The OIE judgement of equivalence

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Presentation by Dr Gideon Brückner, President of the OIE Scientific Commission for Animal Diseases, at the Enhancing safe inter-regional livestock trade workshop held at Dubai, UAE, 13-16 June 2011

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The OIE judgement of equivalence

  1. 1. Enhancing safe inter- regional livestock trade Dubai, UAE 13 – 16 June 2011The OIE judgement of equivalence Gideon BrücknerPresident: OIE Scientific Commission for Animal Diseases 1
  2. 2. EQUIVALENCE - I take the high road and you take the low road
  3. 3. Some determinants of the international meat trade1• Difference in the resource base of countries• Preference for meat types and cuts• Extent of barriers to trade• Industry structure• Fluctuations in domestic demands and preferences• Future growth determined by: – Further liberalization of protectionist barriers – Eradication of animal diseases – Increased sensitivity on food safety – Economic development – Population growth 1 J. Dyke & K. Nelson (USDA, 2007)
  4. 4. Factors favouring international spread of animal diseases 4
  5. 5. Pathogen spread• Pathogens are transported around the world faster than the average incubation time of most animal diseases• There is no place in the world from which we are remote and no one from whom we are disconnected
  6. 6. What are the considerations ininternational trade negotiations from ananimal health equivalence perspective? 6
  7. 7. Key negotiating factor for the international trade in animals and animal productsThe acceptance of the sanitary guarantees of theexporting country and how closely it satisfies thedesired or appropriate level of protection forhuman and animal health and zoonosis of theimporting country 7
  8. 8. International standard-setting organisations animal health andfood safety plant health zoonoses CODEX IPPC OIE Codex = Codex Alimentarius Commission (FAO/WHO) OIE = World Organisation for Animal Health IPPC = International Plant Protection Convention (FAO) 8
  9. 9. WTO SPS Agreement (1995)• Legal framework for international trade• Recognises OIE as a reference organisation for international standards on animal and aquatic health
  10. 10. Terrestrial AnimalHealth Code of theOIE• To facilitate trade in animals and products while avoiding unjustified trade barriers• To support countries in the control of animal diseases and prevention of zoonoses
  11. 11. Using the Codes and Manuals  use the OIE Scientific and Technical Review and other sources to obtain background information  use the Codes to establish health requirements for trade  use the OIE Manuals to ensure the application of correct diagnostic tests and vaccines  use textbooks on diseases to understand the scientific justification for OIE standards  Code is not a textbook on animal diseases
  12. 12. How to use the OIE Code for an IRA on RiftValley Fever (Chapter 8.11) Consider the disease description in Code (infective period, species, epidemiology) Consider safe commodities (hides and skins, wool & fibre) Consider requirements for free zones, country Consider risk mitigations for trade (free country, infected country, different commodities) Consider the requirements of the OIE Manual for vaccines, diagnostic tests Consider the horizontal chapters (Vet services, IRA, certification) 12
  13. 13. Obligations of importing countries• Consider sanitary status exporting country• Choose an appropriate level of protection (ALOP)• Consider the sanitary guarantees offered by the exporting country• Conduct an import risk analysis when indicated
  14. 14. Obligations of exporting countries• Provide sanitary information as requested by the importing country• Inspection, certification by official veterinarian of importing country• Transparency in providing sanitary information
  15. 15. Acknowledgement of the principle of equivalence• Acceptance by importing country that sanitary measures applied in exporting country are appropriate (but may differ)• SPS Agreement (article 4) and OIE Code (chapter 5.3) encourage the recognition of equivalence
  16. 16. Import risk analysisAn import risk analysis has 4components • hazard identification • risk assessment • risk management • risk communication
  17. 17. Risk mitigation provisions in the OIE Terrrestrial Animal Health Code for the import of animals and animal productsApproach in OIE Code animal disease chapters:• Consist of 3 sections within each chapter• Description of disease – case definition• Criteria for being recognised as free – country, zone, compartment• Risk mitigation measures for trade - animals and their products – for import from both free and infected countries
  18. 18. Risk mitigation measures for trade - animals andtheir products – for import from both free and infectedcountries • Risk mitigation measures based on risk assessment • Code in itself do provide for the mimimum import requirements based on risk • If higher sanitary standards or ALOP required – then do additional import risk assesment 18
  19. 19. Facilitation for tradein beef from FMDinfected countries• Pre-abattoir risk mitigation – surveillance, quality of veterinary service delivery• Pre-slaughter risk mitigation at abattoir – ante-mortem inspection, verification of records• Post-slaughter risk mitigation • Detailed inspection • Removal of visible lymph nodes, risk material • Manual deboning • Chilling for 24 hours at pH <6 The OIE Code provides for the export of • pH monitoring animal and animal products from infected countries provided the risk mitigation measures for the inactivation of virus are applied
  20. 20. http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/
  21. 21. EQUIVALENCE(Art 5.3.2 Terr. Code)Context:•Different animal health and production systems among countries•Provision of equivalent animal and human health protectionConcerns for trade:•Manage risk appropriately - different options possible to achieve same level of protection Principles and step-wise process developed to facilitate judgementof equivalence 21
  22. 22. EQUIVALENCEBenefits of applying equivalence:• minimise costs by tailoring animal health measures• maximise animal health outcome for a given level of resource input• facilitate trade by achieving the required health protection through lesstrade restrictive sanitary measures• decrease reliance on costly commodity testing and isolation procedures OIE Code chapters recommend alternative measures for manydiseases/pathogenic agents 22
  23. 23. General considerationsRisk management in the importing country (post import) will rely in part onjudgements about: - animal health and production systems - effectiveness of sanitary procedures in the exporting country• Possible differences : - infrastructure - approaches to pests/diseases present - policies/operating procedures - border security - laboratory systems - internal movement controls.. 23
  24. 24. Prerequisite considerationsApplication of risk assessment=> examination of : - the effect of a measure on a particular step - relative effect of alternative measure(s) on same/related step=> need to define : - purpose of the measure - LOP achieved by the measure - contribution of the measure to achieve the ALOP 24
  25. 25. Prerequisite considerations• Categorisation of sanitary measures => sanitary measures can be applied : - alone or in combination - consecutively or concurrently => include : - test requirements - processing requirements - inspection or certification procedures - quarantine confinements -sampling procedures 25
  26. 26. Prerequisite considerations• Categorisation of sanitary measures (contd) Specific technical Infrastructure Programme design Legislative base requirements Administrative systems /implementation Use of secure facilities … Documentation of systems Treatment Performance Specific tests Decision criteria Procedures (e.g. pre-export Lab. capability inspection) Provision for certification Audit Enforcement Categories not mutually exclusive 26
  27. 27. Principles for judgment of equivalence• Importing country (IC) should: - set its ALOP - describe reason for each sanitary measure - enter into consultation with export. country if so requested - limit data collection to that necessary - evaluate submission: timely, objectively, consistently, transparently - consider request for technical assistance if developing country• Exporting country (EC) should: - demonstrate equivalence of proposed alternative sanitary measure - submission to import country should help to facilitate judgement of equivalence - enable evaluation of procedures/systems by importing country…Using OIE Standards 27
  28. 28. Steps in judgement of equivalenceRecommendations:EC request IC reason for sanitary measure in terms of ALOP + identifyalternative measures to propose IC answers EC demonstrates equivalence and answer any technical concern from IC IC judge, taking into account impact of biological variability and uncertainty, expected effect of alternative. measure(s) on relevant hazards IC notifies the EC of its judgement and reasons within reasonable period of time : recognition/further information/rejection 28
  29. 29. Conclusion - Equivalence• Integral to SPS Agreement• Guidelines on procedures / technical measures provided in OIE Codes/Manuals• Use of risk assessment• Possible use of OIE dispute mediation process to resolve differences of opinion• Measures accepted as part of a system of infrastructure, policies and procedures• Using different ways (roads) to arrive at the same goal (destination) 29
  30. 30. So what is equivalence all about? I take the high road and you take the low road
  31. 31. World organisation for animal healthOrganisation mondiale de la santé animaleOrganizacion Mundial de Sanidad Animal 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 31

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