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Revised International Health Regulations (IHR)

Review Questionnaire

The following information and questions are designed to assist you in providing comments and suggestions regarding the revised IHR draft. The completed questionnaires will be evaluated as a key part of the consultation process to refine the draft. Your cooperation in this process is vital to ensuring that the revised IHR meet your operational needs. The IHR draft you have received contains two principal levels of detail. The rights and obligations for Member States and WHO are essentially unchanging and contained in the Articles, with more detailed provisions in the Annexes. Some of the Annexes are very specific (e.g. the certificate models), whereas others capture general technical requirements that might change over time. Your comments are sought on all parts of the draft. Commentaries and questions are not provided for all Articles, since in many cases they are a continuation of a current provision or they have been revised to be as straightforward as possible. If you wish, please include comments for any Article not contained in the questionnaire. Be sure to identify the Article and paragraph number. The parameters we have suggested for evaluating the Articles are:

• Desirability – is the Article relevant and necessary?

• Feasibility – can the Article be implemented, in operational and legal terms?

• Clarity – is the wording and intent clear? Please list your suggested changes in the space provided below each question, and use an attached page if required for additional comments.

Revised International Health Regulations (IHR) Review Questionnaire

Part I - Definitions, Purpose and Communications Part I introduces a number of new definitions compared to the 1969 text, moves the purpose of the Regulations from the 'Foreword' to the Articles and includes a new Article on ‘Communications’ including the establishment of National IHR Focal Points.

Article 1 Definitions The definitions proposed are specific to the IHR, and although you may see words that are used to describe other public health concepts, please remember the context in which they are being used here. Given this context, are there any definitions that you believe should be modified, added or removed? If yes, please specify the changes in the space below. Proposed changes: We feel that the definition of a ship should be much broader, both technically and legally. We suggest the following definition: <<ship, boat or craft>> means any seagoing vessel sailing on inland waters and undertaking international voyages (this proposal was made by the Canal Authority). Explanation: this is a far broader definition since it also includes small vessels, seaplanes, platforms, canoes etc. and incorporates legal considerations. The definition of conveyance should also include boat and craft. A number of definitions, for example <<port, infection, contamination, point of entry>> include the term itself in their definition, without properly defining it. They should be improved. A definition of <<health certificate, unnecessary interference>> should be included.

Article 2 - Purpose The purpose of the IHR remains essentially unchanged. Do you agree with the purpose of the IHR as stated in the text? If not, please explain why in the space provided below. We agree. Note: We suggest that the word obstacles should be used in preference to interference. The meaning of "unnecessary" should also be defined, to avoid different interpretations.

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Article 3 - Communications The current IHR allow for direct communication between WHO and the health administration of the State, and the designated National IHR Focal Points refine this concept further. Please review the Article in terms of its:

Desirability: This article is both important and necessary.

Feasibility: It is capable of being enforced by law and put into practice.

Clarity: Its wording and intent are clear.

Suggested changes: None. Comments: Proper definitions of National Focal Point and Focal Point should be provided, together with their functions.

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Part II - Surveillance, Notification, Information, Verification and Response

Part II replaces the existing requirement for Member States to notify diagnosed cases of specific diseases (cholera plague and yellow fever). It incorporates key changes in terms of: Member State capacities to detect and respond to national disease events; the replacement of the requirement to notify specific diseases with the notification of events that could constitute a public health emergency of international concern; the use of information from sources other than Member States, and the requirement to verify the status of national public health events.

Article 4 - Surveillance We agree. Observations: 1. Paragraph 1: it is essential that WHO/PAHO ensure compliance with paragraph 1

as part of their surveillance activities to ensure countries possess effective capacity and to provide the necessary support.

2. Paragraph 2. potential to cause international disease spread is of importance for public health (PH). Why is it necessary to link it with whether it interferes with international traffic? Something might potentially interfere and be of importance to public health, which should have priority in the light of the IHR.

Article 5 - Notification The Notification process is substantially changed from the current requirement to notify cases of three diseases, and it allows Member States to provide information in confidence to WHO. This confidentiality may be ended under certain conditions, as listed in paragraph 2. Please review the Article in terms of its:

Desirability: The article is both important and necessary.

Feasibility: It is capable of being enforced by law and put into practice. Clarity: The wording and intent of paragraph 2 of this article are not very clear.

Suggested changes: Paragraph 2 states that "WHO shall retain notifications…". This needs to be amended and suspect cases should be notified to enable countries to make preparations and issue a timely alert in response to the situation.

Comments: 1. This formal notification to the health authorities should not be dependent upon the country's authorization, as this may delay the required measures.

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2. In view of the speed of modern communications, including travel, all countries need to receive proper and timely information in order to deal with events and to avoid learning of them through the press or the Internet rather than through the competent health agency.

Article 6 - Consultation Member States may inform WHO in confidence about national disease events or risks which do not meet the criteria established in the decision instrument (Annex 2) for notification. and thereby benefit from WHO experience and expertise. Information from seemingly separate national public health events may also identify an event that may constitute a public health emergency of international concern, once it is collated in WHO offices. Please review the Article in terms of its:

Desirability: The article is important and necessary.

Feasibility: It is capable of being enforced by law and put into practice.

Clarity: Both the wording and its intent are clear.

Suggested changes: None.

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Articles 7 & 8 - Information and Verification International disease surveillance and response require that all key information sources be used. The WHO outbreak surveillance and verification system uses comprehensive data to identify potential outbreaks, and to initiate a verification procedure when the outbreaks could have international impact. Please review the Articles in terms of their:


Feasibility: The article may be enforced by law and put into practice.

Clarity: As regards the wording and intent, in paragraph 2 it is not clear who is to be responsible for notifying the other State. Is it WHO or the affected State?


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Article 9 - Determination of a public health emergency of international concern

Based on information received from the affected Member State and other sources, WHO will assess the international impact of a public health event and decide if the event constitutes a public health emergency of international concern. Please review the Article in terms of its:

Desirability: The article is important and necessary Feasibility: The article may be enforced by law and put into practice.

Clarity: The wording and intent of paragraph 2 are not very clear.

Suggested changes: Art. 9, para. 2 (b): instead of "In addition, WHO may…" we suggest "In addition, WHO shall…".

Comment: We are concerned about the situation of countries facing a risk or an event representing a risk for international public health and which they are manifestly incapable of handling and who fail to request or turn down the support referred to in this article. What measures may WHO apply to protect international public health?

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Article 10 - Response Many Member States may not currently possess sufficient capacity to contain and control major disease outbreaks, but as stated in the Article 10.2., WHO will provide assistance on request. Please review the Article in terms of its:

Desirability: This article is important and necessary.

Feasibility: The article may be enforced by law and put into practice. Clarity: The wording and intent are clear.

Suggested changes: Article 10, para. 3: we suggest replacing " In the absence of such a request, WHO may offer assistance" by "WHO shall offer assistance..".

Comments: The intent of this change is to ensure that this assistance is always available. Please note any suggested changes for other Articles in Part II by Article and paragraph number.

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Part III - Recommendations Since it is impossible to predict the impact or scope of public health events in advance, even when a known disease may be involved, the revised IHR allows for the issuing of (temporary) recommendations to allow Member States to respond in “real-time” to these events and, if necessary, to modify measures during the course of the event. When these events do not constitute a public health emergency of international concern but still require that international controls be in place, standing recommendations can be developed and provided for Member State use. Please note any suggested changes for the provisions in Part III by Article and paragraph number. Please review the Articles in Part III in terms of their:



Clarity: The wording and intent are clear.

Suggested changes: In Part III - Recommendations, Article 11, paragraph 2: we suggest inserting "and to Members States" before "operators".

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Part IV - Points of Entry Part IV describes the general obligations of health administrations and health authorities for public health services at international points of entry. The provisions of the current (1969) IHR for points of entry are generally retained, but the revised draft also highlights the need for a capacity to provide both routine and emergency public health services.

Article 13 - Health administration Many international ports and airports are now managed by private or semi-private agencies. It is important that the responsible public health authority is clearly designated, to help ensure that both routine and emergency public health services are available for international transport. Please review the Article in terms of its:



Clarity: The wording and intent are clear. Suggested changes: Panama has ports and frontier posts which receive vessels on international voyages and travellers and which are unable to satisfy all the requirements set out in annex 1 (health facilities and services). In view of the very expensive nature of these facilities, designated ports and border posts should be allowed to satisfy through the health system the requirements of ships, boats or craft in transit or of ships and boats navigating on inland waters on international voyages.

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Article 14 - Airports and Ports Member States currently provide a list of international ports in their territories that issue deratting exemption and deratting certificates. International airports are not designated under the current IHR, other than those airports which the State wishes to designate as international sanitary airports. Other than this change, this Article continues the provisions contained in the current IHR. Please review the Article in terms of its:



Clarity: The wording and intent are clear. Suggested changes: None.

Please note any suggested changes for other Articles in Part IV by Article and paragraph number.

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Part V Public Health Measures Part V contains the measures that may generally be applied by health authorities at points of entry. Chapter II contains provisions for conveyances and conveyance operators (see Annex 4.). While retaining many of the general point of entry provisions of the current IHR, this Part puts the general obligations in more of an activity/client format. Please note any suggested changes for the provisions in Part V by Article and paragraph number. Please review the Articles in Part V in terms of their:




Suggested changes: 1. Article 23: see the comments made in respect of vaccination in Part VIII. 2. Article 24: see the comments made in respect of charges in Part VII - Charges. 3. Article 33. para. 2 : delete "…WHO's…" as the response is from all, (WHO and States).

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Part VI Health Documents Health documents are a key part of the routine public health control activities for international transport, and can also add important information when required during public health emergencies of international concern. These documents are usually requested at international points of entry, and relate to the international movement of persons and conveyances. This Part provides the general rules for requiring vaccination, maritime and aircraft health declarations. Please note any suggested changes for the provisions in Part VI by Article and paragraph number. Please review the Articles in Part VI in terms of their:





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Part VII - Charges In most countries, the issuance of certain documents, like deratting/deratting exemption certificates, is a cost-recovered activity. In other cases, Member States cannot charge, for example, for medical examinations given to persons who are not applying for temporary or permanent residence. Please note any suggested changes for the provisions in Part VII by Article and paragraph number. Please review the Articles in Part VII in terms of their:

Desirability:

Feasibility:

Clarity: Suggested changes: None.

Part VII: Charges It should be specified that the examination performed by the health authority in case of public health problems will involve no cost. When the risk or threat to public health disappears, all the costs of providing treatment for those affected shall be borne by the Company responsible for the transport of the crew, passengers and/or stowaways. Once the health authority has dealt with a threat to public health, the patients treated shall be transferred to the chosen medical facility for treatment, and the company responsible for them shall defray their costs. If, on arrival, the traveller, ship or conveyance fails to present the documents or to satisfy the health measures required by the country, the costs deriving from such services shall be defrayed by the traveller or firm responsible. It should also be emphasized that Panama is a country with an important service sector, and that many of the vaccinations and other preventive measures are not required by Panama, but by other States; accordingly, it is appropriate for the health authority to charge reasonable fees when vessels or individuals themselves request any of these services. Application of any other health measures, such as disinsecting, disinfecting or decontamination involves costs which shall be borne by those responsible for the situation.

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Part VIII General Provisions Part VIII contains some new key concepts, including a specific provision protecting the rights of persons under other international agreements, as well as language that deals with the application of excessive measures and special arrangements between States. Please note any suggested changes for the provisions in Part VIII by Article and paragraph number. Please review the Articles in Part VIII in terms of their:




Suggested changes: In Article 34: In view of its proven efficacy and low cost, vaccination should be a public health measure whose requirement is under no circumstances considered excessive, except in the case of proven medical contraindication. States free of disease or in the process of eliminating and/or eradicating them should be able to require that travellers from countries infected/reinfected by outbreaks or epidemics or in which a disease is endemic be vaccinated against diseases other than yellow fever. Article 36 should specify that under international law, any traveller who refuses the health measures established by a State may be refused entry in order to safeguard the country's public health.

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Part IX Final Provisions Two new concepts have been included in Part IX:

Article 45 - Review WHO felt it was important that a committee of external experts be established to monitor the functioning of the IHR, as well as to propose amendments to the IHR and consider disputes between Member States (see Annex 10). Please review the Article in terms of its:




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Article 47 - Settlement of Disputes The current IHR contain provisions for dispute settlement, but the revised IHR draft proposes a process whereby the Review Committee is tasked with considering disputes that cannot be resolved by the Director-General. Other avenues for resolution are also open to Member States in this Article, such as binding arbitration. Please review the Article in terms of its:

Desirability: The article is important and necessary. Feasibility: The article may be enforced by law and put into practice.



Please note any suggested changes for other Articles in Part IX by Article and paragraph number.

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Review of Annexes

Annex 1 - Core Capacity Requirements for Surveillance and Response and Points of Entry

Annex 1 provides more detail for the general obligations contained in the Articles regarding core capacities for surveillance and response and for designated points of entry. The surveillance and response capacity provisions are new, but the requirements for points of entry carry over many provisions of the current IHR. Please review all paragraphs in Annex 1, in terms of their: (please note any suggested changes by paragraph number)



Clarity: The language and intent are clear. Suggested changes:

Include in paragraph 1. (a) "offer access", for the reasons set out in respect of Section IV, Article 13.

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Annex 2 - Decision instrument and parameters Annex 2 provides the decision instrument and further detail regarding the parameters for determining which events may constitute a public health emergency of international concern, and hence require notification to WHO. The ability to detect national events that may constitute a public health emergency of international concern is paramount, since Member States may request WHO assistance in responding to public health emergencies of international concern. Please review all of the information in Annex 2, in terms of its: (please note any suggested changes by referencing the decision instrument or section and item number)





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Annex 3 - Process for determining public health emergencies of international concern and issuing temporary recommendations

Annex 3 establishes the process and procedures WHO will follow in determining if an event constitutes a public health emergency of international concern. It is important to note that an “Emergency Committee” is involved in this process, to provide external review. Please review all of the paragraphs in Annex 3, in terms of their: (please note any suggested changes by paragraph number)




Suggested changes: None. Comment: 1. Section 1. paragraph 2: In view of the rapid speed with which people and goods

now move throughout the world, we are concerned about the time that would be taken for this consultation of a committee, on account of the potential risks to international health.

2. According to paragraphs 7, 8 and 9, ultimate responsibility lies with a single

person; it would be preferable for it to lie with an international organization.

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Annex 4 - Technical requirements for conveyances and conveyance operators

Annex 4 contains many of the current requirements at points of entry for conveyance operators and health authorities, as well as examples of the measures that could be recommended for conveyances and containers at points of entry. Please note that the Ship Sanitation Control Exemption/Ship Sanitation Control Certificate replaces the current Deratting Exemption/Deratting certificate. The much broader requirements of the Sanitation Certificate should help ensure that all important on-board international public health risks are detected and controlled, rather than just rodent-borne disease risks. Please review all of the paragraphs and the model Sanitation Certificate in Annex 4, in terms of their: (please note any suggested changes by referencing the paragraph number or the model certificate)



Clarity: The language and intent are clear.

Suggested changes: In the last line, rather than "The measures will be recommended by WHO" we suggest "States shall establish the measures….." concluding with "… taking into account the recommendations of WHO."

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Annex 5 - Measures for vector-borne disease Annex 5 provides the procedures that should be followed regarding vector control for arriving and departing conveyances. These procedures relate to areas where vectors may be present, or arrivals from these areas. Please review all of the paragraphs and the model Sanitation Certificate in Annex 4, in terms of their: (please note any suggested changes by referencing the paragraph number)



Suggested changes: We repeat the comments made on page 13 in respect of Part VII. Charges. We suggest that Article 82, paragraph 2 of the 1983 IHR be maintained (Article 89 of the 1974 IHR).

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Annex 6 - Vaccination, prophylaxis and related certificates Annex 6 contains the existing provisions for vaccination (based on yellow fever), as well as the addition of prophylaxis as a preventive measure against the international spread of disease. These provisions are based on the need to require proof of vaccination or prophylaxis for international travel from areas considered at risk. A model of a vaccination/prophylaxis certificate is included in this annex. Please review all of the paragraphs and the model Certificate in Annex 6, in terms of their: (please note any suggested changes by referencing the paragraph number or the model certificate)



Suggested changes:

Paragraph 2: In view of the advances made by technology, provision should be made for the possibility of photographing persons, while specifying that it is not mandatory. Paragraph 4: It should be mandatory for the signature to be that of an "appropriate health official", and it should be added that it should also bear the "personal stamp and the official stamp of the centre providing the service". Paragraph 5: Besides French and English, the languages should be restricted to the official languages of WHO.

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Annex 7 - Requirements concerning vaccination or prophylaxis for specific diseases

The only disease requiring an international certificate under the current IHR is yellow fever. Other diseases, for example poliomyelitis, may require international proof of vaccination or prophylaxis in the future. This annex lists the requirements for yellow fever, but will also allow for the inclusion of other diseases as required. Please review all of the paragraphs and the model Certificate in Annex 6, in terms of their: (please note any suggested changes by referencing the paragraph number)




Paragraph 1: we wish to reiterate the following " In Article 34: In view of its proven efficacy and low cost, vaccination should be a public health measure whose requirement is under no circumstances considered excessive, except in the case of proven medical contraindication. States free of disease or in the process of eliminating and/or eradicating them shall be able to require that travellers from countries infected/reinfected by outbreaks or epidemics or in which a disease is endemic be vaccinated against diseases other than yellow fever." Moreover, in view of scientific progress and the challenges posed by emerging and re-emerging diseases, we should not restrict the IHR to a single disease. Paragraph 2: Subparagraph (d): We do not approve of this. There have been cases of non-immunized vaccinees. When a case is suspected on clinical grounds, it should be treated as such until it has been excluded. Subparagraph (h): It should be made clear that the person in question must notify the health authority of any feverish symptoms whose onset is within 6 days of their arrival if they have come from an area in which there is a risk of yellow fever transmission. The health authority shall be responsible for actively monitoring the person. The IHR should explicitly set out, in this annex, what was stated in the previous versions: - the validity of the vaccination ten days after its administration; - the need for revaccination every ten years.

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Annex 8 - Model of Maritime Declaration of Health The Maritime Declaration of Health is included in the current IHR, but has been updated and revised. Please review the model Certificate in Annex 8, in terms of its:

Desirability: The article is important and necessary. Feasibility: The article may be enforced by law and put into practice.


Suggested changes:

Health questions: The note to question 3 needs to be made simpler; we suggest:

Fever Any acute skin rash or eruption with or without fever Severe diarrhoea Jaundice (yellowing of the skin, mucous or sclerae) accompanied by fever Unusual bleeding accompanied by fever Convulsions or sudden change of behaviour without prior diagnosis

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Annex 9 - Aircraft General Declaration, Health Part The Aircraft General Declaration, Health Part, is an International Civil Aviation Organization (ICAO) document, and as such is not included in the IHR revision process. The Declaration will be part of the ICAO review process. Suggested changes: Similar to those suggested for Annex 8. Include the list of symptoms recommended for the Health Questions: Consider the following symptoms as sufficient reason to suspect a disease of an infectious nature:

Fever Any acute skin rash or eruption with or without fever Severe diarrhoea Jaundice (yellowing of the skin, mucous or sclerae) accompanied by fever Unusual bleeding accompanied by fever Convulsions or sudden change of behaviour without prior diagnosis

Annex 10 - The Review Committee The Committee, as proposed, will perform several key review and advisory functions, and provides valuable external expertise to assist the Director-General in establishing standing recommendations, resolving disputes between member States and recommending amendments to the IHR. Please review all of the paragraphs in Annex10, in terms of their: (please note any suggested changes by referencing the paragraph number)

Desirability: The article is important and necessary


Clarity: The wording and intent are clear


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Key points of the International Health Regulations suggested by the Panamanian delegation

Santo Domingo, Dominican Republic

29 April 2004-05-26 1. Part VII Charges

Countries should have the right to require airlines, shipping companies and their passengers who arrive in a country without having satisfied the health requirements which the country has established and published to pay any costs deriving from their failure to comply therewith.

2. Once the International Health Regulations have been ratified by countries and acquired force of law, we believe that they should provide for penalties for Member States, firms or individuals who fail to comply with their provisions.

3. Panama requests that human rights should always be respected, while

emphasizing that the rights of individuals cannot be put above those of the community's public health.

4. The International Health Regulations should explicitly set forth the role of

States in implementing the recommendations made by WHO. 5. Panama suggests that once the Regulations have been adopted and distributed to

countries, they should be accompanied by a written or electronic version of all the documents referred to in these Regulations.

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