"The Third Way": A key to unlock TRIPS Waiver negotiations?

Newsletter Edition #34 [The Friday Deep Dives]

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Hi,

Seldom are changes dramatic. But mostly, changes happen slowly enough for us to miss the significance of any movement, however small.

Writing this week’s story on the on-going discussions at the TRIPS Council on the TRIPS Waiver talks set me thinking on how a variety of factors, beyond anyone’s prediction can come together to potentially shape an outcome. Read on to understand the evolving dynamics of these important discussions as they reach a critical stage.

Today we are also very pleased to share a series of stories that have emerged out of a challenging cross-border investigative project. This project called Behind The Pledge, was funded by grants from Journalismfund and IJ4EU. Reporters in the team examined hacked information from the European Medicines Agency revealing political pressure on the regulator. A fascinating story where cyber leaks, geopolitics and regulatory pressure come together in a race for faster vaccine approvals for COVID-19. Health Policy Watch published it earlier this week. Earlier versions of the story have been published last month, by the team in media across FranceItaly, Germany, and The Netherlands.

It has been my honor to partner with Ludovica Jona (Italy), Lucien Hordijk (The Netherlands), Lise Barnéoud (France) and Hristio Boytchev (Germany) for this project. We learned a lot about the use of sensitive information and learning to read communication from public authorities. We extend our gratitude to editors who worked with us on this important story with careful consideration and trust.

Finally, I am delighted to announce that Geneva Health Files has taken decisive steps towards financial sustainability. Since we wrote to you about it on Wednesday, some of you have already expressed your vote of confidence in us by becoming paid subscribers. We are so encouraged by our readers who want this initiative to survive and succeed. Thank you.

As mentioned, we are offering an early supporter lifetime 30% discount on all annual subscriptions to all those who subscribe before March 31. For those of you who subscribe before March 31, 2021, there is a 15% lifetime discount on monthly subscriptions. After March 31, our individual subscriptions are priced at an introductory rate of Euro 12 per month, or Euro 120 annually.

Our institutional subscriptions with up to five subscribers are priced at Euro 50 per month or Euro 600 per year. Institutional subscribers who buy in before March 31, 2021, will get a lifetime 10% discount. Larger institutional subscriptions such as for bigger organizations or universities can be discussed on a case-by-case basis. 

Do note that in order to benefit from the discounts until March 31, you can access these rates only through the links mentioned above.

This has been very exciting and a sheer privilege to write for this community.

See you next week.

Best,

Priti

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

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1. Story of the week

THE THIRD WAY: UNBLOCKING THE TRIPS WAIVER LOGJAM

The Third Way suggested by Ngozi Okonjo-Iweala, WTO’s new director-general who assumes office on Monday, March 1, may pave the way for negotiations on the TRIPS Waiver proposal, sources in Geneva say. In her remarks recently, Okonjo-Iweala suggested the use of TRIPS flexibilities and the voluntary licensing approach to deftly address the pandemic.

This, proponents of the TRIPS Waiver proposal, say, could be a significant moment in these discussions, which could bring to the negotiating table countries opposing the waiver. So far, opposing countries have locked the proponents of the proposal in a so-called “evidentiary loop” without moving towards text-based negotiations. For five months WTO members have discussed and debated if and whether intellectual property and others kinds of obligations under the TRIPS agreement have impeded the response to the COVID-19 pandemic.

Earlier this week, we reported that the discussions on the TRIPS Waiver proposal continued to be deadlocked at a formal meeting that took place on February 23. Read this debrief by Third World Network for statements by the WTO members on the proposal.

Although nearly two-thirds of WTO members now support the proposal, a handful of powerful, mostly wealthy nations continue to oppose it. Although discussions continue to be deadlocked, there has been material difference to the kind of opposition to the proposal, sources suggest. This reveals potential indications on how positions on the proposal might evolve in the coming months.

Based on conversations with diplomatic sources familiar with the proceedings at WTO, this story takes a closer look at the potential evolution of these discussions going forward.

The waiver proposal seeks to allow all countries to not grant or enforce intellectual property protection for the duration of the pandemic, until widespread vaccination has been achieved. The proposal recognizes intellectual property, trade secrets, industrial designs, as barriers to sharing technology. 

Image Credit: Photo by Alex Green from Pexels

BENEATH THE SURFACE

“There is greater sympathy in the room given the circumstances countries face. Now we have to see how we translate that sympathy to some meaningful engagement to discuss the text of the proposal,” a diplomatic source said.

As indicated by previous statements in the weeks in the run-up to this meeting, proponents of the proposal have been willing to discuss about the time-frame and the scope of the waiver proposal. Proponents now want to understand the specific reservations that opposing countries have on the proposal.

It appears bolstered by a raft new co-sponsors including the African Group and the LDC Group, the proponents are hoping to build on a momentum to head into discussions in the coming weeks with greater determination.
The proposal
 first spearheaded by South Africa and India, in October 2020, now has the following co-sponsors: Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, apart from the regional blocs mentioned above.

In addition, the following countries lent support to the proposal during the meeting this week: Jamaica on behalf of the ACP Group (62 members) Afghanistan, Argentina, Bangladesh, Cambodia, Sri Lanka, Honduras, Cuba, Nepal, Nicaragua, Nigeria, Indonesia, Tunisia, Mali and Mauritius. It is understood that there are indications that the ACP group might be moving closer to becoming a co-sponsor to the proposal.

Chile, China and Colombia, in addition to some developed countries stressed on the need for more evidence-based discussions in the TRIPS Council on the waiver proposal.

USA, EU, Canada, Switzerland, Norway, Singapore, Japan, Australia and the United Kingdom continued to oppose the proposal.

(South Africa pointed out in its statement that countries opposing the TRIPs waiver proposal account for 60% of the globally administered COVID-19 vaccines.)

FACTORS SHAPING THE DISCUSSIONS

A few decisive events can shape these discussions, sources familiar with the matter with say. The rise in the number of variants of SARS-CoV-2, the virulence of these variants, the extent to which existing vaccines will be effective against these new variants, and elections in the countries opposing the waiver proposal.

And believe it or not, vaccine diplomacy could potentially spur discussions, with the increasing perception that western countries are losing out on influence, as powerful vaccine providers such as Russia and China are distributing home-grown vaccines to countries at the back of the vaccines queue.  

(Also check out: Call To Prevent Export Restrictions On Covid-19 Vaccines: Communication From Colombia, Costa Rica, Ecuador, Panama And Paraguay, to be considered by the General Council, next week)

Countries supporting the waiver are closely tracking the data emerging from the epidemiological transition of the pandemic and will potentially use information and insights into their discussions and negotiations on the waiver proposal going forward, a diplomat said.

At the meeting, opposing countries continued to showcase their commitment to a multilateral response to the pandemic by illustrating support to the ACT Accelerator set up to fund the fight against the pandemic and the financial donations to the COVAX Facility, the international vaccines mechanism for COVID-19. But as has been pointed out before, billions of dollars of funding shortfall continues.

Wealthy countries opposing the waiver also talk about donations of vaccine doses. But one diplomatic source from the global south, said, “We do not want second-hand vaccines doses set to expire soon. We want our own production capacity”.

THE THIRD WAY: A KEY TO UNLOCK NEGOTIATIONS?

In her address to the General Council on the eve of her appointment, Okonjo-Iweala said,  “WTO Members have a further responsibility to reject vaccine nationalism and protectionism. They should rather intensify cooperation on promising new vaccines, therapeutics, and diagnostics. There should be a “third way” to broaden access through facilitating technology transfer within the framework of multilateral rules, so as to encourage research and innovation while at the same time allowing licensing agreements that help scale up manufacturing of medical products.” She cited the example of the licensing approach of AstraZeneca.

It is not clear whether those opposing the waiver proposal will effectively work towards technology transfer needed to address production shortages of COVID-19 vaccines.

Consider Canada’s statement at the meeting this week: (excerpt)

“…Madam Chair, vaccines can be produced more or less independently depending on the technology. For certain vaccines, production and scaling up may be contingent not only upon some form of patent freedom to operate, such as through licensing, but also on close cooperation between licensees and licensors to allow full practice of the invention and of the associated art, with a view to producing consistently safe and efficacious products. Canada is thus interested in better understanding how a waiver would incentivize these requisite collaborative relationships; and, where full practice of the art is not possible without the participation of the licensor, we are interested in better understanding the safety, efficacy and regulatory implications of the production of vaccines independently from the licensor.

In other cases, a vaccine technology may be such that production and scaling up is contingent only upon some form of patent freedom to operate. Canada would thus be interested in better understanding how, in situations where holders of patents for such COVID-19 vaccines refused requests for voluntary licences, Members attempted but were unable to apply Article 31 of the TRIPS Agreement...”

Canada

Some believe that countries can be brought together to discuss the use TRIPS flexibilities, and potential voluntary approaches in the context of the pandemic. The distance between WTO members divided on the TRIPS waiver issue, can be addressed to an extent.

Diplomatic sources affiliated with the countries that support the proposal note the transition in the extent of the opposition to the proposal.

“Initially, the proposal was simply dismissed. Now we see greater willingness to engage.” Five months since the TRIPS Council first started discussing the proposal, WTO members have met through a series of informal and formal meetings at the Council. Sources point out that the number of such meetings in the TRIPS Council is unusual for WTO. The proposal was also discussed at the General Council meeting in December 2020. (See the archives of Geneva Health Files that has captured each of these meetings in detail.)

“Getting opposing countries to the table to potentially discuss ways forward is a big win, even if it is to discuss ‘the third way’,” one source said. While countries supporting the waiver are open to discussing the third way, it does not mean they will stop at discussing only voluntary approaches to licensing, the source said.

Trade observers in Geneva believe that the coming weeks and months could see slow, but advancing discussions on the waiver proposal with each side drawing lines as the talks progress.

VACCINE DIPLOMACY AS A TRADE CATALYST

What is also interesting is that sources believe that vaccine diplomacy is shaping trade diplomacy in the context of the access to vaccines. “Western capitals are fast evaluating the implications of the increasing use of Russian and Chinese vaccines in many parts of the world.” The wealthy countries are under pressure to respond. In recent months, a number of countries including India, China, Russia, have made quick advances in distributing or selling vaccines to neighbours and beyond.

In the absence of local manufacturing capacities and the acute lack of access to vaccines even in countries with high burden of COVID-19, has meant that vaccine diplomacy has flourished. This might decisively contribute to the waiver discussions, some officials believe.

WHATS COMING NEXT?

Members agreed to present an oral statement to the General Council meeting on 1-2 March. The next formal TRIPS Council meeting is scheduled for March 10.

In its statement this week, South Africa said, “The reason we called for a text-based discussion is because this will help us to understand direct questions that members have on our proposal. We invite delegations to raise particular concerns on elements they may have concerns about and suggestions as to how we can arrive at a common landing zone, including at the regular TRIPS Council meeting of 10 March 2021 and subsequent informal and informal meetings. We once again call for our deliberation to move to a text-based discussion.”

Proponents of the waiver proposal are hopeful that discussions can move towards “draft modalities” by the end of March.

Discussions in the coming weeks are likely to transition into “defining” what the waiver can entail, how it may apply. “There needs to be specific discussions to negotiate and agree on for example, the kinds of products that the waiver will be applicable for, in the context of this pandemic. It will be very limited to COVID-19”, one source suggested.

Proponents suggest a list-based approach, “but not a closed-list”, the source said. Potentially there could be a mechanism where WTO members notify on their preferences on which the waiver can be applicable.

Countries will need to begin thinking concretely on how they would like to operationalise the waiver, the source added.

Based on bilateral consultations with groups of interested countries and others, the proponents of the proposal, have begun to get an indication on the way some countries might want to use the waiver.

“While a country from a LDC group with no manufacturing capacity may wish to import vaccines, another may wish to use trade secrets. Some have expressed reluctance on suspending copyrights protection under the waiver for example. So countries will need to make their own assessments as to how this waiver could apply domestically,” a diplomatic source explained.

“One country may need access to Active Pharmaceutical Ingredients, another may need access to know-how for the production of the vaccines, some might simply need a source code for an app. The needs are different across countries,” the trade official added.  

The waiver will be an internationally applicable mechanism that aims to absolve countries from certain obligations under the TRIPS agreement for a particular duration in order to fight the pandemic. Countries have the option of implementing the waiver or not, depending on their domestic needs and the epidemiology of the disease. Countries can “selectively prioritize” in line with their needs, the source explained.

(To read in detail on the provisions of the original proposal, see this comprehensive story from October 2020.)

THE ELECTION: THE CHAIR OF THE TRIPS COUNCIL             

At a time when the most path-breaking discussion on intellectual property and access to medicines in decades, comes to a stead, the TRIPS Council will elect a new chair at the General Council meeting next week. This is not insignificant and could likely have an impact on the proceedings, although such changes are routine. The TRIPS Council is currently chaired by Xolelwa Mlumbi-Peter, the South African ambassador.

A source familiar with such appointments to the TRIPS Council suggested that these appointments are political but require neutrality for the conduct of the proceedings of the TRIPS Council. There is a “tacit understanding” that the appointments to these WTO bodies is made by rotation to ensure representation from a Least Developed Country, a developing country and a developed country.  The previous chair of the TRIPS Council was from Mongolia. And therefore it is expected that a representative from a developed country will be appointed now.

It is understood that Norway’s Dagfinn Sørli may be appointed at the General Council meeting next week, sources said. (Politico reported that a proposal to push forward Afghanistan as the Chair of TRIPS Council was “rescinded”). Note that Norway is also a co-chair of the Facilitation Council of the ACT -Accelerator.

Sources told Geneva Health Files, about the absolute professionalism and neutrality shown by the South African ambassador as chair of the TRIPS Council, even as South Africa, has been one of the lead proponents of the TRIPS Waiver proposal.

“In one instance, ambassador Mlumbi-Peter even reminded the South African delegate to stick to time,” one official said recounting meetings from the last few months on these discussions.

Separately, Norway has also asked for a revised proposal on the TRIPS waiver from co-sponsors.

THE BREAKING OF THE DAM?

While the intractable discussions on the waiver proposal continue, WTO members have a greater recognition for the need to put in place a global mechanism that will help prepare countries for future epidemics, sources say.  

Some observers do not rule out a “breaking of the dam”, which may ultimately yield multilateral support for the waiver. Earlier this week, a cross-party group of more than 100 parliamentarians expressed their support for the waiver proposal asking the European Commission and EU member states not to block the proposal. (Declaration from Members of the European Parliament to urge the Commission and Member States not to block the TRIPS waiver at the WTO and to support global access to COVID-19 vaccines)

But no one is expecting miracles. “The pharma industry is too powerful for that,” one source noted.

Corrigendum: Please note that this story was edited soon after publication to add EU as one of the countries opposing the waiver. We had unintentionally missed adding to EU to our original story. We regret this oversight.

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2. PODCAST Corner

Trade Talks: Is the WTO making it harder to end the pandemic?

A nuanced discussion on the TRIPS waiver talks.

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