1. OIE Standards and the OIE Standard-setting process
A General view on OIE Standards and a special focus on OIE standards for vaccines
OIE Regional Workshop on Harmonisation of Veterinary Vaccines
(Pakchong, Thailand, January 2008)
Dr François Diaz
OIE Scientific and Technical Department

2. Introduction Overview of the OIE
OIE Standards and the Standard-setting process
Biological Standards Commission and OIE Standards for vaccines

3. Overview of the OIE

4. 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
adopted by the International Committee on May 2003
Comments (with copyright) / Commentaires (soumis au Copyright) :

5. Americas: 29 – Africa: 51 – Europe: 51 – Middle East: 13 – Asia: 28
172 Members (January 2008) 29 51 13 28
Americas: 29 – Africa: 51 – Europe: 51 – Middle East: 13 – Asia: 28

6. The OIE’s Mandate and priority missions
The OIE’s Mandate is to improve animal health
The OIE achieves this mandate through six priority missions
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Objective 1 : To ensure transparency in the global animal disease situation
“Each Member Country undertakes to report the animal diseases that it detects on its territory. The OIE then disseminates the information to other countries, which can take the necessary preventive action. This information also includes diseases transmissible to humans and intentional introduction of pathogens. Information is sent out immediately or periodically depending on the seriousness of the disease. This objective applies to disease occurrences both naturally occurring and deliberately caused. Dissemination is via the OIE Web site, and the following periodicals: Disease Information, published weekly and the annual compilation World Animal Health.”
Objectif 1 : Garantir la transparence de la situation des maladies animales et des zoonoses dans le monde
« Chaque Pays Membre s'engage à déclarer les maladies animales qu'il détecte sur son territoire. L'OIE diffuse alors l'information à tous les autres pays afin qu'ils puissent se protéger. Cette information concerne également les maladies transmissibles à l'homme. Elle est diffusée en urgence ou de façon différée selon la gravité de la maladie. Ces objectifs de surveillance et de suivi s'appliquent à la fois aux événements sanitaires naturels ou intentionnels. Les supports de diffusion sont le site Web de l'OIE, le courrier électronique et les périodiques suivants : Informations sanitaires, publiées chaque semaine, et le recueil annuel Santé animale mondiale. »

7. The six OIE’s priority missions
1. TRANSPARENCY OF THE ANIMAL DISEASE SITUATION
To disseminate information on the occurrence of animal diseases in a Member Country or Territory (Member’s Commitment) to all other Member Countries so they can take the necessary steps to protect themselves.
2. SCIENTIFIC INFORMATION
Through its first-rate worldwide scientific network, to collect, analyse and publish the latest scientific information on control methods for animal diseases, including those transmissible to humans.
Comments (with copyright) / Commentaires (soumis au Copyright) : [source :
Objective 1 : To ensure transparency in the global animal disease situation
“Each Member Country undertakes to report the animal diseases that it detects on its territory. The OIE then disseminates the information to other countries, which can take the necessary preventive action. This information also includes diseases transmissible to humans and intentional introduction of pathogens. Information is sent out immediately or periodically depending on the seriousness of the disease. This objective applies to disease occurrences both naturally occurring and deliberately caused. Dissemination is via the OIE Web site, and the following periodicals: Disease Information, published weekly and the annual compilation World Animal Health.”
Objectif 1 : Garantir la transparence de la situation des maladies animales et des zoonoses dans le monde
« Chaque Pays Membre s'engage à déclarer les maladies animales qu'il détecte sur son territoire. L'OIE diffuse alors l'information à tous les autres pays afin qu'ils puissent se protéger. Cette information concerne également les maladies transmissibles à l'homme. Elle est diffusée en urgence ou de façon différée selon la gravité de la maladie. Ces objectifs de surveillance et de suivi s'appliquent à la fois aux événements sanitaires naturels ou intentionnels. Les supports de diffusion sont le site Web de l'OIE, le courrier électronique et les périodiques suivants : Informations sanitaires, publiées chaque semaine, et le recueil annuel Santé animale mondiale. »

8. The six OIE’s priority missions
3. INTERNATIONAL SOLIDARITY AND PROMOTION OF VETERINARY SERVICES
To provide expertise and encourage international solidarity in the control of animal diseases.
To improve the legal framework and resources of national Veterinary Services.
4. SAFETY OF INTERNATIONAL TRADE IN ANIMALS AND ANIMAL PRODUCTS
Within its WTO mandate, to safeguard world trade by publishing health standards for international trade in animals and animal products.
Comments (with copyright) / Commentaires (soumis au Copyright) : [source :
Objective 3 : To provide expertise and encourage international solidarity in the control of animal diseases
“The OIE provides technical support to Member Countries requesting assistance with animal disease control and eradication operations, including diseases transmissible to humans. The OIE notably offers expertise to the poorest countries to help them control animal diseases that cause livestock losses, present a risk to public health and threaten other Member Countries.
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.”
Objectif 3 : Apporter son expertise et stimuler la solidarité internationale pour contrôler les maladies animales
« L'OIE appuie techniquement les Pays Membres qui le souhaitent pour soutenir des opérations de contrôle et d'éradication des maladies animales, y compris celles transmissibles à l'homme. L'OIE propose notamment son expertise aux pays les plus pauvres pour les aider à contrôler les maladies animales qui provoquent des pertes dans leur cheptel, peuvent mettre en danger la santé publique et menacent les autres Pays Membres.
L'OIE maintient un contact permanent, au niveau régional et national, avec les organismes financiers internationaux afin de les convaincre d'investir plus et mieux dans le contrôle des maladies animales et des zoonoses. »

9. The six OIE’s priority missions
5. FOOD SAFETY (in collaboration with the Codex Alimentarius)
To provide a better guarantee of food of animal origin.
6. ANIMAL WELFARE
To promote animal welfare using a science-based approach (publication of standards and guidelines).
The OIE's standard-setting activities in this field focus on eliminating hazards existing during production at the farm and prior to the slaughter of animals or the primary processing of animal products (meat, milk, eggs, etc.) that could pose a risk to consumers.

10. INTERNATIONAL COMMITTEE
(consisting of Delegates designated by the Governments of all Member Countries)
Administrative Commission
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
Central Bureau
Deputy Director General
Administration, Finances, Human Resources
Deputy Director General
Animal Health and International Standards
Accounts Unit
World Animal Health and Welfare Fund Coordination
Departments at the OIE Central Bureau:
- Scientific and Technical Department - International Trade Department - Animal Health information Deparmtent - Administrative and Management Systems Department - Regional Activities Department - Publications Deparmtent
Collaborating Centres
Reference Laboratories
Ad hoc Groups
Working Groups
Comments (with copyright) / Commentaires (soumis au Copyright) : [source :
Regional Representations

11. INTERNATIONAL COMMITTEE
(consisting of Delegates designated by the Governments of all Member Countries)
Administrative Commission
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
Central Bureau
Deputy Director General
Administration, Finances, Human Resources
Deputy Director General
Animal Health and International Standards
Accounts Unit
World Animal Health and Welfare Fund Coordination
Departments at the OIE Central Bureau:
- Scientific and Technical Department - International Trade Department - Animal Health information Deparmtent - Administrative and Management Systems Department - Regional Activities Department - Publications Deparmtent
Collaborating Centres
Reference Laboratories
Ad hoc Groups
Working Groups
Comments (with copyright) / Commentaires (soumis au Copyright) : [source :
Regional Representations

12. INTERNATIONAL COMMITTEE
(consisting of Delegates designated by the Governments of all Member Countries)
Administrative Commission
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
Central Bureau
Deputy Director General
Administration, Finances, Human Resources
Deputy Director General
Animal Health and International Standards
Accounts Unit
World Animal Health and Welfare Fund Coordination
Departments at the OIE Central Bureau:
- Scientific and Technical Department - International Trade Department - Animal Health information Deparmtent - Administrative and Management Systems Department - Regional Activities Department - Publications Deparmtent
Collaborating Centres
Reference Laboratories
Ad hoc Groups
Working Groups
Comments (with copyright) / Commentaires (soumis au Copyright) : [source :
Regional Representations

13. 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"

14. Specialist Commissions (cont.)
Role is to use current scientific information to:
Develop and revise OIE’s International Standards
Study problems of epidemiology and the prevention and control of animal diseases
Address scientific and technical issues raised by Member Countries and Territories
but not bilateral trade problems, which OIE may address through mediation

15. OIE Standards and the Standard-setting process

16. Why Standards are necessary
To facilitate relation and cooperation between Member Countries and Territories
To facilitate the development of constructive and harmonized measures or legislation at national or regional level
To narrow the gap between developed and in developing/in transition countries.

17. What are the OIE’s international standards
Terrestrial Animal Health Code – mammals, birds and bees
Aquatic Animal Health Code – fish, molluscs and crustaceans
available on the
OIE Website
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
Manual of Diagnostic Tests for Aquatic Animals

18. General Process for developing OIE’s International Standards
COMMITTEE, COMMISSIONS, DELEGATES
PROBLEM
Specialist
Commissions
General Process for developing OIE’s International Standards
Review
Advice of experts or other Specialist Commissions
Draft text 1 2
DELEGATES
COMMITTEE
OIE INTERNATIONAL STANDARD
Adoption

19. General Process for developing OIE’s International Standards
COMMITTEE, COMMISSIONS, DELEGATES
PROBLEM
Specialist
Commissions
General Process for developing OIE’s International Standards
Review
Advice of experts or other Specialist Commissions
Draft text 1 2
DELEGATES
COMMITTEE
OIE INTERNATIONAL STANDARD
Adoption

20. General Process for developing OIE’s International Standards
COMMITTEE, COMMISSIONS, DELEGATES
PROBLEM
Specialist
Commissions
General Process for developing OIE’s International Standards
Review
Advice of experts or other Specialist Commissions
Draft text 1 2
DELEGATES
COMMITTEE
OIE INTERNATIONAL STANDARD
Adoption

21. General Process for developing OIE’s International Standards
COMMITTEE, COMMISSIONS, DELEGATES
PROBLEM
Specialist
Commissions
General Process for developing OIE’s International Standards
Review
Advice of experts or other Specialist Commissions
Draft text 1 2
DELEGATES
COMMITTEE
OIE INTERNATIONAL STANDARD
Adoption

22. Process for setting and updating OIE Standards (cont.)
In summary:
The elected Specialist Commissions, with help from experts, have the task of formulating proposals
The Delegates decide whether or not to adopt the proposed texts (Democratic system)

23. Transparency in the OIE Standards development process
All documents emanating from OIE Specialist Commissions are published on the OIE public website, at
All comments from organisations/experts with an interest in the OIE’s work are welcome
However, OIE does not solicit comments from anyone other the Delegates and these comments are always given the greatest weight in OIE considerations.

24. Transparency in the OIE Standards development process (cont.)
Opportunity for all to be involved in the development of OIE International Standards

25. BIOLOGICAL STANDARDS COMMISSION (BSC) OIE STANDARDS FOR VACCINES

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

27. OIE Reference Laboratories & Collaborating Centres - OIE Expertise
designated to pursue all the scientific and technical problems relating to a named disease, usually one on the OIE list or a topic
Collaborating Centres
designated to pursue expertise in a specific sphere of competence relating to the management of general questions on animal health issues (e.g. epidemiology, risk analysis, etc.)
They are an essential support to the work of the Biological Standards Commission

28. 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

29. Reference Laboratories network
171 Reference Laboratories in 2008 covering 93 diseases/topics

30. Collaborating Centres network
24 Collaborating Centres covering 22 topics

31. OIE Laboratory Twinning Projects
Principle
Twinning of an OIE Reference Laboratory/Collaborating Centre (Parent laboratory) with candidate laboratories in developing countries
Objectives
Provide a useful tool for improving veterinary services worldwide and expanding the availability of OIE expertise

32. OIE Laboratory Twinning Projects (cont.)
Key points:
Any Candidate or Parent laboratory that has the support of the OIE Delegate of its Country can submit a project proposal / No obligation to have already a pair Candidate-Parent laboratories
OIE provides financial support and coordination for the overall twinning programme.
Training should be an inherent part of the Twinning project and must contribute to the overall objectives of the project

33. OIE Terrestrial Manual What is the Terrestrial Manual?
Describes internationally agreed laboratory methods:
For disease diagnosis,
For production and control of biological products (mainly vaccine)
All the OIE Standards for Vaccines are published in the Terrestrial Manual

34. OIE Terrestrial Manual Structure of the Terrestrial Manual
Shared in two parts :
Part 1: ten introductory chapters on general issue (Sampling method, validation of diagnostic method, etc.)
Part 2: Chapters on specific diseases (mainly for OIE listed diseases)

35. 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 and diagnostic biologicals
- References

36. Developing and updating chapters for the Terrestrial Manual
New edition printed every 4 years (next in 2008)
The Chapter-setting process follows the general standard-setting process with however some particularity

37. General Process for developing Chapter for the Terrestrial Manual
Biological Standards
Commission
General Process for developing Chapter for the Terrestrial Manual
Authors (Experts)
Peer reviewers
Draft text with help of the editorial team 1
DELEGATES
&
Relevant Reference Laboratories 2
COMMITTEE
Adoption of the Chapter
Inclusion on the next edition of the Manual / OIE website

38. Overview of the OIE Standards on Vaccines
There are two general chapters:
Chapter , Principles of Veterinary Vaccine Production
Dr M. Lombard (France), Dr B. Rippke (USDA, USA), Dr D. Mackay (EMEA, EU)
Chapter , Biotechnology in the diagnosis of infectious diseases and vaccine development
Dr D. Knowles & Dr H. Li (USDA, USA) & Prof P.P. Pastoret (OIE)
And the Part C: Requirements for Vaccines and Diagnostic Biologicals, of the chapters on specific diseases when relevant

39. Chapter I.1.7., Principles of Veterinary Vaccine Production
Divided into several sub-chapters that can be grouped into the following general issues:
Generality on vaccine: Nomenclature / Vaccine Types
Generality on vaccine production: Quality assurance / Production Facilities / Facilities Plan / Documentation of the Manufacturing Process / Record Keeping / Inspection of production facilities / Batch-Serial tests
Source and Ingredients: Master seed / Master cell stocks
Tests to carry out: Purity / Safety / Virulence-Risk assessment for the environment / Efficacy-Potency / Interference / Stability / Field
Biotechnology-derived vaccines: classification / licensing / release

40. Chapter I.1.8., Biotechnology in the diagnosis of infectious diseases and vaccine development
Only a part of the chapter is dedicated specifically to the vaccines (Sub-chapter D)
1. Gene deletion vaccines – bacteria
2. Marker vaccines and companion diagnostic tests
3. Virus-vectored vaccines
4. DNA vaccines
5. Other developments in vaccine technology

41. Part C of the diseases chapter
General Template of the Part C:
1. Seed Management
2. Method of Manufacture
3. In-process control
4. Batch control
5. Tests on the final product
a) Characteristics of the seed
b) Method of culture
c) Validation as a vaccine
a) Identity
b) Sterility
c) Safety
d) Potency
e) Duration of immunity
f) Stability
g) Preservatives
h) Precautions
a) Safety
b) Potency

42. Future work / Conclusion
With the expected growth of demand for livestock and livestock products, especially in developing countries, general harmonised guidelines for vaccines are essential
Importance to set up and maintain vaccine banks
New applications in the Biotechnology-derived vaccines. So There is a need for expanded standard

43. Thank you for your attention
OIE HEADQUARTERS
12 rue de Prony
75017 Paris
FRANCE

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Organisation Mondiale de la Santé Animale
World Organisation for Animal Health
Organización Mundial de Sanidad Animal
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