This article outlines and compares current and proposed global institutional mechanisms to increase equitable access to COVID-19 vaccines, focusing on their institutional and operational complementarities and overlaps. It specifically considers the World Health Organization's (WHO’s) COVAX (COVID-19 Vaccines Global Access) model as part of the Access to COVID-19 Tools Accelerator (ACT-A) initiative, the WHO’s COVID-19 Technology Access Pool (C-TAP) initiative, the proposed TRIPS (Trade-Related Aspects of Intellectual Property Agreement) intellectual property waiver and other proposed WHO and World Trade Organization technology (...) transfer proposals. We argue that while various individual mechanisms each have their specific individual merits—and in some cases weaknesses—overall, many of these current and proposed mechanisms could be highly complementary if used together to deliver equitable global access to vaccines. Nonetheless, we also argue that there are risks posed by the proliferation of proposals in this context, including the potential to disperse stakeholder attention or to delay decisive action. Therefore, we argue that there is now a clear need for concerted global multilateral action to recognise the complementarities of specific models and to provide a pathway for collaboration in attaining global equitable access to vaccines. The institutional infrastructure or proposals to achieve this amply exist at this point in time—but much greater cooperation from industry and clear, decisive and coordinated action from states and international organisations are urgently needed. (shrink)

In June 2020, Gilead agreed to provide the USA with 500 000 doses of remdesivir—an antiviral drug which at that time was percieved to show promise in reducing the recovery time for patients with COVID-19. This quantity represented Gilead’s then full production capacity for July and 90% of its capacity for August and September. Similar deals are evident around access to proposed vaccines for COVID-19, and such deals are only likely to increase. These attempts to secure preferential access to medicines (...) and vaccines, so-called vaccine/treatment nationalism, jeopardise supplies of life-saving treatments and vaccines available elsewhere, and jeopardise global equitable distribution of such vaccines/treatments more generally. Much of the focus to date has been on States’ role in negotiating such deals. However, such developments also demonstrate the power patent holders have in controlling access to life-saving healthcare, determining who obtains access first and at what price. This article argues that the extent of control currently given to patent holders for COVID-19 must be questioned. This article demonstrates that patents have significant implications for healthcare acting as private governance tools over patented inventions. It is only by greater probing of patent holders’ role in delivering access to medicines, diagnostics and vaccines for COVID-19 that equitable global equitable access can be achieved. (shrink)

Genome editing enables very accurate alterations to DNA. It promises profound and potentially disruptive changes in healthcare, agriculture, industry, and the environment. This paper presents a multidisciplinary analysis of the contemporary development of genome editing and the tension between continuity and change. It draws on the idea that actors involved in innovation are guided by “sociotechnical regimes” composed of practices, institutions, norms, and cultural beliefs. The analysis focuses on how genome editing is emerging in different domains and whether this marks (...) continuity or disruption of the established biotechnology regime. In conclusion, it will be argued that genome editing is best understood as a technology platform that is being powerfully shaped by this existing regime but is starting to disrupt the governance of biotechnology. In the longer term is it set to converge with other powerful technology platforms, which together will fundamentally transform the capacity to engineer life. (shrink)

This article provides an ethical critique of the Good Clinical Practice (GCP) and Declaration of Helsinki (DoH) documents. While the previous criticisms of GCP are entirely correct, there is much more wrong with the document than has previously been acknowledged, including a circular definition and an astonishing vagueness about ethical principles. In addition to its failure to provide adequate ethical protection of participants, the procedurally dense nature of GCP lends itself to a box-ticking culture where important ethical issues are overlooked (...) because they are not ‘mentioned on the form’. In contrast, the DoH is a much more effective ethical document, but actually goes too far in one respect. It transpires that the best ethical guidelines for clinical research would be neither over-prescriptive in regard to particular ethical issues (as the DoH is) nor neglectful of them (as GCP is); correctly framed ethical principles will provide sufficient protection to participants while also ensuring a culture of ethicovigilance in clinical trials. (shrink)

Cellular differentiation is often accompanied by the expression of specialized plasma membrane proteins which accumulate in discrete regions. The biogenesis of these specialized membrane domains involves the assembly and co‐localisation of a spectrin‐based membrane skeleton. While the constituents of the membrane skeleton in non‐erythroid cells are often immunologically related to erythroid spectrin, ankyrin, and protein 4.1, there are structural and functional differences between the isoforms of these membrane skeleton polypeptides, as well as highly variable patterns of expression during cellular differentiation. (...) We consider this heterogeneity of structure and expression during development in the context of the hypothesis that non‐erythroid spectrin, ankyrin, and protein 4.1 are involved in the formation of specialized membrane domains. (shrink)