1. The Global Fund and the Affordable Medicine Facility-malaria (AMF-m)
Dr Stefano Lazzari
Senior Health Advisor
The Global Fund to Fight AIDS, Tuberculosis and Malaria
APPMG London
9 October 2007

2. The new context of malaria control
After decades of neglect, there is renewed interest in malaria
This has led to establishment of major global initiatives including the RBM Partnership in 1998, the Global Fund in 2002 and the US President Malaria Initiative in 2005.
An effective, integrated strategy has been developed, based on evidence-based approaches and taking advantage of new technical solutions. The strategy is based on a combination of:
Indoor residual spraying (IRS),
Long-lasting insecticide treated nets (LLINs),
Intermittent preventive treatment for pregnant women (IPTp),
Effective treatment for malaria according to the national treatment guidelines
The importance of strengthening health systems and of the role of non-public sectors in the delivery of interventions has been fully ecognized.
Key messages:
A “neglected disease” until 2000, following the failure of the eradication attempts of the 60s, malaria is now at the center of a major international effort backed with substantial financial resources and facilitated by the availability of new prevention and treatment tools.
No single intervention alone can solve the problem of malaria. The GF supports the internationally-agreed strategic approach comprising of prevention, treatment and vector-control, the need to mobilize all sectors and the need to strengthen the basic health system to achieve wide coverage and ensure sustainability.

3. Challenges
Strengthen national malaria programs while also addressing health systems bottlenecks to malaria control.
Ensure the continuous availability of essential commodities, including drugs, diagnostics and LLINs.
Make optimal use of the non-governmental and private sector
Achieve universal access to prevention and treatment by the population at risk, including the rural poor.
Delay the emergence of drug resistance
Ensure sustainable, long-term financing
Continue the research and development of new drugs, diagnostics and effective vaccines
Coordinate efforts, align with national priorities and harmonize international support
Key messages:
The tide has changed but several major challenges remain.
Many malaria control programs need strengthening but we also recognize that the major impediments to scaling up and ensuring universal access to malaria prevention and treatment are the important weaknesses in the overall health systems.
Quality and availability of essential commodities need to be assured, while reducing prices to affordable levels.
We also recognize the urgent need to engage all relevant players in the fight against malaria, including NGOs, FBOs, the private sector and the communities affected by the disease.
And there is a need for donors to ensure sustainable, long term financing while coordinating and aligning their efforts with national strategies and priorities.

4. What is the Global Fund?
The Global Fund is an independent public-private partnership mandated: - To raise and to disburse substantial new funds - To operate transparently and accountably - To achieve sustained impact on HIV/AIDS, TB, and malaria
Raise it
Prove it
Spend it
BG/290607/1

5. Guiding Principles
Operate as a financial instrument, not an implementing entity
Make available and leverage additional financial resources
Support programs that reflect national ownership
Operate in a balanced manner in terms of different regions, diseases and interventions
Pursue an integrated and balanced approach to prevention and treatment
Evaluate proposals through independent review processes
Establish a simplified, rapid and innovative grant-making process and operate transparently, with accountability
BG/290607/2

6. Resources September 2007 Funding to the Global Fund
Total pledges available through 2008 = US$ 10 billion
Approximately US$ 8.6 billion has been paid in
Global Fund funds approved and disbursed
Total proposals approved
2-year budget of US$ 4.7 billion
5-year budget of US$ 11.7 billion (proposed total)
Grant agreements signed
2-year agreement of US$ 4.4 billion
Phase 2 agreement of US$ 2.4 billion
US$4.4 billion disbursed
BG/011007/5

7. The Global Fund and malaria
In 6 rounds the Global Fund has approved funding for 117 malaria grants in 85 countries (41 in Africa).
To date, $2,600 million has been approved and $ 950 million disbursed. Malaria grants represent 22% of the GF portfolio.
Support provided for the initial two years includes:
ACTs: $285 million
ITNs: $109 million
IRS: $ 82 million
Commodities represent about 40% of GF malaria grants
Key messages:
The Global Fund was created in 2002 to finance a dramatic turnaround in the world’s response to this challenge, providing developing countries with the resources they need to turn the tide against the three diseases. In just four years, the Global Fund has become a leading force in the fight against the diseases. It has committed US$ 6.6 billion to over 460 programs in 136 countries, its reach is truly global.
The Global Fund is the world’s largest external source of finance for malaria control programs, providing two-thirds of all international financing. To date, the Global Fund has approved grants with a total value of US$ 2.6 billion over five years to 117 programs in 85 countries to support aggressive interventions against malaria. US$ 950 million has been disbursed so far. Round 7 is likely to lead to a yet stronger increase of Global Fund financing.

8. GF malaria grants performance
Key messages:
Initial performance of the GF malaria grant was weaker that than in AIDS and TB, due to weakness of national programs and delays in procurement of commodities, including LLINs and ACTs.
As these bottlenecks are being removed, malaria grant performance has improved considerably. As supply shortages have resolved, virtually all of the products delivered over that time have been ACTs and LLINs.
Programmatic Results against Targets: By mid 2007, grantees have delivered 30 million ITNs and 28 million drug treatments (ACTs and other malaria drugs).

9. Initial results in malaria prevention
Tanzania: In pilot districts ITN coverage has reached 60%, resulting in under-5 mortality decline of up to 50%
Zambia: Distribution of 900,000 ITNs and access to ACTs has resulted in 90% decline in malaria deaths.
Lubombo region of Southern Africa: A multi-country programme has contributed to 90% reduction in malaria incidence and 53-94% reduction in malaria prevalence in some areas.
Kenya: LLNI coverage rose from 7% in 2004 to 67% in This was associated with a 44% reduction in child mortality.
Rwanda: Reports of rapid decrease in ospitalization in pediatric wards and reduced uptake of ACTs associated with increased coverage with ITNs.
Key messages:
Increased coverage with prevention and treatment is showing its impact on malaria incidence, hospitalization and infant mortality in several African countries.

10. Barriers to scaling-up ACTs
High cost
Limited number of products and manufacturers
Prescription Only Drug
Only available (fully subsidized) in public health facilities with limited coverage of population
Prescribers and consumers habits
Key messages:
Most countries have now adopted WHO recommendation to use ACTs as first-line treatment for malaria.
However, several barriers exists that limit the availability, distribution and uptake of ACTS, particularly through the private sector and in the poor. Rural populations.
Barriers include high cost, limited availability, prescription-only status, prescribers’ habits and consumers being accustomed to older products and treatment regiments.

11. Rationale: to increase the availability of ACTs and replace monotherapies across all sectors
Key messages:
This well-known illustration summarizes the rationale for the facility and the importance of engaging the private sector in the distribution of ACTs.
However, It provides a simplified and static description of what is actually a very diverse and dynamic reality.
For example, it is based on 2005 data and by now the volume, distribution, prices and coverage with ACTs has probably changed substantially.
It also combines under the definition of “Private Sector” a universe of distribution outlets through NGOs, FBOs, formal and informal private providers and sellers, with large differences between countries and the urban or rural settings.
Note: Other category includes MQ, AQ, and others. ACT data based on WHO estimates and manufacturer interviews. Source: Biosynthetic Artemisinin Roll-Out Strategy, BCG/Institute for OneWorld Health, WHO, Dalberg.

12. Home-based treatment of malaria
AMF-m +2 years
A scenario for ACTs coverage taking into consideration the different sub-sectors, the impact of prevention and the expansion of home-based care
Malaria cases prevented
CQ or SP
CQ or SP
CQ or SP
CQ or SP
Coverage by ACTs
ACTs
ACTs
ACTs
ACTs
Key messages:
It would be essential to build more accurate scenarios taking into consideration the different sub sectors, to what extent and how quickly they can be recruited in the distribution of subsidized ACTs, what level and intensity of training and support may be required, etc. This is complex as the situation might differ substantially from country to country, so country scenario will have to be built separately based on a consistent, standard methodology.
We could also take into consideration the potential reduction of treatments required due to ongoing preventive efforts (ITNs, IRS) and of potential impact of home-based care on the delivery of ACTs in the informal private sector.
Of course this is just an example for makign the point, not being based on real data. More work is indeed needed for better analysis of the different possible scenarios in order to:
Build forecasts of actual ACT needs
Allow precise estimates of resources needed
Set realistic targets for the facility
Monitor progress against expect results, and ultimately assess the success of the facility.
Total malaria treatments = 440 million
ACT treatments = 286 million
ACT coverage = 65%
Home-based treatment of malaria

13. AMF-m Objectives
Increase the overall use of ACTs and drive out monotherapies and ineffective drugs from the market by:
Reducing end-user prices to an affordabel level through a properly supported global subsidy of ex-manufacturer prices (CIF basis) – in line with IOM recommendations
Introducing (in country) supporting interventions, including the support for the proper use of ACTs.
Key messages:
The proposed Affordable Medicine Facility for malaria (formerly Global ACT Subsidy) is meant to address these barriers in order to increase the overall availability affordability and use of ACTs.
The Global Fund fully supports the objective and guiding principles of the Facility as approved by the RBM Board in May In particular, the GF supports the importance of quality assurance for products being procured, the essential role of in-country support activities for the success of the facility, and the need for a strong monitoring and evaluation component in its design.
Indeed many current GF grants are providing resources to countries to increase access to ACTs, in some cases through the private sector.

14. Benefits of the AMF-m
Ensure a regular supply of cheap and effective antimalarial drugs to all sectors
Facilitate the involvement of the private sector in ACT distribution
Promote, through the supporting interventions, the strengthening of national capacities in
Procurement and drug management,
Drug quality assurance
Pharmacovigilance
Drug resistance monitoring.
Improve forecast of ACT needs, stabilize the ACT market and reduce ACT price.
Key messages:
While the final impact of the facility on the access to ACTs and the reduction in malaria mortality may be difficult to assess until the actual mechanisms is in place and functioning, there are a number of immediate potential benefits that can be identified, including:
Ensure a regular supply of ACT to all sectors ready to roll them out, including the public sector, without the constraints and uncertainties of the current grant mechanisms.
Facilitate the involvement of the private sector, beyond the initial limited pilot projects currently being implemented.
Promote the strengthening of national capacities in relation to drug procurement, management, quality assurance and monitoring. These benefits go beyond just malaria control and have a potential impact on the whole health system.
A global facility will allow better forecast of needs and assist in stabilizing the ACT market, to avoid periods of scarcity and periods of excessive supply..

15. Several issues still need to be addressed
Improved analysis of what the facility can actually achieve, in what timeframe and at what cost.
Approach to defining, managing and financing of supporting interventions for a “responsible introduction” of the facility.
Making sure that the benefits of the facility are carried forward to the consumer, the rural poor in particular.
Definition of operational model for distribution of ACTs through the informal private sector (through further operational research)
Definition of a clear operational model for price negotiation with manufacturers, that would reduce prices while encouraging innovation and the entry of new manufacturer in the ACT market.
Sources and sustainability of financing for the AMF-m.
Key messages:
In spite of the large amount of quality work conducted in the past year to develop the basic design of the facility, a number of key issues remain. These have been identified by the RBM Task Force and will be addressed before the official launch.
The actual cost of the drug ex-factory is not the only barrier to access to treatment. Other “non-monetary” elements should be addressed through ‘supporting interventions”
Drug related: e.g. drug policies and pricing; quality assurance, pharmacovigilance
Treatment related: e.g. provider training, public education and awareness, drug resistance monitoring.
Supporting interventions are an essential element for the responsible introduction of the ACT facility. In addition, they provide an opportunity for addressing systemic weaknesses in the area of drug policy, procurement and management.
Different sectors (e.g. home based treatment, informal private sellers) in different countries may require different levels of investment in supporting interventions before ACT roll-out.
Supporting interventions can also address some of the potential risks of the Facility (e.g., limited price reduction due to high mark-ups; slow consumer uptake; fraud or over-ordering).

16. Global ACT Subsidy / Affordable Medicines Facility - malaria PSC Discussion Summary
RBM Partnership has requested the Global Fund to consider hosting the AMF-m
Initial analysis shows strong complementarity and potential synergies of between Global Fund and AMF-m objectives and design.
Global Fund Board to consider at its November meeting whether to support hosting the subsidy as an integrated business line within the Global Fund
Conclusion:
The GF sees the AMF-m as providing essential complementary support to its ongoing grants, particularly in facilitating the involvement of the non-governmental sectors in increasing access to ACTs.
The GF is fully engaged with the other RBM partners in further defining the operational model and find appropriate and workable solutions to the outstanding issues.
Eighth Policy and Strategy Committee Meeting
Geneva, September 2007