Propiedades mecánicas: dureza (H) y modulo elástico (E)

CHAIN

Importation, procurement, and supply of pharmaceuticals and medical products in Tanzania are regulated by several key documents. Government procurement and financing of medical

commodities is guided by the National Medicines Policy (revised 2008) and the Public Finance Act (2001), while the Medical Stores Department Act of 1993 created Tanzania‘s MSD under an act of Parliament. The Tanzania Food, Drugs and Cosmetics Act (No.1 of 2003) created the TFDA and, under section 5(c), outlines the National Guidelines for Monitoring Medicines Safety (revised 2010). MSD‘s selection and procurement of medicines are further guided by the National Essential Medicines List (NEML), last updated in 2006, and the Standard Treatment Guidelines, last updated in 2007. Figure 6.1 outlines the flow of pharmaceuticals through the Tanzanian supply chain in the public, PFP, and PNFP sectors.

Figure 6.1: Organization of Tanzanian Supply Chain

6.1.1

THE PHARMACEUTICAL AND SUPPLIES UNIT (PSU)

The PSU (part of the MOHSW) is responsible for the overall management and coordination of Tanzania‘s medical supply chain. Main functions of the unit include the formulation and implementation of the country‘s pharmaceutical policies, budgeting for purchase of medicines and medical supplies, and the provision of technical support to other government supply chain bodies. The MOHSW-PSU holds ultimate responsibility for the effective enactment of the country‘s drug policy, including the preparation of the annual medicines and medical supplies budget for Tanzania‘s public health (and affiliated FBO/NGO) facilities. The MOF allocates funds annually to the MOHSW, which in turn apportion funds to MSD, indicating funds for individual referral hospitals, regional hospitals, and district facilities. District-level budgeting and planning for health services (as well as utilization of MSD subaccounts for pharmaceutical and supply procurement) are carried out by individual CHMTs, which respond to procurement requests and coordinate with health leadership at the facility level.

6.1.2

THE MEDICAL STORES DEPARTMENT

Created in 1993 by an Act of Parliament, MSD is a nonprofit business entity with an

independent board of governors appointed by the MOHSW and the PMO; it is responsible for the procurement, storage, and distribution of medicines and medical supplies to all public and approved NGO/FBO facilities, including CSSC-designated hospitals and health centers. MSD functions include almost all activities in the supply chain management cycle with the exception of dispensing: PSU/MSD collaborative creation of the NEML; assembling a national MSD product catalogue selected from the NEML; ordering and procurement; quality management; and distribution / logistics management. MSD is also responsible for the management and oversight of district procurement subaccounts allocated by government to individual districts/facilities via the District Executive Director account. MSD‘s ability to successfully

perform such a wide range of functions in the Tanzanian medical supply chain is directly related to its autonomy. However, key informants reported that ―recent government control has

tightened,‖ with MSD now performing as a ―near public entity instead of an autonomous body.‖ Laborious public procurement and tender processes, reliance on limited government financing, and restrictions on procurement of key vertical program commodities (e.g., ART, condoms, and malaria medications) have all limited MSD efficiencies and restricted the department‘s ability to adequately service the health system.

Forecasting

Facility-level directors (in both public and government affiliated FBO/NGO facilities) are responsible for forecasting, determining their product needs, and ordering from MSD via the DMO. For most facilities, the ordering and administration of district-level medical supply ―starts and ends with the DMO‘s office‖ (MOHSW, 2008b).

Procurement

Public facilities procure pharmaceuticals primarily via their MOHSW/MOF designated accounts and subaccounts which are held and managed with MSD. Approved NGOs and FBOs are allowed to procure via MSD on a cash-and-carry basis – ensuring MSD procurement cost recovery from these facilities. MSD offers limited procurement opportunities for PFP and unapproved PNFP organizations; distribution to these facilities is restricted to vertical program commodities (such as ARVs, TB medications, and immunizations) and controlled substances such as opioids and analgesics (e.g., pethedine and morphine). Overall, the general advantage of MSD is their ability to pool procurement for the entirety of the public health system and a significant portion of the NGO/FBO sector. MSD also has the capacity to perform some post- importation quality assurance via its independent labs.

Distribution

MSD packages ordered and in-stock supplies and delivers them to the DMO (i.e., district or zonal stores department), who then distributes to individual health facilities. The exception is the larger district, regional, and referral hospitals, which (due to volume) order directly from MSD. Fears regarding uncontrolled leakage of medical products outside Tanzania and regarding competition in the wholesale pharmaceutical market have limited efforts to expand private sector access to MSD distribution. Key informants stated that overall MSD is ―relatively well funded‖ via the MOHSW budget and has a ―fairly extensive storage and distribution system‖ that is able to deliver product to zonal and district stores departments within ―reasonable lead-times.‖ With a reasonably well-developed procurement and distribution infrastructure, MSD is also responsible for the distribution of vertical program public goods (to both public and private health facilities) via the zonal stores, according to the vertical program plan. MSD charges donor distributing agents or the individual vertical programs a 14–18 percent storage and distribution handling fee. Reports from key informants suggest that the government is largely in arrears on this MSD ―handling fee,‖ limiting MSD‘s cost-recovery on vertical program procurement and contributing to MSD‘s ―intermittent cash flow crises.‖ Currently, MSD is rolling out a system of direct delivery to facilities. With support from external partners, phased expansion of the MSD transport fleet is planned over the next three years; previous efforts to outsource distribution more fully have been restricted by Tanzania‘s limited transport and project logistics sector. The USAID/Deliver and PEPFAR supported Supply Chain Management System (SCMS)

Projects provide technical assistance to MSD in operational and supply chain management. The Deliver Project is a global USAID-funded initiative that aims to increase the availability of

essential health commodities worldwide. In Tanzania, Deliver has developed an Integrated Logistics System, which remains largely paper based. The project has supported the

development of an Electronic Resource Planning system, currently being rolled out in several regions. USAID/Deliver has also supported reproductive health commodity security initiatives (in

particular for contraceptives), as well as efforts to improve quantification and procurement of antimalarial commodities via funding from the President‘s Malaria Initiative.

SCMS/Tanzania is a Management Sciences for Health (MSH)/John Snow International joint partnership focused on improving procurement mechanisms through strengthened supply chain management. The project, which runs in parallel to USAID/Deliver, focuses largely on the provision of technical assistance to support the NACP in strengthening the procurement and supply of medicines and products required by PEPFAR-funded activities. SCMS activities include: improving product availability by working to reduce stock-outs of ARVs and other key HIV commodities; supporting the development of MOHSW capacity in commodity forecasting and need quantification; developing MSD infrastructure in order to improve the distribution of HIV/AIDS commodities; and strengthening information management throughout the supply chain. Recently SCMS has supported a proposal for the creation of a Logistics Management Unit that would absorb current SCMS functions of monitoring commodity availability, routine quality assurance, and strengthening the TFDA‘s role in conducting post-market commodity surveillance. The proposal is currently under review, with the ultimate goal of transferring responsibility of these activities (and supporting Logistics Management Unit capacity development) at the central and zonal levels.

6.1.3

TFDA, PHARMACY COUNCIL, AND BUREAU OF STANDARDS

The TFDA, the Tanzanian Pharmacy Council, and the Tanzanian Bureau of Standards (under the Ministry of Trade and Industry) are collectively responsible for oversight of medicine and medical product quality, regulation of wholesale importation, and registration of wholesale premises. Recent changes to laws and regulations (as of November 2011) have mandated the Pharmacy Council with registration of wholesale pharmaceutical premises, while the TFDA maintains responsibility for regulating wholesale importation and providing import permits. However, there are clear challenges in dividing up these two roles. The TFDA is primarily responsible for ensuring quality of medicines and performing post-market surveillance, while the Bureau of Standards is responsible for oversight of medical products such as gloves, condoms, and equipment.

In terms of TFDA regulation, pharmaceutical dispensing in Tanzania is divided into two

approved categories: Part 1 includes pharmacies offering the full range of prescription and non- prescription medicines; and Part 2 includes small private retail pharmacies and duka la dawa baridi (DLDB) drug outlets, which offer a limited range of over-the-counter and non-prescription drugs. A joint assessment in 2001 by MSH and MOHSW on rural availability of medicines found issues of persistent stock-outs at rural facilities as well as non-compliance with Part 2

regulations. The assessment revealed a number of unqualified DLDBs overcharging patients for medications, stocking and dispensing unapproved drugs, and doing inadequate assurance of drug quality (Center for Pharmaceutical Management, 2003). In an effort to improve the quality of Part 2 facilities, Part 2 DLDBs have been replaced by ADDOs in 15 regions, with an

additional six regions planned for transition by July/August 2012. The TFDA has maintained responsibility for finalizing the ADDO program and, once completed, will transition registration and oversight responsibility to the pharmacy council. In areas without a Part 1 facility, the TFDA and the Pharmacy Council are also expanding the dispensing package of some Part 2 facilities to include some items on the NEML, in order to limit deprivation of key medicines in rural areas.

PRIVATE SECTOR SUPPLY CHAINS