TRIPS waiver discussions: moving the needle

Newsletter Edition #13

Hi,

We are still a few weeks away from the close of 2020, but there is growing fear and recognition that low and middle income countries will be left without access to COVID-19 medical products in the medium term.

We are living through the worst excesses of nationalism and yet we continue to witness vacuous statements from leaders about the need for equitable access to drugs to fight the pandemic. (While we are on it, there seems to be divergence even among top WHO officials on if and how low and middle income countries will get access to vaccines. See presser on November 16, 2020.)

A range of actors are responsible for the state of affairs. Both parties of bilateral deals, and countries in the global south for not effectively using their diplomatic capital to raise questions and make their vote count, experts say.

Now is the time for countries to walk the talk, which brings us to the story of the week. We continue to look closely at the evolving discussions on the TRIPS waiver proposal at the WTO. The good news is that the needle has moved, we now have EU countries pushing for the use of TRIPS flexibilities! At this point, it is hard to be optimistic that the proposal will break through the fortified IP protection ecosystem at WTO and elsewhere. The coming weeks, to an extent can be decisive. Its not over, till it is over.

Thank you for reading us. Every single week, we are overwhelmed by the great feedback that we receive from our readers. Do continue to support our reportage for an unblinkered view on this mind-bending reality that we are living through.

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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

TRIPS WAIVER: THE NEEDLE HAS MOVED, BUT THE FIGHT IS ON

EU bloc and others, push for TRIPS flexibilities, a defining departure from the past

Countries are making slow but sure progress in discussing a proposal to temporarily waive certain obligations under the TRIPS agreement at the WTO. After an informal meeting of the TRIPS Council last week, countries are now having bilateral discussions seeking clarifications from co-sponsors of the proposal including South Africa and India.

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. 

While the co-sponsors of the proposal are optimistic about the extent of support the proposal has been gaining steadily, battle-hardened activists and observers who have weathered these tricky discussions on intellectual property and access to medicines for decades, do not see any let up by the few but powerful, key, rich countries opposing this proposal.

Irrespective of the outcome of this proposal, whether it will be ultimately backed by consensus (or a vote) from WTO member states, experts feel that “needle has already moved” as far as discussions on intellectual property as a barrier to access to medicines is concerned. Despite the prevailing uncertainties in the institution itself, WTO has emerged as a forum where these discussions are taking place. As we have pointed out before, this is significant, given that issues on IP and health do not often find adequate space for debate at WHO – even during this pandemic.

This story tries to capture prevailing dynamics shaping the discussions on this proposal, it also reviews key statements from certain countries and presents the possible course the proposal could run in the coming weeks.

Image credit: Photo by Maksim Goncharenok from Pexels

THE TRIPS COUNCIL INFORMAL MEETING – November 20, 2020

As per a previously adopted procedure, the discussion of this item had been suspended (during the meeting on 15-16 October) to give members more time to consider the proposal. The informal meeting was meant to facilitate discussions and to find out if countries could move towards a consensus. Informal meetings do not allow for formal decisions to be taken, and yet are important since these discussions take place at a multilateral level where countries can debate and seek clarifications.

While nearly 30 countries took the floor to air their concerns and seek more details on the proposals, the co-sponsors were of the view that sufficient time was not given to conclude the discussions. (It is hard to understand why it was not possible to enable continuing the discussions on one of the most significant policy decisions this year)

The Chair of the meeting, Ambassador Xolelwa Mlumbi-Peter of South Africa, said that discussions will continue on a bilateral basis.

The proposal is now being co-sponsored by South Africa, India, Kenya, Eswatini, Mozambique and Pakistan. Nigeria has expressed interest in becoming a co-sponsor of the proposal.

The co-sponsors are now working to convert interest shown by some WTO members into firmer support. “There is a silent majority who have not spoken up. But we believe that they are in favour of the proposal”, a diplomatic source briefed this reporter.

It has not been possible to verify the extent of this support. Last week MSF had indicated that the proposal had support from nearly 100 countries.

India, Sri Lanka, Tunisia, Egypt, Cuba, Tanzania (on behalf of the African Group), Venezuela, Nigeria, Bangladesh and Jamaica expressed support for the proposal at the meeting.

It appeared that certain countries in Latin America were still undecided on their position with respect to the proposal including Colombia. Argentina had expressed support for the proposal in the previous TRIPS Council meeting.

While consensus is very much the tradition in WTO, co-sponsors do not rule out a vote completely. “If a country has reservations about the proposal, they might abstain during a vote. Even abstention in the event of a vote, will help us”, a diplomatic source told Geneva Health Files.

There was a perception that although opponents to the proposal remained steadfastly unassuaged, the tone from some of these countries was more constructive and “less attacking”, several people who followed the meeting said.  Brazil, United States, the European Union, Japan, Canada, UK, and Switzerland have opposed the proposal.

SOME EXCERPTS FROM KEY STATEMENTS MADE BY COUNTRIES

We present some excerpts from the statements made by countries, in no particular order. It is instructive to see country positions on this matter.

Eswatini

“…countries that are of the view that they will not benefit from the waiver, or do not meet the waiver should not deny other countries, this policy option and curtail the tools available to them to contain the pandemic.”

India

“The waiver is more than just a legal mechanism. It is a statement of intent, by all countries that they accord highest value to protecting human lives, rather than protecting private profits.

…We believe it would be naive for any country to think that it can win over a virus which knows no boundaries, by simply vaccinating their own population.”

South Africa:

“..Ad hoc, non-transparent and unaccountable bilateral deals that artificially limit supply and competition cannot reliably deliver access during a global pandemic. These bilateral deals do not demonstrate global collaboration but rather reinforces “nationalism”, enlarging chasms of inequity.”

China

“We think in the trade toolkits waivers could be a useful tool to reduce uncertainty. There is no single answer to this proposal in terms of yes or no. It is necessary to have detailed and constructive analysis and to continue discussing.”

Sri Lanka

“…temporary waiver provides a critical policy space for WTO members to take measures to enable competition through multiple producers and ensure adequate supply at affordable rates.”

Mexico

“..We believe that the TRIPS agreement together with a Doha Declaration on the TRIPS agreement and public health are sufficient to address current challenges.

In addition, we should note that in virtue of the TRIPS Council agreement of November 2015, LDCs are already exempted until 2033 of these specific obligations under the TRIPS agreement with regard to pharmaceuticals…”

Brazil

“…Regarding scope, we would like to request the proponents to further elaborate the rationale for including industrial designs in the proposal. Several doubts have also arisen with regards to copyright. We would invite the proponents to further specify the cases in which wavering copyrights could be pertinent for preventing containing or treating COVID-19.

We would like to request the proponents to elaborate on how members, facing legal and institutional difficulties when using flexibilities would automatically and expeditiously overcome legislative and institutional barriers for the successful implementation of a waiver.”

US

“..If the waiver were granted as requested, at least 34 separate paragraphs of the TRIPS agreement would no longer apply. This is a substantial departure from past WTO waivers.

…Regarding proportionality and problem identification could the proponents explain how the waiver is a proportionate response to covid-19? Could the proponents provide to data that establishes that the identified trips obligations have systematically hindered or block the prevention containment or treatment of covid-19?  With respect to scope that the proponents explain how members would determine whether a measure is quote is related to the prevention containment or treatment of covid-19 and this falls within the scope of the proposed waiver…”

EU

“…Domestic legal frameworks should properly reflect the flexibilities provided by the TRIPS agreement, such as the possibility of issuing a compulsory license, including for production for export to vulnerable countries that lack production capacity or including fast-track procedures that can be used in health emergencies. The EU is ready to discuss with all WTO members what can be done to facilitate the implementation of these flexibilities…”

Pakistan

“…Pakistan has found it particularly difficult to implement the compulsory licensing provisions due to various limitations of time, price quantity and regional production. The grant of compulsory license is an extremely arduous and lengthy procedure, posing legal complexities. Therefore, the flexibilities are not effective and insufficient for the scale and urgency of the current crisis.

….As custodians of the world trading order, I believe no one would like to be known for saving fish, but not human lives.”

Israel

“…However so far we have not identified how IP has acted as a barrier to accessing vaccines, treatment or technologies in the global response to covid-19. Israel would like to encourage active dialogue between governments to explore how best to work together to prevent contain and protect covid-19 including using TRIPS compliant license models…”

Singapore

“…the nexus between IP and access is complex and multifaceted. Empirically IP has been an enabler rather than an obstacle to Innovation and Global change. Hence all members must be ready to engage constructively to understand each other's concerns regarding IP in the fight against Covid-19.”

Canada

“..Canada does not see these concerns as suggestive of issues with the trips such as that would necessitate the waiver. Canada remains the only member to have used this special compulsory licensing system under article 31bis and can thus observe on the basis of concrete experience that this system has worked as intended. Article 31bis only used once does not suggest that the system is inadequate rather Canada believes that this suggests that the overall trips regime works as part of the broader international framework that provides members with sufficient latitude and flexibility such as there has been limited or no need to issue compulsory licenses under article 31bis. ..”

United Kingdom

“We would like to stress that and it's hard the intellectual property system has never been about locking up knowledge. It is always been concerned with balancing the need to incentivize Innovation and creativity with the need to allow Society to benefit from the fruit of that Innovation. Having studied the proposal in detail we must ask how would such a waiver even operate, how would it be implemented into national legislation? How would this help countries like in manufacturing capacities and even if limited in time the waiver creates long-term uncertainty and undermines the system for the future including future pandemics. Waiving the intellectual property system, it simply move us away from solution not towards them.

In fact, the generics industry have pointed to support for an effective and balanced intellectual property framework as a key factor to enable research and development accelerate manufacturing scale up and facilitate licensing...”

THE DYNAMICS

The staunchest opposition came from United States and Brazil, two countries accounting for the highest burden of COVID-19.

(In light of these discussions, experts also pointed out how the BRICS as a group have failed to come together on such issues. One diplomatic source rued about Brazil’s change in position on these issues, since the country had traditionally been one of the strongest supporters in actively addressing intellectual property barriers in the access to medicines.)

Some countries had concerns on the waiver addressing copyrights and industrial designs in the same proposal. Observers pointed out that potentially there could be concerns on addressing these different aspects of intellectual property under a single measure since typically these are addressed by different ministries at the national level.

Diagnostics for COVID-19 for example, illustrate how different aspects of intellectual property from copyrights, to industrial designs and patents could play a role in acting as barriers to accessing these technologies, experts point out. Already there are vast disparities in the access to diagnostics.  

One of the most significant changes as a result of these discussions around the waiver proposal has been the way the EU has pushed for the use of existing TRIPS flexibilities at WTO. Experts point out that both the EU and the US have consistently deployed pressure on countries that had attempted to, and those that have used TRIPS flexibilities in the past. These kinds of pressures have led to a chilling effect on the use of such flexibilities, experts say.

“The EU, the US and Switzerland have variously put pressure on Colombia, Thailand, Malaysia, India, whenever these countries sought to issue a compulsory license, for example. While welcome, it is also hypocritical of these countries, to now push for TRIPS flexibilities in the light of this waiver proposal”, K M Gopakumar, Legal Advisor to Third World Network told Geneva Health Files.

The crux of this opposition by producer countries boils down to this: that the waiver can set a precedence, one expert suggested.

While research and development capacities exist in the global north, few developing countries have such capabilities. This difference is already hurting countries’ access to technologies especially at the time of such a pandemic. Supporters of the proposal also highlight that in many countries both research and development, and manufacturing capacities are state-funded. They question how this waiver proposal can affect incentive mechanisms to the private sector, given substantial investments by governments during this pandemic.

Without strong measures to break the barriers that IP poses to access to medicines, the disparities in the access to both vaccines and therapeutics will be perpetuated further, many fear.

Some believe that rich countries’ opposition to the waiver, also stems from the potential repercussions such a waiver can have on “the production of knowledge” as it were, including implications for access to genetic resources now and in the future.

Diplomatic sources believe that this proposal is being seen by some countries as having ramifications beyond COVID-19. They believe, rich countries’ hesitancy towards the proposal is also contributed by what such a waiver can mean for governance of these rights in the digital space, for example.

In addition to traditional concerns on protection of intellectual property rights, implications for access to genetic resources and digital rights could also be contributing to this opposition, one source associated with the proposal said.

“We cannot the change rules of the game in the middle of a pandemic”, a negotiator from a developed country reportedly said in response to the waiver proposal.

WHATS NEXT?

The chair Ambassador Xolelwa Mlumbi-Peter, has said a formal TRIPS Council will be convened on 10 December with the aim of adopting a report that can be submitted to the next General Council, scheduled for 16-17 December.

Countries continue to meet bilaterally to find out if a consensus can be reached on what such a report to the General Council can look like. “Meeting bilaterally bifurcates the debate. We would have liked more time to discuss this during the previous meeting with all member states. But we were not given that”, a delegate from one of the co-sponsoring countries said.

It is not clear to what extent countries will be able to have substantive discussions on the proposal at a multilateral level in the coming days. (It is understood that the next formal TRIPS council will also discuss other items on the agenda, and may not be limited to discussions only on the waiver proposal)

“We put high importance to escalate the matter to the General Council due to the political importance of having the matter considered in the General Council,” a diplomatic source told us.

However, a small possibility exists that this issue could be removed from the agenda of the General Council,  if there is no consensus at the TRIPS Council meeting on December 10th, a source familiar with WTO processes said. (Although the TRIPS Council can also report the lack of consensus to the General Council and discussions on the proposal can continue at the General Council.)

While it remains to be seen if this proposal will succeed, discussions around the proposal have already moved the conversation on these critical issues forward, Sangeeta Shashikant, Legal Advisor to Third World Network said.

This is not only about the final decision text of a potential waiver proposal, it is also about having a forum where countries can debate and discuss the barriers of IP to the access to medicines. And a forum has definitively emerged.

Meanwhile, pressure continues to build outside of WTO. Hundreds of scientists, civil society organizations and other stakeholders across the world have come out in favor of supporting the waiver proposal.

It is the kind of “solidarity” that does not make shiny headlines.

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2. What we found interesting this week:

I. NEW EU STRATEGIES: PHARMA & IP

Activists pushing for greater transparency in prices of medical products seem to love this strategy.

Excerpts we found interesting:

Pharmaceutical Strategy for Europe

“…Generic and biosimilar medicines provide a large number of patients with accessible and affordable treatments. They also allow health systems potential savings in costs through their positive effect on pricing competition. The Commission will consider targeted policies that support greater generic and biosimilar competition, based on the sound functioning of the single market, appropriate market protection mechanisms, the removal of barriers that delay their timely entry to market and increased uptake by health system..

There is a lack of transparency (in particular in R&D costs) and consensus on costing principles. Better understanding and greater clarity are fundamental as a basis for policy debates on the pricing of niche medicines and ‘fair return’ on research contributions…

…Changing business models (e.g. high value acquisitions of promising pipeline products) and novel payment approaches, such as risk-sharing arrangements and deferred payment schemes, may have long-term implications, and thus affect affordability of new medicines. The Commission will foster transparency of price information to help Member States take better pricing and reimbursement decisions, also considering possible knock-on effects for innovation…”

EU IP Strategy:

On the use of compulsory licenses:

“Finally, the Commission sees the need to ensure that effective systems for issuing compulsory licenses are in place, to be used as a means of last resort and a safety net, when all other efforts to make IP available have failed. The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) provides for a possibility, under the conditions listed, to issue compulsory licences, i.e. government’s authority to grant permission to a party seeking use of a patented invention without the consent of the patent owner. The procedure can be fast-tracked in the case of national emergency…”

II. “THE BILL CHILL” - NEW YORK TIMES

Bill Gates, the Virus and the Quest to Vaccinate the World”: New York Times

A fascinating read. We cite excerpts here.

On what seems like the beginning of the ACT Accelerator:

“…On Feb. 14, he and leaders at his foundation, fearing a global threat, gathered to plan a response. From that point on, Mr. Gates recalled, “we’re on Code Red.”

Two weeks later, Dr. Seth Berkley — chief executive of Gavi, the Vaccine Alliance, a nonprofit the Gates philanthropy helped found — flew to Seattle. Over breakfast, he and Mr. Gates considered how to get Covid-19 vaccines to the developing world. On March 13, two days after the W.H.O. declared a global pandemic, Mr. Gates conferred online with 12 top pharmaceutical executives, including the heads of Pfizer and Johnson & Johnson, which both have leading vaccine candidates.”

On the role of the Gates Foundation:

“….But few people publicly criticized his foundation, fearful of losing its support. That self-censorship was so widespread it acquired a nickname: “the Bill Chill”.

…Clemens Martin Auer, a chief negotiator for the European Union, balked, believing that the global vaccine deal was moving too slowly, that prices would be too high and that Europe could do better negotiating on its own.

“I think the Gates Foundation has in many respects a very practical approach when they say this has to be done in a private-public business partnership,” he said. “But I sometimes have my impression that the Gates Foundation doesn’t understand how well-organized governments work.”…

In an article in the New York Times

III. WHY THE INDUSTRY LOVES VOLUNTARY LICENSING DEALS?

A timely interview on the TRIPS Waiver proposal at WTO.

Read Philanthropy Alone Will Not Ensure Global Access To COVID-19 Vaccines – South Africa’s Take: Health Policy Watch

On the global production capacity to make a vaccine:

“…This is why they are now licensing to third parties in the developing world, not because they are magnanimous but because they just don’t have the capacity to produce at the rate that is required.

You’ll see more and more of these voluntary licenses, but it’s a throwback to the model that pharmaceutical companies and biotechnology companies would have chosen to advance their agendas. The fact that they entered into these licensing agreements does not indicate it is because they like us: it shows they need us…”

Mustaqeem De Gama, Counsellor at South African Permanent Mission in Geneva to Health Policy Watch

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3. We are also watching:

DISCUSSIONS ON TRANSPARENCY IN COSTS OF MED AT WHO?

A dedicated reader brought to our attention to potential consultations next week on December 3, 2020 at WHO, on promoting and monitoring transparency of drug prices. We were not able to confirm this by the time this newsletter went to print.

(Global strategy and plan of action on public health, innovation and intellectual property - flows from a decision at the World Health Assembly from earlier this year. Para 3: to call on Member States to further discuss, in informal consultations to be convened by the Director-General in 2020, the recommendations of the review panel on promoting and monitoring transparency of medicines prices and actions to prevent shortages)


TWEET OF THE WEEK

On questioning company press releases on new vaccines

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