Strengthening regulatory capacity for gene drives in Africa: leveraging NEPAD's experience in establishing regulatory systems for medicines and GM crops in Africa.
Strengthening regulatory capacity for gene drives in Africa: leveraging NEPAD's experience in establishing regulatory systems for medicines and GM crops in Africa.
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加强非洲基因驱动的监管能力：利用尼泊德在建立非洲药物和通用农作物的监管系统方面的经验。
DOI：
10.1186/s12919-018-0108-y
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
Ambali A
中科院分区：
文献类型：
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作者：
Glover B;Akinbo O;Savadogo M;Timpo S;Lemgo G;Sinebo W;Akile S;Obukosia S;Ouedraogo J;Ndomondo-Sigonda M;Koch M;Makinde D;Ambali A
非洲发展新伙伴关系（新伙伴关系）机构认识到，非洲正处于过渡时期，这要求探索和利用包括现代生物技术在内的以科学为基础的创新所取得的安全进展。为了有效地推动非洲的生物技术科学，同时保护人类健康和环境，非洲联盟（Au）通过了一份关于现代生物技术的高级别小组报告，题为“创新的自由”，该报告主张采取共同进化的办法，使技术发展与监管齐头并进。此外，大多数Au成员国是《卡塔赫纳生物安全议定书》的缔约国，该议定书是在《生物多样性公约》框架内谈判、缔结和通过的具有法律约束力的国际协定。这是为了指导缔约方建立现代生物技术应用的无害环境管理制度。目前，已有49个Au成员国签署并批准了《生物安全公约》，其中12个国家通过了生物安全法。非洲联盟（Au）成员国在制定现代生物技术应用监管框架方面处于不同阶段，其中包括转基因产品和其他新兴技术。生物技术安全监管框架包括：生物技术和/或生物技术安全政策;法律、条例和准则;行政系统;决策系统;以及公众参与机制。为协助会员国执行农业和卫生应用的实用监管框架，新伙伴关系规划和协调局建立了非洲生物安全专门知识网络和非洲药品监管协调机构。目前，转基因昆虫和转基因作物由国家主管当局监管，其任务来自国家生物安全法。对于转基因作物，在一些非洲国家进行了大量的研究，直至封闭田间试验和多地点试验阶段。布基纳法索拥有功能齐全的转基因蚊子遏制设施，马里和乌干达正在发展这些设施。布基纳法索监管机构已发放许可证，并已收到几套无菌蚊卵，供在封闭设施内进行试验。值得注意的是，荷兰自然资源管理局和非洲生殖健康管理局都与非洲的国家和区域监管机构合作，以提高它们在知情决策、采用最佳做法和遵守国际标准方面的技术能力。新伙伴关系规划和协调局正是在实地知识、经验、专门知识以及对成员国背景和政治敏感性的深入了解的丰富背景下，寻求扩大现有的支助。这将包括加强监管新兴技术的能力，例如应用基因驱动开发控制疟疾传播的转基因蚊子。
The New Partnership for Africa’s Development (NEPAD) Agency recognizes that Africa is in a period of transition and that this demands exploring and harnessing safe advances made in science-based innovations including modern biotechnology. To advance the science of biotechnology in Africa effectively, while at the same time safeguarding human health and the environment, the African Union (AU) adopted a High-Level Panel report on modern biotechnology entitled, Freedom to Innovate, which advocated for a coevolutionary approach where technology development goes hand in hand with regulation. Furthermore, most AU member states are Parties to the Cartagena Protocol on Biosafety (CPB), a legally binding international agreement negotiated, concluded and adopted within the framework of the Convention on Biological Diversity. This seeks to guide Parties in developing systems for the environmentally sound management of modern biotechnology applications. Currently, 49 AU Member States have signed and ratified the CPB, of which 12 have passed biosafety laws. African Union (AU) member states are at different stages in the development of regulatory frameworks for applications of modern biotechnology, which include genetically modified (GM) products and other emerging technologies. Biosafety regulatory frameworks comprise: biotechnology and/or biosafety policy; laws, regulations and guidelines; administrative systems; decision-making systems; and mechanisms for public engagement. To assist Member States to implement functional regulatory frameworks for both agriculture and health applications, the NEPAD Agency established the African Biosafety Network of Expertise (ABNE) and the African Medicines Regulatory Harmonization (AMRH). Currently, transgenic insects and GM crops are regulated by Competent National Authorities whose mandate derives from national biosafety laws. For GM crops, a lot of research has been conducted up to the confined field trial (CFT) and multi-location trials stages in a number of African countries. Burkina Faso has fully functional containment facilities for transgenic mosquitoes while Mali and Uganda are developing theirs. The Burkina Faso regulatory agency has granted permits and has already received sets of sterile mosquito eggs for trials in the contained facility. It is instructive to note that both ABNE and AMRH have worked with national and regional regulatory bodies in Africa to enhance their technical capacities for informed decision making, adoption of best practices, and compliance with international standards. It is against the backdrop of a rich blend of on-the-ground knowledge, experience, expertise, and insight into the context and political sensitivities of member states that the NEPAD Agency seeks to expand existing support. This would include capacity strengthening in the regulation of emerging technologies, such as the application of gene drives in the development of transgenic mosquito for the control of malaria transmission.