key: cord-0816980-lszibfbc
authors: Abbas, Muhammad Zaheer
title: Treatment of the Novel COVID-19: Why Costa Rica’s Proposal for the Creation of a Global Pooling Mechanism Deserves Serious Consideration?
date: 2020-06-26
journal: J Law Biosci
DOI: 10.1093/jlb/lsaa049
sha: 345109d3dd97ea986aa7f73aa016a8fc896510a7
doc_id: 816980
cord_uid: lszibfbc

The COVID-19 is causing not only deaths and fear but also economic and social harm across the globe. Lockdowns, travel restrictions, quarantines, social distancing, and other strict public-health measures are playing their part in delaying the spread of infection, but a safe and potent vaccine, effective therapeutics, point-of-care diagnostics, and other health products are desperately needed because it may not be practically possible for governments to extend these measures for an indefinite period of time. On March 23, Costa Rica submitted a proposal to the Director-General of the World Health Organization for the creation of a global pooling mechanism in order to facilitate access to and use of intellectual property, trade-secret know how, regulatory data, cell lines, product blueprints, and other proprietary data for technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic. This study critically evaluates Costa Rica’s proposal and endeavours to briefly answer the following questions: Why Costa Rica’s proposal deserves serious consideration? To what extent this proposal addresses some of the key concerns related to the COVID-19? To what extent this proposal is practically feasible?

know-how, cell lines, copyrights and blue prints for manufacturing diagnostic tests, devices, drugs, or vaccines". 4 It further proposes that the global intellectual property pooling mechanism "should provide free access or licensing on reasonable and affordable terms, in every member country". 5 Costa Rica urges the WHO to "develop an initial concise memorandum of understanding on the intent to share rights in technologies funded by the public sector and other relevant actors, and reach out to WHO member states, non-profit institutions, industry and others, to sign such an MoU". 6 

may potentially lead to patentable treatments with further work. 15 Moreover, the exclusive rights granted to patent owners negatively impact the affordable and universal supply of innovative health technologies by allowing supra-competitive pricing and by imposing restrictions on massive-scale manufacturing across the globe.

In this context, there are two key concerns in relation to control and treatment of the COVID-19

pandemic: (1) the urgent development of needed health technologies; and (2) the equitable and affordable access to potential health technologies. As noted by Professor Brook K. Baker, "we need to ensure that the medical technologies will be developed and tested urgently, efficiently, and ethically with maximum degrees of universal and equitable access thereafter to all people in all countries". 16 Costa Rica"s proposal for a global intellectual property pooling mechanism deserves serious consideration because it addresses both of these key concerns.

The COVID-19 pooling mechanism has the potential to accelerate scientific discovery by acting as an intermediary or a clearinghouse that will obtain inbound licenses on the broadest possible range of medically relevant intellectual property rights and data from willing right holders across the globe and then sublicense those rights, on royalty-free basis or on equitable terms, to interested and qualified developers, producers or manufacturers of priority health technologies related to the COVID-19. 17 The transaction costs, bureaucratic processes, and risks will be substantially reduced if the patents and the other rights owned by different owners are combined in a pooling mechanism, which serves as a one-stop-shop for all parties involved. The accelerated access to research outcomes, intellectual property, and shared data will accelerate response to the pandemic by facilitating collaborative follow-on innovation of priority health technologies.

The COVID-19 pooling mechanism has the potential to facilitate equitable and affordable access to priority health technologies in these desperate times. To deal with the global pandemic, governments need abundant sources of supply of health technologies. Supplies from a single producer or a small number of producers will not suffice to cope with the challenge of universal access to needed health technologies. The pooling mechanism has the potential to mobilize the maximum available manufacturing or production capacity and to improve affordable and universal supplies by enabling the interested and qualified developers, producers The entire scientific community of biomedical researchers needs to work collaboratively to find and make available vaccines and treatments. The COVID-19 pooling mechanism would be a powerful demonstration of global solidarity and shared responsibility. 19 Several universities, start-ups, and major biopharmaceutical companies are making their best efforts to develop a safe and potent vaccine, to repurpose existing medicines, and to discover and develop new therapeutics, and diagnostic tests. Their efforts need to be better coordinated in order to avoid duplication of effort. The pooling mechanism will provide a tool to everyone in the world to share every success and every advance related to COVID-19 to speed-up the research aimed at achieving the best results for the benefit of all. WHO is working closely with governments and agencies around the world to promote rapid R&D. These efforts are rooted in our commitment to equitable access for all". 26 

Though its implementation will require substantial work, Cost Rica"s proposal for the pooling mechanism is neither novel nor impractical. Patent pools have been around for a century in various industries like oil refinement, aircraft, and semiconductors. 30 Patent pools, in general, can be described as "private arrangements that enable participants to operate under one another"s patent rights, to manage and administer the pooled rights on a centralized basis, and often to grant licenses of the pooled patents to third parties, with the proceeds split among the pool members according to an agreed formula". 31 Patent pools necessarily include a variety of patents held by different owners. Patent pools facilitate collective management of patent rights. The proposed COVID-19 pool is different from traditional patent pools as it is a broader access pool which collects multiple IP and data rights so as to allow broad licensing and access to competitively priced medical products. 27 Cole, supra note 18. 28 (MPP). 32 The MPP was established in 2010 and it proved to be an effective mechanism in terms of improving access to needed drugs through voluntary licensing arrangements. 33 Several drug manufacturing corporations signed licensing agreements with the MPP. 34 The MPP has signed agreements with ViiV Healthcare, Gilead

Sciences, F. Hoffmann-La Roche, Bristol-Myers Squibb, AbbVie, MSD and the NIH for transferring their patents to the pool. 35 Ellen "t Hoen argues that by participating in the MPP to improve global access to medicines, pharmaceutical companies can expect a reputational boost and a significant improvement in their overall public image. 36 The MPP primarily aimed at aggregating patents, clinical trials data and other IP relating initially to HIV antiretroviral medication and making them available at low or no cost to manufacturers that commit to produce and sell drugs to users in low-and middle-income countries. 37 In 2015, the MPP expanded its mandate to include hepatitis C and tuberculosis treatments. 38 In 2018, the MPP further expanded its mandate to include priority medicines on the WHO Essential Medicines List. 39 On April 3, 2020, the MPP announced to include medicines and diagnostics for the COVID-19 in their licensing pool. 40 46 The WHO"s role, articulated in its constitution, includes leading and coordinating international health work among relevant actors and promoting co-operation among scientific and professional groups. 47 It is clear that the WHO not only has the legal capacity to implement Costa Rica"s proposal but also holds a pivotal role in practical implementation of the proposed pooling mechanism because of constitutional mandate to coordinate efforts in global health.

On May 18, 2020, the World Health Assembly reaffirmed the WHO"s constitutional mandate to act as "the directing and coordinating authority on international health work, and recognizing its key leadership role within the broader United Nations response and the importance of strengthened multilateral cooperation in addressing the COVID-19 pandemic". 48 There is, however, a gap between WHO"s mandate and capabilities which negatively impact the organization"s leadership role in global health. The WHO has limited internal legal and technical capabilities especially in its regional offices. 49 WHO"s inefficient response to the Ebola outbreak in 2014 highlighted its limited capabilities. 50 The COVID-19 pandemic provides an opportunity to the WHO to develop the mandate and economic and political power to become a major force at the intersection of global health, health-related human rights, and international trade. It is time for the WHO to enhance its capabilities and gain confidence of the global community in WHO management by taking timely actions in response to the global threat of COVID-19 pandemic. Keeping in view its leadership role, the WHO should assume the maximum amount of responsibility and properly follow-up on the initiative of COVID-19 patent pool.

This study concludes that there are two key concerns in relation to control and treatment of the COVID-19 pandemic: the urgent development of needed health technologies and the equitable and affordable access to existing and new health technologies. Costa Rica"s proposal for a global intellectual property pooling mechanism deserves serious consideration because it addresses both of these key concerns. The COVID-19 pooling mechanism has the potential to accelerate scientific discovery by acting as a clearinghouse for fast-track and equitable licensing of rights for collaborative follow-on innovation of priority health technologies. This pooling mechanism also has the potential to facilitate equitable and affordable access to potential health

technologies by mobilizing the maximum available global manufacturing capacity as it will enable the interested and qualified developers, producers or manufacturers of priority health technologies to license rights in a nonexclusive manner on royalty-free basis or on equitable terms. This proposal enjoys global support and it is clear from the experience of already existing pooling mechanisms, like the Medicines Patent Pool (MPP), that Costa

Rica"s proposal is very much realistic and practically feasible. It is expected that, in near future, the WHO will take practical measures to implement this proposal for the benefit of the whole global community desperately waiting for a safe, potent, affordable, and universally available Corona vaccine and other needed priority health technologies.

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