Today’s biomedical research is a collaborative research enterprise, requiring the contributions of patients, universities and industry. Today’s laws, however, allow only universities and industry, which supply basic knowledge and technology, to profit from their contributions; patients, who supply tissue, may not be compensated. Some consider this unfair, as it allows tissue donated by patients to be wholly appropriated by universities and industry. Others consider this wise, as compensating individual tissue donors could block scientific progress and technological development. Is there a way to redress the double standard in biomedical research that is both fair and wise?
Ironically, the double standard has both a moral and an economic underpinning. European law solemnly declares that the human body and its parts shall not give rise to financial gain , for reasons of human dignity. American law denies patients a property right in their tissue for reasons of economic policy. Recognizing such a right would impose a duty on universities and industry to negotiate fair compensation with every donor of all tissue used in their research. Moreover, compared with the contributions of universities and industry to the end product, the importance of tissue contributed by patients is minimal. Finally, why should tissue donors be entitled to compensation, as they or their progeny may benefit in the long run from the technological advances to which they contribute?
Opponents of the double standard draw on principles of fairness, equity, and distributive justice. They view the double standard as a possible source of public distrust in the biomedical research enterprise. In fact, patients’ contributions to that enterprise are no longer minimal, as they supply university and industry with crucial compilations of tissue and associated medical data. Consequently, they have increasingly abandoned altruistic participation and are demanding compensation for their tissue. However, given current European and American law, these claims require a novel legal underpinning in order to be valid and enforceable. Various models have been proposed.
Charitable trust model . Donors would transfer their tissue to a charitable trust, and would collectively appoint a trustee, who would have legal fiduciary duties to use the tissue for the benefit of the public. The trust agreement could allow the donor group to participate in the governance of the trust and thus have a say in the distribution of any benefits. But, while the model is fair in a number of ways, it implies that parts of the human body can give rise to financial gain. Moreover, the model is unwise to the extent that tissue donors could block the development of knowledge and applications. And, by definition, it would work only if the trust is funded on a public basis.