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The role of NGOs in the implementation of antiretroviral therapy

The role of NGOs in the implementation of antiretroviral therapy. Campaign for Access to Essential Medicines. Objectives. To demonstrate feasibility of ARV programs in low-resource settings To increase access for drugs not only for patients within MSF projects but all patients in countries.

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The role of NGOs in the implementation of antiretroviral therapy

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  1. The role of NGOs in the implementation of antiretroviral therapy Campaign for Access to Essential Medicines

  2. Objectives • To demonstrate feasibility of ARV programs in low-resource settings • To increase access for drugs not only for patients within MSF projects but all patients in countries

  3. MSF experience • MSF started HIV programs in low-resource settings in 1997 • ART programs started in 2001 • To date, 43 ART programs in 22 countries in Africa, Asia, Latin America • Over 11,000 patients

  4. Tools to achieve implementation of ART • National HIV/AIDS treatment plan • WHO Procurement Quality and Sourcing Project (“pre-qualification”) • WHO and national Essential Medicines List (EML) • Maximum use of TRIPS safeguards (patents) • Generic competition • Distributors at country level

  5. Barriers to implementation of ART • Lack of procurement policies (including generics) • Lack of a distribution system at country level • Limited number of registered ARVs • Poor information on international prices and conditions • Unclear patent status • Lack of paediatric formulations and FDCs

  6. The role of MSF • Improving procurement channels • Generating competition • Increasing registration of ARVs • Technical support • Introduction of FDCs • Advocacy

  7. 1. Improvement of procurement channels • The use of local structures (MEDS in Kenya, CENAME in Cameroon …) • Contact with companies representatives • Creating distribution channels (Mozambique, where MSF facilitated contacts originator and generic companies) • Collaboration with Public Hospitals (Kenya) • International procurement channels (differential prices, Untangling the web)

  8. 2. Generating competition • Introduction of generics (MEDS and MSF in Kenya) • Differential prices • MSF produces documents :Untangling the web, Sources and Prices, Surmounting Challenges

  9. 3. Increasing registration of ARV • Collaboration with NDRA and purchasing centers (Cameroon, Thailand) • MSF gets special authorisation and later fully registration • Pressure to companies to register their products • Fast-track registration and WHO pre-qualified ARVs

  10. 4. Technical support • Use of WHO Treatment Guidelines • Adapt to National protocols (Thailand) • Providing information about patents • MSF Doctors • Trainings in district hospitals (MSF B in Thailand) • Participate in National HIV/AIDS treatment programs (Thailand)

  11. 5. Introduction of FDCs • MSF fully suports this strategy • 70 % of patients in MSF projects • Pre-qualified by WHO • Reccomended by WHO • Better solution for scaling up • Less expensive

  12. Prices of First LineINTERNATIONAL OFFERS

  13. 6. Advocacy • Advocacy (Kenya Coalition for Access to Essential Medicines,TAC in South Africa, Thailand) • TAC in South Africa achieved voluntary licenses from BI and BMS • Thai network for people with AIDS got BMS to revoke their patent on ddI in Thailand

  14. Country examples • CAMEROON • KENYA • THAILAND

  15. Cameroon • Procurement through CENAME • Registration: all products available in CENAME are registered or in process. • Patents: flexibility in interpreting intellectual property rule (OAPI) • Prices: competitive tenders (1st line at US$ 277/y)

  16. Kenya • Generics ARV available through special authorisations, but few of them registered • Patents : most ARVs are under patent in Kenya • Beginning of national AIDS program • Procurement: importation and local procurement • Regular contact with Kenya Coalition for Access to Essential Medicines (advocacy)

  17. Thailand • GPO products and all originator registered • Patent protection of pharmaceuticals only possible since 1992. • Local production • Local procurement for non GPO products • Collaboration with local NGOs and activist (revoke of patent of ddI)

  18. Conclusions To succesfully implement ART programs: • Registration (fast track) • Generic drugs • FDC • Local distribution channels • Use of TRIPS flexibilities

  19. REFERENCES • Surmounting challenges: Procurement of Antiretroviral Medicines in Low- and Middle-Income Countries (MSF, WHO, UNAIDS, 2003) • Untangling the web of price reductions: A pricing guide for the purchase of ARVs for developing countries (MSF, 2003) • MSF briefing on fixed-dose combinations (FDCs) of antiretroviral drugs • Drug patents under the spotlight: Sharing practical knowledge about pharmaceutical patents. MSF, May 2003. www.accessmed-msf.org

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