1. 1 The contribution of VICH to the global One Health approach VICH5 CONFERENCE, OCTOBER 2015, TOKYO Jean-Pierre Orand, Anses, France, OIE Collaborating Centre

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6. 66 “One World, One Health” Concept  General Principles: 60% of pathogens that causes diseases in humans are from animal origin… : zoonosis Animal in good health produce more animal-derived protein and play an important role in the World Food Program Animal in good health produce safe food

7. 77 “One World, One Health” Concept  Veterinary Medicinal Products (VMPs) : are veterinary tools, contributing to the improvement of animal (and public health), and to economical development.  The VMPs policy is part of the animal health policy : Vet Drugs shall be sure, secure and efficient To protect Animal health To protect Human Health (residue, zoonosis, AMR) For Environmental safety

8. 8 The “ONE HEALTH” concept ensure political support in coordinated prevention of high public health and animal impact diseases at the human-animal interface “ONE WORLD, ONE HEALTH” CONCEPT

9. 99 The solution A holistic and coordinated management accross the animal, food and human sectors in different ecosystems and geographic locations Improved intersectoral collaboration where regulations of medicines are managed by different entities 9

10. 10 International World Organisation for animal Health World Health organisation Food and Agriculture organisation of the United Nations

11. 11 What do we need? International standards (to harmonise protocols and methodologies) Coordinated research on effectiveness of policies to achieve AMR risk reduction Legislation on access to quality drugs and restricted use Good governance of all sectors related to authorisation and use of VMPs (lab expertise, international standards and legislation development and implementation, surveillance and control) 11

12. 12 Major International Standards Harmonization Efforts for VMPs WHO/FAO Codex Alimentarius Commission  MRL * World Organisation for Animal Health (manufacturing, quality control, AMR…) * International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

13. 13 Role of OIE OIE develops different standards for a good governance of VMPs : Specific part of terrestrial code concerning VMPs legislation (chap.3.4.11), Standards for Antimicrobial resistance Standards for manufacturing and quality control OIE develops a specific program : OIE PVS pathway for capacity building (PVS evaluation, PVS Gap analysis and veterinary legislation audit …) ….

14. 14 OIE and VICH In the context of “One health” approach, for a better harmonisation, OIE strongly supports VICH work : in the 5 th strategic plan, OIE encourages the use of VICH guidelines; Supports the process of setting up the VICH Outreach Forum since the beginning

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16. 16 Goals of ICH To establish harmonised guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines To contribute to the protection of public health from an international perspective; To avoid divergent future requirements through harmonisation of selected topics To Advance Harmonisation for Better Global Health, and in response to a growing interest from beyond the ICH regions in the use of ICH Guidelines, the ICH establishes the ICH Global Cooperation Group (GCG)

17. 17 Goals of VICH The objectives of the VICH are along the same lines as those of the ICH VICH work takes particular note of the ICH work VICH establishes harmonised technical requirements for registration of veterinary medicinal products VICH develops Guidelines : –Study and testing methodology –Post-marketing safety monitoring medicines)

18. 18 VICH Global Outreach During its 21 st meeting, the SC established a task force to enhance the global outreach of VICH...taking into account: –the links with OIE and the potential to maximise synergies –the resources available –the regional harmonisation co operations existing in some non VICH regions –the needs of the countries regarding training and capacity building Bearing in mind the 4th VICH conference and the VICH phase III

19. 19 VICH Global Outreach VICH progresses its objective of wider international harmonisation of technical requirements, which is aimed at the wider dissemination and acceptance of VICH guidelines and co-operation on a more global level, through the VICH Outreach Forum implemented in June 2012 Objectives of the global Outreach : –international harmonisation, –better access to VMPs, –mutual recognition and regional approaches

20. 20 Support provided by the OIE Dissemination of information on VICH to OIE member countries Feedback to OIE Delegates of Outreach Member countries Promotion of VICH and Outreach Forum objectives Support to VICH: Training Strategy development, surveys

21. 21 Thank you for your attention!