[CTC] Updated TRIPS waiver talking points

Mon May 24 07:59:09 PDT 2021

New talking points from GTW…

Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826

TALKING POINTS: GETTING A TRIPS WAIVER ENACTED AND MORE COVID VACCINES, TESTS AND TREATMENT PRODUCED AS SOON AS POSSIBLE TO END THE PANDEMIC   <>

Commending the Biden Administration’s Support for the TRIPS Waiver

The extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. USTR Katherine Tai said that <https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver>when she put the U.S. on the right side of history by announcing support for the temporary COVID-19 emergency waiver of some WTO intellectual property monopolies so we can end the pandemic’s death and economic devastation as speedily as possible.

The Biden-Harris administration is to be commended and thanked for reversing Donald Trump’s self-defeating blockage of WTO negotiations for a temporary, emergency COVID-19 waiver of pharmaceutical monopolies under the Agreement on Trade Related Aspects of Intellectual Property (TRIPS).

The Biden-Harris administration’s support for a temporary waiver of WTO intellectual property barriers to help save the world from the COVID-19 pandemic signals that the U.S. is back as a global leader.

Keeping Americans safe from COVID-19 and revitalizing the American economy to build back better relies on people worldwide having access to COVID-19 vaccines, diagnostic tests and treatments as quickly as possible. The temporary WTO waiver is an important part of that mission.

Ongoing Work Needed to Enact a Comprehensive TRIPS Waiver Agreement as Soon as Possible 

To ensure the speediest end of the COVID-19 pandemic, the U.S. government must secure swift adoption of a temporary waiver of the patent, copyright, industrial design and undisclosed data rules of the WTO’s TRIPS Agreement with respect to vaccines, treatments, diagnostic tests and other medical products to prevent, contain or treat COVID-19 and the inputs and equipment to make such medical products.

The U.S. government must use all diplomatic efforts to convince waiver-opposing WTO member countries to engage in text-based negotiations and agree on a timely and effective waiver.

The scope of the waiver must extend beyond vaccines to also cover the diagnostic tests needed to detect outbreaks and variants, and treatments, ventilators and other medical goods necessary to save the lives of the millions who will contract COVID-19 before sufficient vaccines doses can be made.

A waiver must be of sufficient duration to incentivize and sustain increases in manufacturing capacity for and output of medical goods to prevent, contain or treat COVID-19, taking into consideration that the pandemic may yet escape current vaccines.

The WTO Director General’s December 2021 deadline for a final waiver text is far too late to meet the urgency of the pandemic, which requires agreement on a waiver in a matter of weeks, not months.

Investment in Manufacturing Is Also Needed to Get the Most Out of a Waiver and End the Pandemic 

To most quickly translate enactment of a temporary COVID-19 emergency TRIPS waiver into billions of  vaccine shots in arms, the U.S. government must deploy tools to rapidly promote technology transfer and know-how sharing, including funding incentives to provide reasonable compensation to intellectual property rightsholders, taking into account previous taxpayer investments in research and development, and leveraging existing legal authorities, including the Defense Production Act and the Bayh-Dole Act <https://lpeproject.org/blog/how-to-vaccinate-the-world-part-2/>.

To protect U.S. health, economic recovery and security, the U.S. should launch an ambitious global vaccine manufacturing program <https://www.citizen.org/news/public-citizen-analysis-25-billion-investment-can-vaccinate-the-world/> to scale up production in the United States and in regional manufacturing centers around the world to produce 8 billion more doses by repurposing existing facilities and building new capacity, including by allocating $2 billion in funds <https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/Global-vaccine-program-2-pager-Feb-19-2021.pdf> to capital expenditures to establish additional COVID-19 mRNA vaccine manufacturing lines and providing $23 billion in funding for raw materials, technology transfer and royalty costs to scale up production and shave years from the global pandemic.

When U.S. taxpayers and global public investment funded the research and development of the COVID-19 vaccines, diagnostics, and medicines, it was not only to find a solution to the pandemic here at home, but also to crush the virus around the world. 

No One Is Safe Until Everyone Is Safe: Need for a Comprehensive TRIPS Waiver so More COVID Vaccines, Test and Treatments Are Produced

Absent a major increase in vaccines, medicines, diagnostic tests, ventilators, and other COVID-19-related medical supplies, the pandemic will rage largely unmitigated among a significant share of the world’s population, resulting in increased deaths, a dragging blow to the global economy and a risk that vaccine-resistant variants will put the world back on lockdown and evade immunity for those previously infected and/or vaccinated.

Global COVID-19 vaccine production in 2021 reached 1.4 billion doses in May 2021 as the first trimester ended, while 10-15 billion doses are necessary <https://prospect.org/coronavirus/will-biden-favor-drug-companies-or-billions-of-people-needing-vaccines/> to meet immediate global needs and maybe more on an ongoing basis if boosters are required or if new vaccines are needed to combat variants.

Current global production capacity of COVID-19 vaccines, medicines, and diagnostic tests cannot come close to meeting global needs to detect, treat, prevent, or contain COVID-19. Many in developing nations will not have access to vaccines until 2024 absent significant increases in vaccine production.

A major cause of the shortage is vaccine intellectual property rightsholders’ refusal to issue licenses and transfer technology to and negotiate payment terms with qualified manufacturers in Africa, Asia, and Latin America, creating production bottlenecks and prohibiting urgently needed production of doses worldwide.

The worst global health crisis in a century has resulted in 3.5 million deaths worldwide and is conservatively estimated to cost the U.S. alone $16 trillion <https://news.harvard.edu/gazette/story/2020/11/what-might-covid-cost-the-u-s-experts-eye-16-trillion/> in economic losses <https://www.citizen.org/article/waiver-of-wto-protections-for-big-pharma-will-help-u-s-economic-recovery-and-boost-u-s-employment/>, accompanied by yet greater global losses that have impoverished hundreds of millions of people worldwide.

Debunking Pharma Lies and Spin 

At least 100 Big Pharma lobbyists <https://theintercept.com/2021/04/23/covid-vaccine-ip-waiver-lobbying/> are swarming Washington to ensure the waiver is not agreed or is gutted of all substance. Pharma spent a record $92 million <https://truthout.org/articles/pharma-breaks-lobbying-record-defending-high-drug-prices-and-vaccine-patents/> on lobbying in the first quarter of 2021 alone. Leaked PhRMA talking points <https://theintercept.com/2021/05/14/covid-vaccine-waiver-generic-phrma-lobby/> focus on China fearmongering, phony economic claims, and thinly veiled threats.

A temporary TRIPS waiver does not <https://www.citizen.org/article/dont-buy-pharmas-latest-distraction-a-temporary-wto-ip-waiver-for-covid-meds-would-not-hand-u-s-mrna-technology-to-china/> give China and Russia “U.S. mRNA technology.” First, mRNA research has been conducted by scientists around the world for decades. For instance, the patents on the “Pfizer vaccine” are held by BioNTech, a German firm founded by Turkish immigrants. And China already has mRNA: BioNTech licensed Chinese firm Fosun Pharma to manufacture “Pfizer-BioNTech” vaccine for sale in China. Chinese firms already have developed two additional mRNA vaccines.

IP barriers and corporate concentration are squeezing <https://mattstoller.substack.com/p/why-are-there-shortages-of-plastic> vaccine supply chains and causing input shortages. A temporary TRIPS waiver would help to solve these problems by enabling expanded manufacturing of such goods. Perversely, Pharma has been arguing that supply chain shortages, not intellectual property, are limiting vaccine production. Except now Pharma is arguing that a waiver will cause such supply chain shortages. In reality, many input shortages are caused by IP barriers. Consider single-use bioreactor bags for which 2,800 patents <https://www.prnewswire.com/news-releases/outlook-on-the-single-use-bioreactors-global-market-to-2030---featuring-cytiva-merck-millipore--pall-among-others-301263304.html> have been filed or granted. After mergers and concentration, only four firms monopolize <https://mattstoller.substack.com/p/why-are-there-shortages-of-plastic> the market worldwide and control supply. The waiver must cover inputs and equipment to make COVID-19 vaccines, treatments and tests to ramp up capacity throughout the supply chain.

Big Pharma has been using qualified manufacturers in developing countries to make vaccines and other medicines for years. Pharma’s racist slander that these firms are not good enough to make COVID-19 medicines or that their vaccines will be unsafe conflicts with the reality that Big Pharma uses these firms as contract manufacturers now. India is the world’s largest vaccine manufacturer with dozens of facilities that meet global quality standards. Some firms may need capacity enhancements and specific quality control protocols for specific drugs, which are investments worth making to beat COVID-19. 

A TRIPS waiver that facilitates additional producers won’t encourage counterfeiters. Brand name drug firms selling cheap-to-produce vaccines at high prices give counterfeiters more than enough incentive to make fake products. Indeed, the entry of new producers that will sell at lower prices to developing nations would discourage counterfeiters since they would have fewer potentially desperate customers and a smaller profit margin for their goods. 

Existing WTO “flexibilities” for HIV/AIDS treatments that were agreed in 2001 after hard campaigning  are insufficient <https://www.citizen.org/article/waiver-of-the-wtos-intellectual-property-rules-existing-trips-flexibilities-unworkable-for-scale-up-of-covid-19-medicines-production/> in the COVID-19 context. Pharmaceutical firms have since created IP “thickets,” adding layers of additional copyright, industrial design and other exclusivities to the patent barriers that were the focus of the 2001 flexibilities. Plus, COVID-19 vaccines have complex global supply chains. With various forms of IP barriers limiting access to inputs and production supplies across different countries there are almost insurmountable obstacles to coordinating compulsory licensing across countries even if the existing WTO flexibilities were determined to cover all of the different forms of IP exclusivities involved.
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The vaccine makers stand to make a lot of money <https://www.theguardian.com/business/2021/mar/06/from-pfizer-to-moderna-whos-making-billions-from-covid-vaccines> whether or not there is a waiver. 

Pfizer and Moderna projected COVID-19 vaccine revenue of $26 billion <https://www.pharmaceutical-technology.com/features/pfizer-covid-19-vaccine-revenue/> and $19.2 billion <https://www.cnbc.com/2021/05/06/covid-moderna-mrna-earnings-q1-2021.html#:~:text=Moderna%20raised%20its%202021%20sales,year%20sales%20of%20%2426%20billion.> respectively in 2021 alone. A WTO waiver would not undermine those earnings but could boost them.

A WTO waiver would NOT free governments and firms from paying royalties or providing other compensation under national laws, as the WTO’s own explanation <https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm> of its 2001 HIV/AIDS IP flexibilities decision underscores. Payments for compulsorily licensed technology usually are based <https://www.mondaq.com/india/patent/616430/fair-remuneration-for-compulsory-licensing> on costs and a percentage of profit <https://www.who.int/medicines/areas/technical_cooperation/WHOTCM2005.1_OMS.pdf?ua=1>.

Vaccine monopoly firms are focused not on global access, but on profitable markets. Pharma’s real concern is losing its current monopoly control of production and thus the prospect of competitors in what it sees as lucrative future sales of COVID-19 boosters in wealthy countries. Consider Pfizer’s recent investor briefings <https://www.businessinsider.com/pfizer-execs-highlight-significant-opportunity-hike-covid-vaccine-price-2021-3> about its lucrative 2022 plans to sell annual COVID-19 boosters in wealthy nations at higher prices even as overwhelming majorities in developing countries have no access to an initial vaccine.

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