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) :

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

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

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

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

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

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 2011-2015: consolidation

Trends in Global Population 70 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: 1950-2015 Source: US Bureau of the Census Source : Center for Disease Control and Prevention (CDC) Atlanta

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

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

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

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

OIE International Standards available on the OIE website (www.oie.int) 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

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

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 http://web.oie.int/downld/Antimicrobials/OIE_list_antimicrobials.pdf

OIE International collaboration International meetings on antimicrobial resistance: Joint FAO/WHO/OIE expert consultations since 2003 CODEX Task Force on Antimicrobial Resistance: 2006-2010 (Republic of Korea) Committee on residues on Veterinary Drugs

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 : www.oie.int] 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

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 : www.oie.int] 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

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

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

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

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

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

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

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

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

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

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

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

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

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.

Modernisation or updating of national legislation OIE Guidelines for Veterinary Legislation Essential elements to be covered in veterinary legislation (http://www.oie.int/fileadmin/Home/eng/Support_to_OIE_Members/docs/pdf/A_Guidelines_VetLeg.pdf) First OIE Global Conference on Veterinary Legislation: Djerba (Tunisia), 7-9 December 2010 Recommendations (http://www.oie.int/fileadmin/Home/eng/Conferences_Events/docs/pdf/recommendations/ANG_Recommendations.pdf)

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

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

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.

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