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Business & Regulation COVID-19, Vaccines, Business Practice, Standards & Regulation

The Patent Waiver War

Organization on waiving patent protections for COVID-19 vaccines – joining over 100 countries who already back the proposal. The hope is that this will address inequities and shortages in vaccine supply. However, there is a clear split in opinions on the matter across the world. Here, we round up a selection of quotes from key stakeholders.

Those for

Biden administration (1): “This is a global health crisis and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections but, in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen.”

MSF (2): “The temporary waiver would apply to certain IP on COVID-19 medical tools and technologies until herd immunity is reached. It was originally proposed by India and South Africa in October 2020 and is now officially backed by 58 sponsoring governments, with around 100 countries supporting the proposal overall. Even after one year of this pandemic and 2.5 million deaths, we still see certain governments denying that removing monopolies on COVID-19 medical tools will help increase people’s access to needed treatments, vaccines, and tests going forward. The waiver proposal offers all governments opportunities to take action for better collaboration in development, production, and supply of COVID-19 medical tools without being restricted by private industry’s interests and actions and, crucially, would give governments all available tools to ensure global access.”

UNAIDS (3): “We are in a race to vaccinate the majority of the world’s population to curb death tolls and before more potent variants of COVID-19 emerge, rendering current vaccines ineffective. The faster we can scale up global vaccine supply, the faster we can contain the virus and the less chance we will face a day when variants prove resistant to existing vaccines. As the United Nations Secretary-General Antonio Guterres has said, “No one is safe until everyone is safe.” The TRIPS waiver would enable the sharing of technologies, data, know-how, patents, and other intellectual property rights across the world.”

WTO (4): “The R&D of drugs is often a joint multi-stakeholder effort benefiting from significant amounts of public taxpayer money. For COVID-19, the search for an effective treatment or vaccine is a global effort involving multiple actors – it is not the result of the pharmaceutical industry’s efforts alone. Governments and public funding agencies around the world have poured billions of US dollars of public money to support COVID-19 R&D, especially for drugs and vaccines. However, by and large, no conditions for access or affordability have been included as a precondition to any of that funding. Governments must attach strings to any public money given for COVID-19 medical tools to guarantee that, if they prove safe and effective, they are available to everyone. Today some members have admitted that some conditions had been set on companies, but none of it goes far enough to ensure that IP rights assigned to companies benefiting from taxpayer money do not abuse such rights down the line.”

Those against

IFPMA (5): “A waiver is the simple but the wrong answer to what is a complex problem. Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis. On the contrary, it is likely to lead to disruption while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally: namely, elimination of trade barriers, addressing bottlenecks in supply chains and scarcity of raw materials and ingredients in the supply chain, and a willingness by rich countries to start sharing doses with poor countries.”

EFPIA (6): “This short-sighted and ineffectual decision by the Biden administration puts the hard-won progress in fighting this terrible disease in jeopardy. While we wholeheartedly agree with the goal of protecting citizens around the world through vaccines, waiving patents will make winning the fight against the coronavirus even harder… Increasing capacity to deliver doses to citizens around the world requires the skills and technical know-how of the vaccine developer to bring on board partner manufacturing organizations. You simply cannot achieve this kind of capacity expansion by waiving patents and hoping that hitherto unknown factories around the world will turn their hand to the complex process of vaccine manufacture. A waiver risks diverting raw materials and supplies away from well-established, effective supply chains to less efficient manufacturing sites where productivity and quality may be an issue. It opens the door to counterfeit vaccines entering the supply chain around the world. Capacity expansion is only achievable through voluntary, collaborative partnerships between the innovators behind each vaccine and expert manufacturing partners. All our focus should be on removing barriers to collaboration, ensuring the free flow of materials around the world and continuing the research effort.”

PhRMA (7): “In the midst of a deadly pandemic, the Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.

“This change in longstanding American policy will not save lives. It also flies in the face of President Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery. This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. These are the real challenges we face that this empty promise ignores.

“In the past few days alone, we’ve seen more American vaccine exports, increased production targets from manufacturers, new commitments to COVAX and unprecedented aid for India during its devastating COVID-19 surge. Biopharmaceutical manufacturers are fully committed to providing global access to COVID-19 vaccines, and they are collaborating at a scale that was previously unimaginable, including more than 200 manufacturing and other partnerships to date. The biopharmaceutical industry shares the goal to get as many people vaccinated as quickly as possible, and we hope we can all re-focus on that shared objective.”

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  1. Office of the United States Trade Representative, “Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver,” (2021). Available at https://bit.ly/3vGRMjV
  2. Medecins sans Frontieres, “Countries obstructing COVID-19 patent waiver must allow negotiations to start,” (2021). Available at https://bit.ly/3wNXnVK
  3. UNAIDS, “Statement from the Executive Director of UNAIDS, Winnie Byanyima on the decision by the United States of America to support the TRIPS waiver for COVID-19 vaccines,” (2021). Available at https://bit.ly/3uNzgp3
  4. World Trade Organization, “Waiver From Certain Provisions Of The Trips Agreement For The Prevention, Containment And Treatment Of Covid-19 – Responses To Questions,” (2021). Available at https://bit.ly/3yRdN1n
  5. IFPMA, “IFPMA Statement on WTO TRIPS Intellectual Property Waiver,” (2021). Available at https://bit.ly/3vIXOR9
  6. EFPIA, “EFPIA statement on IP waiver for COVID-19 vaccines,” (2021). Available at https://bit.ly/34xRhNe
  7. PhRMA, “PhRMA Statement on WTO TRIPS Intellectual Property Waiver,” (2021). Available at https://onphr.ma/3i9aywG

About the Author

Stephanie Sutton

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent seven years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

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