Perspectives sharply differ at WTO DG’s vaccine event

Washington DC, 15 Apr (D. Ravi Kanth) – The WTO director-general Ms Ngozi Okonjo-Iweala’s much touted meeting on addressing “equitable distribution of COVID-19 vaccines” brought sharply differing perspectives to the fore on various issues, including the role of IPRs and the need to finalize a decision on the temporary TRIPS waiver in ramping up global production of vaccines for combating the worsening pandemic that has claimed more than 2.9 million lives, said people familiar with the proceedings. At the more than five-hour virtual meeting chaired by Ms Okonjo-Iweala on 14 April, trade ministers from India and South Africa, as well as the World Health Organization director-general, called for the temporary TRIPS waiver in ramping up production of diagnostics, therapeutics and vaccines across countries to prevent and treat the COVID-19 pandemic.
In sharp contrast, the United States delivered a nuanced statement to address the divide between developed and developing countries on access to vaccines.
Washington did not offer any concrete or defined solutions on how to address this divide other than making some somewhat platitudinous remarks.
Despite holding meetings with labour unions, advocacy groups and pharmaceutical lobbies on 13 April, the US Trade Representative (USTR) Ambassador Katherine Tai remained silent on the TRIPS waiver at the meeting convened by the WTO DG on 14 April.
Separately, over 170 former heads of state and government, as well as Nobel Laureates on 14 April, urged US President Joseph Biden to support the proposed TRIPS waiver.
In an open letter, the former world leaders and Nobel Laureates encouraged President Biden to “let this moment be remembered in history as the time we chose to put the collective right to safety for all ahead of the commercial monopolies of the few.”
However, the Republican members of the House Ways and Means Committee fiercely opposed the TRIPS waiver and wrote a letter to President Biden to oppose the waiver at the WTO on 14 April.
The EU, however, spoke about the Ottawa Group’s trade and health initiative, which has few takers at the WTO and addressing export restrictions. Brussels opposed the TRIPS waiver, people said.
The meeting also witnessed differences in perspectives for manufacturing vaccines between Pfizer and Moderna on the one side, and Bharat Biotech from India, Aspen from South Africa, and Incepta Pharmaceuticals from Bangladesh, on the other, said people, who asked not to be identified.
Pfizer and Moderna apparently ruled out any prospect of sharing their mRNA technology-based vaccines with the vaccine firms in developing countries on grounds that they are far too complex and require more than 100 raw materials.
The representatives of these two Northern-based companies, which were bolstered by billions of dollars of public funds for developing their vaccines, maintained that they cannot guarantee safety in the production of vaccines in developing countries.
But vaccine companies from the Global South, particularly Bharat Biotech from India and Aspen from South Africa, pushed back against such hyperbolic claims, saying that unless countries look outside the box, they will not be able to address the root cause that is producing the global shortages of vaccines, said people, who asked not to be quoted.
Dr Sai Prasad of Bharat Biotech said his company is pursuing an mRNA vaccine along with several companies, arguing that if companies tend to look inside the box, there may not be any solutions.
But if vaccine companies are able to look out of the box, there are plenty of solutions, suggesting that there are pharmaceutical companies in Bangladesh, Pakistan and Brazil which can produce complex vaccines if requisite technology transfer is accepted under relaxed IPR conditions, said people familiar with the development.
In her concluding statement at the meeting on 14 April, Ms Okonjo-Iweala acknowledged that there are differences among participants “on issues concerning the future shape of vaccine supply chains, on the appropriate role of intellectual property protections, on issues of vaccine contract transparency – which was pointed to by many as an important factor in appropriate pricing and distribution and a critical part of access and equity.”
She also alluded to a framework agreement on trade and health at the WTO’s 12th ministerial conference (MC12) for addressing future pandemics.
Ms Okonjo-Iweala spoke about the TRIPS waiver in a positive way in her opening statement, but she went back to her original “third way” approach in her concluding remarks, said people, who asked not to be quoted.
The TRIPS Council chair Ambassador Dagfinn Sorli from Norway suggested at the meeting that no clear answers were provided about how certain provisions of the TRIPS Agreement could constitute a barrier, in what seemed to be a false statement, said people familiar with the development.
In sharp contrast to Ambassador Sorli’s statement, the former TRIPS Council chair Ambassador Xolelwa Mlumbi- Peter from South Africa suggested that the time for questions centring on the IPR barriers is over and it is now time for moving rapidly to text-based negotiations so as to arrive at a balanced solution as part of the WTO’s contribution to the TRIPS waiver, said people familiar with the proceedings.
Significantly, the WHO Director-General Dr Tedros Adhanom Ghebreyesus supported the TRIPS waiver at the meeting, while the International Monetary Fund’s Managing Director Ms Kristalina Georgieva pledged considerable support for ramping up production of vaccines through the proposed creation of hundreds of billions of dollars of Special Drawing Rights.
Also, the head of the World Bank’s International Finance Corporation Mr Makhtar Diop said that special funds are being catered to increasing the capacity for producing new vaccines in Africa.
In short, the whole meeting looked like a very shallow conference and also revealed differences in approaches to vaccine equity and ramping-up of production almost along North-South lines.
In her opening remarks, Ms Okonjo-Iweala said she convened the meeting as to what the WTO can contribute to addressing the COVID-19 pandemic.
The DG referred to the TRIPS waiver, stressing that there is a lot of inequality of access, which is not acceptable.
She said the poorer nations don’t have nearly the number of vaccines that they require at this juncture.
Ms Okonjo-Iweala spoke about the complexities in the manufacturing of vaccines, suggesting that in order to manufacture them, there are a lot of things that need to happen, including the sharing of knowledge and transfer of technology, according to the people present at the meeting.
In the absence of collaboration with the right holders and owners of technology, she asked rhetorically whether it could happen as quickly as possible and as required, said people familiar with her statement.
And from that point of view, it is important to see how we could ramp up and whether it is possible to establish capacities in other parts of the world, Ms Okonjo-Iweala said.
The WTO DG also emphasized safety and other considerations, suggesting that it is important to know what role other organizations like the Geneva-based GAVI (Global Vaccine Alliance) are playing.
“It is a nice opening statement from the DG,” said a person, who asked not to be quoted.
However, for some inexplicable reasons, the DG’s opening statement, which was initially displayed on the WTO website, seems to have been removed.
In his strong statement issued at the meeting, the WHO DG Dr Tedros Adhanom Ghebreyesus said the approval and rollout of safe and effective vaccines against COVID-19 were creditable and a stunning scientific development in a matter of one year.
Yet, “there remains a shocking and growing imbalance in the global distribution of vaccines – my sister Ngozi said some of them,” he said.
Dr Tedros offered some shocking statistics at the meeting, saying that “more than 800 million vaccine doses have been administered globally, but over 83% have gone to high-income or upper-middle-income countries, while low-income countries have received just 0.2%.”
He said that it is not surprising as “when HIV emerged 40 years ago, life-saving antiretrovirals were developed, but more than a decade passed before the world’s poor got access.”
Drawing attention to the COVAX facility that was created more than one year ago, he said “although COVAX has distributed almost 40 million doses of vaccine to 110 countries and economies, vaccine nationalism, vaccine diplomacy and severe supply constraints have so far prevented COVAX from realizing its full potential.”
He said global manufacturing capacity and supply chains have not been sufficient to deliver vaccines quickly and equitably where they are needed most.
Dr Tedros said more funds are needed for procuring vaccines, which is only part of the solution.
Ironically, “money doesn’t help if there are no vaccines to buy,” he said, underscoring the need for dramatically scaling up the number of vaccines being produced.
He called for scaling-up production of vaccines, suggesting that governments and pharmaceutical companies need to “go beyond the traditional modus operandi to provide sustainable and effective solutions to address this extraordinary crisis.”
Dr Tedros suggested that “the current company-controlled production sharing agreements are not coming close to meeting the overwhelming public health and socio-economic needs for effective, affordable and equitable access to vaccines, as well as therapeutics and other critical health technologies.”
“This is an unprecedented emergency that demands unprecedented measures,” he argued, emphasizing that “we must leave no stone unturned.”
He called for exploring “every option for increasing production, including voluntary licenses, technology pools, the use of TRIPS flexibilities and the waiver of certain intellectual property provisions.”
He outlined three ways to overcome “the obstacles” faced by members. They include:
1. Companies must share know-how, intellectual property and data with other qualified vaccine manufacturers, including in low-and middle-income countries, as COVAX and COVID-19 Technology Access Pool or C-TAP have failed to deliver results;
2. Countries must strengthen their regulatory capacity; and
3. Countries must invest in local vaccine manufacturing.
He reminded the participants at the meeting that “responding to this unprecedented crisis means thinking and doing things differently.”
Ultimately, said Dr Tedros, “putting aside the old barriers and the limitations of short-term self-interest is the only way to build the safer, healthier and fairer world we all want.”
Without committing to any defined solutions, including the TRIPS waiver proposal at the WTO, the US Trade Representative Ambassador Katherine Tai called for “extraordinary leadership during this extraordinary time.”
Ms Tai “emphasized her commitment to finding solutions that address the gaping divide between developed and developing countries when it comes to access to medicines.”
“Humanity,” said Ambassador Tai, is “facing a public health and economic crisis that we struggle to manage and overcome.”
“Extraordinary crises challenge all of us to break out of our comfortable moulds, our in-box thinking, our instinctive habits,” she argued.
The USTR referred obliquely to WTO reforms, saying that “there are many aspects of the institution of the WTO and its rules that have not adapted to a changed world, a changed membership, changed practices and expectations.”
The European Union’s Trade Commissioner Mr Valdis Dombrovskis spoke in favour of voluntary licenses and using the existing TRIPS flexibilities such as compulsory licenses among others.
He also called for “ensuring transparency and effective monitoring of any temporary export restriction, as proposed by the Ottawa Group.”
In sharp contrast, the trade ministers of India and South Africa pressed for the TRIPS waiver that seeks to suspend several provisions in the TRIPS Agreement relating to copyrights, industrial designs, patents, and protection of undisclosed information to ramp up global production of diagnostics, therapeutics and vaccines in order to combat the COVID-19 pandemic.
India said that the shortfalls in vaccines is due to limited licensing agreements, emphasizing that the TRIPS waiver can address issues concerning prevention, treatment, and containment of COVID-19.
The Indian minister Mr Piyush Goyal also assured the participants that the proposed waiver is not intended to take away the protection offered to pharmaceutical companies.
The waiver is only meant for COVID-19 vaccines, associated medicines and a cure, India said, arguing that although this meeting is focused on the so-called “third-way”, it is important to engage all potential manufacturers on a transparent framework, according to participants familiar with the proceedings.
For quick scaling-up of global production of vaccines, therapeutics and diagnostics, the Indian minister apparently said there is an urgent need for temporary removal of all impediments to the production of COVID-19 medical products, including where necessary Intellectual Property protection.
Mr Goyal spoke about the TRIPS waiver proposal introduced by India and South Africa along with 57 other WTO members.
He said that the TRIPS waiver is a temporary and limited-scope waiver from certain provisions of the TRIPS Agreement relevant to the prevention, treatment and containment of COVID-19.
South Africa’s trade minister Mr Ebrahim Patel also underscored the need for the TRIPS waiver, suggesting that “we have the capacity to take control and engage on issues concerning the ramping-up of production.”
Ms Okonjo-Iweala said “concerns expressed by some about cross-border supply chain operations, including export restrictions and shortages of skilled personnel reinforced my view, and hopefully that of members that the WTO must and can play a central part in the response to this crisis.”
She said various perspectives about the TRIPS Agreement, and whether the existing flexibilities are enough to address developing country needs were put on the table, but these issues were discussed at the TRIPS Council where the sponsors of the TRIPS waiver demonstrated in detail that the existing TRIPS flexibilities like compulsory licensing remain country-specific and inadequate to address the unprecedented pandemic.
Ms Okonjo-Iweala underscored the need for a “business unusual” approach to solve problems concerning issues relating to scaling-up of production, particularly in developed and developing countries.
Speaking at the conclusion of the WTO-organized meeting on “COVID-19 and Vaccine Equity: What Can the WTO Contribute?”, the Director-General said that statements from government ministers, vaccine manufacturers, civil society advocates and leaders of international organizations had identified problems and pointed to potential solutions.
“This is a problem of the global commons, and we have to solve it together,” she said.
Ms Okonjo-Iweala said that during the meeting, roughly 50 speakers took the floor, suggesting that it “would serve as the basis for continued dialogue aimed at delivering results in terms of increased vaccine production volumes in the short-term as well as longer-term investments in vaccine production and enhancing the trading system’s contribution to pandemic preparedness.”
Published in SUNS #9327 dated 16 April 2021