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Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks

Article 26.1 of the Cartagena Protocol on Biosafety left open the option for member countries to include in their biosafety regulatory and technology approval decision making processes the inclusion of socio-economic considerations. Countries may also decide to consider socioeconomic issues as part of their national legislation or regulations for the approval of genetically engineered technologies for deliberate release into the environment. Countries are debating if and how to implement assessment of socio-economic considerations. This paper contributes to the ongoing policy dialogue by discussing issues related to socio-economic assessment including scope, timing, inclusion modalities, methods, decision making rules and standards, and the integration of socio-economic assessments in biosafety and/or biotechnology approval processes. This paper also discusses the implications of socio-economic considerations inclusion for technology flows and public and private sector R&D. If inclusion is not done properly, it may negatively impact technology flows especially from public sector and render an unworkable biosafety system.


Key Conclusions

  • Inclusion of socioeconomics considerations into decision making can have both positive and negative impacts
  • Prudent for countries to evaluate the costs and benefits of socioeconomics inclusion and to reduce the impact of this additional regulatory burden
  • Policy makers need to address the issue of regulatory predictability as it can introduce significant negative impacts including the possibility of introducing disincentives for R&D investments.
  • If countries pursue the option of including socio-economic considerations in their decision making, then it must be done using clear decision-making rules and standards, while ensuring the biosafety system’s transparency and protectiveness
  • Functional approaches include those in Brazil and Argentina. Brazil implements a sequential approach where biosafety assessment is completed by the technical committee and if an issue is raised during consultations and assessments, the approval committee can commission a socioeconomic study or assessment to a third party. Argentina has a mandatory and sequential process focused on specific socioeconomic impacts considering export competivity. Socioeconomic assessments are done after the biosafety assessment is completed and is prepared by a unit within the Ministry of Finance and Trade.


Falck-Zepeda, J.B. and P. Zambrano. 2011. Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks. Review of Policy Research. 28(2): 171-195. http://dx.doi.org/10.1111/j.1541-1338.2011.00488.x