1. 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

2. 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

3. Deliberative events BC 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  Vancouver November 2008 BC BioLibrary  Vancouver March 2009 RDX Bioremediation  Vancouver  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

4. Rowe & Frewer, Typology (2005) Participation Consultation Communication 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 SPONSORSPONSOR SPONSORSPONSOR PUBLICREPSPUBLICREPS PUBLICREPSPUBLICREPS

5. Strengthening democracy through shared knowledge 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. www.participedia.net

6. Rowe & Frewer, Typology (2005) Participation Consultation Communication Rowe & Frewer, Typology (2005) Participation Consultation Communication Flow of Information SPONSORSPONSOR SPONSORSPONSOR PUBLICREPSPUBLICREPS PUBLICREPSPUBLICREPS 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?

7. 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

8. 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?

9. 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

10. 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

11. 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

12. Ways we “constitute the public(s)” Process Recruitment Deliberative questions and information Outputs

13. 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.

14. 2006 International Workshop Deliberative 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

15. 25 Demographically Stratified Participants Pre-circulated website & materials Policy Uptake 12 day break dialogue & information Media and Public Uptake Reports, articles & online materials Second Weekend Deliberation Provide policy advice, noting areas of consensus and persistent disagreement First Weekend Information Expert & Stakeholder Q&A Identify hopes and concerns Structuring a Deliberative Process Emergent Policy, practice & governance

16. 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...

17. 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

18. 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.

19. 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

20. 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’ Identifying a “Representative Public”: Dean Regier, Ph.D. 20

21. 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?

22. 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

23. 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

24. 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

25. 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.

26. 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.

27. 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!

28. 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