Kuszler Patricia C
University of Washington School of Law, William H Gates Hall, Seattle, USA.
Med Law. 2006 Sep;25(3):491-502.
Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug or technology, ethical questions arise with respect to protecting human subjects and society from danger and exploitation by researchers. As development gives way to marketing and dissemination of a new product, government regulators are pressed to get drugs and biologics through the regulatory pipeline into the market faster, walking an ethical tightrope between speed and safety. As new biotechnology products enter the market place, doctors and patients traverse yet another tightrope, that between unknown risk and the promise of benefit. And finally, patent protection is increasingly viewed as a unethical culprit in keeping prices high and depriving the global poor from lifesaving drugs and biologics. Bioethics has, to date, been largely a creation of Western research and medicine. As such it is wholly inadequate to respond to the cascade of ethical issues that flow from a vibrant biotechnology industry. And if biotechnology is in its infancy, as most believe, it is crucial that scientists, entrepreneurs and governments engage in dialogue about the ethical and societal questions raised on the road of scientific progress.
生物技术，无论是涉及源自DNA和基因技术的新药、转基因食品，还是利用活细胞的生物制品，都会在不同层面引发伦理问题。在研究层面，有人担心创业活动正在颠覆而非提升研究的本质。由于大学学术界与私营企业在研究事业中日益结成联盟所导致的利益冲突，美国这一伦理关注领域的问题愈发严重。当我们沿着研究路径进入药物或技术的开发阶段时，就会出现关于保护人类受试者以及社会免受研究人员危害和剥削的伦理问题。随着开发让位于新产品的营销和推广，政府监管机构面临压力，要让药物和生物制品更快地通过监管流程进入市场，在速度和安全之间走一条伦理钢丝。当新的生物技术产品进入市场时，医生和患者又要走过另一条钢丝，即未知风险与获益希望之间的钢丝。最后，专利保护越来越被视为抬高价格、剥夺全球贫困人口获得救命药物和生物制品机会的不道德罪魁祸首。迄今为止，生物伦理学在很大程度上是西方研究和医学的产物。因此，它完全不足以应对蓬勃发展的生物技术产业引发的一系列伦理问题。而且，如果如大多数人所认为的那样，生物技术尚处于起步阶段，那么科学家、企业家和政府就至关重要地要就科学进步道路上引发的伦理和社会问题展开对话。
