ProcurementProcurement ofof ARVsARVs andand rolesroles ofofAIDS Medicines and Diagnostics AIDS Medicines and Diagnostics

ServiceService (AMDS)(AMDS)

Kenji Tamura MD PhD, AMDS/WHO

HIV/STD Program Managers meeting and Informal Consultation on Care and Treatment

in the Pacific Islands Countries16 - 20 August 2004, Nadi, Fiji

ObstaclesObstacles

High prices High prices International patent agreements (WTO, TRIPS) International patent agreements (WTO, TRIPS) and domestic laws and regulationsand domestic laws and regulationsSelection of appropriate productsSelection of appropriate productsLifeLife--long procurementlong procurementDifficult to forecastDifficult to forecastDifferent funding sources (GFATM, PEPFAR, etc.)Different funding sources (GFATM, PEPFAR, etc.)

What is the AMDSWhat is the AMDSThe AMDS supports The AMDS supports countries to procure countries to procure HIV HIV medicines and diagnostics medicines and diagnostics and strengthen their and strengthen their supply management through collaboration supply management through collaboration between the UN, Technical and Donor Partners between the UN, Technical and Donor Partners

Created as the 4Created as the 4thth Pillar of the 3 by 5 StrategyPillar of the 3 by 5 Strategy

Components are: Components are: •• Technical departments of the the WHO, UNICEF, Technical departments of the the WHO, UNICEF,

WORLD BANK, UNAIDS WORLD BANK, UNAIDS •• AMDS team (WHO/HIV) AMDS team (WHO/HIV) = = AMDSAMDS secretariatsecretariat•• Technical and donor partners with HIVTechnical and donor partners with HIV--specific specific

Procurement and Supply Management (PSM) Procurement and Supply Management (PSM) activitiesactivities

Partners and levels of cooperation Partners and levels of cooperation being soughtbeing sought

PARTNERSPARTNERS•• Technical partners (MSH, JSI, MSF, Technical partners (MSH, JSI, MSF, ……) ) •• AAI companiesAAI companies (R & D) (R & D) •• CCompanies of the International Generic ARV ompanies of the International Generic ARV

Manufacturers AssociationManufacturers Association•• Diagnostics Diagnostics manufacturersmanufacturers•• Global Drug Facility (GDF) Global Drug Facility (GDF) for TB for TB •• Malaria Medicines and Supplies Service (MMSS)Malaria Medicines and Supplies Service (MMSS)

Levels of cooperationLevels of cooperation•• Country levelCountry level

RegionalRegionalGlobal Global

AIDS Medicines and Diagnostics ServiceAIDS Medicines and Diagnostics Service

ObjectivesObjectives

Ensure that the supply of quality commodities Ensure that the supply of quality commodities is never an obstacle to is never an obstacle to rapid rapid expanding expanding treatment, care and supporttreatment, care and support, and to 3 by 5, and to 3 by 5

IImprove commodity supply to catalyze rapid mprove commodity supply to catalyze rapid expansion of treatment, to promote equity, to expansion of treatment, to promote equity, to support preventionsupport prevention

AIDS Medicines and Diagnostics ServiceAIDS Medicines and Diagnostics Service

General PrinciplesGeneral Principles

Use all available channels (government, NGOs, Use all available channels (government, NGOs, insurances), build on existing insurances), build on existing structures/systems when possible structures/systems when possible

Use partners to best capacityUse partners to best capacity

Involve all partners in planning and further Involve all partners in planning and further expansionexpansion

What the AMDS does not What the AMDS does not plan to doplan to do………………

No procurement itselfNo procurement itselfbutbut•• Support countries to buy/manage supplies Support countries to buy/manage supplies •• Direct to appropriate servicesDirect to appropriate services

ARVs: ARVs: UNICEF, IDA, WHO supplyUNICEF, IDA, WHO supply serviceserviceDiagnostics: WHO procurement Diagnostics: WHO procurement serviceservice

No repeat / duplicate effortNo repeat / duplicate effort•• Use ongoing workUse ongoing work andand available expertiseavailable expertise•• No new structuresNo new structures

No funding to purchase commoditiesNo funding to purchase commodities

AMDS Functions AMDS Functions (1)(1)

Support Support WHO prequalification WHO prequalification for ARVs and diagnosticsfor ARVs and diagnosticsWHO WHO EEssential ssential HHealth ealth TTechnologyechnology ((diagnosticsdiagnostics))WHO WHO EEssential ssential DDrugs and rugs and MMedicinesedicines (medicine(mediciness))

Support procurement for Support procurement for ARVsARVs and diagnosticsand diagnostics1) 1) UNICEFUNICEF2) International 2) International DispensaryDispensary Agency (IDA)Agency (IDA)3) 3) WHO WHO ssupply serviceupply service

Support inSupport in--country capacity building for country capacity building for procurement procurement service management (PSM), development of service management (PSM), development of technical technical tools for rational use, tools for rational use, and and forecastforecasting of the demands,ing of the demands,etc.etc. ((http://www.who.int/3by5/library/en/http://www.who.int/3by5/library/en/))

AMDS Functions AMDS Functions (2)(2)

Build Build and expand and expand alliances with:alliances with:•• (1) WHO (HIV, EDM, EHT) at HQ, RO and Country (1) WHO (HIV, EDM, EHT) at HQ, RO and Country •• (2) I(2) Interagency nteragency PPharmaceutical harmaceutical CCoo--ordinating (ordinating (IPC)GroupIPC)Group

UNAIDS, UNICEF, UNFPA, World Bank, GFATMUNAIDS, UNICEF, UNFPA, World Bank, GFATMPEPFAR, Clinton Foundation, Gates foundationPEPFAR, Clinton Foundation, Gates foundation

•• (3) NGOs: missions, MSH, MSF, JSI (3) NGOs: missions, MSH, MSF, JSI •• (4) (4) SSuppliers and producersuppliers and producers

Disseminate strategic information Disseminate strategic information •• OnOn AIDS medicines and diagnostics: e.g. prices & AIDS medicines and diagnostics: e.g. prices &

sources, patent, legal and regulatory informationsources, patent, legal and regulatory information•• ThroughThrough a web page embedded in HIV, EDM and a web page embedded in HIV, EDM and

possibly UNICEF and World Bank, a newsletterpossibly UNICEF and World Bank, a newsletter

Disseminate informationDisseminate information

""RRemoval ofemoval of AIDS AIDS medicinesmedicines from the list of WHO from the list of WHO prequalifiedprequalified products"products"

June 17June 17thth, 2004, 2004 ((2 2 CipraCipra productsproducts) ) August 4August 4thth, 2004, 2004 ((3 3 RanbaxyRanbaxy productsproducts))

•• Lack of appropriate data on BioEquvalence (BE)Lack of appropriate data on BioEquvalence (BE)•• BE is not required by many drug regulatory authoritiesBE is not required by many drug regulatory authorities•• May or may not be the same efficacy as their originalsMay or may not be the same efficacy as their originals•• Does not necessarily mean poor qualityDoes not necessarily mean poor quality•• Risk of interruption vs. Possible poor qualityRisk of interruption vs. Possible poor quality•• Prequalified alternatives are availablePrequalified alternatives are available•• Do not replace with lower quality productsDo not replace with lower quality products

FDCs prequalified by WHOFDCs prequalified by WHO9 August 2004

ARVsstrength form company country *Possible lowest

cost/year (USD)1 Lamivudine/

Stavudine150mg/ 30 mg

Tablet Ranbaxy Laboratories Ltd

India 125

2 Lamivudine/Stavudine

150mg/ 40mg

Tablet Ranbaxy Laboratories Ltd

India 135

3 Lamivudine/Zidovudine

150mg/ 300mg

Tablet Glaxo Smith Kline UK 237

4 Lamivudine/ Zidovudine

150mg/ 300mg

Tablet Hetero Drugs Ltd India 197

5 Lamivudine/Stavudine/ Nevirapine

150 mg/ 30 mg/ 200 mg

Tablet Cipla Ltd India 234

6 Lamivudine/Stavudine/ Nevirapine

150 mg/ 40 mg/ 200 mg

Tablet Cipla Ltd India 244

7 Lamivudine/Zidovudine/ Abacavir

150mg/ 300mg/ 300mg

Tablet Glaxo Smith Kline UK 1241

* not applicable for all countries

PPooled procurement and ooled procurement and Centralized price negotiation (1)Centralized price negotiation (1)

Organization of Eastern Caribbean States Organization of Eastern Caribbean States /Pharmaceutical Procurement Services /Pharmaceutical Procurement Services (OECS/PPS)(OECS/PPS)

•• Negotiation and monitoring of drug suppyNegotiation and monitoring of drug suppyRegional Price Contract (RPC)Regional Price Contract (RPC)

•• Sigle supplyer for each item on the contractSigle supplyer for each item on the contract•• Special reserve drug account Special reserve drug account •• Purchase order on behalf of participating countriesPurchase order on behalf of participating countries•• No warehouse or reNo warehouse or re--distributedistribute

AAntigua and Barbudantigua and Barbuda St. Kitts and NevisSt. Kitts and NevisDominicaDominica St. Lucia St. Lucia GrenadaGrenada St. Vincent and the GrenadinesSt. Vincent and the GrenadinesMontserratMontserrat,, British Virgin Islands and British Virgin Islands and AnguillaAnguilla (associate members)(associate members)

PPooled procurement and ooled procurement and Centralized price negotiation (2)Centralized price negotiation (2)

Lima Negotiation (July '02 Lima Negotiation (July '02 --June '03)June '03)•• Supported by WHO/UNAIDSSupported by WHO/UNAIDS•• 11stst line regimen (AZT, 3TC and EFV/NVP )line regimen (AZT, 3TC and EFV/NVP )

(from 1,000(from 1,000--5,000USD to 3505,000USD to 350--690 USD)690 USD)

•• 22ndnd line regimen D4T, DDI and IDV/rtv or LPV/rtv line regimen D4T, DDI and IDV/rtv or LPV/rtv (from 1,600(from 1,600--7,600USD to 1,4007,600USD to 1,400--4,600USD)4,600USD)

•• Price reduction of Rapid test (62Price reduction of Rapid test (62--81%), ELISA (1381%), ELISA (13--33%), CD4 (533%), CD4 (5--70%), and Viral Load (2270%), and Viral Load (22--82%)82%)

Argentine Bolivia Chile Colombia EcuadorArgentine Bolivia Chile Colombia EcuadorMexico Paraguay Peru Uruguay VenezuelaMexico Paraguay Peru Uruguay Venezuela

How to prepare pooled procurementHow to prepare pooled procurement

Standardize regimens and diagnosticsStandardize regimens and diagnostics

Align domestic drug regulationsAlign domestic drug regulationsEstablish single negotiating and ordering agencyEstablish single negotiating and ordering agency•• InterInter--country agemcy (regional AMDS or SPC?)country agemcy (regional AMDS or SPC?)

•• WHO WPRO and its procurement service?WHO WPRO and its procurement service?

(w/support of AMDS/WHO)(w/support of AMDS/WHO)

Revolving fund for small quantity orders Revolving fund for small quantity orders May not be the lowest for all coutries !!!May not be the lowest for all coutries !!!

Further information is available:

WHO AMDS WHO AMDS www.who.int/3by5www.who.int/3by5/amds/en//amds/en/WHO EDMWHO EDM www.who.intwww.who.int/medicines/medicines

THANK YOU