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So Close, Yet So Far: TRIPS Waiver at the WTO
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So Close, Yet So Far: TRIPS Waiver at the WTO

Newsletter Edition #143 [Geneva Health Files Newsflash]

Priti Patnaik
Jun 11
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So Close, Yet So Far: TRIPS Waiver at the WTO
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Hi,

After more than 45 stories on the TRIPS Waiver proposal over the last 20 months, today, we bring you a final update on these negotiations ahead of the WTO ministerial conference commencing tomorrow.

While it has been a sheer privilege to be able to document this, I am also disillusioned and struck by how much of how international policy-making happens not only in silos, but also insulated from ground realities.

Even after millions of vaccine doses have been wasted during COVID-19, the current text has language to restrict sharing of vaccines. This is, but one illustration of how these decisions are being made.

If you are at the Ministerial Conference, drop me a line. We love meeting and learning from our readers who seem to have great perspectives on these technical yet political matters.

We urge readers to support our coverage of the Ministerial, by becoming paying subscribers. You can also make donations towards meeting our reporting costs.

In case you missed it, check out a recent story: Have India and South Africa, Lead Sponsors of the TRIPS Waiver Proposal, Reconciled to a Weak Text?

Until later!

Priti

Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva


So Close, Yet So Far: TRIPS Waiver at the WTO

Proposed Waiver Text in Ministers’ Hand, Key Differences Remain

Less than 24 hours before the 12th Ministerial Conference gets underway in Geneva – the capital of global health, and the seat of pandemic policy-making - WTO members continue to disagree on key aspects of the organization’s response to the pandemic, including an agreement on a potential waiver of a provision of the TRIPS Agreement.

The discussions on the TRIPS Waiver remain on tenterhooks, as ministers will now consider a bracketed text, the WTO reported last night. Key differences remain on how to adapt international trade rules meant to protect intellectual property rights in response to the on-going pandemic. (See more details below)

The world’s gaze turns to Geneva this week, as trade ministers gather after nearly five years for a ministerial conference of the WTO, it’s highest decision-making body. The conference will take place in the backdrop of a shift in geopolitics, war and health emergencies.  It is being seen as one of the most significant events for the WTO, not only because the organization’s legacy is at stake, but also as a barometer for international cooperation at a time when 15 million people globally are estimated to have died in the on-going pandemic.

And yet, 20 months on, from the date when India and South Africa, first brought a proposal to temporarily suspend IP protections in order to ostensibly, decisively, respond to the pandemic, members have not been able to reach agreement on the process to do so.   

For an organization that runs on consensus, compromise is key. But activists have warned that compromising on a much watered down TRIPS Waiver proposal would be detrimental and could even set bad precedent in terms of addressing countries’ access to medical products. 

While some countries remain boxed in their positions, activists continue to push governments to not only abandon their support to the current version of the text, but are also pushing them to adopt a “full” TRIPS Waiver.

Even as pressure grows on countries to conclude an agreement, barricades had risen up, earlier in the week, on the road approaching the WTO – the site of ministerial conference. Civil society organizations have now been barred entry on the first of the conference. “Please be informed that for unexpected security-related reasons, we are unfortunately unable to grant access to the WTO premises on Sunday 12 June”, said a communication from the WTO to CSOs, earlier this week. Protests from Civil Society Organizations are no stranger to WTO ministerials. It is likely that this event will witness protests especially against the weak text on the TRIPS waiver, among others issues.

Image Credit: Priti Patnaik, June 2022, Geneva

NEGOTIATIONS AT THE WTO: SOME “KEPT OUT”, OTHERS “WALK OUT”

The weeks leading up to the ministerial generated much consternation as many developing country members continued to be excluded from smaller negotiating groups, called as “green room” meetings. While CSOs have cried foul on process, seasoned observers maintain that this is an effective strategy in forging solutions in smaller groups before taking it to the wider membership.

To be sure, process dictates outcomes. Take this: members such as Indonesia, reportedly keen on making textual proposals to the TRIPS Waiver negotiations were kept out of the green room processes. (On some occasions only Cameroon, Egypt, India, Nigeria and South Africa, were reported to be a part of these discussions.)

Geneva-based trade sources indicated that the “green room tactics” were allegedly used as forums to put pressure on developing countries including by DG Okonjo-Iweala. This has resulted in a chilling effect on the African Group, some have suggested.

An anonymous, but credible, twitter handle called “@SouthEmpowering” has been sharing snippets of these negotiations at the WTO. The handle describes itself as a “Collective of individuals willing to work for Global South in International Relations”.

In one of the tweets, @SouthEmpowering said: “To propose textual amendments and negotiated is a Sovereign Prerogative. Attempts to silence developing countries in #TRIPSwaiver negotiations diminish @wto's legitimacy. #DG shud [sic] act without bias. #StopClusterNegotiations on #TRIPSwaiver. It is a classic "Divide and Rule" trick to isolate the developing country diplomats…”

Even as mostly developing countries were kept out of deliberations, some developed countries including the EU, the UK and the US, have variously walked out of discussions, as a tactic to get countries to reach an agreement, Geneva-based sources said. (See more on this in the coverage by Third Network Network]

Image Credit: Priti Patnaik, June 2022, Geneva

WHAT THE MINISTERS WILL NEGOTIATE: THE DECISION TEXT

The latest update from the WTO suggested, that negotiations at the technical level have now concluded and the decision text will now be considered at the ministerial level.

"What you have before you now is a text that will be submitted to ministers," TRIPS Council chair Ambassador Lansana Gberie of Sierra Leone told members. "We have come to the brink of our endurance, intelligence and creativity and we will give our ministers a chance to also take a shot, the final shot,” according to the update from the WTO secretariat.

Ministers will also consider the draft text on the WTO response to the pandemic. This “sets out a series of trade-related pledges and objectives in order to support increased resilience to COVID-19 and future pandemics. These include general as well as specific provisions relating to trade facilitation, regulatory cooperation, intellectual property, services, food security and aspects of future work,” the statement from the WTO said.

In his capacity as the facilitator on the WTO's response to the pandemic, Ambassador Dacio Castillo of Honduras is reported as saying, “Through the hard work and substantive contributions of delegations, in just a matter of three weeks, we have transformed the merged text of various proposals to a fully formed document for ministerial consideration at MC12."

Some of the documents related to the ministerial are now online.

THE WAIVER TEXT: JUNE 10 VERSION

Some of the bracketed text is discussed here:

According to the version on June 10 that was sent to ministers (seen by Geneva Health Files), the prickly footnotes qualifying eligibility requirements, remain in brackets. This might indicate that the bilateral negotiation between China and the U.S. on this question is yet to be resolved.

The necessity test in para 1 also continues to be reflected in the current text. (… “an eligible Member may limit the rights provided for under Article 28.1 of the TRIPS Agreement (hereinafter “the Agreement”) by authorizing the use of the subject matter of a patent required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic…”)

Para 3 c of the text is the only waiver in the text. “An eligible Member may waive the requirement of Article 31(f) that authorized use under Article 31 be predominantly to supply its domestic market and may allow any proportion of the products manufactured under the authorization in  accordance with this Decision to be exported to eligible Members, including through international or regional joint initiatives that aim to ensure the  equitable access of eligible Members to the COVID-19 vaccine covered by the authorization.”

But experts wonder if the text is a backdoor method to bring back Article 31bis. (Article 31bis is an amendment, based on a waiver in 2003, that was supposed to have enabled a country to export medicines manufactured under a compulsory license to another importing country. Given additional procedures and notifications, the use of this mechanism has been cumbersome, it is widely acknowledged.)

The text continues to have language to protect anti-diversionary measures, that some say will cramp incentives for local production, and affect vaccine donations. (See The Compromise Text on the TRIPS Waiver Will Undermine Vaccine Donations)

Sources suggested that similar to the demand from the UK, Deputy Director-General, Anabel González, said offered an interpretation that said once the waiver period expired vaccine stock produced under the decision cannot be exported. Countries can use it domestically or destroy them, she is understood to have said.

The rationale for such a measure is difficult to understand given the signs and learnings from the current pandemic. Experts believe that anti-diversionary clauses should be removed to enable importing countries to export what they do not need or use to other countries. This will help dose-sharing, regional procurement, and prevent dose wastage. Millions of doses of vaccines have been wasted globally - a hallmark of poor planning and a consequence of hoarding of vaccines during this pandemic.

 (See Reuters: South Africa's Aspen COVID-19 vaccine plant risks closure after no orders, executive says, and The BMJ Covid-19—How Europe’s vaccine donations went tragically wrong)

The language on re-exportation continued to be negotiated this week. This now has a new foot note.

“(d) Eligible Members shall undertake all reasonable efforts to prevent the re-exportation of the products manufactured under the authorization in accordance with this Decision that have been imported into their territories under this Decision.3 Members shall ensure the availability of effective legal means to prevent the importation into, and sale in, their territories of products manufactured under the authorization in accordance with this Decision, and diverted to their markets inconsistently with its provisions, using the means already required to be available under the TRIPS Agreement.”

*Footnote 3: In exceptional circumstances, an eligible Member may re-export COVID-19 vaccines to another eligible Member for humanitarian and not-for-profit purposes, as long as the eligible Member communicates in accordance with paragraph 5.

(Para 5 in the text is on transparency requirements)

On duration the text reads:

An eligible Member may apply the provisions of this Decision [so that authorized uses continue no later than][until] [3][5][10] years from the date of this Decision. The General Council may extend such a period taking into consideration the exceptional circumstances of the COVID-19 pandemic. The General Council will review annually the operation of this Decision

Most problematic of all, perhaps is the fact that members have not reached a consensus on whether any potential solution will be applicable to therapeutics and diagnostics. “8. [No later than six months from the date of this Decision, Members [will][shall] decide [whether to extend this decision] [on its extension] to cover the production and supply of COVID-19 diagnostics and therapeutics.]” (emphasis ours)

In addition, language on notification requirements also continue to exist in the text. Experts fear that this could result in potential injunctions, trade retaliation, political and commercial pressure on governments and local manufacturers that has often been witnessed.

(Also see our story from last week based on the text of May 30, that discussed some of the provisions of the text: Is the delay the defeat of the TRIPS Waiver discussions at the WTO)

Image Credit: Priti Patnaik [The WTO Atrium: June 2022, Geneva]

PRESSURE TO DUMP TEXT BUILDS ON EITHER SIDES

Curiously the pressure on members to walk away from the text is building on both sides. This will come to a head in the coming days.

“CURRENT TEXT A REVERSAL OF THE DOHA DECLARATION”: FORMER PRESIDENT OF SWITZERLAND

Earlier in the week, in a letter to WTO delegates, Ruth Dreifuss, former President of the Swiss Confederation,  Celso Amorim, former Minister of Defence and Foreign Affairs, Federative Republic of Brazil,  Jorge Bermudez, Senior Researcher at the National School of Public Health, Fiocruz, Brazil; Member of the WHO C-TAP Technical Advisory Group, asked delegates to face their collective responsibility of “removing all barriers to diversified production of vaccines, tests, and medicines in the global South to ensure access in L&MICs.”

The letter said:

“During the height of the HIV crisis, WTO members responded with the Doha Declaration, which stated that “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health”. Without amendments, the current text under negotiation at the WTO is a reversal of the Doha declaration. It undermines the flexibilities in the TRIPS agreement that were emphasized by the commitments made by WTO members in 2001. Moreover, any agreement that adds new barriers could set a dangerous precedent for future pandemics.”

THE ROLE OF THE LEAD SPONSORS RAISES QUESTIONS

Perceptions are rife in Geneva that lead sponsors of the original TRIPS Waiver proposal, India and South Africa do not seem to be leading from the front. (See Have India and South Africa, Lead Sponsors of the TRIPS Waiver Proposal, Reconciled to a Weak Text?)

In a story for The Wire, this week, I reported:   

“A number of observers are perplexed as to why the lead co-sponsors are not bringing in elements from their original proposal to bolster the text under negotiation.

Diplomatic sources tell us that these lead sponsors have not been backed sufficiently by other developing countries. “We have led the way for 18 months, and ultimately it has to be taken forward by others as well,” one official told us.

But this has been disputed. Seasoned observers ask where the coordination and leadership is among developing countries to make sure that the text is strengthened. “They have had no clear strategy,” a source who works with developing countries told us.”

To be sure, this is not only about India or South Africa. A weak text on the TRIPS Waiver could imply that although 100 countries supported the proposal, their negotiating leverage was not effectively deployed. This could alter the way negotiations will occur not only at the WTO, but also at WHO, experts say.

WHAT TO EXPECT THIS WEEK

Now that trade ministers will negotiate on bracketed text, activists fear that those ministers who are not technocrats can easily be pressured to toe the line without fully understanding the implications of what they are endorsing. And indeed, this has happened in the past, sources say, pointing to the Quad process earlier in the year. (There is a perception that the rich, arduous technical work done earlier came undone by pushing up the decisions to the political level.)

“There are three potential outcomes: one, that is a compromise where the final decision text will be weaker than it is now; second, that developing countries walk away from the text; and third, there might be some value in the political significance of any decision in an otherwise unworkable solution that the current text is,” a person closely tracking these negotiations in Geneva told us last night.

Irrespective of the outcome, many believe that this process has shown that there is nothing sacrosanct about the TRIPS Agreement.

Indefatigable access to medicines advocates believe “the fight is still on”.

But another activist said, “the pharma industry could have the last laugh on this given the state of the current text.”

(Also see: recent comments from USTR: ‘Confident that India will be engaging with intentionality at the WTO meet’.

Photo by Ave Calvar Martinez: Pexels

Correction: This story was updated after publication. We had erroneously shown a sentence as “deleted” in the waiver text. The final text for consideration by ministers includes the following sentence in para 6 of the text: “The General Council may extend such a period taking into consideration the exceptional circumstances of the COVID-19 pandemic.”

We regret the error.

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