On 23 February 2021, South Africa delivered two detailed statements at the WTO TRIPS Council’s most recent deliberations on a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19 (IP/C/W/669).
South Africa did not mince words, taking aim at the current donor-driven model of the COVID-19 response.
Irrespective of the amount of money any of the donor country 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. Madam Chair, the problem with philanthropy is that it cannot buy equality. Yesterday the DG of WHO warned that: “Money is not the only challenge we face. If there are no vaccines to buy, money is irrelevant. Even if we have the funds, we can only deliver vaccines to poorer countries if high-income countries cooperate in respecting the deals COVAX has done, and the new deals it is doing.” Even in light of all the additional pledges of monetary support, the ACT Accelerator still faces a gap of at least 22.9 billion dollars to fully financed.
In response to WTO Members who interrogated South Africa on the vaccine manufacturing capacity of the Global South, South Africa provided the following riposte.
I would once again like to thank all delegations that took the floor today. Some delegations wanted more details of manufacturing capacity that exist in the developing world. As we have pointed out at the last session, out of the 158 prequalified vaccines under WHO’s PQ program 72 vaccines are produced by vaccine manufacturers from developing countries. Similarly, LMIC countries have a substantial share in prequalified finished pharmaceutical products, active pharmaceutical ingredients and vaccines. This shows that significant quality manufacturing capability does exists including in developing countries and to ensure global supply, these have to be leveraged.
Some delegations suggest countries who have unused manufacturing capacity on vaccine to pursue voluntary license agreement with vaccine developers for local production. Yet, what we have observed is that among some countries who do not support the waiver proposal, they have experienced difficulties in seeking local production licenses from vaccine developers. It shows, once again, that relying on voluntary license is not sufficient in this pandemic. Canada has just shared their experiences with originators having been rejected by several companies when approached for a voluntary license. Canada’s experience shows relying on voluntary licenses may be highly problematic and evidences the selective approach applied by originators and rights holders. Perhaps Canada can disclose the terms of its license agreement with Novavax to back up its claim that IP is not a barrier to access?
When Singapore and Switzerland used The Guardian’s paean to Adar Poonawalla to assert that there were no IP or know-how barriers to scaling up manufacture of COVID-19 vaccines, South Africa unearthed Sarah Wheaton’s July 2020 profile (Meet the Indian drug mogul who’s challenging the West over vaccines, Adar Poonawalla is seizing on the COVID-19 fight to try to break down the policies protecting Big Pharma) which provided a counter-narrative to Singapore’s and Switzerland’s claims.
We heard Switzerland and Singapore quote Dr. Poonawalla of the Serum Institute. In a recent interview with Politico, Dr. Poonawalla 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,” “If you don’t allow, for example, an Indian producer to sell in the U.S. because of some stupid rules and regulations, even though the product is identical to a U.S. product, you’re going to have a supply situation.” “And guess what,” he continued. “When you’ve got low supply and high demand, what happens to the price? It skyrockets.”
South Africa’s statements are reproduced in full below.
South Africa’s intervention at the formal TRIPS Council meeting of 23 February 2021
Thank you Madam Chair for giving us the floor we thank you for your report on the activities of the TRIPS Council’s consideration of the Waiver Proposal and further consultations you held in small group formation as well as the details put forward in the proposed oral report to be presented to the General Council in March 2021. We would like to welcome the African Group and LDC Group to the fold of cosponsors, the increase number of delegations in our ranks 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, discussions cannot continue to be mired in the evidentiary loop that we have been engaged in over the last few months, Cosponsors have also made it clear that we want to move to text-based discussions, we stand ready to discussion the scope and duration of our proposal in light of comments and observations that Members have made.
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. 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. As much as we may hope that something like this will not happen again, the probability is there that the next event may be even more cataclysmic. Many of the most serious global threats today involve a high degree of uncertainty. Under such conditions, people are notoriously unwilling to make sacrifices for others when the benefits are uncertain. A good example of this type of behaviour is vaccine nationalism, which denotes self-prioritization to the exclusion of others, as many rich government 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 rollout will be the deus ex machina is misplaced, we cannot put the virus back into its bottle, we just cannot go back to the old normal.
According to available data, US, UK and the EU account for about 50% of the over 200 million vaccines administered globally as at 22nd Feb. Countries opposing the TRIPs waiver proposal account for 60% of the globally administered COVID-19 vaccines. Reportedly, just 10 countries have administered 75 per cent of all COVID-19 vaccines. More than 130 countries have not received a single dose. The WTO has to pay need to the caution of the Director General of WHO: “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”.
Sir Jeremy Farrar, the head of Wellcome Trust has also highlighted that “Immunising a lot of people in a few countries while leaving the virus unchecked in large parts of the world would simply allow more variants to emerge in these places. And the more that happens, the higher is the risk that the virus will evolve to an extent that our vaccines, treatments and tests are no longer effective” adding that “We’ve got to understand this is a global problem that must be dealt with globally.”
Our TRIPS Waiver offers a global solution. The world is facing its worst ever crisis since perhaps World War II, and the response of WTO members opposing the waiver proposal is to engage in “business as usual” approaches, and for WTO to do nothing to address IP monopolies around the technology and know-how, to scale up production and to bring this crisis to an end.
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.
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. Instead this approach has limited competition, and is artificially constraining global supply. 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. 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. And sadly, this is probably an optimistic scenario. Cosponsors have often called for the open sharing of vaccine manufacturing technology, IP and know-how through the COVID-19 Technology Access Pool (CTAP).
Madam Chair, we want to clarify that as Cosponsors of the Waiver Proposal, we have always said that we welcome global multilateral cooperative initiatives such as the ACT-Accelerator. The objective of COVAX, its vaccine arm, is laudable, as are financial contributions from WTO Members to this end. However, we have to confront the limits of the architecture of such an approach, it is not meant to address all the needs of developing and least developed countries. A rather large gap exists between what COVAX or ACT-A can deliver and what is required in developing and least developed countries. In this case demand-side requirements outstrips supply-side constraints. Irrespective of the amount of money any of the donor country 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. Madam Chair, the problem with philanthropy is that it cannot buy equality. Yesterday the DG of WHO warned that: “Money is not the only challenge we face. If there are no vaccines to buy, money is irrelevant. Even if we have the funds, we can only deliver vaccines to poorer countries if high-income countries cooperate in respecting the deals COVAX has done, and the new deals it is doing.” Even in light of all the additional pledges of monetary support, the ACT Accelerator still faces a gap of at least 22.9 billion dollars to fully financed.
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. Take the Africa continent for example, as a whole Africa currently imports more than 80 per cent of its pharmaceutical and medical consumables. This is unsustainable and puts the continental population of 1.3 billion people at the mercy of a few monopolistic companies. This is a recipe for disaster as we have witnessed not only with the COVID-19 pandemic but with all other diseases and pandemics that continue to affect the continent.
We recalled in our intervention of 4 February 2021, in which we quoted a study commissioned by the international Chamber of Commerce (ICC) Research Foundation which found that the global economy stands to lose as much as $9.2 trillion if governments fail to ensure developing country economies access to COVID-19 vaccines. We have already argued that there are good moral and legal grounds, as recognized under the TRIPS agreement, to pass the waiver proposal. In addition, this study underscores the importance of ensuring access by developing countries to effective vaccines in order to mitigate the economic social and have consequences in the years ahead. We have already indicated that the artificial shortage of vaccines is primarily caused by the inappropriate use of intellectual property rights, this cannot be allowed to continue. It is now apparent that poor countries would have to wait a long time to access vaccines, during this time the virus will mutate giving rise to strains that will undermine the efficacy of existing vaccines. COVID-19 does not respect national borders; nor does it care about the gross domestic product of a country, no country in the world can insulate itself, even the best plans will be laid to waste. Let us ensure that everyone has access to effective vaccines in the shortest possible time.
In closing, as many cosponsors have reiterated, we 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.
Second intervention
I would once again like to thank all delegations that took the floor today. Some delegations wanted more details of manufacturing capacity that exist in the developing world. As we have pointed out at the last session, out of the 158 prequalified vaccines under WHO’s PQ program 72 vaccines are produced by vaccine manufacturers from developing countries. Similarly, LMIC countries have a substantial share in prequalified finished pharmaceutical products, active pharmaceutical ingredients and vaccines. This shows that significant quality manufacturing capability does exists including in developing countries and to ensure global supply, these have to be leveraged.
Some delegations suggest countries who have unused manufacturing capacity on vaccine to pursue voluntary license agreement with vaccine developers for local production. Yet, what we have observed is that among some countries who do not support the waiver proposal, they have experienced difficulties in seeking local production licenses from vaccine developers. It shows, once again, that relying on voluntary license is not sufficient in this pandemic. Canada has just shared their experiences with originators having been rejected by several companies when approached for a voluntary license. Canada’s experience shows relying on voluntary licenses may be highly problematic and evidences the selective approach applied by originators and rights holders. Perhaps Canada can disclose the terms of its license agreement with Novavax to back up its claim that IP is not a barrier to access?
It is also worth noting that some of the non-vaccine producers have recently been brought into vaccine production in Europe and Japan, such as Bayer and JCR pharmaceutical in Japan. This has yet happened in developing countries at large. While this kind of arrangements were made under selective agreements between companies, this shows that it is practical to explore and leverage the manufacturing capacity even beyond the usual vaccine producers. Yet, relying on originator company’s voluntary willingness is not sufficient. Leveraging the full capacity requires true global collaboration of all countries so that both technological and legal barriers to ensure scale up production and supply can be guaranteed. The waiver proposal provides a legal enabler to facilitate this to happen.
We thank the EU for its statement, the facts and actions spoken about remain vague. 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. It 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 third country report. It has not followed 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 authorisation scheme.
We heard Switzerland and Singapore quote Dr. Poonawalla of the Serum Institute. In a recent interview with Politico, Dr. Poonawalla 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,” “If you don’t allow, for example, an Indian producer to sell in the U.S. because of some stupid rules and regulations, even though the product is identical to a U.S. product, you’re going to have a supply situation.” “And guess what,” he continued. “When you’ve got low supply and high demand, what happens to the price? It skyrockets.”
Some delegations continue to argue that Article 31bis could be used by countries that have no or insufficient manufacturing capacities to seek supply under compulsory license for export issued by another country. Yet, as we have heard from various developing country delegations, the current provisions and requirements of Art 31bis are not fit for purpose during a pandemic of this nature. The waiver proposal provides a quicker and easier option in the pandemic.
On the question posed by Norway on a revised proposal from the Cosponsors, 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. We invite 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 informal meetings. We once again call for our deliberation to move to a text-based discussion.
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