UNITAID is hosted and administered by the World Health Organization

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1 UNITAID is hosted and administered by the World Health Organization

2 UNITAID actions and main achievements (A new innovative mechanism for scaling up access to medicines for HIV/AIDS, TB and malaria) WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies (WHO, Geneva, 8-12 October 2007) Jorge Bermudez Executive-Secretary, UNITAID

3 A Global State of Emergency Medicines are in the North, patients in the South The less developed countries represent: 84% of the world population less than11% of the global health expenditure more than 93% of the global disease burden

4 Global Distribution of Child Deaths (each dot = 5000 deaths) Source: Black et al., 2003 (apud UNICEF IPC Meeting Nov 2006)

5 Estimated Adult and Child Deaths from AIDS (2006) Total: 2.9 ( ) million North America [ ] Caribbean [ ] Latin America [ ] Western & Central Europe [<15 000] North Africa & Middle East [ ] Sub-Saharan Africa 2.1 million [ million] Eastern Europe & Central Asia [ ] East Asia South [ ] & South-East Asia [ ] Oceania 4000 [ ] Number of people living with HIV in 2006: 39.5 million ( million) People newly infected with HIV in 2006: 4.3 million ( million) UNAIDS/WHO "AIDS Epidemic Update: December 2006"

6 2.1 million HIV positive children in the world 660,000 children need ARV Only 40,000 benefit from it Drug resistance is increasing Only 8% of pregnant women get ARV to prevent transmission of the disease to their baby

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9 1st cause of child mortality for a disease that can be cured The disease burden is growing ACTs are the most efficient treatment against growing drug resistances (efficient for 95% cases)

10 THE GLOBAL RESPONSE The MDG (Goals and targets for 2015) The 3x5 accomplishments worldwide UNGASS commitment Universal access to prevention and care for HIV by 2010 Roll-back Malaria Stop TB The GFATM PEPFAR and related initiatives, 120 countries: PSCM (Partnership for Supply Chain Management/ SCMS (Supply Chain Management System) The CHAI approach to negotiate and reduced prices Current discussions for the World Health Assembly

11 Why UNITAID? Unaddressed issues at stake: medicines for children, second-line treatments A plus to existing initiatives, supporting the worst affected and most vulnerable countries A new innovative mechanism for financing treatment Long term funding: manufacturer-attractive Global forecasting ensures supply; a comprehensive approach to access addressing demand and supply factors Building solid and strong partnerships with current initiatives A multi-dimensional approach (addressing quality, regulation, IPR, pricing, in-country support for supply systems) Influencing the Health Agenda

12 For many years the international community has been looking for new tools to ensure sustained financing for development The major advantage of the air ticket tax is its ability to be implemented on a national level, without having negative impact on participating countries

13 What is UNITAID? Innovative funding mechanism based on air ticket levy: sustainable, predictable and additional resources US$ 300 million in 2007 and US$ 400 million in 2008 Specific tool focus on medicine/product market impact

14 Official signature of the five founding countries when UNITAID was launched, on 19 September 2006, at United Nations General Assembly, New York

15 UNITAID Mission and Overarching Principles UNITAID mission is to scale up access to treatment for HIV/AIDS, malaria and tuberculosis for the poorest people in developing countries by lowering the price of quality drugs and diagnosis and accelerating the pace at which they are made available Overarching principles: partnership and complementarities, solidarity and aid effectiveness, adaptability, independence, transparency and accountability

16 UNITAID was established to fill a critical gap in the global health landscape: using purchasing power and an understanding of the market to drive long term reduction in prices of drugs and diagnostics UNITAID plays an important role in influencing manufacturers

17 Not just another partner Commodity Logistics System in Kenya (as of April 2004) Constructed and produced by Steve Kinzett, JSI/Kenya - please communicate any inaccuracies to skinzett@cb.jsikenya.com or telephone Commodity Type (colour coded) Contraceptives and RH equipment Condoms for STI/ HIV/AIDS prevention STI Drugs Essential Drugs Vaccines and Vitamin A TB/Leprosy Blood Safety Reagents (inc. HIV tests) Malaria MOH Equipment Anti- Retro Virals (ARVs) Laboratory supplies Organization Key Government World Bank Loan Bilateral Donor Multilateral Donor NGO/Private Source of funds for commodities U S A I D K f W E U U N F P A D F I D W H O GOK B T C J I C A C I D A G A V I UNICEF G D F K N C V S I D A D A N I D A GOK, WB/ IDA US Gov Global Fund for AIDS, TB and Malaria MSF Procurement Agent/Body U S A I D K f W E U R O P A U N F P A Crown Agents Government of Kenya Japanese Private Company UNICEF MEDS GTZ (procurement implementation unit) C D C The "Consortium" (Crown Agents, GTZ, JSI and KEMSA) MSF Point of first warehousing KEMSA Regional Depots KEMSA Central Warehouse KEPI Cold Store MEDS NPHLS store Organization responsible for delivery to district levels NLTP (TB/ Leprosy drugs KEMSA and KEMSA Regional Depots (essential drugs, malaria drugs, consumable supplies) JSI/DELIVER/KEMSA Logistics Management Unit (contraceptives, condoms, STI kits, HIV test kits, TB drugs, RH equipment etc) KEPI (vaccines and vitamin A) MEDS (to Mission facilities) Provincial and District Hospital Laboratory Staff Private Drug Source Organization responsible for delivery to subdistrict levels Mainly District level staff: DPHO, DPHN, DTLP, DASCO, DPHO, etc or staff from the Health Centres, Dispensaries come up and collect from the District level

18 27 countries already joined UNITAID Guinea has just joined on 30 th August 2007 UNITAID Executive Secretary - August 2007

19 Countries that implemented the air tickets levy Countries that implemented the air tickets levy Tax already in place : - France - Chile - Côte d Ivoire - Congo - South Korea - Madagascar - Mauritius - Niger - Norway (tax on CO2 from airplanes) Countries moving towards the implementation of the levy : Benin, Brazil, Burkina Faso, Cameroon, Cyprus, Gabon, Guinea, Liberia, Mali, Morocco, Namibia, Central African Republic, Senegal, Sao Tome & Principe, Togo

20 UNITAID added value UNITAID use of funds allows to: 1/ have manufactured medicines better adapted to patient needs (fixed dose combinations) 2/ reduce prices: more drugs available for the same budget 3/ contribute to address quality issues (prequalification of products, incentive for manufacturers to invest) 4/ Deliver medicines in the countries in need rapidly (basic model - medicines instead of funds)

21 How UNITAID operates? Articulation of UNITAID value added that is consistent with UNITAID's mission, objectives and principles, including Market Dynamics Clearly assigned principal roles and responsibilities for all activities associated with the action; (UNITAID funds Drugs / Partners funds Operational/implementation costs) Clear description of flow of funds; Estimated funds required in 2007/2008 (requires further detailed breakdown in Agreement & Project Plan); Performance milestones, time-frame and key success factors.

22 UNITAID uses a wide range of tools to help reduce prices and accelerate availability of drugs Predictable funding Volume price negotiation COST plus pricing Pool procurement Market dynamics forecast Encouraging/attracting new manufacturers Prequalification Supporting local registration Patent pool? Lowering barriers to entry on market Information sharing Encouraging market competition Encouraging technology sharing Partnership pricing Reference price / price ceiling

23 A unique partnership model UNITAID works together with well-recognized partners and is hosted by WHO

24 HIV Ped ARV UNITAID MARKET CATEGORIES/ UNITAID s Niches) Market size Projections Coverage Price (indicative end 2006) Millions US $ % % US $ / ,6 80 % $ 200 ppy $ 60 ARV 2e ligne adults % de croissance annuelle / $1,350 ppy $ 800. Malaria ACT Croissance rapide du marché attendue 10-20% $1,5-1 $ TB Ped-TB médicaments % $ 22 New MDR-TB drugs >50% de croissance annuelle 2% $2,000-3,000 ppt - 20/30%

25 In the last months, UNITAID has committed to fund projects against the three diseases

26 Ongoing UNITAID programs HIV/AIDS I/ Pediatric ARV: Have 100,000 new HIV-positive children under adapted ARV treatments in 2007 (today only about 80,000 are covered when 660,000 need it) in 40 countries. II/ 2nd line ARV: reduce prices for 7 products and provide treatments for more than 60,000 patients in 27 countries in Partner: the Clinton Foundation III/ Prevention of mother to child transmission: improve the care, reduce diagnostic prices, have 1.2 million pregnant women tested and 340,000 under ARV treatment in 8 countries in Partners: WHO and UNICEF

27 Better Products at Lower Prices Single dose syrups Fixed dose combination Pediatric AIDS treatment in 2006 consisted of 16 bottles of syrup monthly difficult to administer and store and cost $200 per patient per year. Thanks to UNITAID and CHAI, the price is down to $60 per year for a better product: high-quality dispersible fixed-dose combination tablets in just one bottle per month, and already ordered for 22 countries.

28 53 recipient countries from UNITAID funds against HIV / AIDS AFRO Angola Benin Botswana Burkina Faso Burundi Cameroon Chad DRC Cote d'ivoire Ethiopia Ghana Guinea Kenya Lesotho Liberia Malawi Mali Mozambique Namibia Nigeria Rwanda Senegal South Africa Swaziland Tanzania Togo Uganda Zambia Zimbabwe SEARO India Thailand WPRO Cambodia China Lao Papua New Guinea Vietnam AMRO Dominican Rep. Guyana Haiti Jamaica OECS (Anguilla, Dominica, St Lucia, Antigua & Barbuda, Grenada, St Christopher & Nevis, British Virgin Islands, Montserrat, St Vincent & Grenadines) EURO Moldova Serbia EMRO Djibouti Morocco Tunisia

29 UNITAID first results "My long experience in public policy taught me that even those who don't like taxes are not reluctant to pay a contribution for a good cause. Thanks to UNITAID, we succeeded to lower the annual cost of a treatment for a child with AIDS from 196 $ to 60 $. Each citizen who gets into a plane and pays its contribution should reflect on that: with the same amount of money, we save three times more children.." President Bill Clinton Le Monde 25 th July 2007

30 Ongoing UNITAID programs Malaria I/ ACT scale up: Scale up ACT treatments in eleven countries, until 2010, for 55 million treatments, in order to have an impact on prices, give an incentive to manufacturers, avoid stock out in countries. Partners: The Global Fund and UNICEF II/ ACT program in Liberia and Burundi : Provide nearly 1.3 million treatments in these two countries that had no coverage for 2007, before other donors stepped in. Partners: WHO and UNICEF

31 22 recipient countries from UNITAID funds against malaria AFRO Burundi Cote d'ivoire Eritrea Ethiopia Gambia Ghana Guinea Guinea Bissau Liberia Madagascar Mali Mauritania Mozambique Namibia Somalia Zambia EMRO Djibouti Sudan SEARO Bangladesh Indonesia WPRO Cambodia China

32 Against malaria Arrival on 12 th June 2007 of 670,000 ACT doses in Liberia that will help to prevent the death of 6,800 children per year (partners: UNICEF / WHO)

33 Ongoing UNITAID programs Tuberculosis I/ 1st line TB : Support the transitional provision of 866,000 treatments in for 19 countries and establish a strategic rotating stockpile. Partner: The Global Drug Facility II/ Pediatric TB: provide treatments adapted to children in order to treat 150,000 children in 20 countries by the end of Partner: The Global Drug Facility III/ Multi drug resistant TB : Support the purchase of 4,700 treatments in 2007 for 17 low income and lower middle income countries, with a view to decreasing prices. Partners: The Global Drug Facility and the Global Fund

34 58 recipient countries from UNITAID funds against tuberculosis AFRO Benin Burkina Faso Cape Verde Cameroon Congo Brazzaville DRC Cote d'ivoire The Gambia Guinea Kenya Lesotho Madagascar Malawi Mali Mauritania Mozambique Niger Nigeria Rwanda Somalia Tanzania Togo Uganda Zambia SEARO Bangladesh Bhutan India Indonesia Myanmar Nepal Sri Lanka Timor-Leste EURO Azerbaijan Bosnia-Herzegovina Belarus Bulgaria Georgia Kyrgyzstan Kazakhstan Moldova Tajikistan Uzbekistan EMRO Afghanistan Djibouti Egypt Iraq Lebanon Pakistan Syrian Arab Rep. Yemen WPRO Cambodia Lao Philippines Vietnam AMRO Dominican Rep. Guatemala Haiti

35 More pre-qualified medicines in the market Support to the Prequalification Program Accelerate the access to quality medicines for the three diseases Current focus on medicines for HIV/AIDS (paediatric and second line), TB (first line and MDR TB) and malaria (ACTs) Control the quality of medicines purchased with UNITAID funds and develop local capacity (4 countries to initiate sampling for laboratory tests, also involving NDRA)

36 Facing a global state of emergency, UNITAID contributes to bring solutions In less than a year, UNITAID has already achieved major results

37 1/ First significant price reductions 0% ABC 20mg EFV 50mg D4T+3TC+NVP mg AZT 30 November 2006 on antiretroviral for HIV positive children (with the Clinton foundation) -10% -20% -30% -40% -30% -43% -50% -51% -60% -70% -65% % -33% -29% -26% -39% 8 May 2007 on second-line antiretroviral (with the Clinton foundation) % TDF TDF+3TC TDF+FTC ddl ABC LPV/r

38 2/ More user-friendly medicines With UNITAID funding, new treatments put on the market against HIV/AIDS are more adapted : - Dosages well adapted for children use - Medicines to be taken in the form of tablets (fixed dose combination) : 1 tablet replaces several doses daily (syrup forms) - Heat stable products : no refrigeration needed anymore - No need to dilute them in water (problem of access to drinkable water in some countries). -One FDC / Cipla FDA tentative approval / WHO PREQUAL August 2007

39 3/ The first medicines already in the field against HIV/AIDS Number of children under treatment (31 st May 2007) (000 s) Pediatric ARV program with the Clinton foundation TOTAL Nov '06 Dec '06 Jan '07 Feb '07 Mar '07 Apr '07 May '07 TO DATE 28,229 new children 40,758 children already under treatment Source: Clinton foundation

40 Next Steps Products ARVs Systematic review of key achievement Increase the number of products ACT's Develop a comprehensive approach to increase Quality Artemisinine combined therapy, Avoid market instability raw material in the next two years Ped TB TB first line MDR-TB Increase the number of Children/ Countries/ acess FDC Monitor the implementation of the sktockpile/ Quality Decrease the price (-30 % in two years)

41 Next Steps Partners Global Fund Develop a Road Map (3 main models: share Information/Drugs/funds) WHO UNICEF Prequalification Price reporting data base Technical support Partnership agreement Others products (ACT, RUTF, ) PMTCT

42 UNITAID and the Health Agenda Address by M. Chan, WHO DG (22 Jan 2007): Concerning fixeddose drugs for children suffering from AIDS, tuberculosis, and malaria, we learn that these drugs are often not available because industry has no strong market incentive these are not priority paediatric diseases in the affluent world. WHO Resolution WHA60.20 (Better medicines for children): to report to the Sixty-second World Health Assembly, and subsequently as appropriate, through the Executive Board, on progress achieved, problems encountered and specific actions needed to further promote better access to medicines for children.

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