The laws of different countries allow potential donors to permit or refuse donation, or give this choice to relatives. The frequency of donations varies among countries.
Consent process The term consent is typically defined as a subject adhering to an agreement of principles and regulations; however, the definition becomes difficult to execute concerning the topic of organ donation, mainly because the subject is incapable of consent due to death or mental impairment. The second consent process is presumed consent, which does not need direct consent from the donor or the next of kin.
Opt-in versus opt-out As medical science advances, the number of people who could be helped by organ donors increases continuously. As opportunities to save lives increase with new technologies and procedures, the demand for organ donors rises faster than the actual number of donors. To respect individual autonomy, voluntary
consent must be determined for the individual's disposition of their remains following death. There are two main methods for determining voluntary consent: "opt in" (only those who have given explicit consent are donors) and "opt out" (anyone who has not refused consent to donate is a donor). In terms of an opt-out or presumed consent system, it is assumed that individuals do intend to donate their organs to medical use when they die. For example, Germany, which uses an opt-in system, has an organ donation consent rate of 12% among its population, while
Austria, a country with a very similar culture and economic development, but which uses an opt-out system, has a consent rate of 99.98%. conflicts with extant religious beliefs and the possibility of posthumous violations of
bodily integrity. Even though concerns exist, the United States still has a 95 percent organ donation approval rate. This level of nationwide acceptance may foster an environment where moving to a policy of presumed consent may help solve some of the organ shortage problem, where individuals are assumed to be willing organ donors unless they document a desire to "opt-out", which must be respected. and was implemented starting May 20, 2020. In terms of effective organ donations, in some systems like Australia (14.9 donors per million, 337 donors in 2011), family members are required to give consent or refusal, or may veto a potential recovery even if the donor has consented.
Croatia (40.2 donors/million) The president of the Spanish
National Transplant Organisation has acknowledged Spain's legislative approach is likely not the primary reason for the country's success in increasing the donor rates, starting in the 1990s. Looking to the example of Spain, which has successfully adopted the presumed consent donation system,
intensive care units (ICUs) must be equipped with enough doctors to maximize the recognition of potential donors and maintain organs while families are consulted for donation. The characteristic that enables the Spanish presumed consent model to be successful is the resource of
transplant coordinators; it is recommended to have at least one at each hospital where opt-out donation is practiced to authorize organ procurement efficiently. Public views are crucial to the success of opt-out or presumed consent donation systems. In a study done to determine if
health policy change to a presumed consent or
opt-out system would help to increase donors, an increase of 20 to 30 percent was seen among countries who changed their policies from some type of opt-in system to an opt-out system. Of course, this increase must have a great deal to do with the
health policy change, but also may be influenced by other factors that could have impacted donor increases. Transplant Priority for Willing Donors, also known as the "donor-priority rule", is a newer method and the first to incorporate a "non-medical" criterion into the priority system to encourage higher donation rates in the opt-in system. Initially implemented in Israel, it allows an individual in need of an organ to move up the recipient list. Moving up the list is contingent on the individual opting-in prior to their need for an organ donation. The policy applies nonmedical criteria when allowing individuals who have previously registered as an organ donor, or whose family has previously donated an organ, priority over other possible recipients. It must be determined that both recipients have identical medical needs prior to moving a recipient up the list. While incentives like this in the opt-in system do help raise donation rates, they are not as successful in doing so as the opt-out, presumed consent default policies for donation.
Argentina On November 30, 2005, the
Congress introduced an opt-out policy on organ donation, where all people over 18 years of age will be organ donors unless they or their family state otherwise. The law was promulgated on December 22, 2005, as "Law 26,066". On July 4, 2018, the Congress passed a law removing the family requirement, making the organ donor the only person that can block donation. It was
promulgated on July 4, 2018, as Law Justina or "Law 27,447".
Brazil A campaign by
Sport Club Recife has led to waiting lists for organs in north-east Brazil to drop almost to zero; while according to the Brazilian law the family has the ultimate authority, the issuance of the organ donation card and the ensuing discussions have however eased the process.
Canada In 2001, the Government of Canada announced the formation of the Canadian Council for Donation and Transplantation, whose purpose would be to advise the Conference of Deputy Ministers of Health on activities relating to organ donation and transplantation. The deputy ministers of health for all provinces and territories with the exception of
Québec decided to transfer the responsibilities of the Canadian Council for Donation and Transplantation to
Canadian Blood Services. In Québec, an organization called Transplant Québec is responsible for managing all organ donation; Héma-Québec is responsible for tissue donation. Consent for organ donation by an individual is given by either registering with the organ donation registry established by the , signing and affixing the sticker to the back of one's health insurance card, or registering with either or . In 2017, the majority of transplants completed were kidney transplants. Each province has different methods and registries for intent to donate organs or tissues as a deceased donor. In some provinces, such as
Newfoundland and Labrador and
New Brunswick organ donation registration is completed by completing the "Intent to donate" section when applying or renewing one's provincial medical care. In
Ontario, one must be 16 years of age to register as an organ and tissue donor and register with
ServiceOntario.
Alberta requires that a person must be 18 years of age or older and register with the Alberta Organ and Tissue Donation Registry.
Opt-out donation in Canada Nova Scotia, Canada, is the first jurisdiction in North America to introduce an automatic organ donation program unless residents opt out; what the province refers to as
deemed consent. The Human Organ and Tissue Act was introduced on April 2, 2019. With the legislation, all people who have been Nova Scotia residents for a minimum of 12 consecutive months, with appropriate decision-making capacity and are over 18 years of age are considered potential donors and will be automatically referred to donation programs if they are determined to be good candidates. In the case of persons under 18 years of age and people without appropriate decision-making capacity, they will only be considered as organ donors if their parent, guardian or decision-maker opts them into the program. The legislation took effect on January 18, 2021.
Chile On January 6, 2010, the "Law 20,413" was promulgated, introducing an opt-out policy on organ donation, where all people over 18 years of age will be organ donors unless they state their negative.
Colombia On August 4, 2016, the
Congress passed the "Law 1805", which introduced an opt-out policy on organ donation where all people will be organ donors unless they state their negative. The law came into force on February 4, 2017.
Europe Within the European Union, organ donation is regulated by member states. As of 2010, 24 European countries have some form of presumed consent (opt-out) system, with the most prominent and limited opt-out systems in Spain, Austria, and Belgium yielding high donor rates. Spain had the highest donor rate in the world, 46.9 per million people in the population, in 2017. This is attributed to multiple factors in the Spanish medical system, including identification and early referral of possible donors, expanding criteria for donors and standardised frameworks for transplantation after circulatory death. In England, individuals who wish to donate their organs after death can use the Organ Donation Register, a national database. The government of Wales became the first constituent country in the UK to adopt presumed consent in July 2013. The opt-out organ donation scheme in Wales went live on December 1, 2015, and is expected to increase the number of donors by 25%. In 2008, the UK discussed whether to switch to an opt-out system in light of the success in other countries and a severe British organ donor shortfall. In Italy if the deceased neither allowed nor refused donation while alive, relatives will pick the decision on his or her behalf despite a 1999 act that provided for a proper opt-out system. In 2008, the
European Parliament overwhelmingly voted for an initiative to introduce an EU organ donor card to foster organ donation in Europe.
Landstuhl Regional Medical Center (LRMC) has become one of the most active organ donor hospitals in all of Germany, which otherwise has one of the lowest organ donation participation rates in the
Eurotransplant organ network. LRMC, the largest U.S. military hospital outside the United States, is one of the top hospitals for organ donation in the
Rhineland-Palatinate state of Germany, even though it has relatively few beds compared to many German hospitals. According to the German
organ transplantation organization, (DSO), 34 American military service members who died at LRMC (roughly half of the total number who died there) donated a total of 142 organs between 2005 and 2010. In 2010 alone, 10 of the 12 American service members who died at LRMC were donors, donating a total of 45 organs. Of the 205 hospitals in the DSO's central region—which includes the large cities of
Frankfurt and
Mainz—only six had more organ donors than LRMC in 2010. Scotland conforms to the Human Tissue Authority Code of Practice, which grants authority to donate organs, instead of consent of the individual. This helps to avoid conflict of implications and contains several requirements. To participate in organ donation, one must be listed on the Organ Donor Registry (ODR). If the subject is incapable of providing consent, and is not on the ODR, then an acting representative, such as a legal guardian or family member can give legal consent for organ donation of the subject, along with a presiding witness, according to the Human Tissue Authority Code of Practice. Consent or refusal from a spouse, family member, or relative is necessary for a subject is incapable. Austria participates in the "opt-out" consent process, and have laws that make organ donation the default option at the time of death. In this case, citizens must explicitly "opt out" of organ donation. Yet in countries such as U.S.A. and Germany, people must explicitly "opt in" if they want to donate their organs when they die. In Germany and Switzerland there are
Organ Donor Cards available. In May 2017, Ireland began the process of introducing an "opt-out" system for organ donation. Minister for Health, Simon Harris, outlined his expectations to have the Human Tissue Bill passed by the end of 2017. This bill would put in place the system of "presumed consent". The Mental Capacity Act is another legal policy in place for organ donation in the UK. The act is used by medical professionals to declare a patient's mental capacity. The act claims that medical professionals are to "act in a patient's best interest", when the patient is unable to do so. Many Indian states have adopted the law and in 2011 further amendment of the law took place. Despite the law there have been stray instances of organ trade in India and these have been widely reported in the press. This resulted in the amendment of the law further in 2011. Deceased donation after brain death have slowly started happening in India and 2012 was the best year for the programme. • Source the Indian Transplant News Letter of the
MOHAN Foundation The year 2013 has been the best yet for deceased organ donation in India. A total of 845 organs were retrieved from 310 multi-organ donors resulting in a national organ donation rate of 0.26 per million population(Table 2).
* ODR (pmp) – Organ Donation Rate (per million population) In the year 2000 through the efforts of a non-governmental organization called
MOHAN Foundation state of
Tamil Nadu started an organ sharing network between a few hospitals. The MOHAN Foundation also set up similar sharing network in the state of Andhra Pradesh and these two states were at the forefront of deceased donation and transplantation programme for many years. As a result, retrieval of 1,033 organs and tissues were facilitated in these two states. Similar sharing networks came up in the states of
Maharashtra and
Karnataka; however, the numbers of deceased donation happening in these states were not sufficient to make much impact. In 2008, the
Government of Tamil Nadu put together government orders laying down procedures and guidelines for deceased organ donation and transplantation in the state. These brought in almost thirty hospitals in the programme and has resulted in significant increase in the donation rate in the state. With an organ donation rate of 1.15 per million population, Tamil Nadu is the leader in deceased organ donation in the country. The small success of Tamil Nadu model has been possible due to the coming together of both government and private hospitals, non-governmental organizations and the State Health Department. Most of the deceased donation programmes have been developed in southern states of India. The various such programmes are as follows: In the year 2012 besides Tamil Nadu other southern states too did deceased donation transplants more frequently. An online organ sharing registry for deceased donation and transplantation is used by the states of Tamil Nadu and Kerala. Both these registries have been developed, implemented and maintained by MOHAN Foundation. However. National Organ and Tissue Transplant Organization (NOTTO) is a National level organization set up under Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India and only official organization. Organ selling is legally banned in Asia. Numerous studies have documented that organ vendors have a poor
quality of life (QOL) following kidney donation. However, a study done by Vemuru reddy
et al shows a significant improvement in Quality of life contrary to the earlier belief. Live related renal donors have a significant improvement in the QOL following renal donation using the WHO QOL BREF in a study done at the
All India Institute of Medical Sciences from 2006 to 2008. The quality of life of the donor was poor when the graft was lost or the recipient died. Recently a scoring system, Seth-Donation of Organs and Tissues (S-DOT) score, has been developed to assess hospitals for best practices in tissue donation and organ donation after brain death.
Iran Only one country, Iran has eliminated the shortage of transplant organs—and only Iran has a working and legal payment system for organ donation. It is also the only country where organ trade is legal. The way their system works is, if a patient does not have a living relative or who are not assigned an organ from a deceased donor, apply to the nonprofit Dialysis and Transplant Patients Association (Datpa). The association establishes potential donors, those donors are assessed by transplant doctors who are not affiliated with the Datpa association. The government gives a compensation of $1,200 to the donors and aid them a year of limited health-insurance. Additionally, working through Datpa, kidney recipients pay donors between $2,300 and $4,500. Charity donations are made to those donors whose recipients are unable to pay. The Iranian system began in 1988 and eliminated the shortage of kidneys by 1999. Within the first year of the establishment of this system, the number of transplants had almost doubled; nearly four-fifths were from living unrelated sources.
Japan The rate of organ donation in Japan is significantly lower than in Western countries. This is attributed to cultural reasons, some distrust of
western medicine, and a controversial
organ transplantation in 1968 that provoked a ban on cadaveric organ donation that would last thirty years. A family cannot object unless there is reason to show the person would not have wanted to donate. If a person cannot be found in the national donor registry, because they are travelling from another country or because they are undocumented, their organs are not harvested without family consent. Organs are not harvested from people who die an
unnatural death without the approval of the local attorney general.
New Zealand New Zealand law allows live donors to participate in
altruistic organ donation only. In the five years to 2018, there were 16 cases of liver donation by live donors and 381 cases of kidney donation by live donors. New Zealand has low rates of live donation, which could be due to the fact that it is illegal to pay someone for their organs. The Human Tissue Act 2008 states that trading in human tissue is prohibited, and is punishable by a fine of up to $50,000 or a prison term of up to 1 year. The Compensation for Live Organ Donors Act 2016, which came into force in December 2017, allows live organ donors to be compensated for lost income for up to 12 weeks post-donation. New Zealand law also allows for organ donation from deceased individuals. In the five years to 2018, organs were taken from 295 deceased individuals. The question is required to be answered for the application to be processed, meaning that the individual must answer yes or no, and does not have the option of leaving it unanswered. A 2006 bill proposed setting up an organ donation register where people can give informed consent to organ donations and clearly state their legally binding wishes. However, the bill did not pass, and there was condemnation of the bill from some doctors, who said that even if a person had given express consent for organ donation to take place, they would not carry out the procedure in the presence of any disagreement from grieving family members. The indigenous population of New Zealand also have strong views regarding organ donation. Many
Maori people believe organ donation is morally unacceptable due to the cultural need for a dead body to remain fully intact. However, because there is not a universally recognised cultural authority, no one view on organ donation is universally accepted in the Maori population.
Sri Lanka Organ donation in Sri Lanka was ratified by the Human Tissue Transplantation Act No. 48 of 1987.
Sri Lanka Eye Donation Society, a non-governmental organization established in 1961 has provided over 60,000 corneas for
corneal transplantation, for patients in 57 countries. It is one of the major suppliers of human eyes to the world, with a supply of approximately 3,000 corneas per year.
United Kingdom Wales ,
Welsh Government Health Minister, addresses the
Kidney Research UK Annual Fellows Day; 2017 Since December 2015,
Human Transplantation (Wales) Act 2013 passed by the
Welsh Government has enabled an opt-out organ donation register, the first country in the UK to do so. The legislation is 'deemed consent', whereby all citizens are considered to have no objection to becoming a donor, unless they have opted out on this register.
England The
Organ Donation (Deemed Consent) Act 2019 established opt-out organ donation in England, also known as Max and Keira's law, when came into effect in May 2020. It means adults in England will be automatically be considered potential donors unless they chose to opt out or are excluded.
Scotland The
Human Tissue (Authorisation) (Scotland) Act 2019 established opt-out organ donation in Scotland in March 2021.
Northern Ireland The
Organ and Tissue Donation (Deemed Consent) Act (Northern Ireland) 2022 established opt-out organ donation in 2023. in Guernsey, the Human Tissue and Transplantation (Bailiwick of Guernsey) Law, 2020 established opt-out organ donation in 2023. In the Isle of Man, the Human Tissue and Organ Donation Act 2021 has provisions to establish opt-out organ donation, which have not been enacted.
United States Over 121,000 people in need of an organ are on the U.S. government waiting list. This crisis within the United States is growing rapidly because on average there are only 30,000 transplants performed each year. More than 8,000 people die each year from lack of a donor organ, an average of 22 people a day. In the past, presumed consent was urged to try to decrease the need for organs. The
Uniform Anatomical Gift Act of 1987 was adopted in several states, and allowed medical examiners to determine if organs and tissues of cadavers could be donated. By the 1980s, several states adopted different laws that allowed only certain tissues or organs to be retrieved and donated, some allowed all, and some did not allow any without consent of the family. In 2006 when the UAGA was revised, the idea of presumed consent was abandoned. In the United States today, organ donation is done only with consent of the family or donator themselves. In most states, residents can register to become organ donors through the Department of Motor Vehicles. The driver's license will serve as a legal donor card for the registered donor. U.S. Residents may also choose to register as organ, eye, and tissue donors through a national registry maintained by
Donate Life America. The national website is RegisterMe.org The national registry allows residents to create a login, password, and edit their donation choice by organ. The most common transplants consists of only six (6) organs: heart, lungs, liver, kidney, pancreas, and small intestines. One healthy donor can potentially save up to eight (8) lives through transplants, using the two lungs and two kidneys separately. The most needed organ for transplants overall are kidneys, due to the high rate of hypertension (HTN) or high blood pressure and diabetes which can lead to end-stage renal disease. According to economist Alex Tabarrok, the shortage of organs has increased the use of so-called expanded criteria organs, or organs that used to be considered unsuitable for transplant. Several organizations such as the
American Kidney Fund are pushing for opt-out organ donation in the United States.
Donor Leave Laws In addition to their sick and annual leave, federal executive agency employees are entitled to 30 days paid leave for organ donation. Thirty-two states (excluding only
Alabama,
Connecticut, Florida,
Kentucky,
Maine,
Michigan,
Montana,
Nebraska,
Nevada,
New Hampshire,
New Jersey,
North Carolina,
Pennsylvania,
Rhode Island,
South Dakota,
Tennessee,
Vermont, and
Wyoming) and the
District of Columbia also offer paid leave for state employees. Five states (California, Hawaii,
Louisiana,
Minnesota, and
Oregon) require certain private employers to provide paid leave for employees for organ or bone marrow donation, and seven others (
Arkansas, Connecticut, Maine, Nebraska, New York,
South Carolina, and
West Virginia) either require employers to provide unpaid leave, or encourage employers to provide leave, for organ or bone marrow donation.), would amend the
Family and Medical Leave Act of 1993 to provide leave under the act for an organ donor. If successful, this new law would permit "eligible employee" organ donors to receive up to 12 work weeks of leave in a 12-month period.
Tax incentives Nineteen US states and the
District of Columbia provide tax incentives for organ donation. NOTA prohibits, "any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation." However, NOTA exempts, "the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ," from its definition of "valuable consideration". Tax credits, on the other hand, are perceived as more equitable since the after tax benefit of the incentive is not tied to the marginal tax rate of the donor.
Other financial incentives As stated above, under the
National Organ Transplant Act of 1984, granting monetary incentives for organ donation is illegal in the United States. However, there has been some discussion about providing fixed payment for potential live donors. In 1988, regulated paid organ donation was instituted in
Iran and, as a result, the renal transplant waiting list was eliminated. Critics of paid organ donation argue that the poor and vulnerable become susceptible to transplant tourism. Travel for transplantation becomes transplant tourism if the movement of organs, donors, recipients or transplant professionals occurs across borders and involves organ trafficking or transplant commercialism. Poor and underserved populations in underdeveloped countries are especially vulnerable to the negative consequences of transplant tourism because they have become a major source of organs for the 'transplant tourists' that can afford to travel and purchase organs. In 1994 a law was passed in Pennsylvania which proposed to pay $300 for room and board and $3,000 for funeral expenses to an organ donor's family. Developing the program was an eight-year process; it is the first of its kind. Procurement directors and surgeons across the nation await the outcomes of Pennsylvania's program. There have been at least nineteen families that have signed up for the benefit. Due to investigation of the program, however, there has been some concern whether the money collected is being used to assist families. Nevertheless, funeral aids to induce post-mortem organ donation have also received support from experts and the general public, as the incentives present more ethical values, such as honoring the deceased donor or preserving voluntariness, and potentially increase donation willingness. Some organizations, such as the National Kidney Foundation, oppose financial incentives associated with organ donation claiming, "Offering direct or indirect economic benefits in exchange for organ donation is inconsistent with our values as a society." One argument is it will disproportionately affect the poor. The $300–3,000 reward may act as an incentive for poorer individuals, as opposed to the wealthy who may not find the offered incentives significant. The National Kidney Foundation has noted that financial incentives, such as this Pennsylvania statute, diminish human dignity.
Saudi Arabia According to its Human Organ Donation Law, the Kingdom of Saudi Arabia provides legal backing for both living and deceased donors, following Royal Decree published on 1 April 2021 by the Council of Ministers, which took place on 30 March 2021. The law includes provisions that outline the organ donation process; donor consent; medical determination of death; hospital responsibilities; and penalties for non-compliance. Islamic law (Sharia) governs organ donation and prohibits any type of material or financial reward. Public donations from deceased individuals require either the express consent of the deceased or the consent of the next of kin if the deceased is unavailable to provide consent. All public activities, donor lists, and transplant logistics are held by the SCOT (Saudi Center for Organ Transplantation).
Egypt Law No. 5 of 2010, which governs the regulation of organ and human tissue donation and transplantation in Egypt, strictly prohibits any trade in human organs while permitting donation whether from living or deceased donors under stringent legal and medical conditions. In the case of posthumous donation, it may take place only if the donor has previously given explicit consent before death, and provided that a medical committee formally certifies death in accordance with the established criteria of brain death. However, because of administrative, moral, and religious barriers, the law has not yet been fully implemented. Discussions over the establishment of a national organ donor registry and the efficient enforcement of the law are still going on, and public awareness initiatives have been planned. ==Bioethical issues==