DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 BUSINESS CASE SOUTH SUDAN EMERGENCY MEDICINES FUND What support will the UK provide? The UK plans to provide up to £10 million over the next 18 months (mid 2012 - January 2014) to support the procurement and distribution of emergency medicines in South Sudan. The overall budget of the Programme over this period is expected to be around £27 million. Two other donors (USAID and Norway) are expected to provide the remaining £17 million. Why is UK support required? What need are we trying to address South Sudan is one of the poorest countries in the world. Years of conflict causing erosion of physical and social infrastructure and death and displacement of millions of people have made South Sudan one of the poorest regions in the world. Just over half (51%) of the 8.3 million South Sudanese live below the national consumption poverty line, and most live in rural areas (81%) [MoH 2011]. South Sudan’s health needs are vast due to the high poverty and long history of conflict. The basic health care system is extremely weak, and there are severe shortages of health workers and functional facilities. South Sudan has the highest maternal mortality rate in the world with an estimated 2,054 women dying for every 100,000 births. There are major challenges in delivering services in South Sudan including inadequate infrastructure and access, dysfunctional referral systems and cultural and financial barriers. In addition, returnees to South Sudan from Sudan are adding to the burden placed on health facilities particularly in 12 counties- most of which are on the border between Sudan and South Sudan. More recently the country has been challenged with escalating tension from both internal ethnic clashes and ongoing disputes with Sudan over oil and other issues still unresolved following the 2005 Comprehensive Peace Agreement (CPA). This tension with Sudan has led the Government of the Republic of South Sudan (GRSS) to shut down their oil wells which were providing around 98% of GRSS revenues. Government financial resources could run out in the third quarter of this year if government spending remains the same as it is now. Given this context, and without an early agreement with Sudan on oil, the government will be unable to sustain current spending on health (or other government functions). This means that the international community will need to continue to finance the delivery of many basic health services, prevent a breakdown in the health system and protect the most vulnerable. This is vital to preventing excess morbidity and a further deterioration in the already poor humanitarian situation Background on the pharmaceutical crisis in South Sudan 1 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Essential medicines have over the past three years been procured through the World Bank managed Multi-Donor Trust Fund (MDTF). The fund provided medicines to all public health facilities (47 hospitals, 350 Primary Health Care Centers (PHCCs) and 1,200 Primary Health Care Units (PHCUs) in the 10 States1. The total annual budget was around $32 million. The MDTF ends in December 2012. It is anticipated that the current supply of pharmaceuticals funded by MDTF will last up to January 2013. After this date, there is no planned central supply of medicines in South Sudan. Many NGOs also purchase medicines on an ad hoc basis; however these supplies are inadequate for the complete needs of the country and lead to a more fragmented system which is difficult to monitor. In addition this will only provide medicines for NGO supported facilities. The end of the MDTF will leave many health facilities dependent on private procurement of medicines or facing a complete stock-out of essential drugs. The donor community began discussions with the Ministry of Health (MoH) about the financing of pharmaceuticals in August 2011, when it became clear that there would be gaps in pharmaceutical procurement after the MDTF closed. Since then there have been a number of high-level meetings between donors, the MoH, and the Ministry of Finance and Economic Planning to emphasize the need for GRSS to budget appropriately for pharmaceuticals for the whole country. Given the current oil crisis, it is unlikely that GRSS will have the financial capacity to purchase and distribute pharmaceuticals in time to avoid major stock outs of essential medicines from January 2013. The MoH must reduce its already limited operational and capital expenditures to fall in line with government austerity measures. The MoH has budgeted 35 million SSP (approx. $11m) for food and pharmaceuticals for the financial year 2012 to 2013. However, it is difficult to know if this will actually be allocated to them and when it will be released to MoH. Given that it takes at least 9-12 months to bring medicines into South Sudan it is unlikely to be soon enough to avoid major stock outs. Even if the MoH will receive this money, it will still be vastly insufficient to cover the need of the population. What will we do? With other donors the UK plans to support an emergency medicines fund that will provide South Sudan with a supply of emergency medicines for a one year period. The Fund will allow the procurement of a tailored list of essential medicines and the storage and distribution of medicines up to county level. Support to this fund will enable delivery of primary care health services across most of the country. Who will implement the support we provide? 2 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Options appraisal shows that the best value for money will be achieved by providing donor funds to USAID to support their DELIVER programme. The USAID DELIVER Project assists the development of health supply chains for a broad array of essential health commodities. DELIVER has a list of pre-approved wholesalers of pharmaceuticals which will help speed up the process of procurement. DELIVER would manage the whole supply chain from procurement and storage to distribution up to county level. The emergency medicines fund will need to align closely with activities under the DFID six State Health Pooled Fund to ensure that commodities are reaching health facilities on the ground. What are the expected results? What are the planned results attributable to UK Support? The results for the emergency medicines fund have been developed in line with the anticipated outcomes of the Health Pooled Fund. The emergency medicines fund will contribute to improving health outcomes and saving lives by: reducing under 5 mortality rate from a baseline ratio of 106 (deaths/1,000 live births) in 2010; and reducing maternal mortality from a ratio of 2,054 (deaths per 100,000 live births) in 2006. Data will be disaggregated by gender and poverty quintile. The outcome of the emergency medicines fund is to maintain essential health services through provision of quality priority medicines. The three outcome indicators are: Under 5 consultation rate; Proportion of antenatal clients receiving their second dose of intermittent presumptive treatment (IPTp) Proportion of facilities that access county supplies of medicines How will we determine whether the expected results have been achieved? We will jointly monitor the programme with USAID. In addition we will monitor through the Health Pooled Fund (HPF) as provision of services under the HPF is dependent on the availability of medicines. 3 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Strategic case A. Context and need for DFID intervention Background on South Sudan South Sudan is one of the poorest countries in the world. Years of conflict causing erosion of physical and social infrastructure and death and displacement of millions of people have made South Sudan one of the most underdeveloped regions in the world. Poverty is widespread. Just over half (51%) of the 8.3 million South Sudanese live below the national consumption poverty line, and most live in rural areas (81%) [MoH 2011]. South Sudan’s health needs are vast and partly result from the high poverty and long history of conflict. War has left an already very basic health care system extremely weakened, with severe shortages of health workers and functional facilities. South Sudan has the highest maternal mortality rate in the world with an estimated 2,054 women dying for every 100,000 births. Only 44% of the population lives within 5 kms of a health facility. User rates are low and estimated at 0.2 contacts per person per year. Other major challenges to delivering services include inadequate infrastructure and access, dysfunctional referral systems and cultural and financial barriers. In addition, returnees to South Sudan from Sudan are adding to the burden placed on health facilities particularly in 12 counties - most of which are on the border between Sudan and South Sudan. More recently the country has been challenged with escalating tension from both internal ethnic clashes and ongoing disputes with Sudan over oil and other issues still unresolved following the 2005 Comprehensive Peace Agreement (CPA). This tension with Sudan has led the Government of the Republic of South Sudan (GRSS) to shut down their oil wells which were providing around 98% of GRSS revenues. Government financial resources could run out in the third quarter of this year if government spending remains the same as it is now. Given this context, and without an early agreement with Sudan on oil or sufficient alternative financing being secured, the government will be unable to sustain current spending on health (or other government functions). This means that the international community will need to continue to finance the delivery of many basic health services, prevent a breakdown in the health system and protect the most vulnerable. This is vital to preventing excess morbidity and a further deterioration in the already poor humanitarian situation Background on the pharmaceutical crisis in South Sudan Essential medicines have over the past three years been procured through the World Bank managed Multi-Donor Trust Fund (MDTF). The medicines were supplied in the form of drug kits to all public health facilities (47 hospitals, 350 Primary Health Care Centers (PHCCs) and 1,200 Primary Health Care Units (PHCUs) in the 10 States2. The 2 A total of 31 different kits were supplied, consisting of 11 lots (oral drugs, ACTs, syringes etc.) for the three different levels. 4 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 total annual budget was around $ 28 million - $ 24 million for medicines, and an additional $ 4 million for storage & distribution. Considering the population of South Sudan – approximately 8 million – this is a relatively high per capita expenditure on essential drugs. The MDTF is coming to an end in December 2012 and was the main provider for medicines in South Sudan. It will provide two more instalments (3-months supply) of medicines before it finishes and these are expected to be delivered at Central Medical Stores (CMS) around August and Oct/Nov 2012. It is therefore anticipated that the current supply of pharmaceuticals funded by MDTF will last up to January 2013. After this date, there will be no funded supply of medicines in South Sudan. This will leave health facilities dependent on procuring medicines privately where funding is available, the remainder will face a complete stock-out of essential drugs. Around 70% of the public health facilities receive additional support from national and international NGOs. This support often also includes funding for essential drugs (for counties or facilities to procure themselves) or gifts in-kind. In addition, specific health programmes use parallel mechanisms for the supply of additional medicines, for instance anti-retroviral drugs (ARVs), anti-malarials and anti-TB drugs (funded by the Global Fund, delivered by PSI/UNDP), vaccines (funded and supplied by UNICEF) and Family Planning commodities (USAID). The donor community began discussions with the Ministry of Health (MoH) about the financing of pharmaceuticals in August 2011, as it was becoming clear that there were gaps in pharmaceutical procurement when the MDTF closed. Since then there have been a number of high-level meetings between donors, the MoH, and the Ministry of Finance and Economic Planning to emphasize the need for GRSS to budget appropriately for pharmaceuticals for the whole country. However, given the current oil crisis, it is unlikely that GRSS will have the financial capacity to purchase and distribute pharmaceuticals in time to avoid major stock outs of essential medicines from January 2013. Even with a deal on oil between Sudan and South Sudan, as is now possible, it will be many months before oil revenues resume. The MoH must reduce its already limited operational and capital expenditures to fall in line with government austerity measures. The MoH has budgeted 35 million SSP (approx. $11.1 m) for pharmaceuticals for the financial year 2012 to 2013. This includes funding for feeding centres. However, it is difficult to know how and when this funding will actually be allocated to MoH. Even if the MoH will receive this money, it will still be vastly insufficient to cover the need of the population, especially taking into account further currency depreciation. Why this project is important and why DFID is required to support it? There is a clear need for DFID’s support to the procurement of essential drugs in South Sudan. DFID is currently the lead donor for the proposed Health Pooled Fund (HPF). This is a fund that is expected to be supported by at least five donors - AusAID, CIDA, the EC, 5 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 SIDA and DFID. It aims to provide basic services at primary care level in six 3 of the 10 states of South Sudan, and also to provide emergency obstetric care in county hospitals. The remaining four States will be covered by USAID and the World Bank. Figure 1: Southern Sudan map by county (79) and state (10) The HPF is dependent on the central supply of medicines, and was designed on the basis that the GRSS would fund the procurement and distribution of medicines. However, under the current circumstances GRSS no longer has the capacity to free up adequate finance for the procurement of medicines for the country. Medicines are one of the essential components for delivery of health services [WHO 2007]. Therefore the HPF cannot deliver basic services to the population of South Sudan unless funding for medicines can be made available. DFID has taken a leadership role with USAID on the issue of pharmaceuticals. This has included advocating to GRSS for medicines to be prioritised as well as advocating to donor partners to consider providing financial support for medicines in enable continued health services. In addition to the reduction in GRSS funding for medicines, there is likely to be reduction in GRSS funding for salaries and health services. The health needs in South Sudan are likely to increase across South Sudan from 2012, due to increasing returnees, refugees and IDPs, and a likely food security crisis with resulting malnutrition. The combination of reduction in health services, with increasing returnees and increasing malnutrition will lead to a humanitarian crisis, with significant mortality. A key way of mitigating against the impact of this crisis would be to ensure that there is an adequate supply of essential medicines for South Sudan, in order to be able to maintain basic health services across the country. 3 These include Western Equatoria, Northern & Western Bahl el Ghazal, Warab, Lakes, Unity. Jonglei and Upper Nile have been assigned to the World Bank, while USAID takes responsibility for Central and Eastern Equatoria. 6 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 B. Impact and Outcome that we expect to achieve In line with the Health Pooled Fund, the emergency medicines fund will contribute to improving health outcomes and saving lives by: reducing under 5 mortality rate from a baseline ratio of 106 (deaths/1,000 live births) in 2010; and reducing maternal mortality from a ratio of 2,054 (deaths per 100,000 live births) in 2006. Data will be disaggregated by gender and poverty quintile. The outcome of the emergency medicines fund is to maintain essential health services through provision of quality priority medicines. The three outcome indicators are: Under 5 consultation rate; Proportion of antenatal clients receiving their second dose of intermittent presumptive treatment (IPTp) Proportion of facilities that access county supplies of medicines 7 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Appraisal Case A. What are the feasible options that address the need set out in the Strategic case? Figure 2 outlines the Theory of Change of the emergency medicines fund, which aims to improve health outcomes and save lives. The emergency medicines fund will enable the procurement, storage and distribution of essential drugs to counties in at least the six HPF states for a period of one year. The Fund will also ensure that a transparent and harmonized system is set up to monitor drugs and finances throughout the supply chain. The provision of quality priority medicines will help maintain essential health services, which will in turn improve health outcomes and save lives. This Theory of Change is subject to a number of assumptions; key evidence and theory supporting these assumptions is outlined in the box below. Figure 2: Emergency Medicines Fund - Theory of change Supporting health systems (staff, infrastructure) are available to provide quality care & treatment Access to quality essential medicines improves health outcomes Procurement of medicines Emergency Medicines Fund Storage & distribution to counties in six States Transparent & harmonized system in place for monitoring drugs & finances throughout supply chain Maintaining essential health services through provision of quality priority medicines Availability of medicines improves healthseeking behaviour Improving health outcomes and saving lives GRSS finds additional resources to ensure continuous supply of medicines & medical supply following completion of emergency medicines fund 8 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 The key evidence and theory supporting these assumptions are as follows: Assumption 1: Access to quality essential medicines improves health outcomes One of the key components of a functioning health system is the availability of quality essential medicines to provide care and treatment to those in need. It is commonly accepted that improved access to good quality health services has major impacts on health outcomes, in particular in low and middle-income countries. Indeed, access to essential medicines is directly related to life expectancy [WHO 2004], and is one of the five UN indicators to measure progress in the progressive realization in the right to health [WHO 2011]. Assumption 2: Supporting health systems are available to provide quality care & treatment A health system consists of six main building blocks [WHO 2007]. Each of these components needs to be present and prioritised simultaneously and continuously across the entire health network including in hard to access places if health services are to function efficiently and have an impact on health outcomes. The six blocks are: health services that deliver effective, safe, quality health interventions; leadership & governance ensuring strategy policy frameworks; a qualified health workforce; a health information management system (HMIS); an equitable health financing mechanism; and finally availability of quality medicines & technology. Through its various activities, the Health Pooled Fund (2012 – 2016) aims to address a number of the building blocks, in particular provision of finances to support the delivery of primary care health services in six states, support to the HMIS and to develop leadership & management skills. Other donors (e.g EU, CIDA and UNFPA) focus on training of the health workforce. The emergency medicines fund aims to complement these activities to ensure that this building block is addressed and the health system can provide care and treatment to its population. Assumption 3: Availability of medicines improves health-seeking behaviour of population South Sudan has a very low per capita use of the public health sector: on average, people visit a health facility only 0.2 times per year. Shortage of medicines has been shown to reduce health-seeking behaviour. Indeed, a study in Malawi showed that unavailability of anti-malarial drugs was one of the factors associated with delays in seeking appropriate treatment for fever [Chibwana et al, 2009]. Assumption 4: GRSS finds additional resources to ensure continuous supply of medicines & medical supply following completion of emergency medicines fund The current intervention only covers medicines for one year, and provision of essential drugs will be handed over to the Government of South Sudan at the end (2013). The current business case assumes that the government of South Sudan finds additional resources to ensure continuous supply of medicines & medical supply following completion of emergency medicines fund. It should be acknowledged that if the current crisis continues, this may not happen. Therefore, in parallel to the proposed emergency medicines fund, it is critical that there is continuous dialogue with the GRSS and partners to advocate for the availability and prioritisation of funding for essential medicines. 9 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 In addition to the criteria set out in the Theory of Change and the cost associated with each option there are a number of other critical factors on which the final decision regarding procurement, storage and distribution modality will be based. These include the capacity to set up a transparent system for procurement, storage and distribution and ensure timely supply of quality priority medicines. Lastly, the sustainability of the system will be taken into account. The capacity of a system to deliver is an essential factor to ensure that quality medicines will actually arrive at their final destination. The context in South Sudan is particularly challenging in terms of importation requirements, storage capacity, incountry distribution, and lack of existing reporting systems in place. The capacity to deliver will therefore rely for a large part on the expertise and previous experience of implementing partners. Transparency of the system is critical to ensure that both medicines and funding can be tracked throughout the supply chain. There are currently few official government structures in place for monitoring stock or finances at different levels. This poses a high risk of leakage of drugs to the private sector and diversion of funds. The timely supply of medicines is crucial to avoid a shortage of drugs to the extent possible. After selection and quantification of medicines has been agreed upon and orders are placed with the procurement agent, it takes approximately four months for manufacturing, and an additional three months for quality assurance, kit packaging and transport (by sea/road) to Juba. Subsequently, drugs have to be transported to county and facility level. As mentioned, the essential medicines kits provided through the MDTF are expected to cover the need of the population until approximately the end of January 2013, and emphasis should be placed on a system that can supply medicines as quickly as possible to avoid or at least minimize the period during which facilities are faced with stock-out of priority drugs. In order to ensure that the drugs provided improve health outcomes of the population, it is of paramount importance that quality medicines are provided. Due to weak legislation and absence of a national drug regulatory system, the pharmaceutical market in South Sudan is riddled with low-quality and counterfeit medicines. 4 This highlights the importance of setting up a system whereby medicines imported into the country adhere to strict quality criteria. In addition, quality of medicines should be maintained throughout the supply chain until the final point of use, whereby special emphasis should be placed on proper conditions for storage and distribution. The cost aspect of the different options is discussed in section C. Sustainability of the system is an important criterion for evaluating the options, as the current emergency drug fund only intends to cover the need for priority medicines in the six states for one year. After this period, the government of South Sudan and/or partners should take over. Therefore, attention should be given to a system that is Meeting May 17, 2012 - Ministry of Health/Dept of Pharmaceutical Services: “Quality Assurance & Quality Control of Medicines in South Sudan” 4 10 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 complementary to capacity building initiatives within the Ministry of Health and national structures thus increasing the likelihood of a successful hand-over of the project. The following sections outline the options explored taking into account the theory of change and the critical criteria outlined above. Section A1 summarizes a number of options that are not deemed feasible or realistic, and the rationale for why these are not further explored is laid out. Subsequently, section A2 looks at the feasible options, including the counterfactual. A.1 Procurement, storage & distribution: options not deemed feasible Option: Pooled fund with the Ministry of Health in charge of the procurement & distribution of all essential medicines The Ministry of Health would prefer to procure and distribute all essential medicines themselves. Even though in theory the preferred option would be to use national systems and bodies, in reality there is ample evidence that the MoH does not have the capacity to do this at this time. There is limited technical expertise within the MoH/DPS to manage the tender process in a timely manner. The MoH has no written procedures for supplier performance monitoring, which leads to delayed or non-compliant deliveries [USAID, 2010]. A recent fiduciary risk assessment (FRA) showed that DFID South Sudan cannot at this stage enter into financial aid agreements that directly put funds into government systems. The corruption risk is high and commitment of GRSS to reform is not yet credible and is challenging given the current financial context. In addition, there are major challenges encountered at Central Medical Store (CMS) level. Government storage capacity covers less than half the space needed for one consignment (3-months) of kits (as supplied under MDTF) for the country. The government does not have a fleet of trucks to regularly facilitate distribution to health facilities. Lack of capacity for coordination between the Department of Pharmaceutical Services/MoH leading the process, CMS and the transport agents, makes it difficult for CMS to efficiently organize for dispatch operations. Lack of systems to track & trace the goods distributed to states/counties poses a high risk of leakage of drugs to the private sector. Indeed, there are numerous anecdotal accounts of public-sector drugs surfacing in private pharmacies. Given the current challenges following the oil closure it is likely that leakage of high-value goods from the public sector is going to increase. In light of these factors, the option of procurement & distribution of essential drugs by the MoH with pooled funding is not deemed a feasible option and will not be further considered. Option: Pooled funds with the World Bank to subcontract IMA for procurement & distribution of essential drugs The World Bank aims to deliver drugs to the two States assigned to them – Jonglei & Upper Nile. For this, they plan to contract Interchurch Medical Association (IMA), which 11 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 in turn has an agreement with the Ministry of Finance/MoH, whereby IMA is accountable to the MoH. This option involves considerable involvement of the GRSS, which is likely to slow down the process. In addition, it is as yet unclear how IMA will procure (direct sourcing from manufacturers vs. through a Procurement Agent), store and distribute (to State/County level) the medicines, and what their capacity is. In light of the urgency of the current delivery, there is a real chance that quality priority medicines will not arrive at facility-level in a timely manner. For this reason, this option will not be further pursued. Discussions are ongoing to see whether the WB and IMA may be interested in harmonising their own drug procurement and distribution with USAID and DFID and we have expressed the potential to support the procurement of some commodities depending on the level of funding offered by other donor partners. Option: Pooled funds with a UN-agency to carry out the procurement & distribution of essential drugs Under EU regulation, DFID could directly contract a UN-agency to conduct the procurement and distribution of drugs to the six States. This option has as an advantage that there is no need for international tendering to select a procurement agent, cutting out a time-consuming step in the chain, and UN-agencies are typically capable of handling large orders. For this Business Case, one of the UN-agency’s most involved in supply chain management in South Sudan – UNICEF – has been approached. UNICEF has delivered vaccines and cold-chain equipment throughout South Sudan for many years. From 2005-2007, UNICEF also supplied essential drugs to USAID, but due to long delays in supplying the products the agency switched to IDA as procurement agent. There is also anecdotal evidence that the current provision of cold-chain equipment is subject to major delays. Lastly, UNICEF has indicated that it is not keen to manage the procurement & distribution of essential drugs. For the above-mentioned reasons, this option will also not be further considered. Option: NGOs will be allowed to procure medicines individually through a top-up in their budget Currently, NGOs procure additional medicines individually to avoid stock outs, as the quantity supplied by MDTF is insufficient. The Basic Services Fund (BSF) provides around £900,000 annually to 17 NGOs working in 35 counties to purchase additional essential drugs and supplies, such as anti-malarials and antibiotics. USAID/SHTP II, OFDA and ECHO support other NGOs in the 51 remaining counties. As mentioned before, the tasks and responsibilities of supporting counties have been re-divided amongst donors, and all counties will be supported by an NGO in the near future. This support includes service delivery running costs, salary incentives, county health department capacity building, supervision and potentially provision of selected additional medicines. Whilst this may help alleviate some of the crisis, the HPF will be unable to cover all NGO medicine costs. Additional funding made available by DFID could possibly be channelled to the different NGOs for the purchase of additional essential drugs. 12 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 On the upside, arguably NGOs working at county-level are closest to the beneficiaries and the needs on the grounds. However, this option also has a number of major drawbacks. Funding NGOs to purchase medicines for counties would result in a highly fragmented system, with many parallel supply chains and no involvement from Ministry of Health. This results in a lack of oversight on how finances are used and the quantity of medicines procured, as well as challenges with collating data and moving towards a more harmonized sustainable system where the needs are understood. In addition individual small procurement will not give best value for money and NGOs (in particular smaller NGOs) do not always have strict rules to ensure the quality of medicines purchased. Serious concerns have been voiced over the quality of medicines imported from locally or regionally sourced drugs. Importation of drugs from international sources requires tax exemption for each NGO individually. It has been shown in the past that these waivers are difficult to obtain, and can therefore lead to significant delays in procurement. The capacity of each NGO to select, quantify, procure and monitor medicines use is also unknown. A final challenge is that currently there is not an NGO in every county, and not all facilities in a county are currently covered by an NGO, which implies that procured medicines will not reach all facilities. For the above reasons, this option will not be considered further. Option: DFID to launch international competitive bidding process This option will involve DFID launching an international competitive bidding process to contract agencies to procure – and possibly also distribute – medicines. This option has been discarded for two reasons. Firstly, it will require considerable time (at least 6 months) to run the tendering process to select a procurement and distribution agent. 5 . More time will then be needed to negotiate contracts, and the process after the contract has been awarded. As shown in figure 3, provision of medicines under MDTF from preparing tender documents to arrival of drugs at county-level took around 30 months. Reasons cited for this lengthy process included low capacity related to evaluation of the bids, and cumbersome World Bank procedures to obtain a Letter of Credit. Even using DFID procedures it will take at least 6-9 months from the moment the purchase orders are placed, manufacturing of medicines (4-6 months) and shipped to Juba (2-3 months). Under this option, medicines will therefore certainly arrive in the counties well after February 2013. The second reason why this option has not been considered is that additional DFID capacity would be required and this would take time to recruit. 5 As a comparison, the International Competitive Bidding (ICB) launched by MDTF in 2009 for the supply of essential drug kits received 22 bids from suppliers 13 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Figure 3: Timeline (in months) under MDTF using government systems – from tendering to arrival essential medicines kits at facility-level Source: Personal correspondence, Ministry of Health GRSS & MissionPharma A.2 Procurement, storage & distribution: options to consider Four potential options have been identified for consideration. To appraise the options of ensuring quality essential medicines to the population, the supply chain is regarded in two components: A procurement component, which includes the selection, quantification and procurement of medicines, up to importation and delivery to the warehouse in Juba; A storage, distribution & reporting component, which includes storage in Juba and onwards distribution to all counties in the six DFID-supported States, and also reporting on stock levels and consumption; Both components can be managed by either the International Procurement Agency (IPA) or under USAID’s pharmaceutical programme DELIVER. Including the counterfactual, this results in the following four options: Option 1: Do nothing/counterfactual Option 2: Pooled fund with DFID directly procuring medicines via IPA, and using IPA for storage & distribution Option 3: Pooled fund with DFID directly procuring medicines via IPA, and using USAID’s DELIVER mechanism for distribution Option 4: Using a single source USAID DELIVER Project to procure and distribute the drugs to counties in all six States As described in the previous section, the existing system of storage and distribution of essential medicines has a number of problems. There is low capacity within the MoH/DPS to manage this part of the supply chain, and a high risk of leakage of medicines to the private sector. If DFID provides funding to procure essential medicines, it should ensure that the drugs reach the final destination, in a timely manner, and quality is maintained. Apart from the options discussed here, no other viable alternative for storage & distribution were identified by any of the stakeholders. For the purpose of this business case we have used a very limited list of commodities for procurement cost estimates (See section C) and have focused on distribution to eight states at this time. Discussions are ongoing with the World Bank in case the fund can and needs to cover the two World Bank supported states in addition to the eight 14 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 states supported by USAID and the Health Pooled Fund. Both the number of commodities and the number of states may be expanded depending on the level of funding received from donor partners. All four options are described in turn below. For the last three, roles & responsibilities of the different actors, as well as pros & cons of the option, are discussed. The critical factors to be assessed include capacity, transparency, timeliness, quality medicines, cost and sustainability (see previous section). In addition, implications for the DFID South Sudan office in terms of potential additional human resources needed are taken into account. In addition, it is assumed that the medicines will in each option be delivered down to county level at least. The last part of the supply chain – making sure that drugs get from county to facility level – would utilise local existing mechanisms. Typically, staff from health facilities or NGOs come to collect the medicines at county level. As part of the Health Pooled Fund, NGOs could be contracted to strengthen and support the county health department with the storage of drugs, and distribution from the county warehouse to the final destination. Option 1: Do nothing/counterfactual This option outlines the counterfactual, i.e. DFID does not fund the emergency procurement & distribution of essential drugs to the six HPF-supported states beyond existing projects. Given the current budget and technical constraints, the government will be unable to procure essential medicines when current stocks run out. At the same time, health facilities are for a large part dependent on the supply of essential drugs from CMS to provide treatment to the population. During the past months, DFID has made concerted efforts to lobby humanitarian and development donor partners (those involved in the HPF, but also for instance nontraditional health donors such as Japan and China) to contribute funding to purchase essential drugs for the six States covered by the HPF. This has resulted in some success, with Norway indicating its willingness to contribute, but only on the basis of a DFID lead. And given the lengthy process of procuring & distributing medicines and looming nationwide stock-out occurs, it is improbable (and otherwise, too late) that another partner will address this situation in the near future. The displacement effect, where in the absence of DFID funding the supply of essential drugs would still go ahead thus seems not to apply here. DFID lead is essential. Severe shortages of essential medicines will also undermine the impact of the Health Pooled Fund (HPF), as provision of health care will be badly affected. Amongst other plans, the HPF aims to conduct 70,000 under-5 consultations, provide 30,000 children ages 6-59 months with vitamin A, treat 6,000 pregnant women with malaria treatment and ensure 6000 women attend a 4th ANC where they are immunised; these activities would be severely compromised if medicines are not available [HPF Business Case, Year One Milestones]. It is also very demotivating for health workers if they do not have 15 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 any medicines to give to patients, which may further affect quality of care provided. A sharp fall in the provision and quality of health care service – which is further compounded by increasing returnees, food insecurity and conflict – will lead to significant increases in morbidity and mortality across South Sudan. Option 2: Pooled fund with DFID directly procuring medicines via IPA, and using IPA for storage and onwards distribution This option for procurement would involve MoUs being signed with donors and the money being channelled into a pooled fund. The pooled fund could be used to procure medicines. DFID would not procure goods and associated services directly, and all services and goods with a value over £101,000 need to be purchased through international competitive bidding. A competitive tendering exercise was run to select DFID appointed procurement agents to carry out purchasing duties in the UK and overseas offices. As a result of this exercise, the procurement agent recently appointed for South Sudan is the International Procurement Agency (IPA). For the procurement of essential medicines, IPA would conduct an international competitive 6 bidding process in order to select and contract a Procurement Agent (possible agents mentioned were MissionPharma and IDA). The Procurement Agent would carry out the sourcing of supplies, kit packaging, quality assurance, transport and import in country to central warehouse level. For storage, distribution & reporting, IPA would hire warehousing space in Juba, or possibly use their warehouse in Kampala for bulk storage of drugs. IPA would contract logistics firms in South Sudan for the distribution of medicines to the counties in the six states. A system capturing information on stock levels and consumption data would have to be set up. 6 For a restricted (and speedier) bidding process, whereby selected suppliers are invited to submit their bids, a separate Business Case would have to be submitted to DFID for approval. 16 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Figure 4: Pooled fund with DFID directly procuring medicines via IPA, and using IPA for storage & distribution (Option 2) Roles & responsibilities IPA’s role would be to manage the contract and monitor the process with the procurement agent, arrange storage space (central and/or decentralized level), contract local distributors, and provide regular reporting to DFID. Under a specific service contract, IPA (or a sub-contractor hired by IPA) could also be tasked with arranging tax waivers for importation of medicines, set up distribution schedules for drugs (incl. volume, weight and quantities to be supplied to each county) and manage the reporting system (e.g. determine when which drugs will have to be supplied where). DFID South Sudan (SS) would supply IPA with a list of essential drugs & medical supplies to be procured (incl. quantities and specification), and support the process of arranging tax waivers, of providing input in the distribution schedule and of managing the reporting system. Pros & cons The advantages for the procurement component under this Option can be summarized as follows. IPA is a general procurement services company with experience in essential drugs management, especially TB control programmes. 7 Over the past decade, it has supplied essential drugs, TB medication and malaria drugs to a variety of countries, including for DFID-funded projects e.g. in India8 (performance of IPA on these projects could not be independently verified). The framework contract between DFID and IPA contains Key Performance Indicators to ensure transparency and secures value for money and compliance with EU Directives. Quality of medicines will be ensured through the use of reputable procurement agents (MissionPharma or IDA), 7 http://www.dfid.gov.uk/work-with-us/procurement/procurement-of-goods-and-equipment/internationalprocurement-agency/ ; http://www.ipa-bv.nl/index.html 8 Based on email correspondence with Arie van Vroon, Logistics Manager IPA; May 21 2012 17 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 which use stringent quality control & assurance criteria and have extensive experience with large essential medicines orders for South Sudan. In addition, IPA has a 2.95% fee rate and full transparency of costs. On the downside, an international competitive tendering process that has to be undertaken will require time for launching the tender, receiving and evaluating bids, and awarding the contract. As shown in figure 7, this process is expected to delay the procurement-component by approximately one to two months compared to Option 4, which would translate into two additional months of stock-out of essential drugs at facility level. Another factor on the downside is that the performance of IPA on some other DFID contracts in South Sudan was said not to be unequivocally positive, and examples of delays and poor contract management were cited.9 In terms of storage, distribution & reporting, IPA already has experience with setting up distribution and reporting systems of medicines in various countries. In South Sudan, IPA has managed procurement & distribution activities of anti-malarial treatments for the Malaria Consortium since 2009. IPA already has some framework agreements with logistics firms in South Sudan, which could potentially be used for the distribution of medicines to the counties in the six states. On the downside, IPA has as of yet to establish local presence in the country, which is crucial to facilitate communication and ensure the process is managed at both ends of the supply chain. Procedures for import of medicines are complicated – including obtaining waivers for tax exemption – and there are ample examples of medicines being stuck at the border for long periods of time. In addition, no comprehensive reporting system is in place, even though the MoH is piloting new tools. At this point, IPA does not have established collaboration with the Ministry of Health to facilitate the process of obtaining waivers for importation, making use of available storage capacity, strengthening existing reporting systems, building upon lessons learnt and strengthening the capacity of the national system. In addition, this Option would imply two parallel systems being set up at the same time by USAID & DFID, resulting in more fragmentation (see figure 4). Lastly, for DFID internally choosing Option 2 will strengthen the framework agreement between DFID and IPA, and further establish the relationship between the two entities. However, this option will likely require additional human resource capacity at the DFID SS office on selection & quantification of drugs, support arranging of tax waivers, providing input in the distribution schedule and managing the reporting system. The DFID SS office is already stretched to capacity, and the extra work involved would possibly mean that additional staff has to be employed. Option 3: Pooled fund with DFID directly procuring medicines via IPA, and using USAID’s DELIVER mechanism for distribution 9 Personal communication, DFID Programme Manager SSU 18 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 USAID intends to use DELIVER for the procurement, storage and distribution of essential medicines to the two States they support. A vertical supply system will be set up, whereby DELIVER is responsible for the whole chain, from the moment purchase orders are placed, up to delivery of medicines at county level. For the third Option, a pooled fund would be set up with which to procure medicines, and the procurement of essential medicines for the six states with DFID-funding would follow the mechanism as described under option 2. IPA would tender to contract a procurement agent, and be in charge of managing the supply chain until the medicines arrive in country (CIP Juba). At that stage, the responsibility would be handed over to USAID/DELIVER (see figure 5). In effect, the supply chain managed by IPA would join the USAID/DELIVER supply chain at central warehousing level, and from there DELIVER would take over storage, distribution & reporting (see Option 4 for a description of the second part of the supply chain). Figure 5: Pooled fund with DFID directly procuring medicines via IPA, and using USAID’s DELIVER mechanism for distribution (Option 3) Roles & responsibilities IPA’s role would be to manage the contract with the procurement agent, monitor the process with the procurement agent, arrange tax waivers, manage the hand-over of goods to DELIVER and provide regular reporting to DFID. DELIVER would be responsible for storage and onwards distribution to counties, including setting up a distribution channel, reporting of stock levels and consumption, and feeding back information. Selection & quantification of medicines would be harmonized with USAID, and one reporting system (incl. indicators) agreed upon. 19 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 DFID SS would be responsible for supporting the process of hand-over of medicines from IPA/procurement agent to DELIVER. Pros & cons The pros and cons of using IPA to carry out the procurement of medicines have been described under Option 2. The pros and cons of using DELIVER for the storage, distribution & reporting component are set out under Option 4. A major drawback specific to this Option is the fact that two supply chains managed by two different agencies will come together at Juba-level, while the medicines are possibly supplied by the same procurement agent (e.g. Mission Pharma or IDA, see figure 5). This increases the lines of communication and transaction costs, and enhances the risk of ‘bad linking’ between IPA and DELIVER at country level, which could lead to an over- or undersupply of medicines at warehouse or facility level. For this reason (as well as the fact that important advantages associated with DELIVER relate to the second part of the supply chain), the option of using DELIVER for procurement and IPA for the storage/distribution/reporting component is not considered. In addition, it would put considerable additional management burden on DFID, coordinating the two agents and two supply chains at central level. Option 4: Using a single source USAID DELIVER Project to procure and distribute the drugs to counties in all six States The fourth option entails DFID linking up with USAID and using the vertical lot approach managed by DELIVER for the procurement, import, storage and distribution of medicines. For this to happen, pooled funds or individual funds could be directed to USAID following agreement of MoUs between donors. Funds from the donors could in turn be channelled through USAID’s DELIVER mechanism, which is prequalified by USAID. USAID in turn would contract DELIVER to set up and manage the whole supply chain, providing medicines to the USAID and HPF-supported states (eight in total). DELIVER has five pre-approved wholesalers (amongst which MissionPharma, which has extensive experience in-country10) for the procurement of essential medicines, ensuring a quick process of contracting an agent. USAID/DELIVER would manage waivers for tax exemption and import of medicines. For storage, distribution & reporting, USAID/DELIVER would hire storage space at central or decentralized level, and contract local distributors to arrange transport to counties in all eight states. DELIVER plans to come to South Sudan in shortly to set up a detailed plan of implementation for USAID’s two states, which could possibly be extended to include storage, distribution & reporting of the DFID-funded medicines to 10 Other pre-approved wholesalers include Amstelfarma, Action Medeor, IDA foundation and UNICEF 20 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 the six states. It will do this in close collaboration with the MoH/DPS and the USAIDs supported programme Systems for Improved Access to Pharmaceuticals and Services (SIAPS) which provides technical support to the MoH directorate of Pharmaceuticals. Figure 6: Using a single source USAID DELIVER Project to procure and distribute the drugs to counties in all eight States (Option 4) Roles & responsibilities USAID/DELIVER would be in charge of the whole supply chain, from procurement, import, and storage until the delivery of medicines at county level. They would also report back to DFID on stock levels and drug consumption, and provide support with the possible adjustment of orders for the upcoming (e.g. 3-monthly) supply. DFID would provide information to DELIVER on quantity and type of medicines to be supplied to the six HPF states, and ensure funds are channelled to USAID in a timely manner. Pros & cons The advantages for the procurement component under this Option can be summarized as follows. USAID/DELIVER is not a general procurement agent, but is specialized in strengthening supply systems for essential health commodities and ensuring their sustainability, and has extensive in-house expertise related to every step in the supply chain for essential medicines (e.g. M&E of the system, ensuring transparency). 11 It has a successful track record in delivering timely quality services, including in DFID-funded projects, for instance in the emergency and longer-term supply of family planning commodities for USAID/DELIVER/DFID in Tanzania [USAID, Dec 2011]. DELIVER 11 http://deliver.jsi.com/dhome/topics 21 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 also has pre-approved a limited number of reputable procurement agents, which makes the process of contracting an agent considerably faster than when an international competitive bidding process has to be launched. This is estimated to save approximately two months (see figure 7), translating in two months less stock-out of essential drugs at facility level. As in Option 2 & 3, quality of medicines will be ensured through the use of reputable procurement agents (MissionPharma or IDA). The downside of the first component is that DELIVER charges a 5.5% fee rate, considerably higher than IPA. For storage, distribution & reporting, an important advantage is that DELIVER has local presence in South Sudan via USAID, which is the lead donor in the health sector. It has an in-depth knowledge and understanding of the particularly challenging local context, and close collaboration with key partners and GRSS. It is DELIVER’s core business to set up storage, distribution and reporting systems for health commodities, and it has extensive experience with this. In addition, companies that could be charged with storage and distribution of essential drugs are already prequalified with DELIVER and operate in South Sudan. Importantly, USAID has close links with the MoH/DPS through its SIAPS program, and this option ensures optimal collaboration with and involvement of the Ministry of Health.12 This maximizes opportunities for using existing national systems, facilitates obtaining information (e.g. updates on drug regulations) and permissions (e.g. for import and tax exemptions), builds capacity within the national system, ensures sustainability and increases the likelihood of the MoH taking over the responsibility when the program comes to an end. This set-up involves pooling of orders from both USAID and DFID/HPF into one streamlined harmonized system, with joint quantification, ordering, storage, distribution and reporting mechanisms. This simplifies communication, allows for more flexibility (e.g. temporary exchange between DFID/USAID stock if required) and most likely decreases transaction cost for both partners. It will also reduce the cost of medicines by obtaining economies of scale, and facilitates hand-over of (part of) the system to the Ministry of Health. Lastly, Option 4 provides scope for further discussions on spreading the available funding from USAID, Norway and DFID more equally over the eight (or ten) States. The Ministry of Health has stressed the importance of equitable distribution of resources, 12 USAID/SIAPS works closely with the MoH/DPS on selection and quantification of medicines and reporting on stock levels and drug consumption. Together with the MoH, it set up a continuous monitoring system in the two USAID-supported states capturing key indicators measuring performance of drug availability and management, which DELIVER would link up with. It is important to try and aggregate information that is available currently (e.g. from NGOs, MoH/SIAPS, JSI) and at the same time reinforce the existing PMIS/LMIS and expand a system (CMRS) recently set-up by the MoH in two USAID-supported states to comprehensively monitor stock levels, drug consumption and rational use that will be supplied through the emergency drug fund. Sentinel site monitoring using the MoH HMIS could be set up as part of the Health Pooled Fund. This information can then be used to adjust the content of the kits, start moving towards a push/pull system, and in the end ensure that medicines supplied match the actual needs of the population. 22 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 and pooling of funds for the procurement and distribution of a harmonized package of essential drugs will facilitate moving towards a more equitable supply. For DFID internally, risks & responsibilities can be shared between the two agencies (USAID and DFID), and this set-up will greatly decrease the administrative burden on DFID office. On the downside, DFID will have less control over the process and set-up of a system designed by DELIVER. For instance, DELIVER may opt for quality but expensive distribution options (e.g. airlifting a large amount instead of risking a delay in the supply of drugs) on which DFID has little influence. These issues should be clarified in the Memorandum of Understanding (MoU) between USAID/DELIVER and DFID. Table 1: Summary of pros and cons of IPA vs. DELIVER for the procurement and storage/distribution component Procurement Storage, distribution & reporting IPA DELIVER Pro Capacity: experience with medical procurement, incl. for DFID Transparency: KPIs, one agent responsible (Option 2) Quality: use of reputable Procurement Agents Cost: 2.95% fee rate Con Timeliness: int’l competitive tender – slower Capacity: mixed experience other projects DFID SS; will require significant input from DFID SS team who have limited capacity Capacity: extensive experience with medical procurement, incl. for DFID Transparency: established indicators, one agent responsible (Option 4) Timeliness: use pre-approved procurement agents – faster; Quality: use of reputable Procurement Agents Sustainability: close links with MoH/SIAPS; no fragmentation/one system; more equitable distribution of available resources Risk: shared with USAID Cost: 5.5 % fee rate Pro Capacity: experience with storage/ distribution/reporting systems; existing contracts with companies in SS Con Capacity: no local presence (yet) Capacity: local presence via USAID; extensive experience w storage/distribution/ reporting systems; existing contracts with companies in SS Sustainability: close links with MoH/SIAPS; no fragmentation/one system; equitable distribution of available resources Cost: shared with USAID 23 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 IPA DELIVER Sustainability: no established links with MoH; parallel systems DFID internal Pro Con DFID: strengthen framework agreement with IPA DFID: will require substantial support from DFID SS officethis may need additional HR in the office DFID: requires no additional HR DFID SS office DFID: less control over process Comparison of options When comparing the different Options in terms of capacity, Option 4 (using DELIVER for the whole supply chain) appears to be favourable for the procurement as well as the storage, distribution & reporting component. For transparency, both Option Two and Option Four score substantially higher than Option Three, as only one agent (i.e. IPA or USAID/DELIVER) is responsible for and have overview over the whole system. In terms of timeliness, projected timelines are visualized in figure 7. As shown, Option Four is expected to result in the quickest delivery of medicines, mainly because no International Competitive Bidding has to be launched. Option Three may experience further delays due to administrative procedures, especially around hand-over of medicines between agents (from IPA to DELIVER) at central level. Even under the speediest scenario – Option Four - medicines are not expected to arrive in country before February or March 2013. The final delivery of essential drug kits under the MDTF will take place around October or November this year and is expected to cover the basic needs of the population during three months; hence, there may be a gap in supply and approximately one month whereby facilities will face a stock-out of essential drugs. As soon as there is more clarity on the exact timeline and expected date of delivery of the emergency drugs, the state and county health department (through the MoH), as well as NGOs, should be informed of the situation, so potential gap-filling local procurement can be prepared, and available drugs can be rationed. Both IPA and USAID/DELIVER will make use of reputable Procurement Agents that will ensure quality of the medicines delivered. Possibly, delays due to problems with importation of medicines will mean that medicines are kept in sub-optimal storage conditions, which may affect their quality. Therefore, the likelihood of ensured quality of medicines may be slightly higher under Option Four. Option Four is preferred in terms of time and sustainability: it ensures integration with or involvement of national structures to the extent possible, minimizes fragmentation by harmonizing the USAID and DFID-funded supply of medicines to 8 states, and aims for an equitable distribution of available resources. Section C compares the options in terms of cost. 24 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Figure 7: Projected timeline under Option 2, 3 & 4 – from contracting to delivery at counties & facilities 25 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 B. Assessing the strength of the evidence base for each feasible option In the table below the quality of evidence for each Option is rated as either Strong, Medium or Limited Option 1 2 3 4 Evidence rating Strong Medium/High Medium/High Medium/High The evidence for Option 1 is strong: the scenario of doing nothing will undoubtedly result in increased mortality and morbidity in the six states. The evidence for Option 2, 3 and 4 is rated as Medium to High: DFID has a significant amount of local knowledge, the proposed systems for the procurement, storage and distribution of medicines are based on past experience with the Multi-Donor Trust Fund (MDTF) and USAID/ DELIVER’s track record in other contexts, and the link between outputs and outcomes is well established. What is the likely impact (positive and negative) on climate change and environment for each feasible option? Option 1 2 3 4 Climate change and environment risks and impacts, Category (A, B, C, D) C B B C Climate change and environment opportunities, Category (A, B, C, D) C C C C This BC is mainly about the procurement storage and distribution of essential drugs and medicines in a geographically defined area with poor infrastructure and facilities. The main possible risks associated with this intervention are around the storage and supply of medicines and the possibility that these may go astray, be used for purposes that are not recommended and/or being dispersed in the environment in a manner that could pose a level of threat. Disposal of medicines has an environmental risk especially in relation to the water supply, if handled, treated or disposed of incorrectly some medicinal products can poison people, livestock, wild animals, plants and whole ecosystems. More specifically, the main threat is generally posed by chemical and pharmaceutical wastes, especially large quantities. Some pharmaceuticals are toxic as well. In environmental terms, when chemical and pharmaceutical waste is disposed of in unlined landfills, especially unlined pits, these wastes may contaminate ground and surface water—particularly when large quantities are disposed of. This can also have a direct health impact on 26 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 people who use the water for drinking, bathing and cooking, as well as damaging plants and animals in the local ecosystem. Burning or incinerating healthcare waste, while often a better option than disposal in an unlined pit, may create additional problems (USAID, 2009; WHO, 2005). Furthermore, burning or incineration of healthcare waste may produce toxic air, pollutants such as acid gasses, Nitrogen Oxides (NOx) particulates. In the specific case of drugs and medicines, dioxins can be a concern. Dioxins have been proven to be potent cancer-causing agents; they do not biodegrade; and are persistent organic pollutants, meaning that they accumulate in progressively higher concentrations as they move up the food chain (WHO, 1999, 2004, 2005). In the context of this business case, different options have the potential to be more risky in terms of their level of security and safety in terms of storage and delivery and ensuring that the medicines/medical supplies reach intended recipients and are not disposed of inappropriately. Option 2 presents some level of risk and the possibility that some supplies may go astray during the storage, distribution and handling. It would require the set-up of a system capturing information on stock levels and consumption data. Option 3 would also involve a similar level of risk because of the proposed use of two supply chains managed by two different agencies, which would come together at Jubalevel. This method would not only increase communication and transaction costs, it would also enhance the risk of ‘bad linking’ between IPA and DELIVER at country level. Such a weakness in the chain of supply could in turn lead to an increased risk in mishandling and misappropriation of supplies that in turn could result in inappropriate usage and disposal of medical supplies and resulting environmental problems. Option 4 entails DFID linking up with USAID and using the vertical lot approach managed by DELIVER for the procurement, import, storage and distribution of medicines. USAID/DELIVER would be in charge of the whole supply chain, from procurement, import, and storage until the delivery of medicines at county level. This would likely reduce the risk of mishandling supplies and would facilitate monitoring of movements of supplies thus making it easy to identify possible mishandling of supplies and implement remedy measures. USAID/DELIVER has also successful track record in delivering timely quality services, including in DFID-funded projects and an established local presence in South Sudan via USAID, which is the lead donor in the health sector. Furthermore implementation through USAID as a main partner would likely simplify and speed up the communication process and taking of remedial action if needed through well-established channels of communication and co-operation that have already been tested in several countries and a variety of fields. References: 27 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 USAID (2009): Environmental Guidelines for Small-Scale Activities in Africa; USAID Bureau for Africa Office of Sustainable Development Economic Growth, Environment and Agriculture Division Washington, D.C. WHO (1999): Guidelines for safe disposal of unwanted pharmaceuticals in and after emergencies. World Health Organization, Geneva (http://whqlibdoc.who.int/hq/1999/WHO_EDM_PAR_99.2.pdf). WHO (2004): Findings on an Assessment of Small-scale Incinerators for Health-care Waste. World Health Organisation – Geneva. WHO (2005) Management of Solid Health-Care Waste at Primary Health-Care Centres: A Decision-Making Guide. World Health Organization, Geneva (http://www.who.int/water_sanitation_health/medicalwaste/decisionmguide_rev_oct06.p df) 28 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 C. What are the costs and benefits of each feasible option? In order to determine the type and quantity of medicines to be procured, the first part of the costing section describes the process of selection & quantification of priority medicines. Then, the costs and benefits of each of the four identified options are outlined below. All costs are calculated to cover a limited supply of medicines for a one year period (approximately March 2013 – March 2014), and costs will be incurred in the second half of 2012/first half of 2013. C.1 Selection of priority medicines Medicines procured under the current proposal are intended to cover the basic health need of the population in the six HPF States. In light of limited resources, only the priority medicines for the treatment of the top causes of morbidity and mortality will be purchased. This selection is based on data from the USAID SIAPS programme, MoH and MDTF data was used to support the costings applied for each of the medicines. The final list will depend on the quantity of funding available. Additional funding from USAID and Norway will help cover additional medicines for the other states and depending on the amount of funding available will support a larger list of medicines. The selection of priority drugs is being developed through a consultative process with key stakeholders: the Ministry of Health/ Department of Pharmaceutical Services (MoH/DPS), USAID/SIAPS, USAID, DFID and the World Bank. Various lists have been circulated, ranging from a very narrow selection of tracer drugs to the full MoH essential drug list (EDL). A final harmonized list has not yet been agreed upon between the partners, and for the sake of this Business Case the first three of the following lists of essential medicines/supplies have been costed for the six HPF states: 1. 2. 3. 4. Selection of 14 tracer medicines (MoH PMIS) Selection of 44 essential drugs (WB selection) Selection of 44 essential drugs & 21 medical supplies (WB selection) Selection of 220 drugs and supplies (MoH EDL) Key partners – MoH, USAID, DFID and the WB – are working together to harmonize and agree on the list of medicines to be supplied to each of the counties, in order to harmonize medicines to be supplied, ensure equitable distribution of resources & supplies and simplify the management of the supply chain. Annex 1 shows the medicines included in each of the first three lists, and Annex 2 explains the methodology used for quantification of the medicines and commodities to be supplied to hospital, health centre and health unit level to cover the basic needs of the population in the six states during one year. 29 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 C.2 Costs Medicine cost It has been mentioned that both IPA and DELIVER may select MissionPharma as the preferred procurement agent for this intervention due to their experience in South Sudan, and prices from other agents (e.g. IDA) do not differ dramatically from these. Therefore, unit prices quoted by MissionPharma for MDTF’s Limited International Bidding (LIB) in 2009 with delivery CIP Juba by sea/truck were used as a starting point to calculate the price of the medicines procured with the emergency fund. From 2009 to date, some commodities have experienced huge fluctuation and there are several factors that drive up the unit prices when drugs are purchased today compared to 2009. These include: 1. An increase in the price of oil (Oil Index Oct 2009 USD 84 vs. May 2012 USD which impacts on commodity prices and freight; 2. Commodity cost Indexes in sourcing market have increased Year on Year; 114) On the other hand, the USD has become stronger towards the Indian Rupee (where most medicines are purchased) in the period, lowering the USD cost increases; Based on the above factors, an additional 11% has been added to the prices quoted in the 2009 LIB in order to come up with an estimate of the medicine cost.13. However, the current emergency order does not include infusions and fluids (less freight cost), again decreasing the price. See also the sensitivity analysis below, which assesses cost-effectiveness when the estimate (11%) is varied. As the final decision on which medicines will be purchased has not been taken yet, the cost of the medicines has been calculated for three different lists: 1. Only the tracer drugs are purchased (14 items), 2. 44 essential drugs only 3. 44 essential drugs and 21 supplies.14 As only some of the unit prices for the longer list of 220 items could be obtained, this selection of drugs has not been costed at this stage. In addition it is unlikely that sufficient funds will be available to pursue the procurement of the full list for the six states. For the costing of this business case, the list consisting of medicines & supplies (65 items in total) is used as it has been discussed previously between then MoH and the WB and it provides a list of essential medicines and items that will allow many of the common conditions in children and pregnant women to be treated for the purposes of this costings exercise. 13 These percentages are based on estimates of price increase made by MissionPharma [personal communication] 14 The unit cost of seven supplies could not be obtained, hence a gross amount of $150,000 has been added to the final cost to include an estimate of these cost. This amount is based on the cost price (unit x quantity) of similar items included in the list (e.g. umbilical tape & adhesive tape). 30 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Table 2: Estimate of medicine costs based on different selections/number of items for the six States covered by the Health Pooled Fund Tracer drugs Essential drugs Essential drugs + supplies EDL MoH Number of items 14 44 65 220 Total price (2009-prices) $1,494,456 $4,468,281 $6,230,223 $1,658,846 $4,959,792 $6,915,548 + 12% adjustment * * For costing of the different options, only the process costs is known to differ between Option 2 & 3 on the one hand, and Option 4 on the other, differ. For procurement, IPA applies a 2.95% surcharge fee to the commodity costs, while DELIVER applies a 5.5% surcharge fee on the commodity cost (see table 3). Storage & distribution cost There are many more uncertainties around the estimate of costs related to storage and distribution. For example, the limited costing data that could be obtained from previous storage & distribution cycles (MDTF costing data, Jan 2010) are in South Sudanese Pounds (SSP), and this part of the in-country supply chain will for the current emergency medicines fund also most likely be paid in SSP. Inflation in the country has been very high, with an historical inflation rate of 83% [CPI index Jan 2010 – Jan 2012]15, and a projected inflation rate of 100% until Jan 2013 (Jan 2012 – Jan 2013; IMF)16, when expenses on storage & distribution will likely be incurred. In light of the limited data available from previous storage & distribution cycles for essential drugs; the very high inflation rate which may render predictions on prices to be paid in SSP unrealistic 17 ; lack of information on the volume & weight of the quantified medicines; and the fact that a detailed plan of implementation of the incountry supply chain is not yet available, the current estimate for storage & distribution cost is taken as a percentage of the value of the medicines. Typically, this part of the supply chain represents around 12-13% of the total value of drugs.18 This was also the case in South Sudan, where one instalment (3-months) of essential drugs supplied by MDTF cost around $ 6 million, and around $ 700,000 – 800,000 (including partial air-lifting) was paid for off-loading, storage and distribution (12.5%). On the other hand, however, there are examples where this part of the supply chain represents 100% of the medicines value (e.g. a recent distribution by DELIVER Aggregate Consumer Price Index South Sudan – all item index: Jan 2010 = 74.75, Jan 2012 = 135.6. http://ssnbs.org/cpi/2012/5/12/consumer-price-index-for-south-sudan-april-2012-2.html 16 International Monetary Fund (IMF): Briefing of donor community, March 2012, South Sudan 17 The cost data for off-loading, storage & distribution made in Jan 2010 for MDTF-drugs were converted to cost to be paid in Jan 2013, and adjusted for the smaller quantity and only 6 states. The final cost for storage & distribution came to > 100% of the medicine price, which seems, even in the context of South Sudan, unrealistically high. 18 Personal communication; information from DELIVER May 31,2012; examples from other countries e.g. vertical supply chain for GF-funded medicines in DR Congo; 15 31 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 in two states in Nigeria)19, and uncertainties around the context in South Sudan and possible hyperinflation can easily cause a steep rise in costs incurred. For these reasons, an average percentage mark-up for storage & distribution is varied between 15% and 90%, with an average of 60%. Table 3: Different estimate of costs for off-loading, storage & distribution Value of medicine Storage & distribution Technical Assistance + 4% TOTAL – storage & distribution Estimated average – 60% Lower estimate – 15% Higher estimate - 90% $6,915,548 $6,915,548 $6,915,548 $4,149,329 $1,037,332 $6,223,993 $165,973 $41,493 $248,960 $4,315,302 $1,078,825 $6,472,953 IPA has a fixed fee structure for capacity building and technical assistance, which would be applied to all storage & distribution costs. This will be calculated on a caseby-case basis, and at this stage it was not possible to obtain a reliable cost estimate. For technical assistance (distribution, storage, warehouse, etc.) DELIVER applies a 78% (based on US Negotiated Cost Rate Agreement-NICRA) overhead charge on US home based salaries and expat salaries. Overhead is not applied to local hire salaries. It was confirmed that these costs are included in the storage & distribution cost (so part of the 60/15/90% mentioned above). Finally, DELIVER applies a 4% fixed fee (corporate fee) to the sub-total. Due to the lack of further detailed costing information, for this Business Case it is assumed that the fee charged by IPA and DELIVER for Technical Assistance on storage, distribution & reporting is the same. 19 Phone call DELIVER, May 31 2012 32 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Table 4: Expected resource costs of the intervention Option 1: Counterfactual Option 2: Procurement IPA, storage & distribution IPA Option 3: Procurement IPA, storage & distribution DELIVER Option 4: Procurement, storage & distribution DELIVER Medicines: 2009 prices – 65 items - $6,230,223 $6,230,223 $6,230,223 +11% - $6,915,548 $6,915,548 $6,915,548 Procurement 2.95% 2.95% fee Procurement $7,119,557 $7,119,557 sub-total Storage & $4,149,329 $4,149,329 distribution @60% Technical $165,973 $165,973 Assistance Storage & $4,315,302 $4,315,302 distribution sub-total TOTAL $11,434,859 $11,434,859 (USD) TOTAL £7,559,014 £7,559,014 (GBP)* * www.oanda.com 1 USD = 0.66105 GPB (May 20, 2012) 5.50% $7,295,903 $4,149,329 $165,973 $4,315,302 $11,611,205 £7,675,587 For budgeting purposes, it is important that the estimated range of funding required is taken into account. If the storage / distribution component cost only 15% (the lower bound estimate) the total cost of providing essential medicines to the 6 states would be £5,284,680, whereas if it were 90% (the upper bound) it would cost £8,850,469. £10 million funding is therefore provided by DFID in order to ensure that the basic list of medicines can, with some certainty, be procured, with any additional funding available, plus the Norwegian finance then be used to purchase medicines from the longer MoH EDL list, and/or to support the World Bank supported states, as required. C.3 Benefits The costs associated with the four options need to be balanced with the benefits – both quantifiable as well as non-quantifiable – each of the scenarios brings. The quantifiable benefits relate to the effect that availability of essential drugs has on extending healthy, economically productive lives. These can be measured in disability-adjusted life year (DALY), which reflect overall disease burden and are expressed as the number of years lost due to ill-health, disability or early death. These DALYs are discounted for the different options based on the capacity of the system to deliver quality medicines in a timely manner. 33 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 The non-quantifiable benefits aim to describe how the options differ in terms of transparency and sustainability of the system. Quantifiable benefits The quantifiable benefits of the intervention (Option 2 & 3) are compared to the counterfactual ‘do nothing’ scenario. For this exercise, a conservative estimate of the quantifiable benefits of the intervention is made using WHO CHOICE data for selected childhood illnesses (in particular, diarrhoea and ALRI) and malaria (see table 5 and www.who.int/choice/results/afre/en/index.html). The interventions, in bullet points below, are selected as they address major causes of morbidity and mortality in South Sudan [MoH 2011] for which the current Emergency Drug Fund provides medicines, and are costed by WHO CHOICE. UFV-58: Package of treating children under 5 years with Vitamin A, zinc and oral rehydration therapy UFV-7: Case management of Acute Lower Respiratory Tract Infection (ALRI) in children under five years MAL-42: Provision of intermittent presumptive treatment for pregnant women MAL-47: Case management of artimisin-combination therapy The intervention targets the population in six states, covering approximately 4.5 million people [SSCCSE 2011]. The DALYs derived from WHO CHOICE are adjusted as coverage under WHO is assumed to be 50% - which in the context of South Sudan, may be overly optimistic. Hence, DALYs averted are adjusted down to reflect 30% coverage (in line with HPF business case). Then, WHO CHOICE provides data per 1 million population and the total DALYs averted are multiplied by 4.5, to reflect the number of people that are covered by the Emergency Fund. Were extra states covered with any remaining finance, this would increase the number of people funded beyond this level, making this a conservative estimate of the extent of the benefits to be achieved. In addition, the drugs that are provided are intended to treat a whole range of illnesses. The diseases mentioned in table 5 represent only part of the illnesses treated with the drugs supplied, and therefore give a conservative estimate of the DALYs averted in reality. This is particularly conservative because this is not only a sub-set of the illnesses which can be treated with the essential list of 63 drugs to be procured, it also fails to capture any benefit from any treatments provided from the longer list of drugs that may be purchased, depending on the cost of procuring the essential list. The DALYs averted in the ‘do nothing’ scenario is set at zero: if medicines are not provided, most illnesses cannot be treated and DALYs not averted. As the medicines that will be provided under each option are the same, the DALYs averted across the different options at this stage are set as equal. 34 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Table 5: Expected benefits (in DALYs averted) of the intervention Option 1: counterfactual UFV-58: Vit. A + Zinc + ORT (@ 50%) UFV-7: Case management – ALRI (@ 50%) MAL-42: Intermittent presumptive treatment in pregnancy (IPTp) (@ 50%) MAL-47: Case management with artimisinin-based combination therapy (@ 50%) TOTAL Option 2, 3 & 4: intervention DALYs averted per year per 1 million population Adjusted for @30% coverage DALYs averted in target population (approx.. 4.5 million) - 10,780 6,468 29,106 - 4,389 2,633 11,850 - 91 55 246 - 9,112 5,467 24,602 0 65,804 Subsequently, the different options were assessed in terms of the capacity of a system to deliver quality priority medicines in a timely manner. Following the options appraisal (see table 1), the capacity of the system under Option 2, 3 and 4 is estimated at 80%, 80% and 90% respectively (experience vs. extensive experience, local presence, possible bad linking between agencies for Option 3). The quality of the medicines supplied under all three options is assumed to be optimal (100%), but as a result to potential delays with hand-over of drugs between agents, some quality may be lost due to sub-optimal storage conditions (Option 3, 90%). In terms of timeliness, Option 4 is expected to result in the quickest supply at country level (see table) even though a some stock-out may still occur (95%), followed by Option 2 (75%, 2 months delays) and then Option 3 (65%, 3 months delay). The DALYs averted, discounted with the estimated overall likelihood that quality medicines will be delivered in a timely manner under the different options, are summarized in table 6. Non-quantifiable benefits For Option 1 – the ‘do nothing’ scenario’, the non-quantifiable benefits for this Business Case are negative. In South Sudan there is already a very low per capita use of health care. If health facilities are faced with a prolonged shortage of medicines, this will undoubtedly further negatively affect health-seeking behaviour. Also, lack of medicine to prescribe will be demotivating for health workers, which may further deteriorate quality of care provided. In addition, it is likely to reduce the impact of the Health Pooled Fund, which commences in 2013 and aims to increase access to quality health services. Conversely, the other options will have a synergistic effect with the Health Pooled Fund. 35 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 There is of course always the benefit of funding being available for other uses. However, in light of the dramatic effect the counterfactual scenario would have, it is not likely that funding of other activities would result in more benefits. Option 2, 3 & 4 In terms of transparency, both Option Two and Option Four score substantially higher than Option Three, as only one agent (i.e. IPA or USAID/DELIVER) is responsible for and has an overview over the whole system. The fact that one experienced entity is responsible for the whole supply chain – including procurement, import, storage, distribution and reporting –is more transparent, increases efficiency and simplifies the system, thereby decreasing the risks of delays, over- or undersupply, irrational drug use, wastage and leakage of medicines and funds. For sustainability, Option 4 is preferred: it ensures integration with or involvement of national structures to the extent possible, minimizes fragmentation by harmonizing the USAID and DFID-funded supply of medicines to 8 states, and aims for an equitable distribution of available resources. One harmonized supply chain, which is closely linked and partially integrated with the national system, builds capacity of counterparts and has a much higher likelihood of being handed over, increasing sustainability. For DFID internally, risks and responsibilities will be shared with USAID, and no additional staff needs to be hired. Table 6: Discounted DALYs averted, according to the likelihood of timely delivery of quality medicines under the different options Option 1: counterfactual DALYs averted – not discounted Capacity of system Quality medicines Timeliness Overall DALYs averted – discounted 0% Option 2: IPA/ IPA Option 3: IPA/ DELIVER Option 4: DELIVER/ DELIVER 65,804 65,804 65,804 80% 100% 75% 60% 80% 90% 65% 47% 90% 100% 95% 86% 39,483 30,796 56,263 C.3 Costs vs. benefits Subsequently, it was assessed which of the options represents best Value for Money, i.e. would give most benefits for the costs incurred. Table 7 shows the expected costs and benefits of the different options. The cost given is £10 million (or $15.1 million), the proposed budget, which should cover the essential drug list in 6 HPF states (estimated at maximum £8.8 million), plus some contingency which should allow procurement of a longer list of drugs and/or reaching out beyond the HPF states, with precise decisions 36 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 on the allocation of this finance to be made as the situation on the ground evolves. The benefits are the DALYs anticipated by each option as calculated above. It appears that Option 4 – using a single source USAID/DELIVER supply chain – represents best Value for Money, and also has a number of non-quantifiable benefits that should be taken into account. For instance, the higher likelihood that the system that would be set up under this option is successfully handed over to the Ministry of Health cannot be put into numbers, but is crucial for the longer term impact of the intervention – which also covers the Health Pooled Fund – beyond the one-year funding for essential drugs. And even without taking these factors into account, Option 4 comes out most preferable in this analysis compared to the other options. Table 7: Summary – expected costs & benefits of the four options Estimate total costs Benefits – quantifiable Cost per DALY averted Benefits – nonquantifiable Option 1: counterfactual Option 2: IPA/ IPA Option 3: IPA/ DELIVER Option 4: DELIVER/ DELIVER 0 $15,127,449 $15,127,449 $15,127,449 0 39,483 30,796 56,263 - $383 $491 $269 Negative – decrease in healthseeking behaviour, quality of care affected Transp arency Transpa rency Sustain ability DFIDinternally It should be noted that this likely to be a significant underestimate because while the full costs to DFID are included, the benefits are not. The DALYs produced are based upon just a small sub-set of the drugs to be purchased, and cover only the six HPF states. With the finance anticipated to be remaining once these costs are met (at least £1.2 million, but possibly significantly more) additional drugs will be purchased and/or a wider population reached. While these benefits cannot be included in these calculations (given that it is unclear how much money will be available and decisions on its use will be made at the time based on need), they mean that the true cost per DALY averted can be comfortably said to be lower than each of the three figures provided here. A final assessment examines if the options outlined above represent good Value for Money compared to external benchmarks. One way of assessing this is to compare GNI20 per capita to estimate cost-effectiveness thresholds. According to this approach, interventions are: GNI per capita rather than GDP per capita is used, as the latter includes estimates of South Sudan’s significant oil wealth, which in 2010 accounted for about 71% of GDP. GNI excludes oil revenue. 20 37 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Very cost-effective – if they avert one DALY for less than the average GDP per capita income for a given country or region Cost-effective – if they cost less than three times average per capita income per DALY Not cost-effective – if they exceed three times average per capita income In 2010 GNI per capita was approximately $984. 21 When using this figure as a threshold, all three options appear to be very cost-effective and represent good Value for Money. In light of the current oil crisis, the GNI could fall substantially during the coming period, possibly even halve ($ 500 per capita). Even in that case, the intervention remains very cost-effective for all three options, with the preferred option falling very comfortably below the limit22. Sensitivity analysis Lastly, a sensitivity analysis was conducted by testing the robustness of the findings outlined above. Assumptions underlining key drivers of cost and benefits were adjusted either up or down, and the impact was evaluated on the Value for Money/ Cost per DALY averted. On the cost side, one key assumption used is that the unit cost of medicines has increased by 11% between 2009 and 2012, and this parameter was change to 8% and 16%, respectively. The other key cost driver already tested is the cost for storage and distribution, here represented as a percentage of the medicines’ value. As before, the effect on the Value for Money of changing the 60% estimate to 15% and 90% is tested. However in both cases adjusting the parameter in question did not raise the cost of procuring the desired minimum set of drugs (WB essential list) for the intended minimum population (HPF 6 states) above £10 million. This means that the ‘loss’ in benefits would only be to the extra population to be reached, or the extra drugs to be procured with the remaining finance. These were unquantified benefits, not captured in the cost per DALY calculation provided above, meaning that the cost per DALY would still not be expected to rise above $269. Key assumptions reflecting the benefits of the emergency drugs can be affected in various ways. For one, the coverage is set to an already low estimate of 30%. However, a possible escalating border conflict, food insecurity and displacement of people can further deteriorate attendance rates at health facilities. In addition, shortage of cash of the South Sudanese government may mean salaries of health workers are not paid, resulting in an exit of qualified staff, and a drop in health service provision and corresponding attendance rates. The unstable context may also affect the likelihood that medicines are delivered on time, e.g. it will be impossible to reach certain areas, 21 http://ssnbs.org/home/2011/8/11/release-of-first-gdp-and-gni-figures-for-south-sudan.html Indeed, even if the Norwegian finance is also included, taking the total expenditure to over $25 million, the cost per DALY averted still only reaches $457, with massive uncounted benefits resulting from the extra population and drug purchasing reach associated with the Norwegian finance. It is clear that allocating money towards the purchase of essential medicines represents excellent value for money in the South Sudan context. 22 38 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 nationwide lack of fuel for distribution, and a higher risk of leakage. As the current context is more likely to affect the benefits in a negative rather than a positive manner, the analysis veers towards the lower estimates. As shown in table 8, a key driver determining Value for Money of the provision of the emergency drug fund is the coverage rate: the cost per DALY averted increases to $535 when coverage is only 15%. This means it is of utmost importance that the project places considerable attention to maximize the extent to which medicines can actually reach those in need, and those in need can reach the medicines at the health facility. It should be noted nonetheless that even with this risk reaching its outer predicted limit, the intervention still represents very good value for money under any circumstances except almost total economic meltdown (when GDP per capita is predicted to fall as low as $500 per capita). However even in that scenario it would still be rated as cost effective under WHO guidelines. Table 8: Sensitivity analysis on key drivers of benefits under Option 4 Actual Lower estimate Higher estimate Impact on cost/ DALY averted Benefits Coverage rate 30 % 15 % 35 % [ $535 – $229 ] Likelihood of timely supply 86 % 70 % 100 % [ $328 – $230 ] D. What measures can be used to assess Value for Money for the intervention? The analyses from the appraisal in Section C are used to set out relevant and sensible Value for Money measures. Indicators to monitor both costs as well as the benefits are outlined below. In terms of cost, the total amount spent on the procurement of essential medicines & supplies for one year is a key indicator. Then, the cost for off-loading, storage, and distribution are another indicator, as is the money spent on Technical Assistance. As the sensitivity analysis shows, especially the inflation rate and storage & distribution are key cost drivers, which should be closely monitored. The benefits of the intervention can be monitored according to the critical factors identified to evaluate the different options: the capacity to set up a transparent system for procurement, storage and distribution and ensure timely supply of quality priority medicines, in a sustainable manner. Indeed, the sensitivity analysis demonstrates that the likelihood of timely supply of quality drugs is a key driver of benefits obtained, and therefore Value for Money. Proposed indicators to measure with each of these factors are outlined in table 9 below. 39 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Table 9: Proposed indicators to assess Value for Money for the Emergency Drug Fund Indicator Current estimate Actual (end Year 1) Cost 1. Cost of medicines procured $6,230,223 2. Cost for off-loading, storage, distribution & reporting 50% of commodity cost 3. Fee: Technical Assistance 4% of cost (2) Benefits Capacity: Transparency: Timeliness: Quality: Sustainability: 100% of medicines procured arrive at county level At any point, DFID has overview of funding spent and location of medicines No delays in import of medicines at customs No delays in distribution of medicines to county level 100% of medicines entering the country have proof of adherence to stringent quality criteria Hand-over of (part of the) supply chain to MoH at the end of the project The indicators can be tracked through Annual Reviews or Project Completion Reports in order to help indicate whether the intervention continues to represent good Value for Money. E. Summary Value for Money Statement for the preferred option The costs and benefits of feasible options identified for the emergency medicines fund in South Sudan have been assessed in terms of the capacity of the system to deliver quality priority medicines in a timely manner. The preferred Option 4 would be using a single source USAID DELIVER Project to procure and distribute the drugs to counties in all six States. The costs and quantifiable and non-quantifiable benefits of this Option have been evaluated, and it appears that the preferred Option represents very good Value for Money according to WHO criteria: on average $208 per DALY averted, which is considerably less than the per capita GNI of $984 [2010 figure]23. It evens remains 23 According to WHO approach interventions are: Very cost-effective – if they avert one DALY for less than the average GDP per capita income Cost-effective – if they cost less than three times average per capita income per DALY Not cost-effective – if they exceed three times average per capita income23. GDP per capita in South Sudan is USD $1,546 (2010 figures). However this figure is misleading. The GDP figures are relatively high because they include estimates of South Sudan’s significant oil wealth, which is 2010 accounted for about 71% of GDP. Now that extraction has been temporarily suspended GDP is very different. However, even when the oil was flowing, the associated revenues provided only marginal benefits for the population outside the capital of Juba. A more conservative number can be derived by using GNI per capita (2010) instead of GDP to compare against. GNI excludes oil revenue which goes to foreign firms and governments and is estimated at USD $984. This statistic reflects better the benefit that national income delivers to the population in times when the oil is flowing. It will be over optimistic if oil production does not re-start and no alternative sources of revenue are found, but in this context it is worth noting 40 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 very cost-effective if the GNI drops dramatically over the coming period, as it is expected to do as a result of the oil shutdown. In addition, there are a range of nonquantifiable benefits, which include creating a transparent, efficient and simple drug supply system, whereby DFID and USAID share risks, and which maximize sustainability. A sensitivity analysis showed that even when assumptions of key drivers of costs or benefits are altered, the intervention remains to represent very good Value for Money. that the question of whether the cost of each approach constitutes good value for money under this estimate is not marginal. 41 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Commercial Case Indirect procurement A. Why is the proposed funding mechanism/form of arrangement the right one for this intervention, with this development partner? The options appraisal concludes that best VfM is achieved by providing funding to USAID who will use their DELIVER funding mechanism to manage drug procurement and distribution. Whilst on purely quantitative terms this mechanism is slightly more expensive than using IPA for procurement and distribution there are a number of key reasons why this offers the best VfM in non-quantitative terms: 1. IPA will require significant support from the DFID South Sudan team and in particular the health team- in particular this will require intense support defining distribution schedules, working with MoH to define the medicines list and in promoting and ensuring tax exemption etc. DFID South Sudan does not currently have the capacity to support this. 2. Avoidance of a fragmented system- use of DELIVER will help support one mechanism of medicine procurement and distribution across most of the country. 3. Improved burden and risk sharing between donors. 4. USAID has ongoing presence in the MoH pharmaceutical division through their technical assistance programme SIAPS and 5. The presence of the global contract with John Snow International (JSI) for management of the DELIVER mechanism- this mechanism has been known to deliver medicines in a number of difficult contexts. USAID are the largest bilateral donor in South Sudan. Their programming is executed under the auspices of a Country Transition Strategy (2011-2013). There is no fixed budgetary framework because the value of annual assistance is conditional on central policy objectives (framed in USAID headquarters in Washington DC) and Congressional approval. However in US fiscal year 2011 the overall expenditure on South Sudan was USD 298,332,000 of which Health expenditure was USD 44,874,000. The DELIVER mechanism is a global facility for the fast supply of high quality drugs and pharmaceuticals. JSI won the management contract through a competitive tender following a USAID request for proposals. JSI charge a management fee of 5.5% and DFID will have to pay this (but this is offset by the negation of the local overheads fee for which USAID have agreed a waiver) The DELIVER Programme is linked to a global Performance Measurement Plan which includes a set of progress indicators which are reviewed annually. These performance measurement indicators include value for money as one of the assessment criteria. On auditing, JSI are instructed to sub contract a reputable ‘big five’ accounting firm to 42 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 conduct an annual financial audit. USAID also conducts internal monitoring: the Inspector General will normally assess one or two sample projects a year in a country programme (this does not guarantee of course that the South Sudan Emergency Medicines Fund will be one of the selected sample projects but DFID can seek to influence the USAID decision on this if we have a particular concern on use of our funds). Globally, DFID has no reason to doubt the effectiveness or rigour of USAID internal auditing arrangements and DFID has entered into bilateral agreements with USAID on DELIVER in Tanzania and Malawi. USAID does not hold a national risk assessment plan to the same degree as DFID South Sudan. It does however conduct specific checks on the possible diversion of project funds for the support of terrorism. Contracts include rigorous financial requirements which should mitigate USAID (and partner donors) from the mis-use of funds for non -project purposes. If there is any reason to terminate the South Sudan component of DELIVER this should be achievable (with the authorisation of USAID headquarters) without affecting the global status of the DELIVER contract (e.g. a poorly performing South Sudan component could be terminated but a well performing component of the global contract, hypothetically in Tanzania, would not be affected). DFID can also withdraw from the agreement without it affecting DELIVER globally. This project is not intended to provide long term capacity support to the Ministry of Health, etc, but is an emergency response initiative. However complementarity will be developed between the Fund and a separate USAID funded initiative which has embedded technical support to the Ministry of Health’s procurement department. In conclusion there are clear commercial reasons from operational and value for money perspectives for selecting USAID as the manager of DFID’s contribution to the Fund. 43 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Financial Case A. What are the costs, how are they profiled and how will you ensure accurate forecasting? The expected cost of the DFID contribution is £10 million over 1.5 years (from August 2012 to January 2014 ). 2012/13 2013/14 Programme 7 million 1.5 million Capital 1 million 0.500 million B. How will it be funded: capital/programme/admin? Programme and Capital (storage and warehousing) funded. However the exact proportion of Capital to Programme will be confirmed following discussions with USAID and DELIVER which is implemented by John Snow International. The total value of the Fund is contingent on confirmation of an additional contribution from Norway and additional funding from USAID above the 10m USD made available for the two states that they support. At the time of writing the expected donor funding profile looks like this: Donor USAID DFID Norway STG TOTAL USD 16,000,000 9,000,000 £ ( rate of 0.64378 ) 10,300,500 10,000,000 5,794,040 26,094,540 C. How will funds be paid out? Funds will be paid by DFID to USAID on receipt of a formal request. This will include a financial statement of need for the forthcoming period. Payments for procurement of goods will be made in compliance with USAID Procurement Policy. DFID will make one transfer of £10 million to USAID. DFID funds will be deposited in the US Treasury and will then be drawn down by John Snow International. We have a written assurance from USAID that these funds will only be drawn down in arrears for any management costs incurred by JSI thereby ensuring that this transfer ( which is technically in advance) would not be in breach of Blue Book rules on advance funding. USAID has requested that all of the DFID contribution to be transferred in advance because the USAID/DELIVER Project does not have a facility to forward finance the purchase of pharmaceuticals (categorised by USAID as MCH- 44 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Maternal and Child Health). Funds are therefore required to be deposited in advance so that JSI have the necessary assurance to begin procurement processes through the placement of orders for specified drugs. There is essentially therefore a two- step process: funds are ‘obligated’ in to the JSI contract which makes funds available to them; and JSI then draw down on the account set up for them through their letter of credit as they spend the funds USAID states that: ‘JSI can draw funds as soon as an obligation is added to the Contract. This includes any startup funds needed. However, the only instance where funds are drawn in advance of expenses being incurred is to start operations in country. In that case, JSI draws funds based on a detailed cash flow projection submitted by the project that includes all expected expenses and accruals to be paid over the next month. JSI HQ then sends the requested funds to the field office to be disbursed.* In all other instances, before JSI draws down funds, they have to have received a vendor invoice, which is then given to their Project Administrators for approval as well as providing the supporting documentation (Purchase Order, Proof of goods delivery, etc.). On a weekly basis, the accounting department gathers all invoices, enters them into the accounting system, and prepares “prepayment edit” reports showing the dollar amount to be charged to each project/task order. JSI then completes a spreadsheet that shows the Contract Obligated Amount, MINUS the amount drawn to-date and ONLY draw the difference. Once they confirm receipt of the amount drawn into their bank account, they make sure to pay the vendors within 72 hours (3 business days). At the end of each month, they do another draw down that for other costs such as Direct Labor, etc. JSI draws actual cost only for expenses incurred during the month. They complete a final draw at month end that includes the fee due for the costs incurred during the month.’ (*NOTE: JSI will be opening an office in South Sudan. However, the ‘advance’ of funds to the field office would essentially be a bank account transfer, making funds available to the field office to be spent the same way they are at the JSI Washington DC office- as expenses are incurred, with the management costs and fees drawn down at the end of each month) The Instrument for transfer of funds will be a trilateral Joint Financing Arrangement (JFA) between USAID (the Lead Donor), DFID and Norway. This is likely to be based on Nordic Plus principles and template USAID will hold the contract for management of the implementing partner- John Snow International and will supervise the programme. They will provide reports back to DFID (and Norway) every six months. Reports will be available no later than 30 days after the end of every six months. If the programme is terminated early, through no fault of the implementing partners, USAID, using its procurement policy and guidelines, will give back any unspent funds to DFID. 45 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 DELIVER is funded through a letter of credit agreement with the US Government. Sub recipients of DELIVER invoice on actual for reimbursements. Procurement and transport are paid once the product is delivered, however in some cases vendors want a down payment on procurement purchases whereby the remaining balance is paid out once the procurement is delivered. D. What is the assessment of financial risk and fraud? As most of the procurement will be done using USAID systems (including US Treasury) and the Implementing Agency (John Snow International) are governed by USAID financial regulations we judge the overall level of fiduciary risk for this programme to be low given the extensive financial controls in place for USAID contract management. This judgement is based on DFID’s corporate knowledge of USAID globally, satisfactory experience of working with and through USAID systems in comparable contexts (e.g. in Tanzania). Any potential risks of using these instruments as opposed to DFID- managed commercial contracts will be mitigated through the use of six-monthly tranched releases to USAID, based on six monthly financial and progress reports that are reviewed by programme staff, to ensure that the services provided are appropriate and of high quality and to ensure that funds are released only on clear evidence of financial need. In terms of USAID’s management of fiduciary risk- partners such as DELIVER are required to exercise accountability and to put in place performance and internal controls measures to mitigate corruption. This includes some of the following: frequent physical count of inventory, increasing the visibility of the supply chain, reducing inventory holding points if appropriate, ensuring appropriate warehouse security, conducting monitoring visits to relevant supply points and meeting with key stakeholders, carrying out a zero tolerance policy for corruption with staff and sub-contractors. Additionally, funding balances and expenditures are closely monitored by both DELIVER HQ and the field office. 46 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 E. How will expenditure be monitored, reported, and accounted for? Rigorous monitoring and accounting of expenditure will take place using ARIES in accordance to the ADAMANT principle to ensure value for money and compliance with Blue Book requirements and programme arrangements. USAID will monitor and account for expenditure and will submit to DFID a certified annual statement showing funds received and expended including six monthly financial and progress reports. The Implementing Agency will submit an annual audited account. The reporting will be a single process, with updates as required. DFID and USAID will agree on a common set of indicators to be used for measuring the effectiveness of performance. The frequency of monitoring assessments (including possible joint missions) is yet to be agreed but a minimum of at least two assessments a year is anticipated There will be monthly trilateral discussions between the health technical and programme teams for DFID, USAID and the local DELIVER representative. In addition there will be 6 monthly meetings at head of office level. Whilst primary accountability for DFID funds will reside with USAID through the agreed local Contribution Arrangement for Co-Financing, the implementing partner (John Snow International) will be accountable to USAID. DFID will also monitor the provision of pharmaceuticals via our overview of facilities that will be supported through the Health Pooled Fund (HPF). But primary monitoring and evaluation responsibility lies with USAID as the Lead Donor ( DFID will seek participation in any monitoring visits proposed by USAID) Management Case What are the Management Arrangements for implementing the intervention? The daily management of the programme will be done by USAID, The Agreement Officer’s Technical Representative (A/OTR) is at Headquarters and the Health Advisor at USAID South Sudan will serve as the local Activity Manager (AM) for the award in South Sudan. Specific certification requirements are outlined in USAID’s policies and the Automated Directives System which is a web-based catalogue of USAID rules and regulations. Locally the AM will: oversee the technical activities on the ground develop and monitor the statement of work; serve as the Mission point of contact for visitors; serve as the Partner point of contact ( responding to submitted reports); 47 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 write up minutes for quarterly meetings and place them on file; serve as responsible for site visits and submitting reports; serve as responsible for tracking finances DFID will have monthly trilateral meetings with USAID and DELIVER regarding the programme (NOTE: This could also include Norway). In addition there will be 6 monthly meetings at head of office level. There will also be on-going dialogue with the Ministry of Health regarding the fund. Management structure within DFID: This programme will be managed by the DFID Health Adviser, with the support of the Deputy Programme Manager for Basic Services, based in South Sudan. The DFID programme team will meet at least six monthly with USAID bur will also contact USAID on an ad hoc basis if they have any questions for clarification on USAID management of the intervention. Six monthly progress and financial reports will be produced as well as annual reviews. Regular monitoring will be conducted and reports shared with DFID on a semi-annual basis. DFID will undertake annual project reviews and a Project Completion Report a few months before Programme closure in line with our normal reporting requirements. Any revision of the Key Performance Indicators will be done as part of the annual review process and this will be linked and jointly conducted. Financial reports, compliance and administrative functions will be managed by the USAID and shared with the DFID programme team. Management by USAID. Management by USAID will be as described above as mandated by USAID regulations and policies. Specific terms and conditions will be set out in the local Contribution Arrangement for Co-Financing agreed between DFID and USAID. B. What are the risks and how these will be managed? Risk Delays in procurement: DELIVER cannot forward fund the procurement of commodities, and hence this process can only start when an MoU has been signed, and funds have been transferred from DFID to USAID/DELIVER. Risk of delays in timeliness of the process if administrative issues take longer than anticipated Infrastructure and distribution: Medicines arrive at county level but Likelihood (1 low likelihood; 3 of high likelihood) 1-2 Impact Mitigation 2-3 Start process of drafting MoU/agreement as soon as Option is decided upon, to minimize risk of delay later down the chain 2 2 Communication of county health dept and NGOs so 48 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 are not transported from county level to facility level supply of medicines to facilities can be anticipated and arranged in advance. Include distribution component in contract NGOs as part of HPF. Medicines cannot be delivered due to the rainy season Work closely with USAID and DELIVER to monitor these risks. We will also keep an eye on other logistical support e.g. through WFP or the NGOs and health cluster if there is an emergency situation. Clearly clarify preferences and expectations in MoU between USAID/DFID USAID/DELIVER sets up system that is not according to DFID’s preference (e.g. large part airlifting 1 1 Lack of capacity: Medicines arrive at facility level but not used rationally 2 2 Economics: Inflation 3 3 Medicines are subject to border taxes. This will mean that we cannot afford to procure as many medicines. 3 3 Security and conflict: Delays to distribution of medicines to certain counties 2 2 Link with HPF and other initiatives training health workers Cost of fuel continues to increase meaning that it is more expensive to transport medicines. We will continue to advocate for a resolution to the current oil crisis. In addition we are building flexibility into the budget to try and take account of the potential increase in costs. By working through USAID they can link to their SIAPS programme which is embedded in the MoH Pharmaceutical division. In addition we can make sure any MoUs on the emergency fund include language that ensures that medicines purchased under this mechanism are tax free. Work with NGO partners to try and mitigate against this- may need NGO partners to help support 49 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Looting of drugs from facilities 1-2 2 Budget: Government does not find the funding to support the procurement and distribution of medicines for 2014 3 3 Corruption: Medicines are sold on to the private sector 2 2 DELIVER ( South Sudan component) not performing to expectations distribution in this context. NGOs are used to operating in insecure contexts. They are used to operating remotely, prepositioning drugs/ medical supplies and using village health committees/CHDs to provide an accountability/ oversight function. The link between the medicines fund and the HPF will help to mitigate some of this risk by allowing the NGOs to manage the medicines at county level. We will continue to lobby GRSS to find funds to purchase medicines. We mitigate against this by not using government systems for procurement, storage or distribution. NGOs will work closely with the County Health Departments to make sure this does not happen at county level too. The global contract with John Snow International allows for the termination of a certain county programme if not meeting expectations in the Performance Management Plan C. What conditions apply (for financial aid only)? Not applicable 50 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 D. How will progress and results be monitored, measured and evaluated? USAID has a global Performance Measurement Plan with DELIVER. This includes a set of progress indicators which are reviewed annually. These performance measurement indicators include value for money as one of the assessment criteria. DFID select a set of indicators from USAIDs already comprehensive monitoring framework to be used for measuring the effectiveness of performance. The frequency of monitoring assessments (including possible joint missions) is yet to be agreed but a minimum of at least one assessments a year is anticipated. DFID has selected a subset of key indicators that reflect the different stages in the process: procurement, management, and distribution. Regular monitoring will be conducted and reports shared with DFID on a quarterly basis. DFID will undertake an annual project review. Any revision of the Key Performance Indicators will be done as part of the annual review process and this will be linked and jointly conducted with USAID. In addition DFID will monitor progress through the HPF, the delivery of which is dependent upon availability of medicines through this emergency medicines fund. The outcome indicators for the emergency medicines fund are closely linked to the HPF. The logframe in Flag B provides the overall monitoring framework. In terms of over and underachievement. It is likely even in the best case scenario that there will be stock outs for between 1-2 months regardless of the emergency medicines fund. Overachievement is defined as no stock outs in clinics following the end of MDTF supplies. Underachievement is defined as more than 2 months of stock outs. 51 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 ANNEX 1: Selection of products (46 medicines & 12 supplies, 58 total) & annual quantification for facilities in the six States The14 tracer drugs (list 1) are highlighted in green Product Descriptions Unit Pack Hospital PHCC (High) PHCC (Low) PHCU 21 34 81 445 Total Quantity Oral medicines 1 Acetylsalicylic acid 300mg 1,000 504 409 971 5,340 7,224 2 Albendazole 200mg Chewable Tablet 1,000 252 273 324 890 1,738 3 Amoxicillin 250mg Capsule 1,000 11,340 9,200 14,567 10,680 45,787 4 Ciprofloxacin 500mg Tablet 100 1,764 2,044 2,913 - 6,722 5 Co-trimoxazole 100mg+20mg Tablet 1,000 2,016 1,636 1,942 1,780 7,374 6 Co-trimoxazole 400mg+80mg scored Tablet 1,000 4,032 3,271 3,884 3,560 14,748 7 Diazepam 5mg 1,000 84 68 81 - 233 8 Diclofenac sodium 25mg enteric coated Tablet 100 12,600 14,311 19,422 32,040 78,373 9 Doxycycline 100mg (as hyclate) scored Tablet 1,000 2,520 4,089 9,711 53,400 69,720 10 Erythromycin 250mg 1,000 1,260 1,636 3,884 - 6,780 11 Ferrous sulphate 200mg + Folic acid 0.25mg 1,000 3,024 3,680 4,856 5,340 16,900 12 Magnesium Trisilicate Tablet 1,000 1,008 818 647 1,780 4,253 13 Oral rehydration salt (ORS), 100 sachets 1 2,520 2,044 4,856 10,680 20,100 14 Paracetamol 500mg, double scored Tablet 1,000 15,120 12,267 14,567 26,700 68,653 15 Praziquantel 600mg 1,000 - - - - - 16 Salbutamol 4mg 1,000 504 818 1,942 - 3,264 52 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Product Descriptions Unit Pack Hospital PHCC (High) PHCC (Low) Total Quantity PHCU 17 Tinidazole 500mg 100 - - - - - 18 Vitamin A (Retinol) 200,000IU Caplet 100 1,512 1,840 2,913 10,680 16,945 19 Zinc Sulphate dispersable 20mg Tablet – blisterpack 100 12,600 12,267 19,422 53,400 97,689 Syrups & suspensions 20 Amoxicillin, dry powder for susp. 125mg/5ml Bottle/100 ml 1 2,100 1,704 2,428 8,900 15,131 21 Metronidazole, dry powder for susp. 200mg/5ml B/100ml 1 8,400 6,815 8,093 13,350 36,657 22 Paracetamol Suspension, 120mg/5ml, 60ml Bottle 1 12,600 13,630 16,185 22,250 64,665 378 273 324 - 974 Injectables 23 Ampicillin 500mg powder for inj. 100 24 Benzylpenicillin 1M IU, Vial 50 3,780 4,089 6,798 - 14,667 25 Ceftriaxone, powder for injection 1g vial 10 12,600 4,089 4,856 - 21,544 26 Diclofenac Sodium, for injection 75mg/3ml Amp/3ml 100 1,764 1,227 1,942 - 4,933 27 Gentamycin 40mg/ml, 2ml amp 100 7,560 4,089 6,798 - 18,447 IV fluids/infustion 28 Dextrose 5% Bottle/ 500ml + infusion set 1 189,000 102,222 145,667 - 436,889 29 Dextrose 50% 50 ml Vial Sodium Lactate Compound Solution (Ringers Lactate) Bag/500ml+set 1 18,900 - - - 18,900 1 50,400 40,889 48,556 - 139,844 100 26,250 15,333 24,278 - 65,861 30 31 Water for Injection 10 ml, Plastic Vial Topical preparations 32 Benzoate acid compound (Whitfield's ointment) 40g 1 12,600 12,267 29,133 53,400 107,400 33 Benzyl benzoate 25% application, 200ml 1 2,520 2,044 4,856 10,680 20,100 34 Clotrimazole 500mg Pessary with applicator 1 37,800 40,889 72,833 53,400 204,922 53 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Product Descriptions 35 Tetracycline eye ointment 1% 5g tube Unit Pack Hospital PHCC (High) PHCC (Low) Total Quantity PHCU 50 63,000 40,889 48,556 80,100 232,544 1 5,040 4,089 4,856 10,680 24,664 Disinfectant 36 Chlorhexidine 1.5% +Cetrimide 15%, 1L with dispenser Antimalarial 37 Artesunate + Amodiaquine (Adult) 50+153 mg [24 tabs] 1 8,400 12,778 22,255 33,375 76,807 38 Artesunate + Amodiaquine (Child) 50+153 mg [12 tabs] 1 4,200 6,815 12,139 22,250 45,404 39 Artesunate + Amodiaquine (Toddler) 50+153 mg [6 tabs] 1 4,200 6,815 12,139 22,250 45,404 40 Artesunate + Amodiaquine (Baby) 50+153 mg [3 tabs] 1 3,150 5,111 8,093 11,125 27,479 41 Quinine dihydrochloride inj 300mg/mL 2ml Amp 100 378 409 486 - 1,272 42 Quinine sulphate 300mg film coated 1,000 504 409 647 - 1,560 43 Sulphadoxine+Pyrimethamine 500/25mg Tablet 100 3,780 4,089 5,827 16,020 29,716 Keep cool 44 Oxytocin 10 IU, Amp/1ml 1 50,400 61,333 72,833 - 184,567 45 Lidocaine HCL 1% Vial 20ml 10 1,764 2,044 2,913 - 6,722 46 Diazepam 10mg/2ml Amp/2ml 100 756 - - - 756 47 Supplies Bandage First-aid Medicated (wound plaster) 6.0cm x 5m 8cms wide Roll Roll 50,400 20,444 19,422 26,700 116,967 48 Cotton Wool Absorbent EP/BP 500g Roll Roll 12,600 2,044 2,913 5,340 22,898 49 Gauze Compresses (pads) 12-ply, 10 x10cm, Sterile P/100 1,008 1,227 1,942 - 4,177 50 Tape Adhesive (plaster) 2.5 cm x 5m, each Catgut chromic 2/0(M3.5), 75cm, N: 25mm 1/2 circ.RB, as W448 P/12sa Each 6,300 6,133 9,711 26,700 48,844 P/12 504 - - - 504 51 54 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Product Descriptions Unit Pack Hospital PHCC (High) PHCC (Low) Total Quantity PHCU 52 Catheter Foley CH16 2-way Balloon 5-15ml, sterile disp P/10 P/10 756 409 324 - 1,489 53 Catheter Foley CH18 2-way Balloon 5-15ml, sterile disp P/10 P/10 756 409 324 - 1,489 54 Condoms lubricated male (ISO 4074) square foil, 53mm wide 144 - - - - - 55 Envelope resealable dispensing plastic, bag, 80 x 100 mm P/100 100,800 102,222 145,667 267,000 615,689 56 Gloves Examination latex Non-sterile Medium Disposable P/100 25,200 30,667 48,556 26,700 131,122 57 Gloves Gynecological 7.5 - Medium Latex pre-powdered P/25 12,600 10,222 9,711 - 32,533 58 Syringe Luer 5 ML w Needle, 0.7x30mm, Sterile disp 21G 100 25,200 16,356 23,307 - 64,862 59 Syringe Luer 2 ML w Needle, 0.6x25mm, Sterile disp 23G 100 5,040 3,271 4,694 - 13,005 1 2,520 8,178 11,653 26,700 49,051 60 Malaria RDT (First Response), 25 tests/box 61 Infusion giving set, with air-release & needle 62 Gauze hydrophilic 90cm x 9am 12x 8 mesh 63 Scalp vein infusion sets 21 G (0.80 mm) 64 65 Razor blade 8cm, non sterile, reusable, metal/10 Nylon monofilament 2-0, 75 cm, 3/8 circle 30 mm cutting needle 66 Umbilical tape, 25 m x 3 mm 67 Ethanol (ethyl alcohol) 70 % denatured, 1 litre 55 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Annex 2: Methodology used for quantification of medicines & supplies The quantification of need per medicine per level (reference/state/county hospital, lower/higher PHCC and PHCU) was conducted by the Ministry of Health in close collaboration with USAID/SIAPS. The exercise was based on issue data and consumption data to the extent available, disease prevalence, and knowledge of common stock outs 24 , and resulted in a quantification tool for all 220 items. Some quantities were adjusted, notably the malaria RDTs25, gloves and Ringer’s lactate.26 For the current Business Case and projection of need, the number of hospitals, PHCCs and PHCUs in the six states was derived from the ‘Distribution report for MoH/MDTF Essential Drugs & Supplies kits’, prepared by the MoH/DPS and updated in Jan 2011 (see annex 1). For the quantification exercise, the national distribution of 80 highutilization PHCCs and 270 low-utilization PHCCs was applied to the six States, resulting in 34 higher and 81 lower PHCCs.27 It is acknowledged that the quantity supplied under the current push-system does not accurately reflect the need in the facilities, and there are widespread accounts of expiry of medicines (e.g. IV fluids) and stock-outs (e.g. antibiotics and anti-malarials). However, at the moment consumption data is not collected or aggregated in a consistent manner, and it is therefore difficult to use the limited information available as a solid basis for adjusting the quantities supplied. 24 The full EDL from MoH/SIAPS includes quantities of medicines required for each level for one year. For the list 2 and 3 (44 medicines), five drugs were added to the MoH EDL list, namely acetylsalicylic acid 300mg, erythromycin 250mg, salbutamol 4mg, Whitfield’s ointment 40g, benzylbenzoate 25% application. For these, the forecasted amount needed was based on the quantity supplied in the MDTF-kit. Two drugs are included in the World Bank list but not in the MoH/USAID list nor in the MDTF-kit, namely tinidazole 500mg and praziquantel, and therefore not included in the current quantification. The latter was supplied as bulk (specific areas in the country where it is needed). 25 According to MoH/SIAPS quantification tool, 1.2m malaria RDTs would be needed vs.195,000 malaria ACT treatments. Seen the fact malaria is endemic in South Sudan, the practice of presumptive treatment of malaria in case of fever, the fact other donors (e.g. Global Fund) already provides RDTs, and the relatively high price of RDTs, the quantity to be purchased has been adjusted to 300,000. 26 Reports that there is already much Ringer’s Lactate and many gloves in the facilities (pushed through the MDTF essential kits) 27 When the final list of medicines to be procured and supplied to each county is drafted, an exact breakdown of higher/lower PHCCs should be obtained from the MoH. 56 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Annex 3: List of health facilities per State – six States of the Health Pooled Fund STATE COUNTY Eastern Equatoria Northern Bahr el Ghazal Lakes Unity Western Bahr el HOSP PHCC PHCU Budi Ikotos Kapoeta East Kapoeta North Kapoeta South Lopa/Lafon Magwi Torit TOTAL 1 1 4 4 17 14 0 4 3 0 1 7 3 0 1 1 7 0 3 8 2 26 0 15 18 24 98 Aweil Center 1 2 9 Aweil East 1 5 23 Aweil North 0 2 17 Aweil South 0 1 6 Aweil West TOTAL 0 2 5 15 12 67 Awerial 0 2 6 Cueibet Rumbek Centre 1 2 5 1 3 10 Rumbek East 1 4 11 Wullu 0 1 11 Yirol East 1 1 9 Yirol West TOTAL 1 5 1 14 12 64 Abiemnhom 0 1 2 Guit 0 1 5 Koch 1 3 1 Leer 0 2 3 Mayendit 0 2 12 Mayom 0 3 6 Panyinjar 0 2 21 Pariang 0 2 4 Rubkona TOTAL 1 2 1 17 0 54 Jur River 0 4 17 57 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 STATE Ghazal Warrap COUNTY HOSP PHCC PHCU Raja 1 5 11 Wau TOTAL 2 3 9 18 26 54 Gogrial East 0 2 9 Gogrial West 0 4 11 Tonj East 0 2 4 Tonj North 1 4 13 Tonj South 1 1 9 Twic TOTAL 1 3 9 22 9 55 OVERALL 21 115 445 Source: Ministry of Health Directorate of Pharmaceutical Services – Functional facilities for distribution – April 2011 58 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 Annex 4: List of meetings & people (May 7 – 19, 2012) 1 2 3 4 5 6 7 Organization DFID 8 9 10 11 12 Michael Dunnery USAID Ministry of Health 13 14 15 16 17 18 Name Rurik Marsden Simon Williams Jay Bagaria Laura Chappell Caroline Dale John Benza Hamish Falconer MSH UNICEF UNDP SSU NGO health forum World Bank Heather Smith Anna Hoffman Leila Dr. Mawien Atem Mawien Dr.Mozes Deng Malual Albert Nettey Dr. Romanus Mkerenga Kim Beer Ruth Goehle Mo Ali Henry Owino 19 Dr. M Kamil 20 Josie Muigai 21 22 Mission Pharma BSF/ BMB MottMacdonald Deng Mathach Geertruid Kortman 23 Hannah Yousif 24 Wim Groenendijk 25 Kate Louwes 26 27 28 OVCI Merlin Site visits Helena Karin Aiello Shaheenul Haque Katore PHCC (higher) Malakia PHCC (higher) Lologo PHCC (lower) Position Deputy Head of Office Deputy Programme Manager Health adviser Health economist M&E Commercial adviser Programme Manager Procurement adviser (call Juba – Scotland) Team leader, health Deputy team leader USAID/ DELIVER Director General, Dept of Pharmaceuticals Director, Pharmaceutical Supplies Management MSH SIAPS Procurement & Logistics adviser Chief, Health & Nutrition, UNICEF Procurement adviser NGO coordinator Former NGO coordinator Procurement specialist, MDTF, World Bank Health lead, World Bank Infrastructure Advisory Services, IFC Local representative Primary Health Care Consultant, Officer Primary Health Policy Development/M&E Officer Team leader Reproductive health technical adviser Country Health Director NGO-supported MoH PHCC Non-NGO-supported MoH PHCC NGO-supported MoH PHCC 59 DFID Support for an Emergency Medicines Fund in South Sudan – 3 August, 2012 ANNEX 5: REFERENCES Southern Sudan Centre for Census, Statistics and Evaluation (2011) Key indicators for Southern Sudan. SSCCSE, Feb 8 2011 Ministry of Health (2011) Summary of Findings of the Southern Sudan Household Survey 2011. MoH & SSCCSE, April 2011 PWC (2010) The World Bank Report to the Southern Sudan Multi Donor Trust Fund (MDTF-SS) Administrator; 2ND Quarter Report, April June 2010. PriceWaterhouseCoopers (PWC) August 2010 USAID (2011) Pharmaceutical Logistics Assessment South Sudan. USAID, October 2011 http://resources.ghtechproject.net/content/pharmaceutical-logistics-assessmentsouth-sudan USAID (2010) Assessment of Southern Sudan Pharmaceutical Management System. MSH/SPS & SCMS, USAID, Oct2010 USAID (2011) Final report – DFID funding for contraceptives in Tanzania. USAID Tanzania, Dec 2011 WHO (2004) The World Medicines Situation. World Health Organization (WHO), 2004 WHO (2011) The World Medicine Situation – Access to Essential Medicines as Part of the Right to Health. World Health Organization (WHO), 2011 WHO (2007) Everybody’s business: Strengthening health systems to improve health outcomes. WHOs Framework For Action, 2007 www.who.int/healthsystems/strategy/everybodys_business.pdf Chibwana AL, Mathanga DP, Chinkhumba J, Campbell CH. Socio-cultural predictors of health-seeking behaviour for febrile under-five children in Mwanza-Neno district, Malawi. Malaria Journal 2009, 8:219 60