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Gideon Brückner Deputy Director General

Gideon Brückner Deputy Director General. The role of good veterinary governance for harmonisation of the registration, distribution and quality control over veterinary medicinal products in Africa. OIE CONFERENCE ON VETERINARY MEDICINAL PRODUCTS DAKAR, SENEGAL, 25 – 27 MARCH 2008.

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Gideon Brückner Deputy Director General

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  1. Gideon Brückner Deputy Director General The role of good veterinary governance for harmonisation of the registration, distribution and quality control over veterinary medicinal products in Africa OIE CONFERENCE ON VETERINARY MEDICINAL PRODUCTS DAKAR, SENEGAL, 25 – 27 MARCH 2008

  2. Established in 1924: 172 Members • Intergovernmental organisation – predates the UN • Permanent Regional Representations: Bamako (Mali), Buenos Aires (Argentina), Tokyo (Japan), Sofia (Bulgaria) and Beirut (Lebanon) • Sub-regional Offices: Bangkok (Thailand), Gaborone (Botswana), Panama, Brussels (Belgium) • Regional Commissions: Africa, America, Asia-Pacific, Europe and Middle East World Organisation for Animal Health (OIE) 50 13 29 28 52

  3. OIE MANDATE Historical: ‘To prevent animal diseases from spreading around the world’ The 4th Strategic Plan 2006/2010 extends the OIE’s global mandate to: ‘The improvement of animal health all around the world’

  4. Chapter 1.1.9 International standards, guidelines and recommendations • Terrestrial Animal Health Code • Aquatic Animal Health Code • Manual of Diagnostic Tests and Vaccines for Terrestrial Animals • Manual of Diagnostic Tests for Aquatic Animals Mandated in SPS Agreement of WTO

  5. Good governance – veterinary services Ensuring Good Governance to Address Emerging and Re-emerging Animal Disease Threats Supporting the Veterinary Services of Developing Countries to meet OIE International Standards on Quality Mechanisms and strategies at Global, Regional and National levels

  6. Use of veterinary medicinal products integral to animal disease control in Africa • At least 90% of OIE listed diseases in Africa • High circulation of illegal/counterfeit products • Outdated legislation • Insufficient standards • Division of responsibilities between Ministries • Urgent need for quality control • Need for harmonised market authorisation

  7. Veterinary services – the essential buffer mechanism and guarantee of control Animal health Veterinary Services Control Over Veterinary Medicinal Products Animal Disease Zoonosis Human health Poverty Food security Lack of trade

  8. Evaluation of veterinary services OIE methodology for the evaluation of the performance of veterinary services : PVS - tool

  9. Progress with PVS program

  10. What is the OIE-PVS Tool? • An assessment tool on level of compliance with international standards on Quality and Evaluation of Veterinary Services • Standards mandated in SPS Agreement of WTO • Chapter 1.3.3.: Evaluation of Veterinary Services • Chapter 1.3.4.: Guidelines for the Evaluation of VS

  11. USE OF OIE-PVS • evaluation performed by internal (self evaluation) and/or OIE experts (external evaluation • assessing the performance of VS • process reviewed on a regular basis to monitor improvements

  12. OIE PVS certified experts • 4 Training Sessions (May and July ’06, February ’07 and February ’08) • +140 OIE Certified experts (including 13 FAO Staff) • List of OIE PVS certified experts sent to donors (World Bank) • In Africa: requests 33 – completed evaluations 26 • Gap Analysis to be developed in collaboration with FAO in several countries

  13. OIE PVS TOOL 4 Focal components reflecting service delivery • Human, physical and financial resources • Technical authority and capability • Interaction with stakeholders • Access to markets

  14. OIE PVS TOOL 6 - 12 critical competencies in each focal component I) Human, physical and financial resources • Professional and technical staffing • Competencies of veterinarians and veterinary para-professionals • Physical resources • Funding……

  15. 5 levels of advancement OIE PVS TOOL 4 fundamental components Critical competencies (6 - 12)

  16. OIE PVS TOOL • 5 levels of advancement (qualitative) for each critical competency Level 5full compliance with OIE standards • A higher level assumes compliance with all preceding levels Level 1 No compliance

  17. CHAPTER II - TECHNICAL AUTHORITY AND CAPABILITY The authority and capability of the VS to develop and apply sanitary measures and science-based procedures supporting those measures. Critical competencies: Section II-1 Veterinary laboratory diagnosis Section II-2 Laboratory quality assurance Section II-3 Risk analysis Section II-4 Quarantine and border security Section II-5 Epidemiological surveillance Section II-6 Early detection and emergency response Section II-7 Disease prevention, control and eradication Section II-8 Veterinary public health and food safety Section II-9 Veterinary medicines and veterinary biologicals Section II-10 Residue testing Section II-11 Emerging issues Section II-12 Technical innovation

  18. Critical issues in Africa to facilitate harmonisation of registration, distribution and quality control • Legal control over: • Registration • Importation • Standards – use/conformity/compliance • Distribution • Sales • Quality control • Monitoring – including residues • Implementation of legislation – funds & staff • Regional harmonisation

  19. Role of OIE • Setting the standards* • Evaluate shortcomings in application of OIE standards - PVS • Provide expertise (OIE Reference Laboratories & Collaborating Centres, conferences) • Propose and adopt Resolutions by International Committee to facilitate common committment and ‘buy-in’ • Facilitate donor funding • Can not perform an inspection or policing function

  20. OIE Standards • Not set by OIE Director General or OIE Central Bureau • OIE Standards are proposed and eventually adopted by OIE Delegates = International Committee • Adoption implies taking ownership and committment to compliance and where possible, include into national legislation

  21. Role of OIE • Setting the standards • Evaluate shortcomings in application of OIE standards - PVS • Provide expertise (OIE Reference Laboratories & Collaborating Centres, conferences) • Propose and adopt Resolutions by International Committee to facilitate common committment and ‘buy-in’ • Facilitate donor funding • Can not perform an inspection or policing function

  22. Role players in good governance of veterinary medicinal products

  23. There are already some good systems in place in Africa for veterinary medicinal products …Good veterinary governance to include the following will help us to move forward Regulation Registration Harmonisation Inspection

  24. Thank you for your attention World Organisation for Animal Health 12 rue de Prony 75017 Paris, France Tel: 33 (0)1 44 15 18 88 Fax: 33 (0)1 42 67 09 87 Email: oie@oie.int http://www.oie.int

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