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据《自然》周刊不久前从上海发出的一篇报道,中国已颁布实施了一项内容广泛的有关收集和利用“人类遗传资源”的条例,以期限制国外生物技术和制药公司对它们的利用。 中国已日益认识到,她的庞大人口和较多数量的不同种族群体为搜集疾病基因提供了丰富的资源,而疾病基因对于有利可图的诊断医疗技术具有关键性意义。 据报道,国外公司已通过其在中国与当地研究人员开展的合作研究,在没获得正式批准或保证给予中国研究机构任何有意义回收的情况下获得了有关研究数据。 但根据新的条例,寻求开展有关人类遗传资源“采样、收集、商业化或出口”的任何研究计划都必须获得正式的授权。这里所称的遗传资源被定义为“有关含有人类基因组、基因或基因产品或其部分的任何人体材料”。 条例还规定,如果中国研究机构和国外机构的合作获得有价值的遗传信息的话,由所得专利产生的利益应由两个有关机构按其所做贡献的比例共同分享。对于批准个人计划和出口遗传材料的申请将按季度进行审查和发布。现已开展的合作项目也被要求申请批准。
According to a recent report by Nature Weekly in Shanghai, China has promulgated a comprehensive regulation on the collection and utilization of “human genetic resources” in order to limit the use of foreign biotechnology and pharmaceutical companies. China has increasingly realized that her large population and the larger number of different ethnic groups provide a wealth of resources for the collection of disease genes that are of crucial importance for lucrative diagnostic medical technologies. It has been reported that foreign companies have obtained relevant research data through their cooperative research with local researchers in China and without any formal approval or assurance that any meaningful recovery will be granted to Chinese research institutes. However, under the new regulations, any research program seeking to “sample, collect, commercialize or export” human genetic resources must be formally authorized. Genetic resources, referred to here, are defined as “any human material that contains the human genome, gene or gene product or part thereof.” The regulation also provides that if the cooperation between the Chinese research institutes and foreign institutions obtains valuable genetic information, the benefits arising from the resulting patents shall be shared by the two agencies concerned in proportion to their contribution. Applications for approval of personal programs and export of genetic material will be reviewed and posted on a quarterly basis. Existing cooperation projects have also been asked for approval.