Q&A: Madame Sirleaf; TRIPS Waiver-Fever

Newsletter Edition #12

Hi,

This week I was reminded of a poem by Robert Frost, as I thought about all those who are fighting to address COVID-19.

An excerpt from Stopping by Woods on a Snowy Evening

“…The woods are lovely, dark and deep,

But I have promises to keep,

And miles to go before I sleep,

And miles to go before I sleep.”

Deepening winters in this part of the world, have brought back harsh realities to the fore. Switzerland, for example, reported that all of its intensive care beds are full. If this is the fate in one of the richest countries of the world, it is hard to fully come to terms with what is unraveling in the rural hinterlands, conflict settings and other challenging areas.

While there is a lot of optimism with promising vaccine candidates, it was important to note the tempered reaction from WHO this week. There are enough cheerleaders for the industry’s stupendous efforts, authorities globally must stay the course no matter the urgency.

Today, we bring you an interview with the former President of Liberia Ellen Johnson Sirleaf, Co-Chair of the Independent Panel on Pandemic Preparedness and Response, to get a sense of the challenges of working on this investigation in a highly politicized environment.

We also draw attention to an important report that discusses what access clauses in vaccine contracts look like and what this means for expanding access to more than 7 billion people globally, if Gavi and CEPI enforce these provisions effectively.

We also have a brief update on the momentum that the TRIPS Waiver proposal is gaining with reportedly support from close to 100 countries, as it comes for discussions at the WTO this week.

Finally, we are happy to share that we were invited to moderate a session on multilateralism in global health in the context of COVID-19 at the Geneva Health Forum. It was a free-wheeling discussion on the humanitarian and commerical implications of this pandemic with Robert Mardini, DG of ICRC and Thomas Cueni, IFPMA top boss. While the panelists were optimistic about the future of global health, I came away with the lasting impression that “multistakeholderism” is here to stay.

Less public oversight, and an expanded role of private actors that results from multistakeholderism is defining international development and global health. Help us understand this paradigm shift.

Our role as watchers has never been more crucial. Thank you for reading us. We are truly encouraged by your contributions. It means a lot to us. Readers contributions will help us stay independent.

Share, source and support us.

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

In recent reforms-related discussions at WHO, some countries want independent teams to have access to outbreak sites going forward. Geopolitical pressures and a highly politicized environment has made global health security a defining agenda as a result of the pandemic. In an interview with one of the co-chairs of the Independent Panel on Pandemic Preparedness and Response (IPPPR), we tried to get a sense of the challenges that this panel faces.

Q&A: Former President of Liberia, Ellen Johnson Sirleaf, Co-Chair of the Independent Panel on Pandemic Preparedness and Response

Ellen Johnson Sirleaf [Image Credit: The Elders]

[GHF] 1.       What are the key learnings from previous similar investigations which the panel can apply while examining the response to this pandemic?   

[EJS] There is much we can learn from work that has been done before, both on how a panel can work most effectively and how we can most effectively manage a pandemic.

I must start by saying that it is not for me to criticize previous panels. I believe previous panels have done good work to diagnose key issues and understand what has gone wrong in the past and how things can be improved in the future.

From my experience, it is perhaps not a question of how well a panel has worked.  But, instead, to consider the context in which the panel was operating. It is a question of the times: Was the world ready to hear these recommendations? Was it ready to implement them? And we must also remember that in our multilateral system, including at the World Health Organization, Member States decide what they are ready to do—and what they are not ready to do. Some of the most powerful countries hold a powerful sway. And they can decide whether to implement—and most importantly, invest—in new ways of doing things.

We are now living in different times. This is the first time in many generations, in our living memory, that an infectious respiratory illness has affected almost every country on every continent. And I think that it is because of the widespread nature of this pandemic that countries may be ready to hear—and ready to act on—recommendations made today, when they may not have done so before. For example, we know that several countries already have ideas to amend the International Health Regulations and reform the World Health Organization. And, in early December, the United Nations General Assembly will hear from many countries of the world at a meeting being held to specifically address COVID-19. It is the World Health Assembly itself that requested the initiation of our Panel. These are signs that we are truly in a moment of change.

I am Co-Chairing the respected Independent Panel for Pandemic Preparedness and Response, comprised of some of the leading experts on infectious disease outbreaks and management, on the global health system, on public administration, leadership, on crisis management, on economics and on social issues.  This Panel has a unique ability to find the facts and evidence, while keeping the big picture in clear view.  I am confident the Panel’s recommendations will be right for the times.

The COVID-19 pandemic is redolent of the Ebola crisis, which I faced when I was President of Liberia. And so of course it is natural for us in Liberia, as in other countries that were affected by Ebola outbreaks, to look back on that time, and perhaps draw comparisons between the two.

And as we look back on that time, on that experience, we should be mindful of three things:

First is communication. There must be regular, honest information shared with the public to keep them informed about the status of the pandemic and the responses that are being made to it. And we must work directly with our communities to ensure that the messages make sense. To ensure that people understand how to protect themselves, and their families, from this disease. We must engage people in the response and leave room for ideas to rise from the bottom up.

The second thing of which we should be mindful is partnership and coordination. When we dealt with Ebola, we had to unite everyone around a common agenda, a common purpose, to which everyone committed. We couldn’t do it alone. We didn’t have the capacity, either financial or technical, to solve the issues without help. So, we brought together the people who did, and created new partnerships—locally, regionally, and internationally—to help us beat the virus.

And third, we must have good leadership. Not just nationally, although of course that is critically important, but also good leadership throughout society. For example, in communities, we must have good community leaders, and good community health teams, who are the enablers of behavioral change, and lead the way for the people around them.

In the context of different countries, these three things will translate into different actions—but the intentions must be the same.

[GHF]2.       How will the Panel deal with diverse geopolitical pressures and interests while working on this investigation?

[EJS] The Independent Panel’s work is rooted in science and evidence. It will research, and then present the facts about SARS-CoV-2 and the COVID-19 pandemic. It will seek to understand how it initially infected a small number of people and then spread so quickly to affect just about every country in the world, to affect the lives of just about every human being in the world. This global aspect should, and must, transcend geopolitics.

As we think back to the early weeks of the disease, almost every country, no matter its system of government, no matter its economic status, was affected to a greater or lesser extent in similar ways. Health systems were quickly overloaded as citizens became ill and died. Healthcare workers themselves also became ill and died, while they were trying desperately hard to prepare for and fight a disease that people knew very little about.

Uncertainty defined the time, and new protocols had to be developed and enacted in a matter of days. Teams were learning how to face the unknown, while hospitals were reconfigured, and new quarantine and treatment centers were opened. And there were other effects as non-urgent treatments were cancelled to try and limit the spread of the disease and keep capacity available in hospitals for those who were suffering from COVID-19.

And, while things were uncertain, many countries around the world lacked the supplies needed for their healthcare workers to fight the pandemic. This included the basics, the personal protective equipment, the masks people needed. Rich and poor countries were all affected, the supplies were simply unavailable.

Now, as things stand today, the virus is continuing to affect almost every country. It is continuing to affect health workers, who must continue to adapt as the virus continues to spread in some places and re-emerges in others. 

The pandemic is also affecting economies. In June, prior to the latest surge in infections, the International Monetary Fund predicted the global economy to shrink by 4.9% during 2020. In the second quarter of this year, it has led to the loss of 195 million full time employment roles. And these job losses are affecting people who can afford it the least—in rich and poor countries alike.

Moreover, the pandemic is affecting the very fabric of our societies. We are yet to fully measure the impact of the pandemic on women, on their work, on their safety at home. We cannot yet fully measure the impact of the disruption to education, the loss of access to food, and potential changes in migration. We must better understand the inequities as well including in wealthier countries – the fact this virus is having a bigger impact on people who are poor, people who are racialized and people who are vulnerable, including the aged.

That is why—as impossible as it may sound—we must remove geopolitics from our discussions. Every country has been affected, and just about every country is already paying a price. And, also, every country can most likely agree that they do not want this to happen again. It is in all our interests to understand what happened, to understand how and why it happened, and to understand how we can avoid a similar calamity in the future.

Our mission is clear. We will seek out the facts, distill the lessons learned, and make recommendations for the future.

[GHF] 3. Given the challenge of a tight timeline, how does the Panel propose to complete its investigations before the World Health Assembly in May next year. 

[EJS] It is true that we have an ambitious and rigorous program of work ahead of us. We are looking at four main areas over the next several months.

We begin by building on the past, understanding where we can draw lessons from previous epidemics and pandemics, including both SARS and Ebola.

We are reviewing the present, examining the epidemiology and science of SARS-CoV2 and COVID-19, the warnings and guidance issued by the World Health Organization, the ECDC, the African CDC and other bodies, and how countries have responded to these.

We seek to understand the impacts on our health systems. We will look at the wider impacts – including on economies and society. We’ll also look at how communication played out including the impact of the infodemic - including the rapid spread of misinformation about the virus. Critically, we will also explore the involvement of and impact on communities.

We are looking at what we must change for the future. We will examine the role of the World Health Organization, and ask whether it has the right mandate, the right powers, the right capacities, and the right financing to deliver on pandemic preparedness and response.  And we will also look beyond the WHO, to understand where the multilateral system has, and has not, worked effectively, and what potential changes could be made.

Our Panel is now meeting every six weeks to review these questions and progress our work. And, crucially, we are working every day, closely with the Secretariat and a team of researchers to systematically find the answers. There is a methodical schedule to follow to ensure we have a substantive report that lays out the facts and evidence, distills the lessons, and makes recommendations.

We have clear methodologies and research to guide us. This includes desk literature reviews which involve both published and grey literature, as well as private documents, in-depth interviews, and roundtables with experts.

Beyond this, we also want to learn from a wide range of people who have experience and evidence to share, including of course WHO Member States, academics, civil society, the private sector, and the general public.

When we make recommendations, they will be actionable. They will provide clarity on what needs to change, on who needs to change it, and by when they should do it. We cannot have recommendations that simply sit on a shelf—there is simply too much at stake, for everyone, everywhere.

So, what is the bottom line? It is that the world has gone through and continues to bear a global trauma. We hope that our recommendations, when they are implemented, will ensure the global system and countries are in a better place to identify any pathogen that has pandemic potential, that we can respond to it both rapidly and aggressively, and thus we can minimize the damage to our health, our health systems, our economies, and our society.

There is rarely a moment in history when one can speak for the whole of society. But, in this instance, in this set of circumstances of the COVID-19 pandemic, I think we can all agree that no one wants to go through a set of events like this again.

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2. What we found interesting this week:

I. COVAX CHOICES - A REPORT BY PUBLIC CITIZEN

“What would it look like for COVAX to make a different set of choices?”, this important report by Public Citizen tries to answer this question.

The report discusses different kinds of clauses in some of the vaccine contracts for COVID-19.

Zain Rizvi, author of the report reminds us:

“…COVAX is not merely a final purchaser. Through CEPI, it has also funded research, development, and manufacturing. COVAX could demand more of manufacturers and fully use the leverage provided by CEPI’s critical early-stage funding to share technology and scale-up affordable supply.”

The report highlights some of the clauses that give CEPI oversight authority and mandates distribution of products in low and middle income countries. Instruments such as the public health license, CEPI’s worldwide, royalty-free license, can help improve sharing of technology and therefore access to vaccines.

Recommended reading.

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3. We are also watching:

TRIPS WAIVER DISCUSSIONS AT WTO

If one still needed convincing about the need for a temporary waiver from granting intellectual property and other kinds of protection during the pandemic, the Economist, has this helpful graph on the number of confirmed orders of vaccines doses per person. To an extent, this graph encapsulates the failure of multilateralism - Gavi’s COVAX Facility has secured a woeful number of confirmed orders of vaccines doses per person.

This illustrates not only the problem with vaccines procurement, but a host of other areas as far as addressing this pandemic is concerned – which brings us to the all-encompassing TRIPS Waiver proposal at the WTO.

Image credit: The Economist, November 2020 [Displayed under fair-use]

The TRIPS Waiver proposal is coming up for informal discussions at the TRIPS Council at WTO this week on the 20th. The proposal which seeks a temporary waiver for all countries to be waived of their obligations under TRIPS agreement in order to fight the pandemic comprehensively, has been gaining momentum steadily. MSF has said that the proposal is already backed by 99 countries.

Led by South Africa and India, the proposal has garnered other co-sponsors including Eswatini, Indonesia, Sri Lanka, Venezuela, Rwanda, Kenya and Pakistan.

If approved, such a waiver will allow all countries to not grant or enforce intellectual property protection for the duration of the pandemic, until widespread vaccination has been achieved.

Sources close to the process said that during the previous meeting “The support from the floor was an eye opener. It will remain to be seen how that support translates into members becoming sponsors.” There were more than 40 interventions, majority were positive, the others had varying degrees of opposition, a diplomatic source associated with the process said.

When countries formally support a proposal, the picture begins to change, because that shows political will to back that support.

Getting countries’ buy-in for such a proposal is a mean task. The proposal recognizes intellectual property, trade secrets, industrial designs, as barriers to sharing technology. This has been challenged by not only some countries, but also the industry. They see the protection of these rights as essential to fueling innovation during the pandemic, and point to existing, but cumbersome, flexibilities in the TRIPS agreement.  

Close to a year into this pandemic, supporters of the proposal argue that there has not been adequate sharing of technology. While a few companies have come together to share manufacturing capacities, the collaboration between and across sectors has not been in the order of what is required to meet the demands of the world’s population.

At a recent event discussing the proposal, Carlos Correa, Executive Director of the South Centre pointed out that 15 billion vaccine doses will be required to cover more than 7 billion people worldwide. (Current capacities for vaccines manufacturing alone, do not match even a quarter of the demand.)

As the graph above shows, poorest countries of the world stand virtually defenseless without access to medical products, made worse by bilateral deals that high and middle income countries have struck with manufacturers. Many countries lack the institutional capacities to use TRIPS flexbilities to improve access, and are not in a position to sign Advance Purchase Agreements with suppliers, experts have pointed out. (Experts point out that this waiver proposal is complimentary to, and consistent with, the LDC waiver. )

Over the last few weeks, countries have made their positions on the proposal clear, including at the World Health Assembly earlier this month. (Do note that while WHO clearly supported the TRIPS Waiver proposal, top officials continue to insist that intellectual property has so far not been a problem in ensuring access to vaccines to fight the pandemic.)  

However, this isn’t about vaccines alone. MSF has pointed out

“…several new and repurposed medicines and monoclonal antibodies being trialed as promising treatments for COVID-19 are already patented in many developing countries such as Brazil, South Africa, India, Indonesia, China and Malaysia. And with the exception of one company, none of the COVID-19 vaccine developers have committed to treating IP any differently than the status quo. While some corporations have taken steps through licensing and technology transfer deals to use existing global manufacturing capacity to try and mitigate anticipated supply shortages of potentially successful vaccines, this has been the exception, and the licensing deals often come with clear limitations.”

Countries including United States, the European Union, Japan, Switzerland, and others had already opposed the proposal when it came up for discussion on in October 2020 at the TRIPS Council at WTO.

In the meantime, supporters of the proposal are discussing how such a waiver can be implemented at national levels; providing countries with information on the existing trade in medical goods for example; answering questions on the feasibility for operationalising such a proposal.

“We are trying to build pressure in the room but also outside, in capitals, in Parliaments and, among unlikely allies” the source said.

Sponsors of the proposal say that the discussions at the TRIPS Council meeting will result in a report that will be submitted to the General Council for consideration. The General Council is slated to meet on 17th December.

At the General Council, the dynamics begin to change, the source noted.

According to WTO rules, the TRIPS Council has 90 days to consider this proposal (tabled in early October 2020) and a report is then submitted for consideration by the General Council and at the Ministerial Conference (June 2021).

The decision on the proposal has to be made by consensus as per procedure.

If consensus cannot be reached, the decision can be made by voting. A three-fourths majority is needed for a decision to be made through voting. Most countries would not prefer a vote, the diplomatic source said. “Once you have a vote, it becomes a binding decision,” the person added. Countries usually do not prefer a vote.

In the midst of what could be a turning point in multilateralism and for the response to the pandemic, the WTO does not have a boss. And it seems it does not matter as far as this proposal is concerned. “It does not matter whether WTO has a DG or not. If the proposal reaches the General Council, it could result in a vote,” the source explained.

The wider objective, and potential consequence, of the storm whipped up by the proposal could include difficult discussions on costs, research and development - issues that have long determined the access to pharmaceutical products. “This is an opportunity to lock in certain rules of behaviour, a particular code of conduct,” a source close to the process said.

This will not come easy. The richest countries of the world will fight to stall this initiative, even as they face climbing mortality from the pandemic and worsening inequalities.

The industry has long dismissed voluntary licensing initiatives including WHO’s COVID-19 Technology Access Pool. Thomas Ceuni, Director-General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said this week, that patents have been an enabler to the fast response to COVID-19, that resulted in 200 vaccine candidates.

Notwithstanding the evolving dynamics, the stage is set, but the lines can still be redrawn at WTO’s TRIPS Council in the coming weeks.

Asked if it was realistic to expect that this waiver could become a reality, the source said, “It is more a lack of imagination of what is possible”.

This story was subsequently corrected on 23.11.2020, to reflect that Argentina was not one of the co-sponsors of the TRIPS Waiver proposal, as was previously reported. We regret this error.


TWEET OF THE WEEK:

“Efficacy data as bidding war”

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