Is the International Community Ready for the Next Pandemic Wave? A Legal Analysis of the Preparedness Rules Codified in Universal Instruments and of their Impact in the Light of the COVID-19 Experience

1 Introduction: Terminological Clarifications and Identification of the Legal Basis of the Preparedness Obligations

Infectious diseases and pandemics^[1] have been an endemic part of human history. According to historians, the first recorded pandemic occurred during the Peloponnesian War around 430 BC.^[2] Over the last 100 years, several pandemics have been registered: in 1918 the Spanish flu (with a death toll of about 40 million),^[3] in 1956–1958 the Asian Flu (with a death toll of about two million),^[4] in 1961 the Flu Pandemic (with a death toll of about one million),^[5] in 2005–2012 the HIV/AIDS Pandemic (with a death toll of about 36 million),^[6] and in 2009–2010 the H1N1 Pandemic (with a death toll of about 500,000).^[7] Furthermore, according to the WHO, between 2008 and 2011 there were 1483 epidemic events in 172 countries.^[8] Notwithstanding strenuous efforts to prevent the outbreak of infectious diseases, such events, as confirmed by the COVID-19 case, will continue to affect the international community. A study carried out by the European Centre for Disease Prevention and Control, in close cooperation with the WHO regional office for Europe, states that a future influenza pandemic “is inevitable, although it cannot be predicted when it will happen nor how severe it will be.”^[9] According to the 2019 Annual Report on Global Preparedness for Health Emergencies, if it is true “to say ‘what’s past is prologue’, then there is a very real threat of a rapidly moving, highly lethal pandemic of a respiratory pathogen killing 50 to 80 million people and wiping out nearly 5% of the world’s economy.”^[10] The World Bank has estimated that the annual global cost of a moderate to severe pandemic would be around US$570 billion, or 0.7% of global income.^[11] But if “the world were to face a fast-moving, airborne disease, such as the Spanish flu outbreak of 1918–1919, it would kill more than 33 million people in 250 days and erode 4.8% of global GDP – more than US$3.6 trillion.”^[12] There are many explanations for why pandemics will continue to happen. On the one hand, virologists candidly admit that despite enormous advances in virology and epidemiology, “many fundamental scientific questions concerning the origins, virulence, and diffusion of influenza remain unanswered.”^[13] On the other hand, the new features of the global economy (with incredible increases in the traffic of goods and the number of persons travelling worldwide), represent “a near-ideal condition to spread infections around the world.”^[14]

While prevention remains an essential tool, preparedness measures are becoming crucial to cope with future pandemics.^[15] According to the 2017 WHO document on “A Strategic Framework for Preparedness”,^[16] emergency preparedness is defined as “the knowledge and capacities and organizational systems developed by governments, response and recovery organizations, communities and individuals to effectively anticipate, respond to, and recover from the impacts of likely, imminent, emerging, or current emergencies.” In the 2015 WHO Framework for a Public Health Emergency Operations Centre,^[17] additional elements were provided to better understand the notion of preparedness which is “the product of a combination of planning, allocation of resources, training, exercising, and organizing to build, sustain, and improve operational capabilities based on risk assessments.”^[18]

The same document describes differences between prevention and mitigation on the one hand and preparedness on the other as follows:

Prevention and mitigation involves the treatment of identified risks so as to prevent them or introduce measures to reduce their impact…… Preparedness involves assessment of capacities and capabilities, development of plans, development and maintenance of infrastructure, maintenance of stockpiles, design and implementation of procedures, and training of personnel. It also includes technical capacity building, planning, and training and exercising.^[19]

These definitions, though not codified in binding instruments, are widely used and referred to by the international community.^[20] This article draws on them as well. In doing so, it carefully examines relevant international treaties and also pertinent UN documents. The treaties under investigation deal not only with health issues (first of all the WHO 1946 Constitution and the 2005 International Health Regulations),^[21] but also with more general questions related to managing disasters and especially those in which there is release of chemical, biological, radiological and nuclear substances, as long as they are applicable to pandemics.^[22] Moreover it explores treaties devoted to the regulation of international assistance^[23] which are an essential tool for increasing the effectiveness of future responses to pandemics.^[24] Preparedness obligations can also be found in the frame of rules aimed at protecting fundamental human rights (such as the right to life, health, etc.).^[25] The international monitoring bodies tasked to oversee the implementation of specific Human Rights Conventions, emphasized that

The duty to protect life also implies that States parties should take appropriate measures to address the general conditions in society that may eventually give rise to direct threats to life or prevent individuals from enjoying their right to life with dignity……

Furthermore, States parties should also develop, when necessary, contingency plans and disaster management plans designed to increase preparedness and address natural and man-made disasters, which may adversely affect enjoyment of the right to life, such as hurricanes, tsunamis, earthquakes, radio-active accidents and massive cyber-attacks. ^[26]

The International Law Commission (ILC) confirmed that every State has “the duty to ensure the protection of persons and provision of disaster relief assistance in its territory, or in territory under its jurisdiction or control.”^[27] The jurisprudence of the International Human Rights Courts supports these conclusions. In a well-known case from 2008, the European Court of Human Rights (ECtHR), after clarifying that Article 2 (Right to life) of the 1950 European Convention on Human Rights (ECHR) “lays down a positive obligation on States to take appropriate steps to safeguard the lives of those within their jurisdiction,” concluded that this obligation entails “above all a primary duty on the State to put in place a legislative and administrative framework designed to provide effective deterrence against threats to the right to life.”^[28] States also have the obligation of adopting preparedness measures to protect private property,^[29] whenever regulated by an applicable treaty. The European Court stated, however, that in such a case “the authorities enjoy a wider margin of appreciation in deciding what measures to take in order to protect individuals’ possessions from weather hazards than in deciding on the measures needed to protect lives.”^[30] The ECtHR confirmed that these conclusions are applicable to pandemics as well, as it pointed out that the respective obligation “must be construed as applying in the context of any activity, whether public or not, in which the right to life may be at stake.”^[31] Finally, it is important to note that there is also a thesis that preparedness obligations are codified in an autonomous rule. According to the ILC, “each State shall reduce the risk of disasters by taking appropriate measures, including through legislation and regulations, to prevent, mitigate, and prepare for disasters.”^[32] Moreover, this autonomous rule draws “on principles emanating from international human rights law…… and from a number of international environmental law principles, including the “due diligence” principle,”^[33] and is based on a “widespread practice of States reflecting their commitment to reduce the risk of disasters”^[34] and on the recognition that this commitment has been incorporated by States into their national policies and legal frameworks.^[35]

2 Specific Preparedness Obligations Regulated in Universal Instruments

Prevention and response/recovery obligations in the field of pandemics have traditionally benefitted of a worldwide attention (as confirmed by the high number of international treaties devoted to these two aspects). By contrast, less attention has been dedicated to preparedness.^[36] The likely reason for this deficit is that pandemics occurred infrequently and often did not gain widespread attention when they did happen. More recently, however, they have attracted increased interest, a point well reflected in the activities of various international organizations and in States’ increasing concern about future pandemics.^[37]

In the 1949 WHO Constitution, which is heavily focused on prevention obligations,^[38] providing assistance^[39] and promoting international cooperation, preparedness aspects were, basically,^[40] not considered. Nevertheless, the WHO has been involved in supporting preparedness activities to manage pandemics. Initially it developed soft-law instruments such as Guidelines, Guides, Checklists, etc., which, as we will see shortly, contributed to increase the awareness on how to be better equipped for future pandemics.^[41] The WHO introduced preparedness obligations only at a later moment, mainly through the 2005 International Health Regulations (IHR).^[42] The general goal of the IHR is “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.”^[43] These regulations are binding. Specific preparedness obligations are codified in Article 13, which requests each State party to:

develop, strengthen and maintain as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the capacity to respond promptly and effectively to public health risks and public health emergencies of international concern as set out in Annex 1. WHO shall publish, in consultation with Member States, guidelines to support States Parties in the development of public health response capacities.^[44]

Annex 1 defines the core capacity requirements for surveillance and response and those for designated airports. In this frame, it provides a detailed list of preparedness obligations for the State to be properly equipped (both in terms of decision-making procedures and physical infrastructures) and to have staff duly trained to be ready (a) to detect and report diseases or deaths above expected levels for the particular time and place in all areas within its territory and (b) to manage the health emergency by providing support through specialized staff, laboratory analysis of samples (domestically or through collaborating centres) and logistical assistance (e.g., equipment, supplies and transport). In 2011, the 64th World Health Assembly adopted, in accordance with Article 23 of the WHO Constitution, the Pandemic Influenza Preparedness (PIP) Framework for Sharing Influenza Viruses, Vaccines and other Benefits.^[45] Although focused specifically on pandemic influenza, the framework contains several important recommendations for member States and for the WHO Secretary General. States are requested to introduce national preparedness measures to allow the fast sharing of H5N1 and other influenza viruses with human pandemic potential with the WHO Collaborating Centre on Influenza or WHO H5 Reference Laboratory of the originating Member State’s choice.^[46] National Influenza Centres and other authorized laboratories must make available, without charge, supplies of non-commercial diagnostic reagents and test kits for identifying and characterizing specimens of influenza.^[47] Moreover, influenza vaccine manufacturers must be urged to set aside a portion of each production cycle of vaccines for H5N1 and other influenza viruses with human pandemic potential for stockpiling and/or use, as appropriate, by developing countries.^[48] The WHO Secretary General has been tasked with seeking, in cooperation with several stakeholders, commitments for contributions to maintain and further develop a stockpile of antiviral medicines and associated equipment for use in containment of outbreaks of H5N1 and other influenza viruses with human pandemic potential^[49] and to establish and keep a stockpile of vaccines and associated equipment, including syringes, needles and applicators.^[50]

Although apparently unrelated to the COVID-19 pandemic, unless the virus was produced in a laboratory (which has so far been denied by the interested States), the 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction plays an important role because its preparedness measures contribute to international capabilities for response, investigation and mitigation of outbreaks of any disease, and not only those provoked by an alleged use of biological or toxin weapons. Although in this treaty specific references to preparedness obligations are rare and limited to the international cooperation facet,^[51] during the regular meeting of the States Parties to the Convention, the review conferences (every five years), the inter-sessional meetings^[52] and other occasions, the importance of the need to identify preparedness measures has slowly surfaced and gained increasing attention. While many of the relevant documents are mere political commitments, a few can well be considered binding rules for the member States.^[53] In the December 2014 meeting of the States Parties to the Convention, a list of desired preparedness measures was approved. These measures include effective national capabilities, national plans and detection capabilities; appropriate command, control and coordination of cross-governmental planning and response; and regular training activities to strengthen national capacities.^[54] The Eighth Review Conference, which took place in 2016, reaffirmed that “the international community should be prepared to face such situations well in advance and to dispatch emergency assistance in case of use of bacteriological (biological) or toxin weapons, and also to provide assistance, including humanitarian and other assistance to the requesting State Party.”^[55] The Parties agreed that “national preparedness and capacities also contribute directly to international capabilities for response, investigation and mitigation of outbreaks of disease, including those due to alleged use of biological or toxin weapons.”^[56] During the same conference, the parties furthermore stressed the urgent need for new procedures by which “timely emergency assistance can be provided, including to better identify accessible information on the types of assistance that might be available in order to ensure prompt response and timely emergency and humanitarian assistance by States Parties, if requested in the event of use of biological weapons.”^[57] The increasing interest in preparedness measures is likewise testified by the decision to organize regular Meetings of Experts on Assistance, Response and Preparedness^[58] and by the relevant number of working papers devoted to this issue and submitted in the last years by States Parties.^[59]

The UN system has also played a role in this endeavour to reinforce national capacities to face a pandemic. In UN General Assembly Resolution 60/282 from 2006 approving the Political Declaration on HIV/AIDS,^[60] the Heads of State and Government committed solemnly to

reinforce, adopt and implement, where needed, national plans and strategies, supported by international cooperation and partnership, to increase the capacity of human resources for health to meet the urgent need for the training and retention of a broad range of health workers, including community-based health workers; improve training and management and working conditions, including treatment for health workers; and effectively govern the recruitment, retention and deployment of new and existing health workers to mount a more effective HIV/AIDS response.

In the same year, in the Resolution on the United Nations Global Counter-Terrorism Strategy,^[61] the UNGA requested the UN system

to improve coordination in planning a response to a terrorist attack using nuclear, chemical, biological or radiological weapons or materials, in particular by reviewing and improving the effectiveness of the existing inter-agency coordination mechanisms for assistance delivery, relief operations and victim support, so that all States can receive adequate assistance. In this regard, we invite the General Assembly and the Security Council to develop guidelines for the necessary cooperation and assistance in the event of a terrorist attack using weapons of mass destruction.

Considering its content, the resolution is relevant for the purposes of this article for at least two reasons: a pandemic might be provoked by a terrorist attack releasing highly contagious viruses and, secondly, the preparedness activities implemented to face potential terrorist attacks are usable in non-terrorist pandemic events as well.

On several occasions, the UNSC dealt with major health crises and consistently emphasized the importance of the preparedness measures to be adopted by member States with the support of relevant IOs. In its Resolution 2439 (2018) of 30 October 2018, devoted to the outbreak of the Ebola virus in the Democratic Republic of Congo, the SC requested all relevant parts of the United Nations System “to accelerate their response to the Ebola outbreak, within the overall coordination of WHO, including by supporting the development and implementation of preparedness and operational plans.”^[62] In a Statement by the President of the Security Council issued a few months later, he addressed a similar appeal to member States and civil society in affected and at-risk countries “to work urgently with relevant partners to improve their preparedness for preventing, detecting and responding to possible cases, as well as to implement optimal vaccine strategies that have maximum impact on curtailing the outbreak.”^[63] Although these documents refer to an epidemic event, their relevance for a pandemic is self-evident.

To be effective, preparedness measures need to be highly contextualized and tailored to the specific cultural and socio-economic situation. The regional level seems optimal for addressing the issue in an effective manner because it allows for tactics to be calibrated to the peculiar features of a specific geo-political area. While this article focuses only on universal instruments, the activities promoted at the regional level need to be briefly introduced to paint a comprehensive picture of the overall preparedness measures. The European Union has been very active in this regards, adopting several pieces of sometimes very innovative legislation and political decisions such as the Action Plan to Enhance Preparedness against Chemical, Biological, Radiological and Nuclear Security Risks, presented by the European Commission (EC) at the end of 2017,^[64] the Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on Serious Cross-border Threats to Health,^[65] which introduces an innovative joint procurement procedure to facilitate the advanced purchase of medical countermeasures for serious cross-border threats to health,^[66] the creation of the European Centre for Disease Prevention and Control (ECDC)^[67] and the EU Civil protection Mechanism, which was updated in 2019.^[68] Other European organisations (or regional organisations with mostly European member/participating States) that significantly contributed to honing preparedness obligations are the OSCE,^[69] NATO,^[70] the Euro-Arctic Region^[71] and the Black Sea Economic Cooperation (BSEC).^[72] Relevant rules have also been codified on the American continent (focusing mostly on modalities of requesting international assistance there),^[73] in Africa,^[74] in Asia^[75] and even at the bilateral level.^[76]

3 The Relevant Role of Soft-Law and Guidelines

Considering the specific nature of the preparedness measures and the continuous technological evolution that requires their quick adaptation and revision, more and more international and some national and non-governmental institutions have promoted non-binding documents (Guidelines, Resolutions, Actions Plans, etc.) with recommendations, definitions of standards and innovative tools to increase the level of preparedness of both IOs and States. The so-called soft-law instruments present, generally speaking, several advantages compared to international treaties. The modality of adoption of these documents is usually less time consuming and faster than a treaty and their update is quick and uncomplicated. These key features make soft-law instruments appealing tools even if they are not binding. Nevertheless, both the credibility of the organisation adopting these guidelines and the participatory preparation process that led to their approval contribute to increasing, de facto, their impact. The relevance of these documents is also proven by the fact that they (a) are often used to interpret the existing treaties; (b) are considered useful tools in the reconstruction of a possible customary law rule on a given topic; (c) often represent the starting point of a process that might lead in the future to a codification process and (d) allow for a better perception of new trends and priorities in the international community.

The list of soft-law instruments dealing with preparedness measures to face potential pandemics is very long and includes those adopted by universal and regional institutions as well as by individual States. Within the WHO, especially in the past, soft-law instruments such as Guidelines, Guides, Checklists, etc., have been very popular and contributed to raise awareness among the States about the need to be better prepared to face pandemics.^[77] Given that they provide precious information to all the States, these instruments, which were regularly updated, also proved relevant as a capacity development tool.^[78] In the more general area of disaster management (including pandemics), the 1994 Yokohama Strategy and Plan of Action for a Safer World – Guidelines for Natural Disaster Prevention, Preparedness and Mitigation,^[79] which was updated in 2005,^[80] was one the first soft-law instruments in this area. The original and revised versions provided detailed guidelines for natural disaster prevention, preparedness and mitigation with the goal of reinforcing national legislation and institutional arrangements. In the same vein, it is worth mentioning activities carried out within the framework of the United Nations International Strategy on Disaster Reduction (UNISDR), now United Nations Office for Disaster Risk Reduction (UNDRR): the Hyogo Framework for Action 2005–2015: Building the Resilience of Nations and Communities to Disasters^[81] and the Sendai Framework for Disaster Risk Reduction 2015–2030 (Sendai Framework).^[82] In 2004, the United Nations Interregional Crime and Justice Research Institute (UNICRI) launched the CBRN Risk Mitigation and Security Governance Programme^[83] to encourage States to adopt a comprehensive CBRN approach to preparedness measures.^[84]

Other soft-law instruments address specific issues related to typologies of disasters, the nature of the risk, the location where such events occur or aspects aimed at facilitating international assistance.^[85] The WHO adopted in 2013 the Checklist and indicators for monitoring progress in the development of IHR core capacities in States Parties^[86] It represents an important tool to monitor the development of core capacities at the national, intermediate and community/primary response levels, in accordance with the requirements for core capacity development in Annex 1 of the IHR (2005). A specific part of this Checklist is devoted to preparedness measures to be adopted, suggesting important indicators devoted, for example, to the surge capacity, i.e., the ability of the health system to expand beyond normal operations to meet a sudden increased demand.^[87] Also the International Federation of the Red Cross has been very active in preparing various soft-law instruments related to the preparedness phase: one of the first was the 2011 “Introduction to the Guidelines for the Domestic Facilitation and Regulation of International Disaster Relief and Initial Recovery Assistance”,^[88] aimed at strengthening legal preparedness at the national level for international disaster relief. Considering that most countries do not have special laws in place for facilitating and regulating international relief,^[89] the guidelines offer them a wide spectrum of ideas and suggestions on how they can facilitate international assistance in case of a disaster.^[90]

In major disasters, such as pandemics, the possibility of using not only civilian but also military assets has become crucial. During the COVID-19 lock down, the role of the armed forces has been very visible in many States. The army has been used to support the local police in patrolling the streets and protecting specific targets, provide logistical support to the health system and produce medicine and personal safety equipment in their laboratories. The involvement of military personnel and equipment during a disaster raises several issues, both political and legal in nature. Therefore, the need arose to address and regulate them well ahead of a disaster. Although the use of the army might be considered more an issue to be discussed in the response stage, it has significant repercussions for the preparedness phase because it implies that significant preliminary work needs to be carried out. Issues such as the legal framework of the participation of military staff and assets on the occasion of a pandemic event, coordination between civil and military authorities, a clear definition of the chain of command and the training of military staff, inevitably need to be well organized in advance. For this reason, they are mentioned here as emerging issues to be dealt with in the preparedness phase. The Oslo Guidelines on the use of Foreign Military and Civil Defence Assets (MCDA) in Disaster Relief (Oslo Guidelines), the preparation of which involved all interested stakeholders,^[91] represent an innovative answer to this challenge.^[92] They regulate the use of MCDA “following natural, technological and environmental emergencies in times of peace”^[93] with the aim “to establish the basic framework for formalizing and improving the effectiveness and efficiency of the use of foreign military and civil defence assets in international disaster relief operations.”^[94] Although these guidelines are primarily intended for use by UN humanitarian agencies and their implementing and operational partners, they can also be used “by decision-makers in Member States and regional organizations when considering the use of military and civil defence assets to provide assistance to civilian populations in natural disasters and technological or environmental emergencies in times of peace.”^[95]

Even at the regional level there are numerous soft-law instruments that typically deal with specific issues. NATO has been very prolific in this regard, issuing several Guidance documents such as the 2009 Checklist and Non-Binding Guidelines for the Request, Reception and Provision of International Assistance in the Event of a CBRN Incident or Natural Disaster.^[96] These Checklist and Non-Binding Guidelines are provided “for national preparedness in requesting and receiving international assistance and should be used by emergency planners and managers at operational level.”^[97]

The “Asia Pacific Strategy for Emerging Diseases and Public Health Emergencies (APSED III): Advancing implementation of the International Health Regulations” is another relevant tool for that part of the world.^[98] Finally, between 2014 and 2018, G7 member States made 55 commitments relating to health emergencies specifically, including preparedness.^[99] In the recent Declaration adopted in Paris in May 2019, the G7 Health Ministers confirmed their commitment to “continue to offer assistance to 76 partner countries and regions, building on countries’ expertise and existing partnership, for this implementation, in particular to strengthen and maintain core capacities required; and therefore, to help reduce the vulnerability of countries to public health emergencies.”^[100]

In sum, one can well conclude that there are plenty of soft-law instruments, at both the universal and the regional level,^[101] containing precious suggestions and recommendations on how States can best prepare for a potential pandemic. These instruments, which stimulate awareness among States of the importance of preparedness and contribute to minimizing the consequences of pandemics, are all non-binding. However, considering that in a few cases special mechanisms to monitor the effective implementation of these documents have been introduced^[102] and that in many cases the institutions that prepared them declared their availability and readiness to support, both technically and financially, States wishing to implement them in their national system, the conclusion has to be reached that these guidelines and recommendations are playing a very important role which cannot be neglected.

4 Current Challenges to the Implementation of Preparedness Measures at National Level

A careful examination of the rules codified so far in treaties (including those specifically devoted to deal with pandemics and other disasters insofar as they are applicable to pandemics) and soft-law instruments allows one to conclude that pandemic preparedness measures to be implemented by States and, where relevant, IOs are numerous, diverse and multifold. The investigation of relevant international sources carried out in the previous paragraphs permit the following summary of preparedness activities States are requested/suggested to implement (the relevant sources are indicated in the respective footnotes)^[103]:

• – professional and regularly updated planning of pandemic emergencies;^[104]

• – establishment of legal and operational frameworks to allow both first responders and law enforcement officers (if needed) to intervene quickly and safely;^[105]

• – maintaining effective disease surveillance and laboratory systems with enough capacity to analyse samples (domestically or through collaborating centres);^[106]

• – a system in place that allows immediate reporting of newly emerging diseases that could spread internationally;^[107]

• – a scheme that encourages rapid, systematic and timely sharing of H5N1 and other influenza viruses with human pandemic potential with WHO Collaborating Centres on Influenza and WHO H5 Reference Laboratories;^[108]

• – ensure that the capacities set forth for designated points of entry are developed;^[109]

• – adoption of clear provisions on the chain of command during a pandemic event;^[110]

• – availability, when needed, of enough support from specialized staff and logistical assistance to be activated through a proper emergency organisation and through the establishment of a more extensive global, public health reserve work force;^[111]

• – delivery of adequate training and exercises to prepare and test relevant staff;^[112]

• – maintaining the necessary infrastructure to respond to health emergencies;^[113]

• – laboratories ready to be activated and equipped to detect and report diseases or deaths above expected levels in all areas within the territory of a State;^[114]

• – availability of adequate and updated equipment, including, where appropriate, Personal Protective Clothing, decontamination-lorry, etc.;^[115]

• – maintaining the necessary infrastructure to respond to health emergencies^[116] and ability of the health system to expand beyond normal operations to meet a sudden increased demand;^[117]

• – implementation of all preparedness rules foreseen in the WHO 2011 Pandemic influenza preparedness framework for the sharing of influenza viruses and access to vaccines;^[118]

• – measures in place to share, in the case of an influenza pandemic, Pandemic Influenza Preparedness biological materials to ensure ongoing global monitoring and risk assessment and the development of safe and effective influenza vaccines in conformity with the Standard Material Transfer Agreement;^[119]

• – mobilization of financial resources to facilitate implementation of the obligations under the IHR and, possibly, the creation of a contingency fund for public health emergencies;^[120]

• – specific internal rules for the use of military assets during the crisis;^[121]

• – the organisation of information flows well planned in advance with a clear indication of who is entitled to issue official updates about the event and its consequences;^[122]

• – ensure that designated National IHR Focal Points have the authority, resources, procedures, knowledge and training to communicate with all levels of their government and on behalf of their governments as necessary;^[123]

• – provide coordination and capabilities at the national and regional levels;^[124]

• – the definition of a general legal and political framework that allows States to quickly activate, whenever deemed opportune, an international assistance request and to allow this assistance to be carried out in a pre-defined legal framework;^[125]

• – collecting and disseminating information on S&T developments, including new research in areas relevant to the Convention, exchanging information about databases and networks and ensuring access to such databases and networks;^[126]

• – guarantee that all preparedness measures are consistent with International Human Rights Law and that they take into special account the specific need of persons with disabilities.^[127]

Examining all these measures in light of the COVID-19 pandemic, one can well argue that preparedness measures emerging from international instruments (both hard and soft-law) continue to be relevant, have been continuously updated and integrated^[128] and cover almost all the different fields of action. The real problem concerning their effectiveness is, therefore, related to their implementation at national level. To ensure that all these rules are respected, several monitoring schemes have been introduced in the IHR and in other relevant documents. States Parties and the Director-General were requested to regularly report to the Health Assembly on the implementation of the regulations.^[129] To support and facilitate the work of Member States in preparing their national reports, the WHO developed a monitoring framework^[130] through which States Parties can monitor and evaluate their own implementation of IHR capacities in accordance with the requirements for capacity development outlined in Annex 1 of the IHR.^[131] These national reports are examined by a Review Committee appointed by the WHO Director-General. In its 2014 Report, the Review Committee indicated that at the end of 2014 “64 States Parties had indicated that they met the minimum core capacity standards; 81 States Parties had requested an additional two-year extension of the implementation deadline; and 48 had not communicated their intentions to WHO.”^[132] The IHR Review Committee presented also additional recommendations with the aim “to move from exclusive self-evaluation to approaches that combine self-evaluation, peer review and voluntary external evaluations involving a combination of domestic and independent experts.”^[133] These recommendations led, in 2015, to the development of the Joint External Evaluation (JEE), which was updated in 2017.^[134] The JEE allows Member States “to request as needed to evaluate country capacity to prevent, detect and rapidly respond to public health threats independently of whether they are naturally occurring, deliberate or accidental.”^[135] So far, more than 100 States^[136] have undertaken a JEE, resulting in the detection of more than 6000 critical capacity gaps.^[137] Beside this system, which aims at monitoring States’ compliance with international rules, a new instrument is surfacing. It is based on the opposite approach, namely to convince States to respect the rules by using incentivating measures. The WHO “Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and other Benefits” is a good example of this new approach.^[138] As reflected already in its title, the framework offers several incentives (such as facilitated access to antivirals stockpiles and to vaccines in the inter-pandemic period, tiered pricing, technology transfer^[139] and sustainable and innovative financing opportunities) to those States that fulfil their preparedness obligations. This new modality of encouraging good practices deserves the highest attention.^[140] It will be interesting to see whether, in the near future, it actually increases compliance. The introduction of an increasingly sophisticated monitoring system represents a fundamental step forward in increasing the effectiveness of the preparedness exercise insofar as it stimulates States to act consistently with their international obligations. The ongoing discussion within the WHO on how to continue to improve the IHR’s existing monitoring system^[141] is an important evidence of the increasing attention devoted to this crucial aspect.

In light of the variety of the preparedness measures and considering that in almost all States their implementation is left to a plurality of institutions, both at national and at regional/local level, innovative tools have to be introduced within the national legal systems to carry out in a smooth and timely manner the various activities. In order to be more effective, these envisaged reinforced national coordination tools should be based on a commonly agreed set of principles (rule of law, precautionary approach, sound and effective administration, transparency, accountability). Divergent, fragmented, partial national implementation measures might negatively affect their success, imply a significant increase in their costs and they might even involve the international responsibility of the State for breaches of its international obligations.

The analysis carried out in the preceding paragraphs allows one to conclude that at least some of the previously mentioned measures have attracted a high level of interest in the international community (and, therefore, numerous rules have been codified), while others have received less attention. The rules concerning the implementation of the preparedness obligation to be equipped to call for international assistance are, for sure, among the most popular. During the COVID-19 crisis, the relevance of international cooperation emerged in clear terms: although the virus affected almost all States, international cooperation to face the pandemic has been strongly encouraged^[142] and amplified.^[143] There are dozens of universal, regional, sub-regional and even bilateral treaties devoted to regulating the activation of the international assistance mechanism. The plurality of options available to States should a disaster happen is related to the consideration that, as solemnly stated by the ILC, the affected State has discretionary power “to choose from other States, the United Nations, and other potential assisting actors the assistance that is most appropriate to its specific needs.”^[144] The high number of treaties at the universal, regional and even bilateral levels to regulate all aspects of future incoming or outgoing international assistance operations can well be explained by way of the changing nature of pandemics and the consequences thereof which make it imperative to count on international assistance.^[145] Given that so far no duty to cooperate in providing disaster relief has emerged within customary international law,^[146] these treaties are even more important. Moreover, the obligation to train the first responders (through training courses and full-fledged exercises) has received much attention, and hundreds of specific training initiatives and complex simulation exercises, including pandemic elements, are organized every year worldwide at all levels.^[147] Another preparedness measures which is attracting increasing attention in the international community refers to the disputed and sensitive issue of the use of military personnel and staff to face the consequences of a pandemic. The large-scale use of armed forces during the COVID-19 emergency is clear evidence of this need.

On the other hand, lesser attention has been given to the preparation of well-planned information flows that clearly identify who is entitled to issue official updates about the event and its consequences. Preparation on how to communicate risks during a pandemic is of utmost importance because it increases public and professional confidence and trust.^[148] Lessons learned during the 2009 H1N1 pandemic highlight difficulties that public health authorities faced in communicating scientific uncertainty. Risk communication is targeted to the public but also to key stakeholders and responders such as health workers to continuously update them about the evolving situation and about interventions, in particular the pandemic vaccine. In the recent Fukushima incident, which is unrelated to a pandemic event but raises similar problems, “conflicting information soon after the onset of the Fukushima Daiichi accident because of the lack of preparedness led to distrust in the national and local governments among the public and increased fear of damage caused by radiation.”^[149] Finally, the COVID-19 crisis has made clear that more attention needs to be devoted to preparedness measures in densely inhabited urban areas, which demand specific approaches to enable the management of future health emergencies.

5 A Sensitive Issue Raised in the Implementation Phase: The (High) Costs of Preparedness Measures

The implementation of all the above-mentioned activities requires significant investment. The question of costs has become dramatic, especially in light of the poor financial situation of most of the States. In countries with a reasonably comprehensive and well-functioning underlying health system, it has been calculated that “financing improved preparedness might cost less than $1 per person per year, not a huge sum compared to the scale of the risks to human lives and livelihoods.”^[150] In any case, the benefits that derive from adequate investment in preparedness measures are remarkably clear^[151] and no one can ignore their positive side-effect of reinforcing the fight against endemic diseases, improving general health services and increasing the capacity to deal with other typologies of future disasters (both natural and man-made). Participating in the 2017 Munich Security Conference, Bill Gates underlined the irony “that the cost of ensuring adequate pandemic preparedness worldwide is estimated at $3.4 billion a year—yet the projected annual loss from a pandemic could run as high as $570 billion.”^[152] In most of the countries that have a well-functioning health system, there is still an urgent need for parliaments and public opinion to stimulate and lobby their governments to increase investment in preparedness measures. In low- to medium-income countries, the priority is to have access to specific funds, in the form of both subventions and affordable long-term credits. In both cases, there are at least three main issues that deserve to be briefly addressed: how to reduce the costs of these preparedness measures to make them affordable to most States, how to facilitate access to international financial instruments to support investments in pandemic preparedness and how to define the limits of States’ discretionary powers to set priorities in the preparedness measures to be financed.

Several initiatives aimed at identifying sustainable financing mechanisms and ways to increase and improve the efficiency of domestic and global financing for health security have been carried out within the WHO.^[153] The urgency to ensure “fair, transparent, equitable, efficient and timely access to and distribution of preventive tools, laboratory testing, reagents and supporting materials, essential medical supplies, new diagnostics, drugs and future COVID-19 vaccines” has been emphasized by the UNGA as well in its Resolution 272 of 20 April 2020^[154] and in the Ministerial Declaration adopted on 27 September 2018 by the Group of 77 and China.^[155] At the regional level, the Joint Procurement mechanism regulated in the 2013 Decision 1082/2013/EU of the European Parliament and of the Council as well as the initiatives undertaken by the Asian Development Bank^[156] are good examples in this regard.

On the second issue, the World Bank’s Pandemic Emergency Financing Facility^[157] and Health Security Financing Assessment Tool (HSFAT) offer additional opportunities to national Governments to prioritize national preparedness plans.^[158] Other financial opportunities to support preparedness measures include the Regional Disease Surveillance Systems Enhancement Program of the World Bank,^[159] the International Bank for Reconstruction and Development (IBRD) Catastrophe Deferred Drawdown Option CAT-DDO,^[160] the Global Crisis Response Platform launched by the World Bank Group,^[161] the new initiatives offered by International Development Association^[162] and the increasing disbursement of bilateral donors for preparedness activities.^[163] Although various recent studies have demonstrated that the funds available for preparedness measures are insufficient,^[164] too fragmented and often neither well known nor easy to access by interested States,^[165] it seems that there is at least an increasing awareness of the importance of identifying new instruments to financially support national efforts to reinforce preparedness measures.^[166] Recent initiatives such as the Global Health Security Agenda,^[167] the Global Alliance for Vaccines and Immunisation (GAVI),^[168] the creation, in November 2016, of the International Working Group on Financing Pandemic Preparedness,^[169] which presented in December 2017 a landmark report with several relevant recommendations and suggestions^[170] and the launch, in 2017, of the Coalition for Epidemic Preparedness Innovation’s (CEPI’s), a global partnership between public, private, philanthropic, and civil society organisations,^[171] further testify to the ongoing worldwide efforts to increase the availability of international financial resources for preparedness measures. Even in the 2016 Ise-Shima Declaration, the G7 leaders underlined the importance of mobilizing the financial resources of relevant international organisations for “strengthening preparedness for and prevention of pandemics.”^[172] These efforts are of utmost importance considering that for many countries, especially the poorest and most fragile, “there is clearly a role for international development assistance in reinforcing pandemic preparedness. Here, the challenge is to ensure such contributions are effectively coordinated and prioritized, and that we transition to a sustainable funding arrangement, rather than something that withers when donor priorities change.”^[173]

In terms of the third issue, it should be underlined, once more, that dedicating available domestic resources and recurrent spending for preparedness is an essential part of “national and global security, universal health coverage and the Sustainable Development Goals (SDG).”^[174] Having said this, it has to be noticed that many countries (with the above-mentioned exception of those with a very low-level income) could self-finance pandemic preparedness measures through the national budget and, where possible, through direct financing from the private sector. Nevertheless, it cannot be denied that guaranteeing sustained commitment to financing pandemic preparedness measures often proves to be extremely difficult “since the mark of success is that nothing happens, and there will always be multiple competing priorities.”^[175] In a well-known case, the European Court of Human Rights made clear that “an impossible or disproportionate burden must not be imposed on the authorities without consideration being given, in particular, to the operational choices which they must make in terms of priorities and resources.”^[176] Borrowing a concept widely used in the jurisprudence of the international human rights courts, States enjoy, therefore, a “margin of appreciation” in determining which preparedness measures must go first and which will have to be implemented later.^[177] The exercise of this discretionary power is, however, always subject to the control of the relevant Courts, should there be a dispute over whether a State respected its preparedness obligation.^[178]

The lack of available financial resources, however, does not always justify the delays in the adoption of national preparedness measures that do not require additional financial burdens. While important improvements have been noticed recently,^[179] the degree of respect for these obligations and recommendations is, with few exceptions,^[180] still far from satisfactory, with the consequence that appropriate responses may be absent or delayed, potentially increasing the gravity of the pandemic event. According to the World Economic Forum Global Risk Report 2019,

the weakness of basic preparedness in individual countries is an important obstacle to pandemic responses. Progress has been made, particularly since the 2014–16 Ebola epidemic, but most countries have not yet reached minimum international standards of capacity to detect, assess, report and respond to acute public health threats as set out in binding regulations that took effect in 2007.^[181]

6 Concluding Remarks

This article has identified several pandemic preparedness measures that States are requested /recommended to adopt. Overall, they are relevant, regularly updated and take into consideration almost all the different fields of action. Their primary, though not exclusive,^[182] role is to reduce the number of potential victims of a pandemic event, to protect the health of communities^[183] and to mitigate risk among vulnerable populations. They always have to be carried out in full compliance with international law and, more specifically, with international human rights law, to which restrictions and derogation are permitted but only in conformity with the relevant treaty rules and procedures.^[184]

Unfortunately, available country-level data confirm “that most countries currently have low-to-moderate levels of national preparedness.”^[185] State’s failures to implement preparedness obligations codified in an international binding treaty, amount, unless there are specific circumstances precluding wrongfulness, to a violation of international law. The consequences thereof might be diversified and give raise to an inter-State dispute (which so far has never happened) or, where appropriate, to an individual claim in front of an International Human Rights Court. In this frame it is important to remind that the EctHR has repeatedly confirmed that States have an obligation to ensure the proper organisation and functioning of the public hospital service, or more generally their health protection system. The Court has always emphasized that the States’ substantive positive obligations in this area are limited to a duty to put in place an effective regulatory framework compelling hospitals, whether private or public, to adopt appropriate measures for the protection of patients’ lives. Nevertheless the Court reserved the right to examine a particular case to check whether there has been a failure by the State. This might arise where a systemic or structural dysfunction in hospital services results in a patient being deprived of access to life-saving emergency treatment, provided that the authorities knew or ought to have known about that risk and failed to undertake the necessary measures to prevent that risk from materialising, thus putting the patients’ lives in danger.^[186] In similar cases (which might well happen during a pandemic event, especially when, as in the current COVID-19 one, several waves are expected), the Court did not hesitate to condemn the State for violating article 2 of the ECHR and to order the State to pay the applicant given amounts in respect of non-pecuniary damage. A¹⁸⁷Although these conclusions formally apply only to the specific cases in front of the ECtHR, they have a strong general impact on the interpretation of the ECHR rules and, thanks to the cross-fertilization among international courts, might even have a wider influence.

Discrepancies in the degree of preparedness among States are often correlated to level of development. As to be expected, “countries with greater levels of national income have higher levels of national preparedness. Thirty-nine low-income countries have the lowest levels of preparedness, while higher-income countries score the highest capacity levels for preparedness.”^[188] Notwithstanding commitments to share lessons learned and technologies, and to offer technical and financial assistance to the States in greatest need, the gap is still significant.^[189]

Having in mind the worldwide impact of pandemics, which do not know any artificial or natural border, these discrepancies represent a threat to humanity. The urgent implementation of the universal governance and coordination mechanisms for health emergency preparedness and response is urgently needed^[190] and recent initiatives undertaken in this direction are to be welcomed.^[191] Considering that, differently from the past, it is presently possible “to build an arsenal of new weapons—vaccines, drugs, and diagnostics”^[192] and that we can count on new “technology platforms that leverage recent advances in genomics to dramatically reduce the time needed to develop vaccines,”^[193] inaction in fulfilling universal pandemic preparedness obligations can no longer be justified, whether in legal, political or moral terms. To use the recent words of the WHO Secretary General referred to the COVID-19 pandemic, history will judge all of us “not only on whether we got through this pandemic, but also on the lessons we learned and the actions we took once it was over.”^[194] It is time to act.