UNITAID 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

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

UNITAID 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

UNITAID Mission, Goals & Objectives: 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. GOAL Objectives To support adaptation of products targeting specific populations To assure availability in sufficient quantities and timely delivery to patients To ensure affordable and sustainably priced products To increase access to efficacious, safe products of assured quality products that address public health problems Mission 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]

UNITAID 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

UNITAID Scope of work in the Pharmaceutical value chain

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

UNITAID Over US$ 1 Billion committed funds HIV / AIDS Pediatric ARV$121 million Second line ARV$280 million PMTCT$ 75 million Total$476 million Malaria ACTs (including $ 130 million for AMFm) $ 209 million LLINs$ 109 million Total$318 million Tuberculosis First line TB$ 26 million Pediatric TB$ 11 million MDR-TB$ 87 million Diagnostics$ 87 million Total$ 211 million Cross cutting issues Transversal$ 52.5 million Pre qualification medicines$ 47 million Pre qualification diagnostics $ 7.5 million Total$ 107 million

UNITAID 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

UNITAID PARTNERSHIP FOR PUBLIC GOOD Working through Partners

UNITAID ACTIONS IN COUNTRIES over 93 countries receiving commodities

UNITAID 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

UNITAID 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 Innovation for TB

UNITAID Objective  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  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.  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 Strategy UNITAID Paediatric TB Project

UNITAID UNITAID Paediatric TB Project Action / Achievements  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 planning of stock pile for paediatrics subject to further increased shelf life (36 months)

UNITAID UNITAID Paediatric TB Project Challenges ahead  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 formulations currently available through GDF ProductINNStrengthDosage formUnitPackaging RH 60/30-BRifampicin + Isoniazid60mg+30mgDispersible tabs90Blister pack RH 60/30-BRifampicin + Isoniazid60mg+30mgDispersible tabs84Blister pack RH 60/60Rifampicin + Isoniazid60mg+60mgTablets1000Jar - loose bulk RHZ 60/30/150-B Rifampicin + Isoniazid + Pyrazinamide60mg+30mg+150mgDispersible tabs90Blister pack RHZ 60/30/150-B Rifampicin + Isoniazid + Pyrazinamide60mg+30mg+150mgDispersible tabs84Blister pack H100-BIsoniazid100mgTablets100Blister pack H100Isoniazid100mgTablets1000Jar - loose bulk Z150-BPyrazinamide150mgTablets100Blister pack Z150Pyrazinamide150mgTablets1000Jar - loose bulk E100-BEthambutol100mgTablets500Blister pack

UNITAID Impact of UNITAID support UNITAID Paediatric TB Project Pre-UNITAIDToday # of quality assured manufacturers 0- 3 Lupin, MacLeods, Fatol, (Sandoz) # of paediatric formulations 0- 6  RHZ 60/30/150mg  RH 60/30mg  RH 60/60mg  H 100mg  E 100mg # of paediatric products paediatric formulations are available both in blister and bulk # of WHO pre- qualified paediatric products 0- 3  H 100mg (MacLeods) Bulk only  RH 60/30mg (MacLeods) "  RH 60/30/150mg (MacLeods) "  RH 60/60 (Macleods) "

UNITAID CurrentPotential (short term) Potential (medium term) Diagnostics Access at lowest price to diagnostics (price reduction 80% key reagents) > 6 suppliers (2 additional for rapid speciation) largest existing global initiative of its kind GLC approved country projects/programmes access to treatment GLI/FIND/GDF Expansion of 11 Countries – Scaling up of MDR-TB patients diagnosed (Addressing up to 25% of the estimated global burden- reaching patients in hard to reach settings) What next? Expansion of Partnership SECOND-LINE ANTI-TB

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

UNITAID MDR-TB LPA EID for HIV by PCR Molecular laboratory in Maseru, Lesotho HIV-TB diagnostics platforms 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

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

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

UNITAID Current Potential (short term) Potential (medium term) MDR-TB (2 nd line) Augmentation of the stockpile Scaling-up access through GLC approved country projects/programmes GDF/GLC/GF inclusion of India Decrease delivery lead times and stock-outs Establishment of line of credit – advance financing for drugs Addressing the need for diagnostic capacity at country level Price containment PQ What next? GF Round system – increase volume (strengthen market position) Mapping of API Landscape (action to improve API market dynamics) Second-line ANTI-TB

UNITAID Key Challenges Improve forecasting of demand Close linkages between treatment and diagnostic interventions

UNITAID “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.”

UNITAID Thank you