UNITAID is hosted andadministered by the

World Health Organization

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

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

A Global State of Emergency…

Global Distribution of Child Deaths (each dot = 5000 deaths)

Source: Black et al., 2003 (apud UNICEF IPC Meeting 14-15 Nov 2006)

Estimated Adult and Child Deaths from AIDS(2006)

Total: 2.9 (2.5 – 3.5) million Total: 2.9 (2.5 – 3.5) million Western & Central

Europe12 00012 000[<15 000][<15 000]

North Africa & Middle East36 00036 000

[20 000 [20 000 –– 60 000]60 000]

Sub-Saharan Africa2.1 million2.1 million

[1.8 [1.8 –– 2.4 million]2.4 million]

Eastern Europe & Central Asia84 00084 000[58 000 [58 000 –– 120 000]120 000] East Asia

43 00043 000[26 000 [26 000 –– 64 000]64 000]South

& South-East Asia590 000590 000[390 000 [390 000 –– 850 000]850 000]

Oceania40004000

[2300 [2300 –– 6600]6600]

North America18 00018 000

[11 000 [11 000 –– 26 000]26 000]

Caribbean19 00019 000

[14 000 [14 000 –– 25 000]25 000]

Latin America65 00065 000

[51 000 [51 000 –– 84 000]84 000]

Number of people living with HIV in 2006: 39.5 million (34.1 - 47.1 million)People newly infected with HIV in 2006: 4.3 million (3.6 - 6.6 million)

UNAIDS/WHO "AIDS Epidemic Update: December 2006"

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

1st cause of child mortality for a disease that can be cured

The disease burden is growing

ACTs are the most efficient treatmentagainst growing drug resistances(efficient for 95% cases)

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 (Partnershipfor Supply Chain Management/ SCMS (Supply Chain Management System)

• The CHAI approach to negotiate and reduced prices

• Current discussions for the World Health Assembly

• 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

Why UNITAID ?

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

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

What is UNITAID ?

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

UNITAIDMission 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

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

Not just another partner…

Contra-ceptives and

RHequipment

STIDrugs

EssentialDrugs

Vaccinesand

Vitamin ATB/Leprosy

BloodSafety

Reagents(inc. HIV

tests)

DFID

KfW

UNICEF

JICA

GOK, WB/IDA

Source offunds for

commodities

CommodityType

(colour coded) MOHEquip-ment

Point of firstwarehousing KEMSA Central Warehouse

KEMSARegionalDepots

Organizationresponsible

for delivery todistrict levels

KEMSA and KEMSA Regional Depots (essential drugs, malaria drugs,

consumable supplies)

ProcurementAgent/Body Crown

AgentsGovernment

of Kenya

GOK

GTZ(procurement

implementationunit)

JSI/DELIVER/KEMSA LogisticsManagement Unit (contraceptives,

condoms, STI kits, HIV test kits, TBdrugs, RH equipment etc)

EU

KfW

UNICEF

KEPI ColdStore

KEPI(vaccines

andvitamin A)

Malaria

USAID

USAID

UNFPA

EUROPA

Condomsfor STI/

HIV/AIDSprevention

CIDA

UNFPA

USGov

CDC

NPHLS store

MEDS(to Missionfacilities)

PrivateDrug

Source

GDF

Government

NGO/Private

Bilateral Donor

Multilateral Donor

World Bank Loan

Organization Key

JapanesePrivate

Company

WHO

GAVI

SIDA

NLTP(TB/

Leprosydrugs

Commodity Logistics System in Kenya (as of April 2004) Constructed and produced by Steve Kinzett, JSI/Kenya - please communicateany inaccuracies to skinzett@cb.jsikenya.com or telephone 2727210

Anti-RetroVirals

(ARVs)

Labor-atorysupp-lies

GlobalFund forAIDS, TB

and Malaria

The"Consortium"

(Crown Agents,GTZ, JSI and

KEMSA)

BTC

MEDS

DANIDA

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

MEDS

Provincial andDistrictHospital

LaboratoryStaff

Organizationresponsible fordelivery to sub-district levels

KNCV

MSF

MSF

Guinea has just joined on 30th August 2007UNITAID Executive Secretary - August 2007

27 countries already joined UNITAID

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

Countries that implemented the air tickets levy

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)

UNITAID added value

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.

How UNITAID operates ?

UNITAID uses a wide range of tools to help reduce prices and accelerateavailability of drugs

Pool procurement

Prequalification

COST plus pricingPredictable funding

Encouraging market competition

Lowering barriers to entry on market

Market dynamics forecastVolume price negotiation

Partnership pricing

Encouraging technology sharing

Supporting local registration

Encouraging/attracting new manufacturers

Information sharing

Reference price / price ceilingPatent pool ?

UNITAID works together with well-recognized partners and is hosted by WHO

A unique partnership model

UNITAID MARKET CATEGORIES/ UNITAID’s Niches)

HIV

Malaria

TB

Market size Projections CoveragePrice

(indicative end 2006)

ARV 2e ligneadults

50-10040%

de croissance annuelle/ $1,350 ppy $ 800

.

ACT120-180 Croissance rapide

du marché attendue10-20% $1,5-1 $ 0.44 -1

MDR-TB drugs

15-30 >50% decroissance

annuelle

2% $2,000-3,000 ppt - 20/30%

Ped-TB médicaments

Ped ARV

5 - 8 0 % $ 22 New

/ 9.1- 24,6 80 % $ 200 ppy $ 60

Millions US $ % % US $

In the last months, UNITAID has committed to fund projectsagainst the three diseases…

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 2007.

III/ Prevention of mother to child transmission: improve the care, reduce diagnostic prices, have 1.2 million pregnant women testedand 340,000 under ARV treatment in 8 countries in 2007-2008.

Partner: the Clinton Foundation

Partners: WHO and UNICEF

Ongoing UNITAID programsHIV/AIDS

Better Products at Lower Prices

Fixed dose combinationSingle dose syrups

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.

53 recipient countries from UNITAID fundsagainst HIV / AIDS

AFROAngolaBenin

BotswanaBurkina Faso

BurundiCameroon

ChadDRC

Cote d'IvoireEthiopiaGhanaGuineaKenya

LesothoLiberiaMalawi

MaliMozambique

NamibiaNigeriaRwandaSenegal

South AfricaSwazilandTanzania

TogoUgandaZambia

Zimbabwe

SEAROIndia

Thailand

WPROCambodia

ChinaLao

Papua New GuineaVietnam

AMRODominican Rep.

GuyanaHaiti

JamaicaOECS

(Anguilla, Dominica, St Lucia,

Antigua & Barbuda, Grenada,

St Christopher & Nevis, British Virgin Islands,

Montserrat, St Vincent & Grenadines)

EUROMoldovaSerbia

EMRODjiboutiMoroccoTunisia

"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 – 25th July 2007

UNITAID first results

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.

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: The Global Fund and UNICEF

Partners: WHO and UNICEF

Ongoing UNITAID programsMalaria

22 recipient countries from UNITAID fundsagainst malaria

AFROBurundi

Cote d'IvoireEritrea

EthiopiaGambiaGhanaGuinea

Guinea BissauLiberia

MadagascarMali

MauritaniaMozambique

NamibiaSomaliaZambia

EMRODjiboutiSudan

SEAROBangladeshIndonesia

WPROCambodia

China

Arrival on 12th 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)

Against malaria

I/ 1st line TB : Support the transitional provision of 866,000 treatments in 2007-2008 for 19 countries and establish a strategic rotating stockpile.

II/ Pediatric TB: provide treatments adapted to children in order to treat 150,000 children in 20 countries by the end of 2007.

III/ Multi drug resistant TB : Support the purchase of 4,700 treatmentsin 2007 for 17 low income and lower middle income countries, with a view to decreasing prices.

Partner: The Global Drug Facility

Partners: The Global Drug Facility and the Global Fund

Ongoing UNITAID programsTuberculosis

Partner: The Global Drug Facility

58 recipient countries from UNITAID fundsagainst tuberculosis

AFROBenin

Burkina FasoCape VerdeCameroon

Congo BrazzavilleDRC

Cote d'IvoireThe Gambia

GuineaKenya

LesothoMadagascar

MalawiMali

MauritaniaMozambique

NigerNigeriaRwandaSomaliaTanzania

TogoUgandaZambia

SEAROBangladesh

BhutanIndia

IndonesiaMyanmar

NepalSri Lanka

Timor-Leste

EUROAzerbaijan

Bosnia-HerzegovinaBelarusBulgariaGeorgia

KyrgyzstanKazakhstan

MoldovaTajikistan

Uzbekistan

EMROAfghanistan

DjiboutiEgyptIraq

LebanonPakistan

Syrian Arab Rep.Yemen

WPROCambodia

LaoPhilippines

Vietnam

AMRODominican Rep.

Guatemala Haiti

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)

Facing a global state of emergency, UNITAID contributes to bring solutions

In less than a year, UNITAID has already achieved major results…

1/ First significant price reductions

30 November 2006on antiretroviral

for HIV positive children(with the Clinton foundation)

8 May 2007on second-lineantiretroviral

(with the Clinton foundation)-39%

-57%

-26%-29%

-33%-29%

-60

-50

-40

-30

-20

-10

0

10

20

30

40

TDF TDF+3TC TDF+FTC ddl ABC LPV/r

-30%

-51%

-65%

-43%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%ABC 20mg EFV 50mg D4T+3TC+NVP 6+30+50mg AZT

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

0

10

20

30

40

50

60

70

80

90

100

Nov '06 Dec '06 Jan '07 Feb '07 Mar '07 Apr '07 May '07 TO DATE

Number of children under treatment (31st May 2007)

(000’s)

40,758 children already under

treatment

28,229 new children

TOTAL

3/ The first medicines already in the field…against HIV/AIDS

Pediatric ARV program with the Clinton foundation

Source: Clinton foundation

Next Steps

Increase the number of Children/ Countries/ acess FDC Monitor the implementation of the sktockpile/ Quality

Decrease the price (-30 % in two years)

Ped TB

TB first line

MDR-TB

Develop a comprehensive approach to increase Quality Artemisinine combined therapy, Avoid market instability raw material in the next two years

ACT's

Systematic review of key achievementIncrease the number of products

ARVs

Products

Next Steps

UNICEF

PrequalificationPrice reporting data baseTechnical support

Partnership agreementOthers products (ACT, RUTF,…)PMTCT

WHO

Develop a Road Map (3 main models: share Information/Drugs/funds) Global Fund

Partners

• Address by M. Chan, WHO DG (22 Jan 2007): “Concerning fixed-dose 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”.

UNITAID and the Health Agenda