Access to Essential Medicines and Universal Health Coverage :

1. Access to Essential Medicines and Universal Health Coverage :

2. WHO Reform : 6 leadership priorities • Universal health coverage • Achieving the health related MDGs • Address NCDs • Implement IHR • Increase access to essential, quality-assured and affordable medical products • Reduce inequities by addressing SDH

3. WHO Essential Medicines and health products • Medicines • Vaccines • Medical devices • Diagnostics

4. Shaping a new WHO strategy and action plan • Universal health coverage • MDGs • NCD How we work • Advocacy, leadership, norms/standards , guidance • Supporting countries • Across the organization • Partnerships

5. “Universal health coverage is the single most powerful concept that public health has to offer” Dr Margaret Chan, Director-General of WHO, Address to the Sixty-fifth World Health Assembly, May 2012

6. What is Universal Health Coverage? • All people obtain the health services they need (including prevention, promotion, treatment, rehabilitation, and palliation), of sufficient quality to be effective; • The use of these services does not expose the user to financial hardship

7. Universal Health Coverage • No country fully achieves all the coverage objectives - and harder for poorer countries • But all countries want to : • Reduce the gap between need and utilization • Improve quality • Improve financial protection • Thus, moving “towards Universal Coverage” is something that every country can do

8. Universal Health Coverage

9. There is no standard package of HSS actions to progress towards UHC • Every country already has a health system • This is the starting point for any reform • Solutions need to be tailored to context • Key contextual factors (e.g. fiscal, public administration, political, cultural, etc.) condition both what can be achieved and what can be implemented • Country level analytic capacity is essential • Policy analysis linked to the specific reform agenda (hypotheses) • Much more than tracking standard indicators • Supporting this capacity and strengthening links to decision making is key role for us at country level

10. Why a focus on medicines and medical products ? • Between 20 % and 60 % of the health budget in LMIC goes to medicines/technologies expenditures • In LMIC countries, up to 80 to 90 % of medicines and medical products are purchased out-of-pocket as opposed to being paid for by health insurance schemes • In many LMIC out-of-pocket expenditures for health account for more than 50 per cent of total health spending • Average availability of selected generic medicines in LMICs: • public sector less than 42 % • private sector almost 72 %

11. Ten leading sources of inefficiency in health systems Ref: World Health Report 2010, Chapter 4

12. 1. Rational selection 3. Sustainable financing ACCESS 4. UHC and reliable health and supply systems 2. Affordable prices Access to essential medicines and technologies within UHC framework

13. Public Health, Innovation and Intellectual property • WHO Global Strategy and Plan of Action, WHA 61.21 • A public health based innovation agenda and new R&D models • Local production of medical products • Transfer of technology for local production ( vaccines, biologicals)

14. Support countries in the Regulation of medical products : Quality, Efficacy, Safety • Norms and standards • Licensing of manufacturers, wholesalers, pharmacies • Regular inspection, GMP • Registration of products • Regulate and control promotional activities • Safety, pharmacovigilance… • A regulatory system

15. Prequalification of medical products • Health systems depend a lot on availability of and access to safe, effective quality medical products • Increased international funding for priority health problems : GAVI, Global Fund, PEPFAR, UNITAID, UNICEF, … • Need for quality assured generics and more affordable medical products • Immunization, HIV/AIDS, TB, malaria, reproductive health, …..

16. Prequalification is NOT stand alone activity Many other technical work areas support and link to prequalification (medicines, vaccines, diagnostics and medical devices) • Outside EMP – Disease oriented departments/programs, IVB Department, Strategic Advisory Group of Experts (SAGE) on Immunization; Regional and Country Offices • Inside EMP – Norms and standards work/Quality Assurance, Safety/Vigilance, Activities to combat SFFC medical products, NRA strengthening, Policy, Innovation and technology transfer

17. Vaccines prequalified by WHO: Status 2013 (assured quality) 15 industrialized country mfrs 8 emerging economy country mfrs 29 manufacturers 129 pre-qualified vaccines used in 124 countries 64% total population

18. PQ Diagnostics and medical devices • Current priorities • HIV rapid tests • CD4 technologies • HIV Viral Load and Early infant diagnosis tests • Malaria rapid tests • Adult male circumcision devices • New Priorities • Hepatitis rapid tests • TB tests • Multiplex HIV-HCV and HIV-syphilis rapid tests

19. Regulatory collaboration and convergence • Global and Regional initiatives • ASEAN, EU, APEC, AMRH, PANDRH, … ICDRA • Common standards • Mutual recognition / fast track procedures • Pharmacovigilance collaboration ( WHO CC Uppsala) • SSFFC • Exchange information

20. Selection of Essential Medicines • First edition 1977 • Revised every two years • Now contains 462 medicines including children's medicines • Uses HTA approaches • Patent status NOT considered in selection • Over time has contained 5% to 10% patent protected medicines

21. Many Factors Influence Use of Medicines Intrinsic Prior Knowledge Scientific Information Habits Information Social &Cultural Factors Influenceof Drug Industry Treatment Choices Economic & Legal Factors Workload & Staffing Societal and health system Workplace Infra-structure Authority & Supervision Relationships With Peers Workgroup

22. Low public sector availability leads patients to the private sector, where medicines are unaffordable

23. Medicines supply systems in TANZANIA. 2007 United Republic of Tanzania ESSENTIAL MEDICINES ARVs MALARIA TB OI ARVs Ped REAGENT Blood safety (+ HIV test) VACCINES CONDOMS CONTRACEPTIVES MEDICAL SUPPLIES GOVERNMENT BILATERAL DONOR MULTILATERAL DONOR NGO/PRIVATE C O L U M B I A UN I TA I D CL I NTON GLOBAL FUND C S S C W H O S I D A N O R A D C I D A H A V A R D P E P F A R A X I O S P F I Z E R J ICA C D C G A V I C U A M M U N I C E F U S A I D W B A B B O T T GOVERNMENT Source Of Funds Procurement Agent/Body C L I N T O N H A V A R D E G P A F A X I O S U N I C E F A B B O T T C U A M M C O L U M B I A U S A I D TEC & CCT MEDICAL STORE C R S S C M S MOH & SW J I C A G A V I CROWN AGENTS T M A P C D C Point of 1st warehousing TEC &CCT MEDICAL STORE HOSPITAL CRS IMA AXIOS COLUMBIA CUAMM HEALTH FACILITY HOSPITAL Point of 2nd warehousing TEC &CCT REGIONAL/DISTRICT VACCINE STORE HEALTH FACILITY ZONAL MEDICAL STORE HOSPITAL TEC &CCT Point of Distribution ZONAL BLOOD SAFETY CENTRE DISTRICT STORE HEALTH FACILITY PRIMARY HEALTH CARE FACILITY HOSPITAL PATIENT

24. WHO Guideline on Country Pharmaceutical Pricing Policies • Should countries use price control measures to manage medicine prices? • Should countries adopt measures to control add-on costs in the supply chain? • Should countries promote the use of quality assured generic medicines as a strategy to manage medicine prices?

25. Key principles in implementation: • Countries should use a combination of different pharmaceutical pricing policies that should be selected based on the objective, context and health system. • Countries should make their pricing policies, processes, and decisions transparent. • Pricing policies should have an appropriate legislative framework and governance and administrative structures, supported by technical capacity, and should be regularly reviewed, monitored (including actual prices) and evaluated and amended as necessary. • In promoting the use of affordable medicines, countries should employ a combination of pharmaceutical policies that address both supply and demand issues. • If regulation of pharmaceutical prices is introduced, effective implementation will be required to ensure compliance (e.g. incentives, enforcement, price monitoring system, fines). • Countries should adopt policies to promote the use of quality assured generic medicines in order to increase access and affordability. • Countries should collaborate to promote exchange of information about policies, their impacts, and pharmaceutical prices.

26. Goals for policies on medicines and technologies towards UHC • Equitable access for patients to effective, safe and good quality medicines • Enhancing appropriate use of medicines for better health outcomes • Ensuring value for money, affordability and sustainability, and financial protection for patients • Balance with industrial policy objectives • Underpinning values : equity, solidarity, access, quality, participation

27. Thank you http://www.who.int/medicines