for the assessment of capacities at the human-animal interface

for the assessment of capacities at the human-animal interface

inTERnaTiOnal hEalTh REGulaTiOnS (2005) ihR CORE CaPaCiTY mOniTORinG FRamEWORK

handbook

Global capacities

alert and response

for the assessment of capacities at the human-animal interface

handbook

inTERnaTiOnal hEalTh REGulaTiOnS (2005)

ihR CORE CaPaCiTY mOniTORinG FRamEWORK

WHO Library Cataloguing-in-Publication Data

Handbook for the assessment of capacities at the human-animal interface.

1. Zoonoses. 2. Risk assessment. 3. animal Diseases. 4. Ecosystem. 5. human. 6. animals. i. World health Organization.

ii. World Organisation for animal health.

ISBN 978 92 4 154932 5 (NLM classification: WC 950)

© World Health Organization and World Organization for Animal Health 2015

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Table of ConTenTs

CONTEXT 5

OBJECTIVE OF THE HANDBOOK 6

CONTENT OF THE HANDBOOK 6

STRUCTURE OF THE HANDBOOK 7

HOw TO USE THE HANDBOOK 8

TABlES OF CORRESpONDENCE BETwEEN QUESTIONS IN THE IHR MONITORING FRAMEwORK

AND ASSOCIATED pVS CRITICAl COMpETENCIES 10

ANNEX 1. Key obligations associated with the IHR (2005) for which the veterinary

services obviously contribute 34

ANNEX 2. list of pVS Critical Competencies to be considered in the IHR Monitoring Framework 35 ANNEX 3. Table of correspondence between the questions in the IHR MF Questionnaire

and the Critical Capacities cards in the OIE pathway tools 36

ANNEX 4. Description of the IHR Monitoring Framework and the OIE pVS pathway 39

SECTION 1: ENABLING ENVIRONMENT... 10

lEGAl AND REGUlATORy FRAMEwORK ... 10

• Review of the legal landscape ... 10

• Regulation and policies enabling the IHR NFP and the strengthening of the Core Capacities defined in the IHR (2005) ... 11

• Definition of roles in the IHR Monitoring Framework ... 12

• Existing references ... 13

REVIEw OF STRUCTURES AND RESOURCES AVAIlABlE ... 15

• Mapping of existing structures and operational resources ... 15

• Financial resources... 16

• Human resources ... 16

COORDINATION BETwEEN SECTORS ... 17

• Facilitating mechanisms between responsible Authorities ... 17

• Coordination with stakeholders ... 18

• Operational frameworks ... 19

• Operational procedures ... 21

SECTION 2: OpERATIONAL CApACITy ... 22

CApACITy TO DETECT AN UNUSUAl EVENT AND IDENTIFy ITS ETIOlOGy ... 22

• Global review of the network of collaboration and shared references ... 22

• Interactions during routine surveillance programmes and assessment of potential risks ... 24

• Capacity to assess a correct diagnosis ... 25

• Ensuring laboratory quality ... 26

• Information on risk factors ... 26

• Sharing protocols for the management of public health events ... 27

• Actions for rapid configuration ... 28

• Specific surveillance for AMR... 28

CApACITy TO ENSURE A COORDINATED RESpONSE ... 30

• Rapid response teams (RRT) ... 30

• Mechanisms for rapid action ... 31

• Evaluation of the interventions and quality review ... 32

• Development of a communication plan ... 33

N.B. For ease of reference, sub-sections are colour-coded

ConTexT

With the coming into force of the revised international health Regulations (ihR (2005)), all States Parties

¹

are required to assess the ability of their national structure and resources to meet minimum national core capacities for surveillance and response as specified in Annex 1 of the IHR (2005)

²

, and to develop a plan of action to ensure that these capacities be present and functioning throughout their territories.

Annex 1 of the IHR (2005) provides a list of core functions – the capacity to detect, report, assess and respond to Public health Event(s) of international Concern

(PHEIC) - expected at the three levels of implementation in countries – national, intermediate and local community levels. all States Parties have committed to report their level of compliance with IHR Annex 1 to the World health assembly (Wha) on a yearly basis.

in order to assist States Parties in their responsibility to report to the Wha, WhO has developed a data

collection tool which enables each State Party to provide standardized information on progress of its core capacity development in the implementation of the ihR (2005).

The data collection tool is linked with an online questionnaire derived from the Checklist and indicators for monitoring progress in the development of IHR core capacities in States Parties

³

developed through the ihR monitoring Framework. This questionnaire is designed primarily for use by national ihR Focal Points (nFPs) in collaboration with public health professionals, managers and other sectors and stakeholders responsible for implementing the ihR. This process aims to capture the contribution of the specific sectoral authorities, in reaching the objectives of the ihR (2005).

national Veterinary Services contri- bute to the implementation of ihR – and it is therefore necessary for na- tional ihR Focal Points to obtain this information when filling out the IHR monitoring Framework Question-

naire. Information relating to the Veterinary Services’ contribution can be gathered from the outputs of the OIE Performance of Veterinary Services (PVS) Pathway. The OiE PVS Pathway, among others, assesses the performance of national Veterinary Services and their compliance with OiE intergovernmental standards on the quality of Veterinary Services.

all aspects relevant to the OiE Terrestrial Animal Health Code

⁴

and the quality of Veterinary Services, as per the OIE definition

⁵

, are reviewed using the PVS Tool. During a PVS Evaluation mission, the PVS Expert Team collects and analyses baseline information against 47 Critical Competencies, each of which is described in a specific card (Critical Competency card). more details on the structure of the ihR monitoring Framework and the PVS Pathway can be found in Annex 4.

1 - Certain States Parties that are not members States of WhO may become a party to the ihR by notifying acceptance of the Regulations to the Director-General of the World health Organisation. Currently, 196 States Parties to the ihR (2005) include all WhO member States (194) as well as the holy See and liechtenstein.

2 - Annex 1 of the IHR (2005) includes 2 sections: A - Core capacity requirements for surveillance and Response, and B - Core capacity requirements for designated airports, ports and ground crossing. available at www.who.int/ihr/9789241596664/en/

3 - Checklist and indicators for monitoring progress in the development of IHR core capacities in States Parties. Geneva: World Health Organization, 2013. Available at www.who.int/ihr/checklist/en

4 - The OIE Terrestrial Animal Health Code is available at http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/

5 - In this manual, the terms “Veterinary Authorities” and “Veterinary Services” refer to the definitions in the Terrestrial Cod

- Veterinary authority means the Governmental Authority of an OIE Member Country, comprising veterinarians, other professionals and paraprofessionals, having the responsibility and competence for ensuring or supervising the implementation of animal health and welfare measures, international veterinary certification and other standards and recommendations in the Terrestrial Code in the whole territory.

- “Veterinary Services” means the governmental and non-governmental organisations that implement animal health and welfare measures and other standards and recommendations in the Terrestrial Code in a territory. The Veterinary Services are under the overall control and direction of the Veterinary Authority. Private sector organisations, veterinarians, veterinary paraprofessionals or aquatic animal health professionals are normally accredited or approved by the Veterinary Authority to deliver the delegated functions.

"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 (…), the capacity to detect, assess, notify and report events in accordance with these Regulations… and ...the capacity to respond promptly and effectively…"

IHR (2005), Articles 5 and 13

The OiE and the PVS Pathway

The World Organisation for animal health (OiE) is the intergovernmental organisation responsible for improving animal health worldwide. One of the OIE’s key strengths is providing international cooperation and coordination against the spread of animal diseases, in line with its core mandate, “improvement of animal health, veterinary public health and animal welfare world-wide”. OiE is recognised as a reference organisation by the World Trade Organization (WTO) and in 2015 counted a total of 180 member Countries.

The OiE provides assistance to its member Countries to improve the governance of their national Veterinary Services in order that their capacity may be strengthened and better-aligned with OiE international quality standards. For that purpose, since 2006, the OiE has progressively developed a global programme, the PVS (Performance of Veterinary Services) Pathway. The PVS Pathway is a comprehensive, multi-staged continuous process to strengthen Veterinary Services to and help them improve their governance mechanisms by better aligning with the OiE intergovernmental standards that they have democratically adopted.

This process focuses on building capacities of horizontal systems, giving national Veterinary Services tools to identify weaknesses and develop strategies to address these gaps.

more information on the PVS Pathway is provided on page 45

The use of the PVS Evaluation reports can greatly facilitate the work of the ihR nFPs. When the ihR monitoring Framework questionnaire is completed, the country PVS Evaluation report provides concrete elements on the contribution of a country’s Veterinary Services to specific core capacities defined in the ihR (2005). national ihR Focal Points can issue a request for their country’s PVS Pathway reports by writing to the national Delegate to the OiE of

their country. The OiE website provides up to date list of all national Delegates to the OiE

⁶

.

The contribution of Veterinary Services to the implementation of the IHR may be obvious for some specific hazards (zoonosis, food safety), however there are other key areas that are useful for answering other core capacities in the ihR monitoring Framework Questionnaire. This handbook has been developed to facilitate this exercise. It contains detailed information on the connection between the two processes and how the data contained in a PVS Evaluation report can assist and aid countries to better answer the ihR monitoring Framework questionnaire.

obJeCTIVe of THe HanDbooK

The objective of the Handbook is to facilitate the assessment of existing capacities for areas in which Veterinary Services contribute to the implementation of the ihR (2005). more particularly, it aims at facilitating the annual report on country compliance with IHR (2005) requirements by using the results of the PVS Pathway missions. Through this process, it also endeavours to increase the visibility of Veterinary Services and their contribution to the implementation of IHR (2005).

ConTenT of THe HanDbooK

In order to achieve the above-specified objectives, parallels between the IHR Monitoring Framework questionnaire and the PVS Tool have been established. The questions from the questionnaire for which a contribution of the Veterinary Services can be identified have been matched with the relevant Critical Competency(ies) in the PVS Tool.

The ihR monitoring Framework questionnaire is derived from the ihR Checklist and indicators for monitoring progress in the development of IHR core capacities in States Parties. Figure 1 illustrates the translation from the Checklist to the online questionnaire, using the first indicator of core capacity 1: National legislation, policy and financing as an example.

6 - Available at: http://www.oie.int/en/about-us/our-members/delegates-new/

The OiE Terrestrial Animal Health Code and Aquatic Animal Health Code sets out intergovernmental standards for the improvement of animal health and welfare and veterinary public health worldwide, including through standards for safe international trade in terrestrial animals (mammals, birds and bees), aquatic animals and their products.

The measures outlined in the Terrestrial Animal Health Code and Aquatic

Animal Health Code are used by the veterinary authorities (and the aquatic

Animal Health Services) of importing and exporting countries for early

detection, reporting and control of pathogenic agents to terrestrial animals

and, in the case of zoonoses, to humans, and to prevent the transfer

via international trade in animals and animal products, while avoiding

unjustified sanitary barriers to trade.

The Indicators are specified by several attributes reflecting a ‘one of four capability levels’, (Foundational Level: prerequisites; Level 1: inputs and processes; Level 2: outputs and outcomes; Level 3: additional).

Attributes are reflected in “Yes, No, or Not Known“ answers in the online ihR questionnaire. if a question is not applicable for the country context, this is indicated in the comment box.

When filling out the online IHR questionnaire, this Handbook will help users take into consideration the contribution made by the country’s Veterinary Services in implementing the IHR (2005) and guide them in locating this information from the relevant PVS Critical Competency card(s) in the country’s PVS Evaluation or PVS Evaluation Follow-up report.

Figure 2: Correspondence between a question in the online ihR questionnaire and the relevant PVS Critical Competency cards in the PVS Evaluation report

QuESTiOnS in ThE ihR QuESTiOnnaiRE PVS CRiTiCal COmPETEnCY 1.1.1.1. has an assessment of relevant legislation,

regulations, administrative requirements and other government instruments for ihR implementation been carried out?

iV-1. Preparation of legislation and regulations ii-7. Disease prevention, control and eradication ii-6. Emergency response

sTRUCTURe of THe HanDbooK

The online ihR questionnaire follows the same structure as that of the ihR Checklist and indicators for monitoring progress in the development of IHR core capacities in States Parties: the questions are organized along the eight IHR core capacities, plus Point-of-Entry (PoE), and four sections on specific hazards: zoonoses; food safety; chemical emergencies; and radiation emergencies (Table 1).

Table 1 : The core and specific capacities used in the IHR Monitoring Framework

CORE CaPaCiTiES SPECiFiC CaPaCiTiES

1. National legislation, policy and financing 2. Coordination and nFP communications 3. Surveillance

4. Preparedness 5. Response

6. Risk communications 7. human resource capacity 8. laboratory

9. Points-of-Entry

10. hazards 10.1. Zoonotic 10.2. Food safety

10.3. Chemical emergencies 10.4. Radiation emergencies

Figure 1: IHR Monitoring Framework tools: Translation of the attributes from the checklist to the questions in the online questionnaire

The indicator is the following: “Legislation, laws, regulations, administrative requirements, policies or other government

instruments in place are sufficient for implementation of IHR”

It is apparent that a country’s Veterinary Services contribute to specific hazards on zoonosis

⁷

and food safety, but their activities and actions are also relevant for many other components of the eight core capacities

⁸

. To avoid redundancies and confusion, a linear review along the structure of the questionnaire has been judged inappropriate therefore the questions from the ihR monitoring Framework questionnaire have been organized around the following two pillars

⁹

(Table 2):

1) The first pillar includes questions referring to the environment that enables the implementation of IHR : legal and regulatory framework, resources, coordination mechanisms between the two sectors, etc.

2) The second pillar includes questions exploring the operational capacities used to detect an unusual event, identify its etiology, and ensure a coordinated response.

Table 2: Structure used in the handbook

(N.B. For ease of reference, sub-sections are colour-coded)

7 - The term zoonosis here refers to the definition given in the Checklist and indicator document of WHO, namely: “Any infection or infectious disease that is naturally transmissible from vertebrate animal to human”. In this document, the definition is limited to infectious diseases.

8 - In this version, the specific capacities for PoE, chemical and radiation emergencies have not been considered, as the contribution of Veterinary Services is more difficult to objectify.

9 - The delimitations of these sections have been defined using the experience of strategies and roadmaps developed for intersectoral coordination for zoonosis and of the pilot PVS One health missions (in Costa Rica, Kenya and the Philippines). it should be noted that the OiE has preferred to systematically incorporate a One health approach into all PVS Pathway missions rather than conduct isolated One health PVS missions. moreover, the OiE and WhO are now undertaking WhO/

OIE National Bridging Workshops ; these workshops are centred on country perspectives on IHR/PVS assessments and the development of a national roadmap for improved intersectoral collaboration among animal and human health sectors. more information on these workshops is provided in the “WhO-OiE Operational Framework for Good Governance at the human-animal interface: Bridging WHO and OIE tools for the assessment of national capacities”. This can be accessed at:

http://www.who.int/ihr/publications/WHO-OIE_Operational_Framework/, http://www.oie.int/fileadmin/Home/fr/Media_Center/docs/pdf/WHO_OIE_Operational_

Framework_Final2.pdf.

SECTION 1: ENABlING ENVIRONMENT SECTION 2: OpERATIONAl CApACITy

LEGAL ANd REGuLATORy fRAMEwORk

• Review of the legal landscape

• Regulation and policies enabling the NFP and strengthening the Core Capacities as defined in the ihR (2005)

• Definition of roles and duties in the IHR framework

• Existing references

REVIEw Of STRuCTuRES ANd RESOuRCES AVAILABLE

• Mapping of existing structures and operational resources

• Financial resources

• Human resources

COORdINATION BETwEEN SECTORS

• Facilitating mechanisms between responsible authorities

• Coordination with stakeholders

• Operational frameworks

• Procedures

• Operations

CApACITy TO dETECT AN uNuSuAL EVENT ANd IdENTIfy ITS ETIOLOGy

• Global review of the network of collaboration and shared references

• Interactions during routine surveillance programs and assessment of potential risks

• Existing capacities for obtaining a diagnostic

• Insuring quality in the laboratories

• Information on risk factors

• Sharing protocols for events management

• Actions for rapid confirmation

• Specific surveillance of AMR

CApACITy TO ENSuRE A COORdINATEd RESpONSE

• Rapid response teams

• Mechanisms for rapid action

• Evaluation of the interventions and quality review

• Development of a communication plan

HoW To Use THIs HanDbooK

There are 256 questions in the IHR Monitoring Framework questionnaire. These questions are identified by numbers, the first character(s) being the number of the core capacity they refer to (e.g. 7.x.x.x for a question associated with the core capacity 7), the second character referring to the component, and the third character to the Indicator. The final character is the number of the question (Figure 3).

Figure 3: Codes used to identify questions in the ihR monitoring Framework questionnaire

Example: the first question (1.1.1.1) is identified by

1.-.-.-. : Core capacity 1 1.1.-.-. : Component 1 1.1.1.-. : Indicator 1 1.1.1.1. : Question 1

all of the questions selected from the ihR questionnaire are organized by theme in the structure described above.

Users can explore the contribution of their country’s Veterinary Services to IHR implementation by consulting the selection of corresponding Critical Competency card(s) provided in the tables. The definition and the area covered by the Critical Competency cards are provided in the last column, with special references to areas of interest for the specific question of the IHR Monitoring Framework questionnaire. Where appropriate, a short paragraph has been added below the question to describe or highlight the Veterinary Services’ contribution to the implementation of the respective ihR Core Capacity. Figure 4 illustrates the structure of these tables.

Figure 4: Example of table of correspondence included in this Handbook demonstrating the linkages between a question in the ihR monitoring Framework Questionnaire and the information provided in a PVS Critical Competency card.

QUESTIONS IN THE IHR MONITORING FRAMEwORK

QUESTIONNAIRE

pVS CRITICAl

COMpETENCy DESCRIpTION

1.1.1.1. has an assessment of relevant legis- lation, regulations, administrative require- ments and other government instruments for ihR implementation been carried out?

Veterinary Services (VS) have an active role in the development of the legal and regulatory framework for the prevention and control of animal diseases including zoonoses, food safety, medicines, and several other areas under their mandate¹⁰. The main issues to consider here are: i) the involvement of the VS in the review of existing legal, and the regulatory and administrative instruments covering the core functions defined in the IHR (2005), ii) the description of synergies, overlapping or possible conflicting areas between the legal, regulatory and administrative frameworks developed in the human and animal sectors for the core functions defined in the IHR (2005).

iV-1. Preparation of legislation and

regulations This CC reviews the authority and capability of the VS to actively participate in the preparation of national legis- lation and regulations in domains that are under their mandate, in order to guarantee its quality with respect to principles of legal drafting and legal issues and its acces- sibility, acceptability, and technical, social and economical applicability. This competency involves collaboration with relevant authorities, including other ministries and Competent authorities, national agencies and decen- tralised institutions that share authority or have mutual interest in relevant areas.

The CC reviews inter alia:

- The legislative and regulatory framework of the veteri- nary domain and the mandate of the Veterinary Authority;

- The coordination of the VS with relevant authorities in the development of legislation and regulations regarding areas of joint or shared responsibility;

- Evidence that national legislation identifies the VS’ roles and responsibilities related to activities where there is shared authority with other Competent authorities

In total, the Handbook identifies the contributions made by a country to 98 questions of the IHR Monitoring Framework questionnaire, with additional information extracted from 36 PVS Critical Competencies. The table of correspondence in Annex 3 summarizes the relationship between the selected questions from the IHR monitoring Framework questionnaire and the PVS Critical Competencies. This table facilitates rapid review and overview of the specific actions provided by national Veterinary Services that contribute to the global objectives of the ihR (2005).

10 - Terrestrial Code: Articles 3.2.8 on Animal Health controls and Articles 3.2.9. on Veterinary Public Health controls

How to access pVS pathway reports

The annual IHR report and detailed filled checklist are not available online and interested persons should approach the ihR national focal point (ihR nFP). however, annual summaries per core capacity can be found on the WHO Global Health Observatory: www.who.int/gho/ihr/en/

The results of PVS Pathway reports are the property of the country concerned and are kept confidential by the OiE. To access the report, the ihR nFP may contact the appropriate national authority.

A number of countries have waived the confidentiality of their PVS reports, authorizing that their PVS report be shared with OiE partner organizations and to international donors working jointly with the OiE to strengthen Veterinary Services.

In addition, some countries have authorized the OIE to make their PVS Pathway reports fully public; these can be viewed on the OIE website:

- for the PVS Evaluation and PVS Evaluation Follow-Up reports: under

www.oie.int/en/support-to-oie-members/pvs-evaluations/oie-pvs-evaluation-reports/

- for the PVS Gap Analysis (PVS Costing Tool) reports: under

www.oie.int/en/support-to-oie-members/pvs-gap-analysis/pvs-gap-analysis-reports/

SECTION 1: ENABLING ENVIRONMENT THE LEGAL AN d REG u LA TOR y f RAME w OR k States Par ties need to ha ve an adequate legal frame w ork to suppor t and enable implementation of the ih R. This ma y r equir e that the y adopt implementing or enabling legislation for some or all of their obligations and rights. it can also facilitate coor dination among the diff er ent entities in volv ed in implementation. in ad dition, policies, which identify national structur es and responsibilities as w ell as the allocation of adequate financial resour ces, ar e also impor tant

11

. The k ey obligations fr om the ih R (2005) f or which a contribution fr om Veterinar y Ser vices (VS) can be identified ar e pr esented in Annex 1. In the Monitoring Frame w ork, the cor e ca pacity 1 is specificall y dedicated to “National legislation, policy & financing” but questions r ef er ring to legal issues can also be f ound in other sections of the questionnair e.

11 - http://www.who.int/ihr/legal_issues/legislation/en/index.html. In the context of IHR, the term "legislation, regulations and policy" is referring to the broad range of legal, administrative or other governmental instruments, whether legally binding or non-binding, and which may be available for States Parties to implement the ihR (2005). 12 - OIE Terrestrial Animal Health Code: Articles 3.2.8 on Animal Health controls and Articles 3.2.9. on Veterinary Public Health controls. 13 - OIE-Listed diseases, infections and infestations in force in 2015 are available at http://www.oie.int/en/animal-health-in-the-world/oie-listed-diseases-2015/

Review of the legal landscape QU es TI ons In TH e IHR QU es TI onna IR e PV s CRITIC al C o MP eT en CY (CC) D es CRIPTI on

1.1.1.1.has an assessment of relevant legislation, regulations, administrative requirements and other government instruments for ihR implementation been carried out? The VS have an active role in the development of the legal and regula- tory framework for the prevention and control of animal diseases inclu- ding zoonosis, food safety, medicines, and several other areas under their mandate12. The main issues to consider here are i) the involvement of the VS in the review of the existing legal, and the regulatory and administra- tive instruments covering the core functions defined in the IHR (2005), ii) the description of the synergic, overlapping or possible conflicting areas between the legal, regulatory and administrative frameworks developed in the human and animal sectors for the core functions defined in the IHR (2005).

iV-1. Preparation of legislation and regulationsThis CC demonstrates the authority and capability of the VS to actively participate in the preparation of national legislation and regulations in domains that are under their mandate, in order to guarantee its quality with respect to principles of legal drafting and legal issues and its accessibility, acceptability, and technical, social and econo- mical applicability. This competency includes collaboration with relevant authorities, including other ministries and Competent authorities, national agencies and decentralised institutions that share authority or have mutual interest in relevant areas. The CC reviews inter alia: -The legislative and regulatory framework of the veterinary domain and the mandate of the Veterinary Authority; - VS’ collaboration with other relevant authorities on the development of legislation and regulations regarding areas of joint or shared responsibility; - Evidence that national legislation identifies the VS’ roles and responsibilities related to activities with shared autho- rity with other relevant authorities. ii-7. Disease prevention, control and eradicationThis CC demonstrates the authority and capability of the VS to actively perform actions to prevent, control or eradicate OiE listed diseases13 and/or to demonstrate that the country or a zone is free of relevant diseases. The CC considers inter alia: - The legislative framework, chain of command, and regulations relating to the surveillance and control of animals diseases, including zoonoses; - Procedures and/or protocols regarding roles and responsibilities of other relevant authorities.

Tables of Co RR es Pon D en C e be TW een QU es TI ons In TH e IHR M on IT o RI n G fR a M eW o RK an D asso CI aT eD PV s CRITIC al C o MP eT en CI es

Regulation and policies enabling the IHR N fp and the strengthening of the Core Capacities defined in the IHR (2005)

QU es TI ons In TH e IHR QU es TI onna IR e PV s CRITIC al C o MP eT en CY (CC) D es CRIPTI on

ii-6. Emergency responseThis CC reviews the authority and capability of the VS to response rapidly to a sanitary emergency (such as a signi- ficant disease outbreak or a food safety emergency). The CC considers inter alia: -The legal framework supporting the rapid responses to sanitary emergencies; -The chain of command and the regulatory framework including in the collaboration with relevant authorities.

QU es TI ons In TH e IHR QU es TI onna IR e PV s CRITIC al C o MP eT en CY (CC) D es CRIPTI on

2.1.2.6. has information on obligations of the ihR nFP under the ihR been disseminated to relevant national authorities and stakeholders? 1.1.1.3. has a review of national policies to facilitate ihR nFP func- tions and ihR technical core capacities been carried out? 1.1.1.4. Have policies to facilitate IHR NFP core and expanded func- tions and to strengthen core capacities been implemented? The IHR NFP is in charge of disseminating information to and consolidating input from all relevant government authorities, reporting to WHO events which may constitute a PHEIC, as well as reporting on the strengthening of national core capacities as defined in the IHR Monitoring Framework. In consideration of the aforementioned, the following issues should be taken into consideration by the IHR NFP: i) the existence of coordination mechanisms between the VS and the IHR NF, including a good understanding by the VS of the role and obligations of the IHR NFP; ii) the communication channels and policies enabling the VS to provide required information to the IHR NF, including information related to operational capacities as defined in the IHR (2005).

iV-2.implementation of legislation and regulations and compliance thereof This CC demonstrates the authority and capability of the VS to ensure compliance with legislation and regulations under the VS mandate. This includes inter alia: - The capacity of the VS to take legal action and initiate prosecution in areas of non-compliance in relevant fields of activity; - Formal agreements and standard operating procedures for collaboration with other relevant authorities. iii-1. CommunicationThis CC demonstrates the capability of the VS to keep interested parties informed in a transparent, effective and timely manner, on VS activities and programmes, and of developments in animal health and food safety. This competency includes collaboration with relevant authorities, including other ministries and Competent authorities, national agencies and decentralised institutions that share authority or have mutual interest in relevant areas. This includes inter alia: - Formal communication procedures and mechanisms to inform interested parties, including coordination mechanisms with other relevant authorities including public health authorities and wildlife agencies, among others. i-6. Coordination capability of the Veterinary Services B. External Coordination

This CC demonstrates the capability of the VS to coordinate its resources and activities (public and private) at all levels with other relevant authorities as appropriate, in order to implement all national activities relevant for OiE Codes (i.e. surveillance, disease control and eradication, food safety and early detection and rapid response programmes). Relevant authorities include other ministries and Competent authorities, national agencies and decentralised institutions. This includes inter alia: - Coordination mechanisms with other relevant authorities in areas of joint responsibility; - Described procedures or agreements relating to joint committees involving the VS and other relevant authorities. ii-5. Epidemiological surveillance and early warning a. Passive epidemiological surveillance B. active surveillance

These CCs demonstrate the authority and capability of the VS to determine, verify and report on the sanitary status of the animal populations, including wildlife, under their mandate. The CC consider inter alia: - List of notifiable diseases; - Assessment of animal disease status, including zoonoses, of the country; - Human and physical resources for conducting surveillance; - Collaboration with other relevant authorities and parties in relevant areas (e.g. food safety; zoonoses, emerging diseases, wildlife) as well as established procedures for sharing relevant surveillance information; - Knowledge of OIE standards on surveillance, including obligations to report the suspicion and occurrence of notifiable diseases.

d efinition of roles in the IHR framework QU es TI ons In TH e IHR QU es TI onna IR e PV s CRITIC al C o MP eT en CY (CC) D es CRIPTI on

2.1.2.5. have national stakeholders responsible for the implementa- tion of IHR been identified? 2.1.2.7 a & b. have the roles and responsibilities of relevant au- thorities and stakeholders in regard to ihR implementation been defined (a)? disseminated (b)? The OIE Terrestrial Animal Health and Aquatic Animal Health Codes defined VS as the governmental and non-governmental organizations that implement animal health and welfare measures and are under the overall control and direction of the Veterinary Authority. VS also collaborate with other interested parties from both the public and private sectors. In consideration of the aforementioned, the following issues should be taken into consideration by the IHR NFP: i) ensure that the obligations of the VS and their contributions towards the implementation of the IHR are clearly defined and understood by all parties; ii) ensure that critical duties have been clearly assigned to the appropriate bodies.

i-6. Coordination capability of the Veterinary Services B. External coordination

This CC demonstrates the capability of the VS to coordinate its resources and activities (public and private sectors) at all levels with other relevant authorities as appropriate, in order to implement all national activities relevant for OiE Codes (i.e. surveillance, disease control and eradication, food safety and early detection and rapid response programmes). This CC includes inter alia - Coordination mechanisms with other relevant authorities in areas of joint responsibility; - Described procedures or agreements relating to joint committees involving the VS and other relevant authorities. iii-2. Consultation with interested partiesThis CC demonstrates the capability of the VS to consult effectively with interested parties on VS activities and programmes, and on developments in animal health and food safety. This competency includes collaboration with relevant authorities, including other ministries and Competent authorities, national agencies and decentralised institutions that share authorities or have mutual interest in relevant areas. This CC includes inter alia - Procedures for and evidence of formal consultation with interested parties. iii-6. Participation of producers and other interested parties in joint programmes

This CC demonstrates the capability of the VS and producers and interested parties to formulate and implement joint programmes in regard to animal health and food safety. This competency includes collaboration with relevant authorities, including other ministries and Competent authorities, national agencies and decentralised institutions that share authorities or have mutual interest in relevant areas. This CC includes inter alia - Evidence of active involvement of producers and interested parties in the development, organisation and delivery of programmes. iii-1. CommunicationThis CC demonstrates the capability of the VS to keep interested parties informed, in a transparent, effective and timely manner, of VS activities and programmes, and of developments in animal health and food safety. This competency includes collaboration with relevant authorities, including other ministries and Competent authori- ties, national agencies and decentralised institutions that share authority or have mutual interest in relevant areas. This CC includes inter alia - Formal communication procedures and mechanisms to inform interested parties, including coordination mecha- nisms with interested parties.

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3.2.1.11. Have all of events that meet the criteria for notification under Annex 2 of IHR been notified by the IHR NFP to WHO within 24 hours of conducting risk assessments over the last 12 months 14? All OIE Member Countries must report the occurrence of animal diseases, the emergence of new diseases and significant epidemiological events within 24 hours of the event (OIE, 2012). This also includes diseases trans- missible to humans and the deliberate introduction of pathogens. In consideration of the aforementioned, the following issues should be taken into consideration by the IHR NFP: i) mechanisms used by the VS to receive and share relevant sanitary information; ii) mechanisms for offi- cial reporting within the country; iii) history of reports to the international community and to the OIE ii-5. Epidemiological surveillance and early warning a. Passive epidemiological surveillance

This CC demonstrates the authority and capability of the VS to determine, verify and report on the sanitary status of the animal populations, including wildlife, under their mandate. The CC consider inter alia: - assessment of animal disease status, including zoonoses, of the country - Human and physical resources for conducting surveillance; - Collaboration with other relevant authorities in relevant areas (e.g. food safety; zoonoses, emerging diseases, wildlife) as well as established procedures for sharing relevant surveillance information; - Knowledge of OiE standards on surveillance, including their obligation to report the suspicion and occurrence of notifiable diseases. iV-6. TransparencyThis CC demonstrates the authority and capability of the VS to notify the OiE of its sanitary status and other relevant matters (and to notify the WTO SPS Committee where applicable), in accordance with established procedures. The CC considers inter alia: - Procedures and mechanisms to notify the OIE and other relevant international organisations, Codex and WTO notification and enquiry points where applicable); - OIE Focal Points network; - Familiarity of duties and obligations of membership to international and regional organisations. 11.1.1.1. are national or international food safety standards available? International food safety standards are developed through the Codex Alimentarius. The VS have the opportunity to contribute to the develop- ment of these standards and also to participate to the International Food Safety Authorities Network (INFOSAN) for sharing information on impor- tant food safety related issues of global interest. In consideration of the aforementioned, the following issues should be taken into consideration by the IHR NFP: i) the adoption of normative refe- rences related to food safety at the national level; ii) the concurrence of policies and implementation with these standards

III-3. Official representationThis CC demonstrates the capability of the VS to regularly and actively participate in, coordinate and provide follow-up on relevant meetings of regional and international organisations including the OIE (and Codex Alimen- tarius Commission and WTO SPS Committee where applicable). ii-8. Food Safety a. Regulation, authorisation and inspec- tion of establishments for production, processing and distribution of food of animal origin.

This CC demonstrates the authority and capability of the VS to establish and enforce sanitary standards for esta- blishments that produce, process and distribute food of animal origin. This includes inter alia: - Procedures for inspection of establishments and premises in conformity with international standards; - Regulation and authorisation of establishments and premises; - Records of inspections, audits and sanctions. ii-8. Food Safety B. ante and post mortem inspection at abattoirs and associated premises

This CC demonstrates the authority and capability of the VS to implement and manage the inspection of animals destined for slaughter at abattoirs and associated premises, including for assuring meat hygiene and for the collec- tion of information relevant to livestock diseases and zoonoses. The CC considers inter alia: - Procedures related to inspection at slaughtering facilities and associated premises, including for the collection of information relevant to food-borne diseases and zoonoses in conformity with international standards. 14 - " Each State Party 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 the decision instrument, as well as any health measure implemented in response to those events ". IHR (2005), Article 6.

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ii-8. Food Safety C. inspection for collection, processing and distribution of products of animal origin

This CC demonstrates the authority and capability of the VS to implement, manage and coordinate food safety measures on collection, processing and distribution of products of animal origin, including programmes for the prevention of specific food-borne zoonoses and general food safety programmes. The CC consider inter alia: - Procedures relating to the inspection of facilities, premises and establishments collecting, processing and distribu- ting products of animal origin; - Guidance for coordination regarding the occurrence of human food-borne illness; - Roles and relationships of all interested parties. iV-3. international harmonisationThis CC demonstrates the authority and capability of the VS to be active in the international harmonisation of regu- lations and sanitary measures and to ensure that the national legislation and regulations under their mandate take account of relevant international standards, as appropriate. The CC considers inter alia: - The legislative framework giving the VS the authority to play a role in the international and/or regional harmoni- sation of activities and programmes.

R EVIE w O f STR u CT u RES AN d RESO u RCES A VAIL ABLE Annex 1 of the IHR (2005) stipulates that States Par ties should utilize existing national structur es and resour ces to meet the cor e ca pacity requir ements as defined by the IHR. This includes financial resour ces, human resour ces (both in terms of number and qualification of staff), infrastructur es and ph ysical resour ces. This section concerns the existing national structur es and financial r esour ces a vailable as w ell as the ca pacity to mobilize these r esour ces to meet IHR cor e ca pacity r equir ements. Mapping of e xisting str uctures and operational resources QU es TI ons In TH e IHR QU es TI onna IR e PV s CRITIC al C o MP eT en CY (CC) D es CRIPTI on

5.1.1.1. Has an assessment of the capacity of existing national struc- tures and resources to meet ihR core capacity requirements been conducted? 5.1.1.2. has a national plan to meet the ihR core capacity require- ments been developed? 5.1.1.3. Does the national public health emergency response plan incorporate ihR related hazards and PoE? 5.2.1.3. have national resources been mapped for ihR relevant ha- zards and priority risks? In consideration of the aforementioned, the following issues should be taken into consideration by the IHR NFP: i) existing physical resources and functioning capacities of the VS; ii) resource coordination capacities (both internal and external) to implement activities associated with the detection, assessment, reporting and response to potential PHEIC at all 3 levels of implementation (national, intermediate, local community); iii) coordinating mechanisms with other relevant and competent authorities including public health authorities and the Veterinary Authority; iv) the development of preparedness and contingency plans; v) strategies for strengthening national (infra)structure and operational resources.

i-7. Physical resourcesThis CC demonstrates the VS’ access to relevant physical resources including buildings, transport, telecommunica- tions, cold chain, and other relevant equipment. This includes inter alia: -The geographical and functional distribution of physical resources and the existing of and adherence to proce- dures for their maintenance. i-6. Coordination capability of the Vete- rinary Services a. internal coordination (chain of command) B. External coordination

These CCs demonstrate the capability of the VS to coordinate its resources and activities (public and private sectors) - (A) with a clear chain of command, from the central level (the Chief Veterinary Officer), to the field level of the VS - (B) at all levels with other relevant authorities as appropriate - in order to implement all national activities relevant for the Codes (i.e. surveillance, disease control and eradication, food safety and early detection and rapid response programmes). This includes inter alia: - The definition and documentation of responsibilities (chain of command), structures and coordination mechanisms for the veterinary domain, from national to local community level; - Internal review/auditing mechanisms in place; - Simulation exercises reports; - Collaboration with other related authorities in the implementation of field activities within the veterinary domain in areas of joint responsibility (i.e. activities and programmes relating to food safety, veterinary public health, zoonoses, emerging issues, control of movement of animals and goods); - Coordination mechanisms with other relevant authorities in areas of joint responsibility; - Described procedures or agreements relating to joint committees involving the VS and other relevant authorities; - Development of trans-sectoral national preparedness plans. i-11.management of resources and operationsThis CC demonstrates the capability of the VS to document and manage their resources and operations in order to analyse, plan and improve both efficiency and effectiveness. This includes inter alia: - Procedures and access to funding for establishing, maintaining and/or improving operational infrastructure (budgets, physical and/or human resources); - Costed strategic plans ii-6. Emergency responseThis CC demonstrates the authority and capability of the VS to response rapidly to a sanitary emergency (such as a significant disease outbreak or a food safety emergency). This includes inter alia: - Network of human and physical resources available to determine and respond rapidly to a sanitary emergency; - Legal and financial support to respond to an emergency

financial resources Human resources QU es TI ons In TH e IHR QU es TI onna IR e PV s CRITIC al C o MP eT en CY (CC) D es CRIPTI on

Additional Q, CC1: Funding is available for IHR core capacities, IHR relevant hazards and POE. The regular activities of the VS contribute to most of the IHR core capacities and are funded through their annual budget. Access to exceptional funding to support the implementation of additional programmes or for emergencies may also contribute to the achievement of expected IHR core capacities.

i-8. Operational fundingThe CC demonstrates the ability of the VS to access financial resources adequate for their continued and expanded operations (i.e. disease surveillance, early detection and rapid response, and veterinary public health), independent of political pressure. ii-9. Emergency fundingThe CC demonstrates the capability of the VS to access extraordinary financial resources in order to respond to emer- gency situations or emerging issues. i-10. Capital investmentThe CC demonstrates the capability of the VS to access funding for basic and additional investments (material and non-material) that lead to a sustained improvement in the VS operational infrastructure.

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7.1.1.2. has a needs assessment been conducted to identify gaps in human resources and training to meet ihR requirements? 7.1.1.3. Does a workforce development or training plan that includes human resources requirements for IHR exist? 7.1.1.7. Are there specific programmes, with allocated budgets, to train workforces for ihR-relevant hazards? The needs assessment should also include the needs of those operating within the veterinary domain, both in terms of number of staff15 and qualifications16 . Appropriate staffing of the VS allows technical functions to be undertaken efficiently and effectively. The majority of veterinary and other professional positions should be occupied by appropriately qualified personnel at central, state / provincial and local community (field) levels. In consideration of the aforementioned, the following issues should be taken into consideration by the IHR NFP: i) appropriate number of qualified staff (veterinarian and para-veterinary and other relevant professional profiles) to cover the national territory and all key functions, including adequate capacities to detect, assess and respond to epidemiological events; ii) appropriate initial and continuing education of staff, including, for the latter, the implementation of adapted training programmes to ensure effective implementation of the IHR..

I-1 Professional and technical staffing of the Veterinary Services a - Veterinary and other professionals (university qualification) B - Veterinary para-professionals17 and other technical personnel

This CC reviews the appropriate staffing of the VS to allow for veterinary and technical functions to be undertaken efficiently and effectively. The CC reviews inter alia: - The approach for defining job descriptions, qualifications, experiences and formal appointment procedures; - The procedures for performance assessment and management; - The procedures for supervision of technical staff. i-2.Competencies of veterinarians and veterinary para-professionals a - Professional competencies of vete- rinarians including adherence to OiE guidelines and recommendations on veterinary education18 B - Competencies of veterinary para-professionals

This CC reviews the capability of the VS to efficiently carry out their veterinary and technical functions, measured by the qualifications of their personnel in veterinary and technical positions. The CC reviews inter alia: - The curriculum offered by veterinary faculties, including specific competences related to public health, public vete- rinary health and other ‘One health’ issues; - The curriculum provided to veterinary para-professionals, and a description of specialist qualifications and compe- tencies ascertained by veterinary para-professionals. i-3. Continuing educationThe CC demonstrates the capability of the VS to maintain and improve the competence of their personnel in terms of relevant information and understanding; measured in terms of the implementation of relevant training programmes. This CC reviews inter alia: - Existing training programmes for personnel as well as procedures in place to tailor continuing education on the basis of staff function or position, including on transsectoral and ‘One Health-related’ topics; - Evidence of interaction and collaboration between the Veterinary authority and professional organisations (e.g. Veterinary Statutory Body), including existence of continuing professional development programmes for private veterinarians, veterinary paraprofessionals, and other professionals. 15 - For the purposes of the OiE Terrestrial Animal Health Code and the OiE PVS Tool, Veterinary Services means the governmental and non-governmental organisations that implement animal health and welfare measures and other standards and recommendations in the Terrestrial Code and the OiE Aquatic Animal Health Code in the territory. In this context, this Critical Competence covers both the public and the private Veterinary para-professionals and other technical personnel. 16 - Reference in the OiE Terrestrial Animal Health Code, Article 3.2.5.1.: The Veterinary Services should demonstrate that their human resource component includes an integral core of full-time civil service employees. This core should always include veterinarians. It should also include administrative officials and veterinary para-professionals. The human resources may also include part-time and private sector veterinarians and veterinary para-professionals. It is essential that all the above categories of personnel be subject to legal disciplinary provisions. Data relating to the resource base of the Veterinary Services undergoing evaluation should be available 17 - Veterinary para-professional means a person who, for the purposes of the OiE Terrestrial Animal Health Code, is authorised by the veterinary statutory body to carry out certain designated tasks in a territory, and delegated to them under the responsibility and direction of a veterinarian. The tasks for each category of veterinary para-professional should be defined by the veterinary statutory body depending on qualifications and training, and according to need. 18 - in 2012, the OiE published Recommendations on the Competencies of graduating veterinarians (‘Day 1 graduates’) to assure national Veterinary Services of quality, targeting entry-level. These recommendations are relevant to all member Countries, regardless of the prevailing societal, economic and political circumstances. To support these recommendations, the OiE also developed guidelines for a model core veterinary curriculum. The OiE Guidelines on Veterinary Education Core Curriculum represent a basis on which national needs and circumstances could be added, and are offered primarily to developing and in-transition countries as an initial step to enhance and sustain national Veterinary Services. This document can be accessed at: http://www.oie.int/Veterinary_Education_Core_Curriculum.pdf

C OOR d INA TION BET w EEN SECTORS The eff ectiv e implementation of the ih R r equir es a m ulti-sectoral/m ultidisciplinar y a ppr oach implemented thr ough national par tnerships. it r equir es fr equent and coor dinated collaboration among all inter ested par ties in or der to put into place and maintain eff ectiv e aler t and response systems. The coor dination of nation-wide r esour ces is also a ke y requisite for the implementation of the IHR. In fact, specific mechanisms and netw orks alr eady exist in both the veterinar y and public health sectors and ar e w ell structur ed. Ther ef or e, the role of the NFP is to establish the links betw een the tw o sectors and optimize the use of these existing frame w orks to enhance their contribution to the implementation of the ih R. Concerning the v eterinar y public health sector , the national Veterinar y a uthority is the main interlocutor f or the n FP , and is connected to a br oad range of potential contributors (e .g., pr oducer associa tions/r epr esentativ es, industr y, pharmaceutical companies, academia, v eterinar y statutor y bodies…). i ntersectoral and interministerial coor dination should be organized thr ough formal mechanisms and pr ocedur es co vering the IHR’ s requir ements for sur veillance and response . This also necessitates maintaining a r egularl y updated netw ork of contacts in the diff er ent sectors as w ell as a g ood understanding of r espectiv e r esponsibilities and mandates. facilitating mechanisms between responsible Authorities QU es TI ons In TH e IHR QU es TI onna IR e PV s CRITIC al C o MP eT en CY (CC) D es CRIPTI on

2.1.1.3. is a multi-sectoral, multidisciplinary body, committee or taskforce in place addressing ihR requirements on surveillance and response for public health emergencies of national and international concern? 10.1.1.1. Does coordination exist within the responsible govern- ment authority (ies) for the detection of and response19 to zoonotic events? 10.1.1.3. have focal points responsible for animal health (including wildlife) been designated for coordination with the moh and/or ihR nFP? 11.1.1.6. is your country an active member of the inFOSan20 network? 11.1.1.4. has a coordination mechanism been established between the food safety authorities, e.g. the inFOSan Emergency Contact Point (if member) and the ihR nFP? The establishment of clear intersectoral mechanisms and agreements to support efficient collaboration (at all levels) is often possible in emergency situations. Sustaining such interactions is even more challenging in ‘peace- time’, when diseases appear to be under control and other priorities demand attention. However, the scope of the IHR is precisely to reinforce and develop intersectoral mechanisms and collaboration, as efficient responses to urgent events rely on permanently functioning, flexible, interactive systems capable of managing the unexpected and the unpredictable in the midst of routine.

i-6. Coordination capability of the Veterinary Services B. External coordination

The CC demonstrates the capability of the VS to coordinate its resources and activities (public and private sectors) at all levels (national to local community level) with other relevant authorities as appropriate, in order to implement all national activities relevant for OiE Codes (i.e. surveillance, disease control and eradication, food safety and early detection and rapid response programmes). Relevant authorities include other ministries and Competent authorities, national agencies and decentralised institutions. This includes inter alia: - Coordination mechanisms with other relevant authorities in areas of joint responsibility; - Described procedures or agreements relating to joint committees involving the VS and other relevant authorities. iii-1. CommunicationThis CC demonstrates the capability of the VS to keep interested parties informed in a transparent, effective and timely manner, on VS activities and programmes, and of developments in animal health and food safety. This competency includes collaboration with relevant authorities, including other ministries and Competent authorities, national agencies and decentralised institutions that share authority or have mutual interest in relevant areas. This includes inter alia: - Formal communication procedures and mechanisms to inform interested parties, including coordination mechanisms with other relevant authorities including public health authorities and wildlife agencies, among others; - Communication tools, plans and strategies also relating to in country preparedness/contingency plans and highlighting areas of shared responsibilities; - Network of contact points grouping experts from relevant authorities including public health authorities and wildlife agencies, among others, on areas requiring intersectoral collaboration and cooperation. 19 - note that coordination for surveillance and coordination for response may be the responsibility of different authorities. 20 - The international Food Safety authorities network (inFOSan) is a global network of 177 national food safety authorities, developed and managed by WhO in collaboration with the Food and agriculture Organization of the united nations (FaO), which disseminates important global food safety information and improves national and international collaboration.