COVID-19 pandemic or future such upheavals? We caution that codes face limitations as instruments of policy change because they are inherently interpretive and 'multivocal', that is, they usually underdetermine or provide more than one answer to the question, 'What should I do now?' Nonetheless, as both prescriptive and aspirational documents, codes also serve as tools for reflection and deliberation-collective practices that are necessary to engaging with and addressing the moral and scientific uncertainties inherent to medicine.

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OBJECTIVE: To identify the ethical challenges associated with the development and implementation of new tuberculosis (TB) drugs and diagnostics. METHODS: Twenty-three semi-structured qualitative interviews conducted between December 2015 and September 2016 with programme administrators, healthcare workers, advocates, policymakers, and funders based in the Americas, Europe, and Africa. Interviews were analysed using thematic analysis. RESULTS: Divergent interests and responsibilities, coupled with power imbalances, are a primary source of ethical challenges; the uncertain risk profiles of new drugs present an additional one. Although this challenge can be partially mitigated through stringent pharmacovigilance, respondents highlighted that high-burden countries tend to lack the resources to facilitate safe implementation. Increased advocacy and community engagement are considered an ethical imperative for future TB development and implementation. CONCLUSIONS: This project helps identify some of the ethical challenges of new TB technologies. It demonstrates that investigating ethical challenges through qualitative research is one way to apprehend the difficulty of implementing new TB technologies. Addressing this difficulty will require that those in positions of power reconsider their interests in relation to disempowered communities. POLICY IMPLICATIONS: Efforts to build consensus regarding what values should underpin the global governance of TB research, prevention, and care are essential to facilitate the ethical implementation of new TB technologies.

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Prominent tuberculosis (TB) actors are invoking solidarity to motivate and justify collective action to address TB, including through intensified development and implementation (D&I) of technologies such as drugs and diagnostics. We characterize the ethical challenges associated with D&I of new TB technologies by drawing on stakeholder perspectives from 23 key informant interviews and we articulate the ethical implications of solidarity for TB technology D&I. The fundamental ethical issue facing TB technological D&I is a failure within and beyond the TB community to stand in solidarity with persons with TB in addressing the complex sociopolitical contexts of technological D&I. The failure in solidarity relates to two further ethical challenges raised by respondents: skewed power dynamics that hinder D&I and uncertainties around weighing risks and benefits associated with new technologies. Respondents identified advocacy and participatory research practices as necessary to address such challenges and to motivate sustained collective action to accelerate toward TB elimination. We present the first empirical examination of bioethical accounts of solidarity in public and global health. Our study suggests that solidarity allows us better to understand and address the ethical challenges that arrest the D&I of new TB technologies. Solidarity lends credence to policies and practices that address the relational nature of illness and health through collective action.

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Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

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A growing number of countries in sub-Saharan Africa are considering legalizing the growth of genetically modified organisms (GMOs). Furthermore, several projects are underway to develop transgenic crops tailored to the region. Given the contentious nature of GMOs and prevalent anti-GMO sentiments in Africa, a robust ethical analysis examining the concerns arising from the development, adoption, and regulation of GMOs in sub-Saharan Africa is warranted. To date, ethical analyses of GMOs in the global context have drawn predominantly on Western philosophy, dealing with Africa primarily on a material level. Yet, a growing number of scholars are articulating and engaging with ethical theories that draw upon sub-Saharan African value systems. One such theory, Ubuntu, is a well-studied sub-Saharan African communitarian morality. I propose that a robust ethical analysis of Africa's agricultural future necessitates engaging with African moral theory. I articulate how Ubuntu may lead to a novel and constructive understanding of the ethical considerations for introducing GMOs into sub-Saharan Africa. However, rather than reaching a definitive prescription, which would require significant engagement with local communities, I consider some of Ubuntu's broader implications for conceptualizing risk and engaging with local communities when evaluating GMOs. I conclude by reflecting on the implications of using local moral theory in bioethics by considering how one might negotiate between universalism and particularism in the global context. Rather than advocating for a form of ethical relativism, I suggest that local moral theories shed light on salient ethical considerations that are otherwise overlooked.

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The objective of this paper is to identify and articulate ethical considerations to help guide decision-making around the regulation and monitoring of vaccines post-licensure. While these considerations are not intended to be an exhaustive account of the ethical concerns, they can facilitate the explicit examination of ethical issues in this context. We identify the protection of public from harm as the primary consideration, and identify others that help in the discharging of this governmental obligation. Others include: transparency, a publicly acceptable risk-benefit profile, public trust, minimization of stigma, and special obligations to vulnerable populations. Regulators and researchers can use these ethical considerations to help enhance their reasoning and to improve the accountability of their decision-making. These considerations can be used to inform rational deliberations about how to balance the obligation to protect the public from harm with other relevant considerations such as the need to be transparent, while taking into account the contextual features of the situation. Further research and debate on the relevance and refinement of these ethical considerations is desirable.

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