Smith David, da Silva Manuela, Jackson Julian, Lyal Christopher
CABI, Bakeham Lane, Egham, Surrey TW20 9TY, UK.
Fundação Oswaldo Cruz (Fiocruz), Av. Brasil, 4365, 21040-900 Manguinhos, Rio de Janeiro, Brazil.
Microbiology (Reading). 2017 Mar;163(3):289-296. doi: 10.1099/mic.0.000425. Epub 2017 Mar 29.
Working with genetic resources and associated data requires greater attention since the Nagoya Protocol on Access and Benefit Sharing (ABS) came into force in October 2014. Biologists must ensure that they have legal clarity in how they can and cannot use the genetic resources on which they carry out research. Not only must they work within the spirit in the Convention on Biological Diversity (https://www.cbd.int/convention/articles/default.shtml?a=cbd-02) but also they may have regulatory requirements to meet. Although the Nagoya Protocol was negotiated and agreed globally, it is the responsibility of each country that ratifies it to introduce their individual implementing procedures and practices. Many countries in Europe, such as the UK, have chosen not to put access controls in place at this time, but others already have laws enacted providing ABS measures under the Convention on Biological Diversity or specifically to implement the Nagoya Protocol. Access legislation is in place in many countries and information on this can be found at the ABS Clearing House (https://absch.cbd.int/). For example, Brazil, although not a Party to the Nagoya Protocol at the time of writing, has Law 13.123 which entered into force on 17 November 2015, regulated by Decree 8.772 which was published on 11 May 2016. In this case, export of Brazilian genetic resources is not allowed unless the collector is registered in the National System for Genetic Heritage and Associated Traditional Knowledge Management (SisGen). The process entails that a foreign scientist must first of all be registered working with someone in Brazil and have authorization to collect. The enactment of European Union Regulation po. 511/2014 implements Nagoya Protocol elements that govern compliance measures for users and offers the opportunity to demonstrate due diligence in sourcing their organisms by selecting from holdings of 'registered collections'. The UK has introduced a Statutory Instrument that puts in place enforcement measures within the UK to implement this European Union Regulation; this is regulated by Regulatory Delivery, Department for Business, Energy and Industrial Strategies. Scientific communities, including the private sector, individual institutions and organizations, have begun to design policy and best practices for compliance. Microbiologists and culture collections alike need to be aware of the legislation of the source country of the materials they use and put in place best practices for compliance; such best practice has been drafted by the Microbial Resource Research Infrastructure, and other research communities such as the Consortium of European Taxonomic Facilities, the Global Genome Biodiversity Network and the International Organisation for Biological Control have published best practice and/or codes of conduct to ensure legitimate exchange and use of genetic resources.
自《名古屋遗传资源获取与惠益分享议定书》(ABS)于2014年10月生效以来,处理遗传资源及相关数据需要更多关注。生物学家必须确保他们在如何使用和不能使用所研究的遗传资源方面有明确的法律依据。他们不仅必须在《生物多样性公约》(https://www.cbd.int/convention/articles/default.shtml?a=cbd-02)的精神框架内开展工作,还可能需要满足监管要求。尽管《名古屋议定书》是在全球范围内谈判并达成一致的,但批准该议定书的每个国家都有责任引入各自的实施程序和做法。欧洲的许多国家,如英国,目前选择不实施准入控制,但其他一些国家已经颁布法律,根据《生物多样性公约》或专门为实施《名古屋议定书》提供获取与惠益分享措施。许多国家都制定了准入立法,相关信息可在获取与惠益分享信息交换所(https://absch.cbd.int/)查询。例如,巴西在撰写本文时虽不是《名古屋议定书》缔约国,但有2015年11月17日生效的第13.123号法律,并由2016年5月11日发布的第8.772号法令进行监管。在这种情况下,除非采集者在国家遗传资源及相关传统知识管理系统(SisGen)中注册,否则禁止出口巴西的遗传资源。这一过程要求外国科学家首先要与巴西境内的人员合作并获得采集授权。欧盟第511/2014号法规的颁布实施了《名古屋议定书》中关于用户合规措施的内容,并为通过从“注册保藏机构”的馆藏中选择来证明在获取其生物材料时尽职调查提供了机会。英国出台了一项法定文书,在英国境内实施执行措施以落实该欧盟法规;这由商务、能源与产业战略部的监管执行部门负责监管。科学界,包括私营部门、各机构和组织,已开始制定合规政策和最佳实践。微生物学家和菌种保藏机构都需要了解他们所使用材料来源国的法律,并制定合规的最佳实践;微生物资源研究基础设施已起草了此类最佳实践,欧洲分类学设施联盟、全球基因组生物多样性网络和国际生物防治组织等其他研究团体也已发布最佳实践和/或行为准则,以确保遗传资源的合法交换和使用。