The International Health Regulations

Article 3, principles.

(1) Implementation shall be with full respect for the dignity, human rights and fundamental freedoms of persons, and shall promote equity and solidarity.

(2) Implementation shall be guided by the Charter of the United Nations and the Constitution of the World Health Organization.

(3) Implementation 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) States have, in accordance with the Charter and the principles of international law, the sovereign right to legislate and to implement legislation in pursuance of their health policies, and in doing so they should uphold the purpose of these Regulations.

Article 3(4) is the sovereignty clause, and it is the same reservation the Pandemic Agreement makes in its own article 3(1). Note the drafting: the right is stated as a shall, and the duty to uphold the purpose only as a should.

National machinery: article 4

Each State Party shall designate or establish, in accordance with its national law and context, one or two entities to serve as National IHR Authority and National IHR Focal Point, as well as the authorities responsible for implementing health measures.

Article 4(1 bis), added by the 2024 amendments: the National IHR Authority shall coordinate the implementation of these Regulations within the jurisdiction of the State Party.

Article 4(2). National IHR Focal Points shall be accessible at all times for communications with the WHO IHR Contact Points.

The distinction between the two matters and is new. The Focal Point is a communications channel, reachable at any hour. The Authority is a coordinating body inside the State, and it was created in 2024 because the pandemic showed that a country could have a working telephone number and no one with authority to make the whole machinery move.

Core capacities: article 5

Each State Party shall 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.

Extensions. A State Party may, on a justified need and an implementation plan, obtain an extension of two years; and in exceptional circumstances, on a new plan, a further extension not exceeding two years granted by the Director-General on the technical advice of the Review Committee under article 50. A State that has obtained an extension shall report annually on progress.

Article 5(3). WHO shall assist States Parties, upon request, to develop and maintain those capacities. Article 5(4). WHO shall collect information regarding events through its surveillance activities and assess their potential to cause international spread and to interfere with traffic.

Core capacities are the obligation the whole system rests on and the one most widely unmet. A State that cannot detect an outbreak cannot notify one, so the notification duty is worth only as much as the laboratories, the surveillance and the trained staff behind it. Article 44 provides for collaboration, assistance and financing between States Parties and with WHO, and article 44 bis, added in 2024, establishes a Coordinating Financial Mechanism to support developing States Parties in building and maintaining them.

Notification: articles 6 to 9

Article 6(1), the central obligation. Each State Party shall assess events occurring within its territory by using the decision instrument in Annex 2, and shall 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 in accordance with that instrument, as well as any health measure implemented in response.

Four elements to hold. Assessment against the decision instrument in Annex 2, which is a flowchart and not a discretion. 24 hours from assessment. Through the National IHR Focal Point. And the measures taken must be notified as well as the event.

Article 6(2), the continuing duty. After notification the State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information, including where possible case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed, and shall report the difficulties faced and support needed.

Article 7, unexpected or unusual events. Where a State Party has evidence of an unexpected or unusual public health event within its territory, irrespective of origin or source, which may constitute a public health emergency of international concern, it shall provide to WHO all relevant public health information, and article 6 applies in full.

Those words, irrespective of origin or source, are deliberate. They cover an event that is not natural, so a laboratory escape or a deliberate release is inside the duty.

Article 8, consultation. For events not requiring notification, in particular where there is insufficient information to complete the decision instrument, the State Party should nevertheless keep WHO advised and consult on appropriate measures. Note the should: this is the soft edge of the duty, for the case where a State genuinely does not yet know.

Article 9, other reports. WHO may take into account reports from sources other than notifications or consultations and shall assess them according to established epidemiological principles.

Article 9 is the provision that ended the old system. Under the Regulations that preceded these, WHO could act only on what a government told it. It may now act on media reports, on reports from non-governmental bodies and on its own surveillance networks, which removes the value of concealment.

Article 10, verification. WHO seeks verification from the State Party of reports from other sources, and the State must respond within the time the article provides.

The determination: article 12

Article 12(1). The Director-General shall determine, on the basis of the information received, in particular from the States Parties in whose territory an event is occurring, whether an event constitutes a public health emergency of international concern, including, when appropriate, a pandemic emergency.

The definition of a public health emergency of international concern, in article 1: an extraordinary 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.

The definition of a pandemic emergency, added in 2024: a public health emergency of international concern caused by a communicable disease and which:

(i) has, or is at high risk of having, wide geographical spread to and within multiple States; and

(ii) is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and

(iii) is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and

(iv) requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches.

All four limbs are cumulative. A pandemic emergency is therefore a graded category above a public health emergency of international concern, and the grading was the principal 2024 reform, made because the single category of 2005 had to cover both a regional outbreak and a global catastrophe.

Article 12(2) to (4), the procedure. The Director-General consults the State Party on the preliminary determination. If they agree, he seeks the views of the Emergency Committee established under article 48, following the procedure in article 49. If they do not come to a consensus within 48 hours, the determination is made under article 49 all the same.

The 48-hour rule is the answer to a State that stalls. The Director-General must consult; he need not obtain agreement.

Article 12(4), what he must consider: information provided by the States Parties; the decision instrument in Annex 2; the advice of the Emergency Committee; scientific principles and the available scientific evidence; and an assessment of the risk to human health, of international spread, and of interference with international traffic.

Article 12(4 bis), added in 2024: if he determines a public health emergency of international concern, he shall further determine whether it also constitutes a pandemic emergency.

Article 12(5). He determines that an emergency has ended when it no longer meets the relevant definition.

The response: articles 13 to 18

Article 13, public health response, including equitable access to relevant health products. The addition of the words about equitable access is a 2024 amendment, and it is the point at which the Regulations meet the bargain of the Pandemic Agreement in [Global Health Law and Communicable Diseases].

Article 14 governs cooperation between WHO and intergovernmental organisations and international bodies.

Article 15, temporary recommendations. Once an emergency is determined, the Director-General shall issue temporary recommendations under the article 49 procedure. They may cover health measures to be implemented by the affected State or by other States Parties, regarding persons, baggage, cargo, containers, conveyances, goods including relevant health products, and postal parcels, to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic.

Article 15(3), their life. They may be terminated at any time and automatically expire three months after issuance, may be modified or extended for additional periods of up to three months, and may not continue beyond the second World Health Assembly after the determination to which they relate.

Article 16, standing recommendations, made under article 53 for routine or periodic application in respect of specific, ongoing public health risks.

Article 17, criteria for recommendations. In issuing, modifying or terminating either kind, the Director-General shall consider the views of the States Parties directly concerned; the advice of the Emergency Committee or the Review Committee; scientific principles and available evidence; health measures which, on a risk assessment appropriate to the circumstances, are not more restrictive of international traffic and trade and not more intrusive to persons than reasonably available alternatives that would achieve the appropriate level of health protection; the availability of and accessibility to relevant health products, added in 2024; relevant international standards and instruments; the activities of other bodies; and other relevant information.

Article 17(d) is the proportionality test in the Regulations, and it should be set beside article XX of GATT in [General Principles of International Trade Law], which asks a very similar question about measures necessary to protect human life or health.

Recommendations are recommendations. Neither temporary nor standing recommendations bind, which is a design choice: the Director-General may say what should be done and cannot order it.

Points of entry, conveyances and travellers: articles 19 to 42

Part IV and Part V are the operational half of the Regulations, and a candidate should be able to place them even without working each provision.

Article 11, what WHO gives back. WHO shall send to all States Parties, and as appropriate to relevant intergovernmental organizations, as soon as possible and by the most efficient means available, in confidence, such public health information as it has received under articles 5 to 10 and as is necessary to enable them to respond, subject to the safeguards the article states about information a State has not yet agreed to release.

Article 19, general obligations at points of entry. Each State Party shall ensure that the core capacities set forth in Part B of Annex 1 for designated points of entry are developed within the time frame in articles 5(1) and 13(1); identify the competent authorities at each designated point of entry; and furnish to WHO, as far as practicable, information concerning sources of infection or contamination at its points of entry which could result in international spread.

Article 20, airports and ports. States Parties shall designate the airports and ports which shall develop the core capacities in Annex 1, and shall issue Ship Sanitation Control Exemption Certificates and Ship Sanitation Control Certificates at designated ports. Article 21 applies the same technique to ground crossings. Article 22 sets out the role of competent authorities, which are responsible for monitoring baggage, cargo, containers, conveyances, goods, postal parcels and human remains, for ensuring that facilities used by travellers are kept in a sanitary condition, and for supervising the removal and safe disposal of contaminated water or food, waste and other contaminated matter.

Article 23, health measures on arrival and departure. A State Party may, for public health purposes, on arrival or departure, require information concerning the traveller's destination and itinerary and a non-invasive medical examination which is the least intrusive examination that would achieve the public health objective, and may require proof of vaccination or other prophylaxis or a health measure where evidence of a public health risk exists. No medical examination, vaccination, prophylaxis or health measure shall be carried out on travellers without their prior express informed consent, or that of their parents or guardians, except as provided in article 31(2), and travellers shall be informed of any risk associated with it.

Article 23's consent rule is the point of principle in this Part, and article 31(2) is the exception: where a traveller for whom a State Party may require vaccination or prophylaxis refuses it, the State may, subject to articles 32, 42 and 45, deny entry, or may require the traveller to undergo isolation, quarantine or placement under public health observation if there is evidence of an imminent public health risk.

Articles 24 to 29, conveyances. Conveyance operators must comply with health measures and keep conveyances free of sources of infection and contamination (article 24). Ships and aircraft in transit shall not be subject to health measures, subject to the exceptions stated, and a ship in transit through a canal or waterway is treated as in transit (article 25); civilian lorries, trains and coaches in transit are likewise protected (article 26). An affected conveyance may be disinsected, derated, disinfected, decontaminated or otherwise treated, and the methods used shall be those recommended by WHO (article 27). Ships and aircraft at points of entry, by article 28, shall not be prevented for public health reasons from calling at any point of entry, nor be prevented from taking on fuel, water, food and supplies, and free pratique may be granted by radio or other communication. Article 29 applies similar rules to lorries, trains and coaches at points of entry.

Articles 30 to 34, travellers and goods. A traveller under public health observation may continue an international voyage if he does not pose an imminent public health risk (article 30). Article 31 governs health measures relating to entry, with the consent rule and its exception described above. Article 32 requires that in implementing health measures States Parties treat travellers with respect for their dignity, human rights and fundamental freedoms and minimize any discomfort or distress, including by treating them with courtesy and respect, taking into consideration their gender, sociocultural, ethnic or religious concerns, and providing adequate food and water, appropriate accommodation and clothing, protection for baggage, appropriate medical treatment and means of communication, and by providing for those quarantined, isolated or subject to medical examination. Goods in transit without transhipment shall not be subject to health measures, save in the case of live animals (article 33), and article 34 deals with containers and container loading areas.

Articles 35 to 41, documents and charges. No health documents other than those provided for in these Regulations or in WHO recommendations shall be required in international traffic, subject to the article's own savings (article 35); article 36 governs certificates of vaccination or other prophylaxis; article 37, the Ship Declaration of Health; article 38, the Health Part of the Aircraft General Declaration; article 39, ship sanitation certificates, valid for six months and extendable by one; article 40 prohibits charges for health measures for the protection of public health, and regulates those which may be levied; article 41 governs charges for baggage, cargo, containers and goods.

Article 42, implementation. Health measures taken under the Regulations shall be initiated and completed without delay, and applied in a transparent and non-discriminatory manner.

Article 42 is the general standard against which article 43 must be read, and it is short enough to quote.

Data, machinery and final provisions: articles 45 to 66

Article 45, personal data. Health information which refers to an identified or identifiable person shall be kept confidential and processed anonymously, as required by national law, though States Parties may process and disclose personal data where essential for the purposes of assessing and managing a public health risk, provided the data are processed fairly and lawfully, are adequate and not excessive, are accurate and kept up to date, and are not kept longer than necessary. On request, WHO shall so far as practicable provide an individual with his personal data in an intelligible form, without undue delay or expense and, where necessary, allow for correction.

Article 46 governs the transport and handling of biological substances, reagents and materials for diagnostic purposes, which States Parties shall facilitate subject to national law and international guidelines.

The committees, articles 47 to 53. The Director-General establishes an IHR Expert Roster, from which he draws an Emergency Committee to advise on a determination and on temporary recommendations, and a Review Committee to advise on technical matters, standing recommendations and amendments. Article 47 governs the composition of the Review Committee, whose members are selected from the Roster and, when appropriate, other expert advisory panels, with regard to 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.

Article 51, the conduct of business. Decisions of the Review Committee are taken by a majority of the members present and voting, and the Director-General shall invite Member States, the United Nations, its specialized agencies and relevant intergovernmental and nongovernmental organisations in official relations with WHO to designate representatives to attend its sessions.

Article 52, the reports. The Review Committee shall draw up a report setting forth its views and advice, which shall not commit the Organization and shall be formulated as advice to the Director-General, and where the Committee is not unanimous any member shall be entitled to express his dissenting professional views in an individual or group report, which forms part of the Committee's report.

Article 52's rule that a dissent forms part of the report is worth marking. It is the same institutional idea as a separate opinion in [The International Court of Justice]: the reasoning is on the record, including the reasoning that lost.

Article 54, reporting and review. States Parties and the Director-General shall report to the Health Assembly on the implementation of these Regulations as the Assembly decides, and the Assembly shall periodically review their functioning. Article 54 bis, added in 2024, establishes a States Parties Committee for the Implementation of the International Health Regulations (2005), to facilitate the effective implementation of the Regulations, its work being facilitative and consultative in nature only and conducted in a manner that is non-adversarial, non-punitive, assistive and transparent.

Article 54 bis is the answer to the criticism that the Regulations have no compliance machinery, and it is a careful answer: the Committee is facilitative, consultative, non-adversarial and non-punitive, so it adds a forum rather than a sanction.

Article 55, amendments. Amendments may be proposed by any State Party or by the Director-General, and are submitted to the Health Assembly; the text shall be communicated to all States Parties at least four months before the Assembly at which it is proposed; and amendments adopted by the Assembly come into force for all States Parties on the terms and subject to the conditions provided in articles 22, 59, 60, 61, 62 and 63.

Article 56 is the dispute provision set out above. Article 57, relationship with other agreements. States Parties recognize that the IHR and other relevant international agreements should be interpreted so as to be compatible, and the Regulations shall not affect the rights and obligations of any State Party deriving from other international agreements; nothing prevents States Parties having certain interests in common owing to their health, geographical, social or economic conditions from concluding special treaties or arrangements to facilitate the application of the Regulations, provided they are not inconsistent with the Regulations' rights and obligations. Article 58 provides that the Regulations, as between the States bound by them, replace the earlier international sanitary conventions and regulations listed in the article.

Articles 59 to 66 are the entry into force, rejection, reservation and withdrawal provisions set out at the beginning of this chapter, together with article 64, the position of States not Members of WHO which may become parties by notifying acceptance; article 65, notifications by the Director-General to all Members and Associate Members and to other parties of the adoption of the Regulations and of every rejection, reservation and withdrawal; and article 66, the Arabic, Chinese, English, French, Russian and Spanish texts being equally authentic, the original deposited with the Organization and certified copies sent by the Director-General.

What States do anyway: article 43

This is the article the last decade has been fought over.

Article 43(1). The Regulations shall not preclude States Parties from implementing health measures, in accordance with their national law and their obligations under international law, in response to specific public health risks or public health emergencies of international concern, which achieve the same or greater level of health protection than WHO recommendations, or which are otherwise prohibited by the listed articles, provided such measures are otherwise consistent with these Regulations. Such measures shall not be more restrictive of international traffic and not more invasive or intrusive to persons than reasonably available alternatives achieving the appropriate level of health protection.

Article 43(2), the basis required. A State Party shall base its determination 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 other bodies; and any available specific guidance or advice from WHO.

Article 43(3), the duty to explain. A State Party implementing additional measures which significantly interfere with international traffic shall provide WHO with the public health rationale and relevant scientific information, and WHO shall share it. Significant interference generally means refusal of entry or departure of international travellers, baggage, cargo, containers, conveyances or goods, or their delay, for more than 24 hours.

Article 43(4). WHO may request that the State Party concerned reconsider the application of the measures.

Article 43(5). A State Party implementing such measures shall inform WHO within 48 hours of implementation, with the health rationale, unless the measures are covered by a temporary or standing recommendation.

Read article 43 as the compromise it is. States insisted on keeping the right to close their borders, and in exchange accepted a scientific basis, a proportionality limit, a duty to explain and a WHO power to ask them to think again. What they did not accept is any power to stop them. So when States impose travel bans against WHO advice, they are exercising article 43, and the only sanction is that they must give reasons.

Disputes: article 56

Article 56(1). States Parties in dispute about interpretation or application shall seek in the first instance to settle it through 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 from the responsibility of continuing to seek to resolve it.

Article 56(2). They may agree to refer the dispute to the Director-General, who shall make every effort to settle it.

Article 56(3), the optional clause. A State Party may at any time declare in writing that it accepts arbitration as compulsory for all disputes about the Regulations, or for a specific dispute, in relation to any other State Party accepting the same obligation, the arbitration being conducted under the Permanent Court of Arbitration Optional Rules for Arbitrating Disputes between Two States.

Article 56(3) is article 36(2) of the Court's Statute in miniature, with the same reciprocity requirement, as [The International Court of Justice] explains.

A worked example

State AA detects an unusual cluster of a new respiratory illness on 1 March, completes the Annex 2 assessment on 3 March, and notifies WHO on 12 March. It is unable to say how many cases there are because it has no laboratory capacity. The Director-General proposes to determine a public health emergency of international concern; State AA disagrees. State BB immediately bans all flights from State AA and says nothing to WHO. State CC rejected an amendment to the Regulations eleven months after notification.

State AA's notification. Article 6(1) requires notification within 24 hours of assessment of the public health information. Assessment was complete on 3 March, so notification was due by 4 March, and 12 March is a breach. Article 7 would also have applied from the moment it had evidence of an unexpected or unusual event.

The absence of laboratory capacity. Article 5(1) required State AA to develop and maintain the core capacities to prevent, detect, assess, notify and report within five years of entry into force for it, subject to the extensions in article 5(2). Failure is a breach of article 5, and article 6(2) separately obliges State AA to report the difficulties faced and support needed. Article 44 and article 44 bis then provide the assistance and the Coordinating Financial Mechanism.

The disagreement about the determination. Article 12(2) requires the Director-General to consult State AA on the preliminary determination. Article 12(3): if they do not come to a consensus within 48 hours, the determination is made under article 49 anyway. State AA cannot veto it.

State BB's flight ban. It is an additional health measure under article 43. It must not be more restrictive of international traffic than reasonably available alternatives achieving the appropriate level of protection; it must be based on scientific principles, available evidence and WHO guidance; and because refusing entry or delaying travellers for more than 24 hours is significant interference, State BB must inform WHO within 48 hours and provide the public health rationale and relevant scientific information. Saying nothing breaches article 43(3) and (5). WHO may then ask it to reconsider, and no more.

State CC's rejection. Article 59(1 bis) gives 10 months from notification for rejection of or reservation to an amendment. A rejection at eleven months shall have no effect, so State CC is bound by the amendment.

Change one fact: the illness spreads to twenty States, overwhelms their hospitals and halts trade. The Director-General must then determine under article 12(4 bis) whether the emergency also constitutes a pandemic emergency, on the four cumulative limbs in article 1.

Distinctions table

What it does NOT mean

The Regulations are not a treaty. They are regulations under article 21 of the Constitution, binding under article 22 unless a State opts out in time.

The rejection window is not the same for amendments. Eighteen months for the Regulations, ten for an amendment.

Notification is not triggered by certainty. Article 6 requires notification of events which may constitute an emergency, assessed against Annex 2.

The Director-General cannot order anything. Articles 15 and 16 produce recommendations.

A State cannot block a determination. Article 12(3) allows it to be made after 48 hours without consensus.

Article 43 is not a free hand. Additional measures must be scientifically based, no more restrictive than the alternatives, notified within 48 hours where they significantly interfere, and justified on request.

Being bound is not the same as complying. The Regulations have no enforcement machinery beyond article 56.

Limits and criticism

There is no sanction for breach. A State that notifies late, or not at all, or that imposes measures without a scientific basis, faces publicity, a request to reconsider, and article 56's dispute procedure, which requires the other State's consent unless both have made the arbitration declaration. Nothing else.

Core capacities are widely unbuilt. Article 5 sets a five-year deadline with extensions, article 44 bis creates a financing mechanism, and the deadline has passed for every State Party while a substantial number still lack the capacities the notification duty presupposes.

Article 43 was used, in the events of the last decade, more or less as a permission. Travel bans were imposed against explicit WHO advice, the rationale was often supplied late or not at all, and the only consequence was a request to reconsider, which is exactly what the criticism of the reporting incentive in [Global Health Law and Communicable Diseases] predicts.

The pandemic emergency category is untested. Its four cumulative limbs are demanding, and whether adding a higher tier improves the response or merely delays a declaration while the tests are argued over cannot be known from the text.

Quick revision

Regulations under Constitution article 21(a), binding under article 22. Article 59: rejection or reservation within 18 months for the Regulations, 10 months for an amendment; entry into force 24 months and 12 months respectively; article 59(3), a declaration of outstanding adjustments, achieved within 12 months of entry into force. Amended in 2014, 2022 and 2024.

Article 2: prevent, prepare for, protect against, control and respond to international spread, commensurate with and restricted to public health risk, avoiding unnecessary interference with international traffic and trade.

Article 3: dignity, human rights and fundamental freedoms, equity and solidarity; guided by the Charter and the WHO Constitution; universal application; the sovereign right to legislate, upholding the purpose.

Article 4: a National IHR Authority (coordinating implementation, added 2024) and a National IHR Focal Point (accessible at all times).

Article 5: core capacities to prevent, detect, assess, notify and report within five years, extendable by two and a further two; article 44 bis, the Coordinating Financial Mechanism.

Article 6: assess by the Annex 2 decision instrument, notify within 24 hours through the Focal Point of events which may constitute a PHEIC, plus the measures taken, and keep communicating. Article 7: unexpected or unusual events, irrespective of origin or source. Article 8: consultation. Article 9: WHO may act on other sources.

Article 12: the Director-General determines; consult the State, and if no consensus within 48 hours, determine anyway; 12(4 bis), also determine whether it is a pandemic emergency. PHEIC = an extraordinary event constituting a public health risk to other States and potentially requiring a coordinated international response. Pandemic emergency = a PHEIC caused by a communicable disease, with wide geographical spread, exceeding health system capacity, substantial social or economic disruption, and requiring rapid, equitable and enhanced coordinated international action.

Article 15: temporary recommendations, expiring three months after issuance, extendable by three, never beyond the second World Health Assembly. Article 16: standing recommendations. Article 17: criteria, including measures not more restrictive of traffic and trade and not more intrusive than reasonably available alternatives.

Article 43: additional health measures permitted if they achieve the same or greater protection, based on scientific principles and evidence, not more restrictive than alternatives, with the rationale supplied and WHO informed within 48 hours where interference is significant, meaning refusal or delay of more than 24 hours; WHO may request reconsideration.

Article 56: negotiation and peaceful means; reference to the Director-General by agreement; optional declaration accepting arbitration as compulsory under the Permanent Court of Arbitration Optional Rules.

Test yourself

1. How do the International Health Regulations bind States?

Not as a treaty. They were adopted by the World Health Assembly under article 21(a) of the WHO Constitution, which permits regulations concerning sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease, and they come into force under article 22 for all Members after due notice except for those which notify the Director-General of rejection or reservations within the period stated. Article 59 fixes those periods: eighteen months from notification of adoption for the Regulations themselves, and ten months for an amendment, anything received later having no effect. The Regulations then enter into force twenty-four months after notification, and an amendment twelve months after. A State which cannot adjust its domestic arrangements in time must, under article 59(3), declare the outstanding adjustments and achieve them within twelve months of entry into force for it.

2. What must a State Party do when an outbreak occurs?

Assess the event against the decision instrument in Annex 2, and notify WHO through its National IHR Focal Point, by the most efficient means available, within 24 hours of assessment of the public health information, of all events which may constitute a public health emergency of international concern, together with any health measure implemented in response: article 6(1). It must then continue to communicate timely, accurate and sufficiently detailed information, including where possible case definitions, laboratory results, source and type of risk, numbers of cases and deaths, conditions affecting spread and measures employed, and report the difficulties faced and support needed: article 6(2). Article 7 extends the duty to any unexpected or unusual public health event, irrespective of origin or source, and article 8 asks a State to keep WHO advised even where the event does not require notification.

3. What is a public health emergency of international concern, and how does a pandemic emergency differ?

Article 1 defines a public health emergency of international concern as an extraordinary event determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response. A pandemic emergency, a category added by the 2024 amendments, is 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, is exceeding or at high risk of exceeding the capacity of health systems to respond in those States, is causing or at high risk of causing substantial social or economic disruption including disruption to international traffic and trade, and requires rapid, equitable and enhanced coordinated international action with whole-of-government and whole-of-society approaches. All four limbs are cumulative, and by article 12(4 bis) the Director-General, having determined a public health emergency of international concern, must further determine whether it also amounts to a pandemic emergency.

4. Can a State prevent the Director-General from declaring an emergency?

No. Article 12(2) requires the Director-General, on forming a preliminary view that a public health emergency of international concern is occurring, to consult the State Party in whose territory the event is occurring. If they agree, he seeks the views of the Emergency Committee under the procedure in article 49. But article 12(3) provides that if, following that consultation, they do not come to a consensus within 48 hours on whether the event constitutes such an emergency, the determination shall be made in accordance with the procedure in article 49 all the same. The State's participation is therefore a right to be consulted, not a veto, and the 48-hour limit is what prevents a State from stalling the determination indefinitely.

5. Explain article 43 and why it is criticised.

Article 43 preserves the right of States Parties to implement health measures additional to WHO recommendations, in response to specific public health risks or emergencies, where those measures achieve the same or greater level of health protection. It attaches conditions: the measures must not be more restrictive of international traffic nor more invasive or intrusive to persons than reasonably available alternatives achieving the appropriate level of protection; they must be based on scientific principles, on available scientific evidence or, where that is insufficient, on available information including from WHO, and on any WHO guidance; where they significantly interfere with international traffic, meaning refusal or delay of more than 24 hours, the State must provide the public health rationale and relevant scientific information and inform WHO within 48 hours of implementation; and WHO may request the State to reconsider. It is criticised because that is the whole of the discipline. States have imposed travel bans against explicit WHO advice, supplied the rationale late or not at all, and faced nothing beyond a request to reconsider, which leaves the incentive to conceal an outbreak exactly where it was.

6. What machinery do the Regulations provide for disputes and for enforcement?

Only article 56, and it is weak. States Parties in dispute about the interpretation or application of the Regulations must first seek settlement by negotiation or any other peaceful means of their own choice, including good offices, mediation or conciliation, and failure to agree does not absolve them of the responsibility of continuing to seek a resolution. If that fails, they may by agreement refer the dispute to the Director-General, who shall make every effort to settle it. And a State Party may at any time declare in writing that it accepts arbitration as compulsory for all disputes under the Regulations, or for a specific dispute, in relation to any other State Party accepting the same obligation, the arbitration proceeding under the Permanent Court of Arbitration Optional Rules for Arbitrating Disputes between Two States. There is no sanction for breach of the notification or core-capacity obligations, so compliance rests on publicity and on the States' own interest.