National Organ Transplant Act of 1984

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National Organ Transplant Act
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Long titleAn 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 for other purposes.
Acronyms (colloquial)NOTA
Enacted bythe 98th United States Congress
EffectiveOctober 19, 1984
Citations
Public law Pub. L. Tooltip Public Law (United States)  98–507
Statutes at Large 98  Stat.   2339
Codification
Titles amended 42
U.S.C. sections created42 USC § 273, 42 USC § 274
Legislative history

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]

Contents

Since the initial network contract was finalized in 1986, the United Network for Organ Sharing (UNOS) has served as the OPTN under contract with the U.S. Department of Health and Human Services. OPTN policies are developed by a broad community that includes donation and transplant clinicians and professionals. NOTA and subsequent federal regulation call on the OPTN to emphasize fair and equitable patient access to transplantation, as well as reliance on objective medical evidence and adaptability to evolution in clinical treatment and scientific understanding.

History

Before 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. This meant that the relatives of a deceased person had a possessory right for as long as it took to decide how to bury or dispose of the corpse. This contrasts with a property right in that they do not have a right to transfer, devise, possess, or lease the human organs and tissues. [3]

Due to a shortage in 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. [4] NOTA was a response to this proposal, making it criminal to transfer human organs for valuable consideration for the purposes of human transplantation. [5]

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. [6]

NOTA made it illegal to compensate organ donors but did not prevent payment for other forms of donations (such as human plasma, sperm, and egg cells). Although bone marrow is not an organ or a component of an organ, the act made paying bone marrow donors illegal. At the time the act was passed, donating bone marrow involved a painful and risky medical procedure. [7] 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. [8] The firm argued that the development of apheresis meant that donors who gave bone marrow through blood donation should be allowed to receive compensation. [7] 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. [7] [9] Critics argued that allowing compensation could reduce donation, increase the risk of disease, and lead to the exploitation of the poor. [7] [8] [10] In December 2011, the Ninth Circuit Court of Appeals unanimously ruled that donors giving bone marrow via apheresis were eligible for compensation. [7] 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. [11] [12]

Sections of NOTA

Title I - Task Force on Organ Procurement and Transplantation

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 - Organ Procurement Activities

Title II established the Organ Procurement Organizations (OPO) for deceased organ transplants. These OPO's 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. [13]

NOTA also established the Organ Procurement and Transplantation Network (OPTN), a membership organization transplant-related individuals and organizations, primarily transplant centers. OPTN is currently administered by the private, non-profit organization, United Network for Organ Sharing (UNOS), in Richmond, Virginia. OPTN operates under the authority of the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services. Robert Walsh is the current Project Officer for OPTN. [14]

Their duties include:

The Act also introduced a scientific Federal Registry of all the recipients of organ transplants. This registry includes patient information and transplant procedures. [15]

Title III - Prohibition of Organ Purchases

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 of breaking this law is a fine of $50,000 or up to five years in prison, or both. [16]

Title IV - Miscellaneous

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. [17]

Amendments

1988

The 1988 Amendment of NOTA introduced the Organ Procurement Organizations and Organ Procurement and Transplantation Network explained in detail in Title II of NOTA. [18]

1990

The 1990 Amendment of NOTA introduced the Federal Registry.

Ethics

Some believe that if organ transplantation is a commercial process, incentives for the disfranchised and poor would be created to manipulate them into being more willing to donate. To these detractors, putting a purchase price on a body part resembles slavery and treats a class of people as subhuman. Also, the buying and selling of organs for transplantation as a business arrangement has the potential to lead to misrepresentation of a donor’s medical information, especially if they were in poor financial shape. [19]

Related Research Articles

<span class="mw-page-title-main">Organ donation</span> Process of voluntarily giving away organs

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.

<span class="mw-page-title-main">Organ transplantation</span> Medical procedure in which an organ is removed from one body and placed in the body of a recipient

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.

<span class="mw-page-title-main">Kidney transplantation</span> Medical procedure

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.

<span class="mw-page-title-main">Health Resources and Services Administration</span> United States government agency

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.

<span class="mw-page-title-main">United Network for Organ Sharing</span>

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.

The National Marrow Donor Program (NMDP) is a nonprofit organization founded in 1986 and based in Minneapolis, Minnesota, that operates the Be The Match 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.

<span class="mw-page-title-main">Gift of Life Marrow Registry</span> Public bone marrow and blood stem cell registry

The Gift of Life Marrow Registry is a public bone marrow and blood stem cell registry headquartered in Boca Raton, Florida. Gift of Life facilitates transplants for children and adults suffering from life-threatening illnesses, including leukemia, lymphoma, other cancers and genetic diseases.

<span class="mw-page-title-main">Francis L. Delmonico</span>

Francis L. Delmonico, MD, FACS is a surgeon, clinical professor and health expert in the field of transplantation. He serves on numerous committees and is affiliated with various leading organizations and institutions. He is the chief medical officer of the New England Organ Bank (NEOB) and Professor of Surgery, Part-Time at Harvard Medical School in Boston, Massachusetts, where he is emeritus director of renal transplantation. He served as president of The Transplantation Society (TTS) from 2012 to 2014, an international non-profit organization based in Montreal, Canada that works with international transplantation physicians and researchers. He also served as the president of the United Network of Organ Sharing (UNOS) in 2005, which overseas the practice of organ donation and transplantation in the United States. He was appointed and still serves as an advisor to the World Health Organization in matters of organ donation and transplantation. He was appointed by Pope Francis to the Pontifical Academy of Science in 2016. In 2020, he became the recipient of the Medawar Prize of The Transplantation Society.

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.

<span class="mw-page-title-main">MOHAN Foundation</span>

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. It has offices in Chennai, Hyderabad, Bengaluru, Delhi, Mumbai, Chandigarh, Nagpur, Jaipur and information centers at Kerala and Imphal.

<span class="mw-page-title-main">HIV Organ Policy Equity Act</span> US law

The HIV Organ Policy Equity Act is a law that modifies rules regarding organ donation between HIV-positive individuals. The law authorizes clinical research and the revision of rules about organ donation and transportation as a result of the research. Organs from HIV donors would only be going to individuals who are already HIV positive, but could lead to 600 additional organ transplants a year. The use of HIV-positive organs was previously a federal crime. This bill passed the United States Senate during the 113th United States Congress, and also passed the United States House of Representatives. It was signed into law as PL 113-51 by President Barack Obama on November 21, 2013.

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.

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.

References

  1. ↑ unosadmin (2014-10-20). "National Organ Transplant Act enacted 30 years ago". UNOS. Retrieved 2023-03-24.
  2. ↑ "History and NOTA - OPTN". optn.transplant.hrsa.gov. Retrieved 2023-03-24.
  3. ↑ Mayes, Gwen. "Buying and Selling Organs for Transplantation in the United States." Medscape Education 4, no. 3 (2003): 1-4.
  4. ↑ Mayes, page 1.
  5. ↑ National Organ Transplantation Act of 1984, Pub L. 98-507, 98 Stat. 2339-2348 (Oct. 19, 1984).
  6. ↑ "The National Organ Transplant Act." US Legal Healthcare. US Legal, 2010.
  7. 1 2 3 4 5 Williams, Carol J. (2 December 2011). "Pay ban on donor organs doesn't include bone marrow, court says". Los Angeles Times. Retrieved 10 December 2013.
  8. 1 2 Rubin, Rita (24 February 2010). "Lawsuit urges payment for bone marrow donors". USA Today. Retrieved 10 December 2013.
  9. ↑ Levy, Collin (7 January 2012). "Litigating for Liberty". The Wall Street Journal. Retrieved 9 December 2013.(subscription required)
  10. ↑ The Associated Press (27 November 2013). "Gov't To Keep Ban On Paying Bone Marrow Donors". NPR. Retrieved 20 December 2013.
  11. ↑ Anderson, Erica (14 April 2021). "I Have a Bone to Pick with The National Organ Transplant Act". University of Cincinnati Law Review. No. April 2021. Archived from the original on 2023-01-30. Retrieved 30 Jan 2023.
  12. ↑ Glembocki, Vicki (1 July 2014). "The Case of the Bone Marrow Buyer". The Reader's Digest. No. July 2014. Archived from the original on 2018-04-10. Retrieved 2 May 2015.
  13. ↑ "Organ Procurement Organizations." http://organdonor.gov. US Department of Human Health and Services.
  14. ↑ "Organ Procurement and Transplantation Network." http://optn.transplant.hrsa.gov. U.S. Department of Health & Human Services.
  15. ↑ National Organ Transplantation Act of 1984, Sec. 373.
  16. ↑ National Organ Transplantation Act of 1984, Sec. 301.
  17. ↑ National Organ Transplantation Act of 1984, Sec. 401.
  18. ↑ "Intended Recipient Exchanged, Paired Exchanges and NOTA Sec. 301." Williams Mullen Attorneys, 7 Mar. 2003.
  19. ↑ Mayes, page 4.
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