Determining the current status of the inclusion of socio-economic in the biosafety and/or technology decision-making processes is complicated by the fact that there are several legal and policy instruments where the country expresses its desire to include socio-economic considerations. These may include:

  • National biosafety framework drafts (such as those done under the UNEP-GEF country projects)
  • Laws, bills, and acts
  • Biosafety, biotechnology and/or science and technology policies
  • Administrative regulations (administrative orders, executive orders)
  • Implementing regulations

The following provides an overview of the status of socio-economics in national policies. Note that due to the dynamic nature of laws, regulations and policies, these descriptions may have changed already or are currently in the process of changing.

Canada and the United States: These two countries had not considered socio-economics in their decision making, but this seems to be changing (at least in the United States). In both countries, socio-economic considerations have been addressed in courts of law.

European Union: There is ongoing discussion within the European Union on the inclusion of socio-economics. A proposal made by the Netherlands Commission on Genetic Modifications (COGEM) in 2009 described nine issues for potential assessment. Current debate seems to be whether requirement should for requiring ex ante or ex post assessments.

Norway: The country has formally included socio-economic considerations in its legislation through the Gene Technology Act of 1993. The Norwegian Biotechnology Advisory Board has prepared a document “describing the implementation of the concepts in the Gene Technology Act” (Norwegian Biotechnology Advisory Board, 2009, Preface), which among others includes information for the assessment of benefits to the community. The assessment criteria are not strict, but should include problems being solved, availability of alternatives, and possible problems as applied similarly to approval of antibiotics in Norway.

Argentina: One of the few developing countries with a mandatory requirement for the inclusion of socio-economic considerations in its decision making is Argentina. There is a narrow scope of impacts of approvals on Argentinian exports.

Mexico: In this country, Chapter II Article 5.XIV of 2006 decree (CONACYT, 2007) defining the roles of the competent authority (Comite Intersecretarial de Bioseguridad de los Organismos Geneticamente Mejorados – CIBIOGEM) defines one of its roles to be deciding on the socio-economic studies needed to analyze the impact of GMOs.

Brazil: The Brazil Biosafety Law No. 11.105, which was approved in 2005, considers two distinct bodies for the regulation of GMOs (GoB, 2005). A technical body that is the competent regulatory body, the national biosafety committee (CTNBio), and an independent body called National Biosafety Council (CNBS) that is formed by Ministers and designated experts. CTNBio approves new GMOs by performing an assessment on human health, animal health, and environmental impacts, whereas the CNBS decides on the commercial deployment if any social or economic issue is raised during the evaluation process.

India: The country’s current rules from 1998 do not formally require the inclusion of socio-economics. Studies have been commissioned for some applications to date. How these studies influenced decision making is unclear.


Falck Zepeda, J. B. Socio-Economic Considerations, Article 26.1 of the Cartagena Protocol on Biosafety: What are the Issues and What is at Stake?” 2009. AgBioForum. 12(1):90-107.

Falck Zepeda, J., J. Wesseler, S. Smyth. “The Current Status of the Debate on Socio-Economic Assessments and Biosafety Highlighting Different Positions and Policies in Canada and the US, the EU and Developing Countries”. Paper presented at the World Environmental and Resource Economics Congress in Montreal, Canada, July 2, 2010. Paper can be downloaded from (look under second day Parallel session 1).