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New Cannibal Markets

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Jean-Daniel Rainhorn
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Samira El Boudamoussi

Part 7. Mapping National and International Responses

Medical Products of Human Origin: Towards Global Governance Tools

Luc Noël et Dominique Martin

Texte intégral

1The author is a staff member of the World Health Organization. The author alone is responsible for the views expressed in this article and they do not necessarily represent the decisions, policy or views of the World Health Organization.

2Medical products of human origin (MPHOs) encompass all substances that are derived wholly or in part from the human body and intended for clinical application. The presence of components of the human body in the therapeutic armamentarium may be thought of as a form of “survivor cannibalism” (Youngner 2003, 720): appropriation by necessity of biological materials without which we could not provide a range of medical products that offer the most effective treatment or indeed the sole remedy for many conditions impairing human health and wellbeing. MPHOs consist in or are derived from anatomical components retrieved from the bodies of living persons or from those of the dead, as well as their secretions and excretions. Examples include: organs for transplantation, blood and plasma products, tissue and cell products such as skin grafts for burns and bone matrix materials used in dentistry, ova and sperm used in assisted reproductive treatments (ARTs), and breast milk used to treat premature infants.

3Dependence on human beings to provide the components required for MPHOs distinguishes them from all other medical products. This dependence carries a range of unique responsibilities to ensure ethical and safe procurement, distribution, and use of MPHOs: prerequisites for societal acceptance of the public as source of the necessary human materials. For this reason, the World Health Organization (WHO) has established an organization wide initiative to develop a framework for global governance addressing the issues of self-sufficiency in MPHOs and the non-commercial nature of the human body and its parts as such. In this article, we explain the importance of this initiative and introduce its core strategic elements and ethical concepts.

Why products?

4The word “product” signifies that the component of the human body made suitable for clinical use results from a variable process involving human labor and technological intervention. The process starts with donor recruitment and selection, includes screening tests and possibly interventions to facilitate procurement of the biological materials required, and extends through procurement to testing, refinement, repair, or manufacturing of the product to enhance its quality and safety, as well as its suitability for implantation or use, and to preserve it for storage or transportation. Processing includes various forms of labeling, packaging, and further testing where required, before allocation of an MPHO to a patient directly or through a clinical practitioner or a health-care institution.

5Arguably, the term “product” risks alienating these medical resources from their origins in human donors, and fails to capture the common understanding of such things as transplanted organs or donor gametes. However, “product” aptly describes the reality of even these recognizably “human” therapeutic materials, as well as the hundreds of human “biologics” that are routinely used and recognized as products by regulators and clinicians. Importantly, use of the term “product” serves to reinforce the need for quality systems and for regulatory oversight. It emphasizes the responsibilities of “producers,” clinical users, and the national authorities in the domain of product liability. The transmission of infectious agents has been a concern common to MPHOs since the beginning of their widespread application in the early twentieth century. Several public-health crises involving MPHOs have occurred, such as the transmission of HIV through blood products and Creutzfeldt-Jakob disease through dura mater grafts (Eastlund 1995).

6MPHOs are by no means mere manufactured “medical products”: they are explicitly of human origin, which places concern for the human sources from whose bodies they are derived at the forefront of discussions concerning them. The human origin of MPHOs is easily overlooked as products are alienated from donors through time, distance, and attenuation of recognizably human features, yet it provides a rationale and common ground for a united approach to governance of all MPHOs, regardless of the many differences between them.

The challenges of failed governance

7Insufficient or untimely access to suitably matched MPHOs remains a major challenge within most health-care systems. For some countries, provision of MPHOs such as gametes for use in ART or even organs for transplantation may be a low priority in the face of competing healthcare needs. Nevertheless, shortages are a critical concern for many countries at varying levels of development. The shortage in organs for transplantation is perhaps the best publicized example, yet access to safe blood transfusion still represents a major public-health concern (WHO 2012). Despite estimates of more than 150,000 corneal grafts performed worldwide each year, unmet demand is a major problem in countries from India to Canada (Oliva et al. 2012; Lakey et al. 2007). Little is known about gamete shortages; prospective recipients may wait for two years for sperm in China (Ping et al. 2011), or up to six years for ova in France (Martin and Kane 2014). Demand for human tissue products is also largely unquantified, but sufficiency of supplies remains a concern even in North America where hundreds of thousands of grafts are performed each year (Lakey et al. 2007; Shiroff et al. 2013).

8Where demand for MPHOs exceeds the available supply, this may create opportunities for exploitation of vulnerable prospective source individuals and recipients, especially through commercial activities. The well-being and autonomy of donors and recipients may be compromised where provision of care conflicts with profit making, and equity in access to MPHOs and in donation of materials for MPHO production will be undermined where financial incentives influence donor recruitment or MPHO allocation.

9There are many varieties of trafficking in human body parts, some of which involve trafficking in human beings for removal of organs, ova, or other biological materials used in MPHOs. Trafficking activities also include illicit diversion of legitimately acquired MPHOs, or various illicit activities in procurement, trade or use of MPHOs without trafficking in human beings as such (López-Fraga et al. 2014). Among the diverse reports of illicit activities in MPHO procurement and use, violations of laws and regulations are often revealed seemingly by chance, following the deaths of donors or recipients (e.g., Sachan 2014; Reddy et al. 2013; Martin 2012, 138), or when scandals are uncovered by investigative journalists, researchers or health professionals (e.g., Scheper-Hughes 2006; Jing 2006). Predators take advantage of individuals and communities at moments of vulnerability due to economic crisis, natural disasters, civil unrest or war, to source materials that may be sold for profit. Recipients of such MPHOs may be unaware or disinclined to question the origin of these precious resources. The human source is easily obscured where linguistic, cultural, geographical and political barriers may impair efforts to trace and identify donors. The increasing use of the internet in MPHO trade and trafficking, and the falsification of documents at the point of procurement, throughout processing and in the labeling of MPHOs further undermine transparency.

10A common biology and physiology enables a transnational movement of MPHOs between human beings transcending culture, race, gender, age, religion, and citizenship. In an increasingly globalized world, exchange or sharing of MPHOs may exemplify the reality of a single common humanity. In this setting, “survival cannibalism” may be both justifiable and admirable. Yet, in the absence of effective laws and regulations to protect communities and individuals, procurement and use of MPHOs reveal the darker side of such cannibalism: a consumption that may destroy and efface the donor.

Governance of MPHOs: a responsibility for national authorities

11Although inadequate donation rates—especially of organs—attract significant public attention, the problem of MPHO shortages is multifactorial. In addition to donor recruitment issues, health systems require organizational infrastructure for procurement, processing, allocation, and clinical application of MPHOs. Society, through its governing authorities, has responsibility for the organization and oversight of MPHO services. Measures must be adopted within jurisdictions to enable service delivery during routine and crisis periods. Societal concern for health equity, as well as justice in the distribution of scarce resources contributed by the public, should guide efforts by policymakers to promote equity in access to MPHOs. Objective clinical criteria and ethical norms should inform the allocation of MPHOs, uninfluenced by the economic status of potential recipients or opportunities for financial gain among service providers. Further, authorities must regulate—and where necessary prohibit—practices that could result in harm to donors, recipients, and the public. Legislation is essential but requires an effective implementation and enforcement for protection of donors and recipients. Necessary protective measures include adoption of best practice standards of care, safety, and quality from donor selection and follow-up to assessing long-term outcomes in the recipient.

12National authorities should also recognize governance responsibilities that may arise in the setting of transnational activities. Where domestic policies and practices, or the actions of citizens abroad endanger foreign citizens and communities, authorities should strive to address these issues within the domestic jurisdiction and through international collaboration. A variety of international instruments provide tools with which to address particular areas of concern in the transnational setting, notably the Convention against Trafficking in Human Organs soon to be adopted by the Council of Europe (López-Fraga et al. 2014), and the United Nations Protocol to Prevent, Suppress and Punish Trafficking in Persons (UN 2004), which explicitly addresses human trafficking for the purpose of organ removal. There is, however, no comprehensive legally binding instrument to mandate minimum standards of practice with regards to MPHOs, nor to address the issues of commercialism and trafficking that may arise for any MPHO. International scientific and professional societies such as The Transplantation Society and the International Society of Nephrology, which together led the development of the Declaration of Istanbul on Organ Trafficking and Transplant Tourism, have demonstrated the impact of transnational collaborative action in fostering leadership, capacity building, harmonizing global standards, and combatting unethical practices (Danovitch and Al-Mousawi 2012).

The self-sufficiency paradigm

13The important role of governing authorities in meeting societal needs for MPHOs must be complemented by societal recognition of responsibility for donation of biological materials where possible. Where equitable allocation programs for specific MPHOs are established, all are potential recipients of MPHOs and thus may rightly be considered potential donors: a reciprocal duty to contribute to efforts in meeting needs arises from the expectation of having one’s own needs met. This ethos of shared responsibility and solidarity in meeting needs within a community underpins the self-sufficiency paradigm, which has now been invoked as a goal for policymakers and a foundation for governance of MPHOs in the context of blood (WHO 2012), organs (Delmonico et al. 2011) and gametes (Martin and Kane 2014).

14Self-sufficiency in a particular MPHO consists in meeting the needs of patients from a given population with an adequate provision of transplantation services and supply of that MPHO derived from the population. Key strategies for the successful pursuit of self-sufficiency were identified in the context of organs for transplantation during the Third WHO Global Consultation on Organ Donation and Transplantation (WHO 2011), which may be applied to all MPHOs:

  • government support and oversight, enabling the contribution of all members of society;
  • equity in donation among possible donors and equity in allocation;
  • donation education and health promotion with prevention of needs and integration with public-health programs;
  • trust of all stakeholders including the public, through transparency and professionalism.

15Equity, reciprocity, and solidarity are principles inherent to the self-sufficiency paradigm, in the context of a shared commitment to assist in meeting therapeutic needs while avoiding harm to donors, recipients and the community. These principles are applicable to all MPHOs despite their important differences. Challenges in motivating donation, assuring equity of access, and protecting donors and recipients are common to all MPHOs by virtue of their shared human origins and destinations, although the degree of difficulty in addressing these challenges will vary according to the MPHO concerned and the societal context in which self-sufficiency is pursued (Martin 2010, 388). A population adopting the goal of self-sufficiency in particular MPHOs may be defined by jurisdictional limits or organizational boundaries that are essential to effective procurement and distribution of MPHOs. Transnational agreements may allow small countries to pool their resources and work together to meet needs more efficiently. Furthermore, for some MPHOs meeting needs effectively requires global engagement to assist in matching prospective donors and recipients across the world (Martin 2010, 387).

Rejection of financial gain in the human body

16The use of financial incentives to recruit providers of biological materials for use in MPHOs is excluded by the self-sufficiency paradigm, as these will exacerbate inequities in the distribution of donors. Conversely, the removal of financial barriers to participation in donation opportunities, for example through coverage of expenses incurred by donors, is recommended as a strategy to promote equity and facilitate donation. Financial incentives would also impair efforts to promote donation as a reciprocal duty to be embraced by all those who enjoy the privilege of access to MPHOs. Furthermore, there are well-founded concerns that trade in MPHOs—whether regulated or illicit—exacerbates risks of harm to potential donors and recipients including coercion, exploitation, commodification, and compromised safety (e.g., Epstein et al. 2011; Pfeffer 2011; Pirnay et al. 2012). These harms derive from conflicts of interest that arise where donors, donor families, recipients, health professionals and others involved in procurement, use and distribution of MPHOs may derive profits that exceed the recovery of standard costs incurred during these processes.

17Claims that financial incentives are necessary to assure sufficient supplies of MPHOs are not supported by the evidence of progress towards self-sufficiency where prohibition of trade has been complemented by strategic efforts to remove barriers to donation, to encourage donation, and to prevent needs for MPHOs where possible. For example, Norway is effectively self-sufficient in renal transplantation, with an annual transplantation rate of 60 per million population matching the annual incidence of patients added to the—notably transparent and equitable—waiting list for transplantation (Figure 1) (Reisaeter et al. 2011). The key difference between Norway and the United States—where the gap between supply and demand shows little evidence of shrinking—appears to be the three-fold difference in the incidence of end-stage renal disease in the US. Incentive proposals frame the organ shortage as a simple problem of “supply and demand” that is best resolved by increasing supplies, and fail to consider that public-health interventions may significantly reduce demand.

Figure 1. Waiting list additions versus kidney transplants performed in 2011 per million population—high-income countries. (Data derived from the Global Observatory on Donation and Transplantation and published in Matesanz 2012).

Figure 1. Waiting list additions versus kidney transplants performed in 2011 per million population—high-income countries. (Data derived from the Global Observatory on Donation and Transplantation and published in Matesanz 2012).

Note: In many countries the rate of inclusion on waiting lists is not fully reflecting the incidence of transplantable end-stage kidney disease. There are biases such as the trend to keep patients on dialysis and the use of the waiting list to manage scarce supply of transplant. In Norway the waiting list is known to include all candidates to transplantation.

The WHO MPHO initiative

18All MPHOs present risks for safety that mandate traceability, vigilance, and surveillance; all present potential ethical hazards in donor recruitment and procurement of materials that mandate legislation, transparent consent policies and standards of care to assure respect for the human-rights of potential donors. These commonalities provide grounds for a shared framework for governance of all MPHOs.

19The WHO has developed an initiative on MPHOs that builds on the self-sufficiency paradigm to explore novel strategies and to encourage unprecedented efforts to meet needs, while protecting the human body and its parts as such from becoming the source of financial gain. The initiative is currently undergoing discussion and refinement through consultation with experts, scientific and professional societies and representatives of member states from all regions. It proposes to foster globally harmonized standards of practice for MPHOs and common tools to guide and support services providing MPHOs from donation through to clinical application. Its objective is to address the ethical concerns inherent to the human origin of these medical products while effectively and efficiently meeting patient needs. To achieve this goal, development and implementation of three complementary international resources to harmonize and improve access, safety, quality, and ethics of MPHO services are proposed. First, a set of standards for practice addressing issues inherent to the human origin of these medical products; second, the universal use of a consistent coding system for MPHOs, the Information Standards for Blood and Transplant “ISBT 128” (Warwick et al. 2013); third, a set of tools that exploits the global experience of vigilance and surveillance (V&S) for MPHOs for the benefit of all donors and recipients.

Standards of practice

20The standards of practice inherent to MPHOs derive from various sources including the WHO Guiding Principles on human cell, tissue, and organ transplantation (WHO 2010), and are currently undergoing development and revision. The aim of these crosscutting standards is to encompass the implications of the human origin of these medical products for their procurement, distribution, and use. The standards recognize features of the self-sufficiency paradigm, such as the responsibility of authorities, and through them, of each member of society, for meeting MPHO needs. Likewise, the standards highlight the importance of equity in donation and in the allocation of MPHOs. The standards require free, informed, and specific consent of living donors and recipients of MPHOs, protection of those incompetent to consent, and a legislative framework to support donation after death. Further, they emphasize the provision of education for children about donation and prevention of needs of MPHOs, as a core component of public-health policy, empowering citizens to participate in future donation opportunities.

21In prohibiting financial gain on the human body and its parts as such, the standards affirm the non-commercial nature of MPHOs. Noting that such financial gain is not prohibited in some countries, they emphasize the role of transparency in practice and policy. While protecting the privacy and confidentiality of donors and recipients is critical, transparency establishes and maintains public trust, and facilitates traceability, evaluation of outcomes, vigilance, and surveillance such that quality, safety, and efficiency of MPHO use may be optimized.

Universal coding with ISBT 128

22ISBT 128 is a global coding system for MPHOs used in 75 countries, in all regions of the WHO, by more than 4,600 establishments responsible for MPHO management. The International Council for Commonality in Blood Banking Automation (ICCBBA), a non-governmental organization in official relations with WHO, manages ISBT 128 to ensure a unique identifier is available for each MPHO and for each MPHO establishment in order to provide traceability for each product. ICCBBA maintains a globally consensual terminology of thousands of well-described MPHOs that can be translated in any language and coded with ISBT 128 to create identifying labels of universal readability.

23Harmonization of coding in this way enables information about products, and their characteristics and qualifiers to be transferred without risk of human error thanks to established formats and tables. The use of ISBT 128 strengthens safety and traceability and transparency concerning the origin and nature of MPHOs within a country and internationally. A common, consistent language and identification system facilitates data collection and analysis, including rapid tracing of recipients at risk, or sourcing of urgently needed MPHOs.

Optimizing global vigilance and surveillance

24Under the oversight of health authorities and in close collaboration with professionals, vigilance and surveillance (V&S) enables recognition and management of risks, many of which are common to all types of MPHOs. A risk recognized for the first time with one type of MPHO may be anticipated with others. By sharing V&S data, the global community thus has the opportunity to learn from experiences of adverse events elsewhere in the world, or in different clinical contexts. For instance, the NOTIFY project associates WHO and the Italian National Transplant Centre (CNT), a WHO collaborating center on V&S for human cells, tissues, and organs (Fehily et al. 2013). NOTIFY maintains tools to promote development of national V&S systems and to optimize the use of V&S data by the global community through engagement with scientific and professional societies. The NOTIFY website (www.notifylibrary.org) hosts the NOTIFY library, a public database currently containing more than 1,800 references corresponding to 949 case reports of adverse occurrences wherein a risk was identified or harm incurred.

Conclusion

25The WHO initiative aims to promote recognition and respect for MPHOs as exceptional therapeutic resources through the universal adoption of a globally transparent coding system, ISBT 128, the mutualization of V&S information and tools, and the harmonization of standards of practice as applied to all MPHOs. The initiative also aims to foster global consensus on the non-commercial nature of the human body and its parts as such, and to develop the ethical framework of the self-sufficiency paradigm to assist societies as they strive to meet their needs for these resources responsibly. Insufficient supplies of MPHOs result in premature deaths, missed opportunities to restore health and additional costs for health-care systems. Common origins in the human person distinguish these from all other medical products, and provide grounds for a common approach to governance and strategy in their procurement, distribution, and use.

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Table des illustrations

Titre Figure 1. Waiting list additions versus kidney transplants performed in 2011 per million population—high-income countries. (Data derived from the Global Observatory on Donation and Transplantation and published in Matesanz 2012).
Légende Note: In many countries the rate of inclusion on waiting lists is not fully reflecting the incidence of transplantable end-stage kidney disease. There are biases such as the trend to keep patients on dialysis and the use of the waiting list to manage scarce supply of transplant. In Norway the waiting list is known to include all candidates to transplantation.
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Auteurs

Charge of the Hematology and Transfusion Centre of Versailles and part-time advisor at the French Blood Agency. In 1999, he joined the World Health Organization (WHO) as coordinator, for Blood Transfusion Safety and later Clinical Procedures. He developed the topic of transplantation with WHO updated Guiding Principles on Human Cell, Tissue and Organ Transplantation. He led the WHO initiative for medical products of human origin and is now an independent part-time advisor on issues pertaining to medical products of human origin.

Lecturer in health ethics at the Centre for Health Equity, School of Population and Global Health, University of Melbourne, Australia. Her bioethics research focuses on ethical issues related to procurement, distribution and use of medical products of human origin, particularly where these arise in the transnational setting. She is a member of the Council of the Declaration of Istanbul Custodian Group, and cochair of the Ethics Committee of The Transplantation Society.

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