LLB 184 17 Dissertation 2020. Kennedy Namaswa.Dissertation final

MOI UNIVERSITY SCHOOL OF LAW RESEARCH TOPIC: ASCERTAINING THE LEGAL FRAMEWORK ON ORGAN DONATION IN KENYA. FLB 411 BY NAMASWA KENNEDY THIS RESEARCH IS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF THE DEGREE OF BACHELORS OF LAWS (LL.B) AT MOI UNIVERSITY, SCHOOL OF LAW. SUPERVISOR: MR M. ODUOR FEBRUARY 2021 DECLARATION. I, NAMASWA KENNEDY, solemnly declare that this work is original, both in substance and form, and that it has never, to the best of my knowledge, been presented to any University or Institution of Higher learning. This work is hereby presented to Moi University on: NAMASWA KENNEDY ............................................. .............................. SIGNATURE DATE MR M. ODUOR .............................................. .............................. (SUPERVISOR) SIGNATURE DATE To be presented to ii DEDICATION. I dedicate this work to my family members who instilled great inspiration to me during the course. To my Mum Rukiah K. Namaswa for the prayers, support and the constant encouragement she instilled in me all through the process of making this research paper a success. A special dedication to my Dad who would have been prouder for this great achievement, may his soul continue resting in peace. iii ACKNOWLEDGEMENT I am grateful to the Almighty God for the good health, wellbeing and intellectual power which were crucial for this research. To Mum, I offer my sincere gratitude to you for your moral, financial and material support that you have graced upon my education. Indeed, you have been a source of inspiration to my life. I also acknowledge my brothers and sister: Michael S. Namaswa, Philip W. Namaswa Dickson W. Namaswa and Rehema Nalwende who greatly encouraged me to employ the best possible efforts in this research. To my ever supportive relatives, to you I am indebted! I wish to convey my sincere thanks to my supervisor, MR. MAURICE ODUOR, for the great support, for his motivation, patience, insightful comments, and expertise. His guidance assisted me greatly during the dissertation. To Moi university teaching, non-teaching staff and the Class of 2020, thank you for being resourceful and enabling me to complete this journey. A special mention to Hosea Kibett who was ever at the forefront championing for rights and entitlements, we are grateful Kiongozi. To my best friends, Jacque Jonas, Milcah Kambua, Pauline Hamisi, Malei Lekutukai, Vincent Mutua, Alvin Keverenge, Arthur Tonje, Amos Juma, Daniel Kutai, Calvin Silas, Burtram Mwaringa, Brian Ong’ala, and Oloo Bill you have shown me in the last four years that friends are precious and the best gift that one can ever have. May all our dreams and goals become a reality in the coming future. To Annex Campus Christian Union, I am eternally grateful for the chance you gave me to serve at the Assets committee and as a devoted technician. To the great team: David O, Sandra N, Charity O, Jacky M, Godwin K and June M, thank you for I found a family in you and for always being resourceful. To my spiritual father Bishop Hassar Omega and Pastor Tumusime David, I am iv grateful for your continued prayers and words of encouragement. May our good Lord bless you abundantly. v LIST OF ABBREVIATIONS. CLD’s Commercial Living Donors DBD Donation after Brain Death. DCD Donation after Cardiac Death. ICU Intensive Care Unit. KNH Kenyatta National Hospital. ODR Organ Donation Register. OPO’s Organ Procurement Organisations. UNOS United Network for Organ Sharing WHO World Health Organisation. LIST OF STATUTES. The Constitution of Kenya 2010. Human Tissue Act, cap 252 Laws of Kenya. Health Act, No 21 of 2017 Uniform Anatomical Gift Act, U.S.A. Transplantation of Human Organ Act, India. World Health Guiding Principles on Human Cell, Tissue and organ transplantation. vi LIST OF CASES. Airedale NHS Trust v Bland[1993] AC 789. A.N.N v Attorney General[2013] eKLR, Petition No 240 of 2012. S v Walters Ex parte Minister of Safety and Security [2002] (4) SA 613 Rogers v Whitaker (1992) 175 CLR 479. Secretary, Department of Health and Community Services v JWB and SMB(1992) 175 CLR 218 (Marion’s case). WK v Public Guardian (No 2) [2006] NSWADT 121. vii CHAPTER ONE. 1. Introduction. The medical transplantation of human body organs remains the only worthwhile therapy for patients who are antagonized with the veracity of passing away due to the failure of their vivacious body organs such as the heart, lungs, kidneys, pancreas, and liver. Organ donation and transplant has indeed rapidly evolved areas in medical science bettering survival and quality of life. However, the expectation of improving and lengthening lives on earth has been devastated by the constant scarcity and scantiness of suitable organ donors. The scarcity of human organs is an issue of great concern in public health, both locally and internationally and the current viewpoint is unwelcoming. In Kenya Organ shortage, poor legislations and policies as well as financial and capacity issues have presented a major challenge in the field of organ donation prompting the need for adequate legal and ethical framework. Indeed for organ donation to take root, and flourish, it is important that we have a clear legal and ethical framework to govern it. This study seeks to critically evaluate the social and philosophical arguments on organ donation highlighting the legal framework therein. In a quest to explore the place of organ donation, this study will rely heavily on desktop searches backed by a consultation of both primary and secondary sources of the information related to the study. The study was based on the theory of prototype willingness model and the world system theory. From the study, it is established that Kenya lacks an elaborate regulatory mechanism on matters organ donation. A lack of awareness or educational, religious, and cultural backgrounds and myths regarding organ donation, equally, have negatively impacted organ donation in Kenya. This study recommends further research into organ donation, and the development of a social work model to increase the awareness rate of organ donation. It calls for the re-evaluation of legislation that regulates organ donation in Kenya. 1 1.1 Background to the Study The restorative use of human organs involves the replacement of a non-functional organ for a functioning organ emanating from a donor. This is a practice that has been in existence universally for over the past 50 years.1 Organ transplantation has brought immense benefits to hundreds of thousands of patients and success rates in organ transplants have improved in recent years, with an improve in technological advances.2 It is now the only available treatment for end-stage failure of organs such as the liver, lung and heart and the most cost-effective treatment for end-stage renal failure. The outstanding results of transplants, in terms of life years increased and improvement in excellence of life, have increased the number of indications for which organ transplantation is considered a suitable remedy. Snowballing steadily during the past decades, transplant procedures continue to develop and in the future may offer practical treatment for other unmet medical needs. However, there are major challenges for the use of organs in therapy in Kenya. The 2017 Health Act3, which builds on the Human Tissue Act of 1966, reviewed in 2012, is the current legislation governing organ donation in Kenya. Despite the new law governing organ donations in Kenya being enacted on July 2017, failure by the Cabinet secretary for Health to gazette rules for the approval of organ transplant facilities has left public hospitals long-drawn-out as no new facilities can be “duly authorized” without the rules in place. The horrendous situation is then compounded by the unreasonable cost of medical care, difficulty in getting suitable donors, and lack of capacity in the available medical institutions. Further, hundreds of organ transplant patients are dying in the queues as lack of capacity and proper laws continue to send many to the grave.4 The shortage of organs and the life and death consequences associated with getting an organ create the circumstances that give rise to a black market. The problems involved with a black market include abuse and exploitation of poor donors, quality issues, and the perpetuation of a system 1 Linden PK. History of solid organ transplantation and organ donation. Crit Care Clin. 2009 Jan; 25(1):165-84. The Transplantation Society of Latin America and the Caribbean.Latin American Transplantation.Report 2009.DuroGarcia V, Santiago-Delpin EA, Pestana JOM, editors. San Juan: The Latin American and Caribbean Transplant Society; 2010. 3 HealthActNo.21of2017. 4 For instance, the kidney transplant waiting list at Kenyatta National Hospital, by March 2018, had stretched to 2,019, despite the hospital performing the procedure on a weekly basis. Elizabeth Merab, “organ transplant patients suffer even with Law in place” Daily Nation, March 24, 2018. 2 2 where the wealthy receive a disproportionate share of available organs, both by utilizing the black market and devoting more resources to finding a donated organ. Black markets have a larger presence in marginal and semi-marginal countries, where there is a ready supply of individuals who are satisfactorily desperate for money that they are prepared to risk their health by selling organs.5 It is clear that human organs have pecuniary value and at present the vital organs can fetch relative towering prices. 6 Given the shortage and the demand for organs, organ trafficking has to be expected. The present legal situation in Kenya is that the law stipulates that anyone “who charges a fee for a human organ commits an offence and is liable on conviction to a fine not exceeding Sh10 million or to imprisonment for a period not exceeding 10years or to both a fine and imprisonment”. In India, buying or selling an organ is in contravention of the Transplantation of Human Organs and Tissues Act, a central legislation that governs organ transplants in the country. Black markets are thriving 7 to the disadvantage of the person giving up his/her organ, as the middlemen seem to be the parties benefiting the most financially. These illegal practices will not end, but will continue to thrive until it is replaced with a viable alternative; a clear legal and ethical framework. Technology has made it easier to look for organs within and across borders and therefore black markets are not linked only to specific countries.8 A few suggestions for fighting illegal organ sales in South Africa were proposed; the first possibility is to change the system of organ procurement to that of “opting-out” another solution may be tighter applicable legislation for example, to make organ trafficking a specific crime or to make acts like the Prevention of Organized Crime Act directly applicable to illegal organ sales. Religious practices and institutions also play a part in the donation process. Religious appreciation can be crucial to those potential donors who rely on their religion to tell them that donations are 5 Goodwin 2006 Swaleh Mdoe was willing to sell his kidney for Sh2.5 million which attracted various interested parties, his offer opened debate on whether it was legal to sell an organ on the open market. Elizabeth Merab, “organ transplant patients suffer even with Law in place” Daily Nation, March 24, 2018. 7 C Watson, “The organised crime of organ trafficking” (2006, University of the Free State) 8 Leviticus Awino, a 25-year-old man was willing to sell his kidney for Sh2m. On Facebook, he invited interested bidders to contact him with an offer.similarly, Vanslow, a 24 year old, waneds to sell his kidney citing financial problems. David Odongo, “Chilling Details of The Kidney Trade in Nairobi” Standard Media, 2016. 6 3 allowed and morally appropriate. The fact that there would altogether be serious religious hostile response to the marketization of organs must be included in the computation of whether such a market should be permitted. Such a change in the way organs are procured would reflect a fundamental change in the morality of the act in the eyes of many religious authorities. For many cultures, the body is regarded as a sacred entity and donating an organ honours this sacralisation of bodily resources, whereas the sale of organs is regarded by most cultures to be taboo. And so one argument for maintaining the status quo is that, out of the range of policies that could be implemented, a ban on organ selling and a procurement be put in place making donations only as the most acceptable and therefore the most viable policy In Israel as in Iran, there is a system where donors receive a fixed amount of compensation from the government. There is also a government-sponsored education budget to inform the public about organ donation9. Even if organ sales were legalized, it is not clear what effect this would actually have on the shortage of organs for transplant. Predictions of price and market behaviour are highly uncertain. If sales of kidneys were permitted, would the supply of kidneys catch up with the demand? What would happen to kidney prices? Unregulated, it is difficult to imagine that prices would be affordable to all those in need.10 Contemporary sociologists have been quick to suggest that the supply-side shortage may be cured by legalizing sales; the truth of such claims rests on whether the supply would increase enough to provide an organ for everyone in need. Demand can only increase inasmuch as there are people in need of organs, while the numbers who can give organs is practically limitless. On May 13, 1989, the World Health Assembly endorsed a series of guiding principles on organ transplantation, which intended to provide an orderly, ethical and acceptable framework for regulating the acquisition and transplantation of human organs for therapeutic purposes 11. They The public’s unwillingness to donate organs in Israel and other countries is related to the fear that doctors will declare a patient’s death prematurely in order to collect organs and even profit from them. For that reason polls in Israel show that less than 50 percent of the population is willing to donate. Money spent on public education has the potential to increase that number. 10 Corwin 2011 11 The organ market boom in Russia [in Thai]. Manager Daily News 2000, Oct 23; Sect. 1-2. 9 4 also unanimously resolved to condemn trading and commerce in human organs, and called on all members and governments to enact the law or regulation to make such practices illegal12. Putting a law in place would hence provide hope for patients and doctors, as it will spell different sources and individuals circumstances in which organ donation can be made and ensures availability of tissues for learning. Regulatory pressures could, as is the case in Iran, create a more equitable distribution of organs which does not depend on the ability to pay a premium. Where the policy is the best fit for the greatest number of individuals, the laws should follow. Governments should: establish legal frameworks that support and regulate the development of the medicine and science of donation and transplantation, and ensure quality, transparency, and equity of processes; support donation and transplantation in the health care agenda, allocating adequate financial resources for the development of the required infrastructure, organizational systems, technical expertise, and data registries for ongoing evaluation of programmes, and promote a culture of donation by engaging with the general public and health professionals to increase awareness and understanding, and to overcome misconceptions and cultural and religious barriers.13 The only way to increase the supply of donor organs is to increase the number of people willing to be an organ donor. Steps that can be taken to increase the number of organ donors are: educating the public as to their the role in the organ transplant ecosystem; promoting awareness of organ donation in the population; increasing donor drives to add people to state donor registries; and supporting legal and community advocacy. 1.2 Statement of the Problem Donation of organs and tissues make accessible a relatively scarce resource that has the potential to improve the health and life of recipients. Following this scarcity, the need for more organs for transplantation is pressing and countries are coming up with systems; opt-in and opt-out in which they can adopt to encourage the donation of organs and tissues. These systems provide for both the living and the deceased donors. 12 The organ market boom in Russia [in Thai].Manager Daily News 2000, Oct 23; Sect. 1- 2. Emile Zola Berman, “The Legal Problems of Organ Transplantation” 13 Vill. L. Rev. 751 (1968). 13 5 In Kenya, by virtue of section 81 (1) of the Health Act 2017, the adopted system of organ donation is opt-in. A competent person “opts-in”, that is, through a will or an oral expression in the presence of at least two competent witnesses, a person opts to be a donor upon their death. This is more like registering one's consent to become a donor in a centralized computer register, only that here, it is in a will. Maybe this is one of the reasons we are getting it wrong, maybe we should have this register in place and shift from expressing donation wishes in wills. Further, the Act provides that in absence of an expression to donate organs after death, the spouse or spouses, elder child, parent, guardian, eldest brother or sister of that person, following that specific order, may, after that person's death, donate the body or any specific tissue of that person. For decades, since independence, Kenya has not had full-bodied organ donation and transplant laws as well as regulations which has made it difficult for doctors to offer transplant treatment options to patients. The signing into law of the Health Act of 2017 by President Kenyatta ushered a new era where willing donors would be able to donate organs. The greatest challenge is getting a donor which has given rise to the unmet in the field of organ donation in Kenya. Currently, there are no regulations in place to guide conduct and the manner in which organs can be donated. Despite the development nature espoused under the health Act, a more solid law governing organ donation ought to be formulated. It is vital to note that, just as it is important to shift our system of donation, it is of equal importance to have a comprehensive procurement system and a robust, transparent organizational infrastructure to oversee a successful process, one that Kenyans will have faith and trust in. The Health Act 2017 provides a basic framework, hence the need to develop a detailed regulatory framework. 1.3 Objectives of the Study. The objectives of this research are; 1. To critically evaluate the social and philosophical arguments on organ donation. 2. To significantly appraise the aspects of law relevant to organ donation. 3. To perilously assess the legal framework on organ donation in Kenya. 4. To make a comparison between Kenya and other jurisdictions on the legal framework on organ donation. 5. To look into the possible solutions for the legal framework of organ donation in Kenya. 6 1.4 Research Questions Towards addressing the research problem, this study seeks to answer the following main research question: What are the social and philosophical arguments on Organ Donation? What are the laws relevant to organ donation? Does Kenya have a legal framework on organ donation? What have other jurisdictions considered in relation to putting in place a regulatory framework on organ donation? What are the possible solutions for the regulatory framework of organ donation in Kenya? 1.5 Justification of the study This study is justified on the ground that despite having in place a robust Constitution and a basic legislative framework on organ donation, there are still a gap that introduces a disconnect in the field of organ donation in Kenya; characterized by lack of a detailed framework. For decades, since independence, Kenya has not had robust organ donation and transplant laws as well as regulations. Further, this paper is also justified on the ground universally, there is an increasing demand for organ transplants, and this global shortage of transplants makes organ trafficking a lucrative business that many Kenyans are under a risk of facing illegal organ harvesting for gains. 1.6 Research methodology This research will rely heavily on non-empirical research methodology. As such, it will depend on desktop research. It will be based on consultation of both primary as well as secondary sources of data of the information related to this investigation. Under primary sources the literature was selected using the criteria of empirical studies published in indexed journals, whose aim was to study the views on organ donation and papers published on the same. 1.7 Literature review A lot of ink has literally been poured to express scholarly thoughts on the concept of organ donation on the one hand and on what amounts to adequate legal and ethical framework on the other. The focus of these studies has been on the need to put in place a more comprehensive legal and ethical framework to curb the unmet in the field of organ donation in Kenya. This section 7 reviews some of the existing scholarly imprints for their contributions and identifies the missing links in them which necessitate this current work. In order to curb organ selling and procurement, donation is the most acceptable and therefore the most viable policy. Relying on altruistic motives is indeed compelling. The gift-relationship14 can be summed up as both an unambiguous justification by which donation-making decisions are made and the supply and demand side explanations that lead to these decisions. Richard Titmuss,15writes on the role of altruism for meeting the demand for blood in the United States and Great Britain. The right to give implies that a choice must be made on behalf of the recipient. The present system everywhere except in Iran and a few other countries encourages altruism, seeing it as a principal and acceptable motivation and incentive. For family members, it is undoubtedly the case that donations are motivated by the fear of losing their loved ones, though the same motivation does not apply to donations for strangers. But even between strangers, trading organs for money is unsettling because it implies that a price can be placed on a human good. Additionally, the marketization of organs and blood could have the undesired effect of crowding out the supply of former donors now paid suppliers, because the act of donating an organ would become less morally significant.16 Kieran Healey17offers a brilliant account of the role played by various institutions and actors who are involved in organ procurement and in shaping the gift narrative. He notes that procurement organizations presently promote altruism and the donation of organs, and agrees with some experts that monetizing the organ market would produce a risky environment on the supply side, worsening conditions that are already bad. Put another way, the concern, following Titmuss’ logic, is that monetization destroys altruistic motives and thus decreases supply. If an organ sales market was adopted, Healey argues that the key to its success is fairness of the exchange, such that the poor are not exploited and the many that need organs are able to afford and receive them. Alexandra K. Glazier, ‘The principles of gift law and the regulation of organ donation.’ The Gift Relationship (1971) 16 Titmuss explains, as evidence of the crowding out effect, that the amount of blood donated and the number of people who donated increased in the United Kingdom, where the sale of blood was prohibited, while these numbers declined in the United States, where the sale of blood was allowed. And so we observe, the sale of blood wears away the incentive to give (Titmuss 1971). 17 Last Best Gifts (2006) 14 15 8 1.8 Theoretical framework Various theories have sought to expound on the concept of organ donation; ranging from organ trafficking, consent and altruism as concepts of organ donation. These are as discussed below. 1.8.1 World-systems theory. Under the World-systems theory there is need for a transformative policy to intervene and promote an ethos of fairness and solidarity that transcends national interest. 18 If organ supplies can be increased legally, it follows that fewer people would resort to the black market. In the case of a sales market the general concern is that peripheral countries will be crowded out of the market by wealthier core countries, simply because these actors have more money. What is to stop someone living in poverty in Kenya from selling an organ to the highest bidder in the United States? How will people in Kenya in need of organs compete with wealthier transplant recipients from other countries? Governments would need to cooperate to create a market with enough regulation that it provides fair and adequate compensation to organ suppliers while distributing organs to everyone in need, not just to the well to do. 1.8.2 Prototype willingness model theory. One cognitive theory based on decision making is the prototype willingness model (PWM). The theory states that one’s intentions are influenced by attitude. If one has a positive attitude toward something, they will be more likely to act. 19 The theory speaks to normative belief or subject norms. The premise of this model is that decision making is impulsive and hasty, without pondering long-term outcomes. One is merely looking at the situation or the factors involved at that moment.20 In these situations, there is an element of risk taking that may be attractive to some. Because perception of the direct situation in this case, the decision to become an organ donor has to always be taken into consideration, many people often have an immediate reaction to a situation. Interpretation of the situation may vary from person to person. Basically, the choice is a yes or a no response. The factors of this model include willingness to participate based on attitude, subjective norm perceived pressure from others to do the right thing, past behavior, and the person 18 Barnett, Beard, Kaserman 2002 Hyde & White, 2010. 20 Gibbons, Gerrard, Blanton, & Russell, 1998. 19 9 or the prototype of the behavior the model or the image of the person that performs the behavior; i.e., organ donor. Although the PWM has been used with a variety of health-related behaviors and issues,21 it has not been utilized with altruistic behaviors, specifically organ donation. It is important to remember that the decision to grant consent does not necessarily or always result in the actual behavior of donation, and unless one is consenting to be a living donor, the decision ultimately lies with the parent. According to Simmons, Marine, and Simmons (1987), the decision-making process for living related donors has three criteria. First, is moral decision making, which represents spontaneous or unplanned choice making. Second, is deliberation, which is a conscious or mindful choice. Third, is postponement, where the potential donor delays making a decision and only becomes a donor based on everyone else being ruled out for various reasons. In this situation, the donor takes the position of not having to make a decision until there are no other options or possible donors; however, this still indicates a decision. Janis and Mann (1977) agree that there is a clear process through which one goes when considering becoming a living donor. The process of decision making for next-of-kin, which happens when their loved one is pronounced brain dead, is a completely different situation and one filled with high emotions. Timing of the request and the person making the request may be taken into consideration in these cases.22 Because of this, it is important that family members are aware of their loved one’s wishes. In some cases, the decision-making process may be simplified for next-of-kin by simply knowing what those wishes are. 1.9 Chapter Breakdown. This research will be completed in five distinct chapters: 1.9.1 Chapter one: Introduction This is basically the introductory chapter. It entails background to the study, problem statement, objectives of the study, research questions, hypothesis, justification of the study, literature review and chapter breakdown. 21 22 Rivis, Sheeran, &Armitage, 2006. West & Burr, 2002. 10 1.9.2 Chapter Two: The concept of organ donation. This chapter is an analysis of the concept of Organ donation. Basically, the definition of organ donation, the forms of organ donation and the fundamentals enshrined under the World Health Organization guiding principles on human organ transplant and donation. 1.9.3 Chapter Three: The State of Organ donation in Kenya. In this chapter, the author undertakes to discuss the current status of organ donation in Kenya with a view of identifying possible gaps and problems that faces organ donation in Kenya. The analysis will show the practicability of the approach in ascertaining the legal framework for organ donation in Kenya. 1.9.4 Chapter Four: Comparative Analysis Under this chapter, the author undertakes a comparative study of organ donation in other democracies like USA and India with a view of adopting the best practices. An analysis of the state and extent of organ donation legislations in the comparative study countries will be highlighted and whether they address the problems brought about by lack of adequate regulatory framework as highlighted in Kenya. It will encompass a brief history of development of organ donation and transplant in the comparative study countries, the relevant legal framework and the current realties emanating from the history and legal framework and the practicability of the proposed approach to organ donation. 1.9.5 Chapter Five: Conclusion and Recommendations This chapter entails a conclusion, summary of the finding of the study and the proposed recommendations in order to ensure a suitable organ donation system in Kenya. 11 CHAPTER TWO 2. CONCEPT OF ORGAN DONATION. 2.1 Introduction. Organ donation is defined as the endowment of a biological tissue 23 or an organ24 of the human body, from a living or dead person to a living recipient in need of a transplantation. It is a flourishing technique for replacing a damaged organ from a fit and hale and hearty organ. 25 The history of organ donation dates back to the 18th century which was highlighted by researchers experimenting on various organ transplantation projects.26 Organ donation and transplant has been a fascinating topic and its success today is derivative of a long history of trials, failures, and eventually success hundreds of years ago.27 On December 23rd, 1954, two indistinguishable twin brothers; Richard and Ronald Herrick became a momentous part of surgical history.28 Richard was dying of unremitting nephritis prompting his brother to agree to donate a kidney. This transplant, which lasted for five and a half hours, reserved Richard animate for eight more years and ultimately resulted to thousands of liver transplants and 23 Articles containing or consisting of human cells and/or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Examples include, but are not limited to, musculoskeletal tissue (bone, cartilage, and meniscus), skin, soft tissue (tendons, ligaments, nerves, dura mater, fascia lata, and amniotic membrane), cardiovascular tissue (heart valves, arteries, and veins), ocular tissue (corneas and sclera), bone marrow and hematopoietic stem/progenitor cells derived from peripheral and cord blood and stem cells of any tissue, and reproductive cells/tissues. Oberley E. Public education in organ and tissue donation: Review and recommendations. Madison, WI, Medical Media Publishing 1992. 24 Differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularization, and capacity to develop physiological functions with an important level of autonomy. Ganikos ML, McNeil C, Braslow JB, et al. A case study in planning for public health education: The organ and tissue donation experience. Public Health Rep 1994; 109: 626. 25 Ota K, Current status of organ transplants in Asian countries. Transplantation proceedings 2004;36(9):2535-8. 26 Human organ transplantation began with a series of experimental studies at the beginning of this century. Notably, Alexis Carrel was awarded the Nobel Prize in 1912 for his pioneering work. WHO guiding principles on human cell, tissue and organ transplantation preamble, 2010. 27 Jeana Lyn Shelley, ‘History of organ transplantation’, OMS ii,Des Moines University. December 2, 2010. Available at https://www.dmu.edu/wp-content/uploads/Shelley-History-of-Organ-Transplantation.pdf 28 Merrill JP, Murray JE, Harrison JH, Guild WR. 1956. Successful homotransplantation of the human kidney between identical twins. Journal of the American Medical Association 160(4):277–282. 12 eventual transplants of other organs.29 Dr. Joseph Murray, the lead surgeon, discovered that the twins were identical consequently ideal candidates for the surgery because the procedure lacked immune problems.30 Immunosuppressive medications began to be used in the late 1950s, leading to the first successful transplantation of a kidney from a deceased donor in 1962. 31 This transplantation involved an unrelated donor and recipient and the use of the immunosuppressive drug azathioprine.32 Cyclosporine, which was discovered in 1978, provided significantly improved immunologic tolerance; and numerous subsequent pharmacologic, surgical, and clinical advances have continued to improve the rates of graft survival and reduce the potential for organ rejection. The first successful liver transplant was performed in 1967 with a liver from a deceased donor. Living-donor liver transplantation, which involves the removal of a lobe or partial lobe of the liver, was developed for paediatric recipients and was first performed in 1989.33 The first successful lung transplant was performed in 1963 followed by Human heart transplantation which was successfully accomplished for the first time in Cape Town, South Africa, in 1967.34 In the 18th century, Karl Thiersch, a German surgeon, realized skin grafts did not require subcutaneous tissue and succeeded to prove that transplantation from animal to human was not probable devoid of transplant rejection due to incompatibility flanked by the tissues. Thiersch introduced epidermal skin grafting called the "Thiersch graft." This grafting technique constituted the use of using only the epidermis and a portion of the dermis35 in that the epithelium is split into lean strips and then entrenched onto granulating tissue. This marked an immense advancement in skin donation and transplantation. Similarly in the 18th-century blood transplantation was gaining 29 Morrissey PE, Madras PN, Monaco AP. 2001. History of kidney and pancreas transplantation. In: Norman DJ, Turka LA, eds. Primer on Transplantation, 2nd ed. 30 Jeana Lyn Shelley, ‘History of organ transplantation’, OMS ii,Des Moines University. December 2, 2010. Available at https://www.dmu.edu/wp-content/uploads/Shelley-History-of-Organ-Transplantation.pdf 31 Halloran PF, Gourishankar S. 2001. Historical overview of pharmacology and immunosuppression. In: Norman DJ, Turka LA, eds. Primer on Transplantation, 2nd ed. Mt. Laurel, NJ: American Society of Transplantation. Pp. 73–75. 32 Morrissey PE, Madras PN, Monaco AP. 2001. History of kidney and pancreas transplantation. In: Norman DJ, Turka LA, eds. Primer on Transplantation, 2nd ed. 33 Curran C. 2005. Adult-to-adult living donor liver transplantation: History, current practice, and implications for the future. Progress in Transplantation 15(1):36–42. 34 OPTN (Organ Procurement and Transplantation Network). 2006. National Data Reports. [Online]. Available: http://www.optn.org/latestData/step2.asp? 35 Kilner, T.P.’ The Thiersch Graft. Its preparation and uses.’ Postgraduate Medical Journal 10.103(1934): 176-81. 13 significance. 36 James Blundell, an English gynaecologist, was the first doctor who created a machine specifically for blood transplantation. He found success in a few patients who experienced excessive haemorrhaging. Although the instantaneous accomplishment gained to a great extent sanguinity, post-transfusion reactions proved a vast feat to triumph over. In 1900, Paul Ehrlich discovered erythrocytes in blood transfusions that could potentially create haemolytic antibodies. Karl Landsteiner supplemented more explanation to Ehrlich's breakthrough when he described these antibodies as anti E and anti B and found that they would bind on the erythrocytes of implant recipients.37 In the 20th century, Alexis Carrel experimented primarily with dogs and found a way to successfully anastomose blood vessels. His unearthing, however, did not circumvent the negative response of grafts and transfusions caused by antibodies. Total body irradiation was established to restrain the immune system enough to sustain the transplantation, however, the irradiation also produced profound bone marrow aplasia, which resulted in patient's deaths due to infections. In the 1960s, it was established that total body irradiation was not the best solution for maintaining the transplant.38The limited success then enthused the curiosity in many surgeons to begin experimenting with transplantation of other body organs. Surgical transplantation of human organs from deceased, as well as living, donors to sick and dying patients began after the Second World War.39 Over the past 30 years, organ donation and transplantation has been converted into a worldwide practice and has saved many thousands of lives. It has furthermore improved the quality of life of countless other persons. 40 Unremitting improvements in medical technology, predominantly concerning tissue "rejection", have brought about development of the practice and an augment in the demand for organs.41 An attribute of organ donation and transplantation since its commencement has been the deficiency of obtainable organs. Supply has certainly not contented demand, and this has led to incessant development in Karamehic, Jasenko, Izet Masic, and Armin Skrbo.”Transplantation of Organs: one of the greatest achievements in history of medicine.” From the History of Medicine 6th ser. 62.5(2008): 307-10. 37 Jeana Lyn Shelley, ‘History of organ transplantation’, OMS ii,Des Moines University. December 2, 2010. Available at https://www.dmu.edu/wp-content/uploads/Shelley-History-of-Organ-Transplantation.pdf 38 Ibid. 39 Kaserman, David. “Fifty years of Organ Transplants: the success and failures.”issues in lae and medicine 23.1(2007): 45-69. 40 Ibid. 41 Ibid. 36 14 various countries of procedures and systems to augment supply. It thus can be logically argued that shortage has led to the increase of commercial traffic in human organs, predominantly from living donors who are disparate to the recipients. There is lucid substantiation of such traffic in recent years, and reservations have arisen of the possibility of related traffic in human beings. World Health Assembly resolutions WHA40.13 and WHA42.5 are an expression of international concern over these developments. There are various types of organ donation;42 Auto graft: Transplanting a person’s tissues from one site and use it in another site of his body is called auto graft. For example, removal of skin from the legs and using it for damaged skin face or other exposed part, Allograft: Transplant of an organ between two genetically non identical individuals, it is called allograft. Due to the genetic difference, the donor’s organ will be treated as foreign by the recipient and will try to destroy it. This is called s rejection, Isograft: Transplant of organ/tissue from a donor to genetically identical recipient is called isograft. There will not be any immune response hence no transplant rejection, Xenograft: Transplantation of organ/tissues forms one species to another species. For example, the heart valve of pig is transplanted successfully to human,43 Split transplant: An organ like liver retrieved from the deceased donor can be divided between two recipients, usually an adult and a child, Domino transplant: When the lungs are to be transplanted, surgically it is easier to replace them along with the heart. If the recipient’s original heart is healthy, it can be transplanted into another recipient in the need of one, ABO incompatible transplantation: The immune system of young children aged below 12 months might have developed fully. They can receive organs from incompatible donors. 2.2 W.H.O and Organ Donation. Clear legislative and regulatory frameworks are the essential system requirement to ensure ethical and transparent practices in organ procurement, retrieval, allocation, and transplantation. The specific requirements do entail the legislation and regulation aspects: Kanmani Job and Anooja Antony, ‘Organ Donation and Transplantation: “Life after Death” (2018),intechopen. available at http://dx.doi.org/10.5772/intechopen.76962. 43 Veatch RM, Transplantation ethics, 2000 chapter 17 259-273. 42 15 Under legislation, a lucid definition of brain death and circulatory death is essential to facilitate donation from deceased persons, together with legislation governing the procurement and transparent allocation of organs and the establishment of Organ Procurement Organisations. Legislation should also envelop the anticipation of organ trafficking and commercialism and formal measures for consenting donors. Critical areas for legislation are Declaration of death; deceased and living Organ procurement; Fair and transparent allocation principles; Consent; Establishment of transparent organizations; Prohibition of organ trafficking and commercialism. As for Regulation and oversight, regulatory bodies are central to the monitoring practices, standards, and outcomes of organ donation and transplantation programs and, therefore, must be informed by an all-inclusive surveillance and data collection. Regulatory oversight should steer ethical standards, advance policy, and quality management. Essential areas for regulation and oversight include: Organ procurement procedures; Development of new policies and introduction of new procedures; Reimbursement policies; Eligibility of living donors and consent processes; Quality assurance systems (control/audit and professional education and training); Allocation rules.` The WHO was established by constitution on 7 April 1948,44 which is commemorated as World Health Day.45 The WHO's broad mandate includes advocating for universal healthcare, monitoring public health risks, coordinating responses to health emergencies, and promoting human health and well being. It provides technical assistance to countries, sets international health standards and guidelines, and collects data on global health issues through the World Health Survey The World Health Organisation has provided for Guiding Principles 46 which are intended to provide an orderly, ethical, and acceptable framework for regulating the acquisition and transplantation of human organs for therapeutic purposes. The term "human organ" is understood to include organs and tissues but does not relate to human reproduction, and accordingly does not extend to reproductive tissues, namely ova, sperm, ovaries, testicles or embryos, nor is it intended to deal with blood or blood constituents for transfusion purposes. The Guiding Principles prohibit 44 WHO, constitution of establishment on 7th April 1948, available at <https://www.who.int/governance/eb/who_constitution_en.pdf > 45 WHO, History,< https://www.who.int.> Retrieved 18 March 2020. 46 WHO, guiding principles on human cell, tissue and organ transplantation, As endorsed by the sixty-third World Health Assembly in May 2010, in Resolution WHA63.22 16 giving and receiving money, as well as any other commercial dealing in this field, but do not affect payment of expenditures incurred in organ recovery, preservation, and supply. Of particular concern to WHO is the protection of minors and other vulnerable persons from coercion and improper inducement to donate organs. In resolution WHA40.1347, adopted in May 1987, the Fortieth World Health Assembly requested the Director-General "to study, in collaboration with other organizations concerned, the possibility of developing appropriate guiding principles for human organ transplants". The response to this request was initiated in June 1989 following the adoption by the Forty-second World Health Assembly.48 To take due account of the diversity in systems of health care and law, and of their social, cultural, religious and medical circumstances, the Director-General initiated a process of consultation involving a broad range of organizations and individual experts. The principal initiatives were the establishment of an informal working group at WHO headquarters (with representatives from all relevant WHO programs, as well as the Secretary-General of CIOMS) and the convening of an informal consultation on organ transplantation in Geneva (2-4 May 1990), with international experts in organ transplantation, medical ethics, health policy, and law, and representatives of intergovernmental and non-governmental organizations. The consultation expressed the view that it was "indeed feasible to develop the Guiding Principles that had been called for in resolution WHA40.1349 and reviewed an initial draft of a set of Guiding Principles. Based on the outcome of the consultation as outlined in its report, the initial draft was amended and widely distributed for comment to all participants and other experts on medical, legal, ethical, cultural, religious, and health policy aspects of organ transplantation. It was also sent for comment to all the WHO regional offices. A second informal consultation, with smaller membership, was convened in Geneva on 3 and 4 October 1990, 4 to review the second draft of the Guiding Principles in the light of the comments and suggestions received, and to prepare a third draft from which the final draft is derived. 47 WHO, Draft guiding principles on human organ transplantation" 2019, <https://www.who.int/ > WHO, Guiding principle on preventing the purchase and sale of human organs, resolution WHA42.5, May 1989. 49 WHO Guiding Principles; WHA 40.13/1990. Available at: http://www.who.int/transplantation/en/. 48 17 The draft Guiding Principles are presented as a considered response to the 1987 and 1989 Health Assembly resolutions and as a link in a process that may lead to consideration by the Forty-fourth World Health Assembly of the adoption of Guiding Principles on Human Organ Transplantation, for recommendation to the Member States under Article 23 of the Constitution. The legislation is necessary to ensure that clear definitions of brain death and circulatory death exist to allow the procurement of organs from deceased donors. It is also required to define protocols concerning consent, including presumed consent, and the fair and transparent allocation of organs. Finally, legislation must govern transplantation practice per the WHO Guiding Principles. In particular, this means promoting the altruistic character of organ donation and prohibiting organ trafficking and commercialism. 2.3 Forms of Donation. 2.3.1 Living donation. Living donation takes place when organs are harvested from a living person, and mainly involves the kidney or a part of the liver.50 It is a less common partly because fewer organs are available for harvesting without causing the death of a donor and partly because there is no gain, other than emotional gain, involved for the donor in purely altruistic systems. A living donor is defined as a living human being from whom cells, tissues, or organs have been removed for transplantation. A living donor has one of three possible relationships with the recipient: Related; genetically related, First-degree genetic relative: parent, sibling, and offspring, second-degree genetic relative: grandparent, grandchild, aunt, uncle, niece, nephew, other than first- or second-degree relative; for example cousin; emotionally related: spouse (if not genetically related), in-laws, adopted, friend. And finally, unrelated: not genetically or emotionally related Despite the frequent use of materials donated from deceased donors, the donations from living donors are necessary for some types of transplants or to compensate for the limited supply of 50 While most organ and tissue donations occur after the donor has died, some organs and tissues can be donated while the donor is alive. HRSA, How Organ donation works, <https://www.organdonor.gov/about/process/living-donation.html> at 25th May 2020. 18 material available from deceased donors in order to meet patient needs. Living donation is thus practised despite the fact that it involves risks for the donor that may not be negligible. 2.3.2 Deceased donation. Death is the great certainty of life, an inevitable end. If living donation is not an option, an organ or part of an organ can be given at the time of the donor’s death, hence, deceased donation.51 Most transplants are done through deceased donation. For a deceased donation to take place the dead donor rule must be respected; patients may only become donors after death and the recovery of organs must not cause a donor's death. A death diagnosis has to be adequately conducted; this entails confirmation of the death from evidence acquired through clinical investigation or examination, meeting criteria of a brain, or circulatory death. A possible deceased organ donor is described as a patient with a devastating brain injury or lesion or a patient with circulatory failure and apparent medically suitable for organ donation. WHO Guiding Principles for Human Cell, Tissue, and Organ Transplantation Guiding Principle 3 52 states that: “Donation from deceased persons should be developed to its maximum therapeutic potential." This principle emphasizes the importance of both taking the legal and logistical steps needed to develop deceased donor programs where they do not exist, and making existing programs as effective and efficient as possible. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism 53 confers upon governments, in collaboration with health-care institutions, professionals, and NGOs, to take appropriate actions to increase deceased organ donation. Countries without an established deceased organ donation or transplantation framework are mandated to enacted national legislation that would initiate deceased organ donation and create transplantation infrastructure, to fulfil each country's deceased donor potential. In all countries in which deceased organ donation has been initiated, the therapeutic potential of deceased organ donation and transplantation is encouraged to achieve maximization. 51 UPMC, how you can donate life: Different types of organ donation, <https://share.upmc.com/?_ga=2.164555071.1086470960.1595746793-1200354926.1595746791> at 25th May 2020. 52 WHO Guiding Principles; WHA 63.22/2010. Available at: https://www.who.int/transplantation/en/. 53 Steering committee of the Istanbul Summit. Organ trafficking and transplant tourism and commercialism. The Declaration of Istanbul. Lancet, 2008; 372: 5. Available at: https://www.declarationofistanbul.org. 19 Each country performing deceased donor transplantation is tasked with legally defining brain death, consistent with international standards. This includes legal provisions to remove organs from a deceased person, under local statutes on the determination of brain death and circulatory death. A systematic approach to the process of a donation from deceased persons will help populations to define actions, roles, and responsibilities within the process, tailored to their local circumstances. The possible deceased organ donor when defined as the patient with a devastating brain injury represents the common starting point of two different pathways that activate depending one volition and clinical practice: the process of DBD and the process of DCD. The possible donor defined as the patient with circulatory failure might be the starting point of the process of DCD. a. Donation after brain death. The concept of brain death emerged during the 1950s when, as a consequence of developments in critical care, clinicians were faced for the first time with the prospect of an apparently ‘alive’ patient sustained by mechanical ventilation long after brain function had ceased. 54 A potential donor after brain death (DBD) is defined as a person whose clinical condition is suspected to fulfil brain death criteria. Two possible situations define the actual DBD. The first situation would be that in which an operating incision has been made with the intent of organ recovery for transplantation. In the second situation, the condition of actual donation would be defined when at least one organ has been recovered for transplantation purposes. Eligibility thus would suffice if the person is considered medically suitable for organ donation and is declared dead based on neurologic criteria, as stipulated by the law of the relevant jurisdiction. Regarding medical suitability, it should be acknowledged that medical conditions precluding organ donation might vary between countries according to legal and technical provisions. An eligible DBD would become an actual donor after brain death only after consent has been obtained for organ donation. 54 A definition of irreversible coma. Report of the Ad Hoc Committee of the Harvard Medical School to examine the definition of brain death. J Am Med Assoc 1968; 205: 337–40 20 b. Donation after circulatory death. Donation after circulatory death derives from two conditions; a person whose circulatory and respiratory functions have ceased and in whom resuscitative measures are not to be attempted or continued. The second condition defining a potential donor after circulatory death would be that of the patient in whom the cessation of circulatory and respiratory functions is anticipated to occur within a time frame that will enable organ recovery. This situation usually applies when a withdrawal of life-supporting therapy has been decided based on the ominous prognosis of the patient, according to the family decision, or the request of the family. A potential DCD would become an eligible donor after circulatory death when the person is considered medically suitable for donation and has been declared dead based on the irreversible absence of circulatory and respiratory functions as stipulated by the law of the relevant jurisdiction, within a time frame that enables organ recovery. The steps required for a potential DCD becoming an eligible DCD would be: (1) the identification and subsequent referral of the case for organ donation (if not previously performed); (2) the declaration of death by circulatory and respiratory criteria within an appropriate time frame that allows organ recovery, (3) the consent to proceed with organ recovery (this may occur before or during the process according to local legislation), and (4) evaluation of the medical suitability for donation. An eligible DCD would become an actual donor after circulatory death if an incision has been made for organ recovery and at least one solid organ has been recovered for transplantation. This requires at least continuous medical evaluation, organ allocation, and recovery. Reasons, why an eligible DCD does not become an actual DCD, areas for the process of DBD. A utilized donor after circulatory death is defined as the actual DCD from whom at least one organ has been transplanted. Organ allocation and transplantation are the conversion steps in this process. The same categorical reasons as those described for the process of DBD justify that an actual DCD not be converted to a utilized DCD. 2.4 Organ Donation Process. 2.4.1 Removal. 21 Organ donation entails the removal of an organ or tissue from the human body. This takes various forms; for the case of a living donor, a patient should undergo a non-therapeutically operation for the procurement of organs and tissue. Tissue from cadaveric (deceased) donors is usually removed after it has been established that the patient is deceased. An effective organ procurement system ought to be established to provide for measures to legitimize established removal procedures. The basic requirement before transplanting tissue and organs into the recipient is that informed consent must be present. This requirement assumes that there is a duty of disclosure upon the health practitioner to inform the recipient patient of the advantages, disadvantages, risks, recovery methods, etc.55 2.4.2 Preservation. This is characterized by the use of chemical agents, alterations in environmental conditions, or other means to prevent or retard biological or physical deterioration of organs from procurement to transplantation. Once the tissue has been legally procured, the second phase of the transplantation process sets in, whereby the tissue needs to be protected against harmful factors such as disease and infection transmission.56 The effectiveness of these processes is important to guarantee successful transplantation to the recipient. If an organ is damaged post removal, a range of legal issues can arise 2.4.3 Allocation. The final stage in the completion of the transplantation process is allocating procured organs to a specified recipient. It entails the assignment of human cells, tissues, and organs to a transplant candidate, based on a set of rules. This requires that an individual needs to be chosen from a preestablished waiting list following prescribed regulations. In the past number of years, the ethical implications and fairness of these regulations have been questioned.57 Many questions have been raised regarding the criteria used in the selection of recipients for example whether the criteria should purely be based upon medical prerogatives, or whether an allocation system should rather Van Oosten Medical Law: South Africa – International Encyclopedia of Laws (1996) par 119 – 124. Williams The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis Food and Drug Law Journal 52 (1997) 409; Indech The International Harmonization of Human Tissue Regulation: Regulatory Control over Human Tissue Use and Tissue Banking in Select Countries and the Current State of International Harmonization Efforts Food and Drug Law Journal 55 (2000) 343. 57 Lamb Organ Transplant and Ethics (1990) 126; Pence Classic Cases in Medical Ethics (2000) 31; Veath Medical Ethics (1997) 247. 55 56 22 be a combination of medical, social, economical and other related matters to eliminate unfairness. Other important issues relating to the recipient self are for example, upon which basis does information have to be supplied to the recipient. 2.5 Legal Aspects of Donation. 2.5.1 Removal of organs. Under Guiding principle 2, Physicians determining that the death of a potential donor has occurred should not be directly involved in organ removal from the donor and subsequent transplantation procedures, or be responsible for the care of potential recipients of such organs. This provision is designed to reduce the possibility of a conflict of interest that would arise if the physician or physicians determining the death of a potential donor were also involved in organ removal or implantation. Guiding principle 3 directs for Organs for transplantation to be removed preferably from the bodies of deceased persons. However, adult living persons may donate organs, but in general, such donors should be genetically related to the recipients. Exceptions may be made in the case of transplantation of bone marrow and other acceptable regenerative tissues. An organ may be removed from the body of an adult living donor for transplantation if the donor gives free consent. The donor should be free of any undue influence and pressure and sufficiently informed to be able to understand and weigh the risks, benefits, and consequences of consent. This principle is intended to emphasize the importance of developing cadaveric donation programs in countries where this is culturally acceptable, and to discourage donations from living, genetically unrelated donors, except for transplantation of bone marrow and other acceptable regenerative tissues. Further, it seeks to protect potential donors from undue pressure and undue inducements from others. It emphasizes the necessity for complete and objective information to be given to the donor. It also takes into account issues relating to persons (other than minors) who are legally incompetent to fulfil the requirements for "free consent" or the other conditions specified in this paragraph. 23 Guiding principle 4 provides for the absolute prohibition of the removal of organs for transplantation from legal minors. However, an exception concerning regenerative tissues may be allowed by national legislation. In such cases, the protection of minors could be assured by requiring, among other conditions, the minor's comprehending consent and the consent of the parent(s) or the legal guardian. The parent(s) or the legal guardian may have a conflict of interest, for example, if they are responsible for the welfare of an intended recipient of the donated tissues. In such a case, prior permission of an independent body, such as a court or other appropriate authority of comparable independence or status should be required. However, an objection by the minor should take effect and prevail over any other consent. a. Consent. As per its definition, it is a legally valid permission for the removal of human cells, tissues, and organs for transplantation. Organs may be removed from the bodies of deceased persons for transplantation if any consents required by law are obtained and if there is no reason to believe that the deceased person objected to such removal, in the absence of any formal consent given during the person's lifetime.58 Explicit consent is a legally valid permission for removal of human cells, tissues, and organs for transplantation, otherwise known as "opting-in" or "contracting in." As a system of post mortem organ removal, deceased persons expressly state before death that they approve such removal, or an appropriate family member expresses approval when the deceased person left no statement or other evidence to the contrary. When a deceased person leaves no evidence of opposition to removal, the "opting-in" system normally requires the consent of an appropriate family member for organ removal. Presumed consent is defined as a legally valid presumption of permission for removal of cells, tissues, and organs for transplantation, in the absence of individual pre-stated refusal of permission. Otherwise known as "opting out" or "contracting out." This presumes that organs may be removed for transplantation from the bodies of deceased persons unless those persons when alive stated their objections, or perhaps others who were close to them stated at an appropriate time that the persons objected to their deceased bodies being so treated. In the "opting out" system, no 58 WHO Guiding principle 1(a)(b) 24 consent is required, but family members may take initiatives to state the opposite of the deceased person or themselves. In the case of both the "opting in" and "opting out" systems, any statements or other adequate indications of opposition by persons to posthumous organ removal from their bodies will prevent such removal. b. Organ procurement systems. Legislation concerning organ procurement procedures provides that organ recovery can only be justified through a strict consent process that is guaranteed by the autonomy of the donor who is sufficiently informed or in the setting of legislated presumed consent to donation after death. 59 Organ donation from living persons who are minors or individuals unable to provide informed consent should be prohibited.60 Although it is hoped that the consent of relatives to donation after death will be actively sought in all circumstances, in some jurisdictions where the preferences of relatives may conflict with those expressed by the potential deceased donor, the latter may be upheld.61 a) Explicit consent systems. b) Presumed consent systems. Legislation may be enacted to establish presumed consent for organ donation. 62 This may be effective in increasing potential deceased donors, provided there is social consensus regarding presumed consent.63 For example, in Spain and France, if a brain-dead person has never expressed his or her intention for donation, his or her consent is legally presumed.64 In Germany and selected other European 59 Arnold RM, Siminoff LA, Frader JE. Ethical issues in organ procurement: A review for intensivists. Crit Care Clin 1996; 12: 29. 60 WHO Guiding Principles; WHA 63.22/2010. Available at: http://www.who.int/transplantation/en/. 61 This is not the case in all countries.In practice, relatives’ wishes are often upheld over donor wishes. See Uniform Anatomical Gift Act, United States. 62 Rithalia A, McDaid C, Suekarran S, et al. Impact of presumed consent for organ donation on donation rates: A systematic review. BMJ 2009; 338: a3162. 63 Rithalia A, McDaid C, Suekarran S, et al. A systematic review of presumed consent systems for deceased organ donation. Health Technol Assess 2009; 13: iii, ix-xi, 1. 64 Jousset N, Gaudin A, Mauillon D, et al. Organ donation in France: Legislation, epidemiology, and ethical comments. Med Sci Law 2009; 49: 191. 25 countries, from 13 years of age, individuals may draw up a document rejecting a donation of their organs, and therefore, persons with such a document are considered to be objectors to organ donation, and persons without such a document, assenters. The presumed approach has contributed to an increased provision of organs for these countries, but the local socio-cultural contexts of different counties need to be considered before enacting a mandatory system. Under guiding principle 5, The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment (including any other compensation or reward) for organs should be prohibited. This is designed to prohibit traffic in human organs for payment. The method of prohibition, including sanctions, will be determined independently by each jurisdiction. The Principle does not prohibit payment of reasonable expenses incurred in donation, recovery, preservation, and supply of organs for transplantation. Guiding principle 6 intends to prohibit advertisements that have a commercial (profit-making) purpose. Promotion and encouragement of altruistic donation of human organs and tissues employing advertisements or public appeal are not affected by this Principle. Guiding principle 7 prohibits physicians and other health professionals to engage in organ transplantation procedures if they have reason to believe that the organs concerned have been the subject of commercial transactions. This provision deals with the involvement of physicians and other health professionals in removal, intermediate management, and implantation of organs with knowledge, actual or constructive, that commercial transactions have occurred. Guiding principle 8 prohibits any person or facility involved in organ transplantation procedures to receive any payment that exceeds a justifiable fee for the services rendered. This provision reinforces Guiding Principle 7 by restricting entrepreneurial practice in organ recovery and implantation. A medical or another health practitioner is uncertain whether a fee proposed to be charged is justifiable may seek the opinion of an appropriate licensing or disciplinary authority before the fee is proposed or levied. 2.5.2 Preservation and allocation procedures. Once the tissue has been legally procured, the second phase of the transplantation process sets in, whereby the tissue needs to be protected against harmful factors such as disease and infection 26 transmission. The effectiveness of these processes is important to guarantee a successful transplantation to the recipient.65 Legislation guaranteeing transparency of organ allocation should set out the criteria for organ allocation; it should be set following medical utility, mindful of the characteristics, and preferences of each region or country and the principle of equity.66 Guiding principle 9 advocates for fairness and equitable procedures in that with regards to principles of distributive justice and equity, donated organs should be made available to patients based on medical need and not based on financial or other considerations. 2.5.3 Organ trafficking. Organ trafficking entails the recruitment, transport, transfer, harbouring or receipt of persons, using the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power, of a position of vulnerability, of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for exploitation by the removal of organs, tissues or cells for transplantation.67 The scope of organ sales from commercial living donors (CLDs) or vendors has now become apparent. At the Second Global Consultation on Human Transplantation of the World Health Organization’s (WHO) in March 2007, it was approximated that organ trafficking accounts for 5–10% of the kidney transplants performed annually throughout the world. Transplant Tourism has become a connotation for organ trafficking. The United Network for Organ Sharing (UNOS), recently defined transplant tourism as 'the purchase of a transplanted organ abroad that includes access to an organ while bypassing laws, rules, or processes of any or all countries involved'.68 Patients with adequate possessions in need of organs may journey from 65 Williams The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis Food and Drug Law Journal 52 (1997) 409; Indech The International Harmonization of Human Tissue Regulation: Regulatory Control over Human Tissue Use and Tissue Banking in Select Countries and the Current State of International Harmonization Efforts Food and Drug Law Journal 55 (2000) 343. 66 Neuberger J, Adams D, MacMaster P, et al. Assessing priorities for allocation of donor liver grafts: a survey of public and clinicians. BMJ 1998; 317: 172. 67 UNODC and human trafficking. Available at: http://www.unodc.org/unodc/en/human-trafficking/index.html. 68 UNOS board further addresses transplant tourism. June 26, 2007.Available at: http://www.unos.org/news/newsDetail.asp?id=891. 27 one country to another to purchase a kidney or liver essentially from an underprivileged person. Transplant centres in 'destination' countries have been well known to encourage the sale of organs to 'tourist' recipients from the 'client' countries.69 WHO Guiding principle 5 stipulates that the human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment (including any other compensation or reward) for organs should be prohibited. This Principle is designed to prohibit traffic in human organs for payment and further aims to affirm the special merit of donating human materials to save and enhance life. The method of prohibition, including sanctions, will be determined independently by each jurisdiction. The Principle does not prohibit payment of reasonable expenses incurred in donation, recovery, preservation, and supply of organs for transplantation. It allows for circumstances where it is customary to provide donors with tokens of gratitude that cannot be assigned a value in monetary terms. National law thus should ensure that any gifts or rewards are not, in fact, disguised forms of payment for donated cells, tissues, or organs. Guiding principle 7 prohibits physicians and other health professionals from engaging in organ transplantation procedures if they have reason to believe that the organs concerned have been the subject of commercial transactions. Failing to ensure that the person(s) consenting to the donation has not been paid, coerced or exploited breaches professional obligations and attracts sanctions by the relevant professional organizations and government licensing or regulatory authorities. Guiding principle 8 reinforces Guiding Principles 5 and 7 by forbidding profiteering in the cell, tissue, and organ recovery and implantation. It prohibits any person or facility involved in organ transplantation procedures to receive any payment that exceeds a justifiable fee for the services rendered. Thus, medical or other health practitioners uncertain whether a fee proposed to be charged is justifiable may seek the opinion of an appropriate licensing or disciplinary authority before the fee is proposed or levied. The Legislation about organ trafficking consistent with the WHO Guiding Principles advocates for each country to put in place legislation prohibiting organ trafficking and sales to thwart human 69 D. A. Budiani-Saberi and F. L. Delmonico, Organ Trafficking and Transplant Tourism: A Commentary on the Global Realities. American Journal of Transplantation 2008; 8: 925–929 28 rights abuses. Further, the export and import of organs or tissues or cells and transplantation for foreign patients should also be governed by legislation. 2.6 Regulation Regulatory bodies are tasked with monitoring the activities of organ procurement, allocation, and transplantation organizations to ensure they take place following local, regional, and international law and ethically and effectively. Regulation is necessary for oversight and guidance related to ethical standards, the development of transplantation policies, and quality management in all organ procurement and transplantation practices. a. Donation and Transplantation ethics Regulatory bodies have an important role in establishing ethically appropriate organ procurement and allocation processes. Established ethics committees, under the local, regional, or national regulatory authority, guide organs procurement processes such as informed consent, the implementation of new procedures or practices that have ethical implications, such as DCD, and eligibility criteria for living donors and approving the relationship between a potential donor and a recipient. b. Development of transplantation policy Through surveillance and data collection, regulatory bodies can review existing processes and develop more effective transplantation policies. Regulatory bodies must evaluate and make recommendations concerning the appropriate standards for age, disease, use of DBD, and DCD. Additionally, they must consider and implement where appropriate, innovative strategies for increasing the availability of donor organs. c. Transplantation quality management and professional education Regulatory oversight helps to standardize, and maintain quality in, transplantation performance by promoting uniform procedures and monitoring the performance of each transplantation centre. Regulatory bodies are responsible for ensuring adequate education and training of transplant staff. 2.6.1 The National Transplant Organisation. National Transplantation Organizations (NTO) embodies all processes involved in organ procurement and transplantation at the governmental level. Although they may be responsible for various functions such as the management of waiting lists, matching and allocation, and the 29 maintenance of comprehensive registries, above all they should ensure the implementation of national policy concerning donation and transplantation. Hence, the NTO must have regulatory functions and provide effective oversight of all activities in organ donation and transplantation, monitor trends and performance, and guide informed policy. i. Allocation of Organs There are two models of organ allocation: a centralized system led by government or private corporation aggregate run by a non-profit corporation (e.g., UNOS). Regardless of the structure of organ allocation bodies, their operation and organization should be intimately connected with the NTO.70 To maximize utility, organs are generally allocated based on medical urgency and blood/tissue type matches. Distribution is usually made first on a local, then regional, and finally national level.71 Local patients with the highest points are allocated the organs in descending order, then they are distributed regionally in descending point order, and finally nationally, in the same order.72 ii. Monitoring and Regulation of Organ Donation and Transplantation Registries play a vital role in transplantation systems, including maintenance of the organ transplant waiting list and facilitating the allocation of organs from deceased donors by transparent distribution criteria. They also enable a review of the current status of donation and transplantation, thereby facilitating quality control, evidence-based research, and the development of policies that are guided by the best available information concerning the management of patients and their needs. Each country performing transplantation should develop a registry of organ donation and transplantation activities. Best practice concerning registries consists of, where possible, computer-based, real-time sharing of donor information. For example, when donor information is provided to the EIF and UNOS 70 Examples of organ allocation models: The EIF, found in 1967, is responsible for the mediation and allocation of organ donation procedures in Austria, Belgium, Croatia, Germany, Luxemburg, the Netherlands, and Slovenia (http://www.eurotransplant.org) and UNOS(United States): the national UNOS membership is divided into 11 geographic regions for procurement, allocation, and transplantation (http://www.unos.org). 71 Poli F, Scalamogna M, Cardillo M, et al. An algorithm for cadaver kidney allocation based on a multivariate analysis of factors impacting on cadaver kidney graft survival and function. Transpl Int 2000; 13(suppl 1): S259. 72 Danovitch GM, Cecka JM. Allocation of deceased donor kidneys: Past, present, and future. Am J Kidney Dis 2003; 42: 882. 30 computer systems, the staff at the hospital where the transplant candidate is located can share realtime information and show an intention of acceptance in the system, by which allocation and distribution are made. 2.6.2 Organ Procurement Organisations. An OPO is an independent organization responsible for the process of systematic surveillance for the identification of potential donors and the procurement of deceased donor organs. 73 The identification of potential donors is the starting point of transplantation, and its optimization is possibly the most important process in maximizing the procurement of organs for transplantation. Organ procurement is not just a matter for health authorities, OPOs, and specific hospital personnel. The entire medical community and society as a whole need to be aware of this challenge and become involved, indirectly or directly, in the process of organ procurement. 73 Prottas JM. The organization of organ procurement. J Health Polit Policy Law 1989; 14: 41. 31 CHAPTER THREE. 3. EVALUATING ORGAN DONATION IN KENYA. 3.1 Introduction. Organ donation as a quintessentially disputable issue raises numerous troublesome legal and ethical issues identifying with the procurement of human organs, transplantation and distribution procedures. The principles of donation and transplantation law are a blend of legal principles primarily encapsulated in legislation. In order to establish a viable donation and transplantation, best practice, policy bio-ethical proposals and government policies ought to be harmonized as such a combination addresses complex issues. For a long time, since independence, Kenya has not had a full bodied organ donation and transplant laws as well as regulations, in whose absence has hindered medical professionals from proffering transplant treatment to patients undergoing end stage organ failure. Despite our medical workforce possessing the pre imperative understanding and capability of performing transplant treatment, not a single medical procedure has ever been performed in Kenya. Organ donation is legal in Kenya; however, shortages of organs, poor legislations and policies as well as financial and capacity issues not only continue to stand in the way of fully realising the potential of donation and transplant services but also the commercialisation of organs. Nations with flourishing donation and transplant programmes like the United States, the United Kingdom and parts of Asia tended to such difficulties through instituting elaborate laws which allow for harvesting of body organs from dying people for therapeutic purposes. A great deal of exertion has been set up internationally to handle the difficulties and improve the field of Organ Donation, strikingly in 2010 the World Health Organisation vide the Sixty Third World Health Assembly embraced the World Health Guiding Principles on Human Cell, Tissue and organ transplantation. This was expected to give a deliberate, ethical and acceptable way for acquisition and transplantation of human cells, tissues and Organs, thus countries were encouraged to utilize the principles as reference while formulating organ donation and 32 transplantation laws. Further, the Declaration of Istanbul74, embraced in the year 2008 and updated in the year 2018, provides ethical guidelines for medical practitioners and lawmakers to maximise the advantages of transplantation while ensuring the same is enjoyed impartially among those in need without employing unethical and exploitative methods. This was enforced to curb commercialization of organs otherwise known as organ trafficking.75 In Kenya, prior to the enactment of the Health Act 201776, organ transplantation was governed by the Human Tissue Act77 which was not completely thorough. The Health Act 2017 presented the first legislation in Kenya to broadly provide for donation and transplantation services, this in fact implied an achievement in Kenya’s field on organ donation and transplantation. However, notwithstanding the improvement nature espoused under the Health Act, it merely provides for a basic framework, hence the need to build up a nitty-gritty regulatory framework. The unmet has been furthered by lack of awareness or educational, religious, and cultural backgrounds and myths regarding organ donation which has contrarily impacted organ donation in Kenya. A more solid law governing organ donation ought to be formulated. It is imperative to take note that, similarly as it is essential to shift our system of donation, it is of equivalent significance to have a comprehensive procurement system and a robust, transparent organizational infrastructure to oversee a successful process, one that Kenyans will have confidence and trust in. 3.2 The legal framework of organ donation and transplant in Kenya. In the course of the recent years, organ donation and transplantation has been changed over into a worldwide practice and has saved many thousands of lives. It has moreover improved the quality of life of countless other persons.78 According to data from the World Health 74 Steering committee of the Istanbul Summit. Organ trafficking and transplant tourism and commercialism. The Declaration of Istanbul. Lancet, 2008; 372: 5. Available at: <https://www.declarationofistanbul.org > 75 Organ trafficking was listed as the fifth most lucrative transnational crime by the Global Financial Integrity in its Transnational Crime and the Developing World Report of 2017. Channing Mavrellis, Transnational Crime and the Developing World, Global Financial Integrity. March 27th, 2017. Available at <https://secureservercdn.net/45.40.149.159/34n.8bd.myftpupload.com/wpcontent/uploads/2017/03/Transnational_Cr ime-final.pdf?time=1598974421 > 76 Act No 21 of 2017. 77 Cap 252 Laws of Kenya. 78 Ibid. 33 Organisation, more than 130,000 solid organ transplants are performed worldwide annually; global liver transplants add up to 20,200 annually while 5,400 heart transplants are conducted. Others are 3,400 lung transplants and 2,400 pancreas transplants.79 Organ donation and transplant have received distinctive legal responses in different jurisdictions. This is as a result of the differences in economic backgrounds and reception reactions that have prompted various jurisdictions to have diverse legal and institutional frameworks on organ donation and transplant. An attribute of organ donation and transplantation since its initiation has been the insufficiency of obtainable organs. Supply has unquestionably not placated demand, and this has prompted incessant advancement in various countries of procedures and systems to augment supply. Organ donation and transplantation is definitely not a new concept in Kenya as medical professionals have on various occasions engaged the therapeutic treatment of end stage organ failure predominantly identifying with kidneys and cornea. Albeit regular heart repairs are common, no hospital in Kenya has ever carried out any heart, liver or lung transplants due to technological constraints. Patients who require such transplants have to travel abroad, mainly India or Europe where such procedures are routine. A 2019 insight shows that about 4,300 Kenyans were as per that time undergoing dialysis across the country. In the year 2018, 2,000 of those people were on its waiting list for transplants. KNH for instance, only conducts about 15 transplants a year and only 466 patients have undergone transplants in public and private hospitals since 2006.80 The hospital receives about 15 patients weekly with end stage liver disease.81 Of these about 80 per cent die because they cannot bear the cost of the Sh10 million required for transplant abroad. Mediheal on the other hand has invested intensely in access to sub specialized including 120 dialysis chairs, 20 79 WHO Global Observatory on Donation and Transplantation (GODT) Richard Kamau, ‘You May Soon Be Allowed to Donate Your Kidneys, Body Parts After Death’ Nairobi Wire, 12th April 2019. 81 Gatonye Gathura, ‘Transplant crisis as need for body organs outruns willing donors’, The Standard, December 8th 2019. 80 34 operating theatres and 120 ICU beds among others and have already conducted 30 transplant medical procedures. According to Lions Sight First Eye Hospital, the country has about 50,000 people experiencing corneal blindness with an annual augmentation of 5,000 people, mainly children. With no substitute for human tissue, the only way such ones can regain eyesight is through a cornea transplant.82 On the other hand, Kenya performs about 200 cornea transplants annually with donations mainly coming from the Shah community. 83 As it stands, there is no sound legal framework on organ donation and transplant in Kenya. This section seeks to analyze the legal framework on donation and transplant in Kenya with an aim of giving highlights on the use or gaps surrounding therapeutic treatment of end stage organ failure in Kenya. A glance at the historical backdrop of donation and transplantation provides a decent indication that the evolution of transplantation laws is as yet in its infancy internationally, and there is plenty of opportunity for development. 3.2.1 Legal basis. 3.2.1.1 The Constitution of Kenya. The promulgation of the Constitution of Kenya 2010 greatly impacted matters health, explicitly organ donation, organ transplantation and organ allocation procedures. As the supreme law of the land it is imperative that it is cited as the starting point for the basis of organ donation and transplant in Kenya. Through its various provisions, the constitution has accommodated rights and freedoms which address the idea of organ donation and transplant. To begin with, Article 43 epitomizes different medical care rights which include: the right to reproductive health, the right to healthcare services, which informs the right of every person to the highest attainable standard of health, and ultimately the right of everyone to emergency medical treatment.84 End stage organ failure disrupts the ordinary functioning of the body which thus may result to shutting down of the body or permanently damaging dynamic healthy organs. This will thus call into 82 The hospital opened a cornea storage bank in Nairobi way back in 2010 but report receiving only 10 eyes from Kenyans of Asian origin in a year. Gatonye Gathura, ‘Transplant crisis as need for body organs outruns willing donors’, The Standard, December 8th 2019. 83 Peter Muiruri, ’Why won’t you donate an organ?’, The Standard, 8th June 2020. 84 Article 43(1)(a) and (2) C.o.K. 35 actualization of the tenets of article 43 where one is entitled to the right of health care services; importantly the right to emergency medical treatment. Article 26 of the Constitution provides for the right to life, seemingly, this is the most important article relating to organ donation and transplant. The entrenchment of the right to life requires the state to take a leading role in establishing respect and preservation for human life in Kenya. Thus in the South African context the Constitutional court noted in S v Walters Ex parte Minister of Safety and Security85 that the state has obligations to respect, protect, promote and fulfill the rights in the Bill of Rights. The right to life consequently puts an obligation on the state to ensure the lives of its residents by making conditions which will enable all persons to enjoy the human existence. Human dignity is considered to be what gives a person their intrinsic worth; it educates the substance regarding all the solid rights and assumes a part in the adjusting cycle important to bring various rights and qualities into agreement. The constitutional protection of dignity expects us to recognise the value and worth of all individuals as members of society. The value of human dignity is safeguarded and advanced by the recognition of a right to dignity in Article 28 of the Bill of Rights: “Every person has inherent dignity and the right to have that dignity respected and protected.” The equivalent centrality of human dignity in the Constitution prompted the court in A.N.N v Attorney General86 to describe the right to dignity and the non-discrimination clause as the foundation on which the rest of the Constitution is built. According to article 10 of the Constitution, the national values and principles of governance includes human dignity among other values. Article 19(2) calls attention to the recognition and protection of human rights and fundamental freedoms is to safeguard the dignity of individuals and communities. As a worth that informs the interpretation of possibly all other fundamental rights and being of central significance, human dignity enormously impacts organ donation and transplant; as components pointed towards improving human life organ donation and transplant promote self regard, respect and importantly worth which are integral to dignity. Through advancing organ donation and transplant the state will hence be fulfilling the right to human dignity. 85 86 S v Walters Ex parte Minister of Safety and Security [2002] (4) SA 613 (CC) para 47. A.N.N v Attorney General [2013] eKLR, Petition No 240 Of 2012. 36 Article 29 specifies the freedom and security of the person; it provides that “every person has the right to freedom and security of the person, which includes the right not to be (a) deprived of freedom arbitrarily or without just cause…” this article comprises of two components in particular “security in” and “control over”.87 The former term alludes to the protection of bodily integrity against intrusions by the state and others while the latter term refers to the protection of what could be called bodily autonomy or self-determination against interference. This article ensures each individual the right to bodily and psychological integrity, which includes the right to security in and control over their body hence no person’s organs may be procured for transplantation purposes without the lawful consent as provided for under section 80(1) of the Health Act.88 3.2.1.2 The Human Tissue Act. The Human Tissue Act is a 1977 legislation that governs the same matters as Part XI of the Health Act. This act is not explicitly repealed, perhaps the supposition being that a court confronted with an issue relating to both would exploit rules of interpretation to determine the applicable statute. For an administrator, or a practitioner, that may not be a simple differentiation to make. 3.2.1.3 International Law Article 2(5)89 provides that general rules of international law shall form part of the law of Kenya. Article 2(6)90 provides that any treaty or convention ratified by Kenya shall form part of the law of Kenya under this constitution. Both developed and developing countries share many common problems regarding organ procurement, preservation and allocation procedures. This is the reason behind the need for legislative development at a regional level as so much on an international level, and also that foreign developments pertaining to legislation and policy decisions should be closely monitored, this is as provided by the World Health Organisation guiding principles on human cell, tissue and organ transplantation.91 87 De Waal, Currie and Erasmus, The Bill of Rights Handbook (2000). Act No 21 of 2017. 89 The Constitution of Kenya. 90 ibid. 91 WHO, Draft guiding principles on human organ transplantation" 2019, <https://www.who.int/ > 88 37 3.2.1.3.1 WHO guiding principles on human cells, tissue and organ transplantation Having been established by constitution on 7 April 1948,92 the WHO is mandated with advocating for universal healthcare, monitoring public health risks, coordinating responses to health emergencies, and promoting human health and well being. It provides technical assistance to countries, sets international health standards and guidelines, and collects data on global health issues through the World Health Survey. The World Health Organisation has provided for Guiding Principles93 which are intended to provide a methodical, ethical, and acceptable framework for regulating the acquisition and transplantation of human organs for therapeutic purposes. The draft Guiding Principles are presented as a considered response to the 1987 and 1989 Health Assembly resolutions and as a link in a process that may lead to consideration by the Forty-fourth World Health Assembly of the adoption of Guiding Principles on Human Organ Transplantation, for recommendation to the Member States under Article 23 of the Constitution. The Guiding Principles preclude giving and receiving money, as well as any other commercial dealing in this field, but do not affect payment of expenditures incurred in organ recovery, preservation, and supply. Of particular concern to WHO is the insurance of minors and other vulnerable persons from coercion and improper inducement to donate organs. The guiding principles also give definition to the distinctive donation concepts and further provide for organ allocation and procurement modules. As a recommendation to its member states the WHO has expressed the need and significance of each state coming up with legislations so as to guarantee clear definitions of brain death and circulatory death exist to allow the procurement of organs from deceased donors. They are also required to define protocols concerning consent, including presumed consent, and the fair and transparent allocation of organs. Finally, legislation must govern transplantation practice per the WHO Guiding Principles. In particular, this implies advancing the altruistic character of organ donation and prohibiting organ trafficking and commercialism. 92 WHO, constitution of establishment on 7th April 1948, available at <https://www.who.int/governance/eb/who_constitution_en.pdf > 93 WHO, guiding principles on human cell, tissue and organ transplantation, As endorsed by the sixty-third World Health Assembly in May 2010, in Resolution WHA63.22 38 3.2.1.4 The Health Act 2017. The Health Act is an act of parliament that sets up a unified health system, to coordinate the inter-relationship between the national government and the county government health systems, to provide for regulation of health care service and health care service providers, health products and health technologies and for connected purposes. The Act was assented to on 21st June 2017 and came into force on 7th July 2017. This piece of legislation came into being essentially to expand and offer significance to the specific substance of the right to health, the specific obligations of each of the levels of government and the institutions required to implement the right.94 The Health Act came into being at a time when the country was confronting genuine difficulties in the health sector. One of the major questions had to do with the substance of the right to health and a comprehension of the function of the state in actualizing that right. The other issue, a colossal one, had to do with the definition of functions between the national and county levels of government especially in relation to the human resource for health as exemplified by somewhat drawn out and chaotic strikes by doctors, nurses and clinical officers. 95 The Health Act is viewed as a “mother legislation” as it seeks to actualize the health rights guaranteed by the Constitution. On a substantive right to Health, the Act through its various sections cites entitlements, freedoms, and access to goods, facilities and services that make up the system of health rights and duties. To begin with, section 5 reiterates the provisions of article 43(1)(a) of the Constitution and goes further to add that the right to health incorporates the right to access for provision of promotive, preventive, curative, palliative and rehabilitative services, and hence emphasizing the expansive nature of the right. Furthermore, the section highlights dignity, respect and privacy as mainstay to the realization of the right to health. In addition, the law specifies that maternal and child health as part of the right to health and obliges the national and county governments to provide free and compulsory services in that regard. Maurice Oduor, “A Critical Overview of the Health Act 2017.” February 2018, SSRN Electronic Journal ·. Available at < https://www.researchgate.net/publication/323267945> 95 Ibid. 94 39 Section7of the Act elaborates the article 43(2) edict that “a person shall not be denied emergency medical treatment”. In terms of Section7 (1) “every person has the right to emergency medical treatment”, which includes pre-hospital care; stabilizing the health status of the individual or arranging for referral where the health provider of first call does not have facilities or capability to stabilize the health status of the individual.96Failure to provide emergency medical treatment despite ability, if by an institution, amounts to a criminal offence.97Further, all licensed healthcare providers i.e. doctors, nurses etc have a duty under Section12(1) to provide the emergency medical treatment defined in section7(2). Part XI of the Act creates and elaborates rules on donating, harvesting and transfusion of blood, tissue and organs. Harvesting of tissue or gametes for purposes of transplantation can only occur under the circumstances specified in Section 80. It has to be done in a facility authorized for that purpose, and there must be written authority of a medical practitioner in charge of clinical services or by with the consent of the donor. The Act empowers the Cabinet Secretary to develop regulations prescribing criteria for approval of organ transplants and procedures thereof. The Act further provides for the harvesting of organs for research or teaching purposes or for postmortem pathology. It also sets up an institutional framework to govern donation of blood for transfusion purposes; which is to be regulated by an Act of Parliament which shall establish a body to be known as the Kenya National Blood Transfusion Service.98 This area of law is governed with other previously existing laws, which have not been repealed. Section 80 sets rules for harvesting of organs or gametes. It also calls upon the Cabinet Secretary to prescribe regulations establishing criteria for approval of organs transplant facilities and a procedure to be applied for such approval. It further creates offences section 81 sets criteria for donation of organs through wills. Section 82 regulates donations for pathology purposes. Finally, the Act requires that an Act of Parliament be passed establishing an entity known as the Kenya National Blood Transfusion Service to provide for the institutional organizational of blood transfusion service in the country. 96 S 7(2). S 7(3) 98 Health Act part XI. 97 40 3.2.2 Implications. While the Health Act 2017 made clear the organ donation regulations, Kenya hasn’t noted an increase in donations or an expansion of infrastructure to have most surgeries done locally. Organ donation and transplant continues to be less utilized, this is significantly incurred by lack of proper legal backing. Despite the Health Act, for the first time, presenting the concept of donation and transplant, the Act is currently in a fragmented state in that for its actualization the Act requires an entire scope of statutes, regulations, norms, standards and rules to be passed to give full effect to many of its provisions. As long as these do not exist, there are significant grey areas. For the right to the highest attainable standards of health to be achieved a lot has to put in place to guarantee a cautious shepherding process for the necessary amendments and clarifications. This will see Kenyans benefit from the constitutional promise and statutory recognition of a right to health. Other than statutory impediments, modest family sizes, an inexorably aged populace and an inflexible connection to the dead have led to an intense shortage of transplant organs in Kenya. Presently organ donation and transplant has not taken root in Kenya making it an unfamiliar idea, cultural and religious beliefs continue to stand in the way of amplifying the potential of utilizing organ donation and transplant to treat end stage organ failures. Public sensitization will hence complement a well crafted donation and transplant statute. In relation to the legal question of postmortem and antemortem intercessions to facilitate donation, it is well established that treatment without consent is assault.99 The Kenyan legal framework on organ donation, as it stands, has failed to address the adverse issues brought about by the concept of consent as it only provides for wills as the only means of expressing consent. Borrowing from countries that have put in place elaborate legal frameworks, patients may create anticipatory or advance directives, or appoint various kinds of legally valid guardians. In cases where patients who are potential donors are incapable of providing legally valid consent at the time, an alternative legal decision maker must be identified if there is no pre-existing consent. 99 Rogers v Whitaker (1992) 175 CLR 479. 41 A person consents if he or she agrees by choice, and has the freedom and capacity to make that choice.100 Consent matters because to locate consent with respect to organ donation and transplant is to locate the normative boundary between criminal and non criminal conduct. The concept of consent is greatly premised on an unequivocal voluntary agreement where the person by words, gestures or any form of non-verbal communication, communicates willingness to participate in the specific act. Thus, to absolve a person of criminal liability, consent must be given freely and it must not be obtained by fraud or by mistake or under a misconception of fact. There are two standards used in proxy decision making: known wishes, otherwise known as substituted judgment, and best interests. With the known wishes standard, decision makers must settle on choices as per the known wishes of the patient, that is, the thing that one would have chosen for oneself. The best interests’ standard requires proxy decision makers to exercise authority in the best interests of the patient. Clearly, these contemplations act in tandem, with choices about what the patient would have wanted being tempered by consideration of the best interests of the patient. In practical terms, numerous patients with the potential to be donors after cardiac death are unlikely to have appointed a proxy decision maker, so that decisions about their care should fall under the new legal framework that will be crafted to oversee matters organ donation and transplant in Kenya. The framework should authorise an appropriately appointed guardian to make medical decisions; in circumstances where donation after cardiac death is possible, this is usually a relative. The question of patients’ desires is moderately straightforward in jurisdictions where patients have registered their consent on the Organ Donation Register (AODR), or their families know about their wishes through discussions before the critical incident. As will be indicated below, I have highlighted that it may be ethically substantial to consider that consent to organ donation incorporates consent to all estimates important to guarantee a successful organ donation, particularly where such are not harmful to the patient. On the off chance that this is reflective in the new legal framework governing organ donation and transplant, there should be no hindrances 100 Sections 42 of the Sexual Offences Act, 2006 42 to guardian consent for antemortem intercessions, on the grounds that this is consent in accordance with the individuals known wishes. As to whether antemortem interventions can be justified legally under the best interests standard, antemortem interventions are not necessary to further the physical wellbeing of the patient. Rather, these intercessions to preserve organ quality are in the interests of the potential organ recipient. As they are not in the interests of the patient, it could be argued that the guardian cannot give consent because the intervention is beyond his or her authority. The issue of best interests was addressed by the UK House of Lords in their decision on Airedale NHS Trust v Bland,101 and the interpretation of best interests was recently cited with approval by the Administrative Decisions Tribunal of NSW.102The House of Lords decision concerned withdrawing life-sustaining treatment from 17 year old Anthony Bland who had post-coma unresponsiveness also known as persistent vegetative state after being crushed in the Hillsborough soccer riots in 1989. His interests were said to include his views and personality as well as how his family perceived and remembered him.103 In particular, the Law Lords acknowledged that a scope of contemplations should be taken into account when determining best interests: “The principle of the best interests of an incompetent . . . encompasses wider considerations than futility of treatment. A person is more than a biological collection of organs; they have thoughts and opinions, a personality and an interest grounded in these intangible considerations. When that person is dying, his or her physical interests diminish. The only interests left to be furthered are intangible interests, such as a wish to donate organs.” In Australia, the High Court has underscored that the “best interests approach offers no hierarchy of values” to guide decision making processes in difficult areas, and neither does it provide a general legal principle.104 Putting the above into consideration, for the case of Kenya, If it is inscribed into the new legal framework governing organ donation and transplant that it is 101 WK v Public Guardian (No 2) [2006] NSWADT 121. Ibid. 103 Airedale NHS Trust v Bland [1993] AC 789. 104 Secretary, Department of Health and Community Services v JWB and SMB(1992) 175 CLR 218 (Marion’s case), per Brennan J, 270. 102 43 in a person’s interests to have his or her wishes fulfilled, then taking all necessary measures to do so seems a logical step. 44 CHAPTER FOUR. 4.0 COMPARATIVE ANALYSIS. 4.1 Introduction. The regulation of organ donation and transplant has been marred with different approaches and legal responses all over the world. While some countries have fully employed the World Health Organisation guiding principles on organ donation and transfer, some countries have had problems in the use and regulation of the different modules highlighted under the WHO guiding principles in their jurisdictions. Various countries are yet to come up with elaborate laws in support of the use of organ donation and transplant as a therapeutic means for end stage organ failures, they are therefore, struggling and exposed to the dangers of organ trafficking. This chapter therefore delves into looking at the comparison between U.S.A and India with the conclusion drawing the differences in terms of how these two countries have sought to regulate the use of Organ donation and transplant and how Kenya can borrow largely from the two countries towards its own attempt in regulating the therapeutic use of organ donation and transplant in treating end stage organ failures. 4.2 U.S.A The aging population and increasing prevalence of chronic diseases in the United States are a major public health burden. Chronic medical conditions such as heart disease, cancer, lower respiratory disease and diabetes are the leading causes of mortality in the United States. The United States has witnessed several milestones in the field of organ donation and transplant from the year 1954 to present; in 1954, the first successful kidney transplant was performed. In 1966, the first simultaneous kidney/pancreas transplant was performed. In 1967, the first successful liver transplant was performed. In 1968, the first successful isolated pancreas transplant was performed. Further, the first successful heart transplant was performed. The Southeast Organ Procurement Foundation (SEOPF) was also formed as a membership and scientific organization for transplant professionals. In 1977, SEOPF implemented the first computer-based organ 45 matching system, dubbed the "United Network for Organ Sharing." In 1981, the first successful heart-lung transplant was performed. In 1982, SEOPF established the Kidney Center, the predecessor of the UNOS Organ Center, for round-the-clock assistance in placing donated organs. In 1983, the first successful single-lung transplant was performed and cyclosporine was introduced. In 1984, the National Organ Transplant Act (NOTA) was passed. The United Network for Organ Sharing (UNOS) separated from SEOPF and was incorporated as a nonprofit member organization. In 1986, the first successful double-lung transplant was performed and UNOS receives the initial federal contract to operate the Organ Procurement and Transplantation Network (OPTN). In 1987, the first successful intestinal transplant was performed. In 1988 the first split-liver transplant was performed. In 1989, the first successful living donor liver transplant was performed. In 1990, the first successful living donor lung transplant was performed. In 1992, the first successful living donor lung transplant was performed. UNOS helped found Donate Life America to build public support for organ donation. It prepared the first-ever comprehensive report on transplant survival rates for all active U.S. transplant centers. In 1995 UNOS launched its first Web site for all users with an interest in transplantation. In 1998, the first successful adult-to-adult living donor liver transplant was performed. In 1999, UNOS launched UNetsm, a secure, Internet-based transplant information database system for all organ matching and management of transplant data. In 2000, the U.S. Department of Health and Human Services publishes Final Rule (federal regulation) for the operation of the OPTN. In 2001 For the first time, the total of living organ donors for the year (6,528) exceeded the number of deceased organ donors (6,081). In 2006, UNOS launched DonorNetsm, a secure, Internet-based system in which organ procurement coordinators send out offers of newly donated organs to transplant hospitals with compatible candidates.105 The National Organ Transplant Act (NOTA), having been passed in 1984, established a federal task force that made recommendations for guidance of organ transplantation and authorized federal assistance for organ procurement management. In addition, this task force was instructed to do a comprehensive review of the economic, social, medical and ethical issues involved in organ transplant. The task force was also entrusted to make an assessment of immunosuppressive 105 United Network for Organ Sharing: History of Transplant. Available at http://www.unos.org/donation/index.php?topic=history 46 medication involved in prevention of rejection. 106Importantly, the task force was charged with assessing current methods utilized in coordination and procurement and highlighting barriers that would lead to improved equitable access. Another positive outcome from this act was the establishment of the Organ Procurement and Transplantation Network (OPTN) that would establish a unified national standard of coordination and provide data regarding listing of organs and adopt standards for acquisition and transport of donated organs.107 This OPTN was to be overseen by the U.S. Department of Health and Human Services (DHHS). The NOTA sought to establish a private non-profit organization under federal contract to operate the OPTN.108 The initial administration contract was awarded to the United Network of Organ Sharing (UNOS)109 on September 30, 1986 and continues to date.110 4.2.1 Legal basis of Organ donation and Transplant. 4.2.1.1 Uniform Anatomical Gift Acts The United States operates its organ donation system under an “opt-in” model in which the individual while alive or the next of kin or surrogate after the individual's death must explicitly choose to donate organs.111 U.S. states began enacting organ donation and procurement legislation in the 1960s when organ transplantation became a viable medical procedure. In 1968 the National Conference of Commissioners on Uniform State Laws promulgated the Uniform Anatomical Gift Act (UAGA) with the intent of promoting uniformity among states and simplifying the process of obtaining organs from deceased persons.112 106 National Organ Transplant Act: Public Law 98-507. United States statutes at large 1984;98:2339-2348. Health Resources and Services Administration, U.S. Department of Health & Human Services. OPTN (Organ Procurement and Transplantation Network). http://optn.transplant.hrsa.gov/ 108 National Organ Transplant Act: Public Law 98-507. United States statutes at large 1984;98:2339-2348. 109 United Network for Organ Sharing: About UNOS http://www.unos.org/about/index.php 110 Pomfret EA, Sung RS, Allan J, Kinkhabwala M, Melancon JK, Roberts JP. Solving the organ shortage crisis: the 7th annual American Society of Transplant Surgeons' State-of-the-Art Winter Symposium. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 2008;8(4):745-752. 111 Shepherd L, O'Carroll RE, Ferguson E. An international comparison of deceased and living organ donation/transplant rates in opt-in and opt-out systems: A panel study. BioMed Central Medicine. 2014;12(1). 112 Goodwin M. Black markets: The supply and demand of body parts. New York: Cambridge University Press; 2006. 107 47 The act permitted adults of sound mind to donate all or any body parts at death and required that donor intent be expressed in writing and signed by the declarant and two witnesses. In the absence of the decedent's authorization of donation prior to his or her death and in the absence of the decedent's known objection, the UAGA permitted the decedent's next of kin to donate the decedent's organs. To minimize confusion regarding who among next of kin is legally authorized to donate, the UAGA ranks relatives' legal authority to donate their deceased kin's organs by status. For example, the law ranks spouses above siblings, adult children, and parents. Even though the 1968 UAGA assigned priority to the decedent's prior decision to donate, it did not clearly state that the decedent's decision to donate should override the next of kin's choice.113 However, this priority was explicitly stated in the Comments to the 1968 UAGA: “Subsection (e) [of Section 2] recognizes and gives legal effect to the right of the individual to dispose of his own body without subsequent veto by others” .114 The lack of clarity in the UAGA itself made it easier for organ procurement teams to allow objecting next of kin to override the decedent's prior expressed decision to donate organs.115 The commissioners revised the UAGA in 1987 and again in 2006. The revisions in the 1987 UAGA were intended to accomplish several goals. First, they were intended to increase the supply of organs to meet rapidly growing demand. That is, while the 1968 UAGA clarified the status of who was legally authorized to donate, it did not explicitly attempt to increase the organ supply, even though that was an implicit goal. Second, the 1987 UAGA was drafted to come into compliance with the newly adopted federal law, the National Organ Transplant Act (NOTA).116 NOTA, enacted in 1984, banned the exchange of organs for “valuable consideration,” for example, paying donors for organs. The 1968 UAGA had not indicated whether organs could be sold, leaving the issue open to interpretation. The 1987 version adopted the ban on selling organs, but the “valuable consideration” language of NOTA was and continues to be subject to interpretation by the U.S. Department of Justice. 113 NCCUSL (National Conference of Commissioners on Uniform State Laws). Uniform Anatomical Gift Act. 1968. [August 30, 2017]. www.uniformlaws.org/shared/docs/anatomical_gift/uaga%201968_scan.pdf 114 NCCUSL. Estate, Probate, and Related Laws. 8A. St. Paul, MN: Thompson West; 2003. Anatomical Gift Act (1968) Uniform Laws Annotated. 115 Goodwin M. Black markets: The supply and demand of body parts. New York: Cambridge University Press; 2006. 116 National Organ Transplant Act, Public Law 98-507, 98th Cong. (October 19, 1984). 48 The 1987 UAGA also removed the requirement that two witnesses sign the donation document. Furthermore, it stressed that an individual's choice to donate organs cannot be revoked by others, thereby removing any uncertainty in this matter. It also granted medical examiners and coroners the authority to authorize the removal of a “body part” for transplantation under certain conditions when no prior objection by the decedent was known and when efforts had been made to contact the next of kin.117 Only 26 states adopted the 1987 UAGA, other states adopted nonuniform amendments to their anatomical gift acts resulting in a lack of uniformity among the states.118 Drafters of the 2006 UAGA removed the provision that allowed medical examiners and coroners to authorize removal of a “body part” for transplantation, particularly in response to controversies that had arisen regarding body part removal without authorization and to disparities in race and class that had been observed in these decisions. For example, a California study revealed that more than 80 percent of “presumed consent” cornea donors were black and Latino and that none of the families had been notified that the Los Angeles Coroner's office had procured their decedents' corneas.119 In some instances, where corneas were recovered, the relatives were not asked about their authorization for donation and others explicitly stated that they did not authorize donation.120 Some municipalities were sued in the wake of the 1987 UAGA, specifically in relation to this provision. Relatives of persons whose tissues were removed without authorization claimed that the states had violated their constitutional rights and desecrated their deceased relatives' bodies.121 Like the prior iterations of the UAGA, the 2006 law the most recent version provides that individuals aged 18 years or older may choose or refuse to make an anatomical gift. The law also permits anyone applying for a driver's license to offer authorization, allows for symbolic or oral 117 NCCUSL. Uniform Anatomical Gift Act (1987). 1987. Available at http://www.uniformlaws .org/shared/docs/anatomical_gift/uaga87.pdf. 118 NCCUSL. Revised Uniform Anatomical Gift Act (2006). 2006. Available at http://www.uniformlaws .org/shared/docs/anatomical_gift/uaga_final_aug09.pdf. 119 Goodwin M. Black markets: The supply and demand of body parts. New York: Cambridge University Press; 2006. 120 Frammolino R. Los Angeles Times. Nov 2, 1997a. Harvest of corneas at morgue questioned. http://articles.latimes .com/1997/nov/02/news/mn-49420. Frammolino R. Los Angeles Times. Nov 4, L.A. coroner alters policy on corneas. http://articles.latimes.com/1997/nov/04/news/mn-50061. 121 Newman v. Sathyavaglswaran, 287 F.3d 786, 800 (9th Cir. 2002); Brotherton v. Cleveland, 923 F. 2d 477, 481 (6th Cir. 1991). 49 communication of donative intent, disallows the possibility of authorization for the removal of body parts for transplantation by a medical examiner's office without the decedent's or the surrogate's authorization, and lets individuals other than the decedent make an anatomical gift unless the decedent expressly refused donation during his or her lifetime. The gift may be of the entire body or parts of the body, and the donor determines whether the gift will be used for education, teaching, research, or transplantation. The UAGA establishes the donation as property that can be transmitted to others by authorization of the decedent before death, by will, by next of kin or surrogate after death, or, in their absence, by the state. This statutory scheme is similar to that provided for other forms of property. With the goal of improving uniformity in the organ donation legislation across states, the 2006 UAGA, like the 1987 version, includes a first-person authorization provision preventing any family member or other responsible party from overriding a decedent's documented wish in favor of donation, just as they cannot override the decedent's refusal to make a gift. The act allows for express authorization to make an anatomical gift in several forms, including through a statement or symbol on a driver's license or a donor card or via a donor registry.122 4.2.1.2 National Organ Transplant Act of 1984 No national system existed before 1984 to oversee the recovery and allocation of organs from deceased donors for transplant. Because organs were in short supply, there was competition for and unequal access to donor organs. In response, Congress passed NOTA.123 The intent of NOTA is to ensure an equitable allocation of donor organs and to increase the number of organs available for transplantation. NOTA defines organs as the heart, lungs, liver, kidney, pancreas, and other organs, such as the small intestine, designated by the Secretary of the U.S. Department of Health and Human Services (HHS). NOTA also bans the sale of human organs for transplantation, with violations of the law punishable by up to 5 years in prison and a fine of $50,000. However, NOTA allows transplant surgeons, hospitals, transporters, and organ procurement organizations (OPOs) to receive compensation for their services. Following NOTA's enactment, the Uniform Law Commission amended the UAGA, as noted above, to 122 NCCUSL. Revised Uniform Anatomical Gift Act (2006). 2006. http://www.uniformlaws .org/shared/docs/anatomical_gift/uaga_final_aug09.pdf. 123 McDonald JC. The National Organ Procurement and Transplantation Network. JAMA. 1988;259(5):725–726. 50 prohibit the purchase and sale of organs for transplantation, but generally it remains legal to purchase and sell blood products, sperm, and ova.124 NOTA authorized the Secretary of HHS to form the nationwide Organ Procurement and Transplantation Network (OPTN) to coordinate the donation and transplantation system and process. The Omnibus Budget Reconciliation Act of 1986125 requires that all medical centres performing organ transplantation participate in the OPTN or forfeit their eligibility for federal Medicare and Medicaid payments. While membership in the OPTN is voluntary, in practice this legislation made membership in the OPTN and compliance with OPTN policy mandatory for all U.S. transplant centres because all of them accept federal payments. In 1998 HHS promulgated regulations known as the “Final Rule”126 to guide both the structure and the operation of the OPTN and to direct the OPTN to standardize transplant waitlist criteria and to group transplant candidates by medical urgency in order to allocate organs to the sickest patients first. Per NOTA requirements, the OPTN maintains a national waitlist of organ transplant candidates, allocates deceased donor organs to candidates on the waitlist, establishes policies concerning organ allocation, sets quality standards for the acquisition and transplantation of organs, coordinates the transportation of organs from OPOs to transplant hospitals, analyzes and publishes data concerning transplantation, and reports comparative costs and outcomes from the nation's transplant centres. The United Network for Organ Sharing (UNOS) is a private non-profit entity under contract with the Health Resources & Services Administration (HRSA) to operate the OPTN. NOTA also established regional OPOs, which are non profit entities responsible for coordinating the acquisition, preservation, and transportation of organs from donor hospitals to transplant centres. OPTN divides the United States into 11 geographic regions, which are further divided into donation service areas (DSAs); a DSA is a defined geographical area that is served exclusively by a single OPO.127 The DSAs vary widely in terms of population size, the number of transplant 124 Cohen IG. Can the government ban organ sale? Recent court challenges and the future of U.S. law on selling human organs and other tissue. American Journal of Transplantation. 2012;12(8):1983–1987. 125 Omnibus Budget Reconciliation Act of 1986, Public Law 99-509, 99th Cong. (October 21, 1986). 126 42 C.F.R. Part 121. 127 OPTN (Organ Procurement and Transplantation Network). Policies. Organ Procurement and Transplantation Network. 2017a. https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf. 51 centres and candidates, and the death rate of potential organ donors.128 UNOS promulgates the policies and standards for OPOs, and all OPOs are members of the OPTN.129 Members of the OPTN also include transplant centres, histocompatibility laboratories, medical scientific organizations, and public organizations. The OPTN's policies primarily focus on how individual organs are allocated among waitlisted candidates. There are separate policies for each organ (heart, lungs, liver, kidneys, intestine, and pancreas). Allocation policies take into consideration the location of the transplant candidates and the first criterion for the matching process, with the exception of livers, is the identification of a candidate within the OPO or donor hospital's DSA. If a suitable candidate is not found locally, OPTN/UNOS can offer the organ to regional candidates, followed by national candidates. OPTN/UNOS uses allocation algorithms that consider compatibility and other factors to identify suitable transplant candidates for specific organs. In general, the algorithms take into consideration a candidate's current medical condition, the length of time spent waiting for an organ, and in some cases a candidate's prognosis as determined by objective clinical tests. The allocation systems frequently undergo revision. The transplant coordinator from a transplant centre enters each transplant candidate's medical information into the OPTN/UNOS database, UNetSM, and designates the candidate as “active” meaning that the candidate can receive an organ at any given time or “inactive” meaning either that the candidate is not medically suitable for transplantation at that time or that the candidate needs to complete eligibility requirements before being listed as active. The database matches information about a donor organ with the medical characteristics of active candidates on the waitlist. This generates a list that ranks active candidates according to the allocation rules. The OPTN offers the organ to the transplant centre of the top ranking matched candidate. If the organ is refused by either the transplant candidate or the candidate's transplant hospital, the OPTN contacts the next highest ranking matched candidate's transplant centre. The process continues until the OPTN finds a candidate and transplant hospital willing to accept the organ.130 OPOs receive fees for coordinating this process; under NOTA these fees are defined as “reasonable 128 OPTN. Deceased donors recovered in the U.S. by donor age. 2017b. https://optn.transplant.hrsa.gov/data/viewdata-reports/national-data. 129 OPTN. Members. 2017d. https://optn.transplant.hrsa.gov/members. 130 OPTN (Organ Procurement and Transplantation Network). Policies. Organ Procurement and Transplantation Network. 2017a. https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf. 52 payments associated with the removal, transportation, processing, preservation, quality control, and storage of a human organ.”131 In 1987 NOTA established the Scientific Registry of Transplant Recipients (SRTR) to track information about transplant candidates and recipients and transplant procedures that are deemed necessary for the ongoing evaluation of organ transplantation. The SRTR databases contain both historical and up-to-date information about the transplantation process, including detailed information on waitlist candidates, transplant recipients, and survival statistics. These data help inform the development of “evidence-based policy to support analysis of transplant programs and OPOs, and to encourage research on issues of importance” related to transplantation.132 4.2.1.3 The Common Rule The Federal Policy for the Protection of Human Subjects, or the Common Rule, was published in 1991 and is the basic set of U.S. federal regulations that protect all human subjects in any federally funded research. Specifically, it states “the basic provisions for institutional review boards, informed consent, and Assurances of Compliance,” and it “applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.”133 In addition, “Research that is neither conducted nor supported by a federal department or agency but is subject to regulation as defined in § 46.102(e) must be reviewed and approved, in compliance with § 46.101, § 46.102, and § 46.107 through § 46.117 of [the Common Rule], by an institutional review board (IRB) that operates in accordance with the pertinent requirements of this policy.”134 It is relevant to note that research covered under the Common Rule also “may be subject to further appropriate review and approval or disapproval by officials of the institution.”135 The Common Rule states that “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains Data through 131 National Organ Transplant Act, Public Law 98-507, 98th Cong. (October 19, 1984). SRTR (Scientific Registry of Transplant Recipients). About SRTR. 2017a. https://securesrtr.transplant .hrsa.gov/about.aspx. 133 45 C.F.R. § 46.101. 134 45 C.F.R. § 46.101 (a)(2). 135 45 C.F.R. § 46.112. 132 53 intervention or interaction with the individual, or Identifiable private information.”136 By virtue of not being “living individual(s),” donors who are declared deceased by neurologic or circulatory criteria fall outside of the protections of the Common Rule, and therefore obtaining permission from deceased individuals or their surrogates is not required for their participation in research. To be clear, even though the requirement of informed consent under the Common Rule does not apply to deceased donors, authorization for organ donation, even if the organs are used only for research purposes, is still required under the UAGA. The ethical principles inherent in the UAGA focus on respect for persons by honoring the decedent's determination of what should be done with his or her body after death. A final rule amending provisions of the Common Rule was promulgated on January 19, 2017, with an effective date of January 19, 2018.137 The final rule “is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators”. The purpose of the new regulatory action is to promote research by asking human subjects to “assume risk to advance the research enterprise, which benefits society at large”. The revised definition of human subjects reads, Human subject means a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or bio specimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or bio specimens; or Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable bio specimens.138 Even with this revised language, deceased donors are still not considered human subjects within the meaning of the Common Rule, although authorization for donation is still required for compliance with the UAGA. The Common Rule's regulations that are pertinent to transplant recipients are discussed in detail later in the chapter. 4.2.1.4 U.S. Food and Drug Administration Regulations The U.S. Food and Drug Administration (FDA) has regulations pertaining to research on deceased organ donors that are similar to but not identical with those in the Common Rule. The 136 45 C.F.R. § 46.102(f). Federal Register. Federal policy for the protection of human subjects. Federal Register. 12. Vol. 82. 2017. 2017. pp. 7149–7274. 138 Ibid. 137 54 corresponding definition in FDA regulations reads, “Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.”139 FDA regulations do not specify whether one must be alive to be a human subject. Nevertheless, this language has been understood by ethics, regulatory, and legal communities to imply that deceased donors are not human subjects because they are neither “healthy humans” nor “patients,” and it is strained to think they become a participant in research after death140 , However, significant confusion remains in the transplant community as to how to interpret the above language.141 The committee interpreted the regulations to mean that neither the Common Rule nor FDA's human subjects research regulation applies to deceased organ donors even though the UAGA still applies to deceased donors. 4.2.2 Living and Deceased Donation. According to the U.S. Department of Health and Human Services, organ donation is defined as the “surgical process of providing one or more organs to be used for transplantation into another person”.142 There are two types of organ donors, living and deceased. A living donor can provide one kidney, one lung, and in some limited instances partial liver tissue. A deceased donor can donate six types of organs: heart, lungs, liver, pancreas, kidney and intestines. Deceased donors can also provide other viable tissue such as veins, heart valves, skin grafts and corneas. Organ donation by living donors, either genetically related or non-related, yields a better prognosis for the recipient compared to deceased donors. Recipients receiving organs from deceased donors are 20% less likely to have a functioning organ at 5 years.143 Projected graft half-life estimates have shown living graft survival to be 21.6 years for living donors compared with 13.8 years for deceased donors.144 139 21 C.F.R. § 50.3(g) and § 56.102(e). Glazier AK, Heffernan KG, Rodrigue JR. A framework for conducting deceased donor research in the United States. Transplantation. 2015;99(11):2252–2257. 141 Rodrigue JR, Feng S, Johansson AC, Glazier AK, Abt PL. Deceased donor intervention research: A survey of transplant surgeons, organ procurement professionals, and institutional review board members. American Journal of Transplantation. 2016;16(1):278–286. 142 U.S. Department of Health & Human Services. http://www.organdonor.gov/about/index.htm 143 Health Resources and Services Administration, U.S. Department of Health & Human Services. OPTN (Organ Procurement and Transplantation Network). http://optn.transplant.hrsa.gov/ 144 Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. The New England journal of medicine 2000;342(9):605-612. 140 55 However, availability of organs from living donors is limited the ability to extract a limited number of organs such as only one kidney, partial liver, lung lobe and portion of pancreas or intestine. Additionally, donations of the heart, intestine, and cornea are limited. Deceased donors on other hand are capable of donating multiple organs; therefore deceased donors constitute the majority of the donor pool. To date 82% of donated organs come from deceased donors and 18% from living donors.145 Deceased donation allows for multiple organs to be harvested from deceased donors who previously consented to organ donation, after being declared clinically brain dead or expired. Whereas the process differs slightly by locale, adults over 18 years and minors with parental consent can register to be deceased donors with state agencies at their public offices. For example, in Texas a person may register at the local Department of Public Safety office, or via mail, fax or online at the Glenda Dawson Donate Life Texas Registry, which is the official state site. In addition, there are many non-profit organizations that conduct donor registration drives. Living donations are categorized into related, non-related, non-directed, paired exchange donations; two recipients exchange organs that are more compatible, blood type incompatible, positive cross match; incompatible antibodies and deceased exchange; similar to paired exchange except one organ is from a deceased donor.146 In order to become a living donor, the process requires much more engagement. First, one must contact the transplant centre of choice. Then introduction to the transplant team that deals with your donor organ of interest takes place along with tests to qualify the donor for medical clearance. These tests may include blood testing, tissue typing, cross matching, antibody screening, urine test, psychiatric and psychological evaluation; relationship to donor, financial support, employment impact, childcare, emotional preparations etc. and gynaecological examinations for female donors.147 After completion of the required testing, thorough considerations and risk identification, living donors can then be listed as donors in the UNOS database. The UNOS computer system identifies recipient candidates with a matching donor profile similar to donor profile, and the transplant centres are provided with an electronic rank list. The recipient transplant team will 145 Ibid. United Network of Organ Sharing (UNOS): Living Donation. Avaibla at http://www.transplantliving.org 147 Ibid. 146 56 then consider the organ and choose to either accept or decline the offer. If declined, then the organ is made available to the next recipient on the rank list, and this process continues until the organ is accepted.148 4.2.3 Strategies to Increase Organ Donation The most significant approach to increase the supply of organs as employed in USA has been to increase the number of voluntary organ donors. This has been effected by: educating the public as to their the role in the organ transplant ecosystem; promoting awareness of organ donation in the population; increasing donor drives to add people to state donor registries149; and supporting legal and clinical community advocacy.150 The use of social media such as Facebook, YouTube and other websites bas been instrumental in linking donors to recipients151 and has been utilized to engage prospective donors. Another incentive that has been purposed is offsetting donor’s fiduciary responsibilities, such as in the form of income tax credit and guaranteeing health insurance.152 However, early experience with pure monetary incentives especially in developing countries has been associated with poor outcomes.153 Another strategy that has been utilized in attempts to increase donor availability is the use of expanded donor criteria (EDC), where the donor has pre-existing medical conditions that may lead to organ dysfunction making those organs less than ideal for transplantation, but are nevertheless accepted for donation. However, transplanting such organs has not led to a significant improvement in the morbidity and mortality rates in the recipient post transplant.154 148 United Network for Organ Sharing: About UNOS available at http://www.unos.org/about/index.php Texas Donor Registry: Donate Life Texas. Available at https://www.donatelifetexas.org/about-the-registry 150 American Society of Transplantation. Available at http://www.a-s-t.org/content/ast-transplant-advocacy-award 151 Davis CL. How to increase living donation. Transplant international : official journal of the European Society for Organ Transplantation 2011;24(4):344-349. 152 Rodrigue JR, Crist K, Roberts JP, Freeman RB, Jr., Merion RM, Reed AI. Stimulus for organ donation: a survey of the American Society of Transplant Surgeons membership. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 2009;9(9):2172-2176. 153 Rizvi SA, Naqvi SA, Zafar MN, Mazhar F, Muzaffar R, Naqvi R, Akhtar H, Ahmed E. Commercial transplants in local Pakistanis from vended kidneys: a socio-economic and outcome study. Transplant international : official journal of the European Society for Organ Transplantation 2009;22(6):615-621. 154 Iordanous Y, Seymour N, Young A, Johnson J, Iansavichus AV, Cuerden MS, Gill JS, Poggio E, Garg AX. Recipient outcomes for expanded criteria living kidney donors: the disconnect between current evidence and practice. American journal of transplantation 2009;9(7):1558-1573. 149 57 A better understanding of organ donor and recipient populations has also been put into place to develop strategies that can effectively address the challenges facing the organ supply chain and reduce the impact of chronic diseases for key groups. 4.3 India Kidney transplants in India first started in the 1970s and since that time, India has been a leading country in this field on the Asian sub-continent. The evolutionary history of transplants in the last four decades has witnessed a different facet of transplant emerging in each decade. The first 10 years were spent mastering the surgical techniques and immune-suppression. Its success resulted in a phenomenal rise in the numbers of transplants in the next 10 years and unrelated kidney donation from economically weaker sections started taking place with commerce in organ donation becoming an acceptable integral part of the program. After this was accepted, the ethics of transplants in India has always been on a slippery slope and all kinds of nefarious activities were accepted as normal practice. The general dictum was “when you can buy one why donate?” The next 10 years saw an outcry from the physicians of the western world at the growing numbers of these exploitative transplants being done in India. There were also protests from many sections in India. The pressure on the Government saw the passing of the Transplantation of Human Organ Act (THO) legislation that made unrelated transplants illegal and deceased donation a legal option with the acceptance of brain death.155 Overcoming organ shortage by tapping into the pool of brain-dead patients was expected to curb the unrelated transplant activity. The last decade has seen the struggle of the deceased donation program evolve in India. Simultaneously, it has witnessed the living donation program being marred with constant kidney scandals. In most instances, the donor accused the recipient or the middle man of having not compensated them with the promised sum. It also saw liver, heart, and pancreas transplants from deceased donors. Although the history of cadaver transplants in India is recent, the first attempts to use a cadaver donor's kidney were undertaken in 1965 in Mumbai. The author describes the medical and social problems they faced. The medical problems included technical difficulties in engrafting, immunological problems, and infection. However, it was the hostile reaction from some members of the medical profession and the general public that was a more daunting task to 155 Government of India. Transplantation of Human Organs Act, 1994. Central Act of 1994 Available from: http://wwwmedindianet/tho/thobill1asp. 58 tackle. The whole process was described by some as neo-cannibalism. This was a setback for the cadaver program for not only Mumbai but also rest of the country.156 In India, despite the THO act, neither has the commerce stopped nor have the number of deceased donors increased to take care of organ shortage.157 The concept of brain death has never been promoted or widely publicized. Most unrelated transplants currently are being done under the cloak of legal authority from an authorization committee. The few deceased donations that are taking place are due to the efforts of a few Non Government Organizations (NGO) or hospitals that are highly committed to the cause. Recently, the government has come under much criticism by the public and media and has added a few legislations in the form of a Gazette to curb the illegal unrelated donation activities and has tried to plug the loopholes in the THO act.158 To a large extent, the failure of the THO act has been because of the way it has been interpreted and implemented by authorities and hospitals. 4.3.1 Legal basis. 4.3.1.1 Transplantation of Human Organ Act (THO) For living donation the Act defines those who can donate without any legal formalities, they are highlighted as relatives who include mother, father, brothers, sisters, son, daughter, and spouse. Recently, in the new Gazette grandparents have been included in the list of first relatives. The first relatives are required to provide proof of their relationship by genetic testing and/or by legal documents. In the event of there being no first relatives, the recipient and donor are required to seek special permission from the government appointed authorization committee and appear for an interview in front of the committee to prove that the motive of donation is purely out of altruism or affection for the recipient. 156 The Bombay Experience with Cadaver Transplant—Past and Present Indian Transplant Newsletter. 1999;1:3. Karnataka's unabating kidney trade, Frontline. 2002;19:07. 158 Transplantation of Human Organs Rules. 1995. (GSR NO. 51(E), dr 4-2-1995) [As amended vide GSR 571(E), dt31-7-2008] Available from: http://wwwmedindianet/indian_health_act/The-Transplantation-of-Human-OrganRules-1995-Definitions.htm. 157 59 for brain death to suffice, two certifications are required 6 hours apart from doctors and two of these have to be doctors nominated by the appropriate authority of the government with one of the two being an expert in the field of neurology. Regulation of transplant activities is done by the Authorization Committee (AC) and Appropriate Authority (AA.) in each State or Union Territory. The role of the Authorization Committee include: regulating the process of authorization to approve or reject transplants between the recipient and donors other than a first relative. The primary duty of the committee is to ensure that the donor is not being exploited for monetary consideration to donate their organ. The joint application made by the recipient and donor is scrutinized and a personal interview is essential to satisfy to the AC the genuine motive of donation and to ensure that the donor understands the potential risks of the surgery. Information about approval or rejection is sent by mail to the concerned hospitals. The decision to accept or reject a donor is governed by Sub Clause (3), Clause 9 of Chapter II of the THO act. The role of Appropriate Authority include: regulating the removal, storage, and transplantation of human organs. A hospital is permitted to perform such activities only after being licensed by the authority. The removal of eyes from a dead body of a donor is not governed by such an authority and can be done at other premises and does not require any licensing procedure. The powers of the AA include inspecting and granting registration to the hospitals for transplant surgery, enforcing the required standards for hospitals, conducting regular inspections of the hospitals to examine the quality of transplantation and follow-up medical care of donors and recipients, suspending or cancelling the registrations or erring hospitals, and conducting investigations into complaints for breach of any provisions of the Act. The AA issues a license to a hospital for a period of 5 years at a time and can renew the license after that period. Each organ requires a separate license. 4.3.2 Legal implications. The provisions available in Sub Clause (3), Clause 9 of Chapter II of the THO act states “If any donor authorizes the removal of any of his human organs before his death under sub-section (1) of Section 3 for transplantation into the body of such recipient, not being a near relative as is specified by the donor, by reason of affection or attachment towards the recipient or for any other special reasons, such human organ shall not be removed and transplanted without the prior 60 approval of the Authorization Committee” has been misused or misinterpreted by one and all over the years, since the act was passed. The problem has been on how to use Sub-Clause (3), Clause 9 of Chapter II of the THO act and how to protect the exploitative element in the word affection. In 1997, Dr. M.K. Mani, a leading Nephrologist in Chennai, summarized the above very well when he wrote: “The stalwarts of the unrelated live donor program continue to do as many transplants as they did before the Legislative Assembly of Tamil Nadu adopted the Act. What is more, they do them with the seal of approval from the Authorization Committee and are therefore a very satisfied lot. The law, which was meant to prohibit commercial dealings in human organs, now provides protection for those very commercial dealings.” Dr. Mani's article is titled ‘The Law is an Ass’.159 After a major kidney racket in Tamil Nadu, the Department of Health issued a notification in form of a ‘Government Order’ trying to absolve all responsibilities to prove relationship or any possibility of commerce with AC. It categorically stated that the responsibility to prove such a relationship was solely on the doctors of the hospital who signed the document to request for an interview. However, this was against what the THO act itself states and the role it defines for authorization committee. When the legal standing of the order was questioned, the order was withdrawn. The new Gazette now requires videotaping of the whole proceedings of the interview. In addition, it also gives guidelines to the AC and clearly states that there should be no tout or middleman with the donor having to provide an explanation of why he wishes to donate with documentary proof of having lived together; old Photographs and information about his vocation with financial statements from the previous 3 years. Taking away the ambiguity of the term affection and giving it the seriousness it deserves may go some way in preventing the sale of organs.160 Despite the THO Act coming into force in India it has neither curbed commerce in organs nor helped promotion of the deceased donation program to take care of the organ shortage. The gap between the numbers of organs available and the number of patients joining the waiting list for a 159 Mani MK. Making an Ass of the Law. Letter from Chennai. Natl Med J India. 1997;10:242–3. Sunil Shroff, Legal and ethical aspects of organ donation and transplantation. Indian J Urol. 2009 Jul-Sep; 25(3): 348–355. 160 61 kidney transplant is widening globally. The high demand of organs has led to its commodification which continues to affect the utilization of organ donation and transplant as a therapeutic means of treating end stage organ failures. 4.4 Conclusion Drawing from the above comparative study countries, Kenya has a long way to go in terms of putting in place a viable legal framework. Many countries have resolved to employ the opt out system of organ donation in order to curb organ shortages which has greatly impacted donation and transplant in terms of access by those at the waiting lists. Commercialization of organs and transplant tourism as is the case of India continues to stand in the way of fully utilizing the benefits presented by organ donation and transplant, further, the management of organ registries continues to be hindrance save for USA which has employed technological advancements in that field. Kenya can thus learn a lot from successes and failures from different jurisdictions to come up with a more viable legal framework. 62 CHAPTER 5 5. CONCLUSION AND RECOMMENDATIONS. 5.1 Introduction. Organ donation and transplant has generally received positive responses worldwide as a remedy to end stage organ failures. It may be the only treatment available for some forms of end stage organ failure and is the most clinically effective and cost effective treatment for chronic renal failure. The legal framework on organ donation and transplant in the country is not a robust one despite the fact that therapeutic treatment of end stage organ failures has been in use in the country. Considering that the process of organ donation and transplantation is a complex process which involves a long series of stages which should be followed rigorously in order to be effective, there is need for a new and more specific legislation was to be put into place. This chapter therefore concentrates on the conclusion and recommendations of the thesis paper by giving tentative propositions on coming up with a viable legal framework for organ donation and transplant in Kenya drawing largely from the comparative analysis of countries that have attempted to develop a sound and robust jurisprudence and legal framework surrounding the use of organ donation and transplant to treat end stage organ failures. 5.2 Tentative propositions on coming up with an elaborate legal framework on organ donation and transplant in Kenya. In conclusion, organ donation and transplant poses as much legal challenges as they pose opportunities. The key to striking a delicate balance between these two lies in the regulation of donation and transplant allied transactions in the country. It is also prudent to conclude that as a country, organ donation and transplant as a means of therapeutic treatment of end stage organ failure will be of much benefit to the citizens. As it stands however, the country is likely to face a lot of legal challenges with the current health act provisions on organ donation and transplant. Clear legislative and regulatory frameworks are the essential system requirement to ensure ethical and transparent practices in organ procurement, retrieval, allocation, and transplantation. The 63 specific requirements do entail the legislation and regulation aspects: As for Regulation and oversight, regulatory bodies are central to the monitoring practices, standards, and outcomes of organ donation and transplantation programs and, therefore, must be informed by an all-inclusive surveillance and data collection. Regulatory oversight should steer ethical standards, advance policy, and quality management. Essential areas for regulation and oversight include: Organ procurement procedures; Development of new policies and introduction of new procedures; Reimbursement policies; Eligibility of living donors and consent processes; Quality assurance systems (control/audit and professional education and training); Allocation rules. Under legislation, a lucid definition of brain death and circulatory death is essential to facilitate donation from deceased persons, together with legislation governing the procurement and transparent allocation of organs and the establishment of Organ Procurement Organisations. Legislation should also envelop the anticipation of organ trafficking and commercialism and formal measures for consenting donors. Critical areas for legislation are Declaration of death; deceased and living Organ procurement; Fair and transparent allocation principles; Consent; Establishment of transparent organizations; Prohibition of organ trafficking and commercialism. The Health Act 2017, as it currently stands, can be highlighted to as a legislation of hope rather than a guarantee of access to organ donation services. The demand for donor organs in Kenya has increased inexorably over the years prompting those in need to seek for such services in established countries save for worldwide organ shortage. The gap between those needing life saving transplant and the number of individuals with a desire to donate is far wider hence the demand for organs continues to soar higher. It is indisputable that numerous essentials necessary for clear legal framework relevant to Organ donation and transplant have been left out as per the Health Act 2017. Urgent attention is thus required to resolve outstanding legal, ethical and professional issues in order to ensure that all Organ donors, recipients and medical practitioners are supported and able to work within a clear and unambiguous framework of good practice. The implementation of the Health Act on matters organ donation presents a complex programme of change which entails various ingredients; firstly creating and communicating a vision of organ donation in Kenya, secondly introducing the structural elements of a new legal framework into 64 practise and lastly creating the environment upon which the new elements enshrined under the framework can deliver the overall donation goals. 5.2.1 Promoting and developing organ donation. This entails identifying barriers to donation and transplantation and hindrances to the entire process and prescribing arrangements on approaches to overcome such barriers within existing operational and legal frameworks in Kenya. For donation and transplantation to flourish in Kenya, there is critical need for establishment and improvement of the vital components of the donation pathway. The key elements include: provision of a far reaching and workable professional, ethical and legal frameworks for organ donation; a more effective organizational support for donation and creating a public support for organ donation. It is to my discernment that there is need to establish donation as a ‘typical not irregular’ component of end-of-life care in appropriate patients and recognized that, for every hospital to make donation ‘core business’, additional clinical and operational support would be required locally and nationally. The above proposals are coordinated towards accomplishing the objective of establishing donation as ‘core business’. When viewed as a whole, these represent an intelligible and comprehensive framework for organ donation as was the case in the UK.161 As opposed to being adjusted against explicit components of the donation pathway, the proposals create a framework in which the particular snags to donation can be systematically identified and overcome. Because of a shortage of organ donors in Kenya constant efforts are supposed to be made to improve public education around organ donation and brain death. However, education among medical professionals on matters donation and transplant is still lacking.162 This can in turn be addressed by introducing lectures on organ donation and transplantation in medical schools.163 Despite some financial investment being required to implement these proposals, the delivery would be 161 Murphy P, Bion J. Organ donation update. Bull Roy Coll Anaesth 2010; 61: 6–8 Sobnach S, Borkum M, Hoffman R, et al. Medical students’ knowledge about organ transplantation: A South African perspective. Transplantation Proceedings 2010;42:3368-3371. [http://dx.doi.org/10.1016/j.transproceed.2010.08.036] 163 Muller E, Barday Z, Mendelson M, et al. Renal transplantation between HIV-positive donors and recipients justified. S Afr Med J 2012;102(6):497-498. 162 65 more dependent on people, and noted that overcoming the obstacles to donation would require ‘leadership, boldness and willingness to change established practice’.164 5.2.2 What would be the best donation option for Kenya? Currently, systems such as the UK and the US are moving to amend their laws to augment the potential of organ transplantation. One way they are seeking to do this is by changing the system of organ donation and allowing for reimbursement of living donors. England, for instance, started using a new law from August 2020, the Organ Donation (Deemed Consent) Act, 2019, which changes the system of donation to an ‘opt out’ system. This way, every adult will be considered a donor unless they have expressly decided not to or are in the excluded groups. The US, on the other hand, is proposing new rules to increase the number of organ transplants by, among other things, reimbursing living donors for lost wages during hospitalisation and recovery. There is a huge demand of organs in Kenya which cannot be solved by focusing solely on living donation but on deceased donation too. Kenya has a total population of 54 million people, as at 15th December 2020165, amongst whom many have been affected or are at a risk of contracting diabetes or are hypertensives which are major causes of organ failures. The emphasis on living organ donation alongside deceased organ donation is therefore the need of the hour. In countries where deceased donation rates are high the living organ donation and transplantation are also going on simultaneously. Spain, a country with highest deceased organ donors had 35.1 per million population deceased donors and 8.6 living organ donors pmp in 2013, similarly USA that had 25.9 deceased donors pmp, the living organ donors were 18.8 pmp during the same year.166 The dead are indeed the chief wellspring of organs for transplantation. As it stands, a single organ and tissue donor can save or improve the lives of more than eight people; helping to 164 Organs for Transplants. A Report from the Organ Donation Taskforce. London: Department of Health, 2008. Available from <http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_082122> 165 World meter, Kenyan population live. Available at www.worldmeters.info. 166 IRODaT (December2014).International Registry in Organ Donation and Transplantation .[Online] Retrieved from http://www.irodat.org/img/database/grafics/newsletter/IRODaT%20Newsletter%202013%20.pdf NEWSLETTER 2013 66 restore eyesight, damaged tissues or vital functions.167 For quite a while deceased donors came from those declared brain dead, that is, those who have irreversibly lost their brain function. However, in recent years, many donors have come from those who have died in the sense of circulatory death. Both donation after brain death and donation after circulatory death invite the important philosophical, not just medical, question “what is it to be dead”? Donation after cardiac death offers an alternative pathway to donation for people who do not meet the criteria for donation after brain death.168 Donation after cardiac death, although not a new procedure, was relatively neglected once there was inescable acceptance of organ donation after brain death. Given the relative scarcity of donated organs, there has been renewed interest in donation after cardiac death internationally.169 Donation after cardiac death raises a number of specific ethical and legal issues, including potential or perceived conflicts of interest, treatment withdrawal processes, uncertainty about time of death, and consent. One way of increasing organ donation drastically is to utilize patients after circulatory death in a donation after cardiac death (DCD) programme. Patients who are not brain dead and perhaps won’t become brain dead can still give consent for organ donation after cardiac death if they die of a suitable cause. In most European countries this type of organ donation has extended drastically over the last 10 years. In Spain and the USA, DCD donor rates now equal the traditional brain-dead donor rates. In the case of a dismal prognosis and a choice to pull out treatment from a patient, the treating physician is asked to consider referring the patient to the transplant team as a DCD donor. This is then followed up with a conversation with the family and consent is obtained for organ donation after cardiac or circulatory death. The family does not need to understand the concept of brain death they are only asked for permission to use the patient as an organ donor once the patient’s 167 To give an idea of the impact of organ donors, in 2014, there were 29,532 transplants in the U.S. from just 14,412 donors. Alyse Bernal, ‘The Gift of Life: What to Know About Organ Donation and Transplant’, Seattle children’s hospital and research Foundation, April 30, 2015 168 Bhonagiri D, Wills P. Potential for organ donation in Victoria: an audit of hospital deaths [letter]. Med J Aust 2007; 186: 157. 169 Australians donate. Proceedings of the Non-Heart-Beating Donation Symposium; 2004 Nov 26; Melbourne. 67 heart has stopped and circulation has ceased.170 Drawing from the above exposition, for Kenya to meet the supply of organs in relation to the patients facing end stage organ failure, it would be of great importance to formulate an elaborate legal framework which will be well premised not only on the concept of living donation but also deceased organ donation. The dead are highlighted as the most integral organ donors as a single donor can save up to 8 individuals facing end stage organ failure, thus Kenya should go the “opt out” way as this as this has been established as to meet organ shortage compared to living donation. 5.2.2.1 Increasing organ donation and transplantation by using marginal donors. Numerous new programmes have been introduced to improve organ donor numbers. The use of marginal donors is being explored worldwide and, as a result, the threshold for utilzing patients with pre-existing medical conditions as organ donors is getting lower. South Africa has a tremendous HIV-positive populace and for this reason an HIV positive to positive transplant programme was started at Groote Schuur Hospital in 2008 for HIV positive patients with end stage renal failure, to date 22 patients have received transplants, with good outcomes. 171 This is an efficient example of the many programmes that can be initiated by the new legal framework in Kenya in order to augment donation levels and to ease congestion in the organ recipient list. There is need to develop a protocol to identify potential donors, including the registration of donors, and to clarify the roles and responsibilities of hospital professionals in donor identification. The new legal framework should put into place necessary measures to ensure that: a quality improvement programme for organ donation is put in place in every hospital where there is a potential for organ donation, the quality improvement programme is primarily a selfevaluation of the whole process of organ donation, jointly performed by the specialists in intensive care and the transplant co-ordinator of every hospital. Whatever the nature of the programme, it should represent an appropriate mechanism for monitoring the whole process of organ donation in intensive care units, the hospital programme is harmonised at county and Sobnach S, Borkum M, Hoffman R, et al. Medical students’ knowledge about organ transplantation: A South African perspective. Transplantation Proceedings 2010;42:3368-3371. [http://dx.doi.org/10.1016/j.transproceed.2010.08.036] 171 Muller E, Kahn D, Mendelson M. Renal transplantation between HIV-positive donor and recipients. N Engl J Med 2010;362(24):2336-2337. [http://dx.doi.org/10.1056/NEJMc0900837] 170 68 national level in order to compare adequately the results obtained and to adopt the most appropriate measures to improve organ donation. External audits should be performed by experts from other hospitals, regions or countries regularly after the implementation of the self evaluation programme, in order to further improve the process and provide greater transparency. This will meet the objectives of the programme which are: definition of the theoretical capacity of organ procurement, depending on the characteristics of the hospital, detection of obstacles to the process of organ donation and procurement and analysis of the causes of potential donor losses, as a tool to identify areas for improvement and description of factors with regard to hospitals which can influence the donation and transplantation process. A systematic review of all medical records of patients who have died in intensive care units (ICU) and possibly in other similar units should performed on a regular basis in order to analyse any undetected potential donor and establish means for improvement. In every hospital the following data must be periodically monitored: General data: number of available hospital beds, number of available ICU beds, number of neurosurgery procedures, number of patients admitted to the ICU and emergency rooms. Specific data: hospital deaths, brain deaths, number of potential organ donors and the number of organ donors. Appropriate standards must be defined in every county according to the characteristics of the hospital and the health system in order to compare the results with those of the national hospitals so as to better define the areas for improvement. 5.2.3 National transplant organisation. A properly established and managed transplantation system is essential to maximise the rate of organ and tissue donation and provide equitable access to transplantation services for patients by guaranteeing the allocation of organs and tissues following rules which are transparent, objective and justified according to medical criteria, and by guaranteeing traceability and accountability. The new legal framework should set up a comprehensive national transplantation system (NTS) for the authorisation, organisation and monitoring of organ, tissue, and cell donation and transplantation, taking into account the differences in the procedures of organ, tissue and cell donation and transplantation in member states. 69 The NTS should have a statutory basis which clearly sets out the structure of the system, its powers and responsibilities. It is preferable to have a single public body (a national transplant organisation (NTO)) which is officially recognised, and non-profit making with overall responsibility for donation, allocation, traceability and accountability. However, a combination of county, national and/or international bodies may work together to co-ordinate donation, allocation and/or transplantation, provided that the framework in place ensures accountability, co-operation and efficiency. The NTS should have competencies and mechanisms to organise and oversee the whole process of donation and transplantation including: public education on transplantation, organ and tissue donation and retrieval; national transplant recipient waiting lists, organ and tissue allocation; organ and tissue transportation including international exchanges; authorisation of organ transplant teams or institutions; the traceability of organs and tissues and monitoring of outcomes of transplantation and donations from living donors. Other NTS competencies may include research into transplantation and responsibility for identifying and reporting to the relevant authorities any breaches of the national transplantation law. 5.2.4 Training of professionals. Considering that the transplant process is complex as it involves various services, it therefore requires effective organisation and co-ordination of health care professionals. In states with elaborate legal frameworks, training and employment of health care professionals responsible for detecting potential deceased organ donors and organising the donation process has increased the efficiency of the procurement of organs and improved the functioning of local and national transplant system. It is thus to my recommendation that, a professional responsible for the identification of potential deceased organ and/or tissue donors should be appointed in every hospital with an intensive care unit. This professional should have appropriate training and experience, be independent of any transplant teams, and have clearly defined responsibilities for the establishment, management and audit of a hospital-based system for potential deceased donor identification and organ/tissue procurement. The person should also be responsible for monitoring the donation and procurement process and for identifying and implementing improvements. For the purposes of 70 this recommendation, the professional will be termed a transplant “donor coordinator”. Donor co-ordinators should be properly accountable to senior management of the relevant health institution and to any national or county transplant organisations. Donor co-ordinators may be complemented by, or responsible to, other transplant co-ordinators at regional or national level. Donor co-ordinators, and any other transplant co-ordinators should have a high standard of professional training consistent with internationally recognised standards, to ensure the highest possible professional and ethical standards in organ donation and procurement. Member states should establish formal national or international accreditation for donor co-ordination activities/donor co-ordinators. 5.2.5 Authorisation of facilities. In order to provide high-quality donation and transplant services for the benefit of the citizens, the new legal framework should be inclusive of measures that ensure the highest professional standard; an appropriate mechanism for the authorisation172 of health care facilities carrying out organ transplantations should be set up. In order to obtain authorisation these facilities should meet the following criteria: feasibility of programme, based on clinical need assessment and a documented estimate of organ supply, to ensure that projected activity levels are sufficient to maintain clinical expertise and programme quality, standards of vocational training of team members, and infrastructural conditions relating to availability of beds, intensive care facilities, and diagnostic and therapeutic back-up services, and to care provided by nursing, physiotherapy, social services and related medical professionals. Medical professionals forming part of an organ transplant team should be properly qualified and their previous training in the field of transplantation should be documented and personalised. A quality-management system should be put in place to evaluate performance against established national and/or international standards as applicable, and to ensure the quality of the process of organ procurement and transplantation, following the principles described in the World Health Organisation Guiding Principles. For the purpose of this Recommendation, the term “authorisation” refers to any appropriate mechanism for designating, authorising, accrediting or licensing health care facilities carrying out organ transplantations. 172 71 Authorisations should be regularly reviewed against agreed quality criteria and standards, as well as against audit results. Any transplant centre which, after several warnings, continues to fail to meet activity or outcome criteria may have its authorisation withdrawn. No new transplant centre may be authorised if there are not enough organs available to enable a new centre to reach the required standards. Any new transplant centre should be authorised, accredited or licensed on the basis of agreed criteria and initially should be limited in time. If, within an agreed timescale, the new centre does not achieve the required standards, authorisation shall be withdrawn. 5.2.6 Organ trafficking. The universal shortage of organs and tissues can lead patients to a desperate search for a transplant which may involve unacceptable practices from a legal or ethical point of view. Organ shortage has encouraged illegal organisations to traffic human beings for the purpose of organ transplantation, or to traffic organs obtained as a result of inducement or coercion. Further it has undermine public confidence in organ and tissue transplantation services, decreasing the public’s disposition to legitimate organ donation, thereby exacerbating the shortage of organs and tissues for transplantation. It is to my recommendation that the new legal framework conforms with the following requirements. The new legal framework should protect the dignity and identity of all persons and guarantee without discrimination their fundamental rights and freedoms with regard to organ and tissue donation and transplantation. It should be made clear to all that organ trafficking exploits human beings and is illegal, and should take all possible measures to prevent organ trafficking. The provisions of this recommendation should apply to all living persons and to the removal of organs, tissues and cells from those recently deceased, also to cells, including haematopoietic stem cells. For the purposes of this recommendation the term “organ and tissue trafficking” should apply to: the transportation of a person to a place for the removal of organs or tissues without his or her valid consent; the transportation of a person to a place for the removal of organs or tissues with his or her consent but in contravention of legislation or other controls in operation in the relevant jurisdiction; the transplantation of removed organs and tissues, whether transported or not, in contravention of legislation or other regulations in operation in the relevant jurisdiction or in contravention of international legal instruments. 72 For the purposes of this recommendation the term “transplantation” should cover the complete process of removal of an organ or tissue from one person and implantation of that organ or tissue into another person, including all procedures for preparation, preservation, storage and transportation. The term “removal” should refer to removal from the body of an organ or tissue intended for transplantation, by a surgical procedure or by other means. The framework should ensure the provision of a nationally recognised transplantation system which guarantees equitable access to transplant services. The National transplant waiting lists should be established and it should ensure that: appropriate information is recorded on all organs and tissues removed for the purposes of transplantation, all organs, and where appropriate tissues, are only allocated to persons who are on a nationally recognised waiting list, appropriate information is recorded on all organs and tissues used for implantation or other purposes, information on the risks associated with organs obtained illegally is provided. Accurate information about organ and tissue donation and transplantation should be provided. Organ and tissue donation should be promoted as positive behaviour that contributes to saving lives and improving the health of many people. 5.2.7 Consent/ authorisation. Removal of any organ or tissue should follow a rigorous consent or authorisation process required by national law. Careful consideration should be given to the need for, and purpose of, an organ donor register. In a case whereby the new legal framework assumes that people are willing to donate their organs or tissues unless they have registered their refusal (opt-out system), it must provide for an effective means for people to register their decision. A national register can be an effective means of recording such decisions. Similarly, where consent to donation is actively sought from the donor and/or those close to them prior to organ donation (opt-in system), an organ donor register may also fulfil important functions. The donor register should be as a means of registering the wishes of people willing to donate their organs; as a means of improving the efficiency of the organ and tissue donation process by making those wishes available rapidly after the death of a potential donor has been confirmed; as a means of publicising organ donation, and of involving people and organisations in realising the benefits of organ donations for themselves and for others in society; 73 Consideration should be given to the primary function of the organ donor register. An efficient organ donor registers may be opt-out only, opt-in only; register both choices, or even a third choice, such as “ask my relatives”; allow simply a general agreement to donate organs and/or tissues; allow wishes about the donation of particular organs and/or tissues to be specified; allow registration of wishes with respect to other sensitive procedures, such as post-mortem examinations or the donation of organs/tissue for medical research. The organ donor registers should ensure, that: people wishing to register their wishes can do so easily and reliably; people can, if they wish, specify organs and tissues they do/do not wish to donate; people can revoke their entry at any time; all information on people who die is removed from the organ donor registry. If the organ donor register is intended to facilitate organ donation it must: have details of a high proportion of potential donors/non-donors. If enquiries about potential donors give no results, health professionals will consider it a waste of time trying to access the register; enable easy and rapid twenty four hour access by health professionals needing information about a potential donor. Careful consideration should be given to the costs and benefits of setting up and maintaining an organ donor register: where the new legal framework seeks to employ an opt-out system, it should, as a minimum, have a central register for those who do not wish to donate organs or tissues or any particular organ or tissue; a centrally-run information technology-based organ donor register offers the greatest flexibility in terms of content, updating and rapidity of access, but data security has to be ensured; everyone should be able to register their wishes; registration must be easy, preferably by both written and/or electronic means; written confirmation should be sent to all who register; people should have a simple means of checking and amending their entry; specified healthcare professionals such as intensive care staff and/or transplant coordinators must have twenty-four-hours-a-day access to check the wishes of potential donors by phone, fax or electronically. Such checks should normally be made only after the death of a potential donor; checking the register could be made mandatory as a condition of donation. 74 5.2.8 Waiting list and its management. It is to my recommendation that the new legal framework should guarantee that a system exists to provide equitable access to transplantation services for patients which ensures that organs and tissues are allocated in conformity with transparent and duly justifiable rules according to medical criteria. There should also be a mechanism, enforceable by law or regulations, for establishing and managing an officially recognised regional, national or county waiting list for each of the main types of organ transplantation. Cadaveric organs should only be allocated to patients registered on the official waiting list. Patients receiving organs from a living donor should also be registered if there is any possibility that they might need an organ from a deceased person. Patients may only be registered on one official transplant waiting list be it regional, national, international or at the county level. Individual transplant units may have their own local waiting list but only as a subset of the official waiting list. The criteria for registration on the waiting list should be established by a process of consensus based on medical criteria. Registration should include the data essential to identify patients individually, their location and the criteria for their inclusion on the waiting list. The criteria for inclusion should ensure there is no discrimination on the grounds of race, religion, disability or any other non-medical factor. Priority on the waiting list such as “urgent” or “very-urgent” categories should be based solely on medical factors relating to the severity of risk for the individual patient. If patients are registered who do not normally reside in the area covered by the official waiting list, then those managing the waiting list should make all reasonable efforts to check with other transplant organisations that the patient is only on one waiting list. Only transplant units recognised by the official waiting list should be able to register patients in their charge on the waiting list and should do so directly with the organisation managing the official waiting list. Patients should be informed that they are on the waiting list and notified if for any reason they are subsequently suspended or removed. There should be a nationally recognised organisation responsible for the management of the waiting list and the allocation of organs. Organs should be allocated on behalf of the transplant units on the basis of objective 75 rules. The allocation rules should be agreed by all the relevant transplant organisations within the geographical area covered by the waiting list. The waiting list should be regularly updated in conjunction with the transplant units. In particular, the situation of suspended patients or those who have been on the list for a long time should be reviewed to make sure they still meet the registration criteria. Allocation rules should ensure that, as far as possible, no group of patients waits longer than another group waiting for the same type of organ. Waiting times should be analysed regularly to ensure that no patient group is disadvantaged. The allocation rules should be changed when necessary to ensure similar waiting times for all groups of similar patients on the waiting list. The organisation responsible for managing the waiting list should provide information, on at least an annual basis, for health professionals and the public. 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