Cell Tissue Bank DOI 10.1007/s10561-014-9473-6
MINI REVIEW
Tissue and organ donation and transplantation in Iran Parisa Goodarzi • Hamid Reza Aghayan • Bagher Larijani • Alireza Baradaran Rafiee Khadijeh Falahzadeh • Mehrnaz Sahebjam • Firoozeh Ghaderi • Babak Arjmand
•
Received: 1 April 2014 / Accepted: 28 August 2014 Ó Springer Science+Business Media Dordrecht 2014
Abstract Tissue and organ transplantation is one of the most promising treatments for some incurable diseases. Nowadays, transplantation is the common therapy in many countries. Unfortunately, availability of donated tissues and organs is limited. There are several factors which may affect donation rate for instance; social factors, culture, religion, and family decision. Accordingly, religious beliefs have a crucial role in tissue and organ donation and transplantation. Islam as a code of life has a comprehensive road map to lead mankind. Spiritual view of human life is considered to be much more valuable in Islam. Therefore, saving a human life is one of the most important Islamic teachings. In Iran as a Muslim
country, tissue and organ transplantation program was established based on religious scholars’ permission which has an essential role towards considerable development of the program in Iran.
P. Goodarzi Brain and Spinal Cord Injury Research Center, Cellul Fanavaran Knowledge-Based Organization, Tehran University of Medical Sciences, Tehran, Iran e-mail: [email protected]
A. B. Rafiee Ophthalmic Research Center, Labbafinejad Medical Center, Shahid Behashti University of Medical Sciences, Tehran, Iran
H. R. Aghayan B. Arjmand (&) Chronic Diseases Research Center, Endocrinology and Metabolism Research Institute, Brain and Spinal Cord Injury Research Center, Tehran University of Medical Sciences, Tehran, Iran e-mail: [email protected]; [email protected]
Keywords Middle East Muslims Tissue and organ donation Transplantation
Introduction Transplantation is one of the most arguable subjects in health and medical sector. New developments in transplantation technology have an impact on patient’s
K. Falahzadeh Chronic Diseases Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran M. Sahebjam F. Ghaderi Brain and Spinal Cord Injury Research Center, Tehran University of Medical Sciences, Tehran, Iran
B. Larijani Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Research Institute, Medical Ethics and History of Medicine Research Center,, Tehran University of Medical Sciences, Tehran, Iran
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lifespan and quality of life which could be an outcome of the modern immunosuppressive techniques and social awareness (Akrami et al. 2004). Nowadays, scientists become much more familiar with this challenging issue and the majority of tissue and also organ transplantations are feasible in most of the countries (Tai 2009). Unfortunately, the number of donated tissues and organs is much less than the number of patients in waiting lists therefore lack of donors which results in tissue or organ shortage is a worldwide limitation to the development of transplantation programs (Larijani et al. 2004b; Arjmand et al. 2009b). Moreover, the progress of tissue and organ transplantation program in every society or country is affected by economic situation, religious, public beliefs, healthcare system, and established laws and regulations (Akrami et al. 2004). Additionally, ethical and religious limitations have a fundamental role in tissue and organ shortage. The opinion of religious authorities could impressively direct the society’s view of point on this controversial topic (Kececioglu et al. 2000). In every holy religion human life is believed to be a sacred gift from the God and Islam as the latest religion has special view on the human life (Hedayat et al. 2006). There are approximately 1.62 billion Muslims, constituting more than 23 % of the world population (Religion & Public Life Project 2011). Islam has a comprehensive guideline to every detail of human life. Accordingly, spiritual life has been considered as the most valuable aspect of human life (Albar 2012). With regard to Islamic teachings, the final aim of Islam is to respect human as a sacred creature and preserve the human health is under the authority of bioethical rules (Larijani et al. 2004b; elShahat 1999). Tissue and organ transplantation is a valuable technology which can be used to save human life or improve quality of life. In Iran like any other countries, tissue and organ transplantation has a good established framework, while shortage of donated tissue and organ is the most common limitation which is mainly affected by religious beliefs and other sociocultural factors (Larijani et al. 2004b). The key role of Islamic teachings and beliefs influence the public attitudes about tissue and organ donation, in this review we focus on Islamic points of view about ethical aspect of tissue and organ transplantation and public attitudes in Iran as a Muslim country in the Middle East.
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History of tissue and organ transplantation in Iran The history of transplantation in Iran dated back to the proficient Persian physician, Avicenna, who performed the first nerve repair in the eleventh century [Ministry of Health and Medical Education—Medical ethics with a brief overview of medical history. (In Persian: Akhlaqe Pezeshki be-enzemame mokhtasary az taurikh pezeshki), Tehran]. Following that, Seyed Esmaiel Jorjani demonstrated the regeneration of human bones as a consequence of transplantation of dog bone (Ghods and Savaj 2004). The modern transplantation in Iran started in 1935, with the first cornea transplantation, followed by kidney (1968), bone marrow (1991), liver and heart (1993), lung (2000), and pancreas (2006) transplantation (MahdaviMazdeh et al. 2008b). In Iran, the brain dead patient’s organ transplantation act was accepted in April 2000 by the parliament and subsequently, both tissue and organ transplantations were mentioned in one single law (Aghayan et al. 2009). The Ministry of Health (MOH) supports donation and transplantation program directly (Aghayan et al. 2010). Iranian central eye bank as the unique eye bank in the country was established in 1991 and Iranian Tissue Bank as a multi tissue bank was founded in 1994. Nowadays, four tissue banks provide various types of human tissues in the country (Arjmand et al. 2009a). Based on our suggestion the Iranian Food and Drug Organization (FDO) started to play the role of authorization body since 2010 but this framework is fairly new and there are some challenges and limitations in tissue banking (Aghayan et al. 2010).
Statistical data on donation and transplantation in Iran Since the beginning of the transplantation activity up to 2006, 21,359 kidneys, 338 livers, 122 hearts, 20 lungs, 7 pancreases, 1,898 bone marrows, 28,838 corneas, 1,380 heart valves, and 1,366 bone allografts were transplanted in Iran. In 2006 the donation rate in Iran was 1.8 per million population (PMP) for heartbeating brain-dead donors, 26 PMP for non-heartbeating tissue donors, and 23 PMP for living donors (Mahdavi-Mazdeh et al. 2008b). According to the previous studies, the number of kidney transplantation in Iran reached 25,000 in 2006 (the increasing rate was
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12 % per year), while the prevalence and incidence of end stage renal disease (ESRD) were 357 PMP and 66 PMP respectively. Furthermore, the annual rate of kidney transplantation was around 1,900 (MahdaviMazdeh et al. 2007, 2008a). In 2003, Malek Hoseini et al. (2003) reported over 400 patients with end stage liver disease waited for liver transplantations in Shiraz. Nowadays, liver transplantations are performed in Tehran and Shiraz. Tissue transplantations including musculoskeletal tissues, skin, heart valves, etc. are performed as an ordinary surgery in the country (Zahedi et al.2009a). In spite of developing different transplantation programs in the country, more attempts are needed to achieve an optimum status in tissue and organ replacement therapies.
Religious aspects of transplantation Although no religion officially prohibits tissue and organ transplantation from living or deceased donors, some of the religions are against it (Bruzzone 2008). The Chinese people with Confucianist, Buddhist and Taoist beliefs do not accept the transplantation act since they believe that the dead body is respectful and therefore its manipulation is forbidden (Zhang et al. 2007; Sugunasiri 1990). Furthermore, native Americans, Roma gypsies, Confucians, Shintoists, and some Orthodox rabbis, discourage transplantation plan. According to some south Asia Muslim scholars and jurists belief, the human body is considered as an ‘‘amanat’’ (trusteeship), a gift from God and people are responsible to seriously take care of it, and even after death it is respectful (Bruzzone 2008). Fortunately, the other side of the coin is that the majority of the religious including Christianity, Judaism, Hinduism, and Islam give permission to transplantation (Akrami et al. 2004). For instance, Pope John Paul II in his speech at the XVIII International Congress of the Transplantation Society in 2000 said that ‘‘The criteria for assigning donated organs should in no way be discriminatory (i.e. based on age, sex, race, religion, social standing, etc.) or utilitarian (i.e. based on work capacity, social usefulness, etc.)’’. His statement was in accordance with the Catechism of the Catholic Church Compendium signed by Pope Benedict XVI on June, 2005 (Bruzzone 2008). The Judaism believes that transplantation is a way to save human life and
also Hinduism considers this issue as the way to relieve human distress after death (Rizvi and Naqui 2001). As for Islamic practices communities, the Shia scholars were the pioneers in giving permission to donation and transplantation in 1964. The Sunni religious leaders permitted donation and transplantation subsequently. Accordingly, Muslim investigators have been conducting a large number of researches in the field of donation and transplantation (Aksoy 2001; Ebrahim 1995; Syed 1998; al-Mousawi et al. 1997; Aghayan et al. 2009; Arjmand et al. 2009b).
Islamic perception toward donation and transplantation Islam as a monotheistic world-wide religion was established in 610 A.D. by the God’s messenger holy Prophet Muhammad. Geographic distribution of Muslims shows that there are around 1.6 billion Muslims in the world and the majority of them live in Asia–Pacific and specifically in the Middle East (Hall R 2012). Also, the United States is a country of approximately 5 million Muslims inhabitants including 30 % black, 27 % white (composed of Europeans, Anglo-Americans, Arabs, and Iranians), and 33 % Southeast Asian (Rady et al. 2009). In contrast to this fact that the use of a human tissue and organ is a taboo among Muslims, religious leaders give permission to transplantation. Interpretation of the holy Quran by the experts projects new light on this recently emerging and challenging issue. Some of the clues and evidences can be found in Chapter V, Verse 35 of the Quran saying ‘‘And whose ever saves a human life it is as though he has saved all mankind’’. On the other hand, it is not allowed to treat a donor as a victim to save a recipient (Boobes and Al Daker 2003). There is no papacy in Islam but religious scholars are responsible for legislation of the Islamic religious scholars’ opinion called fatwa (Rady et al. 2009). Since Islam is a dynamic religion it has the potency to keep up with any matters related to the fast-growing transplantation technology. Therefore, Islamic scholars are able to announce new fatwas based on Islamic principles, the holy Quran, the behaviors and teachings of the Prophet Mohammad and his successors (Sunna and Hadith), the consensus of religious scholars (Ijma), and wisdom (Aqul) (Larijani et al. 2004b). When neither of Holy Quran nor Sunna, the main references, to update Islamic positions about
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newly emerged matters, the religious specialists exert Ijtihad, which is a unified opinion of religious experts according to reasons, will provide considerable answers to all the novel questions about all aspects of human life (Rady et al. 2009). Consequently, saving the human life is an important matter in Islam. Although, tissue and organ transplantation is not directly discussed in the two above mentioned references, the permission could be concluded by Ijtihad of Muslim scholars. Accordingly, use of donated tissue and organ to treat a recipient is a permitted act in Islam. Islamic scholars keep on consulting with medical scientists to keep abreast with novel bioethical concerns in order to make the most accurate decision. It is not surprising that Islamic fatwas on a specific medical area may be revised from time to time as a consequence of medical technology progression and keep on encountering new questions (Rady et al. 2009). In Islamic countries such as Iran, religion sounds to be a rigorous validation for convincing the society to accept the religious leader’s fatwa about any newly developed technologies including tissue and organ donation and transplantation. With respect to Islamic teachings and fatwas on organ transplantation, all types of transplantation, under the essential conditions, are permitted (el-Shahat 1999). Interestingly, according to dynamic nature of Islam, Islamic laws from its beginning till now, represent a logical solution for every new challenges including transplantation as a human life saving technology (Zahedi et al. 2009b). Therefore, it could be interpreted that, saving human life is an obligatory duty in Islam. Therefore, transplantations which attempt to improve quality and quantity of human life are allowed by Islamic fatwas (Akrami et al. 2004).
Legislative process of transplantation in a Muslim country Religious scholars play an important role in the personal life of Muslims (Van den Branden and Broeckaert 2011). In Islamic countries legislation and the establishing laws are greatly affected by religious fatwas. For instance in Iran, the transplantation was legally approved following the acceptance by religious scholars (Al-Khader 2002). The transplantation act initially faced lots of criticism until it was clarified by the religious leaders (Zahedi et al. 2009a). Ayatullah Khomeini, the late founder of the Islamic Republic of
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Iran, clarified the transplantation over jurisprudential reasoning and supported it therefore, as a Shia scholar demonstrated transplantation as an ethically, and legally permitted technology (Aqakhani 1996; Zahedi et al. 2009b). Likewise, permission of the transplantation was given by the Association of Sunni scholars in 1982. Subsequently, Sunni religious leaders paid much more attention to the respectfully use of the human body to save others (Aqakhani 1996; Marshall et al. 1996). This level of knowledge of the scholars would be obtained after three decades of training and after receiving confirmation letters from senior Ayatollahs who are responsible for giving fatwas when a new dilemma emerges in the Muslim’s world (Wong 2010). Their level of knowledge is attained after three decades of training which is confirmed by a certificate from the senior Ayatollahs. Accordingly, in Iran, the only Shi’a country with Ithna-Ashari, or Twelver Shi’ism, religious scholars’ fatwas are viewed as a policy making system. Therefore, Iran’s progress in medicine and novel medical technologies varies from the majority of other Islamic countries (Tober 2007). However, religious leaders are not the only decision making source of law legislation. Besides the important role of religious scholars in a Muslim’s life style, religiously permitted matters must again be reviewed in the light of social, political, economic and technological perspectives. This system makes a ratified fatwa much more flexible and logical (Tober 2007). In Iran, charity organizations were allowed by the government to work in the areas of donation and transplantation in 1997 (Larijani et al. 2004a). In 2000 due to the specific consideration of Emam Khomeini and Ayatullah Khamenei, the Transplantation Act was ratified by Parliament. After that tissue and organ donation and transplantation are considered legally approved actions in Iran (Zahedi et al. 2009a). Tissue donation and transplantation are not governed by a separate law but are controlled by the same authority and system as for organs (Aghayan et al. 2009). The religious and legal details of the transplantation story in Iran, was published in a Farsi book to document the complexity of the process (Larijani 2004).
Authorization for transplantation in Iran The management and funding of Iranian tissue and organ procurement and transplantation is performed
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by the ‘‘Management Center for Transplantation and Special Diseases’’ (MCTSD) which is affiliated to Ministry of Health (Mahdavi-Mazdeh et al. 2007). Some permitted tasks of MCTSD which are worthy to be noticed include policy making, integrated controlling, administrating, medical data registry, waiting list management, and financial supports (Mahdavi-Mazdeh et al. 2008b).
Public attitudes and general concern about transplantation in Iran The lack of cadaveric tissues and organs is the most important setback to transplantation worldwide. On the other hand, donation rate is significantly affected by social knowledge and public attitudes towards tissue and organ donation and transplantation. Furthermore, performing educational programs, workshops, and broadcasting information by mass media can increase public knowledge and subsequently, induce a positive attitude regarding donation and transplantation among general population. Iran has a good experience in conducting various relevant programs for healthcare professionals and also for general population using mass media (Arjmand et al. 2009b). Based on this progress and a well established cooperation between religious scholars and scientists, Iran has built one of the most effective platforms of transplantation in the region (Larijani and Zahedi 2006; Mahdavi-Mazdeh et al. 2008a).
pancreases were transplanted in Saudi Arabia up to 2002. Although, several tissue donations were reported but they do not have any tissue banking systems in Saudi Arabia as compared to Iran which has 4 multi tissue banks (Shaheen and Souqiyyeh 2004). Turkey In Turkey, because of organ shortage, many patients die while waiting for transplantation. It has been reported that, 1,131 renal transplantations, 447 liver transplantations, and 53 heart transplantations were performed in 2007 in Turkey whereas, the number of patients in the waiting lists was 45,000 in the same year. Furthermore, 244 organ donations were carried out in 2011. Accordingly, increasing in donation rate and subsequently transplantation rate reflects a high demand for organs in Turkey (Dog˘an et al. 2012). Additionally, human tissue demand is rapidly increasing in Turkey. However, the tissue transplantation generally depends on imported tissue products from other countries. Fortunately, in 1997, the International Atomic Energy Agency (IAEA) started to establish a program on tissue banking in Turkey by providing equipment, training programs, and supervising by tissue experts (Erkol et al. 2003). Although this project was planned in 1997, but in comparison with our experiences in Iran (since 1993), it had a limited progress during several years.
Status of tissue and organ donation and transplantation among Muslims in Europe Status of transplantation in some Muslim countries Saudi Arabia In Saudi Arabia, a strict Muslim country in the Middle East, the Islamic council (Senior Ulama Commission) provided the first declaration about organ donation and transplantation in 1982. The commission allowed tissue and organ transplantation from living or cadaveric donors. Following this permission, the Saudi Center of organ transplantation (SCOT) was established to coordinate and organize donation and transplantation program in Saudi Arabia. Subsequently, various organ transplantation programs were performed in this country. A total of 3,759 kidneys (1,267 cadaver, 2,492 living); 279 livers (225 cadaver, 54 living); 92 hearts; 421 cornea; 8 lungs; and 5 combined kidneys and
European Council for Fatwa and Research (ECFR) issued a fatwa on organ donation in 2000. In addition, there were two other fatwas in the UK [by the Muslim Law (Shariah) Council in 1995] and in the Netherlands (by the Moroccan religious scholars). Based on the mentioned fatwas, donation and transplantation are permitted. In spite of this permission, there are still fewer donors than the average percentage in their respective countries and consequently, patients have to wait longer time for suitable tissue or organ (Ghaly 2012).
Most important challenges for tissue banks in Iran Although, the act of ‘‘Deceased or brain dead donor organ transplantation’’ was issued in 2000, legislation
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framework for tissue preparation and transplantation in Iran is still at early stage. Therefore, process for tissue product registration and also obtaining required approvals from the MOH as the authorization body is an exhaustive and complex process. Accordingly, each tissue bank has its own quality policy and system to continuously improve the quality of their tissue products and some of them adhere to international standards like EATB, and ISO (Aghayan et al. 2010), while they are trying to get the required approvals from the local MOH.
Conclusion Tissue and organ transplantation program in Iran was started based on religious scholars’ permission (Arjmand et al. 2009b). Generally, Iranian people have strong faith in the religious leaders and physicians. Therefore, whenever a debatable issue is approved by both of them, it will probably be easily accepted by the general population. Iran as a developing Islamic country has a successful experience in transplantation. In Iran, all the significant groups such as religious scholars, physicians, prestigious people, and mass media are unified to improve the public attitude and opinion about transplantation and clarified the right conception of irreversible coma in brain dead patients and the value of saving other patients’ life. So it is suggested that the religious scholars could be the best persons to convince the donors’ relatives to donate and help to save patients’ life. The public awareness and attitudes is equally important as legislative process of transplantation (Kececioglu et al. 2000). In Addition, whenever a special effort for medical area is in accordance with religion, social, and cultural attitudes of the country’s inhabitants, it would be considered as a practical act (Aksoy 2001; Hedayat and Pirzadeh 2001). Iran’s accomplishment in transplantation program is comparable to the developed countries (Mahdavi-Mazdeh et al. 2008b). Therefore this experience could be used as a successful model to establish similar framework in other Islamic countries. Acknowledgments The authors would like to acknowledge Shokouh Salimi, Fereshteh Mohamadi-Jahani, and Maryam Kavousi for their considerable assistance.
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MINI REVIEW
Tissue and organ donation and transplantation in Iran Parisa Goodarzi • Hamid Reza Aghayan • Bagher Larijani • Alireza Baradaran Rafiee Khadijeh Falahzadeh • Mehrnaz Sahebjam • Firoozeh Ghaderi • Babak Arjmand
•
Received: 1 April 2014 / Accepted: 28 August 2014 Ó Springer Science+Business Media Dordrecht 2014
Abstract Tissue and organ transplantation is one of the most promising treatments for some incurable diseases. Nowadays, transplantation is the common therapy in many countries. Unfortunately, availability of donated tissues and organs is limited. There are several factors which may affect donation rate for instance; social factors, culture, religion, and family decision. Accordingly, religious beliefs have a crucial role in tissue and organ donation and transplantation. Islam as a code of life has a comprehensive road map to lead mankind. Spiritual view of human life is considered to be much more valuable in Islam. Therefore, saving a human life is one of the most important Islamic teachings. In Iran as a Muslim
country, tissue and organ transplantation program was established based on religious scholars’ permission which has an essential role towards considerable development of the program in Iran.
P. Goodarzi Brain and Spinal Cord Injury Research Center, Cellul Fanavaran Knowledge-Based Organization, Tehran University of Medical Sciences, Tehran, Iran e-mail: [email protected]
A. B. Rafiee Ophthalmic Research Center, Labbafinejad Medical Center, Shahid Behashti University of Medical Sciences, Tehran, Iran
H. R. Aghayan B. Arjmand (&) Chronic Diseases Research Center, Endocrinology and Metabolism Research Institute, Brain and Spinal Cord Injury Research Center, Tehran University of Medical Sciences, Tehran, Iran e-mail: [email protected]; [email protected]
Keywords Middle East Muslims Tissue and organ donation Transplantation
Introduction Transplantation is one of the most arguable subjects in health and medical sector. New developments in transplantation technology have an impact on patient’s
K. Falahzadeh Chronic Diseases Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran M. Sahebjam F. Ghaderi Brain and Spinal Cord Injury Research Center, Tehran University of Medical Sciences, Tehran, Iran
B. Larijani Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Research Institute, Medical Ethics and History of Medicine Research Center,, Tehran University of Medical Sciences, Tehran, Iran
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lifespan and quality of life which could be an outcome of the modern immunosuppressive techniques and social awareness (Akrami et al. 2004). Nowadays, scientists become much more familiar with this challenging issue and the majority of tissue and also organ transplantations are feasible in most of the countries (Tai 2009). Unfortunately, the number of donated tissues and organs is much less than the number of patients in waiting lists therefore lack of donors which results in tissue or organ shortage is a worldwide limitation to the development of transplantation programs (Larijani et al. 2004b; Arjmand et al. 2009b). Moreover, the progress of tissue and organ transplantation program in every society or country is affected by economic situation, religious, public beliefs, healthcare system, and established laws and regulations (Akrami et al. 2004). Additionally, ethical and religious limitations have a fundamental role in tissue and organ shortage. The opinion of religious authorities could impressively direct the society’s view of point on this controversial topic (Kececioglu et al. 2000). In every holy religion human life is believed to be a sacred gift from the God and Islam as the latest religion has special view on the human life (Hedayat et al. 2006). There are approximately 1.62 billion Muslims, constituting more than 23 % of the world population (Religion & Public Life Project 2011). Islam has a comprehensive guideline to every detail of human life. Accordingly, spiritual life has been considered as the most valuable aspect of human life (Albar 2012). With regard to Islamic teachings, the final aim of Islam is to respect human as a sacred creature and preserve the human health is under the authority of bioethical rules (Larijani et al. 2004b; elShahat 1999). Tissue and organ transplantation is a valuable technology which can be used to save human life or improve quality of life. In Iran like any other countries, tissue and organ transplantation has a good established framework, while shortage of donated tissue and organ is the most common limitation which is mainly affected by religious beliefs and other sociocultural factors (Larijani et al. 2004b). The key role of Islamic teachings and beliefs influence the public attitudes about tissue and organ donation, in this review we focus on Islamic points of view about ethical aspect of tissue and organ transplantation and public attitudes in Iran as a Muslim country in the Middle East.
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History of tissue and organ transplantation in Iran The history of transplantation in Iran dated back to the proficient Persian physician, Avicenna, who performed the first nerve repair in the eleventh century [Ministry of Health and Medical Education—Medical ethics with a brief overview of medical history. (In Persian: Akhlaqe Pezeshki be-enzemame mokhtasary az taurikh pezeshki), Tehran]. Following that, Seyed Esmaiel Jorjani demonstrated the regeneration of human bones as a consequence of transplantation of dog bone (Ghods and Savaj 2004). The modern transplantation in Iran started in 1935, with the first cornea transplantation, followed by kidney (1968), bone marrow (1991), liver and heart (1993), lung (2000), and pancreas (2006) transplantation (MahdaviMazdeh et al. 2008b). In Iran, the brain dead patient’s organ transplantation act was accepted in April 2000 by the parliament and subsequently, both tissue and organ transplantations were mentioned in one single law (Aghayan et al. 2009). The Ministry of Health (MOH) supports donation and transplantation program directly (Aghayan et al. 2010). Iranian central eye bank as the unique eye bank in the country was established in 1991 and Iranian Tissue Bank as a multi tissue bank was founded in 1994. Nowadays, four tissue banks provide various types of human tissues in the country (Arjmand et al. 2009a). Based on our suggestion the Iranian Food and Drug Organization (FDO) started to play the role of authorization body since 2010 but this framework is fairly new and there are some challenges and limitations in tissue banking (Aghayan et al. 2010).
Statistical data on donation and transplantation in Iran Since the beginning of the transplantation activity up to 2006, 21,359 kidneys, 338 livers, 122 hearts, 20 lungs, 7 pancreases, 1,898 bone marrows, 28,838 corneas, 1,380 heart valves, and 1,366 bone allografts were transplanted in Iran. In 2006 the donation rate in Iran was 1.8 per million population (PMP) for heartbeating brain-dead donors, 26 PMP for non-heartbeating tissue donors, and 23 PMP for living donors (Mahdavi-Mazdeh et al. 2008b). According to the previous studies, the number of kidney transplantation in Iran reached 25,000 in 2006 (the increasing rate was
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12 % per year), while the prevalence and incidence of end stage renal disease (ESRD) were 357 PMP and 66 PMP respectively. Furthermore, the annual rate of kidney transplantation was around 1,900 (MahdaviMazdeh et al. 2007, 2008a). In 2003, Malek Hoseini et al. (2003) reported over 400 patients with end stage liver disease waited for liver transplantations in Shiraz. Nowadays, liver transplantations are performed in Tehran and Shiraz. Tissue transplantations including musculoskeletal tissues, skin, heart valves, etc. are performed as an ordinary surgery in the country (Zahedi et al.2009a). In spite of developing different transplantation programs in the country, more attempts are needed to achieve an optimum status in tissue and organ replacement therapies.
Religious aspects of transplantation Although no religion officially prohibits tissue and organ transplantation from living or deceased donors, some of the religions are against it (Bruzzone 2008). The Chinese people with Confucianist, Buddhist and Taoist beliefs do not accept the transplantation act since they believe that the dead body is respectful and therefore its manipulation is forbidden (Zhang et al. 2007; Sugunasiri 1990). Furthermore, native Americans, Roma gypsies, Confucians, Shintoists, and some Orthodox rabbis, discourage transplantation plan. According to some south Asia Muslim scholars and jurists belief, the human body is considered as an ‘‘amanat’’ (trusteeship), a gift from God and people are responsible to seriously take care of it, and even after death it is respectful (Bruzzone 2008). Fortunately, the other side of the coin is that the majority of the religious including Christianity, Judaism, Hinduism, and Islam give permission to transplantation (Akrami et al. 2004). For instance, Pope John Paul II in his speech at the XVIII International Congress of the Transplantation Society in 2000 said that ‘‘The criteria for assigning donated organs should in no way be discriminatory (i.e. based on age, sex, race, religion, social standing, etc.) or utilitarian (i.e. based on work capacity, social usefulness, etc.)’’. His statement was in accordance with the Catechism of the Catholic Church Compendium signed by Pope Benedict XVI on June, 2005 (Bruzzone 2008). The Judaism believes that transplantation is a way to save human life and
also Hinduism considers this issue as the way to relieve human distress after death (Rizvi and Naqui 2001). As for Islamic practices communities, the Shia scholars were the pioneers in giving permission to donation and transplantation in 1964. The Sunni religious leaders permitted donation and transplantation subsequently. Accordingly, Muslim investigators have been conducting a large number of researches in the field of donation and transplantation (Aksoy 2001; Ebrahim 1995; Syed 1998; al-Mousawi et al. 1997; Aghayan et al. 2009; Arjmand et al. 2009b).
Islamic perception toward donation and transplantation Islam as a monotheistic world-wide religion was established in 610 A.D. by the God’s messenger holy Prophet Muhammad. Geographic distribution of Muslims shows that there are around 1.6 billion Muslims in the world and the majority of them live in Asia–Pacific and specifically in the Middle East (Hall R 2012). Also, the United States is a country of approximately 5 million Muslims inhabitants including 30 % black, 27 % white (composed of Europeans, Anglo-Americans, Arabs, and Iranians), and 33 % Southeast Asian (Rady et al. 2009). In contrast to this fact that the use of a human tissue and organ is a taboo among Muslims, religious leaders give permission to transplantation. Interpretation of the holy Quran by the experts projects new light on this recently emerging and challenging issue. Some of the clues and evidences can be found in Chapter V, Verse 35 of the Quran saying ‘‘And whose ever saves a human life it is as though he has saved all mankind’’. On the other hand, it is not allowed to treat a donor as a victim to save a recipient (Boobes and Al Daker 2003). There is no papacy in Islam but religious scholars are responsible for legislation of the Islamic religious scholars’ opinion called fatwa (Rady et al. 2009). Since Islam is a dynamic religion it has the potency to keep up with any matters related to the fast-growing transplantation technology. Therefore, Islamic scholars are able to announce new fatwas based on Islamic principles, the holy Quran, the behaviors and teachings of the Prophet Mohammad and his successors (Sunna and Hadith), the consensus of religious scholars (Ijma), and wisdom (Aqul) (Larijani et al. 2004b). When neither of Holy Quran nor Sunna, the main references, to update Islamic positions about
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newly emerged matters, the religious specialists exert Ijtihad, which is a unified opinion of religious experts according to reasons, will provide considerable answers to all the novel questions about all aspects of human life (Rady et al. 2009). Consequently, saving the human life is an important matter in Islam. Although, tissue and organ transplantation is not directly discussed in the two above mentioned references, the permission could be concluded by Ijtihad of Muslim scholars. Accordingly, use of donated tissue and organ to treat a recipient is a permitted act in Islam. Islamic scholars keep on consulting with medical scientists to keep abreast with novel bioethical concerns in order to make the most accurate decision. It is not surprising that Islamic fatwas on a specific medical area may be revised from time to time as a consequence of medical technology progression and keep on encountering new questions (Rady et al. 2009). In Islamic countries such as Iran, religion sounds to be a rigorous validation for convincing the society to accept the religious leader’s fatwa about any newly developed technologies including tissue and organ donation and transplantation. With respect to Islamic teachings and fatwas on organ transplantation, all types of transplantation, under the essential conditions, are permitted (el-Shahat 1999). Interestingly, according to dynamic nature of Islam, Islamic laws from its beginning till now, represent a logical solution for every new challenges including transplantation as a human life saving technology (Zahedi et al. 2009b). Therefore, it could be interpreted that, saving human life is an obligatory duty in Islam. Therefore, transplantations which attempt to improve quality and quantity of human life are allowed by Islamic fatwas (Akrami et al. 2004).
Legislative process of transplantation in a Muslim country Religious scholars play an important role in the personal life of Muslims (Van den Branden and Broeckaert 2011). In Islamic countries legislation and the establishing laws are greatly affected by religious fatwas. For instance in Iran, the transplantation was legally approved following the acceptance by religious scholars (Al-Khader 2002). The transplantation act initially faced lots of criticism until it was clarified by the religious leaders (Zahedi et al. 2009a). Ayatullah Khomeini, the late founder of the Islamic Republic of
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Iran, clarified the transplantation over jurisprudential reasoning and supported it therefore, as a Shia scholar demonstrated transplantation as an ethically, and legally permitted technology (Aqakhani 1996; Zahedi et al. 2009b). Likewise, permission of the transplantation was given by the Association of Sunni scholars in 1982. Subsequently, Sunni religious leaders paid much more attention to the respectfully use of the human body to save others (Aqakhani 1996; Marshall et al. 1996). This level of knowledge of the scholars would be obtained after three decades of training and after receiving confirmation letters from senior Ayatollahs who are responsible for giving fatwas when a new dilemma emerges in the Muslim’s world (Wong 2010). Their level of knowledge is attained after three decades of training which is confirmed by a certificate from the senior Ayatollahs. Accordingly, in Iran, the only Shi’a country with Ithna-Ashari, or Twelver Shi’ism, religious scholars’ fatwas are viewed as a policy making system. Therefore, Iran’s progress in medicine and novel medical technologies varies from the majority of other Islamic countries (Tober 2007). However, religious leaders are not the only decision making source of law legislation. Besides the important role of religious scholars in a Muslim’s life style, religiously permitted matters must again be reviewed in the light of social, political, economic and technological perspectives. This system makes a ratified fatwa much more flexible and logical (Tober 2007). In Iran, charity organizations were allowed by the government to work in the areas of donation and transplantation in 1997 (Larijani et al. 2004a). In 2000 due to the specific consideration of Emam Khomeini and Ayatullah Khamenei, the Transplantation Act was ratified by Parliament. After that tissue and organ donation and transplantation are considered legally approved actions in Iran (Zahedi et al. 2009a). Tissue donation and transplantation are not governed by a separate law but are controlled by the same authority and system as for organs (Aghayan et al. 2009). The religious and legal details of the transplantation story in Iran, was published in a Farsi book to document the complexity of the process (Larijani 2004).
Authorization for transplantation in Iran The management and funding of Iranian tissue and organ procurement and transplantation is performed
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by the ‘‘Management Center for Transplantation and Special Diseases’’ (MCTSD) which is affiliated to Ministry of Health (Mahdavi-Mazdeh et al. 2007). Some permitted tasks of MCTSD which are worthy to be noticed include policy making, integrated controlling, administrating, medical data registry, waiting list management, and financial supports (Mahdavi-Mazdeh et al. 2008b).
Public attitudes and general concern about transplantation in Iran The lack of cadaveric tissues and organs is the most important setback to transplantation worldwide. On the other hand, donation rate is significantly affected by social knowledge and public attitudes towards tissue and organ donation and transplantation. Furthermore, performing educational programs, workshops, and broadcasting information by mass media can increase public knowledge and subsequently, induce a positive attitude regarding donation and transplantation among general population. Iran has a good experience in conducting various relevant programs for healthcare professionals and also for general population using mass media (Arjmand et al. 2009b). Based on this progress and a well established cooperation between religious scholars and scientists, Iran has built one of the most effective platforms of transplantation in the region (Larijani and Zahedi 2006; Mahdavi-Mazdeh et al. 2008a).
pancreases were transplanted in Saudi Arabia up to 2002. Although, several tissue donations were reported but they do not have any tissue banking systems in Saudi Arabia as compared to Iran which has 4 multi tissue banks (Shaheen and Souqiyyeh 2004). Turkey In Turkey, because of organ shortage, many patients die while waiting for transplantation. It has been reported that, 1,131 renal transplantations, 447 liver transplantations, and 53 heart transplantations were performed in 2007 in Turkey whereas, the number of patients in the waiting lists was 45,000 in the same year. Furthermore, 244 organ donations were carried out in 2011. Accordingly, increasing in donation rate and subsequently transplantation rate reflects a high demand for organs in Turkey (Dog˘an et al. 2012). Additionally, human tissue demand is rapidly increasing in Turkey. However, the tissue transplantation generally depends on imported tissue products from other countries. Fortunately, in 1997, the International Atomic Energy Agency (IAEA) started to establish a program on tissue banking in Turkey by providing equipment, training programs, and supervising by tissue experts (Erkol et al. 2003). Although this project was planned in 1997, but in comparison with our experiences in Iran (since 1993), it had a limited progress during several years.
Status of tissue and organ donation and transplantation among Muslims in Europe Status of transplantation in some Muslim countries Saudi Arabia In Saudi Arabia, a strict Muslim country in the Middle East, the Islamic council (Senior Ulama Commission) provided the first declaration about organ donation and transplantation in 1982. The commission allowed tissue and organ transplantation from living or cadaveric donors. Following this permission, the Saudi Center of organ transplantation (SCOT) was established to coordinate and organize donation and transplantation program in Saudi Arabia. Subsequently, various organ transplantation programs were performed in this country. A total of 3,759 kidneys (1,267 cadaver, 2,492 living); 279 livers (225 cadaver, 54 living); 92 hearts; 421 cornea; 8 lungs; and 5 combined kidneys and
European Council for Fatwa and Research (ECFR) issued a fatwa on organ donation in 2000. In addition, there were two other fatwas in the UK [by the Muslim Law (Shariah) Council in 1995] and in the Netherlands (by the Moroccan religious scholars). Based on the mentioned fatwas, donation and transplantation are permitted. In spite of this permission, there are still fewer donors than the average percentage in their respective countries and consequently, patients have to wait longer time for suitable tissue or organ (Ghaly 2012).
Most important challenges for tissue banks in Iran Although, the act of ‘‘Deceased or brain dead donor organ transplantation’’ was issued in 2000, legislation
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framework for tissue preparation and transplantation in Iran is still at early stage. Therefore, process for tissue product registration and also obtaining required approvals from the MOH as the authorization body is an exhaustive and complex process. Accordingly, each tissue bank has its own quality policy and system to continuously improve the quality of their tissue products and some of them adhere to international standards like EATB, and ISO (Aghayan et al. 2010), while they are trying to get the required approvals from the local MOH.
Conclusion Tissue and organ transplantation program in Iran was started based on religious scholars’ permission (Arjmand et al. 2009b). Generally, Iranian people have strong faith in the religious leaders and physicians. Therefore, whenever a debatable issue is approved by both of them, it will probably be easily accepted by the general population. Iran as a developing Islamic country has a successful experience in transplantation. In Iran, all the significant groups such as religious scholars, physicians, prestigious people, and mass media are unified to improve the public attitude and opinion about transplantation and clarified the right conception of irreversible coma in brain dead patients and the value of saving other patients’ life. So it is suggested that the religious scholars could be the best persons to convince the donors’ relatives to donate and help to save patients’ life. The public awareness and attitudes is equally important as legislative process of transplantation (Kececioglu et al. 2000). In Addition, whenever a special effort for medical area is in accordance with religion, social, and cultural attitudes of the country’s inhabitants, it would be considered as a practical act (Aksoy 2001; Hedayat and Pirzadeh 2001). Iran’s accomplishment in transplantation program is comparable to the developed countries (Mahdavi-Mazdeh et al. 2008b). Therefore this experience could be used as a successful model to establish similar framework in other Islamic countries. Acknowledgments The authors would like to acknowledge Shokouh Salimi, Fereshteh Mohamadi-Jahani, and Maryam Kavousi for their considerable assistance.
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