NAF/FIOCRUZ Planning for the sustainability of ARV provision. A study in Peru, Bolivia and Mozambique Claudia Garcia Serpa Osorio-de-Castro Cláudia Du Bocage Santos Pinto Elaine Silva Miranda Thiago Botelho Azeredo Maria Auxiliadora Oliveira Third International Conference for Improving the Use of Medicines Informed Strategies, Effective Policies, Lasting Solutions November 14-18, Antalya, Turkey Center for Pharmaceutical Policies (NAF) Sérgio Arouca National School of Public Health, FIOCRUZ Rio de Janeiro - BRAZIL Research Grant: UNAIDS 1

NAF/FIOCRUZ The provision of ARVs is central to HIV/AIDS programs, because of its impact on the course of the disease and on quality of life. First-line treatments costs have declined, treatment-associated expenses are steeper each year, not only due to more PLWH in need of treatment, but also in face of new and costlier patented medicines incorporated to treatment guidelines. Provision sustainability is therefore an important variable for the success of treatment programs and should be acknowledged during planning and implementation of programs or of provision schemes. Populations of Latin American and African countries have different levels of access to ARVs, which is influenced by the organization of their healthcare systems and HIV / AIDS programs within these systems. Background 2

NAF/FIOCRUZ Objectives To investigate the issues of ARV provision sustainability as identified in a conceptual framework, investigated in Peru, Bolivia and Mozambique; To investigate the knowledge and perception of sustainability issues by coordinators and managers of national programs in the preparation and implementation of programs. 3

NAF/FIOCRUZ The sustainability of the provision of treatment is an important factor in the success of treatment programs. Issues related to sustainability should be considered during both the planning and implementation phases of provision programs. Central coordination is essential to the functioning of a sustainable AIDS program. Methodology Assumptions 4

NAF/FIOCRUZ Conceptual Framework Methodology 5 Sustainability Sustainability an attribute of an intervention, program or policy, resulting in the routinization and standardization of activities and resources required over time in order to achieve objectives. Implementation Implementation operational capacity, reproducibility operational capacity, reproducibility national intervention  local intervention national intervention  local intervention the translation of intentions into actions the translation of intentions into actions Routinization Routinization a process that leads to the establishment of routines within the activities Standardization Standardization existence of formal, legal, normative and institutional standards that guide the intervention.

NAF/FIOCRUZ Investigation questions Methodology 6 What objective variables from the conceptual framework can be investigated? What objective variables from the conceptual framework can be investigated? Which agents are directly involved? Which agents are directly involved? How are activities defined and carried out? How are activities defined and carried out? Which proxy indicators can be identified? Which proxy indicators can be identified? How do coordinators and managers deal with sustainability-related issues? How do coordinators and managers deal with sustainability-related issues? How do the different strategies contribute to strengthen programs? How do the different strategies contribute to strengthen programs?

NAF/FIOCRUZ Research Planning 7 Collection of interview data Semi-structured interviews with key informants Semi-structured interviews with key informants Documents provided by interviewees Documents provided by interviewees Pilot Study Brazil BrazilVisits Peru, Bolivia and Mozambique Peru, Bolivia and Mozambique Organization of data Objective data entered into a worksheet Objective data entered into a worksheet Interviews were recorded and transcribed. All respondents signed informed consent forms (according to Brazilian ethical regulations) Interviews were recorded and transcribed. All respondents signed informed consent forms (according to Brazilian ethical regulations)Analysis The discourse of the subjects was analyzed by means of categories The discourse of the subjects was analyzed by means of categories Information given by respondents x data contained in documents Information given by respondents x data contained in documents

NAF/FIOCRUZ BOLIVIA Bolivia, in addition to external dependence on financing and management of medicine supply, presents problems regarding implementation and routinization of ARV provision activities. 8 The provision of ARVs comes from different sources (mainly by the Global Fund and Brazilian government donations) The provision of ARVs comes from different sources (mainly by the Global Fund and Brazilian government donations) No specific rules cover the allocation of resources for provision of ARVs No specific rules cover the allocation of resources for provision of ARVs Provision is made by different organizations, under government contract Provision is made by different organizations, under government contract National HIV / AIDS Program is not actively involved in provision National HIV / AIDS Program is not actively involved in provision Staff turnover is a major problem Staff turnover is a major problem ARVs part of EML, but different committee selects ARVs ARVs part of EML, but different committee selects ARVs Care for HIV is not integrated into the rest of the health system Care for HIV is not integrated into the rest of the health system

NAF/FIOCRUZ MOZAMBIQUE In Mozambique, provision is almost totally dependent on donations and external aid. A large effort is being undertaken to incorporate ARV provision and care to routine healthcare activities. 9 Increase coverage + continuity of treatment Increase coverage + continuity of treatment Barriers placed by donors conditioning purchases Barriers placed by donors conditioning purchases The flow of resources for AIDS is highly variable. Common health fund for all medicines: small contribution from the government The flow of resources for AIDS is highly variable. Common health fund for all medicines: small contribution from the government Several organizations in operation  coordinated by MINSAU Several organizations in operation  coordinated by MINSAU Integrated care, centralized selection and provision of ARVs, effort in evaluation activities Integrated care, centralized selection and provision of ARVs, effort in evaluation activities Serious storage and stock management problems Serious storage and stock management problems Shortage of health personnel  specific incentives for HIV/AIDS jobs Shortage of health personnel  specific incentives for HIV/AIDS jobs Groups with less access to care and treatment  poverty, stigma Groups with less access to care and treatment  poverty, stigma

NAF/FIOCRUZ PERU In spite of difficulties, evidence of greater sustainability potential of the program was observed in Peru, where provision is implemented and routinized by the National HIV/AIDS Program and expenditures met by the government. 10  ARV provision  MoH with treasury resources; no specific funding channel for ARVs  Small program structure: efforts in data collection and processing  Updated legal framework  EML includes ARVs  Operations are carried out by different organizations; no different logistics requirements for ARVs in relation to other medicines  No overlap of activities or conflict of tasks; personnel were trained to deal with ARVs and HAART

NAF/FIOCRUZ Important issues to consider Examining framework issues in different periods of intervention history. Highlighting existence of institutional patterns. Loss of the intervention's separate identity and its integration into regular organizational activities. 11

NAF/FIOCRUZ Conclusions The conceptual framework was useful in recognizing events that may influence sustainable ARV provision in these countries. Planning ahead for sustainable provision, considering the epidemic profile and population needs, is essential and without it financing sources and mechanisms are not enough. Furthermore, country programs/provision schemes must consolidate themselves in the structure of health services provision as a whole, especially in limited resources settings. 12