Proposal for a Demonstration Project-the Vaccine Policy Analysis Collaborative (VPAC)

1. Proposal for a Demonstration Project-the Vaccine Policy Analysis Collaborative (VPAC) Roger H. Bernier, Ph.D. On behalf of: The Wingspread Public Engagement Planning Group Presentation to the NVAC June 2003

2. Thank you for this opportunity to provide another progress report on our project to enhance public engagement • The first progress report was presented here one year ago in June 2002

3. Wingspread Public Engagement Planning Group • Purpose: Created as part of a special assignment to explore how the immunization community might enhance public engagement in decision making about vaccines • Assumption: Bring together all the interest groups that normally do not interact, work together to create a supportable proposal, and hope that this achievement attracts wider interest in the immunization community and funding support from multiple sources.

4. Wingspread Public Engagement Planning Group • Ad hoc group—no official standing • Not an official government view which is being presented • Any proposals discussed here require further Departmental review • Enhancing public engagement is a work in progress • No endorsement intended or implied by this presentation for the work completed to date

5. Purposes Today • Quick recap of public participation • Describe the process we used in the Planning Group • Describe the proposal we developed • Ask NVAC if it has thoughts on the topic, as refinement of the proposal continues to evolve

6. The Driving Vision • Citizens and public officials interacting honestly, learning from each other, and working together to better inform decisions and achieve better solutions on policy issues related to vaccines.

7. Increasing Level of Participation in Decision Making Levels of Public Participation Inform Consult Collaborate

8. Why Engage The Public? • It’s the right thing to do • It’s the best thing to do • It earns more support • All of the above are Trust Building

9. Original Wingspread Planning Group • Health Professionals (AAP, AAFP, NMA) PHNursing) • Minority Groups (API, NHMA, AA) • Government Agencies (FDA, CDC, NVPO, HRSA, NIH) • “Critical” Public (SafeMinds, NVIC, PROVE, Rollens) • “Neutral”Public (PTA, League of Women Voters) • “Supportive” Public (PKids, IAC)

10. Original Wingspread Planning Group • Academia (Brown, Morehouse) • Industry (Aventis, Merck, Wyeth, GSK) • Private Consultants (Fine, Keystone, Study Circles, America Speaks, Moran, Heierbacher, Perspectives Group, DDC, Princeton Partners, Marcuse) • NGO’s (ASTHO, IOM)

11. Mona Steele, League of Women Voters Sallie Bernard, Safe Minds Trish Parnell*, PKids Barbara Loe Fisher, NVIC Stan Music**, Merck Tom Zink**, GSK Lou Cooper, NNII Ed Marcuse, Children’s Hospital Seattle Kathleen Stratton, IOM Debbie McCune Davis, TAPI Geoff Evans, HRSA Jon Abramson, AAP Amy Fine, Consultant Roger Bernier, CDC Shaunette Crawford, NVPO Bruce Gellin, NVPO Sandra Jo Hammer, California DOH Mary Davis Hamlin, Keystone Center * Withdrew early **Late participation limited Post-Wingspread Steering Committee

12. The Group Worked In A New Way To Help Create A New Way of Working • “Collaborative problem-solving around interests to get the optimal solutions” • -We discussed interests first not solutions first • -We did joint fact finding • -We sought broad solutions meeting the full range of interests • -We worked to refine the most promising options to make them the best they could be

13. Chronology • October 2001 Funds awarded from NIP and Unmet Needs • Early 2002 Stakeholders on board from government, industry, public, and health professionals • April 2002 Johnson Foundation has awarded grant to hold a Wingspread Conference • April 2002 Keystone Center selected as neutral convener and facilitator

14. Chronology continued • July 2002 First Wingspread Conference—Topic deemed worth exploring further • Sept 2002 Steering Committee created • Nov 2002-May 2003 Steering Comm meetings • May 2003 Draft proposal recommended by Steering C • May 2003 Second meeting of Wingspread Planning Group • May 2003 Proposal agreed upon for a Demonstration Project—VPAC • June 2003 & beyond Transitioning from planning by the Wingspread Group to review and consideration by others

15. Commitment Training & Guidance Clarity Linkage Accountability Transparency Timing Resources Information Equity Representation Dialogue Participants Independence Evaluation Principles of Good Public Engagement(Adapted From OECD)

16. Key Features Of Enhanced Process I • Participation: Stakeholder groups + general public phased in in Tier 1 and Tier 2 • Mode of Operation: To have a “Safe Harbor” environment and a “Not Strictly Partisan” work ethic • Activities: Dialogue, analyses of pending decisions, tracking • Agenda: Pending decisions of government • Products: List of options with pros and cons, NO recommendations

17. Key Features of Enhanced Process II • Issue type: Technical + values, cross-cutting program and implementation • Linkage: Government to consider and provide feedback • Funding: Mixed sources if possible through a foundation (e.g. CDC Foundation) • Duration: Three year demonstration project • Goal: Better decisions • Name: VPAC---Vaccine Policy Analysis Collaborative

18. Key Features of Enhanced Process III • Need mechanism which can carry out the key functions of VPAC 1) dialogue, 2) info gathering & interpreting and 3) report writing • Also need mechanism which exists because 1) participants more comfortable this way and 2) will be quicker to implement • Also need mechanism which has flexibility because some functions and techniques of “enhanced” public engagement are and not “business as usual” and need to be integrated

19. Key Features of Enhanced Process IV • Two mechanisms which meet these criteria are the workgroups of federal advisory committees and the roundtables of the Institute of Medicine • Roundtables are to the well known study committees of the IOM as Workgroups are to the well known vaccine advisory committees of the federal government —working level, pre-policy, information exchange mechanisms for groups of participants with relatively few regulations governing them

20. Key Features of Enhanced Process V • Org Structure: Operated jointly and simultaneously as an NVAC Workgroup and an IOM Roundtable • Why using two mechanisms at once? Key tension is around independence—not too much or not too little • 1) Neutral contractor works by consensus with NVAC and the Wingspread Steering Group to appoint workgroup members in a bona fide committee workgroup • 2) IOM appoints these NVAC Workgroup members as members of an IOM Roundtable in a bona fide IOM Roundtable group.

21. Key Features of Enhanced Process VI • NVAC Workgroup functions “normally” side by side with a “normally” functioning IOM Roundtable • The Roundtable serves as the info gathering or research arm of the Workgroup • NVAC Workgroup writes the report to the full committee. IOM writes NO report.

22. IOM implements VPAC –Off the table early on #1 NVAC implements VPAC using a neutral contractor--N=3 #4a NVAC+IOM implement VPAC jointly (IOM Roundtable members appointed, NVAC Workgroup named from the Roundtable roster)—N=0 #4b NVAC+IOM implement VPAC jointly (NVAC Workgroup members appointed, IOM includes Workgroup in the Roundtable roster) N=15 NVAC Evaluates For Itself Whether To Enhance Public Engagement, And If So, How To—N=3 (+Industry 4) Not mutually exclusive of other options. Could do both The Options Considered and The Support Garnered

23. Preferred Option • #4b NVAC+IOM implement VPAC jointly (NVAC Workgroup members appointed, IOM includes Workgroup in the Roundtable roster) N=15+ • Judged by the majority of participants to be the best way of meeting the widest range of interests identified at this time

24. Input Input Feedback Outreach Staff Stakeholders Government Health Professionals Organized Public Industry Stakeholders VPAC NVAC WG as part of an IOM RoundTable (Tier 1) pendingdecisions with public judgment Fed Govt via NVAC General Public (Tier 2) on decisions taken Analyses Tracking Dialogue NVAC WG Report onDecision Options IncreasedMutualUnderstanding Increased Accountability

25. Where We Have Come ToI • We have designed jointly with six major interest groups an enhanced way of engaging the public on immunization issues • The proposal meets the interests of the majority of stakeholders and has their support. • For implementation, the proposal needs a linkage or gateway to and from government agencies and/or immunization advisory committees • Now making presentations to groups in the immunization community

26. Where We Have Come ToII • The proposal does not meet the interests of some industry and pro-vaccine advocates who participated in some or most of the planning process. • Most objections have been about procedural aspects of the planning process (e.g., predetermined, unfair, inappropriate…) • Some objections have been raised about design features of the enhanced proposal (e.g., too critic friendly, not likely to succeed, just about safety…)

27. Where We Have Come ToIII • We have made every attempt to retain the participation of all stakeholder groups • We have recruited replacements for those withdrawing whenever possible • All stakeholders are welcome to return to the Wingspread type of collaborative problem solving process at any time • Others with a mutual interest who have not participated yet are welcome to join the process at any time • Our goal is to remain intact until our process can find a home or be adopted

28. Key MessagesI • The potential benefits are large • Anticipated outcomes are: • Citizens and stakeholders with an enhanced role & voice in immunization • Better solutions/decisions • More ownership and support for decisions taken • As a consequence of the above, more trust built up on all sides

29. Key MessagesII • The potential risks are low • Not a new activity—an enhancement of public engagement • Not a new advisory committee—no recommendations • Not a commitment to a permanent change—a time limited demonstration project • Enhances capacity and does not supplant other tools in the public engagement toolbox • Not likely to be a platform for any one group

30. Key MessageIII • The benefits are very worth having…and the risks worth taking.

31. What Will Success Look Like? • In the future we see for our nation's immunization program… citizens fulfill their responsibility to be informed about vaccines, engage actively and respectfully with public officials, hold them accountable for meeting their immunization needs, and support the good decisions which are made...

32. What Will Success Look Like? • In turn, public officials earn and increase trust as they hear citizens’ voices fairly and openly, seek citizens' ideas and the wisdom of the group on vaccine topics, fully consider the views of citizens, make better decisions informed by citizen input, and meet with citizens to describe the decisions taken and the principal reasons behind them.

33. Acknowledgements • Mary Davis Hamlin, The Keystone Center • Members of the Planning Group (Wingspread & Denver) • Members of the Steering Group • National Vaccine Program Office • National Immunization Program • The Johnson Foundation

34. Thank you We welcome NVAC’s thoughts as the thinking continues to evolve on enhancing public engagement.

35. Extra Slides

36. Drivers For The Project • Lack of understanding about vaccines in the general population • Lack of trust in government in some segments of the public • Increasing public expectations for involvement in decision making • Polarized debates on vaccine issues wasteful and unproductive

37. Familiar Examples of Public Participation • FOIA documents • Hearings • Public meetings • Public comment periods • Open public meetings • Consumer representatives on advisory committees • Focus groups • Public opinion surveys • Workshops

38. Unfamiliar Examples Of Public Participation • Deliberative Polling • Citizens Advisory Committees • Citizens Juries • Policy Councils • Consensus Building Exercises

39. Examples Of Design Choices Wrestled With • What should be the organizational home and structure? • What work products to focus on? • Who will set the agenda? • Who is the public? • More than 20 elements have been considered and preferences expressed in the current design

40. Logic Model Increased Public Participation

41. Examples of Situations Suitable for VPAC • Decision truly not made yet • Decision not urgent • Values at issue, not facts alone • Really want input not just consulting for appearances

42. Examples of Potential VPAC Issues • Should doctors oust children from their practice if parents refuse vaccination? • Should philosophical exemptions to school laws be available in all states? • Should the rotavirus vaccine be reintroduced into the US? • Should we require less proof of causality for awards in the Vaccine Injury Comp Program?

43. Myths about VPAC • That it is only about appeasing vaccine critics • That it makes a negative statement about NVAC • That it preempts NVAC on public participation • That it creates another advisory committee • That the outcome of the planning process was predetermined

44. Fears about VPAC • That it will provide a platform for vaccine critics to gain more power and influence • That we will not get a truly representative public viewpoint • That it is fixing something which is not broken • That we will alienate pro-vaccine supporters • That vaccine critics will never change their views

45. Anticipated Outcomes • Citizens and stakeholders with enhanced roles in immunization • Better solutions/decisions • More ownership and support for decisions taken • As a consequence of the above, more trust built up on all sides

46. Challenges • Lip service vs real commitment and resources • Sharing power on decision making • Convincing that public participation improves decisions • Proving that public participation improves decisions at a price worth paying and a level of effort worth making

47. Challenges continued • Dealing with complexity and technical topics • Picking suitable decisions to analyze • Dealing with the timing of decisions • Finding funding • Shifting the paradigm to see the public as a resource not a drag

48. Implications • Extension to other programs where citizens distrust government and feel disenfranchised • Useful for the conduct of science in democratic societies where the science is complex, citizen consent or support is needed, and scientists and citizens must interact for proper resolution of the issues.

49. VPAC • “Working Together For Wise Decisions About Vaccines”