OIE Activities for the Containment of Antimicrobial Resistance Dr M. Kathleen Glynn Scientific and Technical Department

Contents Introduction OIE International Standards OIE activities for the implementation of standards One decade of OIE antimicrobial resistance related activities Ongoing and future international cooperation

Key Facts about OIE Intergovernmental organisation created in 1924 - 176 Members Five Regional Representations and six sub-regional Offices Regional Commissions: Africa, Americas, Asia-Pacific, Europe et Mid-East The current OIE global mandate - ‘Working for better worldwide animal health, animal welfare and public health protection ’ 29 52 13 28 51 Briefly introduce the OIE. Number of countries 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. 3

WTO SPS Agreement (1995) Legal framework for international trade Recognises OIE as a reference organisation for international standards Animal health and zoonoses

OIE international standards

OIE 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 2 OIE trade standards: terrestrial code first in 1968, aquatic code in 1995 2 OIE biological standards Traditionally animal health and zoonoses, expanded with animal welfare and food safety in the frame work of the new mandate of the OIE: “to improve animal health worldwide” OIE develops and publishes Developed using a science-based approach Health standards for the prevention and control of animal diseases as well as for the safe trade of animals and animal products => Codes Biological standards for diagnostic tests and vaccines => Manuals Adopted by OIE Member Countries and Territories during General Session each May by consensus Code: two volumes – one cross cutting (horizontal standards) and one disease-specific (vertical standards) Manual: Describes internationally agreed laboratory methods for disease diagnosis To enable the requirements for health certification in connection with trade to be met To avoid differences in interpretation of results Covers the production and control of biological products e.g. vaccines Manual of Diagnostic Tests for Aquatic Animals 6 All available at: www.oie.int 6

Terrestrial Animal Health Code, Section 6 (Veterinary Public Health) Chapter 6.8: Harmonisation of national antimicrobial resistance surveillance and monitoring programmes Chapter 6.9: Monitoring of the quantities of antimicrobials used in animal husbandry Chapter 6.10: Responsible and prudent use of antimicrobial agents in veterinary medicine Chapter 6.11: Risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Chapter 1.1.6: Laboratory methodologies for bacterial antimicrobial susceptibility testing

RESPONSIBLE AND PRUDENT USE OBJECTIVES Reference in the Code: chapter 6.10 Prevent or reduce the transfer of resistant bacteria from animals to humans and within animal populations Prevent the contamination of animal-derived food with antimicrobial residues that exceed the established maximum residues level (MRL) => Protect consumer health Maintain the efficacy of antimicrobial agents used in human medicine and in food-producing animals and prolong their usefulness

RESPONSIBLE AND PRUDENT USE RESPONSIBILITIES Of the regulatory authorities Granting marketing authorisation => specify terms of authorisation (criteria for safety, quality, efficacy, etc.) and provide information to vets Combat manufacture, advertisement, trade, distribution and use of unlicensed/counterfeit products Quality control of products Control over prescription, supply, administration Organise training of all antimicrobial users Of distributors For Veterinary Antimicrobial Products (VAP): only by prescription from a veterinarian or authorised trained person Detailed records

RESPONSIBLE AND PRUDENT USE RESPONSIBILITIES Of veterinarians Promotion of good farming practices to minimise the need for VAP Prescription only to animals under their care; when necessary; precise indications (including withdrawal period) Appropriate choice (=> target pathogens) of VAP for efficacy of treatment Detailed records Of food animal producers Implement health & welfare programmes with assistance of a vet. Use VAP only by prescription Comply with withdrawal periods => residue levels do not present a risk to the consumer

How to Implement and Follow a Programme of “Prudent use” Reference in the Code: chapter 6.8 and 6.9 By collecting information and implementing surveillance systems: Origin and quantities of antimicrobials used Antimicrobial use practices Prevalence and trends of resistant bacteria in animal pathogens and in zoonotic species responsible for human infections By developing a comprehensive methodology

Risk Assessment for Antimicrobial Resistance Arising from the Use of Antimicrobials in Animals Reference in the Code: chapter 6.11 Objective : Provide Member Countries and Territories 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 2 of the OIE Terrestrial Code.

OIE Activities for the Implementation of Standards 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. 13

OIE Activities for the Implementation of Standards Functional Veterinary Services Existence of technically and scientifically recognised Laboratories Training Communication

OIE PVS Pathway for efficient Veterinary Services « treatment » OIE works with governments, stakeholders and donors (if needed) « treatment » The quality of national veterinary services functioning under a system of good governance is a Global Public Good Veterinary Services Strategic Plan Modernisation of legislation Public/private Partnerships Evaluation PVS « diagnosis » Gap Analysis « prescription» Follow-Up Evaluation mission Country / Donors Investment / Projects Veterinary Education OIE-PVS tool : Evaluation of the performance of Veterinary Services Takes into account public and private components and interactions with stakeholders Takes into account Veterinary Laboratory capabilities Gap Analysis of PVS outcomes: Evaluation of Needs and Priorities To identify specific activities, tasks and resources required to address ‘gaps’ Preparation of investment programmes (if needed, commitment from donors) Laboratories

Antimicrobial Resistance One decade of OIE Antimicrobial Resistance Related Activities 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. 19

OIE antimicrobial resistance related activities CHRONOLOGY HIGHLIGHTS 1999: Recommendations from the OIE Commissions and OIE International Committee to set up an “International ad hoc Group” => To address: human and animal health risks related to antimicrobial resistance (AMR), and the contribution of antimicrobials usage in veterinary medicine 2003: OIE General Session: four guidelines accepted and published: - Terrestrial Animal Health Code: Surveillance and monitoring programmes of antimicrobial resistance Monitoring the quantities of antimicrobials used in animal husbandry Responsible and prudent use of antimicrobial agents in veterinary medicine - OIE Manual of Diagnostic Tests and Vaccines: Laboratory methodologies for bacterial antimicrobial susceptibility testing The role and the work of the OIE in promoting the responsible and prudent use of antimicrobials in terrestrial and aquatic animals so as to preserve their therapeutic efficacy and prolong their use in both animals and humans, and in promoting the monitoring of antimicrobial resistance (Resolution No. XXV of the 69th General Session 2001, Resolution No. XXX of the 71st General Session 2003, Resolution No. XXXIII of the 74th General Session 2006, and Resolution No. XXVIII of the 75th General Session 2007),

2004: OIE General Session 2005: OIE General Session: OIE antimicrobial resistance related activities CHRONOLOGY HIGHLIGHTS 2004: OIE General Session Risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals (Terrestrial Code) 2005: OIE General Session: Chapter on ‘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)

2009: OIE General Session: Resolution No. XXV on Veterinary Products OIE antimicrobial resistance related activities CHRONOLOGY HIGHLIGHTS 2006: OIE General Session: Resolution No. XXXIII on Veterinary critical antimicrobials 2007: OIE General Session: Resolution No. XXVII: adoption of the Veterinary Critically Important Antimicrobial (VCIA) list 2009: OIE General Session: Resolution No. XXV on Veterinary Products XXV. Promote the responsible and prudent use of veterinary medicinal products, in particular of antimicrobials used in veterinary medicine, and the monitoring of the potential existence or development of antimicrobial resistance. Adopted at the 77th OIE General Session in May 2009 Reflects the aim of promoting a coherent strategy and of strengthening OIE involvement in this field Six recommendations to OIE Members Seven recommendations to the OIE

Ongoing and Future International Cooperation 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. 23

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 and Industry 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 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, To minimise the use of test animals and costs of product development, To provide a basis for widening international harmonisation of registration requirements. 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. 24

Codex Task Force on Antimicrobial Resistance : Jeju (Republic of Korea), 12-16 October 2009 Antimicrobial resistance is a major global health concern inherently related to the use of antimicrobials Need to create an acceptable balance between the need for the use of antimicrobials to protect animal health and the dangers emanating from possible misuse Protection of human health and the prudent and responsible use of antimicrobials in animals is the ultimate objective in antimicrobial risk management The OIE/FAO/WHO Consultative ad hoc Group on Collaborative Activities on Antimicrobial Resistance The Group met on 30 September and 1 October 2009 in OIE headquarters in Paris (France) with the aim of finding common areas for cooperation and maintaining good communication between FAO, OIE and WHO in this field. After mapping out the areas where antimicrobial resistance may arise, the ad hoc Group identified five main areas of activities currently addressed by the three organisations: (1) Guidelines, standards and harmonisation; (2) Legislation, inspection/control; (3) Data collection and surveillance; (4) Capacity building; and (5) Communication. A draft work plan was agreed by the ad hoc Group for common and joint activities between the organisations in the short, medium and long term.

Thank you for your attention 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