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In 1995, the World Trade Organisation (WTO) implemented the Agreement on the Application of Sanitary and Phyto-Sanitary Measures (SPS Agreement) to define the conditions under which countries can impose sanitary conditions on imports of animal and animal and plant products. This Agreement is intended to promote international trade by requiring all member states to use only international standards for reducing disease risks associated with imported products. For animals and animal products, the Agreement identifies the guidelines and recommendations established by the Office International des Epizooties (OIE) as the appropriate and preferred international standard. However, the Agreement also allows governments to use standards developed by other relevant international organisations whose membership is open to all WTO members, or to use higher standards if an appropriate risk assessment provides adequate scientific justification.

In Europe, EU Member States have agreed common standards for the health conditions applying to intra-Community trade in aquaculture animals and their products, based on those recommended by OIE. Countries in the Asia-Pacific Region may also wish to agree on common standards of diagnostic and health assurance tests. However, if international standards established in a particular region differ significantly from those recommended by the OIE, trade with countries outside the region may be adversely affected. For example, if the standard adopted in a region is lower than the OIE standard, countries which apply the OIE standards could rightly refuse imports on the basis that they have insufficient health guarantees. Conversely, if the standard agreed in a region is higher than those of OIE, the same standard must be applied to imports from other regions, to ensure equivalence and protection of the regional health situation. Furthermore, if an individual country adopts higher health protection standards, the SPS Agreement requires scientific justification based on import risk assessment. For diseases not listed by the OIE, trading countries may agree on any mutually acceptable standards.

If a regional training and laboratory accreditation program for molecular diagnosis is to be established in the Asia-Pacific region, the adoption of tests recommended in the OIE Diagnostic Manual for Aquatic Animal Diseases would assist in achieving universally agreed standards. However, as the Manual is revised only every 3 years or so, better methods may emerge from research before the next edition is published. In considering a case for adoption of new molecular diagnostic methods, the suitability must be rigorously assessed in consultation with independent experts. Acceptance is more likely if the method has been published, has received wide scientific acceptance and has been standardised, and preferably validated, in comparison with other standardised methods.

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