1. OIE activities on antimicrobial agents and containment
Dr. Patrick DEHAUMONT
OIE, AFSSA/ANMV
Collaborating Centre on Veterinary medicinal products
BP FOUGERES CEDEX, FRANCE
OIE activities on antimicrobial agents and containment
of antimicrobial resistance 
Comments (with copyright) / Commentaires (soumis au Copyright) :
International Workshop on Antimicrobial Resistance
22 October 2007, Seoul, Republic of Korea

2. Introduction
Rational use of antimicrobials and prevention of antimicrobioresistance,
a challenging issue to be dealt at international, regional and national levels in a global perspective

3. Executive summary The OIE VICH
Objectives
Structure
OIE International Standards
VICH
OIE Antimicrobial Resistance related activities
(guidelines; VCIA; International cooperation)
Conclusion
Comments (with copyright) / Commentaires (soumis au Copyright) : [source :
The International Committee is the highest authority of the OIE.
It comprises all the Delegates and meets at least once a year. The General Session of the International Committee lasts five days and is held every year in May in Paris.
Voting by Delegates within the International Committee respects the democratic principle of 'one country, one vote'.
The International Committee elects the members of the governing bodies of the OIE (President and Vice-President of the Committee, Members of the Administrative Commission, Regional and Specialist Commissions).
He appoints the Director General of the OIE for a five year mandate.
Le Comité international est l’organe suprême de l’OIE.
Il est composé de tous les Délégués et se réunit au moins une fois par an. Sa Session générale, qui dure cinq jours, se tient tous les ans au mois de mai à Paris.
Le vote des Délégués, au sein du Comité international, respecte le principe démocratique de "un pays, une voix".
Le Comité international élit les membres des organes directeurs de l’OIE (Président et Vice-Président du Comité, Membres de la Commission administrative, des Commissions régionales et des Commissions spécialisées).
Il nomme le Directeur général de l’OIE pour un mandat de cinq ans.

4. OIE general presentation
Headquarters in Paris
5 Regional Representatives
an intergovernmental organisation
operating expenses are paid by member country contributions
170 Member Countries

5. 6 OIE Objectives
Comments (with copyright) / Commentaires (soumis au Copyright) :

6. The 6 Objectives of the OIE
The « historical objectives »
ANIMAL HEALTH INFORMATION:
to ensure transparency in the global animal diseases and zoonosis situation
to collect, analyse and disseminate scientific veterinary information
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. »

7. The 6 Objectives of the OIE (cont.)
New objectives
ACTIVITIES 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
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. »

8. The 6 Objectives of the OIE (cont.)
New objectives
INTERNATIONAL STANDARD
to provide a better guarantee of the safety of food of animal origin,
and to promote animal welfare,
through a science-based approach
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 4th Strategic Plan: A new global mandate for 2006/2010
From prevention of worldspread of animal disease to improvement of Animal health worldwide…
…with enhanced role in public health, animal welfare and safety of trade policies…
…including improvement of capacity building

10. Structure
Comments (with copyright) / Commentaires (soumis au Copyright) :

11. INTERNATIONAL COMMITTEE Administrative Commission Director General
Specialist Commissions Code, BSC, 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
International Trade
Department
Administrative and
Management Systems
Department
Collaborating Centres
Reference Laboratories
Ad hoc Groups
Working Groups
Scientific and
Technical
Department
Regional Activities
Department
Comments (with copyright) / Commentaires (soumis au Copyright) : [source :
Animal Health
Information
Department
Publications
Department
Regional Representations

12. Specialist Commissions (cont.)
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"

13. Animal Production Food Safety
Working Groups
Wildlife Diseases
Animal Production Food Safety
Animal Welfare
Comments (with copyright) / Commentaires (soumis au Copyright) : [source :
The Working Groups comprise world-leading scientific experts in their subject areas.
Working Group on Wildlife diseases
Founded in 1994, this Working Group informs and advises the OIE on all health problems relating to wild animals, whether in the wild or in captivity. It has prepared recommendations and oversees numerous scientific publications on the surveillance and control of the most important specific wildlife diseases.
Working Group on Animal Welfare
A permanent Working Group on Animal Welfare was established in 2002 to coordinate and manage the animal welfare activities of the OIE.
Working Group on Food Safety
A permanent Working Group on Food Safety was established in 2002 to coordinate and manage the animal production food safety activities of the OIE.
Les groupes de travail rassemblent des scientifiques reconnus mondialement pour leurs connaissances dans leurs disciplines respectives.
Groupe de travail pour les maladies des animaux sauvages
Créé en 1994, ce Groupe de travail informe et conseille l'OIE sur tous les problèmes sanitaires liés aux animaux sauvages, qu'ils vivent en liberté ou en captivité. Il a préparé des recommandations et supervisé de nombreuses publications scientifiques sur la surveillance et la prophylaxie des principales maladies spécifiques des animaux sauvages.
Groupe de travail sur le bien-être animal
Un Groupe de travail sur le bien-être animal a été créé en 2002 pour coordonner et gérer les activités de l'OIE concernant le bien-être animal
Groupe de travail sur la sécurité sanitaire des aliments
Un Groupe de travail sur la sécurité sanitaire des aliments a été créé en 2002 pour coordonner et gérer les activités de l'OIE concernant la sécurité sanitaire des aliments d'origine animale en phase de production.
Other…

14. OIE International Standards
Comments (with copyright) / Commentaires (soumis au Copyright) :

15. Standards-setting organizations
OIE's WTO mandate
Standards-setting organizations
food safety
CODEX
plant health
IPPC
animal health
OIE
Codex = Joint FAO/WHO Codex Alimentarius Commission
OIE = World Organization for Animal Health
IPPC = International Plant Protection Convention (FAO)

16. OIE’s international standards
OIE develops and publishes
health standards for trade in animals and animal products
biological standards for diagnostic tests and vaccines
adopted by OIE Member Countries during General Session each May by consensus
no other pathway for adoption

17. http://www.oie.int OIE International Standards
Terrestrial Animal Health Code – mammals, birds and bees
Aquatic Animal Health Code – fish, molluscs and crustaceans
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
Comments (with copyright) / Commentaires (soumis au Copyright) :
Manual of Diagnostic Tests for Aquatic Animals
available on the
OIE Website

18. VICH
Comments (with copyright) / Commentaires (soumis au Copyright) :

19. INTERNATIONAL HARMONISATION VICH (1/4)
What is VICH?
VICH = Veterinary International Conference on Harmonisation of Technical Requirements for Registration of Medicinal Products
International cooperation programme
US-JAP-EU (+ AUS/NZ + Canada as observers)
OIE associated member
Discussion forum for Regulatory Authorities + Industry

20. INTERNATIONAL HARMONISATION VICH (3/4)
VICH objectives
To establish harmonised regulatory requirements for veterinary medicines in the VICH regions, that
meet high standards of quality, safety & efficacy to protect public health, animal health & welfare and the environment,
minimise the use of test animals and costs of product development,
provide a basis for widening international harmonisation of registration requirements.

21. INTERNATIONAL HARMONISATION VICH (4/4)
VICH GL 27 (CVMP/VICH/644/01) Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
VICH GL36 - Studies to evaluate the safety of residues of veterinary drugs in human food: General Approach to establish a microbiological ADI

22. One decade of OIE antimicrobial resistance related activities
Comments (with copyright) / Commentaires (soumis au Copyright) :

23. OIE antimicrobial resistance related activities
1997: request from the Regional Commission for Europe
1998: debate at the international session
1999: recommendations from the OIE Regional Commission for Europe, OIE Standards Commission, OIE International Committee to set up an
“International Ad hoc Group”
To address: human and animal health risks related to antimicrobial resistance, and the contribution of antimicrobials usage in veterinary medicine.

24. OIE antimicrobial resistance related activities
1999: First OIE European Scientific conference
2001 : « Second OIE international conference on antimicrobial resistance »

25. OIE antimicrobial resistance related activites
2003 OIE International session:
Four guidelines accepted and published:
Terrestrial Animal Health Code :
Surveillance of bacterial resistance
Monitoring the quantities of antimicrobials used in animal husbandry
Responsible and prudent use of antimicrobial agents in veterinary medicine
OIE Manual of Standards
Laboratory methodologies for AST
2003 International meeting:
Co-organisation and participation to a joint FAO-WHO-OIE experts consultation (Geneva 2003) on non human antimicrobial usage and antimicrobial resistance

26. OIE antimicrobial resistance related activities
2004 OIE International session:
Risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals
Terrestrial Animal Health Code (Chapter 3.9.4)
2004 International meeting:
Co-organisation and participation to a joint FAO-WHO-OIE experts consultation (Oslo 2004) on non human antimicrobial usage and antimicrobial resistance

27. OIE antimicrobial resistance related activities
annex of the Terrestrial Code regarding the responsible and prudent use of antimicrobial agents in veterinary medicine was revised taking into account the recommendations of the Codex Alimentarius in May 2005 (ALINORM 05/28/31)
2005 International meeting:
WHO Canberra expert meeting on CIA
2005 OIE International session:

28. OIE antimicrobial resistance related activities
2006 OIE International session:
Resolution n° XXXIII on Veterinary critical antimicrobials
2006 International meeting:
Co-organisation of a joint FAO/WHO/OIE Expert Consultation on Antimicrobial Use in Aquaculture and Antimicrobial Resistance June 2006, Seoul, Republic of Korea.

29. OIE antimicrobial resistance related activities
2007 OIE International session:
Resolution n° XXVII adoption of the VCIA list
2007 International meetings:
Participation to the WHO Copenhagen meeting on CIA
Participation to the Codex task force in Seoul
Joint FAO/WHO/OIE expert consultation on CIA and VCIA in Rome

30. OIE GUIDELINES
Comments (with copyright) / Commentaires (soumis au Copyright) :

31. OIE Ad hoc group work
Terrestrial animal health codeSection : antimicrobial resistance
Appendix : Guidelines for the harmonisation of antimicrobial resistance surveillance and monitoring programmes
Appendix Guidelines for the monitoring of the quantities of antimicrobials used in animal husbandry
Appendix : Guidelines for the responsible and prudent use of antimicrobial agents in veterinary medicine
Appendix 3.9.4: Risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals
Manual of Diagnostic Tests and vaccines for Terrestrial Animals
Laboratory methodologies for bacterial antimicrobial susceptibility testing

32. Guidelines for the responsible and prudent use of antimicrobial agents in veterinary medicine
Comments (with copyright) / Commentaires (soumis au Copyright) :

33. Objectives of the Responsible and Prudent Use GL
Rational use of antimicrobials with the purpose of optimising both efficacy and safety in animals
Comply with the ethical obligation and economic need to keep animals in good health
Prevent or reduce as far as possible the emergence and transfer of resistant bacteria within animal populations
Maintain the efficacy of antimicrobial agents used in livestock

34. Objectives of the Responsible and Prudent Use GL (contd)
Communication, consensus, training: between the relevant professionals, acting for the prudent use
Need for every country to start a programme aiming at “the responsible and prudent use of antimicrobials”…

35. Objectives of the Responsible and Prudent Use GL (contd)
Prevent or reduce the transfer of resistant bacteria from animals to humans
Prevent the contamination of animal derived food with antimicrobial residues that exceed the established maximum residues level (MRL)
Maintain the efficacy of antimicrobial agents used in human medicine and prolong their usefulness
Protect consumer health by ensuring the safety of food of animal origin

36. …how to implement and follow a programme of “Prudent use”
By collecting information and implementing surveillance systems:
Origins and quantities of antimicrobials used
Antimicrobial use practices
Prevalence and trends of resistant bacteria in animal pathogens and in zoonotic species responsible of human infections
By developing a comprehensive methodology

37. Guidelines for analysing the risks to animal and public health from antimicrobial resistant micro-organisms of animal origin
Comments (with copyright) / Commentaires (soumis au Copyright) :

38. RISK ASSESSMENT FOR ANTIMICROBIAL RESISTANCE ARISING FROM THE USE OF ANTIMICROBIALS IN ANIMALS
Divided in 3 parts :
Guidelines for analysing the risks to animal and public health from antimicrobial resistant micro-organisms of animal origin
Analysis of risks to human health
Analysis of risks to animal health

39. RISK ASSESSMENT FOR ANTIMICROBIAL RESISTANCE ARISING FROM THE USE OF ANTIMICROBIALS IN ANIMALS
Guidelines for analysing the risks to animal and public health from antimicrobial resistant micro-organisms of animal origin
Objective :
provide Member Countries with a transparent, objective and scientifically defensible method of assessing and managing the human and animal health risks associated with the development of resistance arising from the use of antimicrobials in animals.
Within The principles of risk analysis described in Section 1.3. of this Terrestrial Code.

40. *Definition of the risk *Hazard identification *Release assessment
RISK ASSESSMENT FOR ANTIMICROBIAL RESISTANCE ARISING FROM THE USE OF ANTIMICROBIALS IN ANIMALS
Analysis of risks to human health: the internationally adopted methodology
*Definition of the risk
*Hazard identification
*Release assessment
*Exposure assessment
*Consequence assessment
*Risk estimation
*Risk management options and risk communication

41. VCIA
Comments (with copyright) / Commentaires (soumis au Copyright) :

42. ANTIMICROBIAL WORK IN OIE List of critically important antimicrobial agents
VCIA
After 2 joint FAO-WHO-OIE experts consultation (Geneva 2003, Oslo 2004) on non human antimicrobial usage and antimicrobial resistance,
recommendation to develop the concept of “critically important” classes of antimicrobial agents, both in human and veterinary medicine

43. List of veterinary critically important antimicrobial agents
In 2005, the OIE Ad hoc group defined and designated Veterinary critically important antimicrobials (VCIA)
The concept was adopted at the general session
The ad hoc group prepared a questionnaire for the member countries (MC)
Results report presented at the general session in may 2006

44. List of veterinary critically important antimicrobial agents
In May 2006, OIE International committee adopted Resolution n° XXXIII asking to refine the list
The OIE Ad hoc group on Antimicrobial resistance met in September 2006 and proposed a new list
In May 2007 OIE International committee adopted the List of Antimicrobials of Veterinary Importance (Resolution n° XXVII)
The list can be found at:

45. List of veterinary critically important antimicrobial agents
Ad hoc group proposal
Criteria for categorisation
Criterion 1 : This criteria was met when more than 50 % of the respondents identified the importance of the antimicrobial class.
Criterion 2 : This criteria was met when compounds within the class were identified as essential against specific infections and there was a lack of sufficient therapeutic alternatives.

46. List of veterinary critically important antimicrobial agents
Categories :
Critically Important Antimicrobials :
Criteria 1 and 2
Highly Important Antimicrobials :
Criteria 1 or 2
Important Antimicrobials :
Neither criteria 1 or 2

47. OIE Antimicrobial Classification
It is to be noted that in the VHIA category, some classes are critically important for particular animal species
VCIA : Veterinary Critically Important Antimicrobials
VHIA : Veterinary Highly Important antimicrobials
VIA : Veterinary Important Antimicrobials

48. Strengthening implementation
…As far as OIE is concerned:
Mobilisation of the OIE network through information, training, technical assistance, twinning
Strengthening the capacity building of regulatory bodies
International cooperation

49. Conclusion
Aknowledging that AMR bacteria / determinants don’t recognise any frontier,
*their containment needs to take into account all sources (human, animal, plant),
*and therefore all partners should be involved in their area of competence creating synergies and avoiding duplication

50. Think global
Globalisation has created risks and fears, but cooperation and synergies using global talent will lead to global prosperity
Making sustainable the efficiency of antimicrobials is not more, not less

51. World organisation for animal health
OFFICE INTERNATIONAL DES EPIZOOTIES
12 rue de Prony
75017 Paris, France
Tel.: 33 (0) – Fax: 33 (0)
Web Site: