Supply continuity for malaria programs during the COVID-19 crisis

Each year, on World Malaria Day we evaluate how new developments in the market can help supply chain stakeholders improve the outcomes of malaria programs in low-and middle income countries.

This year, we look at the impact of supply chains on malaria programs through the lens of the COVID-19 pandemic.

We know that the already fragile humanitarian- and public health supply chains will come under increased pressure owing to the global measures that have been implemented to curb the spread of COVID-19. Even with risk mitigation measures in place, supply chain stakeholders in the public sector will have to dramatically improve coordination to ensure access to malaria prevention, diagnosis and treatment services is not compromised by the efforts to limit the spread of the new disease1.

For humanitarian- and public health supply chains improved coordination means:

  • increased engagement among stakeholders,
  • expanding supply sources through prequalification,
  • creative problem solving,
  • leveraging alternative modes of transport, and
  • sharing more resources and assets.

Through efforts to better coordinate, organizations have the opportunity to showcase their expertise in supply chain- and risk management, by proactively advising clients such as principal recipients, and government procurement units, on how to best adjust their forecasting, procurement, warehousing, and logistics activities to minimize stockouts during the COVID-19 pandemic.

From a supply chain, and procurement perspective, there are several key activities (downstream and upstream) that are typically implemented as a standard practice to prevent stockouts, but one such activity that stood out to us –  in the face of COVID-19 –  is supplier diversification. In line with this, we found two recent global malaria commodity sourcing developments to be especially relevant during these crisis times.

These developments include:

  1.   New additions to the World Health Organization (WHO) list of prequalified in vitro diagnostic products2 to offer a wider range of fit-for-purpose testing products (for varying epidemiological situations), and to mitigate over-reliance on single products and/or suppliers.
  2. Changes to operational guidance from the Global Fund to Fight AIDS, Tuberculosis and Malaria to make competitive bidding of malaria rapid diagnostics tests (MRDTs) a standard practice thereby reducing the instances of single sourcing3.

More prequalified MRDTs

Since 2018, the WHO updated the list of prequalified in vitro diagnostic products to include a wider range of malaria diagnostic products from four suppliers with production facilities across India and South Korea.  Please see Table 1 below for products and manufacturers.

Table 1: Additional MRDTs included in the WHO prequalified list4

MRTD ManufacturerProduction siteYear of prequalification
STANDARD Q Malaria P.f/P.v Ag
SD Biosensor, Inc.South Korea2020
STANDARD Q Malaria P.f Pan
Ag Test
SD Biosensor, Inc.South Korea2020
STANDARD Q Malaria P.f Ag
SD Biosensor, Inc.South Korea2020
AdvDx Malaria Pf Rapid Malaria
Ag Detection Test
Advy Chemical Pvt Ltd.,India2019
Alere Malaria Ag P.fStandard Diagnostics, Inc.South Korea X 2 sites2019
First Response®Malaria Ag. P.f./P.v. Card TestPremier Medical CorporationIndia2019
First Response® Malaria Antigen P. falciparum (HRP2) Card TestPremier Medical CorporationIndia2018
First Response® Malaria Ag. pLDH/HRP2 Combo Card TestPremier Medical CorporationIndia2018
First Response®Malaria Ag. P.f./P.v. Card TestPremier Medical CorporationIndia2018
SD BIOLINE Malaria Ag P.f/P.f/P.vStandard DiagnosticsSouth Korea2018

In general sourcing terms, a wide and diverse supplier base, and product range, translates to less risk, more competition, and more opportunities for a healthy market. A practical approach for mitigating sourcing risk suggests that two suppliers are used, with meaningful quantities allocated to both  (at least 25% of orders to each), and that the suppliers’ manufacturing, warehouse and distribution sites are not all in the same region5.

Under normal global trading conditions, one would say that there is sufficient diversity in the ranges of malaria tests, manufacturers, and production sites, especially when taking the Global Fund’s list of approved MRDTs6 into consideration as well. However, under the unique circumstances of global lockdown measures, even the most logical and practical of sourcing strategies are tested to their limits; and there is already evidence of the strain in the market.

For example, the Global Fund has already reported moderate risk for the delivery of diagnostics products, mainly because of the COVID-19 lockdown in India. However, the donor also stated that there will be some supply continuity thanks to the geographical diversity of suppliers (in their case Thailand, China and South Korea). This is testament to the importance of having production sites in various regions.

Further, a Notice of Concern has recently been issued to one of the prominent global suppliers of MRDTs. In cases like this, where one supplier’s stock is temporarily affected, it is critical that enough alternative sources are available.

For PFSCM, it is important that this market remain vibrant and healthy, and advocates that malaria initiatives remain a priority to suppliers upstream. From the Ebola outbreak in West Africa from 2014 to 2016, we have learned that one cannot neglect existing health programs when new disease outbreaks strike. For example, during the peak of the Ebola outbreak, stockouts of rapid diagnostics tests were reported8, and the malaria mortality rate increased and surpassed Ebola deaths9.

More suppliers at the table

As mentioned above, having multiple suppliers in various locations, not only ensures supply continuity, but also promotes innovation, drives competition, and builds local economies10 (in the case of local sourcing).

In line with this, another positive development that is bringing more suppliers to the table of malaria programs, is the Global Fund’s update to its Operational Guidance for Procurement of Malaria Rapid Diagnostic Tests.

The update to the guidance, which was confirmed in November 2019, will promote competitive bidding for diagnostics becomes the standard practice; ending the option for countries to single source. In the past some countries did single sourcing of MRDTs as product training across all health facilities and malaria programs were aligned or standardized. Health care workers were thus trained on one main type of MRDT product. Sourcing from multiple suppliers could have possibly negatively impacted health program outcomes during that time.

Malaria tests have now become so similar in use and function, that they are considered interchangeable.

Last year, the Global Fund determined that countries have demonstrated effective use of multiple types of RDTs (targeting the same species) at the same time, and thus training and supervision should be independent of product brand to ensure health workers are able to use the product(s) available at any given time.

Again, from a supply chain and procurement perspective, we welcome this development. When it comes to a practical approach, competitive bidding has many benefits. PFSCM has first-hand experience in this. For us, competitive bidding is considered a standard practice.

An example of the effectiveness of competitive bidding comes from within our own organization. In 2018, we achieved significant cost savings in excess of $800 000, for the procurement of a large order of MRDT kits for an East African country.

The savings came to light after PFSCM proposed competitive bidding for the order of 307,469 packs comprising 25 MRDT kits each. The shipment, comprising more than 10, 40-foot containers, was also tendered to ensure the best delivery and service is achieved.

Table 2: Advantages and disadvantages of competitive bidding

Stimulates healthy market dynamics for best pricing and service levels.More procurement effort.
Reduced risk of production delays, recalls and quality issues.Multiple in-country registrations.

Table 3: Advantages and disadvantages of single sourcing

Good supplier relationships.Lack of market competition could affect pricing and service levels.
Less procurement effort.Risk of production delays, recalls and quality issues.
Long-term forecast and planning for improved production scheduling and framework agreements.
Once-off, in-country registration.


When it comes to MRDTs, countries will continue to procure tests based on the epidemiologic context of malaria in that country, and in alignment with national treatment guidelines and WHO policy. Therefore, it is especially important that enough affordable, high-quality same species and multi-species tests are available and prequalified.

Having enough products prequalified, is only one effort to limit supply risk. The procurement strategies, such as competitive bidding versus single-sourcing, also need to be in place to make sure countries, and procurement agencies, can access these products in an affordable manner.

By prequalifying more products, the WHO is improving the resilience of sourcing strategies for malaria diagnostics, and by encouraging competitive bidding the Global Fund is helping international and local markets grow.

Malaria programs will continue to face uncertainties, and pressure in the face of COVID-19, but by acting upon lessons from the past, and planning for the future, supply chain stakeholders can coordinate their efforts to limit stockouts and ensure the fight to end malaria is not overshadowed by COVID-19.


  1. WHO Epidemics
  2. WHO Diagnostics
  3. The Global Fund Procurement
  4. WHO Prequalification List
  5. Harvard Business Review
  6. The Global Fund Prequalification List 
  7. The Global Fund COVID-19 Response
  8. PLOS ONE Journal
  9. The Global Fund COVID-19 Response Peter Sands
  10. JAGGAER Procurement

World AIDS Day 2019: Supply Chains in the Fight to End HIV/AIDS

The Partnership for Supply Chain Management (PFSCM) was established to improve and strengthen supply chains and health systems to bring lifesaving HIV diagnostic, prevention, and treatment products to countries with a high number of HIV infections.

PFSCM set up shop in 2005 when the HIV crisis was at its peak with more than 30 million people infected on the African continent alone. For over a decade the organization executed one of the largest public heath supply chains in history, making a lasting impact in the lives of millions of people.

Today, the fight to end HIV is still at PFSCM’s core, and each year on World AIDS Day, we reflect on the importance of public health supply chains in ensuring:

  • HIV and other healthcare commodities reach the point of care, on time and in full.
  • Best-value, and best-quality products are procured to make available funds go further.
  • Recipients have access to value-added rental agreements that enable them to use the best in diagnostics, medical devices, and laboratory equipment, at a reduced total cost of ownership.
  • Infrastructure, such as storage facilities, are developed along the supply chain to ensure compliant pharma-grade storage of products.
  • Chain of custody is enforced through technology that captures information about shipment location, product integrity, and patient consumption.
  • Ethical practices are upheld in all phases of the supply chain to reduce waste, and prevent counterfeit products from entering the supply chain.

Today, PFSCM also reflects on a decade’s worth of work in supporting one of the biggest donor-funded projects on the globe.

Over the last 10 years, PFSCM has:

  • Procured and delivered $2.9 billion worth of HIV commodities – including test kits, condoms and antiretrovirals (ARVs) – to low- and middle-income countries helping diagnose, prevent and treat HIV.
  • Procured enough of the bestselling one-a-day ARV product to treat at least 11.4 million people for a year.
  • Seen the cost of the top procured one-a-day ARV treatment drop from around $17 per unit in 2010 to below $6 in 2019.
  • Purchased more than 2.6 million boxes of the bestselling HIV rapid diagnostic test (HRDT) kit. Enough to test 260 million people once.
  • Seen the cost of the bestselling HRDT kit decrease from around $111 in 2010 to around $82 in 2019.
  • Delivered more than 10940 shipments of HIV products to over 70 countries. Countries that procured most HIV commodities: Malawi, Tanzania, Mozambique, Uganda and Nigeria.

PFSCM Perspective: Procurement, Quality Assurance and Logistics

PFSCM buys HIV commodities from the leading global suppliers of diagnostic and pharmaceutical products, ensuring reliable quality, and supply.

Our suppliers have either been approved by a Stringent Regulatory Authority (SRA) or prequalified by the World Health Organization (WHO).

PFSCM also prequalifies suppliers to maintain and grow a supplier network for our clients. Our prequalification audits cover aspects of the WHO’s cGMP and “A Model Quality Assurance System for Procurement Agencies” (MQAS).

Further, we work closely with country recipients and manufacturers to facilitate forecasting and demand discussions for better production and storage planning.

For example, earlier this year, PFSCM was alerted of the tragic HIV outbreak in a poor southeastern town in Pakistan. We reacted promptly to release extra, and emergency shipments of HRDTs and ARVs needed to test and treat hundreds of people – mostly children.

PFSCM’s procurement unit worked closely with various vendors to determine- and release available stock, and plan for the immediate replenishment to supply the new and ongoing orders to Pakistan.

PFSCM also collaborated with the donor and recipient country to clear the waivers as soon as possible. Overall, PFSCM’s freight estimation and purchase order was prepared in only two hours and the supply- and waiver lead time was reduced by 7 to 10 days.

In terms of storage planning, PFSCM has continued to make a notable impact in Uganda in 2019.

In Uganda — one of the top countries for the procurement of HIV products — PFSCM entered a public-private partnership to manage a transit warehouse which takes pressure of the Central Medical Stores (CMS). Products are moved to the transit warehouse before further distribution to the CMS, this prevents products overstaying at ports of arrival and accruing demurrage and detention costs.

The facility has been a great solution for the storage of large amounts of HIV commodities arriving in Uganda. In 2019, Uganda acquired more than $60 million worth of HIV commodities through PFSCM, and over the last 10 years the country purchased almost $360 million worth of products.

In addition, PFSCM participates in global meetings such as the WHO suppliers’ gatherings, the ARV Procurement Working Group and the Global Accelerator for Paediatric Formulations, to stay abreast of developments and treatment guidelines in the HIV sector, while contributing to the development of policies for best procurement practices that drive optimal public health program outcomes.

Most recently, PFSCM strengthened its expertise in areas related to self-testing, medical devices, early infant diagnosis, laboratory equipment, and viral load testing.

A new chapter

For the last 10 years, PFSCM served as the procurement services agent for ARVs for the Global Fund to Fight AIDS, Tuberculosis and Malaria’s Pooled Procurement Mechanism (PPM).

In September this year, PFSCM retired as the PSA for ARVs, and was awarded new product categories:

  • Rapid diagnostic tests (HIV and malaria)
  • Viral load and early infant diagnosis tests
  • Other diagnostics
  • Laboratory and medical supplies and equipment

PFSCM has extensive experience managing these product categories, which are among the most complex health products to source, procure, transport, and store.

Between 2006 and 2016, PFSCM and its partners collaborated to manage the procurement and distribution of laboratory commodities for The President’s Emergency Plan for AIDS Relief’s Supply Chain Management System.

During this time, PFSCM procured more than $500 million worth of laboratory items, developed an innovative laboratory quantification tool, facilitated training courses for laboratory staff, and vetted local vendors for in-field office managed procurement, among other technical support services.

In the meanwhile, we have been procuring various rapid diagnostic tests kits for the Global Fund PPM, and have also procured many non-pharma and laboratory products for both PPM and non-PPM clients.

PFSCM still procures and ships ARVs globally for other clients, and remains an expert supply chain manager in this field.


RHSC Conference brings forth joint statement on oxytocin management and guiding principles on QA

On March 25-28, 2019, PFSCM attended the 19th General Membership Meeting of the Reproductive Health Supplies Coalition (#RHSupplies2019) in Katmandu, Nepal, from which two important pieces of news emerged.

Firstly, WHO, UNICEF, and UNFPA issued a joint statement on “Appropriate Storage and Management of Oxytocin — a Key Commodity for Maternal Health.”

Oxytocin is essential to the prevention and treatment of postpartum hemorrhage, as well as other indications. Managing the oxytocin supply chain — from procurement to cold chain management to clear and consistent product labeling — is critical to ensuring that the medicine is effective when it reaches women.

According to the statement, “Several studies confirm that oxytocin currently circulating in many low- and middle-income countries (LMICs) frequently fails to meet acceptable quality standards. Like vaccines, when oxytocin is not of sufficient quality or when it is not managed in cold chain, the medicine will rapidly degrade and become ineffective.”

WHO, UNICEF, and UNFPA strongly urge the following three actions to ensure effective management of and access to good quality oxytocin:

  1. Ensure that oxytocin is managed in a cold chain of 2-8 °C (35-46 °F) for distribution and storage.
  2. Procure oxytocin that meets the quality requirements established by WHO or a regulatory authority recognized by WHO.
  3. Label oxytocin to clearly indicate storage and transport requirements at 2-8 °C (35-46 °F).

Secondly, the Interagency Supply Chain Group (ISG) — established in 2014 to provide more effective support to country efforts to ensure sustainable access to high-quality essential health commodities — presented its final guidance on the “Guiding Principles for Donors Regarding Quality Assurance of Essential Medicines and Other Health Care Commodities.”

“Donors realize that a disease cannot be treated with a poor-quality product and should not be treated with a product whose quality is uncertain,” the guidance states. “Any amount of poor-quality medicine is unacceptable because it increases morbidity and mortality, jeopardizes the credibility of health services and programs, and in the case of antimicrobials contributes to the development of antimicrobial resistance. In addition, one cannot extrapolate the clinical trial experience (in which quality assured products are used) to the larger patient experience if non-quality assured products are used.”

The ISG sets out six agreed guiding principles that provide the framework to help assure the quality of finished pharmaceutical products that are procured with donor funds.

Read the guidance document here.

The ISG comprises 15 global agencies that support supply chain efforts across all disease areas: the Bill and Melinda Gates Foundation, DFID, Global Affairs Canada, the Global Drug Facility, KfW, the Global Fund, Gavi, NORAD, UNDP, UNFPA, UNICEF, USAID, the World Bank, the World Food Programme, and the WHO.

For more information on outcomes of the RHSC Conference, please contact Marcel Hendriks, PFSCM’s Strategic Advisor, Procurement, at

Non-tarrif barriers: why do they exist and how does PFSCM navigate this environment

Non-tariff barriers are non-tax measures encountered during the importation of commodities. These are frequently encountered by the Partnership for Supply Chain Management (PFSCM) during importation processes.

Some of these contribute little to delays as their overall management is commonplace, routine and relatively straightforward. Other non-tariff measures are less routine, difficult to address and, if not innovatively and precisely managed, can have a tremendous impact on the amount of time it takes to clear commodities.

Non-tariff barriers always serve some purpose. For example, they support rules and regulations that ensure imported items correspond to national standards to protect the well-being of citizens.  Sometimes their purpose may not be as readily apparent as this, and the layers of complexity impeding the import process can seem not only perplexing, but also counterproductive.

The presence of non-tariff barriers can also be frustrating to donors and implementing partners who are contributing to addressing the health needs of countries and would prefer to see the importation process sped up accordingly.  However, as complex and time consuming as it might be, non-tariff barriers are considered to be part of the procurement process and subsequently factored into lead times when they are known. The reasons for its existence can be divided into three categories.

Protecting domestic markets

National government authorities can set restrictions on importation for specific products in order to support established local producers or protect infant industries. When there is an established domestic health commodity industry supplying to the public sector, those industries may raise concerns that imported goods destabilize their markets. Non-tariff barriers may exist to support this perspective.

Protecting consumers

National health standards for determining the safety and effectiveness of health commodities are often established based on evaluations specific to an individual country’s need. Though these may be different than those determined by donors or the manufacturer, they may still be completely valid. The basis for these differences may be various health needs that result from factors such as climate, geography, life expectancy, and disease patterns. Whatever the difference may be, these standards generally result in legislated rules and regulations to protect citizenry from the risks associated with poor quality imports, such as could be experienced with expired, fake, substandard or unregistered products.

Exercising sovereignty

Non-tariff barriers can also be a punitive response directed towards exporting countries that have implemented their own non-tariff barriers to imports from the recipient country. They may also be put in place as a response to disagreements in foreign policy objectives. Sometimes this kind of non-tariff barrier has nothing to do with the product being imported but rather with how it is imported, such as with airlines or trucking companies that are not nationally registered

Examples of non-tariff barriers
  • Pre-inspection
  • Import licenses and/or permits
  • Automatic demurrage
  • Assorted handling fees
  • Packing, language and marking requirements
  • Trade documents
  • Translation services
  • Import deposits
  • Administrative feeds
  • Airline non-objections fees

The added value of PFSCM

PFSCM’s broad awareness of multiple iterations of importation processes, and cognizance of the fact that these can, and do frequently change, enables us to work with vendors and recipients to prepare documents before commodities are shipped, anticipate where new challenges may arise, and compress delivery delays or avoid them altogether.

System strengthening is also something that PFSCM does in this area. Through collecting and documenting the evidence of the impact of non-tariff barriers on behalf of public health programs, we enable the programs to advocate for national-level policy changes that will subsequently improve their supply chains. This could be something relatively straightforward as advocating for a distinction to be made between humanitarian shipments of health commodities and commercial shipments, or raising the awareness of public officials to the human cost and health impact of inefficient port and customs management.

PFSCM also supports recipients to increase their understanding of their role in the importation process to ensure they have the capacity to handle the shipments. PFSCM works with recipient’s staff to determine the specific customs procedures and documentation necessary to bring the shipment into their country.

On occasion we also work with the recipient to draft documents in the country’s official language in order to speed up the customs clearance process.

PFSCM’s experience with a wide supplier base further enables us to consult with suppliers to learn of their experiences as they are often familiar with the importing procedures for a number of countries.

Complementing this is PFSCM’s retention of experienced freight forwarders and logistics services providers who are familiar with the requirements for the importation of health care commodities on a country by country basis

Intervening in the importation of health care commodities, particularly in situations with multiple non-tariff barriers, is not a simple process, especially if relationships between staff from different ministries do not exist.

Further, Ministry of Health programs are often not enabled with the staff or the administrative authority to intervene with other government ministries such as ministries of finance, customs, transportation or pharmacy regulatory authorities.

PFSCM takes pride in aiding in bridging the experience gap between importation authorities and health program implementers to the point where the ability of the host government to manage importation is strengthened, while the needs of public health programs are simultaneously supported.


Non-tariff barriers always serve some purpose such as protecting consumers, protecting domestic markets or exercising sovereignty.

“Red Zone” happens every year and matters for humanitarian supply chains… here’s what to do about it

What is the Red Zone?

Holiday shopping, and the supply chains that meet that demand, are the main cause of the largest annual demand fluctuation in cargo prices. This affects the containerized ocean and air cargo markets at different times, due to the different lead times for each mode of shipment.

Containerized occean prices typically have two annual upswings. The first runs from mid-August through mid-October, as retailers use in-transit fulfillment to hold additional inventory in anticipation of the fourth quarter sales upswing. An additional cargo price increase typically occurs in January and February due to both demand and port closures that result from the Chinese New Year.

Air cargo prices typically peak in a Red Zone that extends from mid-November through early January. An increase in passenger air travel at the same time can affect cargo prices. Prices are impacted by the demand for fuel, which is stimulated by small parcels competing for space with excess baggage on certain flights.

In recent years, the increase in e-commerce has magnified these effects on air cargo prices in the Red Zone – making air shipments more expensive and less predictable during these weeks.

Meanwhile, winter weather in the global north can also cause delays.

What does this mean for public health organizations?

Public health supply chains compete with the retail sector for booking cargo.

The International Air Cargo Association (TIACA) predicts that the industry is better prepared for this year’s demand surge [1]. Likewise, TIACA notes that global air cargo capacity is slightly outpacing demand [2].

However, we cannot rest easy during the Red Zone. A booming global economy means demand for air cargo should be robust. E-commerce is a large and still-evolving sector that makes aggregate demand and cargo patterns difficult to predict; there is also evidence that it may be extending the peak season [3]. A global shortage of air cargo pilots could also affect flight availability [4] [5].

In addition, protectionism and trade disputes have the potential to cause disruption and increase costs.

Disruption or cost increases in commercial freight forwarding impact the humanitarian and public health organizations that depend on these markets for resupply and distribution.

What can supply chains do to manage the Red Zone?

In short, having a solid freight strategy, and exercising proactive logistics planning can make all the difference.

Below are some winning actions that the Partnership of Supply Chain Management executes when it comes to dealing with the Red Zone.

Freight Strategy

  • Negotiate fixed rate cards with third-party logistics (3PL) service providers. 3PLs typically agree to fixed rates cards for all but the lowest-frequency lanes. These rate cards are valid for six months, smoothing cost variance.
  • Standardize rate cards across all onboarded 3PLs. This facilitates quick cost comparisons and gives the supply chain management company the agility of having at least two 3PL options for most lanes, including all high-volume lanes.

Proactive Logistics Planning

  • Proactively engage both upstream suppliers and downstream clients to identify office holidays, warehouse closures, and other events which might disrupt operations. Use and share this information to more easily plan shipments around known end-of-year disruptions.
  • Identify orders with expected delivery dates in the Red Zone. Workshop these with the clients and assigned 3PLs. Where possible, expedite shipments ahead of the Red Zone or delay them until after. When that is not possible, book the shipments as early as possible to reserve the capacity and lock-in prices

Read more about PFSCM’s Freight and Logistics services.




Much progress made by the GAP-f working group in recent months

The Global Accelerator for Paediatric Formulations (GAP-f) — an evolving collaboration among a number of partner organizations — has continued to develop in 2018 and has announced some recent key accomplishments:

New website

The GAP-f website has been launched, which brings together key information on paediatric drug optimization and aims to be the place to go for updates in this broad area of work. The website includes links to guidance (such as the PADO list of priority paediatric ARVs and the IATT paediatric ARV formulary), important peer-reviewed publications, and past and upcoming events.



Papers published in JIAS and the Lancet

Two peer-reviewed commentaries recently published by the GAP-f outline pre- and post-approval activities coordinated by the GAP-f, key features of the GAP-f and its phased implementation, and future opportunities for change that will contribute to ensuring rapid development and uptake of key paediatric drugs in age-appropriate formulations:

  • “Shortening the decade-long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low- and middle-income countries,” published in JIAS in February. This paper is part of a supplement on “Paediatric and Adolescent HIV and the Sustainable Development Goals: the road ahead to 2030,” convened by CIPHER and guest-edited by Douglas Webb, Chewe Luo, and Lucie Cluver. It is available here.
  • “Catalysing the development and introduction of paediatric drug formulations for children living with HIV: a new global collaborative framework for action,” published in The Lancet HIV in early May. It is available here.

Webinar hosted

On April 24, the AIDS Free Working Group co-chairs hosted a webinar among Vatican meeting participants and other key stakeholders to provide an update on their efforts to monitor implementation of the Rome Action Plan and to allow those who made commitments to provide updates. The webinar showed that activities are ongoing on the majority of action points. An overall assessment of implementation status across the Action Plan will be performed to identify any significant gaps.

A recording of the webinar is available upon request to Tamar Gabelnick (



Satellite session to be held at AIDS 2018

At the upcoming 22nd International AIDS Conference (AIDS 2018), GAP-f partners will be hosting a satellite session to present GAP-f concepts and work outcomes so far. The session – to be held Monday, July 23, 10:15-12:15, in Hall 11B of the RAI Convention Center – will include perspectives from different disease angles and stakeholders. More information will be circulated closer to the conference.

PFSCM’s role in GAP-f

In 2017, PFSCM joined this newly formed working group that builds on global efforts to promote a faster, more efficient, more focused approach to paediatric formulation development. Wesley Kreft, PFSCM’s Director of Global Supply Chain, serves as an advisor to the GAP-f initiative in his role as co-chair of the ARV Procurement Working Group (APWG). PFSCM is also part of the team that has prepared and published the IATT Optimal Formulary List of Paediatric ARVs.

Read more about the GAP-f in a post from January on this blog.

World Malaria Day 2018: Reflecting on the public health supply chain with a focus on IRS

Globally, the efforts to end malaria in endemic, high-burden countries are vast and ongoing.

The fight against malaria brings together thousands of entities, from researchers, manufacturers, governments, and funders, to humanitarian groups and non-government organizations (NGOs). Supporting these institutions in their work is a myriad of interwoven service providers (SPs), executing many unseen tasks.

Among these SPs is the public health supply chain, working diligently to ensure:

    • Best value and quality products are procured to make available funds go further.
    • Commodities reach the point of care, on time and in full.
    • Infrastructure, such as storage facilities, are developed along the supply chain to ensure compliant pharma-grade storage of products.
    • Chain of custody is enforced through technology that captures information about shipment location, product integrity, and patient consumption.

On World Malaria Day 2018, the Partnership for Supply Chain Management (PFSCM) reflects on some of its most recent successes achieved in sourcing and moving complex and sensitive malaria commodities to some of the hardest-to-reach places on earth.

Sourcing and moving malaria commodities: IRS focus

PFSCM has been procuring and delivering malaria commodities for the Global Fund to Fight AIDS, Malaria and Tuberculosis since 2009.

Since then, more than 1,600 shipments of malaria commodities, worth more than $527 million, have been delivered to more than 45 countries for the Global Fund.

Commodities include artemisinin-based combination therapy (ACT), malaria rapid diagnostic tests (MRDTs), insecticide-treated bed nets and indoor residual spraying (IRS) products.

In recent years, PFSCM has refined and streamlined processes for the procurement and delivery of IRS products specifically.

IRS in a nutshell
Indoor Residual Spraying (IRS) is the application of long-acting chemical insecticides on the walls and roofs of all houses and domestic animal shelters in a given area, in order to kill the adult vector mosquitoes that land and rest on these surfaces.

The primary effects of IRS toward curtailing malaria transmission are:

  • To reduce the life span of vector mosquitoes so that they can no longer transmit malaria parasites from one person to another;
  • and to reduce the density of the vector mosquitoes.

In some situations, IRS can lead to the elimination of locally important malaria vectors. Some insecticides also repel mosquitoes and, by so doing, reduce the number of mosquitoes entering the sprayed room, and thus human-vector contact.

In terms of IRS, PFSCM mostly procures and ships a World Health Organization Pesticide Evaluation Scheme (WHOPES)-approved long-lasting microencapsulated formulation of the organophosphate insecticide, pirimiphosmethyl. The product is specifically designed for use in IRS programs to provide up to one year’s residual control of mosquitoes and other public health pests. It is effective against pyrethroid resistant Anopheles, Aedes, and Culex species.

PFSCM Senior Procurement Specialist Martin Mugisha says the procurement and shipping of IRS products comes with unique challenges, especially for public health supply chains.

“The sensitivities relating to IRS products are intertwined. These include complex sampling; pre-shipment inspection and quality control testing processes; relabeling; multiple shipments owing to the hazardous classification of products; limited delivery periods to various developing countries; constraints in order placement; and a lack of awareness and education about the role supply chains play in supporting IRS programs.”

Quality control testing, sampling, and pre-shipment inspection: Product quality is of utmost importance to PFSCM, and quality control batch testing is continuously undertaken.

PFSCM works with a WHO-prequalified laboratory in Belgium to execute the critical batch testing, which is especially important for pirimiphosmethyl — although pirimiphosmethyl is a trusted product, quality testing is done on each batch, owing to the hazardous classification of the product.

Further, quality assurance measures include sampling and pre-shipment inspections often undertaken by renowned inspection, verification, testing, and certification company Standard Global Services (SGS).

Sampling and/or pre-shipment inspections may be pursued at SGS’s own discretion, or as a result of a client request or a specific country requirement.

These safety measures are essential in safeguarding humans and the environment. By managing the quality testing process firmly and partnering with world-class laboratories, PFSCM reduces the cost and lead time of quality testing.

Relabeling for country-specific languages: Another important IRS supply chain activity is the translation of user directions and relabeling of the products. This ensures that country-specific language pairs — such and English and French, and English and Portuguese — are clear and accurate for safe and easy use by spray operators and others involved.

This process requires specialized outsourced services, which are undertaken at the manufacturing facility and coordinated by the procurement agent.

Moving hazardous products: The WHO has classified pirimiphosmethyl as a Class U product, meaning it is unlikely to present acute hazard to humans and the environment. Pirimiphosmethyl presents no significant risk to spray operators or householders when used as directed.

However, for the shipment of large quantities of the product, regulations pertaining to the shipment of hazardous cargo need to be followed. These requirements increase the complexity of the shipping procedure and may result in several vessels being used per order to comply with the allowable amount of dangerous goods per ship.

PFSCM has longstanding agreements with reputable freight forwarders who have extensive experience in managing hazardous cargo in a safe and cost-effective manner.

Time-sensitive products: IRS products need to be delivered before the spraying seasons start. Spraying usually occurs before the rainy seasons, and provisions for the in-country distribution and spray operator training need to be made.

PFSCM actively engages with stakeholders to align processes for smooth delivery of goods.

Constraints in order placement: Forecasting and order placement at the in-country level can be challenging, especially when data is in short supply and resources limited. Accurate forecast data plays a crucial role in manufacturer production scheduling and stockholing.

Improved forecasting data generates market confidence and encourages vendors to enter into long-term agreements with SPs, thereby also ensuring that recipients can enjoy better product pricing and stable supply.

The procurement agent and supply chain SPs need to be flexible and agile in responding to the consumption patterns of public health supply chains in developing countries, and need to drive advancements in this area for optimized spend.

Lack of awareness about the role of supply chains: Stakeholders need to be educated on the importance of collaboration, especially where roles start overlapping. Quick execution of waiver applications, accurate monitoring of warehouse capacity, and attention to details such as the availability of staff for unloading cargo can make a significant impact on a project.

In the public supply chain space, PFSCM often acts as advisor and educator, traveling to engage with stakeholders in person, to ensure all parties understand their roles and are equipped to fulfil their responsibilities.

“Having navigated these challenges and barriers for some years, PFSCM has become an expert in the field of IRS procurement logistics,” notes Mugisha.

Adapting to an ever-changing malaria environment
The malaria landscape is evolving, with drug and pesticide resistance, diminishing funding, environmental concerns, counterfeit and stolen goods, and a need for increased supply chain efficiencies driving new treatment innovations.

With new innovations, the supply chain will need to adapt and gear up for temperature-controlled conditions for new vaccines, while contemplating how new biomedical nanotechnology drug delivery systems will impact on the future of public health supply chains and patient care.

Working with SGS

PFSCM and SGS have a well-established business relationship, with SGS playing a key role in PFSCM’s operations for over a decade now.

SGS facilitates the pre-shipment inspections and sampling of IRS products as per client or country requirements.

In 2018, PFSCM and SGS again had the opportunity to share knowledge and engage about ways of streamlining quality assurance systems in the unique IRS environment.

The collaboration has proven exceptionally fruitful ahead of a major consignment of IRS products due for delivery to Mozambique by mid-2018.

Mugisha explains that stakeholder engagement such as this has been essential in orchestrating complex IRS deliveries.

“IRS shipments comprise many individual processes and products, and therefore the harmonious alignment of QC testing and pre-shipment inspection is critical to ensure the order not only arrives on time, but also in its entirety,” stresses Mugisha.

He adds that direct insight into the specialized tasks managed by SGS, as well as continuous interaction, has helped PFSCM simplify quality assurance procedures to reduce lead time, proactively manage risks, and, ultimately, ensure that the most critical logistics step is well executed.

Further, the efficiency of the quality assurance process is also accelerated by reputable vendors offering excellent quality products.

“The outstanding track record of the pirimiphosmethyl we procure is a contributing factor to the success we have had in reducing quality assurance lead time,” notes Mugisha.

Proactive approach in harmonizing major 2017 IRS deliveries to Mozambique

In 2017, PFSCM made inroads in engaging with IRS program stakeholders and aligning various parallel processes for the shipment of IRS products to Mozambique.

In August 2017, PFSCM orchestrated the delivery of a large consignment of IRS commodities to be used in the Mozambique Ministry of Health’s IRS campaign, which took place around October 2017.

The milestone consignment of 33 containers was shipped via 3 ports of entry, across more than 2,000 km, to 7 regional warehouses in Mozambique.

PFSCM Senior Logistics Services Specialist Jerome Sabatier says it was critical that the shipments were delivered on time, that sufficient compliant storage was available in all seven regions, and that the quality sampling and logistics was done in a cost-effective manner.

“This shipment entailed many complex facets. To save time and money, we conducted the product quality testing early in the preparation phase and tendered part of the shipment to save about $50,000. Apart from this, we anticipated that poor infrastructure, language barriers, and bureaucracy would likely attribute to the complexity of distribution.”

Sabatier explains that PFSCM took a proactive approach to solving the logistics challenges and visited several of the designated warehouses, ports, and in-county stakeholders to ensure all requirements were met before the 33 containers of IRS were delivered.

Further, PFSCM also greatly improved supply chain communication channels by building rapport with in-country stakeholders, such as the logistics SPs, agents, warehouse managers, and other institutions.

“Through the in-country groundwork, we avoided many pitfalls, such as incorrect delivery addresses, availability of labor for offloading at warehouses, and import waiver delays.”

The team not only succeeded in ensuring successful deliveries, but also managed to create awareness about the importance of this malaria prevention project and the shipment of commodities that make it possible.

By sharing their expertise and conveying a genuine sense of responsibility, the PFSCM team motivated the various stakeholders to uphold the same level of ownership.

Price reduction to yield future savings

Meanwhile, earlier in 2017, PFSCM negotiated a 17% price reduction on pirimiphosmethyl. Prior to these negotiations, the pricing for this IRS commodity had remained the same since 2014.

The price reduction is expected to yield significant savings on future procurements and will contribute to saving more lives.

Applying refined strategies for IRS to Mozambique in 2018 and expanding into Zimbabwe

In 2018, PFSCM will again deliver a large consignment of IRS products to Mozambique.

In total, 27 containers will be delivered to 3 provinces in preparation for the spraying season, which is again due to start in October.

In addition, an order of 10 containers will also be delivered to Zimbabwe.

For these shipments, PFSCM will leverage the groundwork done and relationships built in 2017 and will again:

  • Actively engage with stakeholders; and
  • Reassess warehouses inspected in 2017.

This year, PFSCM has already achieved major successes by saving $133,000 on ocean freight cost through spot-bidding and strategizing with SGS.

Navigating the Sahel region with SMC products
At the start of 2018, PFSCM received a large order for seasonal malaria chemoprevention (SMC) commodities to be delivered to Africa’s Sahel region between July and September 2018. SMC is a relatively new, highly effective intervention to prevent malaria in children under five years of age, those most vulnerable to the disease’s effects.

SMC is a complete treatment course of amodiaquine plus sulfadoxine-pyrimethamine (AQ+SP), which is administered in up to four monthly doses to children aged 3 to 59 months during the peak malaria transmission season (July to December) in the Sahel region.

The $5 million project will see 15 million co-blisters of AQ+SP procured and distributed to three African countries: Burkina Faso, Chad, and Nigeria. More than 3 million infants and children will likely benefit from this preventive treatment in these regions in 2018.

PFSCM Senior Client Account Manager Eva van Tol says this is an exciting and challenging project for PFSCM. In Burkina Faso and Chad, products will be delivered to a central location, from which further distribution will be undertaken by PFSCM partners, such as CAMEG. In Nigeria, PFSCM will leverage its in-country expertise to assist the Malaria Consortium with in-country distribution. The products are procured as part of the ongoing ACCESS-SMC prevention program, which is a UNITAID-funded project led by the Malaria Consortium in partnership with Catholic Relief Services.


A look at the supply chain implications of TB regimen changes

Even though tuberculosis (TB) is a curable disease, it is still, according to the World Health Organization (WHO), responsible for 4,500 deaths a day.

The reasons behind this are complex and interwoven, ranging from educational and social issues, to a lack of early detection and missed detection opportunities, combined with long diagnostic processes and increasing drug resistance, among others.

Massive global endeavors to address the ever-evolving challenges through research, development, and investment are ongoing. One area of focus for the WHO and global stakeholders is the development of simpler-to-use drugs and treatment regimens that will encourage higher treatment adherence and simplify logistics, while reducing drug resistance.

In 2018, the WHO has already released some new recommendations and treatment guidelines for drug-resistant tuberculosis. These will be incorporated into the Consolidated Guidelines for Treatment and Care of Drug-resistant TB later this year.

Commitment and accountability to manage transition of the TB supply chain

The Partnership for Supply Chain Management (PFSCM)’s Global Supply Chain Director Wesley Kreft says public health supply chains can lead in the fight to end TB through commitment to — and accountability for — effective regimen transitions.

“It is normal for health programs to change — in fact, it is essential to ensuring successful outcomes in changing global markets and environments. The problem is that public health supply chains face unique challenges that often make quick implementation of changes difficult.”

Two such challenges are:

  • The time it takes to make and implement decisions in the public health supply chain; and
  • The operational and logistical weaknesses that hamper flexibility.

According to a report co-authored by PFSCM partner organization Management Sciences for Health (MSH) and entitled Tuberculosis regimen change in high-burden countries, countries committed to considering a change spend about one year on decision making and about two years to roll out or implement changes.

The report — which was compiled after conducting 166 interviews with country stakeholders in 21 of the 22 TB high-burden countries — also found that stakeholders are more often concerned with the program-based implications (logistics and cost) of the change than they are with the patient-focused implications (side effects).

Kreft explains that several logistics and cost factors — such as accurate forecasting, proper phasing out of old and excess products, availability of quality local sources, and uncertainties about future product pricing — need to be addressed during a transition.

He adds that these factors can be difficult for public health supply chains to manage when working with limited resources.

However, Kreft stresses that there are key principles that can be followed to aid in efficient transitions.

1. Preparing and closely monitoring the supply chain

To successfully implement new regimens, the supply chain must align with program changes to ensure proper budgeting, demand forecasting, supply planning, and procurement.

“Regular small orders need to be placed in the introduction phase, and stock and consumption need to be closely monitored to ensure all patients on old regimens can complete their treatment, while enough stock is already available for those newly diagnosed patients. The overlap of these activities should also be finely tuned to ensure as little stock destruction as possible. It is a sensitive process that has both advantages and disadvantages tied to the nature of the TB regimen.”

2. Minimizing risks through vendor pre-qualification and engagement, accurate forecasting, demand planning

Further, Kreft adds that there is also a risk that countries may return to old regimens if new products cannot be produced locally at reasonable prices, local product quality does not meet international standards, or global supply cannot meet demand.

To minimize these complications, it is important for countries to assess the suitability of local sources early in the transition and to determine how national and international guidelines can be harmonized to ensure local economic growth and regulatory compliance.

The challenge is balancing the need for “buying local” with the obligation toward international quality standards.

Countries are always battling the cost-quality dilemma, but pre-qualification groundwork can help governments to bridge the gap between in-country and international regulatory commitments, notes Kreft.

Further, accurate forecasting, demand planning, and vendor engagement is essential to ensure suppliers keep up with demand.

3. Supporting countries that will transition from donor support

In addition, in cases where countries are receiving highly subsidized or free products, there is a risk that the products may become too expensive when countries graduate from donor-funded programs.

“It is important that clear stakeholder engagement is maintained and that agreements or contingency plans are in place for countries with limited budgets or expected future financial constraints.”

Kreft concludes that bringing together multi-sectoral expertise may help countries respond faster to treatment guideline and regimen changes, thereby increasing commitment and accountability in the fight to end TB.

Major donors and health agencies developing Global Accelerator for Paediatric Formulations (GAP-f)

By David Jamieson

As we have discussed in news blogs last year, limited treatment options and sub-optimal formulations have contributed to poor adherence and outcomes for children living with HIV. To improve coordination in tackling the barriers to research and development that remain, major global players are developing an initiative called the Global Accelerator for Paediatric Formulations (to be known as GAP-f), working to build consensus and define the working group’s structure. Formal launch is planned for later this year.

Figure 1 below shows how the GAP-f formalizes collaboration across sectors to ensure accelerated development and uptake of the most-needed drugs and formulations for children.

Figure 1. The GAP-f formalizes collaboration across sectors to ensure accelerated development and uptake of the most needed drugs and formulations for children. SRAs: stringent regulatory authorities. NRAs: national regulatory authorities (in high-burden countries). Source: Penazzato et al. Shortening the decade-long gap between having optimal adult and paediatric drug formulations, JIAS, In press.

In November 2017, at a meeting convened by His Eminence Peter Kodwo Appiah Cardinal Turkson, Prefect of the Dicastery for the Promotion of Integral Human Development, key principles of the GAP-f set the basis for commitments to be known as the Rome Action Plan, which promote three key principles:

  • Focusing on priority paediatric drugs and formulations;
  • Accelerating development, review, and introduction of paediatric formulations; and
  • Collaborating to expedite the development and introduction of paediatric products.

Figure 2 below shows how these principles align with the foundations of GAP-f to address challenges in paediatric drug formulation development.

Figure 2. The GAP-f represents an opportunity to address challenges in paediatric drug formulation development. Challenges are grouped around three areas: dependence on adult drug development, paediatric formulation requirements, and paediatric ARV market. Progress to date in addressing these challenges is depicted along a funnel originating from precursor mechanisms (the existing initiatives that are unified under the GAP-f) and leading up to the GAP-f collaborative model. Legal framework challenges are placed outside of the funnel because of the limited influence of the GAP-f to directly address these. Source: Penazzato et al. Shortening the decade-long gap between having optimal adult and paediatric drug formulations, JIAS, In press.

The team behind the GAP-f is an evolving collaboration between a number of partner organizations, including:

PFSCM is committed to supporting initiatives that will improve the position of children living with HIV, and has supplied paediatric ARVs to many countries. Wesley Kreft, PFSCM’s Director of Global Supply Chain, currently serves as an advisor to the GAP-f initiative in his role as co-chair of the ARV Procurement Working Group (APWG). PFSCM is also part of the team that has prepared and published the IATT Optimal Formulary List of Paediatric ARVs.

Big gains in treatment of children living with HIV

Treatment rates for pediatric patients have always lagged behind adults, but now programs like PEPFAR’S ACT Initiative show this doesn’t have to be the case


by David Jamieson, PFSCM Senior Supply Chain Advisor


In May, we reported on new opportunities for viral load testing of babies and young children at, or close to, the clinic where they see their doctor. In this blog post, we look at how results from PEPFAR’s Accelerating Children’s Treatment (ACT) program show that, with the right policies and a focused approach, rates of treatment of children living with HIV (CLWH) could be as good as those for adults.

When Ambassador Deborah Birx of PEPFAR launched the $200 million ACT initiative in August 2014, the aim was to double pediatric treatment rates in nine African countries in just two years, which would bring 300,000 new patients on antiretroviral (ARV) treatment.

By September 2016, the number of children on treatment worldwide had grown to an estimated 900,0001 with 561,000 patients on treatment in the ACT countries. Even more importantly, the number of children on treatment continues to grow, proving that the ACT program and other initiatives are creating sustained change.

Across the nine ACT countries, the number of children on antiretroviral treatment (ART) increased by 44%. In Kenya, an estimated 73% of CLWH are on treatment; in Zimbabwe, the figure is even higher at 80%, showing that the goal of 90% of known CLWH being on treatment is achievable.

Globally, PEPFAR supports nearly 1.1 million children (0-19 years old) on ART — a 97% increase since 2014.

Though ACT, PEPFAR and the Children’s Investment Fund Foundation focused efforts in high-risk areas, working with local implementers to identify babies, children, and adolescents with HIV and to get them onto treatment without delay, often within a day.

Other barriers tackled included:

  • Training and job aids to overcome health care providers’ lack of confidence in treating pediatric patients.
  • Advocating to change restrictive treatment access policies.
  • Improving the child-friendliness of the medicines — some pediatric solutions tasted bad, making it difficult to get very young children, who could not swallow pills, to take the medicines.


The supply chain for ARVs: A critical component

PEPFAR tasked PFSCM, through the Supply Chain Management System project, with ensuring that the drugs would be available at the health facilities when needed. Identifying CLWH and encouraging parents and caretakers to start children on treatment is an enormous effort. If stock levels were not properly maintained at clinics, all the effort would be in vain.

Managing the supply chain for CLWH is challenging because it involves more drugs than for adults, the formulations change as children grow, and, in many countries, the total requirements are small. It is also necessary to strike a balance between preventing stockouts and not overstocking, which could result in products expiring before being used.

Globally, PFSCM engaged in two important supply chain initiatives. We became founding members of the Pediatric ARV Procurement Working Group (PAPWG), an effort to pool the requirements for pediatric ARVs to create and manage sufficient demand to keep the market attractive to suppliers. By coordinating the demand of major purchasers — such as PFSCM and the Global Fund to Fight AIDS, Tuberculosis and Malaria — with demand from smaller countries, supply became more consistent and flexible.

PAPWG results are described on PFSCM’s website and in a paper published on the Global Fund’s website. The PAPWG — now known as the ARV Procurement Working Group (APWG) and chaired by PFSCM’s Director of Global Supply Chain Wesley Kreft — has expanded to include adult formulations in low demand.

To address the challenge of multiple pediatric ARV formulations, PFSCM also joined a team from the UNICEF Inter-Agency Task Team (IATT) for the Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children to draw up an optimal formulary of pediatric ARVs. From more than 65 approved pediatric ARVs, the team created a formulary of 10 optimal formulations, as well as a list of a further 10 limited-use products.

The IATT team has also advocated for and supported the development and introduction of small pellets that young children can take in soft food to replace the bad-tasting liquid for Lopinavir/Ritonavir, an ARV essential in treating very young children.


What’s next

To build on the achievements of PEPFAR’S ACT program and the other recent progress, the global community is continuing to innovate. Current initiatives include:

  • Start Free, Stay Free, AIDS Free: The ACT Initiative’s lessons are key to UNAIDS’ Start Free, Stay Free, AIDS Free framework — a super-fast-track approach to ending AIDS among children, adolescents, and young women by 2020. The framework is based on the fundamental principle that everyone living with HIV should have access to ART.
  • DREAMS: To address the high risk of contracting HIV for girls and young women, PEPFAR — in collaboration with private sector partners the Gates Foundation, Girl Effect, Johnson & Johnson, Gilead Sciences, and ViiV Healthcare — is driving the ambitious Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) Partnership.

The global community is also continuing to:

  • Update and promote the use of the pediatric ARV optimal formulary.
  • Develop child-friendly effective medicines.
  • Support introduction of new products.

PEPFAR’s 2017 report states: “Saving the lives of children with HIV is not only the right thing to do; it is the smart thing. By treating children early in their HIV infection, they can stay healthy and thrive. Healthy children who can pursue their dreams will grow economies, create jobs and strengthen their communities for decades to come.”

We can’t say it any better, and will continue to do all we can to ensure supply chains support increased treatment for children.

Based on UNAIDS 2017 report of 2.1 million children living with HIV, of whom 43% are on treatment