This article considers some of the ethical and legal issues relating to the ownership and use – including for commercial purposes – of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed.
The management of biological material (cells and tissues) requires a number of considerations, including technical–scientific, organizational, ethical, and legal.1
Biological samples are collected and stored for widely differing purposes:2,3 diagnosis or treatment of the person from whom they are collected (eg, clinical treatment), altruistic donation for therapeutic purposes (eg, blood donation), and donation for purposes of research. The boundaries between purposes may blur, as will be explained below; changing circumstances may lead to samples collected and stored for one purpose being subsequently used for others.4
Proposed criteria for the case in point
With reference to yet another authoritative document, it may be helpful to examine paragraph 2.08 (“Commercial use of human tissue”) of the Code of Medical Ethics published by the American Medical Association (Council on Ethical and Judicial Affairs) already referred to,59 which states:
Physicians contemplating the commercial use of human tissue should abide by the following guidelines:
1. Informed consent must be obtained from patients for the use of organs or tissues in clinical research.
2. Potential commercial applications must be disclosed to the patient before a profit is realized on products developed from biological materials.
3. Human tissue and its products may not be used for commercial purposes without the informed consent of the patient who provided the original cellular material.