OIE Standards and the OIE Standard-Setting Process A general view on OIE Standards with a special focus on Dourine First Workshop of the EU CRL for dourine (Maisons-Alfort, France, 10 December 2009) My name is Sara Linnane and I have worked for a number of years in the Scientific and Technical deparment of the OIE. I am here today to talk to you about the OIE Standards, the standards-setting process, OIE activities with regard to dourine and a little bit about OIE Reference Laboratories. Ms Sara Linnane OIE Scientific and Technical Department

World Organisation for Animal Health An intergovernmental organisation Founded in 1924 by 28 countries Created before the UN World Organisation for Animal Health Organisation mondiale de la santé animale Comments (with copyright) / Commentaires (soumis au Copyright) : Adopted by the International Committee on May 2003

World Organisation for Animal Health (OIE) 174 Members (In June 2009) Headquarters in Paris, France 5 Regional offices 5 Regional sub-offices 29 52 13 51 Regional Representations: Argentina, Bulgaria, Mali, Lebanon and Japan Sub-Regional offices: Panama, Botswana, Tunisia, Bangkok, Brussels 3

WORLD ASSEMBLY OF DELEGATES OF THE OIE (consisting of Delegates designated by the Governments of all Member) Administrative Council Director General Specialist Commissions Code, Laboratories, Aquatic Animals, Scientific Regional Commissions Africa, Americas, Europe, Asia, Far East and Oceania, Middle East Human Resources and Budget Management Unit Headquarters Deputy Director General Administration, Management, Human Resources and Regional Activities Deputy Director General Animal Health, Veterinary Public Health and International Standards Accounts Unit World Fund Coordination Departments at the OIE Headquarters: - Scientific and Technical Department - International Trade Department - Animal Health information Department - Administration, Logistics and Publications Department - Regional Activities Department Collaborating Centres Reference Laboratories Ad hoc Groups Working Groups The OIE operates under the authority of the World Assembly of Delegates of the OIE. It meets once a year in May in Paris. All standards, guidelines, recommendations, working programmes, budgets, etc. must be approved by the Assembly. The administrative Council deals with technical and administrative matters, the working programme and the proposed budgets Day-to-day operation is managed at the OIE headquarters in Paris under the responsibility of the DG who implements the resolutions adopted by the Assembly. These have been developed with the support of commissions, elected by the Delegates, and other OIE Experts. Regional Representations study specific problems encountered by VS and organise cooperation activities at the regional level Regional Representations

OIE key missions Ensure transparency of the global animal disease situation including zoonoses Collect, analyse and diffuse veterinary scientific information Provide expertise and encourage international solidarity on disease control Improve the legal framework and resources of national Veterinary Services Develop international standards: that safeguard international trade of animals and animal products (mandated under the SPS agreement of the WTO) for veterinary laboratories for animal production food safety and to promote science-based animal welfare Transparency: OIE Members undertake to report immediately or periodically, depending on the disease, all diseases detected on their territories. The OIE has a permanent contact to international regional and national financial organizations in order to convince them to invest more and better on the control of animal diseases and zoonosis VS are considered a Globabl Public Good by the OIE and bringing them into line with international standards is seen as a public investment priority. The OIE develops normative documents relating to rules that Member Countries can use to protect themselves from the introduction of diseases and pathogens, without setting up unjustified sanitary barriers. OIE standards are recognised by the World Trade Organization as reference international sanitary rules. They are prepared by elected Specialist Commissions and by Working Groups bringing together internationally renowned scientists, most of whom are experts within the network of about 200 Collaborating Centres and Reference Laboratories that also contribute towards the scientific objectives of the OIE. These standards are adopted by the World Assembly

OIE’s international standards Terrestrial Animal Health Code – mammals, birds and bees Aquatic Animal Health Code – amphibians, crustaceans, fish and molluscs Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Manual of Diagnostic Tests for Aquatic Animals OIE Quality Standard and Guidelines for Veterinary Laboratories: Infectious Diseases

Specialist Commissions Terrestrial Animal Health Standards Commission "Code Commission" Scientific Commission for Animal Diseases "Scientific Commission" Biological Standards Commission "Laboratories Commission" Comments (with copyright) / Commentaires (soumis au Copyright) : Insérer quelques informations sur chacune des commissions Aquatic Animal Health Standards Commission "Aquatic Animals Commission"

General process for setting and updating OIE’s International Standards Assembly, Commissions, Delegates Problem/issue General process for setting and updating OIE’s International Standards Specialist Commissions Review Advice of experts or other Specialist Commissions Draft text 1 2 Comments Delegates Assembly OIE INTERNATIONAL STANDARD Adoption

Terrestrial Animal Health Code The Terrestrial Code defines the measures that should be taken to protect the animal health status of a country, zone or compartment when moving animals or animal products from a different country, zone or compartment. The measures vary according to the nature of the disease in question, and the health status of the locations of both origin and destination for the movement. As I have already said, the Code is developed by consensus among the veterinary authorities and constitutes a reference within the WTO agreement on the application of sanitary and phytosanitary measures as an international standard for animal health and zoonoses.

Terrestrial Animal Health Code Examples may include periods of quarantine, clinical examination for signs of disease, or laboratory tests on samples from the animals or products. These laboratory tests should, wherever possible, be in accordance with the OIE list of Prescribed Tests for specified diseases.

Prescribed and alternative tests Prescribed tests are required by the OIE Terrestrial Code for the international movement of animals and animal products and are considered optimal for determining the health status of animals. At present it is not possible to have prescribed tests for every listed disease. Alternative tests are those that are suitable for the diagnosis of disease within a local setting, and can also be used in the import/export of animals after bilateral agreement. The list of OIE prescribed and alternative tests is included in both the Terrestrial Code and the Terrestrial Manual.

BIOLOGICAL STANDARDS COMMISSION (Laboratories Commission)

Biological Standards Commission Six members elected by the World Assembly for a 3-year term Develop and set International laboratory standards – diagnostics, vaccines, etc. (Terrestrial Manual) Approves OIE Reference Laboratories/OIE Collaborating Centres/Laboratory Twinnings Promotes the preparation and distribution of reagents Provides scientific advice for Standards related to diagnostics for eventual inclusion in the Terrestrial Code

OIE Terrestrial Manual What is the Terrestrial Manual? Is the companion volume to the Terrestrial Animal Health Code Describes internationally agreed laboratory standard methods: For disease diagnosis, For production and control of vaccines (and diagnostic biologicals when they exist e.g. tuberculin)

OIE Terrestrial Manual Structure of the Terrestrial Manual Divied into two parts : Part 1: Eleven introductory chapters on general issue (Sampling methods, validation of diagnostic tests, etc.) Part 2: Chapters on specific diseases (OIE listed diseases and other diseases of importance to trade)

OIE Terrestrial Manual General Template of a disease chapter Each disease chapter is developped following this template: - Summary - A. Introduction - B. Diagnostic techniques - C. Requirements for vaccines - References

The OIE Terrestrial Manual and diagnostic tests The Terrestrial Manual provides detailed descriptions of laboratory tests that can be used in a variety of applications for individual diseases, including diagnosis, disease control, surveillance, epidemiological studies and screening for international movement. Only those tests that are suitable for international movement testing are included in the OIE list of Prescribed and Alternative Tests. Ther are often other tests described in the Terrestrial Manual that may also be of some practical value in local situations or that may still be under development.

The relation between the OIE Terrestrial Manual and the OIE Terrestrial Code Wherever the Terrestrial Code requires that tests are carried out for international movement, the Terrestrial Manual should provide a recommended laboratory method for so doing. Normally this is by designation of a Prescribed Test. Exceptionally, for diseases where there is no well-validated test available, only Alternative Tests may be designated in the Terrestrial Manual. When the Terrestrial Manual does not designate Prescribed or Alternative Tests this is because there is no requirement in the Terrestrial Code for testing for that disease prior to international movements

The relation between the OIE Terrestrial Manual and the OIE Terrestrial Code Although the OIE list of Prescribed and Alternative Tests gives only summary descriptions of the tests (e.g. “ELISA”, or “PCR”) it should not be assumed that all tests under that description are suitable for international movement. Only the method described in the Terrestrial Manual should be used, or else a method that has been fully validated to show equivalent performance to the designated Prescribed Test method. “Validation” in this context means compliance with the OIE validation template and the more detailed description in the validation chapter of the Terrestrial Manual.

Developing and updating chapters for the Terrestrial Manual New edition printed every 4 years (next in 2012). However, selected chapters that need update between editions are revised and presented for adoption each May The process of producing and adopting chapters follows the general OIE standard-setting process

General Process for developing Chapter for the Terrestrial Manual Biological Standards Commission/ Consultant Editor General Process for developing Chapter for the Terrestrial Manual Authors (Experts) Consultant Editor Draft text with help of the editorial team 1 Comments DELEGATES & Relevant Reference Laboratories and other peer reviewers 2 Assembly Adoption of the Chapter Inclusion on the next edition of the Manual/OIE website

One OIE Reference Laboratory for Dourine Prof. V.T. Zablotsky All-Russian Research Institute for Experimental Veterinary Medicine (VIEV), Moscow, RUSSIA One OIE Collaborating Centre involved in dourine research Surveillance and Control of Animal Protozoan Diseases National Research Center for Protozoan Diseases Obihiro University of Agriculture and Veterinary Medicine, JAPAN. Dr Ikuo Igarashi / Dr Noboru Inoue

International Standardisation/Harmonisation: Diagnostic Tests There is currently a programme to develop a reference reagent that can be used in the OIE prescribed test for international trade for Dourine: the complement fixation text Dr Inoue and Claes are working in collaboration to produce standard sera for dourine.

The OIE ad hoc Group on Diagnostic Tests for Trypanosomoses Terms of Reference: to define the species of the parasite(s) and diagnostic criteria for parasite identification, taking account of the best available current scientific knowledge to describe the current global situation regarding dourine and surra to recommend diagnostic tests, and to revise the chapters in the Terrestrial Manual. The Group met from 30 March to 1 April 2009 and its report is available on the OIE web site I understand looking at the agenda of the meeting today that many of the topics addressed by the ad hoc Group will be further discussed today. Regarding the Terrestrial Manual chapters, an updated edition of the chapter on surra has been prepared and will shortly be sent to Members for comment. The revised chapter on dourine is in hand.

Global network of OIE expertise OIE Reference Laboratories – expertise in surveillance and control of a named disease OIE Collaborating Centres – expertise in a specific designated sphere of competence e.g. epidemiology, emerging avian diseases, zoonoses, veterinary medicinal products . 25

Mandate of OIE Reference Laboratories 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 Laboratories may also contribute to: provision of scientific and technical training for personnel from Members; provision of diagnostic testing facilities to Members: organisation of scientific meetings on behalf of the OIE; coordination of scientific and technical studies in collaboration with other laboratories or organisations; publication and dissemination of any information in their sphere of competence

As you can see there are large areas of the globe with no OIE Ref. Lab As you can see there are large areas of the globe with no OIE Ref. Lab. The OIE is trying to redress this situation through its twinning progamme, which encourages capacity building projects between labs in developed countries with those in in-transition or developing countries. The Twinning programme is funded by the World Bank

Summary of the role of OIE RL Essential support for the work of the Biological Standards Commission: Centre of expertise: Help to the development of the chapters of the Manuals in their specific field Development and distribution of OIE International standard sera for some of them Involved in the International standardisation of tests and vaccines Pivotal role in the process of Validation and Certification of Diagnostic Assays They may also provide scientific and technical training for personnel from Member Countries and territories Involved in the OIE twinning projects

Reference Laboratories Collaborating Centres Summary of information on OIE Reference Laboratories and Collaborating Centres in 2009 Reference Laboratories Collaborating Centres Total Number 187 35 222 Countries 36 20 41 Diseases/ Topics 100 33 133 Experts 161 196

Thank you for your attention OIE HEADQUARTERS 12 rue de Prony 75017 Paris FRANCE http://www.oie.int

12 rue de Prony, 75017 Paris, France - www.oie.int – oie@oie.int 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 – oie@oie.int