Dr Catherine Lambert

OIE, AFSSA/ANMV
Collaborating Centre for Veterinary medicinal products
BP 90203 - 35302 FOUGERES CEDEX, FRANCE
[email protected]

International approach for veterinary

medicinal products:
OIE
and
Codex alimentarius

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INTRODUCTION

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 International approach for veterinary medicinal
products: OIE and Codex alimentarius

Benefits Risks

Animal health and Risk for animals

welfare Risks for humans
Human nutrition Risks for the environment
Economic development 3
OIE/ Codex standards and
WTO

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Standards-setting organizations

food safety animal health plant health

CODEX OIE IPPC

Codex = Joint FAO/WHO Codex Alimentarius Commission

OIE = World Organization for Animal Health
IPPC = International Plant Protection Convention (FAO)

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WTO Agreement

Agreement on the Application of Sanitary and

Phytosanitary Measures (SPS Agreement)
• The SPS Agreement calls on countries to harmonize their
national standards with “international standards, guidelines
or recommendations ”(Article 3.1)
• “international standards, guidelines or recommendations”
(Annex A)
! Codex Standards for food safety
! OIE for animal health and zoonoses
! IPPC for plant health
Agreement on Technical Barriers to Trade (TBT
Agreement)
• The TBT Agreement calls on countries to use relevant
international standards when they exist (Article 2.4).

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OIE APPROACH

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•an intergovernmental
organisation
•founded in 1924 by 175 Member Countries
28 countries
•created before the
U.N.

World Organisation for Animal Health

Common name adopted

by the International
Committee on May 2003
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 The 6 Objectives of the OIE

ANIMAL HEALTH INFORMATION

to ensure transparency in the global animal disease and zoonosis situation
to collect, analyse and disseminate scientific veterinary information
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
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

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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

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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

Manual of Diagnostic Tests for Aquatic

Animals
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 INTERNATIONAL COMMITTEE
Administrative Commission
Director General
Specialist Commissions Regional Commissions
Code, Laboratories, Africa, Americas, Europe, Asia- Far East and Oceania,
Aquatic animals, Scientific Middle East

Human Resources and

Budget Management Central Bureau
Unit
Deputy Director General Deputy Director General
Accounts Unit Administration, Finances, Human Animal Health and International
Resources Standards
World Animal Health
and Welfare Fund Administrative and International Trade
Coordination Management Systems Department
Department

Collaborating
Scientific and Ad hoc Groups
Centres Regional Activities Technical
Department Department
Reference
Working Groups
Laboratories
Animal Health
Publications Information
Department Department

Regional Representations 12
Collaborating Centres

Expert Centres on horizontal subjects, for

the OIE and Member Countries
! Assist in the elaboration of procedures to
harmonise animal disease regulations /
international standards
! Coordinate collaborative studies
! Provide technical training
! Organise and host scientific meetings for
the OIE
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OIE veterinary medicinal products
related activities

1994 « need for initiatives and programmes

to foster the harmonisation of
registration requirements for veterinary
drugs »
Resolution N°X, 62nd General Session

OIE antimicrobials and antimicrobial

2001 resistance activities (AMR)
to Resolutions XXV (2001), XXX (2003), XXXIII
2007 (2006), XXVIII (2007)
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OIE antimicrobial resistance related
activities
2003-2004 : Five guidelines adopted and published

Terrestrial animal health code (Section 6)

• Harmonisation of antimicrobial resistance surveillance and
monitoring programmes
" Monitoring of the quantities of antimicrobials used in animal
husbandry
" Responsible and prudent use of antimicrobial agents in
veterinary medicine
" 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
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 OIE antimicrobial resistance related activities

2006-2007: List
of VCIA
“Veterinary critically important antimicrobial
agents”
Concept drawn after 2 joint FAO-WHO-OIE experts
consultation (Geneva 2003, Oslo 2004) on non
human antimicrobial usage and antimicrobial
resistance
Exits both in human (WHO) and veterinary (OIE)
medicine

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OIE VMPs related activities

The OIE conference on VMPs held in Dakar,

Senegal (March 2008) recommends that
• “OIE members promote the control of residues
…. with standards developed by the Codex
Alimentarius …”
• “OIE continue to follow closely the work of VICH
and share the results with all the OIE MC”

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OIE VMPs related activities

• OIE support to VICH initiative

! Established under the auspices of the OIE

! Member of the Steering Committee

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OIE VMPs related activities

A major aim of its 2006-2010 mandate:

to ensure the better provision of safe and
efficacious VMPs

VMPs are taken into account in all OIE

initiatives related to capacity building

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OIE VMPs related activities

Resolution N°25 on veterinary products

77th General Session – May 2009

• Key role of a good governance of VMPs

• Agreed by OIE May 2009 General Assembly

to constitute a key element of OIE’s
upcoming 5th Strategic plan

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OIE Collaborating centre for veterinary
medicinal products

The ANMV is the French Agency for

Veterinary Medicinal Products

Responsibilities in Assessment,
Authorisation, Monitoring, Control,
Inspections

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 OIE Collaborating centre for veterinary medicinal
products : ANMV
# INTERNATIONAL HARMONISATION
• OIE (standards ; methods ; registration of diagnostic assays)
• Represents OIE for CODEX meeting related to VMP
• Participates to WHO/FAO/OIE workshop, expert groups on
VMP
• Represents OIE to VICH
! RESEARCH and EXPERTISE
• Antimicrobial resistance, Benefit/Risk Assessment
• Pharmaceutical regulation
! TECHNICAL ASSISTANCE
• Bilateral and multilateral cooperation and assistance to OIE
member countries (especially developing countries)
• Twinning
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Codex Alimentarius
APPROACH

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• Intergovernmental 182 Member countries and
body
• Status adopted in
1 Member Organization
May, 1963
• Created by FAO and
WHO

Collection of food Latin for

standards, guidelines “food code”
and codes of practice

- C O D E X A L I M E N T A R I US 24
Codex Alimentarius Commission
Mandate

To protect the health of consumers

To ensure fair practices in international
food trade
To coordinate all food standardisation
work done by international organisations

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 Codex organizational chart
CODEX ALIMENTARIUS COMMISSION
Executive Committee Secretariat

General Subject Committees Commodity Committees Regional Coordinating Committees

Methods of Analysis and Latin America
General Principles active Africa
Sampling and the Caribbean
(France) Milk and Milk Processed Fruits (Morocco)
(Hungary) (Argentina)
Products (New Zealand) and Vegetables (USA) North America and
Pesticide Residues Asia
Food Additives (China) the Southwest Pacific
(China) Fish and Fishery Fresh Fruit and (Republic of Korea)
(Samoa)
Residues of Veterinary Products (Norway) Vegetables (Mexico)
Contaminants in Foods Drugs in Foods Europe Near East
(Netherlands) Fats and Oils (Switzerland) (Jordan)
(USA)
(United Kingdom)
Food Hygiene Food Labelling
(USA) (Canada) adjourned
ad hoc Intergovernmental Task Forces
-Food Import and Sugars Meat Hygiene
Nutrition and Foods for
Export Inspection Special Dietary Uses (United Kingdom) (New Zealand) Biotechnology Antimicrobial Resistance
and Certification (Japan) (Republic of Korea)
(Germany) Cereals, Pulses and Vegetable Proteins
Systems (Australia)
Legumes (USA) (Canada) Processing and Handling of
Quick Frozen Foods
Natural Mineral Waters Cocoa Products and (Thailand)
(Switzerland) Chocolate (Switzerland)
dissolved
Fruit and Vegetable Juices Animal Feeding
(Brazil) (Denmark)

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 Codex organizational chart
CODEX ALIMENTARIUS COMMISSION
Executive Committee Secretariat

General Subject Committees

General Principles
(France)

Residues of Veterinary
Drugs in Foods
(USA)

ad hoc Intergovernmental Task Forces

Antimicrobial Resistance
(Republic of Korea)

Activities focussed on main risks linked with the use of VMP

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 Codex Committee on Residues of
Veterinary Drugs in Foods

• to determine priorities for the consideration of

residues of veterinary drugs in foods

• to recommend maximum levels of such

substances (MRL)

• to develop codes of practice

• to consider methods of sampling and analysis

for the determination of veterinary drug
residues in foods

• CCRVDF develop standards based on evaluations by JECFA

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JECFA RISK ASSESSMENT
International expert scientific committee

Evaluate food additives (more than 1500),

contaminants, naturally occurring toxicants
and residues of veterinary drugs in food
(approximately 90 veterinary drugs)

JECFA advice on residues of veterinary

drugs to the CCRVDF:
(i) elaborates principles for evaluating their safety and for
quantifying their risks;
(ii) establishes ADIs and other guidance values for acute exposure
(iii) recommends maximum residue limits (MRLs) for target
tissues; and
(iv) determines appropriate criteria for and evaluates methods of
analysis for detecting and/or quantifying residues in food. 29
Collaboration between OIE
and Codex Alimentarius

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Collaboration between OIE and Codex
alimentarius

No formal agreement with Codex

Separate Agreement between OIE and FAO

and OIE and WHO (2004)

Current Status of OIE in Codex: Observer

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Codex task Force http://codextfamr.kfda.go.kr

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Codex task Force on antimicrobial
resistance (TFAMR)

3 meetings since 2007

Development of scientific standards

Reflect the basic principles of risk analysis

issued by other international organisations
such as OIE, FAO and WHO

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CONCLUSION

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Conclusion

International standards are useful tools for

countries to be used
• Public health
• International trade

OIE cooperates actively with Codex in the field

of Veterinary medicine particularly in CCRVDF
and in Codex Task force on antimicrobial
resistance

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 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: [email protected]
Web Site: http://www.oie.int

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