Update on co-funding grant to Population Services International Myanmar - April 2013

This page gives an update on the Containment of Artemisinin Resistance in Eastern Myanmar project, which is being carried out by Population Services International (PSI) and was recommended to Good Ventures by the Gates Foundation. Good Ventures contributed to this project as part of an effort to learn from major foundations by co-funding projects with them.

Note: This update reflects the progress of the project as of September 2012. Information on recent progress of this project is forthcoming.

Published April 19, 2013

Project progress

In the first half of 2012, the project made slower progress than originally anticipated in the project plan, primarily due to:

• Delayed signing of a memorandum of understanding with the Government of Myanmar. The memorandum of understanding has now been signed.1
• PSI replaced its country representative in Myanmar in the summer of 2012.2

We do not see either of these issues as cause for concern.

In the second half of 2012, PSI made more progress, including packaging and selling the first batches of subsidized ACT to its partner company,3 and completing baseline surveys (some of which were, as of January 2013, still being analyzed).4

In the summer of 2012, PSI discovered that only one AMT (Artesunate), which is supplied by the company PSI has partnered with to supply ACT, had been banned. Artemether, a second AMT supplied by another company, had not been banned. This led Artemether to gain significant market share and PSI's partner to lose market share. As a result, PSI was concerned that sales of its ACT, which came onto the market in October 2012, might be slower than expected.5

PSI convened a meeting in August 2012 that resulted in a ban of the alternative AMT.6

Room for more funding

When Good Ventures provided funding to this project in August 2012, we believed that it had significant room for more funding. We thought that the project needed funding to meet its goals and without additional funding it would fall short. Throughout the course of 2012, we learned that PSI's future financial needs for this project could not be projected with sufficient precision to know whether or not it had needed (or would need) additional funds.7

Sources

• 1

  "The most critical challenge for this reporting period has been the impact of a delayed MoU with the GoM, although PSI worked hard to accelerate activity once the MOU was obtained." PSI progress report form for the Gates Foundation (December 2012), Pg 10.

• 2

  "Linked to the delay in securing a MoU, PSI has had to deal with a transition in organizational leadership in Yangon with a new Country Representative, Barry Whittle, joining the office in the summer of 2012. This undoubtedly hampered managerial capacity for a few months during the reporting period." PSI progress report form for the Gates Foundation (December 2012), Pg 10.

• 3

  "The first ACT orders were delivered to AA in the last month of this reporting period (September 2012). A table summarizing orders by AA to date, and their reported sales is attached (Annex 3)." PSI progress report form for the Gates Foundation (December 2012), Pg 6.

• 4

  "A nationally representative household survey capturing treatment-seeking behavior and use of antimalarial drugs, as well as respondent knowledge of antimalarials, was conducted… The first annual (and therefore baseline) outlet survey has now been completed… The results from this survey, the second Household Survey and Supply Chain Assessment are currently being triangulated." PSI progress report form for the Gates Foundation (December 2012), Pgs 3-4.

• 5

  "At the start of the project, a rapid antimalarial supply chain assessment (conducted in three areas of eastern Myanmar) suggested that one company, AA Medical Products Ltd (AA), dominated the market, accounting for around 70% of all AMT national sales. In short, the antimalarial market seemed remarkably centralized.

  Until very recently, AA’s main antimalarial product has been oral Artesunate (at the time of project start up, this product was by far the most common at all levels of the private sector supply chain). The drug passed international quality standards and was imported legitimately with Myanmar’s Food & Drug Administration (FDA) approval. AA were not aware that oral AMT posed a serious threat to global malaria control efforts (and presumably nor were the FDA at that time). With support and guidance from the World Health Organization, the FDA later moved to ban further importation of oral Artesunate by pharmaceutical distributors, including AA.

  In early 2012, PSI and AA signed an agreement whereby PSI (with donor funding) would supply AA with highly subsidized quality assured ACT to replace oral AMT throughout Myanmar (the subsidy offsetting the cost difference between partial courses of oral AMT and a full course of quality assured ACT). As a result of AA’s dominance in the market, a rapid change in AMT availability versus ACT was anticipated, with an estimated 9 million courses of ACT being sold over three years.

  PSI’s first annual Private Sector Outlet Survey was completed in early 2012 (with analysis completed by October). The purpose of the annual outlet surveys is to identify and monitor trends in the availability, price and relative volumes of antimalarial drugs across a nationally representative sample of private sector outlets throughout eastern Myanmar. Of 3,658 outlets visited, 1,274 were deemed eligible and able to participate in the process.

  The baseline Outlet Survey revealed that not only had Artesunate lost market share relative to Artemether when compared with the rapid supply chain results (60% for Artesunate versus 40% for Artemether), but also AA’s products (mainly Artesunate and some Artemether) now represented only 34% of the total AMT market. More recent information now being analyzed from a full Supply Chain Assessment suggests this share has now diminished significantly, to approximately 2.3%.

  While a reduction in the availability of AA’s Artesunate (and Artemether) was to be expected following the FDA ban on future importation, it was unclear at the time why Artemether would gain market share relative to Artesunate if also banned.
  The answer to this question emerged at the mid-2012 annual partner’s review meeting of the Myanmar Artemisinin Resistance Containment (MARC) framework, where it transpired that not all oral AMT importation had been banned by the FDA. At that time, only Artesunate (AA’s main product) had been banned. The second AMT identified by PSI during the rapid supply chain assessment of 2011- Artemether – was therefore gaining market share relative to Artesunate as a result of the partial AMT ban by the FDA (Note: AA were not yet being supplied with quality assured and subsidized ACT to replace their dominant AMT, resulting in a supply gap that was clearly being filled by competitors with an alternative AMT)."

  PSI progress report form for the Gates Foundation (December 2012), Pgs 1-2.

  "The first ACT orders were delivered to AA in the last month of this reporting period (September 2012)."

  PSI progress report form for the Gates Foundation (December 2012), Pg 6.

• 6

  "The meeting successfully concluded with the FDA publicly stating that oral Artemether monotherapy was also now banned, but it remains unclear as to how well this has been communicated to the major importers of this product, despite encouraging field observations suggesting that this AMT is already becoming scarce in the supply chain." PSI progress report form for the Gates Foundation (December 2012), Pg 7.

• 7

  "An ongoing challenge and learning has been the degree of flexibility and nimbleness needed by PSI in order to handle the highly volatile and unpredictable operational and policy environment. For example, the team does not yet know how much decentralization of health in Myanmar will help or hinder roll out of the project. This will be closely monitored and likely require shifts in and updates in how the project operates or how it operates in some areas. Forecasting demand for ACTs and RDTs (the main cost drivers of the project) is also an ongoing challenge and learning. PSI progress report form for the Gates Foundation (December 2012), Pg 11.