The World Health Organization and COVID-19: How Much Legal Authority Does the WHO Really Have to Manage the Pandemic? by Dr Ayelet Berman

01/05/2020 with [3823 views] no comments

The World Health Organization and COVID-19:
How Much Legal Authority Does the WHO Really
Have to Manage the Pandemic?

by Ayelet Berman

1.      Introduction

The COVID-19 pandemic has placed the World Health Organization (WHO) in the defendant’s seat. It has been accused—mostly by the US but also by other countries—of having been unduly influenced by or too trusting of China in its response to the COVID-19 pandemic. According to these critics, the WHO should have called out China for more transparency , should have declared a Public Health Emergency of International Concern (PHEIC) sooner, and should have restricted trade and travel to and from China. President Trump has now gone so far as to halt WHO funding for these reasons. And on 20 April 2020, US citizens filed a class action complaint against the WHO before the US District Court, claiming damages caused by the WHO’s gross negligence in handling the pandemic.

Even if these criticisms are correct, they ignore two important points: First, the WHO is an intergovernmental organization and it has acted within the limits of the legal framework determined by its member States. This legal framework – the International Health Regulations (IHR) – does not grant the WHO inspection, policing or enforcement powers against its member States. This framework also purposefully includes the State from which the health threat has emerged in the WHO’s PHEIC decision-making process, creating legal openings for State influence on the decision and its timing. Second, the WHO’s work managing COVID-19 goes much beyond the IHR. It has a large, unsung regulatory role providing guidance and information to States and public health stakeholders. Developing countries lacking resources and capacity needed to respond to the pandemic are dependent on the WHO for such guidance. The WHO also has a critical role in coordinating and orchestrating the response to the pandemic among public and private health actors.

The purpose of this note, accordingly, is to clarify the WHO’s legal authority in managing the response to pandemics and enforcing action on its member States. It will further highlight the WHO’s important work as an international focal point of guidance, information and coordination.

The note first addresses the WHO’s authority under the International Health Regulations (section 2) and then the WHO’s regulatory functions (section 3). Section 4 concludes.

2.      International Health Regulations (2005)

The International Health Regulations (IHR) are the cornerstone of the international law for preventing the international spread of infectious diseases. They were adopted under Articles 21(a) and 22 of the WHO Constitution and are binding on all 194 WHO member States. Their origin is in the International Sanitary Convention (ISC), which was first adopted in 1892. The spread of infectious diseases such as cholera, brought about in the 19th century by the rise in international travel and trade, generated a need for collective action. The ISC thus sought to coordinate the pandemic response across nations. In 1969, the WHO’s World Health Assembly, composed of all member States, revised the ISC and renamed it IHR. Following a series of revisions, the IHR were last revised—after the SARS epidemic—in 2005. As I lay out below, the WHO’s legal authority in managing pandemics is very limited, and most authority remains with the States.

A.     Monitoring and Notification

The WHO has been accused of relying solely on the information provided by China. This raises the question: what is the WHO’s authority to compel China to monitor the health situation within its territory and notify the WHO of emerging threats? As set out below, States, not the WHO, are obliged to monitor the health situation within their territory, and to notify the WHO about any public health event within their territory that might develop into an emergency of international concern. The WHO’s authority to independently obtain information and to compel states to provide information is limited.

Article 5 of the IHR obliges States to develop and maintain the capacity to detect, assess and notify events in their territory that may constitute a public health emergency of international concern. Further, Article 6 determines that States ‘shall notify WHO… within 24 hours of assessment of public health information, of all events which may constitute a PHEIC within its territory…’. After this initial notification, the State must also ‘continue to communicate to WHO timely, accurate and sufficiently detailed public health information…’.

While the WHO ‘shall collect information regarding events through its surveillance activities and assess their potential to cause international disease spread’ (Article 5), the WHO does not have the authority to undertake inspections within the State. It also can’t compel States to notify it or provide information. That said, Article 9 determines that the WHO may take into account reports from ‘other sources’. But in such cases considerable power is left with the State, since the WHO must attempt to get a verification from the State before it shares the information with other States (Articles 9, 10, 11).

Even if China were to be found to have violated the IHR, the WHO has no formal enforcement mechanism. The World Health Assembly is the main oversight mechanism for assessing the functioning of IHR (Article 54), and disputes between the WHO and a State may be submitted to the World Health Assembly (Article 56(5)). But this mechanism is effectively obsolete during an emergency. The main accountability mechanism at the WHO Secretariat’s disposal, thus, is naming and shaming. It had used this against China following the 2003 SARS outbreak but has not done so for COVID-19. It is possible that China provided enough information to be considered cooperative. It is also likely that the WHO considered that using a soft approach would achieve better cooperation. Be that as it may, legally, the WHO has no enforcement mechanisms against its members.

B.      The Director-General’s Declaration of a PHEIC

The WHO Director-General has been accused of being too slow in declaring a PHEIC, because of being overly trusting of China. As we shall see, although the Director-General has the authority to declare an emergency, the procedure is designed such that the State from which the threat has emerged remains significantly involved in the decision-making process. Indeed, it provides an express opening for States to try to influence the process.

In the first stage, agreement between the Director General and the State is sought. Article 12(1) of the IHR states that ‘The Director General shall determine, on the basis of information received, in particular from the State Party within whose territory an event is occurring, whether an event constitutes a public health emergency of international concern…’. Yet when ‘the Director General considers… that a PHEIC is occurring’, rather than having the authority to declare as such, the DG ‘shall consult with the State Party in whose territory the event arises regarding this preliminary definition’. If the State party and the Director-General agree on this declaration, the Director-General may issue temporary recommendations (Articles 12, 15). This was likely among the issues discussed during the meeting on 28 January between Director-General Tedros Adhanom and President Xi Jinping, two days before the WHO declared a PHEIC.

But the State and the Director-General may not always come to a consensus. In such a situation, the Director-General has the upper hand and is not bound by the State’s position. Rather than declaring a PHEIC, the Director-General must then seek the views of the Emergency Committee, a committee of international experts. The Committee provides technical advice as to whether an event constitutes a PHEIC (Articles 12, 48). The State in whose territory the event happened is also invited to present its views, and the Emergency Committee provides its views to the Director-General. It is only after this process that the Director-General makes the final decision (Article 49).

Thus, although the Director-General has the ultimate authority to declare a PHEIC, the State from whose territory the threat has emerged remains—by design—involved in the decision-making process. When powerful States are involved, they will likely seek to influence the process in their favour.

C.      The Director-General’s Temporary Recommendations

Following the declaration of a PHEIC, the Director-General may seek the advice of the Emergency Committee and issue temporary recommendations to the State in whose territory the threat has emerged and to the other member States (Articles 12, 49).

The purpose of such recommendations is to provide guidance on health measures ‘regarding persons, baggage, cargo, containers, conveyances, goods and/or postal parcels to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic’ (Article 15). These recommendations are not binding, and States can adopt ‘additional health measures’ provided they ‘uphold the purpose of these Regulations’ (Article 3) and comply with the criteria set out in Article 43, if such measures significantly interfere with international trade and travel. These criteria include having a public health rationale and being based on scientific information.

Indeed, following the PHEIC declaration, the WHO issued temporary recommendations, including the advice (last updated on 29 February 2020) not to restrict travel or trade to countries experiencing COVID-19 outbreaks. Yet, as is well known, States and airlines have largely not followed this advice and have adopted measures that have significantly interfered with travel, such as denial of entry of passengers, quarantines for returning travellers and suspension of flights and more. Since States are not bound by the recommendations, such actions are in compliance with the IHR (subject to fulfilling the criteria in Article 43).

In what follows the note lays out the WHO’s technical and regulatory functions in managing COVID-19.

3.      Technical and Regulatory Functions in Managing COVID-19

While the declaration of a PHEIC raises political tensions, much of the WHO’s work in managing COVID-19 is of a rather technical or regulatory nature. The WHO’s authority for these functions are set in the WHO Constitution (Article 2) and the IHR. These functions are of a soft law nature and do not bind States or other public health actors. They have, nevertheless, considerable normative weight, especially for developing countries, who are dependent on the WHO for expertise, information and training. The WHO also has an important role in coordinating the response to COVID-19 among public and private health actors. Below is an outline of four of its main regulatory functions: Emergency Use Listing (EUL) procedure, guidance, coordination and capacity building.

A.     Emergency Use Listing Procedure

Given the vast number of medical products on the market, and the lack of resources and capacity in developing countries, it is practically impossible for such countries to review the safety, efficacy and quality of medical products themselves, especially in a time of emergency. The WHO has thus established the EUL procedure. This is an expedited process for approving new or unlicensed medicines, vaccines or medical devices that are urgently needed in public health emergency situations. For example, on 7 April 2020, the WHO, under EUL procedure, approved and listed two diagnostic tests for COVID-19. The WHO listings are not binding upon States, but developing countries rely on them to purchase quality-assured medical products.

B.      Guidance

In line with its general mandate (Articles 2, 23 of the Constitution) and the IHR (Article 13), the WHO issues a wide range of guidance addressed to government authorities, health workers and other stakeholders dealing with the COVID-19 emergency.

Technical guidance

The WHO issues technical guidance on preventing and managing COVID-19, covering a wide range of topics: from official naming of the disease (COVID-19) and the virus (SARS-CoV-2), a list of COVID-19 critical items, a COVID-19 Essential Supplies Forecasting Tool (ESFT),which helps governments and health actors to estimate potential requirements for essential supplies, to how to prepare and respond to COVID-19, how to clinically manage patients, how to manage ill travelers at international airports, ports and ground crossings, and many more.

This guidance is developed by public health experts and has normative weight. For example, the official names of the disease and virus have been widely accepted, and such shared language allows for better coordination. That said, the guidance is not binding, and States have applied different rules. For example, while the WHO advises ordinary citizens not to wear masks, a number of States, such as Singapore, has made it mandatory to wear the mask in public. Likewise, while the WHO had initially recommended against the use of ibuprofen in COVID-19 patients, the European Medicines Agency advised that ibuprofen could be administered.

Ethical guidance

When the Ebola epidemic emerged in 2014, there were no medicines or vaccines to treat the disease and there was an urgent need to develop new medicines. Such development is normally subject to ethical rules, but in emergency situations the speed of finding a new medicine is paramount. The WHO, therefore, developed ethical standards for research during emergencies, notably the 2016 Guidance for Managing Ethical Issues in Infectious Disease Outbreaks. One of the issues this guidance addresses is the use of unproven or experimental (‘off-label’ or ‘compassionate’) treatments. Indeed, to treat COVID-19, many doctors have been making compassionate use of malaria and AIDS drugs. It also issued the 2017 WHO Guidelines on Ethical Issues in Public Health Surveillance.

C.      Coordination and Partnerships

The WHO has a critical role in coordinating the global response to COVID-19, among international organisations, government authorities, health workers, the research community, and private developers and producers. It coordinates initiatives for the development, production and supply of diagnostics, drugs, vaccines and medical supplies. Such coordination is part of its general mandate (Articles 2, 70, 71 of the Constitution) and Article 14 of the IHR, which mandates the WHO ‘to cooperate and coordinate its activities with other competent intergovernmental organizations a or international bodies…’. From a legal perspective, these partnerships, networks and other initiatives bringing public and private stakeholders together are informal. Yet they are critical in mounting a rapid and flexible response to COVID-19. Below is a list of some of the main initiatives.

  • GLOPID-R: The WHO is an observer on the Global Research Collaboration for Infectious Disease Preparedness and Response (GLOPID-R), a network of research funding organisations that invest in research related to emerging infectious diseases. In February 2020, the WHO and GLOPID-R also held a global forum bringing together scientists, public health agencies, funders and the private sector pursuing research and developing diagnostics, vaccines and therapeutics for COVID-19.
  • WHO R&D Blueprint: The 2014 Ebola epidemic highlighted the absence of adequate coordination among the scientific and pharmaceutical community, which in turn caused huge delays in developing diagnostics, medicines and vaccines. The WHO, consequently, developed an R&D Blueprint that would improve R&D coordination (such as by setting up a Global Coordination Mechanism), accelerate R&D, and develop norms and standards in future infectious disease outbreaks (such as the Clinical Research During Outbreaks (CREDO) initiative, or standards for enabling transparent and fair research coordination and data sharing). The WHO has activated the COVID-19 R&D Blueprint and in March 2020 published the Global Research Roadmap.
  • Solidarity: On 18 March 2020, in connection with the R&D Blueprint, the WHO launched ‘Solidarity’, an international clinical trial involving 90 countries comparing the efficacy of the four most promising treatment options for COVID-19 (Remedesivir, Lopinavir and Ritonavir, Interferon beta-1a and Chloroquine). It aims to reduce the time normally taken to carry out randomised clinical trials by 80%.
  • Pandemic Supply Chain Network (PSCN): The WHO leads the PSCN, a public-private network (of 350 private sector organisations and 10 multilateral organisations) to drive the emergency supply chain and facilitate procurement of essential COVID-19 items in line with WHO guidance on essential supplies (such as diagnostics, personal protective equipment and ventilators). The PSCN acts as a market matchmaker facilitating connection between available supplies and demand, in particular for developing countries at risk.
  • WHO International Clinical Trials Registry Platform (ICTRP): In 2005 the WHO established a voluntary platform for the registration of clinical trials so as to ensure an international ‘single point of access and unambiguous identification of trials’, which would be open to the public. The ICTRP aims to provide a complete view of all COVID-19 clinical trials in the world.
  • The WHO collaborates with many other international organisations. For example, in the field of aviation, the International Civil Aviation Organization (ICAO) and the WHO issued a joint statement. The WHO has also developed aviation specific guidelines for COVID-19, in collaboration with the ICAO, the International Air Transport Association, the United Nations World Food Programme and other IOs. A further example is the International Chamber of Commerce–WHO Joint Statement.

D.     Capacity Building

Capacity building in developing countries is a central part of the WHO’s mandate (Article 2 of the Constitution), and in particular under the IHR with respect to pandemic preparedness (Article 5) and response (Article 13). For example, the WHO has been carrying out online training and exercises on preparing for COVID-19 and sending out special envoys to different parts of the world.

4.      Conclusion

The WHO is under attack for its treatment of China with the emergence of COVID-19 from China’s territory. The critics, however, have ignored the WHO’s limited legal authority to enforce action on its member States. The purpose of this note has, therefore, been to clarify the WHO’s legal authority. It has also sought to highlight the importance of the WHO’s technical role in managing the response to COVID-19.

This note has shown that the WHO does not have policing powers towards its member States. Its functions are of a soft law nature, and the WHO does not have legal authority to enforce action upon its member States. Inasmuch as the IHR oblige States to monitor the health situation and to notify the WHO of public health events in their territory that may constitute an emergency of international concern, the WHO does not have the legal power to compel them to do so, nor can it carry out independent inspections. Naming and shaming are potentially the main accountability mechanisms at the WHO’s disposal. Further, the State from whose territory the threat has emerged remains involved in the PHEIC decision-making procedure. Indeed, the IHR, by design, institutionalise conflicts of interest into the process. Powerful States will likely take advantage thereof.

This note has further highlighted that much of the WHO’s work in responding to COVID-19 is technical or regulatory: the WHO approves medical products, issues technical guidance, coordinates initiatives and builds capacity in developing countries. These activities too are of a soft law nature.

It may come as a surprise that an organisation from which so much is being expected has so little hard power. But with few exceptions, States — protective of their sovereignty — have historically been reluctant to give intergovernmental organizations control over their internal matters. The WHO is no exception and the IHR have been purposefully designed in this manner by the member States. This is understandable given that a PHEIC declaration can have significant social and economic effects on the State from which the threat has emerged. While such a declaration seeks to protect public health, its implications for trade with and travel to the affected State can—as COVID-19 vividly illustrates—be tremendous.

Sceptics might think that since most of the WHO’s work on pandemics is soft law, it is not important. That is by no means the case. The WHO’s recommendations and guidance have considerable normative weight, especially in developing countries. Lacking the resources and capacity to develop their own expertise, developing countries depend on the WHO’s information and guidance in managing their response to the pandemic. In our interconnected world, an uncontained pandemic in developing countries will rapidly affect other countries. Cutting funds to this already cash-strapped organisation in the midst of this crisis would undermine the response—for all of us. It is, indeed, for this reason, that the US funding cut has caused fear and drawn criticism, with Bill Gates, whose foundation is the WHO’s second largest donor, calling such funding cuts ‘as dangerous as it sounds’.

Finally, in the aftermath of this crisis, some States will likely seek to update the IHR. Proposed reforms might include strengthening the WHO’s inspection powers, reducing State influence on the Director-General’s decision-making, or instituting sanction mechanisms for violations. Such reforms would require States to give up some of their sovereignty and control. The adoption of these or any other reforms will, therefore, ultimately depend on political will and their implementation will depend on sufficient funding.