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OIE Activities Related to Laboratory Support

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1 OIE Activities Related to Laboratory Support
USAID - FAO/OIE/WHO Joint Meeting Strengthening Animal/Human Health Laboratory Capacities 12 June 2009, Rome Key point throughout – OIE does many of these activities in collaboration with FAO, WHO, an countries – but contributed OIE core responsibilities to these collaborations

2 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 52 13 Briefly introduce the OIE. Number of Members is growing all the time. All OIE international standards are adopted by consensus of its Members. 2/3 of the Member Countries and Territories are developing countries. They need support to comply with international standards, achieve food security and economic growth, and participate in international trade. Geographic balance is important throughout the OIE procedures. 29 51 29

3 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

4 OIE Codes and Manuals must be used in context
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

5 Animal Health Standards - OIE Major Texts for Terrestrial Animals
Terrestrial Animal Health Code (Terrestrial Code) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual) OIE Principles – Guidance, Standards, Transparency The OIE functions according to a set of animal health standards, with a major function to ensure the sanitary safety of international trade in terrestrial animals and their products. This is achieved through the detailing of health measures to be used by the veterinary authorities of importing and exporting countries to avoid the transfer of agents pathogenic for animals or humans, while avoiding unjustified sanitary barriers. For terrestrial animals (which include birds), there are two main texts – which I will detail further in a moment. Parallel texts also exist for aquatic animals An overarching goal of providing this guidance is achieving the OIE objectives of standards and transparency

6 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 Same overall AIM as the Terrestrial Code – to facilitate international trade in animals and animal products and to contribute to the improvement of animal health services world-wide. Focused on laboratory diagnostic methods and standards for vaccine and other biologic development Note that the value of the Terrestrial Manual is twofold represents consensus among the veterinary authorities of OIE Members constitutes a reference within the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures as an international standard for animal health and zoonoses

7 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

8 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

9 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 So now I will move to the next topic and discuss notification and reporting As with all things, the standards and guidance are laid out in the terrestrial code. The section on notification is the only section in which the term “Members shall” is used – in all other parts of the code, guidance is provided with “Members should…” The ability to conduct adequate surveillance and therefore support notification and reporting is built upon a framework of a Built upon a framework of a competent veterinary services and effective surveillance program. And unfortunately, we know that this is not always the case, especially in developing countries The small graphic here of a carrot and a stick really does represent the system under which notification and reporting technically occur. On one hand, there can be trade implications for officially reporting listed diseases. On the other hand, in the spirit of transparency, if a country is perceived by its partners to consistently report then a relationship of trust is built between potential trade partners, which can have positive benefits for establishing trade relationships.

10 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 OIE has a series of transmissible diseases termed “listed diseases” agreed upon by the OIE International Committee and set out in the Terrestrial Code These diseases are identified as multispecies diseases – those shown in bold have documented infections in humans and animals, and those in italics have been uncommonly documented or play a putative role in human disease

11 Criteria for listing a disease
EXCLUDE INTERNATIONAL SPREAD? EMERGING? NO YES SIGNIFICANT SPREAD IN NAIVE POPULATIONS? INCLUDE ZOONOTIC POTENTIAL? There is an established process to identify a disease as a listed disease – which also occurs by member vote. The algorithm is here, and I will go through it briefly. It can be found in more detail in the Terrestrial Code. In essence, there are two main questions to be answered. Has international spread been identified? This means either: That international spread has been proven on 3 or more occasions OR That there are more than 3 countries with populations of susceptible animals free of the disease OR reporting to OIE absence of the disease? If No – then the disease wouldn’t be listed based on this critierion The second major question is whether the disease is EMERGING – that is, is a newly recognised pathogen or known pathogen behaving differently. If yes, then the next question is whether there apparent zoonotic properties or rapid spread? ZOONOTIC POTENTIAL has two main components: Has natural transmission to humans been proven AND is human infection associated with severe consequences? (death or prolonged illness) If yes, then the disease would meet the criteria to be listed. Then, for diseases that had potential for international spread, even if the disease is not identified with zoonotic potential, then the question of animal morbidity and mortality is assessed. If the disease exhibits significant morbidity OR mortality at level among animals of a country or zone then it would meet the criteria for being listed, otherwise it would at the end be excluded.

12 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 Notification procedures diseases to OIE are as outlined here. As with all surveillance and reporting, it is a little more complicated that what I am outlining, but for those that are interested I can into more detail later. Members countries shall submit an immediate notification of disease, infection or unusual epidemiologic event for any listed disease or emerging infection with substantial animal morbidity/mortality or with zoonotic potential. This notification shall be within 24 hours of confirmation of the event. This report includes the number and local of outbreaks, when it started and was concerned, how many and of what species animal were affected, and control measures taken. Following all immediate notifications, Weekly reports shall be filed. These reports will occur weekly until a final report is filed. The Final report can tie up the original immediate notification in one of two ways: if the outbreaks have ended (event closed) Or if the country deems that control measures have not and will not be effective, and they declare the situation endemic Even after a final report is filed, countries must still report through Six-monthly and annual reports

13 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

14 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

15 OIE Reference Laboratories and Collaborating Centres*
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) OIE has an extensive network of expertise that allows it to function at a much broader scope and scale than could be achieved through the efforts of the OIE employees alone. As of 2008, the OIE has 177 Reference Laboratories from 32 Member Countries or Territories and 29 Collaborating Centres from 18 Member Countries or Territories. OIE Reference Laboratories are designated to pursue all the scientific and technical issues relating to a named disease on the OIE lists, particularly to function as a centre of expertise and standardisation of diagnostic techniques for its designated disease. OIE Collaborating Centres are centres of expertise in a specific designated sphere of competence relating to the management of general questions on animal health issues (for example epidemiology or risk analysis). In addition to fulfilling their mandate as laid out by OIE, experts from the Reference Laboratories and Collaborating Centres provide technical expertise for training and capacity building, participate in ad hoc Groups and field investigations, and also provide input to official OIE texts through chapter authorship and review. Expertise provided is by the true world experts, and represents the expertise from their geographic region. Thus, a major goal for twinning is to build more geographically representative expertise into the OIE standard setting process, and building scientific communities within countries * As of May 2009

16 OIE Reference Laboratory 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

17 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.

18 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 Does not replace an OIE delegate’s responsibility to officially notify to OIE

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

20 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 Twinning works by establishing a link between an OIE Ref lab (parent lab) and a candidate lab. OIE funded twining project will support this link. Through this mutually beneficial relationship – aim to improve expertise and capacity in candidate lab. With eventual aim of attaining OIE standards. Accepted that not every candidate lab will become a reference lab but will move closer to it. Some areas it will be beneficial to chose a lab that is not far off becoming a reference lab so that objective is more easily attainable. Funding is available for supporting the link, travel, training, reagents etc but not for laboratory hardware. Although a component on training may be to help a lab put together a proposal for funding for hardware.

21 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) the objectives of twinning are to provide a better global geographical coverage of expertise and to provide better coverage for developing and transition countries in areas where it is needed. This will help with early detection of disease, more effective containment and control and will allow member countries ready access to expertise so that they are more able to debate international standards on an equal footing.

22 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 Simply state that there are 13 approved and active to date, with more in the development and approval process

23 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

24 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 I think these will already be discussed in detail by FAO, who I assume will be first on the agenda if we follow alphabetic order, so I am not sure what to prepare for these.

25 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

26 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 In this era of globalisation, the development and growth of many countries, as well as the prevention and control of major biological disasters, depend on the performance of their agricultural and food policies and economies, and this, in turn, directly relates to the quality of their Veterinary Services (VS)1. Important roles for VS include veterinary public health – including food-borne diseases – and regional and international market access for animals and animal products. To meet these new opportunities and challenges, VS will need to operate on scientifically-based principles and be technically independent and immune from political pressures from all sources. Efforts to strengthen VS and to support them to comply with OIE international standards on quality and evaluation of VS require the active participation and investment on the part of both the public and the private sectors. The World Organisation for Animal Health (OIE) has refined an Evaluation Tool developed initially in collaboration with the Inter-American Institute for Cooperation on Agriculture (IICA) to produce, in 2007, a revised publication: the OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool). The OIE PVS Tool is designed to assist VS to establish their current level of performance, to identify gaps and weaknesses regarding their ability to comply with OIE international standards, to form a shared vision with stakeholders 2 (including the private sector) and to establish priorities and carry out strategic initiatives. In the international trade of animals and animal products, the OIE promotes animal health and public health (as it relates to the prevention and control of zoonoses including food-borne diseases of animal origin) by issuing harmonised sanitary standards for international trade and disease control methods, by working to improve the resources and legal framework of VS and by helping member countries comply with the OIE standards, guidelines and recommendations, and the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organization (WTO). The traditional mission of VS has been to protect domestic agriculture. Over time, the majority of its resources were channelled towards the control of diseases that threatened primary production. Services provided began at the national borders and were focused inward. The credibility of these services, in the eyes of its users and of other countries, depended in large measure on the effectiveness of these domestic programmes, and response of VS to emergencies arising from the entry of foreign diseases. In light of the growing international requirements and opportunities facing each country, it behoves VS to adopt a broader mandate and vision, and provide new services to complement the portfolio of existing services. This will entail stronger alliances and closer cooperation with its stakeholders, trading partners and other countries, national VS counter parts and relevant intergovernmental organisations (OIE, Codex Alimentarius Commission, WTO, etc.). II-1 Veterinary laboratory diagnosis The authority and capability of the VS to identify and record pathogenic agents, including those relevant for public health, that can adversely affect animals and animal products. 1. Disease diagnosis is almost always conducted by clinical means only, with laboratory diagnostic capability being generally unavailable. 2. For major zoonoses and diseases of national economic importance, the VS have access to and use a laboratory to obtain a correct diagnosis. 3. For other zoonoses and diseases present in the country, the VS have access to and use a laboratory to obtain a correct diagnosis. 4. For diseases of zoonotic or economic importance not present in the country, but known to exist in the region and/ or that could enter the country, the VS have access to and use a laboratory to obtain a correct diagnosis. 5. In the case of new and emerging diseases in the region or world, the VS have access to and use a network of national or international reference laboratories (e.g. an OIE Reference Laboratory) to obtain a correct diagnosis. II-2 Laboratory quality assurance The quality of laboratories (that conduct diagnostic testing or analysis for chemical residues, antimicrobial residues, toxins, or tests for, biological efficacy, etc.) as measured by the use of formal QA systems and participation in relevant proficiency testing programmes. 1. No laboratories used by the public sector VS are using formal QA systems. 2. Some laboratories used by the public sector VS are using formal QA systems. 3. All laboratories used by the public sector VS are using formal QA systems. 4. All the laboratories used by the public sector VS and most or all private laboratories are using formal QA systems. 5. All the laboratories used by the public sector VS and most or all private laboratories are using formal QA programmes that meet OIE, ISO 17025, or equivalent QA standard guidelines. II-6 Early detection and emergency response The authority and capability of the VS to detect and respond rapidly to a sanitary emergency (such as a significant disease outbreak or food safety emergency). 1. The VS have no field network or established procedure to determine whether a sanitary emergency exists or the authority to declare such an emergency and respond appropriately. 2. The VS have a field network and an established procedure to determine whether or not a sanitary emergency exists, but lack the necessary legal and financial support to respond appropriately. 3. The VS have the legal framework and financial support to respond rapidly to sanitary emergencies, but the response is not coordinated through a chain of command. 4. The VS have an established procedure to make timely decisions on whether or not a sanitary emergency exists. The VS have the legal framework and financial support to respond rapidly to sanitary emergencies through a chain of command. They have national contingency plans for some exotic diseases. 5. The VS have national contingency plans for all diseases of concern through coordinated actions with all stakeholders through a chain of command.

27 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 Note while speaking - Not all national veterinary services have the capacity to fulfill the minimal standards (prevention, surveillance, detection, and control of animal diseases including zoonoses) of a competent Veterinary Services * OIE Terrestrial Animal Health Code, Chapter 3.2

28 PVS Gap Analysis process
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

29 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

30 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])

31 PVS Global Programme State of Play (June 10, 2009)
OIE Regions OIE Members PVS Requests received PVS Missions done Draft Reports received PVS Reports available (Donors & Partners) PVS Gap Analysis Requests received Africa 51 40 36 35 26 20 Americas 29 17 16 14 5 2 Asia & Pacific 13 12 3 Europe 52 10 Middle East 9 8 Total 174 94 85 79 41 30

32 12 rue de Prony, 75017 Paris, France - –
Organisation Mondiale de la Santé Animale World Organisation for Animal Health Organización Mundial de Sanidad Animal 12 rue de Prony, Paris, France - –

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