A TRIPS waiver is urgently needed to make progress on COVID-19 vaccine equity

Vaccine inequity is amongst the most significant social justice issues of our generation, and it poses a major threat to the global COVID-19 response. Donating surplus doses to low-income countries is simply not enough. As public health researchers and practitioners, including those working on epidemic preparedness, response, and vaccine development and deployment, we join others including WHO, MSF, Amnesty International, the Drugs for Neglected Diseases initiative, and scientists around world, in an urgent call to waive the Trade Related Intellectual Property Rights (TRIPS) agreement and allow global manufacturing of vaccines.

Intellectual Property Rights are a crucial bottleneck in research and development and vaccine equity.

Intellectual Property Rights (IPRs) are a crucial bottleneck in research and development and vaccine equity. The proposal to waive TRIPS on COVID-19 products was initially put forward by India and South Africa in October 2020, with the backing of around 100 countries—including, as of May 2021, the US—but it continues to be opposed by some of the world’s richest nations. This proposal is to be discussed further at the World Trade Organization (WTO) General Council meeting on 21 July.

Existing inequalities

Over the last year, the COVID-19 pandemic has taken the lives of over three million people worldwide. Disruptions to social and economic life because of the pandemic and measures to bring it under control have had wide ranging ripple effects from worsening mental health to growing poverty and increased domestic violence. There has been an increased burden of childcare, increased gender-based violence, and women lost an estimated USD 800 billion in income globally in 2020. These ill effects have been shaped by racial disparities and gender inequalities in terms of economic, health, and educational outcomes. This has been more acutely felt by vulnerable and underserved populations throughout the world. COVID-19 has changed our societies in profound ways. Despite hopes that governments and international bodies would act to protect all members of society, the pandemic has instead consolidated existing inequalities within and between countries in terms of prevention and treatment of the virus. COVID-19 has deepened fault lines in global solidarity, while nationalism poses the greatest threat to coordinated global action to end the pandemic. This is nowhere more evident than in the global distribution of COVID-19 vaccines.

The state of COVID-19 vaccination

Vaccines have been widely regarded as the light at the end of the pandemic tunnel. Developed at breakneck speed thanks to the mobilisation of the whole scientific community and large government subsidies, they have made it possible for some countries to start planning an exit from lockdowns and other restrictions. However, so far, abundant vaccine supplies remain a privilege of the few. While high-income countries have reached over 50% coverage of their populations, many African member states have yet to reach 1%. Whilst rich nations such as Canada, the UK, Australia, New Zealand, and the US have purchased enough doses to vaccinate their populations several times over, most people in low-income countries (whose development has been impeded by a long history of extraction by wealthy nations) will not receive a dose until at least 2022. This is both unjust and short-sighted. Tragic developments in low- and middle-income countries (LMICs) remind us that the pandemic is far from over and that allowing new, potentially vaccine-resistant variants to emerge can set back global vaccination efforts.

Availability of vaccines at national level is made possible via bilateral prepurchase agreements between vaccine producers and countries or regions, such as the European Union or the African Union (AU). The AU, with the help of the African Export-Import Bank, has negotiated an agreement to prefinance 670 million doses of vaccines while African countries pool their funds, but still, very few low-income countries have contracts that would provide sufficient volumes to cover their entire populations. In short, different countries are not on an equitable footing for funding and networks in the negotiations. As AU Special Envoy Strive Masiyiwa recently said, “This is a deliberate global architecture of unfairness.”

Barriers to achieving equity: Intellectual Property Rights (IPRs) and COVAX

First, IPRs legitimate the pharmaceutical industry to make exclusive decisions to whom vaccines are sold and at what price. Under the TRIPS agreement by the World Trade Organization, companies owning intellectual property hold exclusive rights to produce vaccines without competing generic products on the market. This way, they are able to control markets and regulate high prices, as there is limited competition with similar products.

A charity model detracts from the realisation of vaccine equity as a social justice issue.

Second, the COVAX programme was established in April 2020 to ensure that vaccines spread globally at equal pace after their authorisation. COVAX is often lauded as a mechanism that holds promise for equitable vaccine access, but its public representation is glossier than the reality. The targeted immunisation coverage for countries participating in COVAX is around 20% by the end of 2021 and timely supply is in question as “high income countries step to the front of the queue for limited supplies of COVID-19 vaccines”. In addition, a charity model is inadequate and insufficient: it detracts from the realisation of vaccine equity as a social justice issue and from the recognition of the role that many high-income countries play in making other countries ‘resource-poor’. A TRIPS waiver would allow for expansion of access to vaccines and other much needed medicines and equipment, and facilitate scaling up of technology transfers and manufacturing, reframing the conversation on global solidarity. This presents an alternative to the charity model and would lay the groundwork for true collaboration in future global health endeavours.

The way forward: A TRIPS waiver and improved vaccine production and distribution

Waiving patents is not a radical or new proposal. The most notable example is the use of compulsory licencing for cheap antiretrovirals in early 2000s. A social movement led by the South African NGO Treatment Action Campaign sued the South African government over the denial of its citizens’ health rights and mobilised the Indian generic pharmaceutical company Cipla to produce cheap generics. The price of antiretroviral medication was reduced by 97%, and with this, access to medications and quality of life for HIV-positive individuals has dramatically increased.

Political will is urgently needed to pass this TRIPS waiver. One key challenge is that the European Commission (EC) currently opposes the waiver, although the European Parliament is in support of one. Any activist mobilisation would need to persuade all EC countries, as the EC speaks in one voice at the World Trade Organization general assembly. Members of EC states can put political pressure on their governments to move the needle on this issue.

The TRIPS waiver is one step in a long-term project to improve equity and the balance of power in global health.

We also recognise that a waiver is only a starting point. It is imperative that vaccine production and distribution capacities are rapidly increased, including high-income countries lifting embargoes on exporting raw materials, such as glass vials to low-income countries. South Africa and Kenya could rapidly scale up vaccine manufacturing. This would need to be paired with comprehensive community engagement to bolster vaccine confidence. Further, this is about building strong global partnerships and an exchange of expertise and ideas. Strategies for transferring knowledge and technology and sustained, transparent and free sharing of critical public health information at all stages of vaccine development are essential. This should also include a broader range of COVID-19 products such as diagnostics and therapeutics. This is one step in a long-term project to improve equity and the balance of power in global health.

Effective global leadership requires that we urgently move beyond vaccine nationalism, addressing both the ethical and moral imperative of vaccine equity and the ‘enlightened self-interest’ of expanded vaccine coverage. Access to vaccines is only the beginning and it must be paired with broader investment in health care systems rather than being a one-time fix. The tide is starting to turn. In the last month, the Biden administration in the US signalled their support for a waiver and the European Parliament has backed a resolution. We are adding our voice to growing calls to “share vaccine knowledge and expand global capacity for vaccine production” and ask opposing governments to urgently reconsider their position on TRIPS waivers for vaccines.

 

Box 1. Countries and bodies currently opposing the TRIPS waiver

  • United Kingdom
  • European Commission
  • Japan
  • Australia
  • Brazil
  • Norway
  • Singapore
  • Switzerland
  • South Korea

 

Authors:

Signed by:

COVID-19 Clinical Research Coalition Social Science Working Group

Michael Abouyannis, KEMRI-Wellcome Trust Research Programme, Kenya

Amina Abubakar, Aga Khan University, Kenya

Ambrose Agweyu, KEMRI-Wellcome Trust Research Programme, Kenya

Arzoo Ahmed, Nuffield Council on Bioethics, UK

Donald Akech, KEMRI, Kenya

Jennyfer Ambe, SAMOCRI, Nigeria

Sarah Atkinson, KEMRI-Wellcome Trust Research Programme, Kenya

Caesar Atuire, University of Ghana, Ghana

Anant Bhan, Yenepoya (deemed to be University), India

Maria Elena Bottazzi, Baylor College of Medicine, USA

James Bukosia, KEMRI – Welcome Trust Research Programme, Kenya

Primus Che Chi, KEMRI-Wellcome Trust Research Programme, Kenya

Sarah Edwards, UCL, UK

Isaac Egesa, KEMRI-Wellcome Trust, Kenya

Lynne Elson, University of Oxford and KEMRI-Wellcome Trust, Kenya

Melanie Etti, St. George’s University of London, United Kingdom

Mohammad Abul Faiz, Dev Care Foundation and Professor of Medicine (Retired), Former Director General of Health Services, GOB, Bangladesh

Andrew Farlow, University of Oxford, UK

David Kaawa-Mafigiri, School of Social Sciences, Makerere University, Uganda

Zarina Nahar Kabir, Karolinska Institute, Sweden

Nancy Kagwanja, KEMRI Wellcome Trust Research Programme, Kenya

Dorcas Kamuya, KEMRI-Wellcome Trust Research Programme (KWTRP), Kenya

Maureen Kelley, University of Oxford, United Kingdom

James Kimotho, KEMRI, Kenya

Samson Kinyanjui, KEMRI-Wellcome Trust Research Programme, Kenya

Frederic Le Marcis, IRD and ENS de Lyon, France

Leesa Lin, LSHTM, UK

Paul Lotay, Centrale Humanitaire Medico-Pharmaceutique, Kenya

Patrick Lukulay, Tech4Health, Ghana

Damaris Matoke-Muhia, KEMRI, Kenya

Charles Mbogo, KEMRI, Kenya

Sassy Molyneux, University of Oxford, UK

Nancy Mwangome, Open university, Kenya

Élysée Nouvet, Western University, Canada

Francine Ntoumi, Fondation Congolaise pour la Recherche Médicale, Republic of Congo

Berrick Otieno, KEMRI- Wellcome Trust Research Programme, Kenya

Andrea Palk, Stellenbosch University, South Africa

Eurek Ranjit, Kathmandu Medical College, Nepal

Raffaella Ravinetto, Institute Tropical Medicine, Antwerp

Enow Sam Agbor, Jhpiego, Cameroon

Eduard Sanders, University of Oxford, Kenya

Kit-Aun Tan, Universiti Putra Malaysia, Malaysia

Alfredo Torres, University of Texas Medical Branch, USA

Ed Vreeke, QUAMED, Belgium

Nicholas White, Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Thailand

Barthalomew Wilson, PREVAIL/FHIC, Liberia

Katharine Wright, Nuffield Council on Bioethics, UK

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Lorenz
2 months ago

BERLIN, April 28 (Reuters) – The granting of intellectual property waivers is not the right way to increase output of COVID-19 vaccines, the founder of German vaccine maker BioNTech said on Wednesday, advocating instead the award of production licences. Such waivers are among the options being considered by the Biden administration for maximising the production and supply of vaccines, though no decision has been made, White House press secretary Jen Psaki said on Tuesday. “This is not a solution,” BioNTech CEO Ugur Sahin said. BioNTech, which makes and markets its messenger RNA-based shot in partnership with U.S. drugmaker Pfizer, considers close cooperation with selected production partners to be the right approach because its vaccine is hard to make. “We are considering ways to issue special licences to competent producers,” Sahin told an online briefing hosted by the German foreign correspondents’ association. This would ensure that the quality of vaccines delivered to different regions of the world is consistent, Sahin said, adding that production by licensees could make a contribution towards the end of this year at the earliest.The BioNTech/Pfizer shot has been widely administered in countries including Israel, the United States and Britain, and is also the lead vaccine in the European Union’s inoculation campaign. Sahin said it was important that shots produced in the EU could be exported to other parts of the world. The region could expect to achieve herd immunity by late summer, but it would be of little use if Europe were safe but the virus continued to rampage elsewhere, he added. BioNTech expects Chinese health authorities to approve its vaccine “by July at the latest”, Sahin told the briefing, adding it should be possible to start distributing it there that month. “I am optimistic that we can help the people of China,” said Sahin, describing its local partner, Shanghai Fosun Pharmaceutical Group Co Ltd as “a great company”.

Megan Schmidt-Sane
2 months ago
Reply to  Lorenz

Hi Lorenz, thank you for sharing this, but voluntary or special licensing will not be sufficient to overcome major inequalities in the current supply. The special license proposal does not solve the fundamental problem that drug companies are monopolizing supply. We agree however that IP waivers are not panacea and need to be accompanied by knowledge and technology transfers and long-term investment in scaling up manufacturing capacity.