Medicines as Emerging Technologies: Unprecedented Opportunities & Continuing Disparity

1. Medicines as Emerging Technologies: Unprecedented Opportunities & Continuing Disparity Chitr Sitthi-amorn, MD PhD Institute of Health Research Chulalongkorn University

2. International Technology Development Unprecedented Opportunities • Late 1890s: aspirin was the only drug manufactured on a large scale. • Since 1940s: • Vaccines & full range of magic drugs • Chronic diseases: DM, HT, CRF, ESRD, gene therapy • Lifestyle drugs: Viagra • People, even the poor, can expect to live longer than Kings and Emperor of the past

3. Medicine Development Continuing Inequity • R&Dof new medicines has favored the problems of the rich (Of the 220+ new chemical compounds developed in the last 20 years, only 10+ have been targeted for problems of tropical diseases – WHO EBM) • Dengue vaccine • MDR strains complicate R&D: Effective drugs more expensive & more inequity.

4. Inequities of Disease Burden Source: Global Forum for Health Research (2000)

5. Inequities: Inverse Care Laws 1.Health care resources: the rich consume more hospital and PH care than the poor, despite less need (Hart 1971) 2. PH and preventive care: immunization coverage is strongly correlated with socioeconomic status (Gwatkin, 1999) 3. Financial risk: the poor that access drugs and services risk medical impoverishment ( Liu and Hsiao, 1997). 4. Poor people still live without medicine. Poor health status parallels poverty.

6. Inverse Care Law: Multifactorial • Private sector growth • Growth of Doctors in private hospitals • Growth of MOPH budget for investment • Increase in Specialists: • Increase in ‘Big Ticket’ equipments • Increase in Imported Drugs & Profits • State responsibility >> Ability to pay

8. Spending on Drug by People:Out of Pocket Payment

9. Key Challenges • Value of Health Systems and Health Research System: • Equity vs. ability to pay • The focus • The Strategies

10. 1. Value: Equity & Ability to Pay

11. 2. The Focus • Settings or Areas where problems are: • Country, areas or settings, Inter-country • Actors: • Government, NGOs, Academic, Intended Beneficiaries, Donors & Development agencies • INRUD (MOH, NGOs, etc) vs. DAP • Issues: Need based equitable access

12. The Strategy: Modified Equity Gauge Pillars Research and monitoring Interventions Empower Social Processes Empower Political Process • Drug Development & Import • Country ED; Registration & De-registration • Facilities • Provider & Consumer’s Behavior • Illnesses Pattern • Existing tools: • New tools and methodology • Evidence Based aimed at inequity • Capacity: • Informing stakeholders • Shaping Public Debate • influencing decision-makers • Raising awareness • Engaging communities • Training & skill development for change agents

13. First Pillar: Some R & M Examples • The National & International Level • NDP formulation & Implementation • The EDL, Registration and Deregistration • The Facility Levels • Indicators for assessing RUD • STG; DUE • Providers and Consumers Levels • ADR, drug interactions, access to IT • New Indicators Needed

14. Signs & Symptoms Diagnosis (Health Problems) Rx Rx Treatment & Referrals (Responses) Rx Technology Plan Rx Adherence (Compliance) Clinical Outcome Rx = focus of standard treatments Guidelines: A Strategy to Influence Technology at Health System & Practice Levels

15. Research & MonitoringExample from India..1 • List of ED published by EBM Committee • Two envelop pooled procurement system by a standing Special Purchase Committee • Quality assurance system for drug products. • Training on Rational Use • All Hospitals procure 90% of drugs from ED & Physicians asked to prescribed ED • STG developed and disseminated • Parliament approval of “Magic Remedy Act” • Regular updates to doctors on quality etc Roy Chaudhury 2002

16. Research & MonitoringExample from India..2 • Fall in drug price from 20%-60% • % of available drugs actually dispensed to patients improved from less than 22 to more than 70 in all hospitals. • Availability of key drugs improved from less than 50% before PP to more than 90% after PP. • % Generic prescription improved from less than 40% in 1995 to more than 80% in 2000. Roy Chaudhury 2002

17. Second Pillar: Intervention • Existing tools: • PRDU, NDP, Mgt Supply, Store Mgt, PTC • New tools and methodology • Effectiveness of EB Interventions aimed at INEQUITY, including PPP & franchising • ARV use (DOTS?), Hospital RUD indicators • Capacity: • Supply & Demand side • Institution & Individual • Development and Retention

18. Cochrane Collaboration www.Cochrane.org To help people make well informed decisions by preparing, maintaining and promoting access to systematic reviews of studies on the effects of health and health care practices and policies. Campbell Collaboration [C2] www.Campbell.org To help people make well informed decisions by preparing, maintaining and promoting access to systematic reviews of studies on the effects of educational, legal and social interventions upon health.

20. Cochrane and Campbell collaboration proposed Methods Group • Cochrane & Campbell: To identify interventions that improve the health status of the poor and reduce health inequities • Series of systematic reviews on effective interventions • Role of WHO, MSH, INRUD & countries in development and refinement of new tools • New inter-country cooperation vs. parent-children relationship

21. Capacity: Supply Side • Knowledge: Individual & Institution • Generation, Access, Collation, translation, application, monitoring & evaluation • System leadership & management: • Stewardship; Management; Leadership • Partnership: Negotiations; teamwork; IEC • Resource mobilization & allocation based on society values (funding based on local plan) • Understanding & upholding ethics & EQUITY • Renewal of HR –New younger generation

22. Capacity: Demand Side • Knowledge Users: • Policy makers; Practitioners; Public & Communities • Potential Research funder • Development Agencies (ICIUM recommendation) • Investors: Pharmaceuticals & Private Hospitals. • Corporates, Media, Other Programs.

23. Capacity Example Situation of Testing for Drug Quality • Most drugs are imported, multiple ports of entry & inadequate inspection • Unregistered drugs are available. • Local pharmaceutical production is typically not GMPcompliant • Resources for marketplacesurveillance are extremely limited. • Drug problem reporting is limited • Counterfeit products & General concerns about drug quality.

24. Capacity Example: Access to Information • While patients in developed countries can enjoy Consultation On-line: • A second opinion • Many resources are available & convenient on internet • Privacy when seeking information on embarrassing issues • People in developing countries are disadvantageous.

25. Third Pillar: Empower Political Process • Secure evidences • Informing stakeholders • Shaping Public Debate • Influencing decision-makers & resource allocation: use politics to support policies >> upscaling • A full range of intervention

26. Fourth Pillar: Empower Society • Raising awareness & Public Advocacy • Engaging communities & societies • Training and skill development for change agents or prime movers • A full range of intervention

27. Example: Empower Politics & Society EB Guide, Comply, Stock, Refer Technical, Admin, Financial

28. Empower Politics & SocietyThe Range of Intervention Target High Risk Behavior National Policies Tax Incentives Social Norms Health Promotion Programs Vaccine Medicine Combination Complication Adherence Target Society Behavior & Values Biological marker Individual Screening & Rx Public Health Community Infrastructure DOWNSTREAM Prevention and Curative Focus UPSTREAM Healthy Public Policy

29. Conclusion • The EQUITY approach to health recognizes that health is a capacity or resource for everyday living, not just a state, • This broader notion of EQUITY recognizes the range of social, economic and physical environmental factors that contribute to health, & will need values, focus & 4 pillars. • RUD is a link in the chain of health. A chain has never been proven stronger than its weakest link –RUD & incentive structures