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

• • • • • • Established in 1924 Intergovernmental Organisation – predates the UN 5 Permanent OIE Regional Representations 5 OIE Sub-Regional Offices 5 OIE Regional Commissions 174 Members 29 52 13 51 29

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

The linkage between OIE Codes and Manuals, animal disease policy and the SPS Agreement Animal Health OIE SPS Agreement 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

• • •

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?

EMERGING?

NO YES ZOONOTIC POTENTIAL?

EXCLUDE YES INCLUDE NO SIGNIFICANT SPREAD IN NAIVE POPULATIONS?

NO EXCLUDE YES 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 or population

,

new geographic or a previously area 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 reporting and informal discussion often precedes official • 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) *

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

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 • 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

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) OIE

Africa Americas Asia & Pacific Europe Middle East

Total

OIE Members

51 29 29 52 13 174

PVS Requests PVS Missions received done 40 17 13 12 12

94

36 16 12 12 9

85

Draft Reports received 35 14 PVS Reports available (Donors & Partners) PVS Gap Analysis Requests received 26 5 20 2 12 10 8

79

5 3 2

41

3 3 2

30

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]