Vital Interests: Rebecca, thanks very much for participating in the Vital Interest Forum. You and Sam Halabi have edited a timely new book titled, Viral Sovereignty and Technology Transfer: The Changing Global System for Sharing Pathogens for Public Health Research. Can you give us an overview?

Rebecca Katz: We're really excited about the book coming out. It's not for everybody because it gets pretty deep in the weeds on a topic that's incredibly important but not very sexy. The dialogue around viral sovereignty has been going on now for at least a decade. There continues to be a lot of confusion in the global infectious disease research community about the conditions under which biological resources should be studied or transferred out of countries.

What we've tried to do is combine years of studying the implementation of the International Health Regulations, the Nagoya Protocol, and all the obstacles that material transfer poses to that process. What we've tried to do in this book is to bring together people from varying perspectives - from biomedical researchers themselves to lawyers, policy makers, and scholars - to work through the question, "What does this actually mean? How does this new evolving international regime work to govern research?"

The challenge is trying to identify the critical problems that arise when negotiating access and benefit sharing and some of the implications of those problems as we figure out what global governance of disease looks like. What does global governance of research look like? What are the specific roles of individuals who are part of this process?

VI: How did the appearance of contagious pathogens like SARS, Ebola, and MERS affect international viral research?

Rebecca Katz: The impetus for all of these discussions around international viral research came out of the debate around H5N1. When that influenza strain emerged and was circulating, Indonesia raised concerns about how samples were shared through the mechanisms that existed for the global sharing of an influenza pathogen with pharmaceutical companies that would then make a vaccine. The concern of the Indonesian government was that any new vaccine would then not be affordable for their own people.This brought up significant issues of social justice and access to frontline medical countermeasures. 

It was at this time that the term 'viral sovereignty' was coined to address the fact that governments could claim sovereignty over viruses in their population, within their territory. To address this need, a supplementary agreement called the Nagoya Protocol on Access to Genetic Research and the Fair and Equitable Sharing of Benefits Arising from their Utilization was added to the  Convention on Biological Diversity in 2010 and entered into force in October 2014. 

For many years there have been issues around equitable sharing. If pharmaceutical companies sent researchers to the Amazon and found tree bark that had properties from which they could develop a new drug, what does Brazil get out of that?

This episode with H5N1 started a long period of negotiation, debate and dialogue in the global health community to try to figure out the proper balance of access and benefit sharing. How does this work when we are collectively trying to fight disease? This dialogue led to the Pandemic Influenza Preparedness (PIP) Framework, and subsequently to years of negotiating Standard Material Transfer Agreement between the WHO and pharmaceutical companies under PIP.  

We have rules of governance that have emerged around this area, but there's also a tremendous amount of confusion, particularly at the individual researcher level. It is not easy to get people who have been doing infectious disease research for a long time to think about what it actually means to negotiate a material transfer agreement. Can you take samples out of a country? What does benefit sharing actually look like? Is it always monetary? Is there something else going on? So it is very complicated and again, not headline making stuff, but  these details  impact how effective your research can be.

VI: Did this prepare the global health community for the COVID-19 outbreak. Did people say, "Yes, this is what we've been expecting, and this is what we should do."

Rebecca Katz: Well, my hesitation in answering that is because there are a couple of things going on. First, for those of us who have been working in this space of global health security and pandemic preparedness, if you had asked any of us at any time over the last decade what we were most worried about, the answer almost uniformly would have been we were most worried about a respiratory virus, either novel influenza or novel coronavirus.

When a novel coronavirus emerged with the potential for sustained human to human transmission, I think the entire community stood up and got really nervous. Did we know this was coming? Yes, in some ways. Was this the thing we were worried about? Absolutely. But  whether all of the work that has been done to date, to build regimes for global governance of disease, to build networks and to build the policies, procedures, supplies, training,  whether all of that sufficiently prepared the world for COVID-19, I think that's a different question.

VI: Are all of the people working on these issues somehow related to the WHO? Was the WHO always in the lead and were there other groups that needed to step up?

Rebecca Katz: First of all, it's not a very large community. In fact, in June of 2019, we organized the first International Scientific Conference on Global Health Security. We had a little over 900 people from around the world who came and were engaged in 400 presentations. Now I assume when we hold the next one our community will have grown a little bit, but it is a pretty niche group,  and it is more than just WHO. 

The main treaty that governs public health emergencies is the International Health Regulations and that is a treaty whose secretariat sits in the WHO. The treaty was negotiated by the World Health Assembly and was concluded under the authorities of the WHO constitution. In that respect, yes, the WHO is the main entity.

In recent years it is becoming very clear that any major public health emergency was more than just a public health emergency -  that, by definition, the threat quickly became multi-sectoral. We saw this in West Africa with Ebola, we certainly saw this in Ebola in the Democratic Republic of Congo.There was an emerging consensus, not regarding what to do about it, but an emerging consensus that these complex public health emergencies and outbreaks are more than just the WHO should handle. We needed a larger governance structure for them. There hadn't been any clear agreement on how to change that governance structure or what entity within the UN structure should be the overseer. There had been proposals, but nothing had come about.

In addition to the WHO, there's the entire humanitarian response community, there's  the Medecins Sans Frontieres (Doctors Without Borders) of the world, the clinical response folks, the researchers from the private, as well as from the public sector. When we think about the actors, drivers, and frameworks in this space, those actors included all the large philanthropic organizations that were having a large influence in the global health arena - like the Gates Foundation and the Wellcome Trust -  and then all the other IOs and International NGOs. The World Economic Forum, and the World Bank were becoming a major player in the space and organizations like CEPI (the Coalition for Epidemic Preparedness Innovations) that evolved from Davos to look at how to build medical countermeasures, to GAVI, to the Global Fund for AIDS, TB, and Malaria, all played in a larger health security space. Again, a lot of different organizations and entities that were trying to figure out how they all could work together.

VI: In addition to the work you've been doing in global public health, you also were involved with the Biological Weapons Convention. Are the lessons from that experience useful in this pandemic or is there a different mindset when you're dealing with biological weapons threats?

Rebecca Katz: My work with the Biological Weapons Convention, the BWC, for the last 15 years has primarily been as an expert consultant to the U.S. Department of State. I supported the U.S. delegation to the BWC for many years and only in the last year and a half have my efforts shifted more to my academic work and thinking about the type of research that we're doing to support the BWC space.

I can say that in some ways the BWC and global health worlds are separate communities, but in other ways, there's a lot of overlap. Where there is overlap is Article VII of the Biological Weapons Convention which is focused on preparedness and response. The text of that article is that states parties have an obligation to come to the assistance of other states parties in the event of a violation of the treaty. What does that actually mean? It means if a biological weapon has been unleashed on a society that other countries would help and help, primarily meaning preparedness and response. How do you respond? How do you support the humanitarian response? How do you do an attribution investigation? How do you come to the aid of the victim country?

Over the last almost 10 years, the dialogue around Article VII has shifted with the understanding that, if there was to be a deliberate biological event, it would be very hard to differentiate a deliberate event from a naturally occurring event, at least in the early days of an outbreak. The types of capacities that are  required to be able to detect and respond would be very similar to what you would need for a naturally occurring outbreak.The BWC discussions around Article VII, which are sometimes linked to Article X, which addresses cooperation and assistance, became discussions around how to build sufficient capacity to be able to prevent, detect, and respond to public health emergencies, regardless of origin.

In that space, there is a lot of overlap and there's been a lot of interesting discussion over the last decade focusing on that kind of capacity building. One of the projects that I was fortunate to work on, while still at the State Department, was looking at the West Africa Ebola outbreak. We asked the question, if there had been a deliberate component of the outbreak, what would have been different? We've actually spent a lot of time studying and investigating that and what parts of the normal outbreak response infrastructure fall apart when there is a deliberate component. 

VI:  Address the idea of capacity and response. That seems to be exactly what was lacking in the COVID-19 situation where there weren't enough masks or testing equipment. Is that a failure to live up to the ideals of the Biological Weapons Convention, when they talked about capacity building?

Rebecca Katz: I'm not sure it's a question of living up to the ideals of BWC, but instead living up to the ideals of the IHR. Under the International Health Regulations, all countries are required to have public health infrastructures and to be able to prevent, detect, and respond to a potential public health emergency. This is a treaty that entered into force in 2007 and there's been a monitoring evaluation framework in place since late 2010 that tried to identify a series of metrics to help countries figure out what exactly their capacity should be to be able to prevent, detect and respond to a potential public health emergency.

That monitoring and evaluation framework has evolved over the years. It now has 19 indicators, and 49 different actions and there was a pretty robust process in place for measuring these capacities around the world. In addition to the formal M&E framework under the International Health Regulations, there were also academic efforts to try to score country capacity. There is something called the Global Security Index that had been put forward by NTI, Johns Hopkins and the Economist. There were also lots of different research teams that came up with their own epidemic preparedness indices.

What I can say as a result of the ongoing COVID response is that either we were measuring the wrong things, or we were looking at the right things and measuring them the wrong way. I think one of the other things that has been difficult to get our heads around is that, for years, the public health space was separate from the health care space. The International Health Regulations never touched on health care but we've learned over and over again, certainly with this COVID response, that you can't actually have a response to an outbreak without a functional health care infrastructure.

VI: With the COVID-19 pandemic spreading around the world, the UN and the European Union are asking for global cooperation when it comes to funding and sharing research to develop COVID-19 vaccines and treatment methods, and also to ensure their wide distribution. The United States is refusing to be part of this cooperation. Before the onset of the pandemic, was there sufficient international cooperation on important public health issues or was that always lacking?

Rebecca Katz: There was a lot of dialogue around global cooperation and collaboration but it was a bit of a house of cards. It was not shocking to me to see countries nationalize their supplies. It was not shocking to see countries quickly close their borders in violation of Article 43 of the IHR. I think there are some things that we hoped wouldn't happen, but many of us secretly feared might. That being said, you talked about the U.S. not necessarily being a player in this global effort of the WHO solidarity trials. Neither is China.

It’s been difficult for those of us who have devoted our careers to trying to strengthen these systems to watch them fall apart. To see the geopolitical challenges creeping into the space at a time when collaboration and cooperation couldn’t be more important.

Once there is a vaccine and diagnostics and antivirals, there are very difficult decisions that are going to have to be made around who gets them and whether to charge a fortune for access to a life-saving vaccine or not. There are statements now from the Elders and from political leaders around the world to make all diagnosis treatment and supplies free of charge.

There are also intellectual property issues that will need to be addressed. Lots of high stakes considerations swirl around this and whether the WTO gets involved. It's going to be interesting to watch.

VI: Over the years there have been successful global vaccination programs that have reduced or eliminated serious diseases such as smallpox, polio, and measles. Were these vaccine programs a result of international organizations like the WHO or individual country’s health departments making sure that these vaccines were distributed and their populations properly inoculated?

Rebecca Katz: Well, each disease is a little bit different. The polio eradication effort is still underway and actually threatened by the COVID response. I think we'll probably be moving backwards. It is an effort that's really been pushed forward by two non-governmental entities, Rotary International teaming with the Gates Foundation.

Those organizations have made a massive push, but it can't be done without national cooperation and collaboration - those organizations working with some of the IOs and through the WHO but then also with the collaboration of individual countries, and the people who, in some cases, put their lives at risk every day to go out and try to vaccinate people.

There have been seven eradication campaigns in the last century - hookworm, yellow fever, yas, polio, guinea worm, and then malaria and smallpox. Of these, only smallpox has been successful to date. In many of these campaigns, it is a combination of the actors, the funding, and the science. It doesn't work unless the science works. There's been different approaches, whether it's been top-down or bottom-up.

Success is often dictated by the level of national engagement, and there are lots of different strategies for thinking about how this can be done effectively. In the case of smallpox, what made it possible was no non-human disease reservoir so there's no carrier state. There were effective tools for surveillance and prevention. Then you had technical factors - there was a stable vaccine that could be applied,  research, to improve community-based surveillance, and there were a set of diplomatic factors.

Specifically, there was support at that time from both the Soviet Union and the U.S. There was a political will, even though there were actually limited resources, which meant that the campaign was dependent on those small, highly trained technical teams that worked within local health systems. There was very little top-down management, empowerment of local personnel, and engagement of local decision-makers. I think we can say, in terms of what a successful campaign looks like, it is this combination of political commitment and leadership and having something that's technically sound and viable, along with surveillance and quality control.

VI: Vaccine programs, certainly, are significant in any public health consideration. However a recent opinion piece by Stuart Blume in the New York Times titled “The Global Fight Over Vaccine” makes the point that vaccines take up enormous resources and there are other tools that public health systems can use to save lives.  He talks about a convention that was held in 1978, where public health officials came from around the world, and there was a lot of sentiment that socio-economic issues should be part of the discussion - clean water, safe working conditions, things that promote broad public health. That sentiment was rejected in support of vaccines by developed countries with pharmaceutical companies that could produce vaccines and distribute them for profits. What do you think of the trade-off of vaccines versus other public health socio-economic programs?

Rebecca Katz: Wouldn’t it be nice if we didn't have to do a trade-off? But that’s the problem in public health. Every single person in the world is now focused on the pandemic. I think a lot of people are asking questions like, why haven't we done this? Why haven't we done that? What about this? Why aren't you applying this methodology? 

The reality is we've been operating in a field that's been grossly underfunded and neglected for a very long time. Well, let me rephrase that. We saw from about 2000 to 2010 an enormous increase in resources for global health. Even with that, we are in a resource-constricted field. I would love to not have to choose. I would love to be able to say that yes we should focus on clean water, and basic access to care and environmental conditions, and making sure everybody has an education, and all the factors that every academic who has ever done a regression analysis can tell you is linked to good health outcomes.

We know these things and we also know that vaccines save lives. We know that certain vaccines are easier to distribute, certain vaccines have higher herd immunity. We know all of this, and I would love to be able to get to a point where we don't actually have to prioritize and say which life do we want to save today?

VI: Speaking of the resource problem, you mentioned different organizations that have gotten involved in developing new drugs to treat malaria, TB and HIV/AIDS and other diseases. Groups like the Bill & Melinda Gates Foundation and NGOs. What role do you think these kinds of organizations will play going forward?

Rebecca Katz: Hopefully, the same roles, if not greater, than they have already been playing. The Bill & Melinda Gates Foundation is one of the largest contributors to global health in the world right now. They're the second-largest contributor to the World Health Organization behind the United States. Now that the United States is  pulling it's funding, it will be the largest contributor. There are large philanthropies all over the world that are really contributing to better outcomes and global health. The challenge is they set their priorities. They have a lot of money so they can decide how they want to spend it and they can prioritize based on what they care about which is not always exactly the same as what the Member States themselves care about.

From the Bloomberg Philanthropies and Welcome Trust and the Gates Foundation and all the other philanthropic organizations that are supporting this cause, to national governments prioritizing public health, to the work of the development banks, there are lots and lots of different organizations who all have an opportunity to contribute to improving global public health outcomes.

The other huge area for opportunity is the private sector. The global health community is dipping its  toe into the waters of public-private collaboration, partnerships, but hasn’t really figured out the best way to operationalize them. There's clearly all the work that pharmaceutical companies do, but how do you use the fantastic technology of organizations like Mastercard? We've seen examples of this in certain situations but it'd be great to figure out how to truly build on new technologies and supply chains and integration with the private sector to enhance global health around the world.

VI: What should be the coordinating body for this? If you have private corporations, the large foundations, the academic community, and then the state-sponsored public health ministries how do they come together to build a sustainable and effective global public health sector?

Rebecca Katz: To date, the only entity that we have to really coordinate that effort is the WHO - and we can spend hours arguing over where their faults are and what they've done well and what they have not done well. There are certainly calls for new institutions but I think that we should focus on how to strengthen the one that we have. 

VI: Is the WHO hampered by being in the UN system which is now so polarized because of superpower rivalries that little can be accomplished? In fact, the WHO seems to be one of the main focal points of conflict between the United States and China due to the COVID-19 outbreak.

Rebecca Katz: Well, I think the WHO suffers from the same challenges that any other member state organization does and the balance it has to strike between being a member state organization and also trying to provide impartial validated evidence.

VI: COVID-19 is  disproportionately impacting  populations with pre-existing conditions like heart disease, diabetes and hypertension, diseases often found in minority and poor communities where access to health care is limited. Is there a possibility that the COVID-19 pandemic will bring to light vulnerable populations and the weaknesses in public health systems?

Rebecca Katz: Sure, absolutely. I think that this is just one of many situations where access to care and other economic disparities influence health. Unfortunately, we absolutely are seeing certain disparities influence the outcomes in some populations. Whether it's the unacceptably high number of fatalities in the African American community throughout the United States or the variation in Brazil between the outcomes of the rich and the poor in the favelas or just in general challenges with access to any type of healthcare around the world and where there are significant comorbidities. The COVID outbreak is certainly shining a light on this and I am hopeful that this will be an opportunity to start to address some of the more systemic issues that contribute to these inequalities.

VI: We're coming to the end of our time - I do appreciate this conversation and the public health insights you have provided. Let's try to conclude on the hopeful idea that, at the conclusion of this terrible pandemic, perhaps we'll have new insights and greater motivation to effectively address public health  and create institutions and methodologies that can promote resilience from these kinds of catastrophic events globally.

Rebecca Katz: I hope so and I think if we can try to find any good in any of this, as I mentioned before, every smart person in the world is singularly focused right now on the pandemic. I fully expect that we're going to see a tremendous amount of innovation and thought and new ideas to get us to a better place.

Dr. Rebecca Katz is a Professor and Director of the Center for Global Health Science and Security at Georgetown University Medical Center. She teaches courses on global health diplomacy, global health security, and emerging infectious diseases in the School of Foreign Service. Prior to coming to Georgetown in 2016, she spent ten years at The George Washington University as faculty in the Milken Institute School of Public Health. Since 2007, much of her work has been on the domestic and global implementation of the International Health Regulations as well as global governance of public health emergencies. She has authored over 80 peer reviewed manuscripts, and three books in addition to numerous op eds, blogs, white papers and book chapters.  From 2004 to 2019, Dr. Katz was a consultant to the Department of State, working on issues related to the Biological Weapons Convention, pandemic influenza and disease surveillance.