Long title | An Act To provide for the establishment of the Task Force on Organ Transplantation and the Organ Procurement and Transplantation Network, to authorize financial assistance for organ procurement organizations and other purposes. |
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Acronyms (colloquial) | NOTA |
Enacted by | the 98th United States Congress |
Effective | October 19, 1984 |
Citations | |
Public law | Pub. L. 98–507 |
Statutes at Large | 98 Stat. 2339 |
Codification | |
Titles amended | 42 |
U.S.C. sections created | 42 USC § 273, 42 USC § 274 |
Legislative history | |
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The National Organ Transplant Act (NOTA) of 1984 is an Act of the United States Congress that created the framework for the organ transplant system in the country. [1] The act provided clarity on the property rights of human organs obtained from deceased individuals and established a public-private partnership known as Organ Procurement and Transplantation Network (OPTN). The OPTN was given the authority to oversee the national distribution of organs. [2]
Since the initial network contract was established in 1986, the United Network for Organ Sharing (UNOS) has acted as the OPTN under the U.S. Department of Health and Human Services. NOTA and subsequent regulations mandate that the OPTN prioritize fair patient access to transplantation while relying on objective medical evidence and adapting to advancements in clinical practices and scientific knowledge.
Before the enactment of the National Organ Transplant Act NOTA was put in place, there was no clear jurisdiction on what property rights were for a human corpse. Instead, America applied a "quasi-right" to a corpse. [3] This meant that the relatives were allowed to decide on burial or disposal. However, this did not grant them the right to transfer or sell organs and tissues, preventing the commercialization of human remains. [4]
Due to a shortage of organs and a growing demand for transplants, people began to use other means to purchase organs outside of a hospital setting; the organ market began to become a commercial market. H. Barry Jacobs, the head of a Virginia company, announced in 1983 a plan to buy and sell human organs on the market. This plan put healthy human kidneys in the price range of up to $10,000 plus a $2,000 to $5,000 commission fee for Jacobs. [5] NOTA was a response to this proposal, making it criminal to transfer human organs for valuable consideration for human transplantation. [6]
At the time NOTA was passed, there was an 80% survival rate for kidney transplants. A new drug, cyclosporin, had also increased the survival rate of liver transplant patients from 35% to 70% in a patient's first year after undergoing a liver transplant. The legislation was aware of a growing need and growing organ shortage when NOTA was passed. [7]
NOTA prohibited compensating organ donors but allowed payment for other types of donations, such as human plasma, sperm, and egg cells. Although bone marrow is not classified as an organ, the act also made compensation for bone marrow donation illegal. At the time of its passage, bone marrow donation was a painful and risky procedure. [8] In the years after the act was passed, a new procedure (apheresis) made it possible to harvest bone marrow cells through a non-surgical procedure similar to blood donation. In 2009, a public interest law firm (The Institute for Justice) sued to allow donors to be compensated for giving bone marrow. [9] The firm argued that the development of apheresis meant that donors who gave bone marrow through blood donation should be allowed to receive compensation. [8] The organization predicted that allowing compensation would increase the pool of available donors, and claimed that 3,000 Americans die each year while waiting for compatible marrow donors. [8] [10] Critics argued that allowing compensation could reduce donation, increase the risk of disease, and lead to the exploitation of the poor. [8] [9] [11] In December 2011, the Ninth Circuit Court of Appeals unanimously ruled that donors giving bone marrow via apheresis were eligible for compensation. [8] In November 2013, the federal government proposed a regulation that would change legal definitions to cover bone marrow regardless of how it is obtained. This would have the effect of keeping the ban on compensating donors in place. However, the proposal was later withdrawn. [12] [13]
Title I states the Secretary of Health and Human Services will establish a Task Force on Organ Procurement and Transplantation to regulate how deceased donor organs are handled and who receives transplantations and the process one must go through in regards to a deceased donor organ transplantation along with other lines of duty. This Task Force is composed of 25 members.
Duties of the Task Force include:
Title II established the Organ Procurement Organizations (OPO) for deceased organ transplants. These OPOs are designed to increase the number of registered deceased organ donors and when those donors become available, they coordinate the donation process from donor to patient. [14]
Additionally, NOTA created the Organ Procurement and Transplantation Network (OPTN), composed of transplant-related individuals and organizations, primarily transplant centers. The United Network for Organ Sharing (UNOS), a private non-profit based in Richmond, Virginia, currently administers the OPTN under the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services. [15]
The OPTN’s responsibilities include:
Moreover, the Act introduced a Federal Registry that documents all organ transplant recipients, encompassing patient information and transplant procedures. [16]
NOTA specifically states "It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce." The penalty for breaking this law is a fine of $50,000 up to five years in prison, or both. [17]
NOTA created a "national registry of voluntary bone marrow donors." Donors on this list have given informed consent and their names are kept confidential. This registry is upheld by the Secretary of Health and Human Services. [18]
The 1988 Amendment of NOTA introduced the Organ Procurement Organizations and Organ Procurement and Transplantation Network explained in detail in Title II of NOTA. [19]
The 1990 Amendment of NOTA introduced the Federal Registry.
Some critics assert that treating organ transplantation as a commercial endeavor may pressure the poor and disenfranchised into donating. They liken placing a price on body parts to slavery, degrading individuals to subhuman status. Furthermore, such practices could lead to misrepresentation of a donor’s medical history, especially for those in financial distress. [20]
Organ donation is the process when a person authorizes an organ of their own to be removed and transplanted to another person, legally, either by consent while the donor is alive, through a legal authorization for deceased donation made prior to death, or for deceased donations through the authorization by the legal next of kin.
Organ transplantation is a medical procedure in which an organ is removed from one body and placed in the body of a recipient, to replace a damaged or missing organ. The donor and recipient may be at the same location, or organs may be transported from a donor site to another location. Organs and/or tissues that are transplanted within the same person's body are called autografts. Transplants that are recently performed between two subjects of the same species are called allografts. Allografts can either be from a living or cadaveric source.
The Uniform Anatomical Gift Act (UAGA), and its periodic revisions, is one of the Uniform Acts drafted by the National Conference of Commissioners on Uniform State Laws (NCCUSL), also known as the Uniform Law Commission (ULC), in the United States with the intention of harmonizing state laws between the states.
Kidney transplant or renal transplant is the organ transplant of a kidney into a patient with end-stage kidney disease (ESRD). Kidney transplant is typically classified as deceased-donor or living-donor transplantation depending on the source of the donor organ. Living-donor kidney transplants are further characterized as genetically related (living-related) or non-related (living-unrelated) transplants, depending on whether a biological relationship exists between the donor and recipient. The first successful kidney transplant was performed in 1954 by a team including Joseph Murray, the recipient's surgeon, and Hartwell Harrison, surgeon for the donor. Murray was awarded a Nobel Prize in Physiology or Medicine in 1990 for this and other work. In 2018, an estimated 95,479 kidney transplants were performed worldwide, 36% of which came from living donors.
The Health Resources and Services Administration (HRSA) is an agency of the U.S. Department of Health and Human Services located in North Bethesda, Maryland. It is the primary federal agency for improving access to health care services for people who are uninsured, isolated or medically vulnerable.
The United Network for Organ Sharing (UNOS) is a non-profit scientific and educational organization that administers the only Organ Procurement and Transplantation Network (OPTN) in the United States, established by the U.S. Congress in 1984 by Gene A. Pierce, founder of United Network for Organ Sharing. Located in Richmond, Virginia, the organization's headquarters are situated near the intersection of Interstate 95 and Interstate 64 in the Virginia BioTechnology Research Park.
NMDP, formerly known as the National Marrow Donor Program and Be The Match, is a nonprofit organization founded in 1987 and based in Minneapolis, Minnesota, that operates a registry of volunteer hematopoietic cell donors and umbilical cord blood units in the United States.
Organ procurement is a surgical procedure that removes organs or tissues for reuse, typically for organ transplantation.
The Healthcare Systems Bureau is part of the Health Resources and Services Administration (HRSA), of the United States Department of Health and Human Services.
Organ trade is the trading of human organs, tissues, or other body products, usually for transplantation. According to the World Health Organization (WHO), organ trade is a commercial transplantation where there is a profit, or transplantations that occur outside of national medical systems. There is a global need or demand for healthy body parts for transplantation, which exceeds the numbers available.
Transplantable organs and tissues may refer to both organs and tissues that are relatively often transplanted, as well as organs and tissues which are relatively seldom transplanted. In addition to this it may also refer to possible-transplants which are still in the experimental stage.
In December 2006, The UK Government set up the Organ Donation Taskforce to identify barriers to organ donation and recommend actions needed to increase organ donation and procurement within the current legal framework.
The Gift of Life Marrow Registry is a non-profit organization founded in 1991 and headquartered in Boca Raton, Florida that operates a public blood stem cell and bone marrow registry while facilitating transplants for children and adults battling life-threatening illnesses, including leukemia, lymphoma, other cancers and genetic diseases.
In the United States, an organ procurement organization (OPO) is a non-profit organization that is responsible for the evaluation and procurement of deceased-donor organs for organ transplantation. There are 57 such organizations in the United States, each responsible for organ procurement in a specific region, and each a member of the Organ Procurement and Transplantation Network (OPTN), a federally-mandated network managed by the United Network for Organ Sharing (UNOS) under federal contract. The individual OPOs represent the front line of organ procurement, having direct contact with the donor's hospital and the family of the recently deceased donor. Once the OPO receives authorization for donation from the decedent's family or through first-person authorization, it works with UNOS to identify the best candidates for the available organs, and coordinates with the surgical team for each organ recipient.
MOHAN Foundation is a not-for-profit, registered non-government charity organisation in India that works in the field of deceased organ donation and transplantation. MOHAN is an acronym for Multi Organ Harvesting Aid Network.
Transplant coordinator is a healthcare professional – doctor, nurse, or allied health science graduate – who coordinates activities related to organ donation and transplantation. Transplant coordinators can either be Donor Coordinators or Recipient Coordinators.
Gregory Lyons Segal is an American entrepreneur.
Organ donation is when a person gives their organs after they die to someone in need of new organs. Transplantation is the process of transplanting the organs donated into another person. This process extends the life expectancy of a person suffering from organ failure. The number of patients requiring organ transplants outweighs the number of donor organs available.
Kidney paired donation (KPD), or paired exchange, is an approach to living donor kidney transplantation where patients with incompatible donors swap kidneys to receive a compatible kidney. KPD is used in situations where a potential donor is incompatible. Because better donor HLA and age matching are correlated with lower lifetime mortality and longer lasting kidney transplants, many compatible pairs are also participating in swaps to find better matched kidneys. In the United States, the National Kidney Registry organizes the majority of U.S. KPD transplants, including the largest swaps. The first large swap was a 60 participant chain in 2012 that appeared on the front page of the New York Times and the second, even larger swap, included 70 participants and was completed in 2014. Other KPD programs in the U.S. include the UNOS program, which was launched in 2010 and completed its 100th KPD transplant in 2014, and the Alliance for Paired Donation.
Organ transplantation in the Indian state of Tamil Nadu is regulated by India's Transplantation of Human Organs Act, 1994 and is facilitated by the Transplant Authority of Tamil Nadu (TRANSTAN) of the Government of Tamil Nadu and several NGOs. Tamil Nadu ranks first in India in deceased organ donation rate at 1.8 per million population, which is seven times higher than the national average.