Proposal for a Proposal for a Demonstration Project-the Demonstration Project-the

Vaccine Policy Analysis Vaccine Policy Analysis Collaborative (VPAC)Collaborative (VPAC)

Roger H. Bernier, Ph.D.

On behalf of:

The Wingspread Public Engagement Planning Group

Presentation to the NVAC

June 2003

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

Wingspread Public Wingspread Public Engagement Planning GroupEngagement 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.

Wingspread Public Wingspread Public Engagement Planning GroupEngagement 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

Purposes TodayPurposes 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

The Driving VisionThe 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.

Inform Consult Collaborate

Levels of Public ParticipationLevels of Public Participation

Increasing Level of Participation in Decision Making

Why Engage The Public?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

Original Wingspread Original Wingspread Planning GroupPlanning 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)

Original Wingspread Original Wingspread Planning GroupPlanning 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)

Post-Wingspread Steering Post-Wingspread Steering CommitteeCommittee

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

The Group Worked In A New The Group Worked In A New Way To Help Create A New Way To Help Create A New

Way of Working 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

ChronologyChronology

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

ChronologyChronology

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

continued

Principles of Good Public Principles of Good Public EngagementEngagement

(Adapted From OECD)(Adapted From OECD)

Commitment

Training & Guidance

Clarity

Linkage

Accountability

Transparency

Timing

Resources

Information

Equity

Representation

Dialogue

Participants

Independence

Evaluation

Key Features Of Enhanced Key Features Of Enhanced Process IProcess 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

Key Features of Enhanced Key Features of Enhanced Process IIProcess 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

Key Features of Enhanced Key Features of Enhanced Process IIIProcess 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

Key Features of Enhanced Key Features of Enhanced Process IVProcess 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

Key Features of Enhanced Key Features of Enhanced Process VProcess 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.

Key Features of Enhanced Key Features of Enhanced Process VIProcess 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.

The Options Considered and The Options Considered and The Support GarneredThe Support Garnered

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

Preferred OptionPreferred 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

Feedback

Stakeholders

Analyses

NVAC WGReport on

Decision Options

Dialogue

IncreasedMutual

Understanding

Tracking

Increased Accountability

Staff

VPACNVAC WG as part of an IOM RoundTable (Tier 1)

Inputpending

decisions Inputwith public judgment

Fed Govtvia NVAC

GeneralPublic

(Tier 2) Outreach

on decisions taken

Stakeholders

GovernmentHealth Professionals

Organized PublicIndustry

Where We Have Come ToWhere We Have Come ToII

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

Where We Have Come ToWhere We Have Come ToIIII

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…)

Where We Have Come ToWhere We Have Come ToIIIIII

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

Key MessagesKey MessagesII

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

Key MessagesKey MessagesIIII

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

Key MessageKey MessageIIIIII

The benefits are very worth having…and the risks worth taking.

What Will Success What Will Success Look Like?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...

What Will Success What Will Success Look Like?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.

AcknowledgementsAcknowledgements

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

Thank youThank you

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

Extra SlidesExtra Slides

Drivers For The ProjectDrivers 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

Familiar Examples of Familiar Examples of Public ParticipationPublic Participation

FOIA documents Hearings Public meetings Public comment periods Open public meetings Consumer representatives on advisory committees Focus groups Public opinion surveys Workshops

Unfamiliar Examples Of Unfamiliar Examples Of Public ParticipationPublic Participation

Deliberative Polling

Citizens Advisory Committees

Citizens Juries

Policy Councils

Consensus Building Exercises

Examples Of Design Choices Examples Of Design Choices Wrestled WithWrestled 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

Intermediate Outcomes

Final Outcomes

Dialogue MutualUnderstanding

Problem Solving Capacity, Trust,

Decision Analysis

Ownership, MutualUnderstanding,

Qual. of Thinking

Support, Effectiveness,

Trust

Outreach to General Public

Understandingabout Vaccines

Relevance, Support, Trust

TrackingUnderstandingof Decisions,

Accountability

Support, Credibility, Trust

Logic ModelLogic Model

Increased Public

Participation

Examples of Situations Suitable Examples of Situations Suitable for VPACfor VPAC

Decision truly not made yet Decision not urgent Values at issue, not facts alone Really want input not just consulting for

appearances

Examples of Potential VPAC Examples of Potential VPAC IssuesIssues

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?

Myths about VPACMyths 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

Fears about VPACFears 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

Anticipated OutcomesAnticipated 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

ChallengesChallenges

1. Lip service vs real commitment and resources

2. Sharing power on decision making

3. Convincing that public participation improves decisions

4. Proving that public participation improves decisions at a price worth paying and a level of effort worth making

ChallengesChallenges

5. Dealing with complexity and technical topics

6. Picking suitable decisions to analyze

7. Dealing with the timing of decisions

8. Finding funding

9. Shifting the paradigm to see the public as a resource not a drag

continued

ImplicationsImplications

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.

VPACVPAC “Working Together For Wise

Decisions About Vaccines”