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Purpose of Review: There is a grave discordance between supply and demand for patients with failing organs largely due to an insufficient donor pool for transplantation. Xenotransplantation has been proposed as a solution to bridge this gap., Recent Findings: Recent success over the last decade in nonhuman primate models, due to emerging gene-editing technologies combined with novel immunosuppression regimens, has produced promising results in pancreatic islet cell, heart, lung, kidney and liver xenotransplantations., Summary: As the prospect of xenotransplantation is realized, safety and ethical considerations have come to the forefront of discussion. The WHO and World Health Assembly have encouraged member states to form regulatory bodies to govern human xenotransplantation studies with the highest standards. Here, we summarize the current regulatory landscape governing preclinical advances toward the first human clinical trials.

This article evaluates two proposals that the Organs Directive along with the commission's Action Plan 2009-2015 can be viewed as a form of hybrid governance. The Organs Directive is the first legally-binding supranational risk regulation devised in the field of organ donation and transplantation. The Directive is modelled on the earlier Directive dealing with blood, tissue, and cells. The Action Plan, which is soft law, will complement the Directive. The Directive and Action Plan requires additional administration procedures from the Member States with the EU Commission regularly monitoring the implementation of the work programme to ensure it is manageable for them. Before probing the Directive, the Impact Assessment (IA) undertaken by the EU Commission on organ donations, which is used to determine the rationale behind the adoption of the stringent Directive with the Action Plan, will be examined. The social, economic, and health impacts of the four regulatory options available to the Commission will be considered. The Directive and the Action Plan, which are finally adopted, will be discussed in detail, before the arguments are placed highlighting the fact that the Directive and Action Plan display a mode of hybrid governance. Next, the advantages and disadvantages of hybrid governance are laid out and conclusions are drawn as to whether the hybrid model was the best form of action in EU healthcare. In the conclusion, the article proposes the emergence of an "integrated model" within the Organs Directive, which is based on the fusion of the three governance structures: the OMC, comitology, and agencies., (Copyright by Cleveland State University.)

Publication is one of the primary rewards in the academic research community and is the first step in the dissemination of a new discovery that could lead to recognition and opportunity. Because of this, the publication of research can serve as a tacit endorsement of the methodology behind the science. This becomes a problem when vulnerable populations that are incapable of giving legitimate informed consent, such as prisoners, are used in research. The problem is especially critical in the field of transplant research, in which unverified consent can enable research that exploits the vulnerabilities of prisoners, especially those awaiting execution. Because the doctrine of informed consent is central to the protection of vulnerable populations, we have performed a historical analysis of the standards of informed consent in codes of international human subject protections to form the foundation for our limit and ban recommendations: (1) limit the publication of transplant research involving prisoners in general and (2) ban the publication of transplant research involving executed prisoners in particular., (Copyright © 2013 American Association for the Study of Liver Diseases.)

Progress in transplantation outcomes depends on continuing research into both donor and recipient factors that may enhance graft and patient survival. A system of licencing for transplantation research, introduced by the Human Tissue Act 2004, which separates it from the transplantation process (then exempt from licencing), has damaged this vital activity by a combination of inflexible interpretation of the 2004 Act and fear of criminal liability on the part of researchers. Now, following the European Union (EU) Directive (2010) on standards of quality and safety of human organs intended for transplantation, new UK Regulations have been drafted, which are intended to implement it. These Regulations impose a compulsory licencing system, similar to that for research, on the whole transplantation process. This goes beyond what is required by the Directive and may even have an inhibitory effect similar to that already seen in research. Initial draft Regulations went further, imposing criminal sanctions for breaches. However, following a public consultation process, the Department of Health (DH) has recently stated that, as a result of the overwhelming view of respondents that the proposed licencing system was unnecessary, all sanctions under the final Regulations are now decriminalised, with the sole exception of operating without a licence. While this does not eliminate the negative effect of licencing, it does suggest an awareness of the DH that excessive regulation unnecessarily harms the transplantation process. An opportunity thus arises for the Human Tissue Authority (the regulatory body for both the new licences and research licences under the 2004 Act) to end the current illogical and harmful separation of transplantation and transplantation research by ensuring that all centres licenced for organ donation, retrieval and transplantation are also fully licenced for related research.

The Declaration of Istanbul is the first document that has been established by the international transplant community that defines and prohibits transplant commercialism and organ trafficking. Its Custodian Group has successfully led various countries to implement legislation against trafficking and commercialism. The question arises, however, whether efforts to prohibit organ trade are realistic and effective. The Declaration differentiates trafficking from commercialism, yet it does not mention how both acts should be approached by policy. Policies that address transplant commercialism work differently from policies that tackle organ trafficking. There is considerable room for improvement in the current prohibitive approach to commercialism and organ trafficking. The Custodian Group and World Health Organization (WHO) should address commercialism by encouraging the expansion of living donation in the same manner as they encourage deceased donation. Furthermore, the Custodian Group and the WHO can improve their strategy to combat organ trafficking by raising awareness for enforcement. To achieve a consistent and effective prohibition of trafficking, legislation and law enforcement must go hand in hand. Ideally, this can best be achieved by close collaboration between the medical field and (international) criminal justice agencies., (© copyright 2011 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Intergovernmental agencies have recognized that inconsistencies in the way that nation states regulate commerce in human kidneys lubricate transplant tourism, and have repeatedly exhorted recalcitrant governments of both organ-importing and organ-exporting nations to criminalize the exchange of cash for kidneys. Yet these same organizations have elected to remain silent on inconsistencies in the regulation of the trade in human eggs that lubricate fertility tourism. This article is a critical feminist analysis of this paradox. Sketches of the histories of regulation of the global markets in human kidneys and human eggs allow attribution of the different approaches to sales of kidneys and eggs to the triumph of neo-liberalism in the 1990s. Neo-liberalism supports the growth of the medical tourism industry and its niche market catering for infertility, and is responsible for exacerbating the relative disadvantage of poor and powerless women in destination countries, thereby creating the conditions for 'bioavailability', that is, the willingness to exchange body parts for cash. The paper identifies a disturbing correlation between deeply engrained conservative attitudes to women and a plentiful supply of eggs, and concludes by suggesting that what women need to lift themselves out of poverty and discrimination is secure and dignified work., (Copyright © 2011 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Organ transplantation must be viewed in relation to the prevailing cultural, religious and economic conditions of a nation. Over the past two decades, Pakistan has emerged as one of the largest centres for commercial renal transplantation. Government efforts, supported by professional associations, civil society organizations and the media, along with World Health Organization technical assistance, have led to the development of legislation regulating this practice and curbing organ trade in conformity with international guidelines. Although only two years have passed since the enactment of the law, there is evidence that conditions have significantly improved, raising hopes for ethical and safe organ transplantation in Pakistan. This study reviews the salient features of the legislation and lists the foreseeable evolving challenges and opportunities.

Purpose of Review: 'Global transplant commercialism' (practices and policies involving international trade in organs from living vendors, e.g., 'transplant tourism') is currently subjected to unprecedented criticism. In parallel, the debate around 'local transplant commercialism' (practices and policies that confine trade in organs from living vendors to national markets or economic unions) is heating up. In an attempt to assess the potential outcomes of these trends, this article reviews and discusses some sociological and ethical issues, ending with a proposal for a reinvigorated anticommercialist strategy., Recent Findings: The current international campaign against global transplant commercialism is conducted by an ad hoc alliance between strange bedfellows, proponents of local transplant commercialism on the one hand and opponents of any transplant commercialism on the other. Disparities in the rigor of the respective ethical discourses, the expanding list of precedents of legitimized commerce in the human body, and the political economy of transplantation, all suggest that the former have the upper hand., Summary: Recent achievements in the struggle against international organ trafficking may not herald the abolition of transplant commercialism but rather presage its reconfiguration in deglobalized forms. In light of such a prospect, those who wish to prevent the pervasive commodification of the human body from entering the gates of transplant medicine should consider devising a new, perhaps more radical, strategy.

Purpose of Review: To consider proposals to use financial incentives for organ donors that have become a subject of intense controversy in both lay and medical press (in contradistinction to the removal of financial disincentives, which is essentially noncontroversial although typically not practiced)., Recent Findings: In a concerned response to the shortage of organs the office of Senator Specter of Pennsylvania has been the source of a proposal to amend the 1984 United States National Organ Transplant Act, which has been interpreted to prohibit such incentives. The proposal would permit various forms of financial incentives for donation to no longer be prohibited., Summary: The amendment would have unintentional negative consequences that could undermine, rather than strengthen, the national and international organ transplant endeavor. These concerns are considered in my personal correspondence to Senator Specter's office on which the text is based.

Organ commercialism, which targets vulnerable populations (such as illiterate and impoverished persons, undocumented immigrants, prisoners, and political or economic refugees) in resource-poor countries, has been condemned by international bodies such as the World Health Organization for decades. Yet in recent years, as a consequence of the increasing ease of Internet communication and the willingness of patients in rich countries to travel and purchase organs, organ trafficking and transplant tourism have grown into global problems. For example, as of 2006, foreigners received two-thirds of the 2000 kidney transplants performed annually in Pakistan. The Istanbul Declaration proclaims that the poor who sell their organs are being exploited, whether by richer people within their own countries or by transplant tourists from abroad. Moreover, transplant tourists risk physical harm by unregulated and illegal transplantation. Participants in the Istanbul Summit concluded that transplant commercialism, which targets the vulnerable, transplant tourism, and organ trafficking should be prohibited. And they also urged their fellow transplant professionals, individually and through their organizations, to put an end to these unethical activities and foster safe, accountable practices that meet the needs of transplant recipients while protecting donors. Countries from which transplant tourists originate, as well as those to which they travel to obtain transplants, are just beginning to address their respective responsibilities to protect their people from exploitation and to develop national self-sufficiency in organ donation. The Declaration should reinforce the resolve of governments and international organizations to develop laws and guidelines to bring an end to wrongful practices. "The legacy of transplantation is threatened by organ trafficking and transplant tourism. The Declaration of Istanbul aims to combat these activities and to preserve the nobility of organ donation. The success of transplantation as a life-saving treatment does not require-nor justify-victimizing the world's poor as the source of organs for the rich" (Steering Committee of the Istanbul Summit).

The number of xenotransplantations may increase despite the many concerns about the likelihood of spreading known and unknown infectious diseases. Regardless of the safety precautions employed in the early trials, the risks remain unknown. Zoonotic and even xenozoonootic diseases are not remote possibilities; they exist in various forms and come from various sources. The nature of transplantation requires the suppression of the immune system to levels where opportunistic infections may take route. Even if procedures to avoid increased levels of immunosuppression to the recipient were successful, risk to third parties, whose immune systems would not be equipped to fight off the infection, would remain. In this context, the PHS Guidelines provide a useful starting point, but they do not go far enough. First, the Guidelines are merely suggestions; this needs to be changed to require institutions undertaking xenotransplantation research and clinical trials to comply with the Guidelines. Second, every possible effort should be made to protect third parties from disease transmission. This requires and justifies placing restrictions on recipients that, in an ordinary context, would be unacceptable. Third, xenotransplantations should occur only after all other medical measures have been exhausted. Until the time when disease transmission risks are scientifically insignificant or cures for the transmitted diseases are found, mandatory guidelines with stringent requirements are the best means of balancing the interests of society against the potential beneficiaries of xenotransplantation.

In 1986 the Belgian Parliament adopted a law on the removal and transplantation of organs and tissues. Five years later, it has become clear that this law needs to be revised. The main difficulties relate to the distinction between the removal of organs for therapeutic and experimental use, which has proved to be unadministrable; the rules regulating the removal of organs from living minors; the definition of and criteria for determining death and the involvement of relatives in the decision to remove organs from dead donors. This article proposes alternative solutions, keeping in mind the need for harmonized rules on the removal of organs in a broad European perspective.