Market Shaping for Family Planning

Publication date: 2014

Market Shaping for Family Planning An analysis of current activities and future opportunities to improve the effectiveness of family planning markets June 2014 Copyright © 2014 Reproductive Health Supplies Coalition Dalberg Global Development Advisors and Reproductive Health Supplies Coalition. 2014. Market Shaping for Family Planning Photo credit: Market by Claudio Matsuoka - | Creative Commons BY 2.0 Contents ▸ Foreword 3 ▸ Executive summary 4 ▸ Rediscovering the power of the marketplace 6 ▸ Framework for understanding market shaping 7 ▸ An overview of market-shaping efforts in the family planning sector 11 ▸ Key tensions and tradeoffs to navigate going forwards 18 ▸ Conclusion 20 ▸ Annex A – Activities focused on market dynamics for family planning 22 ▸ Annex B – List of interviewees 25 ▸ Annex C – List of acronyms 27 Market Shaping for Family Planning2 Acknowledgments This report was commissioned by the Reproductive Health Supplies Coalition (RHSC) to serve as a public good for the community of actors engaged with market shaping in family planning. This report, developed by Dalberg Global Development Advisors, could not have been completed without the guidance and support of John Skibiak and Anita Deshpande of the RHSC, Hema Srinivasan and Alan Staple of the Clinton Health Access Initiative, Aron Betru of Financing for Development, Ben Light of the United Nations Population Fund, and Kate Condliffe, an independent consultant and formerly a staff member at the Clinton Health Access Initiative. We would also like to thank our peer reviewers, James Droop of the UK Department for International Development; Monica Kerrigan, Natalie Revelle and Trisha Wood of the Bill & Melinda Gates Foundation; Anna Mackay of Marie Stopes International; and Mark Rilling and Amy Lin of the US Agency for International Development. Finally, we are grateful to our colleagues in the global family planning community who committed hours of their time during consultations and interviews to share their knowledge and discuss ideas. Market Shaping for Family Planning 3 Foreword Women’s ability to realise their reproductive intentions hinges on their access to a stable supply of high-quality, affordable reproductive health (RH) supplies. Ensuring such access has, for well over a decade, formed the cornerstone of a worldwide movement, now led by the Reproductive Health Supplies Coalition (RHSC), that seeks to leverage the skills and resources of global partners, from advocates, to supply chain specialists, to those with special insight and experience in the market for supplies. It has been amongst the latter group, however, where a number of significant advances have recently taken center stage, from reductions in the price of key commodities, to better insight into the movement of goods, to new opportunities for innovative financing. It is also from within this group that new vocabulary is entering our daily lexicon—a vocabulary peppered with terms such as market dynamics, total market, market segmentation, and more recently, ‘market shaping’. The genesis of this report is, in many ways, a response to these new developments. It is a response to the perceived opportunities of leveraging the market in a more effective manner. It is also a response to concerns within the RH community that much of the work currently underway is taking place with little coordination or cross-pollination and that such gaps threaten to dilute our community’s collective efforts. With these considerations in mind, the authors were commissioned to (1) clarify the new vocabulary as a starting point for a common language within the RH community, (2) establish a framework for making sense of the landscape of market-related activities currently underway, and (3) identify structural tensions and trade-offs arising from the design and implementation of these new activities. As a landscaping exercise, the contents of this report are, by definition, retrospective. However, as a guide for future action, the report focuses squarely on analysis and the identification of gaps, opportunities and, where needed, guiding principles. Clearly, one of the most striking observations to emerge from the current analysis is that, despite the high profile of market-related work, and more specifically that described as ‘market shaping’, there still remains little consensus on terminology or even on the boundaries that divide market shaping from other programmatic activities. One significant outcome of this report, therefore, has been the formulation of working definitions, boundaries and a conceptual framework (Figure 1) which draw from the field of ‘market shaping’ and on the terminology used by those who have established this practice. Recognising the dynamism of this field, these definitions and framework are very much intended to foster greater understanding and coordination across actors, recognising these may be further refined by the community going forward. A second key finding of this report is that, while much progress is being made in improving the effectiveness of contraceptive markets, much remains to be done. In particular, donors and other stakeholders will need to expand efforts in three areas: (1) promoting competition amongst manufacturers, in particular by facilitating global and national registration processes; (2) addressing programmatic gaps, particularly those in supply chain management that both constrain access and reduce supplier incentives to enter new markets; and (3) addressing information gaps that prevent implementers and manufacturers from understanding and addressing the challenges at both local and global levels. A third message to emerge from the landscaping exercise and stakeholder interviews is that, given the complexity and trade-offs involved in market-shaping approaches for family planning, enhanced global coordination and transparency are essential. In any market, interveners must consider complex trade-offs between individual products and approaches, between optimising for the present versus delivering in the future, and/ or between prioritising the delivery of one method versus safeguarding the choice of many. Insofar as changes within the market affect all who operate within it, interveners will need to articulate the logic of their choices and the vision that they seek. Community-wide consensus on all market-shaping trade- offs is unrealistic, and perhaps even undesirable, but to the extent that agreements can be forged on which priorities and on which products, and on how stakeholder resources should be allocated between them, it would allow the community to ensure its collective efforts are aligned around a common vision. As noted previously, this report is intended as a starting point to bring more cohesion to market shaping in family planning, in the hopes that these efforts can ultimately advance choice, equity and health impact. Even in advance of its publication, the presentation of this report’s findings at key international fora has informed the course of future market-shaping work. The establishment in late 2013 of the FP2020 Market Dynamics Working Group, for example, holds out the prospects for stakeholders and decision-makers to prioritise market-shaping activities in a way that ensures broad- based input and structures for coordination. The working group has also set out a work plan that seeks to forge greater consensus around a vision for a well-functioning market and put in place an operational framework for better knowledge management. Finally, a number of the RHSC’s implementing mechanisms—working groups and regional fora—have adopted key findings from this report, particularly in the area of total market approaches and global forecasting to support long-term planning. As this report goes to press, it will have been nearly a year since the RH community witnessed a dramatic fall in the price of contraceptive implants. Few will forget the event, whose impact is already being felt: demand for implants is increasing, production and procurement have kept pace, and more women can choose a method that procurers once had little choice but to ration. Market shaping did not begin with implants. If nothing else, however, the implant deals did succeed in focusing attention on the potential of market shaping to improve women and men’s reproductive health outcomes. New opportunities to leverage the market have burgeoned. This report aims to make sense of all the intersecting trails, illuminate critical signposts, and alert us to the obstacles that lie ahead. It promises to be an eventful journey. John P. Skibiak Director, Reproductive Health Supplies Coalition Market Shaping for Family Planning4 Family planning has enormous untapped potential to transform the lives of women and their families. It can improve health outcomes and foster economic growth. However, hundreds of millions of women in low-income countries lack access to contraception. The market for family planning products is somewhat unique amongst those for global health commodities in that it is not enough to simply deliver a single best product to consumers. Rather, the family planning community seeks to provide women with a range of options, enabling them to choose for themselves how to best fulfill their individual reproductive intentions. These methods include permanent contraception (e.g., sterilisation); long-acting reversible contraception (e.g., implants, intrauterine device [IUD]); short-term periodic contraception (e.g., injectable, oral); dual-purpose contraception (condoms); as well as natural methods and emergency contraception. In addition to the goal of providing women with choice, the family planning community also seeks to achieve sustainable health outcomes and equity, to ensure that the full transformative potential of contraception is realised. In the past two years, family planning has attracted unprecedented attention and investment. Building on momentum and actions of the past several years, in July 2012, the London Summit on Family Planning (FP2020) convened numerous stakeholders, galvanising momentum and resulting in financial commitments of more than US$2.6 billion for family planning initiatives. The summit also resulted in a vision to extend contraceptive access to 120 million more women in the world’s poorest countries by 2020. This increased attention and investment has been accompanied by several high-profile interventions to shape the market for family planning products. Recent volume guarantees for two brands of contraceptive implants have brought together consortiums of suppliers, donors, buyers and implementers to make implants a more affordable option for women in developing countries. The guarantees for Jadelle® and Implanon® will result in price reductions of approximately 50 percent, yielding hundreds of millions of dollars in savings. The savings from Jadelle® alone could save over 310,000 lives through reduced maternal mortality and avert more than 20 million unintended pregnancies over six years. These interventions highlight the promise of market shaping to address one of the family planning community’s central goals—namely, the supply of reasonably priced, high-quality contraceptives. However, at the same time, these examples have also surfaced tensions within the community over the design, execution and implementation of market-shaping efforts more broadly. Executive summary $2.6 $315 billion committed for family planning initiatives from funders and developing countries by stakeholders during the FP2020 Summit million invested in market shaping interventions to date Market Shaping for Family Planning 5 This report, commissioned by the Reproductive Health Supplies Coalition (RHSC), presents a framework for analysing market-shaping interventions for family planning (Figure 1). The report (1) sets a common definition of market-shaping interventions related to family planning, (2) examines inefficiencies that exist in the market and the landscape of current activities to address them, and (3) identifies lessons learnt from recent experiences and the tensions and trade-offs that have surfaced. For the purposes of this report, ‘market dynamics’ has been defined as the interactions between actors on both the supply and demand sides that determine how products are bought, sold, delivered and administered. Within this context, an effectively functioning market for commodities is characterised by the widespread availability of high- quality products which are well designed, affordable, reliably delivered and readily available to end users. Global health actors can proactively influence the dynamics of a given market by engaging in ‘market-shaping’ interventions. Such interventions are typically short-term in nature and are explicitly intended to catalyse change in the marketplace. Over 20 organisations are working on family planning market- shaping interventions, with at least $315 million invested in such efforts to date.1 A large amount of funding has been concentrated on a few, large interventions to reduce prices, including the aforementioned volume guarantees. However, there have also been a number of others initiatives in place to address different market challenges such as delays in regulatory approvals, inefficiencies in procurement and funding flows, and information gaps. These include the Quality of Reproductive Health Medicines (QuRHM) project and the Sino-Implant initiative, which are looking to facilitate regulatory approval for new manufacturers, and the Pledge Guarantee for Health, which is addressing procurement and funding inefficiencies. Preliminary work is also underway to develop an ‘infomediary’ for collecting and aggregating market data needed to support potential market-shaping efforts for reproductive health and other commodities; to conduct market analyses under the umbrella of the United Nations Commission on Life-Saving Commodities; and to coordinate the Sayana® Press pilot programme, spearheaded by PATH. A number of tensions have emerged within the market- shaping interventions underway. These include the difficult trade-offs actors must consider when: (1) applying a product-by-product versus a portfolio approach; (2) taking a consensus-driven versus more compact team-based approach to vetting, designing and executing market- shaping interventions; (3) prioritising short-term versus long-term market considerations; (4) focusing on commodity pricing versus other market outcomes such as quality and supply security; and (5) investing in targeted ‘market shaping’ versus broader ‘programmatic’ interventions (particularly as programmatic delivery issues may at times lie at the heart of observed market issues). Context is critical to resolving each of these tensions; experiences from past interventions can help to weigh trade-offs as the family planning community and the emerging market initiatives seek to improve coordination amongst relevant stakeholders and address outstanding market barriers. Going forward, there is the need for additional action to ensure that family planning market interventions reach their potential. This includes the need for evidence-based analysis across family planning markets to understand the most significant market issues and ensure activities underway are sufficiently positioned and resourced to address them. In addition, to address some market inefficiencies and barriers, there is the need for additional investment, supplementary activities, and at times, the redirection of efforts to best achieve the intended outcomes. Lastly, the challenges of the contraceptive market and the experience of recent initiatives have highlighted the importance of clear communication and consultation amongst stakeholders. This need is driven by two factors. First, the importance of providing balanced choice amongst family planning methods can create complexity and competing interests; activities to promote one product will necessarily influence the supply and demand of alternative methods. Second, the wide range of available contraceptive products has led to an unusually broad and diverse landscape of players and initiatives. As a result, there is need to ensure that activities are better coordinated so that the full effects of potential market-shaping interventions are anticipated, tensions are better navigated, and that lessons learnt are shared and incorporated into future endeavors. A newly established Market Dynamics Working Group within the Family Planning 2020 initiative2 offers the promise of creating a new forum to help address many of these issues. 1 This landscape analysis is not meant to be exhaustive, but rather encompass the range and diversity of recent market interventions in family planning. 2 Family Planning 2020 (FP2020) is a global partnership of governments, civil society, the private sector, and development organizations working to enable 120 million more women and girls to use contraceptives by 2020. FP2020 is an outcome of the 2012 London Summit on Family Planning where more than 20 governments committed to increase access to contraceptive information, services and supplies. Market Shaping for Family Planning6 Access to family planning products and services contributes to positive health, social and economic outcomes for individuals and families, yet the unmet need remains vast. In developing countries, one in four sexually active women who want to avoid pregnancy does not have access to modern contraception. This accounts for 82 percent of unintended pregnancies in the developing world.3 Experts estimate that family planning products could prevent one-quarter of child deaths in the developing world simply by helping women achieve their desired spacing between births.4 In recent years, family planning has attracted marked increases in attention and investment. In the last five years alone, funding for contraceptives grew by 50 percent, reaching $275 million in 2012, driven mostly by increased investments in implants (accounting for 68 percent of total funding growth), and female condoms (20 percent of total growth).5 The 2012 London Summit on Family Planning secured additional donor commitments of nearly $2.6 billion and set the ambitious goal of providing family planning to 120 million more women in the world’s poorest countries by 2020.6 Other health markets have also witnessed visible success, often through efforts at market shaping. UNITAID’s efforts to pool procurement for second line and pediatric anti- retroviral (ARV) drugs, for example, have helped increase competition, ensure supply security, reduce lead times and indirectly incentivise innovation. Market shaping has also been used to address such issues as product design, supply, quality, affordability and availability. Of all these applications, however, it is the price-reduction deals that have attracted the widest attention. These deals have generated significant monetary savings and affordability, yielding improved access and health outcomes for people in the poorest countries. For example, price reductions for ARV drugs generated through market interventions by UNITAID, the UK Department for International Development (DFID), and the Clinton Health Access Initiative (CHAI) generated an estimated global savings of at least $600 million from 2008 to 2011.7 Similarly, recent deals through the GAVI Alliance have reduced the price of pentavalent8 and rotavirus9 vaccines by more than 30 percent. Momentum has been building around market-shaping approaches in family planning, particularly in light of several high-profile deals aimed at expanding access to products through lowering prices. Over 20 organisations have been working to address market inefficiencies including information and data gaps, challenges to gaining regulatory approval, sub-optimal procurement practices, lack of demand predictability, and lack of coordination. This momentum has been further fuelled by recent high-profile efforts to reduce the price of contraceptive implants: in January 2013, a consortium of international donors and Bayer HealthCare signed a deal to supply and purchase 27 million doses of the Jadelle® implant for the coming six years, in exchange for a 53 percent price reduction. A deal in May 2013 also announced price reductions of 50 percent for Implanon®, Merck/MSD’s implant product. Both of these achievements dramatically accelerated the drive, initiated in 2011 by the Reproductive Health Supplies Coalition’s (RHSC) HANDtoHAND Campaign, to reduce implant prices. With this momentum, questions are now being raised amongst the family planning community regarding the boundaries of market dynamics, the extent of activities currently underway, and challenges related to their implementation. Given the current interest in ‘market dynamics’ or ‘market-shaping’ activities, professionals in the field have expressed a desire for more global coordination and an exploration of how to best leverage the collective efforts and accumulation of knowledge in this area. This report, commissioned by the RHSC, represents a starting point for future work in market dynamics. There is much work to be done to understand individual markets within family planning and the potential for achieving more equitable access to a choice of family planning products needed to achieve improved health, social and economic outcomes. This report seeks to (1) provide a definition and framework for understanding market dynamics and market-shaping interventions, (2) apply this framework to understand what activities are underway within family planning, and (3) identify perceived gaps, issues and tensions that are arising. The content presented here represents the synthesis of a consultative process that included a gathering of more than 65 stakeholders hosted by the RHSC in Washington, DC, in May 2013, as well as interviews with 43 individuals representing 26 institutions from around the world. The report also incorporates feedback from presentations of its initial findings delivered at the November 2013 International Conference on Family Planning, the inaugural meeting of the FP2020 Market Dynamics Working Group, and the semi-annual meeting of the Sexual and Reproductive Health and Rights (SRHR) Working Group, held in December 2013 at the German Ministry of Cooperation in Bonn. Ultimately, this report is designed to reflect the work and perspectives of a variety of experts and stakeholders, including both those with deep, classic ‘market- shaping’ expertise, as well as others who are either new to this field or part of the broader family planning community. Hopefully, it can establish a foundation of understanding and help create a common base of knowledge to better inform communication and coordination on future initiatives. Rediscovering the power of the marketplace 3 Darroch JE, Sedgh G, Ball H. Contraceptive Technologies: Responding to Women’s Needs. Guttmacher Institute; April 2011. 4 Ibid. 5 UNFPA Procurement Services Branch. Access RH. 6 Bill & Melinda Gates Foundation and UK Aid. London Summit on Family Planning: Summaries of Commitments. January 2013. 7 UNITAID. “CHAI, UNITAID, and DFID announce lower prices for HIV/AIDS medicines in developing countries.” May 2011. en/resources/news/331-clinton-health-access-initiative-unitaid-and-dfid- announce-lower-prices-for-hivaids-medicines-in-developing-countries 8 GAVI Alliance. “GAVI welcomes lower prices for life-saving vaccines.” 2011. 9 Ibid. Market Shaping for Family Planning 7 Framework for understanding market shaping While an increasing number of actors have become engaged in activities that affect the market for family planning products, there is not always clarity or alignment within the community as to what is meant by terms such as ‘market dynamics’ and ‘market shaping’. This section will (a) establish a definition of these terms, (b) suggest a framework that the family planning community can use when analysing market issues and designing potential interventions, and (c) clarify the boundaries of what is considered to be in- and out-of-scope when it comes to ‘market-shaping work’. To begin, ‘market dynamics’ describes the on-going interactions amongst actors on the supply and demand sides, that determine how products and services are bought, sold, delivered and administered in a market context. This includes producers, buyers and consumers. In global health markets, there are several other actors, such as global normative bodies including the World Health Organization (WHO), regulators and donors, whose actions can have significant influence over the dynamics of a given market. Across the reproductive health community, there is broad-based agreement that a functioning market for family planning commodities should yield at least three broad outcomes. These include (a) choice, or more specifically, the ability of women to choose amongst several contraceptive methods according to personal preference, culture, age, medical condition, sexual and relationship status and other factors; (b) equity, namely the assurance that access to contraception not be constrained by income, social status, geography or other circumstances; and (c) sustainable health outcomes, or the assurance that access to and use of contraception do indeed reduce morbidity and mortality that derive from pregnancy-, abortion- and neonatal-related causes. Given the centrality of the marketplace in ensuring choice, equity and/or sustainable health outcomes, what then are the dimensions by which the market’s effectiveness, efficiency or functionality can be judged? Once again, across the reproductive health (RH) community, there is widespread agreement that an effectively functioning market for health commodities is characterised by at least five elements: appropriate product design, high-quality products, secure supply, affordable prices and availability to end users. Inefficiencies in the marketplace can lead to sub-optimal outcomes across one or more of these dimensions, which may ultimately make it difficult to achieve the end goals of choice, equity and sustainable health outcomes. When actors identify challenges across any of these five dimensions, it may be appropriate to engage in ‘market-shaping’ activity. In this report, the term ‘market-shaping’ refers to activities by global health actors that seek to proactively influence the dynamics of a given market. Such interventions are typically short-term in nature and are explicitly intended to redress disruptions impeding desired key health outcomes. Choice The ability of women to choose from amongst several contraceptive methods according to personal preference, culture, age, medical condition, sexual and relationship status, and other factors. Equity The assurance that access to contraception not be constrained by income, social status, geography, or other circumstances. Sustainable health outcomes The assurance that access to and use of contraception are indeed reducing morbidity and mortality that derives from pregnancy-, abortion-, and neonatal-related causes. Appropriate product design Products are safe and effective, and product designs meet the needs and constraints of end users, providers, and supply chain managers. High-quality products A sufficient number of products meet stringent regulatory authority (SRA) or WHO prequalification (PQ) standards. Product quality is maintained throughout the supply chain globally and locally. Secure supply Total production capacity is sufficient to meet demand. Production capacity is diversified amongst suppliers, guarding against adverse shocks and protecting against risk of monopoly. Affordable prices Prices meet users’ or funders’ ability and willingness to pay, but also incentivize suppliers to remain in the business. Availability to end users Products are made available to end users through effective local supply chains, distribution channels and provider awareness and training. Outcomes of a healthy market Characteristics of market health 4 As se ss o pt io ns to ad dr es s ba rr ie rs De si gn Ex ec ut e M on ito r Re n e Po te nt ia l in te rv en tio ns De m an d ge ne ra tio n Vo lu m e gu ar an te e De m an d fo re ca st in g im pr ov em en ts Et c. Su bs id y fo r up fro nt c os ts o f m ar ke t e nt ry 2 Ev al ua te th e cu rr en t m ar ke t Ch ar ac te ris tic s of an e �e ct iv e m ar ke t Ap pr op ia te pr od uc t d es ig n Se cu re s up pl y Q ua lit y pr od uc ts A� or da bl e pr ic es Av ai la bi lit y to th e en d us er 3 Id en tif y in e� ci en ci es a nd th e ba rr ie rs to th ei r r es ol ut io n In e� ci en ci es in th e m ar ke t La ck o f i ns ig ht in to u se r n ee ds / de si gn re qu ire m en ts La ck o f i nc en tiv es to e nt er m ar ke t In fo rm at io n an d da ta g ap s Su b- op tim al g lo ba l pr oc ur em en t p ra ct ic es La ck o f d em an d pr ed ic ta bi lit y La ck o f i nc en tiv es to m ee t SR A/ PQ re gu la to ry re qu ire m en ts Ch al le ng es fo r c om pa ni es in ga in in g re gu la to ry a pp ro va l Hi gh C O GS Di st rib ut io n & d el iv er y i ss ue s La ck o f u se r a w ar en es s La ck o f c oo rd ia nt io n am on g ac to rs Et c. Ba rr ie rs to re so lu tio n Vo lu m es /r ev en ue s do no t c ov er th e co st s Al te rn at e m ar ke ts ar e m or e lu cr at iv e Ri sk s of in ve st m en t pe rc ei ve d as to o hi gh 1 De te rm in e de si re d ou tc om es O ut co m es Ch oi ce Eq ui ty H ea lth ou tc om es Et c. Fi gu re 1 Fr am ew or k fo r d es ig ni ng m ar ke t- sh ap in g in te rv en tio ns 9Market Shaping for Family Planning They can be performed either by institutional market participants (e.g., buyers, sellers, regulators and funders) seeking to improve how their behaviors affect the health of the market at a strategic level or by third parties aiming to either provide shared goods (e.g., information and research) or to work directly with individual participants to improve their behavior. These interventions can either seek to create new markets, optimise existing ones or fix failing ones. The diagram presented in Figure 1 illustrates the logical process by which market-shaping interventions can be identified and designed. It is a four-step process that rests on some understanding of the root cause(s) of an observed challenge in the current market. Logically, one begins at the left of the diagram by determining which outcomes are under threat; and second, by ascertaining whether the observed market issue (or ‘characteristic’) truly is critical to reaching that outcome. Third, one must identify which general inefficiencies might be causing the identified issue and the specific barriers to resolving them. For illustrative purposes, one of the efficiencies (in this case, the ‘lack of Incentives to enter the market’) has been singled out to reveal some of the barriers, listed in the fourth column, that typically give rise to it. Other inefficiencies will have their own barriers or share some in common. Finally, it is critical to explore the range of potential interventions that exist to address these barriers and how can they optimally be structured, executed and implemented. The analysis must be end-to-end in nature and consider the impact that inefficiencies have on a market’s health and, ultimately, on health outcomes. It must also consider this impact at both local and global levels, and on both the supply and demand sides of the market. This is especially critical because the success of market-shaping efforts often hinges on the implementation of other, equally important ‘programmatic interventions’ such as systems strengthening, training or demand-creation efforts, which are described below in greater detail. Finally, tight coordination is often required to ensure that activities are appropriately adjusted as the relative criticality of different bottlenecks shifts over time. The complex and interconnected nature of markets means that any given inefficiency may affect the market’s health in multiple ways over the short and long term. For instance, undue challenges by manufacturers in navigating the WHO Prequalification of Medicines Programme (PQP) —the seventh box down in the third column—might not only raise the spectre of increased volumes of potentially substandard products entering the marketplace; it could also translate into less competition, higher prices and insecure supply for markets supported by donor funds. Moreover, each inefficiency in the market may confront multiple barriers to resolution, which could potentially be solved through several separate approaches. A lack of insight into future demand, for example, could discourage manufacturers from entering a market or it could discourage them from expanding capacity. Either consequence could be resolved by providing more robust demand forecasts and/or by providing direct volume guarantees. Placing this framework within a broader context, confusion often arises over where ‘market-shaping’ interventions begin and end. This is particularly true at local level where activities are tightly linked across actors and where inefficiencies in service delivery, which may require broader programmatic interventions, are often the primary cause of commodity- related market challenges. Given the integral and often synergistic relationship between ‘market-shaping’ and ‘programmatic’ activities, the distinction between the two remains a fine line at best, and relevant perhaps only insofar as it helps to segment activity between actors who have different skill sets, areas of expertise and relationships. In this report, ‘market-shaping’ activities are classified as those that typically address inefficiencies directly related to the buying and selling of commodities.10 ‘Programmatic activities’, by contrast, are defined as those that often influence the market but relate more closely to a clinical care model and service-delivery design. Market-shaping activities also typically have shorter time horizons, while programmatic activities are usually on-going. To some degree, however, the boundaries will always remain fluid. Services, for example, may be the subject of both market-shaping and programmatic activities. This is particularly true (though not exclusive so) when considering interventions involving long-term contraceptives which require complementary services to administer them. Finally, it is worth acknowledging that the definitions and framework used in this report adhere to what might be considered a ‘classic’ view of market dynamics, coined and propagated by organisations and individuals involved in executing market-shaping interventions in recent years. These definitions and frameworks can be at odds with the perspectives of those who have been working in family planning markets within programmatic or service delivery– oriented roles. These organisations often apply a broader definition of market-shaping interventions, which includes activities that might otherwise be considered service delivery. The framework provided here and applied in the following pages provides a structure that aims to be consistent with other areas of global health. The framework also aims to foster coordinated dialogue and action to ensure programmatic activities and critical service-delivery efforts are considered within market dynamics analysis. 10 This report uses the word ‘commodity’ in the economic sense as a good that can be bought and sold on a market, synonymous with the word ‘product’, rather than engaging the more specific definition that requires the existence of at least three different products of equivalent attributes in the market. Reproductive Heath Interchange (RHI) UNCoLSC-sponsored research on EC, FC and implants USAID supply-side landscape assessments on OC, EC, implants DMPA Advisory Group market analyses UNCoLSC Global Market Shaping Technical Resource Team infomediary In-country market supply and usage surveys (SHOPS, PROGRESS, UNFPA GPRHCS) IMS Health/USAID-Medicines for Malaria Ventures partnership Quality of Reproductive Health Medicines (QuRHM) project Support to WHO Prequalification of Medicines Programme (PQP) Sino-Implant (II) initiative Universal Access to Female Condom (UAFC) International Consortium on Emergency Contraception (ICEC) Medicines360 generic LNG IUD introduction Pledge Guarantee for Health (PGH) Implanon® Access Initiative (IAI), 2011 Implant Access Program (IAP), 2013 USAID/Bayer Contraceptive Security Initiative Sayana® Press pilot introduction In-country total market analyses William Davidson Institute (WDI) market dynamics research USAID/Bill & Melinda Gates Foundation Global Health Market Shaping Lab Clinton Health Access Initiative (CHAI) FP Global Markets Visibility Project • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Id en tif y in e� ci en ci es In e� ci en ci es in th e m ar ke t La ck o f i ns ig ht in to u se r n ee ds / de si gn re qu ire m en ts La ck o f i nc en tiv es to e nt er m ar ke t In fo rm at io n an d da ta g ap s Su b- op tim al g lo ba l pr oc ur em en t p ra ct ic es La ck o f d em an d pr ed ic ta bi lit y La ck o f i nc en tiv es to m ee t SR A/ PQ re gu la to ry re qu ire m en ts Ch al le ng es fo r c om pa ni es in ga in in g re gu la to ry a pp ro va l Hi gh C O GS Di st rib ut io n & d el iv er y i ss ue s La ck o f u se r a w ar en es s La ck o f c oo rd ia nt io n am on g ac to rs Et c 3 Ta bl e 1 Su m m ar y of c ur re nt m ar ke t-s ha pi ng ac tiv iti es in fa m ily pl an ni ng In IT IA TI vE S u nd ER w Ay M AR KE T In EF FI CI En Cy Market Shaping for Family Planning 11 In recent years, actors in the family planning sector have undertaken a diversity of market-shaping interventions across global and local markets. More than 20 of these were identified in the preparation of this report. These initiatives, listed in Table 1, represent in excess of $450 million in donor funding since 2006. To understand better the breadth and diversity of this work, this chapter clusters the various initiatives into a selection of five of the 11 market inefficiencies identified in the third column of the market-shaping framework (Figure 1). They include: • Information and data gaps • Challenges for companies in gaining regulatory approval • Sub-optimal global procurement practices • Lack of demand predictability • Lack of coordination amongst actors The clusters, while they encompass the range of interventions identified during the landscaping exercise, are not mutually exclusive. Indeed, some interventions are linked to more than one cluster. In the pages that follow, we provide a description of each market inefficiency, followed by an overview of the activities taking place to address them. Finally, we discuss remaining concerns and opportunities raised during our interviews and desk research. More detailed information on each of the individual market-shaping initiatives is available in Annex A. InFoRMATIon And dATA gAPS Background Data, information and strong feedback loops are fundamental to the effective functioning of a market. Information on need, demand, consumption, production, production capacity, the relative pricing between countries and suppliers, and the likelihood of market entry of new entrants; and on-the- ground data regarding distribution, usage and stock-outs allow market actors to understand the current state of the market, forecast where it will be in the future, and plan their activities accordingly. In developed markets, such market analyses and data collection activities are often done by private firms (such as IMS Health, Wolters Kluwer, Cegedim and Taylor Nelson Sofres, amongst others), which provide information and services, including market forecasts for the commercial health care industry, for example. In low- income markets and developing countries generally, such information is either not collected or difficult to access. Current and recent work Several bodies are developing deeper market research and analyses to provide a fact base for future market dynamics efforts. The Reproductive Health Interchange (RHI), an online historical database of contraceptive orders has, since 2005, published data for over 80 percent of donor-provided contraceptives in more than 140 countries. Developed by the RHSC and managed by the United Nations Population Fund (UNFPA) under its AccessRH programme, the RHI provides current shipment data for forecasting, financing, procurement, manufacturing, customs clearance and warehousing purposes. Another initiative, the UN Commission on Life-Saving Commodities (UNCoLSC), has a number of work streams focused on identifying global and local market issues for 13 commodities, including three within family planning: female condoms, implants and emergency contraception. UNCoLSC issued its initial working paper in March 2012, and work is still on-going to determine how best to address the relevant market issues for each commodity. One promising initiative by the UNCoLSC’s Global Market Shaping Technical Reference Team (TRT) is the proposed development of an ‘infomediary’ database to track order and procurement data. The TRT aims to consolidate supply- and demand-side data by commodity—compiling data from global purchasers, in-country procurement and forecasting, and demographic information as well as mapping the current supplier landscape. Spearheaded by CHAI and DFID, preliminary mapping efforts are being led through an engagement with Dalberg Global Development Advisors, the co-authors of this report. Additional product-specific analyses were published from 2009 to 2011 by John Snow, Inc. (JSI) and USAID | DELIVER, in the form of supply-side landscape assessments for oral contraceptives, emergency contraceptives and injectables.11,12,13 These included research on the number and type of manufacturers, breadth of national registration, and quantities shipped. In 2013, the Bill & Melinda Gates Foundation (BMGF) commissioned McKinsey, the RHSC, and a larger advisory group consisting of USAID, UNFPA, DFID, KfW Development Bank, Concept Foundation and CHAI to conduct a market analysis to identify solutions for resolving potential short-term shortages of quality-assured injectables. Several other, more focused, initiatives also are attempting to improve on-the-ground data collection efforts. These include country-level surveys in Burundi, the Democratic Republic of Congo and Rwanda on the availability, registration and price of family planning products by I+ Solutions, as well as surveys and analyses on method availability by the UNFPA Global Programme for Reproductive Health Commodity Security (GPRHCS). Several initiatives that tend to focus on more programmatic interventions, such 11 John Snow Institute, “USAID Procurement Strategy: Injectables Market Assessment”. August 2009. 12 John Snow Institute, “USAID Procurement Strategy: Emergency Contraceptive Pills Market Assessment”. September 2010. 13 John Snow Institute, “USAID Procurement Strategy: Oral Contraceptive Pills Market Assessment”. July 2011 An overview of market-shaping efforts in the family planning sector Market Shaping for Family Planning12 as the USAID Strengthening Outcomes Through the Private Sector (SHOPS) and Program Research for Strengthening Services (PROGRESS) projects, also aim to improve on- the-ground data collection as part of their efforts. In 2013, CHAI and the RHSC began work on their Global Markets Visibility Project, under which suppliers could input product- and country-specific shipment data that would then be de-identified and consolidated to highlight market trends and enable broader analyses. Working with industry and donors, CHAI will publish reports that provide insight into the family planning market utilising supplier data and in-country source data on consumption and user preferences. These reports will validate actual supply and demand in the market and help industry and donors with market- shaping, capacity-planning and investment decisions.14 Finally, USAID is working with IMS Health to establish a memorandum of understanding that would develop a routine system of collecting primary essential drug data including contraceptives and maternal and child health drugs, at the lowest level of the supply/value chain in select sub-Saharan African countries. Under this arrangement, USAID would build on a partnership established in 2009 by IMS Health and Medicines for Malaria Ventures (MMV) that aims to routinely track and monitor anti-malarial drug data in four sub-Saharan countries as well as build the capacity of local health regulatory authorities. The data include information on the specific molecules used, brand names, forms, presentations, volumes and prices. This data will support national health authorities’ ability to inform health policy decisions, as well as nongovernmental organisations (NGOs) and partners such as MMV to be able to monitor the impact of policy changes on the availability of life-saving medicine. Remaining concerns and opportunities Lack of reliable local and global data continues to hamper programmes and producers in deciding how much to procure and supply. As a result of weak granular-level data, current forecasting tends to rely heavily on two input sources: consumption data based on historical purchases and information collected through Demographic and Health Surveys (DHS). These data, however, give little insight into what actual demand for a given product would be if it were widely available, or how changes in price or other characteristics would affect women’s choice of method mix. One manufacturer puts it bluntly: while he considers a few countries such as Bangladesh and Kenya to have reliable forecasts, most others “only have wish lists”. Or, as an NGO representative summarised: “No one knows what the market for contraceptives really is”. Lack of clear pricing data may also inhibit competition. Despite the success of efforts to increase pricing transparency through mechanisms such as the RHI, there still exist blind spots. One manufacturer, for example, has recently chosen not to report the price of a key contraceptive it produces and has even prohibited procurers with long- term supply contracts from disclosing public-sector price information via the RHI. Such barriers to transparency make it harder for procurers to leverage their purchasing power since no one knows for sure what others are paying. In other markets, greater pricing transparency data has often had a positive effect. For example, suppliers began announcing voluntary price reductions only weeks after the United Nations Children’s Fund (UNICEF) began publishing manufacturer-by-manufacturer data on vaccine prices.15 At the local level, data on stock-outs, usage and post- marketing surveillance remains missing, insufficiently detailed or unreliable. Stock-out data in particular can be especially problematic. UNFPA’s Global Programme on Reproductive Health Commodity Security (GPRHCS), for example, reported that about 88 percent of service delivery points (SDPs) in the 12 countries it tracked in 2011 offered at least three modern methods—a seemingly reasonable degree of method choice. The fact that nearly half (42 percent) of those SDPs had experienced stock-outs in the past six months, however, suggests that in reality, many users would have encountered fewer than three methods on the day of their visit. In other instances, country-specific stock-out data at both central and service delivery levels have been deliberately withheld from public view, even by international technical agencies, out of concern that the countries may not share data in the future if subjected to public scrutiny and potential embarrassment. Information flows are also weak for other key variables. As a representative of a generic manufacturer commented, “We have no way of tracking what happens to products once they reach the country”. Data is also often only tracked in the public sector; as a representative of another NGO pointed out, even Bangladesh and Kenya—cited above as having strong national-level forecasts—do not track private- or NGO-sector consumption. CHALLEngES In SECuRIng gLoBAL And nATIonAL REguLAToRy APPRovAL Background Companies seeking to sell health products outside their country of production must usually meet at least two additional regulatory hurdles beyond those imposed by their local regulatory body. First, they must gain approval from the national regulatory authority of each country they wish to sell in. Second, for many donors to consider supporting the purchase of their products, they must also have approval from either a stringent regulatory authority (SRA)16, the WHO PQP, or gain an exemption from 14 This summary was taken from CHAI’s concept note from October 2013, ‘Global Market Visibility Project: Ensuring Transparency in Family Planning Markets’ 15 Sandler M. “Buying power.” Every Child. UNICEF; 2013 16 An SRA is defined by the WHO as “the medicine regulatory authority in a country which is (a) a member of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (e.g., a European Union member, Japan and the United States); or (b) an ICH Observer, being the European Free Trade Association (EFTA) as represented by Swiss Medic and Health Canada (as may be updated from time to time); or (c) a regulatory authority associated with an ICH member through a legally binding mutual recognition agreement including Australia, Iceland, Liechtenstein and Norway.” (WHO, “4th Invitation to manufacturers of Active Pharmaceutical Ingredients (API) to submit an Expression of Interest (EOI) for API evaluation to the WHO Prequalification of Medicines Programme”, October 2012; http://apps. Market Shaping for Family Planning 13 the WHO Expert Review Panel. Competitive and healthy markets therefore depend on the ability of suppliers to gain regulatory approval at both national and global levels. Current and recent work Significant work is taking place to create competition by supporting more manufacturers to gain global and local regulatory approval. The QuRHM project, hosted by Concept Foundation, provides technical assistance to more than 30 manufacturers of hormonal contraceptives currently at various stages of the prequalification process. It also works with several manufacturers of active pharmaceutical ingredients. Although the supply base for several products remains relatively weak, QuRHM has set a target of seeing 20 manufacturers qualified by the end of 2014.17 With support from across the RHSC, WHO is pursuing efforts to provide greater transparency and predictability to the PQP approval processes. BMGF and DFID are providing direct funding to WHO to streamline its PQP and to improve its communication with suppliers. WHO has also expanded its series of capacity-building workshops for manufacturers and regulators, and instituted an ERP to provide provisional approval for sale products that have not yet completed prequalification. In 2012 and 2013, the ERP approved 18 reproductive health products, including seven different oral contraceptives, seven emergency contraceptives, two injectable contraceptives, and two uterotonics. Initiatives also exist to support individual suppliers to gain WHO prequalification. FHI 360’s Sino-Implant (II) initiative, funded by BMGF, is providing technical support to help Shanghai Dahua gain prequalification for its implant product. Similarly, I+ Solutions, together with the Universal Access to Female Condom (UAFC) initiative, is working with four prospective female condom manufacturers, supporting functionality studies for new designs and providing direct technical assistance. This assistance resulted in the prequalification of the Cupid® female condom in July 2012. Medicines 360, which is currently working to develop and introduce a low-cost levonorgesterel IUD (LNG20) in the United States, is also anticipating the need to address regulatory hurdles to introduce this product in the developing world. In this case, US Food and Drug Administration and European approvals may help to achieve WHO prequalification and national registrations; however, this will become a key market hurdle for them in the coming years. With support from the RHSC’s Innovation Fund, FHI 360 launched in 2014 a public- private partnership to pilot the introduction of LNG20 in Kenya. In the meantime, work is underway to strengthen local regulatory systems. Under the QuRHM project, Concept Foundation and UNFPA reinforced efforts to improve national regulatory processes by gauging the strength of quality assurance systems and controls in four countries: Ethiopia, Kenya, Nepal and Senegal. Concept Foundation is hopeful these efforts will expand in 2014, though the precise scope of such a follow-on phase of work is still being determined. In parallel, the WHO has been working over the past decade to strengthen and align local systems. Initiatives include the African Medicines Registration Harmonization effort, which aims to harmonise registration processes by aligning approximately 50 different national regulatory authorities into five or six regional groups. The WHO is also collaborating with regulators in the East African Community, namely Burundi, Kenya, Rwanda, Tanzania and Uganda, to ensure that national registration of two specific RH commodities would occur simultaneously with their prequalification by the WHO. The International Consortium for Emergency Contraception (ICEC) has also done work on local registration issues, publishing a country-by-country product registration database on emergency contraception (EC). Some individual total market approaches (TMAs), discussed below, have succeeded in addressing regulatory barriers on a country-by-country basis. In addition to regulatory issues, taxation and restrictive import policies have also been raised as issues limiting access to national markets. While no work has been done to quantify the impact of these barriers on a global scale, several new projects are looking to address these on a country- by-country basis. Marie Stopes International (MSI) Sierra Leone, supported by a grant from the RHSC’s Innovation Fund, has been working with the Sierra Leone Ministry of Health and National Procurement Authority to streamline the procedures for securing import tax waiver on donated RH supplies. The effort not only offers the promise of significant cost savings—an estimated $200,000 per annum in the case of Sierra Leone—but also of informing future policy reform. In a similar vein, MSI Afghanistan is using resources from the RHSC’s Innovation Fund to launch a national-level ‘RH Caucus’ which can advocate for scale-up of family planning efforts, secure the national registration of implants and EC, and ensure their inclusion on the national drugs list. Remaining concerns and opportunities Despite on-going market-shaping efforts, UNFPA and USAID procurement still faces a limited set of eligible manufacturers. Of the more than 60 emergency contraceptive manufacturers worldwide, only two have either SRA or PQP approval.18 Similarly, of 12 oral contraceptive manufacturers identified by USAID | DELIVER, only five have achieved SRA or PQP approval. Only two suppliers each of implants, injectables and female condoms are prequalified, while four suppliers of oral contraceptives have at least one of their facilities certified by the WHO. Because national ministries of health, NGOs, and other private procurers do not always require SRA approval, manufacturers do not always have strong incentives to invest resources towards obtaining it. This is particularly true for products obtained through private markets, such as oral contraceptives. One manufacturer interviewed summarised his position bluntly: “I don’t know if getting WHO prequalification really translates into increased sales”. Markets for several products face severe supply shortages due to capacity constraints on the part of originator 17 Since March 2014, when DFID-financing for QuRHM officially drew to a close, Concept Foundation has continued supporting generic manufacturers of injectable contraceptives to secure PQP and/or ERP approval. 18 UN Commission on Life-Saving Commodities. Market Shaping for Family Planning14 manufacturers and a lack of SRA-approved generic manufacturers. In 2013, for example, Pfizer found itself unable to fulfill UNFPA’s total requested procurement of the injectable contraceptive Depo-Provera® (DMPA). This shortfall coincided with several countries reporting difficulties procuring DMPA supplies. To address this, Pfizer was able to add new production capacity in 2014, thereby increasing volumes of DMPA. In parallel, between two and three generic manufacturers of injectable contraceptives anticipate submitting applications for WHO prequalification in 2014. Meanwhile, the CARHs (Coordinated Assistance for Reproductive Health Supplies) group of the RHSC has, since 2005, worked to avoid country-level stock-outs of DMPA and other contraceptives by reallocating stock and/or shifting orders amongst donors and procurers. Additionally, the Procurement Planning and Monitoring Report (PPMR) offers visibility into the DMPA stock levels at country level.19,20 Local competition may be constrained even for products with multiple globally approved manufacturers. WHO prequalification, for example, has not necessarily translated into smoother approval at countrylevel. Jadelle® required seven years to gain approval in Bangladesh, despite already having been prequalified by the WHO years before. Further, although two EC pills are currently prequalified, over 40 percent of least-developed countries do not have a single EC pill registered. Taxes and other regulatory policies also remain barriers. For example, the demurrage fees formerly paid on non-commercial contraceptive commodities in Sierra Leone from 2008 to 2012 would allow for the purchase of enough contraceptives to reduce the country’s unmet need by nearly one-third.21 SuB-oPTIMAL PRoCuREMEnT PRACTICES Background UNFPA and USAID dominate public procurement of family planning products for the developing world, accounting for 40 and 38 percent of purchases in 2012, respectively.22 While having such large players offers the potential for significant economies of scale, the lack of diversification also exposes the market to risk of failure or bottlenecks. Holdups in appropriations or spending processes can, in turn, delay procurement processes, leading to higher costs and dissuading manufacturers from participating in the market. Furthermore, UNFPA faces several structural challenges which affect its procurement activities, including unpredictable timing of funding from donors, an inability to make multi-year commitments, and an inability to make purchases until funding is formally received. Current and recent work The Pledge Guarantee for Health (PGH) is a major initiative focused on streamlining procurement practices by using commercial financing to smooth donor funding flows. Originally developed as a work stream of the RHSC’s Systems Strengthening Working Group, the PGH was one of two mechanisms (along with AccessRH) designed to overcome the recurrent ‘non-alignment of funding and procurement cycles’. Its strategy is to use commercial bridge loans to ensure that short-term delays in donor financing do not hold up procurement processes. Under an 18-month pilot funded by BMGF and housed within the UN Foundation, PGH completed $17 million in transactions. Today, PGH is moving into its next phase as an independent entity. With financial support from the David and Lucile Packard Foundation, the UN Foundation and the RHSC, coupled with a five-year partial guarantee from USAID and the Swedish International Development Cooperation Agency (SIDA), PGH is now able to leverage a revolving $100 million line of credit. Remaining concerns and opportunities Across the family planning community, respondents agree that much work is still needed to streamline overall procurement processes. Because donor funding is frequently driven by annual appropriations, funding tends to come in large spurts. Actual demand, however, tends to be spread out more evenly over time. This mismatch can lead to suboptimal patterns by which procurement agencies delay tenders until funding arrives, and then conduct relatively rapid-paced bidding rounds for both national-level end buyers and suppliers. While scaling up the PGH may help institutions better manage these realities, there is also need to resolve many of the inefficiencies head-on. Some interviewees cited inefficiencies in the structure of procurement bureaucracies, noting that complex internal procedures can create communication bottlenecks between countries and the agents working on their behalf. InABILITy To PREdICT dEMAnd Background Historically, suppliers have had limited visibility into demand for family planning commodities. Without a clear view of demand and upcoming orders, manufacturers must either produce speculatively (and carry the cost of warehousing if orders do not materialise) or produce based on actual orders, often leading to delays of several months. For many years, this issue had been particularly acute in the case of implants where lack of visibility made it difficult for manufacturers to plan capacity expansions, which in turn led to higher prices. Current and recent work There have been two main initiatives focused on increasing demand predictability for implants: the Implanon® Access Initiative (2011), and the Implant Access Program (2013). The Implanon® Access Initiative (IAI) was the family planning community’s first coordinated multi-agency foray 19 Reproductive Health Supplies Coalition. Summary of DMPA Procurement. June 26, 2013. 20 UNFPA. The Global Programme to Enhance Reproductive Health Commodity Security: Annual Report 2011. February 2012. 21 Kamara A. Duty Waiver Free of Contraceptives and Family Planning Services in Sierra Leone. Health for All Coalition Sierra Leone and Mary Stopes International. 2013. 22 United Nations Population Fund, AccessRH database (http://www.unfpa. org/public/home/procurement/AccessRH) Market Shaping for Family Planning 15 into implant price reductions. The immediate catalyst for this initiative had been the recent entry into the RHSC of Ethiopia, a country whose rural family planning programme relied heavily on the single-rod implant, Implanon®. At the same time, financially strapped procurers in Europe and North America were feeling the impact of only buying SRA-approved implants at twice the cost of a generic alternative. Both of these developments prompted the RHSC to convene UNFPA, USAID, DFID, PGH, PSI, MSI and DKT to explore the potential for expanding access to implantable contraception through a reduction in the price of Implanon®. In June 2011, Merck agreed to reduce the price of Implanon® from $20 to $18 per unit. The deal’s structure was further designed to incentivise the RH community to reinvest the cost savings. If at least 4.5 million units of Implanon® were delivered to the world’s poorest countries between the announcement of the deal and December 2012, the company would reduce the price to $16.50 and apply the savings retroactively. Merck and the consortium then worked closely together to coordinate Implanon® orders and track any changes of regulatory status at the country level. In October 2012, with shipments just slightly short of the 4.5 million target, Merck brought the IAI to a close. It retroactively applied the new $16.50 price to all Implanon® sales since the initiative’s start, thereby yielding a rebate to procurers of just over $6 million. Building on the heightened expectations of the IAI, the Jadelle® and Implanon® price reductions implemented via the Implant Access Program (IAP) have been amongst the highest-profile market-shaping interventions to date in the family planning space. In contrast to the IAI, whose terms offered only partial predictability regarding pricing and demand, the IAP provided market actors complete transparency through a volume guarantee backed up by BMGF, the Norwegian Agency for Development (Norad), the Children’s Investment Fund Foundation (CIFF) and SIDA. In exchange for a guarantee of 27 million doses of its Jadelle® implant over the six-year period from 2013 to 2019, Bayer HealthCare almost halved its price in low-income and low- middle-income countries from $18.50 to $8.50.23 Merck/ MSD signed a similar deal for Implanon®, reducing its price to the same level ($8.50) in the FP2020 countries. In addition to reducing prices, the IAP also aims to increase product uptake by supporting ministries of health in several focus countries to include implants in their national family planning plans, identifying and providing funding to training partners, and supporting social marketing organisations to scale up service delivery. While the price negotiation aspect of the IAP was limited to a small set of donors (BMGF, Norad, SIDA and CIFF), broader implementation of the programme itself involves a wider range of procurers and donors as well as technical and service-delivery organisations across the RHSC. Outside the implant space, another notable market-shaping initiative has been that between USAID and Bayer HealthCare. Under this arrangement, Bayer has agreed to lower the price of its oral contraceptive, Microgynon®, across 11 sub-Saharan African countries. Starting in Ethiopia, Tanzania and Uganda, the Contraceptive Security Initiative will see USAID underwrite Bayer’s marketing and promotion costs in an effort to enhance the product’s affordability to middle-income clients.24 Remaining concerns and opportunities The IAP has demonstrated how volume guarantees can be used to lower prices and achieve greater supply stability by providing critical predictability to manufacturers. Manufacturers often implicitly charge buyers a ‘risk premium’ to cover the chances that they will not able to recoup their investments. The willingness of buyers to guarantee demand can therefore significantly reduce prices, especially for products with high fixed costs and unpredictable demand. The contrast between the IAI and the IAP demonstrates just how much increased predictability can yield greater price reductions. In terms of remaining challenges, the most significant pertain to programmatic areas and service delivery. While the price reductions are a great achievement, there is still much work to be done to ensure uptake of the guaranteed volumes over the next six years. This will require significant investments to train providers, improve supply chains, and optimise the procurement process. Without these, it will likely be difficult to achieve the full potential of the volume guarantees. There is hope that procurement savings produced by the deals will be reinvested into improvements in service delivery, but such reinvestment on any significant scale has not yet materialised. BMGF is funding CHAI and Jhpiego to rationalise and implement training plans. In addition, Norad is supporting social marketing organisations to capitalise on latent health worker capacity as well as other initiatives to support training within the UNCoLSC’s eight priority or so-called ‘pathfinder’ countries. However, larger investments will be needed to realise the desired outcomes. The IAP, therefore, highlights the risk of not having more formal mechanisms to ensure the reinvestment of procurement savings in programmatic work to support scale-up activities at country level. Some stakeholders interviewed also pointed to the history of the female condom as a warning case, arguing that the international community failed to allocate the cost savings of the transition from the FC1 to the lower-cost FC2 design, either towards effectively ensuring uptake or towards larger procurement volumes. Finally, concerns have been raised over the potential for volume guarantees to distort the goal of providing choice. These worries center around whether there will be pressure at both global and local levels to reach the necessary volumes, which in turn could unintentionally skew the method mix, thereby distorting women’s choices. While the extent to which this will prove to be an issue remains unclear, it will clearly be a question worth tracking as implementation of the implant deals proceeds. More broadly, it will be critical to monitor and evaluate the implementation of the new implant pricing deals going forward, and learn from them to inform future market- 23 Bill & Melinda Gates Foundation. “Innovative partnership reduces cost of Bayer’s long-acting reversible contraceptive implant by more than 50 Percent.” February 27, 2013. 24 Bayer HealthCare. Focus on: Contraceptive Security Initiative. 2013 Market Shaping for Family Planning16 shaping interventions. With many outstanding questions, particularly with regard to the programmatic response and ability to absorb the guaranteed volume, it is essential that monitoring and evaluation efforts allow for transparency and learning for the broader global health community. LIMITEd CooRdInATIon AT gLoBAL And LoCAL LEvELS Background One of the greatest challenges in rolling out a new product or health intervention is coordinating the many players required to make the new venture a success. Individual players may know their own specific slice of the problem, but few are able to identify and prioritise amongst bottlenecks; ensure that the activities of manufacturers, programmes, regulators and funders happen in sync; and/or troubleshoot the many problems that arise. Facilitating communication and collaboration can play an important role in developing more efficient markets. Current and recent work Several initiatives have focused on coordinating introduction and uptake of specific contraceptive products. The ICEC works to coordinate efforts to expand access to emergency contraception. In addition to their work at developing the national registration database described earlier, the network conducts global- and country-level advocacy and it facilitates information sharing amongst manufacturers, country programmes and global bodies through its annual EC Jamboree meeting and on-going contact points. The UAFC initiative serves a similar role, addressing gaps in female condom uptake through a broad range of market dynamics– focused and programmatic activities. They provide market intelligence, negotiate prices, offer regulatory and technical support to new suppliers and collect on-the-ground data. In the injectables space, PATH is leading a project aimed at piloting the introduction of Sayana® Press, a new UnjiectTM-based product for delivering DMPA injections in four to six countries in sub-Saharan Africa and South Asia. Funded by BMGF, USAID and DFID, the study is expected to run from 2013 through 2016 and is aimed at identifying the operational, regulatory and usability issues that may stand in the way of broader rollout and uptake. In the implants space, the BMGF is coordinating the programmatic framework through which stakeholders can deliver strategic advice and monitor the progress of the IAP. The framework seeks to provide a forum for ensuring greater communication and coordination amongst the various sectors engaged in the programme. These include key financial stakeholders of the volume-guarantee mechanism as well as specialists within the technical streams of (1) forecasting, supply planning and procurement; (2) training and service delivery; (3) performance monitoring; and (4) communications and advocacy. At the same time, BMGF is supporting efforts to increase access to implants through the development of national-level forecasts. CHAI and JSI, under contract to BMGF, are coordinating with ministries of health in a range of countries to update national family planning goals and provide programme-level support. Other efforts to expand access to implants are being supported by the Implants TRT of the UNCoLSC. The Implants TRT, chaired jointly by DFID and BMGF, and convened by the RHSC, today comprises over 75 representatives from across the family planning community. These include manufacturers, donors, buyers, social marketing organisations, and other key players. It also serves as a forum for more specialised groupings of technical agencies, many under contract to BMGF, to report progress on the programmatic efforts underway to ensure effective implementation of the IAP. Some of these subgroups also meet routinely to share information regarding orders, procurement and production planning, as well as to discuss and resolve any issues which arise. Within this context, there are actions underway to improve the efficiency of the process for implant order aggregation. At the country level, several TMAs have been carried out to optimise public and private provision of family planning services. TMAs are interventions that analyse private for- profit, private nonprofit, and public-sector delivery of family planning products within a given country, to understand the funding and delivery needs for each consumer segment. The overall aim is to engage governments as stewards of a coordinated approach to optimise commodity provision between governmental and nongovernmental actors. TMAs have been carried out in Asia (Indonesia, Thailand and Vietnam), Africa (Cote d’Ivoire and Madagascar), Eastern Europe (Romania, Turkey and Ukraine) and Latin America (Honduras, Mexico, Nicaragua and Paraguay). A range of global implementers and funders have participated, including USAID SHOPS, PATH, MSI, Futures Institute, KfW Development Bank, the Fred H. Bixby Foundation and RHSC, amongst others. For much of the last decade, the RHSC’s Market Development Approaches (MDA) Working Group has supported TMA efforts by formulating a terminology and primer from which the community could design future analyses and interventions. Through these efforts, MDA partners have analysed key barriers to private-sector effectiveness in Nicaragua (such as product registration delays, import taxes and medical eligibility criteria), highlighted the impact of eliminating fees for services on contraceptives in Madagascar, and documented changes to ministry of health procurement and supply chain policies in the Ivory Coast. However, as TMAs have been documented in fewer than 15 countries, their global scalability and overall impact have not yet been evaluated. Finally, efforts are also underway to help ensure coordination and learning amongst actors across different categories. In many cases, the market-dynamics activities of one actor can have significant knock-on effects on others in the market. It is important, therefore, that stakeholders whose actions can affect the entire market coordinate 25 This summary is taken from the ‘July 2013 Market Dynamics Workshop – Meeting Summary’ written by USAID and BMGF in partnership with the William Davidson Institute. 26 This model will be based on a single product or product category which is yet to be determined. Market Shaping for Family Planning 17 and learn from one another, employ a common lexicon, share key concepts and align theoretical frameworks. In 2013, USAID and the BMGF hosted a “Market Shaping Lab/Workshop” with the aim of creating a community of practice (COP) for market dynamics and of developing a common guiding framework to facilitate learning within the space.25 The COP is also completing a primer to provide an overview of market shaping for global health decision makers to foster learning and dialogue about this approach. Many of the frameworks and issues raised at the lab/ workshop were addressed by this consultation (within the context of family planning) and with the expectation that they will be further refined and adapted over time. Another effort to understand the consequences of market shaping interventions on RH supplies is being undertaken by the William Davidson Institute (WDI) at the University of Michigan. Using a modelling methodology known as system dynamics, the analysis reveals causal relationships among events such as the market-entry of new suppliers, price reductions, or changes to task-shifting guidelines.26 The model is able to assess the consequences and implications of market-dynamics interventions so they can be coordinated and discussed in advance. WDI also has plans to conduct a deep-dive diagnosis of market deficiencies for selected contraceptives using a combination of data-driven analysis and triangulated stakeholder perspectives. Finally, WDI will conduct a retrospective analysis of market-dynamics approaches in the reproductive health market with a view to informing decision-making about future interventions. Finally, the Market Dynamics Working Group of FP2020 is working to formulate a shared vision of a healthy market for family planning supplies and identify the indicators needed to track progress towards that vision. By creating a dashboard of these metrics, it is hoped the FP community will be better able to coalesce around common goals and identify the appropriate market shaping opportunities to achieve them. Remaining concerns and opportunities As interest grows in the field of market shaping, and as more and more market-shaping initiatives get underway, the need for coordination will become increasingly important. It could play an important role, for example, in the conception and design of new interventions, as well as in the implementation and monitoring of prioritised interventions. Given the complexity and interconnections amongst markets for contraceptive products, communication and coordination are vital to ensure that actors do not end up working at cross-purposes. Experience to date suggests that the RH community as a whole values the possibility of providing feedback and pressure testing potential interventions prior to their implementation, just to ensure that all risks and dependencies have been thoroughly considered. In addition, once an intervention is executed, there still is a need for continued coordination and stakeholder engagement to ensure that the full potential of the intervention is being realised. In late 2013, a new Market Dynamics Working Group was created within the framework of the FP2020 initiative. Chaired by the RHSC and CHAI, the working group today encompasses more than 20 key actors in the market- shaping space. At the working group’s first meeting, held in November 2013, key findings and recommendations of this report were presented in plenary, many of which later found their way into the working group’s first year work plan. One of these recommendations focused on the need to serve as forum for the RH community, to share new prospects for market-shaping efforts. Under the working group’s new work plan, three technical work streams will focus on (1) knowledge management and data transparency, (2) procurement and regulatory improvements, and (3) reaching consensus around the community’s vision of a well-functioning market. Market Shaping for Family Planning18 Markets are complex systems, in which changes in one area often cause profound second- or third-order effects in another. Tensions frequently arise in market-shaping work where actors are forced to choose between difficult trade-offs or strike a balance between several competing desires. The experience of recent initiatives in the family planning space has been no exception. In this chapter, we draw on examples from the landscaping exercise to explore in greater detail five clusters or ‘tensions’ that have arisen in the market-shaping arena. APPLyIng A PRoduCT-By-PRoduCT vERSuS A PoRTFoLIo APPRoACH Providing women with access to family planning is fundamentally about enabling them to make decisions to fulfill their reproductive intent. This requires striking a delicate balance. Women must not only have physical access to different contraceptive options, they must also be truly free to choose between options without distortions based on the activities of outside actors. As far back as the 1990s, the WHO was voicing concerns over the risks associated with the introduction of new contraceptive technologies, particularly in cases where those technologies were not being introduced within the context of broad method choice.27 Without ensuring alternative options to choose from, introductory efforts ran the risk of introducing biases—among both users and providers. The higher visibility of a new product increased chances that it would be in stock (even if others were not), that providers would receive dedicated training on how to deliver it, and that users would be encouraged, even if only inadvertently, to adopt it. Similar concerns are now being expressed in connection with the potentially distorting effects of market-shaping activities. It is understandable why market shapers should tend to focus on individual products or product categories. Negotiating and closing a deal requires the ability to work quickly and with focus. Coordination costs also tend to increase exponentially as the number of products or partners increases. Further, suppliers are often reluctant to engage in negotiations with multiple competitors out of fear of running afoul of anti-trust laws. Nevertheless, the focus on single products does come at a cost, especially when it comes to maintaining a balance in the market across products. Improving access to one method does have the potential to introduce bias—a concern voiced particularly in connection with the size of recent implant volume agreements. Several interviewees expressed concern that donors, implementers and programmes would face implicit pressure to ensure the committed volumes were realised—potentially at the expense of other products. The solution likely lies in using a balanced portfolio approach. While many, if not most, individual initiatives will focus on a specific product or set of products, the major bodies managing market dynamics work will need to exercise oversight across the whole set of activities to ensure that no product ends up being inappropriately emphasised or pushed. Going forward, it may also be possible to leverage the purchasing power of global procurers to expand access to a wider range of products. For example, many of the larger manufacturers, generic and innovators, produce a wide portfolio of family planning commodities, which may allow for multi-product deals. TAKIng A ConSEnSuS-dRIvEn vERSuS unILATERAL APPRoACH As market-shaping interventions aim to strike a balance between addressing the specific challenges of an individual product and preventing distortions across the market as a whole, a greater focus on consensus-driven approaches would seem to be the natural choice. This is especially important because there is no simple metric for what constitutes a ‘bias’ or a ‘distortion’, nor are there objective criteria for what the ‘right’ product mix should be, either at country level or globally. More limited approaches that engage a much narrower set of stakeholders do offer strong benefits in terms of agility and speed—especially when there is a time- bound window of opportunity for structuring and/or announcing an intervention. However, inclusiveness also has its costs; as one representative from a manufacturer argued, “One of the biggest challenges I see is just the complexity and number of people operating in this space… you have many actors to align, each with different perspectives… [T]hat slows down the activities that ultimately get the product into the hands of the end user”. Nevertheless, there are also distinct benefits from taking a more coalition- or consensus-based approach towards driving change. The complex and interconnected nature of markets suggests anyone considering interventions needs to account for the perspective of organisations with insight into all levels of the system, including suppliers, buyers, funders and especially country programmes. The failure to do so not only increases the risk of important perspectives being overlooked, it also jeopardises the buy-in of players who could prove critical in successfully implementing the intervention. 27 Ruth Simmons, Peter Hall, Juan Diaz, Margarita Diaz, Peter Fajans and Jay Satia. The Strategic Approach to Contraceptive Introduction. Studies in Family Planning, Vol. 28, No. 2 (June 1997), pp. 79-94. Key tensions and trade-offs to navigate going forwards Market Shaping for Family Planning 19 PRIoRITISIng SHoRT-TERM vERSuS Long-TERM MARKET ConSIdERATIonS A number of recent market-shaping deals have drawn attention to the delicate balancing between short- and long-term outcomes. Perhaps the most salient example of these deals is the volume guarantees for implants, where negotiators had to choose whether to strike a deal with innovators that yielded lower prices in the short term but risked discouraging generic producers from entering the market, or to pay higher prices upfront with the goal of creating more healthy competition later. Such choices are by no means unique to the family planning space. The GAVI Alliance and UNICEF, for example, confronted a similar a trade-off in the markets for rotavirus and pneumococcal vaccines and prompted much debate as to whether they successfully struck the right balance.28 As with the other tensions discussed in this section, the ‘right answer’ depends on the specific product market and context. Ideally, market interveners should understand and explicitly articulate which balance they are striking and how it fits into their vision for the market in the long term. EMPHASISIng PRICE vERSuS oTHER MARKET ouTCoMES Historically, price reductions have been a hallmark of market-shaping interventions. This is true for interventions oriented towards the private sector, where users’ ability to pay is paramount, and for those focused on the public sector, where donors seek to maximise the value-for-money of their investments. However, a singular focus on commodity pricing can also have drawbacks. In markets with a limited number of suppliers, or in those with a clear low-cost provider, price-cutting can have the effect of shutting out new entrants or driving out existing ones. Similarly, focusing on price may reduce the incentive of manufacturers to invest in developing new innovations that hold the promise of delivering greater value or improved quality. Additionally, a manufacturer’s full contribution is not always reflected in the price of the commodity alone. Under the RHSC’s IAI, for example, Merck implicitly included support for product delivery, training and other forms of servicing. The more aggressive price cuts of the IAP, by contrast, saw these elements figure less prominently. As such, several interviewees argued that some of the savings may have been overstated, given the extra costs that the health community must now shoulder directly. To some degree, this may have been inevitable; Merck had a far more developed distribution and training network than Bayer, so any deal with the latter would likely have required incurring such extra expenses. However, going forward, it will be important to make explicit which costs are included (and which are not) in each agreement, so as to understand the trade-offs between different deal structures. Such transparency will also help make sure market shapers can make ‘apples-to-apples’ comparisons when considering competing manufacturers or deal structures. More broadly, price may not always be the biggest barrier to achieving choice, equity or health outcomes, and focusing on it may come at the expense of quality, supplier diversity or innovation. Thus, following the logic outlined in Figure 1, market analyses must consider the highest- priority barriers and inefficiencies to be addressed. FoCuSIng on ‘MARKET SHAPIng’ vERSuS ‘PRogRAMMATIC’ InTERvEnTIonS Market-shaping interventions are strong candidates for funding and attention. Their short-term nature and inherently catalytic approach make them attractive to both donors and implementers. They also have the advantage of working with a relatively limited set of institutional actors, meaning that discussion, dialogue and coordination can occur within a manageable set of players. However, of the many problems confronting the family planning sphere, evidence suggests that many may be more appropriately or effectively addressed by programmatic interventions that improve public-, commercial- and nonprofit- sector distribution and delivery. While the focus of this report has been on the implementation of short-term strategies addressing critical market barriers, ‘programmatic’ barriers to access are often much more complex and require higher levels of investment to address. It will be important to ensure that any emphasis on market shaping does not starve funding for the critical programmatic efforts needed to effectively deliver products to those who wish to access them. Ultimately, the RH community must focus on the desired outcomes of health impact, choice and equity and assess in a holistic, critical manner whether the barriers and inefficiencies that impede them can best be addressed programmatically or through market shaping. The two approaches are complementary and both are essential, but efforts to achieve the community’s goals must consider a deep analysis of root causes before determining the solution set. 28 Light D. “Is G8 putting profits before the world’s poorest children?” The Lancet. 28 July 2007; 370(9584):297–298. Conclusion The 2012 London Summit on Family Planning posed the challenge of delivering contraception to an additional 120 million women, thereby reaching more than 380 million users of modern contraception by 2020. This vision, which now forms the cornerstone of the FP2020 movement, will only be achieved when women are able to choose, obtain and use the high- quality, low-cost contraceptives that meet their family planning needs. Ensuring the effectiveness of markets, therefore, is not an option, but a fundamental part of delivering on the commitment articulated in London. As this report has shown, much remains to be done in the next six years. donors and other stakeholders in particular will need to expand efforts in three areas. First, they will need to promote competition amongst manufacturers, especially by facilitating the global and national registration of new supplies. Second, addressing programmatic gaps will be critical, particularly those that constrain access and reduce supplier incentives to enter new markets. Third, donors and stakeholders will need to address information gaps that prevent both implementers and manufacturers from understanding and addressing the issues and needs at both local and global levels. given the complexity and trade-offs involved in market-shaping approaches for family planning, enhanced coordination and transparency are essential. In any market, interveners must consider complex trade-offs between individual products and approaches and between optimising for the present versus delivering on the future. This is especially challenging in the family planning space, where providing women with choice is so fundamental. while optimising delivery for any one method is clearly not sufficient, there remains no objective metric for establishing the right balance to avoid biasing or distorting the market. Consequently, in the absence of global agreement on an optimal set of approaches, it is incumbent upon interveners to articulate the logic of their choices and the vision that they seek. To the extent that consensus can be reached around product priorities and the allocation of resources amongst them, prospects will be enhanced for building a common vision within the RH community. This report should be seen as a starting point to bring more cohesion to market shaping in family planning, in the hope that these efforts can ultimately advance choice, equity and health impact. This is indeed an exciting time for market dynamics for family planning. As recent successful efforts to promote competition, lower prices and raise quality for family planning products have demonstrated, there is tremendous potential for market-oriented approaches to improve women’s access to contraceptive products and help them realise their reproductive intentions. Market Shaping for Family Planning20 Market Shaping for Family Planning 21 Market Shaping for Family Planning22 An ne x A Su m m ar y of c ur re nt a ct iv it ie s fo cu se d on m ar ke t d yn am ic s fo r f am ily p la nn in g IN IT IA TI VE N A M E M AJ O R IM PL EM EN TI N G O RG AN IS AT IO N M AJ O R D O N O RS D ES CR IP TI O N ES TI M AT ED FU N D IN G YE AR R AN G E M ET H O D CO U N TR IE S B AR RI ER AD D RE SS ED Co nt ra ce pt iv e Se cu ri ty In it ia ti ve : Su b- Sa ha ra n Af ri ca M er id ie n G ro up , B ay er H ea lt hC ar e U SA ID U nd er th is p ub lic -p ri va te p ar tn er sh ip , B ay er h as lo w er ed th e pr ic e of it s or al c on tr ac ep ti ve (O C) in se le ct ed s ub -S ah ar an c ou nt ri es . I n re tu rn , U SA ID un de rw ri te s B ay er ’s m ar ke tin g an d pr om ot io n co st s fo r t he d ur at io n of th e pa rt ne rs hi p. 20 10 -2 01 5 O C 11 c ou nt ri es in cl ud in g Et hi op ia , U ga nd a, a nd Ta nz an ia Pr ed ic ta bi lit y dM PA s up pl y an d de m an d m ar ke t an al ys is M cK in se y, RH SC BM G F, D IF D M ar ke t a na ly si s of D ep o- Pr ov er a® s up pl y an d de m an d to id en tif y so lu tio ns to p ot en tia l s ho rt fa lls o f S R A- ap pr ov ed D M PA . $1 80 ,0 00 20 13 In je ct ab le TB D In fo rm at io n an d da ta g ap s Im pl an on ® A cc es s In it ia ti ve (I AI ) RH SC , M er ck / M SD Lo w er ed th e pe r- un it pr ic e of Im pl an on ® /N ex pl an on ® fr om $ 20 .0 0 to $ 16 .5 0 pe r u ni t. 20 11 -2 01 2 Im pl an t G lo ba l Pr ed ic ta bi lit y Im pl an t A cc es s Pr og ra m (I AP ) CH AI , B ay er H ea lt hC ar e, M er ck /M SD , BM G F U SA ID , BM G F, D FI D, SI D A , N or ad , U N FP A , C IF F an d ot he rs Lo w er ed th e pe r- un it pr ic e of Ja de lle ® a nd Im pl an on ® /N ex pl an on ® to $ 8. 50 th ro ug h a co m bi ne d vo lu m e gu ar an te e fo r 4 0 m ill io n de vi ce s ov er s ix y ea rs . $2 30 m ill io n 20 13 -2 01 9 Im pl an t G lo ba l Pr ed ic ta bi lit y In -c ou nt ry m ar ke t su pp ly a nd u sa ge su rv ey s U SA ID | D EL IV ER , I + So lu tio ns , U N FP A , S H O PS , PR O G RE SS , ot he rs Va ri ou s Se ve ra l i ni tia ti ve s ai m to im pr ov e on -t he -g ro un d da ta co lle ct io n eff or ts . T he se in cl ud e I+ S ol ut io ns ’ s ur ve ys in B ur un di D em oc ra tic R ep ub lic o f C on go , a nd R w an da on th e av ai la bi lit y, re gi st ra tio n an d pr ic e of fa m ily pl an ni ng p ro du ct s, a nd U N FP A G PR H CS s ur ve ys a nd an al ys es o n m et ho d av ai la bi lit y an d su pp ly in s el ec te d co un tr ie s in s ub -S ah ar an A fr ic a, A si a an d La tin Am er ic a. In fo rm at io n an d da ta g ap s In cr ea si ng a cc es s to a m or e aff or da bl e ge ne ri c Ln g Iu d M ed ic in es 36 0 An on ym ou s do no r M ed ic in es 36 0 is w or ki ng to c re at e a lo w -c os t le ve no ge st er el IU D, in it ia lly fo r t he U S m ar ke t, th en fo r i nt ro du ct io n gl ob al ly . T he y ar e cu rr en tl y se ek in g U S FD A ap pr ov al a nd , f ro m th er e, a nt ic ip at e ne ed in g to fo cu s th ei r e ffo rt s on a ch ie vi ng p re qu al ifi ca tio n an d na tio na l r eg is tr at io ns . N/ A 20 08 -2 01 4 (a nt ic i- pa te d U S in tr od uc - tio n) IU D U S, th en de ve lo pi ng co un tr y m ar ke ts (T BD ) Re gu la to ry In fo m ed ia ry da ta ba se CH AI , U N Co LS C G lo ba l M ar ke t Sh ap in g TR T, D al be rg TB D D ev el op m en t o f a n in fo m ed ia ry w it h pu bl ic ly a va ila bl e m ar ke t d at a fo r e ac h co m m od it y, b y id en tif yi ng pa rt ne rs c ur re nt ly c ol le ct in g da ta a cr os s LM IC s on m ar ke t s iz e, g lo ba l f or ec as tin g, s up pl ie rs a nd p ri ci ng . U lt im at el y, it a im s to c on so lid at e an d pu bl is h da ta th ro ug h a w eb -b as ed in te rf ac e. In fo rm at io n an d da ta g ap s Market Shaping for Family Planning 23 IN IT IA TI VE N A M E M AJ O R IM PL EM EN TI N G O RG AN IS AT IO N M AJ O R D O N O RS D ES CR IP TI O N ES TI M AT ED FU N D IN G YE AR R AN G E M ET H O D CO U N TR IE S B AR RI ER AD D RE SS ED In te rn at io na l Co ns or tiu m fo r E m er ge nc y Co nt ra ce pt io n (I CE C) FC I BM G F, U N Co LS C W or ks to re du ce g lo ba l a nd c ou nt ry -le ve l r eg ul at or y an d po lic y ba rr ie rs fo r e m er ge nc y co nt ra ce pt io n (E C) th ro ug h ad vo ca cy a nd p ar tn er sh ip w it h m an y gl ob al a nd n at io na l o rg an is at io ns . S in ce IC EC ’s p ilo t pr oj ec t t o re gi st er E C in fo ur c ou nt ri es , p ar tn er s an d m an uf ac tu re rs h av e ex pa nd ed re gi st ra tio n of E C to ov er 1 40 c ou nt ri es s in ce 1 99 6. Ap pr ox . $1 m ill io n (2 01 0- 20 13 ) 19 96 -p re s- en t EC G lo ba l Co or di na tio n n ew p ro du ct re se ar ch BM G F, P AT H , Po pu la tio n Co un ci l, G yn ui ty , a nd ot he rs BM G F Ea rl y st ag e pr oo f- of -c on ce pt a nd p ro du ct re se ar ch to im pr ov e th e de si gn o f w om en -p re fe rr ed p ro du ct s. Ea rl y re se ar ch is b ei ng c on du ct ed o n ho rm on al co m po un ds , o n- de m an d O C, fe m al e co nd om s, di ap hr ag m s, v ag in al ri ng s, in je ct ab le s an d lo ng -a ct in g re ve rs ib le c on tr ac ep ti ve s. TB D 20 13 -2 01 4 G en er al Co or di na tio n Pl ed ge g ua ra nt ee fo r H ea lt h (P g H ) Fi na nc in g fo r D ev el op m en t (F 4D ) U SA ID , SI D A , R H SC , Pa ck ar d Fo un da tio n PG H w or ks to s m oo th fu nd in g fl ow s an d re du ce em er ge nc y or de rs o f h ea lt h co m m od it ie s by ac ce le ra tin g ac ce ss to d on or fu nd in g th ro ug h co m m er ci al b an k br id ge fi na nc in g. $1 00 m ill io n in cr ed it 20 13 -2 01 8 G en er al G lo ba l Pr oc ur em en t Q ua lit y of Re pr od uc ti ve He al th M ed ic in es (Q uR HM ) p ro je ct Co nc ep t Fo un da tio n/ RH SC D FI D, B M G F Pr ov id es te ch ni ca l a ss is ta nc e to a pp ro xi m at el y 30 ho rm on al c on tr ac ep ti ve p ro du ce rs w it h th e go al o f pr eq ua lif yi ng s ev er al g en er ic s fo r e ac h m et ho d by m id -2 01 4. Q uR H M a ls o de ve lo ps th e bu si ne ss c as e fo r ad di tio na l m an uf ac tu re rs to a ch ie ve p re qu al ifi ca tio n, al ig ns p ro cu re rs a ro un d pu rc ha si ng q ua lit y ap pr ov ed pr od uc ts a nd c on du ct s lo ca l m ar ke t a ss es sm en ts (E th io pi a, K en ya , N ep al , S en eg al ). $8 .3 m ill io n 20 12 -2 01 4 Al l ho rm on al N/ A Re gu la to ry Sa ya na P re ss p ilo t in tr od uc ti on PA TH BM G F, D FI D, U N FP A , U SA ID G ua ra nt ee d pu rc ha se o f 1 2 m ill io n un it s of S ay an a® Pr es s ov er tw o ye ar s ai m s to e ns ur e av ai la bi lit y of qu an ti tie s ne ed ed fo r i nt ro du ct io n. $4 5 m ill io n 20 13 -2 01 6 In je ct ab le U p to fi ve co un tr ie s Co or di na tio n Si no -I m pl an t ( II) in it ia ti ve FH I 3 60 BM G F Te ch ni ca l a ss is ta nc e to h el p Sh an gh ai D ah ua g ai n pr eq ua lifi ca tio n fo r S in o- Im pl an t. 20 07 -2 01 8 Im pl an t N/ A Re gu la to ry Su pp ly -s id e pr od uc t l an ds ca pe as se ss m en ts (o C, EC , i nj ec ta bl es ) JS I/ U SA ID D EL IV ER U SA ID Su pp ly -s id e la nd sc ap e as se ss m en ts fo r O Cs , E Cs , an d in je ct ab le s, in cl ud in g re se ar ch o n th e nu m be r an d ty pe o f m an uf ac tu re rs , s hi pm en t q ua nt it ie s, pr oc ur em en t, n at io na l r eg is tr at io n an d di st ri bu tio n. 20 09 -2 01 1 O C, E C, In je ct ab le G lo ba l In fo rm at io n an d da ta g ap s Su pp or t t o m ar ke t dy na m ic s ac ti vi tie s RH SC BM G F, D FI D, U SA ID , U N FP A Co re s up po rt to th e RH SC S ec re ta ri at , i nc lu di ng w or k fo r t he U N Co LS C an d FP 20 20 , a nd fu nd in g to im pr ov e th e le ve l a nd a cc ur ac y of d em an d da ta fo r f am ily pl an ni ng p ro du ct s. 20 13 -2 01 6 G en er al G lo ba l Market Shaping for Family Planning24 IN IT IA TI VE N A M E M AJ O R IM PL EM EN TI N G O RG AN IS AT IO N M AJ O R D O N O RS D ES CR IP TI O N ES TI M AT ED FU N D IN G YE AR R AN G E M ET H O D CO U N TR IE S B AR RI ER AD D RE SS ED To ta l M ar ke t Ap pr oa ch es PA TH Fr ed H . B ix by Fo un da tio n, H ew le tt Fo un da tio n, U SA ID Vi et na m : A im ed to c oo rd in at e pu bl ic a nd p ri va te st ak eh ol de rs to im pr ov e up ta ke o f f am ily p la nn in g in Vi et na m . N ic ar ag ua : A s ta ke ho ld er a na ly si s of 2 4 N G O s an d pr iv at e di st ri bu to rs id en ti fie d a pe rc ei ve d la ck o f go ve rn m en t e ng ag em en t w it h th e pr iv at e se ct or a nd lo ca l p ro du ct re gi st ra tio n ba rr ie rs . ~$ 2m ill io n 20 09 -2 01 1 G en er al Vi et na m , N ic ar ag ua Co or di na tio n To ta l M ar ke t Ap pr oa ch es (T M As ) RH SC (M D A W or ki ng G ro up ), M SI , Fu tu re s In st it ut e, U N FP A , J SI RH SC In no va tio n Fu nd Cr ea te d an a ct io n pl an to im pr ov e co nt ra ce pt iv e se cu ri ty th ro ug h m or e eff ec ti ve a lig nm en t o f p ub lic an d pr iv at e se ct or s. T he T M A w as in it ia te d ba se d on c on su m er s’ p er ce iv ed a bi lit y to p ay , u nm et n ee d ac ro ss s oc io ec on om ic g ro up s, a nd b ar ri er s to p ri va te pr od uc tio n (t ax es , f re e pu bl ic s ub st it ut es , p oo r m ar ke t se gm en ta tio n) . $4 00 ,0 00 20 10 G en er al M ad ag as ca r, H on du ra s Co or di na tio n u n Co m m is si on on L ife -S av in g Co m m od it ie s (u n Co LS C) fo r w om en a nd Ch ild re n U N IC EF , U N FP A an d pa rt ne rs N or ad Co or di na te s ac to rs a nd c om m is si on s m ar ke t an al ys es o n 13 m at er na l, ne w bo rn a nd c hi ld h ea lt h co m m od it ie s, in cl ud in g th re e co nt ra ce pt iv e pr od uc ts : EC , f em al e co nd om s an d im pl an ts . I ss ue d in it ia l w or ki ng p ap er in 2 01 2; c ur re nt w or k on -g oi ng . 20 10 -2 01 5 EC , F C, im pl an ts G lo ba l In fo rm at io n an d da ta g ap s u SA Id M al ar ia M ed ic in es v en tu re / IM S Pa rt ne rs hi p U SA ID IM S H ea lt h A ro ut in e sy st em o f c ol le ct in g pr im ar y es se nt ia l d ru g da ta in cl ud in g co nt ra ce pt iv es a nd m at er na l a nd c hi ld he al th d ru gs a t t he lo w es t l ev el o f t he s up pl y/ va lu e ch ai n in s el ec t s ub -S ah ar an A fr ic an c ou nt ri es . G en er al Su b- Sa ha ra n Af ri ca In fo rm at io n an d da ta g ap s u ni ve rs al A cc es s to F em al e Co nd om s (u AF C) I+ S ol ut io ns , O xf am N ov ib , Ru tg er s/ W FP D ut ch M FA , S ID A, Fi nl an d, O xf am N ov ib , H ew le tt Fo un da tio n, U N FP A Se ek s to b ro ad en a cc es s, a va ila bi lit y an d aff or da bi lit y of fe m al e co nd om s th ro ug h in te gr at ed in -c ou nt ry su pp ly a nd d em an d pr og ra m m in g, p ri ce n eg ot ia tio n fo r c ou nt ry p ro cu re m en t, re gu la to ry s up po rt fo r f ou r ne w fe m al e co nd om m an uf ac tu re rs , m ar ke t r es ea rc h an d aw ar en es s ge ne ra tio n. $6 0 m ill io n 20 09 -2 01 5 Fe m al e co nd om G lo ba l, Ca m er oo n, N ig er ia , M oz am bi qu e Co or di na tio n va gi na l r in g Co g S op tim iz at io n Po pu la tio n Co un ci l BM G F Ai m s to re du ce p ro du ct io n co st s fo r a n ew v ag in al ri ng , u nd er a la rg er g ra nt in cl ud in g lo ca l a cc ep ta bi lit y st ud ie s an d U S FD A su bm is si on in 2 01 4. $1 .6 m ill io n 20 12 -2 01 6 Va gi na l ri ng Ke ny a, Se ne ga l, N ig er ia Co or di na tio n w Ho Pr eq ua lifi ca ti on Pr og ra m m e W H O D FI D, B M G F W or ki ng to im pr ov e th e tr an sp ar en cy a nd e ffi ci en cy of th e pr eq ua lifi ca tio n pr oc es s fo r f am ily p la nn in g su pp lie rs th ro ug h ca pa ci ty -b ui ld in g an d re gi on al re gu la to ry h ar m on is at io n. $9 m ill io n 20 06 -2 01 5 G en er al G lo ba l Re gu la to ry Market Shaping for Family Planning 25 Annex B List of interviewees ▸ Jeffrey Barnes Abt Associates ▸ Caroline Quijada Abt Associates ▸ Pamela Riley Abt Associates ▸ Claudia Queiroz BEMFAM ▸ Muhammad Aslam Bayer HealthCare ▸ Klaus Brill Bayer HealthCare ▸ Hema Srinivasan CHAI ▸ Alan Staple CHAI ▸ Andrew Storey CHAI ▸ Leslie Heyer Cycle Technologies ▸ Lester Coutinho David & Lucile Packard Foundation ▸ James droop DFID ▸ nel druce DFID ▸ venkatesh Iyer FamyCare ▸ Aron Betru Financing for Development ▸ Markus Steiner FHI 360 ▸ Kate Rademacher FHI 360 ▸ valerie diFillipo FP2020 ▸ Jo Ichter Futures Institute ▸ John Stover Futures Institute ▸ natalie Revelle Bill & Melinda Gates Foundation ▸ Trisha wood Bill & Melinda Gates Foundation ▸ Ed oosterman Helm ▸ Marcel Hendriks I+ Solutions ▸ Benjamin Smith I+ Solutions ▸ Elizabeth westley ICEC ▸ Maria Cristina Ramirez IPPF ▸ david Smith IPPF ▸ Alexis Ettinger IRH, Georgetown University ▸ victoria Jennings IRH, Georgetown University ▸ Suzanne veit John Snow Inc. ▸ Shristi gupta McKinsey & Company ▸ Heather Megosh McKinsey & Company ▸ Beatrice Mutali Merck/MSD ▸ Kshama Roberts Merck/MSD ▸ Paul Schaper Merck/MSD ▸ victoria Hale Medicines360 ▸ Sally Stephens Medicines360 ▸ Anna Mackay Marie Stopes International ▸ nomi Fuchs-Montgomery Marie Stopes International ▸ Jill Keesbury PATH ▸ Bonnie Keith PATH ▸ Keith neroutsos PATH ▸ Sara Tifft PATH ▸ Janet vail PATH ▸ Imanol Echevarria Pfizer Market Shaping for Family Planning26 ▸ Ian Askew Population Council ▸ Martha Brady Population Council ▸ Saumya RamaRao Population Council ▸ John Townsend Population Council ▸ Bob walker Population Institute ▸ dana Tilson Population Services International ▸ Mukul Taparia Pregna ▸ Pooja Shaw Results for Development ▸ Campbell Bright UNFPA ▸ Eric dupont UNFPA ▸ Ben Light UNFPA ▸ Jasmine Baleva USAID ▸ Clancy Broxton USAID ▸ Marguerite Farrell USAID ▸ Andrea Harris USAID ▸ denise Harrison USAID ▸ glenn Milano USAID ▸ david Milestone USAID ▸ Mark Rilling USAID ▸ wendy Taylor USAID ▸ Richard Lowe Venture Strategies Innovation ▸ Margot Fahnestock William & Flora Hewlett Foundation ▸ Andrei Sinioukov World Health Partners Annex B List of interviewees Market Shaping for Family Planning 27 ▸ ARv Antiretroviral ▸ BMgF Bill & Melinda Gates Foundation ▸ CHAI Clinton Health Access Initiative ▸ CIFF Children’s Investment Fund Foundation ▸ CogS Cost of goods sold ▸ dFId Department for International Development (UK) ▸ dMPA Depo-Provera or depot medroxyprogesterone acetate ▸ EC Emergency contraception ▸ FC Female Condom ▸ ERP Expert Review Panel ▸ FdA Food and Drug Administration (US) ▸ FP2020 London Summit on Family Planning ▸ gAvI Global Alliance for Vaccines and Immunisation ▸ gPRHS Global Programme on Reproductive Health Commodity Security ▸ IAI Implanon® Access Initiative ▸ IAP Impant Access Program ▸ ICEC International Consortium on Emergency Contraception ▸ IPPF International Planned Parenthood Federation ▸ IRH Institute for Reproductive Health ▸ Iud Intrauterine device ▸ JSI John Snow, Inc ▸ MdA Market Development Approaches ▸ MMv Medicines for Malaria Ventures ▸ MSI Marie Stopes Internatioal ▸ ngo Nongovernmental organisation ▸ norad Norwegian Agency for Development ▸ oC Oral contraception ▸ PATH Program for Appropriate Technology in Health ▸ PgH Pledge Guarantee for Health ▸ PQP Prequalification Programme (WHO) ▸ PRogRESS Program Research for Strengthening Services ▸ QuRHM Quality of Reproductive Health Medicines Project ▸ RH Reproductive health ▸ RHI Reproductive Health Interchange ▸ RHSC Reproductive Health Supplies Coalition ▸ SIdA Swedish International Development Cooperation Agency ▸ SHoPS Strengthening Health Outcomes through the Private Sector ▸ SRA Stringent Regulatory Authority ▸ TMA Total market approach ▸ TRT Technical Resource Team ▸ uAFC Universal Access to Female Condoms ▸ un United Nations ▸ unCoLSC United Nations Commission on Life-Saving Commodities ▸ unFPA United Nations Population Fund ▸ unICEF United Nations Children’s Fund ▸ uSAId United States Agency for International Development ▸ wdI William Davidson Institute ▸ wHo World Health Organization Annex C List of acronyms 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. The Reproductive Health Supplies Coalition Rue Marie-Thérèse 21, 1000 Brussels, Belgium Tel: +32 2 210 0222 / Fax: +32 2 219 3363 / Executive summary Rediscovering the power of the marketplace Framework for understanding market shaping An overview of market-shaping efforts in the family planning secto Key tensions and trade-offs to navigate going forwards Annex A Summary of current activities focused on market dynamics for family planning Annex B List of interviewees Annex C List of acronyms

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