The International Health Regulations (2005), as amended — an instrument study

An outbreak is a national event with international consequences. Left to itself, each State has an incentive to under-report, because reporting invites the closure of its ports and the collapse of its trade; and each other State has an incentive to over-react, because closing a border is cheap for the State that closes it. The Regulations are built to defeat both incentives at once: a hard duty to report, matched by a hard limit on what other States may do in response.

Article 2 states the whole design in one sentence: the purpose and scope are "to prevent, prepare for, 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 risk and which avoid unnecessary interference with international traffic and trade."

Three words in that sentence carry the argument. Commensurate and restricted discipline the response; unnecessary is the standard against which interference with traffic and trade is measured. An answer that quotes only the first half has missed the point of the instrument.

Article 3 sets four.

1. Implementation "shall be with full respect for the dignity, human rights and fundamental freedoms of persons, and shall promote equity and solidarity." Equity and solidarity were added by amendment.
2. Implementation "shall be guided by the Charter of the United Nations and the Constitution of the World Health Organization."
3. It "shall be guided by the goal of their universal application for the protection of all people of the world from the international spread of disease."
4. Sovereignty is preserved: 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."

Note the asymmetry of the fourth: the right is stated as a right; the constraint is stated as should. That is the drafting compromise at the heart of the instrument.

• Disease: "an illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans". The instrument is deliberately hazard-neutral: chemical, radiological and biological events are all within it.
• Event: "a manifestation of disease or an occurrence that creates a potential for disease".
• Health measure: "procedures applied to prevent the spread of disease or contamination; a health measure does not include law enforcement or security measures". The exclusion matters: a State cannot dress up a border closure for security reasons as a health measure.
• Public health emergency of international concern: "an extraordinary event which is determined, as provided in these Regulations" to constitute a public health risk to other States through the international spread of disease, and potentially to require a coordinated international response.
• Pandemic emergency, added in 2024: a public health emergency of international concern "caused by a communicable disease" which has, or is at high risk of having, wide geographical spread to and within multiple States, and which is "exceeding, or is at high risk of exceeding, the capacity of health systems to respond".

Core capacities, Article 5. Each State Party must "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 core capacities to prevent, detect, assess, notify and report events", as specified in Part A of Annex 1. An extension of two years is available on a justified need and an implementation plan, and in exceptional circumstances a further two years, decided by the Director-General on the technical advice of the Review Committee. A State that obtains an extension must report annually on progress.

Notification, Article 6. The single hardest obligation in the instrument. Each State Party assesses events by using the decision instrument in Annex 2 and must "notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory", together with any health measure implemented in response.

Notice the threshold. It is not events which constitute an emergency; it is events which may constitute one. The State is not the judge of whether an emergency exists; it is only the judge of whether the decision instrument is triggered.

After notification the State must continue to communicate "timely, accurate and sufficiently detailed public health information", where possible including case definitions, laboratory results, source and type of the risk, numbers of cases and deaths, conditions affecting spread, and the measures employed, and must report difficulties faced and support needed.

The surrounding duties. Article 7 on information-sharing during unexpected or unusual events; Article 9 on other reports; Article 10 on verification of reports WHO receives from other sources; Article 11 on WHO's provision of information to States Parties, handled in accordance with Article 45 on personal data.

Who decides, Article 12. "The Director-General shall determine, on the basis of the information received, in particular from the State(s) Party(ies) within whose territory(ies) an event is occurring, whether an event constitutes a public health emergency of international concern, including, when appropriate, a pandemic emergency".

The procedure. On a preliminary determination the Director-General consults the affected State. If they agree, the Director-General seeks the views of the Emergency Committee under Article 48 on temporary recommendations, by the procedure in Article 49. If no consensus is reached "within 48 hours", the determination is made under the Article 49 procedure anyway. This is the provision that prevents a State from vetoing a declaration about its own territory.

The five criteria. In determining, the Director-General shall consider information provided by the States Party; the decision instrument in Annex 2; the advice of the Emergency Committee; "scientific principles as well as the available scientific evidence and other relevant information"; and "an assessment of the risk to human health, of the risk of international spread of disease and of the risk of interference with international traffic."

The second tier. Under Article 12(4 bis), having determined an emergency of international concern, the Director-General further determines, on the same matters, whether it also constitutes a pandemic emergency.

Temporary recommendations, Article 15. Issued once an emergency is determined, and may be modified or extended, including after the emergency has ended, for the purpose of preventing or promptly detecting its recurrence. They may be addressed to the affected State or to other States Parties, and may cover persons, baggage, cargo, containers, conveyances, goods including relevant health products, and postal parcels.

They are deliberately perishable. They "shall automatically expire three months after their issuance", may be modified or extended for further periods of up to three months, and "may not continue beyond the second World Health Assembly after the determination of the public health emergency of international concern, including a pandemic emergency, to which they relate."

Standing recommendations, Article 16. Health measures for routine or periodic application, made under Article 53, for specific ongoing public health risks.

The criteria for either, Article 17. The Director-General must consider the views of the States Parties directly concerned; the advice of the Emergency or Review Committee; scientific principles and evidence; availability of and accessibility to relevant health products; relevant international standards and instruments; the activities of other intergovernmental bodies; and other appropriate information. The proportionality criterion is the one to quote: "health measures that, on the basis of a risk assessment appropriate to the circumstances, are not more restrictive of international traffic and trade and are not more intrusive to persons than reasonably available alternatives that would achieve the appropriate level of health protection".

Article 43 is the article on which most examination questions turn, because it is where sovereignty and the instrument meet.

A State Party may implement measures beyond WHO recommendations where those measures "achieve the same or greater level of health protection than WHO recommendations", or are otherwise prohibited under the listed articles, provided they are otherwise consistent with the Regulations. But the same ceiling applies: "Such measures shall not be more restrictive of international traffic and not more invasive or intrusive to persons than reasonably available alternatives that would achieve the appropriate level of health protection."

The decision must be based on scientific principles; available scientific evidence of a risk to human health or, where such evidence is insufficient, the available information including from WHO; and any available specific guidance or advice from WHO.

Where the measures significantly interfere with international traffic, the State must give WHO the public health rationale and relevant scientific information, and must inform WHO "within 48 hours of implementation". Significant interference is defined: "refusal of entry or departure of international travellers, baggage, cargo, containers, conveyances, goods, and the like, or their delay, for more than 24 hours."

WHO's power in response is soft but real: after assessing the information, "WHO may request that the State Party concerned reconsider the application of the measures."

Article 44 obliges States Parties to collaborate, to the extent possible, in detection and response; in technical cooperation and logistical support, particularly for the Annex 1 core capacities; in the mobilization of financial resources, in particular to address the needs of developing countries; and in the formulation of implementing laws. WHO reciprocally assists on request. The amendments added Article 44(2 bis), under which States Parties "shall maintain or increase domestic funding, as necessary, and collaborate, including through international cooperation and assistance, as appropriate, to strengthen sustainable financing", and Article 44 bis establishing a Coordinating Financial Mechanism.

Article 56. Between States Parties: first negotiation or any other peaceful means of their own choice, including good offices, mediation or conciliation, and "Failure to reach agreement shall not absolve the parties to the dispute from the responsibility of continuing to seek to resolve it." Second, reference by agreement to the Director-General, who shall make every effort to settle it. Third, a State may declare in writing that it accepts arbitration as compulsory, conducted under "the Permanent Court of Arbitration Optional Rules for Arbitrating Disputes between Two States"; States that accept it "shall accept the arbitral award as binding and final." A dispute between WHO and a State Party goes to the Health Assembly.

Article 57. States Parties recognize that the Regulations and other relevant international agreements "should be interpreted so as to be compatible", and the Regulations do not affect rights and obligations under other agreements. Special treaties between neighbouring States are expressly permitted for rapid exchange of information between neighbouring territories, coastal traffic, frontier measures, transport of affected persons or remains, and disinfection of goods.

A question on global health law is really a question about the balance the Regulations strike. Structure the answer as a sequence of duties and limits.

1. Capacity — Article 5 and Annex 1, with the five-year clock and the extensions.
2. Notification — Article 6, the 24-hour rule, the Annex 2 decision instrument, and the may constitute threshold.
3. Determination — Article 12, the Director-General, the 48-hour consultation rule, the five criteria, and the pandemic tier added in 2024.
4. Response — Articles 15, 16 and 17, with the three-month expiry and the proportionality criterion.
5. Unilateral action — Article 43, with the ceiling, the evidentiary basis, the 48-hour report and the 24-hour definition of significant interference.
6. Disputes — Article 56, negotiation, the Director-General, optional compulsory arbitration.

Then the evaluation, which is where the marks are. The Regulations bind States to report but give WHO no power to compel. The Director-General may determine an emergency over a State's objection, but may only recommend. A State that over-reacts must explain itself, but the sanction for refusing to reconsider is nothing more than the request itself. The instrument works by information and reputation, not by enforcement, and its relationship to the Charter and to the Constitution of the World Health Organization is stated in Article 3(2) precisely because it has no enforcement machinery of its own.

Module IV names a global health law consortium among its heads. The instruments governing global health and communicable disease do not use that term, and nothing is attributed to it here.