Augusto Carlos, Gutiérrez Conde
Rev Derecho Genoma Hum. 2014 Jul-Dec(41):63-87.
Synthetic biology is a change of paradigm, i.e. from the exploitation of natural and genetic resources to lab production of biological entities. This transitional shift represents a great challenge for developing countries, particularly those which host biodiversity, and users of genetic resources, since the latter might not be longer required to access to actual genetic resources (tangible genetic resources) but rather genetic resources' information (intangible genetic resources) in order to replicate those resources in labs. This could mean that users of genetic resource would not have to comply with the Convention on Biological Diversity (CBD) and its complementary treaty, the Nagoya Protocol, known also as the Access and Benefit Sharing regime (ABS). Both international instrument demands that States create legal mechanisms to secure access and benefit sharing, i.e., users of genetic resources are required to obtain prior informed consent (PIC) from host countries of biodiversity and reach mutual agreed terms (MATs), in which users and countries agree how to share the benefits arise from the utilization of genetic resources. The ABS regime is particularly relevant since its implementation at national and regional level has created tensions between users of genetic resources and developing countries. This situation could lead to users removing interest in the exploitation of genetic resources, subsequently, meaning that their focus would move towards technologies that rely less on tangible genetic resources, including synthetic biology. This papers aim to discuss the scope of the CBD and the Nagoya Protocol in the light of synthetic biology and the implications for developing countries.
合成生物学是一种范式转变，即从对自然和遗传资源的利用转向在实验室中生产生物实体。这种转变对发展中国家，尤其是那些拥有生物多样性的国家以及遗传资源使用者来说是一个巨大挑战，因为后者可能不再需要获取实际的遗传资源（有形遗传资源），而是遗传资源信息（无形遗传资源），以便在实验室中复制这些资源。这可能意味着遗传资源使用者无需遵守《生物多样性公约》（CBD）及其补充条约《名古屋议定书》，即获取与惠益分享制度（ABS）。这两项国际文书都要求各国建立法律机制以确保获取和惠益分享，即遗传资源使用者必须从生物多样性所在国获得事先知情同意（PIC）并达成共同商定的条件（MATs），其中使用者和国家就如何分享遗传资源利用所产生的惠益达成一致。获取与惠益分享制度尤为重要，因为其在国家和区域层面的实施在遗传资源使用者和发展中国家之间造成了紧张关系。这种情况可能导致使用者对遗传资源开发失去兴趣，进而意味着他们的重点将转向较少依赖有形遗传资源的技术，包括合成生物学。本文旨在根据合成生物学探讨《生物多样性公约》和《名古屋议定书》的范围以及对发展中国家的影响。
