National Organ Transplant Act of 1984

On October 19, 1984, the Congress of the United States approved the National Organ Transplant Act (NOTA). It not only established the framework for the U.S. organ transplant system but has served as a model for development of other transplant networks worldwide. Through the establishment of a national Organ Procurement and Transplantation Network (OPTN), the law directed that organ allocation would be managed on a national basis and be developed through a unique public-private partnership. Since the initial network contract was finalized in 1986, 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, as well as people personally touched by the donation and transplant experience. 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 rapid evolution in clinical treatment and scientific understanding. Many of the OPTN’s responsibilities, priorities and policies have changed over the years. Yet the lifesaving gift organ donation, and the continuing need of candidates awaiting a transplant, remain the same today as they did 30 years ago. To fulfill the ultimate goals of NOTA, we must continue to ensure that the national transplant network allocates organs efficiently and fairly. We must also build public knowledge and trust in organ donation to help increase transplant opportunities for everyone in need.

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 long enough to decide how to bury or dispose of the corpse. This does not mean a property right which means they do not have a right to transfer, devise, possess, and lease the human organs and tissues.[1]

Due to a shortage in organs but a growing demand for transplantations, 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 new 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.[2] This brought the issue out into the open. NOTA was a response to this proposal making it criminal to transfer human organs for valuable consideration for the purposes of a human transplantation.[3]

At the time NOTA was passed, there was an 80% survival rate for kidney transplants. A new drug, cyclosporin, that had been introduced had also increased the survival rate of liver transplant patients from 35% to 70% in a patients first year of undergoing a liver transplant. This made it clear that the legislation was aware of a growing need and also growing shortage of organs when NOTA was passed.[4]

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.[5] 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.[6] The firm argued that the development of apheresis meant that donors who gave bone marrow through blood donation should be allowed to receive compensation.[5] 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.[5][7] Critics argued that allowing compensation could reduce donation, increase the risk of disease, and lead to exploitation of the poor.[5][6][8] In December 2011, the Ninth Circuit Court of Appeals ruled unanimously that donors giving bone marrow via apheresis were eligible for compensation.[5] 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. As of July 2014, the proposal was still under review.[9]

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:

  • handling all medical, legal, ethical, economic, and social issues that may rise from obtaining deceased human organs and the transplantation of them.
  • assessing immunosuppressive medication used to prevent organ rejection in transplant patients, including safety, effectiveness, costs, insurance reimbursements, and making sure those who need these drugs can receive them
  • prepare a report including assessments of public and private efforts to obtain deceased human organs, problems in obtaining these organs, recommendations for education and training of health professionals and for education of the general public
  • assessment of the effectiveness and of establishing a national registry of deceased human organ donors

A full list can be found in Sec. 101 (3) in Pub.L. 98–507.[10]

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.[11]

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.[12]

Their duties include:

  • "facilitating the deceased organ matching and placement process through the use of the computer system and a fully staffed Organ Center operating 24 hours a day"
  • "developing consensus based policies and procedures for deceased organ recovery, distribution (allocation), and transportation"
  • "collecting and managing scientific data about organ donation and transplantation"
  • "providing data to the government, the public, students, researchers, and the Scientific Registry of Transplant Recipients for use in the ongoing quest for improvement in the field of solid organ allocation and transplantation"
  • "developing and maintaining a secure Web-based computer system, which maintains the nation's deceased organ transplant waiting list and recipient/donor organ characteristics"; and,
  • "providing professional and public education about donation and transplantation, the activities of the OPTN and the critical need for donation."

The Act also introduced a scientific Federal Registry of all the recipients of organ transplants. This registry includes patient information and transplant procedures.[13]

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.[14]

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.[15]

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.[16]

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.[17]

References

  1. ↑ Mayes, Gwen. "Buying and Selling Organs for Transplantation in the United States." Medscape Education 4, no. 3 (2003): 1-4.
  2. ↑ Mayes, page 1.
  3. ↑ National Organ Transplantation Act of 1984, Pub L. 98-507, 98 Stat. 2339-2348 (Oct. 19, 1984).
  4. ↑ "The National Organ Transplant Act." US Legal Healthcare. US Legal, 2010.
  5. 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.
  6. 1 2 Rubin, Rita (24 February 2010). "Lawsuit urges payment for bone marrow donors". USA Today. Retrieved 10 December 2013.
  7. ↑ Levy, Collin (7 January 2012). "Litigating for Liberty". The Wall Street Journal. Retrieved 9 December 2013.(subscription required)
  8. ↑ The Associated Press (27 November 2013). "Gov't To Keep Ban On Paying Bone Marrow Donors". NPR. Retrieved 20 December 2013.
  9. ↑ Glembocki, Vicki (1 July 2014). "The Case of the Bone Marrow Buyer". The Reader's Digest. No. July 2014. Retrieved 2 May 2015.
  10. ↑ National Organ Transplant Act of 1984, Sec. 101
  11. ↑ "Organ Procurement Organizations." http://organdonor.gov. US Department of Human Health and Services.
  12. ↑ "Organ Procurement and Transplantation Network." http://optn.transplant.hrsa.gov. U.S. Department of Health & Human Services.
  13. ↑ National Organ Transplantation Act of 1984, Sec. 373.
  14. ↑ National Organ Transplantation Act of 1984, Sec. 301.
  15. ↑ National Organ Transplantation Act of 1984, Sec. 401.
  16. ↑ "Intended Recipient Exchanged, Paired Exchanges and NOTA Sec. 301." Williams Mullen Attorneys, 7 Mar. 2003.
  17. ↑ Mayes, page 4.
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