International Health Regulations

The original International Health Regulations (IHR) were adopted in 1969. However, its underpinnings can be traced to the mid-19th century, when measures to tackle the spread of plague, yellow fever, smallpox and particularly cholera across borders, with as little interference to global trade and commerce, were debated.[3][7][8] To address the realisation that countries varied with regards to their sanitary regulations and quarantine measures, the first of these series of early international sanitary conferences was convened in Paris in 1851. This was in the same year that telegraphic communications became established between London and Paris. 12 nations attended this conference, of which 11 were European states and three would sign the resulting convention. In the 19th century. there were 10 of these conferences.[7][8]

1948: the World Health Organization Constitution was founded.[8]

1951: the WHO issued its first infectious disease prevention regulations, the International Sanitary Regulations (ISR 1951), which focussed on six quarantinable diseases; cholera, plague, relapsing fever, smallpox, typhoid and yellow fever.[9]

1969: the ISR were revised and renamed the 'International Health Regulations'.[9]

1973: the Twenty-Sixth World Health Assembly amended the IHR (1969) in relation to provisions on cholera.[10]

1981: in view of the global eradication of smallpox, the Thirty-fourth World Health Assembly amended the IHR (1969) to exclude smallpox in the list of notifiable diseases subject to the IHR (1969).[10]

1995: during the Forty-Eighth World Health Assembly, the WHO and Member States agreed on the need to revise the IHR (1969). Several challenges were placed against the backdrop of the increased travel and trade characteristic of the 20th century. The revision of IHR (1969) came about because of its inherent limitations, most notably:

• narrow scope of notifiable diseases (cholera, plague, yellow fever). The past few decades had seen the emergence and re-emergence of infectious diseases. The emergence of “new” infectious agents Ebola Hemorrhagic Fever in Zaire (modern-day Democratic Republic of Congo) and the re-emergence of cholera and plague in South America and India, respectively;
• dependence on official country notification; and
• lack of a formal internationally coordinated mechanism to prevent the international spread of disease.

In 2005, a values statement document entitled "The Principles Embodying the IHR" was published and said inter alia:[11]

1. With full respect for the dignity, human rights and fundamental freedom of persons;
2. Guided by the Charter of the United Nations and the Constitution of the World Health Organization;
3. Guided by the goal of their universal application for the protection of all people of the world from the international spread of disease;
4. States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to legislate and to implement legislation in pursuance of their health policies. In doing so, they should uphold the purpose of these Regulations.

On 15 June 2007, the IHR (2005) entered into force, and were binding as of June 2020 on 196 States Parties, including all 194 Member States (countries) of WHO.[6]

In 2010, at the Meeting of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and Their Destruction in Geneva,[12] the sanitary epidemiological reconnaissance was suggested as a well-tested means for enhancing the monitoring of infections and parasitic agents. The aim of this recommendation was to prevent and minimize the consequences of natural outbreaks of dangerous infectious diseases, as well as the threat of alleged use of biological weapons against BTWC States Parties. The conference also noted the significance of the sanitary epidemiological reconnaissance in assessing the sanitary-epidemiological situation, organizing and conducting preventive activities, indicating and identifying pathogenic biological agents in the environmental sites, conducting laboratory analysis of biological materials, suppressing hotbeds of infectious diseases, and providing advisory and practical assistance to local health authorities.

In January 2018, a group of WHO bureaucrats published an article in the British Medical Journal on Global Health entitled "Strengthening global health security by embedding the International Health Regulations requirements into national health systems", in which the authors argued that "the 2014 Ebola and 2016 Zika outbreaks, and the findings of a number of high-level assessments of the global response to these crises, [clarified] that there is a need for more joined-up thinking between health system strengthening activities and health security efforts for prevention, alert and response."[13]

In order to declare a PHEIC, the WHO Director-General is required to take into account factors which include the risk to human health and international spread as well as advice from an internationally made up committee of experts, the IHR Emergency Committee (EC), one of which should be an expert nominated by the State within whose region the event arises.[2] Rather than being a standing committee, the EC is created ad hoc.[15]

Until 2011, the names of IHR EC members were not publicly disclosed; in the wake of reforms now they are. These members are selected according to the disease in question and the nature of the event. Names are taken from the IHR Experts Roster. The Director-General takes the EC's advice following their technical assessment of the crisis using legal criteria and a predetermined algorithm after a review of all available data on the event. Upon declaration of the PHEIC, the EC then makes recommendations on what actions the Director-General and Member States should take to address the crisis.[15] The recommendations are temporary and require three-monthly reviews.[2]

The formation of an IHR Review Committee is the responsibility of the DGWHO. They are selected from the IHR Experts Committee, and "when appropriate, other expert advisory panels of the Organization." Furthermore, the DGWHO "shall establish the number of members to be invited to a meeting, determine its date and duration, and convene the Committee."

"The DGWHO shall select the members of the Review Committee on the basis of the principles of equitable geographical representation, gender balance, a balance of experts from developed and developing countries, representation of a diversity of scientific opinion, approaches and practical experience in various parts of the world, and an appropriate interdisciplinary balance."

The IHR requires countries to assess their disease surveillance and response capacities and to identify if they can adequately meet their requirements. The seven Ebola reports universally agree that the country's self-assessment capabilities are insufficient and that verification measures need to be improved upon. A significant problem is the inadequate level of core capacities in some countries, and the question of how to build upon them has been frequently raised. The reports make several recommendations to encourage governments to increase investment in outbreak identification and response programs. These include technical help from external sources conditional on mobilizing domestic resources, external financing for low income countries, pressure from the international community to increase investment, and considering outbreak preparedness as a factor in the International Monetary Fund's country economic assessments, which influence governments’ budget priorities and access to capital markets. Another avenue under discussion is reform of Article 44 of the IHR, potentially through a new pandemic convention.[19]

The second issue frequently raised is ensuring that restrictions on trade and travel during outbreaks are justified. Because of increased attention and concern from the public and the media, many governments and private companies restricted trade and travel during the Ebola outbreak, though many of these measures were not necessary from a public health standpoint. These restrictions worsened financial repercussions and made the work of aid organizations sending support to affected regions more difficult.

There was broad consensus across the reports that bringing such restrictions to a minimum is critical to avoid further harm to countries experiencing outbreaks. Moreover, if governments assume that reporting will lead to inappropriate travel and trade restrictions, they may be hesitant to notify the international community about the outbreak. Potential solutions raised included the WHO and the UN more assertively “naming and shaming” countries and private companies that impose unjustified restrictions on WHO working with the World Trade Organization, International Civil Aviation Organization, and International Maritime Organization to develop standards and enforcement mechanisms for trade and travel restrictions.

The third compliance issue relates to countries’ obligation to rapidly report outbreaks. The reports recommend strengthening this obligation by WHO publicizing when countries delay reporting suspected outbreaks. In contrast, mechanisms ensuring that countries rapidly receive operational and financial support as soon as they do report were also recommended. A novel approach to encourage early notification is the World Bank's Pandemic Emergency Financing Facility. This was created to provide rapid financing for the control of outbreaks and to protect countries from the devastating economic effects of outbreaks via an insurance program.