[This blog post is based on a presentation by Alfred Sadler and Blair Sadler at the opening session of the ULC's 127th annual meeting in Louisville, July 20, 2018.]
Organ Transplantation and the Uniform Anatomical Gift Act: A Fifty-Year Perspective
by Alfred M. Sadler Jr. MD and Blair L. Sadler JD
By the mid 1960’s, Americans were already benefiting from the transplantation of corneas, kidneys, pancreas and liver and the use of the deceased’s tissues for research and therapeutic purposes. When we arrived at the National Institutes of Health in July 1967, to work as a medical legal team as Commissioned Officers in the US Public Health Service, we were asked to explore the medical- legal issues relating to organ and tissue donation. Since 1963, the NIH had supported the collection of thousands of cadaver pituitary glands each year, in order to extract human growth hormone and perform therapeutic studies on hypopituitary children. Although the program was highly successful scientifically, problems had recently surfaced in Minneapolis and Los Angeles, where sensationalized newspaper headlines criticized the practice of taking pituitary glands without consent in cases where the Medical Examiner had authority to perform an autopsy - to determine the cause of death.
After extensive legal research, we learned that most states had adopted four separate laws relating to the dead body; autopsy, medical examiner, unclaimed body and organ donation statutes. None was uniform. We also explored relevant medical issues: including tissue matching, organ preservation and transport, surgical technique and the emerging notion of “brain death”. We met with leading surgeons, scientists, ethicists, and organizations such as tissue banks, the Kidney Foundation, Eye Banks, and even the funeral directors.
We were pleased to discover that the Commissioners had already established a study committee, chaired by Dean Blythe Stason to design a model law for organ donation. We worked very closely with Dean Stason and his Committee, as consultants.
When Dr. Christiaan Barnard performed the first human heart transplant in December 1967 – the event made front page news around the world and was hailed as the dawning of a new technological age. There was extraordinary public interest in new possibilities for saving lives. But there were also ethical issues raised concerning individual rights. Several cartoons captured some of these worries. One was a bumper sticker which read “Drive Slowly – Dr. Barnard May Be Watching.” Another depicted a sign on a hospital patient’s bed - “patient asleep – not an organ donor” 1
From the beginning, the design and drafting of the model law was a collaborative and inclusive process. One example -- in March 1968, at a meeting involving key health care stakeholders, agreement was reached on a single organ donor card that could be used by all organizations and in all states.2 The final draft of the Uniform Act was approved by the Commissioners in July 1968.3 It was enacted in all 50 states and the District of Columbia, in just three years, with little or no change.
Vital to its success was the widespread support of important stakeholders; the considerable public interest; and the fact that the law was based on three cardinal ethical principles which reflected core American values: altruism, autonomy, and trust. Altruism - a gift to another based on consent and voluntary donation. Autonomy - the individual has the right to decide what happens to his body upon his death. Trust - the importance of fostering trust in the medical profession and the American healthcare system - to first do no harm.4
The Central Provisions of the law included:
- Granting the individual the right to donate all or part of his body upon death.
- A specified order of next of kin was authorized to donate, if the deceased had not acted.
- An executed organ donor card and telephonic consent were valid donation instruments.
- The purposes of a gift were broadly defined to include transplantation, research, education, and therapy.
- To avoid a conflict of interest, the time of death was to be determined by the donor’s attending physician.
- Specific criteria for the definition of death were intentionally not defined.
1968-2018:
There has been remarkable progress in the science of transplantation including improved anti-rejection drugs, surgical techniques, tissue matching and organ preservation; which has helped save many lives and improved the quality of life for transplant recipients.
The Uniform Determination of Death Act was adopted by the ULC in 1980 to codify the accepted medical definition of brain death.5
In 1984, a landmark federal law created the Organ Procurement and Transplant Network, operated by the United Network for Organ Sharing (UNOS); with oversight by the Department of Health and Human Services; and a network of regional Organ Procurement Organizations (OPOs) - now numbering 58.
In 1987, the Commissioners amended the UAGA in response to increasing demand to make more organs available. The revised version allowed the Medical Examiner to take organs for transplantation, if next of kin were not immediately available. It was adopted in 26 states.6
In 2006, the Uniform Act was again amended. An important change was to codify what was always implied, that the decedent’s wishes took precedent over objections by the next of kin. The medical examiner provision was removed and this version has been adopted in 48 states.7
What have we learned?
The core principles of the UAGA are as valid today as they were in 1968. The Act has provided a sound and stable ethical and legal platform on which to base the nation’s transplant system. The number of transplants has steadily increased, to 38,000 – last year alone, an increase from 5,000 in 1995. Today, more than 141 million Americans are registered donors, which is over 55% of the eligible population – also a steady increase. Unfortunately, the number of people waiting for transplants has grown even faster –117,000 last year, of whom 7000 died waiting for an organ.
What are solutions?
We must reverse the runaway epidemic of obesity and diabetes which is creating an ever-expanding need for more kidney transplants. In addition, some components of the current decentralized American system do not function optimally. More must be done to improve our system of organ procurement organizations, transplant centers, and donor registries.4
We thank Dean Stason and the members of his committee for their great work fifty years ago and for the opportunity to work closely with him. It was a life changing experience for us ---and we are honored to have been a part of it.
Congratulations to the Uniform Law Commission and your diligent work that has helped save the lives of thousands over the past 50 years!
References:
1 Alfred M. Sadler Jr and Blair L. Sadler “Transplantation and the Law: The Need for Organized Sensitivity” 57 Georgetown Law Journal 5-54 (1968)
2 Alfred M. Sadler Jr, Blair L. Sadler and E. Blythe Stason: “Transplantation and the Law” Progress Toward Uniformity” 282 New England Journal of Medicine 713—717 (1970)
3 National Conference on Uniform State Laws, Uniform Anatomical Gift Act (1968) www.uniformlaws.org/Act.aspx?title=Anatomical%20Gift%20(1968)
4 Blair L. Sadler and Alfred M. Sadler Jr. “Organ Transplantation and the Uniform Anatomical Gift Act: A Fifty-Year Perspective”, Hastings Center Report 48, no2 (2018) 14-18. DOI:10.1002/hast.834
5 National Conference on Uniform State Laws, The Uniform Determination of Death Act (1980) www.uniformlaws.org/Act.aspx...Determination%20of%20Death%20Act
6 National Conference on Uniform State Laws, Revised Uniform Anatomical Gift Act (1987) www.uniformlaws.org/shared/docs/anatomical_gift/uaga87.pdf
7 National Conference of Commissioners on Uniform State Laws, Revised Uniform Anatomical Gift Act (2006)
http://www.uniformlaws.org?Act.aspx?title=Anatomical%20Gift%20Act%20(2006)