[CTC] ICYMI: Several TRIPS/WTO updates

[Arthur Stamoulis]

A number of articles on the TRIPS waiver and the WTO below...


Begin forwarded message:

From: Lori Wallach 
Subject: NEWS: WTO DG to take leaked COVID TRIPS text to wider membership
Date: April 14, 2022 at 11:48:26 AM EDT

After a month of insisting the leaked text would die in Quad unless all four endorsed, the WTO Secretariat apparently concluded that SA, India and US will not endorse… Kudos to civil society in South Africa, India and around world for doing analysis/outreach to help derail the steamroller effort to make a bad text seem like a “compromise.” BUT, the deadly problem of WTO IP monopolies blocking global access to affordable meds remains. We still need a waiver – for COVID – and a way to avoid a 18-month deadlock of WTO not getting out of the way in the face of a global health emergency in future. This will only happen if we fight for it. The leaked text may or may not get some tweaks before going in as a chairman’s text and its fate in TRIPS Council remains to be seen. BUT even with tweaks, the text heading to TRIPS Council is not a waiver or anything like the original SA and India text.. We need to keep our eyes on the prize: getting WTO’s IP barriers out of the way of access to meds. The global waiver campaign has reawakened people worldwide to WTO’s monopolies for Big Pharma and the threat they pose to global health and built a global demand to ROLLBACK these barriers, which is why Big Pharma forces had a news conference yesterday attacking the very concept of a TRIPS waiver… That just spotlights why we need to keep fighting to rollback these WTO IP barriers!
 
Geneva Health Files
https://genevahealthfiles.substack.com/p/newsletter-goes-bi-weekly-q-and-a?r=pnyu9&s=r&utm_campaign=post&utm_medium=email <https://genevahealthfiles.substack.com/p/newsletter-goes-bi-weekly-q-and-a?r=pnyu9&s=r&utm_campaign=post&utm_medium=email>
Public Hearings on a Pandemic Agreement Open Floodgates of Interest; WTO DG To Take Compromise Text on TRIPS Waiver to the Wider Membership
Newsletter Edition #131 April 14, 2022 5 hr ago    Subscribe now <https://genevahealthfiles.substack.com/subscribe?utm_medium=web&utm_source=subscribe-widget&utm_content=52103543>
 <https://substack.com/profile/12777514-priti-patnaik>Priti Patnaik <https://substack.com/profile/12777514-priti-patnaik>
WTO DG To Take Compromise Text on TRIPS Waiver to the Wider Membership

Ngozi Okonjo-Iweala is expected to take the compromise text on the TRIPS Waiver to the wider WTO membership, sources told Geneva Health Files this week. It is learned that some members of the Quad (the US, the EU, India and South Africa) have not signed off on the text.

The leaked compromise text between the four members of the Quad group has struggled to get endorsement and ownership from the US, India and South Africa. It is understood it is only the European Union, that has so far lent support to the current version  <https://genevahealthfiles.substack.com/p/the-lowest-common-denominator-the?s=w>of the compromise text on the TRIPS waiver proposal. (The current text resembles EU’s original proposal  <https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W681.pdf&Open=True>on clarifying rules around compulsory licensing)

While internal consultations continue within countries at the national level, the reasons for not supporting the text vary between these key members. The reasons for not endorsing the text are strategic for the proponents of the Waiver given the deep concessions compared to their original proposal.

As we reported earlier <https://genevahealthfiles.substack.com/p/current-compromise-text-on-the-trips?s=w>, some WTO members and other stakeholders have been pushing for this text to be presented as a facilitator’s text for consideration by the wider membership. After weeks of impasse during which the proponents of the waiver were allegedly asked to sign off on the compromise text, the DG is now expected to take this text to the wider membership, without such a sign off, diplomatic sources said. She had steered the discussions among this small group of members since December 2021.

So far, discussions on this compromise text has not been considered formally within the WTO. No TRIPS Council meetings have been scheduled, by the time this story went to print. The WTO ministerial is less than three months away, and an outcome on the TRIPS Waiver continues to be seen as a short-term panacea to save the relevance of the WTO. (See Politico: WTO faces ‘slow motion train wreck’ amid Ukraine war chaos <https://www.politico.eu/article/wto-faces-slow-motion-train-wreck-amid-ukraine-war-chaos/>)

Drowned by the Ukrainian crisis, the policy attention to the pandemic is already waning, not only at the WTO. Observers point to the glut in the production of vaccines, further complicated by a range of factors including vaccine hesitancy and logistical challenges in immunization programs in many countries. (Earlier this week, Airfinity, the life science analytics firm downgraded global COVID-19 vaccine revenue forecast <https://www.airfinity.com/reports/covid-19-vaccine-market-revenue-forecast-april-2022>)

However, considering that, nearly 3 billion people remain unvaccinated against COVID-19, and the need for therapeutics and diagnostics has not diminished, the relevance of the TRIPS Waiver continues to remain important, activists say.

Some point to the on-going developments with respect to the challenges in using TRIPS flexibilities (the EU’s preferred policy approach as opposed to the waiver). Last month, Knowledge Ecology International, reported about Pfizer’s March 18, 2022 opposition to the KEI request for a compulsory license in Dominican Republic for Paxlovid. <https://www.keionline.org/37566>
What next for the waiver proposal, and for the WTO?

The coming weeks will witness how these negotiations will progress at the WTO. After months of these discussions taking place, outside of the usual, formal processes of the WTO, the compromise text is now likely to be debated among the 164 members.

Sources also suggested that without a formal forum to discuss the compromise text it is difficult for other WTO members to make their positions known. “It is not clear to what extent, other co-sponsors of the waiver proposal, will take this forward.”

Some delegates indicated that if the compromise text “dies a natural death”, there would be scope for improvement on the current text or negotiation on the original waiver proposal. But the appetite for WTO members, especially that of many powerful ones, for engaging in lengthy discussions on the waiver, may be low, given also the political exigencies around the Ukrainian crisis.

It is learned that China has protested vociferously on being excluded from the implementation of a waiver <https://genevahealthfiles.substack.com/p/the-lowest-common-denominator-the?s=w> as understood in the criteria suggested by the current compromise text.

For the proponents, the efforts will be to fight eligibility criteria that seeks to narrow the scope of implementation'; pushing to bring in therapeutics and diagnostics into the product scope of any waiver; and, to challenge the requirement for listing of patents as described in the current text, sources familiar with deliberations told us.

Developing countries are keen to have an outcome on the waiver proposal, failing which they would make conditional their support for the wider WTO response to the pandemic, diplomatic sources indicated. This is even as some opponents to the waiver seek to link the waiver discussions to issues such as food security.

Geneva-based sources also suggested that the small group approach used in these waiver discussions are now being suggested as an approach for negotiations on other WTO matters including on fisheries and agriculture. The small group deliberations have been criticized for being opaque and non-inclusive

Whatever the outcome, time is running out. And it has also shown the reluctance of many countries to address the issues of equity in any meaningful manner at the WTO.

“If the DG wants to save the WTO, she must bring the compromise text in her role as a facilitator”, one developing country diplomat told us.

And in the event the compromise text is dead in the water, activists around the world may be relieved, since many see the current text as setting a bad precedent.

Tailpiece: Industry Groups Beat up Waiver Proposal

In one of the most strident criticisms till date, on the alleged ineffectiveness and the limitations of the TRIPS Waiver, pharma industry group, IFPMA brought together CEOs of large companies, to articulate the contempt for the proposal at a briefing <https://www.youtube.com/playlist?list=PLlH2Lx7y4WvIXgq8CTBa_tbMHtD4c_43M> earlier this week

Drawing attention to a glut in vaccine production, and alleging high vaccine hesitancy in developing countries as reasons for low vaccination rates in some parts of the world, industry leaders repeatedly attacked the idea of a TRIPS Waiver. Some even called it “toxic”.

Thomas Cueni, Director General of IFPMA said that he was stunned that countries continue to debate the TRIPS Waiver.

The timing of the outrage from the industry on the waiver proposal is hard to understand, given that even after 18 months of deliberations, what is now being discussed is a significantly reduced form of the original proposal <https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669R1.pdf&Open=True>.

As these negotiations come down to the wire in the coming weeks, such expressions of outrage will continue to feed headlines <https://healthpolicy-watch.news/with-covid-vaccine-supply-outstripping-vaccination-rates-pharma-giants-question-pursuit-of-ip-waiver/>.

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https://www.reuters.com/business/healthcare-pharmaceuticals/last-few-tweaks-being-made-covid-ip-waiver-deal-wto-chief-2022-04-14/ <https://www.reuters.com/business/healthcare-pharmaceuticals/last-few-tweaks-being-made-covid-ip-waiver-deal-wto-chief-2022-04-14/>

'Last few tweaks' being made to COVID IP waiver deal -WTO chief
By Emma Farge <https://www.reuters.com/authors/emma-farge/> April 14, 2022

GENEVA, April 14 (Reuters) - The head of the World Trade Organization told Reuters on Thursday that negotiations on an intellectual property deal for COVID-19 vaccines were ongoing between the four parties, saying they were seeking to agree on the proposal's final terms.
Since the draft compromise emerged in the media a month ago, pressure from civil society groups has been rising for the parties - the United States, the European Union, India and South Africa - to walk away from the deal. Other public figures have also criticised it such as German Chancellor Olaf Scholz and former U.N. Secretary-General Ban Ki-moon, saying it is too narrowly focused on vaccines.

"People are saying the text is now being rejected. It is not true," Director-General Ngozi Okonjo-Iweala told Reuters by telephone. "They are still trying to iron out the last things. It's just the last few tweaks," she said, without elaborating.

Okonjo-Iweala, who took over the top job a year ago with a mandate to reinvigorate the 27-year-old institution, has been brokering the talks for the past few months in an effort to break a more than year-long stalemate at the WTO.  

India and South Africa, backed by dozens of other WTO members, had proposed a broad waiver of IP rights for COVID-19 drugs and vaccines, but failed to overcome opposition from members like Britain and Switzerland who argued that pharmaceutical research required such protections.

The compromise proposal that Okonjo-Iweala referred to, if finalised among the four negotiators, still needs to be presented to all 164 WTO members which each hold a veto.

No date has yet been fixed for that meeting.

Okonjo-Iweala said in the same interview that she plans to meet U.S. Trade Representative Katherine Tai next week to discuss a ministerial trade conference at the WTO's Geneva headquarters in June and to brief U.S. Congress.



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INSIDE US TRADE
51 House Republicans to Biden: Reject TRIPS waiver compromise
April 11, 2022 at 5:20 PM
A group of House Republicans are urging the Biden administration to reject a potential compromise on a waiver of certain World Trade Organization intellectual property protections for COVID-19 vaccines, arguing that such a deal would undermine U.S. national security.
Vaccine information could easily be turned over to Russia, China or other U.S. adversaries if some countries are allowed to produce vaccines without receiving permission from rights holders, the lawmakers wrote in a letter on Friday to President Biden.
“Russia and China continue to pour money into the developing world to expand their influence, meaning any country they provide with sufficient aid would likely turn over U.S. intellectual property,” 51 Republicans said in the letter <https://insidetrade.com/node/173749>, which was also sent to U.S. Trade Representative Katherine Tai and Commerce Secretary Gina Raimondo.
Signatories include several House Ways & Means Committee members, including trade subcommittee ranking member Adrian Smith (R-NE) and health subcommittee ranking member Vern Buchanan (R-FL), as well as Jason Smith (R-MO), Tom Reed (R-NY) and Darin LaHood (R-IL). Buchanan and LaHood also sit on the trade subcommittee.
The U.S. worked with the European Union, South Africa and India on a proposed agreement <https://insidetrade.com/node/173542> to suspend some aspects of the Agreement on Trade-Related Aspects of Intellectual Property Rights, allowing some WTO member countries to produce vaccines without receiving permissions from rights holders. The text of such a proposal has not yet been agreed to.
“The reported ‘compromise’ neither protects the interests of the United States nor the patients in the developing world who depend on American-designed and American-made medicines. In fact, it would undermine the efforts of American scientists working diligently to develop the drugs needed to manage this current pandemic – and future ones, as well,” the members wrote.
Noting that all three vaccines approved by the Food and Drug Administration were primarily developed in the U.S., the lawmakers said the American biotechnology industry is strong in part because of its intellectual property protections. Without those protections, they argued, U.S. companies would be unable to raise the capital they need for research and development.
The letter argues that there are enough vaccine doses available to vaccinate all adults worldwide with proper distribution, saying the main barrier to vaccine uptake is poor infrastructure. Both India and South Africa, the letter notes, have stockpiles of doses available.
The lawmakers urged the Biden administration to “reverse course and reject this disastrous agreement.”
The letter comes after Republicans in the House and Senate introduced legislation <https://insidetrade.com/node/173719> to restrict the Office of the U.S. Trade Representative’s authority to negotiate a TRIPS waiver without congressional consultation, a public comment process, and other requirements.
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https://www.uschamber.com/intellectual-property/u-s-chamber-letter-on-the-no-free-trips-act <https://www.uschamber.com/intellectual-property/u-s-chamber-letter-on-the-no-free-trips-act>
 
U.S. Chamber Letter on the "No Free TRIPS Act" and the "Protecting American Innovation Act"
This Hill letter was sent to Members of the United States Congress on the "No Free TRIPS Act" and the "Protecting American Innovation Act."
Download <https://www.uschamber.com/assets/documents/220411_NoFreeTRIPSAct_Congress.pdf>
April 11, 2022

To the Members of the United States Congress:
The U.S. Chamber of Commerce strongly supports the “No Free TRIPS Act” and the “Protecting American Innovation Act,” which would prohibit the Administration from negotiating or concluding any modifications to the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, without the explicit authorization of Congress.
International negotiations on IP, focused on undermining the WTO TRIPS agreement, are fundamentally misguided. Any agreement that undermines IP would limit the ability of innovative companies to develop the cure for the next pandemic or global health threat and bargain away US competitiveness. Instead, governments should focus on the overwhelming problem of vaccine distribution and the last-mile delivery.
Intellectual property waiver proposals distract from the real issues preventing more shots in arms, such as logistical hurdles, supply chain bottlenecks, and vaccine hesitancy. Business is delivering on the promise to manufacture safe and effective COVID-19 vaccines for the whole world. Vaccine production is estimated to reach over 20 billion doses this year, enough for everyone. As of March 2022, over 65% of the global population has received at least one dose, and this number is growing every day. The dismantling of IP rights threatens the licensing arrangements that are enabling rapid global production and technology transfer.
The Chamber applauds these Members of Congress for introducing this important legislation and strongly supports the No Free TRIPS Act and the Protecting American Innovation Act.
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Health Experts: COVID Vaccine Inequity Is Still Endangering Millions of Lives
 
By Jake Johnson
 
https://truthout.org/articles/health-experts-covid-vaccine-inequity-is-still-endangering-millions-of-lives/ <https://truthout.org/articles/health-experts-covid-vaccine-inequity-is-still-endangering-millions-of-lives/>
4/13/22
 
In a scathing letter on Wednesday, more than 300 public health experts, academics, labor leaders, and activists accused rich countries of denying the world an “early exit” from the coronavirus pandemic by continuing to stonewall efforts to expand vaccine production and distribution in low-income nations.

Addressed to South African President Cyril Ramaphosa and Indian Prime Minister Narendra Modi, the new letter <https://app.box.com/s/eoye72i9vqfaeryd04llkix53a9zhbbz> calls on the two leaders to reject a recently leaked compromise proposal <https://freepdfhosting.com/4d79fc6c70.pdf> that departs dramatically <https://www.commondreams.org/views/2022/04/11/leaked-wto-covid-patent-waiver-text-very-bad> from South Africa and India’s popular <https://www.msf.org/countries-obstructing-covid-19-patent-waiver-must-allow-negotiations> original plan to waive coronavirus-related patents for the duration of the pandemic.

That plan, first unveiled at the World Trade Organization in October 2020 in an attempt to ensure equitable global access to vaccines and therapeutics, has been blocked by the European Union <https://www.commondreams.org/news/2022/02/18/eu-chief-defends-vaccine-patents-precious-south-africa-demands-waiver> and other rich countries. The pharmaceutical industry, which has reaped huge profits <https://www.commondreams.org/news/2021/11/04/moderna-reports-obscene-profits-covid-vaccine-funded-us-taxpayers> from its monopoly control over vaccine production, lobbied <https://www.commondreams.org/news/2021/06/01/watchdog-shines-light-big-pharmas-fierce-eu-lobbying-campaign-against-vaccine-patent> aggressively against South Africa and India’s proposal.

 “We know that the blame for this inadequate text does not lie with your governments, who have worked tirelessly to deliver a TRIPS waiver,” reads the new letter from experts and campaigners. “The European Union and other rich countries have chosen to block the path to an early exit from this pandemic. They have put the lives of millions of people at risk by perpetuating vaccine inequality, creating the perfect breeding ground for new and potentially more dangerous or vaccine-resistant variants.”

“They have looked the other way,” the letter continues, “while millions have died needlessly because developing countries were not given the rights and the technology to make or import Covid-19 vaccines, tests, and treatments.”

While the text has yet to be finalized <https://www.reuters.com/business/healthcare-pharmaceuticals/no-agreement-yet-wto-vaccine-waiver-compromise-ustrs-tai-says-2022-03-30/>, advocates and experts <https://msfaccess.org/msf-urges-governments-reject-draft-covid-19-text-wto-would-set-negative-precedent> say the compromise proposal in its current form would not meaningfully expand coronavirus vaccine access and would actually create new barriers <https://www.citizen.org/article/leaked-wto-proposal-is-not-the-covid-19-medicines-waiver-we-need/> for low-income countries looking to suspend patents and ramp up production of vaccines, treatments, and test kits as Covid-19 continues to spread.

In a statement on Wednesday, Dr. Mira Shiva of the All India Drug Action Network — a signatory to the new letter — argued that “this isn’t the comprehensive intellectual property waiver that India and South Africa demanded.”

“It isn’t even a compromise,” Shiva said. “The WTO is letting the European Union and United States hammer out a rich country stitch-up. We urge Prime Minister Modi and President Ramaphosa to reject this capitulation and demand the full TRIPS waiver that is needed for the global fight against Covid-19 and future health crises.”

Tian Johnson, head of the African Alliance and convener of the Vaccine Advocacy Resource Group, similarly warned that enactment of the leaked proposal “would only make it harder to manufacture affordable medical products in the Global South.”

“This proposal would only add more conditions before countries can begin production,” said Johnson. “Even the WHO-backed mRNA hub in South Africa wouldn’t be safe from Big Pharma’s lawyers.”

Fresh criticism of rich countries’ refusal to do everything in their power to expand vaccine access comes as coronavirus infections are surging in parts of Europe and Asia, a wave that experts have attributed to a highly contagious Omicron subvariant <https://www.commondreams.org/news/2022/03/14/china-hong-kong-battling-stealth-omicron-surges-us-lifts-restrictions>.

While the origin of the subvariant is not entirely clear <https://theconversation.com/what-is-the-new-covid-19-variant-ba-2-and-will-it-cause-another-wave-of-infections-in-the-us-179619>, the initial Omicron strain was first detected <https://www.commondreams.org/news/2021/11/26/it-was-entirely-avoidable-rich-countries-blamed-new-covid-variant-sparks-global> in southern Africa in late November.

In remarks <https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-public-hearing-regarding-a-new-international-instrument-on-pandemic-preparedness-and-response---12-april-2022> during a pandemic preparedness hearing on Tuesday, World Health Organization Director-General Tedros Adhanom Ghebreyesus said that “the inequities that we have faced in the past two years — for therapeutics, diagnostics, and vaccines — have undermined our efforts to bring Covid-19 under control.”

“Even as some high-income countries now roll out fourth doses of vaccine for their populations,” Tedros noted, “one-third of the world’s population is yet to receive a single dose, including 83% of the population of Africa.”

“And although we are now seeing a welcome decline in reported deaths, the pandemic is still far from over,” he said. “Transmission remains high, vaccine coverage remains too low in too many countries, and the relaxation of public health and social measures is creating the conditions for new variants to spread. Our focus must remain on ending the pandemic — in particular, by supporting all countries to vaccinate 70% of their population.”

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WTO chief warns of possible MC12 failure amid Ukraine tensions
Borderlex, 12/04/2022 by Chris Horseman
Hopes of meaningful agreement on key issues at the upcoming World Trade Organization ministerial conference in Geneva in June have been dealt a serious blow by the Russian invasion of Ukraine, said the organisation’s director-general Ngozi Okonjo-Iweala.
The meeting is set to go ahead after the WTO evolved “workarounds” to allow countries to continue negotiating even in the face of rising diplomatic tensions.
But Ngozi Okonjo-Iweala admitted that it was “beyond doubt” that the war had made it more difficult to prepare for the already twice-postponed MC12.
In principle, the WTO is continuing to press for concrete outcomes on a trade response to the COVID-19 pandemic, an agreement on fisheries subsidies, and a roadmap for further negotiations on agriculture and food security.
But the director-general told a Geneva press conference: “We will have to see which ones of these we can deliver. I can’t guarantee that we’ll be able to deliver all three.”
WTO members ‘need to be open to doing things a bit differently’

Okonjo-Iweala was speaking at the launch of the WTO’s annual trade forecast report for 2022-23, which revealed the extent of the disruptio <https://borderlex.net/2022/04/12/wto-sees-slower-trade-growth-in-2022-amidst-ukraine-war-poor-countries-hit-most/>n to world trade which the hostilities in Ukraine were likely to create.
But the WTO chief’s press conference focused to a large extent on the prospects of the WTO’s brand of multilateral diplomacy surviving the current period of open conflict between two of its more prominent member countries.
The WTO chief attempted to accentuate the positive, stressing that it was “simply inaccurate” to claim that the organisation had been paralysed since the outbreak of war.
“We have developed workarounds that have enabled us to conduct business even with diplomatic tensions running high,” she said, noting that there had been a shift in Geneva towards meetings in small groups and bilateral contacts between delegations.
“We need to be flexible, we need to be open to doing things a bit differently, and we need to keep going,” she told reporters.
A meeting but no declaration?

Ngozi Okonjo-Iweala promised that MC12 would indeed take place mid June as planned. But she noted that “the circumstances warrant that we make this a business-like, streamlined affair with little pomp and circumstance”.
The director-general admitted that she could not tell whether the meeting could result in an agreed ministerial declaration, as is the normal practice – given that any such declaration would have to be approved unanimously by all parties, including both Russia and Ukraine.


Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826




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