Vaccines

Information is provided in chronological order – newest information last

Vaccine development
Medicines Law and Policy (October 2020) published a briefing paper that untangles the various roles/relationships between Oxford University & the Jenner Institute, AstraZeneca and several other actors working on one of the leading candidate vaccines. The ‘Oxford / AstraZeneca’ vaccine is one of the world’s leading hopes in the race to end the Covid-19 pandemic. Its history is not as clear, though, as it may first seem. The media reporting about the vaccine tends to focus either on the very small (non-profit, academic) Jenner Institute at Oxford University, where the vaccine was first invented, or the very large (‘Big Pharma’ firm) AstraZeneca, which is now responsible for organising its (non-profit) world-wide development, manufacture and distribution. However, examining the intellectual property (IP) path of the vaccine from invention to manufacture and distribution reveals a more complex picture that involves other important actors (with for-profit perspectives). The paper also provides comments as well as raises some important questions about what might yet be done better and what lessons can be learned for the future.
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Proposal for TRIPS waiver for Covid-19 related medicines and technologies secures strong support from LMICs
Posted on November 8, 2020 

In a landmark move, India and South Africa on 2 October asked the World Trade Organization (WTO) to allow all countries to choose to neither grant nor enforce patents and other intellectual property (IP) related to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic, until global herd immunity is achieved. 
In the global battle for putting people’s lives before patents and the profits of big pharmaceutical companies, South Africa, India, Kenya, and Eswatini have issued a clarion call for a waiver from certain provisions of the WTO’s TRIPS Agreement for combating the worsening COVID-19 pandemic, participants told the SUNS.

The proposal for a TRIPS waiver by India, South Africa, Kenya and Eswatini (formerly called Swaziland) secured strong support from developing countries, while the United States and the European Union among others rejected it, said participants, who asked not to be identified.

At a meeting of the WTO’s TRIPS Council on 16 October, South Africa, India, Kenya and Eswatini made a comprehensive case as to why provisions governing “certain obligations related to COVID-19 products and technologies” under Sections 1 (copyrights and related rights), 4 (industrial designs), 5 (patents), and 7 (protection of undisclosed information) of Part II of the TRIPS Agreement need to be waived off.

Statement by Sri Lanka at WTO Council of Trips
Ms Gothami Silva, Sri Lankan Ambassador/Permanent Representative to WTO Permanent Mission of Sri Lanka to the WTO provided a very clear detailed statement in unequivocal support of the proposals. She expressed thanks and immense appreciation to India, South Africa, Kenya and other newly joined co-sponsors for presenting their extremely relevant and timely proposal for a Waiver from certain provisions of TRIPS Agreement for Prevention, Containment and Treatment of Covid-19.

In a Tweet posted on 17 October, the director-general of the World Health Organization (WHO), Dr Tedros Adhanom Ghebreyesus, welcomed the proposal tabled by South Africa and India “to ease international and intellectual property agreement on COVID-19 vaccines, treatments & tests in order to make the tools available to all who need them at an affordable cost.”

“Ending the pandemic starts with collaboration,” he said, suggesting that the WHO had launched the “COVID-19 Technology Access Pool in May, inviting countries to share data, knowledge and intellectual property on vital, life-saving health products in the fight against the coronavirus.”

D. Ravi Kanth of Third World Network (TWN) provided a very detailed explanation of the waiver proposal on October 19.

A briefing document prepared by Médecins Sans Frontières (MSF) aims to provide further details related to this important development, including a Q&A; an overview of the impact of IP barriers on access to therapeutics, vaccines and diagnostics; three case studies examining IP barriers in the context of COVID-19; and examples of Article IX waivers that have been granted with respect to provisions under the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) Agreement in the past. 

The MSF document provides answers to the following questions: 
What has been proposed? 
What would it mean if the waiver was granted? 
Is it legal to request a waiver from obligations under the TRIPS Agreement? 
Does the waiver proposed apply only to developing countries? 
How is a final decision reached at WTO on a waiver? 
Has a consensus been reached by WTO members to grant waivers in the past? 
Is the waiver permanent? 
Why is the waiver important at this moment in the pandemic?
Some people say IP is not an issue for COVID-19 tools. If that is true, why is a waiver needed?
Why do countries need a waiver when they can already use TRIPS flexibilities for public health?
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April 2021

The political economy of COVID-19 vaccines – Jayati Ghosh, Third World Resurgence TWN. THE COVID-19 pandemic has been unusual in several ways: the disproportionate extent to which people in rich countries (particularly in Europe and North America) have been affected; the sheer scale of the policy response for containment; and the speed and urgency of the global response.
https://twn.my/title2/resurgence/2021/347/health1.htm

TRIPS waiver proposal being held hostage on “ideological” grounds
Published in SUNS #9333 dated 26 April 2021 – D Ravi Kanth TWN
https://twn.my/title2/intellectual_property/info.service/2021/ip210406.htm

The best hope for fairly distributing COVID-19 vaccines globally is at risk of failing. Here’s how to save it. Deb Gleeson PHM – The Conversation
COVAX, the global initiative to coordinate the distribution of COVID-19 vaccines in an equitable way, is crucial for bringing the pandemic under control.  But COVAX’s aim of delivering 2 billion doses to participating countries by the end of 2021 — including 92 low-income countries that can’t afford to buy vaccines directly from manufacturers — is threatened by chronic under-investment, vaccine nationalism and export restrictions.
https://tinyurl.com/4x25h87s

The Temporary Waiver of Patents on Vaccines -Riccardo Petrella and Roberto Savio – Other News, Voices Against the Tide
It cannot be said often enough: the temporary waiver of the rules laid down in the 1995 WTO-TRIPS (Trade Related Aspects of Intellectual Property Rights) , in particular on private for-profit patents on vaccines would be an important result in the interests of the impoverished and marginalised populations of the world. It would not, however, be a step forward or a new political and social achievement. The waiver is not a call for aid or solidarity. It is a request to apply the WTO treaties.
https://www.other-news.info/2021/04/the-temporary-waiver-of-patents-on-vaccines/

May 2021


US support for waiving COVID vaccine intellectual property is a huge step. Australia must follow
Deborah Gleeson
https://theconversation.com/us-support-for-waiving-covid-vaccine-intellectual-property-is-a-huge-step-australia-must-follow-160443?utm_medium=email&utm_campaign=L

Yesterday, the US Biden administration declared its support for waiving intellectual property rights, including patents, for COVID-19 vaccines. This decision represents a huge breakthrough in discussions at the World Trade Organisation (WTO) that have been deadlocked for more than six months. Shortly afterwards, New Zealand’s trade minister Damien O’Connor announced his country’s support on Twitter, quickly followed by Canada’s expression of support for the proposal. Other nations that have so far resisted pressure to support the waiver are likely to fall like dominoes in the wake of the US in coming days. Today, Australia’s trade minister Dan Tehan said the waiver “will be an important part of trying to get a resolution in the World Trade Organisation”, but it remains unclear whether Australia has unequivocally thrown its support behind the proposal.
Waiving intellectual property rights is a necessary first step to scaling up the global supply of COVID-19 vaccines and correcting worsening inequities in access to these desperately needed products. A decision by Australia to support the waiver would indicate we value human lives more than pharmaceutical industry profits, and are committed to bringing the pandemic to an end globally. Read the whole article here.

June 2021

 The politics of COVID-19 vaccination in middle-income countries: Lessons from Brazil 

 Elize Massard da Fonseca a,b,*, Kenneth C. Shadlen c, Francisco I. Bastos 
 Abtract: As the world struggles to meet the challenges of vaccination against COVID-19, more attention needs to be paid to issues faced by countries at different income levels. Middle-income countries (MICs) typically lack the resources and regulatory capacities to pursue strategies that wealthier countries do, but they also face different sets of challenges and opportunities than low-income countries (LICs). We focus on three dimensions of vaccination: procurement and production; regulation of marketing registration; and distribution and uptake. For each dimension we show the distinct challenges and opportunities faced by MICs. We illustrate these challenges and opportunities with the case of Brazil, showing how each dimension has been affected by intense political conflicts. Brazil’s procurement and production strategy, which builds on a long trajectory of local production and technology transfer, has been riddled by conflicts between the national government and state governments. The regulatory approval process, based around one of Latin America’s most highly-regarded regulatory authorities, has also been subject to acute inter- and intra-governmental conflicts. And with regard to distribution and uptake, in the face of high uncertainty, even with a solid health infrastructure, Brazil encounters difficulties in promoting vaccine delivery. The research also reveals the importance of coordination among these dimensions, in Brazil and beyond. Pandemic preparedness and response must include sharing knowledge of how to produce vaccines and recognition of the crucial linkages between procurement, regulation, delivery, and uptake that are necessary for ensuring access to these products. 

https://doi.org/10.1016/j.socscimed.2021.114093
Read the whole article here