基因检测技术与基因隐私权法律保护

当前,基因检测引发的相关法律和道德问题备受争议。基因隐私权有别于一般隐私权,其有特定的内容、性质及特征,在犯罪DNA库建立、亲子鉴定、雇佣及保险过程中进行基因检测应严格遵循知情同意、知情选择及信息安全等原则,此外也要兼顾公众知情权。应当建立符合中国国情和技术发展的保护机制,以实现合理使用遗传信息与保护基因隐私权的利益平衡。     

基因信息与基因隐私权的保护

基因信息包含了一个人生命的全部秘密，应纳入隐私权的保护范围。基因隐私权的内容包括采样时的知情同意权，基因信息的知晓权，基因信息的保密权，基因信息的利用权。侵犯基因隐私权具有便捷性、隐蔽性、关联性、实质性、长久性等特点。我国立法应确立基因隐私权。侵害基因隐私权应承担相应民事责任。     

Genetic analysis instrumentation innovations built into the SeqStudio ™ Flex Genetic Analyzers

The new Applied Biosystems™ SeqStudio ™ Flex Series Genetic Analyzer have improved the benchmark for research use only for Capillary Electrophoresis (CE) by providing innovative approaches to enhanced hand-free operation, flexibility, ease of use, data quality and connectivity. This newly designed 8 or 24 capillary system supports fragment sizing and DNA sequencing applications providing scientists with medium throughput technology for use in research applications. The steps from system set-up to size or base-called data have been simplified with hardware functionality and user-friendly software enhancements designed into this new CE system.We will discuss innovations related to ease of use including one button start-up, an on-board computer with touchscreen, intuitive software, easier to use capillary arrays, and desktop and cloud-based plate manager software. Innovations related to increased flexibility include continuous plate loading, automated plate linking that be able to maintain traceability from sample to result when using barcoded plates, urgent sample reprioritization, fragment and sequencing samples be run on the same plate, and multi-user support will also be discussed. In addition, gold standard fragment analysis and sequencing data quality has been enhanced through innovative algorithms providing autospectral calibrations, and off-scale recovery of data for fragment analysis. Innovative service and support functionality including remote troubleshooting with instrument system login capability, and on-board instrument help videos are included. Finally, we will touch upon new connectivity, which includes Thermo Fisher connect for remote monitoring, analysis, and data sharing as well as other functionality such as voice commands and Wi-Fi capability that the system will provide. The following summarizes highlights from the developmental validation performed to demonstrate the functionality of SeqStudio ™ Flex Series Genetic Analyzer.     

遗传资源保护与专利申请中遗传资源披露——兼评《专利法修订草案》中的相关条款

“CBD三原则”是处理遗传资源相关利益分配的基本原则。对此,必须通过制定专门的遗传资源保护法给予法律保障。同时,由于遗传资源使用与专利制度之间的关系,决定着专利制度应该作为遗传资源保护法的配套制度之一对遗传资源获取、使用的相关行为作出规范,尤其是规范以相关成果申请专利时的遗传资源来源披露。这可以通过专利制度自身的“充分公开”规则以及设立基于遗传资源管理法中披露要求的“披露规则”来实现;并相应规定不同的法律责任、法律后果。对这些问题,目前的《专利法修订草案》中所确立的原则是正确的,但还是存在某些具体规范上的瑕疵。     

遗传资源惠益分享合同研究

由于话语权的缺失、自身科技发展状况的限制和国际法律体系建立的过程性,目前发展中国家在遗传资源获取和利益分享领域要遵从发达国家的游戏规则,采用"合同模式"。通过对此类合同的解读,分析其性质,明确合同双方的权利义务,以我国为例探讨如何在处于弱势的情况下,能够利用这种合同,获取相对较大利益。     

关于遗传资源保护的相关规定

《专利法》第三次修改,新增了两项有关遗传资源保护的专门规定,即来源披露条款与违法不授权条款。修改后的《实施细则》也增加相应的内容,比如:遗传资源的定义;依赖遗传资源完成的发明创造的含义;遗传资源来源披露的具体内容和要求;不遵守相关规定的法律后果。     

Genetic testing and employee protection

Given advances in the science of genetics it is increasingly possible for individuals to acquire an increased understanding about their DNA. Employers may wish to access such information or may request that employees participate in genetic testing. An examination of the UK legislative framework to accommodate or to prevent such demands raises concern about the need to balance the employer's economic interests and the autonomy of the employee.     

Genetic Exceptionalism and Legislative Pragmatism

Genetic-specific nondiscrimination laws have been enacted in most states, but the laws are ineffective and increase the stigma of genetic conditions. Whether these laws are better than no new legislation depends on their consequences and a recognition of their limitations.