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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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Suggested Citation:"Appendix A: Access to Essential Medicines: Program Examples." Institute of Medicine. 2014. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18380.
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A Access to Essential Medicines: Program Examples COUNTRY PROGRAMS National Health Insurance Scheme–Ghana Albert Akpalu, a neurologist at the Korle Bu Teaching Hospital in Ghana, began by emphasizing that Ghana’s national drug policy is to “improve and sustain the health of the population of Ghana by ensuring the rational use and access to safe, effective, good-quality, and affordable pharmaceutical products.” He went on to explain that in the mid-1980s, Ghana had a “cash and carry” health care system in which payments from patients were required prior to receiving services. Due to high out- of-pocket expenses and low usage of services, the system excluded a majority of the population from access to health care. In the 1990s, community-based mutual health insurance schemes were introduced in which members paid enrollment fees and premiums to receive health insurance coverage with minimum copayments. However, benefit packages were limited to a few health care providers due to the limited ability of patients to make payments and no additional financial support from the government. Akpalu noted that by 2000, it became clear that this scheme was neither sustainable nor able to reach the population beyond the 1 to 2 percent that was covered in these schemes in Ghana (Blanchet and Acheampong, 2013). 93

94 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA In 2003, the Ghana National Health Insurance Scheme1 (NHIS) was established, with the support of both public and private stakeholders, to provide financial access to basic healthcare services through district-level and private health insurance schemes (NHIA, 2012). The goal was to “increase affordability and utilization of drugs and health services in general, and among the poor and most vulnerable populations in particular” (Blanchet et al., 2012). Expenses associated with the NHIS are covered by the National Health Insurance Fund which receives revenue from a variety of sources (e.g., taxes, premiums) (NHIA, 2012). Akpalu emphasized that, although certain health services are excluded from the scheme (e.g., computed tomography [CT] scans, magnetic resonance imaging [MRI], cancer treatments), enrollees are not subject to copayments, deductibles, or lifetime limits. In 2012, revisions were made to improve transparency, reduce opportunities for corruption, and increase effective governance. For the first time, mental, neurological, and substance use (MNS) disorders have been recently integrated into the health insurance scheme, including premium exemptions for persons with MNS disorders. Currently about 50 percent of the population has active membership in the NHIS (NHIA, 2012). He added that since 2005, payments on insurance claims have increased about 81-fold along with significant increases in patient use and active membership (Blanchet et al., 2012; UHCC, 2013). Akpalu referred to the recently enacted Mental Health Bill, drafted with assistance from the World Health Organization (WHO), that includes provisions for improved access to mental health care and regulation of providers, and efforts to combat stigma and discrimination (Doku et al., 2012).2 Overall, Akpalu noted, the implementation of the NHIS in Ghana significantly increased healthcare coverage, availability of services, and use among residents. Using epilepsy as an example of the need for increased access to appropriate essential medicines, Akpalu said 80 percent of those with epilepsy in Africa do not receive treatment (WHO, 2002a). Addressing the four challenges areas highlighted during the workshop, he noted that low demand can be the result of a lack of providers with the knowledge to treat epilepsy. The low number of facilities dedicated to treating MNS disorders results in integration of patients into the primary health care system regardless of a lack of human resources. Akpalu also noted there are insufficient community-based interventions and support for people 1 See http://www.nhis.gov.gh. 2 For more information see http://www.who.int/mental_health/policy/country/ghana/en.

APPENDIX A 95 with epilepsy, which can be exacerbated by the stigma surrounding MNS disorders. He went on to say that selection of antiepileptics remains a challenge due to unreliable data on the size of the patient population. Focusing on supply chain issues, he noted that poor integration of MNS disorders into primary health care has led to fragmented supply and distribution of antiepileptics. Lastly, financing for such medicines continues to be a challenge. Akpalu noted that Ghana needs to clarify the national, regional, and district positions on financing antiepileptic medications before the medicines can become part of the NHIS. Lessons Learned Akpalu discussed several examples of how Ghana is addressing the four challenge areas (i.e., demand, selection, supply chains, pricing/ financing) and provided potential lessons on these issues as they relate to access for MNS disorder medicines. Ghana is looking to improve the demand for services by establishing a health insurance institute to improve and promote NHIS to all residents, with particular emphasis to the poor. The country is also working to improve issuance of membership identification cards to decrease potential service delays. One program aimed at increasing demand is the Ghana Fights Against Epilepsy Initiative (GFAEI), which seeks to strengthen the referral system and develop treatment protocols for the management of epilepsy. In addition, GFAEI is focused on improving the supply of antiepileptic medications and developing mechanisms for better patient follow-up. Another program is the Parkinson’s Disease in Ghana project, which seeks to increase demand by improving provider knowledge and providing free long-term medicines for patients. Ghana has several initiatives targeting selection challenges, including the development of national treatment guidelines and an essential medicines list; in addition, a new national guideline for epilepsy drugs will be released soon. Akpalu highlighted lessons learned about pricing and financing, including several potential measures to enhance sustainability through cost containment and increasing financial resources. From a cost containment perspective, clinical audits can help ensure that providers are complying with standard treatment guidelines. Ghana is currently piloting a capitation system, in which a set fee is paid to health care providers for each NHIS-enrolled patient, regardless of the services provided. A consolidated premium payment account with a one-time

96 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA premium for free health care for life is also being considered; however, Akpalu noted that this approach may not be sustainable. Other potential approaches to contain costs include • Developing a claims processing center with computerized operations to streamline payments (e.g., electronic claims); • Creating a uniform and serialized prescription form to reduce errors, abuses, and fraud; • Linking diagnosis to treatment and e-claims through a coding system for easier processing; • Piloting NHIS medicines at negotiated prices; and • Purchasing medicines via contracts to help reduce prices of branded medicines. Further funding for sustainability includes an increase in national health insurance levies and taxes. Ghana also plans to strengthen audit and risk management systems, as well as programs to reduce fraud and abuse. High-level, evidence-based research on health insurance policy challenges may help inform the direction of future initiatives. Akpalu closed by noting that while challenges remain related to financial sustainability, patient ability to pay premiums, quality of care, pricing of medicines, and supply chains, Ghana is actively working to address each area. Accredited Drug Dispensing Outlets (ADDO)–Tanzania In sub-Saharan Africa (SSA), patients typically purchase medicines from the nearest available supplier, said Jafary Liana, senior technical advisor at Management Sciences for Health and the Sustainable Drug Seller Initiatives (SDSI). Tanzania has more than 9,000 drug dispensaries compared to only 800 registered pharmacies. Ninety-five percent of the population lives within 5 km of a drug dispensary. Local drug dispensaries, given their close proximity, provide a critical opportunity for improving access to medicines for rural populations. There is also a perception that a local dispensary is more personal, offers patients more privacy to discuss concerns with dispensers, and has more flexible payment modalities. For local drug dispensaries, however, there are challenges associated with level of support from the government, training

APPENDIX A 97 of personnel, and inadequate regulatory enforcement (e.g., sale of unauthorized medicines, poor quality medicines, high prices). ADDO was designed to help address these challenges through a series of steps aimed at enhancing regulatory compliance, improving health care provider skills, developing incentives for the legal sale of medicines, and increasing consumer education on the importance of treatment adherence and the quality of medicines. The objective of the ADDO program is to improve the quality, affordability, and availability of medicines in local drug dispensaries (Center for Pharmaceutical Management, 2008). The Tanzania Ministry of Health worked with Management Sciences for Health3 on the development of a comprehensive approach based on the following strategies: • Increase broad-based stakeholder support through the engage- ment of both national and local authorities, and professional and commercial associations. These and other stakeholder groups, are encouraged to participate in project design and implementation. • Develop guidelines for a public-sector-based system responsible for inspecting and regulating processes and capacities at local dispensaries. • Provide training to dispensary owners to improve business and stock management skills, and to dispensary attendants to strengthen dispensing, record-keeping, and communication skills. Dispensary associations may offer additional support to local owners and dispensers through mentoring. • Provide incentives, such as loans, for dispensaries to improve the quality and quantity of available medicines. Expand the list of medicines that shops are legally allowed to stock and sell. • Enhance the availability and quality of approved medicines in accredited dispensaries. • Ensure quality pharmaceutical services by educating, training, and monitoring dispensary staff. • Increase patient and consumer awareness about the importance of treatment adherence and use of quality medicines through marketing, information, and education. 3 For more information see https://www.msh.org/our-work/projects/sustainable-drug- seller-initiatives.

98 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA Implementation of the ADDO program spanned 10 years (2001- 2010) from conception through scale-up. The program is now in the maintenance and sustainability phase, with efforts to integrate public health into the program. As noted earlier, Liana stressed that local community residents feel comfortable going to local dispensaries and as a result these dispensaries serve as the first line of triage for individuals with health concerns. For examples, educating dispensers on early signs of childhood pneumonia and the appropriate actions to take (e.g., referral to a health care provider) may help improve health outcomes. Liana pointed out that a critical component after the pilot phase was determining how to take the program countrywide. The original centralized implementation approach, with the Tanzania Food and Drug Authority as the implementing organization, was revised to a decentralized model in which local governments now facilitate implementation. This allowed for rollout of the ADDO program in multiple regions at the same time—increasing speed, reducing costs, and increasing local ownership of the process. Public–private partnerships and collaborations were essential for successful implementation. With the government of Tanzania as the lead organization, partners included private owners and dispensers, international foundations, and local organizations. The accreditation process for ADDOs is based on a set of standard criteria. For example, there are standards for the premises, and the owner is given a guide on how to bring their outlet to compliance. There are training and qualification standards, including minimum qualifications for a worker in the outlet, and additional training for pharmaceutical dispensing and recordkeeping. Once owners have their shop inspected and accredited, they are required to adhere to dispensing from a standard list of medicines. Liana highlighted several challenges to implementation of the program. Consumer awareness about services was an important component and affected demand, especially in poor areas where there were unique challenges. The lack of trained personnel to run the dispensaries resulted in limits to the type and quantity of medicines dispensed. The initiative required revisions to existing laws and regulations, which was a complex process. Liana noted there was a need to balance the focus on public health and quality of service with pricing issues in a for-profit environment. Resource mobilization for full scale- up was a significant challenge, as was ensuring consistent local regulatory oversight of the large number of ADDOs around the country.

APPENDIX A 99 A limitation was inadequate budgeting by districts to cover the necessary inspections and provide supervision to the dispensaries. Lessons Learned ADDOs are private health outlets that serve the needs of the community and are a major source of medicines at the household level. ADDOs are often preferred because they are convenient and can offer personalized service and payment options, Liana said. In addition, ADDOs can fill the gap when products are out of stock in the public health sector. In the case of Tanzania, the challenges associated with demand were low; however, other challenges associated with access to essential medicines are present, said Liana. Selection of authorized medicines for ADDOs was based on community needs, storage conditions, qualifications of personnel, and public health priorities. Medicines were also selected based on prevalent acute childhood conditions such as malaria, and chronic illness such as hypertension. Regular reviews and updates of the list to address public health needs are important, Liana stressed, with regulations requiring review every 2 years. The expanded list of medicines legally allowed in ADDOs provided an incentive for suppliers to extend their distribution into regions with ADDOs, thereby addressing some of the challenges associated with the supply chain. In addition, a new category of ADDO-restricted wholesalers was established, licensed to operate in districts with no pharmacies. Another mechanism for improve the supply chain involved the pooling of procurements by coordination through district-based ADDO associations. The availability of wholesalers closer to these drug outlets tends to reduce the prices, Liana explained, because travel distances are reduced and it is easier to procure medicines. Experience with the family planning and malaria programs in Tanzania has shown that subsidies for essential commodities provided in the private sector are feasible. Microfinancing loans to ADDOs can also improve availability of medicines. Linking ADDOs with health insurance schemes has reduced the out-of-pocket payments for individuals. The ADDOs have been used as a platform for community-based public health interventions (e.g., malaria, family planning) and are likely to be a good place to build MNS community-based programs, Liana said. ADDO’s extended list of medicines broadens access to quality-assured

100 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA pharmaceutical medicines, especially in rural settings, and the list could be expanded to include essential MNS medicines. Liana noted that households needing access to MNS medicines are already served by ADDOs. Introduction of MNS medicines, like any new intervention, would require training, mentoring, supervision, and regular monitoring of dispensers. Linking with insurance schemes could help MNS patients reduce out-of-pocket spending for medicines. The keys to the success of the ADDO program are stakeholder buy-in, local ownership, and the involvement of government champions and private-sector and development partners. INFECTIOUS DISEASE PROGRAM Multidrug-Resistant Tuberculosis Treatment of multidrug-resistant tuberculosis (MDR-TB) remains a significant unmet medical need, particularly in the developing world (IOM, 2014; WHO, 2011b). Paul Zintl, senior advisor for planning and finance in the Program in Infectious Disease and Social Change at Harvard Medical School, shared the example of MDR-TB to highlight the obstacles to scaling up treatment efforts, and the delays in treatment of patients resulting from a lack of access to quality-assured medicines. In 1996, policies were in place that recommended poor countries not treat patients with MDR-TB because (1) there was a perception that it was not possible to cure patients in resource-poor countries; (2) treatment with second-line TB medicines, which require a 2-year treatment regimen and are typically weak, would increase resistance; and (3) a focus on MDR-TB would divert resources and attention from curing the resurgence of drug-sensitive TB. From 1998 until 2006, Partners in Health4 and other nongovernmental organizations (NGOs), together with country partners, worked to prove that patients in resource-poor settings could be treated and cured of MDR-TB. The project, dubbed “DOTS- Plus,”5 was done in conjunction with WHO and the Green Light Committee (IOM, 2009b, 2013c; WHO, 2006a). During this time, ambivalence about scaling up treatment efforts remained despite policy 4 See http://www.pih.org. 5 DOTS, or directly observed therapy short-course, is the WHO recommended strategy for TB control. DOTS-Plus employs the elements of the DOTS strategy to address the management of MDR-TB using second line drugs (WHO, 2006b).

APPENDIX A 101 changes; this resulted in devastating outcomes to those affected by MDR-TB. Zintl highlighted a 2006 review by the Stop TB Partnership that found that two-thirds or more of patients in DOTS-Plus were being cured and that there was no meaningful spread of drug resistance as a result of this treatment. Around the same time, research demonstrated that primary transmission of MDR-TB was possible despite prior skepticism that the organisms were not fit enough for transmission; co-infection with MDR-TB and HIV was also having devastating effects in many countries, particularly in SSA; and the emergence of extensively drug- resistant TB (XDR-TB) was a cause for serious concern (Gandhi et al., 2006). As a result, in late 2006 the policy recommendations were revised to instruct any country with a significant rate of MDR-TB, and a well- functioning TB program to begin treatment of patients. Although there were shortcomings in the scale-up projects for access to MDR-TB medicines, Zintel noted there are several lessons learned around the four challenge areas that could apply to MNS disorders. Lessons Learned Zintl noted that the initial pilot project included only a small number of patients NGOs working together with local partners to gain access to MDR-TB medicines. Medicine procurement was typically done with one or two suppliers who discounted their prices for some key second line medicines. In 2007, following the revised recommendations, countries began to scale up treatment; however, increased demand coupled with a lack of effective supply chains and additional infrastructure components resulted in medicine shortages and long lead times, Zintl explained. In addition, projects using Global Fund resources needed preapproval for purchases and procurement through the global drug facility, resulting in further delays. Although there was demand in the sense that there were many patients in need, there was limited clinical expertise and diagnostic and laboratory capacity to determine the resistance profile and treatment course. Some of these challenges were solved when the Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis6 was released by the Stop TB Partnership. The guidelines included health care provider-specific recommendations for the diagnosis and care of MDR- TB patients. 6 See http://www.stoptb.org/assets/documents/resources/publications/technical/tb_guidelines. pdf.

102 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA Zintl noted that reliable estimates of patient demand may have helped alleviate issues related to supply chains. For example, countries may inaccurately estimate demand if supply levels are determined based on the projected number of patients instead of the actual number currently enrolled in medication regimens. These inaccurate estimates can lead to decreased confidence by suppliers and result in a market that is small and opaque with high prices. Uncertainties within the supply chain may be decreased with a structured financing and pricing system to ensure payment for medicines. Zintl summarized that due to the lack of access to quality MDR-TB drugs, the threat of drug resistance tuberculosis still remains a concern; however, Zintl noted, this does not have to be the case for MNS disorders. The concept that ignoring MDR-TB would have devastating ramifications had been demonstrated for years and was further emphasized by the findings of primary transmission and MDR-TB and HIV co-infection. Based on his experience with MDR-TB, Zintl cautioned that it is not sufficient to make the case that MNS disorders, if ignored, will have a devastating impact. He stressed that it is necessary to also demonstrate that targeted access to medicines programs improve overall population health outcomes and are feasible. NONCOMMUNICABLE DISEASE PROGRAMS Diabetes Worldwide, 382 million people are diabetic with half of those undiagnosed, said Mapoko Mbelenge Ilondo, senior advisor for Corporate Stakeholder Engagement at Novo Nordisk A/S, Denmark. Four out of five people with diabetes live in low- and middle-income countries; the disease affects approximately 20 million people in Africa (IDF, 2013). Although diabetes cannot be cured, it can be treated and controlled with medication (e.g., glibenclamide, metformin, insulin). Lack of proper disease management can lead to serious complications such as amputation, blindness, and renal failure; management is especially important in SSA due to limited facilities for dialysis treatment due to kidney failure. Access to insulin in SSA, like many essential medicines for non- communicable diseases, is limited in both the public and the private sectors, Ilondo said, adding that the leading cause of death for a child

APPENDIX A 103 with diabetes in SSA is lack of insulin. Even when insulin is available, however, many children die because of lack of access to qualified health care professionals. The actual number of people with diabetes in most SSA countries is unknown. Diagnostic rates are low, especially in rural areas, due to lack of awareness among health care providers and the general population. Therefore, procurement of medicines by governments is sometimes based on arbitrarily determined budgets and not on actual demand. Ilondo noted that because insulin is generally not available at the primary care level, patients often travel long distances to access treatment; transportation-associated costs become a limiting factor in demand. In SSA, the lack of qualified health care providers in the field of diabetes is a major barrier to access to proper diabetes treatment. This in turn impacts access because selection of diabetes medicines depends partly on provider knowledge and understanding of diabetes management. Ilondo described challenges around supply chains due to limited government health care budgets in SSA countries and low priorities assigned to noncommunicable diseases, such as diabetes. Due to logistical challenges, diabetes medicines are generally available only in major cities in SSA. In the public sector, central medical stores within the Ministry of Health organize the distribution to government hospitals and health centers. However, distribution to rural areas is deficient, especially for insulin, which requires adequate facilities for temperature- controlled transportation and storage (cold chain). Ilondo noted that stock-outs are common in the public system as a result of both inadequate procurement and product being diverted to the more lucrative private-sector market, where diabetes medicines are imported and distributed to private hospitals and pharmacies. Limited government budgets for the purchase of medicines often leads to a reliance on donor funds. In the public sector, prices are typically low because of the competitive nature of the tender (i.e., bidding) system. However, that low price is not always passed on to the patient (e.g., price mark-ups to cover distribution costs). In the private sector, patient prices can be high due to import duties, taxes, and serial mark-ups along the distribution chain, often three to five times the price in the government system. Given frequent shortages in the public system, many patients purchase their diabetes medicines at high prices from private pharmacies. In many SSA countries, there is no system for financing of health care, so patients typically pay out-of-pocket for medicines.

104 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA Lessons Learned Ilondo described several steps Novo Nordisk has taken to attempt to address challenges associated with access to diabetes medicines. In the public sector, Novo Nordisk implemented differential pricing for the least developed countries; however, this did not increase procurement as expected. Training in stock management was provided, but this was often perceived as a conflict of interest coming from a manufacturer. Ilondo noted that manufacturers have little leverage in the private sector beyond trying to negotiate profit margin in contracts. In addition, Novo Nordisk worked to strengthen distribution channels to ensure medicines reach rural areas. He added that Novo Nordisk worked with regional diabetes associations to conduct spot checks of end-user prices in the public and private sectors to detect if products were being diverted from the public system to the private system. Ilondo stated that the experience of Novo Nordisk in many countries indicates that accessibility and affordability of diabetes care and medicines is a complicated issue that requires coordinated approaches with multiple stakeholders. Securing cooperation and commitments from key stakeholders such as the ministry of health, regional and district medical officers, industry partners, importers and wholesalers, patient associations, and community organizations is critical to improving treatment of diabetes, noted Ilondo. Moving forward, Ilondo highlighted the need for government involvement in conducting needs estimates; health care provider training on recognition, diagnosis, and evidence-based treatment; and community awareness. Limited health care capacity, inefficient procurement and distribution practices, and inadequate transportation and facilities for storage of insulin are additional challenges. What is needed, he said, is a patient-centered approach, including dedicated clinics with insulin in stock at an affordable price and trained personnel available when patients arrive. Schizophrenia As part of its corporate social responsibility activities, Sanofi has an Access to Medicines program7 that spans pandemic diseases, neglected tropical diseases, and chronic diseases, including MNS disorders, said 7 See http://en.sanofi.com/csr/patient/priorities/access_to_care/access_to_medicines/ access_to_medicines.aspx.

APPENDIX A 105 Francois Bompart, medical director of the Access to Medicines department at Sanofi. The Access to Medicines approach for MSN disorders includes • Tiered pricing for sustainably affordable medicines; • Non-promotional education and information programs for professionals on diagnosis and care, as well as for patients, and communities including psychosocial support and efforts to reduce stigma; and • Industrial expertise (e.g., high quality manufacturing, research and development) to meet emerging needs and transfer knowledge to developing countries. Bompart noted that all three approaches rely on partnerships for success, including ministries of health, NGOs, local experts in the field, the World Association of Social Psychiatry, and patient associations. Ultimately, the patients are at the center of the Access to Medicines program, he said, and attention must be paid simultaneously to addressing the issues surrounding diagnosis and care, affordable quality medicines, and awareness. Simply diagnosing an MNS disorder is not enough, opined Bompart; having access to medicines is critical, as is minimizing stigma which prevents patients from receiving access to care. Only initiatives which simultaneously address the three types of issues outlined above can success be sustained. As examples, Bompart described pilot programs Sanofi is conducting in Mauritania and Morocco. Mauritania is a country of 3 million people served by three psychiatrists resulting in little psychiatric care outside of the capital city. A 2003 survey indicated that 35 percent of the population had at least one MNS disorder (Gérard and Bompart, 2013). Morocco has 30 million people and 350 psychiatrists, most of whom are in major cities. The same survey found that 49 percent of the population has or had at some point in time at least a minor psychiatric disorder. The Sanofi pilot programs were designed to test a comprehensive, scalable model for sustainably improving access to health care for those with schizophrenia. Sustainability is essential because these are chronic, lifelong diseases, Bompart noted. The basic method was to include MNS care in the primary public health care system. Initially political decision makers were informed about the importance of MNS disorder care programs; the pilot project gained support by increasing awareness and through advocacy efforts.

106 ESSENTIAL MEDICINES FOR MNS DISORDERS IN SSA Sanofi was able to increase demand by simultaneously launching awareness initiatives aimed at patients and families and training of primary health care providers. Patients and families received education and psychosocial support via an array of educational materials, including flip charts and comics strips for patients and families developed by Sanofi. The materials convey the same messages, but the text and pictures are adapted to the country (e.g., language, style of dress). Primary health care providers were trained in basic diagnostic procedures and treatment through slide kits, videos of patients, clinical case review and patient interviews. Bompart added that the program also included monthly supervision of providers and innovative new tools such as the use of telemedicine and an interactive version of the WHO Mental Health Gap Action Programme (mhGAP) guide on tablets. Affordability of medicines was addressed through the tiered-pricing policy based on income level. Bompart noted that the most affluent people in the country pay market price in the private sector while in the public sector generics are available at lower prices. However, patients with incomes below the poverty line are only able to access medicines at street markets where prices are affordable but quality can be low. Sanofi’s Access to Medicines Program sought to address this challenge by providing tiered-pricing generics to those below the poverty line; medicines were provided through national tender processes to governmental structures. As a result of the pilot program in Nouadhibou, Mauritania, 6 new outpatient clinics focusing on MNS disorders were opened in the city, nearly 40 health professionals were trained, and medicines were provided at low cost by the National Hospital pharmacy. In addition, more than 1,000 people attended informational meetings, 1,200 patients were followed in clinics, and 342 new patients with schizophrenia were seen over the course of 30 months, reducing the treatment gap from 93 percent to less than 60 percent in that region. Similar results were obtained in Morocco, Bompart said (Gérard and Bompart, 2013). Lessons Learned Bompart shared some of the lessons learned from the pilot programs relative to the challenge areas. Stimulating demand, he reiterated, requires a comprehensive approach, including community awareness, health care provider training, and availability of affordable medicines. Pilot programs such as Sanofi’s can stimulate demand at the ground level

APPENDIX A 107 and raise awareness at the political level, he said. Although the initial focus of the two presented programs was on schizophrenia, these programs can address all MNS disorders. Bompart suggested that the best approach to selection of medicines might be to have local experts select from the WHO list of essential medicines based on transparent criteria. The country list should be limited and sustainable, and accompanied by easy-to-follow treatment guidelines, he said. Medicines must be available at the community level, Bompart continued. Shortages are very detrimental to patients and result in treatment interruption; overstocking should also be avoided. Bompart cautioned not to underestimate the complexities of data collection in low- priority programs in resource-poor countries. Choice of supplier cannot be limited to price alone, but also consider quality and reliability of the supply as well. Bompart suggested that the WHO prequalification process could add value. He emphasized that pricing and financing be considered in a manner that could address both public and private channels. Affordability means not just low purchase price but also controlled profit margins throughout the supply chain. One size does not fit all, Bompart concluded, and initiatives need to be modified on a country-by-country basis. Many programs initially rely on the energy and the charisma of a single individual as a champion. Sustained local political support is vital for long-term success.

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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 disorders. 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 challenge and a critical barrier to scaling up quality care for mental, neurological, and substance use 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.

Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa is the summary of a workshop convened by the Institute of Medicine Neuroscience Forum in January 2014 in Addis Ababa, Ethiopia to discuss opportunities for achieving long-term affordable access to medicines for these disorders. This report examines challenges and opportunities for improving access to essential medicines in four critical areas: demand, selection, supply chains, and financing and pricing. The report also discusses successful activities that increase access to essential medicines both within Sub-Saharan Africa and in other developing countries, and considers the role of governments, nongovernmental organizations, and private groups in procurement of essential medicines for mental, neurological, and substance use disorders.

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