Regulation of Organ Transplants: A Comparison Between the Systems in the United States and Singapore

Abstract

Organ failure is a devastating condition. Transplant offers the hope of “cure” to many patients with end-stage organ failures. The process of organ transplant is highly complicated involving many stakeholders. Important issues, including medical, legal, administrative and ethical, have to be resolved in order to implement a successful organ transplant system and prevent abuses. As such, legislative control of organ transplants is a necessity. Most organ transplant laws cover the donation procedure, types of consent required, establishment of the transplant waiting lists, allocation of organs, certification of brain death, performance of the transplant procedure, and management of post-transplant issues. The regulatory system in the United States builds on the foundation of individual rights and explicit decisions are required for the donation of organs. The operations of the transplant system are largely outsourced to the Organ Procurement and Transplantation Network under a contractual agreement. In contrast, the Singapore system builds on a presumed consent mechanism where residents and citizens are automatically considered as donors upon their death unless they have registered an objection. The operations of the transplant system are centrally managed by the National Organ Transplant Unit within the Ministry of Health. The two systems reflect the unique social and cultural backgrounds of the two countries and they meet the different needs of their people. However, recommendations are made for the United States to strengthen its regulatory system in terms of the need to regulate living donor organ transplants and expand the role of the Food and Drug Administration to ensure the quality and effectiveness of organs and tissues for transplantation.