Implementation, compliance, and pandemic legal obligations.

Negotiations ought not focus on enforcement and sanctions.

Equity in the Pandemic Treaty: Access and Benefit-Sharing as a Policy Device or a Rhetorical Device?

Equity is a foundational concept for the new World Health Organization (WHO) Pandemic Treaty. WHO Member States are currently negotiating to turn this undefined concept into tangible outcomes by borrowing a policy mechanism from international environmental law: "access and benefit-sharing" (ABS).

Sovereignty, sanctions, and data sharing under international law.

Pathogen samples and scientific data are bargaining chips in a global argument about who gets what in a pandemic.

International Collaboration to Ensure Equitable Access to Vaccines for COVID-19: The ACT-Accelerator and the COVAX Facility.

Policy Points Equitable access to a COVID-19 vaccine in all countries remains a key policy objective, but experience of previous pandemics suggests access will be limited in developing countries, despite the rapid development of three successful vaccine candidates. The COVAX Facility seeks to address this important issue, but the prevalence of vaccine nationalism threatens to limit the ability of the facility to meet both its funding targets and its ambitious goals for vaccine procurement. A failure to adequately address the underlying lack of infrastructure in developing countries threatens to further limit the success of the COVAX Facility. CONTEXT: Significant effort has been directed toward developing a COVID-19 vaccine, which is viewed as the route out of the pandemic. Much of this effort has coalesced around COVAX, the multilateral initiative aimed at accelerating the development of COVID-19 vaccines, and ensuring they are equitably available in low- and middle-income countries (LMICs). This paper represents the first significant analysis of COVAX, and the extent to which it can be said to have successfully met these aims. METHODS: This paper draws on the publicly available policy documents made available by the COVAX initiatives, as well as position papers and public statements from governments around the world with respect to COVID-19 vaccines and equitable access. We analyze the academic literature regarding access to vaccines during the H1N1 pandemic. Finally, we consider the WHO Global Allocation System, and its principles, which are intended to guide COVAX vaccine deployment. FINDINGS: We argue that the funding mechanism deployed by the COVAX Pillar appears to be effective at fostering at-risk investments in research and development and the production of doses in advance of confirmation of clinical efficacy, but caution that this represents a win-win situation for vaccine manufacturers, providing them with opportunity to benefit regardless of whether their vaccine candidate ever goes on to gain regulatory approval. We also argue that the success of the COVAX Facility with respect to equitable access to vaccine is likely to be limited, primarily as a result of the prevalence of vaccine nationalism, whereby countries adopt policies which heavily prioritize their own public health needs at the expense of others. CONCLUSIONS: Current efforts through COVAX have greatly accelerated the development of vaccines against COVID-19, but these benefits are unlikely to flow to LMICs, largely due to the threat of vaccine nationalism.

Global health security and universal health coverage: from a marriage of convenience to a strategic, effective partnership.

Global health security and universal health coverage have been frequently considered as "two sides of the same coin". Yet, greater analysis is required as to whether and where these two ideals converge, and what important differences exist. A consequence of ignoring their individual characteristics is to distort global and local health priorities in an effort to streamline policymaking and funding activities. This paper examines the areas of convergence and divergence between global health security and universal health coverage, both conceptually and empirically. We consider analytical concepts of risk and human rights as fundamental to both goals, but also identify differences in priorities between the two ideals. We support the argument that the process of health system strengthening provides the most promising mechanism of benefiting both goals.

C-621/15 - W and Others v Sanofi Pasteur: An Example of Judicial Distortion and Indifference to Science.

This case commentary examines the CJEU's recent decision in C-621/15 W and Others v Sanofi Pasteur MSD SNC [2017] ECR I. This commentary critically examines the decision through the lens of the cultural conflict between law and science. We argue that the CJEU's decision reflects both a distortion of scientific knowledge and an improper indifference to the legitimate methods by which scientific knowledge is generated in the context of vaccines. These judicial approaches may, the authors argue, inadvertently fuel the vaccine scepticism that is growing across the developed world, and in particular in Europe.

The Economic Theory of Patent Protection and Pandemic Influenza Vaccines: Do Patents Really Incentivize Innovation in the Field?

The creation of new vaccines is one of the key challenges in the battle against global infectious diseases. Therefore, creating the optimal conditions for innovation in vaccines is one of the most important roles law may undertake in this battle. In relation to pharmaceuticals, the economic theory of patent protection is commonly cited by industry and in the academic literature to justify the patenting of life-saving medicines and vaccines. The economic theory of patent protection holds that innovation occurs due to patents protecting the research and development investment made by the innovator. Proponents of this theory claim that without patents such innovation in medicines and vaccines would occur at a significantly reduced rate. This Article considers the applicability of the economic theory of patent protection to pandemic influenza vaccines. This Article examines a number of factors relevant to patent law, theory, and innovation including: the patent landscape for pandemic influenza vaccines; the market dominance enjoyed by manufacturers; the actual risk posed by imitators making generic vaccines if patent protection were not in place; and, the licensing and regulatory provisions for creating generic vaccines. According to the economic theory of patent protection, a patent incentivizes innovation by providing an innovator with a temporary monopoly regarding their innovation, and by protecting them from the threat posed by imitators who wish to make a cheap replica of the product. However, even without a patent, pandemic influenza vaccine manufacturers are in this position. Due to economies of scale and the complicated regulatory and licensing frameworks relevant to bringing a pandemic influenza vaccine to market, manufacturers are at little to no risk from generic imitators. Moreover, there is a very strong incentive to innovate because pandemic influenza vaccine manufacturers are selling a product for which demand exceeds supply to a captive market of nations and organizations, each of which is hoping to secure as much vaccine as possible. The unique conditions associated with pandemic influenza vaccines appear to provide more of an incentive to innovate and research in this field than the fact that the innovations can be patented.