OIE Activities Related to Laboratory Support

USAID - FAO/OIE/WHO Joint MeetingStrengthening Animal/Human Health Laboratory

Capacities12 June 2009, Rome

OIE Key Facts

•Established in 1924•Intergovernmental Organisation – predates the UN•5 Permanent OIE Regional Representations •5 OIE Sub-Regional Offices•5 OIE Regional Commissions•174 Members

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OIE Contributions to Global Laboratory Capacity

OIE Goal = Ensuring transparency in the worldwide animal disease situation

• Disease Reporting• Reference Laboratories and Collaborating Centres• Laboratory Twinning• Evaluation of the Performance of Veterinary

Services (PVS) and PVS Gap Analysis (needs and priorities)

• Collaboration – the sum of the combined efforts is greater than what could be achieved by individual partners alone

SPS Agreement

Animal HealthOIE

Food SafetyCODEX

Plant HealthIPPC

International standard setting organizations

OIE Codes and Manuals must be used in context

with Codex Alimentarius and SPS Agreement

The linkage between OIE Codes and Manuals,

animal disease policy and the SPS Agreement

Animal Health Standards - OIE Major Texts for Terrestrial Animals

• Terrestrial Animal Health Code (Terrestrial Code)http://www.oie.int/eng/normes/mcode/en_sommaire.htm

• Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual)http://www.oie.int/eng/normes/mmanual/A_summry.htm

• OIE Principles – Guidance, Standards, Transparency

Terrestrial Manual

• Principal target readership - laboratories carrying out veterinary diagnostic tests and surveillance, plus vaccine manufacturers and regulatory authorities in Member Countries

• Objective - to provide internationally agreed diagnostic laboratory methods and requirements for the production and control of vaccines and other biological products

• Living document, routinely incorporating democratically agreed upon revisions proposed by OIE experts to ensure up-to-date guidance

OIE Guidance and StandardsTerrestrial Manual Chapters

Introductory Chapters• Collection and shipment of diagnostic specimens• Biosafety and biosecurity in the veterinary

microbiology laboratory and animal facilities• Quality management in veterinary testing

laboratories• Principles of validation of diagnostic assays for

infectious diseases• Validation and quality control of polymerase

chain reaction methods used for the diagnosis of infectious diseases

OIE Guidance and StandardsTerrestrial Manual Chapters

Introductory Chapters (continued)• Laboratory methodologies for bacterial antimicrobial

susceptibility testing• Biotechnology in the diagnosis of infectious diseases

and vaccine development • Principles of veterinary vaccine production• Tests for sterility and freedom from contamination of

biological materials• Guidelines for international standards for vaccine banks• The role of official bodies in the international regulation

of veterinary biologicals

…and 113 additional disease specific chapters

Notification and Reporting

• Chapter 1.1. Notification of diseases andepidemiological information to WAHIS/WAHID A Secure Access system• Members shall…..

• Built upon a framework of a competent veterinary services and effective surveillance program

• Reporting from OIE delegate (usually the Chief Veterinary Officer) or proxy

OIE Listed Diseases – Multiple Species Diseases

• Anthrax• Aujeszky's disease• Bluetongue• Brucellosis (B.

abortus/melitensis/suis)• Crimean Congo

haemorrhagic fever• Echinococcosis/hydatidosis• Epizootic haemorrhagic disease• Equine encephalomyelitis

(Eastern)• Foot and mouth disease• Heartwater• Japanese encephalitis

• New world screwworm (Cochliomyia hominivorax)

• Old world screwworm (Chrysomya bezziana)

• Paratuberculosis• Q fever• Rabies• Rift Valley fever • Rinderpest• Surra (Trypanosoma evansi)• Trichinellosis• Tularemia• Vesicular stomatitis• West Nile fever

Criteria for listing a disease

EXCLUDE

INTERNATIONAL SPREAD? EMERGING?

NO YES

SIGNIFICANT SPREAD IN NAIVE POPULATIONS?

NO

NO

EXCLUDE

YES

INCLUDEINCLUDE

YES

ZOONOTIC POTENTIAL?

Notification procedures Types of reports

• Immediate notification of disease, infection or unusual epidemiological events

• Weekly reports: follow-up to the immediate notification

• Final report:• if the outbreaks have ended (event closed)• if the situation becomes endemic

• Six-monthly report• Annual report

Emerging Disease

… a new infection resulting from the evolution or change of an existing pathogenic agent, a known infection spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal or public health

OIE Role in Early Warning, Confirmation, Surveillance

• Unofficial information (including emerging, re-emerging and zoonotic diseases)• Rumor tracking and informal discussion often precedes

official reporting• Information from OIE Reference laboratories of

confirmation using established standards • OIE component of FAO/WHO/OIE collaborative GLEWS

project• Complemented by official notifications with complete

(and ongoing) information on the epidemiologic situation and control measures taken

• Developing new diagnostic assays and algorithms which can be validated and included in “living” Code and Manual

OIE Reference Laboratories and Collaborating Centres*

• Reference Laboratories• 187 laboratories in 36 Member Countries

or Territories on 100 diseases• Expertise on named disease(s) on the OIE

lists• Identified international expert

• Collaborating Centres• 35 centres from 20 Member Countries or

Territories on 33 topics• Expertise in a specific designated sphere

of competence (epidemiology, risk analysis)

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* As of May 2009

OIE Reference Laboratory Mandate

Mandate: • to function as a centre of expertise and

standardisation for a designated disease(s) or topics;

• to store and distribute to national laboratories biological reference products and any other reagents used in the diagnosis and control of the designated disease(s) or topics;

• to develop new procedures for diagnosis and control of the designated disease(s) or topics;

• to gather, process, analyse and disseminate epizootiological data relevant to their speciality;

• to place expert consultants at the disposal of the OIE

OIE Reference Laboratory Mandate

Additional contributions:• provision of scientific and technical training for

personnel from Member Countries of the Office; • provision of diagnostic testing facilities to

Member Countries• organisation of scientific meetings on behalf of

the Office; coordination of scientific and technical studies in collaboration with other laboratories or organisations; publication and dissemination of any information in their sphere of competence which may be useful to Member Countries of the Office.

OIE Reference Laboratory Reporting Responsibility

…provision of diagnostic testing facilities to Member Countries: In the case of results that are confirmed positive for diseases that are reportable to OIE, the Reference Laboratory should immediately inform the OIE Delegate of the Member Country from which the samples originated as well as the OIE Headquarters

List of OIE Reference Laboratories http://www.oie.int/eng/OIE/organisation/en_listeLR.htm

World Distribution of OIE Reference Laboratories (as of May 2008)

Each OIE Laboratory Twinning Project...• Is a link between OIE Reference Laboratory

or Collaborating Centre (Parent) and national laboratory (Candidate)

• Aims to improve expertise and diagnostic capacity with eventual aim of reaching OIE standards - Optimal goal is to achieve OIE Reference Laboratory designation

• Should be sustainable once the project is over

Extending the network of OIE capacity, expertise and standards through Laboratory Twinning• To provide regional support with better

geographical coverage for diseases and topics that are a priority in a given region

• Improved access for more countries to high quality diagnostics and expertise

• Better scientific expertise allows members to:• Readily apply science-based guidelines and

standards of OIE• To debate OIE scientific justification for

standards on an equal footing with other Members (better representation)

Approved and Active Twinning Projects

• Italy - Russia; avian influenza and Newcastle disease

• UK - China; CSF and rabies• USA - Brazil; avian

influenza and Newcastle disease

• Italy - Eritrea; brucellosis• Germany - Egypt; Avian

influenza and Newcastle disease

• Italy - Cuba; avian influenza and Newcastle disease

• UK - Turkey; brucellosis• Italy - Cuba; epidemiology • Italy - Botswana; CBPP• UK - South Africa; avian

influenza and Newcastle disease

• UK - Morocco; bluetongue and African horse sickness

• UK - Botswana; avian influenza and Newcastle disease

• Germany - Turkey; rabies

OIE Activities Related to Laboratory Support – Animal-

Human Interface• OIE Laboratory Twinning Project -

Investigate the capacity/ability of selected national laboratories to enhance the ability to respond to diseases at the animals-human-ecosystem interface (US CDC)

• Collaborative expansion of the Mediterranean Zoonoses Control Programme (MZCP) into a FAO/OIE/WHO center of excellence (e.g. Athens / Padova) to strengthen the tripartite effort to reduce risks of diseases at the animal-human-ecosystem interfaces

Relevant OIE collaborations with FAO and WHO

• GLEWS and related Risk Assessment and Risk Reduction outreach to countries

• OFFLU (OIE/FAO Network on Animal Influenza Expertise) – also with WHO Global Influenza Programme

• Joint Operations Coordination - CMC-AH (FAO/OIE) - SHOC (WHO) Collaboration

• “Strengthening Joint WHO/OIE/FAO Cooperation In the Management of Avian Influenza and other Zoonotic Diseases” (tripartite project with CIDA)

• Regular FAO/OIE/WHO tripartite meetings

PVS Evaluations and PVS Gap Analysis

• PVS and PVS Gap Analysis Trainings

• PVS evaluation of performance of Veterinary Services (using the OIE-PVS Tool)

• PVS Gap Analysis

• PVS follow-up missions

PVS – Chapter II – Technical Authority and Capability

• 4 Fundamental Components – 40 Critical competencies, of which:

• The authority and capability of the VS to develop and apply sanitary measures and science-based procedures supporting those measures• Section II-1 Veterinary laboratory diagnosis• Section II-2 Laboratory quality assurance• Section II-3 Risk analysis• Section II-4 Quarantine and border security• Section II-5 Epidemiological surveillance• Section II-6 Early detection and emergency

response• Section II-7 Disease prevention, control and eradication

Country Evaluation of the Performance of Veterinary

Services (PVS)Competent Veterinary Services is a Global Public

Good

• PVS Evaluation - a qualitative assessment of the performance and the compliance of the Veterinary Services with respect to the OIE international standards* on quality of VS

• PVS Gap Analysis - an identification of needs and the corresponding resources in collaboration with the host country authorities to address improved compliance for priority critical competencies as identified by a preceding PVS evaluation

* OIE Terrestrial Animal Health Code, Chapter 3.2

Qualitative evaluation of the performance on 40critical competencies

Specific Objectives of the Country

Prioritization of the critical competencies and of related needs

PVS Gap Analysis

PVSEvaluation

PVS Gap Analysis process

• Gap identification and PVS Gap Analysis • National use for self improvement and

national budget applications (Ministry of Finance; Parliament)

• External use for financial support (Donors’ investment programs), if needed

• PVS Gap Analysis field visits• Dialogue with the country• Country appropriation/internal consultations• Validation of choices and priorities with the

country concerned

PVS Gap Analysis process

Special PVS Gap Analysis Project Animal-Human Interface

• Project to assess needed support by one or a few selected countries in respect to establishing and strengthening the veterinary services to respond to new or ongoing diseases within the animal-human-ecosystem interface, with an initial focus on avian influenza

• The activity will focus on a PVS Gap Analysis with the specific task to identify the links and potential for coordinated animal and human health response • In collaboration with US CDC avian influenza dedicated country

staff, and country human and animal health representatives• Using the PVS Gap Analysis and results from any existing human

health system evaluation (e.g., US CDC pandemic influenza monitoring and evaluation tool, WHO IHR assessment tool [under development])

PVS Global ProgrammeState of Play (June 10, 2009)

OIE Region

s

OIE Members

PVS Requests received

PVS Missions

done

Draft Reports received

PVS Reports

available (Donors

& Partners)

PVS Gap Analysis Request

s received

Africa 51 40 36 35 26 20

Americas 29 17 16 14 5 2

Asia & Pacific 29 13 12 12 5 3

Europe 52 12 12 10 3 3

Middle East 13 12 9 8 2 2

Total 174 94 85 79 41 30

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OrganisationMondialede la SantéAnimale

WorldOrganisationfor AnimalHealth

OrganizaciónMundialde SanidadAnimal