title: Risk assessment related to veterinary biologicals: specific issues in developing nations.
abstract: The author reviews both technical and socio-economic issues in developing nations, in relation to veterinary biologicals. Health risk assessment is a specific process to estimate the likelihood that animals, humans or ecological systems will be affected adversely by a chemical or physical agent, or biological product, under a specific set of conditions. Some technical issues (quality assurance, good manufacturing practice, education of end-users, field monitoring) apply equally well in developed, industrialised and in developing, pre-industrialised nations. Many regions have documented unique diseases (trypanosomosis, tick diseases, theileriosis) or high disease prevalence which may influence risk assessment results. This emphasises the need for scientifically-valid risk assessment methodologies in developing nations. Developing nations also have various socio-economic concerns, which may not be based on scientific fact but, nonetheless, affect trade in, and use of, veterinary biologicals. These non-scientific but perceived problems and issues are briefly discussed, and possible solutions are presented. The way in which countries deal with such perceived problems and issues in a context of internationally harmonised norms for risk assessment impinges on livestock farmers in developing nations. Finally, the author presents possible ways to correct the potentially widening cost gap between conventional, proven veterinary biologicals and newly-developed products. The results of risk assessment of veterinary biologicals influence risk management in both developed and less-developed nations. It is important to agree upon scientifically-based risk management guidelines which may be applied in all countries. The effect of the agreements of the Uruguay Round of the General Agreement on Tariffs and Trade on trade in veterinary biologicals in developing nations is reviewed.
authors.affiliation: Food and Agriculture Organisation, Animal Production and Health Division, Rome, Italy.
authors.forename: D E
authors.initials: DE
authors.lastname: Ward
mesh_terms: D000818:Animals; D001688:Biological Products / Q000009:adverse effects* / Q000191:economics / Q000592:standards / Q000600:supply & distribution; D003906:Developing Countries; D006801:Humans; D007107:Immune System / Q000503:physiopathology; D007391:International Cooperation; D011786:Quality Control; D018570:Risk Assessment; D014730:Veterinary Medicine / Q000191:economics / Q000592:standards*
chemical_list: D001688:Biological Products