Law, Ethics and Public Policy:
Some Lessons from Genomic Medicine
Dr Ron Zimmern MA, FRCP, FFPHM
Chairman, PHG Foundation
Centre for Medical Ethics and Law
University of Hong Kong
11 Apr 2013
Introductory Remarks
University of Hong Kong
University of Hong Kong
to produce graduates of distinction committed to lifelong learning,
integrity and professionalism, capable of being responsive leaders and
communicators in their fields
Faculty of Clinical Medicine
..to the development of leadership, to the promotion of humanity..
Centre for the Humanities and Medicine
to the conduct of interdisciplinary research and
teaching in relation to three broad interconnected
themes: the challenges posed by the translation of
biomedical technologies into society; the relationship
between disease, health, culture and society; and the
humanisation of our understanding and practice of
medicine
Structure of Talk
1. to say something about my organisation in the UK, the PHG Foundation,
and to suggest how our approach and work might have some relevance
to the Centre here in Hong Kong
2. to give a brief account of the conventional approach to medical ethics
and law and to suggest that this is neither adequate nor sufficient to
meet the needs of health care or health
3. to use some examples from philosophy and law as applied to the practice
of clinical genetics and genomic medicine to illustrate a few
philosophical and legal dilemmas
4. to give a brief personal account as to what some of these issues might
be in the context of health and social care in Hong Kong
The Work of the PHG Foundation
Public Health Genomics
The responsible and effective translation of
genome-based knowledge and technologies for
the benefit of population health
Connectivity of Health Determinants
Determinants of Health
Genetic Endowment
Genetic
Biological
Physical
INDIVIDUALS
Natural Environment
POPULATIONS
Political
Social
Behavioural
Structural Environment
Individual Behaviour
The Enterprise
Society
Knowledge
Generation
Communication and Stakeholder Engagement
Population
Sciences
Genomebased
Science and
Technology
Humanities
and Social
Sciences
Informing Public Policy
Knowledge
Integration
Strategy
Analysis
Within
And
Across
Disciplines
Improvement
Action
in
Population
Evaluation
Developing and Evaluating
Health Services
Education and Training
Research
Health
Genetic and Population Sciences and the Humanities
GENETIC SCIENCE
POPULATION SCIENCES
HUMANITIES
•
•
Epidemiology
•
Sociology
•
Biostatistics
•
Anthropology
•
Environmental health
sciences
•
Law
•
Economics
•
Infectious diseases
•
Ethics
•
Social and behavioural
sciences
•
Metaphysics and
epistemology
•
Health economics
•
Theology
•
Health services
research
•
Political
philosophy
•
Management science
•
Information science
•
•
•
•
•
•
•
Basic concepts of
mendelian genetics
Family histories and
pedigrees
Risk assessment
and communication
Principles of genetic
epidemiology
Principles of
molecular genetics
Genetic testing and
screening
Genetics of common
disorders
Gene-environment
interaction
Disciplines within the PHGF
1.
Geneticists and molecular
biologists
2.
Public health physicians
3.
Epidemiologists
4.
Biostatisticians
5.
Lawyers
6.
Philosophers
7.
Social scientists and social
anthropologists
8.
Information and IT specialists
9.
Educationalists
10. Public involvement specialists
11. Industrial liaison
Strangeways Research Laboratory
“Working under one roof”
Acheson Definition of Public Health
The art and science of promoting health
and preventing disease through the
organised efforts of society
The Conventional Approach
What Needs to Change?
The Role of the State
“the central issue in public health is the extent to
which it is acceptable for the state to establish
policies that will influence population health”
Public Health: Ethical Issues . Nuffield Council for Bioethics (2007)
Thaler and Sunstein’s “Nudge”
Every day we make decisions: about the things that we buy or
the meals we eat….. Unfortunately, we often choose poorly.
We are all susceptible to biases that can lead us to make bad
decisions that make us poorer, less healthy and less happy.
….No choice is ever presented to us in a neutral way. By
knowing how people think, we can make it easier for them to
choose what is best for them, their families and society.
‘Nudging’ and ‘Shoving’
Nudging
“the chances that people act in ways that, on reflection,
they would have chosen themselves”
Shoving
“increasing the chances that people behave in ways
preferred by the shover but not the shoved”
The Wolfenden Report (1957)
1.
to preserve public order and decency
1.
to protect the citizen from what is offensive and
injurious
1.
there must remain a realm of private morality and
immorality which is, in brief and crude terms, not
the law’s business
Standard Medical Law Topics
1.
Consent
2.
Confidentiality
3.
Reproduction and abortion
4.
Negligence and medical liability
5.
Resource allocation
6.
Human tissue
7.
Mental illness
8.
Transplantation
9.
Beginning of life decisions
10. End of life decisions and euthanasia
Beauchamp & Childress
1. Beneficence
2. Non-maleficence
3. Autonomy
4. Justice
Need for Change
1.
Third party payers
2.
Research
3.
Intellectual property
4.
Biomedical innovation and technology
5.
Information systems and technology
6.
Epidemiological trends
7.
Social trends and the rise in consumerism
Nuffield Council for Bioethics (Publications)
Genetic screening: ethical issues 1994
Human tissue: ethical and legal issues 1995
Animal-to-human transplants: the ethics of xenotransplantation 1996
Mental disorders and genetics: the ethical context 1998
The ethics of clinical research in developing countries: a discussion paper 1999
Stem cell therapy: ethical issues 2000
The ethics of research related to healthcare in developing countries 2002
The ethics of patenting DNA 2002
Genetics and human behaviour: the ethical context 2002
Pharmacogenetics: ethical issues 2003
Genetic screening: a supplement to the 1993 report 2006
Critical care decisions in foetal and neonatal medicine: ethical issues 2006
The forensic use of bio-information: ethical issues 2007
Public health: ethical issues 2007
Dementia: ethical issues 2009
Medical profiling and online medicine: the ethics of 'personalised healthcare' in a consumer age 2010
Human bodies: donation for medicine and research 2011
Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review 2012
Emerging biotechnologies: technology, choice and the public good 2012
Need for Change
1.
Third party payers
2.
Research
3.
Intellectual property
4.
Biomedical innovation and technology
5.
Information systems and technology
6.
Epidemiological trends
7.
Social trends and the rise in consumerism
The Creative Destruction of Medicine
New Medicine
Mobile
Connectivity
& Bandwidth
Wireless
Sensors
Internet
Genomics
Super
Convergence
Social
Networking
Imaging
Increased
Computing Power
& Data Universe
Information
Systems
Old Medicine
Adapted from Fig 1: The transformation of medicine today to new individualised
medicine enabled by digitising humans. Eric Topol (2012)
Change, Scenarios and the Trumpet of Uncertainty
Planning and Policy
Topol
Conventional
Physician driven
Technology as aid
Objective values assessed professionally
Medical profession as trusted intermediaries
Patient defers to physician
Community values predominate
Social
Consumer driven
Technology driven
Subjective values predominate
Decline of trusted intermediaries
Patient as partner
Individualism reigns
CHANGE
Other
Technologies
Epidemiology of Disease
Genomics
Need for Change
1.
Third party payers
2.
Research
3.
Intellectual property
4.
Biomedical innovation and technology
5.
Information systems and technology
6.
Epidemiological trends
7.
Social trends and the rise in consumerism
Examples of Legal and Ethical Issues
NIPD: Ethical and Legal Issues
1. The abortion debate
2. Scope of consent
3. Disability concerns
4. Sex selection and global implications
5. Intellectual property
6. Incidental findings
7. Equity
8. Criteria for use
Medical Ethics and Medical law in
Hong Kong
Examples from SCMP
•
HK Privacy Ordinance
•
Disciplinary Hearings at HK Medical Council
•
HA reporting code for serious incidents and private hospitals
•
Corruption in Guangdong hospitals
•
Regulation of beauty parlors and cosmetic treatments
•
Risky treatments by private practitioners (septicaemia)
•
Sharing of e-records between public and private sectors
•
Euthanasia debate (Quadriplegic Tang Siu-pun)
•
Balance of responsibility between individual clinicians and
systems of care (Tuen Mun Hospital)
•
Resource allocation for rare diseases