Bruckner_141-146.indd INTRODUCTION The creation of the Office International des Epi zo o- ties (OIE) as an independent inter-governmental international organisation in 1924, offered the inter- national community well before the creation of the United Nations (OIE 2008a), a totally new and much needed international decision-making forum to guard against the regional and global spread of infectious and trade sensitive animal diseases and zoonosis. From the 28 founding countries, membership has since grown to 172 countries and territories. Known today as the World Organisation for Animal Health, the initial objectives of the OIE remain just as rele- vant as when it was founded. These objectives have been expanded through the years to encompass the overall objective of promoting global animal health. In 1994, the World Trade Organization (WTO) man- dated the OIE as the international reference organi- sation for international standards, guidelines and recommendations related to global animal health with the main purpose of facilitating international trade in terrestrial and aquatic animals and their products and to avoid the introduction of pathogens via international trade in animals and animal prod- ucts, while at the same time preventing countries from setting up unjustified sanitary barriers to inhib- it trade (WTO 1995). The OIE in pursuance of this mandate has also initi- ated several other measures to facilitate the inter- national trade in terrestrial and aquatic animals and their products, the most important being to assist members to identify their needs for veterinary serv- 141 Onderstepoort Journal of Veterinary Research, 76:141–146 (2009) The role of the World Organisation for Animal Health (OIE) to facilitate the international trade in animals and animal products G.K. BRÜCKNER World Organisation for Animal Health (OIE), 12 Rue de Prony 75017, Paris, France ABSTRACT BRÜCKNER, G.K. 2009. The role of the World Organisation for Animal Health (OIE) to facilitate the international trade in animals and animal products. Onderstepoort Journal of Veterinary Research, 76:141–146 The international trade in animals and animal products has become a sensitive issue for both devel- oped and developing countries by posing an important risk for the international spread of animal and human pathogens whilst at the same time being an essential activity to ensure world-wide food secu- rity and food safety. The OIE has since its founding in 1924, applied a democratic and transparent decision-making process to continuously develop and review international standards for animal health and zoonoses to facilitate trade in animals and animal products. The role of the OIE is also mandated by the World Trade Organization (WTO) as international reference point for standards related to ani- mal health. In support of its overall objective of promoting animal health world-wide, the OIE has also launched several other initiatives such as the improvement of the governance of veterinary services within its member countries and territories and to enhance the availability of diagnostic and scientific expertise on a more even global geographical distribution. Several trade facilitating concepts such as country, zonal and compartment freedom from disease as well the trade in disease free commodities has been introduced to enhance the trade in animals and animal products for all its members includ- ing those from developing and transitional countries who are still in the process of enhancing to full compliance with international sanitary standards. 142 OIE to facilitate international trade in animals and animal products ice delivery to progress towards compliance with OIE international standards. THE OIE INTERNAL STANDARDS, GUIDELINES AND RECOMMENDATIONS FOR ANIMAL AND AQUATIC HEALTH The negotiation process between importing and ex- porting countries to initiate the trade in animals and animal products is usually underpinned by the mu- tual understanding between trade partners that trade would be accepted or allowed by the import- ing country if the exporting country can give accept- able sanitary guarantees to protect animal and hu- man health in accordance with the appropriate level of sanitary protection determined and required by the importing country for importing that specific ani- mal or animal product. To facilitate the negotiation process and to discour- age importing countries to insist on sanitary guaran- tees from exporting countries that would inhibit or prevent trade or to require sanitary requirements that are not scientifically justifiable, the WTO has for this very reason mandated the OIE within the San i- tary and Phytosanitary Agreement (SPS Agreement) of the WTO, as the international reference organiza- tion for setting standards for the international trade in animals and animal products. A similar man date was given in terms of the SPS Agreement to the Codex Alimentarius Commission (Codex) for food safety and the International Plant Protection Con vention (IPPC) for matters related to plant health. Some of the key principles within the SPS Agreement are that standards set by the OIE should be science based and must be such that the main aim would be to protect animal and human health without imposing unattainable conditions for trade. Countries that are signatories to the SPS Agreement and who are also members of the OIE are obliged to honor this important requirement in trade negotiations (Brück ner 2004). Countries are therefore encouraged to apply the minimum stand- ards, guidelines and recom mendations set by the OIE and wherever possible incorporate it into their national legislation. Should a standard required by an importing country be higher than that required in the OIE standards recommended for trade purpos- es, it must be scientifically justified and based on a risk assessment on the importing commodity (WTO 1995). OIE standards are by default already the out- come of a risk assessment and need in general not again be subjected to a risk assessment for trade purposes. The Terrestrial Animal Health Code and the Aquatic Animal Health Code of the OIE contain the stand- ards to be applied in the international trade in ter- restrial and aquatic animals and their products. These standards are democratically adopted by the members of the OIE after been debated by special- ist ad hoc groups under guidance of the OIE Spe- cialist Com missions: the Scientific Commission for Animal Dis eases, the Biological Standards Com mis- sion, the Aqua tic Animal Health Standards Com mis- sion and the Terrestrial Animal Health Standards Commis sion. Standards are revised and updated on a continuous basis. The companion complemen- tary volumes, the OIE Manual of Diag nostic Tests and Vac cines for Terrestrial Animals (OIE 2008b) and the similar manual for aquatic animals, specify reference techniques for diagnosing animal diseas- es, tests that are prescribed and recommended for trade purposes, and export certification and quality requirements for vaccines for specific animal dis- eases. While the focus of this paper will mainly be on animal health issues related to terrestrial ani- mals, the same principles apply to aquatic animals. OIE standards reflect a horizontal and a vertical di- mension. The horizontal standards are described in Volume I and vertical standards in Volume II of the 2008 edition of the Code. Horizontal standards are those describing generic aspects, such as ethics in international trade or the quality of national Veter i- nary Services, a sine qua non condition for import- ing countries to trust the reliability of health certifi- cates accompanying consignments of animals and products in cross-border trade. These certificates must be issued exclusively by the veterinary serv- ices under the full responsibility of the government of the exporting country. Other guidelines and rec- ommendations to facilitate trade are also described in the Code such as procedures for pathogen inac- tivation; disposal of carcasses and dead animals; recommendations for disinfection, transport of ani- mals by land, air or sea; identification and traceabil- ity of animals and products; requirements for border control and quarantine station; import risk analysis; equivalence; obligations and ethics in international trade; zoning and compartmentalisation; transfer of biological material and other animal welfare consid- erations such as slaughter of animals. Vertical standards are those describing specific rec- ommendations for each of the OIE listed animal dis- eases and zoonoses. The focus is on the animal health situation in the exporting country and as- sumes that either the disease is not present in the importing country or is the subject of a control or 143 G.K. BRÜCKNER eradication programme. These standards specify for each disease an incubation period based on a safe risk mitigation waiting period for trade purposes; the commodities that can be traded irrespective of the disease status of a country for that specific disease; the requirements to certify a country, zone or com- partment free from that disease and the risk mitiga- tion measures than can be applied by the exporting country or required by an importing country before an animal or product is imported. General surveil- lance guidelines are described that could be applied for most diseases but for some diseases such as foot-and-mouth disease (FMD), highly pathogenic avian influenza and bluetongue, specific surveil- lance guidelines have been developed to prove ab- sence of the circulating pathogen or to confirm claims for freedom from disease. The OIE offers a voluntary dispute settlement mech- anism for mediating trade conflicts between OIE members. This is a science-based approach for find ing alternative solutions and resolving differenc- es, as distinct from the legalistic approach used in the formal WTO system. The role of the OIE is to assist the parties to arrive at a scientifically sound conclusion. OIE standards are developed on the basis of a high- ly meticulous risk analysis taking into account the fact there is no such thing as zero risk. The wealth and range of the standards published in this way enable importing countries to reduce the use of sometimes arbitrary risk analysis methods, and to favour a systematic use of OIE standards, as re- commended in the SPS Agreement (WTO 1995). TRADE FACILITATING INITIATIVES BY THE OIE OTHER THAN THE PROVISION OF INTERNATIONAL STANDARDS, RECOMMENDATIONS AND GUIDELINES More than 70 % of the 172 current members of the OIE are from developing and transitional countries. It would therefore be naïve to accept that all mem- bers of the OIE would have equal opportunities, ca- pacity, expertise, financial means, infrastructure and level of veterinary service delivery to also equally apply these standards. The OIE also fully realizes that the disease situation varies from country to country and that for some it would be much easier to give assurances of disease freedom or absence of disease than for others. More than 70 % of the current OIE listed diseases still occur for example on the African continent—either sporadically or in an endemic form while in some countries in the northern hemisphere, only five to ten of these dis- eases might still be present (Erlacher-Vindel, Brück- ner & Vallat 2007). Evaluation of veterinary service delivery To assist those members who have indicated the wish to know their current level of performance in applying international standards for veterinary serv- ice delivery, the OIE has initiated a process to as- sess the performance of the veterinary services of countries to identify their needs in eventually mov- ing towards compliance with OIE standards. This process known as the PVS evaluation process, ap- plies a specific methodology where trained OIE ex- perts visit countries wishing to be evaluated. The focus of the evaluation is on assessing performance of the country within the context of specific critical components for veterinary service delivery: human, physical and financial resources; technical authority and capability; interaction with stakeholders and ac- cess to markets. The level of advancement of a country is assessed in detail in respect of the critical competencies within each of these four compo- nents. An initial PVS evaluation is ideally followed by either a second evaluation or a more detailed gap analysis to assess the financial and other re- sources needed to advance within the critical com- petencies of each component. More than a diag- nostic instrument, the OIE PVS tool promotes a culture of raising awareness and continual improve- ment, which can be used either passively or actively depending on the level of interest, priorities and commitment of the veterinary services and its stake- holders. In the passive mode, the OIE PVS tool helps to raise awareness and improve the under- standing of all sectors including other administra- tions regarding the fundamental components and critical competencies the veterinary services must have in order to function effectively (OIE 2008a). The active mode is where the maximum outcomes are realised but this mode requires a sustained commitment by both the public and private sectors. In this mode, performance is assessed, differences are explored and priorities are established, strategic actions are outlined, investments are evaluated and agreed to, and commitments made and implement- ed. Continuity of this process requires a true part- nership between the public and the private sectors. Leadership on the part of the public sector is a fun- damental and critical determinant of success. According to G. Funes (personal communication 2008) of the current 172 members of the OIE, 80 countries have to date requested to be subjected to 144 OIE to facilitate international trade in animals and animal products a PVS evaluation with 36 (21 %) from Africa repre- senting 70 % of the current 52 countries in Africa that are members of the OIE. Improvement of veterinary diagnostic capacity Integral to the PVS assessment process, is the iden- tification of the need to establish scientific and tech- nological expertise within these countries to enable them to become self-sufficient in the early detection and diagnosis of diseases and to be able to provide the scientific justification for certification of animals and animal products for trade. The OIE, realising that the majority of its 177 reference laboratories and 29 collaborating centres and expertise are lo- cated mostly in developed countries in the northern hemisphere, accepted that this ideal can only be achieved by actively moving towards scientific ca- pacity building with the eventual aim of establishing focal points of expertise and more reference labora- tories within developing countries. To enable the realisation of this ideal, the concept of twinning be- tween laboratories was born, the aim of which is to ensure eventually an even global geographical dis- tribution of expertise and reference laboratories al- lowing easier access to experts and for the rapid detection and diagnosis of disease. The principle of the twinning initiative is that an agreement is reached between a candidate laboratory in a developing country and a parent OIE reference laboratory or OIE collaborating centre for which the parent labo- ratory over a specified period helps the candidate laboratory to acquire the necessary expertise to eventually be able to qualify to become a designat- ed OIE reference laboratory for a particular disease. The OIE has obtained substantial donor support to facilitate and fund this process (Erlacher-Vindel et al. 2007). In some instances, countries, due to the lack of re- sources and scientific expertise, are prone to ex- ploitation in trade related issues such as the impos- ing of a ban on all imports from a country that has notified an outbreak of an OIE listed disease. Such a decision taken by some members to impose a to- tal ban on imports of animals and products without referring to the relevant provisions of the Code for these commodities is unacceptable. Though this approach is acknowledged for the few days it might take while awaiting more precise information on the animal health situation in the affected country, it should rapidly be replaced by protection measures based on OIE standards and recommendations for each of the commodities concerned. It is therefore important to acknowledge that developing and in- transition countries need a veterinary scientific com- munity that is able to participate in the preparation of standards and to obtain the necessary expertise to challenge non-justifiable trade restrictions. To this end, the twinning concept will create the much needed opportunities to enable developing and in- transition countries to become scientifically compe- tent to debate on an equal footing the scientific jus- tification and application of standards. The concepts of disease-free countries, zones, compartments and commodities as trade facilitating measures Since the early 1990s, the OIE has been given by the International Committee, composed of the del- egates of the OIE member countries, the responsi- bility of compiling a list of member countries or zones that are officially recognised as being free from cer- tain diseases (OIE 2008a). For this purpose, a clearly defined and impartial procedure for declar- ing a member country free from a disease was iden- tified. In May 1995 a new procedure was adopted by the International Committee giving a mandate to the OIE Scientific Commission for Animal Diseases to examine in detail dossiers submitted by the del- egates of member countries in support of a claim that their countries or zones within their countries could be considered free of FMD in accordance with the provisions of the Terrestrial Animal Health Code. In 1996 the first official list of OIE member countries that were FMD free without using vaccination was published after adoption by the International Com- mittee. This process has been expanded to also include rinderpest, contagious bovine pleuropneu- monia (CBPP) and bovine spongiform encepha- lopathy (BSE) (OIE 2008a). However, it also became evident that country free- dom due to factors such as high maintenance costs was not attainable and sustainable by all OIE mem- bers. This realisation resulted in the introduction of the concept where zones within an infected country could be officially recognised free from disease— with or without vaccination (Brückner 2004). This process was again later refined to further facilitate trade from countries for which the achievement of neither country freedom nor zonal freedom was possible by introducing the concept of compartmen- talisation. While the maintenance of either country or zonal freedom is based on maintaining separa- tion of populations of different health status through mainly geographic entities, the concept of compart- mentalisation is based on ensuring the disease free status of an establishment through the application 145 G.K. BRÜCKNER of strict bio-security management practices. The concept of compartmentalisation is not a totally new concept as in certain countries in Africa and also elsewhere in the world, the principle of separating animal populations of different health status through bio-security management practices, was already applied for many years for diseases such as African swine fever and bovine tuberculosis. The OIE fully recognises and acknowledges that advancements in science, new knowledge on the epidemiology of diseases and risk mitigation meas- ures that can be applied to render products of ani- mal origin safe from disease, allows for acceptance of the concept that for certain diseases and certain animal products, a specific animal product or com- modity could under certain provisions be certified safe for trade purposes. This could even be applied in the event where a certain disease is present in a country but where a specific animal product does not pose a risk for transmitting that disease. The concept of safe commodity trade has therefore al- ready been incorporated into the Code where for example milk and milk products, semen, hides and skins, gelatin and collagen from hides and skins and deboned skeletal muscle from cattle under 30 months can be traded without restriction from a country infected with BSE (OIE 2008a). The same principle is also applicable for deboned bovine meat that has undergone maturation and allowing for a lowering in pH below 6 to render it safe from FMD virus. Further research is needed to expand this concept as a trade facilitating measure for other OIE listed diseases. The application of this concept ei- ther on its own or in combination with either compart- mentalisation or zonal freedom from disease would especially facilitate trade from those countries for which country or zonal freedom is not a sustainable option. To promote the development of this concept, the OIE will continue to encourage agrifood indus- tries and research institutions to further the devel- opment of research programmes on unresolved is- sues of major importance to the development of world trade. A better knowledge for example of the conditions under which the FMD virus survives or is killed during the meat maturing process might well have a major impact on the normative provisions and the way in which OIE members apply the stand- ards contained in the Code chapter on FMD. This is an important issue, given that more than 100 OIE members are still infected with this disease. It would however, be naïve and irresponsible to adopt an approach based solely on the systematic inactivation of pathogens in products, which could result in members relaxing surveillance activities for animal diseases and policies on the prevention and control of potential biological disasters. The positive impact of animal health policies on poverty reduc- tion and public health is in itself ample justification for financing and maintaining surveillance networks and rapid response mechanisms to deal with animal health threats and risks. To guarantee the effectiveness of surveillance at the national, regional and worldwide level, a non- negotiable pre-requisite is for all members to com- ply with OIE standards on the quality and evaluation of veterinary services. In addition to their surveil- lance mission, the veterinary services are also re- sponsible for the reliability of the veterinary certifi- cates they issue. These certificates accompany every consignment of animals or animal products transported in international trade globally. Com pli- ance with OIE standards for quality of the veterinary services of a country ensures that these certificates are issued under conditions that guarantee their re- liability, so that granting access to regional and glo- bal markets for all will not pose a threat to the safety of international trade. CONCLUSION Developing countries are increasingly coming un- der pressure to improve their delivery of veterinary services as a prerequisite for entering the competi- tive arena of international trade in animals and ani- mal products. The demands placed on developing countries by predominantly developed countries to comply with international disease prevention stand- ards have also resulted in increasing demands on the financial, human and technological resources of these developing countries. The OIE in pursuance of its mandate offered in the Agreement on the Application of Sanitary and Phyto- sanitary Measures of the WTO and the mandate given to the OIE by its International Committee is committed to facilitate and promote as far as possi- ble within its resources, the international trade in animals and animal products for all its members. Achieving this goal does not allow for shortcuts, will take time and demands a rational and scientific ap- proach for future decision-making. Realising that compliance with OIE standards, guidelines and rec- ommendations are not immediately achievable by all, the exploitation of and research into still more alternatives to facilitate trade without sacrificing the importance of good veterinary governance and the need for eventual compliance with standards, offers 146 OIE to facilitate international trade in animals and animal products a major challenge to not only the OIE but to all inter- national organisations seeking a more liberalized trading environment and market access for all. REFERENCES BRÜCKNER, G.K. 2004. Working towards compliance with inter- national standards. Revue Scientifique et Technique, OIE, 23:95–107. BRÜCKNER, G.K., LINNANE, S. & DIAZ, F. 2007. Responses to a questionnaire on networking between OIE Reference Labora tories and OIE Collaborating Centres, in First Inter- national Conference of OIE Reference Laboratories and Collaborating Centres, edited by M. Lombard & B. Dodet. Developmental Biology, 128:77–82. OIE 2008a. Terrestrial Animal Health Code, 17th ed. Paris: Office International des Epizooties. OIE 2008b. Manual of diagnostic tests and vaccines for terres- trial animals, 6th ed. Paris: Office International des Epi zoo- ties. ERLACHER-VINDEL, E., BRÜCKNER, G.K. & VALLAT, B. 2007. The OIE concept of Laboratory Twinning, in First International Conference of OIE Reference Laboratories and Collaborating Centres, edited by M. Lombard & B. Dodet. Developmental Biology, 128:119–123. WTO 1995.The results of the Uruguay round of multilateral trade negotiations: the legal texts: agreement on the application of disease control and phytosanitary measures. 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