HEALTH POLITICS IN EUROPE IN THE HIA ERA

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HEALTH POLITICS IN EUROPEIN THE HIA ERA
Isabel de la Mata Principal Advisor Public
Health European Commission DG SANCO
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Health and Consumers DG Europe working for
healthier, safer, more confident citizens
Food safety
Public Health
Consumer Affairs
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THE CONTEXT

• "For our own and future generations to continue
  to enjoy a high-quality of healthy life,
  underpinned by Europe's unique social models, we
  need to take action now".
• Europe 2020 Strategy

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EUROPEAN RENEWAL STATE OF THE UNION 2011

• Stability
• Growth
• Discipline
• Solidarity

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• Competitive, inclusive, resource-efficient way
• Deepen economic coordination and integration
• Economic Union
• Commission as guarantor of fairness
• Economy strong if delivers Growth and Jobs
• Innovation
• Smart regulation
• Fundamental values

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SERVICES RESPONSE

• Guarantee quality
• Prioritise
• Best use of resources
• Growth enhancing measeures
• Implementing in full the policies and legislation
  already decided
• Better regulation

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CASE STUDY

• GREECE!!

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Health Response

• Smart and sustainable healthcare systems
• More high quality with less resources
• Innovation (not just technology)
• Prevention
• eHealth and HTA

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• Smart investment
• European Semester Objectives Europe 2020 health
• Health productivity, competitivity, jobs, growth
• Smarter, inclusive and more sustainable Europe by
  2020

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Health for growth

• Strengthening the link between economic growth
  and healthy population
• Promoting health and preventing diseases
• Innovative, efficient and sustainable health
  systems
• More access to better and safe healthcare for EU
  citizens
• Protecting citizens from cross border health
  threats

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• Mainstream health concerns into other policies
  and Funds
• Future Cohesion funds prposal all EU Regions to
  invest in health
• Ehealth, medical equipment, infrastructure,
  access to high-quality health care, healthy
  ageind, training
• Bridging health inequalities, integrated health
  systems

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• Innovation
• Innovation
• Innovation

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• In the ways of running health systems
• In how to spend money on health
• In technology

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EC IMPACT ASSESSMENT

• 2005 Guideliness
• Revised 2009
• No HIA as such
• Health impacts horizontal, but part of the
  social impact chapter

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IA

• Necessary for
• Legislative proposals with significant economic,
  social and environmental impacts
• Non legislative initiatives which define future
  policies
• Certain implementing measures

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Analysis of Impacts

• Environmental

• Economic

• Social

Risk-assessment
Costs-effectiveness analysis
Cost-benefit analysis
Sensitivity analysis
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Integrated approach to IA health part of all 3
pillars

• 3-pillar approach (economic, social,
  environmental)
• Health and Safety impacts (IA Guidelines list
  under Social pillar)
• The health and safety of individuals/populations,
  including life expectancy, mortality and
  morbidity, through impacts on the socio-economic
  environment (working environment, income,
  education, occupation, nutrition)?
• The likelihood of health risks due to substances
  harmful to the natural environment?
• Noise, air, water or soil quality?
• Energy use and/or waste disposal?
• Lifestyle-related determinants of health such as
  diet, physical activity or use of tobacco,
  alcohol, or drugs?
• Specific effects on particular risk groups
  (determined by age, gender, disability, social
  group, mobility, region, etc.)?

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Public health and safety

• Subsidiarity Test expanded - Necessity Value
  Added
• Reinforced role of the IA Steering Groups
• Strong focus on effective stakeholders
  consultation (EU Health Policy Forum)
• Supporting guidance on impacts related to SMEs,
  fundamental rights, consumers, regional etc.,
• Assessing non-market impacts in particular on
  environment and health
• Monetisation of non-market impacts WTP/VOSL
• Quantitative analysis of health impacts (monetary
  and non monetary) Healthy Life Years, QALY / DALY

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Assessing social impact public health and
safety

• Health impacts effect on peoples health
  public health systems
• e.g. financial crisis ? mental health problem ?
  money for HC ?
• Steps of assessment (Ch.7 in Guidance)
• Identification of possible impact and causal
  pathways determination of exposure to risk
  factors / health determinants
• e.g. list of impacts and causal links
• Identification of magnitude of effects on
  peoples health, health systems and
  distributional elements
• e.g. risk assessments, indicators and monitoring
  data
• Quantification / monetisation of impacts of each
  policy option (if possible)
• e.g. Healthy Life Years, QALY, DALY, as well as
  VOSL/WTP methods

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Non paper on valuation of health impacts in the
EC

• Important that health impacts are coherently and
  systematically taken account of in
  decision-making
• Quantification is possible
• Quantification is important for CEA but does not
  allow Cost-Benefit analysis (monetisation)
• CBA necessary in areas where reducing costs to
  zero would be disproportionately costly
• DG ENVI systematically monetises the valye of
  changes in health risk spread over large
  populations
• Perverse results if only Costs of illness (death
  would be a good result)

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Cost-effectiveness andCost-benefit analysis

• Analysis of methods for quantification and
  monetisation of health impacts / benefits
  theory and practice

Costs monetized
Quantification- Cost Effectiveness (Utility)
Analysis
Monetisation- Cost Benefit Analysis
Health outcome / benefit given, cost
optimizedExamplesQALY, DALY, Healthy Life
Years (HeaLY)IA ExamplesSmoke-free
environments, School Fruit Scheme
Health outcome / benefit monetized outweigh costs
ExampleCost-of-illness, Human CapitalVOSL
Willingness-to-pay ?EU 1-3mln US
1-10mlnIA Examples CAFE, Road Safety, Food
Labelling
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Public health and safety analytical problems
and challenges

• Problem definition
• Causality difficult analysis of complex policy
  issues, some solutions multi-factorial systems,
  indirect causation probabilistic or systemic
• Complexity of EU-27 divergent status
• Subsidiarity test added value and necessity
  test
• Policy options
• Identification of legitimate non-regulatory
  options proportionality (e.g. food safety
  acquis)
• Analysis of impacts
• Irregular quantification and monetisation of
  impacts
• Social welfare sum of individual welfares ?
• Behavioural science revealed vs. stated
  preferences

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Examples

• HIA of Wine production
• HIA on dietary fiber production
• CAP
• CAFE (Clean Air for Europe)
• REACH
• Proposal for a Regulation on the provision of
  food information to consumers

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The IA planning key steps
Problem definition (incl. subsidiarity) Data
needs Planning Resource needs (incl. ext study
02 support) Stakeholder consultations/IASG Partici
pants Lead Unit (Director HoUdesk), 02, A3,
A2, 01 other SANCO invite cabinet
IASG must review final IA draft before submitted
to IAB. Minutes of last IASG meeting should be
attached to IA submitted.
Preparation for oral IAB (based on IAB quality
checklist) Participants Lead Unit (HoUdesk), 02
other SANCO
Stakeholder Consultation / IASG / external IA
study (possibly)
Adoption proposal IA
Preparatory Meeting
Follow-up Meeting
IAB Submission
ISC translation
Kick-off Meeting
Mock IAB Panel
Evaluation (poss.)
Scoping Paper
IAB
Roadmap
N-18 Months
N-1 y
Jan N-1 y
N-2 Months
N-2/3 y
N-6 Months
N-3 Months
N
N-4 Months
Plan at least 4 weeks between initial meeting and
launch of ISC since IAB might request revision or
further work in IASG
4 weeks before IAB meeting
Incorporate input from IAB opinion Participants
Lead Unit (HoUdesk), 02 other SANCO
Identification of critical points Review
arguments/structure Participants Lead Unit
(HoUdesk), 02, A3, A2, 01 other SANCO
Based on no IAB resubmission
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Why An Impact Assessement?

• Helps the Commission to design better policies
  and laws
• Analyse significant impacts of different possible
  options
• Allow informed choice, takes into consideration
  advantages / disadvantages, trade-offs, synergies
• Transparency and consultation with Stakeholders
• Coherence of policies

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What is an Impact Assessment?

• Evidence-based for decision making prepares
  evidence for political decision-makers on the
  advantages and disadvantages of possible policy
  options by assessing their potential impacts
• Policy supporting tool a set of logical steps to
  be followed when preparing the policy proposals.
• It is a help for political decision-making, not a
  substitute for it.

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IAs Analytical Steps
1. What is the problem?
2. What are the objectives?
3.What are the policy options?
4. What are the likely economic, social and
environmental impacts?
5. How do the options compare?
6. How could future monitoring and evaluation be
organised?
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Problem definition

• Need for better understanding of the
  multidimensional interactions affecting health,
• Causality difficult analysis of complex policy
  issues,
• Complexity of EU-27 divergent status

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Subsidiarity and proportionality
Is EU action really necessary?
Is the EU level the most appropriate one? Whats
the added-value?
Are the measures proportionate to the objectives?
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On necessity and added value in health policy

• Cross-border aspects pandemics,patient rights,
• Negative effects when one MS acts alone and
  damages interests of others stock piles for flu
  vaccines
• Clear benefits stemming from economies of scale
  research on rare diseases
• Clear benefits for reasons of effectiveness
  common standards to ensure interoperability in
  e-health etc. data gathering, exchange of best
  practice etc.

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Comparison of different options

• Advantages and Disadvantages
• Identification of legitimate non-regulatory
  options
• Tools
• SWOT analysis
• Costs and Benefits
• Effectiveness, Efficiency and Consistency
• Threshold analysis

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Analysis of impacts

• Irregular quantification and monetisation of
  impacts
• Social welfare sum of individual welfares ?
• Use of Behavioural science
• Consideration of ethical issues - Amartya Sen's
  through Capabilities Approach offers one way of
  incorporating these elements in the analysis.
• Development or adaptation of new methods of
  assessments of unquantifiable impacts- tools from
  other social sciences (sociology, psychology)
  could be used.

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Data needs in policy-making
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Data is always a key issue

• Using our data partners
• Eurostat / WHO
• Existing academic studies
• EFSA opinions / EMEA/ECDC reports
• SANCO specific sources
• Consumer Market Score Board
• TRACES
• Health information

• Getting new data
• External consultant
• Consumer Focus Groups
• SMEs panel
• Industry data / Market research
• IPM
• Eurobarometer

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Consultation of stakeholders ..

• Essential part of policy-development process
• Enhances transparency
• Involve stakeholders from the beginning!
• Give Clear feedback on information received from
  stakeholders!