Human-tissue-related inventions: ownership and intellectual property rights in international collaborative research in developing countries
Human-tissue-related inventions: ownership and intellectual property rights in international collaborative research in developing countries
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DOI：
10.1136/jme.2006.019612
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发表时间：
2008-03-01
影响因子：
4.1
通讯作者：
Andanda, P. A.
中科院分区：
文献类型：
--
作者：
Andanda, P. A.
与使用在研究过程或诊断程序中获得并保留以供进一步研究使用的人体组织有关的复杂的、悬而未决的伦理、法律和社会问题。从这些样本衍生的商业上可行的产品或程序的知识产权问题，以及参与者是否适合放弃其对样本的权利的问题需要迫切关注。这些问题的复杂性在于，知识产权与知识产权所依据样本的所有权或权利之间的关系要么被忽视，要么被视为理所当然。同样使问题变得复杂的是，可能会从发展中国家的参与者那里获得样本，然后出口到发达国家进行分析和研究。重要的是，研究伦理委员会在审查提出此类问题的研究方案时要谨慎行事，以确保适当的惠益分享协议到位，特别是与发展中国家的协议。本文试图分析从人体组织样本中提取的商业可行产品的所有权和知识产权相关的关键问题。与工业品外观设计等其他形式的知识产权不同，专利法被用作参考，因为这是大多数发明人就与组织有关的发明申请的权利。这些关键问题是在对同行评议的期刊文章进行系统分析后提出的，这些文章报告了对该领域相关问题的原始调查。本文提到的大多数案例和报告的研究并不直接涉及艾滋病毒/艾滋病研究，但其基本原则也有助于艾滋病毒/艾滋病研究。讨论了道德操守审查委员会成员在这方面应重点关注的相关问题，并以道德操守审查委员会应考虑的具体问题的形式提出了对这些问题采取适当办法的建议。同样，还提出了关于进一步研究和行动领域的具体建议。
There are complex unresolved ethical, legal and social issues related to the use of human tissues obtained in the course of research or diagnostic procedures and retained for further use in research. The question of intellectual property rights over commercially viable products or procedures that are derived from these samples and the suitability or otherwise of participants relinquishing their rights to the samples needs urgent attention. The complexity of these matters lies in the fact that the relationship between intellectual property rights and ownership or rights pertaining to the samples on which the intellectual property right is based may either be overlooked or taken for granted. What equally makes the matter complex is that samples may be obtained from participants in developing countries and exported to developed countries for analysis and research. It is important for research ethics committees to tread carefully when reviewing research protocols that raise such issues for purposes of ensuring that appropriate benefit sharing agreements, particularly with developing countries, are in place.This paper attempts to analyse the key questions related to ownership and intellectual property rights in commercially viable products derived from human tissue samples. Patent law is used as a point of reference as opposed to other forms of intellectual property rights such as industrial designs because it is the right that most inventors apply for in respect of human tissue-related inventions. The key questions are formulated following a systematic analysis of peer reviewed journal articles that have reported original investigations into relevant issues in this field. Most of the cases and reported studies that are referred to in this paper do not directly deal with HIV/AIDS research but the underlying principles are helpful in HIV/AIDS research as well. Pertinent questions, which members of ethics review committees should focus on in this regard are discussed and suggestions on appropriate approaches to the issues are proposed in the form of specific questions that an ethics review committee should consider. Specific recommendations regarding areas for further research and action are equally proposed.