Cadaveric Organ Donor Act

Living Organ Donor Act

Journal of Corporation Law

Spring 1993

18 Journal of Corporation Law 523 (1993)

Proposed Federal Statutes

FOREWORD

Sheldon F. Kurtz

Michael J. Saks

Copyright © 1993 University of Iowa (The Journal of Corporation Law); Sheldon

The Cadaveric Organ Donor Act (CODA) and The Living Organ Donor Act (LODA), together with the accompanying reports, are the products of an intense, often controversial, year-long seminar at The University of Iowa College of Law convened to draft a proposed federal law to increase the supply of organs for transplantation purposes. The topic was selected from a number of possibilities under the more general heading of "law and technology" and is the third in a series that has focused on the interplay between law and medicine, and in particular the law's response to ever-increasing improvements in medical technology. [FN1]



There is general agreement that the demand for organs for transplant purposes far exceeds the supply. In the United States, which bans the sale of organs, the principal method by which the law seeks to redress the imbalance is the procurement of organs by resort to the Uniform Anatomical Gift Act, which is premised on the principle of altruism. Outside of the United States, organs are procured by a variety of other methods, some of which are beginning to find their way into state law. Broadly speaking, other devices to assist in the procurement of organs include "mandated choice," [FN2] "required request," [FN3] and "presumed consent." [FN4] CODA and LODA borrow, and hopefully improve upon, ideas underlying these three devices, while at the same time not discouraging donations for purely altruistic motives.



CODA and LODA are the results of the significant efforts of fifteen committed law students who enrolled in a University of Iowa Law School seminar to wrestle with the legal, medical, moral, social, economic, theological, and cultural concerns surrounding the procurement of human organs for transplantation purposes. The seminar's goals were to grapple with the issues as broadly as possible, debate and vote upon alternative social policies and legislative solutions, and draft a detailed and comprehensive statutory scheme governing the procurement of organs for transplantation purposes. Unlike our prior experiences, this particular group of students was never able to reach consensus. This fortunate fact led to sharpened debates, as well as the production of a minority report and a response to that report.



In a sense, CODA and LODA really began when students registered for the seminar in the spring of 1992. Students with wide-ranging undergraduate majors, life experiences, backgrounds, and attitudes toward the topic of organ procurement enrolled in the seminar. The students were provided a reading list and articles, including papers produced the year before by a number of law students enrolled in another seminar addressing a myriad of issues relating to organ transplantation. In truth, our preliminary information regarding the students' attitudes towards organ transplants never adequately prepared us for the disparate attitudes these students had on the issues surrounding organ transplantation and the tenacity with which each student was prepared to hold to those views during the early months of the seminar.



At the start of the 1992 fall semester, the class defined a range of topics and issues relating to organ transplantations. Since much research already existed on the topics, the students had to do little independent research. Their time was well spent on literature reviews and thinking and re- thinking their positions on the issues. The students then engaged in substantial, oftentimes contentious, debates over the broad policy issues in class sessions held in the evenings and on weekends that easily lasted between 6 and 8 hours. By majority vote, the students adopted the policy positions reflected in the Acts. Thereafter, the basic outlines of the Acts were drawn, and drafting assignments were made to individuals or small groups of students who drafted their respective sections with preliminary comments. Then, class members were assigned to edit sections originally drafted by others. Thereafter, the class, acting as a drafting committee of the whole, edited and often wholly rewrote the drafts of statutory language. For editing purposes, the proposed language was projected from a computer onto a large screen, permitting group participation in the editing process. The actual drafting, of course, made evident further disputed policy issues and refinements that the class needed to debate and decide. After the preliminary texts of CODA and LODA were largely completed, the class reviewed and debated the concepts, justifications, and explanations to be developed in the accompanying reports and completed the drafting of the reports.



Once fairly complete drafts were in hand, copies were sent to a wide range of people and groups we thought might be interested and a public hearing was scheduled. At the public hearing, a number of physicians and other health care providers involved in the procurement of organs, as well as two organ recipients, testified. Their comments, as well as those solicited in writing from persons throughout the United States knowledgeable about the topic, were reviewed by the students and in a number of instances were used as the basis to revise certain sections of the Acts before they were finalized. Once the Acts were completed, both a minority report and a response to that report were written.



The reports to both Acts detail their most significant provisions and include the students' intent and rationales. The salient features of both Acts are also reflected in the executive summaries preceding each report and therefore will not be summarized here. Nonetheless, because they are departures from current practice in this country, a few significant features bear mentioning in this forward.



CODA essentially adopts mandated choice, under which an individual must register as a donor, a non-donor, or a restricted donor on a National Organ Donor Registry at the time he or she applies for a social security number, driver's license, or alien registration number. These events were chosen because of their pervasiveness as "rights of passage" in our country. Under CODA, the donative status of an individual, with limited exceptions generally applicable only to deceased minors, cannot be altered once the registrant has died. Thus, for the most part, CODA rejects the current fashion of allowing family members to overturn the donative desires of the decedent. The National Registry is consulted by the appropriate health care professional, who is entitled to rely exclusively on the Registry to determine whether a deceased patient is a donor, non-donor, or restricted donor. Provisions are made in CODA for the registration of minors and incompetent adults.



LODA by its nature is the more controversial of the two Acts and, admittedly, is less likely to be seriously considered by legislators at the present time. Essentially, LODA permits the removal of organs from living persons for transplantation purposes if the removal is authorized by the prospective donor (or, in certain cases, by his or her attorney-in-fact, parent, or guardian) and the prospective donor would not die or have a long- term dependence on medical technology as a result of the organ donation. However, this restriction is inapplicable to terminally ill persons, persons on death row, and persons who execute directives permitting donations should they be diagnosed as being in a persistent vegetative state, even if the donation would result in death, and to anencephalics. LODA also contains a national health care power of attorney form that would independently warrant serious consideration by all legislators.



As evidenced by this very brief description of the substantive provisions of CODA and LODA, the students have proposed controversial legislation. That characterization, however, in no way denigrates the significance of what they have accomplished, the care with which they have proceeded, or the educational experiences they have had working as a group considering important and contentious issues of public policy and reducing their considered judgment to a comprehensive and integrated statute.



Few experiences in legal education, or any other education, for students or for teachers, involve this much time spent together-time spent in exploration and discussion, deeply felt argument, dissection of logic, and the creation of a product that is the result of group effort and that has the potential to be law and not merely to be about law. Because very few of the votes on any given provision were unanimous, students also learned how law grows out of conflict and compromise. Because of the sheer time spent together, and the way the time was spent, and perhaps because every session was unavoidably about our thoughts and feelings about life and death, we believe we got to know these students (and they probably got to know us and each other) in a way that is rare in education. We are different teachers and human beings for the time we invested with these students and they with us and with each other.



FN1. The prior two seminars produced the Model Human Reproductive Technologies and Surrogacy Act , 72 Iowa L. Rev. 943 (1987) and the Model Aid-in-Dying Act , 75 Iowa L. Rev. 125 (1989).



FN2. Mandated choice requires prospective donors to declare their organ donative intent in connection with their participation in some other event such as the application for a driver's license.



FN3. Required request imposes an obligation on health care professionals to seek a donation from members of a prospective donor's family, typically while the prospective donor is in extremis or recently expired.



FN4. Presumed consent creates a presumption that an individual consents to the removal of his or her organs at death for transplantation purposes. Variations occur with respect to how the presumption can be rebutted.



CADAVERIC ORGAN DONOR ACT

A BILL



To regulate the donation of human cadaveric organs for transplantation purposes in order to increase their supply.



Be it enacted by the Senate and the House of Representatives of the United States of America in Congress assembled,



SECTION 101. SHORT TITLE AND TABLE OF CONTENTS.

(a) SHORT TITLE. This Act may be cited as the "Cadaveric Organ Donor Act."

(b) TABLE OF CONTENTS.

Title I. Definitions.

Title II. Cadaveric Organs.

Sec. 201. National Organ Donor Registry.

Sec. 202. Removal of Cadaveric Organs.

Title III. Sales.

Sec. 301. Prohibition on Sales.

Sec. 302. Repeal of Section 301 of the National Organ Transplantation Act.

Title IV. Miscellaneous Provisions.

Sec. 401. Conscientious Objection, Conflict of Interest, and Transfer of Patients.

Sec. 402. Immunities.

Sec. 403. Liabilities.

Sec. 404. Effects of this Act on Insurance and Health Care.

Sec. 405. Severability.

Sec. 406. Effective Date.



TITLE I-DEFINITIONS.



For purposes of this Act-

(1) the term "adult" means an individual who is at least 16 years of age or who is an emancipated minor;

(2) the term "attorney-in-fact" means the individual designated by a principal in a health care power of attorney that is valid under the laws of the United States or any State;

(3) the phrase "competent adult" means an adult who has not been judicially declared incompetent under the laws of any State;

(4) the term "death" means either the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of all functions of the entire brain, including the brain stem. A determination of death shall be made in accordance with generally accepted medical standards;

(5) the term "decedent" means a deceased individual, including a stillborn child;

(6) the term "donor" means an individual registered on the Registry from whom all organs may be removed for transplantation purposes upon that individual's death or an individual from whom an organ is removed for transplantation purposes;

(7) the phrase "Donor Form" means either National Organ Donor Registration Form A or B;

(8) the term "DOT" means the Department of Transportation of every State or any other State agency responsible for the issuance of driver's licenses or identification cards;

(9) the phrase "emancipated minor" means a minor who has been released from the custody and control of his or her parents or guardian with their permission, or by operation of law;

(10) the phrase "fetal tissue" means any fetus or embryo, living or dead, or a part from that fetus or embryo;

(11) the term "guardian" means a judicially-appointed committee, guardian, or conservator who has authority to make health care decisions for a minor or an incompetent adult;

(12) the phrase "health care" means care relating to an individual's health, including personal care or comfort, treatment, service, or procedure to maintain, diagnose, or treat an individual's physical or mental condition;

(13) the phrase "health care institution" means a hospital, nursing home, hospice, or any other facility where health care is provided that is licensed, accredited, approved, owned, or operated by the United States or any State or receives funds under the Medicare or Medicaid program;

(14) the phrase "health care provider" means a health care institution or an individual who is licensed or authorized by the United States or any State to administer health care in the ordinary course of business or practice of a profession;

(15) the term "hospice" means a facility licensed, accredited, approved, owned, or operated as a hospice by the United States or any State or receives funds under the Medicare or Medicaid program;

(16) the term "hospital" means a facility that is licensed, accredited, approved, owned, or operated as a hospital by the United States or any State or receives funds under the Medicare or Medicaid program;

(17) the phrase "incompetent adult" means an adult who has been judicially declared incompetent under the laws of any State;

(18) the term "INS" means the Immigration and Naturalization Service;

(19) the phrase "interstate commerce" means commerce between a State and a place outside of that State;

(20) the term "minor" means an individual who is not an adult, including a stillborn child;

(21) the term "non-donor" means an individual registered on the Registry from whom an organ may not be removed for transplantation purposes upon that individual's death;

(22) the phrase "nursing home" means a facility that is licensed, accredited, approved, owned, or operated as a nursing home by the United States or any State or receives funds under the Medicare or Medicaid program;

(23) the term "organ" includes human organs, tissue, and cells processed for transplantation purposes, but does not include fetal tissue;

(24) the terms "parents" and "parent" include a biological or adoptive parent of a child. The word "parents" means both parents and the word "parent" means either parent, unless only one of the parents has legal custody of a minor, in which case the words "parents" or "parent" mean only that parent who has legal custody, or unless a guardian has legal custody of a minor, in which case the words "parents" or "parent" means that guardian;

(25) the term "person" means an individual, corporation, business trust, estate, trust, partnership, joint venture, association, government, governmental subdivision or agency, or any other legal or commercial entity;

(26) the term "physician" means an individual licensed or authorized to practice medicine or osteopathy under the laws of any State;

(27) the term "principal" means an individual who has executed a valid health care power of attorney;

(28) the term "Registry" means the National Organ Donor Registry;

(29) the phrase "restricted donor" means an individual registered on the Registry from whom some but not all organs may be removed for transplantation purposes upon that individual's death;

(30) the term "Secretary" means the Secretary of the Department of Health and Human Services;

(31) the term "SSA" means the Social Security Administration;

(32) the term "State" includes the District of Columbia, the Commonwealth of Puerto Rico, and a territory or insular possession subject to the jurisdiction of the United States;

(33) the phrase "State Law" means the laws of that State in which the decedent dies;

(34) the phrase "transplantation purposes" means grafting, transplanting, or implanting an organ to the body of another individual; and

(35) the phrase "valuable consideration" shall not include reasonable payment or reimbursement for the maintenance, removal, preservation, transfer, and transplantation of an organ. Valuable consideration includes a tax or other financial incentive designed to encourage consent or to elicit consent for the removal of an organ for transplantation purposes.



TITLE II-CADAVERIC ORGANS.



SEC. 201. NATIONAL ORGAN DONOR REGISTRY.

(a) CREATION OF THE NATIONAL ORGAN DONOR REGISTRY.-The Secretary shall adopt rules and regulations for the creation and maintenance of a National Organ Donor Registry.



(b) INITIAL REGISTRATION OF INDIVIDUALS ON THE REGISTRY.-

(1) REGISTRATION OF INDIVIDUALS APPLYING FOR SOCIAL SECURITY NUMBERS.-The Secretary shall require an individual applying for a social security number to complete the appropriate Donor Form for the individual who will receive the social security number before that number is issued.

(2) REGISTRATION OF INDIVIDUALS APPLYING FOR DRIVERS' LICENSES OR IDENTIFICATION CARDS.-The first time after the enactment of this Act that an individual at least 16 years of age applies for a State driver's license or a State identification card, or for the renewal of a State driver's license or a State identification card, the DOT shall require that individual to complete Donor Form A before that license or identification card is issued.

(3) REGISTRATION OF INDIVIDUALS APPLYING FOR ALIEN REGISTRATION NUMBERS.- The Attorney General shall require an individual applying for an alien registration number to complete the appropriate Donor Form for the individual who will receive the alien registration number before that number is issued.

(4) REGISTRATION OF INDIVIDUALS BY OTHER MEANS.-

(A) REGISTRATION OF COMPETENT ADULTS.-A competent adult not registered on the Registry under the provisions of Section 201(b)(1)-(3) may, at any time, register himself or herself on the Registry by filing Donor Form A.

(B) REGISTRATION OF MINORS OR INCOMPETENT ADULTS.-A parent of a minor or a guardian of an incompetent adult may, at any time, register that minor or incompetent adult on the Registry by filing Donor Form B, if the minor or incompetent adult is not registered on the Registry under the provisions of Section 201(b)(1)-(3).



(c) ALTERING THE STATUS OF INDIVIDUALS ON THE REGISTRY.-

(1) MANDATORY ALTERATIONS AT AGE 16.-The Secretary shall delete the status of a minor registered on the Registry when that minor attains the age of 16.

(2) OPTIONAL ALTERATIONS AT ANY TIME.-

(A) COMPETENT ADULTS.-A competent adult may, at any time, change his or her status on the Registry by filing a new Donor Form A.

(B) MINORS OR INCOMPETENT ADULTS.-A parent of a minor or the guardian of an incompetent adult may, at any time, change the status of that minor or incompetent adult on the Registry by filing a new Donor Form B.



(d) EFFECTIVENESS OF REGISTRATION.-The status of an individual on the Registry is effective only after the information on that individual's Donor Form is recorded on the Registry.



(e) REGISTRY EXEMPTION FROM THE FREEDOM OF INFORMATION ACT.-The information contained on the Registry shall be exempt from the provisions of the Freedom of Information Act.



(f) DUTIES.-

(1) DUTY OF PARENTS TO APPLY FOR NEWBORNS' SOCIAL SECURITY NUMBERS.-A parent of a newborn child shall apply for a social security number on behalf of that child within 30 days after the child's birth.

(2) DUTIES OF THE DOT AND ATTORNEY GENERAL.-

(A) DUTY TO FORWARD INFORMATION TO THE SECRETARY.-The DOT and the Attorney General shall forward the information contained on a Donor Form they receive to the Secretary within a reasonable period of time (as determined by the Secretary) after the DOT or INS receives the Donor Form.

(B) DUTY TO INFORM THE PUBLIC ABOUT ORGAN DONATION.-The DOT and Attorney General shall, in every DOT and INS office, provide the public with all written educational material regarding organ donation they receive from the Secretary.

(3) DUTIES OF THE SECRETARY.-

(A) DUTY TO RECORD INFORMATION IN A TIMELY MANNER.-The Secretary shall-

(i) record the information from a Donor Form he or she receives within a reasonable period of time (as determined by the Secretary) after the Secretary receives the information;

(ii) register an individual for whom a Donor Form is filed as either a "donor," a "restricted donor," or a "non-donor;" and

(iii) utilize the individual's social security account number for the purpose of identifying the individual as a donor, restricted donor, or non-donor.

(B) DUTY TO MAKE THE INFORMATION ON THE REGISTRY AVAILABLE.-The Secretary shall make the information on the Registry available to every health care institution, every organ procurement organization, and to every other person the Secretary may designate. The Secretary also shall, upon request, make the information on the Registry regarding an individual registered on the Registry available to that individual or, if he or she is a minor, to his or her parent or, if he or she is an incompetent adult, to his or her guardian.

(C) DUTY TO MAKE DONOR FORMS AVAILABLE.-The Secretary shall make Donor Forms available at every office of the SSA, the DOT, the INS, the United States Postal Service, every physician, every health care institution, and at every other place the Secretary may designate.

(D) DUTY TO INFORM THE PUBLIC ABOUT ORGAN DONATION.-The Secretary shall provide written educational material regarding organ donation for distribution to every office of the SSA, the DOT, the INS, the United States Postal Service, every physician, every health care institution, and at every other place the Secretary may designate. The Secretary shall also disseminate that information in any other manner the Secretary determines to be appropriate.

(E) DUTY TO DISTRIBUTE DONOR FORMS PRIOR TO EFFECTIVENESS OF REGISTRY.- The Secretary shall make Donor Forms, together with written educational material regarding organ donation, available to all citizens and residents of the United States in order to comply with the effective date provisions of section 406.

(F) DUTY TO EVALUATE THIS ACT.-Seven years after the effective date of this Act, the Secretary shall submit a report to Congress evaluating the effectiveness of this Act in meeting the need for organs in the United States and the fairness of the allocation of organs in the United States and shall make recommendations that the Secretary deems advisable.

(g) NATIONAL ORGAN DONOR REGISTRATION FORMS.-

(1) NATIONAL ORGAN DONOR REGISTRATION FORM A (COMPETENT ADULTS).-



DONOR FORM A



ADULTS AND MINORS AT LEAST 16 YEARS OF AGE

NAME [ print your name ]:



SOCIAL SECURITY NUMBER OR ALIEN REGISTRATION NUMBER IF KNOWN [ print your number ]:



DATE OF BIRTH: mmm/mmm/mmm



CHECK ONLY ONE OF THE FOLLOWING:

[Donor status] Upon my death, I wish to make all of my organs available for transplantation.

[Restricted Donor status] Upon my death I wish to make all of my organs available for transplantation, except for the following:

[Non-donor status] Upon my death, I do not wish to make any of my organs available for transplantation.



Your signature



The following notarial certificate need not be completed if this form is filed at an office of a State Department of Transportation, the Immigration and Naturalization Service, or a health care institution if this form is signed in conjunction with admission to, or discharge from, the health care institution.



NOTARIAL CERTIFICATE





STATE OF  ) .. ss:



COUNTY OF  )





On this mmmmm day of mmmmmmmmmmmm, mmmmm, before me a Notary Public in and for the State of mmmmmmmmmmmmmmmmmmmmmmmmmmm personally appeared mmmmmmmmmmmmmmmmmmmmmmm [ Insert name of person above ], to me known and known to me to be the individual named in and who executed the foregoing Adult Donor Form, and he or she acknowledged to me that he or she executed the same as his or her free act and deed.

Notary Public in and for the State of



NOTICE



With this form you may donate all or some of your organs if they are needed after your death for transplantation purposes. You may refuse to donate any of your organs. You may complete this form at any time and are required to do so before you receive a driver's license or identification card the first time you apply for one after your 16th birthday. You are also required to complete this form before you receive a social security number, or if you are an alien, an alien registration number.



When you complete and return this form, you will be registered on the National Organ Donor Registry. This Registry will be used at your death to determine whether or not you want your organs donated to people who need them. At your death, your wishes regarding the possible donation of your organs will be followed regardless of what anyone else says. It is a good idea to inform your family of the decision you made on this form so that in the event of your death they know of your intent.



Your status on the Registry may be changed by you at any time after you turn 16 if you complete and return another one of these forms. Forms are available at Department of Transportation offices, Social Security Administration offices, Immigration and Naturalization Services offices, post offices, hospitals, and physicians' offices.



If you return a completed form to a State Department of Transportation office, an Immigration and Naturalization Service office, or to a health care institution in conjunction with your admission to, or discharge from, that institution, you do not have to have your signature notarized. If you mail a completed form directly to the office that maintains the Registry, you will have to have your signature notarized to insure that no one else is attempting to change your status on the Registry.



[Insert name and address of office that maintains the National Organ Donor Registry.]

(2) NATIONAL ORGAN DONOR REGISTRATION FORM B (MINORS AND INCOMPETENT ADULTS).-



DONOR FORM B



MINORS UNDER 16 YEARS OF AGE OR INCOMPETENT ADULTS



(TO BE COMPLETED BY EITHER PARENT OR GUARDIAN)

NAME [ Print name of child or ward ]:



CHILD OR WARD'S SOCIAL SECURITY NUMBER OR ALIEN REGISTRATION NUMBER [ Print your child or ward's number ]:



[ Insert "Applied for" in the space provided for the social security number if this form is part of an application for a social security number .]



DATE OF BIRTH OF CHILD OR WARD: mmm/mmm/mmm



CHECK ONLY ONE OF THE FOLLOWING:





[Donor status] Upon the death of the child or ward, all of his or her



organs may be removed for transplantation.



    [Restricted Donor status] Upon the death of the child or ward, all of his



  or her organs may be removed for transplantation, except for the following:



    [Non-donor status] Upon the death of the child or ward, none of his or her



  organs may be removed for transplantation.





Signature of Parent or guardian



The following notarial certificate need not be completed if this form is filed at an office of a State Department of Transportation, the Immigration and Naturalization Service, or a health care institution if this form is signed in conjunction with admission to, or discharge from, the health care institution.



NOTARIAL CERTIFICATE





STATE OF  ) .. ss:



COUNTY OF  )





On this mmmm day of mmmmmmmmmmmm, mmmm, before me a Notary Public in and for the State of mmmmmmmmmmmmmmmm personally appeared mmmmmmmmmmmmmmmmmmmmm [ Insert name of parent or guardian ], to me known and known to me to be the individual named in and who executed the foregoing instrument, and he or she acknowledged to me that he or she executed the same as his or her free act and deed.

Notary Public in and for the State of



NOTICE:



With this form you may donate all or some of the organs of your minor child or ward if they are needed after his or her death for transplantation purposes. You also may refuse to donate any of your child or ward's organs. You may complete this form at any time and, if you are the parent of a minor child, must do so when you apply for the child's social security number.



When you complete and return this form, your child or ward will be registered on the National Organ Donor Registry. This Registry will be used at his or her death to determine whether or not his or her organs may be donated to people who need them. At a ward's death, your wishes regarding the possible donation of his or her organs will be followed regardless of what anyone else says. At a minor's death, a minor's parents may authorize the removal, or may refuse to authorize the removal, of his or her organs regardless of the minor's status on the Registry.



Parents of minors and guardians of incompetent adults may change the status of the minor or ward on the Registry at any time by filing a new form. However, a minor's status on the Registry is automatically deleted from the Registry when the minor attains age 16. Thereafter, only the minor may alter his or her status on the Registry. Forms are available at Department of Transportation offices, Social Security Administration offices, Immigration and Naturalization Services offices, post offices, hospitals, and physicians' offices.



If you return a completed form to a State Department of Transportation office, an Immigration and Naturalization Service office, or to a health care institution in conjunction with your child or ward's admission to, or discharge from, that institution, you do not have to have your signature notarized. If you mail a completed form directly to the office that maintains the Registry, you will have to have your signature notarized in order to insure that no one else is attempting to change your child or ward's status on the Registry.



[Insert name and address of office that maintains the National Organ Donor Registry.]



SEC. 202. REMOVAL OF CADAVERIC ORGANS.



(a) GENERAL RULE.-Upon the death of an individual, the health care institution in which a decedent dies or to which a decedent's body has been transported shall initiate all necessary procedures to maintain, remove, preserve, and transfer all of that decedent's organs that can be used and are needed for transplantation purposes.



(b) EXCEPTIONS.-An organ shall not be removed from the decedent if-

(1) the Registry registers the decedent as a non-donor or a restricted donor with respect to that organ, unless the decedent is a minor whose parents authorize the removal of that organ;

(2) the decedent is not registered on the Registry and the decedent's attorney-in-fact, or, if none, guardian, or, if none, surviving spouse, or, if none, any one of decedent's competent adult children, or, if none, either one of decedent's parents objects at the time of the decedent's death;

(3) the identity of the decedent cannot be determined;

(4) the decedent was a minor whose parent objects to the removal of that organ at the time of that minor's death;

(5) the removal of that organ would interfere with a pending autopsy or official investigation under the laws of the United States or any State; or

(6) the decedent is known not to be a citizen or resident of the United States unless the decedent's attorney-in-fact, or, if none, guardian, or, if none, surviving spouse, or, if none, any one of decedent's competent adult children, or, if none, either one of decedent's parents authorizes the removal of an organ at the time of the decedent's death.



(c) DISPOSAL OF A DONOR'S BODY.-After the removal of an organ from a donor or a restricted donor, the decedent's body shall be disposed of in accordance with State Law.



(d) DUTIES OF HEALTH CARE INSTITUTIONS.-

(1) DUTY TO REQUEST COMPLETION OF DONOR FORMS.-On or before the admission of a patient to a health care institution, or as soon as practicable after admission, the health care institution shall determine the status of that patient on the Registry. If the patient is not registered on the Registry, the health care institution shall inform the patient if the patient is a competent adult, or the patient's parent if the patient is a minor, or the patient's guardian if the patient is an incompetent adult of the option to register the patient on the Registry and shall provide the patient, or the patient's parent or guardian, with the appropriate Donor Form.

(2) DUTY TO FORWARD INFORMATION ON DONOR FORMS IMMEDIATELY.-If a patient, or the patient's parent or guardian, files a Donor Form with a health care institution following the request mandated in section 202(d)(1) at any time up to the time of the patient's discharge, the health care institution shall advise the individual who signed the Donor Form that the patient's status as either a donor, restricted donor, or non-donor will not become effective until the information on the Donor Form is recorded on the Registry. The health care institution shall then immediately forward the information contained on that Donor Form to the Secretary. The signatures on a Donor Form forwarded under the provisions of this paragraph need not be notarized.

(3) DUTY TO LOCATE OR REQUEST CONSENT FROM FAMILY MEMBERS NOT IMPOSED.-This Act does not impose an affirmative duty on a health care institution to locate an individual or request a decision from an individual who may authorize or object to the removal of an organ under the provisions of section 202(b).

(4) DUTY TO CHECK THE REGISTRY.-Prior to the removal of the donor's organs, the health care institution in which an individual dies or is transported to after death shall search the Registry to determine the individual's status on the Registry and shall record that status in the decedent's medical records.



TITLE III-SALES.



SEC. 301. PROHIBITION ON SALES.



A person shall not knowingly purchase, sell, or otherwise transfer for valuable consideration an organ for transplantation purposes, except blood, blood derivatives, semen, and ova, if the purchase, sale, or other transfer affects interstate commerce.



SEC. 302. REPEAL OF SECTION 301 OF THE NATIONAL ORGAN TRANSPLANTATION ACT.



Section 301 of the National Organ Transplantation Act (relating to the prohibition of organ purchases) is repealed.



TITLE IV-MISCELLANEOUS PROVISIONS.



SEC. 401. CONSCIENTIOUS OBJECTION, CONFLICT OF INTEREST, AND TRANSFER OF PATIENTS.



(a) CONSCIENTIOUS OBJECTION AND CONFLICT OF INTEREST.-Subject to the provisions of section 401(b) (relating to the transfer of a patient), a health care provider who has a conscientious objection or a conflict of interest with respect to any aspect of a transplantation procedure involving a deceased individual's organ may refuse to participate, directly or indirectly, in any aspect of a transplantation procedure.



(b) TRANSFER OF PATIENTS.-A health care provider that has a conscientious objection or conflict of interest (within the meaning of section 401(a)) regarding a particular patient shall refer or transfer that patient as soon as possible to another health care provider who is willing to participate in the transplantation procedure.



SEC. 402. IMMUNITIES.



(a) HEALTH CARE PROVIDERS' RELIANCE ON THIS ACT.-A health care provider who acts or declines to act in accordance with the provisions of this Act or attempts in good faith to do so shall not be subject to civil or criminal damages or penalties or discipline for unprofessional conduct for participating, directly or indirectly, in a transplantation procedure.



(b) HEALTH CARE PROVIDERS' RELIANCE ON THE REGISTRY.-A health care provider who relies on the information recorded in the Registry shall not be subject to civil or criminal damages or penalties or discipline for unprofessional conduct for participating, directly or indirectly, in a transplantation procedure.



(c) DONORS NOT LIABLE FOR EFFECTS OF TRANSPLANTATIONS.-An individual who, under the provisions of this Act, donates an organ on behalf of himself or herself or on behalf of another individual shall not be subject to civil or criminal damages or penalties for any injury that may result from the transplantation of that organ.



SEC. 403. LIABILITIES.



(a) PERSONS' LIABILITY FOR SUITS TO PREVENT ORGAN REMOVAL.- Nothing in the Act precludes a person from being held liable under the laws of any State for malicious prosecution if that person interferes with the removal of an organ as authorized under the provisions of this Act by instituting or threatening to institute a civil suit.



(b) PERSONS' LIABILITY FOR NONCOMPLIANCE WITH THIS ACT.-A health care provider or other person who knowingly fails to comply with this Act shall be subject to civil penalties of not more than $50,000 or treble the amount received by the health care provider or other person in connection with all activities related to the action that is in violation of this Act, whichever is greater, and also may be subject to civil damages under the laws of the United States or any State. In addition, a person who violates Title III of this Act shall be sentenced to a term of imprisonment of not more than 5 years, additional civil penalties of not more than $50,000, or both.



SEC. 404. EFFECTS OF THIS ACT ON INSURANCE AND HEALTH CARE.



(a) EFFECT ON INSURANCE.-The registration of an individual on the Registry shall not affect the sale, procurement, issuance, or terms of a health, life, or annuity policy, nor shall it affect, impair, or modify the terms of any existing health, life, or annuity policy. A health, life, or annuity policy is not legally impaired or invalidated by any act or procedure authorized by this Act.



(b) DONOR FORMS AS IMPROPER CONDITION TO RECEIVE INSURANCE.-A person shall not prohibit or require the execution of a Donor Form as a condition to receive or be insured for health care.



SEC. 405. SEVERABILITY.



If a provision of this Act (or the application of a provision to a particular person or circumstance) is held invalid or found to be unconstitutional, the remainder of this Act (or the application of that provision to other persons or circumstances) shall not be affected.



SEC. 406. EFFECTIVE DATE.



Except for the provisions of section 202 of this Act, this Act shall take effect 1 year after its enactment. Section 202 of this Act shall take effect 18 months after] the enactment of this Act (or if the Secretary certifies that the Registry is operational before that 18 month period has elapsed, then at the time of the certification), provided that section 202 shall not take effect until 3 months after the Secretary complies with the provisions of section 201(f)(3)(E) (relating to the solicitation of Donor Forms). Section 201(f)(3)(E) expires 18 months after the enactment of this Act



CADAVERIC ORGAN DONOR ACT--REPORT





I. Summary of The Bill.

A. Overview.

B. Summary of Provisions.



II. General Reasons for the Bill.



III. Explanation of the Bill.



TITLE I. Definitions.



TITLE II. Cadaveric Organs.

Sec. 201. National Organ Donor Registry.

Sec. 202. Removal of Cadaveric Organs.



TITLE III. Sales.

Sec. 301. Prohibition on Sales.

Sec. 302. Repeal of Section 301 of the National Organ Transplantation Act.



TITLE IV. Miscellaneous Provisions.

Sec. 401. Conscientious Objection, Conflict of Interest, and Transfer of Patients.

Sec. 402. Immunities.

Sec. 403. Liabilities.

Sec. 404. Effects of this Act on Insurance and Health Care.

Sec. 405. Severability.

Sec. 406. Effective Date.



I. SUMMARY OF THE BILL



A. OVERVIEW



The Cadaveric Organ Donor Act (CODA) provides a comprehensive, national program for the donation of cadaveric organs.



The principal provisions of the bill are the following:

. Creation of National Organ Donor Registry

. Cadaveric Organ Donations

. Mandatory choice opportunities.

. Persons (or their parents or guardians acting on their behalf) can be registered on the National Organ Donor Registry at the time they apply for a social security number, driver's license, identification card, alien registration card, or at any other time.

All persons may elect to be a "donor" (of all organs), a "restricted donor" (of some organs), or a "non-donor" (of no organs).

. Persons can change their listing on the Registry at any time prior to death.

. A deceased person whose identity is known but who failed to take the opportunity to register as either a donor, restricted donor, or non-donor is treated as a donor of all organs unless certain members of his or her family object.

. A deceased person whose identity is unknown is treated as a non-donor.

. The status of an individual as a donor, a restricted donor, or non- donor cannot be changed after death, unless the decedent was a minor. In that case, the parents or guardian can elect to permit or refuse to permit removal of organs.

. Prohibits Sales of Organs



B. SUMMARY OF PROVISIONS



1. Introduction.



CODA proposes a new, comprehensive, national approach to the donation of human organs for transplantation purposes with its National Organ Donor Registry and broad acceptance of the concept of mandated choice. CODA should significantly increase the supply of available organs for transplantation.



2. National Mandated Choice Law.



CODA proposes a national mandated choice law. Under CODA, every individual over the age of sixteen is provided an opportunity to file a National Organ Donor Registration Form (Donor Form) on which he or she can elect to be a donor of all organs, a donor of only some organs, or not to be a donor at all. This Donor Form shall accompany the individual's application for a social security number, driver's license, identification card, or alien registration number. Similar elections can be made on behalf of an individual under the age of sixteen by his or her parents, or an incompetent adult by his or her guardian. All elections are filed on a National Organ Donor Registry (Registry) to be maintained by that organization designated by the Secretary of Health and Human Services.



Registration on the Registry is to be made at the same time that an individual (or his or her parent or guardian) first applies for a social security number. It can also initially be made when the individual applies for either a driver's license, an identification card if issued by the state Department of Transportation (DOT), or an alien registration number. Furthermore, the status of an individual on the Registry as either a "donor," "restricted donor," or "non-donor" can be changed at any time prior to death by the filing of a new Donor Form, which can be obtained at offices of the Social Security Administration (SSA), state DOTs, the Immigration and Naturalization Service (INS) and most health care providers, including physicians.



The status of an individual over the age of sixteen who is listed on the Registry cannot be changed by anyone after the individual dies, including members of his or her family. Parents of a minor under age sixteen may elect either to donate or refuse to donate the minor's organs without regard to how the minor is listed on the Registry. In the unlikely event a person is not listed on the Registry, that person is treated as a donor of all of his organs if his identity is known and certain members of his or her family do not object.



CODA prohibits the sale of organs and other body parts, other than blood, blood derivatives, semen, and ova.



II. GENERAL REASONS FOR THE BILL

A 1993 Gallup survey found that approximately eighty-five percent of Americans support organ transplantation and sixty-nine percent would be very or some what willing to donate their own organs for transplantation purposes. [FN1] However, in 1991, out of an estimated 12,000 to 15,000 potential donors, organs from only 4,357 cadavers were available for organ donation.



The number of transplants performed in this country has continued to increase with 9,949 kidney, 2,954 liver, 2,215 heart, 532 pancreas, 51 heart-lung, and 401 lung transplants performed in 1991. [FN2] Presently there are approximately 30,000 individuals on a national waiting list for an organ transplant and, subsequently, seven people die each day because a suitable organ is not available. [FN3] It has been stated that a single donor has the ability to provide enough tissue to treat 150 persons. [FN4]



CODA's purpose is to fill the gap between the number of potential donors and the number of actual organ donations in order to increase the supply of needed organs for transplantation. CODA seeks to meet this objective through a system of mandated choice, requiring all persons applying for a social security number, driver's license, identification card, or alien registration number to state whether they wish to be an organ donor. Applicant responses are recorded on the Registry maintained by an organization designated by the Secretary and are to be made available to most health care providers.



While mandated choice may sound like a radical departure from the current system, several states have actually begun experimenting with a form of mandated choice implemented through their driver registration system. In Colorado, for example, drivers are asked to state directly on their license whether they wish to be a donor. The reverse side of the license acts as an organ donor card. With this system, approximately sixty percent of all Colorado drivers are registered as organ donors.



By implementing an even more extensive system of mandated choice, CODA will relieve the medical community of the burden of requesting organ donation from the family at a very stressful time in their lives. It will also increase the personal autonomy of the donor by ensuring that a competent adult's decision to donate (or not to donate) his or her organs will be carried out, regardless of contrary family opinion. The concepts of volunteerism and altruism, which underlie the current system, may appear to be undermined by requiring an individual to state his or her choice as a condition of receiving a drivers' license, etc. However, allowing an individual to change his or her status at any time with minimal effort belies any coercive effect to the concept of mandated choice and reinforces the voluntary and altruistic nature of the individual's decision.



In addition, CODA respects the traditional decision-making role of parents and guardians. An incompetent adult's guardian or the parent of a minor is permitted to complete a Donor Form on behalf of the ward or child. This seems only logical since that adult's guardian or minor's parents will make every other decision, health care related and otherwise, for that individual. Even without CODA, the guardian of an incompetent adult or parent of a minor child may currently make this decision for the ward or child as well as many other health care decisions that can have far greater impact, such as consenting to life saving treatment. The practical reality is that decisions are and must be made for incompetent adults and minor children on a daily basis in health care settings across the country. CODA merely requires the parents or guardians to make organ donation decisions before, rather than after, the child or ward dies.



For the relatively few identified persons who are not listed on the Registry, organs may be removed absent objection from close family members. Unlike some consent systems adopted in Europe and other countries, however, there is no conclusive presumption that a decedent would intend to have his or her organs removed. A decedent's close family members can object to the removal of an organ if they choose. This "opt out" provision effectively requires members of the decedent's family to authorize organ donations, a system much like that generally prevailing in this country at the present time.



III. EXPLANATION OF THE BILL



Title I-Definitions.



The definition of "adult" differs from the prevailing national view by treating persons at least sixteen years of age as adults. Age sixteen was selected because most states allow persons sixteen years or older to apply for a driver's license.



Individuals between the ages of sixteen and eighteen who have been judicially declared incompetent are treated as incompetent adults under this Act, and are not entitled to complete a Donor Form. For these individuals, the Donor Form can be completed only by his or her guardian.



In light of these rules, competent individuals between the ages of sixteen and eighteen, and not their parents, are entitled to complete the Donor Form. Since a minor's previously registered status is automatically deleted once he or she attains age sixteen, completion of the Donor Form by the sixteen year old (or, if he or she is a judicially declared incompetent, his or her guardian) is necessary at or after he or she attains age sixteen to create a status on the Registry.



The term "death" as defined in this Act currently excludes persons diagnosed as being in a persistent vegetative state (PVS) because this condition does not meet the requirement that there be a cessation of all brain functions, including the brain stem. This definition accords with the definition in the Uniform Determination of Death Act. [FN5] Because CODA also uses a "whole brain" test, it would also not permit an anencephalic to be treated as a deceased person. Thus, CODA would not permit organ donations from these individuals.



The term "donor" includes any individual from whom an organ is removed for transplantation purposes. In addition, an individual who has been registered on the Registry as willing to donate all organs for transplantation purposes is considered to be a donor.



For the purposes of this Act, an individual is deemed to be "incompetent" only if he or she has been judicially declared incompetent under the laws of any State. Individuals who have not been judicially declared incompetent are deemed to be competent and, if an adult, are free at any time to complete a Donor Form to register themselves on the Registry. An individual may only be declared incompetent in accordance with State law. CODA provides no guidance on how a state court is to make that determination.



The term "organ" includes human organs, tissue, and cells to be processed for transplantation purposes, other than organs from a fetus. Thus, CODA has no application to non-human animal organs.



Throughout the Act, parents of a minor are given authority to file Donor Forms and to consent or to withhold consent to the removal of organs. In some cases, CODA requires both parents to agree while in others, the decision of one parent is binding. Furthermore, the word "parents or parent" may mean a guardian in those instances where a person, other than a minor's parent, has been appointed as the minor's guardian. The definition of "parents" and "parent" combined with the use of the singular or plural form in different sections of the Act determines whether one or both parents must act under certain circumstances. For example, under section 201(f)(1), the parent of a newborn must apply for a social security number for the newborn within thirty days of the newborn's birth. Since the singular "parent" is used, either parent may make that application. However, if only one of the parents has legal custody of the minor, then only the parent with legal custody can apply for the social security number. If neither parent has custody but a guardian has been appointed for the newborn, then the guardian is deemed to be the parent and only the guardian can apply for the newborn's social security number.



Conversely, under section 202(b)(1), the "parents" of a minor who is registered on the Registry as a non-donor may authorize the removal of the minor's organ. Since the plural is used, both parents must authorize the removal, unless only one parent has legal custody. In that case, only the parent with legal custody can authorize the removal of the organ. Furthermore, if neither parent has custody but a guardian has been appointed for the minor, then only the guardian can authorize the removal of the organ.



TITLE II-Cadaveric Organs.



Sec. 201. National Organ Donor Registry.



Section 201(a) mandates the creation of a Registry by the Secretary. The purpose of the Registry is to provide a single uniform database recording the decisions that citizens or residents of the United States have made regarding their donative status. This database shall be made accessible to all health care institutions, organ procurement organization, and other persons the Secretary designates. Furthermore, any individual, upon request, can ascertain his or her status on the Registry.



Section 201 provides the Secretary with broad discretion to delegate the creation and operation of the Registry to either the SSA or to another agency or organization. For example, this Act would not preclude the Secretary from delegating the operation of the Registry to the National Organ Procurement Organization. If the Secretary designates an entity other than the SSA to maintain and operate the Registry, the Secretary should determine whether Donor Forms accompanying applications for a social security number should first be sent to the SSA or to the other entity.



Section 201(b) provides that an individual (acting on his or her own behalf or through a parent or guardian) shall have the opportunity to make a donative decision when applying for a social security number, a driver's license, an identification card, or an alien registration number. Individuals who do not apply for social security numbers, driver's licenses, identification cards, or alien registration numbers may mail Donor Forms directly to the Secretary, although their signatures on the Donor Forms must be notarized unless the Form is filed in conjunction with admission to, or discharge from, a health care institution.



Section 201(c)(1) requires the Secretary to delete the status of an individual as either a donor, restricted donor, or non-donor upon his or her sixteenth birthday to allow the individual to make his or her own decision regarding organ donation status on the Registry. A previously registered minor will continue to be listed on the Registry although once he or she attains age sixteen, he or she will be listed without a status until a new Donor Form is filed. Should that individual die prior to filing a new Donor Form, his or her organs can be removed (assuming his or her identity is ascertainable at death), unless close family members object.



Critics of CODA may argue that the removal of organs from a decedent who leaves no close family members (1) whose identity is known, and (2) whose donative status cannot be determined from the Registry violates the principle of autonomy. This argument, however, assumes that the decedent wanted to be a non-donor. However, this assumption seems unwarranted. Most likely, decedent's donative status cannot be ascertained because the decedent failed to register. There are any number of possibilities why the decedent was not registered. One probable reason is that the decedent failed to register on or after his or her sixteenth birthday, at which time the decedent's donative status was deleted from the Registry.



A decedent's failure to register could also be explained for other reasons, only one of which is that the decedent did not wish to be a donor. If the decedent's attitudes toward organ donations conform to the attitudes of the overwhelming majority of Americans, however, this was not the reason the decedent failed to register. In fact, just the opposite is true-the decedent had no objection to being an organ donor. Furthermore, the fact that the decedent was not registered on the Registry suggests that the decedent was not inclined to register as a non-donor since the decedent should have known that, in the absence of registration and close family members, he or she would be a donor. This fact creates the maximum incentive for an individual who desires to be a non-donor to register as such on the Registry.



Section 201(c)(2) allows individuals (or their parents or guardians) to change their status on the Registry at any time and as often as they desire. Thus, the goal of personal autonomy in organ donation decision making is re- enforced.



Section 201(d) specifies that an individual's donative status is effective only when the information on that individual's Donor Form has been recorded on the Registry. Thus, if an individual listed as a donor on the Registry completes a new Donor Form indicating a desire to be a non-donor, and the individual dies before the information on the new Donor Form is recorded on the Registry, the individual is treated as a donor. This is consistent with the concept that health care providers are to rely solely on the Registry to determine a decedent's status.



Section 201(f)(1) requires a parent to apply for a social security number within thirty days of the child's birth and to simultaneously complete a Donor Form for the minor. This assures that a donative choice has been made on behalf of the newborn shortly after birth. Only one parent need complete the Donor Form. In the case of a deceased minor under sixteen, however, the status on the Registry is not conclusive since the parents may elect to change that status after the minor has died. Consequently, if no change is communicated, then the health care provider must rely on the Registry to determine the minor's status.



Either parent can list a newborn as a donor on the Registry. However, because either parent can object to the removal of the minor's organs at the minor's death without regard to the minor's status on the Registry, effectively both parents must agree to the use of a minor's organs for transplantation purposes. Conversely, if either parent lists a newborn as a non-donor, both parents must agree to the removal of the organ at the minor's death notwithstanding the status of the minor on the Registry. Read together, these provisions assure that, without regard to how a minor is registered on the Registry, the organs of a minor cannot be removed for transplantation purposes unless both parents agree. If, however, only one of the minor's parents has legal custody, then only that parent's decision controls. No similar opportunity to alter the status of a registered incompetent adult is provided to his or her guardian for the reasons discussed in conjunction with section 202(b).



Section 201(f)(2)(A) imposes duties on each state's DOT or on the INS to forward to the Secretary any information it receives regarding an individual's donative status contained on a Donor Form within "a reasonable time." The determination of a "reasonable time period" is left to the Secretary since what is "reasonable" cannot be sufficiently determined until the actual procedures for transferring information from the Donor Forms to the Registry are implemented. Timely recording, however, is contemplated and is particularly important since an individual's donative status does not change until that information is recorded on the Registry. While some delay can arise between the completion of a Donor Form and the transfer of the information on that form to the Registry, the intent is to have the process expedited in order to carry out the Registrant's intent. By designating a short period of time between receipt and recordation, the Secretary is limiting the unlikely possibility that a person may die before his or her intent is recorded on the Registry. The procedural ease of having the Registry be the decisive list of donative intent outweighs the possible harm from the rare instances where intent is not accurately reflected on the Registry. This section also requires those offices to make organ donation educational materials received from the Secretary available to the public.



In anticipation that a significant public educational program will need to be waged to advise citizens and residents of the opportunity to register as donors, restricted donors, or non-donors, section 201(f)(2)(B) directs the Secretary to provide appropriate written educational materials to be made available at offices of the SSA, state DOTs, INS, United States Postal Service, licensed physicians and health care institutions, and any other location designated by the Secretary. This educational material should include information regarding the need for and benefits of organ donation.



Section 201(f)(3)(A) places upon the Secretary a duty to record all information on Donor Forms received within a reasonable time period, as determined by the Secretary. Registration shall be as a "donor," "restricted donor," or a "non-donor." The Act authorizes the use of the individual's social security number as the individual's number on the Registry. It is expected that persons having access to the Registry will be able to easily ascertain an individual's donative status by calling up that individual's social security number.



Under section 201(f)(3)(B), the Secretary shall insure that every health care institution and organ procurement organization has access to information on the Registry. This may be accomplished by any means that the Secretary deems technologically feasible ( e.g. , via modem). In addition, the Secretary shall make the status of each individual on the Registry available to that individual or to his or her parent or guardian.



Sections 201(f)(3)(C), (D), and (E) require the Secretary to provide individuals with easy access to Donor Forms (A and B) together with written educational materials regarding organ donation by causing them to be distributed at the offices of the SSA, state DOTs, INS, United States Postal Service, licensed physicians and health care institutions, and any other location designated by the Secretary. This duty, when read in conjunction with the effective date provisions set forth in section 406, ends eighteen months after the enactment of the Act. Thereafter, all citizens and residents can register by the processes set forth in section 201(b). While consideration was given to requiring the Secretary to mail Donor Forms and educational materials to all citizens and residents (estimated to be in excess of 260,000,000), it was determined that the Secretary have discretion in how best to distribute Donor Forms and to determine the most efficient and cost effective way to comply with this responsibility. For example, the Secretary might mail Donor Forms to every household in the United States but make educational materials available though newspaper inserts or at offices where Donor Forms are otherwise available.



The impetus for CODA is the need to increase the supply of organs in the United States. The Secretary is directed by Section 201(f)(3)(F) to evaluate the effectiveness of the Act in meeting this objective in a report to be submitted to Congress within seven years after the Act becomes effective. This report should evaluate the availability of organs and the fairness in organ allocation. If this Act's mandated choice provisions fail to provide adequate organs, amendments to allow incentives for organ donation might be considered. Options to encourage donation include: (1) offering a free driver's license; (2) providing funeral expenses; (3) reimbursing hospital expenses; (4) allowing tax credits; (5) giving actual cash payments; and (6) creating a priority for a member of the donor's family in the event they need a transplant.



CODA should result in an increase in the supply of organs. Additionally, medical technology should improve to both decrease or eliminate the risk of rejection and increase the time in which a retrieved organ can be used in a transplantation procedure. In light of these factors, it is conceivable that the myriad of allocation systems currently in place could be replaced with a more equitable system. While CODA does not incorporate any particular allocation scheme, a number of ideas concerning allocations merit further consideration at such time as it becomes appropriate to reconsider the current allocation schemes.



First, at some time in the future one national waiting list for all solid organs could replace the current system which generally allocates organs first on a local, then a regional, and finally on a national basis. This list would not favor large centers over small centers if the supply of organs was sufficient to meet demands and would service the needs of individuals on the waiting list without regard to their location within the country. A single national list would also eliminate the current practice under which individuals may register at more than one transplant center, a practice that tends to favor wealthier individuals who can afford to be listed at multiple centers.



Furthermore, in prioritizing the individuals listed on the single waiting list the following factors, most of which are currently used, could be taken into account:



1. The familial relationship of an individual on the waiting list to the donor, provided that relationship is made known prior to the removal of the organ. This factor is not currently taken into account in allocating cadaveric organs although it predominates in the transplanting of organs from living individuals to others. It also is less advantageous than the "directed donation" provisions in section 6(a)(3) of the 1987 version of the Uniform Anatomical Act permitting donors to select their donees. A provision, such as this "leg up" suggestion, should create some incentive for individuals to register as a donor or restricted donor on the Registry.



2. The individual's length of time on the waiting list.



3. The probability of non-rejection of the organ by the individual.



4. Medical urgency.



5. Age of the individual if medically relevant.



6. Expected years of additional life for the individual.



7. Physical characteristics affecting the likelihood of transplant success.



8. Other factors which may mitigate the inequitable distribution of organs.



There is also concern about the ability of wealthy nonresident aliens to come to this country and use local facilities and organs. If the supply of organs equaled demand, this concern would still exist because such aliens, in most cases, would not have otherwise contributed and would not have made a commitment to contribute in the future to the financing of the health care system in this country. Thus, a special fee should be payable by nonresident aliens. However, since CODA does not address allocation issues, the following suggested provision was not included in the Act:

In order to be eligible for the National Organ Transplant Waiting List, an individual shall be a citizen or resident of the United States or a nonresident who:

"(a) pays a nonrefundable fee to the Organ Procurement and Transplantation Network at the time of registration on the national waiting list that is equal to the average prevailing cost of a transplant of the organ of the type needed by such individual at the organ transplant center where the transplant procedure is to be performed; and,

"(b) pays an additional fee of like amount to the Organ Procurement and Transplantation Network at the time of his or her selection for a transplant."



These fees shall be in addition to any other expenses incurred by the nonresident alien in connection with the transplant of the organ.



Fees collected from nonresident aliens should be used to defray the cost of transplants for financially needy residents or citizens.



Section 201(g) sets forth the Donor Forms to be used in the implementation of mandated choice. Both forms attempt to appeal to the altruistic nature of prospective donors.



The initial costs of creating the Registry could be substantial. While the minority report dubs these "immense," the estimated savings in overall costs to the health care system in the United States (even ignoring the benefits to the GNP resulting from organ recipients being able to return to a productive work life) far outweigh the initial costs of creating the Registry. Furthermore, once the Registry is established, the ongoing costs of maintaining the Registry are relatively paltry. Nonetheless, some source of funds should be considered to create and operate the Registry. While CODA does not specifically address the issue of funding for the Registry, the following alternatives might be considered: (1) a fee to accompanying each Donor Form that is filed with the Secretary; (2) a surcharge to accompany the state fee charged to obtain a state driver's license, identification card, or an alien registration number; (3) general revenues; (4) a check-off of a fixed amount on the federal income tax form; (5) a tax on those consumer items shown to play a part in causing a need for an organ transplant; (6) private donations; and (7) financial savings resulting from a decreased need for kidney dialysis. [FN6]



Sec. 202. Removal of Cadaveric Organs.



Section 202(a) directs the health care institution in which a decedent dies or to which a decedent's body has been transported to initiate all necessary procedures to remove and transfer the organs. Protocols should be established to determine whether a decedent's organs meet the statutory "used" and "needed" tests, which are included to avoid unnecessary harvesting. While it should be fairly easy to ascertain whether an organ is currently needed by a review of the organ waiting lists, the removal and storage of organs for future use would not be precluded by the Act, particularly as organ preservation technology improves. The "can be used" requirement, however, assumes that not all decedents will have useable organs and that medical judgment will have to be exercised to determine whether there is any medical justification for removal.



Section 202(b) sets forth important exceptions under which a decedent's organs cannot be removed. Under section 202(b)(1), an organ cannot be removed if the decedent is registered as a non-donor or a restricted donor with respect to a particular organ. This exception, based upon the principle of autonomy, assures that organs are not removed from a decedent's body against the decedent's expressed wishes as reflected on the Registry.



If the decedent was a minor, parents are provided an opportunity to reconsider a prior Registry decision as a non-donor or restricted donor and to authorize the removal of the organ. The parents are allowed to alter the status of the deceased minor on the Registry which they likely created at an earlier time, such as when they applied for decedent's social security number. Many parents are likely to want to permit an organ donation because their subsequent reflections convince them that an organ donation would be appropriate.



The converse may also be true. Thus, under section 202(b)(4), parents may object to the removal of an organ from a minor whose status on the Registry is either "donor" or "restricted donor." CODA purposely does not expressly provide a fixed time or manner in which a parent can alter the minor's donative status after the minor's death. Health care providers will have to make decisions regarding the respect to be given to the Registry's designation of a minor, taking account of all the facts and circumstances existing at the time of the minor's death.



If the deceased minor is listed as a donor, restricted donor, or non-donor on the Registry and the minor's parents are not available after the minor's death to change that status, the health care provider is bound by the status as reflected on the Registry.



A minor's parents can alter the minor's status on the Registry after the minor's death. No similar opportunity is provided to the parent or guardian of a deceased adult. This distinction was intentional. Once an individual has reached the age of sixteen, it is assumed the individual is capable of making an autonomous informed medical decision, and as an adult under CODA, he or she is assured that his or her donative intent will be carried out according to his or her wishes. Thus, in the case of a competent adult or a once competent adult, the onus is on him or her to have the Registry reflect his or her donative status and once expressed is inviolate even as against the desires of his parent or guardian after his or her death. Of course, if a once competent adult has a guardian, the guardian is free to change the ward's status on the Registry at any time before the ward's death.



In the case of the incompetent adult who was never competent, parents and guardians (unlike parents and guardians of minors) cannot change the incompetent adult's donative status after the incompetent adult dies. This distinction is warranted in light of the fact that there was likely to have been ample time for the guardian to reflect on the ward's appropriate donative status divorced from the emotional joys that coincide with the birth of a child which might have colored the decision-making processes of a newborn's parents. Furthermore, because the grieving process for parents of minors differs from that of incompetent adults, CODA affords the parents of a deceased minor the opportunity to once more rethink their child's donative status at the time of a minor child's death.



Because some decedents may not have a status listed on the Registry, [FN7] a statutory choice had to be made whether to treat such decedents as donors or non-donors. Since only those people who have never received a social security number, driver's license, alien registration number, or never knew of and failed to exercise their right to voluntarily register will not be on the Registry, only a very small percentage of the population will not be registered as either a donor, restricted donor, or non-donor. Section 202(b)(2) treats these individuals as donors but permits an attorney-in-fact, guardian, spouse, child, or parent, in that priority order, to object to the removal of an organ. This exception is intended to assure that the organs of persons who affirmatively failed to elect to donate organs are not removed against the wishes of close family members. Since the overwhelming majority of the public wishes to become organ donors at death, it is reasonable to assume that the average unregistered donor would also wish to be an organ donor at death. At worst, it can only be assumed that the unregistered donor was indifferent or simply preferred to have close family members decide. Furthermore, it is reasonable to assume that if he or she did not want to donate, he or she would have registered as a non-donor. This assumption will be even more supportable once CODA is enacted and its terms become widely known. Only registration on the Registry, therefore, binds family members. If the decedent is survived by none of the persons listed above, the decedent's organs may be removed for transplantation purposes.



The majority specifically rejected presumed consent for the unregistered in favor of letting close family members decide what to do with the organs of the unregistered individual. Based on the testimony of experts, it is believed that hospitals, in those rare instances when an unregistered decedent's family is not at the hospital at the time of the decedent's death, will always wait until family members are consulted before removing an organ. This is due both to a physician's unwillingness to remove an organ without someone's consent and because negative publicity surrounding the procedure could drastically reduce the number of people who choose to become organ donors, eroding public confidence in the system. CODA does not affirmatively require hospitals to seek permission from family members for one reason only: to insure that CODA does not become obsolete when public awareness of organ donations makes it unlikely a family member would ever object. For example, family acceptance of organ donations should eventually reach the same level of acceptance or higher than that attained for autopsies conducted in conjunction with civil or criminal investigations. According to one expert witness, if people can accept what happens to a family member during an autopsy, in time they can also come to accept the much less invasive organ removal procedure as well.



However, under section 202(b)(3), if a person's identity cannot be reasonably ascertained at the time of death so that his or her status cannot be determined from the Registry, organs cannot be removed. This rule is based upon the fact that it would be unfair to remove organs for transplantation purposes from an individual who may have registered with the Registry as a non-donor but whose identity could not be ascertained at the time of death.



There is an important difference between an unidentifiable individual and an unregistered individual. An unregistered individual, by definition, is an individual who has not registered a decision. By contrast, there is no way to tell whether an unidentifiable individual has registered a decision. Thus, there was a chance that someone who had registered a decision not to be a donor, perhaps for religious reasons, would nevertheless have organs removed because it was not possible to look up the status of an unidentifiable individual. The majority felt the protection of the decisions of these unidentified non-donors outweighed the loss of a small number of organs. CODA's commitment to autonomy for registered donors and families of unregistered persons is bolstered by its treatment of persons whose identify cannot be ascertained. For such persons, CODA's reluctance to deviate from the principle of autonomy, for them or their families, results in the rule that under no circumstances can their organs be removed.



Lastly, under section 202(b)(6) organs may not be removed from individuals who are known not to be citizens or residents of the United States since these persons would not have had an opportunity to be registered on the Registry and avoids organ removal which may be contrary to a decedent's intent. Organs of nonresident aliens who die in the United States, however, may be removed for transplantation purposes if a family member authorizes the removal of the organ.



Section 202(c) stipulates that a decedent's body shall be disposed of in accordance with the provisions of state law after the organs are removed. This Act, however, would not prohibit a decedent from making particular arrangements for the disposal of his or her body prior to death. If applicable state law includes, for example, the Uniform Anatomical Gift Act, decedent's wishes would be controlling if the decedent or other members of decedent's family acting under such law were to direct that after the removal of decedent's organs the body be disposed of in the manner decedent provided. For example, the decedent may have been a restricted donor permitting only the removal of a kidney. Decedent may also have signed an anatomical gift giving his remains (after removal of the kidney) to a medical school. In this situation, after the kidney is removed, decedent's body would be delivered to the medical school- donee.



Section 202(d) imposes duties on health care institutions. At the time of the patient's admission to a heath care institution or as soon thereafter as may be practicable, the health care institution shall check the patient's status on the Registry. If it finds the individual is not registered, it shall inquire whether the patient would like to register and, if so, provide the patient with a Donor Form. If the patient returns the Donor Form to the health care institution, the patient's signature need not be notarized. The institution shall immediately forward the information on the Donor Form to the Secretary and shall advise the patient that registration is not effective until the patient's status is actually recorded on the Registry. Institutions who receive Donor Forms from admitted patients should expedite the filing of the forms with the Secretary and should consider faxing the forms so that patients can be registered as soon as possible. The "as soon as may be practicable" language recognizes that under certain circumstances, such as an emergency admission, complying with the request rule in section 202(d)(2) may not be possible.



When section 202 is read in conjunction with the immunities and liability provisions in Title IV, it is clear that health care providers: (1) have a duty to remove needed organs of donors and restricted donors; and (2) can rely exclusively on the Registry to establish the status of an individual as a donor, a restricted donor, or non-donor, except for the case of minors under age sixteen. CODA, therefore, frees the health care provider from any concern that a donor's judgment can be ignored or second-guessed by surviving family members.



Section 202(d)(3) imposes no affirmative duty on a health care institution to locate family members. The obligation rests on the family member if they wish to object or authorize an organ removal.



Health care institutions in which an individual dies or to which he or she is transported after death must check decedent's status on the Registry immediately following that individual's death. Decedent's status shall be documented in his or her medical record. This procedure ensures hospital compliance for determining an individual's donative status before organ removal may proceed.



Title III-Sales.



Sec. 301. Prohibition on Sales.



Section 301 states the general rule prohibiting the sale of organs with specific exceptions. This section is modeled after section 301 of the National Organ Transplantation Act (relating to the prohibition of organ purchases), which consequently, pursuant to section 302 of this Act, is repealed. Underlying the prohibition is the conclusion that sales should be unnecessary to increase organ availability in light of the Act's scheme of mandated choice. If indeed CODA is successful in providing the necessary organs, the potential negative consequences [FN8] of incentives to donate and sales of organs are avoided entirely.



The general prohibition is phrased broadly to include all human organs that may be transplantable in the future. Section 301 also lists limited exceptions. Thus, sales are permitted for blood, blood derivatives, semen, and ova. For the most part, the medical procedures to acquire blood, blood derivatives, semen, and ova impose few risks on the donor. Additionally, their sales are currently allowed and present little danger of coercion or undue influence.



Title IV-Miscellaneous Provisions.



Sec. 401. Conscientious Objection, Conflict of Interest, and Transfer of Patient.



Section 401 recognizes situations where a health care provider may be unwilling to participate in organ tissue retrieval or transplantation procedures for moral or ethical reasons or a conflict of interest. This section: (1) permits the health care provider to refuse to participate, directly or indirectly, in any aspect of a transplantation procedure involving organs; and (2) requires the health care provider to transfer or refer the individual to another health care provider. Transfers might include inter- hospital transfers or inter-physician transfers or both.



Sec. 402. Immunities.



Sections 402 (a) and (b) protect health care providers from potential civil and criminal liability, so long as the provider makes a good faith effort to comply with this Act. It is hoped that affording complete legal protection to those involved with organ donation will encourage more aggressive organ retrieval behavior. The verb "act" in section 402(a) encompasses every action or inaction addressed by CODA, and not just those acts required by section 401 relating to the transfer of a patient.



Section 402(b) was drafted specifically to alleviate health care provider concerns of suffering potential legal liability for relying on the Registry to identify an individual's donative status.



The health care provider enjoys complete legal immunity from any mistakes made by the Registry in recording the decedent's donative status. This protection (coupled with the potential liability for violating the provisions of the Act in section 403(b)) eliminates the need to engage in defensive organ procurement behavior, thereby increasing the number of potential organs retrieved. For example, if a physician refuses to transplant an organ of a registered donor because of family objections, the physician could be liable for fines and damages; whereas if the physician proceeds to remove and transplant the organ over family objections, section 402(b) shields the physician from liability. Furthermore, section 403(a) preserves the right of any adversely affected person to sue the family for malicious prosecution.



By affording legal immunity to any individual who donates an organ from harms caused by that organ, section 402(c) should encourage more individuals to become organ donors.



Sec. 403. Liabilities.



Section 403(a) is meant to discourage interference with the lawful compliance of the Registry. This section also is intended to support a health care provider's effort to comply with the Registry in situations where outside parties threaten suit. Since the purpose of this Act is to increase the supply of organs, persons whose attempts to comply with this Act are thwarted by others' threats of suits or actual suits are not precluded from bringing malicious prosecutions actions. For example, if a competent adult has registered as a donor and consequently his or her child threatens the attending physician with legal action if an organ is removed, the attending physician has a right to institute a malicious prosecution action against the child. This section is designed to eliminate any argument that state malicious prosecution suits are preempted.



Similarly, section 403(b) attempts to protect the sanctity of an individual's decision to donate organs by imposing significant financial penalties on any individual or institution that fails to comply with the provisions of this Act. Thus, if in the proceeding example, the attending physician knowingly refuses to remove an organ from a registered donor, the physician could be held liable for noncompliance with this Act. Since the physician received no monetary benefit for his actions, a penalty of $50,000 could be imposed in addition to any civil damages. Substantial penalties, in addition to damages, are employed to ensure compliance with the advanced decision as noted on the Registry. Penalties are imposed because damages may be difficult to prove. These penalties should deter health care providers from inappropriate behavior. Additional penalties for persons who violate the provisions of Title III relating to the sale of organs are also imposed.



A physician who knowingly transplants an organ from a registered non- donor or an organ that has been unlawfully purchased is liable, under section 403(b), for civil penalties in an amount equal to the greater of $50,000 or treble the amount received by the physician in connection with all activities that are in violation of the Act. Thus, if the physician received a payment for the entire surgical procedure, including pre-operative and post-operative care, in the amount of $100,000, the physician would be liable for up to $300,000 in civil penalties. These penalties are in addition to potential civil damages and, if an unlawfully purchased organ were used, up to five years in jail and an additional $50,000 in penalties.



Sec. 406. Effective Date.



Section 406 incorporates a complicated effective date rule. The purpose of the rule is to give the Secretary adequate time to create the Registry, provide all citizens and residents with an opportunity to complete Donor Forms, record the received Donor Form information on the Registry and to provide that information to health care institutions and others. Eighteen months is viewed as a reasonable time in which to accomplish this important task. However, it is also important that individuals have adequate time to reflect on how to respond to a Donor Form. The Act mandates that section 202 (relating to the removal of cadaveric organs) shall not take effect until three months after the Secretary complies with the provisions of section 201(f)(3)(E) (relating to the solicitation of Donor Forms). Thus, if the Secretary is unable to distribute Donor Forms under that provision until seventeen months after this Act is enacted, section 202 cannot become effective until three months later. Obviously, this would result in a violation of the eighteen month rule in this Act. More likely, the Secretary will be able to have the Registry operational earlier than eighteen months after the enactment of this Act. In that case, section 202 becomes effective when the Registry becomes operational, provided citizens and residents had at least three months to complete Donor Forms. For example, if Donor Forms are distributed seven months after the effective date of this Act, the Registry could become operational and section 202 would apply ten months after the effective date of this Act.



FN1. Iowa Statewide Organ Procurement Organization, Communication is Key for Organ Donation , Des Moines Sunday Reg. , April 18, 1993, at A7 [hereinafter Communication is Key for Organ Donation ].



FN2. Iowa Statewide Organ Procurement Organization, How Organ and Tissue Donations Save Lives , Des Moines Sunday Reg. , April 18, 1993, at A6.



FN3. Communication is Key for Organ Donation, supra note 1, at A7 [hereinafter How Organ and Tissue Donations Save Lives ] (quoting Michael Evanisko, President of the Partnership for Organ Donation).



FN4. How Organ and Tissue Donations Save Lives, supra note 2, at A6.



FN5. 12 U.L.A. 362 (Supp. 1992). The following states have adopted a form of this Act: Arkansas, California, Colorado, Delaware, District of Columbia, Georgia, Idaho, Indiana, Kansas, Maine, Maryland, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia and Wyoming.



FN6. In 1990, the federal government spent more than $3.5 billion treating individuals suffering from end stage renal disease, with dialysis treatment. Teri Randall, Too Few Human Organs for Transplantation, Too Many in Need . . . and the Gap Widen s, 265 JAMA 1223 (1991).



FN7. For example, a minor for whom no social security number was obtained or an adult whose status on the Registry was not changed when he or she attained age sixteen such that the pre-sixteen status was automatically deleted.



FN8. Depending on how an incentive or sales system is administered, the potential negative consequences of such a system include: (1) discouraging organ donations and altruistic values; (2) escalating prices for organs as donations decrease; (3) discriminating effect on the poor who may sell their organs at great risk to their health and profits going to "brokers"; (4) discriminating effect on those unable to afford organs; (5) the coercive impact of money on the process of making an informed medical decision; and (6) the administrative costs of such a program.

MINORITY REPORT



Copyright © 1993 University of Iowa (The Journal of Corporation Law)



I. INTRODUCTION



The Cadaveric Organ Donor Act (CODA) and the Living Organ Donor Act (LODA) are the culmination of a lengthy inquiry into the medical and philosophical state of modern America and our cultural regard for human living and dying. The precise focus of the effort was to increase organ availability without unduly infringing on personal autonomy and the dignity and sanctity of the transition between life and death. Despite its admirable goals, CODA and LODA are far- reaching, unworkable, and in conflict with the moral stead of a large portion of the American public. The Acts propose to implement a scheme of mandated choice and presumed consent regarding cadaveric organ donations, to facilitate live organ donations, to establish a comprehensive national registry, and to create regulatory authorities vested with responsibility for allocating these newly-acquired resources. These may be entirely valid methods for eliminating the shortage of organs for transplantation in the United States and, in this respect, CODA and LODA live up to their purpose. However, the Acts fail to meet the qualification of their stated purpose-CODA and LODA do unduly infringe on personal autonomy and the dignity and sanctity of the transition between life and death.



The costs of the system proposed by CODA and LODA could be immense; even conservative estimates suggest that the system envisioned will require hundreds of millions of dollars, while the Acts fail to provide any substantial sources of funding. Aside from this financial burden, however, the most devastating costs will be reflected in the erosion of respect for life and the degradation of the uniquely human virtue of generosity. LODA's most pernicious provisions allow for live organ donations which will result in the death of their donors, and for the donation of the tissue and organs of aborted human fetuses. Additionally, CODA, in certain circumstances, seeks to implement "presumed consent" on behalf of persons who have failed to officially record their intentions as to the donation of their organs.



Without question, the United States is experiencing a shortage of organs for donation, and countless lives could be enhanced, lengthened, or saved through a system which would alleviate, and perhaps eliminate, that shortage. Lawmakers must, in addressing this vital issue, seek a rational, morally conscious, and medically justifiable plan, one likely to meet with the approval and understanding of those who will bear its costs and receive its benefits, the American people. CODA and LODA do not present such a plan; rather, they constitute a radical and drastic leap into a river where cautious and considered steps are required.



II. LODA - TAKING CERTAIN LIVES TO SAVE OTHERS.



A. ANENCEPHALICS AND PERSONS IN PVS.



"Death" is a difficult concept to grasp and to confront. It is generally feared, as are many facets of our world which are seemingly beyond the reach of our understanding. Certainly, death may at times bring a long-awaited release from the immense suffering of those afflicted with illness and disease, and in this sense, it is a positive aspect of humanity. However, whether the prospect of death is "good" or "bad" in any particular instance, the definition of death itself cannot be molded to fit in such a way as to relieve the pain of those who must endure conditions which seem to be anything but "living."



Prior to the advent of modern technology, death was determined on the basis of cessation of circulatory and respiratory function. By the 1960s, however, research and technology had allowed the medical community to indefinitely maintain the circulatory and respiratory functions of individuals who may never regain higher brain activity. Since that time, legislatures have acted to re- define "death," recognizing that the traditional understanding of the concept is incompatible with our recently acquired medical capabilities. By 1986, the laws of forty-three states provided that death is established either by the cessation of circulatory and respiratory function or, alternatively, by the cessation of all brain activity. Neither the condition of persistent vegetative state (PVS) nor anencephalia can be included under these definitions of "death." Therefore, to take the organs of those who are so afflicted by these conditions is, plainly, to terminate human life. Yet, sections 202(a)(1)(B)(i), 202(b)(1)(B)(i), and 203(a)(2)(A) of LODA provide for the killing of individuals in PVS and anencephalics by way of the removal of their vital organs for transplantation purposes. Members of the medical community have vehemently stated that the vast majority of their peers would not participate in these acts. The routine performance of these procedures, and their sanction by law, would recast the role of the health care community from one characterized by treatment, healing, and saving lives into that of a community abandoning its once-fervent attempt to save lives, assuming a function of garnishing what society may find usable from these resources (formerly considered to be "patients").



LODA's provisions relating to minors and individuals who were never competent are even more offensive. [FN1] Once these individuals are declared to be in PVS, death may be effectuated by mere consent of a parent or guardian. Of extreme concern is that the decision to hasten death's arrival will, in nearly all such situations, be made by the same parties faced with the emotional and financial burden of allowing the patient's life to continue until its natural cessation; clearly, a tremendous conflict of interest arises. In these situations, the question must be squarely addressed: whose suffering is sought to be eliminated by the life-terminating organ removal-the patient's or the decision-maker's?



Medical authorities readily admit that their understanding of the human brain is severely limited, and their understanding of the human spirit (or "soul," as believed by large portions of our society) even more so. There is simply not enough knowledge to assert with any degree of certainty that individuals in PVS and anencephalics are not experiencing life in a cognitive sense other than that through which we perceive our surroundings, the passage of time, and our own existence. Neither can medical authority explain the concept of an afterlife, yet the vast majority of society professes to believe in some sort of post-earthly existence, albeit existence in a form outside the realm of our current comprehension. It is inappropriate for us to once again redefine death, this time to broaden its reach to encompass anencephalics or those in PVS, so as to further our goals of obtaining organs. If the human body still functions when provided with proper nutrition and hydration, as required by all humans, that individual is still alive. If the brain still functions, even to a slight degree, that individual is still alive. If and when medical technology acquires the potential for indefinitely maintaining brain functions, we will once again need to re-examine and perhaps alter our definition of death. Until then, however, we have no justifiable basis, either medically, politically, economically, or morally, for manipulating the concept.



B. THE TERMINALLY ILL.



A discussion of the definition of death does not fully confront LODA's faults. Provisions [sections 201(a)(2)(A)(B), 202(a)(1)(B)(i), 202(b)(1)(B)(i), and 203(a)(2)(A)] advocate the termination of what is admittedly "life" for purposes of increasing the organ supply in other situations, primarily where donors are terminally ill or scheduled for criminal execution. The ethical debate regarding the latter issue goes far beyond the scope of this discussion. However, in the context of the terminally ill, and where state law allows for the termination of life ( i.e. , cessation of life-sustaining treatment, or perhaps in the future, active euthanasia), LODA's provisions simply condone suicide. To suggest that inducing the premature termination of life is appropriate when society can benefit by obtaining a terminally ill individual's organs carries the connotation that the donor is worth more dead than alive. Further, this provision may imply that the individual ought to submit to such a procedure to avoid further financial and emotional burden on his or her family. The lack of respect for human life in such a provision is overwhelming. The existence of a euthanasia law which allows a particular donor a right to die does not presuppose the worthlessness of his or her life. The terminally ill often make far greater contributions to the growth and understanding of society than do the young and healthy, perhaps since the former have lived longer and experienced more, or perhaps because they have been forced to reevaluate their priorities and perceptions of life in this world, upon being faced with the prospect of their impending death. Furthermore, members of the medical community have expressed a similar unwillingness to end the lives of terminally ill patients through the performance of organ removal procedures, finding such functions incompatible with their moral obligations to "do no harm," and inconsistent with their traditional role of preserving life and waging war against death.



Like the PVS provisions, the allowance for life-ending donations in the case of terminally ill individuals is especially disturbing when applied to minors and those who were never competent. Where state law permits the termination of life, the authority of the parent or guardian to decide to end their child or ward's life is limited only by the condition that the child or ward must not object. This clearly places the onus upon classes of individuals long considered to be unable to fully protect themselves, and highly subject to the influences of the parents or guardians who provide for their daily care and comfort. In all likelihood, these are the very decision-makers who will have a vested interest in avoiding the heavy financial and emotional burdens looming ahead.



C. THE PREGNANT DONOR IN PVS OR TERMINALLY ILL.



The provision of section 204 of LODA that suspends the directive of a pregnant individual who is in PVS or who has a terminal condition and is on life support where the fetus could be maintained to the point of viability is a welcome departure from the Act's prevalent theme of acquiring all potential organs at the earliest possible moment. This position is absolutely essential, since enforcing a life-terminating directive in such a situation would amount to government-directed abortion. Given that the asserted rationale for organ donation is the preservation of human life, the elimination of a potentially healthy child's existence on the pretense of saving or improving others is disturbingly ironic.



D. THE USE OF FETAL TISSUE.



LODA provides a glaring contrast among unborn children, depending upon the purposes for which they were conceived. Unlike the unborn children of the pregnant PVS or terminally ill individual, [FN2] if a woman becomes pregnant for the purpose of allowing the child to live only long enough so that the child's tissue and organs may be used, or if a woman simply decides that some "good" might as well come from her accidental pregnancy, LODA provides for the abortion and subsequent use of such fetuses. This is perhaps the most offensive of all the Act's provisions. Here, LODA allows for the creation and subsequent destruction of human life for the purpose of utility. This is less the realm of "medicine" than it is the realm of "farming": the Act allows human life to be treated as if a mere growing crop, planted and subsequently harvested, with its owner reaping the benefits and determining the allocation of the yield. The sanctity of human life could not be more derisively mocked.



Even in the case of fetuses who were not conceived for the purpose of harvesting, the dissection and salvaging of unborn children is morally repugnant. The observation that fetuses may be used for medical research and technology may be invoked to console those who choose to abort their children- to make abortion seem a little less wrong. Aside from the objections to abortion itself, there is something sacrosanct about this object, whether considered "life" or "the potentiality of human life," which might have been carried to term and become the focus of what is, for many, the most joyous moment in the course of a lifetime, the birth of a child. To violate the wholeness of this being, as small as it is, with the intention of confiscating whatever may be salvaged, is the height of invasiveness. The denial of the child's opportunity to live is tragic enough; our society's attempt to capitalize upon the tragedy is abhorrent.



III. CODA - GENEROSITY, PRESUMED CONSENT, AND DISREGARDED CHOICES.



The term "donation" implies the volitional transfer of a particular resource, without expectation of compensation in return. Hence, a system of "organ donation" would presumably have its foundations in the exercise of individual autonomy, with a corresponding consciousness of generosity. In contrast, CODA denies the opportunity for the exercise of altruism, mandates donation (a contradiction in terms) by certain groups within our society, and defeats the express organ donation decisions of others. The harmful consequences of these provisions will be suffered by members of three broad groups: those who have failed to officially record their organ donation decisions, as well as minors and individuals who were never competent.



A. THOSE WHO HAVE FAILED TO OFFICIALLY RECORD THEIR ORGAN DONATION DECISIONS.



CODA section 202(b)(2) provides that, upon the death of an individual whose organ donation decision was not officially recorded in the National Registry, medical authorities may presume that the individual or an appropriate decision- maker has consented to the donation of all needed organs. CODA's drafters made a superficial attempt to ameliorate the harshness of this provision by conceding that a decedent's family may object to the organ removal. Yet, section 202(d)(3) declares that there is no affirmative duty on the part of medical personnel to locate or request a decision from any individual who may authorize or object to the removal of an organ under section 202(b). This supposedly watered-down "weak presumed consent" is unjust and unrealistic, since the removal of organs from an individual is dependent upon how quickly his or her family can be notified and race to the hospital, and upon whether they are aware of the individual's wishes.



This does not depict a system of organ "donation," but rather one of organ "taking," seemingly inconsistent with the precepts of a free and democratic society where individual autonomy is prized. A default rule mandating that organs will revert to the state hints more of a socialist regime than of a nation which had its inception in declarations of human liberty. That persons have not formally acknowledged their right of choice in a matter so invasive, so intrusive upon spheres of individual privacy, is not sufficient justification to assume that such individuals have not made these choices, do not care or, in the extreme, affirmatively seek to become organ donors. Under CODA's scheme, one individual's perhaps inadvertent failure to execute a negative directive produces the same consequences as another individual's affirmative directive to donate; such a result ignores the possibility that the former did not wish to donate his organs, and demeans the admirable decision of one who has made a positive, fully-conscious choice to help save others' lives.



In contrast, CODA section 202(b)(3) properly concedes that the organs of unidentifiable decedents should not be available for transplantation. The disparate treatment accorded to one who has failed to make a choice, as compared to his unidentified counterpart, is unjust; in each case, attendant medical personnel are faced with the absence of information as to the decedent's donative status. To appropriate the organs of one but not the other, merely because the former's name is known, is arbitrary, illogical, and inequitable. If for no other reason, consistency concerns alone should instruct that the organs of neither individual be available. Our inability to discern a decedent's prior decision should not be capitalized upon as a convenient opportunity to snag a few more organs within our net.



Further, the organ donation decisions of those who do execute written directives, but who fail to record the intentions reflected in these instruments with the National Organ Donation Registry, may simply be disregarded. Section 201(d) instructs that where an individual currently registered as a donor completes a new donor form indicating a desire to be a non-donor, yet dies before such information can be officially recorded on the Registry, the individual's legal status is that of a donor. The invocation of a "presumption" which directly defeats the documented and undisputed intentions of an individual is perverse and dishonest, and is inconsistent with a scheme professing to respect the autonomy of each individual. Further, this provision places medical personnel in an impossible predicament: forced to choose between respecting what they know to be the patient's wishes and complying with the legally-directed disposition of the individual's organs.



B. MINORS AND INDIVIDUALS WHO WERE NEVER MENTALLY COMPETENT.



Under CODA, the intentions of minors and incompetent persons, including the desire not to serve as organ donors, are entirely irrelevant, subject to no consideration whatsoever. In the case of a deceased minor, section 202(b)(1) allows a parent or guardian to disregard, without penalty, a prior negative organ donation directive, even where such directive was the product of great reflection or vehement conviction on the part of the minor. Conversely, section 202(b)(4) allows a minor's parents to frustrate the minor's previously expressed intention to donate his or her organs. To permit a parent or guardian to ignore the previously established donative status of a child or ward defeats the entire purpose underlying mandatory registration of all individuals-that is, to provide for rational and objective decision-making outside the highly emotional and often tragic circumstances surrounding the time of death.



Further, CODA section 201(b)(4)(B) provides for cadaveric donations on behalf of individuals who were never competent, and thus could never had made conscious, informed decisions to share their organs for the benefit of others. Any pretense of having this organ donation scheme appear to be based upon the human virtues of kindness, selflessness, and generosity is foregone by allowing organs to be taken from persons who simply could not have comprehended the benefits and consequences of organ donation. Incompetent donors are thus treated as though mines from which valuable ores may be carved out and extracted. These provisions display a distressing insensitivity to the personal freedoms of mentally incompetent individuals. Certainly such persons still are protected by the United States Constitution, yet CODA virtually ignores any right of privacy or due process liberty interest they may have.



The provisions of CODA allowing for presumed choice and disregarded choice in reference to these three groups of donors radically transform the character of this organ procurement scheme from a system which encourages the exercise of the virtue of generosity to a utilitarian action plan for the acquisition of as many organs as possible, with the ready sacrifice of autonomy. The human body is more than simply a shell. It is what defines each individual, that which allows him to function within the world. It is the medium through which all emotions are released, all expressions are shared, and all achievements come to fruition. It provides the sole means for experiencing human intimacy and for perpetuating our existence. The body inextricably defines each individual. It is each person's finest treasure. The suggestion that something so priceless becomes immediately worthless (except as an organ field prime for harvesting) upon "death," however defined, is a denial of the human condition, which acknowledges that the experience of life on earth is inseparably bound to the receptacle of the human body. It is concededly a sentimental attachment, but humans are sentimental creatures. When not the product of a conscious decision to sever that attachment, the invasion of a body and the appropriation of its parts upon the cessation of life manifest a profound disrespect for the individual whose presence in the world was that body. Supporters of CODA cannot sincerely contend that the Act does not unduly infringe upon personal autonomy; more accurately, several of its provisions ignore or even defeat conscious organ donation decisions. Furthermore, donative consent which is demanded or presumed cannot be characterized as altruistic. Therefore, CODA fails to respect the two elements which give credence to the practice of organ donation: altruism and autonomy.



FN1. LODA 203(a)(2), 202(b)(1)(B).



FN2. LODA 204.



END OF DOCUMENT



RESPONSE TO THE MINORITY REPORT



Copyright © 1993 University of Iowa (The Journal of Corporation Law)



I. INTRODUCTION.



The minority report raises a number of issues concerning both the Cadaveric Organ Donor Act (CODA) and the Living Organ Donor Act (LODA). In order to intelligibly address these issues, however, it is first necessary to reiterate the goals underlying each Act for they are not, as the minority seems to suggest, uniform for both Acts.



II. CODA.



A. RESPONSE TO THE MINORITY REPORT'S CHARACTERIZATION OF THE GOALS UNDERLYING CODA.



CODA is designed to increase the supply of cadaveric organs available for transplantation purposes without drastically altering the present organ procurement system, thus increasing the likelihood it could be adopted in the foreseeable future. [FN3] A wide range of proposals were considered to increase the supply of organs, including instituting a nation-wide system of presumed consent, [FN4] conscription, [FN5] or organ sales. Each of these proposals has been the subject of serious scholarly debate and each, to varying degrees, has supporters and detractors among physicians, ethicists, and other public policy commentators. For a variety of reasons, however-some ethical, some practical- each of these alternative proposals was rejected in favor of the approach adopted in CODA, an approach based on the principle of autonomy. This principle recognizes that organ donation is morally justifiable when the donor (or the donor's surrogate decision-maker) has affirmatively chosen to make that gift.



The approach adopted by CODA-the one the minority labels "far-reaching, unworkable, and in conflict with the moral stead of a large portion of the American public"-basically requires people to complete a Donor Form the first time they apply for either a social security number, a driver's license, a state identification number, or an alien registration number. [FN6] This approach has been dubbed "mandated choice." No incentives are offered to individuals who choose to become organ donors; if they do so it is due to their own generosity and altruism. In addition, no penalty is imposed upon an individual who chooses not to be an organ donor or chooses to be only a restricted donor. Thus, the autonomy of all individuals is supported and respected. Furthermore, and contrary to the minority's assertions, mandated choice does not incorporate the concept of presumed consent. Therefore, it is unclear which provisions of CODA, as the minority charges, "infringe on personal autonomy and the dignity and sanctity of the transition between life and death" and contribute to "the erosion of respect for life and the degradation of the uniquely-human virtue of generosity." Quite the contrary, requiring individuals to fill out Donor Forms before receiving a social security number, driver's license, state identification card, or alien registration number to participate in a national effort to save thousands of lives-the lives of mothers, fathers, daughters, sons, sisters, and brothers-is essentially life-affirming. By opposing the reform attempts of the majority without offering any constructive suggestions for improvement of the current system (which even the minority recognizes is woefully inadequate in meeting the need for transplantable organs), the minority effectively condones the current system, a system which allows family members to override the express wishes of an individual to donate his or her organs after death. [FN7] How does that value personal autonomy?



B. RESPONSE TO THE MINORITY REPORT'S SPECIFIC CRITICISMS OF CODA.



1. CODA'S TREATMENT OF INDIVIDUALS NOT REGISTERED ON THE NATIONAL ORGAN DONOR REGISTRY ("REGISTRY").



Under CODA, individuals applying for a social security number, driver's license, state identification card, or alien registration number must complete a Donor Form setting forth their intent to be a donor, restricted donor, or non-donor. [FN8] Because only those people who have never received a social security number, driver's license, state identification card, or alien registration number will not be registered on the Registry, only a small percentage of the population will not be registered as either a donor, restricted donor, or non-donor. [FN9] All of the minority report's invective seems related to how CODA treats this small group (the "unregistered").



The minority asserts that CODA provides a quasi-"socialist" presumed consent system for the unregistered by allowing hospitals to presume that they had consented to organ donation. [FN10] There were certainly compelling arguments to adopt presumed consent, most notably that presumed consent legislation would reflect the expressed desires of an overwhelming number of Americans to become organ donors. [FN11] Since the overwhelming majority of the public wishes to become organ donors at death, it is reasonable to assume that the overwhelming number of unregistered individuals would also wish to be organ donors at death. If this is not the case, it can only be assumed that, in all likelihood, the unregistered individual was indifferent or simply preferred to have close family members decide. Furthermore, it is reasonable to assume that if an individual did not want to be an organ donor, the individual would have registered as a non-donor. This assumption is even more supportable if CODA is enacted and its terms become widely known, as they surely will. CODA's approach for the unregistered is comparable to the decisions states have made concerning the disposition of property belonging to an intestate. [FN12]



Despite these compelling reasons and after much deliberation, the majority specifically rejected applying presumed consent to the unregistered in favor of allowing their close family members [FN13] to decide whether to donate. [FN14] Yet the minority report still seems troubled by the manner in which the majority worded the applicable section of CODA ("An organ shall not be removed from the decedent if the decedent is not registered . . . and the decedent's [family member] objects.") Based on the testimony of expert witnesses, it is believed that, in those rare instances when an unregistered decedent's family member is not at the hospital at the time of an individual's death, health care providers will wait to remove organs, if possible, until the family has the opportunity to object.



CODA does not affirmatively require any health care provider to ask for family members' permission to donate their relatives' organs for two reasons. First, the burden to make a donative decision should be on each prospective donor (or his or her parent or guardian). If the prospective donor does not make a donative decision, a burden to seek approval from his or her family should not be imposed upon the health care provider. Second, if the health care provider had a burden to affirmatively determine whether family members had an objection to the removal of a decedent's organs and the family was absent at the time of the decedent's death, there would be a high risk that decedent's organs would not be useable for transplantation purposes. In most cases, of course, family members will be present at a decedent's death. Furthermore, and as a result of the educational materials required to be prepared by the Secretary, family members will be knowledgeable of the provisions of CODA, including the provision not requiring health care providers to affirmatively ascertain whether they object to organ removal. Thus, they will have sufficient opportunity to make their objections, if any, known. [FN15]



The minority also claims CODA is inconsistent in that it does not allow a health care institution to remove the organs from an unidentified individual. [FN16] The minority fails to recognize the important difference between unidentified individuals and unregistered individuals. An unregistered individual is an individual whose identity is known but who, for one reason or another, does not have a status on the Registry. The principle of autonomy warrants that, if this individual's donative decisions cannot be determined from the Registry, an assumption permitting the removal of the individual's organs should be subject to some check by his or her family members who effectively become surrogate decision-makers. Because of the inability to check the Registry for an unidentified individual, there could be a risk (if the Act had not otherwise provided) that his or her organs would be removed even though he or she had actually registered a decision not to be a donor, perhaps for religious reasons. CODA reflects the view that the protection of these unidentified possible non-donors outweighs the loss of a small number of organs.



CODA's commitment to autonomy for registered donors, thus, is bolstered by its treatment of individuals whose identity cannot be ascertained. For unidentified individuals, CODA's reluctance to deviate from the principle of autonomy results in the rule that prohibits the removal of their organs. It does so at the cost of losing the organs of registered donors whose identities cannot be determined.



2. CODA'S TREATMENT OF PEOPLE WHO MAKE "DEATH BED" DECISIONS.



The minority report criticizes CODA as "perverse" and "dishonest" because it directs a hospital to determine the donative status of an individual based solely on Registry information. [FN17] Compelling reasons to do this exist. If a hospital could rely on a written instrument rather than the Registry, hospitals would be placed in the difficult position of never knowing whether they could really rely on the Registry. [FN18] Furthermore, a family member could produce a fraudulent document purportedly from the decedent to defeat the decedent's donative decision. However, even using the minority report's hypothetical situation (involving a hospital that knows a decedent has filed a new Donor Form that is not yet effective), there is little cause for concern. If the decedent died of a terminal illness, the decedent would likely have been ineligible to be a donor. If the decedent died of a sudden accident, the hospital almost certainly would be unaware the decedent has a new Donor Form being processed. If the hospital is aware of a pending Donor Form, it could maintain a brain-dead individual on life-support systems for a few hours until the information on the new Donor Form was registered on the Registry. [FN19] Furthermore, if, upon admission, the hospital determines that a patient is not registered on the Registry, CODA requires the hospital to give the patient the opportunity to immediately complete a Donor Form that will immediately be forwarded to the Registry. [FN20] The Report accompanying CODA even suggests that in these cases Donor Forms should be faxed to the Registry to expedite filing. It must be emphasized that CODA's "reliance" policy is designed to increase administrative efficiency and make the jobs of hospitals easier. It is not intended to retrieve organs from people who have changed their minds to become non-donors. The policy applies equally to individuals who wish to become donors, but are still registered as non-donors on the Registry pending the processing of a new form.



3. CODA'S TREATMENT OF INCOMPETENT ADULTS.



The minority report reaches new levels of stridency in its discussion of CODA's treatment of incompetent adults. It appears that the minority report's sole objection is that CODA allows the guardian of an incompetent adult, who in almost every case will be a parent or family member, to complete a Donor Form on behalf of the incompetent adult. [FN21] This provision seems only logical since an incompetent adult's guardian can make every other decision, health care-related and otherwise, for that individual. Even without CODA, guardians may currently make this decision for incompetent adults as well as many other health care decisions, such as consenting to life-saving treatment. The minority's call for sensitivity "to the personal freedoms of mentally incompetent individuals" ignores the practical reality that decisions are and must be made for incompetent adults on a daily basis in health care settings across the country. CODA merely requests that the guardian make the organ donation decision before, rather than after, the adult dies. [FN22] Does the minority report really want to limit the rights of guardians even under current law? [FN23]



C. CONCLUSION.



While the minority purports to be protecting the autonomy of individuals by opposing mandated choice legislation, the minority's conclusion makes it clear that there is more than a concern for autonomy behind its opposition. The minority describes the human body as "what defines each individual" and "each person's finest treasure." The minority's extreme view of the human body as the sole means of defining an individual is contrary to what many others believe. The minority's desire to incorporate such a polar view into public policy supports the desirability, if not the necessity, of mandated choice. Mandated choice as provided in CODA provides every individual with the opportunity to express his or her organ donative preference presumably based upon a personal assessment of the relative importance of mind over body, and vice versa.



While the majority may agree with some of the minority report's characterizations of the human body, and may quibble with others, [FN24] the minority report's conclusion ultimately sheds no light on the real distinction between the positions of the majority and the minority. The majority believes that the tragedy of wasted productivity, senseless death, and needless grief due to the dearth of organs demands that national legislation be enacted promptly. Therefore, CODA proposes the most moderate of all possible modifications to the present organ procurement system. The minority, on the other hand, proposes no alternative, thus implicitly favoring the continuation of the status quo . Perhaps this is because the minority feared its proposal, like CODA, would be dissected, described in only the most inflammatory terms, and summarized as if its most obscure and minor features were its heart and soul. [FN25]



II. LODA.



A. RESPONSE TO THE MINORITY REPORT'S CHARACTERIZATION OF THE GOALS UNDERLYING LODA.



Contrary to the suggestion of the minority report, LODA is not meant to increase the supply of organs available for transplantation. LODA is meant to regulate the transplantation of organs from one living individual to another because no regulation currently exists. In fact, because LODA provides numerous safeguards to the donor, donation of organs from living individuals may, in many instances, be easier now than under the provisions of LODA, if enacted. Unlike CODA, LODA is likely to be controversial. It was not anticipated that LODA would be acceptable to Congress today. To the contrary, LODA is designed to reflect the serious opinions of persons deeply concerned with ethics and morality and to serve as a focus for further public discussion of the important issues that arise from live organ donations.



B. RESPONSE TO THE MINORITY REPORT'S SPECIFIC CRITICISMS OF LODA.



Although the minority report's discussion of LODA could be rebutted, point- by-point, only a few of the minority report's assertions are discussed here. LODA does not require any physician to perform an act contrary to his or her conscience. It expressly provides immunity for physicians who have a conscientious objection to procedures authorized by LODA. [FN26]



Many of the minority's concerns about physicians being perceived as killers, if they comply with LODA, were raised in the debates surrounding proposals to alter the traditional definition of death to include whole brain death. These concerns were ultimately found unconvincing as evidenced by the Uniform Determination of Death Act. The minority now readily embraces the inclusion of the whole brain death test in the legal definition of "death," but might, the majority suspects, have found it "offensive" at the time it was proposed.



LODA does not give individuals the right to receive "aid-in-dying" (or "the right to die"). It merely provides the option of organ removal if a state already has aid-in-dying legislation; none currently do. [FN27] If the majority thought for a moment that LODA would encourage people to end their lives, the majority would not have proposed these provisions.



The minority accuses LODA of showing a "lack of respect for human life" by allowing organ donations as a method for state-permitted aid-in-dying and accuses the majority of "unduly infring [ing] on . . . the dignity and sanctity of the transition between life and death." Unfortunately, the minority fails to acknowledge that there is more than one moral view on how to respect human life and how to preserve the dignity of the dying process. For example, allowing a competent adult, either directly or through his or her chosen decision-maker, to refuse medical treatment to hasten or even cause death is to many people a morally defensible position that respects life, personal autonomy, and the transition between life and death. Most people believe there is no distinction between withholding life support and withdrawing life support and this view has been incorporated into the laws of most states relating to end-of-life decision-making. Others believe that if the withdrawal or withholding of life support is morally justifiable for seriously ill individuals, then hastening death also is morally justifiable. While these views are clearly controversial (and LODA takes no view on the controversy), espousing them clearly is not disrespectful of human life; rather it is respectful of the dignity of human life and the individuality of each human life. [FN28]



The minority seems to believe that an individual in a persistent vegetative state or who is terminally ill is at risk from that individual's family. The majority believes that the family who knows and loves that individual is better able than the government (or unrelated moralists) to make life and death decisions that are in the individual's best interests.



The minority report expresses revulsion that the "sacrosanct" aborted fetus should ever be used for research purposes. Should medical school research or dissection be banned as well, or is the aborted fetus more sacrosanct than a cadaver?



The minority's position is premised on one immutable belief-that life begins at conception and ends at death as it is currently defined. The minority fails to recognize other well-respected moral views as to when life begins and what it means to be dead. The minority seeks to incorporate its own limited view on these issues into the great public policy debates of our time. The minority is entitled to do that but appears more than content to do it by belittling the ideas of those with whom the minority disagrees, rather than by developing persuasive arguments that at least recognize other views, honestly held, concerning when life begins and ends.



C. CONCLUSION.



The majority hopes LODA will stimulate discussion concerning the important issues surrounding live organ donation. We believe that the minority will agree that we may succeed in that goal.



FN3. This response will not reiterate the necessity for increasing the supply of organs for transplantation purposes; those reasons have been set forth in the Report accompanying CODA.



FN4. Presumed consent legislation generally allows or compels a hospital to presume a deceased individual had consented to being an organ donor unless he or she expressly stated a contrary intent during his or her life.



FN5. Conscription legislation compels a hospital to remove transplantable organs from a deceased individual if they are needed, regardless of the express wishes of the decedent while living.



FN6. CODA 201(b). This proposal was supported by 14 of the 15 members of the committee that drafted CODA. The committee members have moral, religious, and political views that run the gamut. In addition, expert witnesses at a public hearing to discuss CODA [hereinafter expert witnesses], including a transplant surgeon, a transplant coordinator, and an organ procurement specialist, were near unanimous in their support and exuberant praise of the proposal. Needless to say, the majority of the committee does not believe its views are out of the mainstream in this case.



FN7. Under the provisions of the 1968 Uniform Anatomical Gift Act, family members could override the organ donative decisions of a decedent. The 1968 Act, or portions thereof, have been enacted in every state. Under the 1987 Act, which has been adopted in at least eight states, family members cannot override a decedent's directive. Uniform Anatomical Gift Act 2(h) (1987).



FN8. CODA 201(b).



FN9. Even many of these people may be registered because of the extensive opportunities CODA provides to voluntarily register. See CODA 201(b)(4).



FN10. This is ironic considering no socialist country has adopted presumed consent, but numerous capitalist countries have, including Argentina, Austria, Belgium, France, Israel, Italy, Singapore, Spain, and Switzerland to name only a few.



FN11. See CODA-Report at part II.



FN12. For example, when an individual dies intestate, his or her property is distributed in a manner mandated by state law. Most intestacy laws reflect what the state believes would be the intent of the average individual regarding the disposition of his or her property. Would the minority have us bury a decedent's property with him or her lest the state make a mistake with its disposition? But, the majority can almost hear the minority shout, "it is offensive to characterize an organ as property!" Perhaps probate law does not provide the perfect analogy, but it is nonetheless valuable. The United States, for example, currently treats "body parts" as property when it permits the sale of blood, blood derivatives, ova, and semen, and when it prohibits the sale of all other "body parts." The minority report also speaks of organs in terms of property in its due process argument regarding the removal of organs from incompetent adults.



FN13. More specifically, CODA 202(b)(2) provides that an organ cannot be removed from a decedent if the decedent's attorney-in-fact, or, if none, guardian, or, if none, surviving spouse, or, if none, any one of decedent's competent adult children, or, if none, either one of decedent's parents, objects.



FN14. CODA 202(b)(2).



FN15. Family acceptance of organ donations should eventually reach the same, or an even greater level of acceptance than autopsies conducted in conjunction with civil or criminal investigations have attained. According to one expert witness, if people can accept what happens to a family member during an autopsy, in time they can also come to accept the much less invasive organ removal procedure as well.



FN16. CODA 202(b)(3).



FN17. CODA 201(d).



FN18. Should a hospital rely on a written note the family claims a decedent wrote before he died or the information on the Registry? Should it rely on an un-notarized, but otherwise completed, Donor Form or the information on the Registry? And what if the note or Donor Form is dated from the previous month, should the hospital try to discover when the Registry information was recorded to discover which source of information is more recent?



FN19. CODA mandates that the information on a Donor Form be recorded in an expedient manner so that situations like this one are extremely unlikely to occur. See CODA 201(f)(3)(A)(i), 202(d)(2).



FN20. CODA 202(d)(1)-(2).



FN21. CODA 201(b)(4)(B).



FN22. The minority report contends that a deceased incompetent adult might have a due process or right to privacy claim under the Constitution. It is doubtful a deceased individual could ever have any claim under the Constitution. Setting aside the issue of justiciability, CODA would not violate an incompetent adult's due process or privacy rights. However, a full discussion of that issue is impossible here.



FN23. Perhaps of all the minority report's accusations, the most troubling is that the majority wants organs at all costs and that "kindness," "selflessness," and "generosity," have no role in this process. That accusation is untrue and unfair. The majority could just as easily accuse the minority report of so relishing playing the role of a morally superior and righteously outraged defender of the sanctity of human life that it is unwilling to make even the most minor of compromises. Yet surely we can debate the merits of CODA without resorting to the use of needlessly inflammatory and insulting rhetoric.



FN24. An individual's body "inextricably defines" that individual? And what part of CODA implies a body is "worthless" after death? Quite the contrary, CODA was drafted precisely because an individual's body retains value after that individual dies.



FN25. The minority report also makes a reference to the costs of CODA. The matter of costs and funding is addressed in the report accompanying CODA.



FN26. LODA 501(a).



FN27. See, e.g. , LODA 201(a)(2)(A).



FN28. The minority, which frequently bolsters its arguments by reference to the principle of autonomy, is more than willing to quickly abandon that principle when it does not serve its purpose-such as in its discussion of end- of-life decisionmaking. This further supports the majority's suspicion that the minority is far more concerned with the promotion of a particular moral view than it is with personal autonomy.



LIVING ORGAN DONOR ACT



Copyright © 1993 University of Iowa (The Journal of Corporation Law)



A BILL



To regulate the donation of human organs from living individuals for transplantation purposes.



Be it enacted by the Senate and the House of Representatives of the United States of America in Congress assembled,



SECTION 101. SHORT TITLE AND TABLE OF CONTENTS.

(a) SHORT TITLE. THIS Act may be cited as the "Living Organ Donor Act."

(b) TABLE OF CONTENTS.



Title I. Definitions.



Title II. Organs from Living Individuals.

Sec. 201. Removal of Organs from Competent Adults.

Sec. 202. Removal of Organs from Incompetent Adults.

Sec. 203. Removal of Organs from Minors.

Sec. 204. Removal of Organs from Pregnant Women.

Sec. 205. Duties Regarding Informed Medical Decisions.

Sec. 206. Allocation of Organs from Living Individuals.

Sec. 207. Health Care Power of Attorney.

Sec. 208. Organ Transplant Boards.



Title III. Fetal Tissue.

Sec. 301. Use of Fetal Tissue from Spontaneous or Legally Induced Abortions.

Sec. 302. Use of Intrauterine Fetal Tissue.

Sec. 303. Allocation of Fetal Tissue.



Title IV. Sales.

Sec. 401. Prohibition on Sales.

Sec. 402. Repeal of Section 301 of the National Organ Transplantation Act.



Title V. Miscellaneous Provisions.

Sec. 501. Conscientious Objection, Conflict of Interest, and Transfer of Patients.

Sec. 502. Immunities.

Sec. 503. Liabilities.

Sec. 504. Effects of this Act on State Homicide Laws, Insurance and Health Care.

Sec. 505. Severability.

Sec. 506. Effective Date.



TITLE I-DEFINITIONS .



For purposes of this Act-

(1) the term "adult" means an individual who is at least 18 years of age or who is an emancipated minor;

(2) the term "aid-in-dying" means the State-authorized withdrawal, withholding, or other abatement of life-sustaining treatment, or the administration of a drug for the purpose of producing death;

(3) the term "anencephalic" means anencephalic as diagnosed by generally accepted medical standards and may include the congenital absence of skull, scalp, and forebrain (cerebral hemisphere), even if the brainstem (midbrain and pons) is present;

(4) the term "attending physician" means the physician who has primary responsibility for the treatment and care of a patient;

(5) the term "attorney-in-fact" means the individual designated by a principal in a health care power of attorney that is valid under the laws of the United States or any State;

(6) the phrase "competent adult" means an adult who has not been judicially declared incompetent under the laws of any State and has the decisional capacity to make an informed medical decision;

(7) the term "death" means either the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of all functions of the entire brain, including the brain stem. A determination of death shall be made in accordance with generally accepted medical standards;

(8) the term "decedent" means a deceased individual, including a stillborn child;

(9) the term "donee" means an individual who is the recipient of an organ;

(10) the term "donor" means an individual from whom an organ is removed for transplantation purposes;

(11) the phrase "emancipated minor" means a minor who has been released from the custody and control of his or her parents or guardian with their permission or by operation of law;

(12) the phrase "fetal tissue" means any fetus, living or dead, or a part from that fetus, but does not include an embryo or a part of an embryo;

(13) the term "guardian" means a judicially-appointed committee, guardian, or conservator who has authority to make health care decisions for a minor or an incompetent adult;

(14) the phrase "health care" means care relating to an individual's health, including personal care or comfort, treatment, service, or procedure to maintain, diagnose, or treat an individual's physical or mental condition;

(15) the phrase "health care decision" means consent, refusal to consent, withdrawal of consent, direction to permit aid-in-dying if permitted by State Law or any other decision related to an individual's health care, including decisions regarding the selection or discharge of an individual's health care provider and decisions regarding a program of medication, diagnosis, and surgical procedures;

(16) the phrase "health care institution" means a hospital, nursing home, hospice, or any other facility where health care is provided that is licensed, accredited, approved, owned, or operated by the United States or any State or receives funds under the Medicare or Medicaid program;

(17) the phrase "health care power of attorney" means a written instrument that is valid under the laws of the United States or any State in which a competent adult, as principal, appoints another individual as his or her attorney-in-fact to make health care decisions for the principal in the event the principal becomes an incompetent adult;

(18) the phrase "health care provider" means a health care institution or an individual who is licensed or authorized by the United States or any State to administer health care in the ordinary course of business or practice of a profession;

(19) the term "hospice" means a facility licensed, accredited, approved, owned, or operated as a hospice by the United States or any State or receives funds under the Medicare or Medicaid program;

(20) the term "hospital" means a facility that is licensed, accredited, approved, owned, or operated as a hospital by the United States or any State or receives funds under the Medicare or Medicaid program;

(21) the phrase "incompetent adult" means an adult who has been judicially declared incompetent under the laws of any State or an adult who does not have the decisional capacity to make an informed medical decision;

(22) the phrase "informed medical decision" means a decision by an individual when that individual appreciates and has been informed of the medical risks involved, the nature of the procedure, the probability of successful transplant when applicable, the available feasible alternatives to transplantation when applicable, and the prospective donor's chance of recovery from a persistent vegetative state or any other condition for which State Law would permit aid-in-dying;

(23) the phrase "interstate commerce" means commerce between a State and a place outside of that State;

(24) the phrase "long-term dependence on medical technology" means a dependency on medical technology that is caused by the removal of an organ from a donor;

(25) the phrase "medical technology" means a medical procedure or intervention, including the provision of nutrition or hydration, which uses mechanical or other artificial means to sustain, restore, or supplant a vital body function;

(26) the term "minor" means an individual who is not an adult, including a stillborn child;

(27) The phrase "nursing home" means a facility that is licensed, accredited, approved, owned, or operated as a nursing home by the United States or any State or receives funds under the Medicare or Medicaid program;

(28) the term "organ" includes human organs, tissue, and cells processed for transplantation purposes;

(29) the term "OTB" means an Organ Transplant Board;

(30) the terms "parents" and "parent" include a biological or adoptive parent of a child. The word "parents" means both parents and the word "parent" means either parent, unless only one of the parents has legal custody of a minor, in which case the words "parents" or "parent" mean only that parent who has legal custody, or unless a guardian has legal custody of a minor, in which case the words "parents" or "parent" means that guardian. For purposes of Title III, the terms "parent" or "parents" also means those individuals or individual who would be recognized as the parents or parent of the fetus under the laws of the State where the spontaneous or legally induced abortion occurs or where the intrauterine fetal tissue is obtained;

(31) the phrase "persistent vegetative state" means a persistent vegetative state as diagnosed by generally accepted medical standards and may include the presence of brainstem functions, such as spontaneously normal blood pressure, heart rate, and respiration, in a patient who exhibits no behavioral or cerebral metabolic evidence of possessing cognitive function or of being able to respond in a learned manner to external events or stimuli and who only has reflex response to painful stimuli;

(32) the term "person" means an individual, corporation, business trust, estate, trust, partnership, joint venture, association, government, governmental subdivision or agency, or any other legal or commercial entity;

(33) the term "physician" means an individual licensed or authorized to practice medicine or osteopathy under the laws of any State;

(34) the term "principal" means an individual who has executed a health care power of attorney;

(35) the term "Secretary" means the Secretary of the Department of Health and Human Services;

(36) the term "State" includes the District of Columbia, the Commonwealth of Puerto Rico, and a territory or insular possession subject to the jurisdiction of the United States;

(37) the phrase "State Law" means the laws of that State in which a donor or principal resides at the time a health care decision affecting that donor or principal is made under the provisions of this Act;

(38) the phrase "transplantation purposes" means grafting, transplanting, or implanting an organ to the body of another individual; and

(39) the phrase "valuable consideration" shall not include reasonable payment or reimbursement for the maintenance, removal, preservation, transfer, and transplantation of an organ. Valuable consideration includes a tax or other financial incentive designed to encourage consent or to elicit consent for the removal of an organ for transplantation purposes.



TITLE II-ORGANS FROM LIVING INDIVIDUALS .



SEC. 201. REMOVAL OF ORGANS FROM COMPETENT ADULTS.



(a) REMOVAL OF ORGANS THAT WILL RESULT IN COMPETENT ADULTS' DEATHS.-

(1) GENERAL RULE.-A competent adult may not authorize the removal of an organ from his or her own body for transplantation purposes if the removal of that organ would necessarily result in the competent adult's death after the organ is removed.

(2) EXCEPTIONS.-Subject to the provisions of section 204 (relating to the removal of an organ from a pregnant woman), the provisions of section 201(a)(1) shall not apply and a competent adult may authorize the removal of an organ from his or her body for transplantation purposes if the competent adult-

(A) has a medical condition for which State Law permits the termination of his or her life and elects to have his or her life terminated by the removal of an organ from his or her body for transplantation purposes instead of another manner allowed by State Law, or

(B) is a convicted criminal scheduled for execution who elects to be executed by the removal of an organ from his or her body for transplantation purposes instead of the manner provided by State Law.



(b) OTHER ORGAN REMOVALS FROM COMPETENT ADULTS.-

(1) GENERAL RULE.-A competent adult may not authorize the removal of an organ from his or her own body for transplantation purposes even if the competent adult could survive after the removal of that organ.

(2) EXCEPTIONS.-Subject to the provisions of section 204 (relating to the removal of an organ from a pregnant woman), the provisions of section 201(b)(1) shall not apply and a competent adult may authorize the removal of an organ from his or her own body for transplantation purposes if the competent adult could survive without long-term dependence on medical technology after the organ is removed.



SEC. 202. REMOVAL OF ORGANS FROM INCOMPETENT ADULTS.



(a) REMOVAL OF ORGANS FROM INCOMPETENT ADULTS WHO WERE ONCE COMPETENT.-

(1) REMOVAL OF ORGANS THAT WILL RESULT IN ONCE COMPETENT ADULTS' DEATHS.-

(A) GENERAL RULE.-An organ of an incompetent adult who previously was a competent adult or who at any time had executed a health care power of attorney may not be removed from the incompetent adult's body for transplantation purposes if the removal of that organ would necessarily result in the incompetent adult's death after the organ is removed.

(B) EXCEPTIONS.-Subject to the provisions of section 204 (relating to the removal of an organ from a pregnant woman), the provisions of section 202(a)(1)(A) shall not apply and an organ may be removed from an incompetent adult's body for transplantation purposes if-

(i) the incompetent adult has a medical condition for which State Law permits the termination of his or her life or is in a persistent vegetative state;

(ii) the incompetent adult does not expressly object to the removal; and

(iii) the incompetent adult's attorney-in-fact, acting under the authority of and consistent with the incompetent adult's health care power of attorney, authorizes the removal of the incompetent adult's organ for transplantation purposes.



[ ](2) OTHER ORGAN REMOVALS FROM ONCE COMPETENT ADULTS.-

(A) GENERAL RULE.-An organ of an incompetent adult who previously was a competent adult may not be removed from the incompetent adult's body for transplantation purposes even if the incompetent adult could survive after the removal of that organ.

(B) EXCEPTIONS.-Subject to the provisions of section 204 (relating to the removal of an organ from a pregnant woman), the provisions of section 202(a)(2)(A) shall not apply and an organ may be removed from an incompetent adult's body for transplantation purposes if the incompetent adult could survive without long-term dependence on medical technology after the organ is removed if the incompetent adult does not expressly object to the removal, and if-

(i) the incompetent adult's attorney-in-fact authorizes the removal of the incompetent adult's organ under the authority of a health care power of attorney executed by the incompetent adult while competent; or

(ii) in the absence of a health care power of attorney executed by the incompetent adult, the appropriate OTB approves a request, initiated by the incompetent adult's guardian, to remove the incompetent adult's organ for transplantation purposes.



(b) REMOVAL OF ORGANS FROM INCOMPETENT ADULTS WHO WERE NEVER COMPETENT.-

(1) REMOVAL OF ORGANS THAT WILL RESULT IN NEVER COMPETENT ADULTS' DEATHS.-

(A) GENERAL RULE.-An organ of an incompetent adult who was never a competent adult may not be removed from the incompetent adult's body for transplantation purposes if the removal of that organ would necessarily result in the incompetent adult's death after the organ is removed.

(B) EXCEPTIONS.-Subject to the provisions of section 204 (relating to the removal of an organ from a pregnant woman), the provisions of section 202(b)(1)(A) shall not apply and an organ may be removed from an incompetent adult's body for transplantation purposes if-

(i) the incompetent adult has a medical condition for which State Law permits the termination of the incompetent adult's life or is in a persistent vegetative state;

(ii) the incompetent adult does not expressly object to the removal; and

(iii) the incompetent adult's guardian authorizes the removal of the incompetent adult's organ.



(2) OTHER ORGAN REMOVALS FROM NEVER COMPETENT ADULTS.-

(A) GENERAL RULE.-An organ of an incompetent adult who never was a competent adult may not be removed from the incompetent adult's body for transplantation purposes even if the incompetent adult could survive after the removal of that organ.

(B) EXCEPTIONS.-Subject to the provisions of section 204 (relating to the removal of an organ from a pregnant woman), the provisions of section 202(b)(2)(A) shall not apply and an organ may be removed from an incompetent adult's body for transplantation purposes if the incompetent adult could survive without long-term dependence on medical technology after the organ is removed, and if-

(i) the incompetent adult does not expressly object to the removal; and

(ii) the appropriate OTB approves a request, initiated by the incompetent adult's guardian, to remove the incompetent adult's organ for transplantation purposes.



SEC. 203. REMOVAL OF ORGANS FROM MINORS.



(a) REMOVAL OF ORGANS THAT WILL RESULT IN MINORS' DEATHS.-

(1) GENERAL RULE.-An organ of a minor may not be removed from the minor's body for transplantation purposes if the removal of that organ would necessarily result in the minor's death after the organ is removed.

(2) EXCEPTIONS.-Subject to the provisions of section 204 (relating to the removal of an organ from a pregnant woman), the provisions of section 203(a)(1) shall not apply and an organ may be removed from a minor's body for transplantation purposes if-

(A) the minor is anencephalic, or has a medical condition for which State Law permits the termination of his or her life, or is in a persistent vegetative state;

(B) the minor does not expressly object to the removal; and

(C) the minor's parents authorize the removal of that minor's organ.



(b) OTHER ORGAN REMOVALS FROM MINORS.-

(1) GENERAL RULE.-An organ of a minor may not be removed from the minor's body for transplantation purposes even if the minor could survive after the removal of that organ.

(2) EXCEPTIONS.-Subject to the provisions of section 204 (relating to the removal of an organ from a pregnant woman), the provisions of section 203(b)(1) shall not apply and an organ may be removed from a minor's body for transplantation purposes if the minor could survive without long-term dependence on medical technology after the organ is removed, and if-

(A) the minor does not expressly object to the removal; and

(B) the appropriate OTB approves a request, initiated either by the minor or the minor's parent, to remove the minor's organ for transplantation purposes.



SEC. 204. REMOVAL OF ORGANS FROM PREGNANT WOMEN.



Until a pregnant woman's fetus reaches viability and is delivered or until a physician determines that her fetus cannot be carried to the point of viability, an organ may not be removed from the woman for transplantation purposes if she might not be able to sustain the life of the fetus after the removal of the organ.



SEC. 205. DUTIES REGARDING INFORMED MEDICAL DECISIONS.



(a) DUTY OF INDIVIDUALS TO MAKE INFORMED MEDICAL DECISIONS.-An individual authorizing the removal of an organ from himself or herself or from another individual under the provisions of this Act shall do so only after making an informed medical decision.



(b) DUTY OF PHYSICIANS TO OBTAIN AND DOCUMENT INFORMED MEDICAL DECISIONS.-An attending physician of an individual from whom an organ may be removed for transplantation purposes under the provisions of this Act shall obtain the informed medical decision from that individual or that individual's attorney- in-fact, parent, or guardian, and shall document that decision in the prospective donor's medical records.



SEC. 206. ALLOCATION OF ORGANS FROM LIVING INDIVIDUALS.



(a) DIRECTED DONATIONS.-An organ removed from an individual under the provisions of this Act may be transplanted to an individual selected by the donor or by his or her attorney-in-fact or, if the donor is a minor, by his or her parent or, if the donor is an incompetent adult, by his or her guardian.



(b) OTHER DONATIONS.-In the absence of a directed donation as authorized by section 206(a), or if the intended recipient cannot use the organ after it has been removed from the donor, an organ removed from a donor shall be allocated under the provisions of section 372 of the National Organ Transplant Act.



SEC. 207. HEALTH CARE POWER OF ATTORNEY.



(a) CREATION OF HEALTH CARE POWERS OF ATTORNEY.-A competent adult may execute a health care power of attorney. A health care power of attorney executed prior to the effective date of this Act shall not include the powers set forth in section 207(f)(2) and (3) of this Act unless expressly granted in that health care power of attorney.



(b) EXECUTION OF HEALTH CARE POWERS OF ATTORNEY.-A health care power of attorney shall be in writing, shall be dated and signed by the principal (or by another in the principal's presence, and at the principal's express direction, if the principal is physically unable to sign), and shall be-

(1) witnessed by at least two competent adults who signed the health care power of attorney within a reasonable time after they witnessed either the signing of the health care power of attorney or the principal's acknowledgment of the principal's signature, or acknowledgment of the health care power of attorney; or

(2) notarized before a Notary Public of a State.



(c) RESTRICTIONS ON WHO MAY BE NOTARIES PUBLIC OR WITNESSES.-A Notary Public or at least one of the witnesses to a health care power of attorney shall not be related to the principal by blood, marriage, or adoption within the third degree of consanguinity as determined under the civil law method and none of the following individuals shall witness or notarize the signature of the principal on a health care power of attorney:

(1) Any of the principal's health care providers as of the date the health care power of attorney is signed.

(2) Any employee of the principal's health care providers as of the date the health care power of attorney is signed unless the employee is related to the principal by blood, marriage, or adoption within the third degree of consanguinity as determined under the civil law method.

(3) The individual named in the health care power of attorney to be the attorney-in-fact.

(4) A minor or incompetent adult.



(d) RESTRICTIONS ON WHO MAY BE ATTORNEYS-IN-FACT.-None of the following individuals may be the attorney-in-fact:

(1) Any of the principal's health care providers as of the date the health care power of attorney is signed.

(2) Any employee of the principal's health care providers as of the date the health care power of attorney is signed unless the employee is related to the principal by blood, marriage, or adoption within the third degree of consanguinity as determined under the civil law method.

(3) An individual who witnesses or notarizes the health care power of attorney.

(4) A minor or incompetent adult.



(e) ACTIVATION OF HEALTH CARE POWERS OF ATTORNEY.-The principal's health care power of attorney shall become effective only if, in the judgment of the principal's attending physician, the principal is unable to make health care decisions for himself or herself.



(f) POWERS OFATTORNEYS-IN-FACT.-Except to the extent otherwise expressly limited in the principal's health care power of attorney, an attorney-in-fact acting under the authority of a health care power of attorney executed after the effective date of this Act (and without regard to whether the health care power of attorney is the one provided in section 207(h)) may examine all of the principal's medical records and has the sole authority-

(1) to make all health care decisions for the principal;

(2) to authorize the life-terminating removal of the principal's organ if the principal is-

(A) in a persistent vegetative state, or

(B) has a medical condition for which State Law permits the termination of the principal's life;

(3) to authorize the removal of the principal's organ if the principal could survive without long-term dependence on medical technology after the organ is removed;

(4) to consent to disclosure of the principal's medical records; and

(5) to exercise all other powers granted to the attorney-in-fact under State Law to the extent that State Law is not inconsistent with the provisions of this Act.



(g) DUTIES OF ATTORNEYS-IN-FACT.-

(1) DUTY TO FOLLOW PRINCIPALS' DIRECTIONS.-The attorney-in-fact shall act in accordance with the directions of the principal as conveyed to the attorney-in-fact by the principal in the health care power of attorney or in any other manner.

(2) DUTY TO ACT IN PRINCIPALS' BEST INTEREST.-In the absence of direction from the principal, the attorney-in-fact shall act in the best interest of the principal as determined solely by the attorney-in-fact.



(h) OPTIONAL FORM.-A health care power of attorney executed under the provisions of this section may be in the following form:



HEALTH CARE POWER OF ATTORNEY

Notice: Under the provisions of the Living Organ Donor Act, your attorney-in-fact is authorized to donate your organs under the circumstances outlined in the directions accompanying this form. If you wish to negate or limit these powers, you must do so on the reverse side of this form.



I, the principal, mmmmmmmmmmmmmmmmmmmm [ Insert your name ], presently residing at mmmmmmmmmmmmmmmmmmmmmmmmmmmmmm [ Insert your current address ], hereby designate mmmmmmmmmmmmmmmmmmmmmmm [ Insert your attorney-in-fact's name ], presently residing at mmmmmmmmmmmmmmmmm [ Insert your attorney-in- fact's current address ], as my attorney-in-fact.



I give to my attorney-in-fact the power to examine and disclose all of my medical records and to make health care decisions for me when, in the judgment of my attending physician, I am unable to make my own health care decisions. When acting on my behalf, my attorney-in-fact must act consistently with my directions as expressed on the other side of this document or otherwise made known to my attorney-in-fact. In the absence of directions, my attorney-in-fact shall act in my best interest, as determined solely by my attorney-in-fact.



In addition, my attorney-in-fact shall have all the other powers listed in the Living Organ Donor Act regarding the donation of my organs to the extent I have not limited those powers on the other side of this document.[ep]



I, the principal, mmmmmmmmmmmmmmmmmmmm [ Insert your name ], have signed this document on the mmmm day of mmmmmmmmmmmmmm, mmmm.



mmmmmmmmmmmmmmmmmmmmmm



Your signature



This document must be signed by you and must be either (1) witnessed by 2 competent adults no more than one of whom may be related to you, OR (2) notarized.



The undersigned witnessed either the signing of this health care power of attorney or the principal's acknowledgement of the principal's signature or of this health care power of attorney.



Witness's Signature Witness's Address Date



Witness's Signature Witness's Address Date



STATE OF ) ss:



COUNTY OF )



On this mmmmm day of mmmmmmmmmmmmmmmmm, mmmm before me, a Notary Public in and for the State of mmmmmmmmmmmmmmmmmmmmm, personally appeared mmmmmmmmmmmmmmmmmmmmmmmmmmm, the principal, to me known and known to me to be the individual named in and who executed the foregoing health care power of attorney, and he or she duly acknowledged to me that he or she executed the same as his or her free act and deed.



mmmmmmmmmmmmmmmmmmmmm



Notary Public's signature



When exercising his or her power to make health care decisions for me, my attorney-in-fact is subject to the following directions:



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mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm



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mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm



The power of my attorney-in-fact regarding the donation of my organs is subject to the following limitations:



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mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm



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(i) MANDATORY INSTRUCTIONS TO ACCOMPANY HEALTH CARE POWER OF ATTORNEY.-A pre-printed health care power of attorney form shall be accompanied by the following instructions, or substantially similar instructions:

The purpose of this form is to protect you, the principal, in theevent that for some reason in the future you are unable to make health care decisions for yourself. At that time, the individual whom you name as your attorney-in-fact will be able to make health care decisions for you.

When choosing your attorney-in-fact, keep in mind that this individual may someday have the responsibility to make vital health care decisions for you. You may choose anyone whom you trust to make vital health care decisions on your behalf. For example, you may choose your spouse, child, another family member, or a close friend as your attorney-in-fact. Your attorney-in-fact, contrary to what the word suggests, need not be an attorney. There are, however, some restrictions on who may be your attorney-in-fact. None of the following individuals may be your attorney-in-fact:

(1) Any of your health care providers as of the date you sign the health care power of attorney.

(2) Any employee of your health care provider as of the date you sign the health care power of attorney, unless the employee is related to you by blood, marriage, or adoption.

(3) An individual who witnesses or notarizes the health care power of attorney.

(4) An individual under the age of 18 years or an incompetent adult.

If your physician determines you are unable to make health care decisions for yourself, your attorney-in-fact will have the exclusive power to make them regardless of any opinions expressed by your family or friends.

The powers of your attorney-in-fact include:

1. The power to make all health care decisions for you when you are unable to make them for yourself. For example, your attorney-in-fact may make decisions regarding the selection or discharge of your physicians and other health care providers. Your attorney-in-fact may also make decisions regarding all surgical and medical treatments you receive. Furthermore, and to the extent permitted by State Law, your attorney-in-fact may make decisions regarding the withholding or withdrawing of a life sustaining treatment or a decision to administer aid-in-dying. In short, your attorney- in-fact may make any health care decision for you that you could have made for yourself when you were competent.

2. The power to view and disclose your medical records.

3. The power to authorize the life-terminating removal of your organs for transplantation if you are in a persistent vegetative state or have a medical condition for which State Law would permit your life to be terminated.

4. The power to authorize the non-life-terminating removal of your organs for transplantation.

You may tell your attorney-in-fact how to exercise these powers by telling him or her in person or by writing instructions in the appropriate space on the health care power of attorney. Remember, though, that written instructions may better insure that your exact wishes are followed.

If you want to completely deny your attorney-in-fact the right to exercise any these powers, you should say so in writing in the appropriate space on the health care power of attorney. For example, if you wish to deny your attorney-in-fact the power to make any organ donations on your behalf, you could do so by writing:

"My attorney-in-fact does not have the power to make decisions pertaining to the donation of my organs."

Of course, if you do not complete this document, you will not have an attorney-in-fact who may make health care decisions of any kind for you.

Make sure that your instructions are clearly worded to mean only what you intend to say and no more or no less. It is recommended that you discuss these instructions with your attorney-in-fact before you sign this form. Keep in mind that if your attorney-in-fact is acting on your behalf, he or she will value any instructions you have expressed. This guidance will make those decisions easier. To the extent you do not instruct your attorney-in-fact, he or she must act in what he or she believes to be your best interest.

To complete this power you must sign and date it in the space provided and either have it witnessed before two witnesses or, alternatively, have your signature notarized. If you are physically unable to sign the form, someone acting at your request and in your presence may sign the form for you. There are also restrictions on who may be a witness or notary. None of the following individuals may be a witness or notary:

(1) Any of your health care providers as of the date the health care power of attorney is signed.

(2) Any employee of your health care providers as of the date the health care power of attorney is signed unless the employee is related to you by blood, marriage, or adoption.

(3) The individual named in the health care power of attorney as the attorney-in-fact.

(4) An individual under the age of 18 years or an incompetent adult.



It is a very good idea to give a copy of this form to both your attorney-in-fact and to your personal physician for inclusion in your medical records.



SEC. 208. ORGAN TRANSPLANT BOARDS.



(a) CREATION AND COMPOSITION OF OTBs.-The Secretary shall-

(1) establish one or more OTBs;

(2) appoint 5 members, including the chair, to staggered 5-year terms on an OTB;

(3) appoint no two members to an OTB who have the same occupation or, if professionally licensed, practice in the same speciality or subspeciality; and

(4) issue rules and regulations to govern the terms, manner, and conditions of the OTB members' service.



(b) POWERS OF OTBs.-

(1) OTB'S POWER TO RULE.-An OTB shall rule on a request to approve the removal of an organ from a minor or incompetent adult as allowed under the provisions of this Act.

(2) OTB'S POWER TO SUBPOENA.-An OTB shall have subpoena power.

(3) RESTRICTIONS ON OTB'S POWER.-The OTB shall act in accordance with the provisions of this Act and the procedural rules and regulations issued by the Secretary so long as those rules and regulations are not inconsistent with the provisions of this Act.



(c) PROCEDURES OF OTBs.-

(1) NOTICE OF HEARINGS TO INDIVIDUALS.-An OTB shall, in addition to following the procedural hearing guidelines required under the Federal Administrative Procedure Act or issued by the Secretary, to the extent those guidelines are not inconsistent with the provisions of this Act, give notice of a hearing regarding a request to approve the removal of an organ-

(A) to the prospective donor, unless the donor is an incompetent adult, or minor under the age of 7, or is in a persistent vegetative state;

(B) to the parents of the minor or the guardian of the incompetent adult who is the prospective donor;

(C) to the prospective donor's attending physician; and

(D) to the prospective donee's attending physician, if the prospective donee is known.

(2) VOTING OF OTBs.-Members of an OTB may meet personally, electronically, or telephonically. A majority of an OTB shall constitute a quorum. If a quorum is present at an OTB meeting when a vote is taken, the affirmative vote of a majority of the Board present at the meeting shall be valid.

(3) OTB'S HEARINGS ON THE RECORD.-An OTB shall make a final ruling on a request to remove an organ only after there is a hearing on the record.

(4) DEADLINES FOR OTB RULINGS.-An OTB shall make a final ruling on a request to approve the removal of an organ within fourteen days after it receives that request, unless a finding is made that good cause exists for an extension.

(5) STAY OF OTB'S RULINGS PENDING JUDICIAL REVIEW.-An OTB shall stay its final ruling on a request to approve the removal of an organ for two business days after it makes that ruling, unless a finding is made that good cause exists for an extension. During that time the independent advocate or an individual described in section 208(c)(1) may seek judicial review as authorized by section 208(e).

(6) DISTRIBUTION OF OTB'S RULINGS.-An OTB shall send a written copy of its final ruling on a request to approve the removal of an organ to the prospective donor's attending physician for placement in the prospective donor's medical records.



(d) ROLE OF INDEPENDENT ADVOCATES.-Upon a request to approve the removal of an organ, the OTB chair shall appoint an independent advocate to represent the prospective donor and to present a case for denying the request to approve the removal of an organ. An individual shall not serve as both an independent advocate and an OTB member in the same adjudicative proceeding.



(e) INDIVIDUALS' RIGHT TO JUDICIAL REVIEW OF OTB'S RULINGS.-The independent advocate or an individual described in section 208(c)(1) may obtain judicial review of an OTB final ruling on a request to approve the removal of an organ in the manner provided by the Federal Administrative Procedure Act.



(f) STANDARD OF REVIEW TO BE APPLIED BY OTBs.-

(1) REQUIREMENT FOR SUBSTANTIAL EVIDENCE ON THE RECORD.-An OTB shall base a ruling to approve a request for the removal of an organ solely upon the record made at the hearing. The OTB's ruling shall be supported by substantial evidence when the record is reviewed as a whole.

(2) BEST INTEREST STANDARD.-An OTB may approve the removal of an organ if the removal is in the best interest of the prospective donor. The removal is in the best interest of the prospective donor if-

(A) the prospective donor is not likely to suffer more than minimal physical, emotional, or psychological harm from the removal of the organ or from the long-term consequences of the removal of the organ; and

(B) the prospective donor will receive some measurable physical, emotional, or psychological benefit.



TITLE III-FETAL TISSUE.



SEC. 301. USE OF FETAL TISSUE FROM SPONTANEOUS OR LEGALLY INDUCED ABORTIONS.



Fetal tissue obtained from a spontaneous or legally induced abortion may be donated for transplantation or research purposes, provided neither parent objects within a reasonable time after the abortion to the use of the fetal tissue for those purposes.



SEC. 302. USE OF INTRAUTERINE FETAL TISSUE .



Intrauterine fetal tissue may not be removed for research or transplantation purposes unless the parents of the fetus consent to that removal and the woman's attending physician determines, based upon accepted medical standards, that the fetus, if carried to term, is unlikely to be harmed by the removal of the tissue.



SEC. 303. ALLOCATION OF FETAL TISSUE .



The fetal tissue obtained under the provisions of this Title may be used for research or transplantation purposes in accordance with the rules and regulations adopted by the Secretary. The parents who consented to the use of fetal tissue under the provisions of this Title may not select a recipient of that tissue.



TITLE IV-SALES.



SEC. 401. PROHIBITION ON SALES.



A person shall not knowingly purchase, sell, or otherwise transfer for valuable consideration an organ or fetal tissue for research or transplantation purposes, except blood, blood derivatives, semen, and ova if the purchase, sale, or other transfer of that organ or fetal tissue affects interstate commerce.



SEC. 402. REPEAL OF SECTION 301 OF THE NATIONAL ORGAN TRANSPLANTATION ACT.



Section 301 of the National Organ Transplantation Act (relating to the prohibition of organ purchases) is repealed.



TITLE V-MISCELLANEOUS PROVISIONS.



SEC. 501. CONSCIENTIOUS OBJECTION, CONFLICT OF INTEREST, AND TRANSFER OF PATIENTS .

(a) CONSCIENTIOUS OBJECTION AND CONFLICT OF INTEREST.-Subject to the provisions of subsection 501(b) (relating to the transfer of a patient), a health care provider who has a conscientious objection to, or a conflict of interest with, any aspect of a research or transplantation procedure involving fetal tissue or an individual's organ may refuse to participate, directly or indirectly, in any aspect of a transplantation or research procedure.

(b) TRANSFER OF PATIENTS.-A health care provider that has a conscientious objection or conflict of interest (within the meaning of section 501(a)) regarding a particular patient shall refer or transfer that patient as soon as possible to another health care provider who is willing to participate in the transplantation or research procedure.



SEC. 502. IMMUNITIES.

(a) HEALTH CARE PROVIDERS' RELIANCE ON THIS ACT.-A health care provider who acts in accordance with the provisions of this Act or attempts in good faith to do so shall not be subject to civil or criminal damages or penalties or discipline for unprofessional conduct for participating, directly or indirectly, in a transplantation or research procedure.

(b) DONORS NOT LIABLE FOR EFFECTS OF TRANSPLANTATION.-An individual who, under the provisions of this Act, donates an organ or fetal tissue on behalf of himself or herself or on behalf of another individual shall not be subject to civil or criminal damages or penalties for any injury that may result from the transplantation of that organ or fetal tissue.



SEC. 503. LIABILITIES.

(a) PERSONS' LIABILITY FOR SUITS TO PREVENT ORGAN REMOVAL.- Nothing in the Act precludes a person from being held liable under the laws of any State for malicious prosecution if that person interferes with the removal of an organ or the use of fetal tissue authorized under the provisions of this Act by instituting or threatening to institute a civil suit.

(b) PERSONS' LIABILITY FOR NONCOMPLIANCE WITH THIS ACT.-A health care provider or other person who knowingly fails to comply with this Act shall be subject to civil penalties of not more than $50,000 or treble the amount received by the health care provider or other person in connection with all activities related to the action that is in violation of this Act, whichever is greater, and also may be subject to civil damages under the laws of the United States or any State. In addition, a person who violates Title IV of this Act shall be sentenced to a term of imprisonment of not more than 5 years, additional civil penalties of not more than $50,000, or both.



SEC. 504. EFFECT OF THIS ACT ON STATE HOMICIDE LAWS, INSURANCE, AND HEALTH CARE.

(a) DETERMINATION OF SUICIDE OR HOMICIDE.-A death resulting from the removal of an organ under the authority of, and in compliance with, this Act shall not constitute suicide or homicide under the laws of the United States or any State.

(b) HEALTH CARE POWERS OF ATTORNEY'S EFFECT ON INSURANCE.-The execution of a health care power of attorney shall not affect the sale, procurement, issuance, or terms of a health, life, or annuity policy, nor shall it affect, impair, or modify the terms of an existing health, life, or annuity policy. A health, life, or annuity policy is not legally impaired or invalidated by any act or procedure authorized by this Act.

(c) HEALTH CARE POWERS OF ATTORNEY AS IMPROPER CONDITION TO RECEIVE INSURANCE OR HEALTH CARE.-A person shall not prohibit or require the execution of a health care power of attorney as a condition to receive, or be insured for, health care.



SEC. 505. SEVERABILITY.



If a provision of this Act (or the application of a provision to a particular person or circumstance) is invalid or unconstitutional, the remainder of this Act (or the application of that provision to other persons or circumstances) shall not be affected.



SEC. 506. EFFECTIVE DATE .



This Act shall take effect one (1) year after its enactment.



END OF DOCUMENT



LIVING ORGAN DONOR ACT



Copyright © 1993 University of Iowa (The Journal of Corporation Law)



_____________________



REPORT



I. Summary of the Bill.

A. Overview.

B. Summary of the Provisions.



II. General Reasons for the Bill.



III. Explanation of the Bill.

Title I. Definitions.

Title II. Organs from Living Individuals.

Sec. 201. Removal of Organs from Competent Adults.

Sec. 202. Removal of Organs from Incompetent Adults.

Sec. 203. Removal of Organs from Minors.

Sec. 204. Removal of Organs from Pregnant Women.

Sec. 205. Duties Regarding Informed Medical Decisions.

Sec. 206. Allocation of Organs from Living Individuals.

Sec. 207. Health Care Power of Attorney.

Sec. 208. Organ Transplant Boards.

Title III. Fetal Tissue.

Sec. 301. Use of Fetal Tissue from Spontaneous or Legally Induced Abortions.

Sec. 302. Use of Intrauterine Fetal Tissue.

Sec. 303. Allocation of Fetal Tissue.

Title IV. Sales.

Sec. 401. Prohibition on Sales.

Sec. 402. Repeal of Section 301 of the National Organ Transplantation Act.

Title V. Miscellaneous Provisions.

Sec. 501. Conscientious Objection, Conflict of Interest, and Transfer of Patients.

Sec. 502. Immunities.

Sec. 503. Liabilities.

Sec. 504. Effects of this Act on State Homicide Laws, Insurance, and Health Care.

Sec. 505. Severability.

Sec. 506. Effective Date.



I. SUMMARY OF THE BILL



A. OVERVIEW



The Living Organ Donor Act (LODA) provides a comprehensive, national program for the donation of organs from living individuals.



The principal provisions of the bill are the following:

. Live Organ Donations

. Competent adults cannot donate organs if the donation results in death or long-term dependence on medical technology. There are limited exceptions for the terminally ill and individuals on death row.

. Incompetent adults and minors are subject to the same general prohibitions with different exceptions, including the authority under limited circumstances to donate if the incompetent adult or minor is terminally ill, is in a persistent vegetative state, and the donation is approved by an Organ Transplant Board (OTB). A special rule exists relating to the removal of organs from anencephalics.

. Donations from living individuals can be directed to a specific donee.

. Pregnant Women Specially Treated

. Restrictions apply to the ability of a pregnant women carrying a pre- viable fetus to make organ donations while living.

. Health Care Power of Attorney-National Form

. Creates a national health care power of attorney form that can be used in lieu of state forms and provides that an attorney-in-fact (whether executed in conformity with LODA or with state law) shall have the power to make organ donations on behalf of a principal, under certain circumstances, unless that power is specifically negated in the form.

. Donations of Fetal Tissue

. Permits donations of fetal tissue for research and transplantation purposes.

. Prohibits Sales of Organs



B. SUMMARY OF PROVISIONS



1. Introduction.



Most organs used for transplantation purposes are obtained from cadavers. There are some instances where organs from living individuals are used, most notably in intra-family kidney transplants. LODA proposes that organs may be removed from living individuals for transplantation purposes under very limited circumstances. The Act distinguishes between: (1) competent adults; (2) incompetent adults; and (3) minors. Two concepts are embraced throughout LODA: (1) individual autonomy; and (2) protection for those individuals who are unable to make an informed medical decision.



A competent adult may not donate an organ if, after the organ's removal, the competent adult would die or have long-term dependence on medical technology. A competent adult, however, may donate an organ if that adult otherwise has a medical condition for which state law permits aid-in-dying and the competent adult elects to die by the removal of an organ. A competent adult who is a convicted criminal scheduled for execution may elect to be executed by the removal of an organ. A competent adult may also elect to make a non-life- terminating organ donation if the competent adult can survive without long-term dependence on medical technology after the organ's removal.



An organ may not be removed from an incompetent adult who was once competent if, after the removal of the organ, the incompetent adult would die. An organ may be removed, however, if: (1) the incompetent adult is in a persistent vegetative state or has a medical condition for which state law permits the termination of the incompetent adult's life; (2) the removal of the organ is authorized by the incompetent adult's attorney-in-fact acting in accordance with the authority granted to the attorney-in-fact under a health care power of attorney that had been signed by the incompetent adult when competent; and (3) the incompetent adult does not expressly object.



In situations where an organ donation from an incompetent adult who was once competent will not result in death, an organ may be removed unless after the organ's removal the incompetent adult would have a long-term dependence on medical technology or the incompetent adult objects. The removal must be authorized by the incompetent adult's attorney-in-fact acting in accordance with the terms of the health care power of attorney. In the absence of a health care power of attorney, an OTB must approve a non-life-terminating organ removal in a proceeding initiated by the incompetent adult's guardian, provided an OTB finds the non-life-terminating organ removal is in the incompetent adult's best interest.



If the incompetent adult was never competent, similar proscriptions on organ removal apply. Organ removal that would result in the incompetent adult's death are permissible if: (1) the incompetent adult is in a persistent vegetative state or has a medical condition for which state law permits the termination of the incompetent adult's life; (2) the incompetent adult does not expressly object to the removal (assuming the incompetent adult has a medical condition for which state law permits the termination of life); and (3) the incompetent adult's guardian authorizes the removal.



Live organ donations that will not result in death are also permitted from the incompetent adult who was never competent if: (1) the incompetent adult would not have a long-term dependence on medical technology; (2) the incompetent adult does not expressly object to the removal; and (3) the removal is approved by an OTB in a proceeding initiated by the incompetent adult's guardian, provided an OTB finds the non-life-terminating organ removal is in the incompetent adult's best interest.



LODA also prohibits the removal of organs from minors if death will result. This rule, however, does not apply if the minor: (1) is anencephalic; (2) is in a persistent vegetative state or has a medical condition for which state law permits the termination of the minor's life; and (3) does not object to the removal of the organ. Furthermore, the minor's parents or guardian must authorize the removal of the organ. Organ removals that will not result in death are permissible if after the removal the minor would not have long-term dependence on medical technology, the minor does not object, and the removal is approved by an OTB in a proceeding initiated by either the minor or the minor's parent, provided an OTB finds that the non-life-terminating organ removal is in the minor's best interest.



Organs removed from living individuals may be transplanted to an individual selected by the individual from whom the organ is removed or by the parent or guardian authorizing the removal.



2. Pregnancy.



A special rule is provided for pregnant women. This rule is designed to prohibit donations that could adversely affect the fetus's survivability.



3. Health Care Power of Attorney.



LODA incorporates a statutory national health care power of attorney, which enables an attorney-in-fact to make health care decisions for a principal. Unless specifically negated in the health care power of attorney, an attorney- in-fact can authorize the life-terminating removal of the principal's organs if the principal is in a persistent vegetative state or has a medical condition for which state law permits the termination of the principal's life.



4. Fetal Tissue Donations.



LODA authorizes the use of fetal tissue for transplantation and research purposes, but prohibits directed donations.



5. Prohibited Sales.



Lastly, LODA prohibits the sale of organs and other body parts, other than blood, blood derivatives, semen, and ova. It also prohibits the sale of fetal tissue.



II. GENERAL REASONS FOR THE BILL



The main purpose of LODA is to address current and future legal issues involving organ donations from living individuals. The Act focuses on maintaining the autonomy of the competent adult donor and protecting the interests of the incompetent adult or minor.



The Act respects the autonomy of the competent donor by authorizing the donation of any organ, as long as the removal would not result in death or long-term dependence on medical technology. Currently, only kidneys, and to a lesser extent lungs, can be transplanted from one living individual to another. However, LODA was written with the expectation of advancements in medical technology that will ultimately allow for other types of living donor transplants.



LODA has anticipated changes in state law regarding euthanasia and capital punishment. LODA grants an individual whose life may be legally terminated under state law the option of making a life-terminating organ donation. An individual's right to have his or her life terminated does not originate in LODA but only under applicable state law. In this way, LODA attempts to further support the autonomy of individuals and respects the policies of the states. LODA also recognizes that the law of some states allows convicted murderers to be sentenced to death and that other states with no current law providing for the imposition of a death sentence may decide to adopt such a law in the future. In those states permitting the death penalty, LODA permits the convicted murderer to elect to die by a life-terminating organ removal procedure. The provisions in LODA concerning capital punishment (and, implicitly, euthanasia, assuming state law permits that as a form of aid-in- dying) also anticipate changes in the attitudes of the medical profession and the community at large towards donations from living individuals resulting in death. Health care providers willing to participate in permissible organ removals that result in death are shielded from liability by section 502, including disciplinary actions for alleged "unprofessional conduct." Health care providers who find participation in organ removal procedures contrary to their ethics may be conscientious objectors provided they comply with the provisions of section 501(b).



A second focus of LODA is to protect the interests of a minor or incompetent adult donor through the creation of an OTB. Currently, state courts have the burden to determine when minors or incompetent adults would have their best interests served by making a live donation. It is also in the court's discretion to determine when it is appropriate to substitute the judgement of the parent or guardian for that of the minor or incompetent adult. By the establishment and use of an OTB, the determination of when an organ donation from an incompetent adult or minor is appropriate is placed in the hands of individuals who are knowledgeable in the processes and consequences of organ donations. This will become especially important as medical technology expands to encompass a greater array of donation procedures, requiring a greater expertise to evaluate the risks and benefits of organ donation.



Finally, LODA provides national uniform standards for transplantations from anencephalics, individuals in a persistent vegetative state, and fetal tissue. Rather than allow state courts to continue to struggle with these issues, the adoption of LODA would provide a single national plan which allows the parent, guardian, or attorney-in-fact to authorize life-terminating organ donations from anencephalics and individuals in a persistent vegetative state. Where fetal tissue is concerned, LODA permits the use of legally obtained tissue for research or transplantation.



III. EXPLANATION OF THE BILL



Title I-Definitions.



The definition of "adult" coincides with the prevailing national norms in that an adult is a individual who is at least eighteen years of age.



The phrase "aid-in-dying" incorporates the "withholding or withdrawing of life support" which is a common feature of most states' statutes authorizing end-of-life decision-making. However, in anticipation that some states might expand their "right to die" concept, LODA's definition also includes the administration of a drug for the purpose of producing death, commonly known as death by euthanasia, but only to the extent it is authorized by the state in which a prospective donor resides at the time a health care decision for a prospective donor is made. To date, no state has adopted any form of active euthanasia, although it is permitted in the Netherlands. Proposals for a broad form of euthanasia have been made. [FN1] LODA neither condones nor condemns active euthanasia. It merely provides that if a state were to permit active euthanasia, the individual who is to be euthanized could be an organ donor if the other requirements of LODA are satisfied.



The phrase "informed medical decision" as defined in LODA parallels the concept of informed consent, but is tailored to accommodate LODA's purposes. The phrase contemplates that the individual who is to make an informed medical decision has the ability to make a decision after taking into account factors that include the medical risks involved, the nature of the procedure, the probability of successful transplant when applicable, the available, feasible alternatives to a transplantation, and the chance of recovery from a persistent vegetative state or terminal illness. The type and quantity of relevant information will vary with the organ being donated. For example, blood and semen donations require less information than a kidney donation because they pose less of a threat to the life of the donor.



The phrase "incompetent adult" encompasses individuals who have either been judicially declared incompetent or individuals who are unable to make an informed medical decision. The phrase also includes those adults in a presently unconscious state who have not been judicially declared incompetent. However, the Act makes important distinctions between incompetent adults who were once competent and those who were not.



An individual may only be declared incompetent in accordance with state law. LODA provides no guidance on how a state court is to make that determination. In addition, LODA would not prevent a judicially declared incompetent from participating in health care decisions affecting him or her. For example, if for any reason an incompetent adult objects to being a live organ donor, that objection controls, even if his or her guardian seeks to authorize the removal.



The term "death" as defined in this Act currently excludes anencephalics and individuals diagnosed as being in a persistent vegetative state (PVS) because this condition does not meet the requirement that there be a cessation of all brain functions, including the brain stem. This definition accords with the definition in the Uniform Determination of Death Act. [FN2] While this definition excludes an anencephalic or an individual in a persistent vegetative state, under certain circumstances, organ donation is permissible from anencephalics or individuals in PVS, even if the donation will result in death.



The phrase "long-term dependence on medical technology" refers to a dependency caused by the removal of an organ from the donor and is not meant to include short term use of intravenous fluids, oxygen, etc., which may be required immediately post-operatively after an organ has been surgically removed. An individual should not be a live organ donor if, after the donation, the donor would have a long-term dependence upon medical technology to survive. For example, an individual would not be allowed to donate both kidneys while still alive because this would result either in that individual's death or long-term dependence on dialysis for survival. However, an individual who is in a persistent vegetative state and is already dependent upon medical technology would be allowed to be an organ donor because the dependency was not directly caused by the donation.



The term "organ" includes only human organs, tissue, and cells to be processed for transplantation purposes. LODA does not in any way address or regulate transplant procedures using alternatives to human organs, tissues, and cells such as animal organs or mechanical substitutes.



Throughout LODA, parents are given authority to act on behalf of a minor. Parents must consent or withhold consent to the removal of organs. In some cases, both parents must agree; in others cases, only one need act. In the situation where only one parent has legal custody, only that parent is authorized to make decisions on behalf of the minor. Furthermore, the words "parents" or "parent" may mean a guardian in those rare instances where an individual who is not a minor's parent has been appointed the minor's guardian. The definition of "parents" and "parent" combined with the use of the singular or plural in the Act determines whether one parent or both must act.



The definition of "persistent vegetative state" incorporates the criteria which is accepted today as evidence of that state under prevailing medical standards. However, the definition is expandable to take into account changes in neurological diagnostic procedures. The diagnosis of persistent vegetative state might require that the following criteria be met:

1. The patient displays no evidence of awareness of self or surroundings. Reflex or spontaneous eye opening may occur.

2. No communication between the examiner and the patient, auditory or written, that is meaningful and consistent can be established. Target stimuli are not usually followed visually, although visual tracking can occasionally occur. There is no emotional response by the patient to verbal input.

3. There is no comprehensible speech or mouthing of words.

4. Smiling, frowning, and crying may occur occasionally, but are inconsistently related to any apparent stimulus.

5. Sleep-wake cycles are present.

6. Brainstem and spinal reflex activity is variable. Primitive reflexes such as sucking, rooting, chewing, and swallowing may be preserved. Pupillary reactivity to light, oculocephalic reflexes, grasp reflexes, and tendon reflexes may be present.

7. The presence of voluntary movements or behavior, no matter how rudimentary, is a sign of cognition and is incompatible with the diagnosis of PVS. There is no motor activity suggesting learned behavior and no mimicry. Rudimentary movements (such as withdrawal or posturing) may be seen with noxious or disagreeable stimuli.

8. Blood pressure control and cardiorespiratory functions usually are intact. Incontinence of bladder and bowel is present. [FN3]



TITLE II-Organs from Living Individuals.



Sec. 201. Removal of Organs From Competent Adults.



Section 201(a)(1) prohibits organ donations by a competent adult that will result in the donor's death. LODA generally respects the right of individuals to make even life-terminating health care decisions. However, it does not go so far as to authorize the death of a presumably healthy individual by the removal of the individual's organs to provide only a chance of survival to another who would in all likelihood not have a normal life expectancy post-transplant. At best such a transplant would only result in trading one life for another.



Section 201(a)(2)(A) provides an exception for a competent adult who has a condition for which state law allows aid-in-dying. In that situation, an individual is afforded the option to have his or her life terminated in a manner consistent with organ retrieval, rather than through another life- terminating procedure that could damage healthy organs. Life-terminating donations under these circumstances are likely to be rare because individuals with terminal conditions are not likely to have organs that will be useable for transplantation purposes. It is anticipated that state aid-in-dying laws would require the informed consent of an individual who seeks to end his or her life by means of a life-terminating organ donation. However, section 205 of LODA would require the individual to make an informed medical decision prior to a donation. In all events, an individual desiring to make a life-terminating organ donation must meet the state's criteria for aid-in-dying before the option of a life-terminating organ donation can be considered.



While the option to make an organ donation may be a factor in the decision of an individual considering aid-in-dying, allowing this alternative is not likely to coerce individuals with the will to live to submit to death. It is not LODA's intent to encourage individuals to choose death to donate organs if they would have otherwise, under the same circumstances, chosen to live. In addition, while LODA provides for the opportunity to donate organs within the context of state-sanctioned aid-in-dying, it in no way authorizes such donations in those states that have not adopted an aid-in-dying statute.



Section 201(a)(2)(B) is similar to section 201(a)(2)(A) in that it does not change the circumstances under which death will occur. Rather, it provides an alternative method of execution of a convicted criminal which facilitates organ retrieval. This section is intended to override any state- mandated form of execution that would harm healthy organs. Altruistic behavior in the making of an organ donation by a convicted murderer may be this individual's highest expression of atonement and should not be discouraged. In addition, the requirement that the potential donor be "scheduled" for execution prevents any acceleration of death.



Section 201(b)(1) and (b)(2), taken together, codify an individual's right to donate an organ if the donation will not result in the individual's death. The only limitation is that the individual may not donate an organ if after the donation the donor would have long-term dependence on medical technology.



Sec. 202. Removal of Organs from Incompetent Adults.



Under LODA, the circumstances under which organs may be removed from an incompetent adult vary, depending upon whether the incompetent adult was ever competent and able to make an informed medical decision.



If an individual was capable of making an informed medical decision at some time during his or her adulthood, section 202(a), pertaining to the removal of organs from an incompetent adult who was once competent, controls. An adult who for most of his or her life was competent, but is in a persistent vegetative state as a result of an automobile accident, would be treated as an incompetent adult even though he or she had not been judicially declared incompetent. However, since this incompetent adult was once a competent adult, section 202(a), rather than section 202(b), applies to the removal of organs from this individual.



If an individual was never able to make an informed medical decision during adulthood or was a judicially declared incompetent throughout his or her adulthood, section 202(b) (relating to the removal of organs from an incompetent adult who was never competent) applies. Thus, an individual who has been severely mentally retarded since birth but was not judicially declared incompetent until the age of thirty would be treated as an incompetent adult under section 202(b) because he or she was never able, as an adult, to make an informed medical decision.



Undoubtedly, some grey areas are present. For example, whether section 202(a) or section 202(b) applies to an individual who is judicially declared incompetent at the age of forty is dependent on whether he or she was ever a competent adult. Since there is a presumption of competency, anyone claiming that an incompetent adult was never competent would have the burden to prove that at no time was the individual a competent adult. However, if the presently incompetent adult had ever executed a health care power of attorney he or she is conclusively treated under section 202(a) as an incompetent adult who was once competent. Thus, if an individual executes a health care power of attorney that is valid under either federal or state law and later becomes comatose, he or she is treated as an incompetent individual who was once competent without any further need to inquire into his or her prior competency.



Section 202(a)(1)(A) generally prohibits organ donations on behalf of an incompetent adult who was once competent if the donation would result in the donor's death. However, section 202(a)(1)(B) allows life-terminating donations under limited circumstances if the once competent, but now incompetent, adult: (1) is either in a persistent vegetative state or has a medical condition for which state law would permit the termination of his or her life; (2) if the latter, does not object to a life-terminating organ donation; and (3) had executed a health care power of attorney, while competent, that authorizes an attorney-in-fact to make health care decisions on the principal's behalf and did not specifically negate the statutory power of the attorney-in- fact to make organ donations on behalf of the principal. [FN4]



If the attorney-in-fact already has the power to withdraw or withhold life-sustaining treatment from a principal who either is in a persistent vegetative state or has a condition for which state law allows aid-in-dying, the effect of section 202(a)(1)(B) is to do no more than permit the attorney- in-fact to cause the death of the principal by the removal of an organ rather than state-authorized aid-in-dying. While the terminally ill principal must be incompetent for the attorney-in-fact to authorize a life-terminating organ donation, the principal need not be comatose, or even unconscious, and may override the decision by merely objecting to the donation. This section is predicated on the notion of patient autonomy as evidenced by a duly executed health care power of attorney which empowers the attorney-in-fact to make a life-terminating organ donation on behalf of the principal.



Section 202(a)(2) authorizes organ donations that will not result in the death of an incompetent adult who was once competent so long as the donation does not cause long-term dependence on medical technology. Additionally, the incompetent adult must not expressly object to the organ removal, and the incompetent adult's attorney-in-fact must authorize the organ removal under a health care power of attorney. If the once competent adult executed a health care power of attorney that did not proscribe organ donations by the attorney- in-fact, for all practical purposes the attorney-in-fact steps into the shoes of the principal. For example, this section allows an attorney-in-fact to authorize the donation of a kidney from the principal to the principal's sibling. Effectively, the limitations on non-life-terminating organ donations from once competent adults who are represented by an attorney-in-fact correspond to those applicable to competent adults under section 201(b).



In the absence of a health care power of attorney, an OTB must approve a non-life-terminating organ donation from an incompetent adult. The incompetent adult's guardian must initiate the request. Therefore, if an incompetent adult who was once competent never executed a health care power of attorney, and the incompetent adult has no state-appointed guardian, a guardian must first be appointed to initiate a request to an OTB. OTB approval is predicated upon a finding that the removal of the organ would be in the incompetent adult's best interest. See section 208 for additional information regarding the procedures, safeguards, and standard of review to be applied by OTBs.



Section 202(b)(1)(A) generally prohibits organ donations that will result in the death of an incompetent adult who was never competent. However, under section 202(b)(1)(B), the incompetent adult's guardian may authorize a life-terminating organ removal if: (1) the incompetent adult is in a persistent vegetative state or has a medical condition for which state law permits aid-in- dying; and (2) at any time prior to the removal, the incompetent adult does not expressly object. [FN5]



Section 202(b)(2) addresses the removal of an organ from an incompetent adult who was once competent that will not result in death or long- term dependence on medical technology. Under this section, an organ can be removed if the incompetent adult does not object and his or her guardian initiates and obtains approval from an OTB. Approval must be obtained regardless of whether the guardian is a family member and without regard to the identity and relationship of the donee to the donor. Because there may be inherent conflicts of interests that affect a guardian's decision-making, such as when the guardian is the parent of both the incompetent adult and the prospective donee of the organ, LODA requires that an OTB approve non-life- terminating organ donations. This eliminates the possibility that an incompetent adult can be used as an organ farm without regard to the interests of the incompetent adult.



Sec. 203. Removal of Organs from Minors.



Section 203(a) prohibits removal of an organ from a minor that will result in death. However, under section 203(a)(2), the removal of organs from a minor is permitted with the authorization of the minor's parents if the minor: (1) is anencephalic; (2) is in a persistent vegetative state; or (3) has a condition for which state law permits aid-in-dying. The parents' authorization to make a life-terminating organ donation does not require OTB approval. However, parents may not authorize a life-ending organ removal over the minor's express objections whether or not the child is competent or capable of making an informed medical decision. Thus, the donation of a minor's organs requires the approval of both the minor and the parents if the minor is capable of expressing an objection.



This section recognizes the difficult decisions parents confront when their child is born anencephalic or enters into a persistent vegetative state and the often contentious environment in which they are asked to make health care decisions for that child. LODA codifies the primacy of the parents' right to make even life-terminating organ donation decisions for their anencephalic or PVS child. While the drafters acknowledge that the parents' interest in limiting their financial burden may influence the choices made, this conflict is pervasive throughout all health care decisions and is in no way unique to this particular circumstance. Thus, this section respects parental autonomy and is consistent with prevailing rules recognizing parents rights and obligations to make health care decisions for their children. It is not LODA's intent to encourage the parents of a terminally ill child to choose the death of the child in order to donate organs if the parents would have otherwise, under the same circumstances, chosen to keep the child alive. In addition, while LODA provides for the opportunity to donate organs within the context of state-sanctioned aid-in-dying, it in no way authorizes such donations in states that have not adopted an aid-in-dying statute.



Section 203(b) deals with removal of organs from a minor that will not result in death or long-term dependence upon medical technology. In this situation, there is a need to avoid the possibility of parents offering a child's organs to a sibling, relative, or friend without complete consideration as to the effect of the organ removal on the child. Although most parents will act in the best interests of their children, parental judgment may be clouded by the fact that the donation will not cause the death of the donor child and could save the life of the potential recipient who may be equally near and dear to them. Thus, an OTB must approve the decision.



Either parent or the minor can initiate a proceeding before an OTB. An OTB, as an objective third party, can weigh the advantages and disadvantages of the donation for both the potential minor donor and the potential donee. An OTB should, in making its decision, consider evidence and testimony from the parents or guardian of the potential minor donor, the potential minor donor, [FN6] the donee, and other family members if an OTB would consider their testimony germane to its decision-making process. [FN7] The use of an OTB is not limited to situations in which there is a recognized intra-family conflict of interest. In all cases, under section 208, the standard of review is the prospective donor's best interest-a very high threshold and one that is not expected to be met in many cases.



Sec. 204. Removal of Organs from Pregnant Women .



Section 204 involves the situation where a pregnant woman (or her substitute decision-maker) desires to make a live organ donation. This section does not serve as a per se ban on all organ donations but merely delays an organ donation from a pregnant woman carrying a viable fetus. A woman, who may otherwise have an abortion under state law, is not prohibited from terminating her pregnancy. If a pregnant woman wishes to make an organ donation which may adversely affect the viability of the fetus, nothing in this Act precludes her from choosing to first have an abortion under applicable state law. However, the pregnant woman is precluded from using organ donation as an alternative form of abortion.



In the case of a pregnant woman in a persistent vegetative state or with a condition for which state law permits aid-in-dying, the effect of section 204 is to temporarily invalidate a directive authorizing the removal of her organs, even if the directive expressly authorized the removal during pregnancy. Since the directive was probably drafted before conception, it may not be an accurate representation of the woman's wishes. However, even if the possibility of pregnancy is addressed in the directive, LODA limits the woman's autonomy in this situation. Given the absence of higher brain function in PVS, the interest that a woman in PVS has in controlling her body is outweighed by the state's interest in the potential life of the fetus. Ignoring the directive until the fetus is viable and delivered, or until it is determined that the fetus cannot be carried to the point of viability, does not significantly burden the woman.



Sec. 205. Duties Regarding Informed Medical Decisions.



Section 205(a) states that an individual has a duty to make an informed medical decision before authorizing a live organ donation. Under subsection (b), the attending physician must obtain and document that an informed medical decision has been made prior to donation. Under this provision, a competent adult or the attorney-in-fact, guardian, or parent acting on behalf of an incompetent adult or minor must make an informed medical decision.



Sec. 206. Allocation of Organs from Living Individuals.



Section 206(a) permits donors, or individuals acting on behalf of donors, to direct the donation of an organ to a specified individual. This section reflects the fact that without the ability to direct a donation there is little likelihood that a live organ donation would be made. However, section 206(b) provides that if for any reason the intended donee cannot use the organ after it has been removed, then the organ shall be allocated to another donee as if the organ were a cadaveric organ. For example, if the donor's kidney is not able to be transplanted to the donee after it is removed from the donor, it would be treated under present law as a cadaveric kidney.



Sec. 207. Health Care Power of Attorney.



The growing recognition of the principle of autonomy in medical decision- making has led to the growing acceptance of the health care powers of attorney. Essentially, a health care power of attorney permits the principal to empower an "attorney-in-fact" to make health care decisions for the principal whenever the principal is unable to make health care decisions for himself or herself. The existence of a readily identifiable decision-maker, who has been chosen by the principal and has full authority to make all health care decisions for the principal when the principal is judged to be incapable of making those decisions, serves many purposes. These objectives include the assurance of individual autonomy, the simplification of the decision-making process by having only one identified individual having the power to make those decisions, and the allowance and incentive for principals to make their thoughts, wishes, and beliefs with respect to their health made known to their attorneys-in-fact.



A growing number of states have enacted laws authorizing the execution of health care powers. At the present time, a uniform national act relating to health care powers also is under consideration by the Commissioners on Uniform State Laws. LODA also incorporates its own version of a health care power of attorney, which specifically addresses the powers of an attorney-in-fact regarding the donation of the principal's organs. The provisions of LODA apply to all health care powers executed after LODA becomes effective, whether executed under the authority of LODA or the authority of state law. Health care powers executed prior to LODA's effective date, however, are not deemed to include the powers in section 207(f)(2) and (3) relating to the attorney-in-fact's power to donate a principal's organs.



LODA also includes an optional model form which may be used in lieu of model forms provided by state law. While states are free to adopt their own forms, they are subject to the provisions of LODA regarding: execution, restrictions on who may be a notary, a witness, or an attorney-in-fact, powers and duties of the attorney-in-fact, and the mandatory instructions that must be included in all pre-printed health care powers under section 207(i).



LODA's execution formalities for a health care power reflect the current trend in state law pertaining to wills. Under sections 207(c) and (d), certain individuals cannot act as a notary public, a witness, or an attorney-in-fact, preventing potential or real conflicts of interest and ensuring that all medical decisions on behalf of the principal are in the principal's best interest.



Section 207(f) enumerates the powers of an attorney-in-fact. This section applies regardless of whether LODA's form or a state form is utilized, provided that the power is executed after LODA's effective date and does not expressly prohibit those powers. Under section 207(f), the attorney-in-fact may examine all of the principal's medical records and has the sole authority to: (1) make all health care decisions for the principal; (2) authorize the life-terminating removal of the principal's organ if the principal is in a persistent vegetative state or has a medical condition for which state law permits aid-in-dying; (3) authorize the removal of the principal's organ as long as the removal does not result in the principal's long-term dependence on medical technology; (4) consent to disclosure of the principal's medical records; and (5) exercise all other powers granted under state law to the extent that state law is not inconsistent with LODA.



Section 207(g) specifies the duties of an attorney-in-fact and supersedes any contravening state law regardless of which form is utilized. The attorney- in-fact has a duty to: (1) follow the principal's directions as conveyed in the health care power of attorney or in any other manner; and (2) to act in the best interest of the principal as determined solely by the attorney-in-fact.



Section 207(h) provides a national health care power of attorney form. Section 207(i) specifies mandatory instructions to accompany all pre-printed health care powers of attorney either verbatim or in substantially similar form, whether the LODA or a state form is used. The mandated instructions in section 207(i) are to be used only with pre-printed forms available to the public so that individuals may complete the form without the assistance of an attorney. The instructions are not intended to be a necessary part of a health care power of attorney drafted by an attorney for a specific client. Forms prepared by the American Bar Association and state bar associations would be pre-printed and subject to section 207(i) even if they are completed under the supervision of an attorney.



Sec. 208. Organ Transplant Boards.



OTBs are created under section 208 to provide protection for donors incapable of making an informed medical decision in situations where conflicts of interest make a guardian or parent's decision suspect. [FN8]



The Secretary should create as many OTBs as necessary to efficiently and satisfactorily comply with the requirements of LODA. The composition of the five member boards should be varied and include members from the general population as well as the medical community. The use of staggered, five year terms will promote variety in board composition. It is anticipated that a training program will be implemented by the Secretary to inform prospective board members about OTB procedures and their powers and duties as members. The training program should also develop necessary inquisitorial and investigative skills.



Consistent with the Federal Administrative Procedure Act, the Secretary should not hesitate to disqualify a board member because of a conflict of interest or to remove a board member for malfeasance. A board member should not be allowed to consider a case if the board member's integrity is in question.



Section 208(a)(3), requires that no two members appointed to an OTB can have the same occupation. Thus, two teachers could not simultaneously serve on the same OTB. However, this section also stipulates that if the members are professionally licensed, the sole limitation is that they can not practice in the same specialty or sub-specialty. Thus, two physicians could simultaneously serve on the same OTB if one practices cardiology and the other urology. However, this section would prevent two obstetricians from serving on the same OTB. This requirement promotes diversity on an OTB and prevents occupational or professional biases from coloring decisions.



Section 208(b) sets forth the basic powers of an OTB. The primary duty is to rule on requests for organ donations that will not result in death from adults who have never been competent, incompetent adults who were once competent but never executed a health care power of attorney, and minors.



The procedural requirements of section 208(c) and the role of the independent advocate guarantee maximum procedural due process which is appropriate given the significance of the potential donor's interests. Section 208(c)(1) identifies a non-exclusive list of individuals an OTB is required to notify of a pending hearing. Since it is likely that there may be other individuals not listed who may testify as to the best interests of the donor, an OTB is given subpoena power, under section 208(b)(2), to obtain any other relevant evidence.



Under section 208(c)(3), a hearing on the record must occur before a ruling can be made. Flexibility is given to the voting process under section 208(c)(2) and any decision is valid if a quorum votes in the affirmative. This flexibility is designed to expedite the ruling of a request for organ donation before an OTB. Because complexities in cases may vary, flexible time constraints are imposed upon an OTB to promote full evaluation before a decision is made. Under section 208(c)(4), a final ruling regarding an organ donation must be made by an OTB within fourteen days after receiving the request unless good cause exists for an extension.



Section 208(c)(5) mandates a stay on all final rulings for two business days to provide adequate time to file a request for judicial review of the ruling under section 208(e). These time limits can be shortened or extended upon a showing of good cause. Since an OTB's jurisdiction extends only to cases involving the removal of organs from individuals who could survive the removal without long-term dependence upon medical technology, there will usually be no need for urgent decision-making so long as all interested individuals properly plan the event. A written copy of a final ruling shall be sent to the prospective donor's attending physician and shall be placed in the prospective donor's medical record.



Under section 208(d), an independent advocate shall be appointed by an OTB chair for the purpose of advocating a denial of the organ donation request. This appointed individual can not simultaneously serve as both an advocate and an OTB member in the same proceeding. The role of the independent advocate is to assure that all relevant evidence is presented.



Section 208(f) sets forth the standard of review to be applied by an OTB. A ruling by an OTB must be based solely upon a substantially supported record. An OTB shall approve a donation when the donation is in the best interest of a donor. This standard is imposed to protect individuals who are unable to adequately make decisions in their own best interest from being subject to an invasive medical procedure with no perceivable return benefit. Section 208(f)(2) enumerates the two conditions which must be satisfied before a donation is determined to be in the best interest of a donor. First, the risks of the operation, as well as the risks of long-term physical, emotional, and psychological harm to the donor, must be minimal. Second, the transplant must result in some measurable physical, emotional, or psychological benefit to the donor.



The specific facts of each situation and the emotional and cognitive capabilities of the donor will determine if the donor derives a measurable benefit from the donation. The benefit could be intangible, such as the donor's altruistic feelings or the avoidance of grief if the donation saves the life of a loved one. On a practical level, the donor may benefit if the donee is a present or future caretaker of the donor. [FN9]



Title III-Fetal Tissue.

Currently, federal regulations leave the disposition of aborted fetal tissue to state and local regulation. [FN10] This has severely limited research and medical advancements that might have been achieved through the use of fetal tissue, as well as the treatment of certain debilitating conditions including immunodeficiency and hematologic disorders, diabetes, Parkinson's disease, and Alzheimer's disease. Although use of fetal tissue in treating these diseases is still considered experimental, human fetal tissue transplantation research may eventually lead to beneficial therapeutic approaches to treatment as well as possible cures. [FN11]



Title III permits the use of tissue obtained from spontaneous and legally induced abortions, as well as intrauterine fetal tissue if both parents authorize the removal. Embryos were consciously omitted because, outside of the womb, the potential for life still exists; whereas, once a fetus is aborted, the potential for life ceases to exist.



Section 303, which prohibits directed donations of fetal tissue, is inconsistent with the Uniform Anatomical Gift Act (UAGA). The UAGA, where enacted by state law, is superseded to the extent that it is inconsistent with this Act. This restriction on directed donations prevents conception, coupled with abortion, for the sole purpose of organ donation.



The primary focus of abortion providers should not become one of obtaining tissue for research purposes. LODA addresses a major concern that physicians may inappropriately influence the abortion decision to obtain more fetal tissue for research or transplantation purposes. In order to avoid this conflict, the physician performing the abortion should not derive any benefit from the fetal tissue. Thus, the consent form for an abortion should be signed before the parents are approached with the issue of fetal tissue donation and authorization is obtained. The form should be presented by a health care professional other than the doctor performing the abortion, and in no way should any member of a transplant team be involved in the abortion process. [FN12]



Title IV-Sales.



Sec. 401. Prohibition on Sales.



Section 401 prohibits the sale of organs, including fetal tissue, and is broadly phrased to include all organs that may be transplantable in the future. This section was modeled after the National Organ Transplantation Act (relating to the prohibition of organ purchases) which, under section 402, is repealed. Section 401 also lists limited exceptions, and permits the sale of blood, blood derivatives, semen, and ova. For the most part, the medical procedures to acquire blood, blood derivatives, semen, and ova impose few risks on the donor. Additionally, their sales are currently allowed and present little danger of coercion or undue influence.



Title V-Miscellaneous Provisions.



Sec. 501. Conscientious Objection, Conflict of Interest, and Transfer of Patients.



Section 501 recognizes situations where a health care provider may be unwilling to participate in organ or fetal tissue retrieval or transplantation procedures for moral or ethical reasons or because of a conflict of interest. This section: (1) permits the health care provider to refuse to participate, directly or indirectly, in any aspect of a transplantation or research procedure involving organs and fetal tissue; and (2) requires the health care provider to transfer or refer the individual to another health care provider.



Sec. 502. Immunities.



Section 502(a) protects health care providers from potential civil and criminal liability if the provider makes a good faith effort to act in accordance with this Act. It is hoped that affording complete legal protection will encourage more aggressive organ retrieval behavior by those involved. The verb "act" in section 502(a) encompasses every action or inaction addressed by LODA, and not just those acts required by section 501 relating to the transfer of a patient. Thus, if a physician removes an organ from an individual upon authorization of the principal's attorney-in-fact, the physician is immune from liability. If later it is determined that the health care power of attorney was improperly witnessed but the impropriety was not readily apparent from the face of the instrument and the physician did not have individual knowledge of the impropriety.



Similarly, by affording legal immunity to any individual who donates an organ or fetal tissue, it is hoped section 502(b) will serve to encourage more individuals to become organ donors, thus increasing the supply. For example, if an individual who donates a kidney tests negative for the HIV virus during the "window period" and subsequently converts to "positive" for HIV, that individual is immune from liability.



Sec. 503. Liabilities.



Section 503(a) discourages interference with the lawful compliance of LODA and preserves state-authorized malicious prosecution actions against individuals attempting to thwart the lawful removal of transplantable organs and tissues. Thus, if a competent adult consents to an organ donation but his or her parent threatened the attending physician with legal action if the organ is removed, a suit for malicious prosecution could be brought against the parent.



Similarly, section 503(b) attempts to protect the sanctity of an individual's decision to donate organs by imposing a civil penalty on any individual or institution that fails to comply with the provisions of this Act. Section 503(b) specifies the penalties for noncompliance with the provisions of this Act. A minimum fine of $50,000, or treble the amount received by the health care provider or other individual in connection with all activities related to the action in violation of LODA, plus civil damages, are employed to ensure compliance. Thus, if a physician knowingly transplants a kidney from an individual without the appropriate consent and approval and receives $100,000 for the entire procedure, including pre-operative and post- operative care, the physician could be fined up to $300,000 plus civil damages. Additionally, any individual who violates section 401, relating to a prohibition on the sale of organs, could be sentenced to no more than five years imprisonment and additional civil penalties of not more than $50,000. Thus, if in the foregoing example the physician had also purchased the kidney, he or she would also be liable for either additional civil penalties of not more than $50,000 or imprisonment not to exceed five years, or both.



Sec. 506. Effective Date.



The effective date of LODA is postponed one year in order to provide ample opportunity for its provisions to become known and for individuals to execute health care powers of attorney.



FN1. See Model Aid-in-Dying Act , 75 Iowa L. Rev. 125 (1989).



FN2. 12 U.L.A. 362 (1992 Supp.). The following states have adopted a form of this Act: Arkansas, California, Colorado, Delaware, District of Columbia, Georgia, Idaho, Indiana, Kansas, Maine, Maryland, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming.



FN3. Persistent Vegetative State: Report of the American Neurological Association Committee on Ethical Affairs, in 33 Issues in Clinical Neuroscience: ANA Committee On Ethical Affairs, Annals of Neurology 386, 386- 87 (April 1993).



FN4. Under 204, the attorney-in-fact may not authorize a life-terminating organ donation if the incompetent-principal is pregnant and the fetus would die as a result of the organ donation. However, if the fetus is viable and is delivered or the fetus is not viable and in the physician's opinion cannot be brought to the point of viability, the attorney-in-fact may consent to a life- terminating organ donation.



FN5. If the incompetent adult is pregnant, the conditions of 204 must first be met before an organ can be removed.



FN6. If the potential donor is the age of seven or older, he or she must be notified of any hearing before an OTB pursuant to 208(c)(1)(A).



FN7. See 208(c)(1) (relating to those individuals an OTB must provide notice of an impending hearing).



FN8. See 202(a)(2)(B)(ii) (relating to removal of an organ from a once competent adult who had never executed a health care power of attorney where the donation will not result in death); 202(b)(2)(B)(ii) (relating to the removal of an organ from a never competent adult that will not cause the adult's death); 203(b)(2)(B) (relating to the removal of an organ from a minor that will not result in the minor's death).