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Ensuring access to essential medicines in developing and least developed countries

This framework outlines the challenges faced in developing and least developed countries in terms of access to essential medicines. It provides a framework for collective action to address these challenges, including rational selection of medicines, sustainable financing, reliable health and supply systems, and affordable prices. It also discusses the importance of modernizing the essential drugs concept and promoting competition to reduce costs.

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Ensuring access to essential medicines in developing and least developed countries

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  1. Ensuring access to essential medicines in developing and least developed countries framework for action Jonathan D. Quick, MD, MPH Essential Drugs and Medicines Policy (EDM) World Health Organization (WHO) March 2002

  2. The challenge People are needlessly suffering and dying - medicines unavailable, unaffordable, unsafe, or wrongly used In Africa and S.E.Asia: • 1/2 of deaths among children, young adults due to 6 diseases • prompt diagnosis and treatment could save over3 million lives per year

  3. Transitional economies (15-30 %) Developing countries (24 - 66 %) Developed countries (7 - 30 %) The challenge In poorer countries drugs are largest household and second largest public expenditure for health Pharmaceutical spending, as % of total health spending Greece Germany Italy France Spain Denmark UK United States Netherlands Norway Bulgaria Czech Rep. Hungary Croatia Poland Estonia Slovenia Lithuania Mali Egypt China Indonesia Thailand Tunisia Jordan Argentina South Africa 0 10 20 30 40 50 60 70

  4. (36) 1 = <50% (36) 1 = <50% (68) 2 = 50-80% 3 = 80-95% (33) (41) 4 = >95% (1) 5 = No data available The challenge Access to essential drugs has increased from 2 to4 billion people in 20 years - but a huge gap remains Percentage of population with regular access to essential drugs (1997) Source: WHO/DAP (1998)

  5. 1. Rational selection 3. Sustainable financing 1. Rationalselection 3. Sustainablefinancing ACCESS ACCESS 4. Reliable health and supply systems 4. Reliable health and supply systems 2. Affordableprices 2. Affordable prices Access framework Ensuring access to essential drugs- framework for collective action

  6. WHO Clinical guidelines: - guidelines for guidelines - review of 200 guidelines Evidence-base: - reasons for inclusion - systematic reviews - key references WHO Model Formulary: - drug monographs Indicative cost information: - per unit - per treatment - per month - per case prevented Quality information: - basic quality and screen tests - international Pharmacopoeia - reference standards 1. Rational selection Modernizing the essential drugs concept -Creating a WHO Essential Drugs Library WHO Model List of Essential Drugs • 11th model list • 306 drugs

  7. Taxes & duties Retailer’s margin Distributor’s margin Producer’s price / Importer’s price 2. Affordable prices Many factors contribute to the final price of a drug Margins may be 20% to 80% of final price

  8. 2. Affordable prices Affordable prices - promote competition & reduce costs • price information • price competition - generic drugs of assured quality • price control - producer, distributor, retailer • reduce duties, taxes, markups • differential pricing of newer essential drugs • apply WTO/TRIPS safeguards as appropriate

  9. Drugs and diagnostics for HIV/AIDS • 82 drugs, 20 diagnostics - UNICEF, UNAIDS, and MSF • Pharmaceutical starting materials • 213 active ingredients - WTO and UNCTAD • Antiretroviral drugs • 3 information services for ARV prices in the Americas • AFRO Essential drugs • 300 products - 24 Member States 2. Affordable prices WHO indicative price information • MSH-WHO essential drugs price indicator • 499 products

  10. No competition Competition (2 to 6 producers per product) 2. Affordable prices Competition is highly effective in reducing prices - the example of antiretrovirals Source = UNAIDS, B. Samb, 2000

  11. 2. Affordable prices Building a large generic market takes time- and requires a combination of strategies National strategies for generics: 1. Supportive legislation & regulation 2. Reliable quality assurance 3. Professional, public acceptance 4. Economic incentives Percent of new prescriptions, U.S.

  12. 2. Affordable prices Declaration on the trips agreement and public health -WTO Ministerial Conference, Doha, November 2001 • Gravity of public health problems in developing countries • HIV/AIDS, tuberculosis, malaria, other epidemics • Intellectual property protection important for new medicines • Recognize concerns about effect on prices • TRIPS to be implemented in a manner, “to protect public health and to promote access to medicines for all.” • WTO Members have rights to use flexibilities: • Provisions to be read in the light of TRIPS objectives and principles • Compulsory licences and right to determine the grounds (solution to be found for non-producing countries) • Regime of “exhaustion” without challenge (“parallel imports”) WT/MIN(01)/DEC/W/2 , 14 November 2001, World Trade Organization, MINISTERIAL CONFERENCE, Doha, 9 - 14 November 2001

  13. Checklist for policy-makers: Globalization,TRIPS and access to pharmaceuticals • Government process and resources: • Identify focal point within Ministry of Health • Establish contacts, working group, with trade and other ministries • Develop mechanism to monitor the health impact of agreements • National patent and related legislation should: • Promote standards of patentability that take health into account • Permit compulsory licensing, parallel importation and other measures to promote availability and ensure fair competition • Permit requests for extension of transitional period for TRIPS implementation, if needed and if eligible • Consider national public health interests before TRIPS-plus

  14. Meeting on TRIPS in OAPI countries (Yaoundé, May 2002) (15) Meeting on the impact of globalization (Jakarta, May 2000) (9) Briefing on TRIPS (SADC) South Africa, June 2000) (7) Workshop on TRIPS (Harare, August 2001) (4) Participants in both, South Africa and Harare meetings (11) Intercountry meeting on the TRIPS Agreement (Warsaw, September 2001) (22) Country support (9) WHO policy and technical support on TRIPS to over 60 countries - health, trade and patent officials

  15. WHO policy and technical guidance for countries- collaborative work with international organizations • Perspectives on the WTO/TRIPS agreement • TRIPS and pharmaceuticals • Traditional medicines and intellectual property • Public health and patent legislation • Network for monitoring impact • Annotated bibliography * Globalization, TRIPS and access to pharmaceuticals. WHO Policy Perspectives on Medicines No. 3 March 2001

  16. UN Drug Access Initiative Domestic production Accelerated access initiative Generic offers 2. Affordable prices Advocacy, corporate responsiveness, & competition have reduced antiretroviral prices 95% in 3 years ??

  17. 2. Affordable prices Differential pricing - adaptation of prices to purchasing power of governments and households • Already practiced with reductions over 90% - Key factors: • bulk purchasing - competition - skillful negotiation • Feasibility has been demonstrated • economically feasible • compatible with WTO TRIPS agreement • Key factors for wider use include • preventing leakage of products to unintended markets • preventing leakage of prices into developed market decisions • Sustainable mechanisms for single-source products • bilateral agreements  voluntary licensing • compulsory licensing  patent waivers Prices do matter -- especially for low-income countries & poor households Source: Report of WHO-WTO Workshop on Differential Pricing and Financing of Essential Drugs, April 2001

  18. 3. Sustainable financing Public financing - in 38 countries public drug expenditure is < US$ 2.00 / capita Public drug expenditure per capita(US$) (n = 193) US$ 51->100 (7) US$ 11-50 (26) US$ 3-10 (22) US$ <1-2 (38) No data (100)

  19. Drugs covered by public health insurance (71) 3. Sustainable financing Drug benefits in public health insurance - insurance coverage rising in most regions

  20. ? 3. Sustainable financing The new Global Fund to Fight AIDS, TB, Malaria -international solidarity for prevention and treatment Pledges May-August 2001 US $ millions By March 2002 = $ 1,900 million

  21. 3. Sustainable financing Drug financing - develop all viable funding sources within overall health care financing policy • Expand external funding - grants, donations • interim measure which should not undermine national policy • Appropriate government funding • public sector user charges are a transitional measure • Expand health insurance coverage & drug benefits • Extend employer role in health and drug financing • Support NGOs, other community and local financing • Better use out-of-pocket spending

  22. Regional bulk purchasing - centralized, multi-country Direct delivery system - privatized, decentralized Primary distributor system - privatized, centralized Autonomous medical stores - partly private, centralized 4. Reliable supply systems Reliable health and supply systems - successful examples exist in all regions

  23. 4. Reliable supply systems Substandard drugs often have no active ingredient - antibiotics, anti-malarials, anti-tuberculars included Percentage breakdown of data on 325 cases of substandard drugs Source: reported from around the world to WHO database

  24. 4. Reliable supply systems Key actions - ensure availability and quality • integrate drug management in health systems development • create an efficient mix of public, private, not-for-profit services • assure drug quality through production & distribution chain • promote rational prescribing, dispensing, use by patients

  25. Conclusion Ensuring access to essential medicines in developingand least developed countries - framework for action Medicines for all?s for all? - inequities - opportunities - unanswered questions Essential medicines have a huge impact - too often unavailable, unaffordable, unsafe, wrongly used Access depends on - rational selection, affordable prices, sustainable financing, reliable systems Globalization has a significant influence - international agreements, funding, innovation

  26. Questions for consideration • What percent of the population in this region - in your country - has regular access to the medicines they need? • What are the biggest barriers to access? Availability? Price? Financing? Quality? Supply systems? • Which of these barriers are related to “globalization”? Which barriers are local?

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