关键词: 《名古屋议定书》, 获取和惠益分享, 病原体共享, 数字序列信息

Abstract: Timely sharing of pathogens is critical for pathogens early identification, risk assessment, evidence-based interventions initiation, and subsequent development of diagnostic tools, vaccines and medicines. The negotiating history of the Nagoya Protocol indicates that the pathogens falls within the scope of the Nagoya Protocol. The preamble of the Nagoya Protocol explicitly refers to pathogens, and not only that, but its general rules on access and benefit-sharing as well as special considerations also apply to pathogens. The issue of pathogen sharing faces different aspects of challenges as the Nagoya Protocol requires states' compliance. Since the Nagoya Protocol takes the bilateral approach to the access and benefit-sharing, the implementation of the Nagoya Protocol has resulted in the delay or limit of sharing of certain pathogens, such as for seasonal influenza virus. The relationship between the Nagoya Protocol and the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and other Benefits has not yet been clearly defined, thereby producing legal uncertainty surrounding the sharing of influenza viruses with human pandemic potential. The tendency that the use of digital sequence information presumably substitutes the physical materials has emerged as a result of technology developments, but the Nagoya Protocol leaves a major gap in regulating the use of digital sequence information, especially for the sharing of benefits arising from the use of digital sequence information. The Contracting Parties should introduce special measures, procedures and arrangements at the domestic level, such as fast-track procedure for access to pathogens. At the same time, the Contracting Parties should put forward effective countermeasures based on collective consultative decision-making in order to respond to the challenges. In the future, the sharing of pathogen will play stronger role in the public health preparedness and response through the efforts made by the Contracting Parties.

Key words: Nagoya Protocol, access and benefit-sharing, sharing of pathogen, digital sequence information