The Obligation of a State Party to Report Matters under

the International Health Regulations (2005)

Xiangqian Gong

Professor, Beijing Institute of Technology Law School

China

2020.06.26

I. Introduction

1. The obligation to report or notify has now become a procedural obligation under international law under some circumstances. In fact, the principles of international law, such as the no harm principle, the international cooperation principle, the non-discrimination principle and the prevention principle, and so on, show the common values of the international community in dealing with challenges in the fields of environment, health and safety, and provide a theoretical source for the development and practice of the reporting or notification obligation. Some scholars have pointed out that the procedural obligations such as notification, provision of information, and risk assessment provide the necessary foundation to address a common concern, although these broad rules could not guide all specific practices, and public health and environment are a pair of interrelated but different concepts in international law.

2. Since 1851, the international community began to seek prevention against the international spread of infectious diseases through international legal instruments, requiring: 1) States to report other countries of the outbreak of specific diseases; 2) apply reasonable restrictions at the entry and exit points of diseases (such as seaports and airports) (Neville M. Goodman, International Health Organizations and Their Work, 2nd edn, 1971, at 42–50). The objective of the traditional international health legal system is to minimize the interference of public health measures on international trade and travel, to make more transparent the information on disease outbreaks, to establish an international monitoring system for infectious diseases, and to coordinate national quarantine regulations, so as to facilitate member States to adopt appropriate public health measures for international transportation and passengers. Similarly, the International Health Regulations (2005) (IHR 2005) requires a State party to report to the World Health Organization (WHO)  public health events of international concern within its territory. However, since the adoption and implementation of the IHR 2005, every major public health emergency of international concern has caused controversy and suspicion about the international obligations. Therefore, it is of value to choose the reporting obligation as an example to interpret carefully the key global instrument for protection against the international spread of infectious disease.

II. Procedural obligation of ex-post notification

3. Generally speaking, international law provides two paths for the prevention of cross-border damage: first, “prevention in advance”, that is, prior to the occurrence of accidents and dangers, the risks are taken seriously through strengthening “risk management” measures, such as inspection and regulation of high-risk facilities or projects, to guard against the true occurrence; and, second, “control after the event”, that is, technical means and cooperation procedures are taken timely to minimize the impact of damage and loss after the accidents. At the level of specific institutional arrangements, international treaties mainly endow the contracting States with relevant procedural obligations. Among them, reporting/notification is the most important international procedural measure of prevention and control of transnational damage.

4. The notification obligation in international law could be divided into “prior notification” and “ex-post notification”. Under international law, the former includes “notification” for planned projects and “notification” as a “prior informed consent” procedure, while the latter mainly refers to the obligation of timely notification in cases of industrial accidents or natural disasters. Pandemics, to some extent, constitute a kind of natural disaster. On 13 April 2020, the Pennsylvania Supreme Court reasoned in part that “the COVID-19 pandemic is of the ‘same general nature or class as those specifically enumerated,’ and thus is included, rather than excluded, as a type of ‘natural disaster’” (Friends of Danny Devito v. Wolf, 227 A.3d 872 (2020), at 889).  Certain events that could develop into a pandemic have been required to be notified in international sanitary law since 1851.

5. According to Article 6 on “Notification” of IHR 2005, “Each State Party shall notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events.” From the wording of this article, one can see that the notification obligation is a kind of “ex-post notification”. On the one hand, IHR 2005 expands the scope of notification, that is, from historically limited to specific diseases (cholera, plague and yellow fever) to including “Public health emergencies of international concern” (PHEIC), which relates to all kinds of emerging infectious diseases; on the other hand, it provides a Decision Instrument as a reference for assessing the risk caused by the known diseases and newly discovered viruses, so as to guide States parties to judge whether a disease event may constitute a PHEIC (Annex 2 to IHR 2005, Decision Instrument for the Assessment and Notification of Events that May Constitute a Public Health Emergency of International Concern).

6. Under IHR 2005, the obligation to report imposed on the parties include the following five steps: 1) assessment obligation, i.e. each party assesses the events in its territory (Article 6, paragraph 1, sentence 1); 2) notification obligation, i.e., passing the assessment result of the disease event in its territory that may constitute  PHEIC to WHO within 24 hours, as well as the health measures to be taken (Article 6, paragraph 1, sentence 2); 3) subsequent reporting, i.e. the State Party shall continue to report to WHO in a timely manner the exact and fully detailed public health information after the first report (Article 6, paragraph 2); 4) obligation to share information: State party shall provide all relevant public health information to WHO, if there is evidence that a disease event is taking place in its territory that may constitute a PHEIC, regardless of its origin or source (Article 7); 5) obligation to verify information: when requested by WHO, each State Party shall verify relevant information and provide reply, confirmation, and health information within 24 hours upon WHO’s request (Article 10).

7. Although IHR 2005 does not clarify the interests or rights corresponding to a State party which must fulfill the obligation to report, we can infer them from the general jurisprudence on the relation between rights and obligations or between interests and burdens. First of all, since a State Party reports an epidemic or detects the virus at the first time has the obligation to inform the WHO of the event that may constitute a PHEIC, then, other States have the right to obtain information from WHO about the event relating to the PHEIC. As to whether the State has to directly inform other relevant Parties of the public health information, IHR 2005 does not address this issue. Second, if the State Party becomes the first to report or detect an outbreak fulfils the obligation of notification, other States should have the obligation to restrain their trade and travel restrictions in accordance with IHR 2005 and WHO’s relevant recommendations. Thirdly, because IHR 2005 only requires public health information to be notified and does not require the sharing of virus materials, the State Parties that obtain the relevant virus sequences and then successfully develop vaccines or drugs should, in theory, share them with the suppliers of virus materials. However, the rules of IHR 2005 distribute the obligations involved in global sharing of public health information among the various stakeholders, but have not achieved the balance between such obligations and rights, which is important to international health cooperation.

III. Notifiability assessment of the disease event

8. The IHR 2005 expanded the scope of disease notification. However, large or small cases of disease transmission occur worldwide every day, which makes whether parties should notify a controversial problem. Obviously, if a Member State reports a small and common disease event to WHO, it only causes unreasonable rumour and panic. Similarly, almost all of the international legal documents emphasize that only when the accident may cause serious transboundary damage, the contracting State where the accident occurs should bear the notification obligation, which results in the conflict between the time of “notification” and the premise of “notification”. For example, Article 1 of Convention on Early Notification of a Nuclear Accident refers its “Scope of application” to “an international transboundary release that could be of radiological safety significance for another State”. On the one hand, international treaties may require a country to notify other countries as soon as it learns of the event; On the other hand, when a State is just aware of the accident, but does not have sufficient information, it cannot decide whether the risk caused would reach the level of “international concern”.

9. During the revision of the IHR in 2004, WHO developed a “decision tree” to guide member States to determine the public health risks of international concern. As Professor David Fidler analyses, the current Decision Instrument (Annex 2 to IHR 2005) contains three ways for contracting parties to determine whether they should notify WHO: 1) if the disease event involves a case of smallpox, poliomyelitis due to wild-type poliovirus, human influenza caused by a new virus subtype, or SARS, it shall be notified to WHO; 2) if the disease event involves cholera, pneumonic plague, yellow fever, viral haemorrhagic fevers, West Nile fever or other diseases that are of special national or regional concern, then States parties must use the decision instruments to assess whether the event constitute a PHEIC; and 3) States Parties should apply the Decision Instrument to any disease event not falling under the other two pathways, for example the emerging infectious diseases or any other unknown virus (David P. Fidler, From International Sanitary Conventions to Global Health Security: The New International Health Regulations, 4 Chinese Journal of International Law (2005), 370-372).

10. Therefore, the first sentence in Paragraph 1 of Article 6 of IHR 2005 should not be neglected, as the State Party’s implementation of its notification obligations under this Article 6 depends on a domestic assessment of four issues: 1) Is the impact of the incident on public health serious? 2) Is this unusual or unexpected? 3) Is there a significant international spread risk? 4) Is there a significant risk of international travel or trade restrictions? Simply put, whether there is a serious public health impact is a big premise, while whether a major risk of international spread is a small one. In fact, there are discovery and detection procedures before this assessment, because the State that is to notify the outbreak needs to obtain sufficient cases and relevant information, as well as rigorous scientific tests such as virus separation and recognition. So, IHR 2005 only requires the notification as soon as possible (within 24 hours) after the assessment has been made, but not as soon as the first case is found or the virus is detected.

11. In the notifiability assessment, the State Party usually would encounter many practical difficulties, one of which is the scientific uncertainty caused by the emerging infectious diseases “not falling under the other two pathways” of the Annex 2 of IHR 2005. For example, the detecting and verification of COVID-19 experienced a gradual process of cognition as a new coronavirus, and concerned with the origin and transmission of the virus, the disease progression and lethality and so on. Long time investigation, research and experiment are needed to answer these questions. The unknown problems in scientific research or the differences of opinion among scientists will sharpen the discrepancies of views and uncertainties in science. These uncertainties include the possibility that objective stage scientific research results may be overthrown by follow-up research. Therefore, the media and even scientific research institutions often have to “refute their own rumors”. As uncertainty is an important reason for the public’s distrust in the government or international organizations, rigorous assessment is an indispensable part of the pre-processing of the notification obligation.

12. Since the Decision Instrument in Annex 2, which is not legally binding, provides only examples of assistance to States parties in their assessment, member States have the ultimate power to determine whether or not the event constitutes a PHEIC and therefore should be notified to WHO. Moreover, the wordings of the “where possible”, “as far as practical”, or “as soon as possible” in IHR 2005 (Articles 6, 9, and 13) show its “constructive ambiguity” as commonly used in international treaties. Hence, even if there is any inaccuracy and/or delay in a notification or report, that is not sufficient reason to conclude that IHR 2005 is violated. After this outbreak of COVID-19, China quickly provided detailed samples and gene sequences of viruses, epidemic stages and analysis reports of virus transmission routes, which has always been recognized and praised by WHO (WHO Director-General’s statement on IHR Emergency Committee on Novel Coronavirus (2019-nCoV), 30 January 2020, https://www.who.int/dg/speeches/detail/who-director-general-s-statement-on-ihr-emergency-committee-on-novel-coronavirus-(2019-ncov)).

IV.  Obligation to cooperate with WHO regarding surveillance

13. Early warning of disease events is an important function of WHO. According to IHR 2005, Article 5(4), WHO shall share with all States parties the public health information collected through its monitoring activities and reports from States, assess the risk of possible international spread, and determine the necessity of a PHEIC alert. On 31 December 2019, the Wuhan Municipal Health Commission, China, reported a cluster of cases of pneumonia. From 3 January 2020 on, China began to update, on a regular basis, WHO, relevant countries, and regional organizations, as well as its own regions of Hong Kong, Macao and Taiwan, on the development of the disease; during 20-21 January, WHO experts from its China and Western Pacific regional offices conducted a field visit to Wuhan; and on 30 January, WHO made a PHEIC alert on COVID-19. This process is shown in WHO Timeline—COVID-19 ( https://www.who.int/news-room/detail/27-04-2020-who-timeline---covid-19), which represents the regular information flow in WHO’s surveillance system.

14. It is worth mentioning that Article 9 of IHR 2005 specifically states that WHO “may consider reports from sources other than official notifications or consultations”. Therefore, even if governments do not notify a disease event, WHO can obtain and filter a substantial amount of unofficial information through its Global Outbreak Alert and Response Network (GOARN). Non-governmental organizations (NGOs) or internet companies have strong intelligence collection systems and “infinite possibilities” in health information communication. In order to prevent WHO from being misled by the information received from non-governmental sources without seeking to verify it with the affected member States, Article 10 of IHR 2005 requires WHO to verify reports from NGOs. It is clear that States parties have not only an obligation but an incentive to cooperate with WHO to verify information and respond to public health threats. In addition, “States Parties shall, as far as practicable, inform WHO within 24 hours of receipt of evidence of a public health risk identified outside their territory that may cause international disease spread” (Article 9, paragraph 2). All these institutional innovations of IHR 2005 undoubtedly increase the channels of States parties to report and promote transparency in IHR 2005.

15. The 2004 Draft IHR required States parties to allow WHO to conduct field visits in their territories to determine whether a PHEIC is occurring and then to take appropriate control measures. However, many member States consider these provisions “neither acceptable nor feasible” based on the principle of national sovereignty; for them, “WHO teams can only enter countries with the consent of the affected Member States” (World Health Organization, Summary Report of Regional Consultations, A/IHR/IGWG/2, 14 September 2004, para.8). Finally, States parties are not obligated to accept WHO’s assistance or proposals for on-site visits, but WHO can independently determine any risk of international spread of disease events, and sent the information to all States parties and relevant intergovernmental organizations as soon as possible and as appropriate through the most effective way and make it public when necessary (Article 10, paragraph 3-4).

16. Article 13 of IHR 2005 stipulates that the health administration department of each State Party shall, in accordance with the requirements of Annex I, strengthen and maintain its capability to respond to public health risks and public health emergencies of international concern promptly and effectively, and cooperate with the assessment and investigation activities of WHO. Annex I of IHR 2005 provides for core capacity requirements at the local community level and /or primary public health response level: 1) to detect more than expected events involving disease or death in all areas of the territory at a specific time and place, and 2) to immediately report all important information to the corresponding health care institutions. Annex I also provides for capacity requirements for assessment and notification at the national level: 1) assessment of all emergency reports within 48 hours; and 2) immediate notification of disease incident to WHO through the National IHR Focal Point when the assessment indicates the event is notifiable (Annex I to IHR 2005, Paragraphs 4-6). Of course, these are only a capacity-building indicator, and IHR takes into account the actual situation of each State, especially in developing countries. The requirements for public health response at the primary level and even at the intermediate level are relatively loose, and there is no time limit. Whether, when or how to report level by level depends on the assessment of each level. Sara Davis pointed out that many developing countries, particularly in ASEAN, have significantly improve their capacity and communication in the detection and reporting of disease outbreaks since 2005, although some of them still have reporting “black holes” (Sara Davis, Containing Contagion the Politics of Disease Outbreaks in Southeast Asia, Johns Hopkins University Press, 2019, at 157).

17. Besides, the dispute on virus sharing directly relates to the interpretation of the obligation to report and the operation of WHO’s surveillance system. For example, some States claim that access to and use of viral materials or samples collected on their territory should follow the principle of “prior informed consent” under the Convention on Biological Diversity, which, after all, states that “Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party” (Article 15(5)), while opponents believe that Article 6 of IHR 2005 requires States parties to report to WHO, as soon as possible, accurate and sufficiently detailed public health information; and according to a good faith interpretation of the purposes and objectives of the regulations, “virus samples” should belong to “public health information”, and States have the obligation to share such samples. However, the IHR should “be interpreted in a coordinated manner with other relevant international agreements” and the resolutions on the sharing of influenza viruses and access to vaccines relating to implementation of the IHR “recognize the sovereign rights of States over their biological resources”. (Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits,WHA60.28, 23 May 2007.) Accordingly, the proper interpretation is that there is no obligation for States to provide virus samples to WHO.

V. Conclusion

18. The reporting obligation stipulated in IHR 2005 aims to speed up the communication between WHO and member States, especially the timely and accurate information flow on public health emergencies of international concern to WHO. The possibility of unnecessary and inappropriate trade and travel restrictions in other countries can be reduced by promoting the early notification of outbreaks and transparency of information among States Parties to IHR 2005. Once it detects an outbreak that may constitute a PHEIC, a State Party should notify WHO as soon as possible. Moreover, the assessment before notification needs to follow a domestic procedure with regard to international standards. Obviously, a member State’s obligation to report is a duty of conduct.

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Notes about the author:

Xiangqian Gong is a Professor of Law at Beijing Institute of Technology (BIT). He is currently acting as the vice president of the Institute of International Dispute Prevention and Settlement at BIT. He received his Ph.D. in international law from Wuhan University in June 2005, and got his post-doctoral experience in Tsinghua University (2005-2007). He has presided over several key research projects on international health law and environmental law from the National Social Sciences Foundation of China and the Humanities and Social Science Foundation of the Ministry of Education. He has won the first prize of Higher Education Achievement Award of Beijing and the Excellent Achievement Award from China Law Society. He is also a member of China Health and Quarantine Expert Committee, a standing member of China Health Law Research Association, and executive director of China European Law Research Association. He has published more than fifty articles & review essays in Chinese and English. He may be contacted at gongxiangqian@bit.edu.cn.