Important issues concerning the national legislation of access to genetic resources and benefit-sharing

Abstract

The Nagoya Protocol (NP) entered into force on 12 October 2014 and was fully implemented thereafter. The effective implementation of the NP at the national level requires strong support through national legislation. In this regard, the Chinese government is drafting regulations on the administration of access to biological genetic resources, which are included in the State Council legislative plan for 2015. To provide recommendations, this study presents a discussion on several aspects that should be concerned and focused on the development of national legislation on access and benefit-sharing (ABS), for instance, the legal status, terms and definitions, access and approval process, follow-up supervision, and monitoring. We further propose views to provide references for establishing national ABS regulation and to ensure effective implementation. These include: (1) National ABS regulation should be combined with current legislation to synergically supervise biological genetic resources and traditional knowledge related to genetic resources, thus to identify the ownership of biological genetic resources and related traditional knowledge, and to distinguish commercial and non-commercial acquisition; (2) Developing items and definitions to clarify concepts and promote the operation of certain legal provisions; (3) Clearing ABS authorities, resources management authorities and the required materials lists for acquisition, as well as forms and content of the acquisition application. In addition, supervising and approving acquisition activities should be completed using categories, thus to encourage scientific research and regulate commercial developments, especially for outbound acquisition activities. In particular, it is necessary to consider specific administration and managementregulations; (4) Monitoring follow-up activities from the perspective of both provider states and user states using the certificate of compliance; and (5) Reserving records and documents on access to samples, and setting up checkpoints to monitor and regulate access, utilization, intellectual rights and other aspects.