Bioethics in the Real World

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Bioethics in the Real World
European Association of Centres of Medical Ethics
21st Annual Conference

• Institute of Biomedical Ethics
• University of Zurich
• Zurich, Switzerland
• 13-15 September 2007

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International Norms for Organ Transplantation
Second Session Bioethics Expertise in the
Public Sphere 14 September 2007

• Panel on From Deliberation to Norm
• Bioethics, Policy and Law
• Alexander M. Capron
• University Professor
• University of Southern California
• Los Angeles, California, USA

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From Deliberation to NormBioethics, Policy and
Law

• This presentation will try to weave together
• Stages in the process of moving from deliberation
  to norm to policies laws
• Illustrated by work of two intergovernmental
  norm-developing organizations
• In the context of developing national policies
  and laws on organ transplantation
• With attention to the dual meaning of doing
  bioethics in the real world the reality of the
  coal face and the world of politics

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From Deliberation to NormBioethics, Policy and
Law

• Stages in the process (with loops-back)
• Issue identification (scandals crises academy)
• Scholarly analysis
• Deductive (principlist deontological virtue)
• Inductive (consequences internal consistency)
• Public deliberation (within IGOs)
• Norm formulation (within IGOs critics)
• Policy promulgation
• Policy objectives and responsibilities
• Legislation
• Regulation (implementation interpretation)
• Adjudication

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1. Issues Identified in the Real World

• Basic investigations of organ transplantation
  one hundred years ago
• Pioneering work of Alexis Carrel (Nobel Prize
  1912)
• Post-WW II, further investigation kidney
  transplants between identical twins
• Development of immunosuppression
• Reliance principally on living donors
• First human-to-human heart transplant (1967)
• Definition of death
• Growing reliance upon organs from deceased donors
• Supply never meets demand (waiting lists)
• Transplantation becomes world-wide practice
• 1980s organ trafficking scandals

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2. Scholars Analyze Issues

• Living donors
• Autonomy (altruism) vs. nonmaleficence
• Risk to minors (limits to surrogates authority
  benefit)
• Deceased donors
• Definition of death (accuracy conflict of
  interests)
• Consent pre-mortem by donor presumed
  next-of-kin?
• Waiting lists
• Fair methods of allocation (medical vs. social)
• What measures does the shortage justify
• Commercialism
• Autonomy (voluntariness) vs. nonmaleficence
  (exploitation of desperate, poor donors
  vendors)
• Transplant tourism (internet advertising of
  package deal including donor, at bargain
  prices)

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3. Public Deliberation WHO

• World Health Organization
• 1987 concern over commercial trade (WHA 40.13)
• Noted reports about commercial brokers
  exploitation
• Concern transplantation benefits will be
  overshadowed
• 1989 global standards needed (WHA 42.5)
• International movement of patients and physicians
• 1991 WHO Guiding Principles adopted (WHA 44.25)
• 2004 Update GP collect more data (WHA 57.18)
• 2003 Global Consultation on transplantation
  (Madrid)
• 2004-2006 Series of meetings on cells, tissues,
  organs
• 2006 Global Knowledge Base on Transplantation
• 2007 Global Observatory (Spanish Ministry of
  Health)
• 2007 Second Global Consultation (Geneva)

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4. Formulating Norms WHO

• 1991 Guiding Principles articulated norms
• Underlying premise need international standards
• Deceased donors preferred ( separation of
  diagnosis)
• Among living donors, related donors preferred
• No commercial transactions in human body its
  parts ( prohibition on advertising and on excess
  fees)
• Equitable access to donated organs (vs.
  financial)
• 2008 Are norms maintained in revising GP?
• Preference for deceased tempered by practice
  changes
• Among living donors, wider door for unrelated
• Commercial ban maintained, but what incentives
  allowed? (tangible vs. intangible recognition)
• Activities transparent scrutinized privacy
  safeguarded
• Quality, safety, efficacy assured for donors
  recipients

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3. Public Deliberation UNESCO

• United Nations Educational, Scientific and
  Cultural Organization
• 1993 International Bioethics Committee
  established ( later, Intergovernmental Bioethics
  Committee)
• 1997 Universal Declaration on the Human Genome
  and Human Rights
• 2003 International Declaration on Human Genetic
  Data
• Both relate to scientific research UNESCOs
  claim to be UNs agency for philosophy and ethics
• Brought in human rights, an ideological
  framework . . . that does not feature
  particularly prominently in professional
  bioethical analysis (W. Landmann U Schüklenk,
  Editorial, Developing World Bioethics, Nov. 2005)

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4. Formulating Norms UNESCO

• 2005 Universal Declaration on Bioethics and
  Human Rights
• Rapidly prepared by IBC (2004-2005)
• Revised substantially in IGBC two meetings of
  meeting of government experts
• Aims to be universal framework of principles and
  procedures to guide States in the formulation of
  their legislation, policies or other instruments
  in the field of bioethics
• Also aims to guide actions of individuals,
  groups, (etc.), to promote respect for human
  dignity and protect human rights, and to foster
  dialogue

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4. Formulating Norms UNESCO

• Apply following principles to organ
  transplantation
• Human dignity, human rights and fundamental
  freedoms are to be fully respected.
• The interests and welfare of the individual
  should have priority over the sole interest of
  science or society.
• In applying . . medical practice . . . direct
  and indirect benefits to patients . . . and other
  affected individuals should be maximized and any
  possible harm to such individuals should be
  minimized.
• The autonomy of persons to make decisions, while
  taking responsibility for those decisions and
  respecting the autonomy of others, is to be
  respected.

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4. Formulating Norms UNESCO

• In applying . . medical practice. , human
  vulnerability should be taken into account.
  Individuals of special vulnerability should be
  protected and the personal integrity of such
  individuals respected.
• The importance of cultural diversity and
  pluralism should be given due regard. However,
  such considerations are not to be invoked to
  infringe upon human dignity, human rights and
  fundamental freedoms, nor upon the principles set
  out in this Declaration, nor to limit their
  scope.
• Solidarity among human beings . . . is to be
  encouraged.

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4. Formulating Norms Problems

• UNESCO
• Far removed from the reality of the practices
  (laws on bioethics or laws on health care
  etc?)
• Contradictory or imprecise guidance on real
  problems (dignity, autonomy, welfare of living
  donors solidarity benefits culture of
  gifts)
• Formulated in passive voice (shall be
  respected)
• Real world of sovereign nations not wishing to
  be bound (declarations vs. conventions)
• A mistake to assess with purely academic
  criteria an instrument which is . . . a kind
  of compromise between a theoretical
  conceptualisation made by experts and what is
  practically achievable given the political
  choices of governments. (Andorno 2006)

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4. Formulating Norms Problems

• WHO
• What is ethical foundation of Guiding
  Principles? (Right to the highest attainable
  standard of health not the absence of disease
  but total well-being?)
• How can such principles balance universal norms
  against claims of cultural difference?
• My view
• Politics intrude everywhere part of real
  world.
• Norms formulated in context of specific real
  world problems are a better basis for moving to
  laws and policies that those that are formulated
  as general principles without reconciliation
  among their contradictions or ambiguities.
• Specific approach risks ad hoc justifications.

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5. Promulgating Policies

• Ministries of health play central role in
  policymaking
• 50 countries adopted laws giving effect to norms
  in 1991 Guiding Principles
• In current re-examination, new laws promulgated
• China law adopted in 2006 sets standards
• Requires licensing of transplant facilities (many
  closed)
• Bans commercial transactions
• Establishes criteria for deceased donor programme
  and equitable allocation of organs
• Ending process of using organs from executed
  prisoners
• Pakistan law adopted in 2007 bans commercialism
• Aims to restrict transplant tourism