The global context
Given that it is broadly agreed that universal access to quality healthcare is one of the foremost and urgent global challenges facing humanity, especially after the onset of COVID-19, it is critical that the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement of the World Trade Organisation (WTO) is revisited with a fresh perspective. This article will focus on the TRIPS Agreement and its implications for public health and universal access to quality healthcare.
The TRIPS Agreement aims at establishing minimum standards of intellectual property rights, with a scope covering all products and processes in all technologies. The length of patent protection is 20 years with exceptions limited to very specific cases. Provisions in the agreement that protect intellectual property are specific, binding, and actionable.
The TRIPS Agreement aims at establishing minimum standards of intellectual property rights, with a scope covering all products and processes in all technologies.
The Agreement has been controversial from its very origin, particularly in the health context, because it was designed primarily to benefit Big Pharma and other industries and their patent regimes. This has come at the expense of access to affordable drugs and medical equipment, since their prices are higher than they would otherwise have been. TRIPS also restricts reverse engineering by countries and companies with the capacity to produce generic versions of patented drugs. There are also significantly increased waiting times for the availability of low-cost generic versions of patented drugs because of the length of patent protections provided, which disproportionately benefits
powerful companies that have research capacity located primarily in the United States (US) and Europe while disadvantaging developing countries and their citizens. This has also had negative implications for newly industrialising economies with significant generic pharmaceutical manufacturing capacities—like India—and those who rely on them for access to affordable medicines, particularly vulnerable or low-income countries in Africa and elsewhere.
TRIPS in trade agreements
For these reasons, amongst others, there were numerous critiques and protests more than two decades ago against TRIPS’ inclusion in the WTO, especially at the failed 1999 ministerial meeting in Seattle and at the 2001 WTO Doha Round. Despite this, the powerful global pharma lobby represented by the US Trade Representative and many European Union governments and Switzerland succeeded in getting an agreement on a version of TRIPS, which was neither good for affordable access to medicines nor for the human right to universal access to health.
Protests and pressures for a more humane, development-friendly, and flexible Agreement led to the Doha Declaration on TRIPS and Public Health, reaffirming the right of developing countries to interpret the Agreement through a public health lens. Although an important milestone in the TRIPS debate, the Agreement remains asymmetric. COVID-19 has once again brought the controversies surrounding TRIPS to the global centre stage, also raising the unsuitability of including intellectual property (IP) in trade bargaining and negotiation contexts such as the WTO, or worse, in more asymmetric Free Trade Agreements (FTAs). The latter, especially the US-led ones, have gone beyond the WTO with TRIPS-PLUS provisions undermining even what was agreed on at the 2001 WTO Doha ministerial meeting.
The TRIPS Agreement has come into effect even for the least developed countries, who were, at that time,given a waiver during a grace implementation period of over a decade.
TRIPS and the COVID-19 “test”
More than two decades after the WTO’s Doha Round, the TRIPS Agreement has come into effect even for the least developed countries, who were, at that time,given a waiver during a grace implementation period of over a decade.
A key question today is whether the WTO can pass the COVID-19 “test”, which, by all serious accounts, it has, thus far, failed. This is most clearly evidenced by the dilution of the joint
India–South Africa TRIPS waiver proposal (October 2020), which relied on Article IX of the WTO Agreement to address shortages of products required for the prevention, control, and treatment of COVID-19. This proposal, made to the WTO TRIPS Council, suggested that the application of certain provisions of the TRIPS Agreement be waived for the duration of the pandemic to facilitate wider access to technologies necessary for the production of vaccines and medicines. There were 63 co-sponsors while more than 105 WTO members supported this proposal. It surprisingly received limited support from even the US in May 2021, one of TRIPS’ strongest advocates. This resulted in additional support from other wealthy countries such as Australia, Canada, and Norway, and a revised version of the original India-South Africa proposal. Despite this, the waiver proposal, blocked at the council for months by the United Kingdom, European Union (EU) and Switzerland despite the urgency of the global COVID-19 health crisis, continued to be negotiated for another year. The
version agreed to, after 18 months of negotiations, in June 2022, at the 12th WTO Ministerial Conference was very different from the original India-South Africa proposal, falling well below the pass mark since it waived only one provision of the TRIPS Agreement—allowing the export of vaccines under a compulsory license. The original proposal provided full freedom for members to remove IP barriers on all COVID-19 response tools, not just vaccines.
India and South Africa allegedly abandoned their own proposal under EU pressure since the Agreement excludes therapeutics and diagnostics, crucial for COVID-19 prevention, control, and treatment.
Nevertheless, it was agreed in June that discussion would continue on the extension of the Agreement to include coverage of therapeutic and diagnostics, with a decision on the matter necessary no later than six months from the 17 June 2022 waiver decision. While this gives the WTO TRIPS Agreement a second chance to prove that it can be responsive to reasonable, people-centered human development concerns, time is running out fast. A decision must be made to extend the June waiver to include all therapeutics and diagnostics before 17 December. The waiver will need to be invoked in the broadest possible manner and cover the broadest range of medical and healthcare tools and products if the WTO is to pass the COVID-19 “test.”
India and South Africa allegedly abandoned their own proposal under EU pressure since the Agreement excludes therapeutics and diagnostics, crucial for COVID-19 prevention, control, and treatment.
The June Agreement’s duration is another limitation that must be revisited sooner rather than later.The limited waiver for vaccines is only valid for five years from mid-June. Given the evolving context of multiple new COVID-19 variants still continuing to emerge, many health experts now believe that there is no possibility of a post-COVID-19 world.
India must redouble its efforts in the WTO and other relevant global forums
India continues to, perhaps too gently, push for the waiver to be extended to cover therapeutics and diagnostics. It must urgently redouble its efforts and push for the extension of the WTO waiver to cover production and supply of all crucial COVID-19 prevention, control, and treatment tools before the mid-December 2022 deadline. It should also use both its 2023 G20 Presidency and the India, Brazil, South Africa (IBSA) Forum to push this global public health priority.
The years 2023-25 should put the IBSA Partnership for South-South Cooperation at the centre stage, while the consecutive presidencies of the G20 for India, Brazil, and South Africa during the same period offer the rare possibility to forge a common agenda on this issue in both forums, converting the COVID-19 crisis into an opportunity for them to become more relevant to the Global South’s current and future challenges. India and South Africa have already led joint advocacy on the TRIPS waiver in the WTO and a resurgent Brazil under Señor Lula’s presidency will almost certainly add Brazil as an active co-sponsor of future efforts in all three forums.
India must lead the way as the first to assume the G20 Presidency from next month. India also potentially has the most to offer the Global South on the COVID-19 agenda of equitable healthcare. Despite many public healthcare infrastructure shortcomings, India is well-known as leading in three critical healthcare-related areas: Low-cost vaccine technology, effective health immunisation delivery at scale, and low-cost generic pharmaceutical manufacturing. All three were in evidence and continue to be crucial for the global response to the COVID-19 crisis. Leveraging India’s digital and information technology (IT) expertise can also help the health sector with renewed, more systematic, continuous, consistent, and scaled-up efforts. India should not just export medicines using an extended and more comprehensive TRIPS waiver for COVID-19 vaccines, therapeutics and diagnostics, but establish joint manufacturing facilities for all these products with appropriate local companies or governments sharing the thinking, technology, government-enabling policies, innovations, processes and systems behind its success which may then be replicated.
India and South Africa have already led joint advocacy on the TRIPS waiver in the WTO and a resurgent Brazil under Señor Lula’s presidency will almost certainly add Brazil as an active co-sponsor of future efforts in all three forums.
The IBSA Partnership should develop a common three-year agenda in this area, which should be translated into tangible offerings backed by a substantial financing package
for the Global South primarily through the IBSA Fund, which is managed by the UN’s Special Unit for South-South Cooperation located within UNDP. Relevant UN agencies, especially UNDP and the WHO, who are long-standing trusted partners of IBSA, can facilitate this crucial task as neutral parties.
More broadly, and beyond its application during COVID-19, a key issue that the WTO and particularly its TRIPS Council should now seriously consider, especially in the likely context of more frequent future pandemics, is a TRIPS-minus Agreement that significantly reduces the length and scope of patent coverage. Such an approach will be much more responsive to the needs of the vast majority of the world’s citizens, especially those in vulnerable or low-income countries.
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