The International Health Regulations are an international legal instrument which is legally binding on all WHO Member States who have not rejected them (or, subject to the procedure foreseen in the IHR, who have made reservations) and on all Non-Member States of WHO that have agreed to be bound by them.

The purpose of the International Health Regulations adopted in 1969 (IHR(1969)) is to ensure maximum security against the international spread of diseases with a minimum interference with world traffic. The IHR(1969) only apply to three infectious diseases: cholera, plague and yellow fever.

Because of their narrow scope of application and other limitations (see Question 3 below), the IHR(1969) were revised by the WHO Member States. In May 2005, the World Health Assembly adopted the revised International Health Regulations (IHR(2005)) (see Question 2 below). The current IHR(1969) will be replaced by the IHR(2005) when the latter come into force on 15 June 2007.

The purpose and scope of the IHR(2005) 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. The IHR(2005) also establish a single code of procedures and practices for routine public health measures at international airports and ports and some ground crossings.

The cholera epidemics that overran Europe between 1830 and 1847 were catalysts for intensive infectious disease diplomacy and multilateral cooperation in public health. This led to the first International Sanitary Conference in Paris in 1851. In 1948, the WHO Constitution came into force and in 1951 WHO Member States adopted the International Sanitary Regulations, which were replaced by and renamed the International Health Regulations in 1969. The Regulations were subject to minor modifications in 1973 and 1981.

The IHR were originally intended to monitor and control six serious infectious diseases: cholera, plague, yellow fever, smallpox, relapsing fever and typhus. Under the current IHR, only cholera, plague and yellow fever are notifiable, meaning that States are required to notify WHO if and when these diseases occur on their territory.

In the early 1990s, the resurgence of some well known epidemics such as cholera in parts of South America, plague in India and the emergence of new infectious agents such as Ebola haemorrhagic fever resulted in a resolution at the 48th World Health Assembly in 1995 calling for the revision of the Regulations.

In May 2001, the World Health Assembly adopted resolution WHA 54.14, Global health security: epidemic alert and response, in which WHO was called upon to support its Member States in identifying, verifying and responding to public health emergencies of international concern.

In May 2003, resolution WHA56.28 Revision of the International Health Regulations, established an intergovernmental working group (IGWG) open to all Member States to review and recommend a draft revision of the International Health Regulations for consideration by the World Health Assembly. The IGWG held two sessions in November 2004 and February/May 2005 with a view to endorsing a final text for consideration by the World Health Assembly at its 58th meeting. The World Health Assembly adopted the IHR(2005) on 23 May 2005 by way of resolution WHA58.3.

The revision was needed to address limitations in the current IHR(1969) identified through experience in detecting and responding to disease outbreaks with international dimensions.

In recent decades, cross-border travel and trade have increased and communication technology has developed markedly. New challenges have arisen in the control of emerging and re-emerging infectious diseases. The world has entered an information age in which news spreads via a multitude of formal and informal channels.

The focus on just three diseases (cholera, plague and yellow fever) by the IHR(1969) does not address the multiple and varied public health risks that the world faces today. In addition, some unwarranted and damaging travel and trade restrictions have led to reluctance by some countries to promptly report disease outbreaks and other events. The IHR(2005), which are firmly grounded in practical experience, broaden the scope of the 1969 Regulations to cover existing, new and re-emerging diseases, including emergencies caused by non-infectious disease agents.

The IHR(2005) establish a legal framework for the rapid gathering of information, for determining when an event constitutes a public health emergency of international concern (see Question 8 below), and for countries seeking international assistance. The new reporting procedures are aimed at expediting the flow of timely and accurate information to WHO about potential public health emergencies of international concern (see Question 9 below). WHO, as a neutral authority with an extensive communications network, can assess information, recommend actions and provide direct technical assistance when needed, tailored to events as they unfold.

The adoption of the IHR(2005) is one important step in strengthening the world’s collective defences against infectious disease risks.

Notification
The IHR(2005) require States to notify WHO of all events that may constitute a public health emergency of international concern (see Question 8 below) and to respond to requests for verification of information regarding such events. This will enable WHO to ensure appropriate technical collaboration for effective protection of such emergencies and, under certain defined circumstances, inform other States of the public health risks that merit action on their part.

National IHR Focal Points and WHO IHR Contact Points
A further change requires the establishment of National IHR Focal Points and corresponding contact persons or officials. National IHR Focal Points ensure the operational link between States and the WHO on IHR matters. National IHR Focal Points provide to and receive information from WHO on a 24 hour a day basis, seven days a week. Furthermore, under the IHR(2005), WHO is required to inform States of its IHR Contact Points at the headquarters or regional level.

Definition of core capacities 
The IHR(2005) set out the basic public health capacities a State must develop, strengthen and maintain at the primary, intermediate and national levels in order to detect, report and respond to public health risks and potential public health emergencies of international concern. In addition, specific capacities are required for the implementation of measures at certain international airports, ports and ground crossings.

Recommended measures
WHO’s response to a public health event may include recommended measures for application by the State affected by a public health emergency of international concern, by other States and by operators of international transport.

Temporary recommendations are made by WHO on an ad hoc, time-limited, risk-specific basis, as a result of a public health emergency of international concern.

Standing recommendations indicate the appropriate measures for routine application for specific ongoing public health risks at certain international airports, ports and ground crossings and are for routine or periodic application.

Measures could be directed towards persons, baggage, cargo, containers, ships, aircraft, road vehicles, goods or postal parcels.

External advice regarding the IHR
The IHR(2005) include procedures for obtaining independent advice concerning IHR implementation. The first procedure is the establishment of an Emergency Committee to advise the Director-General of WHO in determining whether a particular event is, in fact, a public health emergency of international concern and to provide advice on any appropriate temporary recommendations. An IHR Review Committee is tasked with advising the Director-General on technical matters relating to standing recommendations, the functioning of the Regulations and amendments thereto.

The IHR(2005) will become legally binding on all WHO Member States except those that have rejected them or submitted reservations within 18 months of notification of adoption of the IHR(2005) by the World Health Assembly. However, if a reservation is compatible with the object and purpose of the IHR(2005) and it has not been objected to by at least one-third of the other States within six months of its notification, the Regulations enter into force for the reserving State, subject to the reservation. Non-Member States of WHO may notify the Director-General of WHO that they agree to be bound by the Regulations.

The responsibility for implementing the IHR(2005) rests with WHO and all States that are bound by the Regulations. Within countries national health administrations are responsible for implementing the IHR(2005) and WHO will support States in this task.

In addition to national health authorities, international transport operators or other appropriate entities may be involved in the implementation of WHO-recommended measures.

Under the IHR(2005), WHO is required to collaborate with States in a number of areas such as in the evaluation, assessment and strengthening of their public health capacities. This assistance includes supporting States in identifying the required financial resources to develop and maintain these capacities. Additionally, WHO shall continue to provide technical and logistical assistance to States in order to facilitate the full and effective implementation of the Regulations.

According to the IHR(2005) a public health emergency of international concern refers to an extraordinary public health event which is determined:

i. to constitute a public health risk to other States through the international spread of disease; and
ii. to potentially require a coordinated international response.

This definition broadens the scope of the IHR(1969) from just cholera, plague and yellow fever to cover existing, new and re-emerging diseases, including emergencies caused by non-infectious disease agents. The definition underlines the need to take into account the context in which an event is occurring as well as the causal agent (if known).

The occurrence of a specific disease does not in itself provide enough information to assess the risk of international spread. The geographical setting, time, size of outbreak, closeness to an international border or airport, speed of spread and mode of transmission, amongst other factors, are all relevant in analysing whether the event is an international public health risk.

To help States identify what may or may not constitute a public health emergency of international concern, the IHR(2005) provide States with a decision instrument (Annex 2 of the Regulations). It directs States to assess events occurring within their territory and to notify WHO of those that may constitute a public health emergency of international concern according to the following criteria:

i. seriousness of the public health impact of the event;
ii. unusual or unexpected nature of the event;
iii. potential for the event to spread internationally; and/or
iv. the risk that restrictions to travel or trade may result because of the event.

Timely and transparent notification of events combined with a coordinated assessment of the risks by the concerned State and WHO , along with effective risk communication, will greatly enhance international confidence during such emergencies and reduce the likelihood of unilateral imposition of trade or travel restrictions.

In determining when a particular event constitutes a public health emergency of international concern the IHR(2005) provide for the establishment of an independent Emergency Committee to inform this process by advising the Director-General of WHO.

Once WHO has determined that a particular event constitutes a public health emergency of international concern, the IHR(2005) require WHO to make a ‘real-time’ response to the emergency. Based on the details specific to each emergency, the Director-General of WHO will recommend measures for implementation by the affected State as well as by other States. These time-limited recommendations are made available to States and, subsequently, made public. Depending on the evidence, recommended measures could be modified or ended. The Emergency Committee (see Question 4 above) will advise the Director-General on these recommendations.

The IHR(2005) aim to enhance communications between WHO and the States. The establishment of a National IHR Focal Point will give WHO direct access to officials within the State with the decision-making power to alert and notify WHO of events that may constitute a public health emergency of international concern.

Under the IHR(2005), States will be required to notify the WHO IHR Contact Point, at the headquarters or regional level (see Question 4 above), of the occurrence of such an event within their territory. WHO will also be in a position to seek verification from States concerning reports received from sources other than States themselves. The State, through the National IHR Focal Point (see Question 4 above), is required to cooperate in the verification process. The IHR(2005) seek to encourage affected States and WHO to work together through the provision of technical cooperation and support, including, when necessary, access to WHO-facilitated expert teams assembled through the Global Outbreak Alert and Response Network (GOARN).

Under the IHR(2005), the key obligations for States are:

• to designate a National IHR Focal Point (see Question 4 above)
• to assess events occurring in their territory and to notify WHO of all events that may constitute a public health emergency of international concern using the decision instrument included in Annex 2 of the Regulations (see Question 8 above);
• to respond to requests for verification of information regarding events that may constitute a public health emergency of international concern (see Question 10 above);
• to respond to public health risks which may spread internationally;
• to develop, strengthen and maintain the capacity to detect, report and respond to public health events;
• to provide routine inspection and control activities at international airports, ports and some ground crossings to prevent international disease transmission; and
� �� to provide the public health rationale and scientific justification for any additional measures which significantly interfere with international traffic adopted in accordance with Article 43 of the IHR(2005) and to review such measures as required under that provision.

Under the IHR(2005), the key obligations for WHO are:

• to designate WHO IHR Contact Points at the headquarters or the regional level (see Question 4 above)
• to collect information regarding events through its surveillance activities for verification with States and to assess their potential to cause international disease spread;
• to determine whether or not a particular event notified by a State under the Regulations constitutes a public health emergency of international concern;
• to offer technical cooperation to States in their response to public health risks and emergencies of international concern;
• to offer guidance to States to develop, strengthen and maintain their existing surveillance and response capacity to contain and control public health risks and emergencies of international concern;
• to develop and recommend measures for use by States, including in response to public health emergencies of international concern, based on a consistent process of risk verification and assessment; and
• to prepare supporting guides and propose amendments to the IHR(2005) as necessary to maintain scientific and regulatory validity.

By becoming bound by the IHR(2005), States will benefit from support from international public health resources, including:
• guidance in building the core capacities necessary to quickly report, assess and respond to public health risks and public health emergencies of international concern;
• guidance during the outbreak verification process, including the management of information in emergency situations;
• outbreak containment advice where necessary;
• a framework for joint risk assessment and coordinated risk communication, as well as for containment and control actions during emergencies; and
• access to the Global Outbreak Alert and Response Network (GOARN), a “one-stop shop” of global resources to help manage a public health emergency of international concern.

The IHR(2005) aim at preventing the international spread of diseases while limiting unnecessary restriction on the free movement of travellers. During public health emergencies of international concern or in connection with specific public health risks, measures affecting travel may be recommended to avoid the international spread of disease. A number of specific provisions deal with health information, basic examinations and vaccination documentation, which may be required of a traveller by States. At the same time, States are required to treat travellers with respect for their dignity, human rights and fundamental freedoms and are assigned a duty of care in the treatment of personal data under the IHR(2005).

The IHR(2005) focus on minimizing unnecessary restrictions to travel and trade by specifying, in real-time, the appropriate public health measures for the assessed risk. WHO will provide neutral expert guidance to help limit unnecessary restrictions on trade and travel. During a public health emergency of international concern, however, application of time-limited measures affecting international travel and trade may be recommended.

The IHR(2005) have been agreed upon by consensus among WHO Member States as a balance between their sovereign rights and shared commitment to prevent the international spread of disease. Although the IHR(2005) does not include an enforcement mechanism per se for the States which fail to comply with its provisions, the potential consequences of non-compliance, especially in economic terms, are a powerful compliance tool. Working together with WHO to control a public health event and to communicate accurately any associated to other States or their populations helps to protect against unjustified measures being adopted unilaterally by other States.

Under the IHR(2005), States recognize that the Regulations and other relevant agreements should be interpreted so as to be compatible. The IHR(2005) require WHO to cooperate with other competent intergovernmental organizations or international bodies in the implementation of the Regulations. WHO will therefore continue to foster its longstanding working relationships with a number of organizations such as the International Atomic Energy Agency, the International Air Transport Association, the International Civil Aviation Organization, the International Maritime Organization, the World Tourism Organization, Food and Agriculture Organization of the United Nations, the Office International d'Epizooties (World Organisation for Animal Health) and the World Trade Organization. In addition to these specialized organizations, WHO will work with regional economic integration organizations such as the European Union and the Mercado Común del Sur (MERCOSUR) in implementing the Regulations in the countries of their respective regions.

The IHR(2005) contain a dispute settlement mechanism to resolve conflicts arising between States in respect of the application and/or the interpretation of the Regulations. The mechanism emphasizes the amicable settlement of differences. Several options are open to States under this mechanism, including negotiation, mediation and conciliation. Disputes may also be settled by referral to the Director-General of WHO or by arbitration, if agreed to by all the parties to the dispute.

Prior to June 2007, States are encouraged to take appropriate measures to guarantee the full and effective implementation of the Regulations. This will include developing, strengthening and maintaining the public health capacities required under Annex 1 of the IHR(2005), and mobilizing the resources necessary for that purpose; adopting the necessary legal and administrative provisions and preparing for the use of the decision instrument (Annex 2 of the Regulations) for the assessment and notification of events occurring within their territory that may constitute a public health emergency of international concern (see Question 8 above). WHO will, in turn, strengthen its own internal capacity to fulfill its obligations under the IHR(2005), including, supporting countries in the detection, assessment and response to public health risks and emergencies.