Legal Principles and

Variations

in

Donation Systems

Alexandra K. Glazier, JD, MPH

VP & General Counsel, New England Organ Bank

Chair, OPTN/UNOS Ethics Committee

Adjunct Professor of Law, Boston University

Legal Principles: Gift Law

Gift law provides an international legal

framework for donation

Civil Law and Common Law Countries

3 legal elements to a Gift

○ Donative Intent

○ Transfer

○ Acceptance

Legal Principles of Gift law

Gift defined:

A gift is a voluntary and legally

binding uncompensated transfer

Legal Principles: Gift Law

Undermining gift law principles may

have unintended legal consequences to

donation

Legally binding transfer

Prohibition on valuable consideration

Altruism and volunteerism

Uniform Anatomical Gift Act (UAGA)

State law

Consent a reserved power of the states

Federal regulation of transplantation

UAGA is not based on informed consent legal principles

○ authorization

○ legal permission

United States

Primary Legal Models

Presumed Consent

Explicit Consent

Defining the terms

Presume: to take for granted that something is true

Consent: Agreement as to a course of action.

Presumed consent: The assumption that a particular

action would have been approved

if permission had been sought

Presumed Consent

defined for donation

The legal authority to

recover organs from

deceased adult individuals

unless a refusal to donate

was registered.

Legal Models

Opt-out

Legal default

Opt-In

Explicit consent

Countries with Presumed Consent

Argentina Austria Belgium Bulgaria Croatia Cyprus Czech Republic Estonia Finland France Greece Hungary

Italy Latvia Luxemburg Norway Panama Paraguay Poland Portugal Sinagapore Slovak Republic Slovenia Spain Sweden Turkey

Countries with Explicit Consent

Australia

Canada

Chile

Cuba

Denmark

Estonia

Germany

Guatemala

Ireland

Japan

Jordan

Malaysia

Lithuania

Mexico

Netherlands

New Zealand

South Africa

South Korea

Thailand

United Kingdom

United States of America

Venezuela

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Deceased Donors

Per Million Population (PMP)

Source: IRODaT

34.2

26.1

14.7 14.612.1

9.8

5.3 4.5

0.10

5

10

15

20

25

30

35

40

Spain

USA

U.K

.

Ger

man

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Aust

ralia

Isra

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ong

Saudi A

rabia

Japan

Deceased Donors Per Million

Population (PMP)

Source: Annals of Internal Medicine Volume 153, Number 10; November 2010

Enforcement of presumed

consent has been shown to

vary, and next-of-kin consent

for organ procurement is still

obtained in many nations.

Nations with presumed

consent have higher rates of

deceased kidney

transplantation than nations

with explicit consent.

However, nations with

presumed consent also have

lower rates of living kidney

transplantation.

These are key considerations

in the decision and planning

to adopt presumed consent.

Evaluating Legal Models

2011 Transplantation, Boyarsky, Hall,

Deshpande et al, “Potential Limitations of

Presumed Consent Legislation.”

Similar findings on DDPM

Other factors

Donation always discussed with the family

Donation did not proceed if family objected

Social, cultural, and operational factors, rather

than legal structures could explain differing

donation rates

Comparing Legal Models

SYSTEM

DESIGN

LEGAL

PRINCIPLE

ETHICAL

CONCEPTS

AUTHORIZE

FAMILY

OBJECTION

OPT-

OUT

Based on

social

duties

Social

compact or

utilitarian

Authorized

unless

registered

objection

No recovery

of organs

OPT-IN

Based on

individual

rights

Autonomy

Authorized

explicitly by

patient or

family

Recovery of

organs

(intent)

First Person Authorization

Adult individuals have the

right to make a legally

binding anatomical gift prior

to death.

Ethical Basis of

First Person Authorization

Self-determination concept that adult

individuals should be able to make their own

decisions about donation of organs after their

death

Consistent with ethical principles behind other

advanced directives

History of U.S. as a

Developing Opt-In System

The 1968 Uniform Anatomical Gift Act

An individual may make an anatomical gift to be effective after death by use of a document of gift

Next-of-kin consent not required if donor executed a valid document of gift

Law versus practice In past, document not found so family

authorization sought

History of U.S. as a

Developing Opt-In System

Development of Donor Registries

an electronic donor card

Donor registries changed first person authorization practices

Checked by OPO at time of death referral

The law recognizes donor registration as a document of gift.

Fulfills “donative intent” element

History of U.S. as a

Developing Opt-In System

Statutory immunity from liability ○ A person that acts in accordance with this act or

with the applicable anatomical gift law of another state, or attempts in good faith to do so, is not liable for the act in a civil action, criminal prosecution, or administrative proceeding.

○ A person may presume that a document of gift or amendment of an anatomical gift is valid unless that person knows that it was not validly executed or was revoked.

Upheld in court

“A ship is safe in the

harbor, but that's not

what ships are for.” - William Shedd

0

20,000,000

40,000,000

60,000,000

80,000,000

100,000,000

120,000,000

Q4

07

Q1

08

Q2

08

Q3

08

Q4

08

Q1

09

Q2

09

Q3

09

Q4

09

Q1

10

Q2

10

Q3

10

Q4

10

Q1

11

Q2

11

Q3

11

Q4

11

Donor Designation in the U.S.

101,380,994 as of 12/31/11

19%

27%25%

27%

33%

28%30%

38%

33%

37%

42%

36%

42% 42%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

Organ Donors Tissue Donors Eye Donors

2007 2008 2009 2010 2011

Donor Registry Impact on Donation

2007-2011 Designated Donors Among Recovered Donors

STATE %

AK 79%

MT 79%

WA 75%

OR 73%

UT 67%

CO 66%

VA 64%

IA 64%

ND 64%

MO 64%

OK 61%

WY 60%

NM 60%

Designated Donor Share, 12/31/11 STATE %

MN 60%

ID 60%

IN 59%

AL 58%

LA 58%

OH 58%

NC 57%

WI 56%

AR 56%

GA 56%

SD 55%

ME 53%

HI 52%

STATE %

IL 51%

DE 50%

MD 50%

NE 48%

MA 48%

RI 47%

PA 44%

FL 42%

DC 41%

NV 40%

CT 39%

AZ 38%

KY 35%

STATE %

WV 34%

KS 34%

TN 34%

NJ 33%

MI 32%

CA 31%

NH 28%

SC 23%

MS 21%

NY 18%

TX 12%

VT 1%

ALL 42.7%

Key Measures, 2011

State DD Share DOD

Share DTD Share DED Share DD Rate

AK 79% 48% 62% 66% 77%

AL 58% 36% 44%

AR 56% 22% 0% 0%

AZ 38% 32% 44% 46% 23%

CA 31% 28% 34% 32% 27%

CO 66% 63% 58% 63% 67%

CT 39% 41% 48% 39%

DC 41% 23% 46% 54% 34%

DE 50% 47% 59% 60%

FL 42% 37% 45% 16% 40%

Evaluating Legal Models

Designing a new legal system

Normalized defaults

Signaling effect

Changing laws in an existing system

Potential for rates to go down

○ US conversion rate 75%

○ Would more than 25% of the population opt-out?

Cultural or legal mismatch controversy

○ Lawsuits

○ Media

Legal Strategies

beyond Opt-out and Opt-in

Allocation priority tied to consent

Israeli model

Incentive Non-monetary benefit remains consistent with gift law

Supported by equity and utility principles

Conclusion

Gift Law as an international framework for donation

Within the legal principles of anatomical gifting there are varying models and strategies to increase deceased donation

The model will be most effective when aligned within the legal, ethical and cultural context.

Beyond Legal Principles