Ethical Issues in Transnational Eye Banking

REVIEW

Dominique E. Martin, PhD, MBBS, BA (Hons),* Richard Kelly, MD, BBiomed,† Gary L. A. Jones, BSc (Econ),‡ Heather Machin, RN, MBA,§ and Graeme A. Pollock, PhD, MPH, BSc (Hons)¶

discussion of issues relating to tissue-derived products and Purpose: To review ethical issues that may arise in the setting of musculoskeletal tissue banking, rather than eye banking transnational eye banking activities, such as when exporting or specifically.2,5 As recognized in the recent World Health importing corneal tissue for transplantation. Organization (WHO) Initiative on MPHOs, which aims “to Methods: A principle-based normative analysis of potential common support the development of global consensus on guiding dilemmas in transnational eye banking activities was performed. ethical principles for the donation and management of [MPHOs],”6 a number of ethical concerns are common to Results: Transnational activities in eye banking, like those in other all MPHOs, including ocular tissues used in transplanta- fields involving procurement and use of medical products of human tion.1,7 Common concerns associated with transnational origin, may present a number of ethical issues for policy makers and movement of MPHOs include national self-sufficiency, donor professionals. Key ethical concerns include the potential impact of autonomy, equity in resource distribution, and care of donors export or import activities on self-sufficiency of corneal tissue supply and recipients.1 In this article, we briefly review several within exporting and importing countries; potential disclosure ethical issues that may be associated with transnational eye requirements when obtaining consent or authorization for ocular banking activities, using the example of importation and tissue donation when donations may be exported; and difficulties exportation of corneas for transplantation. inherent in assuring equity in the allocation of tissues available for In 2012, an estimated 11% of corneal transplants export and in establishing and respecting standards of safety and performed worldwide used imported tissue, with 27 countries quality across different jurisdictions. wholly dependent and 43 countries partially dependent on imported tissue.4 Eight percent of corneal tissue procured Conclusions: Further analysis of specific ethical issues in eye annually was reportedly exported, primarily from the United banking is necessary to inform development of guidelines and other States, which accounted for 85% of corneal exports, Sri governance tools that will assist policy makers and professionals to Lanka (9%), and Italy (3%).4 Thus, of the 116 countries support ethical practice. currently active in corneal transplantation, at least 70 of these Key Words: ethics, eye banking, corneal transplantation are directly involved in transnational eye banking activities.4 Although such transnational eye banking activities may be (Cornea 2017;36:252–257) a rare occurrence or represent a small proportion of activity for many eye banks, for others, the export or import of corneas may substantially influence their capacity to meet the thical issues concerning the transnational movement of transplant needs of the population they serve. In reviewing medical products of human origin (MPHOs) such as E ethical dilemmas that may arise in the setting of import or organs, gametes, and blood products have been extensively – export of corneas, we lay the foundations for further ethical explored in the academic literature in recent decades.1 3 In analysis of global eye banking activities, which is necessary contrast, issues related to the transnational movement of to inform the development of guidelines for governance of human ocular tissues such as corneas have received little 6 attention, despite a significant volume of global activity.4 MPHOs such as those being prepared by the WHO. To our Corneas are usually referenced only in the context of broader knowledge, there are no analyses dedicated to the ethics of eye banking activities in the extant peer-reviewed literature. Throughout the text, we highlight recommendations for Received for publication May 22, 2016; revision received October 6, 2016; practice grounded in our analysis, which we summarize in accepted October 9, 2016. Published online ahead of print December 1, Boxes 1–4. 2016. From the *School of Medicine, Deakin University, Geelong, Australia; †St Vincent’s Hospital, Melbourne, Australia; ‡Veneto Eye Bank Foundation, Box 1. Recommendations for promoting self-sufficiency Zelarino-Venice, Italy; §Lions Eye Donation Service, Centre for Eye Research With the exception of transnational eye banking Australia, Royal Victorian Eye and Ear Hospital; and ¶Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia. activities involving a reciprocal exchange of tissues and/or The authors have no funding or conflicts of interest to disclose. collaboration in the pursuit of regional self-sufficiency, Reprints: Dominique E. Martin, PhD, MBBS, BA (Hons), Geelong Waurn import or export activities should be designed as temporary Ponds Campus, Locked Bag 20000, Geelong 3220, Australia (e-mail: strategies that are implemented in conjunction with, rather [email protected]). 8 Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. than as substitutes for, eye bank development programs.

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Copyright Ó 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Cornea Volume 36, Number 2, February 2017 Ethical Issues in Transnational Eye Banking

1. Export activities should be conditional on the exis- the Eye Banking association of Australia and New tence of a feasible “exit plan” outlining steps for the Zealand.9 These principles should be reviewed to development of local infrastructure and resources ensure that they are fit for the purpose and required to provide services in the long-term; or; consistently applied to local and transnational 2. If local eye bank service development is considered activities. Consultation of an ethicist and relevant unfeasible in the long term, for example, because of stakeholders will assist in development of guide- a low population, then a long-term plan for meeting lines to support ethical policy and practice. patient needs should be elaborated. 2. Checklists identifying requirements or expectations of import or export activities should be developed. These may include items such as • Code of ethics to be followed; • Required documentation such as evidence of Box 2. Recommendations for promoting autonomy legislation governing procurement, import or 1. Donation decision makers should routinely be export, and use of human tissues as well as informed of the possibility that donated tissue may consent forms, and of accreditation by an appro- be exported if there is no suitable local recipient. priate licensing body; details of operating systems 2. Information about regional or international tissue and standards, etc; fi • Mechanisms for reporting of outcomes; sharing programs and the bene ts of export activi- • ties, etc, should also be made available to donation Fees and charges. decision makers. 3. Potential recipients of corneal tissue should routinely be informed that their transplant will involve use of a product of human origin, and, where this possibility exists, that it may be obtained from tissue donated in POTENTIAL ETHICAL CONCERNS IN THE a foreign country. CONTEXTOFEXPORTANDIMPORTOFCORNEAS Self-Sufficiency in Donation and Transplantation fi Box 3. Recommendations for assuring quality and safety Self-suf ciency in corneal transplantation refers to the Before engaging in import or export of corneal goal of meeting needs for transplantation within a given tissues, both sending and receiving agencies or individuals population using transplant services and corneal tissue 1 fi should confirm: obtained from within that population. Self-suf ciency in 1. The procurement of corneal tissues in a manner that many MPHOs such as blood or organs is commonly pursued respects donors and the integrity of donation at the national level, but regional collaboration often occurs to decision making; ensure that smaller populations can together meet their needs for transfusion or transplantation in a timely manner.1,10 2. The necessary written authorization from relevant fi health authorities for the export, import, and/or Economies and ef ciencies of scale in procurement and application of these tissues; processing systems as well as distribution networks may be 3. The availability of professionals who are suitably better achieved through regular or ad hoc subnational or qualified and legally authorized to use the supranational collaborations, in which donor tissue is shared, imported tissue; which involves potential export and import of tissue by all 4. That recipient health services are adequately equip- collaborating partners as required. Australia, for example, has ped with operating rooms and staff responsible for a cooperative relationship with New Zealand in which postoperative follow-up; resources such as organs or corneas for transplantation are 5. Mechanisms for traceability and reporting of out- shared between both countries to meet urgent needs and fi 11 comes of tissue use. ensure that available resources are used ef ciently. Although controversial in the context of some MPHOs such as plasma-derived products,12 the pursuit of self-sufficiency in other MPHOs such as deceased donor organs is commonly a goal of health authorities.13 Box 4. Tools to assist organizational and professional In the absence of an established program of interna- decision making tional cooperation in donation and distribution of corneal tissues, there is a reasonable expectation on the part of 1. Ethical guidelines societal members—who comprise the potential donor pop- • fi Identi cation of the ethical principles that should ulation—that their donations will be used primarily to meet govern policy and practice within an institution or the needs of that population. This norm accords with country is essential (see, for example, the Bioethical customary donation promotion strategies, which highlight Framework for Policy and Procedure (2015) from the value of donation in meeting the needs of potential

Copyright Ó 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Martin et al Cornea Volume 36, Number 2, February 2017 recipients within that population, and perception of MPHOs domestic programs. Such costs include those associated with as societal resources.10 A New York eye bank, for example, establishment of legislation, governance mechanisms, eye bank highlights New Yorkers as recipients of donations on its Web staff training and infrastructure, and development of long-term site (www.eyedonation.org). The prioritization of the needs of donor awareness programs in the community. Exporting eye the local population or those of domestic citizens and banks should work with importers to ensure that the short-term residents over those of potential recipients who reside in benefits of increased tissue supply do not occur at the expense foreign countries is often justifiable on practical and ethical of longer term benefits such as development of a sustainable grounds. Practically, allocation of many MPHOs, including local supply of tissue. The availability of tissue for export from corneas, is most feasible—and transplant outcomes may be some countries serves an important role in addressing shortages better—within jurisdictional borders and limited geographical internationally, but establishing adequate domestic supply regions.14 Ethically, respect for reciprocity and solidarity provides greater protection and independence from the dynam- underpins the case for prioritization of domestic patients— ics of international supply over which importing banks may those who have the potential to shoulder the burdens of have less control, as advocates of self-sufficiency in other donation should be entitled to share in the benefits of MPHOs have noted (Box 1).8 transplantation.15 In contrast to forms of “directed donation” in which individual potential deceased donors seek to ensure allocation Donation Decision Making and Disclosure of of their organs or tissues to members of specific domestic Export Activities subpopulations, such as members of particular ethnic, reli- Respect for the dignity and autonomy of donors and their gious, or gender groups,16 prioritization of the needs of families is the foundation for the ethical procurement of human domestic patients through transplant access or allocation biological materials. Systems of consent for, or authorization policies is an accepted international norm, albeit one that is of, donation may be based on a presumption of consent, or rarely made explicit. In practice, such prioritization usually require an explicit choice to donate. In both cases, the final occurs before allocation of MPHOs, with the exclusion of donation decision should be the result of an informed and foreign patients from waiting lists for organs or tissues, or voluntary choice. Donation decision makers, including indi- from publicly funded health care services in which MPHOs viduals registering their intention to donate and next-of-kin are distributed.15,17 In Australia, for example, foreign patients authorizing donation on behalf of the deceased, should be able are not entitled to join national transplant waiting lists, except to choose freely whether to donate and should be competent in “exceptional circumstances.”11 Once access to the list is and sufficiently informed to understand the implications of granted, there is no further discrimination on the grounds of their decision. Although some information is not deemed nationality or residency in allocation of organs. In some essential for donation decisions, such as disclosure of the countries, domestic residents are prioritized at a later stage, identity of potential recipients of deceased donations, informa- with foreign patients granted access to the waiting list but tion about the background conditions of the system in which accorded lower priority in organ allocation protocols.15 donation, allocation, and use of MPHOs forms an important Where the collected donated materials are in excess of contextual framework for informed decision making. the domestic population’s needs, unilateral export activities— Most donors and their families willingly entrust eye in which no reciprocal import of tissue is anticipated—may banks to make specific decisions about the allocation and use enable fulfillment of donors’ altruistic goals. In Sri Lanka and of donations; however, such trust is grounded in societal in the United States, for example, corneal donations are beliefs about the background conditions of deceased donation sufficient to meet the needs of domestic patients, and practices and systems. Donation decision makers are likely to additional corneas procured are exported to other countries.18 assume that donation activities are legal, that donations will However, experience from the field of solid organ trans- be allocated fairly and for the purpose of improving health, plantation indicates that export-type activities such as alloca- and, as already discussed, that donations will primarily be tion of deceased donor organs to foreign patients do not used to address the needs of others living in the country or always occur in the context of a supply that is surplus to the region of donation. Information provided to donation decision needs of domestic patients.15 This is particularly the case makers when encouraging donation or obtaining consent where financial barriers to transplantation may preclude should address important background assumptions, especially access for domestic patients while encouraging provision of if these may be inaccurate.19 transplant services to wealthier foreign patients.15 Eye banks Where there is a possibility that donated tissue may be may not intend to prioritize foreign patients; they may have exported, disclosure of this fact constitutes information that is limited abilities to improve access to corneal transplantation necessary for informed consent of donation decision makers. for domestic patients, as such access often depends on First, because exportation may significantly alter the pro- universal coverage of health services. cesses and outcomes of donation, and thus may influence the Where tissues are available for export, eye banks should donation decision, and second because the information is also be concerned about the impact of exports on the pursuit of likely to be inherently valued by decision makers even when self-sufficiency in importing countries. Reliance on regular it does not influence the decision. We briefly elaborate on supply of corneal tissue from foreign eye banks may discourage these claims below. domestic efforts to develop sustainable eye banks, particularly Although there has been no investigation of the when significant investment costs may be required to establish potential influence of export activities on decisions about

Copyright Ó 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Cornea Volume 36, Number 2, February 2017 Ethical Issues in Transnational Eye Banking ocular tissue donation, and media reports in exporting benefits of collected donor tissue while promoting equity of countries such as Sri Lanka suggest that export of corneal access to these benefits. Determining acceptable standards of tissues is a point of national pride,20 potential donors may service delivery to justify the export of tissue to particular support prioritization of the needs of fellow nationals where destinations will require careful evaluation by the interna- donations are insufficient to meet the needs of domestic tional community of outcomes of tissue use in various patients. Research in the field of solid organ donation settings. Establishment of standards for international eye suggests that some people may be unwilling to donate organs banking activities by the WHO in collaboration with pro- when there is the possibility that these may be transplanted fessional organizations such as the Global Alliance of Eye into foreign patients, especially if this occurs at the expense of Banking Associations (GAEBA) would help to encourage meeting domestic patients’ needs for transplantation.21 and support export activities that are consistent with the The consequences of corneal donation may also be promotion of best practice care for donors and recipients in all altered by the prospect of tissue export because clinical countries. International consensus on standards for export and outcomes of corneal transplantation will be influenced by import of corneal tissues should aim to reduce disparities in factors such as the health care system in which tissue is used quality and safety, which may be seen as reflecting a multi- and the health and socioeconomic status of the intended tiered system of quality in eye banking and corneal trans- recipient population.22 It is thus reasonable to assume that plantation, and also to ensure that concern for the potential donors may have an interest in receiving information optimization of transplant outcomes does not unduly com- about the policy for allocation of donated tissue, including promise equity of access to corneal transplantation (Box 3). information about the possibility of export of tissue. Even if the possibility of export does not significantly influence decision making by potential donors, decision Equitable Allocation of Exported Corneas makers may value disclosure. Provision of this information, Concern for the promotion of health and quality of life including reassurance that export policies do not undermine should encourage both importers and exporters of corneas to efforts to meet transplant needs of domestic patients, may be engage with international collaborators that have well- required to ensure that donor autonomy is respected. The Eye established systems of quality and safety control. However, Bank Association of America, for example, informs pro- other factors may influence the selection of destinations for spective donors that “While EBAA members are able to fulfill exported tissue, or of sources for importing tissue. In particular, all of the demand for corneas in the US, and provided economic factors such as the costs of procuring, processing, a further 28,000 corneas for use internationally, there are 10 and exporting tissue from a specific country may encourage million cornea-blind individuals worldwide.23” Fear of exporters to select wealthier destinations, and importers to decline in consent rates should not discourage disclosure select lower cost foreign banks. As stated in the WHO Guiding when weighed against the potential consequences of loss of Principles on Cell, Tissue, and Organ Transplantation, “All trust in procurement and allocation programs,24 as may occur health care facilities and professionals involved if export activities are retrospectively discovered by donor in.tissue.procurement and transplantation procedures families and the wider community (Box 2). should be prohibited from receiving any payment that exceeds the justifiable fee for the services rendered.27” Care must therefore be taken in the context of export and import activities Improving Human Health Through to avoid commercialism and profiteering, and also to protect Corneal Transplantation transnational eye banking activities from trafficking. Ethical obligations of exporting banks include non- Even unfounded allegations or fears of trafficking may maleficence, duty to protect potential recipients from harm, undermine public support for donation, and trust in eye and beneficence, duty to promote the beneficial impact of banking systems. Actual trafficking undermines the equitable exported tissue through appropriate use in patients requiring allocation of products and also exploits vulnerable populations transplantation. A number of practical factors may influence who are most likely to suffer harm through use of trafficked the overall balance of benefits and harms associated with the products that may be unsafe or of inferior quality. Trafficking export or import of ocular tissue. These include the quality of of tissues may involve falsification of documents attesting to tissue selected for export; the ability of transport and storage the origins and qualities of available tissues, as occurred in systems to maintain the quality and integrity of the sent tissue; 2013 with corneal tissue exported from the United States to and the ability of receiving banks or professionals to ensure Egypt (K Corcoran, personal communication, December 3, that exports are appropriately used, and to provide care and 2013); it may also involve illicit trade or procurement of tissue follow-up for recipients. Although eye banks in many from deceased persons without legally valid consent.28,29 countries follow qualified minimum medical standards Trafficked corneas may expose recipients to increased risks and technical guidelines such as those established by the of infection or other complications including graft failure, if European Eye Bank Association,25,26 differences remain in inadequate donor screening, tissue evaluation, and quality of international standards of practice for the quality and safety of processing and transportation occurs.30 tissues, as well as differences in risk profiles of recipients and When eye banks procure more corneas than can be used in the urgency and severity of need for corneal transplants in by the domestic patient population, externally justified and particular countries. These differences may create ethical transparent criteria should be determined and guidelines estab- uncertainty for exporting banks striving to maximize the lished to assist exporting banks in equitably allocating corneas to

Copyright Ó 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Martin et al Cornea Volume 36, Number 2, February 2017 foreign eye banks or to foreign or domestic corneal surgeons above have been explicated in greater depth, we provide some (eg, those performing surgery abroad18) who will in turn allocate preliminary general recommendations for eye banks and these to foreign recipients. Due consideration must be given not surgeons involved in the export or import of corneas. only to feasibility concerns and equality of opportunity for First, we note that legislation is a critical governance foreign countries to import tissue, but also to the utility of mechanism that supports ethical practice and policy.33 corneal grafts in particular populations, and the availability of Some countries that lack eye banking programs may also alternative sources of corneas. The ability of stakeholders within lack legislation or regulations governing the importation the recipient nation to use imported tissue as part of a strategic and use of human tissue, whereas other countries may lack plan for development of domestic eye banking, consistent with specific provisions governing transnational movement of the pursuit of self-sufficiency should also be considered. human biological materials. All those involved in impor- Experience in the Philippines, for example, suggests that tation or exportation of corneas should be familiar with importation of tissue can support eye bank development.31 relevant laws and regulations in all jurisdictions that may Efforts to promote equity in allocation of corneas to foreign have a stake in their activities. Those involved in exporting banks or service providers such as surgeons may be undermined tissue to countries where legislation may be absent, for if those receivers do not in turn distribute transplantable material example, countries that have not established an eye bank, equitably within their own population. Discussion of local should be particularly sensitive to potential ethical and allocation systems should form part of decision making for legal issues that may be exacerbated in the absence of eye banks and surgeons considering export of tissue.18 regulatory safeguards. Second, we urge eye bank staff and surgeons to consider implementing the strategies outlined in this article ADDRESSING THESE ETHICAL CONCERNS within their own institutions, countries, or regions, or aligning The first step in addressing these ethical concerns is them with their existing policies and procedures. These for professionals involved in transnational eye banking recommendations are also applicable to any other human activities to become familiar with them, and to explore their tissues and cells intended for ocular application (Box 4). implications within the context of specific health care systems and socioeconomic environments. Second, specific issues require deeper exploration in the form of local, CONCLUSIONS regional, or international consultations and empirical Despite increasing globalization of the eye banking research, for example, the issue of the potential impact of community, as evident in the creation of the Global Alliance export or import activities on the pursuit of self-sufficiency. of Eye Banking Associations (www.gaeba.org) by conti- Third, development of clinical and technical standards for nental eye bank associations and their members, trans- specific populations will be enhanced by international national eye banking activities remain the province of collaborations establishing an evidence-base for such stand- individual eye banks and partnerships between individual ards and developing ethical guidelines to govern practice in banks or within specific regions. Import or export of corneas the cross-border setting. may occur rarely, on an ad hoc basis, or may constitute The WHO has already established a number of global asignificant proportion of a large eye bank’sregular tools that serve to address issues relevant to all MPHOs, activities. Although individual relationships between im- including corneal tissues used in transnational eye banking porting and exporting institutions play a fundamental role in activities. These include the aforementioned Guiding Princi- determining the process and outcomes of such activities, ples of Human Cell, Tissue, and Organ Transplantation and potential ethical concerns and oversight of activities can be current MPHO Initiative6,27; the Global Glossary of terms and obscured in the transnational setting. Professional ethical definitions on donation and transplantation32; the ongoing obligations are not limited by jurisdictional borders, and eye NOTIFY project, which provides a registry for reporting of bankers and corneal surgeons should take responsibility for outcomes and serious adverse events or reactions30; an Aide- the consequences of their decisions to export or import Memoire with advice for national health authorities regarding tissue from abroad. Those responsible for regulation or management systems for organization of tissue and cell governance of domestic eye banking activities should also banking activities33; and an Aide-Memoire on “key safety take care to ensure that their ethical considerations encom- requirements for essential minimally processed human cells pass extrajurisdictional concerns. and tissues for transplantation.34” Global tools that facilitate Collaboration between foreign professionals is essen- best practice care and ethical decision making would also tial to ensure that governance of cross-border activities is include systems of coding and traceability for ocular tissues informed by the realities of practice in different jurisdic- and cells (such as ISBT 128 www.iccbba.org); and interna- tions. At present, many eye banks and corneal surgeons tional accreditation, licensing, or certification programs for confront ethical dilemmas of exporting or importing ocular institutions and/or individuals. tissue independently, albeit sometimes with the support of national eye banking organizations. We conclude this article with a call for the international professional community to PRELIMINARY RECOMMENDATIONS establish a program of work in this field, beginning with the Until global guidelines and tools are established and/or development of an international ethical framework dedicated fully implemented and the complex ethical issues reviewed to the governance of transnational eye banking activities.

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