IIIèmes RENCONTRES FRANCO-CHINOISES DE BIOETHIQUEIII FRENCH-CHINESE BIOETHICS CONFERENCE

Wuhan 14-16 November 2008

Sadek Beloucif, M.D., Ph.D.

Chair, scientific advisory board, Biomedicine agency

www.agence-biomedecine.fr

Non-Living Donor Organ transplantation in France: ethical, legal and social aspects

General Principles of the law

• Inalienability of the human body : revocable consent at any time

• Interdiction of any advertisement in favor of a person or an organism

• non instrumentalization of individuals : free gift

• Anonymity of donor and recipient

• Principles of sanitary safety

The French law (1994, revised 2004)

• Absolute dogma of a gift :– free, – Anonymous and – implicit

• any person who failed to express a refusal (national registrar) is theoretically presumed having consented

• But in case of brain death, request of information from the family to know whether the person had expressed orally a refusal.

Deathlegal definition

• pre-1968: death = irreversible cessation of cardiac and pulmonary function

• 1968: ‘irreversible coma’

• 1981: Uniform Determination of Death Act– cardiopulmonary death– ‘brain death’

Death by Neurologic Criteria: A Uniform Determination of Death Act of 1981

“An individual who has sustained either:(1) irreversible cessation of circulatory and

respiratory functions, or :

(2) irreversible cessation of all functions of the entire brain, including the brain stem,

is dead.

• A determination of death must be made in accordance with accepted medical standards.”

Guidelines to Determining Brain Death

Prerequisites -proximate cause is known and demonstrably irreversible -metabolic derangements corrected to extent possible -no drug intoxication -core temperature > 32 °C

Three Cardinal Findings in Brain Death 1) Coma

no cerebral response to noxious stimuli in all extremities 2) Absence of Brainstem Reflexes

no pupillary response,no oculocephalic response, no oculovestibular response,no corneal reflex, jaw reflex, grimace,

gag, or cough 3) Apnea- core temp 36.5, SBP >90, no tidal volume with PCO2>60mmHg

Confirmatory Tests

Choice of testing is left to the discretion of the attending physician.

• Radioactive Isotope Angiography (T-99)

• Transcranial Doppler Ultrasonography

• Conventional Cerebral Angiography

• Electroencephalography

• Somatosensory evoked potential

Legislation for Brain Death in Europe (2000)

1979Spain

Austria

Belgium Law

Switzerland

Holland

France

Portugal 1993

Norway

Sweden

UK

Germany 1997

Italy 1999

Law

Law

Law

Law

Law

No Federal Law

Recommendations

Council of Europe & WHOsoft law

3rd Conference of European Health Ministers 1987“A removal may only be effected once death has occurred. The fact of death must be established by at least

one doctor in the light of recent scientific knowledge. It is acknowledged that on the basis of total and irreversible loss of brain function. The doctor establishing the fact of death

should not belong to the team which will effect the removal of transplantation”.

3rd Conference of European Health Ministers 1987“A removal may only be effected once death has occurred. The fact of death must be established by at least

one doctor in the light of recent scientific knowledge. It is acknowledged that on the basis of total and irreversible loss of brain function. The doctor establishing the fact of death

should not belong to the team which will effect the removal of transplantation”.

Council of Europe: Resolution of 11 may 1978Death having occurred, a removal may be effected even if function of some organ other

than brain may be artificially preserved.  Death must be established by a doctor who does not belong to the team which will

effect the removal, grafting or transplantation” 

Council of Europe: Resolution of 11 may 1978Death having occurred, a removal may be effected even if function of some organ other

than brain may be artificially preserved.  Death must be established by a doctor who does not belong to the team which will

effect the removal, grafting or transplantation” 

WHO Declaration of 44th World Assembly 1991Each competent legal authority should establish the criteria of death

WHO Declaration of 44th World Assembly 1991Each competent legal authority should establish the criteria of death

Brain Death and Persistent Vegetative

States:

Easy Questions ?

Laureys S, Nature Reviews-Neurosicence, 6: 899-909, 2005

Brain Death vs. PVS

Laureys S, Nature Reviews-Neurosicence, 6: 899-909, 2005

Brain Death and Organ Donation

• The After-Death

• Does the introduction of medical technology (“Brain Death”) in a private and intimate human domain change our approach/understanding of death?

Schematically,

• Catholics, Protestants and Muslims – acknowledge the concept of brain death,– but leave to the medical community the task

of determining the moment of death;

• Whereas Jews, Orthodox and Buddhists – would refuse this criteria – by advancing a delay (traditionally of 3 days)

between the occurrence of death and departure of the soul.

In fact,

The criteria of brain death

“are, in fact, accepted by those who contest it on anthropologic and religious grounds”,

as they promote these signs of solidarity and love towards other human beings.

Humans always seek new frontiers

• This person who just presented a cardiac arrest and falls in a state of apparent death, can, thanks to an appropriate cardiac resuscitation, continue to live in certain cases a normal life…

• The situation of brain death is very different. The irreversible character of the destruction of brain parenchyma is now synonymous of the definition of death.

Medical technology could modify our approach of our cultural understanding of death

• What is the status of this “brain” death that could be not a “true” death?

• Can we simply use the corpse ?

• Who “owns” the body ? : the person itself, its family, the Society ?

• The neurophysiologic evidences cannot suppress the philosophic, psychological and social considerations of what is a person.

Van Norman GA, Anesthesiology 2003; 98: 63-73

Van Norman GA, Anesthesiology 2003; 98: 63-73

Different perceptions?

Brain

Death

Cardiac

Arrest

Family/Public

Ph ysicians/Nurses

Different perceptions?

Brain

Death

Cardiac

Arrest

Family/Public

Ph ysicians/Nurses

Presumed vs. Explicit Consents• Surveys show that the percentage of persons

willing to donate their own organs is smaller than the percentage of persons willing to donate their relative’s organs. – This would be against an “opting-out” strategy.

• In theory the model is a “first-person” choice, although in practice it is in fact a “third-person” choice.

• More studies including comparative data from various horizons (including psychology, sociology, or anthropology) in addition to medicine are needed in this difficult subject.

Different kinds of Consents in Europe

• Europe is still divided between :– countries where Tx after brain death is governed by

presumed consent (like in Austria, Belgium, Luxembourg or Slovenia)

– and other where informed consent in mandatory (like Germany or The Netherlands).

• “opting in” or “opting out” systems are probably determined within a society upon:– the value of solidarity among citizens, – carefully balanced with the respect for autonomous

choices.

Alternative theoretical solutions to shortage of organs

• enlarge the current definition of death (e.g. to persistent vegetative state patients);

• make the “presumed consent” system mandatory;

• include non-heart beating donors;

• living donation.

Some of these theoretical solutions raise concerns

• linked to the concept of ownership of the body,

• or of the fundamental definition of what is a human being,

• or raised by the financial aspects:– very strong European tradition against selling organs

and in favor of solidarity;– 1996 Convention of Human Rights and Biomedicine

prohibits financial gain and disposal of a part of the human body: “The human body and its parts shall not, as such, give rise to financial gain” (Art. 21).

Issues are probably more complex than imagined…• We need to:

– promote solidarity and fair reciprocity;

– work on the different concepts of • Equality vs. Equity• Autonomy vs. Harmony• Moral Fundamentalism vs. Cultural Relativism

(Universal Ethics vs. Cultural Diversity);

– follow the path towards the concept of a ‘negotiated pluralism’ between/within individuals?

Tx medicine can be seen as a model of inter-human relationships, with a new definition of solidarity, as reciprocity is important in in this matter.

• What is the role of politics ? • The task of the political power is to show the frontier

between :– what is legal and what is not, – what can be bought/sold, and what should not,

• and this for all kind of societies:– contract-based “horizontal”,– solidarity-based “vertical”, – or honor-based “circular”.

Les Trois Grâces,Raphaël (1504—1505)

The gift:

Giving-Receiving-Giving back