Xenotransplantation and Human Organ Trafficking: The Impact of Increased Organ Availability

ABSTRACT

The global shortage of organs for allotransplantation contributes to illicit trade in human organs. While clinical xenotransplantation is proposed as a potential solution to this global shortage, diverse factors contribute to human organ trafficking including global shortages, underdeveloped and under supported organ procurement infrastructures and related legislation, inadequate access to advanced medical therapies or insurance coverage, and poverty and corruption allowing exploitation of vulnerable populations. This article assesses competing predictions regarding the relationship between the advent of xenotransplantation and the global black market for organs. Some argue that a plentiful supply of xenografts will reduce or eliminate the demand that drives organ trafficking. This analysis highlights significant countervailing risks regarding (i) cost, availability, and equitable access; (ii) perceived quality / desirability of an allograft versus a xenograft; and (iii) the emergence of new illicit markets. We conclude that the effect of xenotransplantation on organ trafficking is presently unpredictable but an important metric for success in this field.

1. Introduction

Legally available organs for transplantation represent an estimated 10% of the global organ transplant need [1, 2, 3, 4, 5, 6]. Trafficking in persons for the purpose of organ removal and organ trafficking for transplantation represent two separate criminal activities under international legal frameworks and prey most on individuals in situations of acute vulnerability (e.g., undocumented migrants, refugees, detainees and/or people living in hardship poverty). Organ trafficking refers to the illicit removal and sale of organs, while trafficking in persons for organ removal involves the recruitment and exploitation of individuals for that purpose [7, 8]. While data are incomplete due to the clandestine nature of the criminal activity, organ trafficking has been reported in North Africa, South and South‐East Asia, Central America, and Europe [7]. Furthermore, United Nations documentation highlights the difficulty of detecting these crimes, as illicit transplants frequently occur within legitimate clinical settings, relying on the complicity of medical professionals and hospital infrastructures [7]. Currently, the Santiago de Compostela Convention, which opened for signatures on March 25, 2015, is the first and only binding international criminal law instrument in the field. The Convention criminalizes the trafficking of human organs, while also protecting the rights of the victims and promoting cooperation at national and international levels [9].

In 2004, the World Health Assembly (WHA) adopted resolution WHA 57.18, “Human organ tissue and transplantation.” Within the resolution, the WHA urged Member States “to take measures to protect the poorest and vulnerable groups from “transplant tourism” and the sale of tissues and organs, including attention to the wider problem of international trafficking in human tissues and organs.” [10] This provided the impetus for the original 2008 Declaration of Istanbul on Organ Trafficking and Transplant Tourism—a consensus document that, among other goals, urges governments to take measures to prevent organ trafficking and transplant tourism. The Declaration of Istanbul does not contain legally enforceable obligations, but rather is a statement of non‐binding principles. In 2018, the Declaration of Istanbul was revised, and the Preamble to the revision states that the achievements of organ donation “have been tarnished by numerous instances of organ trafficking, of trafficking in persons for the purpose of organ removal, and of patients who travel abroad to purchase organs from poor and vulnerable people. In 2007 it was estimated that up to 10% of transplants worldwide involved such practices.” [11] The United Nations estimates that the number could be significantly higher [12].

While the Changsha Communiqué states that xenotransplantation should not occur without enforceable national regulation capable of prohibiting unregulated procedures, the Declaration of Istanbul does not address xenotransplantation. The Declaration of Istanbul also fails to consider the potential commercialization of xenografts or how xenotransplantation might impact the illicit trade of human organs globally. This is unsurprising, as, until very recently, xenotransplantation had not reached significant application in human studies. Nonetheless, as of 2025, clinical trials of genetically modified kidney and extracorporeal liver xenotransplantation have been approved in the United States by the Food and Drug Administration [13]. Additionally, studies of xenogeneic kidneys and livers are being conducted in China [14]. Hence, the time is ripe for the transplantation community to consider potential beneficial impact of xenotransplantation on human organ trafficking. In short, is organ trafficking simply a matter of supply and demand or how can xenotransplantation be advanced to address this aspect of transplantation worldwide?

This article assesses predictions of the impacts of safe and effective clinical xenotransplantation on human organ trafficking. While successful xenotransplantation may reduce organ trafficking, we propose that significant uncertainty remains, additional problems may arise with the growth of xenotransplants, and continued vigilance will be required. Our discussion is limited to solid organ xenotransplantation with implications for cell and tissue xenotransplantation.

2. Organ Trafficking and Xenotransplantation: Competing Predictions

How will the introduction of xenotransplantation as a safe and effective clinical alternative to allotransplantation impact the global illicit trade in organs? There is considerable epistemic uncertainty. Some have suggested that the rise of xenotransplantation will reduce or even end human organ trafficking. Ekser and colleagues stated that, “Illegal organ trafficking and the use of organs from executed prisoners will be obviated.” [15] Solbach wrote, “Increased xenotransplantation would also help reduce illegal human organ trafficking and the incidence of potentially life‐threatening complications from living human donation.” [16] Recently, a position paper of the International Xenotransplantation Association (IXA) stated:

The gap between demand and supply of organs for transplant has led to organ trafficking, organ tourism, and commercialism. This problem remains an overwhelmingly negative issue and raises ethical dilemmas that could be resolved if xenotransplantation were successful and broadly adopted [17].

Competing theories exist. Richard Horton predicted the following regarding xenotransplantation:

The current donor system is based on altruism—donors give their organs without expecting anything in return. The commercial production and sale of organs will create a market that risks worsening disparities in access to transplantation [emphasis added]. Organ trafficking may intensify. All of these challenges we can predict today. It is time to prepare the public for this approaching new reality now [18].

These competing perspectives highlight uncertainty surrounding xenotransplantation's impact on human organ trafficking. In the following section, we analyze the rationale underpinning these predictions.

3. Assessment of Current Arguments

Xenotransplantation is predicated on addressing the demand for human organs which constantly outstrips the altruistic supply. Even in regions with “presumed consent” and optimized programs for procurement (e.g., Spain), organ shortages persist [19]. The argument that xenotransplantation will decrease or eradicate human organ trafficking are based on forecasted inverse supply and demand relationships: if the supply of organs from xenotransplantation increases, there will be a corresponding decrease in human organ trafficking. This seems theoretically plausible, for if xenografts are abundantly available there may be little reason for illicit trade in human organs. However, this model relies on a series of complex assumptions (see Table 1).

TABLE 1.

Xenotransplantation market scenarios and predicted effects on organ trafficking.

Xenograft access (cost, regulation, infrastructure)	Perceived equivalence (clinical & socio‐cultural valuation)	Market dynamic	Predicted impact on illicit organ trade
Broad (high)	High (viewed as clinically equal or superior to allografts; socially accepted)	Market displacement	Xenotransplantation (XTx) fundamentally disrupts the scarcity model. The demand for organs is met through legal, regulated channels, collapsing the economic viability of the black market.
Broad (high)	Low (viewed as a bridge therapy, clinically inferior, and/or stigmatized)	Market stratification	XTx becomes standard of care for some patients who cannot achieve allotransplantation. Marginalized, while affluent patients continue to seek allografts, sustaining a lucrative, specialized illicit market.
Restricted (low)	High (viewed as equivalent/superior, but highly expensive and restricted to HICs)	Market exclusivity	XTx serves only select patients. Global health disparities widen. Unmet demand among LMICs remains high, potentially intensifying human organ trafficking.
Restricted (low)	Low (experimental, prohibitively expensive, and/or clinically inferior)	Market stagnation	XTx fails to achieve clinical or economic viability. The current paradigms of organ scarcity and human exploitation remain unaffected.

3.1. Cost, Availability, and Equitable Access

Horton's prediction posits significant concerns: worsening disparities in access to transplantation may accrue with xenotransplants that may intensify human organ trafficking. We can only hypothesize about this supposition. Even within high‐income countries (HICs) with established allotransplantation, significant disparities in access exist across socioeconomic and demographic groups. The introduction of xenotransplantation may widen these gaps. Projected costs are uncertain [20]. Anticipated costs associated with breeding genetically modified source animals, complex novel immunosuppressive regimens, and post‐operative biosurveillance, make accessibility of clinical xenotransplantation dependent on inclusion in comprehensive health insurance and universal healthcare models. Such costs may not become apparent in sponsored clinical trials. If these therapies are not integrated into national coverage schemes or require substantial out‐of‐pocket expenses, xenotransplantation may become an option available only to the affluent. Rather than alleviating the organ shortage equitably, the lack of insurance coverage would further solidify healthcare disparities, leaving marginalized groups within HICs to face the same organ shortages that fuel the illicit human organ trade. HIC may be able to absorb these expenses. The cost of xenotransplantation may be justified as for allotransplantation when compared to the long‐term costs of therapies like hemodialysis for end‐stage renal disease or mechanical assist devices for cardiac dysfunction. Such options are less likely to be an option for patients in low‐ and middle‐income countries (LMICs). LMICs are unlikely to be able to absorb the costs of xenotransplantation infrastructure when they struggle with the costs of hemodialysis [21, 22, 23]. Such controversy emerged, for example, with costs associated with effective therapies for hepatitis C virus infection, including in publicly‐supported healthcare systems in higher income countries.

Given that most organ trafficking is concentrated in LMICs, this creates a paradox: the proposed solution (xenotransplantation) may not be available where this problem is most acute. As noted above, less affluent patients globally would continue to wait for human organs. Even with a sufficient xenograft supply, demand for illicit organs might persist due to economic, non‐economic and systemic factors (e.g., religious barriers to pig organ acceptance; views of xenograft inferiority to allografts; payments for organs), limiting the impact of xenotransplantation on organ trafficking. This might worsen the desperation that fuels the current black market. This is especially true as the global burden of noncommunicable diseases (e.g., hypertension, diabetes) driving organ failure continues to rise, driving the need for organ transplantation and intensifying pressure on the system. Such a scenario directly challenges the core principle of equitable access to healthcare.

This perspective must be balanced with a different reality. In regions without robust transplant infrastructures–due to the absence of organ procurement organizations or legislation or significant cultural opposition to living or deceased donation–xenotransplantation may provide a viable therapeutic alternative where none currently exists. In such contexts, the introduction of xenotransplantation could create a new standard of care, entirely separate from the dynamics of organ trafficking.

3.2. Perceived Quality and Desirability of a Xenograft

We do not yet know whether xenotransplantation will be a safe and effective clinical alternative to allotransplantation or as a bridge to allotransplantation. A thought experiment illustrates the issue: If xenografts have lower success rates and continue to require more intense life‐long immunosuppression than allografts, the demand for human organs may continue to increase among those who can afford them and maintain the black market for wealthy buyers unwilling to accept what they perceive as a lower‐quality xenograft. A decline in global organ trafficking requires that xenografts will be desirable compared to allografts. Cultural and religious acceptance challenge this assumption. In a large survey in Türkiye, approval for xenotransplantation from non‐halal animals, such as a pig, was very low (23.9% acceptance) among highly religious individuals [24]. While religious leaders among Muslims and Jews have generally endorsed xenotransplantation to save or to improve a life [25], public engagement will be required to operationalize clinical xenotransplantation. Cultural and religious objections, as well as stigma against receiving a pig organ, could complicate xenotransplantation's role as a universal solution to human organ trafficking.

3.3. The Emergence of New Illicit Markets

Might xenotransplantation create new illicit markets? This risk appears in the Changsha Communiqué and is plausible under weak regulation: “WHO should promote public awareness of the potential benefits of successful xenotransplantation and of the dangers of unregulated xenotransplantation, including xenotourism.” [26] There is a risk that individuals with high incomes could seek illicit xenografts particularly if xenotransplantation is framed or perceived as a temporary bridge to allotransplantation, creating new black‑market demands despite formal clinical availability. The commercialization of animal organs could open new avenues for illicit trade, including clandestine xenotransplant procedures using unregulated animal organs or theft of valuable, genetically modified animals. It may seem fanciful to think a physician would transplant a xenograft from an unknown source herd. Yet, surgeons in the illicit human organ market use organs from unscreened and uninformed donors. Commercialization of clinical xenotransplants risks making acceptable organ commodification that current laws are designed to prevent. This precedent suggests that, however unlikely, a black market for xenografts is not outside the realm of possibility.

While the emergence of new illicit markets seems unlikely, the lack of international harmonization of regulations for xenotransplantation (e.g., microbiological surveillance) poses a barrier to the long‐term, specialized medical care of recipients moving between countries with differing xenotransplant monitoring and clinical infrastructure. This may create clinical gaps in immunosuppressive management and xenozoonotic monitoring, posing risks to the individual and to public health.

4. Conclusion

The relationship between xenotransplantation and organ trafficking is uncertain. The optimistic view that a new supply of organs will eliminate the illicit trade risks oversimplification that ignores critical barriers of cost, equitable access, and perceived quality. Conversely, the pessimistic view suggests that commercializing organs could worsen health disparities, reduce voluntary donation, and create new, unregulated black markets for human and animal organs.

Ultimately, it may be most accurate to view xenotransplantation not as an adjunct to allotransplantation, but as a disruptive innovation. As with true innovation, its final impact on complex systems like allotransplantation and organ trafficking is unpredictable. We do not know the impact of key variables including clinical efficacy, costs for the genetically modified pig organs, and associated immunosuppressive therapies, organ quality, and distribution. While the future is unknown, the challenges are foreseeable. As the science of xenotransplantation advances, the global health and policy community must address these issues proactively.

The development of a comprehensive global regulatory framework—as a proactive measure to manage these risks—is complicated by a policy incentive gap. Many nations lack the immediate motivation to prioritize xenotransplantation policy, particularly LMICs where the more pressing need is for basic healthcare infrastructure and functional allotransplantation systems. The lack of prioritization allows illicit markets to take root as traffickers gravitate toward jurisdictions with the weakest oversight. To prevent the emergence of regulatory havens for illicit xenotourism, the international community must move to cohesive governance including:

• International policies must be aligned and updated including expansion of the Santiago de Compostela Convention and the Declaration of Istanbul to explicitly govern xenografts, with a focus on mitigating commercialization risks posed by animal‐derived organs.

• The global health community must develop frameworks for equitable distribution. These guidelines must emphasize enforceable national regulations and proactive public engagement to prevent exacerbation of the multi‐tiered global healthcare system.

• To accurately track the impact of xenotransplantation on illicit markets, international transplant registries and regulatory bodies must implement surveillance metrics. Key indicators should include tracking price shifts in illicit human organs, monitoring cross‐border activity for allo‐ and xeno‐tourism, and evaluating waitlist pressures across varying socio‐economic regions.

Ultimately, it is imperative that international regulatory authorities confront these multifaceted challenges, establishing ethical principles and harmonized frameworks necessary to ensure this promising technology solves, and not exacerbates, exploitation.

Disclosure

DJH is Chair of the International Xenotransplantation Association (IXA) Ethics Committee. LAP and EC are members of the IXA Ethics Committee. JF is IXA President. The views expressed here are their own and do not necessarily represent the IXA.