Risk and cost considerations bound biosafety assessments and biotechnology decision-making processes (Viscusi, Vernon, and Harrington, 2000). It is also noteworthy that the time value of money lost from regulatory approval delays tend to be greater than the cost of compliance itself (Bayer et al., 2008). The high cost of generating adequate data for regulatory purposes, maintaining functional biosafety regulatory structures, and ensuring regulatory compliance is well documented (Bayer et al., 2010; Bradford et al., 2006; Jaffe, 2005). In the specific instance of discovery, development and authorization of a new biotech crop or trait, the cost is estimated to be US$136 million (McDougall, 2011). A regulatory system must be established in a manner that it is workable, science-based, cost efficient, and does not compromise on acceptable safety standards. Only relevant regulatory data should be requested at any stage of the regulatory process and the regulatory structures and requirements should be efficient and commensurate with the level of risk posed by GMOs. Thus there is the need to clearly define data needs and establish acceptable data sources and methods of validation.
Most African countries and institutions lack the financial and technical resources for mandatory risk assessment and compliance monitoring. However, a false and detrimental premise in establishing regulations is the assumption that foreign multinational companies will be the only developers and users of the technology and will offset the high regulatory costs with profits from approved products. This assumption penalizes public institutions that are interested in applying GMOs that focus on crops and traits of national and regional interest. Many public research institutions in Africa have partnered with foreign public and private counterparts to undertake GM R&D activities, but the products of these initiatives never reach African farmers primarily because of the prohibitive cost of regulatory approval and the long delays associated with regulatory decisions.
An additional cost mitigation consideration would be the acceptance of regulatory food safety data from other countries and environmental data from regions with similar agro-ecological systems. If farmers and consumers in Africa are to benefit from improved planting materials, there is the need to build regulatory systems that are an incentive for investment.
Key issues that can lead to disagreement and stymie progress towards implementing functional regulatory frameworks include: terminology differences; inconsistency with international obligations; inclusion of socio-economic issues; labelling of GM products; and choice of liability and redress regime. Considering that most African countries are parties to the Cartagena Protocol on Biosafety, consistency with provisions of the Protocol is of prime importance and consensus documents from the Protocol can be used to help establish harmonised regulations or processes.
- Biosafety regulatory costs to government
- Regulatory costs to technology developers.