'An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study' by James Scheibner, Jane Nielsen and Dianne Nicol in (2022) 9(2) Journal of Law and the Biosciences comments
This article posits that Australia, as an affluent country with increasing capacity to manufacture vaccines, has an obligation to assist its regional (and global) counterparts in implementing vaccination programs that protect their populations. First, the article explores the capacity of high-income nations to meet their obligations, assist their neighbours and refrain from vaccine nationalism. This inquiry involves an analysis of the optimal ethical strategy for distributing vaccines globally, and the role that Australia might play in this distribution strategy. Secondly, the article examines the intellectual property landscape for vaccines in Australia, focusing on the patents that cover vaccine compositions and manufacturing techniques (recognizing the potential for know-how and access to materials as well as patents to affect manufacturing capacity). This article then discusses the strategies the Australian Government has at its disposal to counter potential intellectual property impediments whilst complying with existing obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), as an ethically appropriate response to the pandemic. This article also considers whether a so-called TRIPS waiver could provide better options and concludes that the challenge of compelling disclosure of know-how remains.
The authors argue
The race for effective vaccine candidates to fight the current COVID-19 pandemic has been like no other vaccine race in history. The extent of impacted populations, coupled with the rapid transmissibility of the virus, has prompted a push for vaccines on both public and private fronts that is unique in scale. In recognition of the fact that many nations lack both the capacity to manufacture vaccines and the funds to purchase them at market prices, COVAX was established in 2020 by the WHO, along with The Vaccine Alliance (GAVI) and the Coalition for Economic Preparedness Innovations (CEPI). The stated purpose of COVAX is to ‘… support the research, development and manufacturing of a wide range of COVID-19 vaccine candidates, and negotiate their pricing’. To this end, COVAX negotiated supply agreements with vaccine manufacturers in earlier phases of the pandemic.
Whilst COVAX was meant to be the primary avenue for the global vaccine rollout in response to COVID, the extent to which this goal was achieved was hampered by a number of factors. One significant weakness was that nations which had secured supply of vaccines via bilateral agreements only decided to make them available once they had become surplus to their own needs. Rutschman notes that if governments engage in this form of ‘vaccine nationalism’, reserving vaccine supplies for their own population, this will undermine public health outcomes in other nations, particularly low- and middle-income nations. The tendency for nations in possession of vaccines surplus to their requirements to enter into bilateral agreements also appears to have increased the price of vaccines available via COVAX.
This article uses Australia as a case study to examine the role and responsibility of high-income nations in contributing to the global effort to suppress this pandemic and respond to future pandemics. We suggest that nations such as Australia have an ethical responsibility to engage in vaccine distribution grounded in moral cosmopolitanism extending beyond state borders. We recognize that this duty should include provision of assistance to low- and middle-income nations to assist them in developing their own domestic manufacturing capabilities, to fulfill their moral nationalist obligations to their own citizens. However, the primary focus of this article is not so much on the ways in which nations like Australia could fulfil this duty (which we recognize as a laudable long-term goal). Instead, this article focuses specifically on the responsibility and freedom that nations like Australia possess to manufacture vaccines for supply to those nations in response to pandemic diseases such as COVID-19. Through an assessment of the intellectual property landscape associated with approved vaccines, this article concludes that intellectual property rights over vaccines, including patents, know-how and bilateral licensing agreements, do have the capacity to hinder domestic manufacture of vaccines. As such, high-income nations like Australia need to consider utilizing the full armoury of current and proposed flexibilities under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) in attempting to fulfil their global responsibilities.
The first section of this article involves an examination of what might be the optimal, ethical strategy for distributing vaccines globally, and the role that Australia can play in this distribution strategy. The Australian Government’s primary focus was on vaccinating the Australian population, although it has also assisted with the global vaccination effort. These programs have involved both formalized global vaccine-sharing commitments and bilateral arrangements with Australia’s nearest neighbours. Australia is a signatory to COVAX, and in this role the Government has committed to contribute to the distribution of vaccines for lower-income nations through the COVAX Advanced Market Commitment scheme. Bilaterally, the Australian Government responded to acute COVID crises in India through donation of materials and equipment and in Papua New Guinea (PNG) through an initial donation of 8000 doses of AstraZeneca vaccine. Notwithstanding the importance of these contributions to the welfare of peoples in the region, the potential negative impact of bilateral arrangements on the COVAX response should not go unmentioned.
In addition, the Australian Government was an early signatory to contracts with vaccine producers to allow it to gain access to large quantities of manufactured vaccine. Given that the Australian Commonwealth Serum Laboratories (CSL) already had existing capacity to manufacture viral vector vaccines, the Government also made an early decision to contract CSL as a producer of AstraZeneca’s Vaxzervria vaccine. However, CSL indicated that it would not renew this contract in late 2021. The Government has since also announced an intention to build capacity to manufacture mRNA vaccines in collaboration with the State of Victoria and Moderna, with a view to commencing manufacture in 2024. As such the Government appears to be prepared to work with the major vaccine producers in formulating its plans for domestic manufacture of COVID vaccines into the future.
In parallel, the Australian Government has expressed some support for a draft waiver proposed by the so-called Quadrilateral or ‘Quad’ of the United States, European Union, India and South Africa, currently before the TRIPS Council, to waive some COVID-related intellectual property rights. This proposal, initially sponsored by India and South Africa, sought to temporarily waive TRIPS provisions with respect to relevant intellectual property rights associated with COVID-19 vaccines, diagnostics and therapeutic tools. As originally intended, the waiver might have applied not only to formal intellectual property rights, such as patents, copyright and geographical indications, but also to ‘informal’ intellectual property rights, such as trade secrets and know-how. However, the current waiver being considered is significantly narrower, and only applies to certain patents on COVID-19 vaccines.
If the waiver is passed by the TRIPS Council and implemented domestically, intellectual property rights holders would no longer be able to enforce relevant rights against other manufacturers or nations producing versions of their therapeutics. Proponents of the waiver argue this needs to be implemented because intellectual property rights have been used to deter developed nations from fully participating in the global effort to defeat the COVID-19 pandemic. It should be noted, however, that there are other flexibilities already available under TRIPS, particularly those relating to uses without authorization under TRIPS Article 31, which could be used legitimately either by governments or by third-party manufacturers without authorization from the rights holders.
The impact of intellectual property rights on the capacity of governments in developed nations to distribute COVID-19 vaccines to low- and middle-income nations, together with the utility of the TRIPS waiver, is a central theme of the later sections of this article. This article examines the extent to which intellectual property rights have impeded Australia’s capacity to contribute to this strategy in a meaningful way. This examination includes an analysis of the Australian intellectual property landscape surrounding the main vaccine candidates that have reached clinical trials and/or been approved for clinical use. The final section of the article analyses potential workarounds to intellectual property impediments (focusing particularly on existing legislative provisions permitted under TRIPS), to ascertain whether Australia is in fact in a legitimate position to assist other nations in surviving this pandemic and future pandemics.
