The global impacts of COVID-19 have been calamitous, unleashing widespread human suffering and exacerbating health crises, all while worsening pre-existing inequalities and transgressing fundamental human rights. Despite earnest pleas from the United Nations and developing nations for an equitable distribution of COVID-19 vaccines, these appeals were largely unheeded. Instead, major pharmaceutical manufacturers and high-income countries (HICs) had maintained a stranglehold on vaccine technology through the safeguarding of intellectual property rights (IPRs), leading to exorbitant pricing and preferential distribution to affluent regions. This vaccine hoarding has left low- and middle-income countries (LMICs) with delayed and insufficient supplies, endangering the lives of the most vulnerable. The stringent enforcement of IPRs mechanisms, rather than aligning with international human rights obligations, has further marginalised the right to life, health, and access to vaccines and medicines, particularly in LMICs. This study ardently advocates for a policy shift that promotes the decolonisation of human rights in the context of IPRs and global health law.

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow.

High pharmaceutical pricing practices in Europe have been increasingly on the radar of the European Union, academia and civil society as a risk to Member State health budgets. It is therefore hardly surprising that, in recent years, competition authorities have resuscitated the excessive pricing prohibition contained in Article 102(a) TFEU. Focusing on this phenomenon, this piece highlights the diverse ways in which the United Brands test has been applied in pharmaceuticals by conducting a comparative study of the decisional practice of national competition authorities. Several observations and arguments are then derived therefrom, demonstrating that, while difficult (most notably in respect to patent-protected products), competition authorities and courts have established sophisticated ways of determining whether a pharmaceutical price is excessive in the sense of Article 102(a) TFEU. These findings should encourage hesitant competition authorities and private plaintiffs to at least carry out preliminary investigations when they suspect excessive pricing in pharmaceuticals is taking place.

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).

The paper surveys the intellectual property (IP) laws of seven Southern African Development Community countries to better understand the nature, scope, and depth of their patent laws with particular focus on their utilisation of TRIPS flexibilities to facilitate pharmaceutical access. The selected countries – Botswana, Malawi, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe – represent a mix of both major and modest economies. While the current literature contains widespread assertions on the impact and effect of TRIPS on access to medicines in these countries and less-developed countries in general, this paper finds that the countries lack explicit and workable provisions implementing key TRIPS flexibilities. Hence, available TRIPS flexibilities have not been well utilised and it is often the complicated and unworkable domestic framework – rather than TRIPS – which becomes the stumbling block to pharmaceutical access. Another major finding is that patents may not be a major impediment in the region given that few patents and even fewer pharmaceutical patents are filed. The paper argues that since the surveyed countries are mainly net IP importers with similar developmental contexts and aspirations, the best approach would be to fully take advantage of existing flexibilities and more aggressively leverage policy space to engender access to cheaper medicines.

A significant issue in combatting the Covid-19 pandemic is the need to enhance developing states’ access to Covid-19 vaccines. The present paper considers the request for a temporary waiver of intellectual property rights in relation to Covid-19 technologies and treatments submitted to the World Trade Organization and analyses a key argument against the proposed waiver: that the compulsory licensing provisions set out in the TRIPS Agreement are sufficiently flexible to help states get access to vaccines. The compulsory licensing flexibilities set out in TRIPS, including the amendment to TRIPS in Article 31bis, are evaluated, to explore whether compulsory licensing could be an effective tool in helping developing states to access Covid-19 vaccines. Key issues are explored from a human rights perspective to examine whether a rights-based approach to the compulsory licensing provisions could offer further insights as to how the provisions could be more workable, to enhance access to medicines and vaccines for developing states.

The current debate over the global distribution of COVID-19 vaccines once again highlights the many shortcomings of the modern intellectual property (IP) system, especially when it comes to equitable access to medicines. This essay argues that the (unspoken) conceptual center of struggles over access to new pharmaceuticals rests in the IP system's colonial legacy, which perceives the world as uncharted territory that is ripe for discovery and ownership. This vision of the world as a blank canvas, or terra nullius, sets aside any other models of ownership and devalues other traditional modes of relating to territory and nature. Several examples show the long-lasting exclusionary effects of this hidden legacy of colonial conquest in the field of public health, ranging from the spiraling price of insulin to the distribution of COVID-19 vaccines to the negotiation of sharing mechanisms for virus samples. In all of these cases, the continuing marginalization of other interests by the IP system can lead to exploitation, without either the “sources” of materials, such as those from whom the samples were taken, or the recipients of the eventual product having any say in matters of price and access. This legacy of fundamental exclusion needs to be recognized and addressed in order to arrive at more equitable solutions to public health emergencies such as the current pandemic.

Access and benefit sharing (ABS) is a transactional mechanism designed to allow countries to trade access to their sovereign genetic resources for monetary and non-monetary benefits, with the ultimate goal of channelling those benefits into sustainable development and environmental conservation. Arguments about how pathogens are not the sort of genetic resources the world ought to conserve eventually gave way to a recognition that pathogens are indeed sovereign genetic resources under the Convention on Biological Diversity and its Nagoya Protocol, and that the ABS transaction may be an effective way to deliver scarce vaccines to developing nations as benefits received in exchange for shared pathogen samples. This article argues that categorising vaccines as benefits given in exchange for access to pathogen samples creates opposing incentives for providers and users of virus samples and undermines the human right to health because it makes that right a commodity to be bought. The provision of pathogen samples to the global research commons and the fair and equitable distribution of medicines should be two parallel public goods to be pursued as goals in and of themselves. We conclude that the linking of these goals through the ABS transaction should be reassessed.

This paper focuses on the drivers steering companies’ behaviour over uses of patented health technologies, taking Covid-19 as a case study. Global equitable access to health technologies is vital to bringing the pandemic under control. Reflecting this, global mechanisms for rightsholders to share intellectual property rights, data and know-how over such health technologies have been developed. Yet, to date, there is limited support from corporate rightsholders for such mechanisms. Instead, health technologies have been licensed largely based on bilateral deals, with vast global inequalities emerging. Given the traditional focus within company law on prioritising shareholders' short-term financial value, we argue that it is unsurprising that many corporate rightsholders adopt a protectionist approach to patents, even in the face of health crises. However, we argue that the tide may now be starting to shift, catalysed by an emergence of engaged shareholders petitioning for socially responsible corporate behaviour, including for uses of intellectual property over health technologies in a manner that more clearly aligns with public interests. If harnessed and encouraged, such engaged shareholder behaviour could present an opportunity to reframe the conception of shareholder value towards one that considers a long-term sustainable approach and ultimately to shift corporate behaviour around uses of intellectual property over health technologies to take public interests into account.