View on Existing Models, Applicability and Limitations: Public Health Perspective

The European Commission s science and knowledge service Joint Research Centre View on Existing Models, Applicability and Limitations: Public Health Perspective Jan Wollgast ILSI Europe Workshop Identifying Preferred Approaches for Quantifying the Health and Economic Impact of Modifying Nutrient Intakes - Brussels, 07/04/2017 Disclaimer: This presentation and its contents do not constitute 4an official position of the European Commission or any of its services. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of this presentation or its contents

Public health perspective on existing models - link to workshop objectives Objectives: To identify "[ ]preferred model /modelling approaches to estimate the health and economic impacts of changes in the nutritional composition of foods or changing food and nutrient intake" Expected outcome: Recommendations for models "[ ] to make informed decisions for action, and to help to estimate the potential health and economic benefits of modifying nutrient intakes and help achieving global dietary recommendations." 2

Outline Health & economic burden of disease in the EU Public health policy/decision making EC Better Regulation guidelines & toolbox Case study: Trans fatty acids in the EU Methodological considerations for public health/nutrition economics "Nutrition policy" in the EU focus food composition 3

Burden of disease in the EU The health burden in the EU for: CVD -> 49 million living with CVD (European Heart Network, 2017) Cancer -> 2.7 million new cases of cancer diagnosed (OECD, 2016) Diabetes -> 7% of EU population (OECD, 2016) The economic burden in the EU for: CVD -> 210 billion EUR (European Heart Network, 2017) Cancer -> 126 billion EUR (Luengo-Fernandez et al, Lancet, 2013) Diabetes -> 100 billion EUR (OECD, 2016) Chronic diseases account for approx. 70-80% of healthcare budgets (European Commission, 2014) 1.3 TRILLION the avoidable costs of health inequalities across the EU Spending on disease prevention accounts for only 3% of total health spending (OECD, 2016) 4

DALYs attributable to metabolic risks in the EU High bodymass index High fasting plasma glucose High systolic blood pressure High total cholesterol Low bone mineral density Impaired kidney function Institute for Health Metrics and Evaluation GBD 2015 2017 University of Washington: http://vizhub.healthdata.org/gbd-compare/ 5

DALYs attributable to dietary risks in the EU Diet suboptimal in calcium Diet low in whole grains Diet low in vegetables Diet low in seafood omega-3 fatty acids Diet low in polyunsaturated fatty acids Diet low in nuts and seeds Diet low in milk Diet low in fruits Diet low in fiber Diet high in trans fatty acids Diet high in sugarsweetened beverages Diet high in sodium Diet high in red meat Diet high in processed meat Institute for Health Metrics and Evaluation GBD 2015 2017 University of Washington: http://vizhub.healthdata.org/gbd-compare/ 6

What public health is Public health is defined as the art and science of preventing disease, prolonging life and promoting health through the organized efforts of society (Acheson, 1988; WHO). Main public health challenges for Europe: economic crisis; widening inequalities; ageing population; increasing levels of chronic disease; migration and urbanization; and environmental damage and climate change. http://www.euro.who.int/en/health-topics/health-systems/public-health-services/public-health-services 8

Policy/decision making in public health Justify action under competing use of (public) resources Evidence-based/non-discretionary Defend against alternative use of resources Need to assess and compare impacts of policy options (including non-action) ex-ante Often complex multifactorial issues Multiple actors Multiple policy areas concerned 9 Source: JRC Foresight study Tomorrow s Healthy Society Research Priorities for Foods and Diets.

Better regulation guidelines Better Regulation Guidelines (SWD(2015)111final) "ensure that political decisions are prepared in an open, transparent manner, informed by the best available evidence" "impact assessments must compare the policy options on the basis of their economic, social and environmental impacts (quantified as far as possible)" http://ec.europa.eu/smart-regulation/guidelines/toc_guide_en.htm 11

Better regulation toolbox -> complements the main guidelines on Better Regulation -> provides more specific and operational guidance Chapter VIII: -> summarises methods to identify, assess and quantify costs and benefits and provides insight into how to use Visual Aids and present quantitative data. http://ec.europa.eu/smart-regulation/guidelines/toc_tool_en.htm 12

Providing scientific support (including modelling) to impact assessments Science (models) Science (models) Science (models) http://ec.europa.eu/smart-regulation/guidelines/tool_8_en.htm 13

"Case study": Reducing trans fatty acids (TFA) in foods and diets in the EU population The "problem" of TFA in the EU High TFA intake increases risk of Coronary Heart Disease Sources of TFA: i) natural (ruminant), ii) industrial (partially hydrogenated vegetable oils, PHVO) PHVO have many technological benefits for food industry Alternatives to PHVO are widely available today Recommended intakes: < 1 % of energy intake (WHO) As low as possible within an adequate diet (EFSA) Presence of TFA in food and diets in EU are greatly reduced, however products with high TFA remain and some parts of the population may be at relevant risk

European Commission initiative to limit industrial trans fats intakes in the EU -> Inception Impact Assessment published (October 2016) http://ec.europa.eu/smart-regulation/roadmaps/docs/2016_sante_143_trans_fats_en.pdf Policy options: Option 0 No EU policy change (baseline scenario) Option 1 Establishment of a limit for the industrial trans fats content in foods Sub-option 1a: a voluntary agreement Sub-option 1b: a legally-binding measure Option 2 Introduction of the obligation to indicate the trans fats content of foods in the nutrition declaration Option 3 Prohibition of the use of partly hydrogenated oils (PHO) in foods Sub-option 3a: a voluntary agreement Sub-option 3b: a legally-binding measure

Assessing economic, social, and environmental impacts of policy options Issues to be addressed/considered: Public health benefits Burden (costs) to food industry (SMEs) Technological alternatives Costs to the public Food prices Consumer literacy/motivation Health inequalities Environmental impacts Trade Functioning of the internal market Competitiveness/Innovation Proportionality of measure

Public health economic evaluation of different European Union level policy options aimed at reducing population dietary trans fat intake Objective and approach: To assess the added value of EU-level action by estimating the costeffectiveness of 3 possible EU-level policy measures to reduce population dietary TFA intake. This was calculated against a reference situation of not implementing any EU-level policy (i.e., by assuming only national or self-regulatory measures). Findings: Either a legal limit or voluntary agreements may provide added value by providing health benefits and savings to the public. The legal limit option is projected to provide the greatest health benefits. Mandatory TFA labelling may also provide some additional health benefits; however, this would likely not be a cost-effective strategy. Am J Clin Nutr 2016;104:1218 26; http://dx.doi.org/10.3945/ajcn.116.136911

Methodology for economic evaluation of TFA policy options Study perspective: -> Societal perspective including direct health care costs (government), other direct costs (interventions from government), indirect costs (incurred by patients) and loss of productivity Model: -> Computer-simulated, state-transition (Markov cohort) model Time horizon: -> life-time Discounting rate: -> Costs and effects were discounted at 3.5%/yr Dealing with uncertainty: -> Probabilistic sensitivity analysis (PSA) & 3 alternative scenarios of initial population TFA intakes

Selected suggestions from a JRC workshop on public health economics Challenges in establishing (and modelling) causal links between interventions, nutrient intakes/diet, risk factors, disease and mortality (often multifactorial and complex) Cost-effectiveness (cost-utility) analyses (CE(U)A) most developed and widely used (societal perspective preferable) Some limitations of CEA/CUA for use in nutrition/public health economic evaluations, e.g., measures "only" the health but not overall societal value of public spending Equity considerations need to be encouraged 21 https://ec.europa.eu/jrc/en/event/workshop/public-healthand-nutrition-economics-numbers-behind-prevention

Selected suggestions from a JRC workshop on public health economics cont'd Cost-benefit analysis could be an alternative to CEA/CUA, but has other shortcomings and needs development for application to public health evaluations Multi-criteria decision analysis was suggested to provide guidance for decision making -> Combination of different approaches for better informed decision making? Promote 'sound/responsible' use of modelling/quantification (see also p393 of Better Regulation Toolbox) Communicate openly and honestly the extent to which particular models can be used to support policy decisions and what their limitations are 22 https://ec.europa.eu/jrc/en/event/workshop/public-healthand-nutrition-economics-numbers-behind-prevention

Reflections on the outcomes of the economic evaluation of TFA policy options Study limitations: high uncertainty and lack of data on current TFA intake; wide variability for many parameters between countries; lack of data, such as the number of CHD events per year (CHD-related hospital discharges were used instead). Nevertheless, the study outcome is a comparison between different policy options The 'ranking' of the options in terms of their incremental cost-effectiveness over reference scenario (no EU-level action) are robust Emphasis put on policy option's relative performance rather than 'absolute numbers' for costs and health benefits Reminder: A cost-effectiveness analysis is a specific framing provides only one element to be considered when comparing policy options! need to assess key economic, social and environmental impacts of the alternative TFA policy options

Selected suggestions from the EConDA (Economics of Chronic Diseases) project "The key findings of the consensus meeting were: Various measures of cost-effectiveness should be used. A societal perspective should be taken to account for costs beyond healthcare. Country-specific measures of cost-effectiveness should be included where possible. It is sometimes a challenge to source the necessary data to generate the most accurate estimates on costeffectiveness of interventions." (from the EConDA final project report: http://www.econdaproject.eu/publications_23_4222484709.pdf ) 24

EU policy frame and current focus on food reformulation/ food product improvement EU strategy on Nutrition, Overweight and Obesity-related health issues Saturated Fat Annex Added Sugar Annex Roadmap for Action on Food Product Improvement 2008 2011 2007 2012 2015 EU Action Plan on Childhood Obesity EU Framework for National Salt Initiatives EU Framework for National Initiatives on Selected Nutrients 26

Monitoring & Evaluation RECOGNISES THAT [ ] 25. Regular, transparent, credible and independent monitoring of product composition is essential for insight into the market situation and into the results of actions undertaken. CALLS UPON THE COMMISSION TO [ ] b) [establish] working groups with experts from both Member States and stakeholders within the EU Platform for Action on Diet, Physical Activity and Health: to work on improving the methodology, quality and share the results of monitoring activities 35. Continue to support the improvement of the scientific basis, monitoring and data collection and sharing at EU level regarding improved products, consumption and new production methods. Monitoring of progress to be outlined with the Joint Action on Nutrition and Physical Activity (JANPA) coordinated by France and to be seen in the light of the work of ongoing activities of WHO Europe, the European Commission and the Joint Research Centre (JRC). 27

Many questions to be addressed Impact of 10% added sugars reduction in food products by 2020 (against 2015 baseline)? Impact of 10% saturated fat reduction in food products by 2020 (against 2012 baseline)? Impact of continued effort towards reduction of salt in food products Impact of increased use of whole grains in food products Impact of food reformulation/product improvement overall? Overall impact of voluntary/self-regulatory measures? Impact on? Nutrient intakes Overall diet Metabolic risk factors (including (childhood) obesity) Chronic disease Direct/indirect costs Economic, societal, environmental impacts

Food composition is only one of the aspects of a multifactorial public health policy approach http://www.thelancet.com/series/obesity-2015

Outline (recap) Health & economic burden of disease in the EU Public health policy/decision making EC Better Regulation guidelines & toolbox Case study: Trans fatty acids in the EU Methodological considerations for public health/nutrition economics "Nutrition policy" in the EU focus food composition 30

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