基于生物遗传资源保护的事先知情同意探析

Study on the prior informed consent based on the protection of biogenic resources

对抗发达国家的生物剽窃行为,保护发展中国家生物遗传资源主权,应建立遗传资源获取与惠益分享制度。兼顾公平与效率的事先知情同意是该制度的基本原则与核心程序。《生物多样性公约》及其议定书形成了较为完善的事先知情同意的国际立法,作为公约的缔约国,中国应充分借鉴印度、哥斯达黎加等国家的立法经验,完善国内的相关立法。事先知情同意包括"事先"、"知情"、"同意"三个构成要素。"事先"作为事先知情同意的时间要素,明确作为申请者向所有者或利益相关者提供信息及谈判的最后期限。"知情"包括实体与程序上的要求。"同意"为核心要素,是相关授权者以法定的形式和方式对遗传资源获取申请者所提出的申请及拟定的相关计划进行审查并作出明确的意见。

We should establish the Access Benefit Sharing System of Genetic Resources to confront bio-piracy of developed countries and to protect developing countries’ national sovereignty on biological genetic resources.Prior informed consent is the fundamental principle and core procedure of the system,which take account of both just and efficiency.＂The Convention on Biological Diversity＂,as well as its protocols,has formed more improved international legislation.As the contracting party to the Convention,China should improve relevant legislation drawing lessons from the experience abroad such as India and Costa Rica.Prior informed consent is composed by three elements including ＂prior＂,＂informed＂ and ＂consent＂.As the time element of the procedure,＂prior＂ means to crystallize the deadline that applicants supply information to the owners or stakeholders and negotiate with them.＂Informed＂ includes requirements both on substance and procedure.＂Consent＂,the core element,means that relevant franchisors examine the applications and relevant programs from the applicants of biological genetic resources and make definite answers in a prescribed form and manner.