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Vaccine Decisions: Policy Making and Priority Setting in Canadian Health Care Systems Charlotte Moore Hepburn, MD, FRCPC, FAAP Lead, Child Health Policy Initiative Faculty Pediatrician, Division of Pediatric Medicine, The Hospital for Sick Children Assistant Professor, Department of Pediatrics, University of Toronto School of Medicine

Objectives Structure of Canadian health care system Processes supporting evidence-informed policy Challenges with evidence-informed policy-making Realities of priority setting in publicly-funded health care systems

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The Greatest Canadian

Canadian Constitution VI. DISTRIBUTION OF LEGISLATIVE POWERS ARTICLE 91: o Powers of the Parliament ARTICLE 92: o Exclusive Powers of the Provincial Legislatures

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Vaccine Decisions (1) Approval for Use Health Canada (Biologics and Genetic Therapies Directorate) Federal Recommendations for Use National Advisory Committee on Immunization (NACI) Federal Recommendations for Policy and Program Development Canadian Immunization Committee (CIC) National (F/P/T) Decisions regarding Public Funding Ministries of Health Provincial/Territorial

Vaccine Decisions (2) Procurement Public Works and Government Services Canada (PWGSC) Federal Monitoring for Post-Market Vaccine Safety Health Canada (Biologics and Genetic Therapies Directorate) Federal Surveillance for Vaccine-Preventable Disease Ministriesof Health Provincial/Territorial Measuring Vaccine Coverage Ministries of Health Provincial/Territorial

Recommendations for Use National Advisory Committee on Immunization (NACI) Federal All-volunteer, scientific advisory committee o o Experts in pediatrics, infectious disease, immunology, medical microbiology, internal medicine, public health Serve in disease-specific working groups Supported by the Public Health Agency of Canada Approached by manufacturers, governments, scientific community Offer recommendations for the use of vaccines currently or newly approved for use in humans in Canada o Including definition of vaccine schedules, catch-up schedules, and identification of at-risk groups for whom vaccine programs should be targeted

Recommendations for Use National Advisory Committee on Immunization (NACI) Federal Scientific Recommendations Only No economic analysis No policy or program delivery-related recommendations No funding-related decision-making authority Aims to: o Influence clinical activities (noting medial-legal implications) o Influence P/T jurisdictions

Recommendations for Policy and Program Development Canadian Immunization Committee (CIC) National (F/P/T) Federal/Provincial/Territorial delegate body o Experts in public health and public health policy Supported by the Public Health Network Council, reporting to the F/P/T Deputy Ministers of Health Provides policy and program recommendations related to the implementation of publicly funded vaccine programs

Structured Approach to Policy and Program Analysis 16

Erickson-DeWals Criteria Burden of Disease Outstanding Research Vaccine Questions Characteristics Equity Strategy Selection Ethical Considerations Cost-Effectiveness Legal Considerations Acceptability Program Conformity Feasibility Political Considerations Capacity to Evaluate

Recommendations for Policy and Program Development Canadian Immunization Committee (CIC) National (F/P/T) Science into Policy Recommendations Provide economic analysis Provide policy and program delivery-related recommendations No funding-related decision-making authority Aims to: o o o Reduce duplication of effort across P/T jurisdictions Influence decisions of P/T jurisdictions Promote harmonization of immunization schedules across the country

Science Science-Informed Policy Advice NACI CIC Federal, all-volunteer expert body Scientific recommendations with scheduled public release Moral Authority National, F/P/T delegate body Policy and program recommendations consistent with F/P/T norms Enabled Collaboration No resource-allocation decision-making No formal linkage to vaccine procurement process

Science Science-Informed Policy Advice 13 Different Vaccine Schedules 13 Different Procurement Strategies

Science Science-Informed Policy Advice 13 Different Vaccine Schedules 13 Different Procurement Strategies http://www.phac-aspc.gc.ca/im/ptimprog-progimpt/table-1-eng.php

Decisions regarding Public Funding Ministries of Health Provincial/Territorial Hepatitis B: Birth, 1 month, 6 months First introduced 1995 Hepatitis B: Grade 4 First introduced 1998 Hepatitis B (DtaP-HB-IPV-Hib): 2 months, 4 months, 6 months First introduced 1992

Decisions regarding Public Funding Ministries of Health Provincial/Territorial ): 12 months No Rotavirus Vaccine Program Oral Rotavirus Vaccine: 2 months, 4 months

Decisions regarding Public Funding Ministries of Health Provincial/Territorial NACI Recommendation: ): 2 months, 4 months, 6 months 12 July months 2010 Statement No Rotavirus Vaccine Program Oral Rotavirus Vaccine: 2 months, 4 months

Three Streams 1 Problem Policy Politics Kingdon, JW. (1995) Agendas, Alternatives and Public Policies. Longman, London.

Informing the Political Stream Evidence Platform Commitments Stakeholder Advocacy Legislative / Legal Imperative THE POLITICAL STREAM Resources Media Attention Public Expectations Time 1 1. Mitton, C et al. Difficult Decisions in Times of Constraint: Criteria based resource allocation in the Vancouver Coastal Health Authority. BMJ Health Services Research 2011; 11: 169

Three Streams 1 Problem NACI Policy CIC Politics Provincial Jurisdictions Kingdon, JW. (1995) Agendas, Alternatives and Public Policies. Longman, London.

Three Streams 1 Problem NACI Policy CIC Politics Provincial Jurisdictions WINDOW OF OPPORTUNITY Occasional, Sudden, Brief Kingdon, JW. (1995) Agendas, Alternatives and Public Policies. Longman, London.

Decisions regarding Public Funding Ministries of Health Provincial/Territorial Policy recommendations into policy Provincial / Territorial variation in o Burden of disease Differences in local epidemiology, populations and immigration patterns o Capacity to finance new vaccine programs Differences in provincial health priorities / pressures o Capacity to articulate policy case for new vaccine investment Differences in public health / health policy processes and resources o Capacity to implement new vaccine program Differences in vaccine delivery models Informed by P/T-level Vaccine Advisory Bodies (i.e. PIDAC)

Decisions regarding Public Funding Ministries of Health Provincial/Territorial Policy recommendations into policy Variation in o Burden of disease Differences in local epidemiology, populations and immigration patterns o Capacity to finance new vaccine programs Differences in provincial health priorities / pressures o Capacity to articulate policy case for new vaccine investment Differences in public health / health policy processes and resources o Capacity to implement new vaccine program Differences in vaccine delivery models

Willie Sutton School of Public Policy Safe, Effective and Cost Effective = Necessary Not Sufficient

Decisions regarding Public Funding Ministries of Health Provincial/Territorial ): 12 months Funded HPV Vaccination Programs

Priority Setting in Publicly Funded Health Systems New Vaccine Programs Capital Enhancements for Public Health Laboratories Enhanced Communicable Disease Surveillance Public Heath Priority Innovative Chronic Disease Prevention Programming Enhanced Breastfeeding Supports and Services Increased Food and Water Safety Protection Officers

Priority Setting in Publicly Funded Health Systems New Vaccine Programs Expansion of Newborn Screening Services Child Heath System Priority Funding for Double Cochlear Implants Investment in School- Based Mental Health Services Improved Access to Level III NICU Care

Priority Setting in Publicly Funded Health Systems New Vaccine Programs Expansion of Telemedicine Services to Remote Communities Heath System Priority Improved Access to Level III NICU Care Investment in System- Wide Electronic Health Records Reduced Wait Times for Joint Replacement Surgery

Priority Setting in Publicly Funded Health Systems New Vaccine Programs Creation of Affordable Public Housing System Priority Smaller Elementary School Class Sizes Investments in critical elements of transportation infrastructure New Job Training Programs for Seasonal Workers

Favorable Vaccine Environments Prosperous economic conditions Opportunity for secondary economic gain Well organized political support o Industry Lobby o Public Health Lobby * o Provincial Medical Associations * o Child Health Advocates Aligned political commitments / priorities o Easily executed health promotion / disease prevention promises Leading cross-jurisdictional comparators Receptive public Compelling policy narrative

Measuring Vaccine Coverage Ministries of Health Provincial/Territorial 13 systems to measure vaccine coverage o Varied delivery systems o Varied IT capacity o Varied requirements regarding vaccine coverage reporting o Varied province-level health services research infrastructure New horizon = PANORAMA o Common data definitions o National-level public health data collection (partial participation)* Opportunity for important health services research o Need to discern differences in outcomes across jurisdictions