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					Zambia: Access to Essential Medicines- Problems and Solutions For the majority of the population in Zambia, access to essential medicines remains limited due to a number of factors that touch on administrative, operational, strategic or political 1. The main problems in access to essential medicines: Access is limited or is erratic, due to  Lack of an agreed procurement policy  Lack of a single, MOH- led procurement strategy  Lack of an integrated procurement approach (MOH, donors, NGOs, vertical programmes)  Poor forecasting arrangements and tools  Funding structures and arrangements not always able to support procurement  Procurement arrangements with suppliers not effective  Poor fund management and use at MOH  Non- compliance to basic procurement rules and regulations  Weak regulatory infrastructure / underpinnings  Low staff morale due to low salaries and selective retention scheme  Problems exacerbated by drawn- out MOH restructuring process  Poor human resource pool at all levels, due to a number of reasons such as lack of career structure, low salaries, migration of staff from MOH and chronic brain drain  Poor management of the supply chain at many district levels  Limited use of private sector services resulting in high investment and running costs by Ministry of Health in respect to transport services a) Problems of high prices  Lack of human resources to perform global market analysis of commodity markets (availability, price)  Lack of experience in dealing with manufacturers and wholesalers on a business partnership basis  Too much emphasis on the ‘Tender process’ as the sole avenue for getting better price  Concern that negotiating price discounts, etc, is probably against tender regulations and ‘fairness’  Lack of appreciation of the strength of the pharmaceutical cartels that may exist in respect to the Zambia market  While no formal price survey has been done in Zambia, evidence suggests that local prices are influenced by high import taxes and duties on both raw material and finished goods. Locally manufactured products tend to be priced higher than similar imported products due to the current tariff system which is in favour of imported products. Most raw materials used in the manufacture of medicines (Excipients and packaging materials) are subject to high import and duties  The tariff systems combined with lead taken by private sector to set retail prices results in high product prices, specifically for imported patented products. If tariffs were reduced, it remains to be seen if the mark- up on product prices would be ‘reasonable’ and therefore for products to be affordable  In the recent past, MOH was procuring goods on ‘emergency’ basis, due to a number of reasons. In that situation, the key factor was arrival of goods in Zambia, than price  Consequently, prices offered to Zambia MOH are probably higher than those offered to other buyers in the same region (Point to note: SADC is pushing for joint procurement in the Region for certain medicines such as ARVs, TB drugs. However, this is possible for
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these products that enjoy special global attention. It is possible that this strategy by SADC might extend to all essential drugs) Poor payment practices at MOH also must impact on prices offered to MOH. A number of suppliers (both for goods and services) are not paid on time due to poor finance management within the Ministry

b) Problems of quality – including counterfeit and substandard products  The autonomous PRA strategy must be based on setting, promoting and then enforcing standards of pharmaceutical practices  On that basis, to then address unprofessional practices, or unregistered business that result in counterfeit of sub- standard products  Loop- holes exist in government policy as there have been a number of medical practices that have been provided permits to practice. For example, proliferation of so-called alternative/traditional medical practices without providing additional regulatory tools and capacity to serve these services  Government has spent little effort in securing the regulatory bodies i.e. PRA and the Medical Council of Zambia, resulting in these loopholes  Inability of the regulatory bodies to establish firm policy on setting standards, registration and monitoring of all registered products and licensed practitioners  Limited and therefore selective enforcement of regulations due to lack of human, financial, technical and material resources  Consequently, the presence on the Zambian market of poor quality or counterfeit has been observed, though the extent is not known  The newly established PRA with the help of the WHO, USAID/MSH has taken measures specifically to (a) remove from industry all those ‘players’ not registered under the Pharmaceutical Act (b) to establish the concept of basic testing centres at selected ports of entry that will be either permanent or mobile (c) to strength its operations and resources to enable regular inspections (d) firm pharmacovigilance through out the public and private sector and (e) initiate active postmarket surveillance activities  Political will from government must be there to enforce compliance to the Pharmaceutical Act, by also removing political ‘interference’ in implementation or enforcement of the Pharmaceutical Act c) Availability and accessibility – in both public and private sectors  In general, availability of all classes of medical products in Zambia improved following liberalisation of the economy, specifically after 1991  However, this improvement is nullified by the high cost of medicines from the private outlets, and also by the poor financing, erratic procurement and poor distribution of essential commodities in the public sector and weak regulatory mechanisms  Retail prices of pharmaceutical products appear to be set by the market with some degree of regulation  There are ‘successes’ in the public sector, namely at Faith- based organisations.  However, commercially, the focus for the few retail pharmacies, is on the high value branded products, or high turnover, low value core products such as pain- killers, etc  The concentration of retail pharmacies remains in the few major cities (Lusaka, Kitwe, Ndola and Livingstone; that is, along the ‘Line of Rail’ from Livingstone in the Southern Province, to the Copperbelt towns north of Lusaka)  Most of the districts have no commercial pharmacies

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Due to a serious shortage in pharmacists (in fact this phenomenon appears to be common in the region), specifically those in retail practice, the number of commercial outlets is further reduced, and this more so at the district level The common source thus becomes either the MOH clinics and hospitals, or Faith- based organisation, or the few commercial or fee paying private hospitals and clinics, or the few NGO health facilities or unlicensed outlets Availability of essential drugs and medical supplies in the public sector depends on firm procurement and supply practices which are further based on firm planning, assured financing of goods and services, firm commitments to pharmaceutical and medical suppliers in form of procurement contracts Where the above is uncertain or erratic, confidence is absent from all stakeholders, specifically industry, resulting in abnormal prices and terms and conditions As a result, access to essential drugs is critically reduced The ‘success’ at Faith- based medical centres probably results in high patient attendance levels due to the perceived reliability in availability of drugs and medical supplies, leading to higher workload and stress at these centres

2. Policy and initiative the Government and Cooperating Partners (CPs) are implementing:  The DSBL initiative (MOH and Cooperating Partners)  Strengthen the planning and procurement platforms at MOH, as well as the Supply chain (MOH and CPs)  MOH and CPs are investing in strengthening drug storage, in- country logistics and stock management (eg, improvements at Medical Stores Limited; MOH’s Logistic Management Unit)  MOH and CPs will be approached with a DSBL/ PRA proposal on ideas to strengthen the Pharmaceutical Regulatory Authority (policies, strategies, and activities)  MOH/WHO to conduct retail drug market and unit prices in 2007 These initiatives address in a holistic manner, the whole procurement, supply, access and usage cycle for essential medicines 3. Some initial ideas on areas where the Medicines Transparency Alliance might be able to further support the country in the goal of improving access through increased transparency, in partnership between the Government, civil society, industry and other stakeholders:      The success of MeTA will be in focusing on ‘do- able’ activities whose implementation will lead not only to achieving immediate results, but will also set a change in systems management and a change in institutional behaviour The Drug Supply Budget Line concept is worth considering as a planning, decision platform that can be promoted to other governments’ health institutions Advocate for better financing of mechanisms that would lead to increased access to essential drugs. It is important for all stakeholders, but specifically for MOH and Ministry of Finance to recognise their combined ownership of health sector in Zambia Encourage Finance Ministry to recognise efforts taken by MOH and CPs in creating and setting up transparent operational systems are in place, Using above evidence, assist Ministry of Finance to establish a system to release funds in time for annual procurement of essential medicines releasing funds in time and in significant quantity to allow significant procurement.
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Advocate for the support of the Pharmaceutical Regulatory Authority as it is the basis that secures access to quality and safe essential medicines Advisory services to all NGOs working in health to work within the MOH’s Standard List of Essential Medicines, and refer to the Annual Procurement Plan on what products need to be procured, and seek advice from PRA on what goods to procure, etc Advise to all Embassies based in Zambia not to offer medicines, but rather to either (a) offer funds or (b) seek advice from MOH on what products to procure and from which suppliers. This is to avoid supply of unregistered products Advocate and encourage training in procurement, contract management and obligations. Governments’ accounts and procurement units need to be enlightened on contractual obligations and therefore good finance management, to avoid the practice of misallocation of funds and avoidance of payments to suppliers Encourage and support the MOH, CPs, NGOs and others to focus attention service improvements at the district level, specifically the rural districts where improved and sustained services would lead to increased access to quality and safe essential medicines Support the key commercial healthcare institutions (eg, the Church Health Association of Zambia, the fee paying Mine hospitals and other large private hospitals) that provide some of the core health services in Zambia Advocate for firm commitments to results- based capacity building efforts from CPs, NGOs and other development agencies so that governments can own and conduct credible procurement services: Encourage Zambia government to support enforcement of Acts related to pharmaceutical services and practice, and so remove ‘interference’ and ‘bias’ Advocating for investing in people: Government needs to be challenged to invest in healthcare staff, by ensuring that salary upgrading is part of annual budget exercise. Staff want to see proper salary review and upgrading and not ‘ retention schemes’ that are more about patronage by rather due reward and are subject to challenge from and negotiation with other institutions such as Parliament, Cabinet Office Encourage government to re- establish the Directorate of Pharmaceutical Services: Governments needs to be reminded that by removal of this Directorate from MOH, that action has contributed to the many failures in the performance of the pharmaceutical services in Zambia. The absence of this Office at MOH has forced many young pharmacists and technician to seek employment elsewhere. Encourage the Zambian government to support our local pharmaceutical manufacturers through reduced duties and taxes on raw materials for essential medicines Explore the economic implications of regional group procurement, given the economic difference within regions, and therefore the ‘buying power’ per country Advocate for and support regional efforts such as setting up regional reference and testing centres for pharmaceutical products Support MOH and CPs in exploring innovative services available from private sector that if applied at MOH would lead to increased and sustained access to essential medicines. For example, contracting logistics services for in- country distribution and support services Advocate for holistic approaches to ‘access’ issues, so that attention is provided to all essential medicines and not only certain products (e.g., ARVs), since the same infrastructure is expected to procurement, supply and manage all supply chains Assist governments in reviewing budgets to include activities such as annual mapping exercises and surveys that are currently not in place

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