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The Role of UNITAID in Redressing the Shortage of TB medicines in International Procurement

The Role of UNITAID in Redressing the Shortage of TB medicines in International Procurement Improving the Quality of Essential Antituberculotic Medicines & Impacting Global Markets to Address Tuberculosis. Lorenzo Witherspoon Procurement Advisor. Beijing, China 31 March, 2010.

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The Role of UNITAID in Redressing the Shortage of TB medicines in International Procurement

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  1. The Role of UNITAID in Redressing the Shortage of TB medicines in International Procurement Improving the Quality of Essential Antituberculotic Medicines & Impacting Global Markets to Address Tuberculosis • Lorenzo Witherspoon • Procurement Advisor • Beijing, China • 31 March, 2010

  2. UNITAID membership From 5 founding countries (2006): Brazil, Chile, France, Norway, UK Now (2009): supported by 29 countries and the Gates foundation

  3. Sustaining Long-term, Predictable Financial Flow • Funding from multiple countries from both North and South • Predictable funding gives UNITAID flexibility to respond quickly • UNITAID increases funding through • Strengthening donor commitments • Increasing number of country contributors • Supporting the Voluntary Solidarity Contributions on airline tickets, through the Millennium Foundation Long term financing = commitment to projects = ability to impact markets

  4. Mission, Goals & Objectives: GOAL Objectives Mission To increase access to efficacious, safe products of assured quality products that address public health problems UNITAID’s mission is to contribute to scaling up access to treatment for HIV/AIDS, malaria and tuberculosis, primarily for people in low-income countries, by leveraging price reductions for quality diagnostics and medicines and accelerating the pace at which these are made available. [Constitution] Using innovative, global market based approaches to improve public health by increasing access to quality products to treat, diagnose and prevent HIV/AIDS, tuberculosis, malaria and related co-morbidities in developing countries. To support adaptation of products targeting specific populations To ensure affordable and sustainably priced products To assure availability in sufficient quantities and timely delivery to patients

  5. Rationale: Why UNITAID?: • Strategically deployed funds in time-limited interventions • Innovative health financing mechanism raises money through air ticket levy from high and low income countries • Targeted interventions in global markets to improve patient access to health products • Works with and funds Partners to implement projects • Leverage investments to produce global public goods that generate positive externalities

  6. Scope of work in the Pharmaceutical value chain

  7. 93 countries already receive UNITAID support… HIV / AIDS 49 recipient countries Malaria 29 recipient countries Tuberculosis 72 recipient countries • ACT • LLIN • AMFm • US$318 m • - First line TB • - Paediatric TB • MDR-TB • Diagnostics • US$211 m • - Paediatric ARV • - Second line ARV • PMTCT • US$476 m - Cross cutting programs: US$109 m for PQ of drugs & diagnostics and transversal programs

  8. Over US$ 1 Billion committed funds

  9. Duration for Project Support and Transition Strategy • Objectives: address market shortcomings and remedy market failure • Recognise project uniqueness and further funding requirements to ensure sustainability • Time limited funding – Partners to assume responsibility and assist in ensuring further funding • Limited bridge funding to avoid disruption • Upfront Transition Plan from project's inception

  10. PARTNERSHIP FOR PUBLIC GOOD Working through Partners

  11. ACTIONS IN COUNTRIES over 93 countries receiving commodities

  12. Quality Assurance Standard • Medicines are prequalified by WHO Pre qualification Programme or a Stringent Regulatory Authority (SRA) • For single or no prequalified source: GMP compliant and complete dossier submitted to WHO PQP or a SRA = technical evaluation of the product

  13. Innovation for TB • Paediatric • Child friendly formulations • First-Line • Uninterrupted supply • MDR-TB Diagnostics • New diagnostic tools • MDR-TB • Strategic Revolving Fund • Advance financing • Strategic Rotating Stockpile • Delivery lead time reduction • Treatments • Scale-up of access

  14. UNITAID Paediatric TB Project • Scale up treatment of children by providing anti-TB medicines for 150,000 patients in 20 countries in 2007 and up to a total coverage for 750,000 patients in 58 countries by 2014. • Ensure production of appropriate-strength fixed dose combinations (FDCs) for children aged 5-15 and catalyze development of child-friendly formulations (CFFs) for children aged under 5. • Reduce prices of new products through price negotiation, competition stimulation and scale economies. Objective Strategy • Stimulate market interest for paediatric anti-TB medicines by pro-actively engaging manufacturers • development of optimal child-friendly formulations • ensuring high quality products through WHO pre-qualification programme • ensuring product supply security and competition for price reductions

  15. Paediatric anti-TB treatment - 379,000 patient treatments were supplied to 56 countries by end December 2009 • Child-friendly formulations - development of paediatric FDC’s (RH, RHZ) - development of new products (E100) - availability of dispersible tablets and blister products • Improvement of shelf life - increase from 12 to 24 months (H100, Z150) • Pre-qualified products - currently 3 products WHO-prequalified (H100, RH60/30, RHZ) • Supply security - ensured min. 2 suppliers for most demanded products (FDC’s, H100) - ensured price competition/reduction through multiple sources and demand forecast - entered into agreements with manufacturers (price security) & planning new tendering for 2010 - planning of stock pile for paediatrics subject to further increased shelf life (36 months) UNITAID Paediatric TB Project Action / Achievements

  16. low market volume for paediatric anti-TB medicine  development of market through scale up of paediatric anti-TB treatment in NTPs  incentive for more manufacturers to develop and offer paediatric formulations • lack of high quality, pre-qualified products  through close collaboration with manufacturers encourage and facilitate submission to WHO Pre-Q  cost recovery for WHO Pre-Q vs. lower product prices • new paediatric treatment guidelines  potential stagnation of current progress made on incentivising suppliers for pre-qualification of their products  working closely with manufacturers for development of new child-friendly formulations, while ensuring availability of current products and continuity of paediatric anti-TB treatment • reliable forecasting  imperative for ensuring product availability of current formulations throughout transition period for new paediatric formulations  how rapid new treatment guidelines will be adopted by countries will affect the accuracy of forecasting for current and new products UNITAID Paediatric TB Project Challenges ahead

  17. Paediatric formulations currently available through GDF

  18. Pre-UNITAID Today UNITAID Paediatric TB Project Impact of UNITAID support

  19. SECOND-LINE ANTI-TB SECOND-LINE ANTI-TB

  20. MDR-TB DIAGNOSTICS < 3 years major achievements March 2009, Addis Ababa

  21. HIV-TB diagnostics platforms EID for HIV by PCR MDR-TB LPA Molecular laboratory in Maseru, Lesotho EID for HIV by PCR MDR-TB LPA Implementation of MDR-TB LPA in Regional lab with EID molecular testing capacity for HIV in Ethiopia

  22. Key Challenges • Diagnostics outpacing MDR-TB control efforts • Close linkage between treatment and diagnostic interventions • Inadequate support of non-UNITAID funded component (laboratory strengthening)

  23. Upcoming Major Tasks • Finalization of 1st Amendment to Diagnostics Project (anticipated to be the largest Global initiative) • Alignment with Strategy – independent evaluation of market impact

  24. Second-line ANTI-TB

  25. Key Challenges • Improve forecasting of demand • Close linkages between treatment and diagnostic interventions

  26. “Price governs the choices of the poor”[Margaret Chan, WHO Director General, 2009] “For me, one of the most encouraging trends in public health is the power of commitment to unleash the best of human ingenuity. I admire the Affordable Medicines Facility for Malaria initiative as a brilliant innovation. This is the kind of hard-nosed pragmatism that gets results in public health. It looks at the reality of conditions in the developing world, identifies the forces that shape the reality, and then outsmarts them. If price affects access, make the price of the best products competitive, and thus drive ineffective, substandard or counterfeit products off the market.”

  27. Thank you

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