affordable medicines facility - malaria 2 agenda background summary of achievements to date –amfm...
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Affordable Medicines Facility - malaria
3
Agenda
Background
Summary of Achievements to date–AMFm Technical Design–Ensuring that AMFm will work
Requested Board Action–Proposed Decision Points–Management of AMFm
Next steps
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Rationale for the AMFm: to increase the availability of ACTs and substitute artemisinin monotherapies across all sectors
Chloroquine (CQ)
Sulfadoxine-Pyrimethamine (SP)
Artemisinin monotherapies
ACTs
Other
Chloroquine (CQ)
Sulfadoxine-Pyrimethamine (SP)
ACTs
Private Public
~400 ~150Total = ~550
0
20
40
60
80
100%
2006 Antimalarial Treatment Volumes (Million)
Note: Other category includes Mefloquine, Amodiaquine and others. ACT data based on WHO estimates and manufacturer interviews. Source: Biosynthetic Artemisinin Roll-Out Strategy, BCG/Institute for OneWorld Health, WHO, Dalberg.
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ACT prices are relatively high and affordable to only few in the private sector - major barrier to usage
ACT Artemisininmonotherapies
Sulfadoxine-Pyrimethamine
(Generic)
Chloroquine (Generic)
8.0
6.5
0.5 0.30.0
2.0
4.0
6.0
8.0
10.0
Average Prices (USD)
Range(USD) 6-10 5-8 0.4-0.7 0.2-0.4
Note: Ranges indicate variance across countries and products excluding outliers; N (observations): (ACT, 222); (AMT, 227) ; (CQ, 37) ; (SP, 118).Source: Dalberg field research (Kenya, Uganda, BF, Cameroon), Observations by World Bank and Research International (Nigeria). Smaller pricing observations were also performed in Ghana, Rwanda, Burundi, Niger and Zambia), but due to low n not included. Sulfadoxine-Pyrimethamine and Chloroquine data complemented with HAI and IOM observations
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Objective and design principles (endorsed by Board in May)
Objective: Increase overall use of ACTs
• Promote the use of ACTs and drive mono-therapies and ineffective drugs from the market by:
–Reducing end-user prices to an affordable level
–Introducing supporting interventions including those for proper use of ACTs
Objective: Increase overall use of ACTs
• Promote the use of ACTs and drive mono-therapies and ineffective drugs from the market by:
–Reducing end-user prices to an affordable level
–Introducing supporting interventions including those for proper use of ACTs
AMFm design principles
• Pricing & availability – to all sectors and countries
• Management – small secretariat
• Eligibility – standards for products, suppliers, buyers
• Importance of in-country supporting activities to ensure responsible introduction and use
• Monitoring & evaluation - linked to RBM Strategic Targets for 2015
AMFm design principles
• Pricing & availability – to all sectors and countries
• Management – small secretariat
• Eligibility – standards for products, suppliers, buyers
• Importance of in-country supporting activities to ensure responsible introduction and use
• Monitoring & evaluation - linked to RBM Strategic Targets for 2015
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Agenda
Background
Summary of Achievements to date–AMFm Technical Design–Ensuring that AMFm will work
Requested Board Action–Proposed Decision Points–Management of AMFm
Next steps
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The AMFm will offer ACTs to first-line buyers at a similar price range as CQ and SP through existing channels (illustrative)
AMFm
Medicines
Money
Information
Multiple eligible ACT Manufacturers
Private Buyers (e.g. National Wholesalers)
NGO Buyers(e.g. PSI, MSF)
Retailers, private clinics and public providers
Co-payment
Patients
DistributorsE.g. Central
medical stores
National distributors
Public Buyers(e.g. Ministry of
Health)
Supporting interventions
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Impact of AMFm on prices at each level of the supply chain(illustrative example)
Manufacturers
Current
Private buyers Public buyers
Retailers / providers Public providers
Patients Patients
USD 4-5 USD 1
USD 5-6 Free / fee
USD 6-10 Free / fee
Manufacturers(MSP reduced to USD
1 for all buyers)
Future, with co-payment
Private buyers Public buyers
Retailers / providers Public providers
Patients Patients
USD 0.05 USD 0.05
USD 0.2-0.4 Free / fee
USD 0.2-0.5, for majority of patients
Free / fee
AMFm
USD 0.95
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Ensuring that the AMFm will work
Examples of key issues
•Will the co-payment be passed through to the patient?
•Will it reach the poor?
•Will it increase resistance?
•Is it a subsidy for manufacturers?
•What is the opportunity cost?
•What is the cost-effectiveness?
•How will drug quality and safety be assured?
Examples of key issues
•Will the co-payment be passed through to the patient?
•Will it reach the poor?
•Will it increase resistance?
•Is it a subsidy for manufacturers?
•What is the opportunity cost?
•What is the cost-effectiveness?
•How will drug quality and safety be assured?
Approach
•Ex-ante analysis
•Piloting
•Eligibility criteria
•Supporting interventions
Approach
•Ex-ante analysis
•Piloting
•Eligibility criteria
•Supporting interventions
•Conceptual evolution from “Global ACT Subsidy” to AMFm
•Conceptual evolution from “Global ACT Subsidy” to AMFm
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Illustration – will the co-payment passed through to the patient?
PilotingPiloting Supporting interventionsSupporting interventions
Eligibility criteriaEligibility criteriaEx-ante analysisEx-ante analysis
• Detailed analysis of existing markets for other essential medicines, e.g., low-cost antimalarials CQ, SP
• Research on the impact of Global Fund financed programs that are selling subsidized ACTs through private-sector pharmacies in Senegal (IRD)
• Introduction of subsidized ACTs in Tanzania (Clinton Foundation)
• Baseline research in Uganda (Medicines for Malaria Ventures)
• Buyer eligibility criteria
• Wholesaler incentives and pricing / price control mechanisms
• Public information
• M&E, operational research
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Evolution from ”Global ACT Subsidy” to AMFm
CORE AMFm FUNCTIONS(Executed by Facility)
• Negotiation of terms for low-cost antimalarials • Processing co-payments for low-cost products
purchased by first line buyers• Setting prices and terms for international distribution• Transparent sharing of information and forecasts
ELIGIBILITY CRITERIA / REQUIREMENTS(Set by Facility)
PARTNER / SUPPORTING INTERVENTIONS(Monitored or coordinated by Facility)
• ACT treatment requirements• Buyer eligibility requirements• Country preparedness requirements
• National policy and regulatory preparedness
• Wholesaler incentives and pricing / margin control mechanisms
• Public education and awareness (IEC)
• Provider training• National monitoring and quality
preparedness (resistance monitoring, pharmacovigilance, and quality surveillance)
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Estimated impact and funding requirements
Year 1 Year 2 Year 3 Year 4 Year 5
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287 282 289274
0
50
100
150
200
250
300
Global ACT Subsidy Funding (USD Million)
MedicinesandInternationalDistribution
Supportinginterventions
Org costs
AMFm Funding (USD Millions) Expected impact
•Reduce retail prices from current level of USD 6-10 to USD 0.20-0.50 for majority of patients
• Increase demand from current level of 100 million treatment courses per year to 360 million
•Shift most purchases away from ineffective medicines and possibly eliminate the market for artemisinin monotherapies
•Save 174,000-300,000 lives per year, in a fully-funded scenario
Expected impact
•Reduce retail prices from current level of USD 6-10 to USD 0.20-0.50 for majority of patients
• Increase demand from current level of 100 million treatment courses per year to 360 million
•Shift most purchases away from ineffective medicines and possibly eliminate the market for artemisinin monotherapies
•Save 174,000-300,000 lives per year, in a fully-funded scenario
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Update on Tanzania’s Pilot ACT Subsidy Project
Roll Back Malaria Partnership 13th Board Meeting29 November 2007
15
Background and context
Results to date
Implications and Next Steps
Today’s presentation
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The pilot project is being led by the Ministry of Health and Social Welfare and implemented by PSI – Tanzania and the Clinton Foundation
• Manage procurement of drugs and implementation of supporting interventions• Lead communication to global partners
• Lead partners: TFDA and NMCP• Manage relations with local government• Conduct dispenser training
• Implement in-country social marketing and repackaging• Build on lessons learned from ACT repackaging/subsidy
experiences in other countries
Tanzania Pilot ACT Subsidy
Project
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The project aims to answer three key questions through a design which varies interventions across districts
Key questions:
1. What is the final price paid by patients for subsidized drugs?
2. What is the effect of a package of accompanying interventions (e.g., SRP, repackaging, social marketing) on end-user price and uptake?
3. What is the impact of the subsidy on the purchase and use of ACTs compared to other anti-malarials?
Kongwa
Shinyanga Rural
Maswa
Social
Marketing SRP
M&E
Explores effects of a subsidy without SRP
Explores effects of a subsidy with SRP
Serves as a control
Subsidy
OTC
StatusRepackag-ing
Supporting interventions
SRP ranges from US$0.25 to $1.00 based on dose
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Wholesaler
Regional Distributor“Indirect”
Regional Distributor“Indirect”
Clinton Foundation
Drug Shops
DrugShops
ACTs procured at public sector
price
ACTs sold to wholesaler at 90% subsidy
Novartis
Kongwa DistrictMaswa District
Regional Stock Point
“Direct”
Regional Stock Point
“Direct”Shops pick up drugs
from distributorsTrucks/bikes deliver
direct to shopsTrucks/bikes deliver
direct to shops
Subsidized ACTs are distributed to retailers through two commonly used channels– via a regional distributor or directly to shops
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Background and context
Results to date
Implications and next steps
Today’s presentation
20
There are inherent limitations to this study and caution should be taken in interpreting and applying its findings
• ACTs are being distributed only through – and data collected at – rural drug shops, which are an important source of malaria treatment in Tanzania, but are more formal and less pervasive than general stores.
• There is the potential for the Hawthorne effect (behavior is altered due to the knowledge of being studied) and social desirability bias. The study was designed to deliberately minimize these biases
Formal v. informal sector
Limitation Description
Potential study biases
• Initial data was collected one month after distribution of subsidized ACTs began. Experience has shown it takes time for a market to adjust to a new product
Preliminary data
• The study was designed to examine price and volume in drug shops. Some other important questions such as impact on total anti-malarial access in the district cannot be answered
• Study is conducted in 3 rural districts of Tanzania. Conditions vary widely across sub-Saharan Africa
Limited scope
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Subsidized ACTs have quickly gained market share, appearing to displace sales of both SP and AQ for adults…
Products purchased in Kongwa and Maswa: August vs. November
% of adult exit interview customers purchasing anti-malarials
Other ACT + artemisinin monotherapy
SP
Amodiaquine (AQ)
QuinineOther
2% 2%
65%55%
25%
4%
3%
12%4%
1%
231100% = 323
August
(pre-subsidy)
November
26%
Subsidized ACT
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… with higher uptake for children under 5 seeming to cause significant displacement of AQ
Products purchased in Kongwa and Maswa: August vs. November
% of exit interviews purchasing for an anti-malarial for a child under 5
SP
Amodiaquine (AQ)
QuinineOther
7%
47%
89%
2%2%
3%
44100% = 58
40% Subsidized ACT
10%
August
(pre-subsidy)
November
23
14% 14%
3%
79% 83%
7%
Under 5
5-15
Adult
608100% = 90
August
Exit
Interviews
November
ACT
Purchases
~ 2.1 million
2002 census adjusted by fever incidence
Intended recipient of exit interview purchases by age group
676*
November
Exit
Interviews* Includes purchases of ant-pyretics
While a greater proportion of subsidized ACTs were purchased for children, adults continue to be overrepresented compared to estimated
fever incidence
26%36%
23%
66%
41%
9%
Comparison of subsidized ACT purchases versus fever incidence by age group
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Price paid for subsidized ACTs is in line with other commonly-available anti-malarials, with no variation in pricing behavior observed between
shops regardless of location
$0.00
$0.50
$1.00
$1.50
$2.00
$2.50
$3.00
ACT Maswa ACT Kongwa SP AQ Art.Monotherapy
In the price intervention district, consumers paid exactly the SRP (~US$1)
Mean and standard deviation of price paid
% of adult exit interviews buying a full dose of an anti-malarial
US
Dol
lars
In both districts, 100% of customers paid the
same price
(only 3 observations)
25
$0.42 $0.42$0.50
$0.67
$1.00
$0.17
SP Subsidized
ACT
Subsidized
ACT
Subsidized ACT
AQ SP
Price paid for subsidized ACTs compared to most common alternative
Median price (US$)
Maswa Kongwa
Adult Child < 5 Adult*
Prices paid for subsidized ACTs compare favorably with common alternatives in Maswa, but the SRP appears to have inflated prices in
Kongwa
* Insufficient observations of AQ or alternatives for children under 5 to enable comparison
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42 12 25
40
1
8
16
12
9
7
451
22
28
13
Among similarly-priced products, shopkeeper recommendation plays an important role in determining consumer choice
Subsidized ACT
Reasons for buying each drug
% of 443 exit interview customers buying anti-malarials
Any SP
Any AQ
Shopkeeper recommendation Prescribed
Previous use
Most effective Price
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11%
4%
13%
41%47%
10%
29%
61%66%
23%
72%
23%
Consumers interviewed continue to be skewed towards the wealthier quintiles and wealthier individuals appear to buy subsidized ACTs more
often than others
Quintile 3
“Neither rich nor poor”
Socioeconomic status of consumers by district
% of customers buying anti-malarials or anti-pyretics
Quintiles 4 & 5
“Rich & Richest”
Maswa (n = 322)
Kongwa (n = 128)
Quintiles 1 & 2
“Poorest & Poor”
Shinyanga (n = 219)
Total (n = 670)
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Background and context
Results to date
Implications and next steps
Today’s presentation
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These preliminary findings highlight potential important lessons and areas for further exploration
• Continuing lack of consumers from lowest SES quintiles in private sector drugstores need to explore treatment-seeking of this group from other outlets
• Uptake of subsidized ACTs has been higher among children, but, in general, drug shops seem not to be the preferred access point for caregivers of children under 5 data and other studies indicate that they seem to be served by public/NGO health facilities
Socioeconomic status
Area Implication
Access for children U5
• The subsidy has been passed through to consumers, with retail prices generally at or below those for alternatives. The SRP can serve as an effective ceiling, but can perversely inflate prices
Pricing
• Stocking of subsidized ACTs by storeowners has occurred rapidly, though it has been lower in more remote areas
• It appears that the subsidized ACT is displacing AQ, and to some part SP
Uptake and displacement
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While the pilot provides important information, we must move rapidly to large-scale implementation to increase access to ACTs
• Close to half of Tanzanians access malaria treatment through the private sector and are currently using inappropriate or ineffective treatments due to high price of ACTs
• A pilot has been launched in Tanzania to help determine how this challenge can be best addressed, including subsidizing ACTs and implementing supporting interventions
• Preliminary data suggests that the subsidy is being passed through to patients in rural areas and that uptake of subsidized ACTs by both consumers and retailers has been rapid
• However, low numbers of poorer individuals and children under five seeking treatment at the targeted drugstores is a potential cause for concern, and additional efforts to increase points of access for these groups should be explored
• Tanzania is firmly committed to expanding access to ACTs through all sectors and supports global and national initiatives to accomplish this goal
Providing a subsidized ACT through the private sector
Ministry of Health Uganda Medicines for Malaria Venture Pilot
Contents
• The pilot • Baseline findings• Next steps
MoH-MMV pilot to provide a subsidized ACT through private sector
SUDAN
TANZANIARWANDA
Kanungu
DEMOCRATIC REPUBLIC CONGO
Kisoro
Masindi
Nakasongola
Kasese
Hoima
Kibaale
Kiboga
Luwero
Apac
MukonoKAMPALA
Mubende
Kabarole
Nebbi
Arua
Gulu
Adjumani
Kabale
Mbarara
Rakai
Sembabule Masa
ka
Kalangala
Iganga
Busia
Mle
Tororo
Kapchor wa
Pallisa
Kumi
Katakwi
Moroto
Kotido
Kitgum
Soroti
Lira
Mpigi
Bushenyi
Rukungiri
Kamuli
Ntungamo
Moyo
KENYAKamwenge
Kyenjojo
Knga
Yumbe Pader
Sironko
Nakapiripirit
Kmaido
Bugiri
Mayuge
Wakiso
Jinja
Fort Portal
Bukedea
KiruhuraIbanda
Isingiro
Budaka
Butaleja
Nakaseke
Kaliro
= 6 Intervention districts
• Total population in study areas: 3 million• Different transmission settings (high / medium)• 6 intervention and 2 control districts • Baseline data in study district powered to test different interventions
= 2 control districts
Most children continue to be treated with ineffective drugs
(despite free Coartem at formal health facilities)
38,9
24,4
28,9
20,1
46,5
31,5
0
10
20
30
40
50
Kamuli (N=711) Pallisa (578) Soroti (545)
%
24 hrs from onset of fever 48 hrs from onset of fever
Proportion of under 5s, with fever in last 2 weeks, in rural areas who received
Any antimalarial: Less than 30% ACT: Less than 4%
3,2 3,8 3,55,5 6,6 5,1
0
10
20
30
40
50
Kamuli (N=711) Pallisa (N=578) Soroti (N=545)
%
Within 24 hours Within 48 hours
Source: MoH-MMV household surveys
Over 60% of people from the lowest economic quintiles get antimalarials from the
private sector
Source: MoH-MMV household surveys
Source of antimalarials for children under 5s by socio-economic quintiles
0% 20% 40% 60% 80% 100%
Lowest quintile (n=111)
Second quintile (n=165)
Middle quintile (n=89)
Fourth quintile (n=181)
Highest quintile (n=159) Govt healthfacilityCMD
Private disp./ clinicDrug shop
Pharmacy
Other
Only a quarter of all outlets provide ACTs largely due to the prohibitive price
Public sector
NGO
CDDPharmacy
Drug shops (licensed)
Priv. Disp
Stores (unlicensed)
Market
Outlets providing antimalarials in study districts
Source: MoH-MMV supply side survey
ACTs available but
frequent stock-outs
431 outlets identified in 3 districts using census approach in enumeration areas in 3 districts
Urgent need to close the private sector access gap
• Private sector is an integral part of the antimalarial landscape • Must engage to provide effective and affordable
treatment through outlets close to communities• Will complement public sector delivery
• AMFm provides the framework to address key constraints limiting access
Key elements of the pilot
• Finding innovative solutions for underserved areas• Aligning incentives with the existing supply chain to maximize
availability • Promoting a distinct product offering (repackaged Coartem)
with clear user instructions• Testing different approaches
– packaging, pricing, promotional intensity • Training to ensure correct dispensing
• Strong monitoring and evaluation
Launch 2Q 2008
MoH-MMV pilot is generating valuable data for AMFm
• Baseline data provided insight for AMFm design issues• Operational research will inform the roll-out of the AMFm on a
regular basis with emphasis on – ensuring correct dispensing and use of ACTs through the
private sector– uptake and impact of subsidized drug by socio-economic
groups – displacement of ineffective drugs– reaching underserved communities
Communities and patients need the AMFm
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Agenda
Background
Summary of Achievements to date–AMFm Technical Design–Ensuring that AMFm will work
Requested Board Action–Proposed Decision Points–Management of AMFm
Next steps
42
Partners must address challenges from announcement to launch of AMFm
Five implementation challenges
Challenge 1. Ensuring quality assurance, pharmaco-vigilance, strengthening treatment practices (maximize points of access, diagnostics, mono-therapies), local manufacturing
Challenge 2. In-country supporting interventions, particularly around patient information, education, retail price setting, communication and country level monitoring
Challenge 3. Developing and agreeing a business plan for AMFm management
Challenge 4. Supplier sourcing and forecasting
Challenge 5. Resource mobilization
Five implementation challenges
Challenge 1. Ensuring quality assurance, pharmaco-vigilance, strengthening treatment practices (maximize points of access, diagnostics, mono-therapies), local manufacturing
Challenge 2. In-country supporting interventions, particularly around patient information, education, retail price setting, communication and country level monitoring
Challenge 3. Developing and agreeing a business plan for AMFm management
Challenge 4. Supplier sourcing and forecasting
Challenge 5. Resource mobilization
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Proposed Terms of Reference for Reconfigured AMFm Task Force
MembershipMembership
Roles and Responsibilities Roles and Responsibilities
• Address outstanding questions from partners around each of the five implementation challenges
• Work with Global Fund as it performs its due diligence to develop a business plan for submission at the April Board meeting
• Develop work plans and identify resources needed to prepare for launch of AMFm
• Organize two consultations with endemic country civil society, private sector and government representatives (one in West Africa and one in East Africa, countries TBD)
• Representation: WHO, UNICEF, World Bank, Gates, Global Fund, UNITAID, CHAI MMV, Industry, Endemic Countries (2), UNF, NGO, bi-lateral
• Co-chairs: RBM Executive Director, DFID
Ways of WorkingWays of Working• Action-oriented with emphasis on timely deliverables of good quality
• Sub-groups will be formed to address specific issues; sub-group membership will not be confined to membership of the AMFm Task Force. Membership will depend on willingness and ability to make a clear contribution
• Role for RBM working groups on several issues, in particular key role for the Harmonization Working Group (needs assessment and planning for technical assistance) and the PSM Working Group (local manufacturing and forecasting)
TimelineTimeline• December 2007 – April 2008
• Review and update terms of reference after the Global Fund Board decision
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Proposed decision points
(1) Endorses the design of the AMFm as outlined in the executive summary of the technical design submitted by the AMFm Taskforce. (2) Declares its support for the creation of an Affordable Medicines Facility for malaria (AMFm) to be implemented in accordance with the agreed technical design, noting that a launch is contingent upon resolution of five implementation challenges in the following areas: (i) pharmaceutical standards and treatment guidelines, (ii) supporting interventions, (iii) developing and agreeing a business plan for managing the AMFm, (iv) supplier sourcing and forecasting, (v) resource mobilization. (3) Invites the Global Fund to Fight AIDS, Tuberculosis and Malaria to consider taking on full responsibility as AMFm manager at its earliest convenience, for the implementation of this facility in accordance with the agreed design principles. (4) Expresses its gratitude to the co-chairs, secretariat, including advisers, members of the RBM AMFm Taskforce and other resource persons for having successfully achieved their mandate. (5) Decides to re-configure the AMFm Task Force to address the implementation challenges in a timely manner, in accordance with the terms of reference attached here.
(6) Encourages interested donors to hold consultations with the Task Force to secure financing for the AMFm.
(1) Endorses the design of the AMFm as outlined in the executive summary of the technical design submitted by the AMFm Taskforce. (2) Declares its support for the creation of an Affordable Medicines Facility for malaria (AMFm) to be implemented in accordance with the agreed technical design, noting that a launch is contingent upon resolution of five implementation challenges in the following areas: (i) pharmaceutical standards and treatment guidelines, (ii) supporting interventions, (iii) developing and agreeing a business plan for managing the AMFm, (iv) supplier sourcing and forecasting, (v) resource mobilization. (3) Invites the Global Fund to Fight AIDS, Tuberculosis and Malaria to consider taking on full responsibility as AMFm manager at its earliest convenience, for the implementation of this facility in accordance with the agreed design principles. (4) Expresses its gratitude to the co-chairs, secretariat, including advisers, members of the RBM AMFm Taskforce and other resource persons for having successfully achieved their mandate. (5) Decides to re-configure the AMFm Task Force to address the implementation challenges in a timely manner, in accordance with the terms of reference attached here.
(6) Encourages interested donors to hold consultations with the Task Force to secure financing for the AMFm.
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Agenda
Background
Summary of Achievements to date–AMFm Technical Design–Ensuring that AMFm will work
Questions & Answer session
Requested Board Action–Proposed Decision Points–Management of AMFm
Next steps
46
Next steps
• December 2007: First meeting of the AMFm Task Force to develop work plan
• April 2008: Expected acceptance by GFATM to take on the management of the AMFm
• December 2007: First meeting of the AMFm Task Force to develop work plan
• April 2008: Expected acceptance by GFATM to take on the management of the AMFm
47
BACK-UP
48
Some issues still require consensus – no pure technical answer
• Over-the-counter status
• Use of diagnostics
• Banning mono-therapies
• Drug quality standards
• Negotiation framework to set subsidy levels
• Over-the-counter status
• Use of diagnostics
• Banning mono-therapies
• Drug quality standards
• Negotiation framework to set subsidy levels