Trafficking in Organs, Tissues and Cells and Trafficking in Human Beings for the Purpose of the Removal of Organs

Home , Organ procurement, Organ theft, Organ trade

COUNCIL CONSEIL United Nations OF EUROPE DE L’EUROPE

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs

Joint Council of Europe/ United Nations Study 100

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs

Joint Council of Europe/United Nations study

Prepared by

Arthur Caplan, PhD, Chair of the Department of Medical Ethics and Director of the Center for Bioethics, University of Pennsylvania (United States of America)

Beatriz Domínguez-Gil, MD, PhD, Medical Adviser, National Transplant Organisation (Spain)

Rafael Matesanz, MD, PhDm, Director of the National Transplant Organisation (Spain), President of the Iberoamerican Network/Council of Donation and Transplantation and former Chair of the European Committee on Organ Transplantation of the Council of Europe

Carmen Prior, Mag. Iur., Public Prosecutor (Austria)

Directorate General of Human Rights and Legal Affairs Council of Europe 2009 Acknowledgements

The preparation of this Joint Study Department of Medical Ethics and Representatives of the secretariats of was carried out in the framework of Director of the Center for Bioethics at the World Health Organization and co-operation between the Council of the University of Pennsylvania in Phil- the United Nations Office on Drugs Europe and United Nations. adelphia (United States of America), and Crime, as well as the European The commitment and leadership of and Rafael Matesanz and Beatriz Directorate for the Quality of Medi- Maud de Boer-Buquicchio, Deputy Domínguez-Gil of the National Trans- cines and Healthcare and the Health Secretary General of the Council of plant Organisation (Spain). Mr Mate- and Bioethics Department of the Europe, and Rachel N. Mayanja, Assist- sanz and Ms Domínguez-Gil are both Council of Europe, generously shared ant Secretary-General of the United representatives on the European Com- their experience, research, reports, Nations and Special Adviser on mittee on Organ Transplantation data and other material. Gender Issues and Advancement of (CD-P-TO). Many thanks also to Francis L. Del- Women, made the preparation of this The authors were assisted by the Sec- monico, MD, Director of Medical Study possible. retariat of the Council of Europe Con- Affairs at the Transplantation Society The Study was prepared jointly by the vention on Action against Trafficking for reading the Study and offering val- legal expert appointed by the Council in Human Beings and the Office of the uable advice. of Europe: Carmen Prior, Public Prose- Special Adviser on Gender Issues and cutor (Austria), and the scientific Advancement of Women at the United experts appointed by the United Nations Department of Economic and Nations: Arthur Caplan, Chair of the Social Affairs.

The opinions expressed in this work are the responsibility of the authors and do not necessarily reflect the official policy of the Council of Europe.

The views expressed in this study are those of the consultants and do not necessarily represent the views of the United Nations.

Secretariat of the Council of Europe Convention on Action against Trafficking in Human Beings Directorate General of Human Rights Council of Europe F-67075 Strasbourg Cedex http://www.coe.int/justice/

Printed in France Contents

Foreword...... 5

Executive summary ...... 7

I. Introduction ...... 9

II. Overview of organ donation for transplantation purposes ...... 15

A. Transplantation of organs and tissues Transplantation: a historical The dire consequences of organ The process of deceased donation: perspective ...... 17 and tissue shortage ...... 21 organisational and technical Solving the organ and tissue initiatives for dealing with organ Outcomes associated with organ shortage...... 24 shortage ...... 24 transplantation ...... 18 Non-heart beating donation Organ shortage: a universal (donation after cardiac death)...... 27 problem ...... 19 Living donation...... 27

B. Bioethics – the ethical framework for organ and tissue procurement The existing bioethical framework Organ markets...... 31 Distributing organs: what is just for obtaining organs and tissues . . . 30 Presumed consent ...... 32 and fair? ...... 32 Increasing the supply ...... 31

C. Existing international standards World Health Organization and European Union ...... 42 World Medical Association ...... 46 World Health Assembly...... 34 The Iberoamerican Network/Council Council of Europe ...... 35 of Donation and Transplantation (RCIDT) ...... 45

D. National legislation on organ transplantation 3

E. Organisational measures Council of Europe ...... 49 Iberoamerican Network/Council of European Union...... 50 Donation and Transplantation (RCIDT) ...... 51

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs III. Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of organ removal ...... 53

A. Current situation and consequences Trafficking in OTC and trafficking Consequences of trafficking in in human beings for the purpose OTC and trafficking in human of organ removal – known facts . . . 57 beings for the purpose of organ Myths concerning trafficking in removal ...... 61 OTC and trafficking in human beings for the purpose of organ removal ...... 60

B. Trafficking in OTC: international standards and initiatives United Nations General Assembly . 65 The Iberoamerican Network/Council The Transplantation Society and World Health Organization ...... 65 of Donation and Transplantation the International Society of (RCIDT) ...... 73 Nephrology ...... 74 Council of Europe ...... 68 Asian Task Force on Organ European Union...... 70 Trafficking ...... 75

C. Trafficking in human beings: international standards and their application to organ removal Binding international legal The application of international instruments on action against standards to organ removal ...... 77 trafficking in human beings ...... 76

IV. Conclusions and recommendations ...... 91 “Trafficking in organs, tissues and Organ donation and organ Trafficking in organs, tissues and cells” and “Trafficking in human transplantation: promotion of cells: need for an internationally beings for the purpose of the organ donation, organisational and agreed definition ...... 96 removal of organs”: two different technical measures to increase Trafficking in human beings for phenomena and two different organ availability and existence of the purpose of removal of organs: crimes ...... 93 organisational and technical the effectiveness of existing The prohibition of making capacity for transplantation of international standards and no financial gains with the human organs...... 94 need for further international legal body or its parts: the paramount “Trafficking in organs, tissues and instruments ...... 97 principle ...... 93 cells” and “Trafficking in human beings for the purpose of the removal of organs”: need to collect reliable data ...... 95

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs Foreword by the Deputy Secretary General of the Council of Europe and the Assistant Secretary-General and Special Adviser on Gender Issues of the United Nations

Trafficking in human beings is a real its parts as such to give rise to finan- beings for the purpose of organ and growing problem all over the cial gain. Its Additional Protocol con- removal in particular, as well as with world. Human beings are bought and cerning Transplantation of Organs and regard to live donators implicated in sold as a commodity. The criminals Tissues of Human Origin prohibits traf- trafficking in organs, tissues and cells. responsible for these massive viola- ficking in organs and tissues. Together The Deputy Secretary General of the tions of human rights and the rule of with the Council of Europe activities to Council of Europe and the Assistant law are buying and selling human increase the availability of organs, Secretary-General of the United beings for different reasons, but the tissues and cells for transplantation Nations and Special Adviser on trafficking for the purpose of the purposes, this multi-sectoral approach Gender Issues and Advancement of removal of organs is clearly one of its placed the Council of Europe in a very Women decided to join their efforts most abhorrent forms. In spite of that, strong position to contribute to com- and agreed that the study should be this form of trafficking has been rela- bating trafficking in organs, tissues prepared jointly in the framework of tively unknown and insufficiently and cells and trafficking in human co-operation. As well as considering researched. beings for the purpose of the removal both the medical and legal aspects, it The Council of Europe Convention on of organs. was agreed also to look at ethical Action against Trafficking in Human The Assistant Secretary-General of the problems and organisational and Beings is an effective new instrument United Nations and Special Adviser on other measures, with a view to provid- to fight human trafficking in all its Gender Issues and Advancement of ing an overview of the current legal forms, including for the purpose of the Women was concerned that organ and factual situation, including from a removal of organs. Following its entry trafficking and trafficking in human gender aspect, examining existing into force in 2008 the Deputy Secre- beings for the purpose of organ measures to combat both forms of tary General of the Council of Europe removal, long considered to be myths, crime and exploring further avenues took the initiative to explore the Con- seem to be realities all over the world. to fight them. vention’s specific application to this These phenomena exist for many rea- form of trafficking and the protection sons, but particularly because of Our intention is to use the conclusions afforded to its victims. It quickly extreme poverty and discrimination, and recommendations made by the 5 became apparent that the phenome- including gender discrimination. In authors in this study as food for non would have to be examined in the general, victims of trafficking in thought for both the Council of context of the wider problem of traf- human beings tend to be women and Europe and the United Nations. We ficking in organs, tissues and cells. In children who know far too little about are convinced that the study will make 1997, the Council of Europe Conven- their rights or how to appropriately us stronger in our fight against traf- tion on Human Rights and Biomedi- assert them. It is important to look ficking in organs, tissues and cells and cine laid down the principle that it is into the existence of a gender aspect trafficking in human beings for the not permissible for the human body or with regard to trafficking in human purpose of the removal of organs.

Maud de Boer-Buquicchio Rachel Mayanja Deputy Secretary General of the Council of Europe Assistant Secretary-General of the United Nations and Special Adviser on Gender Issues and Advancement of Women

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs

Executive summary

In 2008, the Council of Europe and the ficking in OTC” and “trafficking in tant in order not to jeopardise the United Nations agreed to prepare a human beings for the purpose of the donation system based on altruism, Joint Study on trafficking in organs, removal of organs”. Thirdly, the Joint both from living and from deceased tissues and cells (OTC) and trafficking in Study underlined that the solutions donors, which must be the basis of the human beings for the purpose of the for preventing the two types of traf- organ transplantation system. Given removal of organs. This Joint Study has ficking had to be different because the that trafficking in organs mainly exists been prepared in the framework of “trafficked objects” are different: in because of the lack of available the co-operation between the two one case the “organs, tissues and cells” organs, it is also essential to take the international intergovernmental and in the other case the “person him/ organisational measures needed to organisations, in particular in keeping herself” who is trafficked for the spe- increase the availability of organs for with the United Nations General cific purpose of removing his/her transplantation. Assembly Resolution on Co-operation organs. One of the major aims of this Taking into account the above- between the United Nations and the Joint Study is therefore to distinguish mentioned considerations, the main Council of Europe (A/RES/63/14), which between trafficking in OTC and traf- conclusions and recommendations of specifically states: ficking in human beings for the this Joint Study could be summarised “[The General Assembly] Takes note purpose of organ removal. as follows: with appreciation of the entry into This Joint Study only covers trafficking The need to distinguish clearly force on 1 February 2008 of the in OTC for the purpose of transplanta- between “Trafficking in OTC” and Council of Europe Convention on tion. Other purposes of trafficking in “Trafficking in human beings for Action against Trafficking in Human OTC are outside the scope of the Joint the purpose of the removal of Beings, to which any non-member Study. The starting point of the Joint organs”. The two are frequently State of the Council of Europe may Study is the prohibition of making confused in public debate and in accede after having obtained unani- financial gains with the human body the legal and scientific commu- mous consent of the parties to the or its parts. This principle was estab- nity. This leads to general confu- Convention, commends the lished for the first time in a legally sion and consequently hinders enhanced co-operation between the binding instrument in Article 21 of the effective efforts to combat them United Nations and the Council of 1997 Council of Europe Convention on and also to provide comprehen- Europe in this regard, and expresses its Human Rights and Biomedicine [CETS sive victim protection and assist- appreciation for the preparation of a No. 164]: “The human body and its ance. 7 joint study on trafficking in organs, parts shall not, as such, give rise to The principle of the prohibition of tissues and cells and trafficking in financial gain”. The principle was then making financial gains with the persons for the purpose of the reaffirmed in the 2002 Additional Pro- human body or its parts should be removal of organs”. tocol to the Convention on Human the paramount consideration in The present Joint Study noted, first of Rights and Biomedicine concerning relation to organ transplantation. all, that trafficking in human beings Transplantation of Organs and Tissues All national legislation concern- for the purpose of organ removal was of Human Origin [CETS No. 186]. ing organ transplantation should a small part of the bigger problem of Article 22 of the Protocol states: conform to this principle. trafficking in OTC. Secondly, the Joint “Organ and tissue trafficking shall be The need to promote organ dona- Study pointed out the existence of prohibited”. The principle of the prohi- tion and establish organisational widespread confusion in the legal and bition of making financial gains with measures to increase organ availa- scientific community between “traf- the human body is also very impor- bility. Preference should be given

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs to deceased organ donation, Joint Study did not aim to provide ficking in Human Beings [CETS which should be developed to its a definition of “Trafficking in OTC”. No. 197] and in the United Nations maximum therapeutic potential. Such a definition should be Protocol to Prevent, Suppress and In addition, there is a need to agreed upon at international level Punish Trafficking in Persons, espe- extend worldwide the organisa- with the involvement of all the rel- cially Women and Children, Supple- tional and technical capacity for evant players. While underlining menting the United Nations the transplantation of organs. that all national systems should be Convention against Transnational The need to collect reliable data based on the principle of the pro- Organised Crime. Indeed, the defi- on trafficking in OTC and on traf- hibition of making financial gains nition of trafficking in human ficking in human beings for the with the human body or its parts, purpose of organ removal. There the starting point for such a defi- beings set out in both legal instru- is limited knowledge of the two nition should be the idea that any ments explicitly states that exploi- issues since little information is organ transaction outside the tation also includes the removal of available from official sources. The national systems for organ trans- organs. The principles and meas- information about the number of plantation should be considered ures applicable to other forms of victims and trafficked OTC there- organ trafficking. It is therefore exploitation of trafficking in fore remains rather fragmentary. recommended that an interna- human beings must also be This hinders both the quantifica- tional legal instrument be pre- applied to combat this type of tion of the two and also their qual- pared, setting out a definition of trafficking for organ removal. itative description. The data “Trafficking in OTC” and the meas- There is no need for the further should be disaggregated by sex in ures to prevent such trafficking development of a legally binding order to assess whether and to and protect the victims, as well as international instrument at uni- what extent the processes dispro- the criminal-law measures to versal or regional level. All rele- portionately affect women and punish the crime. vant aspects for preventing and girls. States should make efforts in “Trafficking in human beings for terms of data collection in relation the purpose of the removal of combating trafficking in human to both problems. organs” is included in the defini- beings for organ removal are set The need for an internationally tion of trafficking in human out in the above-mentioned agreed definition of “Trafficking in beings in the Council of Europe legally binding international organs, tissues and cells”. This Convention on Action against Traf- instruments.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs I. Introduction

I. INTRODUCTION

Introduction

In 2008, Maud de Boer-Buquicchio, human beings for the purpose of the constituent elements of the Deputy Secretary General of the organ removal had never been the crime – the object of the criminal Council of Europe, and Rachel N. May- subject of in-depth studies despite the offence. In the former case, the object anja, Assistant Secretary-General of fact that this form of exploitation is of the crime is the organs, tissues and the United Nations and Special covered by the definition of trafficking cells, while in the latter case it is the Adviser on Gender Issues and in human beings in the Protocol to Pre- trafficked person. It was therefore Advancement of Women, agreed that vent, Suppress and Punish Trafficking in decided to enlarge the scope of the it would be helpful to prepare this Persons, Especially Women and Chil- Joint Study from trafficking in human Joint Council of Europe-United Nations dren, Supplementing the United Nations beings for the purpose of organ Study on trafficking in organs, tissues Convention against Transnational removal and also cover trafficking in and cells and trafficking in human Organised Crime (hereafter the United OTC. beings for the purpose of the removal of Nations Trafficking in Persons Proto- organs. The work has been carried out col) and the Council of Europe Conven- Following this decision and because in in the framework of co-operation tion on Action against Trafficking in public debate, in publications and in between the two international inter- Human Beings [CETS No. 197] (hereaf- legal documents the issues are often governmental organisations, in partic- ter the Council of Europe Anti-Traffick- confused or dealt with together, one ular in keeping with the United ing Convention). However, it quickly of the main aims of this Joint Study is Nations General Assembly Resolution became obvious, first of all, that traf- to distinguish between trafficking in on Co-operation between the United ficking in human beings for the OTC and trafficking in human beings Nations and the Council of Europe (A/ purpose of organ removal was a small for the purpose of organ removal. RES/63/14), which specifically states: part of the bigger problem of traffick- Some trafficking in OTC may originate “[the General Assembly] Takes note ing in organs, tissues and cells (OTC) in trafficking in human beings and will with appreciation of the entry into and therefore the former could not be therefore fall within the scope of the force on 1 February 2008 of the examined without the latter. Secondly, United Nations Trafficking in Persons Council of Europe Convention on the existence of serious confusion in Protocol and the Council of Europe Action against Trafficking in Human the legal and scientific communities Anti-Trafficking Convention. But traf- Beings, to which any non-member between “trafficking in OTC” and “trafficking in OTC is much broader in State of the Council of Europe may ficking in human beings for the scope than trafficking in human accede after having obtained unan- purpose of the removal of organs” was beings for the purpose of organ imous consent of the parties to the identified. Thirdly, the solutions for removal. Indeed, in the broader 11 Convention, commends the preventing both types of trafficking context of trafficking in OTC, traffick- enhanced co-operation between should necessarily be different ing in human beings for the purpose the United Nations and the Council because the “trafficked objects” are of organ removal might be considered of Europe in this regard, and different: in one case the “organs, a marginal phenomenon. On the expresses its appreciation for the tissues and cells” and in the other case other hand, trafficking in human preparation of a joint study on traf- the “person him/herself” who is traf- beings covers types of exploitation ficking in organs and tissues, includ- ficked for the specific purpose of other than the removal of organs and ing trafficking in persons for the removing his/her organs. To express is therefore more than an issue of traf- purpose of the removal of organs. this idea in legal terms, it could be said ficking in OTC. Trafficking in human Indeed, the starting point for the that trafficking in OTC differs from traf- beings also involves a combination of preparation of this Joint Study was the ficking in human beings for the three basic elements (action, means acknowledgment that trafficking in purpose of organ removal in one of and purpose) which may not neces-

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs I. INTRODUCTION

sarily be present in cases of trafficking “to take measures to protect the and holistic way. Both are complex in OTC. poorest and vulnerable groups from problems which have to be dealt with In addition to the unequal distribution transplant tourism and the sale of on a multidisciplinary basis. The study of wealth in the world, it is widely rec- tissues and organs, including atten- mainly focuses on medical and legal ognised that the main root cause of tion to the international trafficking in aspects, as this is where the differ- trafficking in OTC and trafficking in human tissues and organs”. The princi- ences and overlaps can best be dem- human beings for the purpose of ple of the prohibition of making finan- onstrated, most efforts have already organ removal is shortage of organs cial gains with the human body is also been made and the effectiveness of for transplantation purposes. For this essential in order not to jeopardise the the existing measures can be ana- reason it was decided to focus on the donation system which must be the lysed. However, the study is not analysis of trafficking particularly in basis of the organ transplantation limited to these aspects, but also relation to transplantation of OTC system. encompasses ethical problems and while omitting from the scope of the This Joint Study has acknowledged organisational and other measures. In report embryos, gametes, blood and that there is no internationally agreed general, it gives an overview of the blood derivatives. It was agreed to definition of trafficking in OTC, current legal and factual situation, devote a section of the report to an although several attempts to provide examines existing measures to overview of donation for the purpose a definition have been made by inter- combat both forms of crime and of transplantation of OTC and a com- national bodies and initiatives. Under explores further avenues to fight prehensive review of the principles set some of these definitions, trafficking them. at international level in this regard. in OTC is deemed to occur when profit is the main intention linked to the act The Council of Europe and the United The principle that it is not permissible of donation and transplantation. Nations both take a human rights for the human body or its parts as Under other definitions, any illicit approach to trafficking in OTC and such to give rise to financial gain is action related to donation and trans- trafficking in human beings for the established Council of Europe legal plantation according to the current purpose of organ removal. This Joint acquis and is the starting point of this national or international standards is Study aims to reflect how this Joint Study. It was first stated interna- deemed to constitute trafficking in approach has influenced the meas- tionally in Resolution (78) 29 of the OTC. Lastly, some of the definitions of ures taken up to now and how it could Committee of Ministers of the Council trafficking in OTC correspond to the be further developed. A further aim is of Europe and was confirmed, in par- definition of trafficking in human to give an overview of the current ticular, by the final declaration of the beings for the purpose of organ state of affairs from a gender perspec- 3rd Conference of European Health removal, which once again highlights tive and examine whether trafficking Ministers (Paris, 1987) before being the lack of distinction between the in OTC and trafficking in human definitively laid down in Article 21 of two types of crime. the 1997 Convention on Human Rights beings for the purpose of organ and Biomedicine [CETS No.164]: “The For the purpose of facilitating the removal have a more serious impact human body and its parts shall not, as reading of this Joint Study, trafficking on women and girls. There is a such, give rise to financial gain”. At in OTC could preliminarily be growing concern and a body of evi- United Nations level, there is no described as follows: trafficking in OTC dence that trafficking in human legally binding instrument which sets occurs when there is (a) the illicit beings has been affecting women and out the principle of the prohibition of removal, preparation, preservation, girls disproportionately, as one of the making financial gains from the storage, offering, distribution, broker- root causes is poverty and discrimina- 12 human body or its parts. However, the age, transport or implantation of tion, including sexual discrimination, World Health Organization Guiding organs, tissues or cells (cells for the and women and girls make up the Principles on Human Cell, Tissue and purpose of therapeutic transplanta- majority of the poor and of victims of Organ Transplantation, which clearly tion); and (b) the possession or pur- sexual violence. The conclusions and include this principle, have been chase of organs, tissues or cells with a findings of the study will provide a incorporated in many professional view to conducting one of the activi- basis for examining existing measures standards and laws and are not only ties listed in (a); solely for financial or to combat trafficking in OTC and traf- widely recognised but also basically other economic gain (for this or a third ficking in human beings for the undisputed in terms of standard-set- person’s benefit). purpose of organ removal and explor- ting. Moreover, in May 2004 the 57th This Joint Study seeks to deal with ing possible further avenues for devel- World Health Assembly in Resolution trafficking in OTC and trafficking in oping policies and programmes in WHA57.18 on Human Organ and Tissue human beings for the purpose of way that addresses the needs and Transplantation urged member states organ removal in a comprehensive concerns of both women and men.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs I. INTRODUCTION

This Joint Study has been prepared by provided valuable input for the prepa- Abuse of a position of vulnerability: scientific and legal experts appointed ration of the Joint Study. any situation in which the person by the United Nations and the Council Lastly, in order to facilitate the reading involved has no real and acceptable of Europe. Statements in the study are of this Joint Study, some internation- alternative but to submit to the abuse based on the research and personal ally agreed definitions of key terms involved.4 opinions of the authors and do not should already be set out in this intro- Deceased donor: a human being reflect the official position of the ductory section. legally declared, by established United Nations or the Council of Transplantation: the complete medical criteria, to be dead and from Europe. The scientific experts, process of removal of an organ or whom cells, tissues or organs were appointed by the United Nations, tissue from one person and implanta- recovered for the purpose of trans- were Arthur Caplan, Chair of the 5 tion of that organ or tissue into plantation. Department of Medical Ethics and another person, including all proce- Director of the Center for Bioethics at Transplant tourism: travel for trans- dures for preparation, preservation, the University of Pennsylvania in Phil- plantation if it involves trafficking storage and transportation.1 adelphia (United States of America), and/or transplant commercialism or and Rafael Matesanz and Beatriz Removal: removal from the body of the resources (organs, professionals Domínguez-Gil of the Spanish an organ or tissue intended for trans- and transplant centres) devoted to National Transplant Organisation plantation, by a surgical procedure or providing transplants to patients from (Organización Nacional de Trasplan- by other means.2 outside a country undermine the country’s ability to provide transplant tes). Mr Matesanz and Ms Domínguez- Trafficking in human beings, includ- Gil are both representatives on the services for its own population. Travel ing for the purpose of the removal of for transplantation would be defined European Committee on Organ Trans- organs: the recruitment, transporta- as the movement of OTC, donors, plantation (CD-P-TO). The legal expert, tion, transfer, harbouring or receipt of recipients or transplant professionals appointed by the Council of Europe, persons, by means of the threat or use across jurisdictional borders for trans- was Carmen Prior, Public Prosecutor of force or other forms of coercion, of plantation purposes. Transplant com- (Austria). abduction, of fraud, of deception, of mercialism would be understood as a the abuse of power or of a position of The authors were assisted by the Sec- policy or practice in which an organ, vulnerability or of the giving or receiv- retariat of the Council of Europe Con- tissue or cell is treated as a commod- ing of payments or benefits to achieve vention on Action against Trafficking ity, including by being bought or sold the consent of a person having control 6 in Human Beings and the Office of the or used for material gain. over another person, for the purpose Special Adviser on Gender Issues and of exploitation. Exploitation shall 3. Article 3 of the Protocol to Prevent, Suppress Advancement of Women at the United and Punish Trafficking in Persons, especially Women include, at a minimum, the exploita- Nations Department of Economic and and Children, supplementing the United Nations tion of the prostitution of others or Convention against Transnational Organised Crime Social Affairs. Representatives of the and Article 4 of the Council of Europe Convention other forms of sexual exploitation, secretariats of the World Health on Action against Trafficking in Human Beings. forced labour or services, slavery or 4. Travaux préparatoires of the negotiations for Organization and the United Nations the elaboration of the United Nations Convention practices similar to slavery, servitude against Transnational Organised Crime and the Pro- Office on Drugs and Crime, as well as or the removal of organs.3 tocols thereto, interpretative note regarding Article the European Directorate for the 3. 5. WHO Glossary of terms on donation and Quality of Medicines and Healthcare 1. Article 2 (5) of the Appendix to Council of transplantation. and the Health and Bioethics Depart- Europe Rec (2004) 7 on trafficking in organs. 6. Modified from the Declaration of Istanbul on 2. Article 2 (4) of the Appendix to Council of Organ Trafficking and Transplant Tourism. Trans- ment of the Council of Europe, also Europe Rec (2004) 7 on trafficking in organs. plantation 2008; 8: 1013-1018. 13

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs

II. Overview of organ donation for transplantation purposes

A. TRANSPLANTATION OF ORGANS AND TISSUES

A. Transplantation of organs and tissues

Transplantation: a historical perspective

The first successful kidney transplant Nowadays, liver, heart and lung trans- tissues that can be transplanted and was performed at the Peter Bent plantation represent a unique thera- the many uses to which they can be Brigham Hospital in Boston in 1954 peutic approach for patients with end- put. Corneal transplants restore vision; and subsequently led to the awarding stage liver, heart and lung failure, heart valve transplants involve lower of a Nobel Prize.7 The transplant was although liver transplantation has also morbidity rates than porcine or artifi- performed between identical twins, been applied in the treatment of special valves; bone is used to repair overcoming the main difficulty in per- cific pathologies not causing end- damage due to trauma, cancer or forming successful organ transplants stage liver failure. Pancreas transplan- degeneration; dural matter trans- at that time – the immunological dis- tation of various types has become an plants are used to protect the brain crepancies between donors and recip- option for re-establishing insulin after traumatic head injury leaves it ients – which inevitably led to secretion in selected diabetic patients. exposed to infection; joints and activation of the alloimmune Small bowel transplantation usually tendons are transplanted to restore response, resulting in rejection and performed as part of a multi-organ mobility and independence; and skin loss of the graft. transplant is still a relatively rare pro- is used extensively in the treatment of cedure of mixed efficacy. burns. Fat and other tissue is used Since that first successful kidney trans- The consolidation of organ transplan- both in reconstructive and in cosmetic plant, organ transplantation has tation is clearly demonstrated by the surgery. developed into a well-established clin- large number of procedures per- From the first successful kidney trans- ical therapy which saves the life and formed every year. According to data plant back in 1954 to the situation improves the quality of life of thou- provided by the Global Observatory today, where transplantation of all sands of patients every year. Kidney on Donation and Transplantation,11 kinds of solid OTC is a routine practice transplantation now represents the almost 100 000 patients worldwide in many countries, several different most desirable therapeutic option for receive a solid organ transplant every historical milestones have been patients with end-stage renal disease, year (Figure 1, page 18). Additionally, a achieved. After 1954, various renal providing better outcomes in terms of large number and variety of tissues transplants were conducted between survival8 and quality of life9 than other and cells are implanted on a routine identical twins, but this option was renal replacement therapies. Kidney basis to treat a wide range of patholo- very limited and patients’ needs could 17 transplantation is now considered to gies, many of them life-limiting. The only be met in the very fortunate have a more favourable cost- exact number of tissue transplants cases of twins. The need to overcome effectiveness ratio than dialysis ther- performed nowadays is unknown, but the immunological reaction when apy, the alternative treatment for end- is considerably higher than the transplantation was performed stage renal disease.10 number of organ transplants. The between non-HLA identical persons number of tissue transplants done is was the key limiting factor in organ 7. Merrill JP, Murray JE, Harrison JH, Guild WR. high because of the large number of Successful homotransplantation of the human transplantation. The description of kidney between identical twins. J Am Med Assoc 1956; 160 (4): 277-282. 10. Winkelmayer WC, Weinstein MC, Mittleman azathioprine in the 1960s and its use 8. Wolfe RA et al. Comparison of mortality in all MA, Glynn RJ, Pliskin JS. Health economic evalua- in combination with steroids made patients on dialysis, patients on dialysis awaiting tions: the special case of end-stage renal disease transplantation, and recipients of a first cadaveric treatment. Med Decis Making 2002; 22: 417-430. kidney transplantation between close transplant. N Engl J Med 1999; 341: 1725-1730. 11. Global Observatory on Donation and Trans- relatives a reality without excessive 9. Keown P. Improving the quality of life. The plantation. http://www.transplant-observatory.org/ New Target for Transplantation 2001; 72: 567-574. default.aspx. risks. In 1976, Jean Borel discovered

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

Figure 1. Estimates of the number of solid organ transplants performed annually worldwide, according to the Global Observatory of Donation and Transplantation (http:// www.transplant-observatory.org/ default.aspx)

the potent immunosuppressive effect transplantable kidneys was either degree of development below which of Cyclosporine A. This drug dramati- living donors or deceased donors who having a consolidated deceased dona- cally improved the results of trans- had died from cardio-respiratory tion programme is highly complex. plantation overall, and from related arrest (non-heart-beating donors or living donors in particular. Its incorpo- donors after cardiac death). The On the other hand, the successful ration in the immunosuppressive description of brain death12 in 1959 results obtained with living kidney armamentarium and the subsequent and the wide scientific and legal transplantation, which are clearly description and commercialisation of acceptance of its diagnostic criteria better than those obtained with other agents in recent years has resulted in brain death donors [or kidney transplantation from deceased enabled the immunological difficul- donors after brain death (DBD)] gradu- organ donors, added to the problem ties of transplantation gradually to be ally becoming the main source of solid of organ shortage, have renewed the overcome in such a way that the organ transplants in subsequent interest in living kidney transplanta- importance of HLA compatibility years, at least in more developed tion as a complementary activity to between donors and recipients as a countries. In many countries, however, deceased organ donation even in factor impacting on post- cultural, socio-economic and health- more developed countries. A similar transplantation results has gradually care structural factors have prevented situation has occurred with donation been reduced. These developments the development or consolidation of after cardiac death (DCD). In recent paved the way for transplantation deceased donation activity. For exam- years, advances in preservation tech- between genetically unrelated donors ple, there seems to be a significant link niques and better results than those in and recipients, with extraordinary between the Human Development the very first days of attempting trans- results. Index (HDI) and deceased donation plants of this kind, combined with the Alongside the advances in immuno- activity in terms of donors per million increasing need for organs for trans- 18 suppression, the development of population (pmp) (Figure 2, page 19), plantation, have led to rapid growth in donation from deceased organ donors suggesting that there is a minimum this type of deceased donation in has been remarkable. In the early days several countries throughout the 12. Mollaret P, Goulon M. Le coma dépassé (prelim- of organ transplantation, the source of inary memoir). Rev Neurol (Paris) 1959 Jul; 101: 3-15. world.

Outcomes associated with organ transplantation

Results with nearly all types of solid the advances in immunosuppression, transplant teams. According to the organ transplantation can be combined with advances in surgical OPTN/SDRD 2007 Annual Report,13 in regarded as excellent today. The and preservation techniques, as well the United States, unadjusted five- improved results may be explained by as by the experience acquired by the year graft survival was 79%, 67.6% and

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. TRANSPLANTATION OF ORGANS AND TISSUES

Figure 2. Link between HDI (2005) and deceased donation activities pmp in 40,0 several countries (N=79) throughout the N=72 world (last available data). Source: r=0.696 Global Observatory on Donation and p<0.0001

Transplantation 30,0

20,0 Deceased Donors pmp

10,0

0,0

0,400 0,500 0,600 0,700 0,800 0,900 1,000 HDI 2005

51% for kidney transplant recipients Transplant Registry, while 10-year grafts are lost mainly due to the who received their grafts during the patient and graft survival were 36% widely known phenomenon of period 1994 to 1999 from a living and 31% respectively for liver trans- “chronic rejection” and death with a donor, a deceased non-expanded-cri- plants performed from 1968 to 1988, functioning graft. The main causes of teria donor or a deceased expanded- the corresponding figures were 61% death in the transplanted patients criteria donor (ECD) respectively. Cor- and 53% for patients who received include cardiovascular disease and responding figures were 80.2%, 69.8% their liver grafts after 1988.15 tumoral diseases. These causes of and 55.1% respectively for patients The half-life of adult patients who death are closely related to the transplanted from 2000 to 2005. These received heart transplants from 1982 chronic use of immunosuppression by data also show that results after living to 1991 was 8.8 years, reaching 10.5 kidney transplantation have remained years for those patients transplanted recipients, which is still needed today. better than those achieved after from 1992 to 2001, and survival Transplantation is also linked to a set kidney transplantation from a figures also continue to improve for of other immediate and long-term deceased donor. Indeed, the better lung transplant recipients according complications. The inherent risk of results achieved with live kidney to the International Registry of Heart transmissible diseases linked to the transplantation apply even when no and Lung Transplantation, with a half- transfer of any human material, genetic relationship exists between life of 3.9 years for patients trans- whether organs, tissues or cells, and 14 the donor and the recipient. planted from 1988-1994 to 5.5 years hence to transplantation should be for those patients transplanted from Patient and graft survival after a liver underlined. Transmission of infectious 2000 to 2006.16 and tumoral diseases from donors to transplant has also gradually But challenges regarding post-trans- improved over time in an impressive recipients of their OTC has been plant results remain. In the long run, 19 way. According to the European Liver widely described in the literature. This 15. European Liver Transplant Registry website. risk is usually minimised and control- 13. OPTN/SRTR 2007 Annual Report. OPTN web- Accessible at http://www.eltr.org/. Last access: 26 site. Accessible at: http://www.optn.org/. Last August 2009. led through careful medical evalua- access: 26 August 2009. 16. The International Society for Heart and Lung tion of the donor, according to pre- 14. Cecka JM. The OPTN/UNOS Renal Transplant Transplantation website. Accessible at: http:// Registry 2003. Clin Transpl. 2003: 1-12. www.ishlt.org/. Last access: 26 August 2009. established standards.

Organ shortage: a universal problem

Although many problems still have to vents many patients from receiving sive increase in the number of patients be resolved in the field of organ trans- the benefits of transplantation. The on waiting lists. The lengthening plantation, the main challenge excellent results achieved with organ waiting lists worldwide are also linked remains organ shortage, which pre- transplantation have led to a progres- to the fact that the capacity to

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

perform transplants is increasing increasingly require retransplantation Union (EU), while only 25 932 corre- every year as new programmes are as the organs they initially received sponding transplant procedures were opened. In addition, as their skills begin to fail. Hence, demand for performed during that year. Figure 3 increase, transplant teams are willing organs for transplantation is increas- shows kidney transplantation activity to accept far sicker patients than were ing. However, the number of organ for countries in the EU in relation to put on waiting lists only twenty years donors and organs available for trans- the demand for kidneys for transplan- ago. Third, as populations age in the plantation has never been enough to tation as represented by the number developed world, more and more meet the increasing need for organs. of patients on the list at the end of people find themselves afflicted with As a result, there is a significant gap 2007 for individual countries and for diseases that lead to organ failure. between supply and demand in terms the EU as a whole. Similar figures Fourth, changes in diet and lifestyle of organs to be transplanted. apply in other areas of the world. In are causing significant increases in the According to the Council of Europe,17 the United States 95 150 patients were incidence of diseases such as diabetes at the end of 2007, 58 182 patients on the waiting list for a kidney, liver or and coronary vessel disease which were waiting for a kidney, a liver or a heart transplant at the end of that lead to organ failure and, thus, the heart transplant in the European year. That far outstrips the number of need for more transplants. And, lastly, kidney, liver and heart transplant pro- people who have received transplants 17. International Figures on Organ Donation and cedures performed in the country Transplantation – 2007. Newsletter Transplant 2008; are living longer but, as a result, they 13 (1). during 2007: 25 328 transplants.

Figure 3. Number of kidney transplant procedures pmp from deceased (white boxes) and living donors (blue boxes) and number of patients pmp on the waiting list for a kidney in countries in the European Union

These figures only show the tip of the Lastly, demand for organs for trans- While organ shortage for transplanta- iceberg of the universal problem of plantation is expected to increase in tion is a universal problem, it is clear organ shortage. Waiting list numbers the near future, particularly in the case that the systems in place differ sub- have traditionally been presented as of kidney transplantation. It has been stantially in their effectiveness in tack- the number of patients waiting at a projected that the number of patients ling the problem. Table 1 shows with diabetes mellitus will double deceased organ donation activity for 20 particular point in the year, not the total number of patients who were on from the year 2000 to 2030, especially different regions and major countries 18 19 the list at any time throughout a given in developing countries. This epi- throughout the world for 2007. The year. There is also a delicate balance demic of diabetes, added to the notable discrepancies observed in between supply and demand in terms ageing of the population, arterial deceased organ donation stem from very significant differences between of organs for transplantation. Organ hypertension and obesity is expected the countries regarding transplanta- shortage prevents physicians from to have a significant impact on the tion activity and hence the likelihood including some patients on the waiting prevalence of end-stage renal disease worldwide and hence on the need for of transplantation for their citizens. list, especially those with low expectan- kidneys for transplantation. When these figures are compared, cies of survival. In contrast, criteria for however, some of the differences may including patients on the list may be 18. Wild S, Roglic G, Green A, Sicree R, King H. be explained by the degree of socio- more flexible in countries where pro- Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care curement of organs is higher. 2004; 27 (5): 1047-1053. 19. See note 13, page 19.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. TRANSPLANTATION OF ORGANS AND TISSUES

Table 1. Deceased donation and transplantation activities pmp in several areas and large countries across the world for 2007 United States European Union Canada Australia/New Iberoamerica Zealand

Deceased donors pmp 26.6 16.9 14.8 9.4 5.7

Deceased Kidney Tx pmp 34.8 29.2 22.8 16.2 8.9

Living Kidney Tx pmp 19.9 6 14.4 12.9 7 Liver Tx pmp 21.4 13.4 14.6 7.3 3.2

Heart Tx pmp 7.3 4.2 5.2 2.9 0.7

Lung Tx pmp 4.8 2.6 5.5 3.7 0.2

Pancreas Tx pmp 4.4 1.6 2.2 1.2 0.5 economic development and structural with a quite similar degree of develop- age of organs for transplantation. aspects of healthcare systems. ment are compared, such important Subsequent differences regarding Unfortunately, these differences differences regarding deceased dona- transplantation might also depend on remain when countries with a quite tion activity remain. This leads to the structural differences such as the pres- similar background are compared. conclusion that some systems in place ence of a specific transplant pro- Table 2, page 22, shows deceased are more effective than others in tack- gramme or the existence of organ donation and transplantation activity ling the universal challenge of short- exchange agreements, but the link for countries in the EU.20 It can easily between donation and transplanta- be seen that even when countries 20. See note 13, page 19. tion rates is clear.

The dire consequences of organ and tissue shortage

The most serious consequence of the not, hard choices have to be made Another major problem stemming shortage of organs to meet the about who will live and who will die. from organ shortage is the fact that demand for transplantation is the fact alternatives to kidney transplantation that many patients will never be According to data collected by the in terms of renal replacement thera- placed on the waiting list. There are Council of Europe, more than 4 000 pies, i.e. dialysis, produce poorer clear variations in the figures for trans- patients died in the EU while waiting results and are more expensive than plantation throughout the world for a kidney, liver, heart or lung during kidney transplantation. The cost of (Figure 4, page 23). 2007, which means that 12 EU citizens haemodialysis per patient is lower These differences largely depend on died every day while waiting to be than transplantation in the first year. variations in the prevalence and inci- transplanted (Figure 5, page 23). This However, the cost related to kidney dence of end-stage organ diseases is by far the most serious consequence transplantation falls sharply after the throughout the world and the exist- of the shortage of organs for trans- first year, producing a more favoura- ence of basic infrastructure in the plantation. ble cost-effectiveness ratio than dialy- countries for the actual performance sis treatment. Moreover, the greater Another less well-known conse- of transplantation. However, they may cost-effectiveness of kidney transplan- 21 quence of long waiting times is the also be explained by variability in the tation has been demonstrated both in fact that time spent waiting for a flexibility of inclusion criteria, largely developed and also in developing kidney transplant has proven to have due to the problem of shortage of countries.22 23 a negative impact on graft survival organs for transplantation, as already Lastly, the desperation of patients after kidney transplantation.21 The pointed out. For patients on the lists, waiting for transplants leads to longer the time spent on the waiting organ shortage results in longer another tragic consequence, namely list, the worse the outcome results are waiting times, meaning patients may trafficking in OTC and the most terri- deteriorate or even die while waiting after kidney transplantation, whether for an organ. These deaths are espe- from a living or from a deceased organ 22. Shakuja V, Sud K. End-stage renal disease in donor. India and Pakistan: Burden of disease and manage- cially tragic, as many could be pre- ment issues. Kidney Int Suppl 2003; (3): p115-8. vented if there were more organs 23. Rizvi SA, Naqvi SA. Need for increasing trans- 21. Cecka JM. The OPTN/UNOS Renal Transplant plant activity: a sustainable model for developing available to transplant. Since there are Registry 2003. Clin Transpl 2003; 1-12. countries. Transplant Proc 1997; 29 (1-2): 1560-1562.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

Table 2. Deceased donation and transplantation activities pmp in countries within the European Union 2007 Deceased Deceased Living kid- Liver Tx pmp Heart Tx Lung Tx pmp Pancreas Tx donors pmp kidney Tx ney Tx pmp pmp pmp pmp

Spain 34.3 45.9 3 24.6 5.3 4.1 1.7 Belgium 28.2 42.4 4 25.2 7 8.8 1.7

France 25.3 42.3 3.7 16.8 6.1 3.5 1.5

Portugal 23.9 42.2 3.5 25.1 4.8 0.4 1.8 Austria 22.3 40.5 7.5 14.3 6.9 9.9 3

Czech.R 21.1 35 3.3 11.2 6.7 1.2 2.6

Ireland 21 33.6 1.2 14 1.7 1 1.2

Italy 20.5 27.2 1.7 18.4 5.4 1.9 1.3 Latvia 18.7 31.3 0.4 0 1.3 0 0

Finland 17.2 31 1 10 4.2 2.8 -

Germany 16 28.4 6.9 14 5 3.5 1.6 Hungary 15 26.3 1.7 4.1 2.2 - 0.5

Sweden 14.5 27.9 13.4 14.8 5 4.7 1.1

Lithuania 14.1 24.4 2.7 2.7 4.4 12 - Netherlands 16.9 28.4 22 9.1 3.2 4 1.7

Denmark 13.2 21 10.2 7.9 5.3 6 -

Estonia 13.2 21 10.2 7.9 5.3 6 - United Kingdom 13.2 23.5 13.4 10.7 2.3 2 4.1

Slovenia 11.4 14.9 0.5 5 5.5 - -

Poland 9.2 17.1 0.6 5.1 1.7 2 0.6 Greece 5.8 9.2 7.9 2.9 0.5 0.2 -

Luxembourg 2.1 25.2 0 0 - - -

Romania 1.7 3.3 7.2 1.5 0.4 0 0 Bulgaria 1.3 1.5 2.2 1 0.4 0 0

Cyprus - 25.7 51.4 - - - -

ble form of trafficking in this regard, circumstances in which trafficking in misery in many areas of the world. All trafficking in human beings for the human beings to obtain organs, organ these factors provide the basis for the purpose of organ removal. Organ trafficking and what is sometimes development of these practices as a 22 transplantation exists in a world of referred to as transplant “tourism” can modern horror added to the endless extreme economic disparity. There are flourish. These circumstances also list of tragic disasters affecting the also huge inequities in the access encourage trafficking since the rich whole world. which people throughout the world can shorten the time they have to wait However, the relationship between have to transplantation services. For a for a transplant by exploiting the dis- organ shortage and these phenom- variety of reasons, many countries advantages faced by the very poor. ena might be even more complex, have also not engaged in policies that Lack of organs as an immediate solu- with additional elements contribut- would enable them to become self- tion for patients in need leads them to ing to their emergence and continua- sufficient in terms of the supply of OTC search for alternative solutions and tion over time. One of the technical for medical purposes. The great scar- cut corners in order to secure a trans- solutions for tackling shortage of city affecting the supply of organs and plant. Criminal groups take advantage organs for transplantation is the use of the growing demand for organs and of this desperation which is added to so-called expanded-criteria donors tissues as medicine advances produce that stemming from poverty and (ECD) (see below), whose age and/or

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. TRANSPLANTATION OF ORGANS AND TISSUES

Figure 4. Number of patients pmp placed on the waiting list (blue bars) and on the waiting list at the end of the year (red bars) for a kidney transplant in several countries of the world in 2007. Source: Council of Europe. Newsletter Transplant 300 Patients admitted in the kidney wl pmp Patients in the kidney wl at 31 December pmp 250

200

150

Patients pmp 100

USA Portugal Turkey Brazil Cyprus United Kingdom Bulgaria New Zealand Latvia Cuba Uruguay Canada Italy Argentina Ireland Slovak Republic France Austria Germany Spain Switzerland Croatia Greece Belgium Romania Israel Denmark Hungary Australia Lithuania Netherlands Czech Republic Finland Poland Slovenia Norway Estonia Panama Sweden Venezuela Luxembourg Mexico Colombia Costa Rica Ecuador

co-morbidity characteristics are tion of organs from these donors pro- recipients.25 Patients might therefore known to have a negative impact on duces very acceptable results in prefer to search for a living donor, the quality of organs for transplanta- appropriate recipients,24 it is also true especially because of changes in the tion. The increase in the use of these that results in the long term are profile of deceased organ donors in donors is a strategy which partially poorer than those obtained with more their countries. Moreover, many would explains the higher levels of transplan- ideal donors and far poorer than opt to look for a living donor outside tation activity in several countries. results obtained with living donors in their immediate environments the case of kidney transplantation. because of the lack of willing relatives The need for the use of ECD also stems Better results involving kidney trans- or because of a desire to avoid risks or from the fortunate decrease in deaths plantation from living donors are putting pressure on loved ones, which due to traffic accidents in many devel- achieved even when no genetic rela- once again may lead to trafficking. oped countries and hence the need to tionship exists between donors and adapt to the new profile of organ donors in order to meet the transplan- 24. Pascual J, Zamora J, Pirsch JD. A systematic tation needs of the population. While review of kidney transplantation from expanded 25. Collaborative transplant study website. Acces- criteria donors. Am J Kidney Dis 2008; 52 (3): 553- sible at: http://www.ctstransplant.org/. Accessed it is quite clear that the transplanta- 586. 26 August 2009.

Figure 5. Deaths (absolute figures and pmp) on the waiting list for a kidney, liver, heart or lung transplant in the 23 European Union. 2007

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

Solving the organ and tissue shortage

Live donation on its own cannot solve expressed consent means that, if the sumed consent, relatives are fre- the transplantation needs of a popula- will of the donor is unknown and no quently approached in order to clarify tion, one reason being that the trans- relatives are available to make a deci- the deceased person’s wishes regard- plantation needs for specific organs sion, organs cannot be recovered. In ing organ donation and if the wishes and tissues will never be met through contrast, the model of presumed of the deceased are at odds with those live donation. Dealing effectively with consent is based on a refutable pre- of the relatives, the will of the latter is organ shortage requires the develop- sumption and a person who does not always respected. Of course, this prac- ment of a deceased donation pro- wish to become an organ donor after tical similarity between the two gramme to enable each country to death must express his/her objection systems might not be the case for reach its maximum therapeutic poten- during his/her lifetime in accordance non-European countries. tial from deceased donors. Live dona- with the provisions of national legislation should therefore be generally tion. Other conventional approaches for regarded as a complement to There are conflicting reports about tackling organ shortage have also deceased donation activity. the existence of significantly higher proven to be of limited usefulness. This section is intended briefly to deceased donation rates in countries Promotional campaigns, for example describe a set of measures that have with a presumed consent policy, and involving advertisements on bill- been developed to increase deceased about the impact of a change from an boards or buses, seem to have a tran- 26 27 28 donation rates and maximise organ opt-in to an opt-out system. This sient impact, if any, on deceased and tissue availability from deceased basically stems from the fact that pre- donation rates, although they may organ donors. sumed consent is not usually strictly help to increase awareness of the applied. In the context of two projects Over the years, various conventional need for donation among the general funded by the European Commission, 30 approaches for tackling the scarcity of population. Lastly, the development ALLIANCE-O and DOPKI, it was noticed organs and donors for transplantation of tools which may facilitate the that the two policies do not differ sub- have proven to be of limited useful- expression of the wishes of the stantially in day-to-day practice.29 In ness. One approach involves changing deceased regarding organ donation many European countries with pre- the legal framework regarding the during lifetime may be regarded as a social tool that is far from being effec- type of consent required to proceed 26. Low HC, Da Costa M, Prabhakaran K, Kaur M, with organ donation, moving from an Wee A, Lim SG, Wai CT. Impact of new legislation on tive in increasing donation rates. presumed consent on organ donation on liver expressed (opt-in) to a presumed (opt- transplant in Singapore: a preliminary analysis. Today, it is widely recognised that out) system. The idea behind the Transplantation 2006; 82: 1234-1237. proper organisation of the process of 27. Hitchen L. No evidence that presumed model of expressed consent is that the consent increases organ donation. BMJ 2008; 337: deceased donation, optimising every 1614. step (see below), is the right approach person has to express his/her will to 28. The potential impact of an opt-out system for donate explicitly during his/her life- organ donation in the United Kingdom – An inde- to deal efficiently with the shortage of pendent report from the Organ Donation Taskforce. time. This approach may be modified Available at: http://www.dh.gov.uk/en/ organs for transplantation. Some tech- in such a way that if the donor did not Publicationsandstatistics/Publications/ nical initiatives are also proving to be PublicationsPolicyAndGuidance/DH_090312. Last communicate his/her will during his/ access: 26 August 2009. highly useful as a means of increasing her lifetime, consent may be obtained 29. White Paper ALLIANCE-O (European Group for the availability of organs. Co-ordination of National Research Programmes on from relatives or other persons who Organ Donation and Transplantation 2004-2007). had a close relationship with the Web page ALLIANCE-O. Available at: http:// 30. Frates J, Bohrer GG, Thomas D. Promoting www.alliance-o.org/news/. Last accessed: organ donation to Hispanics: the role of the media 24 donor. Applying the concept of 26 August 2008. and medicine. J Health Commun 2006; 11: 683-698.

The process of deceased donation: organisational and technical initiatives for dealing with organ shortage

Organisational initiatives to stressed that no more than 1% of fore limited. However, it is difficult to increase donation and trans- deceased individuals and no more attain the potential of DBD, since plantation activities than 3% of people who die in hospital organ donation and procurement is a Deceased donation activity is prima- fall into this category. The number of very delicate and complex process rily based on DBD. It should be potential brain-dead donors is there- that requires the co-operation of

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. TRANSPLANTATION OF ORGANS AND TISSUES

many players and can easily be inter- for transplantation. This compounds tion of the process described. In rupted at any time.31 Moreover, the the weaknesses of the process itself. general terms, it should be underlined whole process must take place in a Several basic steps may be identified that there is no lack of potential very short period of time, as organs here (Figure 6). The different steps are donors, but a failure to identify them with long ischaemic times (periods areas of potential loss of donors and and subsequently activate and effec- with no blood supply) are unsuitable organs for transplantation. Because of tively develop the deceased donation process. 31. Meeting the organ shortage: current status its nature and characteristics, develop- and strategies for improvement of organ donation. ing an effective deceased donation A European consensus document. Council of Europe web page. Last accessed: 26 August 2009. programme requires proper organisa-

Figure 6. Steps in the process of donation after brain death DONOR DONOR DETECTION MAINTENANCE

BRAIN DEATH DIAGNOSIS P R O CONSENT TO ORGAN C U DONATION R TRANSPLANTS E M E LOCAL AND N ORGANISATIONAL FACTORS T

The importance of organisational tals with the main responsibility of countries, in terms both of their posi- measures as applied to deceased developing a proactive detection of tion with respect to the procurement organ donation has been stressed by potential donors is identified as a hospitals and of their professional the Council of Europe, the European basic requirement for improving backgrounds. Union and the Iberoamerican deceased donation rates.33 34 Other The need for a supra-hospital organi- Network/Council of Donation and responsibilities for these key figures sation or agency stems from the spe- Transplantation (see below, page 45) (also called “Transplant Co-ordina- cific nature and characteristics of the and has been clearly reflected in con- tors”) would include increasing the deceased donation and transplanta- sensus documents, recommendations level and quality of deceased donation process and is regarded as one of and specific actions and activities. tion, including educational, training the basic requirements for guarantee- Moreover, organisational aspects are and research activities. In contrast, ing the success of a donation pro- the key characteristics of models that there is no such clear agreement on gramme. However, the structure and are benchmarks at a global level the profile of these key figures and responsibilities of such organisations because of their high deceased dona- their position with regard to the pro- vary greatly between countries. The tion rates and transplantation activity, curement hospitals. As stated in differences depend on their origin and for instance the Spanish Model of several recommendations,35 the ideal the background and profile of the pro- 25 Donation and Transplantation.32 Some situation would involve in-hospital fessionals who founded and manage of these organisational measures are figures with a close relationship with them, as well as on economic and summarised in this section. the intensive care unit, which would health-structure issues in the relevant The establishment of a network of facilitate detection of potential donors countries, among other factors. procurement hospitals under the and subsequent activation of the Although there is no single formula to umbrella of a supranational organisa- process. In practice, the profile of guarantee the success of a pro- tion is the recommended structure. these figures varies greatly between gramme, in general terms, the ideal The appointment of “key donation situation is for the body to be in professionals” at procurement hospi- 33. See note 29, page 24. charge of organ allocation and distri- 34. See note 31, page 25. 35. Rec (2005) 11 of the Committee of Ministers to bution and also to act as a support 32. Matesanz R, Domínguez-Gil B. Strategies to member states on the role and training of profes- agency for the entire process of optimise deceased organ donation. Transplant Rev sionals responsible for organ donation (transplant 2007; 21: 177-188. “donor co-ordinators”). deceased organ donation.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

Supporting the deceased donation be further requirements for tackling pared with cases of recipients receiv- process could involve a wide range of the problem of shortage of organs for ing their organs from traditional or actions and activities, many of which transplantation. In particular, educa- more ideal donors.39 This would are clearly indicated in the corre- tion and communication are highly include extreme age and donors with sponding Council of Europe recom- relevant activities for creating positive potentially transmissible diseases mendation.36 Focusing on the need to attitudes in society towards donation (infections and neoplasias) or other solve the problem of organ shortage, and transplantation and building trust pathologies. The conditions and a supra-hospital organisation should, in the system, both of which are pathologies in question have tradi- if necessary, evaluate and propose needed to facilitate the involvement tionally been regarded as formal legislative measures in order to ensure of society. contra-indications for organ dona- a legislative framework in line with tion. However, there is increasing evi- current scientific knowledge with Technical initiatives to increase dence that when organs from these regard to donation and transplanta- donation and transplantation donors are used in appropriate and tion. It ought to act as a genuine inter- activities specific conditions the results may be face between the political and the There are also technical initiatives that very acceptable and even similar to technical level. Logistical co-ordina- have been considered as a means of those obtained with organs from tion of all activities in the process increasing donation and transplanta- more ideal donors. The use of organs should be performed on a timely and tion rates: the use of ECD and of from ECD has therefore gradually effective manner by the body, in co- special surgical techniques to maxim- become a real way of expanding the operation with procurement and ise the use of organs for transplanta- donor pool and they actually repre- transplantation centres. Material and tion, for instance split and domino sent a very significant percentage of transplantation and double kidney human resources are therefore deceased organ donors in many coun- transplantation with kidneys from needed and activities should be devel- tries. For example, more than 40% of ECD. These strategies are outside the oped without improvisation and deceased organ donors in countries scope of this study, but we will never- according to pre-established proto- such as Italy and Spain are aged 60 theless look at ECD, as they are cols so as to ensure that the maximum years or over (DOPKI data, not pub- becoming quantitatively significant in number of organs is obtained and the lished). As previously stated, using countries with well developed organs and/or teams are transported these organs is becoming essential in deceased donation programmes. effectively and quickly. In short, it is order to maintain transplantation essential for the concept of “quality” To increase the supply of organs for activity, especially in countries where to be incorporated in the process of transplantation, the medical contra- deaths due to cranioencephalic trau- deceased donation. indications for donations have been matisms overall and in young people altered over time. Increasing use is in particular are fortunately decreas- In close liaison with the procurement now made of organ donors who had ing over time. hospitals, the development of specific not traditionally been accepted as programmes aimed at detecting, eval- such because of specific pathologies Consistently discarding organs from uating and correcting problems in the or conditions. These donors have ECD may worsen the shortage of donation process is vital. In line with been termed ECD, or sometimes mar- organs for transplantation, but con- this need, the development of quality ginal or suboptimal donors. sistently accepting them may involve assurance programmes allowing esti- Several definitions have been pro- an element of risk to the recipient mation and monitoring of donation vided for ECD. The United Network for outcome in terms of morbidity and 26 potential, areas for improvement and Organ Sharing (UNOS) defines ECD as mortality and a decrease in graft sur- overall effectiveness (or performance) persons with one or more of the fol- vival, unless they are used in very spe- in the deceased donation process has lowing factors: age over 55 years, over cific conditions. The decrease in graft also been recommended.37 Lastly, pro- ten-year history of hypertension, over survival due to the use of ECD may moting research, training profession- ten-year history of diabetes mellitus, also worsen the imbalance between als involved directly or indirectly in the DCD and cold preservation time over organ supply and demand, since loss donation process, educating people 36 hours.38 ALLIANCE-O gave a more of function of a previous graft is and communicating properly seem to general definition of ECD, as persons increasingly becoming a cause of indi- potentially associated with poorer viduals returning to the waiting lists. 36. Recommendation Rec (2006) 15 of the Com- results in the recipients when com- These peculiarities raise a series of mittee of Ministers to member states on the background, functions and responsibilities of a National ethical considerations which are cur- Transplant Organisation (NTO). 38. Ojo A et al. Survival in recipients of marginal rently a subject of debate. 37. Recommendation Rec (2006) 16 of the Com- cadaveric donor kidneys compared with other mittee of Ministers to member states on quality recipients and wait-listed transplant candidates. J improvement programmes for organ donation. Am Soc Nephrol 2001; 12: 589-597. 39. See note 24, page 23.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. TRANSPLANTATION OF ORGANS AND TISSUES

Non-heart beating donation (donation after cardiac death)

As mentioned above, in the early days in the United States, activity in this improved through careful donor of organ transplantation, the source of area is very limited in Europe and selection, but are still worse than transplantable kidneys was either other regions of the world, with some those obtained with DBD. Although living donors or deceased donors who exceptions. In 2007, only five Euro- the results have improved compared had died from a cardio-respiratory pean countries actually did record a to the first experiences, they are still arrest. However, wide acceptance of significant number of DCD: 186 in the unsatisfactory and research is under the brain death definition and criteria United Kingdom, 114 in the Nether- way in order to improve them. While meant that the use of organs from lands, 88 in Spain and 39 in Belgium there are many challenges in the field brain death donors subsequently and France. These low figures are of DCD, it is regarded as a useful and almost fully replaced the use of the probably a reflection of the legislative, realistic approach for expanding the former category. The shortage of ethical and overall organisational and donor pool. However, concern has organs for transplantation, combined technical difficulties and dilemmas lately arisen because of its potential with promising results with kidney that this activity involves. negative impact on DBD, as described transplants from these donors, has 45 There are several technical and organi- in some countries. renewed interest in obtaining organs sational issues that increase the com- from DCD. This has led to several con- 43. Sánchez-Fructuoso AI, Marques M, Prats D, plexity of DCD when compared to Conesa J, Calvo N, Pérez-Contín MJ, Blazquez J, ferences and meetings which have Fernández C, Corral E, Del Río F, Núñez JR, Barrientos DBD. Moreover, while proven to be sought to address the inherent techni- A. Victims of cardiac arrest occurring outside the hospital: a source of transplantable kidneys. Ann 40 41 42 quite successful with proper donor cal, ethical and legal issues. Intern Med 2006; 145: 157-164. selection after kidney43 or even lung44 While activity with DCD has increased 44. De Antonio DG, Marcos R, Laporta R, Mora G, transplantation, results after liver García-Gallo C, Gámez P, Córdoba M, Moradiellos J, Ussetti P, Carreño MC, Núñez JR, Calatayud J, Del Río 40. Kootstra G. The asystolic, or non-heartbeating, transplantation are still a matter of F, Varela A. Results of clinical lung transplant from donor. Transplantation 1997; 63: 917-921. concern. These poor results have uncontrolled non-heart-beating donors. J Heart 41. Donation after cardio-circulatory death. A Lung Transplant. 2007; 26: 529-534. Canadian Forum. Report and Recommendations. 45. Cohen B, Smits JM, Haase B, Persijn G, Van- Canadian Critical Care Society. Canadian Society of 42. Bernat JL, D’Alessandro AM, Port FK et al. renterghem Y, Frei U. Expanding the donor pool to Transplantation. Feb. 17-20-2005 Vancouver, British Report of a National Conference on Donation after increase renal transplantation. Nephrol Dial Trans- Columbia ISBN O-9738718-06 July 2005. Cardiac death. Am J Transplant 2006; 6: 281-291. plant 2005; 20: 34–41.

Living donation

In the first days of successful kidney tion, in recent years, living donation According to data from 2007, living transplantation, the organs came from has also become an effective source of kidney transplant activity in Europe living related donors. After the first organs for liver and, indeed, lung, pan- ranged from less than 1 procedure successful kidney transplant between creas and intestine transplantation, pmp to 51.4 procedures pmp in identical twins was performed in although the latter types of organs are Cyprus (Table 2, page 22). Living liver 1954, the first kidney transplant from a not yet quantitatively so significant. donation activity is still limited, since non-genetically related donor took Nowadays, in countries with no fully the complexity of partial hepatectomy place in the Foch Hospital in Paris in developed deceased donation pro- and the risks for the living donor are 1955. Living donation was the only grammes, transplantation activity clearly higher than those with a available source of organs for trans- mainly or totally relies on live donors. nephrectomy. While more than 40% of 27 plantation until some transplantations The situation in countries with a rea- kidney transplants performed world- with DCD were carried out and the sonably well developed system of wide are from living donors, only concept of brain death was defined deceased donation is different. In par- about 15% of liver transplants come and came to be widely accepted. Over ticular, living donation is seen in many from this source.46 the years, many patients have of these countries as another possibil- Living donation involves clear benefits received transplants from genetically ity for increasing the availability of for the recipient and the system. First, or non-genetically related living organs for transplantation, at a time of unlike deceased donation, living donors and, among the latter, from shortage of deceased organ donors. In donation is an elective procedure. donors with whom they may or may this context, living donation activity Second, and because of the thorough not have a personal relationship. has increased progressively in recent evaluation and selection of the donor, Moreover, while living donors were years in many western countries, but initially used for kidney transplanta- still varies significantly between them. 46. See note 13, page 19.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

the kidney or the liver to be trans- Survival of living liver-transplanted incidence of chronic renal failure or planted should be of high quality. patients is similar to that described for other medical complications than Third, damage to the graft in the recipients of livers from deceased those observed in the general popula- context of the physiopathological donors. However, living liver recipients tion. However, most of these reports changes of brain death and have been shown to develop higher are retrospective, with a significant ischaemia-reperfusion injury is mini- post-transplantation morbidity. number of cases not being followed mised. Fourth, living kidney transplan- Similar results were obtained in the up, and make outcome comparisons tation may be performed on a pre- Collaborative Transplant Study.49 Sur- in relation to the general population, emptive basis, avoiding dialysis ther- vival of living liver-transplanted which might not be the most appro- apy, with the corresponding savings patients is similar to that described for priate basis, since living kidney donors to the healthcare system and benefits recipients of livers from deceased should be considered healthier than for the recipient in post-transplant donors. However, living liver recipients the general population. There are also outcomes. have been shown to develop higher reports of living donors developing a post-transplantation morbidity. progressive decline in renal function As a result, living kidney transplanta- and of some of them becoming Living donation must deal with the tion is associated with better results kidney transplant candidates in the issue of whether it violates the tradi- than those obtained with kidneys long run. Long-term follow-up of tional first rule in medicine, “primum from deceased donors, regardless of living kidney donors has not generally non nocere” (above all, do not harm), the genetic relationship between the revealed a higher incidence of chronic since no single surgical procedure, donor and the recipient. According to renal failure or other medical compli- including nephrectomy and hepatec- the OPTN, one-year graft survival of cations than those observed in the tomy, is completely risk-free. Living kidney transplants is 89% for recipi- general population. However, most of kidney donation is regarded as a rela- ents from deceased donors as against these reports are retrospective, with a tively low-risk procedure for the 95.1% for those from living donors, significant number of cases not being donor. Mortality risk has been put at these differences being more pro- followed up, and make outcome com- 0.03%, according to several studies.50 nounced with longer follow-up, with parisons in relation to the general The risk of short-term complications five-year survival rates of 66.5% and (such as bleeding or infection) is low, population, which might not be the 79.7% respectively.47 Kidney trans- although it varies depending on the most appropriate basis, since living plantation from living donors also surgical technique used to perform kidney donors should be considered offers benefits in terms of patients’ the nephrectomy in the donor.51 healthier than the general popula- 52 survival compared with deceased Living donation must deal with the tion. There are also reports of living 48 donors. As a result, living kidney issue of whether it violates the tradi- donors developing a progressive transplantation is associated with tional first rule in medicine, “primum decline in renal function and of some better results than those obtained non nocere” (above all, do not harm), of them becoming kidney transplant 53 with kidneys from deceased donors, since no single surgical procedure, candidates in the long run. regardless of the genetic relationship including nephrectomy and hepatec- Besides the medical complications between the donor and the recipient. tomy, is completely risk-free. Living that have been described among According to the OPTN, one-year graft kidney donation is regarded as a rela- living organ donors, some reports survival of kidney transplants is 89% tively low-risk procedure for the have noted the possibility of non- for recipients from deceased donors donor. Mortality risk has been put at medical complications.54 For instance, as against 95.1% for those from living 0.03%, according to several studies. psychological and/or social repercus- 28 donors, these differences being more The risk of short-term complications sions of living donation, including pronounced with longer follow-up, (such as bleeding or infection) is low, financial and occupational disadvan- with five-year survival rates of 66.5% although it varies depending on the tages, have been described in the lit- and 79.7% respectively. Kidney trans- surgical technique used to perform erature and are a matter of concern for plantation from living donors also the nephrectomy in the donor. Long- offers benefits in terms of patients’ term follow-up of living kidney donors 52. Ommen ES, Winston JA, Murphy B. Medical survival compared with deceased has not generally revealed a higher risks in living kidney donors: absence of proof is not proof of absence. Clin J Am Soc Nephrol. 2006; 1: donors. Similar results were obtained 885-895. in the Collaborative Transplant Study. 49. Collaborative transplant study website. Availa- 53. Delmonico F. A report of the Amsterdam ble at: http://www.ctstransplant.org/. Last accessed: Forum on the Care of the Live Kidney Donor: data 26 August 2009. and medical guidelines. Transplantation 2005; 79: 47. Organ Procurement and Transplantation 50. Matas AJ, Bartlett ST, Leichtman AB, Delmon- Suppl 6: S53-S66. Network website. Available at: http:// ico FL. Morbidity and mortality after living kidney 54. Brown RS Jr, Russo MW, Lai M, Shiffman ML, www.optn.org/latestData/rptStrat.asp. Last donation 1999-2001: survey of United States trans- Richardson MC, Everhart JE, Hoofnagle JH. A survey accessed: 26 August 2009. plant centers, Am J Transplant 2003; 3 (7) 830-834. of liver transplantation from living adult donors in 48. See note 47, page 28. 51. See note 47, page 28. the United States. N Engl J Med 2003; 348: 818-825.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. TRANSPLANTATION OF ORGANS AND TISSUES

the international transplantation com- strophic complications, defined as the protection of the donor, such as the munity.55 death of the donor, the need for a liver Amsterdam Forum59 on the living The outcome for living liver donors transplant or the development of a kidney donor and the Vancouver differs from that described for living vegetative state has been shown to be Forum60 on the living non-kidney kidney donors, given the risks related not insignificant, with rates of 0.4% to donor. Other international recommen- 0.6%.58 to the performance of a partial hepa- dations, in particular two recently tectomy, even in a healthy person. The In this context, there are a range of issued by the Council of Europe, have incidence of complications associated ethical considerations relating to been produced in the same connec- with living liver donation varies, living donation which have been eval- tion and as a guide for the develop- depending on the series. However, the uated within the scope of interna- level of these complications has tional legal instruments (see below) ment of international and national 61 62 proven to be as high as 21% to 28% in and various international consensus legislation. some cases.56 57 The rate of cata- conferences aimed at ensuring the 59. The Ethics Committee of the Transplantation Society. The Consensus Statement of the Amster- 55. Reimer J, Rensing A, Haasen C, Philipp T, Piet- 57. Lo CM. Complications and long-term dam Forum on the Care of the Live Kidney Donor. ruck F, Franke GH. The impact of living-related outcome of living liver donors: a survey of 1 508 Transplantation 2004; 78 (4): 491-492. kidney transplantation on the donor’s life. Trans- cases in five Asian centers. Transplantation 2003; 75 60. See note 58, page 29. plantation 2006; 81: 1268-1273. (Supp 3): S12-S15. 61. Resolution CM/RES (2008) 4 on Adult-to-adult 56. Brown RS Jr, Russo MW, Lai M, Shiffman ML, 58. Pruett TL et al. The ethics statement of the living donor liver transplantation. Richardson MC, Everhart JE, Hoofnagle JH. A survey Vancouver Forum on the live lung, liver, pancreas, 62. Resolution CM/RES (2008) 6 on Transplanta- of liver transplantation from living adult donors in and intestine donor. Transplantation 2006; 81: 1386- tion of kidneys from living donors who are not the United States. N Engl J Med 2003; 348: 818-825. 1387. genetically related to the recipient.

This section on the transplantation of needs of the population, which OTC and trafficking in human organs and tissues may be summarised are underestimated and are set to beings for the purpose of organ in the following key points: increase in the coming years. removal. Organ transplantation has The degree of development of become a unique therapy able to donation and transplantation Solving the shortage of organs for save the life or increase the quality activities varies greatly between transplantation requires the of life of patients with end-stage countries, with the result that development of an effective organ failure. It is a consolidated there is unequal access to trans- deceased donation programme. therapy which benefits almost plantation services throughout The effectiveness of such a pro- 100 000 patients worldwide every the world. For a variety of reasons, gramme mainly depends on year. Activity involving the deceased donation programmes organisational aspects. While implant of tissues and cells of have not been developed or fully there is no lack of potential human origin also takes place on a consolidated in many countries, deceased organ donors, there is large scale and is able to treat a where transplantation activity, if an inability to identify them and wide range of conditions, many of any, mainly relies on live donation. successfully activate and develop them life-limiting diseases. As a result of shortage of organs the process of deceased donation. Mainly because of the excellent for transplantation, many patients results obtained with transplanta- will never be placed on the Living donation should be seen as tion, demand for the therapy has waiting list. Many patients on being complementary to gradually increased over the years, waiting lists will deteriorate or die deceased donation. However, it with a higher number of patients while waiting for an organ. has been the main or the only being placed on the waiting lists, Organ shortage, plus the extreme source of transplantable organs in 29 while the number of donors and economic disparities and inequi- many countries. Living donation organs has not increased at the ties in access to transplantation involves risks for donors and same rate. At present, it is not pos- services throughout the world, are cannot on its own meet the trans- sible to meet the transplantation the main causes of trafficking in plantation needs of a population.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

B. Bioethics – the ethical framework for organ and tissue procurement

To close the gap between demand summarised in the previous section. In on the waiting lists should receive and supply of organs for transplanta- order for policy-makers to consider transplants first. Fairness is a crucial tion, all manner of ideas are being the merit of new options for encour- element in determining the supply of floated on how to encourage people aging people to donate OTC, it is nec- donated organs and tissues. If the to give more organs when they die, essary fully to understand the public do not believe the allocation of optimise performance in the process bioethical framework that has guided organs and tissues is fair, they will be of donation, enable more people to organ and tissue donation in nearly far less willing to donate their organs act as living donors and even find new every part of the world since its incep- or tissues upon their death or as living sources of organs and tissues by tion in the 1950s. donors. Trust and altruism require fair- rethinking organ procurement and It is also necessary to think hard about ness as a basis for organ and tissue the definition of who can be a the most effective and fair way of dis- donation. deceased donor. These ideas were tributing scarce organs, including who

The existing bioethical framework for obtaining organs and tissues

The existing bioethical framework for without my permission. To do so is to the huge dangers that would loom for obtaining organs and tissues is based commit an assault upon a living human health and welfare if trade for on four key values – respect for indi- person or to desecrate the body of a profit in human body parts from the viduals, autonomy, consent and altru- newly deceased person. Part of the dead or the living were permitted. ism. The notion that organs or tissues notion of treating individuals with Altruism is the bioethical foundation can be removed for the purposes of dignity is that they have control over as reflected in the use of the term transplantation, whether the individ- what is done with their own bodies “donation” for obtaining organs in a ual concerned is alive or dead, without and their parts. manner consistent with human dig- voluntary consent is one that has not Another core element of the existing nity. 30 been accepted except in highly bioethical framework is that the body In order to obtain organs and tissues unusual circumstances (i.e., unclaimed and its parts must not be made the from the living, there is agreement bodies at morgues in some countries). subject of trade. The prohibition of that, from an ethical standpoint, it is Individuals are recognised as having slavery and of trafficking in persons necessary to have a legally competent an interest in controlling their bodies for prostitution is based upon the individual who is fully informed and in life and upon death. They are to be ethical principle that human beings can make a voluntary, uncoerced treated with dignity and not merely ought not to be bought and sold as choice about donation. In cases where used to serve the health needs of objects, and transplantation has incor- organs and tissues are sought from others. So even though someone porated this view in the prohibition of the deceased, the notion of voluntary might well benefit from obtaining my trading in body parts for profit. In part, consent has been extended in many liver or receiving bone marrow from this is a bioethical view that rests upon countries to the recognition of donor my body, these organs and tissues the fundamental dignity of individu- cards or, for those not wishing to ought not to be removed from me als. In part, it is a principle that reflects donate, the recording of objections in

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs B. BIOETHICS – THE ETHICAL FRAMEWORK FOR ORGAN AND TISSUE PROCUREMENT

computer-based registries. While Proposals to increase the supply of existing bioethical framework, major various policies about who is responsi- organs must be weighed up very care- religious groups who have long sup- ble for giving consent exist through- fully against this existing bioethical ported it or healthcare workers, the out the world, from a bioethical framework which has long been effec- majority of whom firmly believe that perspective, it is voluntary, informed tive in protecting the interests of pro- the current bioethical framework is consent that is crucial in making organ spective donors. Changes in the the right one for governing organ, and tissue procurement ethical. relevant values might well alienate the tissue and cell procurement for trans- public who have grown used to the plantation purposes.

Increasing the supply

A number of steps have been taken Some countries began requiring hos- While these policies have been effec- over the years in many countries to try pitals to ask all patients’ families about tive, the gap in supply has continued to increase the supply of organs. An organ and tissue donation upon to increase. Some people now there- early measure was to pass laws per- death. Most recently, some countries fore argue for a shift away from reli- mitting the use of organ donor cards now require hospitals to honour a ance on voluntary altruism in organ that enabled families to consent to patient’s donor card even when a donation towards either a paid market donating a deceased relative’s organs. family member opposes donation. or presumed consent.

Organ markets

Two basic strategies have been pro- ment itself which remunerates the sion, but that does not make it a posed to provide incentives for people “voluntary” donors and provides them matter of free, voluntary choice. to sell their organs upon their death. with one year medical insurance and Watching your child go hungry when One strategy is simply to permit organ with social recognition for the act of you have no job and a wealthy person sales by allowing individuals to broker donation. The model has been shown waves a wad of money in your face is contracts while alive with persons to attain its objectives: Iran is the only not exactly a scenario that inspires interested in buying at prices mutually country in the world with no waiting confidence in the “choice” made by agreed upon by both parties. At least list for kidney transplantation, the those with few options but to sell in an underground sense, markets system produces excellent post-trans- body parts. Talk of individual rights already exist on the Internet between plant outcomes and it has avoided the and autonomy is hollow if those with potential live donors and people in problem of transplant tourism by pro- no options must “choose” to sell their need of organs. hibiting transplantation to foreigners organs to purchase life’s basic necessi- The other strategy is a “regulated” with organs from local donors. The ties. Choice requires information, market in which the government supporters of this controlled organ options and some degree of freedom, would act as the purchaser of organs – trade state that it is the most suitable as well as the ability to reason about setting a fixed price and enforcing model in the particular context of the risks without being blinded by the conditions of sale. Iran appears to country, which might not be under- prospect of short-term gain. have such a market in operation, standable from a western perspec- It is hard to imagine many people in although data on how it is specifically tive. However, Iranians have wealthy countries being eager to sell organised and how well it functions themselves openly recognised the their organs either while alive or upon 31 raise important ethical questions limitations of this system, including their death. In fact, even if compensa- about the approach.63 In 1998, with a the common additional remuneration tion is relatively high, few will agree to transplantation programme based on usually paid by the recipient to the sell. That has been the experience related living donors which was unrelated living donor. with markets in human eggs for unable to cope with the demand for research purposes and with paid sur- kidney transplantation within the Both proposals have drawn heated rogacy in the United States – prices country, a model of unrelated living ethical criticism. One criticism is that have escalated, but there are still rela- donation, involving payments but only the poor and desperate will want tively few sellers. controlled by the government, was to sell their body parts. If you need Selling organs, even in a tightly regu- developed in Iran. It is the govern- money, you might sell your kidney to lated market, violates the existing try and feed your family or to pay back bioethical framework of respect for 63. Ghods AJ, Mahdavi M. Organ transplantation in Iran. Saudi J Kidney Dis Transpl 2007; 18: 648-655. a debt. This may be a “rational” deci- individuals since the sale is clearly

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

being driven by profit. In the case of removing body parts from people tain about the degree to which appro- living persons, it also violates the solely to abet those people’s interest priate care was being offered and ethics of medicine itself. The core in securing compensation as well as to continued and whether a person ethical norm of the medical profession let middle-men profit. might be worth more ‘dead than alive’. is the principle, “Do no harm.” The only The resulting distrust and loss of pro- Is this a role that the health profes- way that removing an organ from fessional standards is a high price to sions can ethically countenance? In a someone seems morally defensible is pay for gambling on the hope that a market – even a regulated one – if the donor chooses to undergo the market might secure more organs and doctors and nurses still would be harm of surgery solely to make tissues for those in need. using their skills to help living people money. harm themselves solely for money. In The creation of a market in body parts a deceased market, they would risk puts medicine in the position of making families and patients uncer-

Presumed consent

There is another option for increasing alive by carrying a card indicating Respect for individuals and voluntary, organ supply that has been tried in their objection or by registering their altruistic consent remains the moral countries such as Spain, Italy, Austria, objection in a computerised registry foundation for making organs availa- Belgium and Singapore. These coun- or both. They may also tell their loved ble. The main ethical objection to pre- tries have passed laws establishing ones and rely on them to object sumed consent is fear of mistakes in presumed consent. Under this system, should procurement present itself as the event of consent being presumed the presumption is that a deceased an option. when, in fact, either the individual had person wishes to be an organ donor What is important about this strategy failed to indicate their objection or the upon their death – basically an ethical from a bioethical perspective is that it record of their objection had been default reflecting the desirability of is completely consistent with the lost. donation. People who do not wish to existing bioethical framework govern- be organ donors have to say so while ing organ and tissue procurement.

Distributing organs: what is just and fair?

Rationing is unavoidable in organ values shape their decisions, and it time on the waiting list and the per- transplantation, but the system for can be argued that some centres son’s physical condition. There have allocating organs must be just and fair. invoke these values in ways that are been some moves in recent years to Justice requires some rule or policy not truly just. Among these considera- steer organs toward those who are not which makes sure that the supply of tions, many transplant centres will not seriously ill so as to maximise the donated organs is used wisely and in accept people over 75 years of age. chances for successful transplantation. accordance with what donors and Some centres exclude patients with UNOS used to allocate organs locally, 32 their families would wish. Fairness moderate mental retardation, HIV, a but recently it has moved to more demands that like cases of need be history of addiction or a criminal treated alike and that the allocation record. regionalised distribution arrange- system is transparent so that all indi- Value judgments may also influence ments in the interest of fairness. viduals on waiting lists know why the process of matching deceased It is crucial from a bioethical perspec- some are selected and some are not. donor organs with patients on waiting tive that the criteria used to determine The existing bioethical framework lists. For example, in the United States, who receives a transplant are trans- cannot function without public confi- the UNOS bears this responsibility. At dence and trust. present, its overriding concerns are to parent, open to public debate and Transplant centres are the gatekeep- match donors and recipients by blood consistently applied. If not, confidence ers who decide who will or will not be type, tissue type and organ size. Some in transplantation would be lost with a accepted as transplant candidates. weight is also given to the urgency or devastating impact on organ and Their policies vary. Many non-medical need for a transplant as reflected by tissue donation.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs B. BIOETHICS – THE ETHICAL FRAMEWORK FOR ORGAN AND TISSUE PROCUREMENT

This section on the ethical framework must be weighed up very carefully tions of medicine, undermining a for organ and tissue procurement may against this existing bioethical system based on altruism that be summarised in the following key framework. already works in many countries. points: Organ markets as a solution for It is crucial from a bioethical per- The existing bioethical framework increasing organ supply do not spective that the criteria used to for obtaining OTC for transplanta- respect this bioethical framework. determine who receives a trans- tion is based on four key values – Free, voluntary choices cannot be plant are transparent, open to respect for individuals, autonomy, made in the case of living donors public debate and consistently consent and altruism. Proposals to when purchase is the reason applied. Otherwise, loss of confi- increase the supply of organs behind donation. Commerce in dence in transplantation would donation and transplantation have a devastating impact on would shake the basic founda- organ and tissue donation.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

C. Existing international standards

World Health Organization and World Health Assembly

The World Health Assembly first transplant recipients still face several the adoption of measures to protect expressed its concern regarding traf- risks which call for safety and quality the poorest and vulnerable groups ficking in organs and the need for measures. Lastly, the report underlines from “transplant tourism” and the sale global standards for transplantation in that proposals to offer financial incen- of tissues and organs, including by Resolution WHA40.13 adopted by the tives for the provision of human body giving attention to international traf- 40th World Health Assembly in May material in the hope of increasing ficking in human tissues and organs. 1987 and in Resolution WHA42.5 on access to transplantation need to be preventing the purchase and sale of carefully scrutinised. Resolution WHA57.18 on Human human organs adopted by the 42nd In May 2003, the Executive Board of Organ and Tissue Transplantation was World Health Assembly in May 1989. the WHO agreed at its 112th session to followed by a number of activities and In response to these resolutions, the set up a group of experts to prepare a discussions, including the Second World Health Assembly in 1991 report regarding organ and tissue Global Consultation on Human Trans- adopted Resolution WHA44.25 endors- transplantation, including xenotransplantation: Towards a Common Global ing a set of Guiding Principles on plantation. Attitude to Transplantation, held in Human Organ Transplantation. These In October 2003, the First Global Con- Geneva from 28 to 30 March 2007. At Guiding Principles – whose emphases sultation on “Ethics, access and safety this meeting, an update of the 1991 include voluntary donation, non- in tissue and organ transplantation: Guiding Principles was also strongly commercialisation, genetic relation of Issues of global concern” took place in favoured by participants. The Global recipients to donors and a preference Madrid. At this meeting, issues regard- Observatory on Donation and Trans- 64 for deceased over living donors as ing ethics, access and safety in transplantation was also developed by sources – have considerably influ- plantations were analysed. Because of the Spanish National Transplant enced professional codes, legislation changes in practices and attitudes Organisation (ONT) in collaboration and policies. regarding organ and tissue transplan- with WHO in response to some of the In its report “Human organ and tissue tation, in May 2004, the 57th World requests made in WHA57.18, for transplantation” (EB112/5) of 2 May Health Assembly in Resolution instance collecting global data on 34 2003, the World Health Organization WHA57.18 on Human Organ and Tissue practices and ensuring transparency (WHO) refers to medical and legal Transplantation – based on the find- of the systems in place. developments. While still favouring ings in the above-mentioned report – At its 123rd session on 26 May 2008, deceased donors, the report empha- requested that the Director-General, the WHO Executive Board took note of sises that improvements in immuno- inter alia, continue examining and col- the revised WHO Guiding Principles on suppression reduce the need for living lecting global data in order to update Human Cell, Tissue and Organ Trans- donors to be genetically related to the the Guiding Principles on Human plantation, and it is anticipated that a recipient, which means that still more Organ Transplantation. Furthermore, resolution of the next Executive Board attention must be paid to ensuring it called for enhanced co-operation, session will lead to these revised that consent is given on an informed the setting up of ethics groups, exten- Guiding Principles being presented to and voluntary basis. Despite advances sion of the use of living kidney dona- the World Health Assembly in 2010. in safety measures for human organ tions when possible, in addition to and tissue transplantation, donors and donations from deceased donors, and 64. See note 13, page 19.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs C. EXISTING INTERNATIONAL STANDARDS

Council of Europe

Resolution (78) 29 on harmoni- removal procedure or preceding the commercialisation of organ pro- sation of legislation of member examination, under a social secu- curement, exchange and transplanta- states relating to removal, graft- rity or other insurance scheme. tion activities, to develop an ing and transplantation of These basic rules can now be information policy on the significance human substances found in all modern legal instru- of organ transplantation and to 65 The Council of Europe started activi- ments and recommendations and promote European co-operation. ties related to transplantation at an their substance is undisputed. The text dealt with issues regarding early date: as far back as 1978, the However, several questions seem the removal of organs (including skin Committee of Ministers adopted Reso- to remain open concerning their and bone marrow, but excluding testi- lution (78) 29 on harmonisation of legis- meaning, especially the range of cles, ovaries, embryos, ova, sperm and lation of member states relating to expenses that are excluded as blood) from deceased and living removal, grafting and transplantation regards the term “non-profit”, as donors, establishing guidelines and of human substances, which deals with became evident, inter alia, during restrictions for the procedure to be substances from living and deceased the discussion of the draft EU applied and the cases in which such persons, setting out certain principles framework decision concerning pre- removals should take place. for both. It is important to note that vention and control of trafficking in The need for free, legal consent was the basic principles are already laid human organs and tissues (see expressly reiterated, along with the down in this document: below, page 70). principle that no removal should be The issue of consent in the case of In addition, respect for the donor’s effected from a legally incapacitated living donors is dealt with promi- and recipient’s anonymity except person.66 nently. Article 2 provides that the in cases of close personal or family donor and, in the case of a minor relationships between the two The second main aspect, namely the or otherwise legally incapacitated was already clearly defined principle of non-commercialisation of person, his or her legal represent- (Article 2 (2) regarding organs human organs, was also reiterated: ative must be given appropriate from living donors and Article 13 Chapter II, paragraph 16, of the final information before the removal regarding organs from deceased declaration states that a human organ about the possible consequences donors). must not be offered for profit, but that of the removal, in particular the The main principles for transplanta- this does not prevent the compensa- medical, social and psychological tions were therefore already set out in tion of living donors for loss of earn- ones, as well as about the impor- this resolution, which must be seen as ings and any expenses caused by the tance of the donation for the one of the first international instru- removal or preceding examination. recipient. Article 3 lays down the ments ever to deal with the topic. The Council of Europe thereby principle that the removal must However, the resolution is not binding stressed this aspect for a second time, not be effected without the and does not include any provisions showing clear political will, but still in consent of the donor and that this on sanctions. a non-binding format. consent must be given freely. Chapter III of the conclusions estab- The second major issue is dealt The conclusions of the 3rd Con- lishes clear criteria for the use of with in Article 9 for substances ference of European Health Min- human organs, i.e. rational use of from living donors and in isters (Paris, 16-17 November organs where there is the maximum Article 14 for those from deceased 1987) prospect of success, solely based on 35 persons: no substance (organ) The conclusions of the 3rd Conference medical criteria. The necessary con- may be offered for profit. For of European Health Ministers (Paris, trols to ensure that both removals and living donors, the resolution 16-17 November 1987) on the subject transplantations take place in officially nonetheless provides that loss of of “Organ transplantation” set out recognised institutions with ade- earnings and any expenses agreed guidelines which were based quately trained and experienced staff caused by the removal or preced- on Resolution (78) 29 but further elab- and equipment are mentioned in ing examinations may be orated them and formed a basis for Chapter IV. refunded and that the (potential) future work and co-operation within donor must be compensated, the member states of the Council of 65. See: Paragraph 6 of the conclusions of the 3rd Conference of European Health Ministers (Paris, independently of any possible Europe. It was unanimously agreed 16-17 November 1987). medical responsibility, for any that there was a need to protect indi- 66. Conclusions of the 3rd Conference of Euro- pean Health Ministers (Paris, 16-17 November damage sustained as a result of a vidual rights and freedoms, to avoid 1987), paragraphs I.B. (9) and (10).

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

Chapter V covers information policy to examine the possibility of preparing a With regard to trafficking in organs inform the public of the significance of framework convention “setting out and the main issues related to it, the organ transplantations in saving lives common general standards for the following should be noted: Chapter II and respective organisational meas- protection of the human person in the of the convention deals with the ures. As early as 1987, the importance context of the development of the general issue of consent. Article 5 of organisational measures for the biomedical sciences”. In June 1991, the lays down the general rule that an promotion of European co-operation Parliamentary Assembly, in Recom- intervention in the health field may was recognised. Chapter VI recommendation 1160, supported the idea only be carried out after the person mended that in order to avoid of a framework convention compris- concerned has given free and wastage of organs resulting from ina- ing a main text with general principles informed consent to it and that he or bility to find the right recipient, organs and additional protocols on specific she may freely withdraw his or her which, on the basis of medical criteria, aspects. In September 1991, the Com- consent at any time. This article cannot be used in the donor’s country mittee of Ministers instructed the affirms the already well-established should be made available on the basis CAHBI to prepare “a framework Con- principle of patients’ autonomy, of the same criteria to patients in vention, open to non-member states, meaning that no person should other countries, preferably through setting out common general stand- undergo any intervention without his European exchange organisations on ards for the protection of the human or her consent. An individual must a strictly non-commercial basis. person in the context of the biomedi- therefore be able freely to give In short, the conclusions of the 1987 cal sciences and Protocols to this Con- consent to any intervention involving 3rd Conference of European Health Min- vention, relating to, in a preliminary their person and to refuse it at any isters already included most of the ele- phase: organ transplants and the use time. But consent alone is not enough; ments of modern recommendations of substances of human origin; it needs to be informed and has to be and standards and served – together medical research on human beings”. given freely. According to Article 5 (2), with Resolution (78) – as the basis for the person must therefore be given In July 1994, an initial version of the the leading international instrument appropriate information beforehand draft convention was subjected to in this field, the 1997 Convention for as to the purpose and nature of the public consultation and submitted to the Protection of Human Rights and intervention as well as its conse- the Parliamentary Assembly. In the Dignity of the Human Being with regard quences and risks. light of the Assembly’s opinion and of to the Application of Biology and Medi- Informed consent: Naturally, such several other positions adopted, a cine: Convention on Human Rights and information should be given by the final draft was drawn up by the Steer- Biomedicine (CETS No. 164). As such, responsible healthcare professionals, ing Committee on Bioethics (the suc- the declaration was a strong political as it is they who know the details of cessor to the CAHBI) on 7 June 1996 statement, but in a non-binding the planned intervention and of possi- and again submitted to the Parliamen- format. ble alternatives, as well as the charac- tary Assembly. Finally, the convention teristics of the patient on whom the (CETS No. 164) was adopted by the The Convention for the Protec- intervention is going to be performed Committee of Ministers on tion of Human Rights and Dig- (age, sex, specific health risks, etc.) and 19 November 1996 and opened for nity of the Human Being with which can influence its outcome. signature on 4 April 1997 in Oviedo regard to the Application of According to the explanatory report (Spain). It entered into force on Biology and Medicine: Conven- on the convention, Article 5 (2) men- 1 December 1999 and had been tion on Human Rights and Bio- tions only the most important aspects signed by 34 states and ratified by 22 36 medicine (CETS No. 164) of the information which should as at December 2008. After various activities within the precede the intervention, but should Council of Europe, it became apparent The aim of the Convention on Human not be seen as an exhaustive list, i.e. that greater efforts to harmonise exist- Rights and Biomedicine is to guarantee informed consent may imply addi- ing standards regarding the applica- everyone’s integrity, rights and funda- tional elements, depending on the cir- tion of biology and medicine were mental freedoms with regard to the cumstances. needed. The European Ministers of application of biology and medicine As is the case for any other informa- Justice adopted Resolution No. 3 on and protect the dignity and identity of tion, it must be sufficiently clear and bioethics at their 17th Conference human beings in this sphere suitably worded for the patient to (Istanbul, 5-7 June 1990), recommend- (Article 1), thereby putting the human understand. He or she must be put in ing that the Committee of Ministers being before the interest of society or a position to evaluate the need for and instruct the ad hoc Committee of science (Article 2) and, moreover, usefulness of the intervention and the Experts on Bioethics (CAHBI) to before all other considerations. methods to be applied, as well as the

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs C. EXISTING INTERNATIONAL STANDARDS

risks. This means that the information Specific cases: Article 6 of the Con- understand, his or her consent may be should not only be provided in a lan- vention on Human Rights and Biomedi- necessary. guage the patient understands, but cine takes account of the fact that Organ and tissue removal from living also that the terms used should be interventions may also have to be donors for transplantation pur- understandable. carried out on persons who do not poses: A separate chapter of the Con- have the capacity to give full and valid Article 5 does not require a special vention on Human Rights and Biomedi- consent. According to Article 6 (1), an cine deals with organ and tissue form for the consent; it can be express intervention may only be carried out removal from living donors for trans- (either verbal or written) or implied. on such a person for his or her direct However, for invasive interventions, plantation purposes (Chapter VI). As a benefit. Deviation from this rule is general rule, Article 19 provides that express consent may be required and possible in only two cases: medical removal of organs or tissue from a in the case of the removal of body research and the removal of regenera- parts for transplantation purposes the living person for transplantation pur- tive tissue (Articles 17 and 20). poses may be carried out solely for patient’s express, specific consent the therapeutic benefit of the recip- must be obtained (Article 19). Where, according to law, a minor ient and where there is no suitable (Article 6 (2)) or an adult – because of organ or tissue available from a Free consent: Freedom of consent a mental disability, a disease or for deceased person and no other alter- implies that it may be given and with- similar reasons68 (Article 6 (3)) – do not native therapeutic method of compa- drawn at any time and that the deci- have the capacity to consent to an rable effectiveness. sion has to be respected; no pressure intervention, the intervention may of whatever kind may be used and only be carried out with the authorisa- In line with the previous work of the nobody may ignore this requirement. tion of their representative or an Council of Europe in this field, the The patient is entitled to information, authority or a person or body pro- purpose of this chapter is to establish but, as provided for in Article 10 (2), vided for by law. Nonetheless, the a framework to protect living donors the wishes of individuals not to be opinion of the minor must be taken in the context of organ or tissue informed must be observed. However, into consideration as an increasingly removal. Underlining the dignity and Article 10 (3) limits this insofar as in determining factor in proportion to human rights of individuals, it is made exceptional cases restrictions may be his or her age and degree of maturity clear that the first requirement for the placed by law on the exercise of this and the adult unable to consent must removal of organs or tissues from a right in the interests of the patient. as far as possible take part in the living person for transplantation pur- authorisation procedure. poses is the therapeutic benefit of the Basically, the patient’s exercising of recipient. Of course, the recipient’s the aforementioned right is not This means that in certain situations needs have to be known before the regarded as an impediment to the which take account of the nature and removal of the organ, as it would be a validity of his or her consent to an seriousness of the intervention, as well violation of basic human rights princi- intervention; e.g. he or she can validly as the minor’s age and ability to ples if an organ were to be removed consent to the removal of a cyst understand, the minor’s opinion without the immediate and urgent despite not wishing to know its should increasingly carry more weight need of a specific patient and thereaf- nature,67 but there are certain circum- in the final decision. This could even ter maybe even be wasted because of stances where it could also be appro- lead to the conclusion that the inability to find a matching recipient. priate to inform an individual that he consent of a minor should be neces- The second principle is that the use of or she has a particular condition when sary, or at least sufficient for some organs or tissues from deceased there is a risk not only to that person interventions.69 Taking into account donors should be preferred to those 37 but also to others. The right also has to the nature and seriousness of removal from living donors whenever possi- be qualified if there is a major risk for of organs, it can therefore be inferred ble because an intervention always the person him- or herself, e.g. before (in line with Article 12 of the bears a certain risk for the patient. And invasive interventions like the removal United Nations Convention on the the last condition in the case of living of organs, where the risk for the donor Rights of the Child) that, depending on donors is that the therapeutic is so high and the consequences so the child’s age, maturity and ability to benefit for the recipient cannot be far-reaching that valid consent is not achieved by alternative therapeutic possible without the donor receiving 68. The term “similar reasons” refers to such situations as accidents or states of coma, for example, methods of comparable effective- certain information in order to give where the patient is unable to formulate his or her ness. such consent. wishes or to communicate them (Explanatory report on the Convention on Human Rights and In view of all these requirements, it Biomedicine, paragraph 43). can be seen that the Convention on 67. Explanatory report on the Convention on 69. Explanatory report on the Convention on Human Rights and Biomedicine, paragraph 67. Human Rights and Biomedicine, paragraph 45. Human Rights and Biomedicine care-

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

fully takes into account the human where the chances of tissue incompat- that, in cases where the organ appears rights of both donors and recipients: it ibility are much higher). Moreover, the not to be suitable for transplantation balances patients’ need for transplan- authorisation of the representative of purposes, it may exceptionally be tations with a restriction on the use of the person unable to consent must be used for research. organ and tissue removals from living given – in accordance with Article 6 (2) According to Article 23, parties to the donors because of the risk involved; and (3) – specifically and in writing, in convention must provide judicial pro- there can be no justification for resort- accordance with the law and with the tection to prevent or stop unlawful ing to living donors if there are other approval of the competent body. Of infringements of the rights and princi- methods for bringing the same course, this approval must be given ples set out in the convention. benefit to the recipient. The transplant before the removal can be carried out. Article 24 provides that persons suf- must therefore be necessary in the Lastly, the removal may not be carried fering undue damage resulting from sense that there is no other solution out if the potential donor objects; an intervention are entitled to fair with similar results. In this respect, such an objection must be observed compensation according to the condi- dialysis treatment is not considered to in all circumstances. tions and procedures prescribed by provide results in terms of the Chapter VII sets out a basic principle law. And lastly, according to Article 25, patient’s quality of life comparable which has now achieved worldwide parties must provide for appropriate with those obtained by a kidney trans- recognition, namely the prohibition sanctions to be applied in the case of 70 plant. of financial gain, and also covers the infringement of the convention’s pro- Regarding consent, Article 19 (2) issue of disposal of parts of the visions. makes the general rule of Article 5 human body. Article 21 is the most stricter by stating that, in the case of prominent provision of the Conven- Additional Protocol to the Con- organ removal, the necessary consent tion on Human Rights and Biomedicine: vention on Human Rights and must have been given expressly and “The human body and its parts shall Biomedicine concerning Trans- specifically either in written form or not, as such, give rise to financial gain”. plantation of Organs and Tis- before an official body, e.g. a court or a It directly applies the principle of sues of Human Origin (CETS No. notary. This is because the invasive human dignity provided for in 186) nature of this intervention entails Article 1. According to Article 21, With the Additional Protocol to the Con- more requirements for valid consent organs and tissues must not be traded vention on Human Rights and Biomedi- because of the risks it involves for the or give rise to financial gain – either cine concerning Transplantation of person. for the donor or for a third party. How- Organs and Tissues of Human Origin Article 20 (1) clearly prohibits organ or ever, the provision does not prevent a (CETS No. 186; hereafter: the Addi- tissue removal being carried out on a donor from receiving compensation tional Protocol), the Council of Europe person who does not have the capac- which, while not constituting remu- seeks to ensure the protection of indi- ity to consent under Article 5. neration, compensates the individual viduals in the area of transplantations. Article 20 (2) further specifies that for expenses incurred or loss of On the basis of Recommendation 1160 exceptionally and under the protec- income. (1991) and the Committee of Minis- tive conditions prescribed by law, the According to Article 22, when in the ters’ instructions to the ad hoc Com- removal of regenerative tissue from a course of an intervention any part of a mittee of Experts on Bioethics (CAHBI) person who does not have the capac- human body is removed, it may be to prepare protocols to the Convention ity to consent may be authorised, pro- stored and used for a purpose other on Human Rights and Biomedicine, vided that certain conditions are than that for which it was removed, “relating to, in a preliminary phase: 38 met: the first condition is that – within only if this is done in conformity with organ transplants and the use of sub- reasonable limits – no compatible appropriate information and consent stances of human origin; medical donor is available who is able to con- procedures (Article 5). Depending on research on human beings”, the CAHBI sent. Additionally, in the absence of the circumstances (nature of the use in November 1991 appointed a the donation, the recipient’s life must of the removed parts, collection of Working Party on Organ Transplanta- be in danger, and the risks to the sensitive data about individuals, etc), tion to prepare the draft protocol. As donor must be acceptable. Also, the the information and consent require- the work on the convention itself took recipient must be a brother or sister of ments may vary. Article 22 is no precedence, the work on the protocol the donor to avoid efforts being made exception to the principle in Article 19 was postponed until January 1997. In to find a donor at any price (such as that removal of organs for transplan- June 1996, the Steering Committee on donors at a distant level of kinship tation purposes may be carried out Bioethics (CDBI) extended the only for the benefit of the recipient. Working Party’s terms of reference to 70. Explanatory report on the Convention on Human Rights and Biomedicine, paragraph 119. But it does provide for the possibility examine the draft protocol in the light

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs C. EXISTING INTERNATIONAL STANDARDS

of the text of the convention. After a organisations, which must ensure the advance and be transparent in order consultation process, the Additional rights and freedoms of (potential) to exclude malpractice. This also Protocol was adopted by the Commit- donors and recipients. Because of the means that, apart from these criteria, tee of Ministers on 8 November 2001. shortage of organs, they must be allo- the person or body responsible for The Additional Protocol to the Conven- cated in such a way as to maximise the determining them must be clearly tion on Human Rights and Biomedicine benefit, which means that transplan- known and must be accountable for concerning Transplantation of Organs tation services must be equally acces- the decisions taken. Moreover, and Tissues of Human Origin (CETS sible on a non-discriminatory basis to patients may only be registered on No. 186) was opened for signature in any person within the jurisdiction of a one waiting list so that all patients Strasbourg on 24 January 2002. States state. have equal chances. which signed the Convention on Article 8 is closely linked with this pro- For international organ exchanges, Human Rights and Biomedicine can vision. It requires states to inform justified and effective distribution of also become signatories to this proto- health professionals and the public organs according to the solidarity col. It entered into force on 1 May about the need for organs and tissues principle within and among the par- 2006. As at December 2008, 20 states and the conditions for removal and ticipating countries is required had signed and eight had ratified the implantation, including issues of (Article 3 (3)). The traceability of protocol. consent and authorisation, especially organs and tissues must be ensured The Additional Protocol aims to protect regarding removal from deceased per- (Article 3 (4)), which means that it the dignity and identity of individuals sons. This is important for raising must be possible to track organs and and the respect for their integrity and awareness and promoting organ and tissues from the donor to the recipi- other rights and fundamental tissue donations, while making the ent(s) and back. This is not only neces- freedoms regarding transplantation of system known and acceptable to the sary for health reasons (e.g. in case of organs and tissues of human origin public and establishing trust in it. transmissible diseases) but also in (Article 1) and cells (including haemat- Article 3 (2) provides that organs and order to evaluate the use of trans- opoietic stem cells; Article 2 (2)), tissues may be allocated only to planted material and prevent traffick- thereby excluding issues of xenotrans- patients on waiting lists, in conformity ing in organs and tissues. plantation. Under Article 2 (3), repro- with transparent, objective and duly Article 4 reiterates the basic rule ductive organs and tissues (a), justified rules according to medical already laid down in Article 4 of the embryonic or foetal organs and criteria. National systems may estab- Convention on Human Rights and Bio- tissues (b) and blood and blood deriv- lish different criteria for transplanta- medicine that all interventions in the atives (c) are also excluded from its tion of various organs and tissues, but field of transplantation must be scope. they must all follow medical criteria. carried out in accordance with rele- It furthermore only concerns the According to the explanatory report, vant professional obligations and removal of organs or tissues from this should be understood in the standards. First of all, these require someone who has been born and the broadest sense, “in the light of the rel- that the persons involved act in the implantation of that organ or tissue, evant professional standards and obli- patient’s best interest and that the for therapeutic purposes, into gations, extending to any potential benefit to the recipient out- someone else who has been born, circumstance capable of influencing weighs the risks to the donor. In addi- including procedures of investigation, the state of the patient’s health, the tion, the existence of a clear medical preparation of donors and recipients quality of the transplanted material or indication for transplantation must be and preservation and storage of the outcome of the transplant. Exam- verified and all professional and organs and tissues (Article 2 (1) and ples would be the compatibility of the ethical codes of conduct must be 39 (4)). organ or tissue with the recipient, complied with. Among other things, In line with the Convention on Human medical urgency, the transportation different doctors need to take care of Rights and Biomedicine and numerous time for the organ, the time spent on the donor and the recipient so as to recommendations of the Council of the waiting list, particular difficulty in guarantee the best treatment for both Europe and the World Health Organi- finding an appropriate organ for patients and avoid conflicts of inter- zation, Article 3 (1) requires Parties to certain patients (...) and the expected est. 71 the Additional Protocol to provide transplantation result.” In short, the Closely linked with these principles equitable access to transplantation criteria must be objective and patient- are the requirements to provide services for patients. The Additional oriented and it goes without saying medical follow-up to the donor and Protocol leaves it to states to decide that they must be determined in the recipient after the transplantation whether to fulfil this obligation (Article 7) and that all professionals 71. Explanatory report on the Additional Protocol through national or international (CETS No. 186), paragraph 37. involved must take the necessary

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

measures to minimise the risks of is a counterbalance to Article 4 able to withdraw it at any time (see transmission of disease and to avoid because clearly there is always a Chapter II.C.1.c.). However, unlike the actions which might affect the suita- certain risk connected with donations, act of giving consent, no specific for- bility of organs or tissues for trans- which must be outweighed by the malities apply for its withdrawal. This plantation. benefit to the recipient. However, if is an important measure to protect Article 5 reiterates the recipient’s right that risk seriously endangers the the donor’s human rights and the vol- to comprehensive information prior to donor, the donation procedure has to untary nature of the donation. The the intervention in a language he or be stopped. This is also one more possibility of withdrawing consent she can understand so that he or she argument in support of the require- applies to the removal, and only the can give informed consent to the ment that different medical teams removal. The provision does not tackle transplantation. should take care of the potential the issue of what should happen if the Chapter III deals with organ and donor and the recipient, as different donor suddenly withdraws consent to tissue removals from living persons. aspects have precedence for the two the planned implantation. Such issues Article 9 reiterates the content of individuals and could otherwise lead have to be addressed by national law. Article 19 of the Convention on Human to a clash of interests. To avoid psychological problems or Rights and Biomedicine, i.e. that organs The next articles are closely linked keep them to a minimum, to avoid or tissues may be removed from living with one another and the issue of undue pressure to donate and also to persons solely for the recipient’s thera- informed and free consent. Accord- enable donors to cope with potential peutic benefit, where there are no ing to Article 12 of the Additional Pro- rejection by the potential recipient of suitable organs or tissues available tocol, the donor must be given the organ, psychological assistance from deceased persons and where appropriate information beforehand must be regarded as part of the infor- there is no alternative therapeutic regarding the purpose and nature of mation (Article 12) which is the basis method of comparable effectiveness. the removal, its consequences and for informed consent. Article 10 restricts potential living risks. This means that the information Article 14 of the Additional Protocol on organ donors to those having a close has to be comprehensive and in a the protection of persons not able to relationship with the recipient as form the potential donor understands consent to organ or tissue removal defined by law or under the condi- (including both the language and also repeats Article 20 of the Convention on tions defined by law and with the its level, e.g. in the case of minor Human Rights and Biomedicine. approval of an independent body (e.g. donors). The same right applies to a Article 15 limits the requirements for an ethics committee). Some national person or body in charge of approving such cell removals from living laws do not define close relationships, such an intervention if the donor is donors which involve a minimal risk while others do – and in various unable to consent. and burden for the donor. It allows degrees; such relationships may Article 12 (2) further specifies that the states not to apply two of the strict include relatives (of various degrees), donor must also be informed of the requirements, i.e. limiting the recipi- spouses and even close friends. If such legal rights and safeguards, inter alia ent to the donor’s brother or sister and close relationships do not exist, trans- to have access to independent advice that the donation should have the plantation may still be proposed, but by experienced health officials not potential to be life-saving. However, an independent body must be involved in the whole procedure. Con- the other conditions set out in involved in the procedure to prevent sequently, an additional requirement Article 14 remain applicable in any organ trafficking. applies: the potential donor must be case. Article 11 protects the potential donor given enough time for his or her deci- Chapter IV of the Additional Protocol 40 by keeping the risks for him or her to a sion, especially since the decision is deals with issues regarding organ and minimum. Article 11 (1) requires one with far-reaching impacts. Written tissue removal from deceased per- appropriate medical investigations information which can be studied by sons. Article 16 is designed to safe- and interventions (examinations, the donor and can serve as a basis for guard patients and public trust in tests, medical acts, etc) to be carried information and questions is helpful transplantations, while at the same out before any organ or tissue removal and should be handed out. time preventing unethical behaviour takes place so as to evaluate and Article 13 of the Additional Protocol is by requiring that a person must first reduce physical risks to the health of based on Articles 5 and 19 (2) of the be certified dead in accordance with the donor. Article 11 (2) provides that Convention on Human Rights and Bio- the law before any removal from his or the life and health of the potential medicine. A donor must give free, her body takes place and that the donor must take precedence, i.e. no informed and specific consent to the doctors certifying brain death must removal is to be carried out if there is a removal, either in written form or not be directly involved in the removal serious threat to them. In this sense, it before an official body, and must be of organs or tissues from that person,

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs C. EXISTING INTERNATIONAL STANDARDS

in any subsequent transplantation or fessionals and the public, setting up intervention, transport, storage, have any responsibility for the care of transplant systems and providing etc.), but no more and especially the potential recipient, so as to avoid legal frameworks for consent and not in terms of their making finan- any conflict of interests. The system authorisation. cial gains from such transactions for establishing brain death is left to Chapter V of the Additional Protocol or, indeed, illegitimate ones. states. deals with the particular circumstance The last indent allows compensa- According to Article 17, no removal that organs or tissues are removed for tion for undue damage resulting may take place until the consent or purposes other than donation for from the removal of organs or authorisation required by law has implantation but are donated at a tissues which is not a normal con- been obtained, in particular no later stage. It requires the person from sequence of transplantations. It is removal is to be carried out if the whom the organ or tissue is removed closely linked to Article 25. Article deceased has objected to it. This pro- to be informed of the consequences 21 (2) prohibits advertising the vision requires states to have a legally of the implantation into another need for, or availability of, organs recognised system regulating the person (examination, tests, recording and tissues with a view to offering conditions for the authorisation of of data for traceability, information on or seeking financial gain or com- the removal of organs and tissues risks, etc) and his or her consent (or parable advantage. from deceased persons, but leaves it that of an authorised person in the Article 22 of the Additional Protocol to them to decide upon its nature. It case of individuals who cannot legally expressly sets out the prohibition of therefore leaves scope for “opt-in” and consent) to implantation to be organ and tissue trafficking, which “opt-out” solutions (see chapter XXX). obtained. All the provisions of the pro- are key examples of making financial However, Article 17 clearly indicates tocol, except those in Chapters III and gains from the human body or its that the wishes of the deceased IV, are applicable. parts. Moreover, organ and tissue traf- persons have to be respected and Chapter VI on the prohibition of ficking infringe human rights, exploit should be ascertained. For example, in financial gain further elaborates the vulnerable persons and undermine several states there are official regis- general principle laid down in public trust in the official transplant ters for recording consent to dona- Article 21 of the Convention on Human system. tions or objections to such; there are Rights and Biomedicine. It is a basic and Article 23 lays down the principle of also registers of last wills. If the will of recognised principle that the human confidentiality of data relating to the deceased is not known, there body and its parts must not give rise donors and recipients; the data must must be a law indicating the proce- to financial gain or comparable advan- be handled in accordance with the dure to be applied. The arrangements tages. Article 21 (1) of the Additional provisions on data protection. How- are also left to states and they may Protocol draws a clear line between ever, this must not prevent the tracea- either allow the removal if no objec- this prohibition and payments whose bility of the organ or tissue or prevent tion is known or provide for consulta- purpose is not financial gain but, on the medical teams involved in the tion of relatives and friends to the contrary, the prevention of finan- transplantation process obtaining the establish the wishes of the deceased. cial disadvantages. In particular, three necessary medical information; other- Unless national law provides other- types of payments are allowed: wise, proper medical interventions in wise, however, it is the will of the The first indent allows living the transplantations and any subse- deceased person only – and not of his donors to receive compensation quent diseases would not be possible. or her relatives – that is relevant. If a for loss of earnings or other justifi- According to Article 24, unlawful person dies in a country in which he or able expenses caused by the infringements of rights or principles she is not resident, every effort should removal or related examinations. set out in the protocol must be 41 be made to ascertain the wishes of the This is an important measure, as stopped at short notice by appropri- deceased. the intrusive nature of the inter- ate judicial means. Persons suffering Article 18 extends the right of integ- vention means lengthy periods of undue damage resulting from trans- rity of the human body to deceased sick leave are likely and may result plantation procedures are entitled to persons in stating that the corpse in economic disadvantages for the fair compensation in accordance with must be treated with respect and all donor. states’ legal conditions and proce- reasonable measures be taken to The second indent allows hospi- dures (Article 25), which are not restore its appearance. Article 19 calls tals and staff to receive payment defined by the protocol. As each trans- on states to take all appropriate meas- of justifiable fees for legitimate plantation involves some damage, ures to promote the donation of medical or related technical serv- Article 25 is limited to undue damage organs and tissues, which in any case ices rendered in connection with resulting from transplantation. Partic- should involve informing health pro- the transplantation (examinations, ular attention should be paid to

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

damage affecting (potential) living tional and technical issues in the field. Resolution CM/Res (2008) 4 on donors, as they consent to organ The main ones are listed below: adult-to-adult living donor liver removal for altruistic reasons. Recommendation No. R (94) 1 on transplantation, In the case of infringements of provi- human tissue banks, sions in the protocol, states must Recommendation No. R (97) 15 on Resolution CM/Res (2008) 5 on provide appropriate sanctions Xenotransplantation, donor responsibility and on limi- according to Article 26. While leaving Recommendation No. R (97) 16 on tation to donation of blood and it to states to determine which form liver transplantation from living blood components, and they should take, the text clearly indi- related donors, Resolution CM/Res (2008) 6 on cates that the sanctions provided for Recommendation Rec (2001) 4 on transplantation of kidneys from must take into account the serious- the prevention of the possible living donors who are not geneti- ness of the offences and their conse- transmission of variant Creutz- cally related to the recipient. quences for individuals and society. feldt-Jakob Disease (vCJD) by blood transfusion, Article 27 highlights the importance Both Resolutions CM/Res (2008) 4 and Recommendation Rec (2001) 5 on of co-operation between the parties, CM/Res (2008) 6 are linked to the issue the management of organ trans- not only with regard to information of trafficking in organs and point out plant waiting lists and waiting exchange, but also through rapid and that there is a need to protect individ- times, safe transportation of organs and ual rights and freedoms and to Recommendation Rec (2003) 10 tissues through their territory in order prevent the commercialisation of on xenotransplantation, not to waste organs or tissues if suita- parts of the human body involved in ble matches are found in other coun- Recommendation Rec (2003) 12 organ procurement, exchange and tries. It is therefore recommendable to on organ donor registers, allocation activities. They also enter into regional or international Recommendation Rec (2004) 7 on acknowledge the scarcity of organs transplantation programmes. organ trafficking, for transplantations and the fact that Lastly, Article 28 of the Additional Pro- Recommendation Rec (2004) 8 on organ transplantation is a well- tocol states that the aforementioned autologous cord blood banks, established, life-saving and effective provisions are to be regarded as addi- Recommendation Rec (2004) 19 treatment and may be the only treat- tional articles to the Convention on on criteria for the authorisation of ment available for some forms of Human Rights and Biomedicine and organ transplantation facilities, end-stage organ failure. They there- that the convention’s provisions apply Recommendation Rec (2005) 11 fore state that organ removals from accordingly. on the role and training of professionals responsible for organ living donors may be envisaged when Recommendations of the Coun- donation (transplant “donor co- suitable organs from deceased donors cil of Europe Committee of Min- ordinators”), are not available, provided that all isters Recommendation Rec (2006) 15 safeguards are implemented in order In addition to the Convention on on the background, functions and to guarantee the freedom and safety Human Rights and Biomedicine and its responsibilities of a National of the donor and a successful trans- Additional Protocol, a wide range of Transplant Organisation (NTO), plant in the recipient, and stress that recommendations of the Committee Recommendation Rec (2006) 16 no organ removal may be carried out of Ministers to member states exist. on quality improvement pro- on a person who does not have the Many of these deal with organisa- grammes for organ donation, capacity to consent. 42 European Union

Directive 2004/23/EC of the the use of organs to some extent Even though human organs were not European Parliament and of the raises the same issues as the use of included in substantive terms, the Council of 31 March 2004 on set- tissues and cells, but nevertheless directive nonetheless stressed two ting standards of quality and decided that the two subjects should important points which should be safety for the donation, pro- not be covered by the same instru- mentioned: curement, testing, processing, ment because of the differences.72 It the need to promote information preservation, storage and distri- does not therefore cover human and awareness campaigns at bution of human tissues and organs, blood or blood products. national and European level on cells (OJ L 102, 7.4.2004) the donation of tissues, cells and This directive recognised the fact that 72. Directive 2004/23/EC, Recital 9. organs based on the theme “we

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs C. EXISTING INTERNATIONAL STANDARDS

are all potential donors” in order declares the right to the integrity of Council Conclusions on Organ to help European citizens to the person and provides that every- Donation and Transplantation decide to become donors during one has the right to respect for his or On 6 December 2007, the Health their lifetime and let their families her physical and mental integrity. In Council adopted conclusions75 in line or legal representatives know the fields of medicine and biology, this with the above Commission Commu- 73 their wishes; and includes the free and informed nication. The text invites member the provision in Article 12 (2) that consent of the person concerned, states to promote and enhance the member states must take all nec- according to the procedures laid performance of transplantation sys- essary measures to ensure that down by law, and the prohibition on tems, to collect information on trans- any promotion and publicity making the human body and its parts plant medicine that would be helpful activities in support of the dona- as such a source of financial gain. for designing and monitoring efficient tion of human tissues and cells policies and to exchange best prac- comply with guidelines or legisla- The question of the legal status of the tices and experience on organ dona- tive provisions and include appro- Charter has been the focus of debate tion and transplantation. The priate restrictions or prohibitions ever since it was drawn up. Full legal European Commission is invited to on advertising the need for, or status would be obtained through its continue its work under the proposed availability of, human tissues and incorporation in the Treaty establish- action plan aimed at increasing the cells with a view to offering or ing a Constitution for Europe. This availability of donor organs and, in seeking financial gain or compara- treaty was signed on 29 October 2004 consultation with the member states, ble advantage. but has still not been ratified by all EU to continue its examination of the member states, which is the require- need for an EU framework on quality Commission Directive 2006/17/ ment for its entry into force. and safety for human organs taking EC of 8 February 2006 imple- into consideration the specificities of menting Directive 2004/23/EC Communication from the Com- organ transplantation and the work of the European Parliament and mission to the European Parlia- carried out by the Council of Europe of the Council as regards certain ment and the Council on “Organ and, lastly, to co-ordinate, promote technical requirements for the and strengthen the co-operation Donation and Transplantation: donation, procurement and between the member states on organ Policy Actions at EU level” (COM testing of human tissues and donation and transplantation on the (2007) 275 final) cells (OJ L 38/40, 9.2.2006) basis of agreed objectives and priori- Commission Directive 2006/17/EC indi- In May 2007, the European Commis- ties. cates that the risk of disease transmission adopted a Communication on sion and other potential adverse Organ Donation and Transplantation Motion for a European Parlia- effects in recipients can be reduced by in which three priority areas of action ment Resolution on organ dona- careful donor selection, testing of were identified: improving the quality tion and transplantation: Policy each donation and the application of and safety of organs, increasing organ actions at EU level (2007/2210 special procedures for procuring availability and making transplanta- (INI)) tissues and cells. Alongside several tion systems more efficient and acces- Because of the steady increase in the provisions implementing certain tech- sible. Two different actions were need for organ transplantation in nical requirements for the donation, suggested: an action plan for Europe, the fact that safety issues are procurement and testing of human strengthened co-ordination between often ignored in illegal commercial 43 tissues and cells, the directive includes member states on organ donation and organ transplantation and organ traf- four annexes covering selection crite- transplantation and an EU directive on ficking and the rapid growth in trans- ria and laboratory tests for donors, as quality and safety of human organs plant tourism, the European well as donation and procurement (see below, page 43 ff.). Parliament in 2007 launched a new procedures and reception proce- initiative. Following the Commission dures.74 74. Annexes: Annex I: Selection criteria for donors Communication, on 22 April 2008 the of tissues and cells (except donors of reproductive cells) as referred to in Article 3 (a). European Parliament therefore EU Charter of Fundamental Annex II: Laboratory tests required for donors adopted a resolution on organ dona- (except donors of reproductive cells) as referred to Rights in Article 4 (1). tion and transplantation by a large Annex III: Selection criteria and laboratory tests majority. Article 3 of the European Union’s required for donors of reproductive cells as referred Charter of Fundamental Rights to in Articles 3 (b) and 4 (2). Annex IV: Cell and/or tissue donation and procure- 75. http://ec.europa.eu/health/ph_threats/ ment procedures and reception at the tissue estab- human_substance/documents/organs_ 73. Directive 2004/23/EC, Recital 3. lishment as referred to in Article 5. council15332_en.pdf.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

The European Parliament stressed that strict legal provisions in connection inconsistent with the most basic it looked forward to the Commission with transplantation from unrelated human values86 and asked the Com- proposal for a directive laying down living donors, in order to make the mission to fight against the practice of quality and safety requirements for system transparent and exclude the organ and tissue trafficking, including organ donation, procurement, testing, possibility of illicit organ selling or the transplantation of organs and preservation, transport and allocation coercion of donors.80 tissues from minors, from the mentally 87 across the EU and the resources Additionally, the European Parliament disabled or from executed prisoners needed to meet these requirements, called for a European donor card, and called on the Commission and but did not wish it to create an addi- complementary to existing national member states to take measures to tional administrative burden. With systems,81 and for more international prevent “transplant tourism” by regard to organ transplantation, co-operation to promote availability drawing up guidelines to protect the reducing the organ (and donor) short- and safety of organs. To underline the poorest and most vulnerable donors age were described as the main chal- importance of increasing public from being victims of organ traffick- lenge that EU member states face; the awareness of organ donation and ing, adopting measures that increase European Parliament therefore looked transplantation, it called on the Com- the availability of legally procured forward to the Commission’s Action mission, member states and civil organs and by exchange of waiting list Plan for strengthened co-operation society to enhance structurally the registrations between existing organ between member states in order to promotion of organ donation82 and to exchange organisations to avoid mul- “increase organ availability, enhance promote World Donor Day.83 In addi- tiple listing. the efficiency and accessibility of tion, it favoured the establishment of Additionally, it asked the Commission transplantation systems, increase a transplant hotline with a single tele- to promote a common approach public awareness, and guarantee phone number managed by a which aims at compiling information 76 quality and safety.” national transplantation organisation on national organ trafficking legisla- that can be reached 24 hours/day and tion and to identify the main problems The European Parliament pointed out 88 is staffed with appropriately trained and potential solutions. Member that member states are responsible for and experienced professionals who states were urged, where necessary, to their own legal model (“opt-in”, “opt- can rapidly provide relevant and accu- amend their criminal codes to ensure out”) and considered it unnecessary to rate information.84 that those responsible for organ traf- adapt or harmonise legal systems. In ficking are adequately prosecuted, Lastly, it stressed the necessity to any case, it called on member states to including sanctions for medical staff ensure the quality and safety of organ achieve the full potential of post- involved in transplantation of organs 77 donation and transplantation and to mortem donations. Furthermore, it obtained from trafficking, while create and develop national regula- underlined the need to ensure that making every effort to discourage tions and a regulatory framework to organ donations stay strictly non- potential recipients from seeking traf- 78 enhance quality and safety, without commercial and endorsed measures ficked organs and tissues; which this having a negative impact on the which aim at protecting living donors should include consideration of crimi- availability of transplant organs.85 and ensuring that organ donation is nal liability of European citizens who made altruistically and voluntarily, A separate chapter deals with organ have purchased organs inside or thus ruling out payments between trafficking. The European Parliament outside the EU.89 donors and recipients, any payment highlighted the link between organ Lastly, member states were called on to being confined solely to compensa- shortage and organ trafficking, stating take the necessary steps to prevent tion which is strictly limited to making 44 that organ trafficking undermines the healthcare professionals from facilitat- good the expense and inconvenience credibility of the system for potential ing organ and tissue trafficking as well related to the donation. Member voluntary and unpaid donors. It as health insurance providers from facili- states were called upon to define the emphasised that any commercial tating activities that directly or indirectly conditions under which compensa- exploitation of organs is unethical and promote trafficking in organs90 and to tion can be granted.79 Furthermore, sign, ratify and implement the Council of they were urged to adopt or maintain 80. Motion for a European Parliament Resolution on organ donation and transplantation, para 24. 81. Motion for a European Parliament Resolution 86. Motion for a European Parliament Resolution 76. Motion for a European Parliament Resolution on organ donation and transplantation, para 34. on organ donation and transplantation, para 49. on organ donation and transplantation: Policy 82. Motion for a European Parliament Resolution 87. Motion for a European Parliament Resolution actions at EU level, para 9. on organ donation and transplantation, para 36. on organ donation and transplantation, para 50. 77. Motion for a European Parliament Resolution 83. Motion for a European Parliament Resolution 88. Motion for a European Parliament Resolution on organ donation and transplantation, para 12. on organ donation and transplantation, para 40. on organ donation and transplantation, para 52. 78. Motion for a European Parliament Resolution 84. Motion for a European Parliament Resolution 89. Motion for a European Parliament Resolution on organ donation and transplantation, para 22. on organ donation and transplantation, para 43. on organ donation and transplantation, para 53. 79. Motion for a European Parliament Resolution 85. Motion for a European Parliament Resolution 90. Motion for a European Parliament Resolution on organ donation and transplantation, para 23. on organ donation and transplantation, para 45. on organ donation and transplantation, para 54.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs C. EXISTING INTERNATIONAL STANDARDS

Europe Convention on Action against framework for organ donation and states. It proposes that a competent Trafficking in Human Beings and the Traf- transplantation, minimising the risk national authority be created or desig- ficking in Persons Protocol if they have for the organ transplant recipients and nated in each member state to ensure not already done so.91 improving and optimising the alloca- compliance with EU quality and safety The members of the European Parlia- tion of organs across the European standards. The tasks of such an ment regretted that Europol had not Union, as well as providing the trans- authority would include the establish- come up with a survey on organ plant surgeon with the necessary ment of a traceability system for selling and trafficking because it information to make the best choice. human organs and a reporting system claims that there are no documented This proposal for a directive covers for serious adverse events and reac- cases. Referring to reports of the human organs that are used for trans- tions. In addition, data collection on Council of Europe and WHO which plantation, during all the phases of the specific organ characteristics would give evidence that the organ trade is process – donation, procurement, be standardised and national quality also a problem for EU member states, testing, preservation, transport and programmes would ensure continu- the members of the European Parlia- use – and aims to ensure their quality ous monitoring. ment asked the Commission and and safety and hence a high level of The added values are expected to be Europol to improve monitoring of health protection.92 It excludes blood ensuring quality and safety for cases of organ trafficking. and blood components, human patients at EU level and the protection of donors, as well as facilitating co- Proposal for a directive of the tissues and cells, as well as organs or tissues and cells of animal origin and operation between member states European Parliament and of the and cross-border exchanges. Council on standards of quality relates to the purpose of transplanta- and safety of human organs tion only. It aims to ensure that human intended for transplantation organs used for transplantation in the (COM (2008) 818 final, 2008/ EU comply with the same quality and 0238 (COD)) safety requirements so as to facilitate The proposed directive of 8 December their exchange between member 2008 aims at providing a clear legal 92. Proposal for a Directive of the European Parlia- ment and of the Council on standards of quality 91. Motion for a European Parliament Resolution and safety of human organs intended for transplan- on organ donation and transplantation, para 55. tation: Introduction, Recital 12.

The Iberoamerican Network/Council of Donation and Transplantation (RCIDT)

The aim of the Iberoamerican To date, the RCIDT has produced Recommendation Rec RCIDT 2005 Network/Council of Donation and eleven recommendations and consen- (5) on the Training Plan for train- Transplantation (RCIDT) is the devel- sus documents: ing professionals in donation and opment of co-operation between its transplantation, Recommendation Rec RCIDT 2005 members in terms of organisational, Recommendation Rec RCIDT 2006 (1) on autologous cord blood legislative, professional-training, (6) on solutions to organ shortage banks, ethical and sociological aspects (phases of the deceased donation related to donation and transplanta- Recommendation Rec RCIDT 2005 process – areas for improvement), 45 tion of OTC in Iberoamerican coun- (2) on the role and training of pro- Consensus Document: Criteria to tries. The proposal to set it up was fessionals responsible for organ prevent the transmission of neo- approved at the 7th Iberoamerican donation (transplant donor co- plasic diseases through transplan- Conference of Health Ministers in ordinators), tation, Granada (Spain) in September 2005 Recommendation Rec RCIDT 2007 Recommendation Rec RCIDT 2005 and confirmed a month later at a (7) on guides for the quality and (3) on the functions and responsi- summit of the Heads of State and Gov- safety of cells and tissues of bilities of a National Transplant ernment in Salamanca (Spain). The human origin for transplantation, Organisation, ONT is in charge of its permanent sec- Recommendation Rec RCIDT 2008 retariat. The network is made up of 21 Recommendation Rec RCIDT 2005 (8) on bioethical considerations Spanish and Portuguese speaking (4) on Quality Assurance Pro- on donation and transplantation countries. grammes in the Donation Process, of organs, tissues and cells,

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

Recommendation Rec RCIDT 2008 Of particular interest is Recommenda- mendation, the RCIDT sought to (9) on harmonisation of criteria for tion Rec RCIDT 2008 (8) on bioethical define a set of ethical principles to be the diagnosis of brain death in considerations on donation and trans- followed by its members in connec- Iberoamerica, plantation of organs, tissues and cells, tion with the organisational and legis- which was approved at the 6th lative measures concerning the Declaration against transplant meeting of the Council in Havana donation and transplantation of OTC. tourism in Latin America. from 26 to 28 May 2008. In this recom-

World Medical Association

In October 2006, the 58th WMA takes place on a free and informed ever, reasonable reimbursement of General Assembly in Pilanesberg basis without any pressure or coer- expenses such as those incurred in (South Africa) revised the World cion. procurement, transport, processing, Medical Association Statement on The universal principle of non-com- preservation, and implantation is per- Human Organ Donation and Trans- mercialisation of organ transplants missible.” plantation which had been adopted was also expressly reiterated: in para- by the 52nd WMA General Assembly graph 30, the WMA clearly stated: In paragraph 31, reference is also in Edinburgh (Scotland) in October “Payment for organs for donation and made to the (ethical) obligation on 2000. In the light of advances in transplantation must be prohibited. A doctors: “Physicians who are asked to medical sciences which have made financial incentive compromises the transplant an organ that has been possible a significant increase in suc- voluntariness of the choice and the obtained through a commercial trans- cessful organ transplantations, the altruistic basis for organ donation. Fur- action should refuse to do so and WMA developed a policy based on thermore, access to needed medical should explain to the patient why ethical principles to provide guidance treatment based on ability to pay is such a medical act would be unethi- to medical associations, physicians inconsistent with the principles of jus- cal: because the person who provided and other healthcare providers, as well tice. Organs suspected to have been the organ risked his or her future as to those developing policy and pro- obtained through commercial trans- health for financial rather than altruis- tocols regarding these issues. In the action must not be accepted for trans- tic motives, and because such transac- statement, the WMA underlined the plantation. In addition, the tions are contrary to the principle of need to improve organ donations and advertisement of organs in exchange justice in the allocation of organs for measures to ensure that donor choice for money should be prohibited. How- transplantation.”

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs D. NATIONAL LEGISLATION ON ORGAN TRANSPLANTATION

D. National legislation on organ transplantation

Laws and regulations are a crucial transplantation takes place in 7 out of prohibits financial gain from the basis of national organ donation and 14 countries devoid of any legislative human body and its parts, aimed at transplantation services to protect the framework. stopping the exploitation of vulnera- live donor and the transplant recipi- The law prohibits giving or receiving ble persons for the benefit of wealthy ent, as well as to meet patients’ needs payment for organs (including any foreigners in need of a kidney. In the while maintaining society’s principles. other compensation or rewards) in 55 Philippines the implementing rules The donation of human material for countries (60%). Of these 55 countries, and regulations for the organ traffick- transplantation must be defined by 52 have defined penalties for coming part of the human trafficking law law. This applies to procurement from merce in donated organs. However, became effective on 21 June 2009. It deceased citizens and residents as expenditure associated with live quotes the 1991 WHO Guiding Princi- well as to donations from live donors. donations are covered in 62 countries ples “The human body and its parts A legal framework for transplantation out of 91 (68%) so that donors do not cannot be the subject of commercial provides a clear structure for the have to pay in addition to their dona- transactions. Accordingly, giving or organisation in charge of donation, tion. It is worth noting that 42% of receiving payment (including any allocation and transplantation of OTC, countries do not have a legal require- other compensation or reward) for including national co-ordination of ment for traceability of the organ and organs should be prohibited.” (Article the service, but also for its overview by that in 54% of countries the law does IV, section 6). Egypt is also progressing authorities. Indeed laws and regula- not mandate control of importation towards defining a legislative frame- tions set requirements to comply with and exportation of organs. work as the People’s Assembly has ethical principles as well as to achieve Within the last four years several coun- approved a new transplantation law quality, safety and effectiveness. tries have adopted legislation or banning commercialism in transplan- National transplantation laws are nec- amended existing legislation on dona- tation that could be adopted before essary instruments to combat traffick- tion and transplantation to better the close of the current parliamentary ing in organs tissues and cells. combat organ trafficking and traffic in session. The Global Observatory on Donation human beings for the purpose of The responsibility to meet patients’ and Transplantation is a result of the organ removal, transplant tourism and needs in organs for transplantation collaboration between the ONT, the commercialism in transplantation. from national resources whenever Spanish transplantation organisation Major progress has been achieved in possible leads to improved effective- and the WHO. The Observatory pro- countries where organ trafficking and ness of donation and transplantation vides a global database on legal and transplant tourism was thriving in services in many countries, including 47 organisational framework for dona- 2005 due to lack of legal prohibition of by introducing legislation and amend- tion and transplantation services in commercial transplantation. In April ments to existing legislation to member states, as well as on donation 2007 the State Council of China increase donation after death and and transplantation activities adopted a donation and transplanta- reinforce organisations. For instance throughout the world. tion law whereby inter alia it prohibits Japan adopted, in June 2009, an So far, the Observatory includes data commercial transplantation and sets amendment recognising the defini- on 105 member states representing up effective overview of hospitals car- tion of death on neurological criteria 89 % of the global population and rying out transplantations. In Septem- and simplifies consent to donation. more than 99 % of the global organ ber 2007 an Ordinance signed by The Republic of Korea is also planning transplantation activity. There is spe- President Musharaf of Pakistan also to initiate this year a revision of the cific legislation on donation and trans- provided a framework for donation law in order to simplify consent for plantation in 91 countries. Kidney and transplantation activities which donations from deceased donors.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

Despite new efforts towards self suffi- ised institutions and individuals carry- als. The Executive Board of WHO in its ciency in organs for transplantation, ing out illegal transplantation and 124th session in January 2009 many patients are not transplanted or have to combat adversaries deter- adopted Resolution EB124.13 on have to endure long delays on waiting mined to hold on to their profits. “Human Organ and Tissue Transplan- lists in all countries. Desperate Other countries have initiated major tation” to be presented to the World patients remain tempted to by-pass onslaughts on clandestine or camou- Health Assembly in 2010. This resolu- national systems and to obtain a flaged illegal organ transplantation as tion urges member states to oppose transplant through organ trafficking in the Gurgaon case in India in 2008 or commercialism, organ trafficking and or transplant tourism. Countries recently, in July 2009, in the United transplant tourism, “including by where foreign patients were welcome States. encouraging healthcare professionals have now set legal barriers. However Now that transplant tourism has to go to notify relevant authorities when transplant tourism, fuelled by hefty into hiding even in countries where it they become aware of such practices profits, continues undercover and ille- was thriving a few years ago, the only in accordance with national capacities gally, but probably at a much reduced way to identify illegal transplantation and legislation”. scale. Both in China and in Pakistan at large is through the collaboration of enforcement authorities have penal- national authorities with profession-

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs E. ORGANISATIONAL MEASURES

E. Organisational measures

Council of Europe

At the Council of Europe, the Commit- avoid organ trafficking and, in general, Day in a different country every year tee of Experts on the Organisational elaborating high ethical, quality and (1998: Austria, 2000: Cyprus, 2002: Por- Aspects of Co-operation in Organ safety standards in the field of organ tugal, 2003: Greece, 2004: Sweden, Transplantation (SP-CTO) was set up transplantation. 2005: Switzerland, with the 1st World following the 3rd Conference of Euro- These activities include communica- Organ Donation Day, 2006: Turkey, pean Health Ministers in Paris in 1987 tions at international specialist meet- 2007: Ireland, 2008: Slovenia). The on the ethical, organisational and leg- ings, publications (e.g. Guide to safety European Day for Organ Donation and islative aspects of organ transplanta- and quality assurance for the transplan- Transplantation will take place in tion. The conference considered that tation of organs, tissues and cells – 3rd Germany in 2009 and Georgia in 2010. the organisational aspects of organ edition (2007)), surveys and interna- A booklet for national authorities on transplantation were particularly tional data collection (e.g. Transplant living donor transplantation prepared important in meeting the organ short- newsletter, annual survey of figures for by a working group was scheduled for age and that European co-operation organ donation and transplantation in publication by the end of 2008. It will was needed to ensure efficient organi- Europe, Latin America, Australia, recapitulate the relevant Council of sation. Canada and the United States), the Europe recommendations and resolu- Carrying forward the work of the SP- organisation of visits to countries to tions and give state-of-the-art infor- CTO, the Council of Europe Steering help them implement programmes mation available in fields not yet Committee on Organ Transplanta- for promoting compliance with the covered. tion (CD-P-TO) was set up under the relevant Council of Europe resolutions The Council of Europe Select Commit- aegis of the European Directorate for and conventions and the preparation tee of Experts on the Organisational the Quality of Medicines and Health- of drafts which serve as a basis for Aspects of Co-operation in Organ care (EDQM) and held its first meeting Committee of Ministers resolutions. Transplantation (SP-CTO) in 1996 on 17 and 18 April 2007. The work pro- Carrying forward the work of the defined the solution of the deceased gramme includes the establishment of former Committee of Experts in Blood organ shortage as its main priority for a working group to discuss the revi- Transfusion and Immunohaematology future actions. The first draft of the sion and updating of the Guide to (SP-HM), the Council of Europe Steer- document “Organ Shortage: Current Safety and Quality Assurance for the ing Committee on Blood Transfusion Status and Strategies for the Improve- 49 Organ Donation – A European Transplantation of Organs, Tissues and (CD-P-TS) was set up under the aegis ment of Consensus Document”93 was prepared Cells. of the European Directorate for the and approved by the committee after Through its activities in the field of Quality of Medicines and Healthcare being circulated among transplant transplantation, the Council of Europe (EDQM) and held its first meeting on professionals and international scien- contributes actively to the implemen- 20 and 21 March 2007. The steering tific societies. The document was sub- tation of high standards for the pro- committee appointed a working sequently analysed by all member tection of public health and for the group to discuss the revision and states and approved by the Health promotion of human rights and dig- updating of the Guide to the prepara- Committee. nity. The committee focuses on elabo- tion, use and quality assurance of blood rating and promoting the principle of components. 93. http://www.edqm.eu/medias/fichiers/Organ_ non-commercialisation of organ Since 1998, the Council of Europe has shortagecurrent_status_and_strategies_for_ improvement_of_organ_donation_A_European_ donation, strengthening measures to organised European Organ Donation consensus_document.pdf.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

The purpose of the document is to dence and describing relevant inter- ment have been further developed by provide an analysis of, and guide to, national experience. The document the SP-CTO and the CD-P-TO in spe- the steps required to procure the focuses on the technical and organisa- cific recommendations summarised maximum number of high-quality tional aspects of deceased organ previously. organs for transplantation, taking into donation. Some of the aspects account the available scientific evi- covered by this comprehensive docu-

European Union

The Communication from the Commis- Priority action 4: Improve the ethical standards regarding pro- sion “Action plan on Organ Donation knowledge and communication tection and registration practices and Transplantation (2009-2015): skills of health professionals and relating to living organ donors;97 Strengthened Co-operation between patient support groups on organ Alliance-O-project: an ERANet co- Member States” (COM (2008) 819 transplantation. ordination action, which was 94 final)) concerns a six-year plan with Priority action 5: Facilitate the financed for three years (2004- ten priority actions addressing the identification of organ donors 2007) by the European Commis- three key challenges in organ dona- across Europe and cross-border sion and involved institutions tion and transplantation in Europe: donation in Europe. from seven EU member states: improving the quality and safety of Priority action 6: Enhancing the France (Agence de la bioméde- organs across Europe, increasing organisational models of organ cine), Germany (Deutsche Stiftung organ availability and making trans- donation and transplantation in Organtransplantation), Hungary plant systems more efficient and the EU member states. (Hungarotransplant Psc), Italy (Isti- accessible. It will promote strength- tuto Superiore di Sanità, Centro Priority action 7: Promote EU-wide ened co-operation between member Nazionale Trapianti), Portugal agreements on aspects of trans- states based on the identification and (Organização Portuguesa de plantation medicine. development of common objectives, Transplantação), Spain (Organiza- Priority action 8: Facilitate the guidelines, indicators and bench- ción Nacional de Trasplantes y interchange of organs between marks and on identification and Medicina Regenerativa) and national authorities. sharing of best practices. On the basis United Kingdom (UK Transplant).98 of these actions, member states Priority action 9: Evaluation of It addressed questions regarding should develop their own sets of post-transplant results. the co-ordination of national pro- national priority actions. A mid-term Priority action 10: Promote a grammes in organ transplantation review (mid-term review 2012) of the common accreditation system for and produced position papers on actions will be carried out to evaluate organ donation/procurement and the following issues: expansion of the efficacy of the action plan. transplantation programmes. donor pools, allocation rules and The following priority actions are indi- Furthermore, the European Commis- equity, increasing safety and cated: sion’s Directorate-General for Health quality of organ transplantation, Priority action 1: Promote the role and Consumers funded and co- evaluation of transplantation per- of transplant donor co-ordinators funded several projects on organ formance, fundamental research in every hospital where there is donation and transplantation,95 activities, and ethical and legal 50 potential for organ donation. including: aspects; Priority action 2: Promote Quality European Training Programme on European Registry for Organs, Improvement Programmes in Organ Donation (ETPOD): a Tissues and Cells (EUROCET): every hospital where there is project aimed at designing a cor- aimed at collecting and publish- potential for organ donation. responding professional training ing figures on corresponding Priority action 3: Exchange of best programme;96 donation and transplantation activities;99 practices on living donation pro- European living donation and DOPKI – Improving the knowl- grammes among EU member public health: aimed at helping to edge and practices in organ dona- states: Support registers of living reach a consensus on legal and donors. tion: addressing the problem of 95. http://ec.europa.eu/health/ph_threats/ 94. http://ec.europa.eu/health/ph_threats/ human_substance/oc_organs/docs/useful_ 97. http://www.eulivingdonor.eu/. human_substance/oc_organs/docs/organs_ information.pdf. 98. http://www.alliance-o.org/. action_en.pdf. 96. http://etpod.il3.ub.edu/etpod.html. 99. http://www.eurocet.org/.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs E. ORGANISATIONAL MEASURES

organ shortage and developing a Transplantation Research Integra- tifying priorities in the field of common methodology to tion in Europe (TRIE): a Specific transplantation research, focus- improve organ donation rates;100 Support Action supported by the ing on themes common to cell Reprogramming the Immune 6th EU-RTD Framework Pro- and solid organ transplantation System for Establishment of Toler- gramme aimed at developing a and by providing recommenda- ance (RISET): aimed at research coherent strategy for integrating tions to the EC regarding priority 102 regarding ways to improve research in transplantation in actions to be implemented. acceptance of the transplant by Europe, namely by means of iden- the human body;101 101. http://www.risetfp6.org/cgi-bin/WebObjects/ 102. http://www.transplantation-research.eu/cgi- 100. http://www.dopki.eu/. Awo3.woa. bin/WebObjects/Trie.woa.

Iberoamerican Network/Council of Donation and Transplantation (RCIDT)

The RCIDT believes that organisational Ecuador, the Dominican Republic, tackled more effectively. This support aspects are especially relevant for Colombia, Cuba and Guatemala. Addi- was confirmed in the Declaration tackling the shortage of organs for tionally, training actions are planned against Transplant Tourism. transplantation and that co-operation or are in progress in Central America The following results of the process is essential for achieving maximum and the Caribbean. In particular, a pro- and the various activities developed effectiveness of the systems. Its activi- gramme for Central America and the by the RCIDT should be mentioned: ties are based on scientific advances Caribbean on training trainers in the Donation and transplantation and individual human values. communication of bad news was organisations have been set up, Since its establishment in October launched in April 2008. Under these restructured or revived in coun- 2005, the RCIDT has held seven meet- programmes, teams of monitors are tries which lacked this type of ings which have been complemented being trained in Cuba, the Dominican system or where there was little or by ongoing interaction between its Republic and Venezuela and will be no activity. These organisations members involving frequent discus- able to develop courses in their own depend on or are supported by sion of the key issues through a countries and in others in the region. the health authorities, following sophisticated IT platform, and has pro- Lastly, as part of this broad training the Spanish model, and are being duced several recommendations and programme, courses on quality and organised as a co ordination net- documents. safety in the management of tissue work. The RCIDT regards training as essential banks are also being developed, with Training activities for co ordina- and has developed a training pro- wide levels of acceptance and increas- tors are being consolidated, gramme in aspects related to dona- ing demand, mainly in countries of the through the ALIANZA master’s, tion and transplantation activities. Southern Cone. and courses conducted in Latin Through this ALIANZA master’s course The problem of practices such as traf- America in co operation with in donation and transplantation, pro- ficking and transplant tourism which several countries. Training is being fessionals put forward by the various are occurring in some of the countries focused on the different areas in health ministries in Latin America in the region was raised at the the region and tailored to their countries are trained as transplant co- meeting of the RCIDT in Havana in specific needs. ordinators in Spain. The course has May 2008. Since its inception, the 51 been run annually since 2005 and so RCIDT has expressed its complete Initiatives to harmonise criteria, in far almost 150 professionals have opposition to these practices, which agreement with scientific societies been trained, all of whom are already facilitate transplant commerce, and and in accordance with interna- working in their countries and many has condemned them as morally tional standards, are being devel- of whom occupy positions of respon- unacceptable because they lead to oped, focused on a wide number sibility at a national level. the obvious exploitation of the of aspects, including diagnostic Alongside the ALIANZA master’s poorest and most vulnerable groups. criteria for brain death and clinical course, training courses on specific The RCIDT is providing specific evaluation criteria for possible aspects of the process of deceased support to the organisations in charge donors. donation and transplantation have of overseeing donation and transplan- The RCIDT is being established as been held or are due to be held in tation activity in countries affected by a technical, ethical, training and Argentina, Chile, Uruguay, Mexico, these problems so that they can be co operative benchmark for the

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs II. OVERVIEW OF ORGAN DONATION FOR TRANSPLANTATION PURPOSES

development of transplant pro- activities increased by as much as The RCIDT has ensured closer ties grammes in all the countries in the 60% in Colombia, 30% in Cuba, between health care authorities and region. 27% in Venezuela, 22% in Chile, professionals in charge of donation At the same time, deceased dona- 20% in Uruguay and 11% in and transplantation in Latin America, tion activities are progressively Argentina. Uruguay achieved providing a basis for the region to take increasing in countries in the deceased donation rates close to on a leading position in the world region, the most notable change those described in the United regarding donation and transplanta- being from 2005 to 2006: in just a States. tion activities. single year, deceased donation

This section on national legislation may from deceased persons over those The need to develop an effective be summarised in the following key from living persons, the prohibi- deceased donation programme to points: tion on making financial gain from cover the transplantation needs of There is an impressive range of the human body and its parts, the the population is clearly recogn- existing recommendations, reso- vital importance of valid consent ised by all these international lutions and international legal and the need to promote altruistic organisations. In addition, organi- instruments dealing with trans- donations and establish appro- sational measures to increase plantation of OTC. There are no priate professional standards. organ availability from deceased discrepancies between these These principles are upheld by all organ donors have been reflected instruments and they comple- major international organisations in recommendations, consensus ment one another in an interna- dealing with this topic: the WHO, documents and specific actions tionally recognised body of law. the Council of Europe, the EU and and activities related to training, From the outset, the general prin- the recently founded RCIDT. education and promotion. ciples have been very clear: the preference for organs and tissues

Trafficking

As already pointed out in the intro- include the root causes, which are organs, this results from the interven- duction to this study, in public debate mostly the same: shortage of organs tion, as many of the donors encounter and in publications and legal docu- to meet demand for transplantation, medical problems after it, in particular ments, trafficking in OTC and traffick- inequities in health care and poor eco- if there is no follow-up medical care, as ing in human beings for the purpose nomic and other conditions that put often applies in trafficking cases. of organ removal are often mixed up persons in vulnerable situations. They These persons also face consequences or dealt with together. This leads to often therefore end up finding it hard in psychological terms: they are often confusion both in theory and in prac- not to agree to take part in the pro- traumatised and feel ashamed. tice and consequently hinders effec- posed activities and (seemingly) to The fundamental difference between tive efforts to combat the two consent – however comprehensive, the two cases lies in the fact that traf- categories of crime and also provide detailed and correct their knowledge ficking in organs is a crime where the comprehensive victim protection and about what awaits them might be. organ and the use of it are the central assistance. Of course, some cases of Selling an organ sometimes seems to elements; it does not matter whether trafficking in OTC result from traffick- be the only way out of a miserable the organ has been removed from a ing in human beings. However, traf- economic situation. In addition, some living or a deceased donor. In contrast, ficking in OTC is broader in scope than individuals are in family or cultural trafficking in human beings is a crime trafficking in human beings for the relationships where other people where the exploitation of an individ- purpose of organ removal. On the decide what happens to them and ual is the central aspect and where a other hand, trafficking in human where those people either offer or combination of three elements beings covers not only exploitation for deliver them to traffickers for sexual or (action, means, purpose; see below) the purpose of organ removal but also labour exploitation or to brokers or to has to apply in order for the crime to other forms of exploitation. For effec- hospitals involved in illegal organ be constituted. Therefore, trafficking tive prevention, protection and prose- transplantations or consent to their in human beings for the purpose of cution, it is necessary to distinguish being exploited sexually or for labour organ removal can only be committed between trafficking in OTC and traf- purposes or to their organs being if organs are removed from living ficking in human beings for the removed. donors in one of the cases mentioned purpose of organ removal so that a The consequences for the individuals in the definition. targeted approach to the two prob- are also similar: they face stigmatisa- lems can be developed and imple- tion and discrimination in their com- As the exploitation of the victim mented. munities for “what they have done” or results in the removal and further use 55 The link between trafficking in OTC “what has happened to them”. When of an organ, a case of trafficking in and trafficking in human beings for they return to their own environment organs (and thereby both offences) the purpose of organ removal has not they have to live with the fact that also applies. However, as the aim of been clearly established. This part of other people there know that they the two crimes is not the same, they the study provides an overview of the have sold (part of) their body overlap but differ in scope. Trafficking two problems and the legal frame- or that something (their sexual integ- in organs can be committed sepa- work dealing with them. To begin rity or organs) has been taken from rately from trafficking in human with, it should be noted that there are them involuntarily – both of which are beings, e.g. if organs are removed several similarities between the two, morally sensitive issues. And they face from deceased donors or if no illegal but also certain differences. long-term consequences regarding activities or means have been used The similarities between trafficking in their physical health and bodily integ- with respect to a living donor but, e.g., OTC and trafficking in human beings rity. In the case of the removal of if the requirements for legal interven-

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs III. TRAFFICKING IN ORGANS, TISSUES AND CELLS AND TRAFFICKING IN HUMAN BEINGS FOR THE PURPOSE OF ORGAN REMOVAL

tions and transactions have been removal only. However, it should be purpose of organ removal need a far infringed. made clear that this does not prevent more comprehensive protection Additionally, per definitionem, traffick- states broadening the scope, as even regime, as they have been affected by ing in human beings for the purpose the definition of trafficking in human a serious crime. On the other hand, of organ removal is limited to removal beings itself provides that exploitation deceased donors do not need such of organs; all of the documents (the should include “at a minimum” the protection measures at all, but there United Nations Trafficking in Persons purposes listed. This indicates clearly must be a system in place to prevent Protocol, the Council of Europe Anti- that the drafters did not wish to illegal activities and unethical behav- Trafficking Convention and the restrict the scope to the purposes iour, among other reasons, because of Optional Protocol to the Convention listed. States are therefore free to the serious damage that these activi- on the Rights of the Child on the sale include the purposes of removal of ties cause to the image of donation of children, child prostitution and cells, tissues and body parts in and transplantation, which further child pornography) only mention the national legislation. heightens organ shortage by preclud- removal of organs and none makes Because of these situations, it is neces- ing altruistic donation. any reference to cells or tissues. The sary to look at the framework both for In Current situation and conse- travaux préparatoires to the United trafficking in OTC and for trafficking in quences, below, the extent of the Nations Trafficking in Persons Protocol human beings for the purpose of problems of trafficking in organs and show that the discussions did, indeed, organ removal so as to analyse which trafficking in human beings for the cover the issue of broadening the provisions already exist, where there purpose of organ removal and their scope to include the removal of cells, are loopholes in international instru- consequences will be dealt with tissues and body parts, but, ultimately, ments and which measures are miss- jointly, while the international stand- the decision was taken only to include ing. ards and initiatives regarding organ the removal of organs in the defini- A clear distinction between the two trafficking and the application of the tion, so all provisions regarding traf- crimes is also needed, on the one international standards regarding trafficking in human beings refer to cases hand, to better prevent and prosecute ficking in human beings for the of the removal of organs only. such acts and especially because the purpose of organ removal will be dealt More specifically, all provisions regard- needs of victims can be completely with separately under Trafficking in ing criminalisation and assistance to different. Living donors involved OTC: international standards and ini- and protection of victims must be “only” in trafficking in OTC have tiatives (page 65) and Trafficking in implemented on an obligatory basis certain needs for protection and care, human beings: international stand- for cases of trafficking in human but living donors who fall victim to ards and their application to organ beings for the purpose of organ trafficking in human beings for the removal (page 76).

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. CURRENT SITUATION AND CONSEQUENCES

A. Current situation and consequences

Trafficking in OTC and trafficking in human beings for the purpose of organ removal – known facts

Trafficking in organs and traf- should first be noted that this form of was probably the earliest known case ficking in human beings for the trafficking, either in organs or in of a practice possibly related to traf- purpose of organ removal human beings for the purpose of ficking in persons for the purpose of While there is information about the organ removal, is a global issue. There organ removal for transplantation pur- legal activity in organ donation and is an international bioethical frame- poses. transplantation, for many countries work which is properly reflected in In 1997, the Bellagio Task Force the numbers regarding victims and existing standards. In addition, trans- headed by the American anthropolo- trafficked organs remain rather incom- plantation needs are universal, but are gist Nancy Scheper-Hughes, whose plete. Both the quantitative and also dealt with unequally by individual members included physicians, sur- the qualitative description of traffick- countries, in spite of those standards. geons, human rights activists and ing in organs and trafficking in human Trafficking here commonly therefore scholars, met in Bellagio (Italy) to beings for the purpose of organ involves different countries and discuss transplantation, bodily integ- removal are hindered by the lack of usually takes advantage of a situation rity and reports of global organ traf- universal agreement about what is in which particular countries do not ficking and trafficking in human involved in the former and by the have a well developed or imple- beings for the purpose of organ 103 limited amount of detailed informa- mented regulatory framework to removal. After the meeting, WHO, tion available from official sources. prevent trafficking and protect the live the WMA, the Council of Europe, the donor. Although the simultaneous UN, the Transplantation Society and There is possibly therefore a high involvement of different countries in other organisations and societies con- number of unreported cases for the these practices is possibly the com- vened conferences to discuss current two crimes. This is because of the monest form of trafficking related to laws, practices and procedures. huge profits and rather low risks for organ transplantation, there are cases the perpetrators. Victims/donors are Today, many countries throughout the confined to specific nations involving also mostly ashamed and frightened world have been alleged to be among national donors and recipients. to report cases, recipients of organs the world’s leading providers of traf- 57 ficked organs. Other countries are will remain silent and the other In this connection, prosperous Asians increasingly having to deal with the people who know about the interven- began travelling to parts of Southeast situation of nationals travelling tions are mostly directly involved in Asia to obtain organs from poor abroad to obtain trafficked organs. the trafficking offences; thus it is very donors – an early form of ethically Most of them come back to their difficult to investigate the crimes. The suspect “transplant tourism”. These countries of origin for post-transplant numbers and trends available are practices were documented by many follow-up care. A comprehensive therefore mostly based on estimates media organisations which showed update on the current state of what and rumours, as well as on certain offi- that few benefits accrued to the very was named “the international organ cial data which – as already pointed poor persons who sold a kidney. Con- out – remain incomplete. cerns were also raised about poor out- 103. Rothman, DJ et al. The Bellagio Task Force When describing practices in traffick- comes associated with organs bought Report on Transplantation, bodily integrity and the international traffic in organs. Transplant Proc 1997; ing related to transplantation, it from these very poor persons. This 29: 2739-2745.

trade” was given at the Second Global country where the transplantation going to the professionals and inter- Consultation on Human Transplanta- procedure is then performed. mediaries involved. Hence, abuse, tion104 at WHO headquarters in fraud and coercion are common. Most of the cases described concern- Geneva in March 2007 and subse- ing organ trade and transplant In Shimazono’s report, several coun- quently published.105 tourism are either cases of trafficking tries were highlighted as “organ- Yosuke Shimazono presented the in organs or cases of trafficking in exporting”, meaning those where results of research into trade related to human beings for the purpose of organs from local donors are trans- transplantation, based on a systematic organ removal. The procedures are planted into foreigners through pur- review of different available sources usually facilitated and organised by chases or sales. Most of the countries during a five year period, including intermediaries, either in the countries in this category do not have a legal academic journals, media sources, of origin of the potential recipients or framework in place or duly imple- transplant tourism websites, trans- in the destination countries. Recipi- mented to ban and prosecute traffick- plant registries and reports from ents are offered the possibility of ing in organs and trafficking in human health authorities. He found only 309 transplantation in different ways here, beings for the purpose of organ “relevant” documents, of which 243 even by healthcare professionals in removal. Moreover, they also lack were media reports and emphasised charge of them. Recently, many of systems for protecting live donors the need for “further medical and these “services” have been offered properly against coercion, abuse or social scientific research,” without openly through dedicated websites in exploitation. In some cases, legislation which he thought this “global health form of “packages” including the has been passed in this connection issue” could not be addressed effec- travel and the transplantation proce- and has been followed by a decrease tively. Practices described clearly fell dure itself. The price of “kidney pack- in trafficking-related activities. How- under the scope of trafficking in ages”, for example, may range from ever, this has been followed by an organs, but sadly, it did more fre- US$70 000 to US$160 000. These web- increase in transplantation to foreign- quently fall under that of trafficking in sites are easily found on the Internet. ers, presumably as a result of traffick- human beings for organ removal. On the other hand, “donors” are usu- ing, in other countries. However, it is well described that practices still The form described most frequently ally, but not always, recruited in their remain in many of these countries occurs in the context of what has been countries of origin. There have been despite the enacted law, since there called “transplant tourism”. Transplant cases reported in which donors are are no effective mechanisms to tourism usually involves travel from recruited and transferred to other countries, where the organ extraction prevent and prosecute them. This rich countries in the North to poor and the transplantation procedure gives an idea of the loopholes that countries in the South, with wealthy takes place. According to the various exist for perpetrators. Organ- recipients desperate to find a quick sources, the intermediaries involved in exporting countries are basically solution to their need for an organ this entire process have included indi- located in Africa, Asia, eastern Europe travelling to mostly developing coun- vidual agents, travel agencies, hospi- and South America. In contrast, many tries, where impoverished and vulner- tals, healthcare professionals and even western European and North Ameri- able people sell organs to solve their embassy officials. It should therefore can countries and some rich Asian desperate economic needs. The term be emphasised that underlying cor- countries, among others, are currently “transplant tourism” obviously fails to ruption is present in many countries. known to have nationals travelling capture the ethical issues related to Sometimes, previous victims of traf- abroad every year for purchased this practice, but has been widely ficking are involved in the recruitment organs (“organ-importing countries”). used in international health discus- 58 of donors. In many instances, family Estimates have been carried out sions. There have been other types of members act also as intermediaries in regarding the quantitative signifi- travel by potential donors and recipi- such recruitment when they have any cance of these various practices. On a ents in connection with trade in kind of power to do so. Notably, it has global level, it is estimated that up to organs. Cases reported either describe been repeatedly denounced that 5%-10% of kidney transplants per- the potential donors travelling to the donors are not sufficiently or com- formed annually around the world are recipient’s country or both the donor pletely informed about the procedure, the result of trafficking. Given the and recipient travelling to another if any information is provided at all. It Global Observatory on Donation and 104. http://www.who.int/transplantation/ seems also a frequent practice that Transplantation’s estimate of overall publications/ReportGlobalTxConsultation_March_ the donor is not paid as initially prom- activity of about 68 000 kidney trans- 2007.pdf. 105. Yosuke Shimazono. The state of the interna- ised. The amount received in general plants a year, this would mean that tional organ trade: a provisional picture based on terms is quite low compared to what 3 400-6 800 kidney transplants are integration of available information. Bulletin of the World Health Organization 2007; 85: 955–962. was paid by the recipient, the majority being carried out on the basis of these

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. CURRENT SITUATION AND CONSEQUENCES

forms of trafficking, which is obviously Trafficking in tissues out through a careful clinical history a quantitatively significant figure, Human tissues are sold across national performed either on the donor during although still possibly an underesti- boundaries worldwide, but this activ- his lifetime or on his relatives after his mate. ity is not explicitly banned in any death. The better known form of trafficking country since the charges or costs A recent example of tissue trafficking related to organ transplantation relate to handling and processing was revealed involving a company unfortunately usually involves living rather than the direct purchase of which supplied human tissues for unrelated donors. These cases mainly human tissues. However, trafficking in transplantation. The company was dis- fall under the scope of trafficking in tissues has been more widely covered to be paying some funeral human beings for the purpose of described than trafficking in organs. homes to obtain all types of tissues organ removal. However, as previously The fact that donation and transplan- from cadavers through irregular and stated, there are reports which involve tation of tissues is less complex than in unsafe practices. Several documents/ deceased donors. This has been the the case of organs in terms of restric- certificates were forged, including case in some South American and tions affecting ischaemic times and those related to the consent to organ Asian countries, where organs from storage possibilities makes trafficking donation and to the cause of death. deceased donors have been provided in tissues more feasible than organ This highlights that trafficking in on a commercial basis for foreigners trafficking. There are reports about the organs and tissues involves not only requiring transplants, including kid- finding of corpses lacking certain ethical and legal problems but also neys, livers and hearts. There is a well- pieces of anatomy.106 Far from repre- public health threats, since the tissues known example of an Asian country senting irrefutable proofs of traffick- procured and distributed in this case where organs from executed prisoners ing in organs, what lies behind these had obviously not undergone any have allegedly been used for the and other cases is possibly the obtain- types of checks for transmissible infec- majority of the transplants performed ing of material susceptible of being tious or tumoral diseases.107 in the country. Doubts concerning the converted into implantable tissues validity of consent obtained from the either directly (corneas) or after cryo- Socio-demographic issues of executed prisoners, as a vulnerable preservation or lyophilisation (heart trafficking in human beings for group, and the fact that organs were valves, bones, ligaments, dura matter, the purpose of organ removal: is mainly allocated to foreigners might etc). Those responsible for these prac- there a gender issue? lead this practice to be regarded as a tices are international brokers supply- Lack of data regarding current figures particular form of trafficking in organs. ing tissues to the powerful industry in on trafficking related to transplanta- While knowledge of practices in organ human tissues. tion also hinders research regarding trafficking and trafficking in human The use of tissue in modern medicine whether there is a socio-demographic beings for the purpose of organ is massive and is set to increase in the issue, in particular a gender issue, removal is gradually improving and future. However, the main difference related to trafficking in human beings although precise data are still lacking, from organs is that there is no scarcity for the purpose of the removal of it is important to point out that several of tissue at least in general terms and, organs. Trafficking in human beings of the governments concerned have when there is a shortage, it is the for any purpose easily affects the most been taking specific measures to result of an organisational problem vulnerable groups in a population and combat these practices, taking inter- and a lack of will or a failure to allocate this could also be the case for traffick- national standards as a reference. human and material resources to ing in human beings for the purpose Hence, several countries have issued ensure tissue procurement. In this of the removal of organs. Few data new legislative frameworks which context, quite apart from the related available provide the impression that 59 address, among others, the require- ethical and legal problems, the fraud- the gender issue, if it does exist in this ments for medical centres for trans- ulent use of cadavers poses a major case, might vary from country to plant services, ban financial risk of transmission of diseases, which country relying basically on cultural compensation to organ donors, are sometimes not detectable with and societal issues. This should be out- ensure priority to nationals as trans- routine analytical procedures. This is lined under the general conception plant recipients and protect the living because many risk situations involving that live donation is, even under legal donor. While these new legislations the transmission of diseases through circumstances, more frequently per- represent a clear compromise from the transplantation of organs and formed by females. Why this occurs governments to prosecute these tissues can only be reasonably ruled 107. Centers for Disease Control and Prevention crimes, it remains to be proven that (CDC). Brief report: investigation into recalled efforts are being made in their practi- 106. In Pearson (#20). Chaudury, V. Argentina human tissue for transplantation – United States, uncovers patients killed for organs. British Medical 2005-2006. MMWR Morb Mortal Wkly Rep 2006; 55: cal implementation. Journal 1992; 34: 1073-1074. 564-566.

might respond to several causes, he was ill. Two women admitted that Therefore, available information does among others because males are their husband had obliged them to not allow us to conclude that there is a more prone to develop end stage “donate”. The authors stressed that gender issue related to trafficking in renal disease than females. since the survey was performed in human beings for the purpose of Taking that concept as a general state- front of some family members, the organ removal. What can be said is ment, some available reports have cases of women who could have been that commercial living donors do have confirmed the female predominance forced to donate was possibly higher. a baseline poor economical status, as commercial living donors in some However, the female predominance in many are labourers or street vendors Asian countries. In a survey performed the available reports is not constant. and frequently are living below the in India of 305 commercial living As a matter of fact, a majority of males poverty line. This is obviously a sad donors, 71% of them were female.108 as commercial living donors has been fact when financial gain, rather than When they were asked why they had observed in studies performed in altruism, is the underlying reason for acted as commercial living donors other countries, such as Egypt109 or “donating” an organ. Commercial instead of their spouses, the most fre- Iran.110 living donors are frequently illiterate, quent reason proffered was that the which makes them especially vulnera- man was the breadwinner and/or that 109. Budiani D. Consequences of living kidney ble. donors in Egypt. 10th Congress of the Middle East Society for organ transplantation; 2006 Nov 26-29, 108. Goyal M, Mehta RL, Scheneiderman LJ, Sehgal Kuwait. AR. Economic and health consequences of selling a 110. Zargooshi J. Quality of life of Iranian kidney kidney in India, JAMA 2002; 5: 29-73. “donors”. J Urol 2001; 166: 1790-9.

Myths concerning trafficking in OTC and trafficking in human beings for the purpose of organ removal

Trafficking in OTC and trafficking in United States government agencies the sewn-up incision on his own, human beings for the purpose of issued denials concerning these prac- without a note or emergency call.113 organ removal are a dramatic reality tices. A second type of organ-snatching that has been added to the tragic mis- There are several variations of the urban legend – and the one repeated eries of humanity during the last dec- basic organ-theft urban legend. The most often – involves the removal of ades. However, there are also stories most common one involves a business organs from children. These cases are surrounding the two crimes that have traveller to some big city, who takes a even more horrifying because the never been realistically proven and are break after a long day and has a drink victim is a defenceless child. A typical easy to dismantle through clear tech- in a hotel bar. A prostitute approaches claim is that children from countries in nical arguments.111 It is important to him and they flirt. They end up in his Asia, Latin America or Africa are kid- highlight these stories to clearly dis- hotel room, where he soon blacks out. napped and sold to rich Americans or tinguish the myths from the facts. He wakes up the next morning in the Europeans for their organs. The most The stories about tourists waking up hotel room’s bathtub to find a note commonly claimed thefts are those of to find a kidney stolen or young chil- taped to the wall instructing him to kidneys and corneas.114 It must be said dren being kidnapped or adopted and call the emergency services from a that these legends are constructed on then killed so that their organs can be nearby telephone. He does, and the a basis that confers them some degree 60 used for transplantation can clearly be emergency operator instructs him to of credibility: thousands of children categorised as myths. These stories, feel for a tube protruding from his worldwide disappear as a result of which are frequently reported in the lower back. He finds one, and begins violent acts or are simply sold by their media, generate a state of alarm at an to panic. He is told to lie still, as one of own parents and then sold on for international level. Indeed, rumours his kidneys has been removed, and adoption or for sexual or labour grew so intense on some occasions that an ambulance is on the way. He is exploitation. Sometimes they are that there were attacks on North later told of a vicious gang of kidney simply killed on the streets in some Americans in Latin American countries thieves who sold his kidney to the countries because of a supposed in the early 1990s because they were highest bidder in a clandestine organ threat to society. suspected of trafficking children for market. In some cases, the tub is filled the purpose of organ removal.112 with ice; in others, the man discovers 113. Radford B: Kidney thieves. Times, September 2002. 114. Todd Leventhal: The child organ trafficking 111. Matesanz R. Organ and tissue trafficking. 112. Kadetsky, E. Guatemala inflamed. Village Voice. rumour: a modern legend. Report of the United Organs and tissues 2003; 6 (2): 85-91. May 31, 1994. States Information Agency, Dec, 1994.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. CURRENT SITUATION AND CONSEQUENCES

None of these claims has ever been trial scale had been proven. In particu- To be effective and lucrative, this kind reported to the police or confirmed by lar, the document referred to a of activity would obviously have to be serious evidence, even after thorough European country hosting 3 000 chil- targeted at adult recipients and hence investigations by international bodies. dren from Latin America who had based on adult donors. Several investigations into these been “sent” there for that purpose. As stories have failed to show that they a result, the European Parliament Second, the process of donation and are true. The main problem occurs approved a resolution against organ transplantation is a complex one when one of these myths, whatever trafficking, which admittedly was of which requires well trained profes- the particular details, attracts great great value but gave credence to the sionals and sophisticated techniques publicity and appears in the media or assertions made in the report without to evaluate the suitability of the gets caught up in politics. These sto- any evidence to back them up. This organs for transplantation, prepare ries, combined with actual current study had a negative impact on Euro- the recipients and perform the proce- trends in trafficking related to trans- pean public opinion, which was dure of removal and transplantation plantation, generate a climate of inclined to believe any accusation itself, while also involving preserva- distrust in the donation and transplan- coming from such a highly regarded tion techniques and solutions. After- tation system, with a resulting nega- institution as the European Parlia- wards, transplanted patients require tive impact on much-needed altruistic ment. the long-term use of immunosuppres- donation. None of these stories or any of the sive medication and also examina- Several such urban legends have many other older ones reported in the tions and other specialised medical 115 emerged concerning child disappear- medical literature, has been proven care. If the myth were true, it would ances, especially in Latin America: for to be true. Lack of evidence and clearly be easy to find the infrastruc- example, a young girl was said to have simple technical arguments suffice to ture behind it and traces of a huge been kidnapped and then turned up dismantle the stories. First, paediatric number of transplanted patients with minus her eyes but with 3 euros on organs (in particular those from new- organs from a clandestine market of her; some men dressed as clowns in a borns, the group most frequently this kind. suburb claimed to have enticed chil- mentioned in the stories) are not ideal dren into a van where they killed them for transplantation because of a lack Third, transportation of organs from and then sold their organs. of maturity and/or the difficulty of one part of the world to another, The stories of children being kid- finding suitable recipients for such which is sometimes also reported, napped or sold to serve as organ organs in terms of size. Organs from faces the problem of long ischaemic donors have been given credence children would be suitable for children time that would invalidate the subse- even by international organisations. A or small adults and it is quite unusual quent utilisation of these organs for very particular example was the for children to be in need of an organ. transplantation (a heart can barely report prepared by an MEP in 1993, support ischaemic times of 2-3 hours, 115. Matesanz, R: Tráfico de órganos. Hechos, fic- claiming that trafficking on an indus- ciones y rumores. Nefrología 1994: 14: 633-645. the liver 6-7 hours).

Consequences of trafficking in OTC and trafficking in human beings for the purpose of organ removal 61 Trafficking and ethics commodity. Others maintain markets Each of these arguments is important It is important to distinguish debate are ethically wrong because, if permit- and may constitute a valid reason to about the morality of markets in ted, they will lead to undesirable con- discourage the establishment of organs from debate about the sequences such as a fall in the overall markets in organs and tissues from problem of trafficking in organs and supply of organs and tissues, skewing living or deceased persons. However, tissues and trafficking in human of the distribution of organs and there would seem to be further prob- beings in order to obtain organs or tis- tissues towards the rich, a decline in lems involved with trafficking that sues. Critics of markets in body parts the quality of organs and tissues avail- have not been identified or go beyond maintain that they are ethically wrong able because sellers are more inclined issues involving voluntary, controlled because they violate a fundamental to misrepresent their health status markets. The two most important ethical norm that the body should not and the inability of regulation to moral dimensions that distinguish be treated either as property or as a protect the interests of sellers. trafficking from controlled markets

and make trafficking, particularly traf- However, when an individual is ative examples of such initiatives have ficking in human beings for the coerced by threats of violence to been the Amsterdam Forum on the purpose of organ removal, especially themselves or to others they are not evaluation and care of the live kidney heinous are coercion and exploitation. making choices. Nor are those for donor120 and the Vancouver Forum121 Every individual has the basic human whom the sale of their bodies is the focusing on the non-kidney living right to control their own life. Respect only possible option they have for donor (liver, pancreas, lung and intes- for human dignity and autonomy earning income to maintain their very tine). implies respect for each individual’s existence. Treating someone solely as Even in the best-case scenarios, decisions. “Every human being of a portable source of organs and involving the scrupulous implementa- adult years and sound mind has the tissues is both degrading to human tion of the recommendations made by right to determine what should be dignity and offensive to the notion of these forums, live donation is associ- done with his own body”.116 Selling respect for human liberty and auton- ated with a series of complications, one’s kidney may be a reflection of omy that derives from the concept which have been described previ- ‘autonomy’ or free choice in academic that each individual should be free to ously, including not only medical debates about selling organs and tis- control his or her own destiny as aspects but also psychological and sues, but that is not the case when acknowledged in United Nations and social problems. Unfortunately, the either somebody is threatened with Council of Europe conventions and consequences of live donation still harm unless they provide the kidney declarations. need to be addressed carefully, espe- or making a kidney available is the Trafficking in human beings for the cially in the long term. The lack of only option available to the desper- purpose of organ removal can thus be detailed information about the evolu- ately poor.117 characterised by the presence of tion of the live donors in this regard Free choice is imperilled by force. It either the element of force or threat to even in the most controlled circum- can also be rendered irrelevant by obtain organs or tissues (coercion) or stances highlights still more clearly high compensation, not because the the taking advantage of the extremely the precariousness of living donors in sellers are rendered irrational by the limited choices which an individual many situations where the donation prospect of money, but, for those in has (exploitation). Coercion and took place in the context of an eco- need of money, certain offers, no exploitation are the moral hallmarks nomic transaction. of trafficking in human beings for the matter how degrading, are irresisti- There could well be medical problems 118 purpose of organ removal. They are ble. “Those in severe debt with no detected during the evaluation of the what makes this crime especially alternatives cannot truly be said to donor and complications related to morally heinous. They are additional choose to become organ vendors if donation that arise thereafter. It is factors that render it unacceptable, those to whom they are in debt force quite unlikely for the local healthcare quite apart from the moral argument them into sales. Choices require system to assume any responsibility that the human body should not be options as well as the ability to reason for these problems and complications. used solely as a commodity. about them.” Poverty and dire circum- So what happens with persons acting stances not only interfere with an indi- The individual consequences of as commercial live donors who are fre- vidual’s autonomy but conflict with trafficking quently victims of trafficking in individual liberty. human beings? Some argue that it is paternalistic to For the live donor Some studies have been published on favour prohibition of organ sales: The impact of trafficking related to the consequences of live kidney To prevent them making these transplantation on the living donor “donations” when the “donation” has 62 decisions is to judge that they are includes medical, psychological and taken place in the context of a sale or unable to make a decision about social problems. Concern about living purchase. They show deterioration in what is best for their own lives.119 donors has been reflected in the rele- the perceived health status of the vant consensus documents drawn up donor in 58% to 86% of the 116. Scheper-Hughes, Nancy. “Bodies of Apartheid: at major international conferences on cases.122 123 124 Depression and anxiety The Ethics and Economics of Organ Transplantation in South Africa.” Given 28 September 1999. Organs- establishing international standards Watch - University of California, Berkeley. Available: for evaluation and care for live donors 120. Delmonico F; Council of the Transplantation http://sunsite.berkeley.edu/biotech/organswatch/ Society. A Report of the Amsterdam Forum on the pages/bodiesapart.html. Accessed: 3 June 2008. and in the development of a position Care of the Live Kidney Donor: Data and Medical (Hereafter “Scheper-Hughes. ‘Apartheid.’”). of the transplantation society about Guidelines. Transplantation 2005; 79 (6 Suppl): S53- 117. Budiani-Saberi, D.A., and Delmonico, F.L. 66. “Organ Trafficking and Transplant Tourism: A Com- the responsibility of the community 121. Pruett TL et al. The ethics statement of the mentary on the Global Realities.” American Journal for living donors. The most represent- Vancouver Forum on the live lung, liver, pancreas of Transplantation 2008; 8: 925-929. and intestine donor. Transplantation 2006; 81: 1386- 118. Caplan, Arthur L. “Transplantation at Any 1387. Price?” American Journal of Transplantation 2004; 4: 119. Savulescu, J. “Is the sale of body parts wrong?” 122. See note 108, page 60. 1933-1934. Journal of Medical Ethics 2003; 29: 138-139. 123. See note 109, page 60.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs A. CURRENT SITUATION AND CONSEQUENCES

have been reported. This might be tion is inadequate and when an eco- which included cases of active tuber- facilitated by a poor baseline quality nomic transaction, bearing no relation culosis and fungal infections that of life and increased risk of experienc- to altruism or solidarity, was the caused the death of two patients. ing more stressful life events, as reason behind the donation. More recently, a similar series was recently recognised by Iranians, reported by the University of Califor- emphasising the need for a proper For the recipient nia, Los Angeles (UCLA), on the follow- psychological evaluation and follow- There are undoubtedly more abun- up of 33 kidney recipients who had up to these cases even in this “regu- dant data series available in the litera- travelled abroad for transplantation.128 lated 125market”. Social isolation and ture describing the medical evolution Most of them had received their stigmatisation associated with a of recipients of organs obtained in the kidneys from unrelated living donors. person for having sold his kidney have context of a commercial transaction, Four patients required urgent hospi- also been described. Series are con- usually far from the recipient’s country talisation immediately after present- sistent with the fact that the main of residence, and as part of trafficking ing at UCLA, three of whom lost their underlying motivation for donation is related to transplantation. The results grafts. Seventeen (52%) patients had poverty. Donors usually live in misera- concerning the progress of these infections, with nine requiring hospi- ble circumstances. Notably, far from patients are contradictory. Some data talisation. One patient lost her graft being resolved, the financial problems show similar progress of these recipi- and subsequently died from compli- which meant these people were ents compared to that of patients cations related to donor-contracted forced to sell their organs are com- transplanted in their own country. In hepatitis B. contrast, other data show lower pounded when the family income The existence of data series like this patient and graft survivals and many drops because of the deterioration in shows that when a commercial trans- studies have found a higher incidence the healthcare status of the donor, action is the motivation for donation, of transplant-related complications which might be more evident because the standards in the selection and than those described in normal condi- of labour-intensive jobs. Most of the evaluation of the donor and/or the tions. These complications include the commercial living donors express organs and the peri-operative man- transmission of infectious diseases regret for having sold a kidney and agement of the recipient would and the development of surgical com- would never recommend others to do appear to be poor. However, some plications. so, as acknowledged by some of the authors acknowledge that the fre- scarce available literature. For example, Prasad described the quency of the complications referred The consequences of commercial progress of 20 recipients who received to has been declining over the years, living donation seem also to reach a kidney transplant from an unrelated which would suggest the gradual beyond the donor, to the family and living donor on the basis of commer- sophistication of the procedures in an the community to which he/she cial transactions in other countries attempt to promote an attractive belongs. “The sale of a kidney by one from 1998 to 2005 and returned to image for an awful but tremendously family member can inevitably lead to Canada for post-transplant follow-up lucrative business. 127 subtle and not-so-subtle pressures on care. Three-year graft survival was others to follow suit, and it carries with 60%, significantly lower than that The global consequences of traf- it the potential for the eventual stig- described in the centre for living ficking in OTC and trafficking in matization of individuals and of whole donor kidney transplantation from human beings for the purpose communities as organ sellers.” 126 donors with a genetic or emotional of organ removal relationship with the recipient. The If the lack of evidence is a problem in Organ trafficking and trafficking in lack or inadequacy of documentation the case of live donation in controlled human beings for the purpose of 63 on relevant aspects of the transplant circumstances, one can only imagine organ removal, real facts and myths, procedure was a common problem the consequences, which are merely erode the image of organ donation which complicated the management 129 hinted at in some of these reports, in and transplantation worldwide. of the recipients from the medical countries where the healthcare situa- Data from a Spanish multi-centre point of view. Thirty-three percent of national survey130 documented a sig- 124. See note 110, page 60. the patients required urgent admis- 125. Quality of life and life events of living unre- sion to hospital on arrival, 70% devel- 128. Gill J, Madhira BR, Gjertson D, Lipshutz G, lated kidney donors in Iran: a multicenter study. Cecka JM, Pham PT, Wilkinson A, Bunnapradist S, Nejatisafa AA, Mortaz-Hedjri S, Malakoutian T, oped a surgical complication and 52% Danovitch GM. Transplant tourism in the United Arbabi M, Hakemi MS, Haghighi AN, Mohammadi a serious opportunistic infection, States: a single-center experience. Clin J Am Soc MR, Fazel I. Transplantation. 2008 Oct 15; 86 (7): 937- Nephrol 2008; 3 (6): 1820-1828. 40. 129. Matesanz R. Organ donation, transplantation 126. Moazam F, Zaman RM, Jafarey AM.Conversa- 127. Prasad GV, Shukla A, Huang M, D’A Honey RJ, and mass media. Transplant Proc 2003; 35: 987-989. tions with kidney vendors in Pakistan: an ethno- Zaltzman JS. Outcomes of commercial renal trans- 130. Martín A. Donación de órganos para tras- graphic study. Hastings Cent Rep. 2009 May-Jun; plantation: a Canadian experience. Transplantation. plante: Aspectos psicosociales. Nefrología 1991; 11: 39 (3): 29-44. 2006 Nov 15; 82 (9): 1130-5. 62-68.

nificant relationship between the reporting by a foreign journalist at one of the reasons behind many of degree to which the public is prepared international level. In 1996, the jury these refusals and negative atti- to accept organ donation on the one made up of relevant personalities tudes,138 particularly in countries tradi- hand and the belief that transplanta- decided to confer the award on the tionally pinpointed as being affected tion is a good and positive element of Brazilian journalist, Beatriz Magno, for by trafficking, thereby causing addi- health care on the other. Both ordi- her work at the Correio Braziliense with tional difficulties for the development nary citizens and also health workers a series of articles regarding organ of a deceased donation programme not specifically involved in transplan- trafficking and trafficking in humans based on the principle of altruistic tation medicine are negatively influ- beings for the purpose of organ donation. enced by the various stories,131 132 removal in Latin America. The articles which tend to create a negative concerned were merely a recapitula- Commercial living donation has been atmosphere in this area. This, in turn, is tion of all the reports on the issue recognised to negatively impact upon an important drawback when which had already circulated in many the development of a deceased dona- approaching families to request organ countries, with just one original new tion programme, which is an essential donation or to inquire about the version of the urban legend of stolen requirement to effectively deal with wishes of the deceased, one of the kidneys. the shortage of organs for transplan- most sensitive moments in the tation. Transplant tourism also under- Despite the fact that the stories had process of organ donation and trans- mines a country’s ability to achieve not been proven and the fear plantation.133 134 self-sufficiency when providing expressed by the United States gov- organs for transplantation for nation- The mechanism behind this effect is ernment about the potential danger als. This negative impact is also true not straightforward. Instinctively, it is of a prize giving credence to them, the for altruistic live donation. When there easy to relate the negative impact to media impact of the news was enor- was an increase in unrelated commer- an increase in the rate of refusals to mous and the issue of trafficking cial live donors in some of the affected donate following deterioration in the related to transplantation stayed in countries, the number of donations image of transplantation among the the media spotlight for a week. This performed between family members, general public, but the process is very led to a decrease, albeit limited, in the predominant until that moment, frequently more complex. Instead of deceased donation rates in Spain. A simply disappeared with time. or in addition to the increase in refus- link with negative images of trans- als, there might be a decline in the plantation, as conveyed in this case by Organ trafficking and trafficking in detection of potential donors by the the media on the basis of unproven human beings for the purpose of relevant physicians, possibly because stories about trafficking does there- organ removal, including current they adopt a defensive position in fore exist. tragic realities and rumours surround- response to public distrust of the ing the two issues, may damage the system when any of these scandals Detection of potential deceased organ image of donation and transplanta- occur. donors and obtaining consent to proceed with organ donation are con- tion to such an extent that they under- An example of the particular impact of sidered the two weakest links in the mine public trust in the system, one of news about organ trafficking related complex chain of the process of the mainstays for ensuring the success to transplantation on organ donation deceased donation.135 A positive atti- of a deceased donation and transplan- rates occurred in Spain in 1996, in tude on the part of professionals is tation programme. These practices what was the largest media scandal essential and will obviously be hinder the development and consoli- on the subject in the country to date. missing if there is the slightest suspi- dation of a deceased donation pro- 64 One of the most prestigious awards in cion about criminal practices sur- gramme and have a negative impact Spain is the “Juan Carlos I” award, rounding donation. Refusals to donate on altruistic live and deceased dona- which includes a prize for the best are one of the most serious obstacles tion. Ultimately, this situation perpet- 131. Cuzin, B, Dubernard, JM: The media and organ in the process, reaching figures of well uates one of the fundamental shortage. In Organ Shortage: The Solutions. Ed by over 40% in the United States136 and in problems behind these practices: JL Touraine et al, Kluwer Academic Publisher, Dord- 137 recht, 1995, p 287. many European countries. Fears of shortage of organs for transplanta- 132. Matesanz, R: Tráfico de órganos. Hechos, fic- trafficking in organs will probably be tion. ciones y rumores. Nefrología 1994: 14: 633-645. 133. Miranda B, Matesanz R. International issues in transplantation. Setting the scene and flagging the 135. Matesanz R, Domínguez-Gil B. Strategies to 137. International figures on organ donation and urgent and controversial issues. Ann N Y Acad Sci. optimise deceased organ donation. Transplant Rev transplantation – 2007. Transplant Newsletter – 1998; 862: 129-143. 2007; 21: 177-188. Council of Europe 2008; 13 (1). 134. Matesanz R, Miranda B: A decade of continu- 136. Sheehy E, Conrad SL, Brigham LE, Luskin R, 138. Coelho JC, Cilião C, Parolin MB et al. Opinion ous improvement in cadaveric organ donation: The Weber P, Eakin M, Schkade L, Hunsicker L. Estimat- and knowledge of the population of a Brazilian city Spanish Model. Journal of Nephrology 2002: 15 (1): ing the number of potential organ donors in the about organ donation and transplantation. Rev 22-28. United States. N Engl J Med 2003; 349 (7): 667-674. Assoc Med Bras 2007; 53 (5): 421-425.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs B. TRAFFICKING IN OTC: INTERNATIONAL STANDARDS AND INITIATIVES

B. Trafficking in OTC: international standards and initiatives

Several international standards and then a reality. This section summarises violation of the principle that the initiatives exist to tackle trafficking in the main existing standards in this human body and its parts must not OTC, having been developed in area. It should be noted in advance give rise to financial gain, a principle accordance with the medical that there is no universally agreed def- of non-commercialisation that has advances in the field, which made traf- inition of trafficking in OTC, although become international legal acquis. ficking in this regard a possibility and these practices are usually linked to

United Nations General Assembly

In Resolution 59/156 of 20 December states to exchange experience in and become a commodity, being traded in 2004 entitled “Preventing, combating information on preventing, combat- an unfair and inequitable manner and punishing trafficking in human ing and punishing trafficking in across the globe. Furthermore, the organs,”139 the United Nations General human organs. report pointed out that the absence of Assembly deplored the commerciali- As a follow-up to this resolution, the internationally agreed definitions and sation of the human body and urged United Nations Secretary-General sub- legal standards to provide a frame- the member states of the United mitted a report to the General Assem- work for co-operation in the area of Nations, should they ascertain that bly on preventing, combating and combating the trafficking in human such a phenomenon exists in their punishing trafficking in human organs made it more difficult to country, to adopt the necessary meas- organs. This report concluded that the understand and analyse the problem ures to prevent, combat and punish extent of the problem of trafficking in and its extent and to take appropriate the illicit removal of and trafficking in human organs and tissues remained countermeasures at the national, human organs. It encouraged the unclear and that the issue had not regional and international levels. received priority attention. However, it 139. http://daccessdds.un.org/doc/UNDOC/GEN/ N04/485/62/PDF/N0448562.pdf?OpenElement. found that human organs had

World Health Organization 65

Trafficking in human organs and ment of guiding principles for human demned the purchase and sale of tissues has been condemned repeat- organ transplants140 in May 1987 and human organs and called on national edly by the WHO. The World Health asked the Director-General to study legislators to intensify their efforts. Assembly first condemned the trade the possibility of developing appropri- In 1991, the World Health Assembly, for profit in human organs among ate guiding principles for human through resolution WHA44.25, living human beings as being incon- organ transplants. Resolution WHA42.5 endorsed a set of Guiding Principles on 141 sistent with the most basic human on preventing the purchase and sale of Human Organ Transplantation, values, and contravening the Univer- human organs of May 1989 con- which had a great influence on profes- sal Declaration of Human Rights and sional codes and legislation. The the spirit of the WHO Constitution, in 140. http://www.who.int/transplantation/en/ WHA40.13.pdf; adopted by the 40th World Health 141. http://www.who.int/ethics/topics/ Resolution WHA 40.13 on the develop- Assembly in May 1987. transplantation_guiding_principles/en/.

Guiding Principles prohibit giving and ble for the care of potential recipients Guiding Principle 6 prohibits com- receiving money and any other com- of such organs so as to prevent any mercial advertisements of the need mercial transactions in this field, but conflicts of interest. for or availability of organs; the pro- do not affect payment of expenditures motion of altruistic donations is not, Guiding Principle 3 stresses that incurred in organ recovery, preserva- however, prohibited. organs should be removed prefera- tion and supply. Particular attention is According to Guiding Principle 7, the bly from the bodies of deceased paid to the protection of minors and involvement of physicians and other persons. Donations from adult living other vulnerable individuals from health professionals in organ trans- persons are deemed permissible, but coercion and improper inducement to plantation procedures (including preference is given to such donors donate organs. removal and implantation) should be being genetically related to the According to Guiding Principle 1, prohibited if they have reason to recipients – except for transplantation organs may be removed from the believe that the organs concerned of bone marrow and other acceptable bodies of deceased persons for the have been the subject of commercial regenerative tissues. As a major rule, purpose of transplantation if con- transactions. Guiding Principle 3, paragraph 2, sents required by law are obtained seeks to protect donors from any This principle is reinforced by Guiding and there is no reason to believe undue influence and pressure and Principle 8, which prohibits any that the deceased person objected requires that adult living donors give person or facility involved in organ to such removal, in the absence of any their free consent to organ removal transplantation procedures, i.e. doc- formal consent given during the per- and are sufficiently informed to be tors, health practitioners and hospital son’s lifetime. able to understand and weigh the staff, as well as medical centres, from The WHA thereby gives precedence to risks, benefits and consequences of receiving any payment that exceeds the principle that free and informed consent. a justifiable fee for the services ren- consent is the ethical cornerstone of dered. Consequently, those persons all medical interventions. National leg- Guiding Principle 4 prohibits the and institutions are not asked to offer islation has to define the prerequisites removal of organs from living their services for free but, on the other for obtaining consent. Irrespective of minors for the purpose of transplan- hand, should not make profits out of whether an “opt-in” or “opt-out” tation. However, exceptions are these activities and should receive system is implemented, any statement deemed permissible under national only justifiable fees for their services. or indication of objection or refusal by law in the case of regenerative tissues. Lastly, Guiding Principle 9 provides individuals regarding the removal of According to the commentary, in such that donated organs should be made organs after their death prevents any cases, the protection of minors could available to patients solely on the such removal. be assured by e.g. requiring the basis of medical need and not consent of the minor and of the par- Although express consent is not because of financial or other consider- ent(s) or the legal guardian. In the case required in an “opt-out” system, insti- ations. of a conflict of interest on their part, tutions may be reluctant to remove In Resolution WHA57.18 on Human prior permission of an independent organs or tissues if the relatives Organ and Tissue Transplantation body should be required, but in any oppose the donation, even if national adopted in May 2004, the 57th World case, an objection by the minor legislation does not require the rela- Health Assembly requested the should prevail over any other consent. tives’ consent. Alongside psychologi- Director-General to update the cal issues involving the relatives, it According to Guiding Principle 5, the Guiding Principles, to protect the should be borne in mind that it is the human body and its parts must not poorest and vulnerable groups from 66 will of the deceased that prevails over be the subject of commercial trans- “transplant tourism” and to pay atten- that of his or her relatives. If permis- actions; giving or receiving payments tion to the sale of tissues and organs, sion is not sought from relatives, (including any other compensation or including the international trafficking donor programmes should review the reward) for organs should be prohib- in human tissues and organs. deceased’s medical history with them ited. This is the central provision for In October 2006 at the 58th WMA to increase the safety of transplanta- prohibiting traffic in human organs for General Assembly, the World Medical tion. payment. The commentaries clarify Association Statement on Human Guiding Principle 2 provides that phy- that the choice of methods, including Organ Donation and Transplantation, sicians determining the death of a sanctions, is left to states and that no which had been adopted by the potential donor should not be payment of reasonable expenses 52nd WMA General Assembly in directly involved in organ removal incurred in donation, recovery, preser- October 2000, was revised. The WMA from the donor and subsequent trans- vation and supply of organs for trans- reiterated the universal principle of plantation procedures, or be responsi- plantation is prevented. non-commercialisation of organ trans-

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs B. TRAFFICKING IN OTC: INTERNATIONAL STANDARDS AND INITIATIVES

plants in paragraph 30, in which it informed and voluntary consent, pro- cial transactions also refers to trans- pointed out that financial incentives fessional care of donors, proper organ- plant tourism. compromise the voluntariness of the isation of follow-up and scrupulous Guiding Principle 6 is more detailed choice and the altruistic basis for application and monitoring of selec- and aims at prohibiting commercial organ donation and that access to tion criteria for donors. These require- solicitations, including offers to pay needed medical treatment based on ments, together with the obligation to individuals, the next of kin of ability to pay is inconsistent with the inform living donors of the probable deceased persons or other parties for principles of justice. The statement risks, benefits and consequences of cells, tissues or organs, and thereby further provides that organs sus- donation in a complete and under- targets brokers and other intermediar- pected to have been obtained standable fashion and for them to be ies as well as direct purchasers. through commercial transactions competent and capable of weighing In the commentary on Guiding must not be accepted for transplanta- the information, stress the importance Principle 7, the WHA takes note of the tion. Reasonable reimbursement of of protecting the health of living situation physicians may find them- expenses, e.g. those incurred in pro- donors. selves in when confronted with curement, transport, processing, pres- Guiding Principle 4 further provides patients willing to pay for cells, tissues ervation and implantation is that specific measures should be in or organs either before or after the permissible. Commercial advertise- place to protect minors and legally intervention in the course of follow-up ment of organs, however, should be incompetent persons and that, wher- treatment. It states that physicians prohibited. Moreover, physicians ever possible, their assent should be and healthcare facilities should not asked to transplant an organ that has obtained before donation. refer patients to transplant facilities – been obtained through a commercial The principle of non-commercialisa- either in their own countries or abroad transaction should refuse to do so and tion in Guiding Principle 5 is set out in – which make use of the commercial explain that this would be unethical. much more detail. The provision calls obtainment of cells, tissues or organs, At its 123rd session on 26 May 2008, for an explicit ban on purchasing, or or seek or accept payment for doing the WHO Executive Board took note of offering to purchase, cells, tissues or so. As for post-transplant care, they the Revised WHO Guiding Principles on organs for transplantation and on are permitted to provide it to patients Human Cell, Tissue and Organ Trans- their sale, and states that they should who have undergone transplantation 142 plantation, which are expected to only be donated freely, without any at such facilities, but should not face be adopted in 2010. In terms of major monetary payment or other reward of professional sanctions if they decline changes, the following should be monetary value. However, reimburs- to provide such care, provided they pointed out: ing reasonable and verifiable refer such patients elsewhere. In the commentary on Guiding expenses incurred by the donor, Guiding Principle 9 is supplemented Principle 3, the WHA takes note that including loss of income, or paying by the requirement that allocation genetic or legal relationships between the costs of recovering, processing, rules should be defined by appropri- donor and recipient may be therapeu- preserving and supplying human ately constituted committees and be tically advantageous, but that some cells, tissues or organs for transplanta- equitable, externally justified and donations by unrelated donors – tion is explicitly excluded from this transparent, whereby transparency though they have been a source of ban. should be central to all aspects of concern – are unexceptionable and This provision bears in mind that transplantation. that many altruistic donations also recipients may provide donors with Two new guiding principles are originate from emotionally related tokens of gratitude that cannot be added: donors. However, with live donation, assigned a value in monetary terms, Guiding Principle 10 underlines that 67 particularly by unrelated donors, psy- while stressing that national legisla- high-quality, safe and efficacious chosocial evaluation of the motivation tion should ensure that any gifts or procedures are essential for donors and expectations regarding out- rewards are not disguised forms of and recipients alike and that the long- comes may help identify forced or payment. However, compensation term outcomes of donation and trans- paid donations. for the costs of making donations is plantation should be assessed for the Furthermore, Guiding Principle 3, permitted, as is payment of legiti- living donor as well as the recipient in paragraph 2, is extended insofar as mate costs of procurement and of order to document benefit and harm. basic prerequisites for the accepta- ensuring the safety, quality and They are also essential to the consent bility of live donations are specified, efficacy of human cell and tissue process and for adequately balancing namely: obtainment of the donor’s products and organs for transplan- the interests of donors and recipients. tation. The commentary specifically The implementation of quality sys- 142. http://www.eurotransplant.nl/?id= newsdetail&newsid=684. underlines that the ban on commer- tems, including traceability and vigi-

lance, with adverse events and tion and transplantation activities, as most up-to-date and comprehensive reactions reported, is also required in well as their clinical results, are trans- regulation of transplantations and order to maintain and optimise the parent and open to scrutiny, while the thereby constitute an effective tool for level of safety, efficacy and quality of personal anonymity and privacy of preventing trafficking in organs and human cells, tissues and organs for donors and recipients are always pro- tissues if they are implemented. transplantation on an ongoing basis. tected. Guiding Principle 11 requires that the These updated Guiding Principles – organisation and execution of dona- once adopted – will provide for the

Council of Europe

Additional Protocol to the Con- selling their organs, and expressly dis- organs if they fail to alert the health vention on Human Rights and approved of trends towards less authorities. However, the report Biomedicine concerning Trans- restrictive laws, which would allow expressly stated that paid donors plantation of Organs and Tis- greater scope for unrelated living should not be held criminally respon- sues of Human Origin (CETS No. donation. The report drew attention sible insofar as most sell their organs 186) to the fact that while member states because of their poor economic situa- Article 22 of the Additional Protocol legally prohibited organ trafficking, tion or because they are deceived into expressly prohibits organ and tissue most countries still had legislative doing so. trafficking, which are key examples of loopholes. It stated that organ traffick- The Parliamentary Assembly called on making financial gain from the human ing should not remain the sole the Council of Europe to consider body or its parts. In addition, organ responsibility of so-called “donor drafting an additional protocol to the and tissue trafficking infringe human countries” in Eastern Europe and rec- Council of Europe Anti-Trafficking rights, exploit vulnerable persons and ommended a number of measures to Convention which was under debate undermine public trust in the official be taken in “donor” and in “demand” at that time. It also recommended that transplant system. countries to minimise the risk of organ all member states sign and ratify the trafficking in Europe. main international legal instruments Parliamentary Assembly Recom- The report was the basis for Recom- in this field, namely the Convention on mendation 1611 (2003) on traf- mendation 1611 (2003) on trafficking in Human Rights and Biomedicine and its ficking in organs in Europe organs in Europe, which was adopted Additional Protocol concerning Trans- Following the questionnaire of the Sec- by the Council of Europe Parliamen- plantation of Organs and Tissues of retary General of the Council of Europe tary Assembly on 25 June 2003. Human Origin, the UN Convention for member states on organ trafficking, In the recommendation, all states against Transnational Organized Crime including legal and practical aspects were called on to implement meas- and its Protocol to Prevent, Suppress relevant to transplantations and traf- ures to reduce demand, promote and Punish the Trafficking of Persons, ficking in organs, issued in May 2002 organ donation, maintain strict legis- Especially Women and Children, and and the publication of the analysis of lation in regard to live unrelated the Optional Protocol to the Convention the replies of 40 European states in a donors, guarantee the transparency of on the Rights of the Child on the Sale of report by the Steering Committee on national registers and waiting lists, Children, Child Prostitution and Child Bioethics in 2004,143 further action was establish the legal responsibility of the Pornography. Member states were taken by the Council of Europe Parlia- medical profession and share informa- further called on to strengthen exist- 68 mentary Assembly. tion. The Parliamentary Assembly ing mechanisms of co-operation at The Parliamentary Assembly pointed therefore recommended that states Council of Europe level (SP-CTO), out in its report on “Trafficking in clearly establish criminal responsibil- improve funding for assistance activi- organs in Europe” (Rapporteur: ity for organ trade in their national ties, adopt and apply the recommen- Ms Ruth-Gaby Vermot-Mangold) of criminal codes, which should include dations adopted by the 52nd WMA 3 June 2003 that international criminal brokers, intermediaries, hospital/ General Assembly and intensify their organisations had identified the lucra- nursing staff and medical laboratory co-operation under the auspices of tive “gap” between organ supply and technicians involved in the illegal Interpol and Europol. demand, putting more pressure on transplant procedure, as well as people in extreme poverty to resort to medical staff who encourage and In addition to those recommendations provide information on “transplant to all states, the report contained rec- 143. Document CDBI/INF (2003) 11 rev. 2 of 2 June tourism” or are involved in follow-up ommendations specifically targeted at 2004; http://www.coe.int/t/dg3/health/Source/ CDBI_INF(2003)11_en.pdf. care of patients who have purchased “donor” and “demand” countries:

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs B. TRAFFICKING IN OTC: INTERNATIONAL STANDARDS AND INITIATIVES

Specific measures recommended for bodily integrity and the international exists to date. According to Article 2 “donor countries” were the improve- traffic in organs. (4), organ and tissue trafficking ment of prevention (through encompasses: awareness-raising and peer educa- Committee of Ministers Recom- the transportation of a person to a tion) and primary healthcare, as well mendation (2004) 7 to member place for the removal of organs or as steps towards identification of states on organ trafficking tissues without his or her valid illegal donors, identification of poten- Also at the Council of Europe, the consent; tial victims and the strengthening of Committee of Ministers on 19 May the transportation of a person to a transplant systems. Moreover, these 2004 adopted Recommendation (2004) place for the removal of organs or states were called on to restrict the 7 of the Committee of Ministers to tissues with his or her consent but donation of organs and tissues from member states on organ trafficking, in contravention of legislation or prisoners and other individuals in which took account of Resolution (78) other controls in operation in the custody (with the exception of dona- 29 on harmonisation of legislation of relevant jurisdiction; and tions for members of their immediate member states relating to removal, the transplantation of removed family), and implement national grafting and transplantation of human organs and tissues, whether trans- poverty-reduction strategies. With substances, the final text of the 3rd ported or not, in contravention of regard to law enforcement, donor Conference of European Health Minis- legislation or other regulations in countries were urged to include spe- ters (Paris, 16-17 November 1987), and operation in the relevant jurisdic- cific provisions on organ trafficking in the World Health Organization Resolu- tion or in contravention of inter- their criminal codes and undertake tion WHA 42.5 condemning the pur- national legal instruments. effective measures to combat traffick- chase and sale of organs of human Article 2 (5) defines the term “trans- ing in organs, including the imple- origin, as well as the Convention for the plantation”, which covers the com- mentation of national anti-corruption Protection of Human Rights and Dignity plete process of removal of an organ programmes. of the Human Being with regard to the or tissue from one person and implan- Application of Biology and Medicine. It tation of that organ or tissue into Similarly, “demand countries” were applies to all living persons and to the another person, including all proce- called upon to maintain strict laws in removal of organs, tissues and cells dures for preparation, preservation, regard to transplantation from unre- (including haematopoietic stem cells) storage and transportation, as well as lated living donors and to introduce in from those recently deceased. the term “removal”, w h i c h r e f e r s t o their criminal law sanctions for removal from the body of an organ or medical staff involved in carrying out The objective of the recommendation tissue intended for transplantation, by operations resulting from organ traf- (Article 1) is to protect the dignity and a surgical procedure or by other ficking. It was further stated that identity of all persons and guarantee means. national medical insurance should without discrimination their funda- deny reimbursements for illegal trans- mental rights and freedoms with According to Article 3, prevention of plants abroad and for follow-up care regard to organ and tissue transplan- organ trafficking should be under- of illicit transplants, donor awareness tation. It expressly states that organ taken in an integrated way by improv- should be improved and strict control trafficking exploits human beings and ing organ and tissue availability and and transparency of organ registers is illegal, and that member states approving a legal framework which and waiting lists should be estab- should take all possible measures to strictly forbids any kind of commer- lished, along with clear responsibili- prevent it. The scope is broad, cover- cialisation of the human body and its ing the removal of organs, tissues and parts, which should be extended to ties. Data should be harmonised, 69 “broker” advertising tracked down cells, including haematopoietic stem include citizens going abroad. and necessary support provided to cells, from living and recently Regarding medical aspects, it recom- Interpol and Europol. It was also rec- deceased persons. Blood and blood mends that medical care should not ommended that co-operation meas- derivatives are excluded. Besides defi- be denied and that the traceability of ures be strengthened and expertise nitions of the terms transplantation human organs and tissues should be provided to “donor” countries. and removal, the main value of the assured through the accreditation and recommendation is a definition of the control of centres for procurement With regard to professional ethics, the term “organ and tissue trafficking”. and/or transplantation, tissue banks report drew attention to the World Although it groups issues of traffick- and the follow-up of patients. In the Medical Association statement on ing in organs together with those of case of a living donor transplant, human organ and tissue donation and trafficking in human beings for organ member states should provide for offi- transplantation and the Bellagio Task removal, it is still an advance, as no cial authorisation of all such trans- Force report on transplantation, worldwide definition of the term plants and all payments to the donor

should be strictly prohibited and con- the removal and the implantation international agencies (Article 6). sidered a criminal offence. While of organs and tissues except in Moreover, the general public should clearly reaffirming the principle that centres or circumstances recogn- be informed about organ trafficking all payments to living donors should ised for the purpose and by health and the penalties that may be be strictly prohibited, the recommen- professionals with appropriate incurred, while organ and tissue dona- dation provides that this should not training and experience, tion and transplantation should also apply to payments which do not financial gain from the human be promoted as positive behaviour constitute a financial gain or a com- body or parts of the body that contributes to saving lives and parable advantage, in particular: intended for transplantation, improving the health of many people compensation of living donors for advertising with the intention of (Article 7). loss of earnings and any other jus- securing persons or organs or tifiable expenses caused by the tissues for trafficking or for finan- removal or by related medical cial gain; and organising or Committee of Ministers Resolu- examinations; running an organisation or service tions (2008) 4 on adult-to-adult payment of a justifiable fee for involved in organ or tissue traffick- living donor liver transplanta- legitimate medical or related tech- ing. tion and (2008) 6 on transplan- nical services rendered in connec- Member states should establish trans- tation of kidneys from living tion with transplantation; and plantation systems guaranteeing donors who are not genetically compensation in case of unjusti- equitable access to transplantation related to the recipient fied harm resulting from the services and national transplant Both Resolutions CM/Res (2008) 4 on removal of organs or tissues from waiting lists (Article 5). In any case, adult-to-adult living donor liver trans- living donors. the system must ensure that appropri- plantation and CM/Res (2008) 6 on To avoid illegal transactions, it is rec- ate information is recorded on all transplantation of kidneys from living ommended that in cases where the organs and tissues removed and used donors who are not genetically related living donor is a foreign citizen, the in connection with transplantation, relevant officially recognised bodies in that they are only allocated to persons to the recipient are linked to the issue the country of transplantation and in who are on a nationally recognised of trafficking in organs. They provide the home country of the living donor waiting list and that information on that organ removals may be envis- must be informed. the risks associated with organs aged when suitable organs from According to Article 4, states should obtained illegally is provided. The deceased donors are not available, ensure that there are legal instru- information should ensure traceability provided that all safeguards are imple- ments in place which prohibit the traf- from donor to recipient, but data pro- mented in order to guarantee the ficking of persons for the purpose of tection must be observed. freedom and safety of the donor and a organ or tissue transplantation and As organ trafficking is a universal successful transplant in the recipient, the trafficking of organs and tissues problem, the recommendation draws and stress that no organ removal may themselves and that these instru- attention to the need for full co-opera- be carried out on a person who does ments prohibit: tion with all other states and with not have the capacity to consent.

European Union

Trafficking in organs has not been and Commission Directive 2006/17/EC Trafficking in Persons Protocol, but 70 included in the scope of relevant EU of 8 February 2006 implementing Direc- differs from it in certain respects, most instruments. The three most closely tive 2004/23/EC of the European Parlia- importantly in its scope, as the Frame- related instruments, namely the ment and of the Council as regards work Decision covers only the pur- Council Framework Decision of 19 July certain technical requirements for the poses of sexual and labour 2002 on combating trafficking in donation, procurement and testing of exploitation and not exploitation for human beings (OJ L 203, 1.8.2003), human tissues and cells (OJ L 38/40, organ removal. Directive 2004/23/EC of the European 9.2.2006) do not cover the issue of Directive 2004/23/EC of the European Parliament and of the Council of trafficking in organs. Parliament and of the Council of 31 March 2004 on setting standards of The definition of trafficking in human 31 March 2004 on setting standards of quality and safety for the donation, pro- beings in the Council Framework Deci- quality and safety for the donation, procurement, testing, processing, preserva- sion of 19 July 2002 on combating traf- curement, testing, processing, preservation, storage and distribution of human ficking in human beings basically refers tion, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004) to the definition of the United Nations tissues and cells recognised the fact

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs B. TRAFFICKING IN OTC: INTERNATIONAL STANDARDS AND INITIATIVES

that the use of organs to some extent 1. The recruitment, transporta- b. participation by medical or raises the same issues as the use of tion, transfer, harbouring or recep- nursing staff in the transplantation tissues and cells, but nevertheless tion of a person, including any of an organ in the knowledge that it decided that the two subjects should exchange or transfer of control over has been the object of one of the not be covered by the same instru- that person, where above-mentioned acts. ment because of the differences.144 It a. use is made of force or threats, Article 2 (1) is similarly structured to did not therefore include human including abduction; or the offences in the Council Framework organs, blood or blood products. b. use is made of fraudulent Decision of 19 June 2002 (which is means; or limited to sexual and labour exploita- Initiative of the Hellenic Repub- c. there is an abuse of authority or tion), whereas Article 2 (2) and (3) lic with a view to adopting a of a position of vulnerability which reflect specific features and issues Council Framework Decision is such that the person concerned related to trafficking in human organs. concerning the prevention and has no real or reasonable possibility The punishment of instigation, aiding control of trafficking in human of avoiding such abuse; or and abetting are required by Article 3. organs and tissues d. payments or benefits are given Effective, proportionate and dissua- or received in order to obtain the As trafficking in organs was not sive criminal penalties which may con- consent of a person having control addressed by these EU instruments, stitute the basis for extradition are over another person with the aim of Greece in 2003 presented the Initiative provided for in Article 4. The penalties removal of an organ or tissues from of the Hellenic Republic with a view to must be increased in cases of aggra- the latter. adopting a Council Framework Decision vating circumstances. These provi- 2.a. the removal of an organ from sions are supplemented by provisions concerning the prevention and control a living donor effected using force, on the liability of legal persons of trafficking in human organs and tis- threats or fraud; (Articles 5 and 6) and jurisdiction and sues,145 which took account of the facts prosecution (Article 7). Jurisdiction is that removal of human organs and b. the removal of an organ from a extended to cases where the crime is tissues is a form of exploitation of donor who has consented thereto committed outside national territory, human beings and that the legislation further to the payment or promise thereby specifically including jurisdic- in the member states differs substan- of financial consideration; tion for cases of “transplant tourism”, tially regarding the definition of the c. the payment, offer or promise i.e. travel by EU citizens to countries penalties. of a financial consideration, directly with lower standards to avoid the or via third parties, to a donor in strict legislation in EU member states. Article 1 of the initiative sets out defi- order to obtain his consent to the nitions of transplantation and tissues removal of an organ; Pursuant to Article 39 (1) of the EC and provides that the scope of human d. the receipt of or demand for Treaty, the Council consulted the Euro- organs and tissues does not cover financial consideration by a donor pean Parliament on this initiative. The 146 reproductive organs and tissues, or a third party so that the donor Committee on Citizens’ Freedoms and 147 embryonic organs and tissues or will agree to the removal of an Rights, Justice and Home Affairs 148 blood and blood derivatives. organ; adopted a draft legislative resolution Article 2 describes a whole range of on the initiative on 30 September e. action as an intermediary in 2003. The European Parliament149 acts that should be punished as carrying out any of the acts set out offences constituting trafficking in approved the amended version of the in points (a), (b), (c) and (d); 71 human organs and tissues: Initiative of the Hellenic Republic and f. the demand for, receipt, pay- called on the Council to alter its pro- ment, offer or promise of financial Article 2 posal accordingly. It also insisted that consideration with the aim of offer- Offences concerning trafficking the Council refrain from adopting the ing or acquiring or, more generally, in human organs framework decision prior to the adop- trafficking in human organs and tis- tion of the European Parliament and Each member state shall take the sues. Council Directive on human tissues and necessary measures to ensure that 3.a. the purchase, possession, cells. The Parliament proposed the fol- the following acts are punishable: storage, transport, import, export or transfer of possession of human 149. Draft European Parliament legislative resolu- 144. Directive 2004/23/EC, Recital 9. tion on the Initiative of the Hellenic Republic with a 145. OJ C 100, 26.4.2003, p. 27. organs removed by means of one view to adopting a Council Framework Decision 146. Article 1 (3) (a). of the acts set out in paragraphs 1 concerning the prevention and control of traffick- 147. Article 1 (3) (b). ing in human organs and tissues (7247/2003 – C5- 148. Article 1 (3) (c). and 2; 0166/2003 – 2003/0812 (CNS)).

lowing major amendments in particu- transactions with a person in another On the other hand, it also wanted to lar: country where payment is not unlaw- make sure that payments to donors The European Parliament (EP) pro- ful. It therefore proposed which do not constitute a financial posed that the term “trafficking in to reorder the definition of offences gain or a comparable advantage are human organs” be changed to “illegal set out in Article 2 into three broad not prevented, trafficking in human organs, parts of categories:156 in particular: organs and tissues”,150 as the original – compensation of living donors 1. Trafficking in human beings for title was “ambiguous in its reference for loss of earning and any other the purpose of organ and tissue to ‘trafficking’, which can imply both justifiable expenses caused by the removal; legal and illegal trade. It is necessary legal removal or by the related to acknowledge that a legitimate and 2. Commercial dealings in human medical examinations; regulated trade exists for medical pur- organs and tissues; and – payment of a justifiable fee for poses, such as fertility treatment”.151 3. The removal of organs by force, legitimate medical or related tech- The Parliament further stated that “(i) coercion and deception. nical services rendered in connec- Illegal trade in human organs should The EP also proposed that the provi- tion with transplantation; be understood as the conscious sion of comparable advantages – compensation in case of undue engagement and participation in any should be regarded as equivalent to damage resulting from the legal form in provision, acquisition or use of the payment of a financial considera- removal of organs, part of organs or 162 human organs that breaches the con- tion so that the ban on organ traffick- tissues from living persons. 152 ditions for legal transplantation.” It ing would not be too easily In addition, it proposed that donors also argued that it was necessary to circumvented.157 be allowed to receive compensation look for alternatives aiming to end the so that they agree to the removal of an Additionally, it said that the provision shortage of donated cells, tissues and organ163 and justified this amendment 153 which would make living donors crim- organs. as follows: inally responsible for selling, or offer- Furthermore the EP proposed the ing to sell their organs158 should be The fact that the human body deletion of Article 1 (3), which limited removed, as it “does not seem appro- should not be a source of profit is at the scope of the term “human organs priate to criminalise a donor, who, in the very core of this proposal. How- and tissues” to be covered by the the vast majority of cases, will have ever, as already laid out in the Addi- instrument154, underlining that the been persuaded or coerced by crimi- tional Protocol to the Convention on scope needed to be extended, as the nal networks in the hope of escaping the Transplantation of Organs and aim must be to combat illegal traffick- from extreme poverty.”159 The main Tissues of Human Origin, this should ing in all circumstances.155 The EP aim of the initiative should be to not prevent voluntary donors from made it clear that it did not seek to tackle the agents of the illegal traffick- being offered reasonable compen- prohibit legal trade in reproductive ing in human organs, not to exacer- sation, such as for loss of earnings organs and tissues, but to criminalise 164 bate the suffering of its victims.160 and travel costs. such trade where it takes place According to this provision, In line with Article 21 (2) of the Addi- outside the legal regulatory frame- organs, parts of organs or tissues tional Protocol to the Convention on the work for the relevant activities. should not be bought or sold or Transplantation of Organs and Tissues It also took note of the fact that there give rise to direct financial gain for of Human Origin, the European Parlia- is evidence that a growing number of the person from whom they have ment proposed the punishment of EU nationals, desperate for a trans- been removed for a third party. Nor anyone who advertises, “via the Inter- 72 plant, are entering into commercial should the person from whom they net or any other medium, the need for, have been removed, or a third 150. Amendment 1 (throughout the text and in or availability of, organs, parts of party, gain any other advantage the title). organs or tissues, with a view to offer- 151. Draft European Parliament legislative resolu- whatsoever comparable to a finan- tion on the Initiative of the Hellenic Republic with a ing or seeking financial gain or com- cial gain, such as benefits in kind or view to adopting a Council Framework Decision parable advantage”.161 concerning the prevention and control of traffick- promotion. A third party involved in ing in human organs and tissues (7247/2003 – C5- 0166/2003 – 2003/0812 (CNS)); in the following: 156. Draft European Parliament legislative resolu- the transplant process, such as a Draft European Parliament legislative resolution; tion; explanatory statement, page 28. health professional or a tissue bank, explanatory statement, page 26. 157. Amendment 30 (regarding Article 2 (2) (c)). 152. Draft European Parliament legislative resolu- 158. Amendment 31 (regarding Article 2 (2) (d)). tion; Justification regarding amendment 1. 159. Draft European Parliament legislative resolu- 162. Justification regarding Amendment 35 153. Draft European Parliament legislative resolution; explanatory statement, page 28. (regarding Art 2 (2b) (new)). tion; Justification regarding amendment 4. 160. Draft European Parliament legislative resolu- 163. Amendment 35 (regarding Article 2 (2b) 154. Amendments 19 to 22 (regarding Article 1 (3)). tion; Justification regarding amendment 31. (new)). 155. See: Draft European Parliament legislative res- 161. Amendment 34 (regarding Article 2 (2) (fa) 164. Draft European Parliament legislative resolu- olution; Justification regarding amendment 19. (new)). tion; explanatory statement, page 28.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs B. TRAFFICKING IN OTC: INTERNATIONAL STANDARDS AND INITIATIVES

may not make a profit from organs, the field of organ trafficking, the ficking are adequately prosecuted, part of organs or tissues or any Motion for a European Parliament Reso- including sanctions for medical staff products developed from them.165 lution on organ donation and trans- involved in transplantation of organs This proposed paragraph was not plantation: Policy actions at EU level obtained from trafficking, while meant to create any exception to the (2007/2210 (INI)). making every effort to discourage principle laid down, but to give A specific chapter deals with organ potential recipients from seeking traf- examples of compensation to avoid trafficking. The EP highlighted the link ficked organs and tissues; this should possible financial disadvantage between organ shortage and organ include consideration of criminal lia- which may otherwise occur that are trafficking, stating that organ traffick- bility of European citizens who have not to be treated as financial gain or ing undermines the credibility of the purchased organs inside or outside 166 170 comparable advantage. system for potential voluntary and the EU. The draft framework decision was dis- unpaid donors and emphasised that Lastly, member states were called on cussed in the Working Party on Sub- any commercial exploitation of organs to take the necessary steps to prevent stantive Criminal Law of the Council of is unethical and inconsistent with the healthcare professionals from facilitat- the European Union from February most basic human values.167 It asked ing organ and tissue trafficking as well 2003, with several delegations the Commission to fight against the as health insurance providers from requesting from the outset that the practice of organ and tissue traffick- facilitating activities that directly or experts who were at that time examining, including the transplantation of indirectly promote trafficking in 171 ing a draft directive on the quality of organs and tissues from minors, from organs and to sign, ratify and imple- tissues be involved in the discussions. the mentally disabled or from exe- ment the Council of Europe Anti- Several EU member states raised res- cuted prisoners168 and called on the Trafficking Convention and the United ervations regarding the text and the Commission and member states to Nations Trafficking in Persons Protocol 172 need for the instrument, arguing that take measures to prevent “transplant if they have not already done so. in most member states no cases of tourism” by drawing up guidelines to The members of the European Parlia- trafficking in organs were known. It protect the poorest and most vulnera- ment regretted that Europol had not was also pointed out that the ble donors from being victims of come up with a survey on organ outcome of a study under the Falcone organ trafficking, adopting measures selling and trafficking because it Programme should be awaited as a that increase the availability of legally claims that there are no documented more substantial basis for the discus- procured organs and by exchange of cases. Referring to reports of the sions. Accordingly, as the initiative had waiting list registrations between Council of Europe and WHO which not received sufficient support from existing organ exchange organisa- give evidence that the organ trade is delegations, the discussions on the tions to avoid multiple listing. also a problem for EU member states, initiative were suspended, pending In addition, it asked the Commission the members of the EP asked the further detailed information on the to promote a common approach Commission and Europol to improve situation in the European Union. which aims at compiling information monitoring of cases of organ trafficking. Motion for a European Parlia- on national organ trafficking legisla- ment Resolution on organ donation and to identify the main problems 169 tion and transplantation: Policy and potential solutions. Member actions at EU level (2007/2210 states were urged, where necessary, to (INI)) amend their criminal codes to ensure The European Parliament in 2007 that those responsible for organ traf- launched a new initiative for action in 73 167. Motion for a European Parliament Resolution 170. Motion for a European Parliament Resolution on organ donation and transplantation, para 49. on organ donation and transplantation, para 53. 165. Draft European Parliament legislative resolu- 168. Motion for a European Parliament Resolution 171. Motion for a European Parliament Resolution tion; Justification regarding amendment 35. on organ donation and transplantation, para 50. on organ donation and transplantation, para 54. 166. Draft European Parliament legislative resolu- 169. Motion for a European Parliament Resolution 172. Motion for a European Parliament Resolution tion; Justification regarding amendment 35. on organ donation and transplantation, para 52. on organ donation and transplantation, para 55.

The Iberoamerican Network/Council of Donation and Transplantation (RCIDT)

The RCIDT Declaration against trans- WHO guiding principles on donation and transplantation (especially plant tourism in Latin America173 was Guiding Principles 5, 6, 7 and 8) and adopted recently. It is based on the 173. http://www.grupopuntacana.org/materiales_ the RCIDT statements on bioethical consejo/declaraturismotraspla.pdf.

considerations. The document was oppose and/or take measures in their entire region”. It also states that all citi- drawn up because some Latin Ameri- legislation to control and sanction the zens of countries in the network who can countries have been pinpointed promotion of and publicity for trans- need a transplant must be able to as places where practices such as plant tourism, “as these practices access the latter in a manner charac- transplant tourism, deceptive public- promote inequity, exclusion and social terised by transparency, efficiency and ity and organ commercialisation injustice, and violate human rights of quality, through their own actions or occur. national recipients”. It indicates that it through co-operation agreements that are fair, equitable and involve sol- In the declaration, the RCIDT voices its will give support “to move forward the idarity between the countries in the concern about the confirmation of identification of promoters and spon- network, giving priority to transplan- transplant tourism in some Latin sors of transplant tourism that is detri- tation for those in need with organs American countries and expresses its mental to the citizens of the country from donors from their own country. opposition to and disapproval of the where the transplant is performed, practice. In addition, it recommends and distorts the general activity [i]n that governments of member states donation and transplantation of the

The Transplantation Society and the International Society of Nephrology

At the International Summit on Trans- on all types of advertising (including heroic act while combating transplant plant Tourism and Organ Trafficking electronic and print media), soliciting tourism, organ trafficking and trans- held by the Transplantation Society or brokering for the purpose of transplant commercialism. In particular, it is and the International Society of Neph- plant commercialism, organ traffick- recommended that the medical and rology from 30 April to 2 May 2008, ing or transplant tourism and that psychosocial suitability of the living the Declaration of Istanbul on Organ such prohibitions should also include donor should be determined accord- Trafficking and Transplant Tourism was penalties for acts (such as medically ing to the recommendations of the adopted. The declaration points out screening donors or organs, or trans- Amsterdam and Vancouver Forums, that all countries need a legal and pro- planting organs) that aid, encourage and that systems and structures fessional framework to govern organ or use the products of organ traffick- should ensure standardisation, trans- donation and transplantation activi- ing or transplant tourism. Further- ties, as well as a transparent regulatory more, it states that practices that parency and accountability of support oversight system that ensures donor induce vulnerable individuals or for donation. The care of organ and recipient safety and the enforce- groups (such as illiterate and impover- donors, including those who have ment of standards and prohibitions on ished persons, undocumented immi- been victims of organ trafficking, unethical practices, which are partly grants, prisoners and political or transplant commercialism and trans- an undesirable consequence of the economic refugees) to become living plant tourism, is said to be a critical global shortage of organs for trans- donors are incompatible with the aim responsibility of all jurisdictions that plantation. It recommends that all of combating organ trafficking, trans- sanctioned organ transplants utilising countries should implement measures plant tourism and transplant commer- such practices. 74 to meet the transplant needs of their cialism. residents from donors within their It is also pointed out that provision of Consistent with the principles in this own population or through regional care includes medical and psychoso- declaration, several strategies to co-operation and that the therapeutic cial care at the time of donation and increase the donor pool and to potential of deceased organ donation for any short- and long-term conse- prevent organ trafficking, transplant should be maximised. quences related to organ donation. commercialism and transplant Lastly, the importance of comprehen- Principle 6 underlines that organ traf- tourism and to encourage legitimate, ficking and transplant tourism violate life-saving transplantation pro- sive reimbursement of the actual, doc- the principles of equity, justice and grammes are suggested. Their aims umented costs of donating an organ is respect for human dignity and should are especially to increase deceased mentioned, which does not constitute therefore be prohibited. It accordingly organ donation and to ensure the pro- a payment for an organ, but is part of recommends that prohibitions on tection and safety of living donors and the legitimate costs of the recipient’s these practices should include a ban appropriate recognition for their treatment.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs B. TRAFFICKING IN OTC: INTERNATIONAL STANDARDS AND INITIATIVES

Asian Task Force on Organ Trafficking

In January 2008, the members of the In the recommendations, relevant ment. In addition, organisational Asian Task Force on Organ Trafficking organisations and governments are issues are addressed, inter alia in the issued the Recommendations on the urged to promote greater awareness recommendations urging Asian coun- Prohibition, Prevention and Elimination of the ethical, legal and social issues tries to achieve national self-suffi- of Organ Trafficking in Asia (Taipei Rec- relating to organ trafficking in Asia ciency in order to provide a sufficient ommendations).174 These are based through education. With respect to number of organs for their residents upon “persistent reports of unethical legislation, international legal action is who need transplantation and to and unjust practices relating to the advocated for the effective implemen- establish registries of transplant recip- tation of international norms that transplant of organs in Asia involving ients and waiting lists, as well as regis- relate to organ trafficking, as is citizens of the region as well as those tries of living donors. Exchanges of national legislation clearly defining of other parts of the world” and information and technical experience prohibitions as well as allowable prac- as well as scientific research are also “worldwide reports on the exploita- tices pertaining to organ transplanta- recommended. tion of poor and other vulnerable indi- tion, including those related to the viduals as organ donors”. recovery and donation of organs. The document is comprehensive and also covers important technical- In addition to listing several aspects of To increase the supply of organs, Asian organisational aspects, calling on organ trafficking and making refer- countries are urged to rely more on deceased donation and to identify countries to observe transparency and ence to ethical principles set out in alternative solutions in order to accountability in regulations and prac- international documents and declara- decrease organ demand, such as pre- tices, adopt policies to discourage citi- tions, the text formulates several rec- vention and treatment of organ fail- zens from transplantation tourism and ommendations regarding trafficking ure. Recommendations to address consider a reasonable and socially in human organs. However, the rec- prevention, assistance (e.g. involve- accepted cost reimbursement as com- ommendations might also be consid- ment of civil society, ensuring the pensation for altruistic living organ ered with regard to trafficking in physical and psychological health of donors, while urging insurance com- tissues and cells. live organ donors by providing coun- panies to abstain from policies with selling and supports) and monitoring the effect of supporting illegal prac- 174. http://www.law.ntu.edu.tw/center/wto/ 04research.asp?tb_index=403. measures are also part of the docu- tices in organ transplantation.

C. Trafficking in human beings: international standards and their application to organ removal

This section will focus on existing African slave trade or certain large- organ removal, as a very modern international standards dealing with scale construction projects. Legal initi- development, was only included in trafficking in human beings for the atives also started more than a international measures this century. purpose of organ removal and seek to century ago. However, the early instruments laid differentiate the latter from organ traf- In the past, however, trafficking in the foundations for modern legisla- ficking, as previously addressed. human beings was not understood in tion and provided the basis for the Trafficking in human beings seems to the same comprehensive way as it is legal framework for national and inter- be a very modern and new topic. But nowadays, and legal instruments did national action in cases of trafficking in the international context, trafficking not deal with all its forms from the in human beings for the purpose of in human beings and slavery have a very beginning. The early instruments organ removal. This section describes very long history: we only need to focused on specific aspects of traffick- the international legal instruments think here of the consequences of the ing in human beings, namely sexual which deal specifically with trafficking Spanish Conquest in America, events and labour exploitation. Trafficking in in human beings and their application in other former European colonies, the human beings for the purpose of to organ removal.

Binding international legal instruments on action against trafficking in human beings

United Nations Optional Proto- convention sets the standard for all child pornography176 elaborates more col to the Convention on the international legal measures involv- specifically on those aspects in defin- Rights of the Child on the sale of ing children, with the definition of a ing in Article 2 (a) the term “sale of children, child prostitution and child being every human being below children” as “any act or transaction child pornography the age of eighteen years – unless whereby a child is transferred by any under the law applicable to the child, person or group of persons to another The first binding international legal majority is attained earlier. for remuneration or any other consid- instrument explicitly covering traffick- eration”. In this context, according to 76 ing in human beings for the purpose In the context of trafficking in human Article 3 (1), the following acts and of organ removal was the Optional beings, Articles 34 to 36 should also activities must be fully covered under Protocol to the Convention on the be mentioned: Article 34 covers all the criminal law of the parties, Rights of the Child on the sale of chil- forms of sexual exploitation and whether committed domestically or dren, child prostitution and child por- sexual abuse, Article 35 the abduction transnationally: nography. The United Nations of, the sale of or traffic in children for Convention on the Rights of the Child175 any purpose or in any form and (i) offering, delivering or accept- is without any doubt the central inter- Article 36 all other forms of exploita- ing, by whatever means, a child for national legal instrument for the pro- tion prejudicial to any aspects of the the purpose of: tection of children. Article 1 of the child’s welfare. a. sexual exploitation of the child; The Optional Protocol to the Conven- 175. General Assembly Resolution 44/25 of 20 tion on the Rights of the Child on the 176. General Assembly Resolution A/RES/54/263 of November 1989, entered into force on 2 September 25 May 2000, entered into force on 18 January 1990. sale of children, child prostitution and 2002.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs C. TRAFFICKING IN HUMAN BEINGS: INTERNATIONAL STANDARDS AND THEIR APPLICATION TO ORGAN REMOVAL

b. transfer of organs of the child Punish Trafficking in Persons, Especially Beings (CAHTEH), whose task was the for profit; Women and Children, supplementing preparation of a convention focusing c. engagement of the child in the United Nations Convention against on the protection of the human rights forced labour. Transnational Organised Crime, were of the victims of trafficking and, bal- In contrast to the convention, where opened for signature at the High-level anced with this concern, the prosecu- only sexual and labour exploitation Political Signing Conference in tion of traffickers. are explicitly mentioned and traffick- Palermo (Italy) from 12 to ing in human beings for the purpose 15 December 2000 and entered into The CAHTEH started negotiations in of organ removal can only be sub- force on 25 December 2003. By September 2003 and held eight meet- sumed under “other forms of exploita- December 2008, there were already ings to finalise the text. The Council of tion” (Article 36), “offering, delivering 117 Signatories and 124 Parties to the Europe Anti-Trafficking Convention is or accepting, by whatever means, a Protocol. the most comprehensive international child for the purpose of transfer of The United Nations Trafficking in legal instrument on combating traf- organs of the child for profit” is specifi- Persons Protocol itself is a milestone in ficking in human beings. It covers all cally mentioned in Article 3 (1) (a) (i) international measures against traf- forms of trafficking (national, transna- (b) of the Optional Protocol. ficking in human beings. For the first tional, whether linked to organised time, a comprehensive definition of crime or not) based upon the defini- United Nations Protocol to Pre- trafficking in human beings, in which tion in the United Nations Trafficking vent, Suppress and Punish Traf- exploitation was not limited to various in Persons Protocol, in particular with ficking in Persons, Especially kinds of sexual and labour exploita- a view to victim protection measures Women and Children, supple- tion but also included exploitation for and international co-operation. menting the United Nations the removal of organs, was agreed Among other matters, the convention Convention against Trans- upon at universal level. Moreover, the deals with prevention and co-opera- national Organised Crime protocol deals not only with criminal tion, measures to protect and The Ad Hoc Committee on the Elabo- aspects but also has a broader scope, promote the rights of victims, criminal ration of a Convention against Tran- involving prevention and protection law and co-operation. Its main added snational Organised Crime set up by measures, as well as provisions on co- value is the monitoring mechanism to United Nations General Assembly operation. ensure that parties implement its pro- Resolution 53/111 of visions effectively. 9 December 1998 to elaborate a com- Council of Europe Convention prehensive international convention on Action against Trafficking in The Council of Europe Anti-Trafficking against organised transnational crime Human Beings Convention was adopted by the Com- and – among others – an international On 30 April 2003, the Council of Eur- mittee of Ministers on 3 May 2005 and instrument addressing trafficking in ope’s Committee of Ministers opened for signature in Warsaw on 16 women and children, began its work approved the proposal to prepare a May 2005, on the occasion of the 3rd on 19 January 1999 and held 12 ses- Council of Europe Anti-Trafficking Summit of Heads of State and Govern- sions. Convention and adopted the specific ment of the Council of Europe. It The United Nations Convention against terms of reference setting up the multi- entered into force on 1 February 2008. Transnational Organised Crime and the disciplinary Ad Hoc Committee on By December 2008 it had been signed Protocol to Prevent, Suppress and Action against Trafficking in Human by 40 states and ratified by 20.

The application of international standards to 77 organ removal

Definitions adopted in Article 4 of the Council of recruitment, transportation, transfer, Europe Anti-Trafficking Convention. harbouring or receipt of persons, by The United Nations Trafficking in means of the threat or use of force or Persons Protocol for the first time sets Definition of trafficking in other forms of coercion, of abduction, out a comprehensive definition of traf- human beings of fraud, of deception, of the abuse of ficking in human beings in a binding According to Article 3 (a) of the United power or of a position of vulnerability international legal instrument that has Nations Trafficking in Persons Protocol or of the giving or receiving of pay- been globally accepted. The definition (and Article 4 (a) of the Council of ments or benefits to achieve the set out in Article 3 of the Protocol was Europe Anti-Trafficking Convention) consent of a person having control groundbreaking and was therefore “trafficking in persons” means “the over another person, for the purpose

of exploitation. Exploitation shall fined to the use of certain means and The receipt of persons is not limited to include, at a minimum, the exploita- therefore also includes the use of receiving them at the place where the tion of the prostitution of others or modern information technologies. As exploitation takes place either, but other forms of sexual exploitation, the term is described generally, also means meeting victims at agreed forced labour or services, slavery or recruitment by one of the means for places on their journey to give them practices similar to slavery, servitude the purpose of organ removal is further information on where to go or or the removal of organs.” regarded as trafficking in human what to do. To constitute the crime of trafficking beings for the purpose of organ Means: As in all other cases of traf- in human beings, a combination of removal regardless of how the recruit- ficking in human beings, the means three basic elements is necessary: ment is performed – whether through used by the traffickers in cases involv- an action (recruitment, transporta- personal contact or contact through ing the removal of organs also vary. tion, transfer, harbouring or receipt third persons, newspapers, advertise- The words “threat or use of force” do of persons) by certain means ments or the Internet. not need to be explained explicitly. (threat or use of force or other Transportation is also a general term They indicate in any case that the forms of coercion, of abduction, of and does not define any particular removal took place against the indi- fraud, of deception, of the abuse of means or kinds of transportation. The vidual’s will, as fear or harm meant the power or of a position of vulnerabil- act of transporting a person from one choice was not free and any consent ity or of the giving or receiving of place to another constitutes this ele- was not established voluntarily. payments or benefits to achieve the ment; as in the cases of trafficking in Other forms of coercion encompass the consent of a person having control human beings for sexual or labour fact that not only physical harm to the over another person) for the exploitation, it is not necessary for the victim but also psychological pressure purpose of exploitation (which victim to have crossed any borders, can limit a person’s free will. This may includes at a minimum, the exploi- nor is it necessary for the victim to be include threatening the victim’s tation of the prostitution of others present illegally in a state’s territory. family, as well as other forms of eco- or other forms of sexual exploita- The offence therefore includes tran- nomic pressure, etc. tion, forced labour or services, snational and national trafficking. Abduction is a means that is also heard slavery or practices similar to slav- of in connection with cases of traffick- The transfer of a person includes any ery, servitude or the removal of ing in organs where people are kid- kind of handing over or transmission organs). napped and their organs removed. It of a person to another person. This is The actions mentioned (e.g. transport) is in any case a special form of use of particularly important in certain cul- precede the exploitation, which force. tural environments where control over means that the offence is already con- Fraud frequently occurs in cases where individuals (mostly family members) stituted if a victim was subjected to individuals may initially be willing to may be handed over to other people. one of the actions, by one of the have their organs removed and enter As the term and the scope of the means for one of the purposes. into contracts in which they are prom- offence are broad, the explicit or With regard to trafficking in human ised certain sums of money for them. implied offering of a person for trans- beings for the purpose of organ The offence may therefore be consti- fer is sufficient; the offer does not have removal, the definition needs to be tuted in several ways, most commonly to be accepted for the offence of traf- looked at in more detail to analyse its by not handing over any money at all ficking in human beings to be consti- scope: to the donors or by paying only part of tuted if the other elements are also Actions: The actions mentioned the agreed sums. present. 78 encompass a variety of activities start- Deception is closely connected with ing before the actual exploitation and The harbouring of persons means fraud, but should be seen more in involve more than just the physical accommodating or housing persons terms of cheating as regards a person’s transportation from one place to in whatever way, whether during their knowledge and will than as regards another. As such, they are neutral journey to their final destination or at economic aspects. Deception includes actions, which become criminally rele- the place of the exploitation. This, of misleading individuals about facts, vant if they are conducted with the course, also includes the accommoda- conveying falsehoods or withholding intention of exploiting others. tion of persons in a medical clinic or the truth or relevant information from Recruitment is to be understood in a other place where the illegal removal donors, thereby compounding their broad sense, meaning any activity of organs is conducted – and the crim- misconceptions or ignorance. In the leading from the commitment or inal liability of the individuals involved case of exploitation for organ removal, engagement of another individual to who use one of the means described the issue of informed consent is of his or her exploitation. It is not con- below to exploit the victims. major importance in this respect. Only

if a person is fully informed about the on such a person for his or her direct and brokers can therefore be held operation itself, its risks and long-term benefit and with the authorisation of liable under this provision. consequences, can informed consent his or her representative. The element The principle that the human body or to the medical intervention be given. can therefore be constituted if the parts of it must not give rise to finan- The offence can therefore be estab- representative misuses his or her cial gain is an accepted international lished if the donor is not fully power in agreeing to the intervention standard and established Council of informed about the risks of the contrary to the victim’s benefit, Europe legal acquis (see, in particular, removal or the need for follow-up human rights and human integrity. Article 21 of the Convention on Human care, is promised medical follow-up The above-mentioned cultural envi- Rights and Biomedicine and Article 22 which is subsequently not provided ronments where there are situations of the Additional Protocol concerning and also, e.g., if he or she is misled of “ownership” over other persons also transplantation of organs and tissues of about the need for the medical indica- fall under this term. human origin). tion for the removal of an organ. In general, it should be noted that As already mentioned, the definition The abuse of power is especially rele- many of these means are closely inter- specifically includes only removal of vant in cases where an individual has related and, in some cases, may be organs, while at the same time stating the power to take decisions over other seen more as various degrees than as that this is just a minimum. National people, e.g. medical doctors who different means. However, for the legislation can therefore go further infringe laws and ethical requirements offence of trafficking in human beings, and include the purpose of removal of and remove organs from individuals in the particular means used is of no rel- cells and tissues. This is not only con- order to sell the organs even though evance; if any of the means was used sistent with the text of the definition, there was no medical indication for in one of the actions described with it is also in line with the spirit of the the removal of the organs and no will the purpose of exploitation in one of documents, especially as the means to donate. the forms indicated, then the crime is and actions employed are the same as According to the travaux préparatoires deemed to have been committed. for the removal of organs and the of the United Nations Trafficking in potential health consequences for the Persons Protocol,177 the misuse of a Purpose: This provision stipulates victims may be the same. For example, position of vulnerability refers to any that the perpetrator’s intention was in the case of reproductive cells, situation in which the person involved the exploitation of an individual. As exploitation takes place if they are has no real and acceptable alternative with the removal of organs, given the removed in such quantities (once or but to submit to the abuse involved. severity of possible injuries, risks and on several occasions) that severe The vulnerability can be of any kind: (long-term) consequences for the health problems may result for the physical, psychological, economic, donor, it means that the removal of an donor. If the removal of organs or cells social, emotional, legal (e.g. illegal res- organ from a living donor for another take place for medical reasons (to re- idence in a country), etc. In general, person’s benefit cannot be justified. If establish or improve the health of the the person in question must be in the removal is nonetheless carried individual, in case of a tumour, etc.), such a situation that he or she virtually out, it in any case results in a severe no exploitation occurs. It therefore has no choice and has to accept being bodily injury with long-lasting and seems advisable to include the exploited. sustainable consequences which is purpose of removal of cells and tissues The giving or receiving of payments or punishable in any country, even if no in national legislation. benefits to achieve the consent of a special provisions on trafficking in person having control over another human beings for the purpose of Definition of victim person in particular refers to the organ removal or on trafficking in The United Nations Trafficking in 79 misuse of a person’s authority over organs exist. Persons Protocol does not define the another individual, especially with It is not necessary for the organ to be meaning of victim of trafficking in regard to children and persons who removed at the phase where the per- human beings. Article 4 (e) of the are not capable of giving full and valid petrator was involved in the process, Council of Europe Anti-Trafficking consent. According to international nor is it necessary for the organ to be Convention defines victim as “any standards (see, for instance, Article 6 removed at all. What matters is that natural person who is subject to traf- of the Council of Europe Convention on one of the actions was committed ficking in human beings as defined in Human Rights and Biomedicine), an with one of the means with the this article”, i.e. as defined in Article 4 intervention may only be carried out purpose of exploitation of an individ- (a) (see above). It is therefore the only 177. Travaux préparatoires: United Nations Con- ual for organ removal. Even persons binding international document vention against Transnational Organised Crime; A/ recruiting potential donors using one which gives a definition of victim of 55/383/Add.1, paras. 63-68; interpretative notes on Article 3. of the illicit means and intermediaries trafficking in human beings. A victim

of trafficking in human beings for the the offence is constituted, even if information must be comprehensive, purpose of organ removal is accord- consent might appear to have been in a language and form the potential ingly defined as any person recruited, given – such consent is deemed to donor understands and he or she transported, transferred, harboured or have been invalidated by the perpe- must be given sufficient time to received, by means of the threat or use trator’s use of illicit means. In other decide. Under Article 13 of the Addi- of force or other forms of coercion, of cases where there never was apparent tional Protocol, the donor must give abduction, of fraud, of deception, of consent, the offence is deemed to free, informed and specific consent to the abuse of power or of a position of have been committed without this the removal either in written form or vulnerability or of the giving or receiv- extra step of investigating whether before an official body, which he or ing of payments or benefits to achieve such means were used. she can withdraw at any time. the consent of a person having control It is also important that the (valid) Article 14 of the Additional Protocol on over another person, for the purpose consent of the victim at one stage of the protection of persons not able to of exploitation by way of removal of the process may not be taken to be consent to organ or tissue removal organs. consent for the entire process – repeats Article 20 of the Council of consent may be withdrawn voluntarily Europe Convention on Human Rights The issue of consent at any time. and Biomedicine. Article 3 (b) of the United Nations Traf- In contrast to trafficking in human For further details, please refer to ficking in Persons Protocol refers to beings for sexual or labour exploita- Existing international standards, the issue of the consent of a victim of tion, where there is merely a general page 34. In any case, the requirements trafficking in persons to the intended notion as to the requirements for con- set out in these instruments must be exploitation set forth in Article 3 (a) sent, in the case of trafficking in regarded as those which must be met and provides that such consent is irrel- human beings for the purpose of to establish valid consent. evant where any of the means set organ removal, there are internation- There is only one exception to the forth in Article 3 (a) have been used. ally recognised standards for consent general rule that a combination of the This basically means that consent to which can be inferred from legal doc- three elements, action, means and the exploitation is legally impossible if uments dealing with organ and cell purpose, is needed for the crime of such consent has been obtained by transplantations. trafficking in human beings to be the illicit means mentioned in Article 3 Alongside the WHA Guiding Principles committed: in the case of child vic- (a). The question of consent is a tricky on Human Organ Transplantation, tims, trafficking does not require any one, as it may sometimes be difficult Article 19 of the Council of Europe Con- of the above-mentioned means to be to determine where free will and self- vention on Human Rights and Biomedi- involved. It is also immaterial whether determination end and undue pres- cine provides that, in the case of organ or not the child has consented to the sure begins. Some people may even removal, the necessary consent must exploitation. Article 3 (d) of the United know what they are consenting to, but have been given expressly and specifi- Nations protocol expressly provides they may not be completely aware of cally either in written form or before that child means persons under the all the risks and especially the (long- an official body, e.g. a court or a age of 18. term) consequences they will be notary. Article 20 (1) prohibits organ To avoid misunderstandings, the facing – and they would not consent if or tissue removal from a person who drafters of the United Nations Traffick- they did know. It is important that this does not have the capacity to consent. ing in Persons Protocol noted that the provision establishes the offence The issue of consent with respect to removal of organs from children with regardless of whether the victim con- the removal of organs is dealt with the consent of a parent or guardian for 80 sented to his or her exploitation, as more comprehensively in the Addi- legitimate medical or therapeutic otherwise the defence might raise the tional Protocol to the above Convention reasons should not be considered 178 argument that the victim had con- concerning Transplantation of Organs exploitation. However, this also sets sented to the exploitation and that and Tissues of Human Origin. Under the limit for legitimate consent of therefore the offence was not consti- Article 12 of the Additional Protocol, parents or guardians; if they consent tuted and the perpetrator was not the donor and/or person or body to removal of organs other than for liable. responsible for approving such an legitimate medical or therapeutic rea- Article 3 (b) makes it clear that in any intervention if the donor is unable to sons, the offence of trafficking in case in which one of the activities consent must be given appropriate human beings is committed. Regard- occurred and one of the means men- information beforehand regarding the 178. Interpretative notes on Article 3 regarding tioned in the definition of trafficking purpose and nature of the removal subparagraph (a) in lit. (c) of the protocol approved in human beings (Article 3 (a)) was and its consequences and risks, as well by the Ad Hoc Committee and included in its report on the work of its first to eleventh sessions used for the purpose of exploitation, as the legal rights and safeguards. The (see A/55/383/Add.1, paras. 63-68).

ing the question of what legitimate requirements, namely in Article 18 instruments regarding trafficking in medical or therapeutic reasons are, (“Criminalisation of Trafficking in human beings includes a provision of reference must again be made to rec- Human Beings”) and in Article 21 this kind. It does not in any sense seek ognised medical and ethical stand- (“Attempt and Aiding or Abetting”). to restrict victims’ economic well- ards. Regarding children, Article 3 (1) (i) (b) being or hinder their social rehabilita- The provisions in Article 3 (b) of the of the Optional Protocol to the Conven- tion, but is intended to punish those United Nations Trafficking in Persons tion on the Rights of the Child on the who exploit their services and thereby Protocol were included in Article 4 (b) sale of children, child prostitution and take advantage of and/or profit from of the Council of Europe Anti- child pornography provides for the the person’s exploitation in the knowl- Trafficking Convention. criminalisation of the offering, deliver- edge that he or she is a victim of traf- ing or accepting, by whatever means, ficking in human beings. On the other Criminalisation a child for the purpose of transfer of hand: if somebody is unaware that the Article 5 of the United Nations Traf- organs of the child for profit, whether person is a victim of trafficking in ficking in Persons Protocol requires committed domestically or transna- human beings, he or she cannot be states to adopt such legislative and tionally. It is left to states to make this punished. Consequently, the provision other measures as may be necessary a specific criminal provision or to has not been made binding, but is still to establish as criminal offences the include it in a general provision crimi- considered to form part of the added conduct set forth in Article 3 of the nalising trafficking in human beings value of the convention. protocol, when committed intention- (for organ removal). The requirement The case of the removal of organs ally (Article 5 (1)), as well as attempt- itself must also be interpreted with differs significantly from the other ing to commit, participating in and respect to the interpretative notes on forms of exploitation. While several organising or directing other persons the United Nations Trafficking in services from victims of sexual or in the commission of offences estab- Persons Protocol, according to which labour exploitation come to mind, it is lished in accordance with paragraph 1 the removal of organs from children rather difficult to think of services of of the article (Article 5 (2)). with the consent of a parent or guard- victims of organ exploitation. Indeed, The protocol does not require states ian for legitimate medical or therapeu- the explanatory report on the conven- to criminalise the individual elements tic reasons should not be considered tion does not give any examples and addresses them solely in the exploitation. It is a provision designed either. The service which such a victim context of trafficking in human to protect children as one of the most would give would most certainly be beings. It requires states to establish vulnerable groups. In addition to the the donation of the organ – and, con- the combination of the elements as a special requirements for consent sequently, the use of the service criminal offence. Moreover, according regarding children and persons not would be the removal of the organ for to Article 3 (b), the consent of the legally able to consent, this provision the purpose of implantation into victim does not alter the trafficker’s establishes further protective meas- another person. And here there is a criminal liability. The exploitation does ures to prevent advantage being major difference compared to the not actually have to have taken place. taken of children. Parents or legal other forms of exploitation, in particu- The text leaves it to states to decide guardians may therefore consent to lar for the person receiving the serv- how to implement the provisions: first the transfer of organs of their child for ice. If a person knowingly uses a of all, states may decide whether to legitimate medical or therapeutic victim’s sexual or labour services, it implement Article 3 by way of the reasons only: in no case, however, may might be difficult to prove the knowl- adoption of one or of several provi- they offer, deliver or accept a child or edge of the fact in practice, but there sions. It is also left to states to decide his or her organs for profit. National is no doubt that the relevant conduct 81 whether Article 5 (2) is implemented legislation must establish criminal cannot be justified, as the person has by way of general provisions in their provisions to punish such behaviour. the choice not to make use of the national legal systems regarding service without encountering nega- attempts to commit the offences and Criminalisation of the use of the tive consequences. In the case of aiding and abetting others to do so, or services of the victim organs, the situation is trickier. by the introduction of special provi- According to Article 19 of the Council As already mentioned several times, it sions. The article merely establishes of Europe Anti-Trafficking Conven- is an undisputed principle that the the principle that all the said activities tion, states must consider adopting a human body and parts thereof must and types of conduct must be crimi- provision that criminalises persons not give rise to any financial profit. The nalised. who knowingly use the services of a Council of Europe Convention on The Council of Europe Anti-Trafficking victim of trafficking in human beings. Human Rights and Biomedicine, the Convention lays down the same None of the other international legal Additional Protocol to the Convention

concerning Transplantation of Organs United Nations Trafficking in Persons trator with regard to that person. And, and Tissues of Human Origin and the Protocol, and Articles 18 and 21, of course, criminal liability is possible WHA Guiding Principles on Human Council of Europe Anti-Trafficking if the living donor infringes national Organ Transplantation all reiterate this Convention). laws which forbid such behaviour, in principle, which is the basic provision On the other hand, travelling to particular the selling of organs for for preventing and combating illegal another country and thereby circum- profit to third persons. It must be trade and trafficking in organs. It is an venting stricter laws in one’s own made clear, however, that this involves important rule for protecting human country (transplant tourism) in the criminal liability for trafficking in rights and the altruistic nature of knowledge that the organs may most organs, not trafficking in human organ donations. Nobody should probably come from a person in a des- beings for the purpose of organ profit financially from the sale of body perate situation who might be a removal. parts – and clear political will is shown victim is definitely morally and ethi- The criminalisation of such donors is that no brokers, medical staff, health cally highly reprehensible behaviour sensitive, as in many cases they have institutions or others should profit which should be prevented as far as been deceived or coerced by criminal financially from a commercial transac- possible. However, it also reflects the groups or their desperate economic tion between third persons, namely hopeless situation of the individual, situation has forced them to partici- the donor(s) and the recipient(s) of which should be taken into account pate in the transaction. As they are organs, almost all of whom are in a when discussing whether such behav- likely to suffer from the consequences desperate and vulnerable situation. iour should be criminalised or of the removal and to become victims Similar to donors who often find whether other sanctions and meas- of trafficking in human beings at the themselves in situations where they ures (especially measures to increase latest once their organ has been see no alternative but to participate in the availability of organs, in particular removed, states should refrain from the transaction, the situation of recipi- from deceased persons) should be holding these individuals criminally ents is almost always desperate. developed to prevent the need for liable. In this respect, reference should (Potential) recipients of organs from and hence the commission of such be made to Article 26 of the Council of victims of trafficking in human beings acts. Europe Anti-Trafficking Convention, are in such a desperate situation In this context, it is worth noting that the so-called “non-punishment provi- because they most probably have situations may arise where recipients sion”, according to which states must, tried everything to obtain an organ can be excluded from criminal liability in accordance with the basic princi- legally, but without success. And they because of their emergency situations ples of their legal system, provide for also face severe consequences if they or other exculpating factors. The com- the possibility of not imposing penal- fail to obtain an organ, ranging from plexity of the issue was one of the ties on victims for their involvement in further dependence on life- reasons that no agreement could be unlawful activities, to the extent that prolonging measures which do not reached on the draft EU framework they have been compelled to take have the same therapeutic effect as decision concerning the prevention and part in such activities. Article 26 leaves organ transplantations through to control of trafficking in human organs it to states to comply with this provi- death. The recipients are therefore and tissues, as several states had sion by establishing either a substan- under enormous pressure which must objections to a provision of this kind. tive criminal provision or a procedural also be taken into account. criminal-law provision – or any other These cases cannot therefore be Criminalisation of living donors measure, which also (alternatively) treated on the same basis as the Another sensitive issue is the criminal- means administrative law provisions 82 others, i.e. either users of services of isation of living donors. First of all, it because Article 26 does not restrict victims of sexual and labour exploita- should be stated clearly that a living the requirement to establishing crimi- tion or brokers and health staff who donor can be a potential victim of traf- nal provisions. Article 26 must also be participate in transplantations for ficking in human beings for the applied to unlawful activities which their financial benefit only. Criminal purpose of organ removal, but not a are covered not by criminal law but by liability therefore has to be discussed potential perpetrator in a case related administrative law (e.g. illegal entry very sensitively. If a potential recipient to his or her person; this is impossible into or residence in a country’s terri- abets somebody to initiate the illegal under the definition, as no activities tory, etc.). removal of an organ from another can be conducted with the relevant In its draft legislative resolution on the person, he or she is directly liable for means to exploit oneself. However, it Initiative of the Hellenic Republic with a trafficking in human beings for the is, of course, possible for a living donor view to adopting a Council Framework purpose of organ removal in connec- to be involved in the exploitation of Decision concerning the prevention and tion with abetting (Articles 3 and 5 (2), another person and become a perpe- control of trafficking in human organs

and tissues,179 the European Parlia- The position is somewhat different for Tissue and Organ Transplantation, ment also called, inter alia, for the pro- medical staff. If they are directly which explicitly takes note of such sit- vision which would make living involved in the trafficking process uations and states that doctors should donors criminally responsible for with one of the activities mentioned, not face professional sanctions if they selling or offering to sell their organs they commit the crime as direct per- decline to provide post-transplant to be deleted because the main aim of petrators. They may also be held liable care for patients who have undergone the initiative should be to tackle the for aiding and abetting if they do not transplantation at facilities of the agents of the illegal trafficking in actually perform any of the actions above kind, provided that they refer human organs, not to exacerbate the themselves, but aid or abet the traf- such patients elsewhere). However, if suffering of its victims.180 States should fickers, e.g. by deceiving the victim national legislation requires them to therefore refrain from holding living about the risks or dangers of the inform the authorities about such donors liable for any participation in removal of organs or the need for and cases and they breach these require- activities connected to trafficking in amount of follow-up care, etc., in ments, they may be held liable for human beings for the purpose of order to obtain the victim’s consent. infringements of those provisions. organ removal, except for cases when Doctors “just” giving information In the case of hospitals and hospital they start actively participating in traf- about the possibility of transplant staff, the provisions regarding criminal ficking activities involving other tourism without any further involve- liability of legal persons also have to persons and become traffickers them- ment are not guilty of trafficking in be taken into account. If hospitals or selves. human beings, as their action would natural persons with a leading posi- be too limited to be regarded as tion in them are involved in trafficking Criminalisation of medical staff, falling under the term “recruitment”. activities for the benefit of the hospi- brokers, intermediaries, etc. Guiding Principle 7 of the Revised tals, then criminal liability can be Considering the broad definition and WHO Guiding Principles on Human Cell, established for both the natural and the accompanying provisions on Tissue and Organ Transplantation bears the legal persons. If the hospital (staff) aiding or abetting, many of the in mind that physicians may find know(s) about the planned or persons involved in the whole process themselves in situations where they ongoing trafficking activities or is/are of trafficking in human beings can be meet patients willing to pay for cells, actually facilitating or actively offering held liable under these provisions. In tissues or organs and underlines that potential donors, then the action (in addition to the explanations above, they should not refer them to trans- any case harbouring, as the victims are the following principles apply: plant facilities – in their own or other accommodated in the hospital; but countries – that make use of cells, possibly also recruitment or receipt) Brokers who try to find potential tissues or organs obtained commer- and the purpose (exploitation) are donors should be considered as falling cially, or seek or accept payment for established, and the third element, directly within the scope of Article 5 of doing so. Nonetheless, such behaviour the use of illicit means, will most often the United Nations Trafficking in may infringe other legal and ethical also occur if the victims are deceived Persons Protocol (Article 18 of the provisions and may lead to criminal (about the need for the intervention, Council of Europe Anti-Trafficking liability because of other offences. the risks, the consequences, the price, Convention) if they use one of the The same applies to doctors involved etc.), threatened or if advantage is illicit means, which mostly is the case, in the follow-up care of individuals taken of their vulnerability, etc. as the action must then be considered who obtained illegal transplants. If most often as recruitment. Other such doctors were not directly Criminalisation of acts relating intermediaries should also be consid- involved in the exploitation of the to travel or identity documents 83 ered as falling directly within the victim, but confronted with the recipi- Article 20 of the Council of Europe scope if they use deceit, threats or one ent after the transplantation, they Anti-Trafficking Convention requires of the other means in transferring, cannot be held liable for trafficking in the following to be established as transporting, harbouring or receiving human beings. Moreover, in accord- criminal offences, when they are com- the victim prior to exploitation. In ance with the medical and legal stand- mitted intentionally and for the addition, there are always possible sit- ards applicable in many countries, purpose of enabling trafficking in uations in which they can be held doctors will not be in a position to human beings: forging a travel or liable for aiding or abetting the perpe- deny the recipient medical care and identity document (a), procuring or trators. may be bound by rules on medical providing such a document (b) and 179. 7247/2003 – C5-0166/2003 – 2003/0812 secrecy (see also the commentary on retaining, removing, concealing, dam- (CNS). Guiding Principle 7 of the Revised aging or destroying a travel or identity 180. Draft European Parliament legislative resolution; Justification regarding amendment 31. WHO Guiding Principles on Human Cell, document of another person (c).

This is an important provision for pre- tion of liberty which can give rise to ures and international legal co-opera- venting international trafficking in extradition. tion therefore also apply to the crime human beings for the purpose of For the crime of trafficking in human of trafficking in human beings under organ removal, as many (potential) beings, Article 24 of the Council of the United Nations Trafficking in donors cross national borders to sell Europe Anti-Trafficking Convention Persons Protocol. This includes such their organs in a country other than requires states to regard the following important accompanying measures as their country of origin because traf- circumstances as aggravating circum- those to combat money laundering fickers often use false documents to stances when determining the pen- and corruption, two crimes which are traffic victims in other states and exert alty: closely linked to organised trafficking pressure on them by withholding their the offence deliberately or by in human beings. documents and thus increasing their gross negligence endangered the Criminalisation of legal persons dependence. life of the victim (a), According to Article 10, UNTOC, (and For this to be fully effective, states the offence was committed Article 22, Council of Europe Anti- must have effective border control against a child (b), Trafficking Convention), legal persons measures (Article 11, United Nations the offence was committed by a must be held criminally liable for their Trafficking in Persons Protocol, and public official in the performance participation in trafficking in human Article 7, Council of Europe Anti- of her/his duties (c), and beings for the purpose of organ Trafficking Convention) and systems the offence was committed within removal involving an organised crimi- to ensure the integrity and security of the framework of a criminal nal group and must be subject to travel or identity documents organisation (d). effective, proportionate and dissua- (Article 12, United Nations Trafficking In addition, under Article 25 of the sive sanctions, which, according to in Persons Protocol, and Article 8, Council of Europe Anti-Trafficking Article 23 (2) of the Council of Europe Council of Europe Anti-Trafficking Convention, states must provide for Anti-Trafficking Convention, includes Convention) and must verify within a the possibility of taking into account monetary sanctions. This is an impor- reasonable time the legitimacy and final sentences passed by other states tant principle because, in implement- validity of travel or identity docu- in relation to offences mentioned in ing these measures, not only the ments (Article 13, United Nations Traf- the convention when determining the traffickers themselves but also institu- ficking in Persons Protocol, and penalty. This does not involve an obli- tions like hospitals involved in the traf- Article 9, Council of Europe Anti-Traf- gation for national judges or public ficking network are criminalised and ficking Convention) issued or pur- prosecutors actively to investigate are subject to penalties. ported to have been issued in their whether such previous convictions name. exist, but means that – if such are Confiscation and seizure States are required to implement pro- Sanctions known – they must be taken into account when penalties are deter- visions on confiscation and seizure Article 5 of the United Nations Traf- mined. They will then have to be (Articles 12 to 14, UNTOC, and ficking in Persons Protocol requires regarded as aggravating circum- Article 23 (3), Council of Europe Anti- states to adopt such legislative and stances and will most probably lead to Trafficking Convention) of proceeds of other measures as may be necessary higher sentences in the event of con- crime or of property corresponding in to establish as criminal offences the victions. value to that of such proceeds derived conduct of intentional trafficking in from trafficking in human beings and human beings (Article 5 (1)) and Other criminal law provisions of property, equipment or other 84 attempting to commit, participating Article 1 (3) of the United Nations Traf- instrumentalities used in or destined in and organising or directing other ficking in Persons Protocol expressly for use in trafficking in human beings. persons in the commission of such states that the offences established in These measures are effective tools offences (Article 5 (2)). accordance with Article 5 of the proto- because the main motivation for this Article 23 (1) of the Council of Europe col are to be regarded as offences crime is financial profit and it is there- Anti-Trafficking Convention requires established in accordance with the UN fore necessary to confiscate the states to adopt measures to ensure Convention on Transnational Organised money from the traffickers. The that the criminal offences established Crime (UNTOC). According to UNTOC also contains provisions on in the convention are punishable by Article 1 (2), the provisions of the extradition, mutual legal assistance, effective, proportionate and dissua- UNTOC apply, mutatis mutandis, to the joint investigations and special inves- sive sanctions, including, in the case protocol unless otherwise provided. tigative techniques. They round off of the crime of trafficking in human All the provisions in the UNTOC the legal framework which needs to beings, penalties involving depriva- regarding criminal procedural meas- be established in order effectively and

comprehensively to combat traffick- ment, which also places emphasis on course of judicial proceedings. ing in human beings. co-operation with civil society. In Because of the differences in legal sys- accordance with the conditions pro- tems, it is left to states to decide how Closure of establishments and vided for under internal law, states to achieve these aims. According to denial of the exercise of duties must ensure that any group, founda- the case-law of the European Court of Under Article 23 (4) of the Council of tion, association or non-governmental Human Rights, the following meas- Europe Anti-Trafficking Convention, organisation which seeks to combat ures could be used, for instance: states must also adopt measures to trafficking in human beings or protect non-public hearings (for part or all enable the temporary or permanent human rights is able to assist and/or of the trial if required by the inter- closure of any establishment which support the victim, with his or her ests of a juvenile or the protection was used to carry out trafficking in consent, during criminal proceedings. of the private life of a victim), human beings, without prejudice to anonymous testimony (avoidance the rights of bona fide third parties, or Protection during and after of the public disclosure of the to deny the perpetrator, temporarily criminal proceedings identity of victims, while at the or permanently, the exercise of the Under Article 28 of the Council of same time guaranteeing the activity in the course of which the Europe Anti-Trafficking Convention, defence an adequate opportunity offence was committed. In the event victims, witnesses, when necessary, to question the victim), of health facilities and hospitals being members of their families and individ- use of audio and video technol- involved in the trafficking activities, uals who co-operate with judicial ogy: for taking evidence and con- this would require their closure to authorities must be afforded effective ducting hearings to avoid the prevent further cases. In addition, doc- and appropriate protection from repetition of hearings and face-to- tors, nurses and other staff intention- potential retaliation or intimidation, in face contact between the victim ally participating in any activities particular during and after investiga- and the perpetrator (to avoid any related to trafficking in human beings tion and prosecution of perpetrators. kind of pressure or undue influ- for the purpose of organ removal Such protection may include physical ence that might deter victims (information, examinations, transplan- protection, relocation, identity from giving evidence), and tations, providing care, recruiting, changes and assistance in obtaining the possibility of using make-up accommodating, etc.) would have to employment. This provision is prima- or disguise. be denied the right to exercise their rily aimed at protecting the victims, In the event of a conviction, the extent duties, which would be an effective but is also an important tool for law of the handicaps to the defence must tool for combating trafficking in enforcement because, only if victims be taken into account so as to create a human beings for organ removal and feel that they and their family fair balance with the defence rights trafficking in organs. members are sufficiently safe and and provide for a fair trial. secure, will they be willing to co- Ex-officio applications Victim protection operate in criminal proceedings Under Article 27 of the Council of against perpetrators and, as experi- Europe Anti-Trafficking Convention, Protection of the privacy and ence shows, such co-operation is states must ensure that investigations identity of victims of trafficking crucial for convictions in most traffick- into and prosecution of trafficking in human beings ing cases. offences do not depend on the report This is essential both to ensure the or accusation made by a victim. If indi- Article 6 (1) of the United Nations Traf- physical protection of victims and viduals fall victim to trafficking in ficking in Persons Protocol requires their families from the perpetrators another state, the competent authori- states to provide for the possibility of and also to avoid them suffering addi- 85 ties either have to take action them- confidential legal proceedings for the tional psychological pressure. It is also selves or transmit the complaint sake of the protection of victims. necessary in order to protect their without delay to the competent Article 30 of the Council of Europe chances of social reintegration. Legal authority of the country in which the Anti-Trafficking Convention also takes proceedings (especially, but not only, offence was committed. note of the need to protect victims in court proceedings) in cases of traffick- court proceedings and to balance this ing in human beings can aggravate Victim assistance in criminal with the need to ensure a fair trial. the unfortunate consequences for the proceedings Measures to ensure the protection of victims. In addition, media coverage Article 27 (3) of the Council of Europe victims’ private life and, where appro- can seriously invade victims’ privacy, Anti-Trafficking Conventionis one of priate, identity, as well as their safety resulting in stigmatisation and making the key provisions highlighting the and protection from intimidation, it even more difficult for victims to human rights approach of this instru- therefore have to be provided in the reintegrate socially. Article 6 (1) of the

United Nations Trafficking in Persons Appropriate housing (Article 6 (3) (a), erence to medical assistance, the Protocol and Article 11 of the Council United Nations Trafficking in Persons Council of Europe Anti-Trafficking of Europe Anti-Trafficking Convention Protocol), appropriate and secure Convention distinguishes between therefore require the protection of the accommodation (Article 12 (1) (a), access to emergency medical treat- privacy and identity of victims. They Council of Europe Anti-Trafficking ment (Article 12 (1) (b)), which must also require measures to ensure that Convention) be granted to all persons whom the the identity, or details allowing the It is not enough for the victim to be authorities have “reasonable grounds to believe” are victims, and more com- identification, of a child victim of traf- accommodated after his or her identification; he or she must be housed prehensive “necessary medical or ficking are not made publicly known, appropriately and safely. Shelter can other assistance”, which is only to be except, in exceptional circumstances, be provided in facilities provided by provided for victims lawfully resident in order to facilitate the tracing of governmental or non-governmental in a state’s territory who do not have family members or otherwise secure institutions. However, detention adequate resources and need such the well-being and protection of the centres or other facilities where vic- help (Article 12 (3)). “Lawfully resi- child. tims’ freedom of movement is dent” means nationals of the state restricted are not considered to be concerned or persons with a residence Physical, psychological and appropriate. If the victim is suffering permit. social recovery of victims from health problems resulting from However, even with the restriction to the removal of an organ, the appropri- emergency medical treatment, Whereas Article 6 (3) of the United ateness of the housing will also denying victims of trafficking in Nations Trafficking in Persons Protocol depend on whether the quality of the human beings for the purpose of is non-binding, Article 12 (1) of the shelter is sufficient to take the health organ removal any follow-up care, as Council of Europe Anti-Trafficking aspects into account; in some cases, often happens, is incompatible with Convention requires states to adopt only accommodation in a hospital or a these provisions. No waiver which a such measures as may be necessary to comparable health institution may be victim may have signed in the belief assist victims in their physical, psycho- considered appropriate. that the document provides other- logical and social recovery. It should Psychological and material assistance wise can relieve states of the obliga- be expressly reiterated and under- (Article 6 (3) (c), United Nations tion to provide for the necessary lined that the adoption of these meas- Trafficking in Persons Protocol), medical treatment to restore the indi- ures is an obligation for all states – psychological and material assistance vidual’s physical well-being – regard- both countries of origin and countries (Article 12 (1) (a), Council of Europe Anti- less of how or where the treatment is provided. It may be provided in of destination. The vulnerability of Trafficking Convention) special healthcare institutions or by victims does not end at borders. On Victims of trafficking in human beings are often traumatised and need psy- certain doctors; how this is done is left the contrary, victims need this assist- chological assistance. Material assist- up to states; what matters is that the ance whether they remain in a country ance covers adequate and at least medical care is provided. or are repatriated or returned to their basic kinds of support which a victim country of origin – in both situations, Counselling and information, in par- might need for living, in particular these measures are necessary for the ticular as regards their legal rights, in clothes, food, etc. a language that the victims of traf- victim’s social recovery and social Medical assistance ficking in persons can understand reintegration. The following measures Especially in cases of trafficking in (Article 6 (3) (b), United Nations Traf- are to be regarded as the minimum 86 human beings for the purpose of ficking in Persons Protocol, and assistance to be provided (“in particu- organ removal, it is obvious that Article 12 (1) (d), Council of Europe lar” (United Nations Trafficking in certain medical assistance is needed Anti-Trafficking Convention), which Persons Protocol), “at least” (Council of as well. The assistance is not supposed includes counselling and informa- Europe Anti-Trafficking Convention)): to cover all possible kinds of treat- tion regarding the services available ment, but at least those which are to victims: Victims have the right to Standards of living capable of ensur- needed to (re-)establish or ensure the be counselled by lawyers and/or ing their subsistence: Article 12 (1) physical safety and integrity of the support services. The phrase “in par- (a) of the Council of Europe Anti-Traf- victim and to record any evidence of ticular as regards their legal rights” ficking Convention requires states to the violence for further judicial pro- highlights the importance of those provide services guaranteeing a ceedings. Whereas Article 6 (3) (c) of aspects, but also makes it clear that certain standard of living to ensure the United Nations Trafficking in the provision is not restricted to them. victims’ subsistence, in particular: Persons Protocol makes a general ref- It is also important for victims to be

informed about the possibilities which they can understand. The infor- Translation and interpretation serv- regarding all services available to mation must be comprehensive. ices: Article 12 (1) (c) of the Council of them, especially medical care, Regarding court proceedings, it must Europe Anti-Trafficking Convention employment, repatriation and social include details about the scope, also provides that translation and integration, etc. It is crucial that the length and consequences of criminal interpretation services must be pro- information is given in a language that proceedings against the perpetra- vided, when appropriate, as this is a the victim can understand and that it tor(s) or even against victims them- prerequisite for victims being able to is given on time, i.e. as soon as possi- selves (if criminal proceedings are also exercise their rights and obtain knowl- ble, so as to enable the victim to exer- launched against living donors in edge of and gain access to the serv- cise his or her rights. certain countries), as well as about ices available to them. It is an The legal rights may be the rights and civil proceedings (see Article 6 (3) (b), important provision for ensuring that victims have access to their rights, duties of victims as witnesses, protec- United Nations Trafficking in Persons tion measures available to them, ways which is a precondition for access to Protocol). Information about adminis- to obtain compensation from perpe- justice. trative proceedings relates in particu- trators or other persons or entities and lar to possible difficulties which Physical safety of victims: Under possibilities for legalising their resi- victims could encounter with regard Article 6 (5) of the United Nations Traf- dence in a country, etc. The informa- to their residence in the country (if ficking in Persons Protocol and tion should enable victims to assess they had travelled to another country Article 12 (2) of the Council of Europe their situation and make an informed for their organ to be removed) or to Anti-Trafficking Convention, states decision about the possibilities open proceedings involving health insur- must provide for the physical safety of to them. victims of trafficking in persons while ance issues. Employment, educational and train- they are within their territory. For the ing opportunities: These measures Assistance to enable the views and sake of completeness, the Council of mentioned in Article 6 (3) (d) of the concerns of victims to be presented Europe Anti-Trafficking Convention United Nations Trafficking in Persons adds victims’ protection needs to this and considered at appropriate Protocol are important for the re-inte- requirement. Account must be taken stages in criminal proceedings gration of the victim into society; their of the fact that the real needs of the against offenders: Under Article 6 (2) level and nature depend on the age victims may differ from one person to (b) of the United Nations Trafficking in and knowledge of the victim. another. Persons Protocol, such assistance Article 12 (1) (f) of the Council of must be provided in a manner that is Possibility of obtaining compensa- Europe Anti-Trafficking Convention not prejudicial to the rights of the tion: Article 6 (6) of the United grants all children for whom there are defence. Article 12 (1) (e) of the Nations Trafficking in Persons Protocol reasonable grounds to believe that Council of Europe Anti-Trafficking grants victims the possibility of they are victims of trafficking in obtaining compensation for damage Convention more specifically refers to human beings access to education. suffered, and leaves it to national legal assistance to enable the rights and Under Article 12 (4), access to the systems to determine the measures by interests of victims to be presented labour market, to vocational training which this requirement is met. and considered at appropriate stages and education only has to be provided Article 15 of the Council of Europe of criminal proceedings against for victims of trafficking in human Anti-Trafficking Convention deals in offenders, thereby drawing more beings lawfully resident within a greater detail with this right and seeks attention to the aim to make sure that state’s territory. to ensure that victims obtain ade- the victim’s rights are taken into Information on relevant court and quate compensation. Article 15 (3) 87 account properly during criminal pro- administrative proceedings: lays down the right of victims to com- Article 6 (2) (a) of the United Nations ceedings. The provisions do not pensation from the perpetrators. The Trafficking in Persons Protocol spe- specify whether such assistance compensation is financial and covers cifically requires information to be should be given by lawyers or special both material costs (e.g. for medical provided on relevant court and support services, but regardless of treatment) and non-material damage. administrative proceedings. Article 15 how the service is provided, it must States must establish a legal frame- (1) of the Council of Europe Anti-Traf- enable the victim’s perspective to be work in which victims can claim com- ficking Convention further stipulates considered in criminal proceedings. In pensation. This may be in the course that this information must be given to any case, it is important that states of criminal proceedings against traf- victims of trafficking in human beings, maintain a balance between the rights fickers in which the courts decide as from their first contact with the of the victims and those of the upon compensation, or in proceed- competent authorities, in a language defence so as to guarantee a fair trial. ings in civil courts. Full compensation

is rarely obtained because the perpe- needs of children (Article 6 (4)), United interests (i.e. not in cases where the trators are often not found, disappear Nations Trafficking in Persons Proto- family appears to have sold the child). or have hidden all their assets. col, and Article 12 (7), Council of Article 15 (4) therefore requires states Europe Anti-Trafficking Convention). The status of victims of trafficking in to take steps to guarantee compensa- persons in countries of destination: Moreover, Article 12 reiterates the self- tion for victims of trafficking in human explanatory principle that assistance When identified, victims who are ille- beings. It is left to them to decide how to victims must not be made condi- gally present in a state’s territory or to do this, for instance by setting up a tional on their willingness to act as who are legally resident with a short- compensation fund or introducing witnesses (paragraph 6) and that serv- term residence permit are traumatised measures or programmes aimed at ices are provided on a consensual and after their suffering and are also likely social assistance and social integration informed basis (paragraph 7), in other to be removed from the territory. of victims, which could be funded by words, assistance is granted on the Article 13 of the Council of Europe assets of criminal origin. basis of free and informed consent. Anti-Trafficking Convention therefore Legal aid and legal assistance: grants a recovery and reflection Under Article 15 (2) of the Council of Identification of victims: Article 10 of period of at least 30 days when there Europe Anti-Trafficking Convention, the Council of Europe Anti-Trafficking are reasonable grounds to believe that each state must provide, in its internal Convention tackles the issue that in the persons concerned are victims. law, for the right to legal assistance order for all the measures to be Such a period must be sufficient for and to free legal aid for victims under applied to victims, the latter first have the persons concerned to recover and the conditions provided by its internal to be identified as such. It therefore escape the influence of traffickers law. As all kinds of court and adminis- requires states to provide their com- and/or to take an informed decision trative procedures are usually very petent authorities with trained and on co-operating with the competent complex and, in particular, difficult to qualified persons and ensure co-oper- authorities. During this period, no understand for traumatised victims, ation between different authorities expulsion order may be enforced such assistance is necessary to enable and relevant support organisations, so against them and they must be victims to claim their rights. This provi- that victims can be identified in a pro- authorised to remain in the country. sion does not grant victims an abso- cedure duly taking into account the However, this provision is without lute right to free legal aid, and it is up special situation of women and child prejudice to the activities carried out to individual states to determine the victims. If the competent authorities by the competent authorities in all conditions and requirements accord- have reasonable grounds to believe phases of the relevant national pro- ing to which such aid may be granted that a person has been the victim of ceedings, and in particular when to applicants who lack financial means trafficking in human beings, states investigating and prosecuting the and are therefore unable to afford a must ensure that the person con- offences concerned. The only case lawyer. cerned is not removed from their terri- where the provision does not apply is tory until the identification process if grounds of public order prevent it or All the above measures have in has been completed by the compe- if it is found that victim status is being common that they are not restricted tent authorities and also that the claimed improperly. to specific categories of countries, i.e. person receives assistance. Moreover, both countries of origin and countries Under Article 7 (1) of the United in appropriate cases, such persons of destination must provide them for Nations Trafficking in Persons Proto- must be issued with residence per- victims in an appropriate way. There col, states must permit victims to mits. are no indications that this provision remain temporarily or permanently in 88 could be understood in the sense of If the age of victims is uncertain and their territory in appropriate cases. victims being placed in a better posi- there are reasons to believe that they Although this is not an absolute right, tion than they would have been in had are children, they must be presumed measures must nonetheless be taken they not become victims of trafficking to be such and must be afforded so that victims can remain in a given in human beings. However, the vic- special protection measures. If an country in special circumstances. The tims’ integrity must be restored and unaccompanied child is identified as a aspects to be taken into account when they must be protected, with the victim, he or she must be provided considering such cases are humanitar- above measures being provided on an with legal representation acting in his ian and compassionate factors appropriate level. In any case, in pro- or her best interests. The necessary (Article 7 (2), United Nations Traffick- viding these services, states must take steps must also be taken to establish ing in Persons Protocol). Several coun- into account the age, gender and his/her identity and nationality and tries have implemented this provision special needs of victims of trafficking every effort made to locate his/her by way of granting residence permits in persons, in particular the special family when this is in the child’s best on humanitarian grounds.

Article 14 of the Council of Europe which must facilitate and accept their ments or authorisations to enable the Anti-Trafficking Convention takes return without undue or unreasonable victims to travel to and enter their ter- account of the different legal systems delay, having due regard for their ritory (paragraph 4 in both instru- within Council of Europe member safety (Article 8 (1), United Nations ments). states and provides that states must Trafficking in Persons Protocol, and The Council of Europe Anti-Trafficking issue renewable residence permits to Article 16 (1), Council of Europe Anti- Convention also requires states to victims if the competent authority Trafficking Convention). Paragraph 2 establish repatriation programmes considers that their stay is necessary of both instruments sets out the corre- designed to avoid re-victimisation for the purpose of their co-operation sponding obligation for countries of (paragraph 5) and to make available to with the competent authorities in destination, which must also have victims contact information for struc- investigations or criminal proceed- regard for victims’ safety when return- tures which can assist them in the ings or owing to their personal situa- ing them. They must also take into country to which they are returned or tion (i.e. on humanitarian grounds) – account the status of legal proceed- repatriated (paragraph 6). Moreover, or in both situations (paragraph 1). ings related to the fact that the child victims must not be returned to The non-renewal or withdrawal of persons are victims, in order not to a state, if there are indications, follow- such residence permits is subject to affect the rights they could exercise in ing a risk and security assessment, the conditions laid down by national proceedings (especially with regard to that this would not be in the best law (paragraph 3). Most importantly, compensation). The repatriation of interests of the child. the granting of such residence permits victims should preferably be volun- Lastly, both instruments require states must be without prejudice to the right tary. to take measures for the effective pre- to seek and enjoy asylum (paragraph Accompanying provisions for vention of trafficking in human beings 5). paragraph 1 are the requirements that and re-victimisation, to promote co- Repatriation and return of victims: states must verify whether the operation with civil society, to tackle The provision on repatriation of persons concerned are nationals or the root causes (poverty, underdevel- victims is an important guarantee for have the right of permanent residence opment, lack of equal opportunity) non-discrimination and victims’ social (paragraph 3 in both instruments), and to discourage demand. Informa- reintegration. Victims have the right to facilitate their repatriation and there- tion exchange and staff training are return to their countries of origin, fore also issue the necessary docu- also called for.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs

IV. Conclusions and recommendations

IV. CONCLUSIONS AND RECOMMENDATIONS

“Trafficking in organs, tissues and cells” and “Trafficking in human beings for the purpose of the removal of organs”: two different phenomena and two different crimes

One of the major aims of this Joint of organ removal. Indeed, in the despite the confusion that exists Study has been to distinguish broader context of trafficking in OTC, between them. The “trafficked between “Trafficking in OTC” and trafficking in human beings for the objects” are different: in one case the “Trafficking in human beings for the purpose of organ removal might be “organs, tissues and cells” and in the purpose of removal of organs”. The considered a marginal phenomenon. other case the “person him/herself” two are frequently mixed up in public On the other hand, trafficking in who is trafficked for the specific debate and in the legal and scientific human beings covers types of exploi- purpose of removing his/her organs. community. This leads to confusion tation other than the removal of To express this idea in legal terms, it and consequently hinders effective organs and is therefore more than an could be said that trafficking in efforts to combat both phenomena issue of trafficking in organs: traffick- organs, tissues and cells differs from and also to provide comprehensive ing in human beings involves a combi- trafficking in human beings for organ victim protection and assistance. nation of three basic elements (action, removal in one of the constituent ele- Some trafficking in OTC may originate means and purpose) which may not ments of the crime – the object of the in trafficking in human beings and will necessarily be present in cases of traf- criminal offence. In the former case, therefore fall within the scope of both ficking in OTC. the object of the crime is the organs, international legal instruments men- As mentioned above, “Trafficking in tissues and cells, while in the latter tioned above. But trafficking in OTC is OTC” and “Trafficking in human case it is the trafficked person. much broader in scope than traffick- beings for the purpose of removal of ing in human beings for the purpose organs” are two different phenomena

The prohibition of making financial gains with the human body or its parts: the paramount 93 principle

The principle that it is not permissible and was confirmed, in particular, by financial gain”. The principle was then for the human body or its parts as the final declaration of the reaffirmed in the 2002 Additional Pro- such to give rise to financial gain is 3rd Conference of European Health tocol to the Convention on Human established Council of Europe legal Ministers (Paris, 1987) before being Rights and Biomedicine concerning acquis. It was laid down in Committee definitively established in Article 21 of Transplantation of Organs and Tissues of Ministers Resolution (78) 29 on har- the 1997 Council of Europe Convention of Human Origin [CETS No. 186]. monisation of legislation of member on Human Rights and Biomedicine Article 22 of this Additional Protocol states relating to removal, grafting and [CETS No. 164]: “The human body and states: “Organ and tissue trafficking transplantation of human substances its parts shall not, as such, give rise to shall be prohibited”.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs IV. CONCLUSIONS AND RECOMMENDATIONS

At United Nations level, there is no legally binding, they have been incor- based on altruism, both from living legally binding instrument which sets porated in many professional stand- and from deceased donors, which out the principle of the prohibition of ards and laws and are not only widely must be the basis of the organ trans- making financial gains from the recognised but also basically undis- plantation system. Legislation on the human body or its parts. However, the puted in terms of standard-setting. recovery of organs from living and World Health Organisation Guiding The principle of the prohibition of deceased donors for transplantation Principles on Human Cell, Tissue and making financial gains with the should be passed in all countries and Organ Transplantation clearly lay human body is also essential in order should conform to this principle. down this principle. Although not not to jeopardise the donation system

Organ donation and organ transplantation: promotion of organ donation, organisational and technical measures to increase organ availability and existence of organisational and technical capacity for transplantation of organs

There is an impressive range of exist- Network-Council of Donation and are shared. The same applies to tech- ing recommendations, resolutions Transplantation (RCIDT). nical measures and the degree of and international legally binding Key organisational measures to development of alternatives to DBD as instruments dealing with transplanta- increase organ availability and sources of organs for transplantation. tion of OTC. It should be noted that improve the safety and quality of In fact, the use of ECD and DCD varies international activities in this area donation and transplantation have substantially between countries as a started very early and have since been been described by all these interna- consequence of the many related ethi- continued on a consistent basis. When tional organisations and have been cal, legal and practical issues, which all existing international standards given effect in recommendations, dec- should be addressed in a universal and instruments dealing with trans- larations and specific actions and fashion but, once again, with a locally plantation of OTC are considered, it activities related to training, education tailored approach. can be seen that there are no discrep- and promotion. However, the extent The above paragraphs relate to to which such organisational meas- medical and legal standards. However, ancies between them; they comple- ures are developed varies significantly there are other important issues that ment one another in an between countries, often as a result of have to be taken into account as well. internationally recognised body of limitations affecting their practical This mainly involves the promotion of law. From the outset, the general prin- implementation. Approaches geared organ donations. Actions like the ciples have been very clear: the prefer- towards an ideal structure for an effec- European Organ Donation Day and ence for organs and tissues from tive system for deceased donation the International Organ Donation Day deceased persons over those from must take into consideration the par- should be continued and supple- living persons, the prohibition of ticular context of individual countries. mented by regional awareness-raising financial gains and the need to 94 Legal, economic, socio-demographic activities and improved information promote donations and establish and health-care structural factors and, campaigns by governmental and non- appropriate professional standards. indeed, social and cultural particulari- governmental organisations. Promo- These principles have remained the ties may have a significant impact on tion is considered to be of limited use- same in substance, but have in the the number of potential donors in a fulness as a means of effectively course of time been further devel- given country and the extent to which combating the shortage of organs for oped and clarified. They are set out in the above-mentioned measures are transplantation. However, the cam- all documents and instruments of all applicable. Efforts need to be made in paigns might increase public aware- major international organisations this regard. It is important to identify ness of the need for organs for dealing with this topic: the World and explore models that work in dif- transplantation. Transparent informa- Health Organisation, the Council of ferent settings and to promote co- tion is also crucial to ensure public Europe, the European Union and the operation at an international level so trust in the donation and transplanta- recently founded Iberoamerican as to ensure that these best practices tion systems.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs IV. CONCLUSIONS AND RECOMMENDATIONS

A point to be stressed is the fact that plantation has proven to be cost- especially in the case of patients for many of the above measures require effective even in low-resource envi- whom finding a suitable donor is diffi- the involvement of national authori- ronments. Lastly, the organisational cult in smaller countries. ties in the field of donation of OTC if and technical capacity to perform Organ shortage and the extreme eco- they are to be effective. The issue of transplantation must be developed in nomic disparities and inequities in donation and transplantation must be all countries, which should not pre- access to transplantation services placed on the political agenda. Gov- clude international co-operation throughout the world are the main ernments have a central role in estab- when needed. causes of trafficking in OTC and traf- lishing laws on transplantation and Co-operation must be strengthened ficking in human beings for the also in carrying out oversight of dona- even more, not only between states, purpose of organ removal. Every effort tion and transplantation practices in but also between approved institu- must therefore be made to find solu- accordance with international stand- tions active in the transplantation tions for legally facilitating the pool of ards. The development of successful process and among states and NGOs. available organs and preventing the programmes for deceased donation Information exchange about waiting above-mentioned illegal activities. also needs effective support from lists and available organs and tissues Needless to say, the promotion of health-care authorities, which should should be enhanced in order to make organ donation must be closely invest in such programmes. This is transplantation systems as effective as accompanied by extensive informa- something which has been achieved possible and ensure their transpar- tion and by discussion of the issues. It in many countries, but not in many ency. Furthermore, states should join goes without saying that such discus- others. Obviously, donation and trans- transplantation exchange services, sion must include psychological, plantation competes with other when appropriate, to give their citi- ethical and religious aspects, as other- health-care interventions in many zens better chances of obtaining nec- wise the public acceptance that is current situations. However, trans- essary organs, tissues or cells, needed will hardly be achieved.

“Trafficking in organs, tissues and cells” and “Trafficking in human beings for the purpose of the removal of organs”: need to collect reliable data

There is limited knowledge of the This limited data availability hinders where organs from local donors are current situation regarding trafficking the quantification of the two phenom- transplanted. Local donors are mainly in OTC and trafficking in human ena and hence the evaluation of the the poorest and most vulnerable beings for the purpose of organ effectiveness of measures to prevent members of the relevant communi- removal. This is because little informa- and prosecute them. Their qualitative ties. The cases described also involve tion is available from official sources, description is also difficult. The data local deceased organ donors whose with figures and trends mostly coming should therefore be disaggregated by organs are preferentially allocated to from estimates and rumours. Details sex in order to assess whether and to foreigners through commercial trans- of the number of victims and traf- what extent the processes dispropor- actions. ficked OTC accordingly remain rather tionately affect women and girls States should make an effort to collect fragmentary. There is possibly there- because of the feminisation of pov- reliable data on both forms of traffick- 95 fore a high number of unreported erty. With estimates that 5-10% of ing. To that end, they should ensure cases in both instances. This is kidney transplants worldwide are traf- traceability of all organs transplanted because of the huge profits and rather ficked, it is clear that trafficking in from donors to recipients and vice low risks for the perpetrators. Victims/ organs and trafficking in human versa. Professionals should be encour- donors are also mostly ashamed and beings for organ removal is a global aged also to report any such practices frightened to report cases, recipients issue, commonly occurring in the form detected to the relevant local authori- of organs will remain silent and the of what has been defined as trans- ties. They should ensure proper other people who know about the plant tourism. The better known form knowledge of the origin of every interventions are mostly directly (which does not mean it is the most single organ for transplantation and involved in the trafficking offences; common) involves travel by potential confirm that it has been obtained in thus it is very difficult to investigate recipients from rich Northern coun- accordance with international stand- the crimes. tries to poor Southern countries ards and local legislation.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs IV. CONCLUSIONS AND RECOMMENDATIONS

Trafficking in organs, tissues and cells: need for an internationally agreed definition

It is clear that there are many major Paragraph 119 of the Explanatory – the transportation of a person statements and international instru- Report to the Additional Protocol to a place for the removal of organs ments which refer to trafficking in specifies the following: or tissues without his or her valid OTC. However, there is no single defi- consent; “As stated by Article 21 of the Con- nition that has achieved international – the transportation of a person vention, the human body and its consensus. It is important to reach to a place for the removal of organs parts shall not, as such, give rise to consensus as to the definition of traf- or tissues with his or her consent financial gain. Any trade in organs ficking in OTC for three reasons. First, but in contravention of legislation and tissues for direct or indirect enforcement of the prohibition of traf- or other controls in operation in the financial gain, as defined by ficking in OTC requires clarity with relevant jurisdiction; Article 21 of this Protocol is prohib- respect to the activity that is being tar- – the transplantation of removed ited. Organ trafficking and tissue geted. Second, consensus about the organs and tissues, whether trans- trafficking are important examples definition is important at a time when ported or not, in contravention of of such illegal trading and of direct many groups and some states are con- legislation or other regulations in financial gain. Organ or tissue traf- sidering amending legislation and operation in the relevant jurisdic- fickers may also use coercion either public policy to permit various forms tion or in contravention of interna- in addition to or as an alternative to of financial incentives and reimburse- tional legal instruments.” offering inducements. Such prac- ment for some forms of organ and What is notable about these defini- tices cause particular concern tissue donation. Third, consensus is tions and explanations is that there is because they exploit vulnerable important since the definitions used a remarkable consensus that traffick- people and may undermine peo- highlight the dimensions of conduct ing in organs and tissues is heinous, ple’s faith in the transplant system. and activities that are regarded as unethical and illicit. Why that is the This is why the prohibition of traf- illicit and it is important to achieve case is not, however, reflected as a ficking in organs and tissues is spe- international agreement on precisely matter of consensus in these various cifically referred to in Article 22.” why particular types of conduct and definitions of trafficking and it is clear practices are unacceptable even The 2008 Declaration of Istanbul that the two problems, organ traffick- though they help to reduce the defines trafficking in OTC as: ing and trafficking in human beings demand for organs and tissue for for the purpose of organ removal, are transplantation. “the recruitment, transport, trans- confused. Despite the fact that there fer, harbouring or receipt of living or The Bellagio Task Force Report on are some international standards that deceased persons or their organs Transplantation, Bodily Integrity, and do address trafficking in OTC, mainly by means of the threat or use of the International Traffic in Organs in the above-mentioned legally force or other forms of coercion, of published in 1997 defines trafficking binding Council of Europe instru- abduction, of fraud, of deception, of in OTC as follows: ments, the lack of an agreed definition the abuse of power or of a position of organ trafficking creates a real “the purchase of organs from living of vulnerability, or of the giving to, problem in terms of identifying differ- persons or the provision of eco- or the receiving by, a third party of ent situations as trafficking in OTC and nomic incentives to the kin of payments or benefits to achieve the qualifying as a criminal offence spe- deceased donors.” 96 transfer of control over the poten- cific situations involving such illicit Article 22 of the Council of Europe tial donor, for the purpose of exploi- trafficking. Additional Protocol to the Convention tation by the removal of organs for There is therefore a need to adopt an on Human Rights and Biomedicine con- transplantation.” internationally agreed definition of cerning Transplantation of Organs and “Trafficking in OTC” set out in a legally Council of Europe Recommendation Tissues of Human Origin prohibits binding international instrument. Rec (2004) 7 of the Committee of Minis- organ and tissue trafficking, with traf- Such a definition should be agreed ters to member states on organ traffick- ficking defined as being in violation of upon at international level with the ing defines trafficking in OTC as Article 21 of the Protocol, which involvement of all the relevant players. follows (Article 2, paragraph 4): states: While underlining that all national “The human body and its parts shall “For the purposes of this recom- systems should be based on the prin- not, as such, give rise to financial mendation the term “organ and ciple of the prohibition of making gain or comparable advantage.” tissue trafficking” applies to: financial gains with the human body

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs IV. CONCLUSIONS AND RECOMMENDATIONS

or its parts, the starting point for such trafficking. It is therefore recom- ing and protect and assist the victims, a definition should be the idea that mended that an international legal as well as the criminal-law measures any organ transaction outside the instrument be prepared, setting out a to punish the crime. national systems for organ transplan- definition of “Trafficking in OTC” and tation should be considered organ the measures to prevent such traffick-

Trafficking in human beings for the purpose of removal of organs: the effectiveness of existing international standards and no need for further international legal instruments

All relevant aspects for preventing and with less strict laws. Unfortunately, areas and lay down the basic rules for combating trafficking in human this involves a much higher risk of combating trafficking in human beings for organ removal are set out in nationals of that state becoming beings for organ removal. The meas- the Council of Europe Anti-Trafficking victims of trafficking in human beings. ures in Council of Europe Convention Convention and in the United Nations But even states which have ratified CETS No. 197 go even further, espe- Trafficking in Persons Protocol. Both these instruments and implemented cially regarding assistance and protec- instruments are comprehensive and their provisions have so far mostly not tion for victims. cover the major issues ranging from paid attention to the aspect of organ The Council of Europe Anti-Trafficking criminalisation to assistance and removal. In the international debate, Convention [CETS No. 197] is a holistic protection – thereby covering the so- this aspect has hardly been men- instrument which does not leave any called three “P”s: prevention, protec- tioned at all and many states do not questions or needs open; its frame- tion and prosecution, which are essen- consider the matter to be of great work is comprehensive and it includes tial for tackling the issue of trafficking importance, as not many cases of this a broad range of obligations for states in human beings effectively. kind are known of in their jurisdiction. to implement. As mentioned through- These instruments provide a very In many states implementation has out this Joint Study, no big issues good basis for states all over the world therefore remained incomplete, as remain open which are not already to implement their provisions. By countries failed to pay special atten- covered by the convention or require signing and ratifying these instru- tion to this aspect of exploitation. the drafting of an additional protocol ments, which – as explained above – When implementing the criminal law or instrument, especially against the set out a broad range of obligations provisions, it is important to make background of the convention’s the- for states on different issues and sure that victims are not punished for matic link with the Convention on require the development of a compre- their involvement in unlawful activi- Human Rights and Bioethics and its hensive system of victim protection ties connected to the crime. Addition- Additional Protocol. The Council of and assistance, states can show their ally, the focus in implementation Europe Anti-Trafficking Convention political will really to want to combat should be on the punishment of those [CETS No. 197] must in any case be the trafficking. As the definition of individuals who exploit other individ- read and implemented in conjunction trafficking in human beings, including uals, their health and bodies, for finan- with the latter, as they include many for the purpose of organ removal, is cial profit, i.e. mainly brokers and provisions which are prerequisites for the same worldwide, setting up such intermediaries, as well as doctors, properly understanding, implement- 97 systems in all countries would estab- health staff and hospitals directly ing and interpreting provisions lish a sound and strong framework to involved in the exploitation network. regarding the purpose of organ prevent perpetrators from carrying On the other hand, states should keep removal (especially regarding con- out offences and enhance interna- in mind the specific situation and vul- sent). Taken together, these instru- tional co-operation, in particular nerability of both the donors and the ments provide not just a basis for regarding prosecution of offenders recipients of organs when drafting tackling trafficking in human beings and victim assistance. legal provisions. They are often in situ- for organ removal, but a very compre- The problem is that not all states have ations where they see no way out but hensive, strong and good one. At signed and ratified the instruments, to participate in the illegal transac- European level, there is clearly there- which leaves loopholes for perpetra- tions. fore no need for an additional legally tors, as they can avoid higher risks and Both the legally binding international binding instrument concerning traf- carry out their “business” in countries instruments tackle all the important ficking in human beings for the

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs IV. CONCLUSIONS AND RECOMMENDATIONS

purpose of organ removal (e.g. addi- included in the Council of Europe really attached to the illegal sale of tional Protocol to Council of Europe Anti-Trafficking Convention [CETS organs (especially the frequent denial Anti-Trafficking Convention [CETS No. 197], as its provisions are more of follow-up-care) and what kind of No. 197]). comprehensive and detailed than illicit means (in particular deception) The Council of Europe Anti-Trafficking those in the United Nations Trafficking are used by the perpetrators. Together Convention [CETS No. 197] also pro- in Persons Protocol and set out even with information about legal organ vides for an independent monitoring more obligations. As the Council of donation methods, this would help mechanism (GRETA) to monitor Europe Anti-Trafficking Convention build trust in national health systems whether its provisions have been [CETS No. 197] is also open to non- and could increase the quantity of properly implemented and issue rec- member states, other states could also organs available legally. ommendations as to what requires decide to join it to show their clear Improved co-operation between special attention and which additional and strong will to combat trafficking states is necessary, in terms both of steps have to be taken by individual in human beings and be bound by mutual legal assistance and providing countries. GRETA should pay special even stronger commitments. victim assistance and also of joining attention during the forthcoming There is no need for further legal regional or international transplant monitoring rounds to the aspect of action on a global or regional level. organisations that provide for equita- trafficking in human beings for organ What is really needed is strong politi- ble allocation of organs among the removal, i.e. making sure that this cal will to sign, ratify and implement states involved. Every means of com- aspect is taken care of and included in the existing international legal instru- bating the shortage of organs and of national legislation as well. This is par- ments. Besides, if states wish to go improving the donor pool is an effec- ticularly important since the relevant further in some areas, they are always tive measure against trafficking in EU Framework Decision on trafficking in free to do so. However, no major issue human beings for organ removal. human beings only covers issues of has been left open in the existing Co-operation with civil society sexual and labour exploitation and international documents that would remains an important issue and explicitly not those of organ removal. involve a need for any further interna- should be improved, in particular as The focus in several EU member states tional legal action. regards medical and psychological may well therefore have been on the Where international action is really follow-up care of victims of trafficking sexual and labour exploitation aspects needed is in the following areas: in human beings for organ removal only, especially since the aspect of Information and media campaigns and as regards prevention. organ removal has hardly been dis- have been part of international and As previously stated, enhanced infor- cussed at all until now. In addition, national activities for a long time, but mation exchange and research is one GRETA will have to monitor not only still remain important. The focus has of the major issues. It is difficult to whether criminal provisions cover this been on particular types of victims obtain an overview of the real situa- aspect but also whether the assistance (women, children) and awareness-rais- tion, the number of cases and victims and protection measures are suited to ing, with the emphasis initially mainly and trends, etc. As data of this kind are the purpose as well. being on sexual exploitation and, necessary for the development of Other states should in any case sign more recently, also on the aspect of strategies and programmes, interna- and implement the United Nations labour exploitation. It is important tional organisations should strive to Trafficking in Persons Protocol, paying also to raise awareness about the gather as much data as possible so as special attention to trafficking in aspect of trafficking in human beings to be able to shed more light on the human beings for organ removal. In for organ removal. In this way, preven- dark area of this crime and to tailor 98 implementing the protocol, they tion could be improved as people new programmes and initiatives to should take account of the provisions were shown what kind of risks are combat it.

Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs

Directorate General of Human Rights and Legal Affairs 100

Council of Europe 95 F-67075 Strasbourg Cedex 75 www.coe.int/trafficking

0 100