1. Participative Processes for Health Care Priorities: Why and How Norman Daniels, HSPH Santiago, Chile, October 5, 2010

2. Overview The Problem: Designing and modifying benefit packages encounters conflicting needs, limited resources, reasonable disagreements Existing economic tools aim at maximization, efficiency, ignore fairness and other ethical concerns Procedural justice--why and what Provide legitimacy in face of disagreement Accountability for Reasonableness--a proposal Participative processes--why and how

3. Bottom Line Fair, deliberative (and participative) process is needed to assure legitimacy and fairness given reasonable disagreement about design of benefit package inclusions/exclusions create winners and losers with different claims absence of consensus on principles means we need procedural justice (Just Health, Cambridge 2008; (with Jim Sabin) Setting Limits Fairly, Oxford 2002,8

4. The problem: benefit design Two goals of health policy: improving population health and distributing health fairly under resource limits Sometimes goals coincide but often in tension Competing public and provider demands on benefit increments--aging population, epidemiological transition, new technologies, access to information Decisions create winners and vocal losers

5. Limits of Economic Tools CER US: limited questions, political opposition Germany (IqWIG)--limited use, mainly for price negotiation CEA UK (NICE) and some Commonwealth and European Distributive insensitivity--(partial response: flexibility in threshold in NICE)

6. CEA vs. Fairness (equity) (why we should go beyond CEA) CEA FAIRNESS BO vs FC BOWeighted chances Priority to worst off None Some--varies Aggregation Any Some

7. Unsolved rationing problems (and CEA cont’d) extreme positions described by principle (CEA takes one), but not endorsed by many in between positions not described by principle, more acceptable to people reasonable disagreement about trade- offs (modified) form of pure procedural justice needed (no prior agreement on principle)--outcomes of a fair process count as fair (here only defensibly fair), enhances legitimacy if broad buy-in to process as fair

8. Example Suppose patient with worst prognosis without treatment is worst off We can give no priority to her, maximum priority to her, or something in between If treatment has little effect, tempted to no priority (or get bottomless pit); if treatment has big effect, tempted to a lot of priority CEA favors no priority, contrary to public concerns that we give some priority Reasonable disagreement about how much

9. Procedural justice: why If we have no prior agreement on principle regarding what is a fair or just allocation of resources, we may accept the outcome of a fair process as fair and legitimate (pure procedural justice)* presupposes we can better agree on fair process than on principle where there is disagreement on values, respect for the disagreement is important, and showing that respect in the process is key to establishing legitimacy for the decision * distinguish types of procedural justice

10. Accountability for Reasonableness (A4R) Publicity (transparency including reasons) Publicity (transparency including reasons) Relevant reasons (as judged by appropriate stakeholders) Relevant reasons (as judged by appropriate stakeholders) Revisability (in light of new evidence, arguments, appeals) Revisability (in light of new evidence, arguments, appeals) Enforceability (assurance that other conditions are met) Enforceability (assurance that other conditions are met)

11. A4R: remarks Process at various levels with adaptation of it to each level Conditions necessary (but not clearly sufficient) to assure legitimacy, fairness Considerable room to adapt to political culture (one size does not fit all)-- realizable to different degrees (more less transparent, revisable, etc)

12. A4R yields: Presumption of similar treatment for similar cases Presumption of similar treatment for similar cases Commitment to coherent use of reasons Commitment to coherent use of reasons “Similarity” defined by reference to reasons and principles “Similarity” defined by reference to reasons and principles Rebuttal Rebuttal Show relevant difference in cases Show relevant difference in cases Show rationale for revising principle Show rationale for revising principle Public record of commitments - behavior matches pronouncements Public record of commitments - behavior matches pronouncements Similar to case law Similar to case law resolving moral disagreement by deliberation, not mere vote resolving moral disagreement by deliberation, not mere vote

13. International Experience with A4R WHO equity guidelines for 3 by 5, Canada, Norway, Sweden--adopting features WHO equity guidelines for 3 by 5, Canada, Norway, Sweden--adopting features UK--NICE UK--NICE Mexico Mexico NZ NZ

14. Some Implications Implicit vs explicit rationing debate Divergent results of fair process Consumer voice--stakeholder participation Social learning curve Contribution to democratic deliberation

15. Stakeholder participation not for enhanced democracy, but for improved deliberation--broader consideration of arguments, more transparency can enhance buy-in because more voices included (so voices to be broadly relevant) especially important in publicly administered or heavily publicly regulated private schemes risks: pure lobbying, domination of debate, power intrudes and controls; avoid tokenism selection is key: relevant to level of decision

16. Publicity: Does decision-maker (at whatever level): Provide public access to full rationales Provide public access to full rationales Hold public hearings, wide consultations Hold public hearings, wide consultations Make rationales comprehensible Make rationales comprehensible Use stakeholder involvement in generating rationales to promote transparency Use stakeholder involvement in generating rationales to promote transparency Make public objections from other levels Make public objections from other levels

17. Relevant Reasons: Does Decision-maker: Gather relevant evidence Gather relevant evidence Distinguish ethical issues Distinguish ethical issues Welcome relevant stakeholders to deliberation Welcome relevant stakeholders to deliberation Support, empower stakeholders with info, respect Support, empower stakeholders with info, respect Respect disagreements, seek agreement Respect disagreements, seek agreement Deliberate about process for resolving disputes Deliberate about process for resolving disputes Develop rationales inclusive of points of disagreement Develop rationales inclusive of points of disagreement Give adequate room for local discretion and authority Give adequate room for local discretion and authority Insist on fair process at other levels Insist on fair process at other levels

18. Revisability: Does decision-maker: Invite disagreements from other levels Invite disagreements from other levels Respect need for iterative decision- making Respect need for iterative decision- making Assure decision-makers at other levels they have responsibility to raise objections, provide opportunity to do so Assure decision-makers at other levels they have responsibility to raise objections, provide opportunity to do so Assure appropriate stakeholders involved in revising decisions Assure appropriate stakeholders involved in revising decisions Provide mechanism for appeals Provide mechanism for appeals Use appeals to improve quality of decision-making? Use appeals to improve quality of decision-making?

19. Enforcement: Does decision-maker: Make itself accountable to lower levels for carrying out fair process? Make itself accountable to lower levels for carrying out fair process? Challenge decisions when fair process missing? Challenge decisions when fair process missing? Seek international agreements and national regulations on elements of fair process Seek international agreements and national regulations on elements of fair process Seek agreements across levels of decision- making on components of fair process Seek agreements across levels of decision- making on components of fair process

20. Summary Benefit design creates winners and losers, faces reasonable ethical disagreement To enhance legitimacy and assure fairness in benefit package design, there is need for fair deliberative process (A4R) Process adapted to various levels in system Key element is stakeholder participation Checklists for features of process