TWN Info Service on Trade, Intellectual Property and Health
25 February 2021
Third World Network
Two-thirds of WTO members issue call for a TRIPS waiver
Published in SUNS #9293 dated 25 February 2021
Geneva, 24 Feb (D. Ravi Kanth) – In support of putting billions of human lives before the profits and patents of Big Pharma, more than two-thirds of the World Trade Organization’s 164 members have issued a clarion call to support the proposed temporary TRIPS waiver to combat the COVID-19 pandemic by ramping up production of diagnostics, therapeutics and vaccines to ensure equitable and affordable access worldwide, negotiators told the SUNS.
The waiver seeks to temporarily suspend provisions in the WTO’s TRIPS Agreement relating to copyrights, industrial designs, patents, and protection of undisclosed information until the COVID-19 pandemic is brought under control.
It is aimed at ensuring equitable and affordable access as well as for preventing the rapid mutation of the Sars-Cov-2 virus, which causes COVID-19, negotiators said.
The proponents and the supporters of the TRIPS waiver, including the Holy See, underscored the need to put billions of human lives before the profits and patents of Big Pharma in waging the grim battle against the COVID-19 pandemic, said a TRIPS negotiator, who asked not to be quoted.
The large majority of developing and least-developed countries pressed for entering into text-based negotiations for reaching an immediate outcome on the waiver, amid a groundswell of support from international civil society organizations, said another negotiator, who asked not to be quoted.
Yet, major developed countries – the United States, the European Union, Japan, Canada, Switzerland, Norway, and Australia – continued to adopt “diversionary” tactics to stall the progress towards text-based negotiations.
The opponents to the waiver changed their stance from outright opposition to the waiver, to engaging in interminable dialogue without any outcome, the negotiator said.
Significantly, 57 developing and least-developed countries (LDCs), including South Africa, India, Kenya, Eswatini, Mozambique, Pakistan, Egypt, Bolivia, the African Group, and the LDCs, have so far co-sponsored the waiver proposal.
Sixty-two countries including the ACP (Africa, Caribbean, and Pacific) group, Afghanistan, Argentina, Bangladesh, Cambodia, Sri Lanka, Honduras, Cuba, Nepal, Nicaragua, Nigeria, Indonesia, Tunisia, Mali, and Mauritius strongly supported the waiver proposal.
At a time when the Sars-Cov-2 virus is mutating rapidly with well over 111 million cases and 2.4 million deaths from COVID-19 worldwide, the proponents of the TRIPS waiver said that unless the global community treats the virus on a war footing by suspending IPRs (intellectual property rights) for ramping up production of therapeutics and vaccines, the virus will continue to wreak havoc globally, said participants, after the meeting.
However, industrialized countries that are able to procure vaccines – the United States, the United Kingdom, Canada, Australia, and the European Union among others – vacillated over the TRIPS waiver proposal on extraneous grounds, merely saying that they are prepared to continue the dialogue, said participants familiar with the development.
Norway, which is likely to chair the TRIPS Council from next month, has sought a revised proposal to discuss the scope and duration of the waiver.
Singapore, Japan, Australia, and the UK continued to oppose the waiver, according to participants, who asked not to be quoted.
At the regular TRIPS Council meeting held virtually on 23 February, the overwhelming support for the TRIPS waiver within four months after it was proposed by South Africa and India sent a strong signal to the international community, particularly the civil society, that without an early decision on the waiver, the WTO’s credibility will be irreparably damaged, said a participant, who asked not to be quoted.
However, around 10 industrialized countries seem prepared to stall the progress on the waiver at any cost to put the profits and patents of Big Pharma before billions of human lives, the participant said.
TRIPS CHAIR’S REPORT
The chair of the TRIPS Council, Ambassador Xolelwa Mlumbi-Peter from South Africa, issued a short report, saying that “at the meeting of the TRIPS Council on 15-16 October 2020, India and South Africa introduced document IP/C/W/669, requesting a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19, which had been circulated on 2 October 2020 and has since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe and Egypt.”
“The Council continued its discussions under that agenda item at informal meetings on 20 November and 3 December, as well as at its resumed meeting on 10 December 2020. Following the status report to the General Council on 16-17 December 2020, the Council continued its consideration of the waiver request at informal meetings on 19 January and 4 February 2021, and at its formal meeting on 23 February 2021.”
“At those meetings,” she said, “delegations highlighted the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all.”
The chair said that “delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information, including through documents IP/C/W/670, IP/C/W/671, IP/C/W/672, IP/C/W/673 and IP/C/W/674, on the waiver request but could not reach consensus, including on whether it is appropriate to move to text-based negotiations.”
Further, “delegations indicated a need for further discussions on the waiver request and views exchanged by delegations,” Ambassador Xolelwa said.
“This means that the TRIPS Council has not yet completed its consideration of the waiver request. The TRIPS Council will therefore continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement,” the chair explained.
According to several participants, the chair reminded members that the single most important priority of the global community is to stop the COVID-19 pandemic, halt its rapid transmission, reduce the risks of the variants, and reverse the trend of consequential global crises.
The chair quoted the recent statement of the new director-general Ms Ngozi Okonjo-Iweala that in order to reverse the current downturn in the global economy and return to sustained growth, the global community, particularly the rich countries that have huge stocks of COVID-19 vaccines at their disposal, must share vaccines, therapeutics, and diagnostics on an equitable and affordable framework, said participants.
Ambassador Xolelwa underscored the need for frank, candid, and good faith discussion on what is required to scale-up global production in these unprecedented times of public health crisis.
She emphasized the need for a solution-oriented process for boosting productive capacity to manufacture products that are essential to deal with COVID-19 globally, stressing that the WTO members must demonstrate their commitment to overarching goals of universal and equitable access to COVID-19 medical products not only in words but through deeds, said participants, who asked not to be quoted.
PROPONENTS OF TRIPS WAIVER
South Africa’s TRIPS negotiator, Mustaqeem De Gama, said that increasing number of sponsors of the waiver proposal “demonstrate the growing importance of the Waiver Proposal and the need to scale up access in order to ensure equitable and timely access to COVID-19 medical products, including vaccines, therapeutics, diagnostics and other equipment.”
“Moving forward,” he said, “discussions cannot continue to be mired in the evidentiary loop that we have been engaged in over the last few months.”
“We want to move to text-based discussions, we stand ready to discuss the scope and duration of our proposal in light of comments and observations that Members have made,” he assured the opponents.
Mr De Gama cautioned that “a pandemic like COVID-19 has not been seen in a century, and much remains unknown and evolving about the situation and the virus that causes it,” suggesting that “while many regard the virus as a sort of black swan, it was not entirely unexpected and was preceded by several other viruses and semi-global pandemics in recent times.”
Mr De Gama warned that “as much as we may hope that something like this will not happen again, the probability is that the next event may be even more cataclysmic.”
He said that given the uncertainty, “people are notoriously unwilling to make sacrifices for others when the benefits are uncertain.”
The South African negotiator cited the example of “vaccine nationalism, which denotes self-prioritization to the exclusion of others, as many rich governments have done on the assumption that individual action can yield results on its own.”
“However, this is not the case, the idea that a vaccine roll-out will be the deus ex machina (God from the machine) is misplaced, we cannot put the virus back into its bottle, we just cannot go back to the old normal,” Mr De Gama warned.
He said that data suggests that “US, UK and the EU account for about 50% of the over 200 million vaccines administered globally as at 22nd February.”
Little wonder that “countries opposing the TRIPS waiver proposal account for 60% of the globally administered COVID-19 vaccines,” he said, suggesting that “reportedly just 10 countries have administered 75 percent of all COVID-19 vaccines.”
More disturbingly, more than 130 countries have not received a single dose.
He urged members to consider what the WHO director-general had said: “The longer it takes to suppress the virus everywhere, the more opportunity it has to change in ways that could make vaccines less effective – an opportunity to mutate”.
Mr De Gama pointedly said, “many of the opposing WTO members, under pressure from their pharmaceutical industry, have for more than two decades, been known to dissuade developing countries from incorporating TRIPS flexibilities in their national law and using such flexibilities to promote access, and yet now insistently assert that such sufficient flexibilities exist, although we have presented concrete arguments against it.”
Unsurprisingly, these same WTO members stress on “business-as-usual voluntary licensing” as the way out of this pandemic and yet one year on, this “business-as-usual” approach premised on voluntary, secretive, limited and restrictive licensing has failed to leverage global expertise and capacity to scale-up manufacturing and deliver equitable access.
“These “business-as-usual” approaches championed by opposing countries is not the global solution but really the root cause of why to date we have vaccinations that are “wildly uneven and unfair” as pointed out by the UN Secretary-General, according to the South African negotiator.
“At the current vaccination rate, it will take an estimated 4.8 years to cover 75% of the population with a two-dose vaccine, according to Bloomberg, on the path to immunity around the world,” Mr De Gama argued.
He said that the “co-sponsors have often called for the open sharing of vaccine manufacturing technology, IP and know-how through the COVID-19 Technology Access Pool (CTAP),” and welcome the ACT-Accelerator and COVAX facility.
But, sadly none of these mechanisms “can deliver what is required in developing and least developed countries.”
Given the reality that “demand-side requirements outstrips supply-side constraints, irrespective of the amount of money any of the donor countries may throw at the problem, the model of donation and philanthropic expediency cannot solve the fundamental disconnect between the monopolistic model it underwrites and the very real desire of developing and least developed countries to produce for themselves,” he argued.
Against this backdrop, “the Waiver Proposal constitutes a very real compromise that will immediately enable countries to tap into unused production capacity by accessing spare capacity in the developing world which will satisfy the ongoing demand for COVID-19 vaccines (including therapeutics and diagnostics) and will also negate the need for any donations from rich countries,” he said.
He said that the co-sponsors are ready to go to a text-based discussion in order to arrive at an immediate solution.
“This will not only save lives but also enable us to return to a situation of relative normalcy. No one is safe until everybody is safe.”
As regards the question posed by Norway on the revised proposal from the co-sponsors, Mr De Gama said “the reason we called for a text-based discussion is because this will help us to understand direct questions that members have on our proposal.”
The co-sponsors, he said, want “delegations to raise particular concerns on elements they may have concerns about and suggestions as to how we can arrive at a common landing zone, including at the regular TRIPS Council meeting of 10 March 2021 and subsequent informal and formal meetings.”
In his second intervention, Mr De Gama debunked the claims made by the European Union, saying that the EU “does not support the waiver proposal, nor does it take any action to ensure technology sharing and transfer by companies operating in EU.”
The EU “does not commit that it will no longer suppress developing countries from using compulsory license and other flexibilities as it did in its IP enforcement in a third country report,” Mr De Gama said.
He charged the EU for not following “through its rhetoric of treating vaccines as a global common good but rather continue its inward-looking strategies in vaccine access including activating an export authorization scheme.”
In a sharp response to the statements made by Switzerland and Singapore about the sharing of technology with the Indian vaccines company the Serum Institute of India, Mr De Gama referred the two countries to an interview that Dr Poonawalla (chairman of Poonawalla Group, which includes the Serum Institute of India), gave to the US Politico news agency.
In that interview to Politico, Dr. Poonawalla said he “believes that the sheer urgency of the virus – and the fact that coronavirus anywhere is a threat to people everywhere – should prompt a reassessment of patent and intellectual property laws that limit access to immunizations in the developing world, while simultaneously jacking up their price in wealthier countries.”
“That’s become very evident today in the Covid crisis,” Dr Poonawalla said.
According to the head of the Serum Institute, “if you don’t allow, for example, an Indian producer to sell in the US because of some stupid rules and regulations, even though the product is identical to a US product, you’re going to have a supply situation.”
“And guess what,” Dr Poonawalla said. “When you’ve got low supply and high demand, what happens to the price? It skyrockets.”
With more than 130 countries not having received a single dose, India warned that, “If the virus is allowed to spread like wildfire in the global South, it will mutate again and again and that this can prolong the pandemic significantly, enabling the virus to come back to plague the global North.”
India said the proponents had cautioned about the dire situation that the world is facing now, suggesting that the proponents made the TRIPS waiver proposal “for removing IP barriers temporarily to ramp up rapid global manufacturing.”
The Indian official lamented that “our apprehensions, subsequently supported by evidence, were dismissed as hypothetical as the vaccines were yet to arrive at that time.”
“We are not feeling happy about being proven right in raising concerns in advance,” India said, arguing that, “Today our fears have not only proven to be true but the very Members who dismissed our argument in this Council that there would be shortages of vaccines if manufacturing remains limited, are themselves facing shortages in their jurisdictions even after having successfully negotiated advance purchase agreements of volume way beyond their need.”
“That the situation could be this worse, even the proponents of Waiver did not predict,” India said, pointing out that it had supplied 28.84 million vaccine doses to 26 countries as on 21 February 2021 under its Vaccine Maitri, i.e. Vaccine Friendship Initiative.
India said it will supply vaccines to 40 more countries, adding that the “proponents answered all questions posed in various sessions of the TRIPS Council, yet certain delegations have this tendency to ask further questions and delay the start of text-based negotiations.”
India said that “after the first emergency use authorization of vaccines, we need to close the evidentiary loop and get down to textual negotiations that can further refine the waiver proposal that we tabled.”
India expressed concern over the repetition of similar questions in the last few meetings, suggesting that “maybe answers to some of those questions lie in text-based negotiations.”
“Moving to a text-based negotiation may appear to be yielding from the high moral ground of being the sole protectors of IP rights for some members, but not doing so means a willingness to stand by a poor choice, devoid of ground realities and just opposite to what is the need of the hour,” India cautioned.
“The delegations that oppose the waiver have argued on one hand that the Waiver, if granted, will not result in augmenting the manufacturing capacity and on the other hand, they argue that the waiver will impact the commercial interests of existing IP holders as a lot of manufacturing could come into play without agreement with the IP holders,” India said.
The proponents, India said, would like to “understand this dichotomy that if Waiver will not lead to increase in manufacturing capacity, meaning, no new manufacturers will enter into production of Covid products even with the proposed waiver in place, then how will the commercial interests of existing IP holders be impacted?”
“On the other hand, if manufacturing is going to increase significantly and thereby impacting commercial interests of IP right holders, then are we not agreeing that the final objective in the present scenario is to increase manufacturing,” India said.
Citing the recent statement of the WHO director-general that “the ACT Accelerator and COVAX Facility were created to increase equity, but with every passing day, that goal is at risk,” India said the WHO DG Dr Tedros underscored the need to scale-up manufacturing to increase the volume of vaccines.
India said that “there is no alternative to augmenting manufacturing to address supply side constraints of goods critical for prevention, containment and treatment of COVID-19, and allocation of money alone for securing such supplies would not suffice. The Waiver Proposal, which seeks to address supply-side bottlenecks, will thus further help the Covax mechanism to achieve its goal.”
India said despite the TRIPS Agreement that has been in force since 1995, never in the recent history of medical science, “have vaccines been developed in such a short span of time of less than one year.”
“This proves that it is not the IP system alone that has delivered, but also the public funding, the institutional support in terms of research contributions by public universities, the global collaboration in sharing of genome sequencing data and public health information that has led to the development of successful vaccines in record time,” India said.
India said the “proponents respect the intellectual property rights and their value as incentives for innovation, but Covid-19 pandemic being unprecedented as it is, where research and innovation has mostly been spearheaded by massive public funding, expedited regulatory approvals, and global collaboration, we need to put lives before private profits.”
To questions on how manufacturing can be ramped up once the waiver is granted, India said “once the waiver is in place, the existing manufacturing capacity worldwide can be put to immediate use for production of Covid products.”
India reiterated that it is seeking a temporary waiver, suggesting that the time period is to be negotiated by Members in the TRIPS Council.
“Moreover, waiver, once granted, will be reviewed annually by the General Council,” and “the duration could be some fixed number of years together with a conditional criteria for termination,” India said.
The proponents “want to have frank discussions on the text of the Waiver, relating to both its duration and scope, in order to find answers to these questions and to find a landing zone to operationalize the waiver in the shortest possible time,” India said.
“We cannot continue to engage in endless discussions while millions of lives are lost to the coronavirus pandemic,” India argued, underscoring the need for concerted efforts by all WTO Members to ensure that the WTO makes a meaningful contribution to defeat COVID-19.
“COVID-19 has shown that our fates are inextricably linked,” India said, cautioning that “whether we win or lose, we will do so together.”
In its intervention, Pakistan said that “it is a known fact that much of the vaccine and monoclonal anti-body technology and know-how is protected by intellectual property, particularly patents and trade secrets.”
“Lifting IP monopolies around technology and know-how will facilitate the sharing of such technology, expedite production, and also give potential manufacturers legal certainty and freedom to operate,” Pakistan said, suggesting that “it is important to ask whether the regulatory agencies of the developed countries are ready to share the vaccine regulatory dossiers to scale up vaccine production.”
In its intervention, Indonesia said that “vaccines nationalism and vaccines rolling which are mostly taking place in a few rich countries” shows that supply for global access be will very much limited.
In this context, Indonesia said, “we believe the waiver offered by the co-sponsors will be a possible solution of this issue, by eliminating certain IP barriers and scaling up the production.”
“The waiver will also defer the possible monopoly created by the IP system and will assure the global access of medical products, especially for developing and least developed countries,” Indonesia said.
Indonesia urged the opponents to “also provide written replies to the questions posed by the co-sponsors in document IP/C/W/674 in order to reflect their intentions to move forward with these proposals.”
Chad, on behalf of the LDC group, supported the waiver proposal, saying that IP rights should not constitute an obstacle to timely access to affordable medical products.
Chad questioned the effectiveness of voluntary technology transfer initiatives, suggesting that the lack of transparency with regard to costs and other issues have translated into companies showing no interest in licensing or offering technology transfer for their patented products.
Mozambique and Namibia along with Tanzania, Egypt, Bangladesh, Eswatini, Venezuela, Sri Lanka, Mali, Nepal and Nigeria supported the TRIPS waiver proposal.
INTERVENTION BY THE HOLY SEE
At the TRIPS Council meeting, the Holy See, which has observer status at the WTO, made a powerful statement in support of the waiver.
It said that “the world is on the brink of a catastrophic world failure, and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”
The Holy See pointed a finger at the existing mechanisms for compulsory licenses under Article 31 and Article 31bis of the TRIPS agreement, saying that they contain territorial and procedural restrictions that make the practice of issuing compulsory licenses a complex process.
“A decision to waive the IP waiver proposed by South Africa and India will be a strong signal, demonstrating real commitment and engagement, and thus moving from declaration to action in favour of the entire human family,” the Holy See concluded.
OPPONENTS OF TRIPS WAIVER
At the meeting, the EU intervened twice to clarify its positions in the face of mounting criticism over its allegedly hypocritical positions, said a participant, who asked not to be quoted.
The EU denied that it did not exert pressure on countries seeking to avail of compulsory licensing.
The EU said that while it can support universal and equitable access to COVID-19 vaccines and treatments, it endorsed the questions raised by Australia, Canada, Chile and Mexico on intellectual property challenges experienced by members in relation to Covid-19.
Despite the growing evidence that the WHO’s ACT-A (Access to COVID-19 Tools Accelerator) and the WHO- GAVI facilities have not been able to deliver vaccines in the Global South, the EU official said the main global mechanism to achieve global access is the COVAX facility, which has just received a major financial boost, following the G7 meeting last week where the United States, Japan, Canada and the EU pledged solid financial support.
The EU said that the current major challenge is to ensure rapid and predictable production of new vaccines, while simultaneously increasing levels of production, and maintaining the supply of other medicines and vaccines.
It suggested that any available manufacturing capacity anywhere in the world should be used to the full extent.
Brussels stuck to its “theological” view that IP is a key factor in providing a framework that enables collaboration, said a participant, who asked not to be quoted.
Brussels reckons that the IP system is crucial in providing an equal legal framework for the collaboration and dissemination of any new technology, the participant added.
According to the EU, the objective of an IP system is not merely to create exclusivity for the owner of intellectual property, but also to ensure the publication and dissemination of research results.
Brussels said concerns raised by the proponents can be addressed with a combination of, on the one hand, licensing and expanding manufacturing capacity by manufacturing agreements, and, on the other hand, the framework of the TRIPS Agreement and the flexibilities it offers.
INTERVENTION BY THE US & SWITZERLAND
The US, which has all along been blocking the TRIPS waiver proposal, claimed that the Biden Administration has pledged to COVAX and is “committed to working with International Partners to end the devastating public health and economic effects of this pandemic.”
The US said it is ready to work with partners to identify practical ways to catalyze the needed capacity to address this pandemic.
The US maintained that it is paramount that we collectively increase access to facilitate equitable distribution of COVID-19 vaccines, and that we support policies that drive the rapid development of new vaccines and medicines.
The US said that it looks forward to engaging in further discussions on the questions that a number of members have raised about the proposal, with the aim of finding multilateral solutions to amplify the public health, and humanitarian responses to the ongoing crisis, while bearing in mind the importance of incentives for innovation.
In its intervention, Switzerland said suspending large parts of the TRIPS Agreement would be counterproductive, as it would undermine currently ongoing efforts to scale up manufacturing to achieve global access.
The Swiss official emphasized that never before had such novel and highly complex biotech vaccines been made available to the whole of the world population in such a short time, and this has been possible due to protection provided to intellectual property rights.
CANADA’S “AMBIVALENT” STANCE
Canada said that it is interested in understanding the specific nature and scope of any concrete IP challenges experienced by members related to or arising from the TRIPS Agreement in their responses to COVID-19, and expressed hope that concrete consensus-based solutions can be found.
Canada also acknowledged that production of COVID-19 diagnostics, therapeutics, vaccines, devices and equipment has been and remains extremely challenging including in view of limited production capacity, among other logistical challenges.
INTERVENTION BY NORWAY
Norway, which is likely to chair the TRIPS Council from next month, said it agrees “that nobody’s safe until everybody’s safe.”
Ensuring a fair and equitable distribution of vaccines, diagnostics and medicines should have our highest priority.
Norway said it is working hard to make this happen through various International Cooperative efforts.
“As to the issue at hand,” said Norway, “we have listened carefully to the views expressed by members in both formal and informal settings.”
“In this context, we have taken note of statements from proponents, that they are willing to discuss the scope and duration of the waiver,” Norway said.
Norway asked the proponents whether they are considering presenting a revised proposal, as a basis for further deliberations, said a participant, who asked not to be quoted.
Other opponents to the waiver such as Singapore, Japan, Australia and the United Kingdom, were of the view that IP rights have played a key role in fostering an ecosystem that promotes continuous innovation by allowing the key stakeholders such as governments, researchers and pharmaceutical companies to collaborate in developing and producing COVID-19 vaccines.