1. Recent OIE initiatives and resolutions relating to
veterinary medicines and their
expected impact on availability and use
Elisabeth Erlacher-Vindel
Deputy Head, Scientific and Technical Department World Organisation for Animal Health (OIE)
Comments (with copyright) / Commentaires (soumis au Copyright) :

2. CONTENTS Introduction
OIE past activities related to veterinary medicines
OIE International Standards
Antimicrobials as an example
International collaboration
Resolution on veterinary products and the OIE strategy
Current and future activities
Concluding remarks
Moving towards sustainable availability and use

3. World Organisation for Animal Health
An intergovernmental organisation preceding the United Nations
Creation of the Office International des Epizooties (OIE)
World Organisation for Animal Health
Creation of the United Nations
1924
2003
1945
to prevent the spread of animal diseases throughout the world
the improvement of animal health, veterinary public health and animal welfare world-wide
2010

4. Headquarters in Paris (France)
Structure
Headquarters in Paris (France) 5 6

5. Network of experts: OIE Reference Laboratories and Collaborating Centres (updated in 2010)
Total
Number
190 37
227
Countries 36 21 41
Diseases/ Topics
101 35
136
Experts
161
198
*Countries hosting both labs and Centres are not counted twice

6. Some countries belong to more than one region
178 Members (2011) 36
Africa 52 – Americas 30 – Asia, the Far East and Oceania 36 – Europe 53 – Middle-East 20
Some countries belong to more than one region

7. Improve animal health and welfare worldwide
Transparency of world animal disease situation (including zoonoses)
Collect and publish veterinary scientific information, notably animal disease prevention and control methods
Sanitary safety of international trade in animals and their products under the mandate given by the WTO
Fifth Strategic Plan : consolidation

8. Trends in Global Population70 65 60 55
1950 75 80 85 90 95
2000 05 10 15 1 2 3 4 5 6 7 8
Billions
Total
Global Population:
Source: US Bureau of the Census
Source : Center for Disease Control and Prevention (CDC) Atlanta

9. Animal health is essential to food security, food safety and public health
Key components
Prevention
Early detection
Control
Basic requirements
Strong Veterinary Services
Sufficient laboratory capacities
Effective diagnostic and control tools

10. The OIE Fifth Strategic Plan 2011 - 2015
Mentions explicitly the need to:
Develop and update standards, guidelines and recommendations on diagnostic tests, vaccines and veterinary drugs including antimicrobials
Integrate the relation between animal production and the environment: new sanitary and environmental risks need to be anticipated
Impact of climate and environmental change on the emergence of animal diseases
Relationship between animal production systems and climate change

11. CONTENTS Introduction
OIE past activities related to veterinary medicines
OIE International Standards
Antimicrobials as an example
International collaboration
Resolution on veterinary products and the OIE strategy
Current and future activities
Concluding remarks
Moving towards sustainable availability and use

12. 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 Members during General Session each May by consensus
Developed using a science-based approach

13. OIE International Standards
available on the
OIE website (
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”
Manual of Diagnostic Tests for Aquatic Animals 13 13

14. Examples related to antimicrobial agents and antimicrobial resistance
Terrestrial Animal Health Code, Section 6
Chapter 6.7: Harmonisation of national antimicrobial resistance surveillance and monitoring programmes
Chapter 6.8: Monitoring of the quantities of antimicrobials used in animal husbandry
Chapter 6.9: Responsible and prudent use of antimicrobial agents in veterinary medicine
Chapter 6.10: Risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals

15. Examples related to antimicrobial agents and antimicrobial resistance
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
Chapter 1.6: Laboratory methodologies for bacterial antimicrobial susceptibility testing
Resolution No. XXVIII (adoption at the 75th General Session in May 2007) on the OIE LIST OF ANTIMICROBIALS OF VETERINARY IMPORTANCE

16. OIE International collaboration
International meetings on antimicrobial resistance:
Joint FAO/WHO/OIE expert consultations since 2003
CODEX
Task Force on Antimicrobial Resistance: (Republic of Korea)
Committee on residues on Veterinary Drugs

17. VICH
VICH = Veterinary International Conference on Harmonisation of Technical Requirements for Registration of Medicinal Products
International cooperation programme: USA-JAPAN- EU (+ AUS/NZ + Canada: observers)
OIE associated member
Supports global outreach
Discussion forum for Regulatory Authorities + Industry
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. 17

18. OIE / VICH questionnaire
Sent in June 2009 to OIE Members
Answers from:
26 VICH countries and
62 non-VICH countries
Answers clearly show that
Situations differ in regions and countries
Specific needs have to be identified
Answers need to be adapted
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. 18

19. Different Reality in different Countries / 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

20. CONTENTS Introduction
OIE past activities related to veterinary medicines
OIE International Standards
Antimicrobials as an example
International collaboration
Resolution on veterinary products and the OIE strategy
Current and future activities
Concluding remarks
Moving towards sustainable availability and use

21. RESOLUTION No. 25 on Veterinary Products
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 21

22. Recommendations to OIE Members
Promote and enhance in their respective countries good veterinary governance, which includes the compliance of Veterinary Services with OIE international standards, as an instrumental and essential prerequisite to the establishment and effective implementation of adequate and appropriate legislation covering all aspects of products for veterinary use, including registration, quality control, distribution and final use.
Develop and improve international and regional cooperation in the establishment and enforcement of legislation to harmonise the regulatory framework between Members so as to assist countries in need to effectively institute and maintain such mechanisms. 22

23. Recommendations to OIE Members
Allocate appropriate human and financial resources to Veterinary Services and laboratories to correctly implement the OIE standards and guidelines related to veterinary products and their control.
4. Nominate a national focal point for OIE on matters related to veterinary products according to the suggested Terms of Reference and encourage his/her participation in training sessions and appropriate international gatherings and meetings. 23

24. Recommendations to OIE Members
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.
6. Actively encourage the recognition and application of the international recommendations, guidelines and tools developed by the OIE and adopted by the International Committee on veterinary products. 24

25. Recommendations to OIE
Continue to develop and update standards, guidelines and recommendations on diagnostic tests, vaccines and veterinary drugs, including antimicrobials.
2. Continue to work on the use of biotechnologies to improve vaccines and diagnostic tests, as well as on the innocuity of recombinant vaccines with regard to food safety. 25

26. Recommendations to OIE
Continue to strengthen capacity building activities including training particularly directed at Delegates and focal points, to enable OIE Members to organise, manage and implement appropriate legislation for veterinary products including registration, quality control, distribution and final use of veterinary products preferably using a regional or sub-regional basis.
Provide and promote communication on OIE standards, guidelines, and recommendations related to veterinary products, particularly on veterinary drugs and vaccines. 26

27. Recommendations to OIE
Continue to actively participate in and support VICH activities and to share outcomes with OIE Members with a view to promoting VICH guidelines at global level.
Develop and improve collaboration with relevant international and regional organisations on issues related to veterinary products and, whenever appropriate, in support of the mandate of the OIE.
7. Include and strengthen all above-mentioned matters within the Fifth Strategic Plan of the OIE. 27

28. CONTENTS Introduction
OIE past activities related to veterinary medicines
OIE International Standards
Antimicrobials as an example
International collaboration
Resolution on veterinary products and the OIE strategy
Current and future activities
Concluding remarks
Moving towards sustainable availability and use

29. Development and updating of international standards and guidelines
ad hoc Groups on antimicrobial resistance
Terrestrial animals
2 revised Chapters (6.7 and 6.8) sent for Member comments
2 chapters to be updated at the meeting in June 2011
Aquatic animals
2 Chapters proposed for adoption in May 2011
Principles for responsible and prudent use of antimicrobial agents and Introduction to the recommendations for controlling antimicrobial resistance
ad hoc Group on vaccine quality
ad hoc Group on validation of diagnostic tests

30. Support to Veterinary Services / laboratories
OIE PVS Pathway for efficient
Veterinary Services
OIE works with governments,
Stakeholders and donors (if needed)
« treatment »
Support to Veterinary Services / laboratories
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
Laboratories

31. The Laboratory Twinning Programme
Each OIE Laboratory Twinning Project...
Is a 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 - Optimal goal is to achieve OIE Reference Laboratory designation
Should be sustainable once the project is over
Twinning works by establishing a link between an OIE Ref lab (parent lab) and a candidate lab.
OIE funded twining project will support this link.
Through this mutually beneficial relationship – aim to improve expertise and capacity in candidate lab. With eventual aim of attaining OIE standards. Accepted that not every candidate lab will become a reference lab but will move closer to it.
Some areas it will be beneficial to chose a lab that is not far off becoming a reference lab so that objective is more easily attainable.
Funding is available for supporting the link, travel, training, reagents etc but not for laboratory hardware. Although a component on training may be to help a lab put together a proposal for funding for hardware.

32. Modernisation or updating of national legislation
OIE Guidelines for Veterinary Legislation
Essential elements to be covered in veterinary legislation (
First OIE Global Conference on Veterinary Legislation: Djerba (Tunisia), 7-9 December 2010
Recommendations (

33. Communication and Capacity building
Regional Training Workshops of OIE National Focal Points for Veterinary Products (first cycle)
Europe: 26 to 28 July 2010, Serbia
Americas: 20 to 22 September 2010, Colombia
Africa: 23 to 25 November 2010, South Africa
 Asia-Pacific: 28 to 30 June 2011, Cambodia
Covers all main subjects on autorisation, surveillance, distribution, use and control of veterinary products
Collaboration with international organisations and new partners
Second cycle under developpment

34. Concluding remarks
OIE Strategy on veterinary products is based on complementary approaches:
Development and updating of international standards and guidelines
Support to Veterinary Services and laboratories
Modernisation or updating of national legislation
Communication and capacity building
Collaboration with international organisations and partners
Moving towards sustainable availability and use of veterinary medicines

35. Dialogue with various stakeholders
Moving towards sustainable availability and use of veterinary medicines
Dialogue with various stakeholders
Standards covering new and emerging technologies
Internationally supported research initiatives
Innovative public–private collaboration
Harmonisation of requirements for veterinary product registration
Support to countries
Twinning works by establishing a link between an OIE Ref lab (parent lab) and a candidate lab.
OIE funded twining project will support this link.
Through this mutually beneficial relationship – aim to improve expertise and capacity in candidate lab. With eventual aim of attaining OIE standards. Accepted that not every candidate lab will become a reference lab but will move closer to it.
Some areas it will be beneficial to chose a lab that is not far off becoming a reference lab so that objective is more easily attainable.
Funding is available for supporting the link, travel, training, reagents etc but not for laboratory hardware. Although a component on training may be to help a lab put together a proposal for funding for hardware.

36. 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, Paris, France - –