Pandemics, intellectual property and 'our economy': A worldview analysis of Canada's role in compromising global access to COVID-19 vaccines.

Despite self-congratulatory rhetoric, Canada compromised COVID-19 vaccine equity with policies impeding a proposed global waiver of vaccine intellectual property (IP) rules. To learn from Canada's vaccine nationalism we explore the worldview - a coherent textual picture of the world - in a sample of Government of Canada communications regarding global COVID-19 vaccine sharing. Analysed documents portray risks and disparities as unrelated to the dynamics and power relations of the Canadian and international economies. Against this depoliticised backdrop, economic growth fueled by strict IP rules and free trade is advanced as the solution to inequities. Global vaccine access and distribution are pursued via a charity-focused public-private-partnership approach, with proposals to relax international IP rules dismissed as unhelpful. Rather than a puzzling lapse by a good faith 'middle power', Canada's obstruction of global COVID-19 vaccine equity is a logical and deliberate extension of dominant neoliberal economic policy models. Health sector challenges to such models must prioritise equity in global pandemic governance via politically assertive and less conciliatory stances towards national governments and multilateral organisations. Mobilisation for health equity should transform the overall health-damaging macroeconomic model, complementing efforts based on specific individual health determinants or medical technologies.

The World Health Organization was born as a normative agency: Seventy-five years of global health law under WHO governance.

The World Health Organization (WHO) was born as a normative agency and has looked to global health law to structure collective action to realize global health with justice. Framed by its constitutional authority to act as the directing and coordinating authority on international health, WHO has long been seen as the central actor in the development and implementation of global health law. However, WHO has faced challenges in advancing law to prevent disease and promote health over the past 75 years, with global health law constrained by new health actors, shifting normative frameworks, and soft law diplomacy. These challenges were exacerbated amid the COVID-19 pandemic, as states neglected international legal commitments in national health responses. Yet, global health law reforms are now underway to strengthen WHO governance, signaling a return to lawmaking for global health. Looking back on WHO's 75th anniversary, this article examines the central importance of global health law under WHO governance, reviewing the past successes, missed opportunities, and future hopes for WHO. For WHO to meet its constitutional authority to become the normative agency it was born to be, we offer five proposals to reestablish a WHO fit for purpose: normative instruments, equity and human rights mainstreaming, sustainable financing, One Health, and good governance. Drawing from past struggles, these reforms will require further efforts to revitalize hard law authorities in global health, strengthen WHO leadership across the global governance landscape, uphold equity and rights at the center of global health law, and expand negotiations in global health diplomacy.

The WHO's 75th anniversary: WHO at a pivotal moment in history.

The World Health Organisation (WHO) was inaugurated in 1948 to bring the world together to ensure the highest attainable standard of health for all. Establishing health governance under the United Nations (UN), WHO was seen as the preeminent leader in public health, promoting a healthier world following the destruction of World War II and ensuring global solidarity to prevent disease and promote health. Its constitutional function would be 'to act as the directing and coordinating authority on international health work'. Yet today, as the world commemorates WHO's 75th anniversary, it faces a historic global health crisis, with governments presenting challenges to its institutional legitimacy and authority amid the ongoing COVID-19 pandemic. WHO governance in the coming years will define the future of the Organisation and, crucially, the health and well-being of billions of people across the globe. At this pivotal moment, WHO must learn critical lessons from its past and make fundamental reforms to become the Organisation it was meant to be. We propose reforms in WHO financing, governance, norms, human rights and equity that will lay a foundation for the next generation of global governance for health.

A Global Health Law Trilogy: Transformational Reforms to Strengthen Pandemic Prevention, Preparedness, and Response.

This is a pivotal moment in the global governance response to pandemic threats, with crucial global health law reforms being undertaken simultaneously in the coming years: the revision of the International Health Regulations, the implementation of the GHSA Legal Preparedness Action Package, and the negotiation of a new Pandemic Treaty. Rather than looking at these reforms in isolation, it will be necessary to examine how they fit together, considering: how these reforms can complement each other to support pandemic prevention, preparedness, and response; what financing mechanisms are necessary to ensure sustainable health governance; and why vital norms of equity, social justice, and human rights must underpin this new global health system.

International treaties have mostly failed to produce their intended effects.

There are over 250,000 international treaties that aim to foster global cooperation. But are treaties actually helpful for addressing global challenges? This systematic field-wide evidence synthesis of 224 primary studies and meta-analysis of the higher-quality 82 studies finds treaties have mostly failed to produce their intended effects. The only exceptions are treaties governing international trade and finance, which consistently produced intended effects. We also found evidence that impactful treaties achieve their effects through socialization and normative processes rather than longer-term legal processes and that enforcement mechanisms are the only modifiable treaty design choice with the potential to improve the effectiveness of treaties governing environmental, human rights, humanitarian, maritime, and security policy domains. This evidence synthesis raises doubts about the value of international treaties that neither regulate trade or finance nor contain enforcement mechanisms.

Between rules and resistance: moving public health emergency responses beyond fear, racism and greed.

In times of a public health emergency, lawyers and ethicists play a key role in ensuring that government responses, such as travel restrictions, are both legally and ethically justified. However, when travel bans were imposed in a broadly discriminatory manner against southern African countries in response to the Omicron SARS-CoV-2 variant in late 2021, considerations of law, ethics or science did not appear to guide politicians' decisions. Rather, these bans appeared to be driven by fear of contagion and electoral blowback, economic motivations and inherently racist assumptions about low-income and middle-income countries (LMICs). With a new pandemic treaty and amendments to the WHO's International Health Regulations (IHR) on the near-term horizon, ethics and international law are at a key inflection point in global health governance. Drawing on examples of bordering practices to contain contagion in the current pandemic and in the distant past, we argue that the current IHR is not adequately constructed for a just and equitable international response to pandemics. Countries impose travel restrictions irrespective of their need or of the health and economic impact of such measures on LMICs. While the strengthening and reform of international laws and norms are worthy pursuits, we remain apprehensive about the transformative potential of such initiatives in the absence of collective political will, and suggest that in the interim, LMICs are justified in seeking strategic opportunities to play the same stark self-interested hardball as powerful states.

A virus unites the world while national border closures divide it: Epidemiologic, legal, and political analysis on border closures during COVID-19.

This article critically examines the use of national border closures at the outset of the COVID-19 pandemic. After explaining why targeted border closures generally do not work and how they violated international law at the time, we examine the unprecedented case of total border closures. Positing that since the current instruments and institutions of global health governance did not anticipate this phenomenon, the legality of total border closures rests on less certain grounds. Then, after asking why nearly every government implemented some form of border closure in March 2020 if neither science nor law provided adequate motivation for their use, we conclude that in the face of a global health emergency, border closures represent an opportunity for political leaders to show determined action, redirect blame to other jurisdictions, and reinforce nationalism. We proceed to argue that both targeted and total border closures have profound legal, epidemiological, and political significance as performances that contradict global realities while undermining notions of global solidarity. Such political theatre means that citizens must weigh these consequences against any perceived benefits of border closures as they would any other politically driven government action, and contest and challenge them appropriately. Citizens must not unduly defer to scientists or lawyers on early COVID-19 border closures because these were primarily political-not scientific or legal-decisions. In this vein, we conclude with some guiding political considerations for scrutinizing government decisions to close borders and observations for the future of global health cooperation during infectious disease outbreaks.

Health and human rights are inextricably linked in the COVID-19 response.

To mitigate the spread of COVID-19, governments throughout the world have introduced emergency measures that constrain individual freedoms, social and economic rights and global solidarity. These regulatory measures have closed schools, workplaces and transit systems, cancelled public gatherings, introduced mandatory home confinement and deployed large-scale electronic surveillance. In doing so, human rights obligations are rarely addressed, despite how significantly they are impacted by the pandemic response. The norms and principles of human rights should guide government responses to COVID-19, with these rights strengthening the public health response to COVID-19.

Decoding disclosure: Comparing conflict of interest policy among the United States, France, and Australia.

"Sunshine" policy, aimed at making financial ties between health professionals and industry publicly transparent, has recently gone global. Given that transparency is not the sole means of managing conflict of interest, and is unlikely to be effective on its own, it is important to understand why disclosure has emerged as a predominant public policy solution, and what the effects of this focus on transparency might be. We used Carol Bacchi's problem-questioning approach to policy analysis to compare the Sunshine policies in three different jurisdictions, the United States, France and Australia. We found that transparency had emerged as a solution to several different problems including misuse of tax dollars, patient safety and public trust. Despite these differences in the origins of disclosure policies, all were underpinned by the questionable assumption that informed consumers could address conflicts of interest. We conclude that, while transparency reports have provided an unprecedented opportunity to understand the reach of industry within healthcare, policymakers should build upon these insights and begin to develop policy solutions that address systemic commercial influence.

Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

AIMS: This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. METHODS: Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. RESULTS: There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001. CONCLUSIONS: Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators.