What Forms of Public Engagement are Appropriate for Drug Policy?

What Does the Evidence Say: HTA to Support Policy and Practice2015 CADTH Symposium

April 12-14, 2015 Saskatoon, SK

Michael M BurgessProfessor and Research Chair in Biomedical Ethics

W. Maurice Young Centre for Applied EthicsSchool 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 eventsBC Biobank deliberation

Vancouver April/May 2007

Mayo Clinic, Biobanks September 2007

Rochester Epidemiology Proj. November 2011

Western Australia Stakeholders: Aug 2008

Public: November 2008

Salmon Genomics Vancouver November 2008

BC BioLibrary Vancouver March 2009

RDX Bioremediation

Vancouver April 2010

Biofuels

Montreal Sept/Oct 2012

Biobank Project Tasmania

April 2013

California Biobanks

LA: May 2013

SF: Sept/Oct 2013

Priority setting in Cancer Control

Vancouver June, 2014

Newborn Screening

California Sept/Oct 2015

Rowe & Frewer, Typology (2005)

Participation

Consultation

Communication

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.

Flow of Information

SPONSOR

PUBLIC

REPS

Strengthening democracythrough 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.

www.participedia.net

Rowe & Frewer, Typology (2005)

Participation

Consultation

Communication

Flow of Information

SPONSOR

PUBLIC

REPS

• 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

What is the goal?

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 values1. Illustrate with reference deliberative public

engagement2. 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 WorkshopDeliberative Democracy & Biobanks

Democracy & engagement• Archon Fung, Kennedy School of

Government, Harvard University

• John Gastil, Communication, University of Washington

• Simon Niemeyer, Australian National University

• Mark Warren, Political Science, University of British Columbia

• Janet Joy, Community engagement, Vancouver Coastal Health Authority

Genomics & biobanks• Angela Brooks-Wilson, Genome

Sciences Centre, BC Cancer Research Centre • Peter Watson, BC Cancer Agency Tumor

Tissue Repository. PI BC BioLibrary

• Richard Hegele, UBC & iCAPTURE Centre

Ethics & law• Susan Dodds, University of Tasmania

(then U of Wollongong), Australia

• Barbara Koenig, UCSF (then Mayo Clinic, Minnesota)

• Nola Ries, University of Victoria

25 Demographically Stratified Participants

Pre-circulatedwebsite &materials

PolicyUptake

12 day break

dialogue &informationMedia and

Public Uptake

Reports,articles & online

materials

Second Weekend

Deliberation

Provide policy advice, noting areas of consensus and persistent disagreement

First WeekendInformation

Expert & StakeholderQ&A

Identify hopes and concerns

Structuring a Deliberative Process

EmergentPolicy, practice & governance

Deliberative Democracy

PW Hamlett (2003). Technology theory and deliberative democracy. Science, Technology, & Human Values 28 (1): 121-2.

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.

not simply to ensure that “excluded groups” are given access to decision making about technology, however desirable this may be in itself. . .

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

Goodin, RE, Dryzek, JS 2006. Deliberative Impacts: The Macro-Political Uptake of Mini-Publics. Politics & Society, 34(2): 219-244.

“mini-public” can provide insight into how informed and deliberating citizens understand and assess important issues

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 strategyFuture work to incorporate ‘reasoning’

Identifying a “Representative Public”: Dean Regier, Ph.D.

20

Public Expertise & Deliberation

What are good measures of effectiveness and cost-effectiveness?

How can the health care system be more sustainable?

Would [this proposal] encourage increased physical activity or improved

diet in your community?

What would be necessary for you to trust decisions to include or exclude health services?

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

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?

Priority setting & the high cost of cancer drugs: Key deliberative questions

23

Stuart Peacock, Colene Bentley, BCCRC

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.”

“. . .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.”

T Caulfield, AL. McGuire, M Cho, et al (2008). Research Ethics Recommendations for Whole Genome Research: Consensus Statement. PLOS Biology 6.3: 430 – 435.

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 Practice2015 CADTH Symposium

April 12-14, 2015 Saskatoon, SK

Michael M BurgessProfessor and Research Chair in Biomedical Ethics

W. Maurice Young Centre for Applied EthicsSchool of Population and Public Health

Department of Medical Genetics