Head of French Agency for Veterinary Medicinal Products ... · Antimicrobial agents as other veterinary medicinal products (VMPs) are veterinary tools, contributing to the improvement

World Organisation for Animal Health · Protecting animals, Preserving our future | 1

Dr Jean-Pierre OrandHead of French Agency for Veterinary Medicinal Products

OIE Collaborating Center for Veterinary Medicinal products

Combatting Antimicrobial resistance through a One Health approach:

Actions and OIE Strategy

Paris 24 May 2016

84th General Session


AMR – shared responsibility

Antimicrobial resistance (AMR) is not a new phenomenon, but concerns are growing

Antimicrobial agents are essential to ensure human health, animal health and welfare, and food security

The human, animal and plant sectors have a shared responsibility to prevent or minimise the development of antimicrobial resistance by both human and non-human pathogens.


One Health Approach

A holistic and coordinated management across the animal, food and human sectors in different ecosystems and geographic locations

Improved intersectoral collaboration where regulations of medicines are managed by different entities


FAO-OIE-WHO Tripartite Agreement/Vision

The Global Action Plan published by WHO in 2015 is a next step in the collaboration between WHO, FAO and OIE:- Tripartite approach, collective actions to fight

against AMR- Ensure that antimicrobials continue to be effective

and useful- Promote prudent and responsible use- Ensure global access to medicines of good quality


International Standards and Guidelines

Good Governance to ensure good quality and prudent use of antimicrobial agents

Surveillance and collection of data on the use of antimicrobial agents in animals

Capacity building and PVS tools

Communication

The OIE fully contributes to this strategy:


Point 1

International Standards and Guidelines


OIE Standards and GuidelinesWHO and FAO participate in the ad hoc Group on AMR

Terrestrial and Aquatic Code “Chapters” cover Harmonisation of national antimicrobial resistance

surveillance programmes Monitoring of the quantities and usage patterns Responsible and prudent use Risk assessment (linked to the use of antimicrobial

agents in animals) Veterinary legislation

Updated and adopted between 2012 and 2015

http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/


OIE Standard and Guidelines

Manual of Diagnostic Tests and Vaccines for Terrestrial Animals defines General Guidelines :

3.1. Laboratory methodologies forbacterial antimicrobial susceptibility Testing

revision will be needed in light of veterinary pathogen resistance surveillance

http://www.oie.int/en/international-standard-setting/terrestrial-manual/access-online/


OIE List of Antimicrobial Agents of Veterinary Importance

Updated in 2014 to take into account concerns for human health

For a number of antimicrobial agents there are no or few alternatives for the treatment of diseases in target species. Among the Veterinary Critically Important Antimicrobial Agents, some are also of critical importance for human health (third and fourth generation Cephalosporins, and Fluoroquinolones):

• Not to be used as preventive treatment in feed or water or in absence of clinical signs

• Not to be used as first line, unless justified and bacteriolgicaltest

• Extra label/off label limited and reserved for instances no alternatives are available.

http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/OIE_list_antimicrobials.pdf


Point 2

Good Governance to ensure good quality and prudent use of

antimicrobial agents


Good GovernanceBenefitsAntimicrobial agents as other veterinary medicinalproducts (VMPs) are veterinary tools, contributing to theimprovement of animal and public health worldwide, and toeconomic development

Risks Animal safety User safety Food safety Environmental safety Antimicrobial resistance

Good Governance for good quality, safety, efficacy

Manufacturer

Wholesaler

Retailerveterinarianspharmacist

others

Consumer

Antimicrobial chain

Farm

Importer

IllegalImport

CounterfeitingFalsification

Animal HealthZoonosis, decrease of

production

EnvironmentPollution

efficacy toxicity

residue

Manufacturer

Wholesaler

Retailerveterinarianspharmacist

others

Authorisation: antimicrobials, premisesand activities

Farm

Importer

LicenseFor activity

Transparency :- Official list of

the premises- website

Good practices :- Conditions of manufacturing- Traceability- Conditions of Storage- Conditions of deliverance

GMPGDP

Registrationof Antimicrobials


VICH =International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VMPs)

Canada

Observers

Full Members

OIE : Associate Member, IFAH : Secretariat

Outreach Forum

14

Registration of VMPs harmonisation


Role and benefits of VICH

• To harmonise technical requirements for data necessary for registration

• Use of internationally harmonised guidelines to: Increase availability of new Veterinary Medicinal

Products, facilitate and accelerate their authorisation, Ensure safe, efficient products of good quality, Reduce animal testing and costs of development Contribute to public/animal health, environment

Manufacturer

Wholesaler

RetailerveterinariansPharmacist

others

Control of Antimicrobials

Farm

Importer

Control of :- Antimicrobials are authorised- Traceability- Conditions of Storage- Conditions of deliverance

InspectionSampling

IllegalImport

CounterfeitingFalsification

Quality Control


Veterinarians play a crucial role with their responsibility in prescribing and delivering antimicrobial agents

Education of Veterinarians and paraprofessionnals

OIE ad hoc Group on Veterinary Education develop OIE Guidelines setting out minimum competencies required:• Best practices for antimicrobial agents

• Mechanism leading to AMR


Point 3

Surveillance and collection of data on the use of

antimicrobial agents in animal


Recommendations of the OIE Global Conferenceon the responsible and prudent use of antimicrobial

agents for animals

To the OIE Member Countries3. To develop and set up an official harmonised

national system for collecting data on the monitoring of antimicrobial resistance in relevant animal pathogens and quantities of antimicrobial agents used in food producing animals at the national level based on the OIE standards.

To the OIE7. To collect harmonised quantitative data on the

use of antimicrobial agents in animals with the view to establish a global database.


Supported by tripartite (FAO/OIE/WHO)

Developed and followed by ad hoc Group (WHO and FAO participate)

Tested in OIE National Focal Point Trainings

Part of Global Action Plan on AMR

Endorsed by OIE Delegates (Resolution No. 26 adopted in 2015)

OIE global database on the use of antimicrobial agents in animals


Status: OIE global database on the use of antimicrobial agents in animals

Phase One: questionnaire sent to Member Countries: October/November 2015

Training of OIE Regional and Sub‐regional technical contact points: October 2015

4th cycle National Focal Point training (Uganda,Japan, Senegal)

Ad hoc Group meeting: January and June 2016 Feedback to the OIE World Assembly: May 2016

global sustainable long-term investment


Baseline information [All]all OIE Member Countries (MCs) can provide at least part of the requested details

Three Reporting Options:

REPORTING OPTIONS

1 Overall amount sold for/used in animals by antimicrobial class; with the possibility to separate by type of use (therapeutic use / growth promoter)

2 Overall amount sold for/used in animals by antimicrobial class; with the possibility to separate by type of use and species group

3 Overall amount sold for/used in animals by antimicrobial class; with the possibility to separate by type of use, species group and route of administration

OIE Database on the use of antimicrobial agents


81,5

65,5

81,3

67,9

41,7

AFRICA AMERICA ASIA EUROPE MIDDLE EAST

Proportion of OIE Member Countries submitting questionnaires by OIE Region

44/5419/29

26/3236/53

5/12130 (72%)Member Countries responded


Completeness of Templates (global)

Baseline Information + Option

28%

23%

49%

No reply

Baseline Information onlyn=180


Reporting Options

n=89

32%

64%

3%33%

68%

BASELINEINFORMATION

OPTION 1

OPTION 2

OPTION 3

Quantitative

QualitativeData


Proportion of OIE Member Countries that authorise antimicrobial agents as growth promoters

YES = 34 NO = 96n=130

26%74%

YES NO

Decrease in % of countries that authorise growth promotors(49% in 2012)


42

9

33

61

11

7

17 17

IMPORTS MANUFACTUERS MARKETINGAUTHORISATIONS

HOLDERS

WHOLESALERS FEEDMANUFACTURES

USE VETERINARIANS PHARMACIE0

10

20

30

40

50

60

70

Global Data Source

n=89


84%

15%

1%

Oral Injection Other

Global Route of Administration

n=29


1,9% 0,9% 0,0% 0,3% 0,3% 0,1%

4,0%

0,0% 0,3% 1,1%

15,8%

0,1% 0,1% 0,1%

7,4%

0,5%

4,8%

0,1% 0,0%

7,3%

47,8%

0,6%

7,0%

0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

60,0%

First evaluation of the respective use of the antimicrobial classes

n=89


How the OIE global database will benefit Member Countries

The database will not only provide a solid foundation for the work of the three organisations in their fight against bacterial resistance, but the information gathered will also make it easier for Member Countries to:

• analyse and control the source of the veterinary products, • obtain more reliable information on imports, • trace their movements, and • better evaluate the quality of the products in circulation• to measure trends in the use of antimicrobial agents in

animals over time


Point 4

Capacity building and PVS tools


OIE support to Good Veterinary Governance

• Collaborating Centres

• Twinning

• PVS Evaluation

• Network of National Focal Points

• Standards and Guidelines

World Organisation for Animal Health · Protecting animals, Preserving our future | 33World Organisation for Animal Health · Protecting animals, Preserving our future | 33

Capacity Building, Specific Activities,

Projects and Programs

PVSGap Analysis

PVS Evaluation

PVS EvaluationFollow-Up Missions

Veterinary Legislation

Public / PrivatePartnerships

VeterinaryEducation

Laboratories

Diagnosis Prescription

Treatment

including Veterinary Services’ Strategic Priorities

The OIE collaborates with governments, donors and interested parties

PVS Pathway: A tool for evaluation of veterinary governance


Twinning Twinning Programme involves creating and supporting a

link that facilitates the exchange of knowledge, ideas and experience between two Veterinary entities

Method for improving institutional capacity in Member Countries

Ultimate aim is to create more centres of excellence for veterinary education/Labs in geographical areas that are currently under-represented

Twinning is part of the wider OIE initiative to improve the capacity of Veterinary Services; it therefore has synergy with the OIE PVS Pathway


National Focal Points for Veterinary Products

The OIE has launched a global programme of capacity building for OIE Delegates and OIE National Focal Points.

One of the objectives is to provide good governance concepts to the main actors of National Veterinary Services.

Among the elements of governance, the OIE grants great importance to the good management of veterinary products, from both animal and public health points of view.


Resolution No. 25 (2009) Recommendations to OIE Member Countries

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.


Establish a network of veterinary product experts within his/her country or communicate with existing network;

Establish and maintain a dialogue with the Competent Authority for veterinary products in his country, and to facilitate cooperation and communication among several authorities where responsibility is shared;

Terms of Reference: Specific tasks


OIE Relevant Collaborating Centres:

• ANSES (ANMV), Fougères, France

• NVAL, Tokyo, Japan

• FDA (CVM), Rockville, USA

• USDA, Ames, USA


Point 5

Communication


Communication on AMR

• AMR is a whole of society problem

• To promote behavioural changes needs awareness of all actors including consumers

• OIE actions for communication: – World Antibiotic Awareness: Free access material to facilitate

communication– Materials: Codes, Scientific and Technical Review, compilation of

OIE standards, guidelines and Resolution– International conferences– website


Information is available at the OIE website

41

Antibiotic Awareness Week

Access the WHO page dedicated to World Awareness Week 2015

http://www.oie.int/es/para-los-periodistas/amr-es/related-links-es/

http://www.oie.int/en/for-the-media/amr/waaw2015/


Communication and capacity building

The OIE Strategy regarding antimicrobial agents

Now available from www.oie.int/boutique

Product title: Antimicrobial resistance in animal and public health Scientific and Technical Review 31 (1)

Author(s): J. Acar & G. Moulin; Ed.: 2012

Summary :The focus of this Review is to address the various factors that must be taken into account when trying to understand the antimicrobial resistance problem, with a particular focus on the use of antimicrobials in animals.



Information is available at the OIE website

ANTIMICROBIAL RESISTANCE (AMR):

• http://www.oie.int/en/our-scientific-expertise/veterinary-products/antimicrobials/

• http://www.oie.int/en/for-the-media/amr/multimedia-ressources/

OIE Standards, Guidelines and Resolution on antimicrobial resistance and the use of antimicrobial agents

Author(s) : O IE; Ed. 2015

This special publication has been prepared to support the Global Action Plan on Antimicrobial Resistance (GAP-AMR) that WHO is developing in collaboration w ith FAO and OIE


Conclusion


Conclusion

AMR is a major public health concern

Awareness raising at all levels, AMR is a priority and the OIE developped several actions

to help control the risks: • Setting standards and guidelines• Implementation of capacity building programmes for better

governance with the aim of improved veterinary stewardship on veterinary products

• Surveillance and data collection on antimicrobial use in animals

• Awareness and communication


Conclusion

OIE seeks for support to enable Member Countries

to implement standards and recommendations

to build capacity and strengthen veterinary services

to establish national action plans


Conclusion

In line with the OIE Sixth Strategic Plan (2016 - 2020) and contributing to the Global Action Plan on AMR adopted in May 2015 , all OIE actions should be

compiled and presented as the

OIE Strategy on antimicrobial resistance


12, rue de Prony, 75017 Paris, France www.oie.int

[email protected] - [email protected]

Thank you for your attention

Jean-Pierre [email protected]

Documents

Head of French Agency for Veterinary Medicinal Products ... · Antimicrobial agents as other veterinary medicinal products (VMPs) are veterinary tools, contributing to the improvement