OIE activities on antimicrobial agents and containment Dr. Patrick DEHAUMONT OIE, AFSSA/ANMV Collaborating Centre on Veterinary medicinal products BP 90203 - 35302 FOUGERES CEDEX, FRANCE p.dehaumont@anmv.afssa.fr 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

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

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 : www.oie.int] 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.

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

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

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 : www.oie.int] 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, e-mail 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. »

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 : www.oie.int] 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. »

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 : www.oie.int] 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. »

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

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

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 : www.oie.int] Animal Health Information Department Publications Department Regional Representations

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"

Animal Production Food Safety Working Groups Wildlife Diseases Animal Production Food Safety Animal Welfare Comments (with copyright) / Commentaires (soumis au Copyright) : [source : www.oie.int] 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…

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

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)

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

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 http://www.oie.int

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

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

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.

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

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

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.

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

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

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

OIE antimicrobial resistance related activities annex 3.9.3 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:

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.

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

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

OIE Ad hoc group work Terrestrial animal health codeSection - 3.9 : antimicrobial resistance Appendix 3.9.1 : Guidelines for the harmonisation of antimicrobial resistance surveillance and monitoring programmes Appendix 3.9.2 Guidelines for the monitoring of the quantities of antimicrobials used in animal husbandry Appendix 3.9.3 : 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

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

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

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”…

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

…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

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) :

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

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.

*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

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

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

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

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: http://www.oie.int/downld/SC/2007/A_BSC_Jan2007.pdf

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.

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

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

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

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

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

World organisation for animal health OFFICE INTERNATIONAL DES EPIZOOTIES 12 rue de Prony 75017 Paris, France Tel.: 33 (0)1 44.15.18.88 – Fax: 33 (0)1 42.67.09.87 E-mail: oie@oie.int Web Site: http://www.oie.int