At the centre of the international response to the COVID-19 pandemic was a set of public health obligations called the International Health Regulations (IHR). The IHR is a legally-binding instrument designed to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide. They include specific obligations for the World Health Organization to declare a public health emergency of international concern if certain thresholds are met.
This week on Contain This we talk to Australian Assistant Professor Alex Phelan who has made the IHR her area of expertise at Georgetown University in Washington, D.C. Alex is an Assistant Professor at the Center for Global Health Science and Security at Georgetown University Medical Center, and also Adjunct Professor of Law at Georgetown University Law Center. In this episode, she talks to Australian Ambassador for Regional Health Security Stephanie Williams about what went wrong with the response to COVID-19 and outlines some proposed changes to strengthen international public health law in the future.
Our conversation also celebrates the phenomenal Australian women working in public health in the Indo-Pacific and around the world. It’s always a pleasure to meet remarkable women like Alex, making important contributions in her chosen field. We hope you hope enjoy the conversation and follow @CentreHealthSec.
Ambassador Stephanie Williams 0:02
Welcome to Contain This. I'm Stephanie Williams, Australia's Ambassador for Regional Health Security. Today we present the first of two episodes of Contain This to celebrate International Women's Day this year.
As the world enters the third year of the COVID-19 pandemic, countries are grappling with the question of how we can reform our global health frameworks, rules and laws to respond more quickly and more effectively to health emergencies.
Dr Alexandra Phelan, currently based at Georgetown University in Washington D.C., is the Assistant Professor in the Center for Global Health Science and Security and an Adjunct Professor of Law at the Georgetown Law Center.
Dr Phelan is steeped in global health law, has deep expertise in the international legal and policy aspects of infectious diseases, including in the international health regulations.
In 2020, Alex co-authored a paper for the Independent Panel on Pandemic Preparedness and Response, it was called International Health Law and Perspective. That paper informed the panel's considerations of what the future could look like for global health law. That's what we talked about today. Hope you enjoy.
Alex, thanks for speaking with me today. Can you tell us a bit about your current role and what led you to global health law working in Washington, D.C.?
Dr Alexandra Phelan 1:31
I'm an assistant professor at the Center for Global Health Science and Security at Georgetown University Medical Center, and also Adjunct Professor of Law at Georgetown University Law Center.
I work on the international law and governance of infectious diseases, particularly epidemics and pandemics. And I come from a background of both biomedical science and law and then specialising in international law.
I worked for a few years in a law firm, and then wanted to find a way to bring my passion together. And I had spent some time at WHO and was offered to come and do a PhD here at Georgetown University that I'll be honest, I didn't really know much about at the time. And I was fortunate enough to get the General Sir John Monash scholarship, that could let me go anywhere in the world. And so I followed up to that invitation and came to Georgetown, with Professor Larry Gostin, the world leader in global health law. And that was nine years ago. I intended to only be here a couple of years, but it's, it's been a wonderful, wonderful nine years.
Ambassador Stephanie Williams 2:40
So nine years ago, it was a smaller field than it is now - the interest in global health and law. What was happening in infectious diseases in the world nine years ago that made you so interested in this?
Dr Alexandra Phelan 2:53
So I actually did my undergraduate law thesis on a piece of international law called the International Health Regulations. And I was interested to see how Australia, given that we don't have a Bill of Rights or, you know, constitutional Bill of Rights, how could we implement the human rights protections under that new piece of international law, given that we also have a lot of interest in biosecurity and global health security in the region.
And so that kind of started my love story with the International Health Regulations and with that piece of international law. And I think for me, I've always been trying to find ways to weave together my different interests. I spent a lot of time growing up in China and speak Mandarin. And so for me, there was all these overlaps that kept coming up. In my final year of high school, there was the SARS epidemic that interweaves my interest in infectious disease and China and international law. And that led to the adoption of these, that piece of international law, the International Health Regulations. And so it kind of feels like a natural pathway where everything has sort of woven together to get me to where I am today working on this full time.
Ambassador Stephanie Williams 4:01
So you mentioned the International Health Regulations and my exposure to that is on the practitioner side, both working for a country that has signed up to the International Health Regulations and undertaking reporting and sharing information. But also on the WHO side of receiving those notifications. Can you boil down for us what the essence of those regulations are, and then what some of the reviews and evaluations of how they functioned in the pandemic are saying to us?
Dr Alexandra Phelan 4:33
So these regulations actually have over 170 years of history. In fact, they are perhaps one of the first examples of countries coming together to solve a health problem. And at their heart, they're about countries sharing information and telling each other when there is an outbreak that could potentially impact other countries, balanced with a general attempt to ensure that there isn't interference with international trade and the movement of people. And so in the mid 19th century, you had the Industrial Revolution and steam ships and steam trains all crossing borders. And so if suddenly, a whole ship was quarantined, that had huge economic implications. And we now know what that is like, having lived the last two years. And so these these laws tried to balance that.
And when they were updated at the beginning of the millennium, after the SARS epidemic, they were expanded to be much broader than that. And they were about building up public health capacities in countries around the world. So that countries could prevent, detect and respond to infectious disease threats, but also all hazards all types of health threats, so not just infectious diseases. And so really this piece of law is our framework for building up global health security capacity in countries whilst also the very beginning stages of detecting and notifying each other about an outbreak.
Ambassador Stephanie Williams 6:00
How does an international law actually help capacity building in a country say, in our region in Fiji or in Timor Leste?
Dr Alexandra Phelan 6:11
So the first part is it helps set establish minimum standards for countries to assess their capacities against. So you know, do we have labs that can conduct tests to determine if we have a particular infectious disease? Do we have a healthcare workforce that can, can respond and help during an emergency and work during an emergency?
And so there's that real practical side of the IHR in terms of building up certain public health strengths. And the international law is one way of setting those obligations to require that all countries around the world meet those obligations. Because we're all so interconnected, and so interdependent on each other's public health capacities, that one way of ensuring that and protecting that is through a piece of international law.
And what makes these this law so special, is it's one of the very few examples that we have anywhere where countries actually have to opt out. So rather than most treaties, where countries go through the process of signing and ratifying, which means that you know, you probably won't get every country on Earth, the founders of the WHO deliberately created this power, so that we could rapidly update with technical knowledge, and also make sure that everyone in the world was meeting the same minimum standards.
Ambassador Stephanie Williams 7:30
So the IHR have the standards and requirements for countries, when they were revised, they also changed some of the expectations and of who, what they do in an outbreak. Can you talk about what WHO is bound to do by the IHR, and about how that reporting process was reviewed in the early stages of the pandemic?
Dr Alexandra Phelan 7:58
Yeah, so it's actually a great example, is, so WHO have a whole range of obligations that the member states that countries have assigned to it. And that is when they receive a report from, say, a non state source or from the media, or from a country that isn't a WHO member, that they actually have to go and verify it, first, they have to check with the state and they have to follow it up. So that was a big change from the SARS epidemic, where WHO could only act on reports that it was given by by a state by member state.
So we actually saw that - I was involved is in the independent panel on pandemic preparedness and response. And one of the things that we found in a chronology that we published in The Lancet was that there really was a bit of confusion of between who at the HQ, and then at the regional levels, about this follow up. And we're only talking between six and 48 hours in terms of confusion, but we know that every every moment was counted, and is now being, you know, scrutinised, looking back. So that was a situation where they'd received reports from the media from, from other countries. And, you know, it really, really was an opportunity to start that information gathering a lot earlier, in the absence of a formal notification.
There's also a really unique power that the WHO Director General has, and that is when there has been a report, either through from another source or from a country of a potential public health emergency of international concern, they can convene an emergency committee, which is a committee of experts, that's convened for each outbreak, and they can then determine whether the conditions for a public health emergency of international concern have been met. And the Director General can declare this PHEIC - that's the acronym - declare this PHEIC. And we saw on the 23rd of January, the WHO Emergency Committee met, and they couldn't come to consensus and unfortunately, a PHEIC wasn't declared. You know, I at the time, and as we were at the time, you know, I think that was a mistake. But a week later, on the 30th of January, the Director General did declare a PHEIC.
And really that is the main alert that we have, you know, there's been a lot of talk about declaring a pandemic. But there's that doesn't exist under this law. There's no pandemic declaration power. The power is, is declaring a PHEIC. And the reason is, is a pandemic is a failure of a PHEIC. A pandemic occurs when states don't respond to this call to action. And that's what we saw, we had a pandemic, because in particularly in February in that 30 days or so, after the declaration of a PHEIC, countries around the world didn't necessarily respond in the way that was needed to respond to the scale of the threat of what we're facing with a respiratory pathogen.
One of the challenges is, though, the IHR doesn't put any obligations on countries to respond in a particular way. They have to follow the advice of WHO generally, but that's not necessarily legally binding, if they want to put in place their their own measures, they just have to justify with WHO, why.
And really, the reality is, is there's a lot of things that we thought were not useful before the pandemics that we now know are very useful. So things like masks, our mask data was very poor beforehand, so it really wasn't a recommendation. Imagine if that had been implemented, you know, immediately around the world. Travel restrictions. We see the successes in New Zealand and Australia. And we see that travel restrictions coupled with strong local public health responses, like compulsory quarantine, which to be honest, it is probably the compulsory quarantine that actually was the key public health measure that made a difference for incoming passengers. And we know that there's a bit of nuance now about how travel restrictions could slow. And I say that as an Australian, who, you know, has been over here, stuck over here. I think there's nuance though, when travel restrictions are actually useful versus just punitive and discriminatory. So there's a lot there that we need to fix.
Ambassador Stephanie Williams 12:00
So when we talk about in the US call it a PHEIC, I call it a PHEIC, PHEIC, a Public Health Emergency of International Concern. I've seen some of your commentary and and other commentary around the lack of familiarity with what that actually meant at the time. So observations that countries didn't stand up with vigour the responses universally. But when we started to hear about a pandemic, behaviour changed.
Do you think with a better understanding of the existing mechanisms within the IHR, such as what leads to a PHEIC or Public Health Emergency of International Concern declaration, we can do better next time?
Dr Alexandra Phelan 12:49
So this is the hope right? We do hope that past experience informs future performance. And unfortunately, that doesn't necessarily play out completely. But I think what has changed is this has been a health issue that has now been elevated to the highest levels of government. Now, often, health ministers are the ones that are sort of reserved dealing with health crises and this is an example where we've had two and a bit years now, of something that's impacted all of our lives in in a whole wide range of ways well beyond beyond health. And so I think that level of political attention has the power to make a difference. And that's where I think proposals like the new pandemic treaty, that will be at that high level of government, potentially are an opportunity to use that political attention, political motivation, to take the steps that we need to so that when we are faced with the next threat, countries know how to respond, and they have obligations that they know that they need to fulfil, and they understand the scale of the threat that we're facing.
Ambassador Stephanie Williams 13:52
So if the IHR takes us up to a point of a declaration of a potential Public Health Emergency of International Concern, what areas are there for a treaty to legislate? What else needs to be governed or considered with an international legal framework?
Dr Alexandra Phelan 14:15
So I think the biggest issues that we have are equitable vaccine access. We have seen how inequitable the global distribution of vaccines, diagnostics and therapeutics have been throughout the pandemic. And that has been a creation of, of, in many cases, decisions by governments, either to, we saw the EU, for example, closing, closing exports, except for a very sort of select group. And that was because countries are going to want to prioritise their citizens' health. And you can see that they entered into these contracts to secure many doses, sometimes much more than their own population, to protect, protect their country.
The challenge with that is, is we know that not only is global equitable vaccination, a human right or an ethical obligation. But it's the only way that we're going to end this pandemic, because without stopping transmission, more variants could emerge. And there's every chance that a variant that emerges will undermine the vaccines that we currently have. So there's lots of reasons why ensuring equitable vaccination when we have a pandemic, or a public health emergency, is front of mind and is structured into the way countries act, and that we've put in place the resources beforehand that we can have that global supply of vaccines. So that's a really big one.
There's also the fact that, you know, as we're talking countries didn't necessarily know, or some countries didn't necessarily have at the highest levels of government care for what their obligations were under the current law. By having a negotiation at these highest levels, maybe putting in place mechanisms like the the COPs, the Conference of Parties that we see for climate change negotiations, we can have those regular meetings where countries are reiterating what you know what might have changed and technical standards, what has recently happened, and really building those norms of global cooperation for global health security. And so I think there's there's the broader governance question.
There are a number of other areas, and I will just list some of the topics is, is one health, so including animals and zoonotic risk, and that potential spillover infectious diseases. Potentially planetary health issues, so where we have land use change, that means that animals and humans are coming into contact or climate change increasing, we just had the IPCCAR6 six report, so the their assessment report number six came out this week that demonstrated that, you know, we do have this impact of climate change on increasing risk of infectious diseases in certain parts of the world. So, you know, we need to be thinking about all these challenges that we're going to be facing going forward that are way beyond the scope of what the international health regulations can do legally, but also were envisaged, envisaged to do.
Ambassador Stephanie Williams 17:01
So I want to come back to the vaccine question, but just on the treaty, or the instrument currently being discussed, through member state negotiations of WHO, do you see the IHR and a potential instrument coexisting? How does one relate to the other?
Dr Alexandra Phelan 17:23
Yeah, so I very much see these as as coexisting instruments. You know, the IHR, they they are quite limited in what they're supposed to apply to, we've kind of already stretched the limits of what they're supposed to apply to. You know, under the constitution of the WHO it's only supposed to be for international sanitary and quarantine measures. So we're kind of already at the limits there. So we have to have something for these other issues. There are a number of reforms that I think the IHR need, and I've been pushing for even even before the pandemic. And so the IHR have have a lot that they need to be updated and brought into the 21st century, even though they were adopted at the beginning of this century.
But at the same time, there are these much bigger issues. Pandemics are much, much more than just simply under knowing that they exist, they're much more than travel restrictions, and they our responses have to be more than travel restrictions. So I think a pandemic instrument whether it be a treaty or convention, whatever form it ends up taking, needs to also expressly acknowledge the IHR, you know, I think we need to make sure that there is there is cohesion between the instruments, and other areas of international law. And we can even be very express about that, you know, there have been suggestions that maybe the IHR becomes recognised as a protocol to the treaty, maybe we have other protocols that deal with specific issues. So we can get through the negotiations and don't get stuck on thorny points, but we make sure we resolve them with that political commitment.
Ambassador Stephanie Williams 18:50
So on the examples of areas to consider to legislate, if you will, under a treaty, you mentioned about vaccine access, what is the what is a law say about that? What are the words, and what changes as a result of putting that topic in an international legal framework?
Dr Alexandra Phelan 19:14
So there are lots of ways you can regulate an issue, right, the first would be say, direct regulation. So you could actually directly say, and have an obligation that countries will not impose export restrictions on vaccines, except in these circumstances, or except subject to these particular conditions. So you could have that, that direct prohibition, you know, countries will not enter into advanced purchase agreements with a with a pharmaceutical company unless it satisfies these conditions, you know, for example, a minimum percentage of production for distribution globally.
You could put in place regulations, you can put in place procedures to start building capacities around the world. So you can indirectly regulate how vaccines are available, and how they're being distributed by building up regional capacities. And, you know, there's there's some smart ways you could do it. For example, where are the countries in the world that have low populations, but vaccine manufacturing capacity, that they would very quickly satisfy their domestic supply, and then be available to produce for for regions. So there are just two examples there.
We can get into more complex examples and an example of that we've seen with COVAX, which is a mechanism for distributing vaccines for everyone coming in to purchase, to financially support the development of vaccines and purchasing the vaccines through a mechanism that equitably distributes those vaccines say based on population or public health need. And so you can create these governance structures that facilitate more equitable vaccine distribution. And so they're just, they're just three snapshots of how you could approach it. And, you know, there's a range of different ways beyond that the would also be available. So minimum standards, procedures, governance and norms, kind of a four pronged way you can you can try and address these issues.
Ambassador Stephanie Williams 21:15
I'm interested in the idea that, and I know, it's an just an example that you've given, that a member state or a country might pre-agree to, in entering into an advanced purchase arrangement allocate a certain percentage for the global good. Have you tested that idea in, has an idea been tested in forums? It seems to me a very noble and good idea. When we look back at the practice of advanced purchase arrangements, what we were actually seeing is countries who could afford to make a bet on multiple technologies, none of which were proven, were they had the spending power to hedge their bets on technology, versus another narrative about intending to buy five for one. And I think that distinction is really important, because it was about the purchasing power to back the science, which, which is important.
Dr Alexandra Phelan 22:29
Ambassador Stephanie Williams 22:30
So what do you think of the outer limits of that area of negotiating technology purchase that a treaty or an instrument might come up against quickly?
Dr Alexandra Phelan 22:43
So, you know, I think that I think there's a reality that states are fundamentally, if they're democratic, they do have a primary responsibility to protect their citizens health, or the people in their country's health. And so, you know, we need to realise that countries will be trying to go, trying to do everything they can, using not just financial power, but political power and legal power. So you know, not entering into indemnity arrangements and things like that. So I think we need to pre-empt that in the approach that we take. And we need to acknowledge and not acknowledge that these are realistic things that will happen. So whether it be we pre negotiate these template agreements, whether it be we set up a mechanism that allows for rather than using money to hedge bets through advanced purchase agreements, we use a mechanism where we everyone pools their money and there are multiple candidates all funded at once through sort of the leverage of that corporation, and use the benefit of pooling our resources, financial technical legal into one place. That then means that you know, you haven't picked the wrong horse in the race, that it actually is more efficient for you to be involved in that process.
Ambassador Stephanie Williams 23:57
You've done some thinking about influenza preparedness with a similar theme. Can you talk about what has been negotiated for influenza pandemic and vaccine access?
Dr Alexandra Phelan 24:08
So there's another piece of international law, it's non-binding, but it's pretty persuasive. It's called the Pandemic Influenza Preparedness Framework, the PIP Framework. And what it does is it essentially sets up a similar regime to what we've been talking about that pharmaceutical companies enter into contracts with the WHO to reserve a certain percentage of their production in the case of an influenza pandemic. So we asked, well, why would they enter into these contracts with WHO? Well, there's seasonal influenza. And for seasonal flu, pharmaceutical companies need that constant supply of access to pathogen samples, which is a system that the WHO, for influenza runs a system that shares the samples. And so if a pharmaceutical company wants to get access to a sample that it needs to produce seasonal flu vaccine, it will enter into this agreement. So it promises that when there is a pandemic under a legally binding contract, it will, when it produces pandemic flu vaccines, it will provide these to the WHO or for purchase, either donation or purchase at lower prices.
Now, we haven't actually tested it. That came into force in 2011. Not into force but it was adopted in 2011. And so we haven't had, thankfully, a pandemic flu. But there have been calls that maybe that this is some form of model that we can think of, for the sharing of pathogens and sequences, and then that equitable distribution of vaccines, therapeutic therapeutics and diagnostics, you know, it's not perfect, and I don't think the perfect should be the enemy of the good. I think it's a it's a first step for us to take in building what we might want for coronaviruses more broadly or for other epidemic or pandemic potential pathogens.
Ambassador Stephanie Williams 25:54
2022 is going to be a beginning of a long journey in the negotiation of a potential new global health law, let's call it that. Where do you think we'll get to by the end of the year, based on what you're observing in these processes? And could you also comment on, as an academic and part of civil society groups, the role that your sector can play in these discussions? So a bit of a prediction, and a bit of participation question.
Dr Alexandra Phelan 26:29
So, you know, this high-level political commitment, we want to, we want to capture this political momentum and let it move towards a pandemic instrument of some form. But if you bottle it, so rather than capture it, if you bottle it, then we can run out of steam, we can, we can lose that momentum on trying to get a treaty. I think that is a very real risk, given how exhausted everyone is and for very many reasons. So you want to use that momentum to to negotiate these really tough issues and get consensus on issues where there are ideological differences.
The real risk is, though, if that drags on too long, you lose that political commitment and that momentum. So it's going to be a careful balance between the level of detail and solving the issues that we need to solve, and, and keeping that political interest. That's tough. And I think ideally, the timeline that we have at the moment, which is an instrument by 2024, with, you know, a draft this year, to then work on and negotiate over a year is an ambitious timeline. I do think it's possible, right now. Things could change in the world that makes negotiating a pandemic treaty, deprioritised. But I hope that this stays front of mind, we don't see the sort of loss of energy that we've kind of seen in pandemic response generally also apply to the treaty.
In terms of participation, there are a range of civil society groups that have official status with WHO and are involved in observing and the different negotiation bodies, meetings and sessions. But you know, I really do believe that this is an opportunity for greater civil society participation. I think that there is a real risk that if we don't have that participation, we lose the the authenticity of what we need, we also lose the persuasiveness and the power of the treaty. And because we know that civil societies have been so involved in pandemic response, and so I think that's an area for improvement. I think gender representation on the negotiation body is another area for urgent improvement. So there are places where I think civil society can have a really important role. And, you know, countries should realise that civil society are going to be critical for implementing any any treaty and its success.
Ambassador Stephanie Williams 28:48
I'm so enjoying this conversation, and I promise this is my last question. A, the instrument, whether it's a treaty or not, sounds like it needs to be opt in rather than opt out like the IHR. Is that correct?
Dr Alexandra Phelan 29:05
So I think there it is the most likely of what we're going to have, we're going to have a there's a particular provision in the WHO constitution for a classic treaty that will be opt in. And I think that that is the the most likely avenue we go, there have been there has been some talk of using the same power as the IHR, to have have an opt out instrument. Now the challenge is, the more binding instrument appears to states, the less likely they will want to be automatically bound. So if we want a strong and rigorous pandemic treaty, we're more likely to go under Article 19. Even though an article 21 instrument is just as legally binding. I think there's there's sorry, an article like the IHR, just as legally binding. I think both options are still on the table, but the most likely is absolutely as an opt in, opt in classic treaty.
Ambassador Stephanie Williams 29:58
Would you hazard a guess of the 192 member states, what would be enough to opt in for a treaty?
Dr Alexandra Phelan 30:07
You know, I imagine they'd probably set it quite high. They'd set the sort of minimum number of states before it enters into force quite high, you know, at least 80 to 100 potentially more. I think because global health is so used to such high participation in its treaties that will also be that by setting a higher standard, we'll be sending a message that this is something that all countries should should not have any pause to sign and ratify.
Ambassador Stephanie Williams 30:38
Like I said before, I’m so enjoying this conversation and I’ve got so many more questions I want to ask but I will stop for today and thank you for coming in close to International Women's Days and a successful Australian woman in D.C. to share some of your deep knowledge and and insight to the global health law that exists today and that might exist in the future with us. And I hope we can come back in and check in in about a year's time to see to see how this discussion relates to what's happening in March 2023 at least to begin with. Thank you, Alex.
Dr Alexandra Phelan 31:14
Thank you so much Ambassador.
Ambassador Stephanie Williams 31:18
Thank you for listening to this International Women’s Day episode with Australian academic Dr Alexandra Phelan, currently based at Georgetown University as an Assistant Professor in the Center for Global Health Science and Security and an Adjunct Professor of Law at the Georgetown Law Center.
The second episode in this special series for International Women’s Day will air tomorrow. I joined Beverly Kirk to record a special session about the impact of COVID-19 on women and girls. We hope you tune in.