Lessons learned: Leveraging the role of national distributors to accelerate access to medical abortion combi-packs in sub-Saharan Africa

Publication date: 2021

Lessons Learned Leveraging the role of national distributors to accelerate access to medical abortion combi-packs in sub-Saharan Africa Acme Acme Formulation Private Ltd. ABBEF Association Burkinabé pour le Bien-Être Familial CIFF Children’s Investment Fund Foundation Zizhu China Resources Zizhu Pharmaceutical Co., Ltd. IPPF International Planned Parenthood Federation LMIC low- and middle-income country MA medical abortion MPL Melcome Pharmaceuticals Ltd. Combi-pack mifepristone/misoprostol co-packaged product MOH ministry of health Naari Naari Pharma Private Ltd. NGO nongovernmental organization WHO-PQ Prequalification from World Health Organization RHSC Reproductive Health Supplies Coalition SMO social marketing organization SRA stringent regulatory authority SSA sub-Saharan Africa Sun Pharma Sun Pharmaceutical Industries Ltd. Acronyms 1 INTRODUCTION/SUMMARY 3 RHSC PROJECT METHODOLOGY 5 LESSONS LEARNED 7 It is important to understand the combi-pack supply chain actors, including the small but diverse base of major manufacturers 7 Manufacturers play the decisive role in market entry; their main focus is on profitability and sustainability 8 Commercial sector actors often do not view combi-packs as simply one more pharmaceutical product to market or sell 9 We can benefit from collaboration with distributors (and manufacturers) even if the motivations driving us are very different 10 Francophone Africa has distinctive supply system practices and regulations 11 Combi-pack market realities, combined with the product’s small supply base, increase the challenges for growing markets, and not fragmenting them 12 CONCLUSION 14 Table of contents 2 Introduction COMMERCIAL SECTOR ACCESS TO COMBI-PACKS Approximately 56 million abortions occur each year globally, and almost half of them are unsafe.1 The risk of dying from an unsafe abortion is highest in Africa.2 Medical abortion (MA), using a combination of mifepristone and misoprostol, is a safe and effective method of pregnancy termination that can be managed by different levels of health care providers or self-managed by women. Mifepristone and misoprostol may be obtained in a co-packaged product (combi-pack), which contains one mifepristone 200mg tablet and four misoprostol 200mcg tablets. Combi-packs are not yet broadly accessible in many countries in sub-Saharan Africa (SSA). Where combi-packs are available in SSA, they are often accessed through the supply chains of social marketing organizations (SMOs), or, less frequently, through ministries of health (MOHs). Although local commercial distributors (private sector actors who procure, store, and re-sell pharmaceutical products) are important links within these supply chains, it is not very common for a major combi-pack manufacturer to contract directly long-term with a commercial distributor in SSA, without the collaboration of an SMO partner. RHSC INITIATIVE ON COMMERCIAL DISTRIBUTION OF COMBI-PACKS The Reproductive Health Supplies Coalition (RHSC) is the largest network of reproductive health organizations in the world, bringing together more than 525 member organizations from all sectors, including governments, commercial sector actors, technical agencies, and civil society organizations. More than a third of its membership is based in low- and middle-income countries. In mid-2018, RHSC began a three-year project, funded by the Children’s Investment Fund Foundation (CIFF) and an anonymous donor, “Leveraging the role of national distributors to accelerate access to medical abortion combi-packs in sub-Saharan Africa”. This project’s intent was to test the efficacy of innovative approaches with commercial distributors as a means of enabling them to play a more active role in increasing access to combi-packs in SSA. Specifically, the project aimed to 1) identify the obstacles preventing distributors from pursuing national regulatory approval for combi-packs and increasing access to this product; 2) identify a range of interventions to help distributors overcome the barriers; and 3) pilot test a selection of interventions in countries where local markets can sustain the introduction of one or more combi- pack options. It is important to understand the combi- pack supply chain actors, including the small but diverse base of major manufacturers Manufacturers play the decisive role in market entry; their main focus is on profitability and sustainability Commercial sector actors often do not view combi- packs as simply one more pharmaceutical product to market or sell LE S S O N S LE A R N ED 1 Barot, S. (2018, March). The Roadmap to Safe Abortion Worldwide: Lessons from New Global Trends on Incidence, Legality and Safety. Retrieved from: https://www.guttmacher.org/gpr/2018/03/roadmap-safe-abortion-worldwide-lessons-new-globaltrends-incidence-legality-and-safety 2 .Ganatra B, Gerdts C, Rossier C, Johnson Jr B R, Tuncalp Ö, Assifi A, Sedgh G, Singh S, Bankole A, Popinchalk A, Bearak J, Kang Z, Alkema L. Global, regional, and subregional classification of abortions by safety, 2010–14: estimates from a Bayesian hierarchical model. The Lancet. 2017 Sep 3 RHSC’s project included a landscape assessment conducted in 10 countries in SSA and an implementation phase. In the implementation phase, RHSC supported the re-introduction of a quality-assured combi-pack into the Zambian market and the registration of a quality-assured combi-pack in Burkina Faso. Due to COVID-19, the implementation phase was curtailed, and additional countries were not added. RHSC was initially engaged for this project based on a set of assumptions regarding the potential for financially incentivizing commercial distributors to take a more active role in fostering combi-pack access. As this project evolved, we realized that these founding assumptions did not accurately reflect market realities. In this report, we explore combi-pack market dynamics in SSA, the role of the commercial sector actors in the supply chain, and the potential for influencing these markets through interventions. National combi-pack markets will continue to evolve, especially if/when more national governments in SSA strengthen their safe abortion policy frameworks, procure combi-packs through the public sector, and/or enable private sector sales through constructive regulations. As the number of countries with such supportive settings increases, the opportunities to influence markets will evolve. We can benefit from collaboration with distributors even if the motivations driving us are very different Francophone Africa has distinctive supply system practices and regulations Combi-pack market realities, combined with the product’s small supply base, increase the challenges for growing markets, and not fragmenting them. AS THE NUMBER OF COUNTRIES WITH SUCH SUPPORTIVE SETTINGS INCREASES, THE OPPORTUNITIES TO INFLUENCE MARKETS WILL EVOLVE. 4 RHSC Project Methodology RHSC’s project consisted of two primary phases: diagnostic and implementation. Using a Request for Proposal process in the second half of 2018, we contracted Mann Global Health, in partnership with MSI Reproductive Choices and WCG Cares, to conduct a landscape assessment in ten countries in SSA. The objective of this effort was to provide a country-specific understanding of the current market dynamics, challenges, and opportunities for engaging local commercial distributors to make affordable combi-packs more available in a diverse range of countries in SSA. After the landscape assessment, RHSC launched the implementation phase of the project. To complement the assessment findings, we reached out to major combi-pack manufacturers and other actors in the safe abortion space, such as SMOs and NGOs. Additionally, travel conducted in mid-2019 to Zambia, Uganda, and Burkina Faso greatly added to our understanding of national market dynamics and of the viability of various private sector approaches. Throughout the project, we sought to learn from, and align with, RHSC members active in this space. The project’s implementation phase envisioned two rounds. In the first, RHSC piloted approaches to increase combi-pack access in Burkina Faso and Zambia. The second round, which was to have been conducted in 2020, was canceled due to the impact of COVID-19 on international travel, supply chains, marketing/detailing activities, and business conditions. In the first round, RHSC reintroduced a quality- assured combi-pack into Zambia through a commercial distributor who had not previously managed combi-packs. In Burkina Faso, the intervention entailed registration of a quality- assured combi-pack. PILOTED APPROACH TO INCENTIVIZE COMBI-PACK SALES IN ZAMBIA At the outset of this project, at least three combi-packs existed in the Zambian market: two were legally registered, and one was not. One of the two registered products was manufactured by Acme Formulation Private Ltd. (Acme) and distributed by MSI Reproductive Choices. The other was manufactured by Sun Pharmaceutical Industries Ltd. (Sun Pharma), but due to a conflict with its local distributor, had not been procured for about one year. This was the product towards which RHSC targeted its efforts. Supported by Sun Pharma, RHSC contracted a commercial distributor who was already managing (procuring in bulk, storing, and re-selling to local wholesalers, pharmacists, and health facilities) many Sun Pharma products, though not combi-packs. Through RHSC’s agreement with them, Melcome Pharmaceuticals Ltd. (MPL) assumed responsibility to procure and sell combi-packs to wholesale and retail pharmacies, and to health facilities in the country. Sun Pharma has a team of medical representatives in Zambia, responsible for marketing and detailing (promotional activity typically done face-to-face with prescribers and pharmacists to educate and encourage them to prescribe or buy the product) in the public and private sectors. This team’s manager agreed to add combi-packs to their marketing/detailing activities in the country, although we did not contract directly with Sun Pharma; their marketing/detailing activities were coordinated with MPL’s sales activities through the life of the project. PLANNED APPROACH TO INCENTIVIZE COMBI-PACK MARKETING IN BURKINA FASO In mid-2019, two combi-packs were available in Burkina Faso, only one of which was legally registered. That product was manufactured by Naari Pharma Private Ltd. (Naari) and sold in partnership with DKT International. The non-registered combi-pack, manufactured by Sun Pharma, had entered the country under temporary authorizations for use in health facilities by Association Burkinabé pour le Bien-Être Familial (ABBEF), the local affiliate of the International Planned Parenthood Federation (IPPF). 5 BURKINA FASO ZAMBIA RHSC agreed to support the registration of Sun Pharma’s combi-pack with a view to subsequently incentivizing marketing/detailing and increasing product availability in the country. At that time, Sun Pharma had been expecting to file for registration in the fall/winter of 2019. Our approach was based on a strategy designed to incentivize those behaviors that we wanted to encourage. What we learned, however, was that “who” one incentivizes is just as important as “what” one incentivizes. And the “who” varies depending on context. In Anglophone Africa, potential incentivization of commercial distributors can make sense because of the decision-making powers that the distributors often exercise, in combination with manufacturers, over procuring and selling combi-packs in a country. In Francophone Africa, the same is not true because commercial distributors in the region serve essentially as middlemen, servicing the needs of their pharmacists and distributing a range of products ultimately determined by others, in this case of French exporters. Moreover, the local base of distributors in this region is quite concentrated compared to other regions in SSA. Many of these distributors are actually subsidiaries of larger international logistics corporations, so any new initiatives undertaken by them would require at least some approval from beyond national borders. Therefore, in Burkina Faso, we chose to incentivize the promotional agency, which performs marketing/detailing functions. This alternative approach offered new lessons and insights on the workings of combi-pack supply systems in this region of SSA. Implementation of such an incentivization scheme and the supporting contracts would require negotiation and formal approval from Sun Pharma’s executive management and from the local promotional agency. The dossier and product samples were submitted to the national regulatory authority, Agence Nationale de la Règlementation Pharmaceutique several months later than anticipated, largely due to COVID-19-related factors. Because of this delay, the uncertain timeline for registration, and the manufacturer’s extended production lead-times due to the pandemic, RHSC was unable to carry through with the incentivization of marketing/detailing activities as originally planned. 6 Lessons Learned RHSC was initially engaged for this project based on a set of assumptions regarding the role of commercial distributors and the potential for financially incentivizing distributors to take on a more active role in growing combi-pack access. During the life of the project, we realized that these founding assumptions did not accurately reflect the realities of combi-pack markets. In this section, we highlight lessons learned about combi-pack markets, the role of both commercial distributors and manufacturers, and the potential to expand combi-pack access through the private sector. Globally, there are many manufacturers of misoprostol, mifepristone, and even combi-packs. Most of these manufacturers are not quality-assured (with prequalification from the World Health Organization [WHO-PQ], or approval by a Stringent Regulatory Authority [SRA]). And it is well known that many products that are substandard or of unknown quality circulate in low- and middle-income countries. There is only a small number of combi-pack manufacturers who have achieved global quality assurance standards or are ostensibly on the path toward attainment. To better understand combi-pack market dynamics and the potential for private sector market interventions aimed at commercial distributors, we engaged in multiple discussions with each of these manufacturers. During this process, we quickly learned that, while they share a commitment to achieving global quality assurance standards, the manufacturers differ in many ways. For instance, they have contrasting approaches to sales in low- and middle-income countries, to distribution strategies, and to pursuing sustainability. COMPANIES ON THE PATH TO ACHIEVING GLOBAL QUALITY-ASSURANCE STANDARDS In addition to the few quality-assured manufacturers of combi-packs, two other manufacturers have a very significant presence in SSA, holding many national registrations: Acme and Naari. Acme’s presence in markets in SSA is almost entirely in collaboration with a variety of SMOs such as DKT International, MSI Reproductive Choices, and Population Services International. Naari’s market presence in SSA is also primarily through agreements with SMOs. Manufacturers’ arrangements with SMOs often provide for contracts, exclusivity, registered product, and active distribution channels. Viatris, formerly Mylan Laboratories Ltd., which manufactures quality-assured contraceptives, also produces a combi-pack which is not yet quality-assured; this combi- pack is registered in a very small number of countries in SSA and is sold in collaboration with SMOs. China Resources Zizhu Pharmaceutical Co., Ltd. (Zizhu) Currently, Zizhu is the only combi-pack manufacturer with WHO-PQ; this approval was awarded in November 2019. Since achieving this status, Zizhu has begun filing for registration in select LMICs. Linepharma International Linepharma International is SRA- approved. They have relationships with SMOs and many of their combi-pack sales are in a small number of higher- income countries. Sun Pharmaceutical Industries Ltd. (Sun Pharma) Sun Pharma is SRA-approved. Sun Pharma has a relatively small but growing number of national registrations in SSA, as well as in other regions. They sell combi-packs through commercial distribution and also have relationships with SMOs. It is important to understand the combi-pack supply chain actors, including the small but diverse base of major manufacturers. QUALITY-ASSURED MANUFACTURERS OF COMBI-PACKS 7 MANUFACTURERS’ PRIMARY FACTORS FOR CONSIDERATION OF MARKET ENTRY At the outset of this project, RHSC was engaged to pilot finance-based interventions with potential to help commercial distributors overcome combi-pack registration and distribution barriers and to increase access through the private sector. In other words, the notion that gave rise to this project was that commercial distributors drive local private sector markets in SSA. During the life of our project, RHSC realized that this premise was not correct. Manufacturers play the decisive role in market entry of combi-packs across sectors; their main focus is on long-term profitability and sustainability. Before entering new markets, manufacturers consider the opportunity costs of their investments, as well as the expected rates of return on the investments. Expectations for profitability in a national combi-pack market are often linked to arrangements with SMOs or to future national tenders. If a manufacturer does not expect future public sector procurements or a collaboration with an SMO, it is much less common for a manufacturer to enter a new market and sell combi-packs through the private sector. Also, commercial distributors cannot decide independently to register a manufacturer’s combi-pack or to procure that combi-pack directly from the manufacturer. Manufacturers select local partners strategically and are influenced by their existing relationships and contractual arrangements. The local partners chosen by manufacturers are not permanently established. Depending on business relationships, the competitive landscape, and emerging opportunities to engage more profitably with new partners, manufacturers can shift their alliances. This may be more easily done in some countries than in others, depending on local regulations. While implementing this project, RHSC held many conversations with combi-pack manufacturers to discuss the potential for collaboration on specific market interventions in SSA. Through this process, we gained some understanding of the priorities of manufacturers when considering market entry or expansion of market presence. While each combi-pack manufacturer may evaluate priorities differently, they are all motivated to register in a country only if they have a favorable sales outlook. The table below lists primary factors for consideration in entering new national markets. Manufacturers play the decisive role in market entry; their main focus is on profitability and sustainability. Size of market Saturation of market Enabling environment (supportive laws and regulations) for safe abortion services and private sector sales Local partners for registration and distribution, selected on basis of existing relationships and market knowledge Price points for MA in market sectors Potential for national tenders Presence and commitment of SMO partners 8 While the ability of SMOs to conduct marketing/detailing activities is well-known in the safe abortion community, other business models exist and can be viable, depending on the context. During the life of our project, we encountered examples of these business models being used by combi- pack manufacturers, although each business model was not being implemented for the combi-pack product category. • A manufacturer may employ its own team of medical representatives in a country to conduct marketing/ detailing activities and to build and maintain key business relationships; use of this model would depend on the expected relative return on investment. Manufacturers using this model are most likely selling multiple pharmaceutical products in a country. • Some commercial distributors have the capacity for marketing/detailing, and may conduct such activities, as agreed with the product’s manufacturer. • In certain regions and countries, such as in Francophone Africa, promotional agencies exist and may be contracted by manufacturers to promote their products to wholesalers, pharmacists, and prescribers in the private and public sectors. When considering any of these business models for the marketing/detailing of combi-packs, it is helpful to understand that commercial sector actors don’t often view combi-packs as simply one more pharmaceutical product to market or sell. They perceive risks associated with marketing this product, and they seek to reduce or avoid these risks. Although, as stated above, some commercial distributors possess the capacity to conduct marketing and promotional activities for pharmaceutical products, it is rare for a distributor to actively market combi-packs. In some countries, actively marketing combi-packs is prohibited; in other settings where legally permitted, distributors may fear a backlash that would negatively impact their overall business. Commercial distributors we spoke with in Uganda and Zambia during the implementation phase of our project strongly implied that t hey feared being seen as contributing to higher numbers of abortions being performed in a region, or to “illegal” sales transactions (e.g., pharmacy sales conducted without a prescription). The relatively small profits gained from marketing or selling combi-packs would not be worth such a risk to a commercial sector actor. Commercial sector actors often do not view combi-packs as simply one more pharmaceutical product to market or sell. THE NOTION OF ‘COMMERCIAL DISTRIBUTOR’ IS HIGHLY DIVERSE 9 The private sector market discourse tends to present the notion of “commercial distributor” as basically homogeneous, when in fact it is highly diverse. Commercial distributors are responsible for sourcing product from manufacturers (or other suppliers) and ensuring that products are imported and/or transported, warehoused, and re-sold, while complying with national regulations. Distributors vary widely in size, structure, and capability. Their service offerings may shift over time in response to market conditions, company strategies, and regulations. Level of autonomy is an important characteristic by which commercial distributors may differ. Many distributors are small, independent businesses, while many others are subsidiaries of international corporations. During the implementation phase of our project, when we met with distributors who had a parent company or headquarters based in another country, they typically stated that they would need to obtain approval from this foreign entity for major decisions, such as entering into a new initiative. Commercial distributors are not only significant for the private sector; they are critical in supporting the supply of pharmaceutical products across all market sectors. The figure below illustrates potential types of customers that a distributor may serve. When considering the distribution of combi-packs, it is helpful to remember that distributors are not immune to stigma, and they recognize risks associated with selling combi-packs. They may have concerns stemming from their personal beliefs around abortion, and/or may fear a backlash from prescribers, pharmacists, or public sector officials that harms their overall business. Many commercial distributors do not want to be perceived as “generating demand” (e.g., increasing the number of abortions performed) or contributing to “illegal” sales (e.g., sales without a legal prescription). They often prefer to have an organization, such as an SMO, generate awareness and education in the community for the product; this is the preference of the combi-pack manufacturer who is part of this collaboration, as well. Distributors will not take actions to increase sales of MA if they believe their actions may result in a backlash that negatively impacts their overall business. We can benefit from collaboration with distributors (and manufacturers) even if the motivations driving us are very different. CUSTOMERS OF COMMERCIAL DISTRIBUTORS BY SECTOR PUBLIC SECTOR PRIVATE SECTOR NGO SECTOR National tenders / MOHs Health facilities / offices Other distributors / wholesalers Retail and wholesale pharmacists Health facilities Other types of businesses International or local NGOs and SMOs Faith-based organizations 10 When exploring the potential for market interventions in Francophone Africa, RHSC held conversations with manufacturers, distributors, promotional agencies, SMOs, public sector officials, and NGOs. There is a lot more than language that differentiates Anglophone and Francophone Africa. Supply chain management for pharmaceutical products in Francophone Africa has distinctive characteristics, not commonly found in other areas of SSA. For one thing, pharmaceutical products usually do not flow directly from the international manufacturer to the local recipient in country. Instead, manufacturers must typically contract with an intermediary pharmaceutical exporter based in France. This intermediary enters purchase orders with the manufacturer and sells, consolidates, and ships purchase order quantities for legally registered products to commercial distributors in Francophone Africa. Another distinctive feature of the region is that the network of commercial distributors/wholesalers in each country is more concentrated than elsewhere in SSA. The figure below depicts the typical flow of activities and products in Francophone Africa, including Burkina Faso. Commercial distributors serve essentially as middlemen, servicing the needs of their pharmacists and distributing a range of products ultimately determined by others, in this case French exporters. Many commercial distributors are actually subsidiaries of larger international logistics corporations, so new initiatives undertaken by them require at least some approval from beyond national borders. Another distinctive supply system practice in Francophone Africa involves the use of promotional agencies for marketing/detailing products. A manufacturer who is not in partnership with an SMO to market/detail their product might employ their own staff in the country to market their products or they might contract with an independent promotional/marketing agency, depending on the expected relative return on investment. Promotional agencies exist in many countries in West and Central Africa: they employ medical representatives who promote pharmaceutical products to local wholesalers, pharmacies, and various types of prescribers across both the public and private sectors. Francophone Africa has distinctive supply system practices and regulations Increase product awareness Conduct marketing/detailing visits Ful�ll orders for local wholesalers Enter orders with manufacturers Receive orders from pharmacists Enter orders with French intermediaries PROMOTE CO NS OL ID AT E W H O LESALE PROMOTE SUPPLY SYSTEMS IN FRANCOPHONE AFRICA 11 INCENTIVIZATION OF PRIVATE SECTOR ACTORS At the outset of this project, RHSC was engaged to identify and pilot finance-based interventions that might help commercial distributors overcome combi-pack registration and distribution barriers and to increase access through the private sector. We quickly learned in the project’s implementation phase, however, that financially incentivizing commercial distributors simply to register a combi-pack in a specific country is not viable . Registering pharmaceutical products in countries in SSA is a routine activity for the major combi-pack manufacturers, and they do not typically seek technical or financial assistance with registration. Manufacturers want to be confident that the national market’s size and health will enhance their market entry and profitability. They also want assurance that the government, an SMO, or potentially a reliable distributor will procure their combi-pack and sell it responsibly in the country. When these perceived needs are met, manufacturers pursue registration, with the engagement of local partners. Incentivization geared towards post-registration access appears to be more viable than incentives for product registration. The former must be structured in a way that is appropriate to the dynamics of the national market and to the safe abortion policy environment. One common challenge faced by distributors is the effective management of working capital or cash flow. As we learned from meetings with private sector actors during the project’s implementation phase, challenges often result from customers’ lengthy payment cycles and unplanned delays in payment, limited availability of affordable financing, and extended product procurement lead-times and product expiries. Incentivization schemes should seek to mitigate the major challenges faced by the supply chain actor, such as with working capital. Incentives that simply provide short-term, incremental profits for one product will not be as attractive as incentives that support the actor’s ability to achieve greater profits over the longer term. Although greatly hindered by the pandemic in 2020, RHSC’s efforts to develop and implement milestone/incentivization structures for in-country private-sector actors have broken new ground. Donor-funded contracts made directly with in-country private sector actors, without an intermediary such as an SMO, are uncommon. Contracts that incentivize specific private-sector activities, rather than directly pay for services or products, are even more rare. We found this to be the case when explaining our project intentions with commercial distributors in Uganda and Zambia during the implementation phase of the project. With the understanding that such interventions should only be undertaken cautiously for the purpose of strengthening markets and access, the figure on the next page lists some guidelines for incentivization schemes. These basic guidelines were developed and tested through use in RHSC’s incentivization scheme piloted in Zambia. Combi-pack market realities, combined with the product’s small supply base, increase the challenges for growing markets, and not fragmenting them INCENTIVIZATION GEARED TOWARDS POST-REGISTRATION ACCESS APPEARS TO BE MORE VIABLE THAN INCENTIVES FOR PRODUCT REGISTRATION 12 IMPLEMENTATION OF MARKET INTERVENTIONS Generally speaking, market interventions to ensure post- registration access must only be undertaken cautiously, to grow markets and avoid fragmenting already fragile markets. This is true even for pilot projects to test out different private sector approaches. There are relatively few countries with supportive safe abortion policies and in which combi-packs may be sold to pharmacies. SMOs have already penetrated these markets and, in many cases, established registrations and sales with the major manufacturers. This market reality, combined with the small supply base for quality-assured combi-packs, increases the challenges for growing and not fragmenting a market. We found this to be true when assessing the potential for interventions in SSA. If the purpose of a market intervention were to achieve sustainability in a purely private sector supply chain, even greater caution should be used before implementing such an intervention. Manufacturers exercise control over whether to maintain registrations and local partners; they will take actions that maximize their overall profits and that support their commercial strategies. Generally speaking, for combi-pack markets in SSA, national tenders and SMO collaborations remain very desirable options, preferred over attempts to drive volumes through only commercial distributors. Also, negotiation and execution of an agreement with a private-sector actor is different from that with an NGO or SMO that works in the safe abortion space. What drives the interest of in-country private-sector actors is profitability, not partnership, per se. They are only willing to take limited risks and efforts for incremental profits. And they can walk away from an agreement mid-negotiation without fear of consequences if they don’t anticipate other future opportunities to do business together. SUGGESTED GUIDELINES FOR ESTABLISHMENT AND MANAGEMENT OF INCENTIVES/MILESTONES Set ambitious, yet realistic, procurement and shipment quantities based on data such as manufacturer’s minimum order quantity, shelf life requirements, production lead-time, estimated MA sales data and/or service provision data for the country, and manufacturer sales experience for that country/region. Factor into the management of the supply chain the fact that pharmacists typically only procure products that have a minimum of six months shelf-life remaining. Conduct in-person verification activities with local individuals. Avoid advance payments to commercial distributors. Make milestones specific, to award distributors for achieving specific objectives and/or tasks; avoid making the milestones inflexible or very complicated. Use specific documents to verify completion of various key milestones. 13 Conclusion RHSC was initially engaged for this project, “Leveraging the role of national distributors to accelerate access to medical abortion combi-packs in sub-Saharan Africa,” based on a set of assumptions regarding the potential for financially incentivizing commercial distributors to take a more active role in fostering combi-pack access. During the life of the project, we realized that these founding assumptions did not accurately reflect the realities of combi-pack markets. We are sharing this report in order to contribute to a broader understanding of combi-pack markets, market actors, and the potential for influencing these markets through interventions. We have emphasized that manufacturers, not commercial distributors, play the decisive role in market entry, and their main focus is on overall profitability and sustainability. Also, when considering interventions involving incentivization, implementers might seek to mitigate the major challenges faced by supply chain actors, such as with working capital. Incentives that simply provide short-term, incremental profits for one product will not be as attractive as incentives that support the actor’s ability to achieve greater profits over the longer term. RHSC’s donor-funded project ends in June 2021, and we will continue supporting discussions and activities involving combi- pack markets through the Safe Abortion Supplies Workstream of the New and Underused Reproductive Health Technologies Caucus. 14 The Reproductive Health Supplies Coalition The Coalition is a global partnership of public, private, and non-governmental organizations dedicated to ensuring that everyone in low- and middle-income countries can access and use affordable, high-quality supplies for their better reproductive health. It brings together agencies and groups with critical roles in providing contraceptives and other reproductive health supplies. These include multilateral and bilateral organizations, private foundations, governments, civil society, and private sector representatives. www.rhsupplies.org communications@rhsupplies.org

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