The current status of the debate on socio-economic regulatory assessments: Positions and policies in Canada, the USA, the EU and developing countries

Article 26.1 of the Cartagena Protocol on Biosafety has the option of considering socio-economic issues in biosafety regulatory approval processes related to genetically engineered organisms. National laws and regulations in some countries have already defined positions and may have enacted policies dealing with socio-economic assessments. Many more countries, especially developing countries, are building their biosafety regulatory systems. This paper considers issues related to socio-economic assessments inclusion in biosafety processes by describing the current status and issues in Canada, USA, EU and selected developing countries. There is broad variation amongst examined countries in terms of inclusion modalities and guidance for assessment implementation. The need exists to define scope and if assessments are strictly socio-economic or expanded to include broader considerations such as ethical, religious, or cultural issues. Countries need to define clearly decision making rules and standards by which to render decisions as unclear procedures can lead to negative outcomes.