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OIE Activities Related to Laboratory Support
USAID - FAO/OIE/WHO Joint Meeting
Strengthening Animal/Human Health Laboratory Capacities
12 June 2009, Rome
OIE Key Facts
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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
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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
The linkage between OIE Codes and Manuals,
animal disease policy and the SPS Agreement
SPS Agreement
Animal Health
OIE
Food Safety
CODEX
Plant Health
IPPC
International standard setting organizations
OIE Codes and Manuals must be used in context
with Codex Alimentarius and 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 Standards
Terrestrial 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 Standards
Terrestrial 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 and
epidemiological 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
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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
INTERNATIONAL SPREAD?
NO
EMERGING?
YES
ZOONOTIC
POTENTIAL?
NO
SIGNIFICANT SPREAD IN
NAIVE POPULATIONS?
YES
EXCLUDE
INCLUDE
NO
YES
EXCLUDE
INCLUDE
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, reemerging 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
• 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
http://photos.news.wisc.edu
OIE Reference Laboratories and
Collaborating Centres*
• 35 centres from 20 Member Countries or
Territories on 33 topics
• Expertise in a specific designated sphere of
competence (epidemiology, risk analysis)
* As of May 2009
http://www.oie.int
• Collaborating Centres
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
World Distribution of OIE Reference
Laboratories (as of May 2008)
List of OIE Reference Laboratories http://www.oie.int/eng/OIE/organisation/en_listeLR.htm
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
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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-humanecosystem 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
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Section II-1
Section II-2
Section II-3
Section II-4
Section II-5
Section II-6
Section II-7
Veterinary laboratory diagnosis
Laboratory quality assurance
Risk analysis
Quarantine and border security
Epidemiological surveillance
Early detection and emergency response
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
PVS Gap Analysis process
PVS
Evaluation
Qualitative evaluation of
the performance on 40
critical competencies
Specific Objectives
of the Country
Prioritization of the critical competencies and of related needs
PVS
Gap Analysis
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
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 Programme
State of Play (June 10, 2009)
Draft
received
PVS
available
(Donors &
Partners)
PVS Gap
Analysis
Requests
received
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35
26
20
17
16
14
5
2
29
13
12
12
5
3
Europe
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12
12
10
3
3
Middle East
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12
9
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2
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174
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85
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OIE
PVS
Requests
received
PVS
done
Africa
51
40
Americas
29
Asia & Pacific
OIE
Total
Organisation
Mondiale
de la Santé
Animale
World
Organisation
for Animal
Health
Organización
Mundial
de Sanidad
Animal
12 rue de Prony, 75017 Paris, France - www.oie.int – [email protected]