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 WitherspoonProcurement Advisor

Beijing, China31 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 / AIDS49 recipient countries

Malaria29 recipient countries

Tuberculosis72 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 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.

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

2010- 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

Product INN Strength Dosage form Unit Packaging

RH 60/30-B Rifampicin + Isoniazid 60mg+30mg Dispersible tabs 90 Blister pack

RH 60/30-B Rifampicin + Isoniazid 60mg+30mg Dispersible tabs 84 Blister pack

RH 60/60 Rifampicin + Isoniazid 60mg+60mg Tablets 1000 Jar - loose bulk

RHZ 60/30/150-B

Rifampicin + Isoniazid + Pyrazinamide

60mg+30mg+150mg Dispersible tabs 90 Blister pack

RHZ 60/30/150-B

Rifampicin + Isoniazid + Pyrazinamide

60mg+30mg+150mg Dispersible tabs 84 Blister pack

H100-B Isoniazid 100mg Tablets 100 Blister pack

H100 Isoniazid 100mg Tablets 1000 Jar - loose bulk

Z150-B Pyrazinamide 150mg Tablets 100 Blister pack

Z150 Pyrazinamide 150mg Tablets 1000 Jar - loose bulk

E100-B Ethambutol 100mg Tablets 500 Blister pack

UNITAID

Impact of UNITAID support

UNITAID Paediatric TB Project

Pre-UNITAID Today

# of quality assured manufacturers

0 - 3 Lupin, MacLeods, Fatol, (Sandoz)

# of paediatric formulations

0 - 6 RHZ 60/30/150mgRH 60/30mgRH 60/60mgH 100mgE 100mg

# of paediatric products

0 - 10 2 paediatric formulations are available both in blister and bulk

# of WHO pre-qualified paediatric products

0 - 3 H 100mg (MacLeods) Bulk onlyRH 60/30mg (MacLeods) "RH 60/30/150mg (MacLeods) "RH 60/60 (Macleods) "

UNITAID

Current Potential

(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-TBSECOND-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 1st Amendment to Diagnostics Project (anticipated to be the largest Global initiative)

• Alignment with Strategy – independent evaluation of market impact

UNITAID

CurrentPotential

(short term)

Potential

(medium term)

MDR-TB (2nd 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