Moment in the sun for TRIPS Waiver plan; Questions on COVAX goals

Newsletter Edition #16

Hi,

With the majority of the world without access to vaccines to fight the pandemic, it is no wonder that the final weeks of 2020 witness a frenzied activity in Geneva with international diplomats, health and trade policy officials, vaccine czars scrambling to address questions on unmet demand.

Countries discussed the TRIPS waiver proposal at WTO’s General Council meeting this week. The Board of Gavi- the Vaccine Alliance, met to discuss, among other matters, the risk of failing to make available vaccines for low and middle income countries. And, at WHO, member states met to discuss the direction reforms processes could take, potentially laying the ground for a resolution at the World Health Assembly in May next year.

Last week, COVID-19 claimed a head of state - Ambrose Dlamini, eSwatini’s Prime Minister died, adding to the growing numbers of more than 1.6 million people who have lost their lives due to the pandemic. This adds to the urgency in the discussions on how to bring this pandemic to an end.

The sooner we confront and acknowledge the limitations to the pandemic response, the faster solutions can be forged. We cannot remain in denial any more - international cooperation at the political level has failed spectacularly - a grave injustice to the efforts of countless foot soldiers working tirelessly.

The year began with WHO and the rest of the world being caught unaware of what was to come. It is ending on a solemn note, and better aware of widening inequities to come.

The premier global health agency and its richer partners have, so far, been unable to secure and distribute vaccines in an equitable manner. Although plans announced today indicate that agreements are now in place for two billion doses to be made available next year in poorer countries, it is not clear if such plans will reach fruition. Gavi, which spearheads the COVAX Facility, faces a high risk in not delivering its vaccines to poor countries, the immunization agency’s risk watchers (Citigroup) have said.

On its part, WHO has reportedly failed in standing up to pressure from some member states. The year demanded a strong WHO like never before. The house view is that despite constraints, WHO could have been tougher with allies, competitors and foes. Exercising political leadership is not always a function of finances.

Despite the cynicism that comes in this trade, we end the year on a hopeful note. Our story this week, looks at possibilities within the WTO. The limits to solidarity have been breached, as the COVAX story tells us. A legal mechanism will provide the much needed impetus to dramatically address the fight against COVID-19.

We will continue to look at health from a variety of different lenses: science, trade and politics. Inform our understanding and support our work.

Check out a snapshot of some of our most important stories in this rather grim year.

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Thank you for your trust, dear readers. 

Best,

Priti

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1. Story of the week

ROAD AHEAD FOR GREATER DELIBERATION IN 2021: TRIPS WAIVER PROPOSAL AT WTO

The General Council at WTO, the organization’s highest level decision-making body, this week, discussed the TRIPS waiver proposal first put forward by South Africa and India in October this year. With this, the proponents successfully pushed this crucial proposal for political consideration before the world’s trade policy makers. The stage is now set for further deliberation in the coming weeks early in 2021. South Africa has also requested for an extraordinary General Council meeting to take this forward.

The significance of the discussion of this proposal at the General Council, is not lost, least of all on countries straining the under the mounting casualties of COVID-19 and those without any visibility of access to vaccines. More than 30 countries took the floor to discuss the proposal, WTO officials said at a press briefing today.

Proponents of the proposal said that the discussions around the proposal had traveled further than many had anticipated. “The foundation of concrete action has been laid. There will be more meetings early in 2021. This matter will be taken to it resolution”, a source close to the process said.

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. The co-sponsors of the proposal include Kenya, Eswatini, Mozambique, Pakistan, and Bolivia.

This story gives a quick update on the proceedings at the General Council this week, and some of the discussions at the TRIPS formal meeting last week.

Photo by Max Andrey from Pexels

DISCUSSIONS AT THE GENERAL COUNCIL (December 16th-18th)

An oral status update on the proceedings at the TRIPS Council over the last few months, was presented at the General Council meeting this week. Although South Africa has requested for an extraordinary General Council meeting on the proposal, it is not clear if such a request will be granted.

The discussions at the General Council on the waiver proposal were described as “an important conversation”, and “a conversation that was not vitriolic or acerbic”, a WTO official told reporters this evening. The proposal will continue to be discussed at the TRIPS Council in the following months.

Countries that favor using existing mechanisms, want to use these discussions going forward, to identify imperfections in the TRIPS agreement that do not make it easy for members to access these flexibilities, particularly as they pertain to compulsory licensing, Keith Rockwell, Director, Information and External Relations Division and Spokesman WTO said at the briefing.

THE PREVAILING DYNAMICS

Sources told Geneva Health Files, efforts were being made to get the African, Caribbean and Pacific Group of States (ACP, a group of 79 states), on-board for stronger support for the proposal such as by becoming a co-sponsor. It is not yet clear if the ACP will eventually commit to doing so. There are 48 countries from Sub-Saharan Africa, 16 from the Caribbean and 15 from the Pacific.

It is also understood that earlier in the week, the waiver proposal was brought up at the Heads of Delegations meet at the Trade Negotiations Committee (TNC) that operates under the authority of the General Council. Such informal meetings allow delegations to discuss matters outside of the big meetings and sometimes, help in moving WTO members towards a consensus on difficult issues. “Countries discussing the proposal at such meetings in a good indication of support for the proposal,” a diplomatic source close to the process said.

“There has been a shift in the positions of some countries, such as Norway, for example. There has been a change in countries’ positions, but perhaps this change has come too late,” the source added. In mid-December, COVID-19 cases had reached more than 63 million worldwide and had claimed upwards of 1.6 million lives globally.

“Countries have now begun to look for solutions. The debate is slowly moving away from theoretical discussions to practicalities aimed at finding solutions,” the source said. There is emerging consensus, a vote may not be required, the diplomatic source added.

TRIPS COUNCIL FORMAL MEETING (December 10th)

We bring you excerpts from key statements made by some countries at the TRIPS formal meeting last week on December 10th. 

From pushing opposing countries for more details on how voluntary licensing approaches may have worked; to raising questions on whether some countries would commit to refraining from putting pressure, in the future, on other countries in their use of TRIPS flexibilities; proponents pushed for specifics on why rich countries were opposing the waiver proposal.

It was pointed out that, according to WHO, nearly one-third of vaccines have fewer than four suppliers. Supporters of the proposal wanted to know how limited number of suppliers possibly could meet the vaccination needs of more than 7 billion people globally. In an intervention, Pakistan said that 14 per cent of the world’s population have bought up fifty-three (53 per cent) of all the most promising vaccines so far. It cited reports which say some countries have put in place plans to acquire up to 9 doses per person, while among 70 developing or poor countries, only one out of every 10 people will be vaccinated by the end of 2021. Some countries might have to wait until 2023 or even 2024 to get vaccines. (A risk also highlighted by Gavi’s risk analysts - Citigroup - this week. See brief later in this newsletter)

Opponents such as the U.S., reminded countries that a vast majority of older medicines are not patented, yet remain out of reach for many patients. The U.K. for example, said that it was working on exploring initiatives such as WHO’s COVID-19 Technology Access Pool (C-TAP) to work within existing mechanisms.

EXCERPTS FROM STATEMENTS AND INTERVENTIONS MADE BY COUNTRIES

South Africa

… “The patent landscape (a document submitted by South Africa) in IP/C/W/670 is a warning shot of the existing and emerging patent barriers to access and the need for the international community to take urgent action to overcome these barriers so that supply may be diversified and scaled-up.

…Why has pressure  been applied on developing countries for implementing and supporting public health safeguards in their intellectual property laws and policies  under EU’s annual IP enforcement report and the annual “Special 301 Report”, which was released even amidst the COVID-19 pandemic!

…The EU and Switzerland both highlight the flexibilities as the key measures for members to use, does it mean the EU and Switzerland will from now on commit not to pressure developing countries when they improve their laws on compulsory license and other TRIPS flexibilities or make use of compulsory license? Would the European Commission from now on exclude compulsory license and other TRIPS flexibilities from its IP enforcement report? Would the USTR do the same to its Special 301 report?”

India

In responding to a question raised by EU: EU has sought an explanation as to how the waiver could operate with regard to the vaccine production, including the transfer of the required technology and know-how and how it would affect the existing licensing mechanisms and Covax in general.

India said:

…..“Today, EU has reiterated that transfer of technology and know-how should be encouraged through licensing. We would like to know how EU plans to persuade pharma companies to enter into transparent, non-exclusive global open licenses, where all manufacturers can be engaged without any restrictions, and what steps EU is taking to ensure full transparency and accountability in the cost of R&D and in licensing agreements.

…We also note the ‘Covid19 and Beyond: Trade and Health’ initiative by EU, Switzerland, Canada and few others, which talks about enhanced preparedness to fight against current and future pandemics. Madam Chair, history will not judge us kindly if we fail to find an expeditious solution to the current pandemic while claiming to prepare for the future ones. We hope the Membership can rise to the demand of this crisis and demonstrate that WTO can actually deliver on timely, equitable and affordable access for all, by agreeing to the waiver. World will remember the contribution of WTO during the pandemic for generations to come.”

Indonesia

…“Indonesia also experienced different case where IP become serious threat to Indonesia public health, despite Indonesia paramount contribution to the development of H5N1 vaccines. 

In  August 2006, Indonesia made unprecedented move by announcing that it will make genomic data on bird flu viruses accessible to anyone. Indonesia was of the view that opening up global access could be the key to unlocking such vital information as to the origin of the virus, how it causes disease, how it is mutating, the sources of infection, and how to prevent or cure the virus.

Despite the fact that, following Indonesia move, developing countries have supplied H5N1 virus to WHO Collaborating Centres for analysis and preparation for vaccine production, the resulting vaccines produced by pharmaceutical companies are in fact unavailable for developing countries such as Indonesia.

The system behind this unfair practice is closely related to intellectual protection of the vaccines development extended to pharmaceuticals companies that benefitted from the openness of Indonesia and other developing countries. It was based on this situation, Indonesia wanted a material transfer agreement for each virus sample which sent to foreign labs, specifying that the sample will only be used for diagnostic purposes and not for commercial gain.

Under that proposal, any commercial use of the virus would require prior consent of the country providing it. By retaining the intellectual property rights, Indonesia believes, a country could allow access to global vaccine stockpiles at an affordable price…”

The EU

… “According to the industry sources, some 1100 potential treatments and vaccines are in development. Much of this rapid response, like for example the vaccines based on mRNA technology, builds on knowledge and research capacity developed over many years with the support of intellectual property incentives. We would not be where we are now without the years of this research.

…What is most needed now, beyond developing vaccines, is the ramping up of manufacturing of vaccines and the best way of achieving that is by disseminating the technology and know-how of those who developed the vaccines through licensing arrangements. Manufacturing cannot take place without the required technology and know-how. In addition, we need these vaccines to be produced in a manner that ensures their efficacy and safety. Intellectual property is a key factor in providing a framework that enables these arrangements. Developers of vaccines can enter into manufacturing agreements, transfer technology and expand production with their licensees. Our main concern is that suspending the relevant IP rights will not enhance such collaboration and manufacturing but, to the contrary, will slow it down or even block it, to the detriment of all.”

The U.S.

….In fact, in the area of COVID-19 therapeutics, licensing by generics manufacturers already exists. It appears that one company has signed nonexclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to manufacture its drug for distribution in 127 countries. The co-sponsors of the waiver proposal are amongst the 127 countries that will benefit from these arrangements.

…Other factors that are relevant to the access question include pricing and procurement policies, taxes, mark-ups and tariffs and other national policies that result in higher costs for consumers and for health systems. In fact, some countries continue to apply tariffs of up to 20% on pharmaceuticals and 10% on vaccines. South Africa’s paper does not explore these critical factors. Instead, South Africa has presented here a “[p]reliminary patent landscape of selected priority COVID-19 candidate therapeutics,” which it acknowledges is a “non-exhaustive snapshot.”

Switzerland

“…Switzerland is of the view that such a step would indeed be counterproductive. It would result in considerable legal uncertainty, at the national and international level. it would thus put into question a key component of the basis on which stakeholders currently engage in international initiatives and partnerships to make fast and equitable global access to medical products against covid-19 a reality.

….if we were to suspend large parts of a WTO agreement during this pandemic, an agreement that embodies a collective consensus more than 25 years and of 164 countries, what signal would we sent to the outside world on the reasons of existence of the multilateral regulatory framework, on its utility and reliability?…”

WHAT TO EXPECT IN 2021 AND BEYOND

The next formal meeting of the TRIPS Council is only in March 2021. It is expected that WTO members will gather for informal discussions on the waiver proposal early in 2021.

“Opponents should move towards where we are. It will be untenable and hypocritical of members such as the EU to continue opposing the proposal, given their thinking on this, within the European Union,” a source said, alluding to recent policy discussions on IP and a wider pharma strategy at the EU level.

It is also interesting to note that these very same countries opposing the proposal, some of them key donors of the WHO, are allegedly upset about WHO’s support to the TRIPS waiver proposal.

The Geneva Observer reported this week:

There is a tangible dissatisfaction of donor countries with WHO's position in support of India, as well as South Africa's proposal to guarantee a waiver to patent enforcement currently being discussed at the WTO. Some countries, opposed to the waiver, consider that supporting the idea is not the WHO’s decision to make but its member states’.

International health and trade interests collide and converge across multilateral institutions. The response to the TRIPS waiver proposal is illustrative of this.

Given the momentum and public support that this proposal has received, proponents feel emboldened at the possibilities of what this might mean in the future. Supporters of the proposal see these discussions evolving into a more long-term shift in the nature of such debates at the WTO.

“The waiver is not the end, it is only the beginning,” said one diplomatic sources. There is a need for rebooting of trade rules, the person added.

Among key factors of production, knowledge is fast becoming, the most important one to capture, the diplomatic source is of the view. This comprises questions on data, genetic sequences, among others in the digital realm, that will be contested in forums such as WTO. The pandemic has advanced discussions on questions on data ownership, and its implications for technology transfer and intellectual property.

Detractors of the proposal had long written off this path-breaking initiative, which many believe may be a game-changer in the response to the pandemic. (There was one report that said that the waiver discussions may not reach the General Council).

In a report in Bloomberg (Vaccinating Billions Means Finding Ways Around a Patent Impasse), a former WIPO official said:

James Pooley, former deputy director general of the World Intellectual Property Organization, reckons that even though the proposal is “unlikely to go anywhere,” it may have an impact down the line.

“It’s the battering ram at the door,” he said. “If they keep bashing at it, a hinge may break.”

Bloomberg, December 2020

As we have reported in these pages before, the needle has moved as far as these discussions on the access to medicines are concerned. Maintaining the status quo of asymmetrical power structures in such discussions may not be tenable anymore. What this will ultimately mean for millions of defenceless people, in the face of this raging pandemic will remain to be seen. 

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2. What we found interesting this week:

I. COVAX RISK OF FAILURE HIGH: SAY GAVI’s FINANCIAL RISK WATCHERS

Risk watchers advising Gavi have said that the COVAX Facility risks not being able to cough up vaccine doses in time for low and middle income countries to fight COVID-19.

The story, WHO vaccine scheme risks failure, leaving poor countries with no COVID shots until 2024 discusses contents of reports which were discussed this week at Gavi’s Board meeting.

“The risk of a failure to establish a successful COVAX Facility is very high as the COVAX Facility is a large, unique and structurally complex undertaking, is being established in record time, and has to navigate uncharted territory in securing equitable access to potential COVID-19 vaccines. Without a successful COVAX Facility there is a very real risk that lower income countries will be left behind, and the majority of people in the world will go unprotected,” according to a board document titled Risk Management Update, seen by Geneva Health Files.

This unfortunately raises apprehensions for low and middle income countries without adequate visibility on their access to vaccines for COVID-19. The lack of transparency in decision-making and governance, in these mechanisms have also left a lot of questions unanswered including on liability provisions in contracts, and even fundamental questions on how many doses has COVAX secured and at what price. It is, for example, unclear, why certain agreements that Gavi has struck are binding, while others are not.

Critics are also beginning to question, the extent of support COVAX has even within low and middle income countries. AP reported earlier this week, that South Africa will consider signing up bilateral deals, although it signed up to COVAX.

This week, Gavi appeared to address questions increasingly being asked on its plans for delivering vaccines on time in the developing world. The powerful global health agency announced today that it had put in place agreements to secure nearly two billion doses, more than half of which will donor-funded doses for 92 low and middle income countries. The immunization agency believes that it will be able to ensure global rollout starting in the first quarter of 2021.

Gavi’s statement breaks up funding received from various donors, and the details on commitments from vaccine manufacturers. However it is not evident, how many of those deals with manufacturers are based on binding commitments.

For example, some experts pointed out that AstraZeneca’s initial commitment for COVAX shrunk from 300 million as announced in June, to 170 million as indicated today.

Responding to a question on transparency on COVAX contracts with countries and companies, Gavi’s top leadership cited confidentiality reasons against making terms of these agreements public.

(We will report on this more comprehensively in the coming weeks)

II. Recommended reads:

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3. We are also watching:

I. COVID-19 vaccines emergency authorizations

WHO and other regulatory agencies around the world are speeding up authorization procedures.

II. Preparations for WHO Executive Board early in 2021

Member states are aligning their visions for reforms at WHO. Watch out for surprises.


TWEETS OF THE WEEK

  • Twitter diplomacy: 2020

  • An important thread on the less celebrated successes of Asian countries including Taiwan, Mongolia, Vietnam among others. (See here a recent story on the successes by some Asian countries)

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