Ethical aspects of medical products of human origin

Abstract

Medical products of human origin (MPHOs) are ‘substances derived wholly or in part from human biological materials and intended for clinical application’. In 2014, the World Health Organization launched an Initiative for MPHOs. One of the primary goals of this Initiative is to establish global consensus on core principles that should guide policies and practices involving MPHO, particularly with regard to the procurement, distribution and use of these products. Like any medical products with therapeutic value for humans, the sufficiency of their supply, risks and benefits for recipients and equity in their allocation present ethical concerns for health policymakers, professionals and patients. Unlike other medical products, however, MPHOs present additional ethical concerns because their source materials are procured from living or deceased human beings. The clinical and psychosocial risks and benefits of donating specific materials for use in MPHOs vary according to characteristics of the donor, the material procured and the procurement process used. Risks and benefits, for example, continue to evolve as new procurement technologies, standards of donor care, and new donor populations emerge. Nevertheless, several core ethical concerns remain constant, distinguishing MPHOs as ‘exceptional’ health products. They include concerns about care of donors, inequities in donation and commercialization of ‘donation’ and MPHOs. In this article, I explore some major donor‐related ethical concerns and argue that these provide a rationale for seeking to establish global consensus on ethical governance of all MPHOs, and a foundation for consensus on issues of donor care, and equity in donation and allocation of these exceptional health products.