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The Legal Implications of the First Pig-to-Human Heart Xenotransplantation

In January of this year, David Bennett became the first living person to receive a genetically modified animal heart. The transplanted pig heart continued to function only for another two months, yet his successful surgery was considered a breakthrough in the medical field. Although his procedure was a huge step forward for healthcare, it also raised many troubling concerns.

Photo Credits: Lucia Macedo

Currently, the FDA has not approved any form of xenotransplantation in humans for both genetically modified and non-modified animal organs. Traditionally, the FDA classifies xenotransplantation as a drug under Section 351 of the Public Health Service Act. This classification means that xenotransplantation products (including pig hearts) must undergo specific trials to be approved by the FDA. Unfortunately, the nature of these trials makes it difficult for the product to fulfill the requirements of each process, including demonstrating the product is fit for transplantation into humans and gathering enough data to prove its safety. Due to these difficulties, getting xenotransplantation approved at the federal level (at least in the United States) is not likely to happen anytime soon. This lack of official approval means that for a legal xenotransplantation surgery to occur, the FDA must approve each individual procedure, making it impossible to perform on a widespread scale.

Much of the demand for xenotransplantation is due to organ shortages, as there are never enough organs to meet needs. However, even if xenotransplantation technology becomes widespread, allocation issues would still be prevalent. Inherently, xenotransplantation products cannot be considered an economic commodity and would require strict regulations to oversee the allocation of resources. Even with strict laws ensuring fair distribution, the surgery would be costly, making it difficult for uninsured or low-income patients to finance the procedure. The argument for focusing research on cost-efficient "preventative" healthcare rather than more expensive "diagnostic" healthcare (such as xenotransplantation) highlights the question of benefiting the select few (those who could afford the surgery) vs. the masses (those in need of basic healthcare). Government funding is not infinite, and developing new biotechnology like xenotransplantation can be extremely costly. Directing funding to such research could take away resources from those who need the most assistance.

One of the most pressing questions about xenotransplantation is the treatment of the animals who supply the organs needed for the procedure. Prior to harvest, donor animals are kept under conditions unsuitable for their biological natures. Many animals in the livestock industry live in a similar environment to the donor animals, often in cramped, artificial spaces created only to house the animal until its harvest. More recently, many countries have begun to attempt to eliminate these systems of abuse due to ethical concerns about the living conditions of such animals. If xenotransplantation becomes commonplace, similar regulations would have to be enforced to ensure the welfare of the donor animals.

In summary, the lack of official regulation, the trickiness of decommercializing the industry, the strained allocation of medical resources, and the ethical issues raised by the procedure all contribute to the growing concerns about the future of xenotransplantation. Legal regulation is crucial for the future success of xenotransplantation and governments will have to make many difficult decisions on how they will control this radical new biotechnology.



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