TWN Info Service on Trade, IP and Health
23 July 2021
Third World Network
www.twn.my

An earlier version of this article was first published in SUNS #9393 dated 23 July 2021

WTO-WHO Dialogue hears call to treat “patents & profits” as second priority due to COVID-19

Geneva, 22 Jul (D. Ravi Kanth) — The World Health Organization (WHO) director-general Dr Tedros Adhanom Ghebreyesus has told Big Pharma to treat “patents and profits” as a second priority due to the COVID-19 pandemic, adding that “unprecedented crisis demands unprecedented action”.

At a virtual high-level dialogue convened by the heads of the World Trade Organization (WTO) and the World Health Organization (WHO) on 21 July, the WHO DG issued a strong statement from Tokyo urging Big Pharma to transfer technology and know-how to the WHO’s C-TAP (COVID-19 Technology Access Pool) facility as well as the newly established technology transfer hub in South Africa.

He also suggested that the TRIPS waiver could be invoked, said a participant, who asked not to be quoted.

The high-level dialogue follows a high-level meeting hosted by WTO Director-General Dr Ngozi Okonjo-Iweala on 14 April 2021, on “COVID-19 and Vaccine Equity: What can the WTO contribute?”.

The objectives of the high-level dialogues as outlined by the organizers include (i) systematically mapping COVID- 19 vaccine production current and potential capacity, state of play of technology transfer and sharing initiatives, including pooling of IP, know-how, and production and supply chains bottlenecks, (ii) engaging key players from governments, the private sector, international organizations and civil society to expanding and diversifying manufacturing, (iii) to maintain momentum towards more systematic and coordinated international action.

However, these dialogues seem to have failed to provide a concrete roadmap on how to expand and diversify manufacturing in order to promote equitable access to COVID-19 vaccines.

In fact, despite the stated objective of engaging key players from civil society, the dialogue has excluded most civil society organizations at the forefront of advocating for equitable access in developing countries.

Even more surprising is the absence of participation from civil society representatives engaged in the various pillars of ACT-A.

The five-hour meeting witnessed representatives of Pfizer, Moderna, Johnson & Johnson, and AstraZeneca, and some governments from Europe and Switzerland adopting “ideological” positions in favour of intellectual property rights (IPRs), while citing their voluntary licensing agreements (although most of these agreements are merely contract manufacturing agreements where the licensee acts as a manufacturer for the pharmaceutical companies).

The problem, according to Big Pharma and the European Union governments and Switzerland, is that of export restrictions, stressing on the importance of global chains open for the flow of key ingredients.

They spoke in favour of bilateral/voluntary licensing agreements to expand the production of vaccines but refused to license to C-TAP or technology access hubs on grounds that vaccine production is complex, requiring several quality and regulatory approvals.

They openly opposed the TRIPS waiver, arguing that it will not solve the problem and neither were they open to treating COVID-19 vaccines as a “public good”.

Pfizer touted the recent agreement it reached with South African company Biovac for the production of mRNA vaccines in South Africa.

However, in a public statement, Prof. Brook Baker from Northeastern University pointed out that the “agreement is nothing more or less than a contract manufacturing agreement for sterile formulation, fill, and finish. The final vaccine produced will be a BioNTech/Pfizer vaccine with marketing approval or emergency use authorization/ listing under BioNTech/Pfizer’s regulatory dossiers.

Biovac will not be an “independent producer” — it will instead be a contract “subsidiary” facility, subject to rigid control by Pfizer. In addition to the vaccine having a BioNTech/Pfizer “brand”, it will have a price set by them.”

“The announcement does not indicate the technology transfer/sharing agreement would ever result in the ability of Biovac to produce the mRNA active ingredient,” Baker said.

He added that “the underlying mRNA tech platform continues to be exclusively controlled by BioNTech/Pfizer, and Biovac will not be given the ability to further develop its own internal technical capacity and expertise that might allow it to manufacture other mRNA vaccines and therapeutics in the future. BioNTech and Pfizer thereby signal their enduring intention to maintain monopoly rights over their basic mRNA technology”.

Many of Big Pharma’s assertions were challenged at the meeting by several developing countries, including South Africa and Pakistan among others.

WHO DG’S SHARP REMARKS

In a sharp opening statement, the WHO Director-General Dr Tedros Adhanom Ghebreyesus thanked Big Pharma for producing vaccines in record time.

However, “there remains a shocking imbalance in the global distribution of vaccines,” the WHO DG said.

“This has created a two-track pandemic: the haves are opening up, while the have-nots are locking down,” he emphasized.

Pointing out the fact that more than 75% of 3.5 billion vaccine doses distributed globally have gone to just ten countries, he said that “vaccine inequity is not only a moral failure, it is also epidemiologically and economically self-defeating.”

NEED FOR DIAGNOSTICS & THERAPEUTICS

The WHO DG said that “vaccines alone cannot solve the pandemic”, arguing that rapid diagnostics and life-saving therapeutics are also vital.

Dr Tedros touched on the ongoing discussions between the WTO, WIPO (the World Intellectual Property Organization) and the WHO, suggesting that the three organizations have committed to intensified capacity-building and providing robust joint technical assistance to countries on COVID-19 health, intellectual property and trade-related matters.

He said the WTO DG and he are working closely together to advocate for immediate, innovative and sustainable solutions to ensure access to COVID-19 vaccines and other technologies.

He offered an estimate of the vaccines needed, especially the critical target of 11 billion doses of vaccines.

Dr Tedros emphasized that the critical supply gap can be addressed “by removing the barriers to scaling up manufacturing, including through technology transfer, freeing up supply chains, and IP waivers.”

While acknowledging that the intellectual property system plays a vital role in fostering innovation of new tools to save lives, he drove home the message that “this pandemic is an unprecedented crisis that demands unprecedented action.”

PROFITS & PATENTS A SECOND PRIORITY

“With so many lives on the line, profits and patents must come second,” the WHO DG said emphatically, suggesting that daily 1,500 lives are lost globally due to lack of access to vaccines.

As part of the WHO-COVAX efforts, the first COVID-19 mRNA vaccine technology transfer hub has already been set up in South Africa, he informed the participants.

He urged Big Pharma to assist in the transfer of technology to the hubs, “to assist countries acquire vaccine technology and know-how as rapidly as possible.”

The WHO, he said, “is also calling for expressions of interest to establish technology transfer hubs to assist countries to acquire vaccine technology and know-how as rapidly as possible.”

He said that “WHO has pre-qualified numerous health technologies including vaccines from manufacturers in middle-income countries.”

According to Dr Tedros, these manufacturers have shown that they can produce according to international standards of quality, safety and efficacy.

Lastly, “whatever options we use, the most important is increasing the production capacity significantly so there is enough pie to share, there are enough vaccines to achieve the 70% by mid next year and open up the world to bring lives and livelihoods to normality,” he concluded.

Under criticism from the participants, including WHO and several governments at the meeting, the representatives of Pfizer, Moderna, and AstraZeneca defended their actions, arguing that they are entering into voluntary licensing agreements.

The representatives of Big Pharma found it difficult to answer a pointed question as to why they have failed to provide/share technology with C-TAP and whether they are willing to transfer technology to the new hub in South Africa.

CO-SPONSORS OF TRIPS WAIVER

At the meeting, several co-sponsors of the TRIPS waiver for suspending key provisions in the TRIPS Agreement relating to copyrights, industrial designs, patents, and protection of undisclosed information debunked Big Pharma’s arguments.

The co-sponsors argued that if IPRs are not the problem, then why are they opposing the waiver?

The TRIPS waiver, the co-sponsors said, is aimed at addressing the issue of the scaling-up of production of diagnostics, therapeutics, and vaccines across countries, as an expeditious solution to an urgent crisis.

South Africa and Pakistan separately issued strong statements in favour of the TRIPS waiver at the meeting.

They said that in addition to their waiver proposal, they are willing to consider other solutions as well, to address the grave COVID-19 crisis.

The United States did not participate in the meeting while the European Union, which has made it a policy to strongly oppose the waiver, did not make any statement at the meeting.

However, some of its member states opposed the waiver at the meeting, said people familiar with the deliberations.

WTO DG’S INTERVENTION

In her opening statement at the meeting, the WTO DG Ms Ngozi Okonjo-Iweala admitted for the first time that “there is little transparency with regard to vaccine contracts or input markets, though the new COVAX marketplace should help match input demand with supply.”

“Unequal access to vaccines is a major reason for the global economy’s K-shaped recovery, in which advanced economies and a few others are surging ahead, while the rest lag behind amid rising poverty, hunger and unemployment,” she said, suggesting that the meeting was convened to get a better understanding of what is happening in terms of vaccine production.

She asked Big Pharma to inform the participants “about your current and projected levels of vaccine production in 2021 and 2022, as well as the bottlenecks you have encountered — and your ideas for tackling these.”

She also asked that “for those managing intellectual property rights, we’d like to hear about the factors influencing your decisions about technology and know-how transfer, as well as when to license IP in particular, and what would encourage these actions.”

She echoed Big Pharma and European countries’ ideas, such as “members have also put forward ideas on a wider set of health-related concerns, such as export restrictions, tariff cuts, trade facilitation, and increasing vaccine production and distribution, in addition to intellectual property issues.”

According to participants, one of her deputies, Ms Anabel Gonzalez, appeared to defend Big Pharma by suggesting that there are three common barriers to vaccine access. These include: (1) market disruption (such as export restriction measures, lack of raw materials, constraints on technology transfer, lack of transparency); (2) diversification in procurement, vaccine production, and technology sharing; and (3) networking the knowledge and skills required, as well as the infrastructure.

WIPO strongly supported the IPR system as well as the efforts made by Big Pharma, including the voluntary licensing agreements.

The WIPO statement appeared to be at odds with what the WHO said at the meeting, said people, who asked not to be quoted.

Civil Society Statements

Médecins Sans Frontières (MSF) was one of the two CSOs invited to participate in the event.

Leena Menghaney, MSF representative based in India said the medical humanitarian organisation had witnessed shortages and high prices of tocilizumab needed for severe COVID-19 and liposomal amphotericin B for mucormycosis, largely caused by monopolies. “Even during a global pandemic, a handful of wealthy governments continue to allow their monopoly-holding corporations to control how much will be produced, set prices and decide where lifesaving medical products are produced, registered and supplied.”

“Many proposals that could help are stalled by inaction”, Ms. Menghaney stressed, adding that “The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) rejects voluntary sharing initiatives like WHO’s COVID-19 Technology Access Pool. Members of IFPMA favour bilateral deals to avoid disclosing terms and conditions, and even in the most vibrant democracies freedom to information requests are met with redacted agreements that undermine accountability and transparency.”

“WHO’s mRNA vaccine technology transfer hub could expand production and supply of mRNA vaccines for COVID-19, especially in low- and middle-income countries. Yet BioNTech, Pfizer and Moderna – makers of WHO-approved mRNA vaccines – have not participated. Governments like Germany and the US that fund and host major biopharmaceutical developers must use their influence to push companies to participate in the WHO mRNA hub”, Ms. Menghaney said.

MSF stressed that the TRIPS waiver is a critical policy proposal to remove legal barriers to increase production and supply of COVID-19 medical products, and yet the European Union continues to delay negotiations of the waiver, referring to the recent EU proposal IP/C/W/681 that reinforces the status quo.

Ms. Menghaney pointed to India’s use of compulsory licensing to reduce prices of an exorbitantly priced patented cancer drug, wherein the Bayer CEO had responded that the company did not develop the cancer medicine for Indians, which effectively sums up everything that was wrong with the way medical products including for COVID-19 are developed. “Reserved for the wealthiest, with pharmaceutical corporations singularly focused on profits, pushing for intellectual property and high prices”, she said.

“CEOs of pharma corporations in the previous session attributed the speedy development of COVID-19 vaccines to the intellectual property system, discounting the contribution of public funding, people’s volunteering in clinical trials and regulatory support”, Ms. Menghaney further said, while stressing that “Millions of people are still waiting to benefit from the important medical innovations of the past year and half, and intellectual property is deepening social and racial injustice across the world.”

Ellen t’ Hoen of Medicine Law and Policy said that “Public funding significantly de-risked companies endeavours to bring vaccines to market rapidly, but failed to ensure, in exchange for this de-risking, the sharing of the knowhow. The lack of conditionalities in these publicly funded contracts is a tangible example of policy failure, particularly because those same governments (this includes the EU) (also celebrated at this meeting) promised that the Covid-19 vaccines would be global public goods or common goods. No-one would own the vaccine, we were told”.

Access to technology “remains the unfulfilled promise of the TRIPS Agreement”, t’ Hoen reminded the meeting.

ROLE OF IPRs

Meanwhile, according to Richard Kozul-Wright, the Director of the Globalization and Development Strategies Division at the United Nations Conference on Trade and Development (UNCTAD), “IPRs are generally sought to compensate the producers for their innovations and inventions and provide incentives for further research and development.”

“However, in the case of COVID-19, studies have shown that public funding accounted for around 99% of finance towards their R&D,” he said, arguing that “these vaccines would not have existed without government funding, which comes primarily from taxes paid by the citizens.”

“We should also not forget the cooperation of millions of people who came forward for testing these vaccines and this is sufficient grounds to declare these vaccines as public goods,” he emphasized.

Commenting on “vaccine inequity,” he said that “wealthy countries have already booked two to three times of vaccine doses as compared to their population. For example, Switzerland, with a population of 8.5 million, has reserved 27.5 million doses. Wealthy countries representing just 13% of the global population have already reserved over 50% of expected COVID-19 vaccine doses till the end of 2021.”+