New COVID-19 Strain, Same Imperial Powers: Intellectual Property Waiver Declined
Analysis by Tala Majzoub, Staff Writer
December 29th, 2020
In a landmark move on October 2nd, 2020, India and South Africa have called for the World Trade Organization (WTO) to suspend intellectual property (IP) rights related to COVID-19 to ensure that not only the wealthiest countries will be able to access and afford the vaccines, medicines, and other new technologies needed to regulate the pandemic, until global herd immunity is reached. South Africa and India’s joint communication to the Trade-Related Aspects of Intellectual Property (TRIPS) Council at the WTO, titled “Waiver from certain provisions of the TRIPS agreement for the prevention, containment and treatment of COVID-19” does not suggest a waiver from all TRIPS obligations, nor does it suggest a waiver beyond what is needed for COVID-19 prevention, containment and treatment. The waiver would cover obligations in four sections of the TRIPS agreement— Section 1 on copyright and related rights, Section 4 on industrial designs, Section 5 on patents and Section 7 on the protection of undisclosed information. It would last for a specific number of years, to be agreed by the General Council, until widespread vaccination is in place globally, and the majority of the world's population has developed herd immunity.
As a result of the waiver proposal, inclusive and comprehensive discussions were first held at the TRIPS Council on 15th-16th October, and subsequently at informal meetings on 20th of November and 3rd of December. As of the 20th of November 2020, Eswatini, Kenya, Mozambique and Pakistan are officially co-sponsoring this proposal. After initial discussions at the Council of TRIPS in October and November, 100 members of WTO have fully supported or welcomed the waiver proposal. Predictably, a small group of members – Australia, Brazil, Canada, the EU, Japan, Norway, Switzerland, the UK, and the US – are withholding support that would help build much needed consensus on the proposal. This comes as no surprise, as much of these high-income countries (HICs) have traditionally utilized the IP system to back the interests of their pharmaceutical corporations.
Despite pressures to make an exception to improve access to drugs for poorer countries, wealthier nations continue to staunchly oppose, saying that the IP system is required to incentivize new inventions of vaccines, diagnostics, and treatments, which might dry up in its absence. They dismiss the claim that IP is a barrier to access, maintaining that equitable access can be achieved through voluntary licensing, technology transfer arrangements, and the donor funded COVAX Advance Market Commitment for vaccines. UK spokesperson declared: “we have not identified clear ways in which IP has acted as a barrier to accessing vaccines, treatments, or technologies in the global response to COVID-19.” The UK Government explains that the world urgently needs access to these new products to fight the pandemic, “which is why a strong and robust multilateral IP system that can meet this challenge is vital”.
The UK, by far the largest funder of the COVAX Facility, urges other countries to contribute further. Similarly, John-Arne Røttingen, chair of the WHO Solidarity Trial for COVID-19 treatment who was recently appointed as Norway’s Global Health Ambassador, says waiving IP might help in producing small molecular weight substances, “but if you want to establish a biological production line, you need a lot of additional information, expertise, processes, and biological samples, cell lines, or bacteria” to be able to document to regulatory agencies that you have an identical product. Instead, he says, individual companies should be pressured to allow non-exclusive licenses and technology transfer of their products, along the lines of the agreements that AstraZeneca and Novavax have established with the Serum Institute of India for vaccines. This partnership model would be much faster, he says. “Instead of going for an unreachable, ‘ideal’ solution that will not fly, they should identify where the barriers are and work on those.”
Wealthy countries’ bilateral actions undermine global initiatives: COVAX and Act-A
The co-sponsors of the patent waiver explain that COVAX, funded mainly through donations from (HICs), is not enough for guaranteeing equitable access to COVID-19 products. On the surface, COVAX aims to produce 2 billion doses of vaccine and to share them equally between HICs and low-income to middle-income countries (LMICs). However, datafrom Duke University suggests that the facility has reserved 700,000 vaccine doses so far, when (HICs) have already reserved 6 billion doses for themselves through bilateral deals with pharmaceutical companies. LMICs, meanwhile, with a combined population of 1.7 billion people, have not yet signed a bilateral vaccine deal. In contrast, the EU aims to reserve 1.5 billion vaccine doses for a population fewer than 450 million. The European commission has in fact urged member states not to sign agreements through COVAX, as it was able to secure better deals directly from manufacturers. Such practices by HICs erode the COVAX negotiation and purchasing power consequently and undermine the application of WHO fair allocation framework.
COVAX is the vaccine access arm of an ambitious collaboration—led by WHO; The Global Fund to Fight AIDS, Tuberculosis and Malaria; Gavi, The Vaccine Alliance; and the Bill & Melinda Gates Foundation— (ACT-A), which has set specific, time-bound procurement targets. For example, of the 2 billion vaccine doses that the COVAX Facility aims to deliver, fewer than 1 billion would go to LMICs. If the vaccine requires two doses, this amount will be enough for fewer than 500 million people. Similarly, ACT-A’s diagnostics pillar aims to procure 500 million tests which, says Peter Sands, executive director of The Global Fund, is “only a fraction” of what is required. As such, ACT-A is, even if fully financed, is at best a partial solution to the access problem. Moreover, because of a massive funding gap, even these targets are far from being reached. To date, donors have provided US$5 billion of ACT-A’s $43 billion required budget for LMICs over the next year. India’s statement to the Nov 20 TRIPS Council meeting reads: “On one hand, these countries are buying up as much of the limited supply as they can, leaving no vaccines in the pie for developing and least-developed countries. On the other hand, and very strangely, these are the same countries who are arguing against the need for the waiver that can help increase the global manufacturing and supply to achieve not just equitable, but also timely and affordable access to such vaccines for all countries.”
ACT-A and COVAX are also limited by the remaining production capacity of IP, holding manufacturers to supply doses and tools. Since its inception, Médecins Sans Frontières (MSF) has called on COVAX to ensure a global scale up of production, including in the Global South, to increase and diversify supply, MSF contends “so long as COVAX primarily competes with high income countries to secure supply from the same limited number of manufacturers, rather than increase the number of suppliers, the problem of global scarcity of COVID-19 vaccine doses will not be resolved. Global efforts should prioritize increasing the number of suppliers”. Access in developing countries should not be defined by the size of financial pledges or spare production capacity of manufacturers in high income countries, while manufacturing capacity in the Global South remains unutilized. It is an unacceptable injustice that a small group of WTO members are denying other countries’ own capacity to supply COVID-19 medical tools when this small group has procured the bulk of the global COVID-19 medicines supply and pre-booked more than enough vaccines doses for domestic use, bypassing global mechanisms.
Voluntary licensing measures have limited impact: Gilead and AstraZeneca
Since the beginning of the pandemic, voluntary contribution of the IP and technologies by companies has been encouraged, yet the results of voluntary contributions have been limited. The pharmaceutical sector has collectively decided not to engage with the WHO COVID-19 Technology access Pool (C-TAP) initiative that endorses the voluntary contribution of IP, technology and data to support global sharing and scale-up manufacturing and supply of COVID-19 medical products. Médecins Sans Frontières’s recent study on voluntary licensing demonstrates the restrictive licensing limitations of IP-holding corporations, including regulated geographic coverage of supply and other conditions that limit the benefits of competition and global supply. Yuanqiong Hu, Senior Legal and Policy Adviser at the MSF Access Campaign, says the India–South Africa IP waiver proposal would also make it a lot easier for non-patent holders to produce necessary medical equipment like ventilators, masks, and protective gear. Regarding the need for technology transfers, she says, it is not an “either/or” question. Governments need the full package of toolkits, including technology transfer deals and legal measures such as the patent ban.
The example of Remdesivir reveals an example of how IP barriers affect global access to COVID-19 therapeutics. The primary patent on the base compound of Remdesivir has been granted to Gilead in more than 70 countries, which means that when countries are not covered by a voluntary license or do not use other measures to overcome the patents, they may be blocked from getting access to generic alternatives until 2031. After ignoring demands calling for non-enforcement of its patents on Remdesivir, Gilead proceeded to secretly sign voluntary licensing agreements with only a few manufacturers of its choosing. The company sold its entire production to the US government, leaving other countries scrambling to get their orders filled. An exception is Bangladesh, where the absence of Remdesivir patents made generic manufacturing and supply for the public health service possible.
Gilead has also licensed its Remdesivir patents to generic manufacturers in India, Pakistan and Egypt for supply in 127 countries. Outside of these territories, where often patents are valid until 2035, countries are struggling with shortages. For example, the shortage of Remdesivir is making headlines today in the Netherlands. The voluntary licensing agreements excluded nearly half of the world’s population from accessing more affordable generics, including most South American countries and many countries with manufacturing capacity, some of which have supported COVID-19 related clinical trials. This dangerous precedent set by Gilead must alert governments that voluntary actions of companies are not reliable.
Another example of the limited results delivered via voluntary company-led initiatives is the AstraZeneca vaccine manufacturing agreements with Indian and Brazilian companies. AstraZeneca, which has the exclusive rights to one of the frontrunner vaccines COVISHIELD, has signed sublicense agreements with several manufacturers in Argentina, Brazil, India, China, and Indonesia. However, these agreements were shrouded in secrecy, and the released terms reveal worrisome particulars. For example, the license is restricted to one of the world’s largest vaccine producers, India’s Serum Institute, when India has multiple other manufacturers of vaccines. Furthermore, the corporation’s deal with Brazilian public research body Fundação Oswaldo Cruz (Fiocruz) gives AstraZeneca the power to declare the pandemic over as soon as July 2021. Meaning, although AstraZeneca publicly promised to supply these vaccines at “non-profit” prices while the pandemic lasts, the agreement between AstraZeneca and Brazilian Fiocrus Foundation allows AstraZeneca to start asking for profit price as early as July 2021.
Most of the vaccine companies, including Pfizer and its partner, BioNTech, have indicated no plans to license or transfer their IP-protected technologies to enable increased global manufacturing capacity and supply. MSF’s past experiences demonstrate that the restrictive licensing terms can have volatile impact on access. This lack of transparency of license agreements underscores the unreliability of voluntary licensing.
IP laws do not serve global communities fairly and adequately
World Health Organization officials held a news briefing on Monday to discuss mutations in the Coronavirus responsible for new strains in both South Africa and UK. However, sources confirm that the variant had been first detected in the UK in September, later leading to around a quarter of the cases resulting from the new mutation in November. Bearing that in mind, as many as 38 MSPs wrote to the UK Government ahead of a key WTO meeting in December to call on conservative ministers to ensure cost is not barrier to fighting the global pandemic. They're drawn from the SNP, Labour, LibDems and Greens — but not a single Tory MSP added their name. Ultimately, the UK government was among the member states to vote against the waiver.
South African spokesperson acknowledges “the emerging second wave of the disease underscores the importance to finding global solutions that ensure equitable access.” He continues to reference past experiences with infectious viruses: “In 2004 the highly pathogenic avian influenza H5N1 re-emerged, developed countries had priority access, while affected developing countries did not. Within 5 years another pandemic flu (H1N1) emerged, and once again rich countries placed large pre-orders of a vaccine buying almost all doses that could possibly be manufactured. Many countries promised to donate vaccines, most of them reneged and moved to secure their own countries’ supply. With COVID-19, history is repeating itself.”
He called for a more responsible approach, in order not to repeat the same mistakes: “Several months into this pandemic, there are no meaningful global policy solutions to ensure access. Given this present context of global emergency, it is important for WTO Members to work together to ensure that intellectual property rights, such as patents,” he added.
The actions by pharmaceutical corporations show that relying on their charitable hand and limited voluntary actions are not sufficient for a pandemic. Given these challenges and limitations, along with the industry’s blatant refusal to routinely offer non-exclusive licenses with worldwide reach to ease global access, governments must address the global crisis as they did nearly 20 years ago under the Doha Declaration on the TRIPS Agreement ad Public Health amidst the HIV/AIDS epidemic, by supporting the temporary waiver proposal. With the mentioned examples above, it should come as no surprise that developing countries are seeking to decrease dependence on wealthier nations, with pharmaceutical corporations continuing with their ‘business-as-usual’ approaches by maintaining rigid control over their proprietary IP rights or by pursuing secretive and monopolistic commercial deals and excluding countries heavily affected by COVID-19. Y
uanqiong Hu, Senior Legal and Policy Adviser at the MSF Access Campaign, reinforces that there exists a “hierarchal model and the poorer countries are being asked to take the leftovers”. The unprecedented situation we are faced with today demands that all IP, knowledge, technology, and data pertaining to COVID-19 be accessibly to everyone to ensure uninterrupted production and supply by competent manufacturers worldwide. Governments have a responsibility to protect public health to ensure equal access to medicine for all. The waiver proposal by South Africa and India to address IP and technology challenges collectively is a substantial initiative on an international level for governments to unite and stand up for public health, global solidarity, and equitable access for all.