What Forms of Public Engagement are
Appropriate for Drug Policy?
What Does the Evidence Say: HTA to Support Policy and Practice
2015 CADTH Symposium
April 12-14, 2015
Saskatoon, SK
Michael M Burgess
Professor and Research Chair in Biomedical Ethics
W. Maurice Young Centre for Applied Ethics
School of Population and Public Health
Department of Medical Genetics
No Conflict of Interest, but . . .
• BC BioLibrary: Banking for Health
(a MSFHR
Technology/Methodology
Platform)
• BC Cancer Agency Tumour Tissue
Repository
• Better Biomarkers of Acute and
Chronic Allograft Rejection
(Genome Canada)
• Canadian Biotechnology
Secretariat
• Canadian Cancer Society and
AARC
• Canadian Institutes for Health
Research
• Canadian Partnership for
Tomorrow
• Canadian Tumour Repository
Network
• Ethics Office, Canadian Institutes
of Health Research (CIHR)
• Genome Canada
• Genome BC
• Institute for Genetics, CIHR
• The James Hogg iCAPTURE Centre,
St. Paul’s Hospital
• Mayo Clinic, Rochester, Minnesota
• Michael Smith Foundation for
Health Research, BC
• National Human Genome Research
Institute, U01HG04599
• UBC Provost’s Office
• Western Australia Department of
Population Health
Deliberative events
BC Biobank deliberation
 Vancouver April/May 2007
Mayo Clinic, Biobanks
 September 2007
Rochester Epidemiology Proj.
 November 2011
Western Australia
RDX Bioremediation
 Vancouver April 2010
Biofuels
 Montreal Sept/Oct 2012
Biobank Project Tasmania
 April 2013
California Biobanks
 Stakeholders: Aug 2008
 LA: May 2013
 Public: November 2008
 SF: Sept/Oct 2013
Salmon Genomics
 Vancouver November 2008
BC BioLibrary
 Vancouver March 2009
Priority setting in Cancer
Control
 Vancouver June, 2014
Newborn Screening
 California Sept/Oct 2015
Rowe & Frewer, Typology (2005)
Participation
Consultation
Flow of Information
S
P
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N
S
O
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Communication
P
U
B
L
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C
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P
S
Arnstein, Sherry R. Journal of the American Planning Association, 35(4):216-224.
Rowe, Gene & Lynn J. Frewer. Science, Technology & Human Values 30(2):251-290.
www.participedia.net
Strengthening democracy
through shared
knowledge
Participedia’s strategy is simple:
crowd-source data on democratic innovations from around
the world from contributors like yourself and then
aggregate this into an open, public database that
continually updates with new contributions.
What is the goal?
• Trustworthy governance
• Incorporate informed civic
views
• Assign relative weights in
trade-off
• Identify what information
is most needed by P&P
• Canadian public values
• Increase credibility
• Stimulate public trust
• Provide detailed public
information
Rowe & Frewer, Typology (2005)
Participation
Consultation
Communication
Flow of Information
S
P
O
N
S
O
R
P
U
B
L
I
C
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P
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Invitation to reflect
Deciding how and who to engage is an act of
reifying particular concepts of patients, publics and
ethics
• “Patients” and “public” are convenient
abstractions for engagement
• PPE does not provide ethical principles or values
1. Illustrate with reference deliberative public
engagement
2. Implications for planning PPE, governance and
advisories
Ethics in PPE
• How can we live together while respecting diversity of
opinion?
– Supplement expert opinion
– Experienced (patient) and stewardship (public) views
• What processes render acceptable or trustworthy
decisions?
– Innovation in governance and use of advisories
• Requires that decision makers
– Want input
– Willing to use and respond to input
• What recruitment will reduce attracting people with
settled opinions?
Representation and reification
How do we represent patients and public?
• Reify: to regard something abstract as a
material or concrete thing
• turning people into groups defined by one
aspect of their identity
• fallacy of misplaced concreteness
Complex & Messy
• All of us have a variety of interests and
roles, sometimes conflicting
• Interest priority changes; time & situations
• Not possible to construct a representative
sample of such complicated and variable set
• Goal is to get “representation” of wide
diversity of interests in a population, relative
to an issue
Is Representation Impossible?
• Consumer participation might improve deliberation
about some matters, but it is unlikely that we could
ever enlist active enough consumer participation to
deliberation about limit setting. . . . there is no
realistic mechanism for making consumers who
participate truly representative of the consumer
population as a whole.
N Daniels & J Sabin 1998. The ethics of
accountability in managed care reform. Health
Affairs. 17 (5):61
Ways we “constitute the public(s)”
• Process
• Recruitment
• Deliberative questions and information
• Outputs
Evaluation of Deliberation
1. Representation
2. Structure of process or procedures
3. Information used in process
4. Outcomes and decisions arising
Abelson J, et al 2003. Deliberations about deliberative methods: issues in
the design and evaluation of public participation processes. Social
Science and Medicine 57, 239-251.
Cf., Beierle, 1999. Webler, 1995.
2006 International Workshop
Deliberative Democracy & Biobanks
Democracy & engagement
Genomics & biobanks
• Archon Fung, Kennedy School of
• Angela Brooks-Wilson, Genome
• John Gastil, Communication,
• Peter Watson, BC Cancer Agency Tumor
• Simon Niemeyer, Australian
• Richard Hegele, UBC & iCAPTURE
• Mark Warren, Political Science,
Ethics & law
Government, Harvard University
University of Washington
National University
University of British Columbia
• Janet Joy, Community engagement,
Vancouver Coastal Health Authority
Sciences Centre, BC Cancer Research Centre
Tissue Repository. PI BC BioLibrary
Centre
• Susan Dodds, University of Tasmania
(then U of Wollongong), Australia
• Barbara Koenig, UCSF (then Mayo
Clinic, Minnesota)
• Nola Ries, University of Victoria
Structuring a Deliberative Process
25 Demographically
Stratified Participants
Pre-circulated
website &
materials
First Weekend
Information
Expert & Stakeholder
Q&A
Policy
Uptake
Emergent
Policy, practice
& governance
Reports,
articles & online
materials
Second Weekend
Media and
Public
Uptake
Provide policy advice, noting
areas of consensus and
persistent disagreement
Deliberation
Identify hopes and concerns
12 day break
dialogue &
information
Deliberative Democracy
not simply to ensure that “excluded groups” are
given access to decision making about
technology, however desirable this may be in
itself. . .
express a reasoned, informed, consensual
judgment forged out of the initially disparate
knowledge, values, and preferences of the
participants, as these have evolved through the
deliberative experience itself.
PW Hamlett (2003). Technology theory and deliberative
democracy. Science, Technology, & Human Values 28 (1): 121-2.
Deliberative Process
• Organize and facilitate to stimulate full
participation and expression of interests
– Strong facilitation, usually small and large groups
• Expert support to avoid unnecessary ambiguity
and misunderstanding
– Held in check to avoid dominance
• Decision maker participation
– Translation and participant motivation
• Encourage clarity of persistent disagreement
– Better to understand lack of convergence than to
force consensus
Deliberative Engagement
• Successful and productive
– MM Burgess, KC O'Doherty, DM Secko (2008). Biobanking in BC: Enhancing discussions of the
future of personalized medicine through deliberative public engagement. Personalized Medicine.
• Incorporates wide diversity of perspectives
– H Longstaff, MM Burgess (2010). Recruiting for representation in public deliberation on the ethics
of biobanks. Public Understanding of Science.
• Critically appraises and utilizes technical info
– S MacLean, MM Burgess (2010). In the Public Interest: Stakeholder Influence in Public Deliberation
about Biobanks. Public Understanding of Science.
– ES Wilcox (2009). Does "Misinformation" Matter? Exploring the Roles of Technical and Conceptual
Inaccuracies In a Deliberative Public Engagement on Biobanks. MA Thesis, UBC.
• Informative
– DM Secko, N Preto, S Niemeyer, MM Burgess (2009). Informed Consent in Biobank Research: Fresh
Evidence for the Debate. Social Science & Medicine.
– KC O'Doherty, MM Burgess (2009). Engaging the public on biobanks: Outcomes of the BC Biobank
Deliberation'. Public Health Genomics.
Recruiting for diversity of
Interests
“mini-public” can provide insight into
how informed and deliberating
citizens understand and assess
important issues
Goodin, RE, Dryzek, JS 2006. Deliberative Impacts: The Macro-Political
Uptake of Mini-Publics. Politics & Society, 34(2): 219-244.
Identifying a “Representative Public”:
Dean Regier, Ph.D.
We recruited on life experience & value
• Demographic proxy for life experience
• Utility proxy for value
Created a sample of 30 (from 80) using novel
sampling strategy
Future work to incorporate ‘reasoning’
20
Public Expertise & Deliberation
Would
[this
proposal]
encourage
WhatHow
would
be
necessary
for
youofto trust
can
the
health
care
system
be
What are good measures
increased
physical
activity health
or improved
decisions
to
include
or
exclude
services?
more
sustainable?
effectiveness and cost-effectiveness?
diet in your community?
Public Expertise
• Engaged as citizens
– Reflect diversity of life experience and goals
• Including vocational, domestic and social expertise
• as individuals and understanding each other
– Values and how they influence
• Acceptable risks
• Trade-offs
• Uncertainty and diversity
– Practical knowledge about their own world
• Trustworthiness of decision making emerges
Priority setting & the high cost of cancer
drugs: Key deliberative questions
Under what circumstances is there an obligation to continue to
fund a cancer drug? (Disinvestment)
How much additional duration of life is needed to justify doubling
the budget?
How much additional quality of life is needed to justify doubling
the budget?
What would make drug funding decisions trustworthy?
Stuart Peacock, Colene Bentley, BCCRC
23
Output and Translation
• Honor responsibilities to participants
– We ratify and publish “deliberative conclusions”
– Include reasons, qualifications
– Persistent disagreements recognized as
conclusions
– Avoid majoritarian tendencies like quantification
• Assess engagement for dominance (e.g.,
polarization)
• Decision makers in events
Experiments in Trustworthy
Governance
“. . .resolving the ethical problems inherent in biobanking lies in
appropriate governance.”
T Caulfield, AL. McGuire, M Cho, et al (2008). Research Ethics
Recommendations for Whole Genome Research: Consensus
Statement. PLOS Biology 6.3: 430 – 435.
“. . .assessment of experiments with different forms of
governance holds the most hope for balancing protection of
participants with the development and distribution of
benefits derived from research using biobanks.”
K O’Doherty, MM Burgess, K Edwards, R Gallagher, A Hawkins, J Kaye, V
McCaffrey, D Winickoff (2011). Adaptive Governance for Biobanks.
Social Science & Medicine. 73: 367-374.
Participatory Governance
• The “public” can incorporate technical and
social information and contribute to decisions
– decision makers’ confidence in public’s capacity
• Direct representation for trustworthy
governance: Advisories & engagement
– Representation of diverse public interests
– Resources to seek wider public input
MM Burgess (2014). From “trust us” to
participatory governance: Deliberative publics and
science policy. Public Understanding of Science.
Creating Opportunities & Communities
• Explicitly construct groups engaged
• “Value” and choices by a population vary across
time and situations
• Represent diversity of interests
• Event-based PPE is inadequate: participatory
governance is required
• Advisories need a way to refresh and reconnect
with the messy world they are to reflect
• These are experiments: Assess!
What Forms of Public Engagement are
Appropriate for Drug Policy?
What Does the Evidence Say: HTA to Support Policy and Practice
2015 CADTH Symposium
April 12-14, 2015
Saskatoon, SK
Michael M Burgess
Professor and Research Chair in Biomedical Ethics
W. Maurice Young Centre for Applied Ethics
School of Population and Public Health
Department of Medical Genetics