Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary (2014)

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1 Introduction and Overview1 Approximately one-third of the developing world’s population does not have regular access to essential medicines. The World Health Organization (WHO) defines essential medicines as “those that satisfy the priority health care needs of the population and are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and community can afford. Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.”2 In 2011 the Grand Challenges in Global Mental Health initiative identified priorities that have the potential to make a significant impact on the lives of people with mental, neurological, and substance use (MNS)3 disorders (Collins et al., 2011). Reduction of the cost and improvement of the supply of effective medicines was highlighted as one of the top five challenges. For low- and middle-income countries, improving access to appropriate essential medicines can be a tremendous 1 The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the Institute of Medicine, and they should not be construed as reflecting any group consensus. 2 See http://www.who.int/medicines/services/essmedicines_def/en. 3 The phrase “MNS disorders” is used throughout this summary to refer broadly to the wide range of mental, neurological, and substance use disorders. This terminology, first adopted by the participants at the 2009 Institute of Medicine (IOM) workshop on reducing the treatment gap for MNS disorders in sub-Saharan Africa (IOM, 2009a), and subsequently used for the 2012 IOM workshop on strengthening human resources (IOM, 2012), has been retained for the current workshop. 1 

2 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA challenge and a critical barrier to scaling up quality care for MNS disorders. Reduction of cost and improvement of the supply of effective medicines has the potential to significantly impact the lives of patients with these disorders. ORIGINS OF THE WORKSHOP Recognizing the importance of quality of care for MNS disorders and the limitations of most sub-Saharan Africa (SSA) countries in treat- ing such conditions, the Institute of Medicine (IOM) Forum on Neuro- science and Nervous System Disorders and the Forum on Health and Nu- trition of the Uganda National Academy of Sciences convened a joint workshop in 2009 in Kampala, Uganda, to address these issues (IOM, 2009a). The purpose of this meeting was to assess the current state of quality of care for MNS disorders and to elucidate, identify, and priori- tize areas that might benefit from improvements that could build on the preexisting or easily obtainable infrastructure. Among the opportunities discussed to decrease the treatment gap and improve the quality of care were: • increasing the number of health care providers with expertise in MNS disorders; and • improving access to medicines to treat MNS disorders. As a result of the discussions from the 2009 workshop, the IOM Neuroscience Forum convened two more workshops focused on these specific opportunities. The first took place in Kampala, Uganda, in 2012, bringing together key stakeholders to discuss candidate core competen- cies that providers might need to help ensure the effective delivery of services (IOM, 2013d).4 The workshop focused on four MNS disorders that account for the greatest burden in low- and middle-income countries: depression, psychosis, epilepsy, and alcohol use. Individual workshop participants discussed a series of candidate core competencies for non- specialized and specialized providers. Competencies were related to three specific areas: screening/identification, formal diagnosis/referral, and treatment/care. It was noted by many workshop participants that the 4 See http://www.iom.edu/reports/2013/Strengthening-Human-Resources-Through- Development-of-Candidate-Core-Competencies-for-Mental-Neurological-and-Substance- Use-Disorders-in-Sub-Saharan-Africa.aspx. 

INTRODUCTION AND OVERVIEW 3 candidate core competencies might apply beyond the four disorders dis- cussed to all MNS disorders. Participants were invited to consider the future needs of MNS health care providers, discuss potential mechanisms for task-shifting and task-sharing, explore potential methods for acquir- ing and maintaining core competencies, and consider tangible next steps for dissemination of the identified candidate core competencies and per- formance requirements and for adaption based on specific country needs. Given the importance of access to appropriate essential medicines to help decrease the treatment gap of MNS disorders in SSA, the IOM Neuroscience Forum convened a third workshop on January 13-14, 2014, in Addis Ababa, Ethiopia. The goal of the workshop was to bring together key stakeholders to discuss opportunities for achieving long- term affordable access to medicines for MNS disorders. His Excellency Amir Aman, State Minister of Health at the Federal Ministry of Health (FMOH) in Ethiopia, welcomed participants to the workshop. He stated that having the workshop in Ethiopia was important as the country continues to make strides in reducing the treatment gap for MNS disorders. The development in 2011 of the Ethiopian National Mental Health Strategy was a critical milestone in the country’s journey toward increasing quality, effective, and accessible MNS care for all, he said (FMOH, 2011). In the past 5 years, there has been a significant increase in the number of psychotropic medicines on the FMOH’s Essential List of Drugs, and the demand for and supplies of these medicines has increased as well. Tedla Giorgis, advisor to the Ethiopian FMOH, charged participants to consider the opportunities for improving access to essential medicines (see Box 1-1, Statement of Task). Giorgis called on participants to consider frameworks and strategies for increasing access to quality medicines for MNS disorders in SSA by learning from successful activities in other countries and for different diseases. BOX 1-1 Statement of Task • Identify critical barriers that impact the procurement of es- sential medicines for mental, neurological, and substance use (MNS) disorders. 

4 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA o Explore challenges and opportunities for improving access to essential medicines in four critical areas: demand, selection, supply chains, and financing and pricing. • Examine successful activities that increase access to essential medicines both within sub-Saharan Africa (SSA) and in other developing countries. o Identify critical components of these models that might be features in SSA programs focused on MNS disorders. • Consider the role of governments, nongovernmental org- anizations, and private groups in procurement of essential medicines for MNS disorders. o Examine current funding and payment practices at each level. o Explore the impact of prescription practices on determining priority setting for acquiring essential medicines. • Identify the key components of a distribution framework that may serve as a demonstration project focused on increasing access for three essential medicines. ORGANIZATION OF THE WORKSHOP AND REPORT In addition to several overview presentations, the workshop was organized around a series of focused discussions on challenge areas identified by the workshop planning committee: insufficient demand, inappropriate selection, ineffective supply chains, and high pricing and poor financing. In the first session, experts presented their individual definition of each challenge area and their perspectives on barriers and opportunities for improving access to medicines across the challenge area (see Box 1-2). BOX 1-2 Defining the Challenges Insufficient Demand Demand for medications to treat mental, neurological, and sub- stance use (MNS) disorders in sub-Saharan Africa (SSA) is driven by several, often inter-related, factors. Factors that influence help- seeking for MNS disorders, their recognition and adequacy of treatment, and the dynamics of supply are important in any consideration of how to improve demand. (Oye Guerje) 

INTRODUCTION AND OVERVIEW 5 Inappropriate Selection Selection of essential medicines for MNS disorders poses several specific challenges: (1) the effectiveness of many medicines for MNS disorders cannot easily be established, as treatment effects are difficult to assess; (2) the cost-effectiveness of most MNS treatments is not very well established, especially for newly developed medicines, which are often costly; and (3) many psychiatrists prefer to use a range of different medicines in the same therapeutic category in order to adapt to individual treatment response and patient preferences. Contrary to short- term treatments, long-term medications are a challenge to the supply system and pose a real threat of catastrophic health expenditure to the patient. A rights-based approach, focusing on a small range of proven cost-effective medicines, is the best guarantee for equitable access to medical treatment of MNS disorders. (Hans Hogerzeil) Ineffective Supply Chains Improved access to medicines for MNS disorders requires a well-functioning supply chain that delivers these medicines to the end population affordably, reliably, robustly, and in an equi- table manner. Numerous challenges exist in the supply chains for MNS medicines, including (1) low levels of current use, often due to lack of provider and patient awareness, leading many supply chain actors to believe the true demand is low; (2) MNS medicines are currently only offered in selected secondary and tertiary health facilities requiring long travel time for patients without a guarantee of access; and (3) carrying out procurement, storage, and distribution of the product from point of production to point of consumption is challenging while maintaining high quality, product integrity, and minimizing diversion or misuse. (Prashant Yadav) High Pricing and Poor Financing Relatively little is known about the price, availability, and afford- ability of medicines to treat mental health conditions in SSA countries. Where there are data, medicine availability is poor especially in the public sector, forcing patients to purchase in the private sector where prices are unaffordable. (Margaret Ewen) Appropriate provision of essential medicines is being held back by a lack of affordability as well as by a lack of service access. Although most essential medicines for MNS disorders are inherently cheap (at the point of production), a combination of import tariffs, sales taxes, mark-ups, and other charges raises the 

6 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA cost to end-users by a considerable—and for the poor, an unmanageable—degree. In populations with low or nonexistent health insurance/financial protection, out-of-pocket spending on medicines for MNS disorders and other costs of care represents a critical barrier to access as well as a potential source of impoverishment. (Dan Chisholm) NOTE: The above statements are the perspective of the indi- vidual speakers. These statements were presented to stimulate discussion and do not reflect group consensus. In the next session, individual speakers presented examples of programs addressing access to medicines to facilitate exploration of best practices and lessons learned from other acquisition and distribution models (see Appendix A). The examples were selected for inclusion by the workshop planning committee and serve to explore various efforts across the globe focused on improving access in low- and middle- income countries. The program examples are meant to provide potential ideas and solutions for each of the challenge areas and are not comprehensive nor a complete examination of literature or information available but the perspective of the individual speakers. The examples included two country-level programs, the Ghana National Health Insurance Scheme (NHIS) and the Accredited Drug Dispensing Outlet (ADDO) program in Tanzania; efforts to increase access to treatments for an infectious disease, multidrug-resistant tuberculosis (MDR-TB); and programs for two noncommunicable diseases, Novo Nordisk’s program aimed at treating diabetes and Sanofi’s Access to Medicines program focusing on schizophrenia. Following the overview and example presentations, individual participants engaged in focused discussions to further explore opportunities to improve access to essential medicines for MNS disorders. The workshop closed with overviews and a broader discussion. The following report summarizes the presentations and discussions by the expert panelists and individual participants. The report is divided according to the four challenge areas: insufficient demand (Chapter 2), inappropriate selection (Chapter 3), ineffective supply chains (Chapter 4), and high pricing and poor finance (Chapter 5). Included in each of these chapters are lessons learned from the examples presented and tables of barriers and potential opportunities that were raised during 

INTRODUCTION AND OVERVIEW 7 discussions with individual workshop participants. Lastly, practical considerations for moving forward are summarized in Chapter 6. During the focused discussions, individual participants engaged in active dialogues on the constraints, barriers, and opportunities related to demand, selection, supply chains, and pricing and financing. In some cases, participants expressed varying opinions about whether a particular opportunity could be useful and included in the list. It is important to note that the workshop was not designed or conducted as a consensus process and the barriers and opportunities described in this report are not a formal consensus product of the workshop. Rather, they are a compilation of all comments by workshop participants and should be attributed to the rapporteurs of this summary as informed by the workshop. Throughout the workshop, many participants employed the phrase “mental health” in reference to health care systems and essential medicines. Many of the same participants commented that their use of the term “mental health” as it related to the workshop discussions was meant to be inclusive of all MNS disorders. BARRIERS TO ACCESS TO ESSENTIAL MEDICINES FOR MNS DISORDERS Sub-Saharan Africa has one of the largest treatment gaps for MNS disorders. Atalay Alem, professor of psychiatry at Addis Ababa University, said that on average, two-thirds of those with MNS disorders do not receive treatment and access to appropriate essential medicines for these disorders remains a challenge. Alem noted that globally, the median percentage of government health budget expenditures dedicated to MNS disorders is slightly less than 3 percent, and country income level does not fully account for the lower levels of funding for MNS disorders (WHO, 2011a). In addition, compared to all other WHO regions, Africa has the lowest number of outpatient facilities with the ability to treat MNS disorders, rates of admission to mental hospitals, and human resources (WHO, 2011a). Alem noted that, even if essential medicines for MNS disorders are available in a country, the absence of trained health care providers to diagnose and treat patients presents a challenge. Furthermore, several countries have restrictions on who can prescribe MNS medicines based on the provider type. This can affect the demand for access to essential medicines for MNS disorders. Alem 

8 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA closed by emphasizing several key areas for focus to improve access to essential medicines for patients in SSA: poor and/or interrupted supply, low funding, and a lack of adequate human resources. A HEALTH SYSTEM FRAMEWORK FOR ACCESS TO MEDICINES Hans Hogerzeil, professor of global health at Groningen University in the Netherlands and former director of essential medicines and pharmaceutical policies at WHO, opened by noting that access to essential medicines can be considered from the perspective that access is one of the elements of the fundamental right to health, which includes accessibility, availability, acceptability, and quality (Hogerzeil, 2006). From a health system perspective, access is an overall attribute of a strong health care system that is necessary to achieve health outcome goals, along with coverage, quality, and safety. The six building blocks of a health system as defined by WHO are (1) service delivery; (2) health workforce; (3) health information; (4) essential medical products, vaccines, and technologies; (5) health financing; and (6) leadership and governance (WHO, 2007). Hogerzeil noted that with regards to the fourth building block, WHO states that “a well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost-effectiveness, and their scientifically sound and cost-effective use” (WHO, 2007, p. vi). In association with achieving the health system strengthening targets of the United Nations Millennium Development Goals (MDGs), WHO formulated an access framework that highlights four key elements that must be in place to ensure medicines are accessible: rational selection, affordable prices, sustainable financing, and reliable health and supply systems (WHO, 2004a,b). Challenges specific for low- and middle-income countries include inappropriate selection of medicines, interrupted supply chains, high pricing, and inadequate financing of medicines (Bigdeli et al., 2013a). Overall, Hogerzeil indicated, there tends to be a fragmented vertical approach—one that focuses on a single disease and is donor driven—to access to medicines and a disconnect in the health system between medical products and the other system building blocks. The interaction among the building blocks is what leads to a functional health system, 

INTRODUCTION AND OVERVIEW 9 with people at the center of the system (Alliance HPSR and WHO, 2009). Using the work of Bigdeli and colleagues, Hogerzeil jump-started the conversation about improving access by describing potential barriers that might exist at various levels within health care systems (Bigdeli et al., 2013b; Hanson et al., 2003). Bigdeli and colleagues assessed barriers at each level of the health care system: individuals, households, and community; health service delivery; the health sector as a whole; country public policies cutting across sectors; and international and regional factors (see Table 1-1). Hogerzeil noted that existing access to medicines frameworks only address part of the system. For example, the Strategies for Enhancing Access to Medicines (SEAM)5 program focuses on health service delivery while the WHO access framework addresses barriers mainly at the pharmaceutical and health sector levels (WHO, 2004a,b). TABLE 1-1 A Multilayer Health System View of Barriers to Access to Medicines Level of the Health System Barriers to Access to Medicines I. Individual, • Physical barriers (geographical location, opening household, and hours, etc.) community • Perceived quality of medicines and health services • Inadequate health-seeking behavior and demand for medicines • Inadequate use of medicines • Social and cultural barriers (stigma related to poverty, ethnicity, gender, etc.) II. Health service • Low quality of health services, including staff delivery capacity and motivation, infrastructure, etc. • Competition between public and private health service delivery • Low level of funding for service delivery • Weak supply of medicines, low availability • Inadequate prescription and dispensing • Low-quality/substandard medicines • High medicine prices 5 Considered at the World Health Organization Management Sciences for Health consultative meeting in Ferney-Voltaire, France, in 2000, see http://projects.msh.org/ seam/5.0.htm. 

10 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA Level of the Health System Barriers to Access to Medicines III. Health sector • Weak governance of the health sector affecting all building blocks: o Absence of stewardship over a pluralistic health system, including private and informal health sector o Absence of partnership with civil society or civil society participation in governance o Weak human resources planning and capacity development o Weak health information system and capacity for monitoring and evaluation o Low level of funding for health, inefficiency in the use of funds, low coverage of pre- payment and social protection schemes, overreliance on donor funding • Weak governance of the pharmaceutical sector affecting all functions: registration, selection, procurement, distribution, licensing of pharmaceutical establishments, inspection, control of medicines promotion, etc. IV. Public policies • Low public accountability and transparency cutting across sectors • Low priority attached to social sectors • High burden of government bureaucracy • Conflict between trade and economic goals for pharmaceutical markets and public health goals V. International and • International donors agenda, including for regional levels medicines • Weak regional development and economic cooperation mechanisms • Unethical use of patents and intellectual property rights • Research and development not targeting disease burden in low- and middle-income countries SOURCE: Hogerzeil presentation, January 13, 2014, adapted from Bigdeli et al. (2013b). Hogerzeil described Bigdeli’s proposed conceptual framework for access to medicines from a health system perspective. This framework 

INTRODUCTION AND OVERVIEW 11 includes three key paradigm shifts: (1) adopting a holistic view on the demand-side constraints, including vulnerabilities of individuals, households, and communities; (2) considering the multiple dynamic relationships among all building blocks of the health system at the service delivery level; and (3) considering multilayer leadership and governance (Bigdeli et al., 2013a). In addition to the framework, Bigdeli and colleagues conducted a priority-setting exercise that included consultation with global stake- holders and literature review (Bigdeli et al., 2013a; Rashidian et al., 2013; Zaidi et al., 2013). The process yielded 18 high-priority policy research questions, of which Hogerzeil listed the top 3 questions: 1. In risk protection schemes, which innovations and policies improve equitable access to and appropriate use of med- icines, sustainability of the scheme, and financial impact on beneficiaries? 2. How do policies and other interventions in private markets impact access to and appropriate use of medicines? 3. How can stakeholders use the information available in the system in a transparent way toward improving access to and use of medicines? In summary, access to medicines can be classified in many ways. These classifications have become increasingly complex, but present a solid basis for action. Policies and interventions can use any entry point, but Hogerzeil said that a wider picture should be kept in mind, taking a more comprehensive, systems approach. OPPORTUNITITES FOR IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR MNS DISORDERS6 Throughout the workshop, individual participants discussed a number of potential opportunities to improve access to essential medicines for MNS disorders related to the four challenge areas: demand, selection, supply chains, and pricing and financing. These 6 The following list highlights recurring topics and is provided here as part of the factu- al summary of the workshop. Items on this list should not be construed as reflecting any consensus of the workshop participants or any endorsement by the Institute of Medicine or the Forum on Neuroscience and Nervous System Disorders. 

12 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA opportunities listed below, as identified by individual participants, are expanded upon in succeeding chapters. Cross-Cutting Opportunities • Commitment and support: Several participants noted that commitment and support from key stakeholders in government, industry, academia, nongovernmental organizations (NGOs), and patients could help raise MNS disorders as a priority focus in health care. Many participants noted that identifying high-profile champions to help advance support for improved care could be beneficial. In particular, several participants suggested that such champions might be able to break down stigmas associated with MNS disorders. • Partnerships: Throughout the workshop many participants noted that improving access to essential medicines might benefit from strong partnerships across all levels of the health care system, organizations, and disease areas. Critical partnerships highlighted by various participants included WHO; ministries of health, finance, and trade; the World Bank; professional organizations; pharmaceutical companies; employers; and NGOs. • Data: Several participants noted a need for epidemiological and surveillance data on the prevalence of MNS disorders within countries to have a better understanding of the demand for access to essential medicines. In addition, a few participants noted that market and supply chain analyses may help stakeholders to identify barriers within the system. Several participants noted that it may be helpful to consider lessons learned from other disease areas (e.g., HIV/AIDS) regarding data collection and analysis of multiple factors influencing access and how these may inform efforts for MNS disorders. • Training: The need for trained human resources, from dis- tributors to providers, was noted by many participants. Several participants suggested that implementing the WHO Mental Health Gap Action Programme (mhGAP) intervention guide would be helpful. In addition, a few participants noted that training prescribers and local dispensary personnel to comply with regulations regarding the quality of medicines is also important. 

INTRODUCTION AND OVERVIEW 13 Challenge Area Opportunities • Insufficient demand: Several participants noted that low demand can be linked to the combination of low perceived need for MNS-specific medical care and inadequate training and education of health care providers and managers about MNS disorders. Implementation of the mhGAP intervention guide and training modules was suggested by several participants as a potential mechanism to address this barrier and increase demand for essential medicines by health care providers. Participants also discussed the impact of policies that limit prescribing practices. Many participants suggested an outcome of increasing the ability of all levels of providers to prescribe medications might be greater access to prescribers and increased demand. • Inappropriate selection: A large number of participants suggested the use of developing coherent and comprehensive national strategies for the treatment and care of MNS disorders. Such a strategy could be based on mhGAP and assist in the development of evidence-based national medicine lists and treatment guidelines. A few participants noted that selection of essential medicines at a national level, and adherence to WHO guidelines, might reduce inconsistencies in the selection and procurement of medicines for MNS disorders. Several participants stressed the importance of training and continuing education about MNS treatment guidelines to include key individuals and organizations involved with selection and procurement of essential medicines. • Ineffective supply chains: Many participants suggested that effective supply chains could result in better forecasting of need and reduced stock-outs or overstocking of medicines. Although challenges may be country specific, several participants noted that some common barriers include the lack of data on supply and demand, long procurement lead times, and multiple and/or unnecessary steps in the supply chain that all compound and lead to fluctuations in the availability of medicines. To address these barriers, several participants suggested development of an information network systems approach to improve availability of data. Increased training and allocation of human resources to supply chains was emphasized by several participants as an important mechanism for determining the needs of health care 

14 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA systems. Many participants noted that the distribution process could be streamlined through reduction in the number of steps between central warehouses and patient distribution centers, improved transportation, and increased funds for national medicine supply agencies. • High pricing/poor financing: Several participants noted that a lack of data and market analysis makes it difficult to understand pricing and financing practices and develop evidence-based policies for procuring essential medicines. Many participants suggested that increased resource allocation by governments, NGOs, and manufacturers might increase demand and, subsequently, drive down prices. A few participants noted that markets in SSA might be unattractive to manufacturers, but that increasing competition and lowering of barriers for entry might lead to decreased prices. Many participants suggested that inclusion of MNS medicines on country-specific essential medicines lists and health insurance schemes might increase coverage for these medicines, lower prices for patients, and prevent catastrophic expenditure because of long-term treatment.