ABSTRACT

Gene technologies, such as transgenesis and new breeding techniques (NBTs), expand the toolbox for plant breeding. Many countries in Africa, however, have long been seen as “slow adopters” of gene technologies for several reasons, one being the lack of, or overly restrictive, biosafety regulatory frameworks. This is sometimes attributed to the influence of the precautionary-oriented EU biosafety policies. This study analyses and compares the biosafety regulatory frameworks and their implementation in Kenya, Nigeria and Uganda, and in the EU member state Sweden. The focus is on (1) the structure of the biosafety regulatory frameworks including the scope of the legislation, (2) the duration and cost of regulatory authorization for field trials with genetically modified (GM) plants, and (3) the regulatory approach to NBT products, i.e. to what extent NBT products are subject to the provisions of the biosafety regulatory framework. The data was collected through studying relevant legal and policy documents as well as interviewing regulatory officers and researchers in the respective countries. We found that the regulatory procedures in the selected countries are relatively straightforward, while the costs and duration may present a challenge. The regulatory approach to NBT products differ between the selected African countries and Sweden, the latter which follows EU regulations. The results are discussed in terms of the impact the regulatory developments in these four jurisdictions may have on international R&D collaborations involving the use of gene technologies and we also weigh the results against the common conception that Europe exerts a heavy influence on African countries in this technology field.

摘要

转基因和新育种技术 (NBT) 等基因技术扩大了植物育种的工具箱。然而，由于多种原因，非洲的许多国家长期以来一直被视为基因技术的“缓慢采用者”，其中之一是缺乏或过于严格的生物安全监管框架。这有时归因于以预防为导向的欧盟生物安全政策的影响。本研究分析和比较了肯尼亚、尼日利亚和乌干达以及欧盟成员国瑞典的生物安全监管框架及其实施情况。重点是 (1) 生物安全监管框架的结构，包括立法范围，(2) 转基因 (GM) 植物田间试验监管授权的持续时间和成本，以及 (3) 监管方法NBT产品，即 NBT 产品在何种程度上受生物安全监管框架规定的约束。这些数据是通过研究相关法律和政策文件以及采访各自国家的监管官员和研究人员收集的。我们发现，选定国家/地区的监管程序相对简单，而成本和持续时间可能会带来挑战。选定的非洲国家和瑞典对 NBT 产品的监管方法不同，后者遵循欧盟法规。就这四个司法管辖区的监管发展可能对国际研发产生的影响对结果进行了讨论