No consensus on TRIPS talks; WHO Foundation

Newsletter Edition #15

Hi,

The WTO TRIPS waiver discussions reached a critical phase with countries not reaching a consensus on the proposal at a formal meeting today.

We have not taken our eyes off the ball. This week we bring you an analysis on the some of the substantive issues being discussed by countries around the TRIPS waiver proposal, and a quick update on the meeting from earlier today.

We also bring you our recent stories on countries spending vast sums of money on a drug that WHO has advised against in the treatment of COVID-19. See here: Covid-19: EU countries spent over €220m stockpiling remdesivir despite lack of effectiveness, finds investigation in the British Medical Journal; Swiss doctors limit remdesivir as government looks to procure more in Swissinfo.ch. We hope to continue to work on such investigations. These stories are part of the Behind the Pledge project - a cross border investigation into the money trail of pandemic related medicines and vaccines. As mentioned previously, this project is in association with other reporters.

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Best,

Priti

Feel free to 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

COUNTRIES FAIL TO REACH CONSENSUS ON TRIPS WAIVER PROPOSAL

Developed countries shift narrative raising questions on safety and efficacy issues around drugs

As images of the elderly in the UK receiving the first vaccine shots to protect against COVID-19 flashed across the world, the reality of the lack of access to vaccines in the poorer countries became stark.

It is in this backdrop, that countries discussed the so-called TRIPS waiver proposal, which seeks to temporarily suspend intellectual property protection to hasten the access to COVID-19 medical products.

Countries today kicked the can down the road so to speak, even as the world is losing crucial time in its fight against the pandemic with deaths from COVID-19 mounting globally. The US, Canada, and the EU, among others, reiterated their opposition to the proposal at the formal meeting today, blocking any consensus on the proposal.

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. 

WTO members met at a formal meeting of the TRIPS council meeting today where they failed to reach a consensus on the proposal for a temporary waiver from the obligations of certain provisions in the TRIPS Agreement.

Members have agreed to keep the waiver proposal in the agenda of future TRIPS Council meetings. The next formal meeting of the TRIPS Council is expected to be in March 2021, and possibly consultations sooner next year.

Only an oral status report from the TRIPS Council is expected to be presented at the next General Council meeting, on 16-17 December. The General Council, is the highest decision making body at the WTO. It is unclear the extent of political consideration this proposal will garner next week.

The proponents, South Africa and India, have sizeable support among WTO members, also acquiring greater depth in recent weeks with concrete backing from capitals across many countries.

However, a handful of powerful countries continue to wield the levers to block this proposal by deploying a shift in the narrative including raising questions on the efficacy and the safety of the drugs from developing countries.

It is also understood that according to a view from Brussels on this proposal, the EU distrusts India. Allegedly, the EU views this proposal as an opportunity for countries like India to “flood the market with their products”, a source aware of these opinions held by the EU, told this reporter. (We were unable to confirm this with the EU at the time of writing.)

In this story, we take a close look at the substantial issues discussed between members, the procedures that will guide the proposal in coming days and, how these consultations can unfold.

Photo by Miguel Á. Padriñán from Pexels

STATE OF PLAY

Informal meetings between WTO members and bilateral consultations in recent weeks, have delved into substantive discussions on how intellectual property and other barriers continue to manifest and interfere in the access to medical products in the course of this pandemic.

South Africa, India and others, have responded to specific questions raised including by United States, European Union, Brazil. They have also provided clarifications to countries who had sought more details on how such a waiver could work at national levels.

“Countries are getting a better understanding on how this could work. Suddenly the message has hit home,” said a negotiator from a country who is one of the proponents of the proposal. At the face of it, we may not have increased the support for the proposal, but members are beginning to have a better understanding on the issues involved, the person added. “This might translate into a higher form of support,” the negotiator said.

The proposal is now co-sponsored by Kenya, Eswatini, Mozambique, Pakistan and Bolivia. Kenya, Sri Lanka, Jamaica and Argentina have also expressed their support to the waiver proposal.

Outside of WTO, the proposal has pushed its way into mainstream discussions on the response to the pandemic. Over 900,000 individuals sent an online petition to the WTO, asking governments, WTO members and pharmaceutical companies for universally accessible and affordable COVID-19 vaccines.

In an opinion piece in the influential New York Times, a health activist and economists called for a suspension of intellectual property rights to make the access to vaccines faster. (Also promptly followed up by a piece by industry leader Thomas Cueni - The Risk in Suspending Vaccine Patent Rules, also in the NYT)

Earlier in the week, the proposal elicited a response from the industry group - International Federation of Pharmaceutical Manufacturers Associations (IFPMA), that said “calls for  the dilution of intellectual property rights are counterproductive.”

At the WTO, some developed countries, including the EU bloc, are raising issues of limited capacity and knowledge in developing countries, insisting that technical know-how resides with the private sector in the west. (Also see the recent, problematic WSJ editorial, suggesting a lack of ability in developing countries to manufacture complex technologies)

“This is wrong. We have both capacity and knowledge in the South, including for mRNA platforms for vaccines production. What we lack is the enabling environment, so that latent capacities can come together. Manufacturers should be able to go ahead and produce without being sued for infringing intellectual property rules,” a source from a developing country who is a part of these discussions at WTO said.

This sentiment of production capacity being a barrier was also articulated this week by a pharma industry leader at the IFPMA briefing this week where the executive said that the developed world had the capacity to “distribute” vaccines in the developing world. (At one point, one of the industry leaders also said “we do not enforce IP provisions in LMICs.)

Developed countries have insisted at WTO, that the COVAX Facility and the ACT Accelerator should be given a chance to meet the demand for medical products. But only a fraction of the total demand can be met through these limited, underfunded mechanisms, proponents of the proposal argue. (It has been reported that COVAX reserved about 700 million doses while more than 90 countries included in the COVAX advance market commitment (AMC) represent over 3 billion people.)

In one of its statements, South Africa cited a recent report from the UNCTAD to underscore the difference in the access to medical products during this pandemic. UNCTAD found that the per capita imports of the medical goods essential to mitigate the COVID-19 pandemic have been about 100 times larger in high income countries in comparison to low-income countries. (Each resident of high-income countries has benefited, on average, from an additional US$10 per month of imports of COVID-19 related products. This number is much lower for middle income countries- at about US$1, and a mere US $ 0.10 for low-income countries.)

EVIDENCE PRESENTED

At a prior informal meeting last week on December 3, South Africa presented a paper with an overview of the preliminary patent landscape of selected priority COVID-19 candidate therapeutics. The paper is a snapshot of the patent filing and granting status on five selected therapeutics candidates that are under review by the WHO Access to COVID-19 Tools Accelerator (ACT-A) therapeutics pillar. (Four out of five candidates are repurposed medicines.)

South Africa cited examples of new patent filing and granting on new monoclonal antibodies and anti-viral therapies involving companies including Regeneron, Merck, Atea Pharmaceuticals, Incety Corp, Roche and others.

Opponents to the proposal, much like the pharma industry have argued that it is the IP system which has delivered medical products including vaccines in record time for COVID-19. Countries such as India and Pakistan, have said at these discussions, that it is not the IP system that has delivered but the public funding and the institutional support in terms of research contributions.

These countries also rejected the claim that voluntary licensing of technologies were already providing access to affordable medicines.

In the previous informal meeting, Australia, Canada, Chile and Mexico also submitted a paper, where they raised questions on the kinds of challenges as a result of IP that countries have faced; sought more details on specific barriers faced by local production or manufacturing for COVID-19 diagnostics, equipment, therapeutics or vaccines; on whether members were able to issue compulsory licenses.

They also sought information on copyright-related, industrial designs-related and undisclosed information-related challenges in specific instances of procurement or of seeking local manufacture or production of COVID-19 diagnostics, equipment, therapeutics or vaccines, that countries may have faced.

In an earlier meeting, Brazil had said that the proposed waiver would pose challenges in implementation and could result in legal uncertainty to the IP system.

Brazil had also raised questions on how waiver as applicable to industrial designs and copyright could be pertinent for addressing COVID-19.

Citing examples from countries including Italy, South Africa said that for medical products such as ventilators, personal protective equipment and other technologies that may be relevant to curbing the spread of Covid-19, copyright and/or industrial design can be a barrier, in addition to patents and trade secrets.

LIMITATIONS OF TRIPS FLEXIBILITIES

A number of countries including Brazil and the EU, continued to emphasize existing TRIPS flexibilities. South Africa explained the limitations of existing TRIPS flexibilities. “TRIPS rules today do not facilitate a collective use of compulsory license (CL) by multiple countries on all components needed to produce a medical product. Both Art 31 and Art31bis licenses are territorial and used on a case-by-case basis raising difficulty of using them to leverage all untended capacity in different countries together. The waiver provides a practical alternative in the context of the pandemic so that countries can be better coordinated,” South Africa in response to questions raised on this.

In its response South Africa had elaborated why using these provisions can be cumbersome in  diversifying and scaling-up manufacturing by relying on the issuance of CLs by way of Art. 31 and Art. 31bis of the TRIPS Agreement.

As an illustration it said that country X with manufacturing capacity decides to override the patent barriers to expand supply. It then has to go through a long process of issuing a compulsory license.

Then, if this country X requires to source patented ingredients from multiple jurisdictions, each of these jurisdictions will also need to issue a CL. Each of these CLs will be limited by the condition of Article 31(f) that it has to be predominantly for the supply of the domestic market. At this juncture, country X with manufacturing capacity, although able to supply, is likely to be hindered due to the number of CLs required, and the conditions imposed. Even if country X overcomes this challenge and manufactures the product under a CL, country X will not be able to export widely to supply even neighbouring countries due to the limitation in Art. 31(f) that a CL has to be predominantly for the supply of the domestic market.

Instead, the manufacturing country X and each and every importing country will have to issue a CL if there is a patent and utilise the procedures of Article 31bis that includes among others specific notification to the WTO by importing and exporting countries specifying the quantities to be imported and exported. As more quantities are imported and exported, more notifications may be needed, in addition to other requirements such as specific labelling or marking of products; special packaging and/or special colouring/shaping of products.

It is also worth noting that whether or not a manufacturing takes place is very much dependent on whether economies of scale exist. Countries may have capacity to manufacture but lack economies of scale hence making manufacturing an unattractive option.

South Africa

“With a waiver, the administrative and procedural delays and conditions linked to Article 31 and 31bis will be avoided, meaning that countries will have full freedom to collaborate, manufacture and supply the required products,” it said.

“It has become clear to countries that without a waiver mechanism, it is not possible to issue clearances quickly in order to ramp up production processes at the regional level,” one negotiator told Geneva Health Files.

EXCEPTIONS IN PUBLIC INTEREST

Southern negotiators, also pointed to exceptions in the US Espionage Act and the EU Trade Secrets Act in the event of emergency. “We understand that the trade secret regime in US and EU recognise disclosure to advance public interest… disclosure to public authorities or disclosure to advance a public policy goal is well permitted under the laws of the US and EU,” South Africa said in one of its clarifications for countries. Specifically it cited the exceptions in the Economic Espionage Act of 1996 in the U.S. and the EU Directive on Trade Secret.

It also added that “in many countries including the US the scope of public policy exception is determined by the court taking into account the facts and circumstances. This is time consuming and can delay the required result in pandemic time. In the present circumstances the waiver will bring the legal clarity with regard to the scope of exception to trade secret.”

Speaking to this reporter, a negotiator said, “Any discussion on waiving obligations towards intellectual property, even in the face of this pandemic, is sacrosanct for these countries”.  

In the same vein of greater disclosure, countries also discussed article 39.3 of the TRIPS agreement. Pakistan said, that the waiver would greatly contribute in ensuring transparency in Covid clinical trial data. Art. 39.3 of TRIPS states “Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

“While disclosure is allowed to protect the public, there is constant pressure from trading partners and the pharmaceutical industry to limit the flexibility allowed under Art. 39.3 of TRIPS,” Pakistan said responding to questions raised by the UK on this matter.

MSF DECONSTRUCTS MYTHS AND REALITIES AROUND WAIVER

Pertinent to this discussion is a recent briefing by MSF deconstructing the myths and realities around this proposal. In its document, MSF points out that “some of the main platform technologies used to develop COVID-19 vaccines were used for the development of other vaccines before the pandemic and remain under patent control, such as those concerning the Oxford/AstraZeneca vaccine candidate.” It also highlighted the “large portfolio of IP, such as hundreds of patents on mRNA technology – an alternative to traditional vaccine platforms – owned by different entities.”

The medical humanitarian group fears that “different types of new IP might be sought on COVID-19 vaccine product, manufacturing process, method of use and related technologies, such as the cold-chain management system for vaccine storage.”

In addition, it flags other kinds of non-patent IP and exclusivities related to vaccines development including manufacturing know-how, test data and cell lines – key to facilitate diversified production and supply worldwide.

“The large portfolio of background patents, emerging new patents and non-patent IP and exclusivities comprise a legal minefield for competent developers to quickly enter into vaccine development, production and supply. The waiver, if granted, can provide the needed legal certainties to competent developers without solely relying on the IP holders’ willingness. This is especially relevant because most multinational corporations holding COVID-19 vaccine IP have shown insufficient plans or no plans to openly license or transfer technologies to all competent vaccine developers globally,” MSF has said.

WHATS NEXT:  

According to WTO rules, the TRIPS Council has 90 days to consider this proposal and a report is then submitted for consideration by the General Council.

Given that this proposal was initially submitted on 2 October, the 90-day time-period expires on 31 December 2020 and the next meeting of the General Council will be the last opportunity for members to take a formal decision, sources said.

In the meeting today, members reportedly agreed on a text for an oral status report that will be submitted to the General Council for consideration next week.

An excerpt:

“…This means that the TRIPS Council has not yet completed its consideration of the waiver request and may not be able to do so within the 90 days stipulated in Article IX:3 of the Marrakesh Agreement. Therefore, the TRIPS Council will continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement."

The next formal meeting of the TRIPS Council is scheduled for March 2021. Chair of the TRIPS Council,  Ambassador Xolelwa Mlumbi-Peter of South Africa has called for further consideration of the waiver proposal, asking members to consider meeting early in 2021 in order to advance discussions.

A CHANGE FOREVER?  

Given the attention that this proposal has received at the highest levels including from elected representatives  from Pakistan, Colombia, the Philippines and Malaysia calling for all governments to support the TRIPS waiver proposal at the WTO, all eyes are on the secretariat, in its role in facilitating these discussions.

There is a perception among developing countries, that WTO secretariat has not often been supportive of these processes. “The secretariat has long been known to adopt “green room” tactics, but this time they know that the world is watching,” a source who works with developing countries in Geneva said.

[In the WTO milieu, green room is the informal name of the director-general's conference room which is often used to hold informal “deal making” meetings between a small group of select delegations to tackle intractable issues, instead of involving all 164 WTO members. Green room meetings can happen anywhere, and does not need to be in the DG’s fold.]

“Even if the waiver proposal does not come through, developing countries will likely be able to force change in these discussions on access to medicines,” the source said.

While it remains to be seen, how long countries can let the proposal remain in the TRIPS Council, the momentum generated in these discussions is likely to decisively influence the response to this pandemic, experts believe.

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2. What we found interesting this week:

I. W.H.O. AND NATIONAL AUTHORITIES

This Financial Times story is important, because it potentially shows the extent to which countries (not just China or the U.S.) can have an impact on the technical leadership at WHO.

It also shines a light on what could follow at national levels, as prosecutors conduct their own analyses on governments and other actors’ response to the pandemic in those crucial early months.

According to this report in the FT, WHO pulled report on Italy’s‘chaotic’ first response to Covid-19, WHO took down a report on Italy’s response to the pandemic, hours after publication in May.

…Mr Zambon, the lead author of the report, challenged the WHO’s statement that errors in the assessment meant it had to be withdrawn. “Never in nine months was I told that the report . . . has inaccuracies and inconsistencies,”….

Financial Times

The story also examines the role of Ranieri Guerra - among others - a serving assistant-director general at WHO, who also worked on Italy’s pandemic response plan during his tenure at the government.

Mr Guerra was interviewed by prosecutors in Bergamo last month but other WHO officials, including authors of the report, have not yet complied with court orders to appear. “National authorities recently informed WHO about court orders issued by the office of the prosecutor in Bergamo. We have formally requested additional information,” the WHO told the FT. Mr Guerra had spoken to prosecutors “in his personal capacity” before the official court orders had been received, the WHO said. “To preserve its objectivity and independence, WHO does not normally become involved in legal matters at the national level,” it said.

Financial Times

II. WHO FOUNDATION

The WHO Foundation appointed Anil Soni as its Chief Executive Officer, effective January 1, 2021. At a recent presser, WHO DG Tedros, said that Foundation hopes to raise US $ 1 billion over the next three years.

Juice for Conflict of Interest (CoI) researchers for months to come. (Yes, these researchers are a tribe in their own right, and may their tribe grow.)

Check out Soni’s interview with Devex. 

Q&A: New CEO Anil Soni on the future of the WHO Foundation via Devex:

Excerpts:

The WHO would not accept a check from the company Viatris or even from the Viatris Foundation, even if it was intended to support something that was not oriented towards our particular area of interest or our particular set of medicines. But the WHO Foundation absolutely could do that.

As told to Devex

On prequalification, we wonder what this will mean:

…So we could for the pharmaceutical industry, for example, say a critically important function of the WHO is to score prequalification, is to ensure that medicines, whoever makes them, are available at a certain quality. That type of an initiative is something that the pharmaceutical industry is very supportive of, in my experience, and it's not about favoring any specific company. That's the type of orientation that might be very relevant for the foundation to mobilize resources for the WHO in a way that it couldn't do itself.

As told to Devex

On raising funds for other actors in health:

(From what we understand, this is bit of the problem, partners of WHO being better funded than the multilateral institution)

Because sometimes the WHO's work, just as other organizations’ work, depends on the WHO. The Global Fund couldn't succeed if it wasn't for the WHO, [and] neither could Gavi, [the Vaccine Alliance]. Likewise, some of the work of the WHO depends on other organizations. And that's why the foundation has the flexibility to give money to those partner organizations.

As told to Devex

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3. We are also watching:

I. The WTO General Council meeting

This will take place next week 16th-17th. It is expected to consider an oral report from the TRIPS Council on the TRIPS waiver proposal.

II. GAVI BOARD MEETING

Another high power week in Geneva. Gavi Board meeting on the 16th-17th next week.

III. WHO EB RESOLUTION DISCUSSIONS: 16th

The EU is reportedly expected to discuss a draft resolution for the Executive Board meeting early in 2021, during informal consultations on December 16th


TWEET OF THE WEEK

A picture for politicians everywhere:

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