International harmonization of standards for diagnostic tests and vaccines: role of the Office International des Epizooties (OIE).

The OIE is recognized as the world organization for animal health. Serving 145 member countries, the OIE provides current information on disease occurrence, coordinates studies on disease surveillance and control, and harmonizes regulations for trade in animals and animal products. This paper focuses on the role of one the OIE's specialist commissions, the Standards Commission. The Standards Commission works in close collaboration with the Scientific and Technical Department of the OIE's Central Bureau on the international harmonization of standards for diagnostic tests and vaccines. The Manual of Standards for Diagnostic Tests and Vaccines, approved by the International Committee, defines the international standards for diagnostic tests and for the production of biological products as applied to mammals, birds, and bees. The Manual lists and details those tests which are prescribed for international trade and others which are suitable for bilateral trade agreements. The Manual represents one of the key scientific and technical references for harmonization of regulations for trade in animals and animal products. The commission coordinates the activities of a network of some 110 OIE reference laboratories and six collaborating centers. By creating and nurturing this network, international harmonization is promoted through the sharing of knowledge and the establishment of collaborative projects related to methods development and standardization, production and distribution of international reference standards, quality assurance, and assay validation. Through a series of guidelines provided to participants, the commission ensures the quality and focus of these projects. In matters of a scientific and technical nature concerning diagnostic tests and vaccines, the Standards Commission collaborates with other international organizations such as the FAO, WHO, IICA, and PAHO, thus promoting harmonization at the international program level. Underscoring the important role of the OIE at this level, the Sanitary and Phytosanitary Agreement of the World Trade Organization, as included in the Marrakech agreement (1994), specifically recommends the use of standards, guidelines, and recommendations developed under the auspices of the OIE in order to promote harmonization of regulations for trade in animals and animal products.