OIE Activities for the Containment of Antimicrobial Resistance Dr Elisabeth Erlacher-Vindel, Deputy Head of the 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
SOME KEY FACTS Established in 1924: 174 Members (April 2009) Intergovernmental organisation predates the UN Five Permanent Regional Representations: Bamako (Mali), Buenos Aires (Argentina), Tokyo (Japan), Sofia (Bulgaria) and Beirut (Lebanon) Five Sub-regional Offices: Bangkok (Thailand), Gaborone (Botswana), Panama, Brussels (Belgium), Tunis (Tunisia) Regional Commissions: Africa, America, Asia-Pacific, Europe and Middle East 53 20 29 51 34 Americas: 29 Africa: 51 Europe: 53 Middle-East: 20 Asia: 34 Some Members belong to more than one Region
OIE World Organisation for Animal Health: Mandate Historical: To prevent animal diseases from spreading around the world The 4th Strategic Plan 2006 2010 extends the OIE s global mandate to: The improvement of animal health all around the world
WTO SPS Agreement (1995) Legal framework for international trade Recognises OIE as a reference organisation for international standards (one of the three sisters )
The three sisters Standard-setting organisations Food safety CODEX Animal health and zoonoses OIE Plant health IPPC Codex = Codex Alimentarius Commission (FAO/WHO) OIE = World Organisation for Animal Health IPPC = International Plant Protection Convention (FAO) 6
OIE OBJECTIVES ANIMAL HEALTH INFORMATION To ensure transparency in the global animal disease and zoonosis situation To collect, analyse and disseminate scientific veterinary information
OIE OBJECTIVES INTERNATIONAL STANDARDS To promulgate health standards for the safety of international trade in animals and animal products (within its WTO mandate) and animal disease surveillance To contribute to food safety and food security and to promote animal welfare, through a science-based approach
OIE international standards
The rational use of antimicrobials and prevention of antimicrobial resistance, a challenging issue to be dealt with at the international, regional and national levels with a global perspective
OIE international standards OIE develops and publishes 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 Developed using a science-based approach
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 Manual of Diagnostic Tests for Aquatic Animals 13
Terrestrial Code (two volumes) Volume I : General Provisions (Horizontal issues) User s guide - Glossary Section 1 : Animal disease diagnosis, surveillance and notification Section 2 : Risk analysis Section 3 : Quality of VS Section 4 : General recommendations : disease prevention and control Section 5 : Trade measures, import/export procedures and veterinary certification Section 6 : Veterinary Public Health Antimicrobial resistance surveillance/prudent use/monitoring Section 7 : Animal welfare Volume II: Recommendations applicable to OIE listed diseases
OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 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
OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Volume I: General Information + OIE Listed Diseases and other Diseases of Importance to International Trade General Information Volume II: Introduction / User s guide List of tests for International trade Glossary Section 1. Introductory Chapters Chapter 1.1.6.Laboratory methodologies for bacterial antimicrobial susceptibility testing OIE Listed Diseases and Other Diseases of Importance to International Trade (continued)
Terrestrial Animal Health Code, Section 6. Chapter 6.5: Harmonisation of national antimicrobial resistance surveillance and monitoring programmes Chapter 6.6: Monitoring of the quantities of antimicrobials used in animal husbandry Chapter 6.7: Responsible and prudent use of antimicrobial agents in veterinary medicine Chapter 6.8: Risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Chapter 1.6: Laboratory methodologies for bacterial antimicrobial susceptibility testing
Guidelines for the responsible and prudent use of antimicrobial agents in veterinary medicine Communication, consensus, training professionals, acting for prudent use
RESPONSIBLE AND PRUDENT USE OBJECTIVES Reference in the Code: chapter 6.7 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 Veterinary Antimicrobial Products 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 6.5 and 6.6 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
Guidelines for analysing the risks to animal and public health from antimicrobial resistant microorganisms of animal origin Antimicrobial resistance surveillance and monitoring programmes should be based on risk analysis
RISK ASSESSMENT FOR ANTIMICROBIAL RESISTANCE ARISING FROM THE USE OF ANTIMICROBIALS IN ANIMALS Reference in the Code: chapter 6.8 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.
RISK ASSESSMENT FOR ANTIMICROBIAL RESISTANCE ARISING FROM THE USE OF ANTIMICROBIALS IN ANIMALS Divided in three parts: Guidelines for analysing the risks to animal and public health from antimicrobial resistant microorganisms 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 Analysis of risks to human health: the methodology * Definition of the risk * Hazard identification * Release assessment * Exposure assessment * Consequence assessment * Risk estimation * Risk management options and risk communication
OIE activities for the implementation of standards
OIE activities for the implementation of standards: Prerequisites to implement standards, to conduct risk assessment and to manage risks Functional Veterinary Services Existence of technically and scientifically recognised Laboratories Training Communication
OIE activities for the implementation of standards: Functional Veterinary Services 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)
OIE activities for the implementation of standards: Functional Veterinary Laboratories 177 OIE Reference Laboratories and 29 Collaborating Centres Collaborating Centre for Veterinary Medicinal Products AFSSA Fougères, Agence nationale du médicament vétérinaire, France OIE- Laboratory twinning programme Link between OIE Reference Laboratory or Collaborating Centre (Parent) and national laboratory (Candidate) Aims to improve expertise and diagnostic capacity with eventual aim of reaching OIE standards
OIE activities for the implementation of standards: Training and Communication OIE-Training of focal points Nomination of national focal points for OIE on matters related to veterinary products including antimicrobials Training Workshops in all five Regions OIE Conference on Veterinary Medicinal Products in Africa: Dakar (Senegal), 25 27 March 2008 OIE Conference on Veterinary Medicinal Products in the Middle East, Damascus (Syria) 2 4 December 2009
One decade of OIE antimicrobial resistance related activities
OIE antimicrobial resistance related activities CHRONOLOGY 1997: Request from the Regional Commission for Europe 1998: Debate at the General Session 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. 1999: OIE European Scientific Conference 2001: OIE International Conference on antimicrobial resistance
OIE antimicrobial resistance related activities CHRONOLOGY 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 2003: International Meeting : Joint FAO-WHO-OIE experts consultation (Geneva 2003) on non-human antimicrobial usage and antimicrobial resistance 2004: OIE General Session: 1 new guideline accepted and published: - Terrestrial Animal Health Code: Risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals
OIE antimicrobial resistance related activities CHRONOLOGY 2004: International Meeting : Joint FAO-WHO-OIE experts consultation (Oslo 2004) on non-human antimicrobial usage and antimicrobial resistance 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) 2006: OIE General Session: Resolution No. XXXIII on Veterinary critical antimicrobials 2006: 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 CHRONOLOGY 2007: OIE General Session: Resolution No. XXVII: adoption of the Veterinary Critically Important (VCIA) list 2007: International meetings: Joint FAO/WHO/OIE expert consultation on CIA and VCIA in Rome 2007, 2008: Codex task force meetings, Seoul 2008: OIE General Session: Resolution No. XXV on Veterinary Products
Ongoing and future International Cooperation
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
VICH 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.
VICH 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 Acceptable Daily Intake (ADI) www.vichsec.org
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
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