Regulating Organ Transplants and Donation

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Experts explore how to improve organ transplantation practices in the United States.

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Organ transplantation began in the early 20th century, with the first successful human organ transplant taking place in 1954. Since then, medical professionals have performed more than 750,000 organ transplants in the United States. In 2019 alone, 39,718 people in the United States received organ transplants. Although the mechanics of organ transplantation have improved with time, the ethical and legal implications of the practice remain unsettled.

Organ transplantation is unique in that the patient’s needs often conflict with the donor’s needs, at least for transplantations from living donors. Professional guidelines and U.S. law attempt to strike a balance between protecting donors and saving the lives of as many recipients as possible.

Organ transplantation in the United States works on an “opt-in” model. Donors or their families must decide to donate. In 1968, the Uniform Law Commission designed the Uniform Anatomical Gift Act (UAGA) to streamline the organ donation process. Most states have modeled their organ donation laws after the UAGA, but the UAGA in action is inconsistent between states.

Separately from the UAGA, the U.S. Congress passed the federal National Organ Transplant Act to govern organ transplantation, establish an Organ Procurement and Transplantation Network (OPTN), and prohibit the sale of organs. The Federal Policy for the Protection of Human Subjects and the U.S. Food and Drug Administration also oversee the regulation of organ transplant research.

This week’s Saturday Seminar focuses on the regulation of organ transplantation and donation.

  • In the Clinical Journal of the American Society of Nephrology, Alexandra K. Glazier of New England Donor Services describes the UAGA’s gift-giving framework for organ donation. Since U.S. federal law bans organ sales, structuring donations as gifts facilitates organ donation under the law. Glazier argues that this voluntary, opt-in policy also suits the “rights-based culture” of the United States. She asserts that under this framework, the United States has a high rate of organ donation compared to other countries. Glazier concludes that, although the United States can do more to increase organ donations, the UAGA represents a step in the right direction.
  • A persistent mismatch exists “between the supply and demand for organs across countries with an established infrastructure to facilitate transplantation,” Adam Arshad, Benjamin Anderson, and Adnan Sharif write in Kidney International. They assess the impact an opt-in system—where individuals must affirmatively consent to donation—versus an opt-out system—where society presumes consent—might have on a country’s organ donation rates. Arshad, Anderson, and Sharif found no significant differences in donation rates between the two systems and caution that legislators in opt-in countries should not expect to raise organ donation rates just by switching to an opt-out model.
  • Although the OPTN is a federal agency, it is operated by a non-profit corporation called the United Network for Organ Sharing. Furthermore, organ allocation policies are delegated to OPTN’s board of directors, which includes transplant specialists, patients, their families, hospitals, organ procurement organizations, and members of the public. In an article published in the Seton Hall Legislative Journal, Daniel M. Bruggebrew of Coblentz Patch Duffy & Bass argues that courts should apply a threshold test to quasi-governmental bodies such as the OPTN to determine whether their decisions are entitled to judicial deference. Bruggebrew claims that, although the courts should give the OPTN some level of deference, the agency should not be immune to constitutional claims.
  • People die every day while waiting for an organ transplant. In a 2017 paper, David K.C. Cooper of the University of Pittsburgh and his coauthors recommend using xenotransplantation—or cross-species transplantation—to address the scarcity of human organ donors. Here, Cooper and his coauthors suggest using pigs as organ donors. As xenotransplantation research continues to progress, Cooper and his coauthors recommend that regulators clarify the requirements for research and procedures related to xenotransplantation to ensure that they are based on medicine rather than misconceptions. The authors also argue that regulators should investigate and consider approving drugs necessary for xenotransplantation such as immunosuppressants.
  • In the Declaration of Istanbul on Organ Trafficking and Transplant Tourism, international organizations issued guidelines for health officials and policymakers around the world to address organ trafficking and transplant tourism. Transplant tourism involves patients, often from wealthy countries, traveling abroad “to purchase organs from poor and vulnerable people.” In a companion document to a 2018 update to the Declaration, Dominique E. Martin and her coauthors note that some policymakers have struggled to implement these international principles in their local communities because of unique cultures and health care norms. They provide additional guidance on how officials can apply the principles of the Declaration in various settings. For example, Martin and her coauthors urge officials to establish a transparent legal framework that clarifies “the scope of reimbursement” for all expenses that donors or their families incur while ensuring that they do not profit from the procedure.
  • Under the HIV Organ Policy Equity Act, U.S. law allows for organ transplants between HIV-positive individuals. Alissa Jade Wright and other doctors argue in Transplantation that, although Canadian law allows such transplants, there remain “significant uncertainties and challenges with routinely offering organ donation to HIV-positive persons.” Canadian policymakers will need more long-term safety information before they fully embrace organ transplantation among Canadians who are HIV-positive, the doctors claim.

The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.