1. Accountability for Reasonableness in Priority Setting: Theory and Applications Norman Daniels, Harvard School of Public Health Rotterdam, Netherlands, December 9, 2010

2. Overview The Problem: In designing and modifying benefit packages and setting other priorities for allocation in health we encounter conflicting needs, limited resources, and reasonable ethical disagreements about what priorities to set (conflicting ethical goals) Existing economic tools aim at maximization, efficiency, generally ignore fairness and other ethical concerns Procedural justice--why and what Provide legitimacy and possibly fairness in the face of disagreement Accountability for Reasonableness--a proposal Some applications

3. Bottom Line Fair, deliberative (and participative) process is needed to assure legitimacy and fairness given reasonable disagreement about design of benefit package, setting priorities inclusions/exclusions and other resource allocation decisions 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. Conflicting ethical goals 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 Reasonable ethical disagreement

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 Consider a group of patients with worst prognosis without treatment - -the “worst off” We can give a) no priority to them, b) maximum priority to them, or c) something in between If treatment has little effect, many want to give no priority (or get bottomless pit); if treatment has big effect, many want to give more priority CEA favors no priority, contrary to public concerns that we give some priority Reasonable disagreement about how much to give

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. Types of Procedural Justice Impure (have principle, need process to apply it) criminal trial cake at birthday party Pure (no prior agreement on principle, outcome of fair process is fair) example: gambling--unconstrained, not defeasible A4R: constrained, defeasible

11. 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)

12. A4R: Remarks (1) Strong publicity requirement compared to market rationale, but middle ground on explicit vs implicit debate Relevant reasons: consensus on what reasons are relevant, but different weights allowed--losers cannot say decision based on wrong or irrelevant reasons Due process-- included in revisability

13. A4R: remarks (2) 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)

14. 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

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

16. 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

17. International Experience with A4R US-- little uptake (land of death panels) US-- little uptake (land of death panels) 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--catastrophic insurance, IMMS formulary (proposal to be described) Mexico--catastrophic insurance, IMMS formulary (proposal to be described)

18. Figura 1. Propuesta para la Priorización de Intervenciones Alto Costo (1) CLÍNICO(2) ÉTICO 1. Priorización numérica cuantitativa 4. Consulta a representantes de la sociedad civil (1) ECONÓMICO (4) ACEPTABILIDAD SOCIAL 2. Opinión cualitativa sobre priorización numérica clínica y económica 4. Analiza y emite opinión sobre los resultados de los grupos clínico, económico, ético y aceptabilidad social y presenta al CSG (5) Consejo de salubridad General 6. Recibe opinión y recomendaciones sobre priorización del CSG 5. Emite opinión final sobre la priorización de intervenciones de alto costo y envía a CNPSS (3) Comisión para Definir Tratamientos y Medicamentos (6) Comisión Nacional de Protección Social en Salud

19. Three further apps Reducing health inequalities, since we encounter unsolved rationing problems in trying Supplementing human rights based approach to health other policy disagreements --e.g., identified vs statistical victims

20. Further research Is it “better”--for what? how to measure? “better decision-making”-- better in what way? how should stakeholder participation be managed? Impact on legitimacy-- should be measurable, but difficult Impact on fairness-- may itself be contested

21. Summary Benefit design, other priority setting 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, to different political cultures Difficult element is stakeholder participation Varied international uptake in A4R--need better evidence it “works”