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The stated purpose and scope of the IHR are; "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." Because the IHR are not limited to specific diseases, but are applicable to health risks, irrespective of their origin or source, they will follow the evolution of diseases and the factors affecting their emergence and transmission. The IHR also require States to strengthen core surveillance and response capacities at the primary, intermediate and national level, as well as at designated international ports, airports and ground crossings.

The International Health Regulations (IHR), a legally binding agreement between 196 States Parties, whose aim is to prevent, protect against, control, and provide a public health response to the international spread of disease, deserve critical examination with regard to their applicability. The emergence and spread of the new mysterious hemorrhagic fever may constitute a public health emergency of international concern (PHEIC) and is therefore notifiable to the World Health Organization under the IHR notification requirement.

IHR (2005) is coordinated by the World Health Organization (WHO) and aims to keep the world informed about public health risks and events. As an international treaty, the IHR (2005) is legally binding; all countries must report events of international public health importance. Countries reference IHR (2005) to determine how to prevent and control global health threats while keeping international travel and trade as open as possible.

IHR (2005) requires that all countries have the ability to do the following:

· Detect: Make sure surveillance systems and laboratories can detect potential threats

· Assess: Work together with other countries to make decisions in public health emergencies

· Report: Report specific diseases, plus any potential international public health emergencies, through participation in a network of National Focal Points

· Respond: Respond to public health events

IHR (2005) also includes specific measures countries can take at ports, airports and ground crossings to limit the spread of health risks to neighboring countries, and to prevent unwarranted travel and trade restrictions.

One of the most important aspects of IHR (2005) is the requirement that countries detect and report events that may constitute a potential public health emergency of international concern (PHEIC) for this matter we are referring to the hemorrhagic fever.

Under IHR (2005), a PHEIC is declared by the World Health Organization if the situation meets 2 of 4 criteria:

· Is the public health impact of the event serious?

· Is the event unusual or unexpected?

· Is there a significant risk of international spread?

· Is there a significant risk of international travel or trade restrictions?

So as soon as the fever was identified in the tropical resorts as an event of concern, there must be an assessment of the public health risks of the event within 48 hours. If the event is determined to be notifiable under the IHR, this must be reported to WHO within 24 hours.

The example case of the mysterious hemorrhagic fever is highly applicable to be a notifiable disease under IHR. The mentioned case appears to hit the tropical resort which is mostly visited by tourists thus making the disease a public health concern. The tourists might easily spread the disease all over the globe. This needs to be reported and ensure that all necessary measures to detect it early, manage and contain it within the area of disease eruption.

As noted, the number of tourists has decreased and economically this has an impact to the affected country. This in some cases might pose hesitation to report among the affected state fearing that it might scare the tourists and hence impact the member state economically. However, the risk of spread outweighs the economic risks. If the disease is not reported, other member states might fail to support. As it is mentioned as the scope of IHR "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."

Some diseases always require reporting under the IHR, no matter when or where they occur, while others become notifiable when they represent an unusual risk or situation.

The world threat posed by the spread of hemorrhagic fever cannot be addressed by individual countries alone, but requires a coordinated international response. Recognizing the applicability of the IHR to this outbreak will serve as a “wake-up call” and strengthen global surveillance and response, which could in turn contribute to containing the spread of the fever. Notifications of events should serve as alerts and can be an important instrument in the chain of “the global early warning function, the purpose of which is to provide international support to affected countries and information to other countries if needed”. The immediate consequence of notification is to initiate an “exclusive dialogue between the notifying State Party and WHO concerning the event at issue” and to make a joint risk assessment. The dissemination of information through the WHO Event Information System (EIS) could expediently increase awareness in multiple countries, allow early implementation of screening measures for persons at risk (e.g., international hospital transfers), and prevent the establishment of new strains in unaffected countries. IHR can also facilitate the international dissemination of appropriate measures to counter the spread of hemorrhagic fever.

Applying the outbreak of hemorrhagic fever to IHR may face obstacles as well, for instance: Even if WHO and a majority of States Parties consider that the fever should be addressed under the IHR, technical, financial, and political obstacles might interfere. Notification of an event to WHO depends on it being detected (requiring a functioning health system and adequate laboratory capacities), and reported to the National IHR Focal Point. There is a concern that many States Parties are far from being compliant with the IHR's minimum core capacity requirements for surveillance and response. Even if relevant information filters through to the national level, notification decisions may be under political control which in many cases cannot be interfered with.

The IHR framework provides a global surveillance infrastructure and orchestrates an appropriate public health response. The IHR are ultimately “owned” by the States Parties, some of whom increasingly understand the extent and urgency of the threats posed by emerging disease outbreaks. However, it is up to WHO to provide leadership on the role of the IHR.

The role of national sovereignty in mounting a global response.

National sovereignty is the beginning of global governance, particularly in the arena of global infectious disease control, encompasses range of integrated policy, information management, command and control mechanisms for facilitating collective action to achieve the objectives of prevention, detection, and response (Global Health Risk Framework, 2016). The structural elements of public health protection and healthcare delivery are controlled by either national governments. The states still remain the most important actor in determining whether health is assigned a high priority, or is ignored. The states remain the principal gatekeepers between global health governance in theory, as well as practice (Stevenson & Cooper, 2009).

The concept of state sovereignty is largely been associated with and understood in association with Westphalian principle. Westphalian principle forbids armed interference by one state in the internal affairs of another. A crucial aspect of world order (agreed upon by most countries), is respect for international borders. There is an unspoken respect for international borders. Millions will die to protect their state’s sovereignty; this reflects the intense depth of commitment to the precept of state sovereignty. Strong loyalty to the sovereignty paradigm endures as states fiercely guard and protect their state’s sovereignty, even if it is meant to bring aid and assistance. Francis Deng, South Sudan’s Roving Ambassador, observes and aptly puts into perspective that “whether international involvement in a domestic problem is strategically motivated or driven by humanitarian concerns, it nearly evokes a reaction that is both appreciative of the assistance and hostile to foreign intervention”. Furthermore, there is the notion that “when the state fails to honor the responsibilities of national sovereignty, the people will retain their consciousness of pride, honor and independence, despite their need for external help” (Etzioni, 2016).

In the emerging post-Westphalian model sees states as just one set, most important, of a complex of multiple actors. These actors have some degree of legitimacy in both inter and intra-state governance. In context of health governance these include health organizations such as WHO, non-governmental organizations (Doctors without Borders), private philanthropic foundations (e.g., Bill and Melinda Gates Foundation), and public-private partnerships (e.g. Global Fund), where business actors partner with public actors in the provision of health related commodities. The post-Westphalian model is linked with both governance (justification for existence) and with global governance (recognition of multiple authorities). There are two well established normatives in global health governance that instruct responsibilities of states within the domain of healthcare delivery and public health protection. The two normatives are: 1) health is a human right which must be safeguarded by states and 2) safeguarding public health is an essential element of preserving collective security in today’s globalized community. Given these normatives, states are responsible and expected to constantly protect population health within their respective territorial jurisdictions; especially those vulnerable to poor health and disease. Simultaneously, these same states are expected to uphold internationally agreed-upon regulations and standards of public health, like those outlined in the International Health Regulations. Adherence to these international regulations (IHR) requires that states acknowledge and recognize the legitimacy of the external authority when developing domestic policy; generally, in this process, some elements of state sovereignty are inevitably are relinquished. State sovereignty in this case, is extremely difficult to capitulate and public health crises and outbreaks are not an exception (Stevenson & Cooper, 2009).

Ultimately, the sovereign state is responsible and accountable to both internal, as well as external constituencies, as we are all interconnected living in a global community, where one thing indubitably affects everything else. In the 2004 UN Secretary-General’s High-level Panel on Threats, Challenges and Change in their report entitled “A More Secure World – Our Shared Responsibility”, “today, the notion of State sovereignty carries with it the obligation, of a State to protect the welfare of its own peoples and meet its obligations to the wider international community.” In order to be a legitimate sovereignty, the state must show responsibility with at a minimum of providing the basic needs of its people (Etzioni, 2016). Ultimately, community engagement is decisive tool/strategy in commanding and controlling outbreaks, people understand, and own a problem, they carve out their own socially and culturally accepted solutions.

Lack of political will and lack of capacity are two major aspects of national sovereignty. Will political leaders place collective action as top priority item on their agenda and will they provide ample funding to build IHR core capacities? The IHR 2005 framed the impact of security upon the global health agenda. States could understand the security rationality behind the implementation of IHR. International anxieties and concerns about health security threats were influential in breaking the sovereign deadlock. According to Davies et al., in the book, In Disease Diplomacy , it was the “the crucial zeitgeist of the securitization of infectious disease” and mobilization of a security conversation that helped to persuade states that it was in their best interest to take a cooperative posture. Also, it was in the states’ best interest to institute mechanisms that would foster both more transparency in disease reporting and a more impactful and commensurate international response (Nunes, 2017).

The way society responds to health conditions (e.g., diseases and risk factors) is based on the framework on national level, as well as on the global level. Faced with set of health situations/conditions, a nation/country articulates a response through its national health system. The more robust, the system, the more efficient and effective a health response is detected and mounted. Ultimately and ideally, national governments should be equipped to be responsible for larger-scale responses sustainably on the foundation of existing community structures. Due to globalization, cross-border health threats, leading to a situation of health interdependence (notion that no nation, entity or organization can singularly handle the potential health threats, rather they must instead lean on others to some extent to mount an effective response. This is the current and most likely, the future reality. The organized social response to health conditions at the global level is referred to as the global health system (Frenk and Moon, 2013). At the national level, there are traditional instruments in place for mobilizing action, such as taxation, routine law enforcement, and democratic decision-making and policy making procedures. The core of the global health system is the national governments with their national ministries, departments and agencies. National governments coordinate their responses to common health challenges through a multiple of mechanisms. Nations must swiftly and effectively harness management of externalities to prevent or mitigate negative health effects or decisions originating in one country may affect another. Responses involve the deployment of such instruments as surveillance systems, coordination mechanisms, information-sharing channels. These instruments are critical for controlling the international transfer of risks and ensuring timely response to threats which can spread across borders (e.g., pandemics, environmental pollutants, drug resistance, etc.). The management of externalities rests on the caliber of national sovereignty and its accountability to respond to global health crises, as well as other situations that would affect the global community (Frenk and Moon, 2013).

The principle of state sovereignty is that it is the state singularly decides on which actions and measures take place within their respective territory. At times, there are areas of conflict between national sovereignty and global health security. For instance, according to the IHR (2005), a WHO member state maintains clear points of contact and thus, they must establish a “National IHR Focal Point”. These focal points are responsible for reporting possible public health threat directly to the WHO, as well as to their respective governments. Once WHO receives this information from the National IHR Focal Point about such a potential threat, WHO has discretion to make such information public via a WHO-issued recommendation. In essence, this action could impede the state’s role of informing its citizens of any domestic health issues. Member states may want to preserve national security, as it may not be in the state’s best interest to have information about a potential public health threat immediately being shared to the public. Member states may need more time (than 24 hours as mandated by IHR 2005) to muster and mobilize exigent resources to prevent a possible escalation of a domestic health threat (Mack, 2006). In addition, IHR 2005 requires each WHO member state to have core capacities to “detect, assess, notify and report events”. However, some member states do not have the resources or capacity to implement such, sometimes drastic, public health programs. It will be demanding task in terms of financial and personnel resources. The implementation of such programs requires certain domestic infrastructure to be in existence along with necessary technological knowledge to execute and maintain such a system. “Some nations are poor and cannot afford sophisticated public health systems, whereas others are failed states in the midst of civil strife, war, or natural disaster” (Mack, 2006). In such developing regions, they face a “double burden” as they are dealing with indigenous diseases and illness originating from their struggles to emerge from poverty. Such nations, certainly do not have the capacity to increase their national capacity for monitoring and surveillance of new, emerging health threats, which are required by IHR 2005. This creates a “triple burden” for the less developed member states. Some critics would argue that such a surveillance requirement (IHR 2005) seems to intrude on a state’s right to address and make decisions on the best ways to monitor initial domestic threats. Another area of national sovereignty which may be compromised by IHR 2005 is the notification of outbreaks of infectious diseases to WHO. Often health authorities are not able to completely understand the scope and impact of newly emerging diseases, information regarding potential public health threats will often more times than not, be unpredictable. This unpredictability factor affects the ability of domestic health authorities to appropriately evaluate all the risks involved in the public health threat. Once WHO public releases information regarding the occurrence of the defined syndromes, those affected member states may run the risk of serious economic and social harm even before any actual disease has been definitely identified. WHO member states can opt not to comply with regulations adopted by the World Health Assembly, but typically do not due to negative backlash. With the continuance of such compliance, as long as it remains beneficial to the member state. The underlying factor influencing any program’s success continues to be the immediate economic benefits stemming from the state compliance. (Mack, 2006). Noncompliance is an option that the affected member state may select, however, it is not often times, the most realistic option. In the case that the affected member state declines collaboration with the international community, the WHO may, “when justified by the magnitude of the public health risk” communicate information regarding the public health risk with other member states. No enforcement mechanisms are outlined in the IHR (2005) provisions for noncompliant state members. However, there are potential ramifications of noncompliance, manifested in economic terms, and serve as a compliance tool (Mack, 2006).

Although health continues to be primarily a national responsibility, the intensified transfer of health risks across boundaries signifies that the determinants of health and the means and subsequently the means to fulfill those responsibilities are typically beyond the control of any individual state or nation, for that matter. As Genest observes that “in a global epidemiological world, there is no place to hide”. We live “in a unified microbial world in which there is no place that can be out of reach of infections and pathologies”. In a global and fluid world, global surveillance and intelligence is viewed as the most effective means to control disease spread. As we have moved beyond the national level for reliance on health response and surveillance to that of a global health surveillance, where there is an associative relationship between health and security/risk issues. States sometimes have displayed a strong incentive to hide epidemiological information and data from the rest of the global community for “fear of the blame and shame boomerang effect”. The development of technologies with potential to be global in scope, the ongoing mechanism of health surveillance evolved to a global perspective via managerial practices, risk analysis, and security preferences. A new mode of surveillance, systemic pre-detection, rests on the collection, interpretation, dissemination and acting on health information. This represents a fundamental shift from traditional sovereign actors and actions (border closure, national emergency plans, internal drug policy, etc.) to a form of communicative and information-based power, no longer the sole capability of the state or nation (Genest, 2015). States are inclined to “stretch” their sovereignty with respect to global health security and surveillance, so that they can have access to information and resources. The cost of sovereignty losses appears to be a tradeoff for better information into, and about the global apparatus of information where they can tap into the global space of diseases. Given the contemporary fluid global community, “health systems must address the wide-ranging effects of poverty, civil upheaval, cultural beliefs, and other factors that undermine. Namely, the rights of sovereign states and the need for global security, each country must be able to detect potential outbreaks. Through appropriate and judicious leveraging of the IHR, WHO is obliged to help countries establish core capacities for early disease detection, timely and transparent notification. A delicate balance exists between preservation of national sovereignty and establishing global security in a borderless world.

Whether priority should be given to prevention or treatment.

Numerous challenges face clinical trials taking place in outbreak situations. In this scenario, decision on whether priority should be given to prevention or treatment is crucial. In developing the guidelines for WHO coordinated response, it is recommended that priority be given to treatment for various reasons.

First, since the discovery is new, there may be a number of unknowns regarding vaccination. For example, the durability and rapidity of immune responses is unknown. Rapidity of an immune response is important because it determines the relative effectiveness of the vaccine in the context of ring vaccination. Ring vaccination strategy has been shown to be effective in preventing new cases and limiting the spread of infectious diseases. Therefore before prioritizing TropicX as vaccine, more research is needed in the area of efficacy and immunogenicity.

Another unknown regarding TropicX as a vaccine relates to adverse events. Although few serious vaccine-related adverse events have been observed, additional large-scale trials need to determine the overall safety of new vaccines (Levy et al, 2018). For example, one of the Ebola vaccine (rVSV-ZEBOV) has been shown to be a risk factor in the development of arthritis to females who have a medical history of arthritis (Levy et al, 2018).

As such, there may also be challenges in administering the vaccine. In an outbreak context, it may be easily interpreted the vulnerable group, children and pregnant women, receive every possible protection from the disease. But since these two groups are seen as particularly vulnerable, they should not be placed on the “front line” of interventions that have yet to be fully tested. Therefore excluding them from the vaccines may raise ethical concerns.

The final unknown relates to community engagement and ongoing trust-building throughout the vaccine process which are crucial. Distrust towards vaccines might exist in the population and negatively affect cooperation with the vaccine administration or even lead to suspension, as occurred in Ghana, where two Ebola vaccine trials were suspended because of negative rumours ( Kummervold et al, 2017).

In addition, the affected population may also not accept the vaccines particularly when the research is led by foreign institutions or personnels. For example, the current outbreak of Ebola in DRC, ring vaccination of those who fall ill and their contacts has not succeeded in limiting the spread of the virus because there is mistrust of the vaccine (www.theguardian.com, 2019). Some people falsely believe that Ebola vaccine is what is making people sick (www.theguardian.com, 2019). Hence there maybe confusion and mistrust since the vaccine is new.

Finally, since the supply of TropicX is limited, managing the demand for vaccine intervention will be challenging. Limited supply of the vaccine means denying somebody the right to an intervention which might be effective. This may raise questions especially in this situation where the case fatality rate from the disease is high.

Thus, priority should be given to treatment because it provides the greatest possible benefit for participants under imminent threat of the disease. Treatment also provides optimal care to patients already suffering the disease. To wrap it up, in absence of approved vaccines, control of the epidemic should rely on treatment or on nonpharmaceutical interventions such as quick identification and isolation of cases.

How to address misconceptions and opposition

We saw in the H1N1 pandemic review how the WHO was exposed as underperforming in their leadership role. 

Thus far, 40% of persons affected by the new hemorrhagic fever at tropical resorts have died. This suggests we are very possibly entering another disastrous season of disappointing unpreparedness.

Clearly, world opinion concurred earlier, and as we are now seeing: WHO desperately needs reconfiguration. It needs to fine tune practices leading to global health safety, security, and sustained ethical global health equity

The WHO thought processes--‘one size fits all’ is an illusion. The complexities of regional differences and the unique needs of populations are real considerations. Insufficient standardized surveillances and responsive follow through, along with dwarf financial allocations, all contribute to negatively impacting sought after total health care. Mismanagement of investor funding coupled with indifference towards poverty driven states, do little to distribute needed health relief. Well-intended investor funding does not reach deeply into the abyss of impoverished people.

But perhaps equally if not, more damaging is the failure of WHO to attend to and build upon establishing confidences among all stakeholders regardless of the country’s economic status. The intrinsic deep care for the poorest and most vulnerable impoverished nation communities is often marginalized. Apparently, WHO’s preoccupation with catering to the pharmaceutical industry can prove more lucrative an attraction and desired goal than prerequisite universal ethical standards on global equity matters—despite initial goodwill intentions under IHR (2005)

We can intensify discussions on systemized surveillance protocols, reporting and assessment enhancements, and enforced restrictions on trade/travel in order to curb transmissions. We can apply excuse for insufficient availability of TropicX. But how do we deal with social media distortions and the transformation of wealthier nations getting on board with committing financially—to embrace the fullness of ethical, global health equity? How do we address misconceptions and opposition reported and the recurring responses bombarding social media which highlight WHO’s oversight and failures, and the distrust of a growing majority—particularly among impoverished nations—when distortions erupt and the status quo is boldly challenged?

Once again, the WHO is caught off guard as with the H1N1 pandemic. Disclosures revealed the failure of Big Pharma Industries (BPI) to manufacture sufficient quantities of TropicX medication; 40% of persons affected with the hemorrhagic fever attack have died. Given the rapid advancement of this eruption, studied preparedness protocol responses and hoped-for positive outcomes are not forthcoming. And the outcomes have not gone unnoticed.

Full transparency and honesty, as well as utilization of accessible communication tools are core expectations worldwide, if global cooperation is truly the end goal. The impact of social media cannot be trivialized. It is the one place where given access, all voices can be heard, privately assessed, then rapidly thrown into center ring across the entire world—in opposition, compliance, and everything in between.

Though the ‘voice’ of social media can be a dominant influencer, national law and the nation’s constitutional constructs on information flow and governing processes is the rule of law. If censorship is the central agenda legislatively, and in the absence of the people’s trust in home government and donor-driven priorities, unbridled suspicions easily gain opportunity.

To move into the zone of increased trust, the WHO will need to engage the people at the planning and development table as primary stakeholders, and include deliberate representation of low to middle income nations. Collectively, populations must see defined, measurable increases in the following areas:

· Early warning and consistent broad-base access to quality medical treatment and health care practices.

· Regarding the ‘human research enterprise’: Clarification on informed consent when channeled into a research study; uncovering its true purpose, along with a guarantee of full continuing post study support for all participants.

· Guarantee of benefitting from successful research study outcomes for participants and their home community--foremost

· Provision of sufficient quantity of dedicated, trained healthcare workers and physicians to care for affected persons, their families and communities, proportionately

· Expanded quantity of access to laboratories and dependable commitment to relay lab outcomes rapidly and in full description of findings, cautions, etc.

· Planned support to protect the health and well-being of field health providers; elimination of syphoning their country’s health care workers off to wealthier nations via incentives and facilitated emigrant privileges

· A visible and consistent presence of compassionate government locals working cooperatively with village leaders, educating, and maintaining respect for religious and social lifeways—values and traditions

· Providing clear evidence and full explanation of the country’s envisioned universal health plan; validating the role each person has in moving it towards success; getting the message out consistently via widely broadcasts frequently, across all available channels of communication

· Removing threats of paternalism or suggesting a hidden agenda that would subjugate or water down the rights of persons to coexist healthily and function productively in their own homeland

· Deriving at ethical decisions systematically: (e.g. provision of priority access to antiretroviral drugs; attentiveness to acknowledging the need/practice of applying different frameworks—despite the surface appearance of similarities—so that specific cultural/regional needs can be met in a timely fashion)

· Gender equity practices: i.e. delivery of needed, quality services and treatments to women and children in order to sustain continuance and safekeeping of the culture and community

· Commitment to schedule stakeholder committees to frequently reconvene, review, make corrections, share relevant new information, any concerns, conflicts and/or solutions

· Institute a media blitz or social media platform that gets to the heart of rapidly correcting misconceptions in an effort to offset opposition and open conflict

· Assistance with strengthening borders surveillances; more efficiency among donor providers and smooth coordination of mutual donor-driven priorities

· Securing pledges from wealthier nations to forge ahead with the political will and accompanying resources they are willing to set in place to ‘help level the playing field’

· Work synergistically to greatly reduce the drain low resource nations experience when trying to take on complex demands of diverse international partners, causing fragmented assistance, in the long run

Guaranteed adherence to pre-agreed criteria and execution of all things promised.

References