RUPRECHT-KARLS UNIVERSITÄT HEIDELBERG Department of Tropical Hygiene and Public Health Master of Science in International Health

Improving access to high-quality low-cost essential medicines in Tanzania – assessing an NGO’s contribution Rapid appraisal

Name of Investigator: Christine Häfele-Abah Name of Thesis Tutor: Dr. Florian Neuhann

Thesis submitted August 2010

DECLARATION OF ORIGINALITY OF WORK

This thesis is the result of independent investigation. Where my work is indebted to the work of others, I have made acknowledgement.

I declare that this study has not already been accepted for any other degree nor is it currently being submitted in candidature for any other degree.

Tönisvorst, 18.08.2010

Christine Häfele-Abah

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TABLE OF CONTENT LIST OF TABLES .......................................................................................................................................................... 5 LIST OF FIGURES ........................................................................................................................................................ 5 LIST OF ABBREVIATIONS........................................................................................................................................... 6 SUMMARY..................................................................................................................................................................... 8

1

INTRODUCTION................................................................................................................. 11

1.1

Access to essential medicines in developing countries ............................................................................. 11

1.2

The situation in Tanzania................................................................................................................................ 12

1.3

action medeor – a non-governmental organization and its activities in Tanzania.................................... 14 1.3.1 action medeor Tanzania (AMT) – drug distribution centre ...................................................................... 16 1.3.2 Capacity building for pharmaceutical manufacturers .............................................................................. 19 1.3.3 Pharmaceutical teaching and development laboratory “Pharm R&D Lab”.............................................. 21 1.3.4 Technology transfer and local production of ARVs ................................................................................. 23

1.4

Purpose of the study....................................................................................................................................... 24

2

LITERATURE REVIEW ...................................................................................................... 25

2.1

The access framework .................................................................................................................................... 25

2.2

WHO essential medicines concept ................................................................................................................ 26

2.3

Quality, safety and efficacy of medicines ..................................................................................................... 27 2.3.1 The problem of substandard and counterfeit medicines ......................................................................... 27 2.3.2 WHO Good Manufacturing, Storage and Distribution Practices ............................................................. 28 2.3.3 WHO prequalification programme........................................................................................................... 29

2.4

Global challenges............................................................................................................................................ 30 2.4.1 “Trade Related Aspects of Intellectual Property Rights” (TRIPS) ........................................................... 30 2.4.2 Research for “neglected diseases” ......................................................................................................... 31

2.5

Current global stakeholders and strategies.................................................................................................. 33 2.5.1 How to reach the MDGs?........................................................................................................................ 33 2.5.2 WHO – more than 30 years of EML ........................................................................................................ 34 2.5.3 The role of the “Global Fund” and other global health initiatives............................................................. 34

2.6

Local challenges in developing countries with a focus on Tanzania......................................................... 37 2.6.1 Financing and affordability ...................................................................................................................... 37 2.6.2 Local supply systems .............................................................................................................................. 39 2.6.3 Regulatory frameworks and quality assurance ....................................................................................... 42

2.7

National and donor policies and strategies in Tanzania.............................................................................. 43 2.7.1 Regulation and national policies ............................................................................................................. 43 2.7.2 Local production of medicines................................................................................................................. 45 2.7.3 Donor strategies and initiatives in Tanzania ........................................................................................... 48

3 3.1

METHODOLOGY................................................................................................................ 49 Study approach................................................................................................................................................ 49 3.1.1 Semi-structured interviews with guided questionnaires .......................................................................... 49 3.1.2 Written self-administered questionnaires ................................................................................................ 52

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3.2

Data collection and data analysis .................................................................................................................. 52 3.2.1 Data collection......................................................................................................................................... 52 3.2.2 Data analysis........................................................................................................................................... 54

3.3

Limitations ....................................................................................................................................................... 55

3.4

Ethical considerations .................................................................................................................................... 55

4

RESULTS ........................................................................................................................... 56

4.1

Policy makers’ and partners’ views on action medeor activities in Tanzania........................................... 56 4.1.1 Cooperation with stakeholders and relation to national policies ............................................................. 57 4.1.2 action medeor Tanzania – drug distribution centre ................................................................................. 58 4.1.3 Capacity building for pharmaceutical manufacturers .............................................................................. 59 4.1.4 Technology transfer and local production of ARVs ................................................................................. 60

4.2

Effects of drug distribution through action medeor Tanzania.................................................................... 60 4.2.1 Perception of AMT by customers and first contact.................................................................................. 61 4.2.2 Assessment of product range and availability......................................................................................... 62 4.2.3 Assessment of quality ............................................................................................................................. 62 4.2.4 Assessment of prices .............................................................................................................................. 63 4.2.5 Assessment of service (customer care, transport, payment modalities)................................................. 64 4.2.6 Results from customer feedback questionnaires .................................................................................... 65

4.3

Capacity building for local pharmaceutical manufacturers ........................................................................ 66 4.3.1 Workshop participants – assessment of the workshop organization ...................................................... 66 4.3.2 Workshop participants – benefits and implementation............................................................................ 67 4.3.3 Comparison with other training providers................................................................................................ 69 4.3.4 Feedback from evaluation questionnaires .............................................................................................. 69 4.3.5 Assessment from pharmaceutical manufacturers ................................................................................... 70

4.4

Current and future opportunities and risks for the Pharm R&D Lab.......................................................... 72

5

DISCUSSION...................................................................................................................... 74

5.1

The NGO’s activities in the light of the access framework.......................................................................... 75

5.2

The integration and localization of action medeor’s activities within the overall health and pharmaceutical system in Tanzania .............................................................................................................. 75

5.3

Effects of drug distribution through action medeor Tanzania.................................................................... 78 5.3.1 Achievements.......................................................................................................................................... 78 5.3.2 Areas for improvement............................................................................................................................ 79

5.4

Capacity building for local pharmaceutical manufacturers ........................................................................ 81 5.4.1 Effects on workshop participants and manufacturing standards............................................................. 81 5.4.2 Management views - challenges............................................................................................................. 82 5.4.3 Rationale for support of local manufacturing........................................................................................... 83

5.5

Current and future opportunities and risks for the Pharm R&D Lab.......................................................... 84

5.6

Limitations of this study and recommendations for future research and activities................................. 85

6

CONCLUSION .................................................................................................................... 86

ACKNOWLEDGEMENTS............................................................................................................................................ 89 BIBLIOGRAPHY.......................................................................................................................................................... 90 ANNEXES.................................................................................................................................................................... 97

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LIST OF TABLES Table 1: Extract of the project planning matrix “Pharm R&D Lab”................................................ 22 Table 2: Extract of the project planning matrix “Local production of ARVs” ................................. 23 Table 3: Characteristics of selected AMT customers ................................................................... 50 Table 4: Selection of interviewees by type of workshop attended................................................ 51 Table 5: Interlinkeage between stakeholders and action medeor activities in Tanzania .............. 57 Table 6: First contact between customer (health facility) and AMT.............................................. 61 Table 7: Average rating of AMT services by customers............................................................... 66 Table 8: Feedback from workshop evaluation questionnaires ..................................................... 70 Table 9: Opportunities and risks for the Pharm R&D Lab as assessed by stakeholders.............. 73 Table 10: Mark-ups on CIF prices AMT 2009 .............................................................................. 97 Table 11: Turnover AMT 2005-2009 ............................................................................................ 97 Table 12: Price comparison AMT-MSD........................................................................................ 97 Table 13: Workshops conducted in Tanzania by action medeor.................................................. 98 Table 14: Anonymized list of interviews conducted.................................................................... 111 Table 15: Implementation activities by the workshop participants.............................................. 112

LIST OF FIGURES Figure 1: action medeor´s activities within the pharmaceutical sector in Tanzania ...................... 16 Figure 2: Distribution of AMT customers in Tanzania .................................................................. 19 Figure 3: Workshop participants 2005-2010 by countries of origin .............................................. 98 Figure 4: Workshop participants 2005-2010 by workplace .......................................................... 99 Figure 5: Companies from different countries represented in the workshops 2005-2010 ............ 99

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LIST OF ABBREVIATIONS ACT AMT API ART ARV CHAI CIF CoA CPD CSSC DANIDA DDH DMO DMS DNDI DRA DSO EAC EC EDL/EML ELCT EPI EPN EU FBO GDP GFATM GMP GNI GPHF GTZ HAI HIV/AIDS HPLC HSSP IMPACT InWEnt IRP IRS

Artemisinin-based Combination Therapy action medeor Tanzania Active Pharmaceutical Ingredient Antiretroviral Therapy Antiretroviral Medicine Clinton Health Access Initiative Cost Insurance Freight Certificate of Analysis Continuing Professional Development Christian Social Services Commission Danish International Development Agency District Designated Hospital District Medical Officer Diocesan Medical Store Drugs for Neglected Diseases Initiative Drug Regulatory Authority Drug Supply Organization East African Community European Commission Essential Drug/Medicines List (or: WHO Model List of Essential Drugs/Medicines) Evangelical Lutheran Church in Tanzania Expanded Programme on Immunization Ecumenical Pharmaceutical Network European Union Faith-Based Organization Gross Domestic Product Global Fund to Fight AIDS, Tuberculosis and Malaria Good Manufacturing Practices Gross National Income Global Pharma Health Fund (until 2007: German Pharma Health Fund) Deutsche Gesellschaft für Technische Zusammenarbeit GmbH Health Action International Human Immunodeficiency Virus/ Acquired Immunodeficiency Syndrome High Performance Liquid Chromatography Health Sector Strategic Plan International Medical Products Anti-Counterfeiting Taskforce Internationale Weiterbildung und Entwicklung gGmbH International Reference Price Indoor Residual Spraying 6

ITN LDC MDG MEMS MOHSW MSD MSH MUHAS NEDL/NEML NGO PEPFAR PIC/S PPP PSU QA QC R&D SCMS SEAM SLF SOP SSA SWAP TB TCMA TFDA TPI TPMA TRIPS TSH TZ UNCTAD UNICEF UNIDO U.S. US FDA WHA WHO WTO VAT

Insecticide-Treated Nets Least Developed Country Millennium Development Goal Mission for Essential Medical Supplies Ministry of Health and Social Welfare (Tanzania) Medical Stores Department Management Sciences for Health Muhimbili University of Health and Allied Sciences National Essential Drug/Medicines List Non-Governmental Organization The United States President’s Emergency Plan for AIDS Relief Pharmaceutical Inspection Convention Scheme Public Private Partnership Pharmaceutical Supplies Unit Quality Assurance (Department) Quality Control (Department) Research and Development Supply Chain Management System Strategies for Enhancing Access to Medicines Saint Luke Foundation Standard Operating Procedure Sub-Saharan Africa Sector Wide Approach Tuberculosis Tanzania Christian Medical Association Tanzania Food and Drugs Authority Tanzania Pharmaceutical Industries Ltd. Tanzania Pharmaceutical Manufacturers Association Trade Related Aspects of Intellectual Property Rights Tanzanian Shilling Tanzania United Nations Conference on Trade and Development United Nations International Children’s Emergency Fund United Nations Industrial Development Organization United States (of America) United States Food and Drugs Administration World Health Assembly World Health Organization World Trade Organization Value Added Tax 7

SUMMARY Background: Access to medicines in developing countries, already addressed by the Alma Ata Declaration in 1978, has been a global health concern for decades. In 2004, the World Health Organization (WHO) estimated that one third of the world’s population lacked regular access to medicines. The reasons for this “access gap” range from economic factors (underlying poverty), high medicine prices and insufficient public spending on health to weaknesses and inefficiencies in the drug supply chain (Quick, 2003). On a global level, trade agreements including patent restrictions and insufficient Research and Development (R&D) for poverty diseases worsen the situation (Biesma et al., 2009). The WHO Access Framework considers “rational selection”, “affordable prices”, “sustainable financing” and “reliable health and supply systems” as key factors to improve access to medicines (WHO, 2004a). Different dimensions of access include “availability”, “affordability”, “accessibility”, “acceptability” and “quality” (CPM, 2003a). Even though a range of major global health initiatives in recent years have contributed to supplying medicines for high-priority diseases (HIV/AIDS, malaria, Tb), access to basic essential medicines remains often neglected (MOHSW, 2008b; Biesma et al., 2009). Tanzania, a least developed country located in East Africa, faces challenges of low availability of medicines, particularly in the public sector, as well as problems of affordability and quality in the private sector (CPM, 2003b). The public procurement agent Medical Stores Department (MSD) being the main supplier of medicines to public health facilities as well as to faith-based organizations, which operate 30% of all health facilities in Tanzania, shows inefficiencies caused by a multitude of factors (MOHSW, 2008b). The non-governmental organization (NGO) action medeor guided by the mission of improving access to medicines worldwide, has been supplying essential medicines from its headquarter in Germany since 1964. In recent years, the focus shifted to strengthening local production and local drug supply systems. The first branch, action medeor Tanzania (AMT), was established as a Drug Supply Organization in Dar es Salaam in 2004, with the goal to ensure availability and affordability of safe, effective and high-quality medicines and medical supplies for the non-profit sector in Tanzania (Roessler, 2009). As a contribution to supporting East African manufacturers to produce high-quality medicines, action medeor in cooperation with the Tanzania Food and Drugs Authority and other local as well as international partners has been offering trainings on Good Manufacturing Practice (GMP) standards since 2005. Furthermore, a pharmaceutical teaching and development laboratory 8

(Pharm R&D Lab) was established at the Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, and a technology transfer project aiming at local production of antiretroviral medicines (ARVs) is currently under way. This study wants to assess if and how these activities undertaken by an NGO in the pharmaceutical sector contribute to improving the supply of and thus access to medicines in Tanzania. Furthermore, alignment with national priorities and harmonization with other stakeholders´ activities are investigated.

Methodology: The study approach contains qualitative as well as some quantitative elements. In order to get the views and perceptions of stakeholders involved in or affected by action medeor activities, 31 semi-structured interviews were conducted with partners, policy makers, customers of AMT and representatives of East African pharmaceutical companies. Purposive sampling was applied to cover different sub-categories of respondents. Interviews were tape-recorded, transcribed and analysed by using the software Atlas.ti. The validity of this study was increased through triangulation, more precisely by inclusion of structured self-administered questionnaires which had been filled anonymously by AMT customers (37 questionnaires) and workshop participants (98 questionnaires) in the recent years.

Findings: The assessment shows that the individual action medeor activities in the pharmaceutical sector in Tanzania comply with respective national policies (National Drug Policy, Pharmaceutical Masterplan) by filling the gaps of the public supply system and by supporting local pharmaceutical production. Customers of AMT, mainly faith-based health facilities but also some public hospitals, which use AMT in addition to MSD and commercial wholesalers, appreciate the product range, availability and quality of AMT products. However, the prices are considered as rather high. The GMP workshops, which reached all Tanzanian and one third of Kenyan pharmaceutical manufacturers, contributed to improved manufacturing standards. Interviewed workshop participants (technical key personnel) implemented processes like risk assessment, validation and qualification in their companies and passed the acquired knowledge to their co-workers. Managers of pharmaceutical companies appreciated the “soft side assistance”; however, they also pointed to the challenges which they faced balancing quality and cost of production. The newly established Pharm R&D Lab at MUHAS has large potential – education of pharmacists and continuing professional development, providing contract services to the pharmaceutical industries and developing new generic drug formulations, which overall can lead to improved quality and possibly increased availability and affordability of medicines in Tanzania and beyond. 9

Risks were seen concerning the level of performance and the sustainability of the lab unless external donors or private investors are attracted.

Conclusion: This study shows that action medeor, though being a small NGO, has managed to contribute to improved quality of locally manufactured drugs in Tanzania – through capacity building and technology transfer – and to increased supply of medicines, especially to private non-profit customers, leading to better availability of medicines at health facility level. This indicates a clear contribution to improved access to medicines within the Access Framework. The success of the individual activities and their overall impact was and is strongly dependent on alignment with national priorities and on a regulatory framework being conducive. Therefore, the attribution gap remains high, and due to the complexity of interactions the contribution to access is not quantifiable. The NGO’s cooperation with national stakeholders has already been strong in the past, however, further exchange is required to ensure the sustainability of the implemented projects and for AMT to widen the customer range as a precondition for lowering the prices. Interaction with other international actors should be improved to increase harmonization and achieve synergistic effects.

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1 1.1

INTRODUCTION Access to essential medicines1 in developing countries As mentioned in the Declaration of Alma Ata (1978), the “provision of essential drugs” is

one of the core elements of primary health care in order to achieve “health for all”. However, access to medicines in terms of availability and affordability remains a major global health concern. Estimates show that 30% of the world’s population do not have regular access to essential medicines and in the poorest developing countries in Africa and Asia even up to 50% of the population are affected (WHO, 2004a). The World Health Organization (WHO, 2003a) has defined essential medicines as follows: “Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. “ In 1977, the first WHO Model List of Essential Drugs (EDL; now: Essential Medicines List – EML) was published, with the objective to standardize and rationalize treatment, prevent inappropriate use of drugs and facilitate drug procurement and distribution (Everard, 2002). Even though the “access gap” is strongly linked to economic, social and educational factors such as income distribution and literacy rate, there are several challenges within the health sector itself (Quick, 2003): -

Health financing and price of medicines: In many developing countries public spending for health is insufficient and patients have to contribute a large percentage as “out-of-pocket” expenses. This affects mostly the poorest, those who are rarely covered by any health insurance programme. Medicines often represent the largest government expense for health services beside personnel cost and the largest health expenditures on household level.

-

Public supply systems in developing countries frequently face problems regarding efficiency and reliability.

-

Overuse, underuse and misuse of medicines are common – examples being the irrational prescribing of antibiotics and the overuse of injections.

Poor quality of distributed medicines due to low manufacturing standards and weak control mechanisms contributes to the problem (Caudron et al., 2008). Further global and local challenges as well as international and national strategies to improve access to medicines will be described later on in this study. 1

The terms “medicines” and “drugs” are used interchangeably in this study.

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1.2

The situation in Tanzania The United Republic of Tanzania, consisting of Tanzania Mainland (formerly Tanganyika)

and the semi-autonomous state of Zanzibar, is a least developed country (LDC) located in East Africa. Tanzania has a population of 42.5 million (2008) and covers an area of 947.3 thousand sq km. Since independence and unification in 1964, Tanzania has been politically stable and experienced modest economic growth. In 2008, the Gross Domestic Product (GDP) increased by 7.5% and the Gross National Income (GNI) per capita in 2008 was 440 USD (compared to 270 USD in 2000). Tanzania has a young population – 44% are below the age of 15 years. Furthermore, 77% of the population are spread in the rural areas of the vast country (WHO AFRO, 2009a). Agriculture is the most important economic factor amounting to 46% of the GDP in 2005 (World Bank, 2010). It is estimated that the majority (57.8%) of Tanzanians are affected by severe poverty, with an income of less than 1 USD per day (WHO AFRO, 2009a). The health situation of the population is severely influenced by these economic and social factors. Life expectancy at birth is 56 years (2008) and under-5 mortality (per 1,000) decreased from 139 in 2000 to 104 in 2008. The maternal mortality ratio was reported to be as high as 578/100,000 for 2003-2008 (MOHSW, 2008a), even though adjusted figures – 950/100,000 for 2005 – give estimates which are even worse (UNICEF, 2010). HIV prevalence among the adult population was 6.2% in 2007 (World Bank, 2010). The generalized HIV/AIDS epidemic has stabilized around this level in recent years. Antiretroviral therapy (ART) has been rolled out on a large scale since 2004 and is currently reported to cover 55% of the 440,000 targeted HIV/AIDS patients in need. The main challenges remain in reaching HIV-infected pregnant women and children (URT, 2010). The WHO Country Cooperation Strategy 2010-2015 for Tanzania (WHO AFRO, 2009a) as well as the Health Sector Strategic Plan III, July 2009 – June 2015 (MOHSW, 2008a) aim at continuing recent efforts made in reduction of maternal and child mortality, HIV incidence as well as malaria and Tb control, in order to reach the health-related Millennium Development Goals (MDGs). Even though malaria awareness and control measures have been promoted, this infectious disease remains the major public health issue in Tanzania Mainland, accounting for 39.4% of attendances at outpatient departments and affecting mainly children below 5 years and pregnant women (MOHSW, 2008a). Severe malaria was found to be the main reason for hospital referral in children below 5 years in Southern Tanzania (Font et al., 2002). The islands of Zanzibar have seen a remarkable decline in malaria prevalence since the introduction and scaling up of multiple interventions like Artemisinin-based Combination Therapy (ACT), InsecticideTreated Nets (ITN) and Indoor Residual Spraying (IRS) (MOSHW, 2008c). 12

Health services in Tanzania are provided by public (56%), by private non-profit (30%) and by private for-profit (14%) facilities. Private non-profit health facilities are run by Non-Governmental Organizations (NGOs) and Faith-Based Organizations (FBOs), most of them under the umbrella of the Christian Social Services Commission (CSSC) (MOHSW, 2008b; MOHSW, 2008c). The health referral system – with a comparably high coverage of primary health services – includes public and private providers and consists of the following levels (MOHSW 2008b; MOHSW 2008c): -

Level A: 4697 dispensaries, each serving a population of 5-10.000 people

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Level B: 481 health centres, each serving 50 – 100.000 people

-

Level C: 154 district hospitals, “district designated hospitals”2 and eventually further hospitals in the district, each district serving 250 – 500.000 people

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Level D: 18 regional and 8 referral/consultant hospitals

The main source of medicines for public and private non-profit health facilities is the public procurement agent Medical Stores Department (MSD), which was created in 1993 and acts as a semi-autonomous unit under the Ministry of Health and Social Welfare (MOHSW, 2008c). Corresponding to the augmented national spending on medicines, MSD’s turnover increased from 38.4 million USD in 2004 to 87.0 million USD in 2006 (MOHSW, 2008c). There are currently seven licensed pharmaceutical manufacturers belonging to the Tanzania Pharmaceutical Manufacturers Association (TPMA), which contribute 30% of the total value of consumed medicines in the country (MOHSW, 2006). Regulation in the pharmaceutical sector is mainly under the responsibility of the Tanzania Food and Drugs Authority (TFDA), which was established in 2003 through the Tanzania Food, Drugs and Cosmetics Act with the mandate to ensure quality, safety and efficacy of distributed drugs in the country. In addition, the Pharmacy Council is the body for regulating and setting standards regarding education, conduct and activities of pharmaceutical personnel, including Continuing Professional Development (CPD) (Pharmacy Act, 2002). The Pharmaceutical Supplies Unit (PSU) at the MOHSW is responsible for issuing and regularly updating the National Essential Medicines List (NEML; formerly: National Essential Drug List – NEDL) as well as the Standard Treatment Guidelines (STG), which were both first published in 1991 (MOHSW, 2007). The number of pharmacists in Tanzania has increased from 365 in 2002 to 699 in 2008; however, it is still very low in relation to the overall population: 1 pharmacist per 50,000 people (WHO AFRO, 2009b). There are only 4 training institutions enrolling about 90 pharmacy students, 80 “District designated hospitals” (DDH) are run by FBOs and function as district hospitals in districts without any public hospital.

2

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pharmaceutical technicians and 20 pharmacy assistants per year. The Muhimbili University of Health and Allied Sciences (MUHAS) in Dar es Salaam has, for a long time, been the only institution to educate pharmacists in the country. A second university admitting pharmacy students just opened three years ago in Dodoma (Kaale, 2010). The national spending for medicines (including donor funds) amounted to 59.06 million USD in the fiscal year 2005/2006, whereof 25.5 million USD were spent on essential medicines (including antimalarials), 5.2 million USD on vaccines (EPI3) and 28.16 million USD on vertical programmes. This means that 10.2% of the national recurrent health expenditures (252 million USD) were spent on essential medicines in 2005/2006, 23.4% if vaccines and vertical programmes were included (EHG, 2007). The total spending on medicines per capita increased from 0.64 USD in 2002 by 152% to 1.61 USD in 2006. One year later, in 2006/2007, the total expenditures for medicines were reported to be 202.65 million USD (including donor funds and in-kind donations). This further significant increase in medicine spending is mainly due to higher coverage and cost of ART for HIV/AIDS patients and the introduction of ACT for malaria patients since November 2006 (MOHSW, 2008b). In spite of increased budget allocation and spending, weaknesses in procurement, forecasting and financial flows lead to inefficiencies and affect regular supply of medicines to health facilities (EHG, 2007). Therefore, access to medicines is affected by insufficient availability of medicines, especially in the public sector. Furthermore, weaknesses concerning quality and affordability exist especially in the private sector (CPM, 2003b). These challenges as well as policies and strategies to improve access to medicines in Tanzania will be discussed in more detail in the literature review.

1.3

action medeor – a non-governmental organization and its activities in Tanzania A wide range of local and international NGOs have been active in reducing poverty and

improving the quality of life in developing countries for decades (Gellert, 1996). Local NGOs, especially church organizations, play an important role in health care provision in sub-Saharan Africa (SSA), where they have traditionally served deprived populations without sufficient access to healthcare. In Tanzania, 90% of the church hospitals were built in rural underprivileged areas (Gilson et al., 1994). Similarly, international social welfare NGOs, despite their diversity, share certain characteristics which distinguish them from other private and public players in the international health arena. They focus on areas of great need and promote local involvement of vulnerable population groups. Furthermore, they operate on a mostly non-profit low-cost basis 3

EPI = Expanded Programme on Immunization

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with committed and mission-minded staff. Their main advantage is being adaptive, innovative and quite independent from the political context (Gellert, 1996). However, the expansion of NGOs since the 1990s and the large-scale funding of sometimes uncoordinated NGO activities bear the risk of weakening of the public sector and leading to fragmentation (Pfeiffer et al., 2008). Therefore, NGOs, like bilateral and multilateral partners, should commit themselves to adhere to the principles of the “Paris Declaration and the Accra Agenda for Action”4 and strive for alignment and harmonization.

The German Medical Aid Organization action medeor e.V. was established in 1964 with the goal to improve access to medicines in developing countries. From its headquarter in Tönisvorst (Germany), the NGO has been delivering high-quality essential medicines and medical equipment on a non-profit basis to around 10,000 hospitals and health centres in developing countries, including Tanzania (action medeor, 2010). Considering the potential of emerging pharmaceutical production capacities in some developing countries and the strengthening of drug regulatory authorities (DRAs) limiting imports of donations, a strategic decision by action medeor was taken to establish branches in various developing countries under a newly founded non-profit company – action medeor International Healthcare gGmbH (charitable Limited). The first and only branch so far, action medeor International Healthcare Tanzania Ltd. (short: action medeor Tanzania – AMT) was opened as a non-profit drug supply organization (DSO) in 2004 in Dar es Salaam. Several feasibility studies in other developing countries were conducted and plans are under way to open branches in Haiti and in West Africa (action medeor, 2010). Besides drug distribution, action medeor started to support local pharmaceutical production in East and West Africa through pharmaceutical advisory services, to ensure the quality of locally manufactured medicines. In Tanzania, this comprises capacity building on Good Manufacturing Practices (GMP), the establishment of a pharmaceutical teaching and development laboratory (Pharm R&D Lab) at MUHAS and a technology transfer project for local production of antiretroviral medicines (ARVs) in cooperation with Tanzania Pharmaceutical Industries Ltd. (TPI) (action medeor, 2010). Figure 1 shows the positioning of the NGO’s activities within the pharmaceutical sector in Tanzania.

The „Paris Declaration“(2005) and the „Accra Agenda for Action”(2008) are international agreements between donor and recipient countries with the goal to enhance aid effectiveness and accelerate progress (www.oecd.org). 4

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Figure 1: action medeor´s activities (yellow) within the pharmaceutical sector in Tanzania HF = health facilities; MEMS = Mission for Essential Medical Supplies

1.3.1

action medeor Tanzania (AMT) – drug distribution centre From its warehouse in Dar es Salaam, AMT as a DSO supplies public and private non-

profit customers with locally and internationally procured medicines, all generally registered in Tanzania. It serves as alternative supplier to already existing systems like MSD and Mission for Essential Medical Supplies (MEMS) – a prime-vendor based approach by the Evangelical Lutheran Church in Tanzania (ELCT). The Minister of Health welcomed action medeor’s initiative since it complements public supply channels and therefore increases access to medicines in the country (Abdallah, 2004). In its complementary role, AMT intends to fill the gaps of MSD, trying to avoid a weakening of the public systems as was seen with dominant donor-funded parallel structures (Biesma et al., 2009). After a preparatory phase in 2004, AMT was registered as a limited company and was licensed by TFDA as a drug wholesaler in 2005. Even though charitable organizations are exempted from taxes in Tanzania, this does not apply for a branch with a German parent company. Therefore, the DSO is charged import duty, income tax and value added tax (VAT) where required. However, medicines and medical equipment are generally VAT exempted.

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Until December 2004, there was 10% import duty on all medical supplies. Within the context of EAC5 harmonization, import duty inside the East African Community was abolished, but then reintroduced with a transition period of three years (2006-2009): -

medicines (except for malaria, Tb and ARV medicines) from non-EAC countries 10%; medical equipment 0%

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medicines (except for malaria, Tb and ARV medicines) from within EAC: 6% in 2006, 4% in 2007, 2% in 2008, 0% in 2009; medical equipment 0%

Since July 2009, there is 0% import duty on all medicines and medical equipment.

The rational selection of medicines at AMT is based on the NEML, the WHO EML, TFDA requirements and customer recommendations. At the end of 2009, the action medeor Essential Medicines List and Medical Supplies List contained approx. 275 medicines and approx. 350 medical supplies (medical equipment, consumables, diagnostics and lab equipment). Tb drugs and ARVs are not included in the product range since they are country-wide supplied through vertical programmes exclusively. In accordance with the policy to support local pharmaceutical manufacturers – without compromising on quality and price, however – a range of Kenyan and Tanzanian manufacturers was selected and prequalified. Procurement from one Kenyan and one Tanzanian manufacturer had to be stopped due to quality concerns. The current Tanzanian manufacturers supplying action medeor are Zenufa, Shelys, A.A. Pharmaceuticals (external preparations only) and Mansoor Daya (external preparations only); the Kenyan suppliers are Regal, Cosmos, Elys and Ivee Aqua. In addition, smaller product quantities are procured mainly from several Indian and European manufacturers, mostly through local importers. Out of 275 products on the action medeor medicines list, 75 were procured from Tanzanian and Kenyan manufacturers in 2009. Quality assurance includes prequalification and auditing of suppliers, provision of batch-specific certificates of analysis and physical check of incoming goods. 11 GMP audits have been conducted at 8 manufacturing sites in Tanzania and Kenya, partly accompanied by experienced senior auditors. Furthermore – adhering to WHO Good Storage Practices – AMT products are stored in two temperature controlled warehouses (storage area about 300 sqm) including four refrigerators for cool storage items (Roessler, 2009).

EAC = East African Community (Tanzania, Kenya, Uganda, Burundi, Rwanda) with its secretariat in Arusha/Tanzania (www.eac.int) 5

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The non-profit customers of AMT comprise faith-based health facilities and other NGO facilities as well as government hospitals. So far, public facilities could procure from AMT only in exceptional cases, due to budget allocations at MSD. However, the customer list shows that 39 public hospitals have already received medicines from AMT. A large proportion of health facilities run by FBOs under the umbrella of the Christian Social Services Commission (CSSC) are registered as customers with AMT, which means that they requested AMT services at least once: 82 out of 89 hospitals (90%), 49 out of 74 health centres (65%) and 125 out of 680 dispensaries (18%). However, only a smaller portion of those have become regular customers; for example, 20 hospitals procure their medicines several times per year from action medeor. Remote FBO dispensaries, due to their small procurement quantities mainly use local sources (MSD, commercial sellers) or procure via Diocesan Medical Stores (DMS). Out of approx. 10 functioning DMS in the country, 5 are registered as AMT customers (Masuki, 2010). Additionally, there is an option for foreign (mainly German) donors to make payment on behalf of the health facilities and use their so-called “donation account” at AMT (Roessler, 2009). The share of donations was highest in 2005 with 35% of turnover and decreased steadily to 17% in 2009. With an annual turnover of approximately 1 million €, AMT’s market share in comparison to MSD is still relatively small (less than 2% of MSD turnover). FBO facilities are the main customers of AMT. In 2009, products with a value of more than 650,000 € were sold to FBO facilities, less than 100,000 € to government facilities. Both customer groups have been steadily growing within the last five years, public hospitals by approx. 30% per year. The DSO issues a price indicator and revises prices every few months, with the goal to cover all operational costs and maintain financial sustainability. The pricing policy started with 28% markup on CIF (cost insurance freight) prices in 2005. After increase in turnover, in 2008 prices were reduced and a staggered pricing system was introduced, with lowest mark-ups on products for dispensaries (level A) and health centres (level B). The goal of this pricing policy is to promote rational use of medicines. The mark-ups for 2009, the annual turnovers (2005-2009) and a price comparison between AMT and MSD can be found in annex 1. The comparison shows that prices of 10 randomly selected medicines6 are up to 30% higher7 at AMT than at MSD. Transport of supplies to the health facilities which are scattered all over the country (see figure 2) is contracted out to private bus or haulage companies. The consignment is brought to the bus stop by action medeor; the customer is informed and is responsible for picking up the shipment at the bus destination. Small parcels are sent by the Tanzanian Post & Parcel Service. Transport Products were taken from a WHO/MOH pricing study (URT, 2005) (precondition: products included in NEML 2007 and same pack size available at MSD and AMT) 7 Exceptions: One item, Amoxicillin tabs. 250 mg, is cheaper at AMT than at MSD; one medicine in a small pack size is more than twice as expensive at AMT compared to MSD (refer to annex 1). 6

18

costs for shipments with a value of more than 10 million TSH8 are covered by AMT. Customers in the Dar es Salaam area mostly collect their consignments directly from the AMT warehouse. Orders are made by e-mail, fax and telephone, or during personal visit (Roessler, 2009).

Figure 2: Distribution of AMT customers (FBO hospitals only) in Tanzania (derived from CSSC map, Survey’s and Mapping Division, 2005)

1.3.2

Capacity building for pharmaceutical manufacturers In order to support regional pharmaceutical production in East Africa, promote

implementation of international GMP standards and thus increase the quality of medicines in the East African market, action medeor e.V., together with its partners, has offered various training workshops for pharmaceutical key personnel in Tanzania since 2005.

8

TSH = Tanzanian Shilling; 1800 TSH = 1 € (exchange rate June 2010)

19

A range of factors contributed to the take-off of this initiative: -

Audits and visits conducted at several Kenyan and Tanzanian manufacturing sites (within the scope of AMT´s supplier prequalification process) revealed the need for capacity building and GMP awareness. An in-depth needs assessment was done in early 2005 at Tanzania Pharmaceutical Industries (TPI) Ltd.

-

The strengthened drug regulatory framework, especially in Tanzania, was seen as an opportunity for enforcement of higher production standards on a sustainable basis.

-

Furthermore, official German development partners realized the significance of local pharmaceutical manufacturing and InWEnt gGmbH9 supported the initiative from the beginning.

The training series started as a Public Private Partnership (PPP) between InWEnt Capacity Building International and TPI Ltd. action medeor facilitated and organized the workshops. TPI, one of the largest pharmaceutical manufacturers in Tanzania, is setting up an additional manufacturing facility for the production of affordable high-quality ARVs in Arusha/ Northern Tanzania, with support of the European Commission (EC) and action medeor (see also 1.3.4). The capacity building initiative, with the goal to ensure compliance with WHO and national GMP standards, covered a cross-section of East African pharmacists and chemists – those working in production, quality control (QC) and quality assurance (QA) departments of pharmaceutical industries as well as those working in the distribution sector, in DRAs and universities. Since all local pharmaceutical industries experience a shortage of skilled personnel, the TPMA supported the initiative throughout. Further important stakeholders were the TFDA, sending inspectors to participate in the training, and the Pharmacy Council, which announced accreditation of the courses. International pharmaceutical experts were recruited to give presentations, guide the group discussions and share their experience. The first three general GMP courses, in 2005 and 2006, were conducted at Saint Luke Foundation (SLF), a training centre for pharmacy assistants and pharmaceutical technicians in Moshi/ Northern Tanzania. Considering the request of participants for more practical exposure, an in-depth course with a focus on “Qualification of equipment and validation of processes” was held at TPI premises in November 2006 for TPI staff and representatives of DRAs and academia. However, this course excluded technical personnel from other commercial manufacturing companies for reasons of competition. With the establishment of a pharmaceutical teaching and development laboratory (Pharm R&D Lab) at the Muhimbili University of Health and Allied Sciences (MUHAS) in Dar es Salaam since Internationale Weiterbildung und Entwicklung (InWEnt) gGmbH; engl.: InWEnt – Capacity Building International, Germany (www.inwent.org)

9

20

2007, there is finally a neutral ground to offer theoretical and practical training to all pharmaceutical industries (see also 1.3.3). In 2008, InWEnt and action medeor (within the scope of the EC funded TPI ARV project) started a follow-up training series at the Pharm R&D Lab – on GMP aspects, product development and quality control (action medeor, 2010). In 2007, the same partners supported a workshop on “TRIPS – Flexibilities in the WTO rules for Intellectual Property Rights10” which was initiated by UNCTAD11. Even though this topic is very relevant for pharmaceutical manufacturing in LDCs, it was not considered in the process of data collection (interviews), since the target group and objective differed from all other workshops. Overall, there were 230 training contacts since 2005. 47 workshop participants attended 2 or more of the offered courses; the number of individuals who ever attended was 158. Among these, the majority came from Tanzanian and Kenyan pharmaceutical manufacturers. All (8) Tanzanian companies were represented in the training workshops and 10 out of 26 Kenyan manufacturers attended (action medeor, 2010; PPB, 2010). An overview of all 9 courses conducted between 2005 and 2010 and the detailed composition of the workshop groups can be viewed in annex 2. 1.3.3

Pharmaceutical teaching and development laboratory “Pharm R&D Lab” A growing number of East African pharmaceutical manufacturers have started or are

planning to start production of ARVs – e.g. TPI, Shelys and Zenufa in Tanzania, Universal and Cosmos in Kenya and Quality Chemicals in Uganda. In the recent years, several of these and further companies have invested in facilities, equipment and personnel to reach higher standards in production, adhere to GMP and finally achieve WHO prequalification (see also 2.3.2). Major challenges are the shortage of qualified pharmacists trained in production, quality control and quality assurance and the lack of research and development (R&D) capacities especially for “new” generic formulations like second-line ARVs (action medeor, 2007). In order to support the growing East African pharmaceutical industry in their efforts to provide high-quality ARVs and other essential medicines and to address the before mentioned challenges, a pharmaceutical teaching and development laboratory (“Pharm R&D Lab”) was set up at the Muhimbili University of Health and Allied Sciences (MUHAS) in Dar es Salaam. For many years, MUHAS has been the only training institution for pharmacists in the country. The objective and aspired results of the project are shown in table 1. The project started in June 2007 as a PPP between the Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) GmbH, action medeor International Healthcare gGmbH and MUHAS. The project volume is 1.024 million €, of which GTZ covers 55%, action medeor approx. 30% and 10 11

TRIPS = Trade Related Aspects of Intellectual Property Rights; WTO = World Trade Oganization (refer to 2.4.1) UNCTAD = United Nations Conference on Trade and Development

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MUHAS approx. 15%. It was expected that the project results would be achieved within 30 months, by November 2009. However, due to delays in the lab renovation phase, the project duration had to be extended by six months, up to June 2010 (action medeor, 2010). The objective of the project is to adapt higher education to the needs of the pharmaceutical industry, to enable the development of HIV/AIDS medicines and compliance to WHO standards for pharmaceutical manufacturers in East Africa. Result 1: A teaching and development laboratory at MUHAS is fully equipped and ready to use Result 2: Selected companies have improved their production and quality control processes and have been consulted to comply with WHO standards Result 3: The lab is used for practical student training and is accessed for production and quality control support by local ARV producers Result 4: The long-term sustainability of the laboratory at MUHAS is assured Table 1: Extract of the project planning matrix “Pharm R&D Lab” (action medeor, 2010)

Within the scope of the project, the pharmaceutical technology lab of the School of Pharmacy was completely renovated, furnished with clean room panels and equipped with key equipment for development of oral solid dosage forms: two single punch compression machines, one fluid bed dryer (for granulating, drying and pellet coating), a pan coater and in-process control equipment. The analytical lab was upgraded with some second hand equipment (HPLCs12) and stability chambers. International senior pharmaceutical experts were recruited to take care of the equipment installation and to train five university staff members working in the lab. Since 2008, 50 pharmacy students in their 5th semester and 25 pharmaceutical technicians are practically trained in the lab each year. Postgraduate Master or PhD courses are planned to be offered. So far, four workshops for industrial personnel were conducted in the lab since 2008 (see also 1.3.2.). It was expected that seven regional manufacturers would rent the services during the project period. However, due to delays in the lab set-up, the operational phase has just started. A “Pharm R&D Lab Demonstration” for pharmaceutical manufacturers was conducted at the end of June, 2010. Consultancy services regarding WHO prequalification could only be realized to a limited extent, during GMP inspections at manufacturing sites and during GMP training for industrial personnel. A business model for the long-term sustainability of the lab is currently being developed (action medeor, 2010). The first formulation projects are already under way, the most advanced one being an ARV triple combination which is recommended as new first-line by WHO (2009a) – Lamivudine (300 mg),

12

HPLC = High Performance Liquid Chromatography

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Tenofovir (300 mg), Efavirenz (600 mg). International collaborations have started as for example through the Roche Technology Transfer Initiative related to the protease inhibitor (ARV) Saquinavir (Roche, 2008). Paediatric formulations are another focus area (action medeor, 2010). On 13th of June 2009, the lab was officially inaugurated by the Honourable Prof. J. Maghembe, Minister for Education and Vocational Training (Kim, 2009). 1.3.4

Technology transfer and local production of ARVs With the overall objective to contribute to the reduction of the devastating social and

economic impact of HIV/AIDS in Tanzania, a technology transfer project for local production of ARVs was launched in December 2006. A WHO GMP compliant manufacturing facility will be constructed in Arusha/ Northern Tanzania under guidance of action medeor e.V. and transferred to the newly registered subsidiary company TPI ARV Ltd. of the local partner, TPI Ltd. A strong capacity building component for East African manufacturers, authorities and institutions forms an integral element of the project (action medeor, 2010). The objectives and planned results are shown in table 2. Overall objective: HIV/AIDS related socio-economic decline in Tanzania slowed down Specific objective: The demand of 100,000 HIV and AIDS patients for first-line antiretroviral treatment can be met by locally produced high-quality ARVs Result 1: Factory compliant with WHO GMP established Result 2: Sufficient production capacity of high-quality first-line ARVs according to the need installed and output achieved Result 3: Knowledge generation and capacity building programmes on GMP and TRIPS supported and/or conducted Table 2: Extract of the project planning matrix “Local production of ARVs” (action medeor, 2010)

The project is financed by the European Commission (EC) (5.0 million €) and TPI (0.7 million €), and the original project duration was scheduled for 40 months. However, due to significant delays and challenges in the planning and tendering phase, this goal could not be met. In accordance with the EC, an addendum was signed in February 2010 by which the project period was extended for 32 months. The tender for the construction of the manufacturing plant was relaunched in April 2010; contract discussions are currently taking place. Pharmaceutical training programmes on GMP and TRIPS have been supported within the scope of this project since 2007 (see also 1.3.2.). Given that the technology transfer part of this project is still in the planning stage, it was considered only marginally during the course of data collection (interviews). 23

1.4

Purpose of the study This study aims to assess the contribution of an NGO to improved access to medicines in

a least-developed country, exemplified by the case of action medeor in Tanzania. The activities undertaken by action medeor in the pharmaceutical sector in Tanzania and East Africa since 2005 are evaluated by getting the views from stakeholders – beneficiaries, customers, partners and health policy makers. Contributions and activities by other national and international players will be considered in a review of literature in order to provide a picture of the overall development of the pharmaceutical sector and to check for alignment and harmonization. Recommendations will be derived for future activities and programmes.

Overall objective: To assess action medeor’s contribution to improve access to high-quality low-cost essential medicines in Tanzania [Prerequisite: the supply side of access is considered]

Specific objectives: a) To assess relevant partners’ and policy makers’ views of the activities undertaken by action medeor in the pharmaceutical sector in Tanzania b) To describe effects on drug supply for non-profit health facilities (customers) receiving drugs from action medeor Tanzania since 2005 c) To assess if and how East African pharmaceutical manufacturers benefited from action medeor’s capacity building interventions d) To describe and assess the current and potential future role of the newly established pharmaceutical teaching and development lab at the Muhimbili University of Health and Allied Sciences (MUHAS) in the pharmaceutical sector

Study questions: -

How do policy makers, partners, customers and direct beneficiaries assess the activities undertaken by action medeor in the pharmaceutical sector in Tanzania and East Africa since 2005?

-

How does action medeor contribute to improve access to medicines in Tanzania?

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2

LITERATURE REVIEW This literature review will cover the following themes:

Based on the problem statement, international frameworks and standards relating to access to medicines will be presented. Then, challenges which can only be solved on a global level will be addressed and the role of current global stakeholders and strategies will be discussed. Considering the specific local challenges within a developing country context, national policies and strategies for improving access to low-cost high-quality essential medicines in Tanzania will be described.

2.1

The access framework The world pharmaceutical consumption increased from 70 billion USD in 1975 to 317

billion USD in the year 2000; however, 80% of the medicines target only 15% of the world population – those living in industrialized countries. A large proportion of people in low- and middle-income countries still have insufficient access to essential medicines since availability and affordability are not assured (Everard, 2002). In 2004, WHO developed the “framework for collective action” on how to ensure “equitable access to essential medicines”. This Access Framework builds on four pillars: Rational selection, affordable prices, sustainable financing and reliable health and supply systems (Everard, 2002; WHO, 2004a). It intends to address the major obstacles and challenges which hold life-saving and curing treatment off a large portion of patients worldwide, e.g.: -

Economic and social problems (underlying poverty)

-

Inappropriate public funding for health – often as a result of health sector reforms

-

Inefficient public supply systems

-

“Out-of-pocket” expenses by the patients accounting for up to 50-90% of medicines in developing countries

-

High treatment costs and global trade agreements threatening access to new patentable medicines

With the goal to develop measurable indicators for “access to medicines”, the term was defined by WHO and other important stakeholders as a construct of several dimensions (CPM, 2003a): -

Physical availability relating to the amount of unexpired key items in stock, to the stock-out time, the number of prescribed items not dispensed and to the existence of a drug information system (e.g. treatment guidelines)

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-

Affordability relating to medicine prices compared to international reference prices (IRP), price differences between branded and generic products, to number of days a poor patient has to work to pay for the treatment and to the extent of risk-sharing or prepayment scheme coverage

-

Geographical accessibility relating to the distance (travel time) between home and health facility, waiting time and operating hours of the health facility

-

Acceptability relating to the patient’s satisfaction with treatment, especially to the acceptance of essential medicines

And the following characteristic affects all before mentioned dimensions: -

Quality of products and services relating to a functioning quality assurance system, quality control tests complying with the specifications, existence of updated essential medicines list and treatments based upon standard treatment guidelines

2.2

WHO essential medicines concept “Essential medicines are those that satisfy the priority health care needs of a population”,

focusing on public health relevance and taking into account quality, safety, efficacy and costeffectiveness (WHO, 2003a). The objective of the WHO essential medicines concept is to standardize and rationalize treatment especially within the context of constrained health systems lacking sufficient qualified human resources. Furthermore, it facilitates drug procurement and distribution which are often hindered by weak and inefficient supply systems (Quick, 2003). The first Model List of Essential Medicines (EML) was developed by WHO in 1977 – it contained 208 priority medicines to address the major global diseases. Since then, the EML has been updated every two years considering new health challenges and progresses in pharmaceutical development. The latest EML version dated March 2009 contains 340 medicines – including those against HIV/AIDS, malaria, Tb and chronic diseases. The WHO EML is supposed to serve as a model for respective national essential medicines lists (NEML) which consider the specific local requirements. Those medicines shall then be made available to all patients through functioning health systems. The use of essential medicines is often laid down in standard treatment guidelines (STG). In 1977, only very few countries had national medicines lists. Today, the majority of WHO member states, at least 156 countries, have implemented NEMLs and STG, mainly linked to comprehensive national medicines policies (WHO, 2007/updated 2010). A review of 17 NEMLs in 2003 showed that many developing countries used the WHO EML as intended. 65% of reviewed lists contained fewer products than listed on the WHO EML (309 in 1999), mainly for three reasons: Some medicines did not appear on the lists due to regional 26

morbidity patterns, e.g. medicines for leishmaniasis. Others were not yet found on the national lists due to a time lag after revision of the WHO EML. And further medicines were deleted from national medicines lists since better and more cost-effective alternatives were available. The last point reveals that some medicines were included or remained on the WHO EML without evidence-based justification. Only in 2002, WHO adopted a new comprehensive evidence-based approach for regular revision of the WHO EML (Laing et al., 2003). Even though essential medicines lists and further policy instruments exist in many countries, there is still room for improvement, especially regarding frequent updating of NEML, STG and national medicines policies (UN, 2008). Tanzania introduced the first NEML in 1991 accompanied by STG, the second edition followed in 1997 and the third in 2007 (MOHSW, 2007). A baseline survey in the pharmaceutical sector in Tanzania (2002) revealed that most of the drugs prescribed (98.5%) were included in the NEML; however, adherence to the STG was very low, resulting mainly in an irrational overuse of antibiotics. Furthermore, only five out of 20 surveyed public health facilities had the current STG available (MOH, 2002). Another more recent study showed that only about 50% of surveyed health facilities procured their medicines according to the NEML, the stated reasons for noncompliance being that local needs were not addressed and that the products were not available at MSD. Furthermore, the revision cycles of the NEML and STG seemed to be too long, meaning that treatment regimens became outdated and prescribers lost confidence (MOHSW, 2008c). According to the National Drug Policy, revision should be done at least every three years (MOH, 1993).

2.3 2.3.1

Quality, safety and efficacy of medicines The problem of substandard and counterfeit medicines The quality of medicines is a major concern of healthcare providers, since poor-quality

medicines may lead to increased morbidity and mortality, to occurrence of adverse effects in case of harmful ingredients and to drug resistance if the products contain sub-therapeutic amounts of active ingredients. Counterfeit medicines, which are illegally produced and distributed may contain no active ingredient, insufficient active ingredient, toxic ingredients or, in rare cases, correct composition of ingredients but fake packaging or labelling. In contrast, substandard products are the result of poor manufacturing practices, lack of technical expertise and insufficient enforcement and control of quality standards by DRAs and purchasers (Newton et al., 2010).

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Exact figures on counterfeiting are difficult to get and prevalence estimates for developing countries range from less than 10% to more than 30% (Newton et al., 2010). Widespread antiinfective medicines seem to be most affected, whereof costly medicines like ACT offer the highest criminal incentive (Amin and Kokwaro, 2007). Even though counterfeit products represent a global challenge, with 1500 reported cases in 2007, developing countries are particularly vulnerable due to their fragile drug supply systems and limited control capacities (WHO, 2009b). As a response, WHO has launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and has set up an action plan, in cooperation with other partners (WHO, 2010b). Whereas counterfeit products have achieved high attention globally, evidence shows that the problem of substandard products prevails, as for example revealed in a review related to antimalarial drug quality in Africa (Amin and Kokwaro, 2007). Typical quality problems were found to be insufficient in-vitro availability (dissolution) and poor stability under tropical conditions; both deficiencies are probably caused by a low quality of raw materials or poor formulation techniques and may lead to sub-therapeutic in-vivo drug levels. In order to combat substandard products, DRAs need to be strengthened and equipped to enforce GMP standards for locally produced and imported medicines. Furthermore, medicines manufactured in developed countries for export to developing countries are to be regulated to the same extent as those for domestic use, and procurement agencies should commit to source their products only from prequalified manufacturers complying with international GMP standards (Caudron et al., 20008). 2.3.2

WHO Good Manufacturing, Storage and Distribution Practices In the late 1960s, the principles of Good Manufacturing Practices (GMP) in the production

and quality control of pharmaceutical products were developed in cooperation with international experts and published by WHO. In 1969, when the “WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce” was launched, the new GMP guidelines were already accepted as an integral part of the scheme. Under the WHO Certification Scheme, national drug regulatory authorities are supposed to issue a “Certificate of Pharmaceutical Product” according to the WHO format before the product can be sold outside the country. This certificate shall confirm, among other things, that the manufacturing of the product complies with GMP. The certification scheme is of particular relevance for importing countries without stringent and comprehensive registration requirements (WHO, 1995). GMP is a system to ensure that “quality is built into a product”. Even though quality control forms a major component of GMP, it is not sufficient on its own since “quality cannot be tested into a product”. The main risks which shall be prevented through GMP are: Cross-contamination and 28

mix-ups, false labelling and incorrect amount of active pharmaceutical ingredients (APIs). GMP covers all areas of production, quality control and quality assurance – including starting materials, equipment and premises, training and hygiene of staff. Documentation of all processes represents an important element to demonstrate that procedures are consistently followed. Integrated approaches like risk assessment, validation of processes and qualification of equipment are applied to ensure continuous reliable product quality (WHO, 2003b; WHO, 2007a). Based on the WHO GMP guidelines, many countries have developed their national GMP guidelines; additionally, there are harmonized requirements within the European Union (EU), the Pharmaceutical Inspection Convention Scheme (PIC/S) and others. In Tanzania, the second version of national GMP guidelines was published in 2007 (TFDA, 2007). In order to ensure the quality of pharmaceutical products along the supply chain up to the patient, further international guidelines, the Good Storage Practices (WHO, 2003b) and Good Distribution Practices (WHO, 2006a) have been developed. They deal with requirements for personnel and premises and consider especially the control and monitoring of storage conditions in warehouses and during transport. Furthermore, they describe how to handle complaints, product recalls and returned goods and emphasize the need for thorough documentation of all key processes in order to assure traceability and avoid mix-ups and infiltration of counterfeit products. The “Model Quality Assurance System for Procurement Agencies” issued by WHO (2007b) assists DSOs with implementing these quality standards and focuses on further aspects like random analytical testing and particularly prequalification of products and manufacturers. One important element of supplier qualification represents auditing of manufacturing sites according to GMP, which, however, requires profound technical expertise and experience. 2.3.3

WHO prequalification programme In order to assist international agencies and developing countries with procurement of

medicines for HIV/AIDS, malaria and Tb, the WHO prequalification programme was set up in 2001. The goal is to ensure quality, safety and efficacy of priority medicines which will be made available to patients in developing countries. The prequalification process comprises two elements: The assessment of the product and product related data including clinical trials (bioequivalence13 studies for generic products) as well as inspection of the manufacturing site and compliance with GMP standards. WHO regularly publishes “Invitations for Expressions of Interest” which include a list of all products eligible for WHO prequalification. Assessment of products and sites is conducted by international experts from stringent regulatory authorities in Bioequivalence: Products showing comparable bioavailability are considered as bioequivalent and usually as therapeutically equivalent. Bioavailability relates to the rate and extent of API availability in the systemic circulation. 13

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cooperation with assessors from developing countries’ DRAs. As further capacity building element, technical support is provided and workshops are conducted for DRAs and pharmaceutical manufacturers in developing countries. At the end of 2009, 237 medicines, manufactured in 16 countries, were WHO prequalified. Whereas most originator products come from Europe or the U.S., a large proportion of generic WHO prequalified medicines originate from Indian manufacturers (WHO, 2010a). Apart from South Africa, there was no WHO prequalified manufacturing site in SSA until 2009. In early 2010, the first pharmaceutical plant in a leastdeveloped country, Quality Chemicals Ltd. in Uganda – a joint venture with Cipla Ltd. (India) –, received WHO approval (Anderson, 2010). In recent years, the scope of the WHO prequalification programme was widened to cover independent quality control laboratories, clinical sites and suppliers of selected APIs. Furthermore, medicines and commodities for reproductive health were included (WHO, 2010a).

2.4 2.4.1

Global challenges “Trade Related Aspects of Intellectual Property Rights” (TRIPS) The emergence of the HIV/AIDS epidemic showed that access to newer medicines can

be hindered by global trade agreements and strong patent protection, with fatal consequences for patients in need. In 2002, 95% of people living with HIV/AIDS, predominantly in SSA, did not have access to life-saving ARVs due to the high prices as a result of patent protection. Only when generic competitors in India started producing ARV triple combinations, the therapy cost per patient-year dropped abruptly from over 10,000 USD to less than 300 USD (Ahmad, 2002). Currently, the annual costs for Lamivudine/ Stavudine/ Nevirapine, which is still widely used as first-line treatment in developing countries, are at around 70 USD per patient; the cheapest “new” first-line therapy (Zidovudine/ Lamivudine/ Nevirapine) costs approx. 140 USD per patient-year (MSF, 2010). In 1995, the World Trade Organization (WTO) was founded and issued the agreement on “Trade Related Aspects of Intellectual Property Rights” (TRIPS) which requested WTO members to implement minimum standards of patent protection like a 20-year patent protection period. Since developing countries’ governments, including all those from Africa, feared that their right for protecting public health would be threatened due to excessive prices for medicines under patent protection, they raised concern. In November 2001, the Doha Declaration on TRIPS and Public Health was adopted, stressing the importance of public health and utilization of TRIPS flexibilities

30

like “compulsory licensing”14 and “parallel imports”15. Furthermore, LDCs were exempted from obligatory pharmaceutical patent protection until 2016. In order to address the concern of “nonmanufacturing countries” not being able to issue compulsory licenses for domestic production, on August 30th, 2003, the respective clause in article 31f of the TRIPS agreement was waived (WTO, 2006). Even though export and import under compulsory licensing are theoretically possible now, first experiences have shown that the procedure is quite cumbersome (t’Hoen, 2009). Although developing countries (except for LDCs) had to implement the TRIPS provisions by the beginning of 2000, for certain changes in the national patent laws there was a transition period of 10 years with a final implementation date on 01.01.2005 (WTO 2006). Important in this respect is the introduction of “product patents” in India, since India has become a large supplier of cheap generic ARVs to the developing world. Before 2005, India granted only “process patents” which implied that the respective product (e.g. an API) could be legally manufactured by using a different process than the patented one (“reverse engineering”). With India´s Patents (Amendment) Act (2005) coming into force, Indian manufacturers are generally not allowed to produce new drugs under patent protection anymore. However, the Indian government has included a number of safeguard provisions to ensure continued availability of current generic ARVs and to restrict the number of future patents granted (t’Hoen, 2009). LDCs which do not have to apply pharmaceutical patent protection until 2016 could utilize this advantage by producing newer generic ARVs in-country – if the technical capacity is assured and if TRIPS exemptions and flexibilities have been translated into the respective national or regional patent laws. Currently, many LDCs like Tanzania do not make sufficient use of their “privileges” yet and are advised to amend their patent laws accordingly (Losse et al., 2007). 2.4.2

Research for “neglected diseases” Since research-based pharmaceutical companies operate as highly profitable businesses,

they invest only in research and development (R&D) where there is a potential market (Henry and Lexchin, 2002). The “Commission on Health Research for Development” (1990) estimated that only 5% of the global health research resources were spent on diseases of developing countries, where 93% of “preventable mortality” occurred. Based on these findings, the “Global Forum for Health” coined the term “10/90 gap”, to express that not more than 10% of all health research resources are devoted to health problems affecting predominantly the poorest 90% of the world’s

A “compulsory license” issued by the government allows the licensee to manufacture a patented product without consent of the patent owner. By article 31f of the TRIPS agreement the use of such a license was limited “predominantly for the supply of the domestic market” (WTO, 2006). 15 “Parallel imports” refer to products marketed by the patent owner in one country (at a cheaper price) and imported into another country without permission of the patent owner (WTO, 2006). 14

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population (Kilama, 2009). Furthermore, out of 1,556 innovator products marketed between 1975 and 2004, only 20 (corresponding to 1.3%) targeted tropical diseases and Tb, which account for at least 12% of the global disease burden (Chirac and Torreele, 2006). Part of the problem is that research institutions and universities in developing countries which are overburdened with undergraduate teaching, poorly managed and sometimes lack essential infrastructure, can hardly contribute to product development required to fight poverty diseases in their countries (Kilama, 2009). In the recent years, however, a number of Public Private Partnerships and Product Development Partnerships - R&D activities of pharmaceutical companies supported by public funding – were launched. Promising partnerships like the Drugs for Neglected Diseases Initiative (DNDI) have started research against malaria, leishmaniasis and other neglected diseases (DNDI, 2010). Due to much greater funding, 26 new products for neglected diseases (including malaria, Tb and HIV/AIDS drugs with applications specific for developing countries) were marketed between 2000 and 2009. The majority of these new drug approvals, however, concerned HIV/AIDS and malaria medicines (Cohen et al., 2010). Though the term “neglected diseases” is differently defined by different organizations, it generally includes a range of poverty diseases16 which together affect 1 billion people, mainly those living in deprived rural and urban settings in low-income countries, and cause between 500,000 and one million deaths per year (Kilama, 2009). Due to the recent high attention for HIV/AIDS, malaria and Tb, many stakeholders (including WHO) do not consider these three diseases as “neglected diseases” (Stirner, 2008). Since patent protection associated with high medicine prices due to a monopoly position still represents the main incentive for pharmaceutical companies to invest, sustainable changes regarding R&D for neglected diseases are uncertain. New mechanisms have been suggested to address this problem, e.g. prize funds as a reward for drug development (for neglected diseases), advanced market commitments by private or public donors to procure a certain drug after development or patent pools collecting patents from patent owners which can then be used under certain conditions by generic drug companies (Stirner, 2008). The latter has already been initiated by UNITAID (2010). In order to address the challenges related to R&D and the availability of innovative products for diseases strongly affecting developing countries, an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property was established by the World Health Assembly (WHA) The “neglected diseases” mainly include buruli ulcer, chagas disease (American trypanosomiasis), cholera, dengue/dengue haemorrhagic fever, dracunculiasis (guinea-worm disease), fascioliasis, human African trypanosomiasis (sleeping sickness), leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, schistosomiasis, soil transmitted helminthiasis, snakebite, trachoma, yaws and yellow fever (Kilama, 2009). 16

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in 2006. The group representing WHO member states but also non-state actors like Médecins sans Frontières (MSF) prepared a “Global strategy and plan of action on public health, innovation and intellectual property“ which was adopted in May 2008. The strategy, under the lead of WHO, shall promote new thinking in innovation and access to medicines by focusing on needs-driven rather than market-driven research. Two of the eight elements of the strategy target capacity building in developing countries and technology transfer in order to facilitate local production (WHA, 2008).

2.5 2.5.1

Current global stakeholders and strategies How to reach the MDGs? Three out of the eight Millennium Development Goals (MDGs) are directly related to

health – MDG 4 “Reduce child mortality”, MDG 5 “Improve maternal health” and MDG 6 “Combat HIV/AIDS, malaria and other diseases”. Whereas all these three goals are only achievable if access to medical care and medicines is ensured, there is one target under MDG 8 “Develop a global partnership for development” which refers directly to access to medicines – target 8e: “In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries.” The MDG gap task force report for MDG 8 (2008) reveals that achievements in the resource mobilization for HIV/AIDS, malaria and Tb treatments have been made; however, access to essential medicines in general remains still inadequate. The indicator for this target refers to the “Proportion of population with access to affordable, essential drugs on a sustainable basis“ (indicator 8.13), “access” being defined as “having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population” (UN, 2008). Surveys revealed that availability in the public sector covers only one third and in the private sector only two thirds of the patients’ needs in developing countries (Cameron et al., 2009). Recommendations to reach the MDGs and close the access gap comprise – on a national level – eliminating taxes on essential medicines, reducing trade margins and increasing availability in public health facilities to serve especially the poor. On a global level, in addition to increased R&D funding for “poverty diseases”, differential pricing policies and generic production should be promoted (UN, 2008). Moreover, the latest MDG gap task force report (2009) stresses the increasing burden of chronic diseases and their associated costs, as well as the necessity to face the effects of the global economic crisis by protecting poor people from increased medicine costs. Furthermore, 33

technology transfer for pharmaceutical production between developed and developing countries as well as development of more paediatric drug formulations are required (UN, 2009). 2.5.2

WHO – more than 30 years of EML Under the slogan “Continuity and Change”, WHO presents its third WHO Medicines

Strategy 2008-2013 (WHO, 2009b), relating to the MDGs and other global trends as well as addressing well-known and upcoming challenges. The continuous elements include WHO’s normative work - setting quality standards for pharmaceuticals, assessment of priority products through WHO prequalification and classification of new APIs - as well as dealing with intellectual property rights and medicine prices. New elements to be strengthened comprise the promotion of health insurance and social protection - to cover medicine cost especially for the poor -, transparency and good governance in the medicine supply sector and enforcement of “access to medicines” as a human right. A renewed focus on Primary Health Care, including affordable essential medicines, within an equity approach is needed (WHO, 2009b). Rational use of medicine has to be promoted in order to achieve good quality of care and reduce cost and wastage of medicines. The value of this concept should be realized by customers and payers; they should acknowledge its promotion as part of procurement cost, since finally it will lead to more cost-effective treatment (WHO, 2009b). The International Network for Rational Use of Drugs (INRUD), which is supported by WHO, has been a strong actor in this field since 1989 and tries to develop and disseminate effective strategies to improve prescribing and dispensing practices, particularly in developing countries (INRUD, 2010). Another WHO strategic field of action is the integration of traditional medicines into national health systems. Many countries have already developed policy documents to support the research and use of traditional medicines, but integration into the overall health system is often still lacking (WHO, 2009b). 2.5.3

The role of the “Global Fund” and other global health initiatives Within the last decade, mainly since the upsurge of the HIV/AIDS epidemic as a global

health threat, several national and multi-national initiatives took off, either to address specific health problems in developing countries or with a wider scope. Among the most influential ones are the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) (Biesma et al., 2009) as well as the Clinton Health Access Initiative (CHAI – formerly Clinton HIV/AIDS Initiative) under the Clinton Foundation (Waning et al., 2010).

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The Global Fund, created in 2001 to intensify the international response to three major diseases prevalent mainly in developing countries, mobilizes resources from multi-national public as well as private partners. Until the end of 2009, proposals from developing countries amounting to 19.2 billion USD were approved – 10.8 billion USD for HIV/AIDS programmes in 140 countries, 3.2 billion USD for TB programmes in 112 countries and 5.3 billion USD for Malaria programmes in 83 countries. A significant proportion of these funds (21% in 2008) are used for procurement of medicines; recipients are obliged to consider WHO prequalified medicines only (GFATM, 2010). The latest strategy of the Global Fund includes the element of procurement-related support for countries, through improved price reporting mechanisms, voluntary pooled procurement and capacity building in the field of supply management (GFATM, 2007). PEPFAR (launched in 2003) and CHAI (launched in 2002) are US-funded initiatives with the initial objectives to support the fight against HIV/AIDS in developing countries. In the meantime, CHAI has widened its scope and included other diseases like malaria and Tb, as well as a strengthening of healthcare delivery systems. Both initiatives have a strong focus on procurement and access to HIV/AIDS related medicines. PEPFAR uses the Supply Chain Management System (SCMS), a consortium of various technical organizations for procurement, and considers generally only medicines approved by the U.S. Food and Drugs Administration (US FDA). CHAI has achieved remarkable price reductions through negotiations with suppliers of ARVs, including paediatric formulations (CHAI, 2010; PEPFAR, 2010). Considering the volume and wide geographical representation, all these and other initiatives have shaped the global health arena remarkably, including access to medicines (Biesma et al., 2009). Looking at the influence of HIV/AIDS funding on health systems in developing countries, one study concludes that HIV/AIDS programmes have strengthened pharmaceutical sectors through innovations in procurement and supply chain management which serve all health needs. Examples given include capacity building for pharmaceutical staff and the replacement of the traditional “push” system – supplying standardized kits to healthcare facilities in routine intervals – by the “pull” system, which considers the specific needs of the health facilities (Embrey et al., 2009). A drug tracking study in Tanzania, however, revealed that primary health facilities using the newly introduced “pull system” did not show a better availability of medicines compared to those facilities still receiving kits. The reasons were mainly seen in low order fulfilment through MSD as well as weak forecasting capabilities; the system shift even increased the burden on MSD’s inventory management (EHG, 2007). A review on the influence of major global health initiatives related to HIV/AIDS control demonstrated that these initiatives led to wider stakeholder participation by channelling funds also to non-governmental actors. However, especially in the beginning, negative effects on national 35

systems were clearly visible by establishing parallel processes that were poorly coordinated. Even though alignment with national priorities has increased to some extent within recent years, challenges regarding harmonized financial management and reporting as well as concerns regarding competition and remuneration for scarce human resources remain. Furthermore, some initiatives, especially PEPFAR, seem to lack transparency in identifying their partners and distributing their funds - mostly to NGOs (Biesma et al., 2009). A mapping of partners in the medicine supply system in Tanzania identified 21 stakeholders and asked them to provide information on their financial, procurement and supply activities – the stakeholders were multilateral partners like the Global Fund, UNICEF17, WHO and UNITAID18, bilateral partners like PEPFAR, CHAI and national development agencies as well as NGOs and private partners. It was shown that most bilateral donors and private partners targeted HIV/AIDS programmes, whereas multilateral donors targeted a range of major diseases. Multi- and bilateral donors increasingly use the public channels, however, some like PEPFAR, USAID 19 and UNITAID used other procurement agents. Better communication and information-sharing is required. In Tanzania, total financial support for procurement of medicines and medical supplies was about 315 million USD in 2006/2007 (including the government share); the portion of essential medicines, however, was only 21% compared to vertical programmes. This raised the concern of neglecting core essential healthcare in relation to few high-priority diseases. Even though the government share (53%) of the budget was still bigger than the contribution of the Global Fund (32%) and other development partners (15%), the influence of the latter is considerable (MOHSW, 2008b). Further challenges regarding the sustainability of treatment progresses made on a global level are discussed by Waning et al. (2010). Whereas pooled procurement and powerful price negotiations by large initiatives show a very positive short-term effect, the long-term effect might be that supply has to rely on few large pharmaceutical companies since smaller companies are pushed aside, and further R&D investment, e.g. for new generic combination therapies, might be limited. This effect is already visible when looking at procurement of improved first-line and second-line ARVs.

17 UNICEF (United Nations International Children’s Emergency Fund): The supply division of UNICEF in Copenhagen is an important player concerning procurement of high-quality pharmaceuticals, vaccines and medical devices for developing countries (www.unicef.org). 18 UNITAID : The International Drug Purchase Facility established by Brazil, France, Chile, Norway and the United Kingdom to improve access to high-quality drugs and diagnostics for AIDS, malaria and Tb in countries with a high burden of disease (www.unitaid.eu). 19 USAID = United States Agency for International Development (www.usaid.gov)

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2.6 2.6.1

Local challenges in developing countries with a focus on Tanzania Financing and affordability In developing countries, expenses for medicines contribute to 20-60% of the health

budget, compared to only 10-20% in developed countries (WHO, 2004b), whereby Tanzania with 23.4% is placed rather at the lower end (EHG, 2007). Furthermore, a large proportion of the medicines have to be paid by the patients through out-of-pocket expenses in low- and middle income countries (WHO, 2004a). Public per capita spending for health varies considerably, from 0.08 USD to 139.76 USD within SSA (UN 2008). Data from the World Health Report 2006 for Tanzania showed that per capita total expenditure on health amounted to 12 USD in 2003 (public per capita spending approx. 7 USD). Private health expenditures contributed 44.6% of total health expenditures. Out of these, 81.1% were out-of-pocket expenses (WHO, 2006b). Tanzania introduced a patient cost-sharing (user-fee) scheme in the public sector in 1994; exemptions apply to pregnant women, children under five years of age, the elderly above 60 years and other justified cases. However, the user fee rates are not fixed - some facilities charge flat rates, others varying prices for medicines and services. And the end-consumer medicine price has been found to be on average twice as high as the public sector procurement price (URT, 2005). The situation in Tanzania is similar to that in other developing countries, especially in SSA, where health sector reforms – inflicted by the World Bank – promoted user fees and involvement of private-for-profit providers since the late 1980s. A review of studies in low- and middle-income countries showed that medical expenses impose a substantial burden on private households which may lead to impoverishment, especially when combined with a sickness-related loss of income. The economic costs of illness represent often more than 10% of the household income, and accumulated expenses during an acute illness lead – due to absence of health-insurance systems – to risky “coping strategies” like borrowing money or selling assets (McIntyre et al., 2005; Leive and Xu, 2008). In Tanzania, Community Health Funds at district level have been introduced (42 out of 114 districts covered in 2004), and the National Health Insurance scheme for civil servants was launched in 2001. The majority of the population, however, is not covered by any health insurance yet (URT, 2005).

Concerning the prices and affordability of medicines, a survey in 36 low- and middle-income countries, under guidance of WHO and Health Action International (HAI), showed that patients across the six WHO regions had to pay 9 - 25 times the International reference price (IRP), 37

derived from the MSH price indicator guide20, for selected medicines in the private market. Public sector procurement prices were with 1.11 times IRP (median) quite low, however, patient prices ranged from 3 - 12 times the IRP in the public sector.21 Considerable mark-ups in the distribution chain contribute to these high patient prices. It was found that wholesale mark-ups reach from 2% to 380% and retail mark-ups from 10% to 552% in the private market (Cameron et al., 2009). The country survey conducted in 2004 on availability and affordability of medicines in Tanzania revealed that availability of key essential medicines in NGO and retail facilities was significantly higher than in the public sector. However, medicine prices that patients were charged were more than twice as high in private and NGO facilities than in public facilities. Medicines in NGO facilities were even slightly more expensive than in the private retail sector. Affordability of treatment represents a challenge especially in case of chronic conditions. The lowest paid government worker, who, however, earns more than the majority of the population, had to spend on average 1.4 days wages to pay the public sector user fees for a monthly asthma therapy. Since there is no price regulation for medicines in Tanzania, end-consumer prices vary significantly between but also within all three sectors (from facility to facility), sometimes by many multiples. The cumulative mark-ups in the supply chain were found to be on average 16.7% in the public sector (only MSD mark-up), 56% in the private and 60% in the NGO sector (URT, 2005). Strategies to reduce medicine costs are of crucial importance to increase affordability and improve access. Bulk procurement based on a national essential medicines list, generics policies, tendering procedures and price negotiations, recommended within the Access Framework (WHO, 2004a), have been implemented in many developing countries like Tanzania (URT, 2005). Further recommendations for policy makers include elimination of duties, tariffs and taxes on essential medicines, as partly realized in Tanzania with the abolition of import tax and VAT on essential medicines (Roessler, 2009), reducing mark-ups in the distribution chain, encouraging local production if feasible and if quality is assured as well as including TRIPS flexibilities into national legislation and applying them (WHO, 2004a). When considering price regulation in the pharmaceutical sector, there is the concern to give the wrong incentives and thus reduce availability of low price generics (Cameron et al., 2009). However, one study conducted in Mali showed that price regulation introduced in the private market did not have any negative effect on availability of essential medicines. On the other hand, retail pharmacy prices were reduced by 23.2%. An important element of the strategy was to include all affected stakeholders in the Management Sciences for Health (MSH) publishes the “International Drug Price Indicator Guide” every year (http://erc.msh.org). The Guide lists a range of current prices for essential medicines from international drug supply organizations and indicates the median price for each product. action medeor e.V. (Germany) and action medeor Tanzania are included in the list. 21 The figures represent median price ratios calculated for each WHO region (Cameron et al., 2009). 20

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decision-making process. The situation in Mali may be special since there was a low level of competition before introduction of the price regulation and thus some wholesalers were in a monopoly position for certain products (Maiga and Williams-Jones, 2010). In order to make medicine financing sustainable, out-of-pocket expenses should be reduced, for example by expansion of health insurance systems, and innovative external funding sources have to be sought (WHO, 2004a). 2.6.2

Local supply systems In order to pool procurement and better control the selection of medicines for the public

sector, many developing countries have established national procurement agencies, like MSD in Tanzania. However, as the WHO/HAI survey shows, medicine availability in the public sector is generally insufficient and low procurement prices are not automatically passed on to the patients (Cameron et al., 2009). The public procurement and supply system in Tanzania mirrors the situation of many developing countries, especially in SSA. Besides its central store in Dar es Salaam, MSD has 8 zonal stores, geographically distributed throughout the country. MSD holds its own vehicles, but also hires complementary private transport services. The distribution process is challenged by poor transportation and infrastructure networks, especially from the zonal stores to the health facilities (MOHSW, 2008c). The District Medical Officer (DMO) coordinates orders from dispensaries, health centres and district hospitals to the zonal medical stores. The zonal medical stores order directly from the central store, according to their needs. Public procurement by MSD is done through tendering; product selection is based on the NEML (MOHSW, 2008c). A country assessment on access to medicines in Tanzania (CPM, 2003b), which was conducted in 2001, concluded that MSD, though it contributes significantly to provision of medicines in Tanzania, would come to its capacity limit in the near future. Whereas MSD procures medicines at highly competitive prices 22 and has a good distribution capacity, inventory management appears to be insufficient with frequent under- and overstocking leading to out-of-stock situations as well as expiry of medicines. The authors found that MSD could supply less than 80% of requested supplies, more recent figures (URT, 2005) show that availability of tracer medicines was 72% (even though this later list included non-NEML-medicines which were not expected to be stored by MSD). This partly explains the low availability of medicines in public health facilities, since, unlike NGO facilities, public facilities are not free to procure from alternative suppliers due to budget allocations with MSD. NGO facilities are eligible to procure from MSD; however, they

22

Average MSD procurement price was 65% of IRP in 1999 (CPM, 2003b) and 69% of IRP in 2004 (URT, 2005).

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often complement their MSD purchases with medicines from alternative sources. Median availability of 44 surveyed medicines in health facilities in 2004 was found to be only 23.4% at public facilities, 42.9% at NGO facilities and 47.9% at private outlets. However, these figures need to be taken with caution, since only 30 out of 44 medicines were listed on the NEML (URT, 2005). In 2007, the MOHSW Tanzania conducted another in-depth assessment of its public medicine supply system. The study found out that availability of medicines at MSD central and zonal stores as well as health facilities was low (e.g. 79% at zonal stores) with stock-out times ranging from 1 to 183 days for 20 tracer medicines of the NEML. Low availability at upper levels of the supply chain automatically affects lower levels. Specific reasons for stock-outs were seen in delayed delivery and errors in forecasting (all levels), quantities delivered not conform to quantities ordered (zonal and health facility level) and missing funds (health facility level). The tendering system, even though it shows advantages regarding pricing, transparency and accountability, leads to long lead times of 3 to 8 months, depending on the mode of shipment. The majority of essential medicines were procured from local manufacturers in 2006, whereas most HIV/AIDS, malaria and Tb medicines came from international manufacturers and suppliers, since donor funding (e.g. GFATM) allows sourcing from WHO prequalified manufacturers only. On the other hand, in order to increase availability of essential medicines on all levels, more flexible procurement should be allowed. The recommendation was made to entitle public health facilities to use 20-30% of their medicines budget to procure medicines from any alternative source, in addition to their budget allocated at MSD (MOHSW, 2008c). A similar recommendation was already made within the scope of a previous study (CPM, 2003b). In 2007, 33% of surveyed facilities stated that they used MSD as only source so far (MOHSW, 2008c). Stock management and storage facilities also needed improvement. Only 22% of health facilities indicated to have adequate storage equipment, and only 52% had cold chain storage available. Furthermore, there is a need for training health staff on quantification processes in order to improve forecasting (MOHSW, 2008c).

The private sector has been involved in healthcare delivery and medicine supply in Tanzania since the 1990s, after the end of the socialistic era (URT, 2005). There are 197 registered private wholesalers, 352 retail pharmacies (concentrated in the urban areas) and about 6,000 small drug shops (“Duka la dawa baridi”) all over the country. The latter are officially allowed selling nonprescription medicines only (EHG, 2007). According to a study conducted in 2001 (CPM, 2003b), commercial wholesalers imported most of their products from China, Egypt, Europe, India, Kenya and Malaysia. They chose their suppliers considering cost, service, reliability, credit terms and 40

“some historical indication of product quality”. Quality was apparently assessed by inspection of labels and reports from clients. None of the wholesalers had established quality control procedures; this was, however, before TFDA started to enforce registration of products and stricter regulations on wholesale premises (CPM, 2003b). All major commercial wholesalers are located in Dar es Salaam. They use private transport companies, including bus and rail, to ship their products to sub-wholesalers and pharmacies which further distribute the medicines to smaller shops in their regions. Major wholesalers and/or importers represent exclusively one or several manufacturers. They supply primarily the private health care sector, selling generics, branded generics and brand (innovator) products in smaller pack sizes compared to MSD. A comparison of prices revealed that undiscounted wholesalers’ prices were about 30% higher than MSD prices; however, price discounts up to 10% are common. In order to increase availability, wholesalers purchase products from one another if need arises (CPM, 2003b). The National Drug Policy emphasizes the need for a better coordination of the public and private sector, at the same time controlling misuse – like counterfeits – and setting standards for ethical drug promotion and advertisement (MOH, 1993). Associated with its Access Framework, WHO explicitly recommends the “creation of an efficient public-private-NGO mix in supply delivery” (WHO, 2004a). In another paper, the former Director of Essential Drugs and Medicines Policy at WHO recommends governments to use a pragmatic approach regarding the set-up of their medicine supply services rather than blindly promoting public or private systems only (Quick, 2003).

In many SSA countries like in Tanzania, the private non-profit sector, mainly faith-based organizations, contributes significantly in delivering healthcare to the population, up to 50% in some countries (WHO and EPN, 2006). Faith-based or non-profit drug supply organizations play an important role in many of these countries, complementing the public procurement systems. A study conducted by the Ecumenical Pharmaceutical Network (EPN) in 2003 found that 15 DSOs in 10 African countries served an average of 43% of the population, ranging from 25% to 60% in the various countries. Whereas customers seem to appreciate DSO services, the quality and prices of products as well as the good customer care, weaknesses were seen in the range and availability of products. Customers also indicated the need for more information-sharing and technical assistance by the DSOs to improve management of medicines at health facility level (e.g. training courses on prescribing, dispensing, rational use of medicines and stock

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management). Furthermore, improvements in quality assurance were key priority areas addressed by the DSOs themselves (WHO and EPN, 2006)23. In contrast to other East African countries like Kenya and Uganda, there is no warehouse-based church-owned drug supply organization in Tanzania. The Evangelical Lutheran Church of Tanzania (ELCT) has initiated a prime-vendor based approach, the Mission for Essential Medical Supplies (MEMS), which, however, has reached limited coverage so far and strongly relies on donor support. The focus of MEMS is rather on technical assistance and drug information services for health facilities (Kopwe et al., 2005). 2.6.3

Regulatory frameworks and quality assurance In many developing countries, due to resource constraints, the regulatory framework is

still quite weak, meaning that the capacity to ensure the quality, safety and efficacy of circulating medicines is limited. It is estimated that less than 30% of all DRAs in SSA are sufficiently resourced to conduct GMP audits and perform postmarketing surveillance (Amin and Kokwaro, 2007). Tanzania has put significant efforts into its regulatory system within the last decade; however, challenges remain (CPM, 2003b; Risha et al., 2008). Officially, since 1978, all medicines have to be registered in Tanzania by the Pharmacy Board (now: TFDA), as required by the Pharmaceutical and Poisons Act. However, registration was not enforced until 1999, when the management of the Pharmacy Board changed. A study conducted in 2001 revealed that 46% of the drugs circulating in the market were still not registered. Nonetheless, the number of registrations had increased by 123% in 2000 compared to 1999, showing a tremendous achievement within a very short time. The Tanzania Food, Drugs and Cosmetic Act (2003) entitled the newly established TFDA to further regulatory tasks, e.g. to combat counterfeiting and to monitor adverse reactions (CPM, 2003b). This move was accompanied by investment in premises and especially human resources (TFDA, 2008). Local manufacturers were encouraged and pushed to comply with GMP standards established in 1998, and TFDA conducted regular audits at the manufacturing sites (Bitegeko, 2007). Even though huge progress can be seen in Tanzania in the field of drug regulatory issues, the vast country still faces enormous challenges: Registration and supervision of the several thousand small drug shops (“Duka la dawa baridi”) is almost impossible, enforcement of strict conditions on the shop owners might even be counterproductive having in mind the overall goal of

AMT as non-profit organization serving mainly faith-based facilities is a member of EPN. However, at the time of the study, it was not operational yet and therefore not included. 23

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“access to medicines”, since these drug shops are often the only or most accessible source of medicines for the rural population (Patouillard et al., 2010). Counterfeits and substandard medicines represent another area of concern. Inappropriate distribution and storage along the supply chain may be a contributing factor. A study conducted by Risha et al. (2002) showed that out of 22 analgetic and antimalarial drug formulations, seven did not meet the requirements for in-vitro availability (dissolution). Five more formulations did not pass the dissolution test after being exposed to simulated tropical conditions (75% relative humidity / 40°C) for 6 months. In 2003, a two-tier quality assurance programme was implemented in Tanzania. In order to save cost and time and cover a higher number of drug samples, a first screening test using the “Minilab®” developed by the German Pharma Health Fund (GPHF) was conducted at four official ports of entry and at three regional TFDA centres for postmarketing surveillance. A full analytical testing at the TFDA quality control laboratory was performed on all samples which failed the screening test. First results after 2.5 years of project implementation (2003-2005) showed that out of 1257 screened batches, only 46 (3.7%) failed the two-tier testing. Out of these, five products were classified as counterfeits (with either no active ingredient, incorrect ingredient or incorrect amount of active ingredient). As the sampling was limited to official ports of entry and retail outlets, the actual number of substandard and counterfeit drugs in the country might be much higher (Risha et al., 2008).

2.7 2.7.1

National and donor policies and strategies in Tanzania Regulation and national policies In order to address challenges like increased drug costs, weaknesses and missing

regulations in the drug supply and distribution systems, lack of qualified personnel and training opportunities in the health sector as well as an insufficient availability of reference materials and information sources for treatment, the Tanzanian Ministry of Health started implementing the Tanzania Essential Drugs Programme in 1984. The programme, supported by DANIDA 24 , UNICEF and WHO, comprised the development of the National Essential Drug List of Tanzania and the STG (MOH, 1993). Main policy in the pharmaceutical sector up to now is the National Drug Policy (1991), which is currently in the final stages of a revision process. According to the Chief Pharmacist at MOHSW, the format of the revised policy differs considerably from the former

DANIDA, the Danish International Development Agency, has prioritised “access to essential medicines” for a long time, by providing support to the Pharmaceutical Supplies Unit at MOHSW and pilot projects like MEMS (EHG, 2007). 24

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one, due to a necessary alignment to the National Guidelines for Formulation of Policies, even though the components stayed almost the same (Muhume, 2010). The drug policy of 1991 as an integral part of the National Health Policy (1990) with the aim of “health for all” has the overall objective to “make available at all times the essential pharmaceutical products which are of quality, proven effectiveness and acceptable safety at a price that the individual and the community can afford, when these are needed to prevent, cure or reduce illness and suffering.” The National Drug Policy is guided by the following core principles (MOH, 1993): -

Drug availability, implying drug selection according to the essential drug concept, promotion of generic drugs, procurement preferably from local or regional manufacturers, distribution of registered drugs only, better coordination between the public and private sector, investment in appropriate storage facilities and implementation of quality assurance through inspections and quality control testing

-

Rational drug use, comprising education and training on all levels of healthcare, dissemination of scientifically based information, including the development of a national formulary, control of the misuse of drugs, establishment of therapeutic committees on hospital level as well as ethical drug promotion and advertising – restricted to over-thecounter drugs

-

National pharmaceutical production, including promotion and preferential use of locally manufactured drugs, an increase of national manufacturing capability with the long-term goal of producing also intermediary and raw materials to achieve self-sufficiency

-

Traditional medicines - promotion of the use of safe traditional medicines and investment in research and production

Along with the National Drug Policy goes the Masterplan for the Pharmaceutical Sector of Tanzania Mainland 1992-2000 (which is currently being updated as well). It deals with the implementation aspects of public sector procurement, drug regulatory affairs and local production under the principles of GMP. With the overall goal to contribute to the National Strategy for Growth and Reduction of Poverty (in Kiswahili: MKUKUTA), the Health Sector Strategic Plan (HSSP) III 2009-2015 as well as the second National Health Policy (2007) seek to “ensure quality and availability of sufficient medicines and supplies” among other through promotion of PPPs. The HSSP aims at improving accessibility at all levels, promoting rational drug use and addressing the human resources shortage as well as enhancing the capacity and efficiency of the public supply system through well-timed disbursement of financial resources and other means. TFDA shall be strengthened to

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combat substandard and counterfeit products, and local production will be promoted (MOHSW, 2008a). As described in the previous chapter, the Tanzania Food and Drugs Authority (TFDA) as an executive agency is responsible for regulation in the pharmaceutical and food sector, assuring “quality and safety of food, drugs, herbal drugs, medical devices, poisons and cosmetics”. It issues licenses for manufacturing, wholesale and retail facilities and supervises the compliance with regulations and standards. Even though product registration is a general requirement for drugs being distributed in Tanzania, exceptions are possible for specific purposes. Whereas the former Pharmacy Board was responsible for all regulation in the pharmaceutical sector, including human resources, the TFDA is responsible for products and premises only (Tanzania Food, Drugs and Cosmetics Act, 2003). Regulation of pharmacists, pharmaceutical technicians and pharmaceutical assistants is under control of the Pharmacy Council which was established by the Pharmacy Act (2002). The Pharmacy Council registers and enrols all pharmaceutical personnel, sets standards of conduct and activities and develops and approves training curricula, in close collaboration with training institutions (Pharmacy Act, 2002). Within the East African Community (EAC), the harmonization of drug regulatory affairs is aspired to by the DRAs of Kenya, Uganda, Tanzania (Mainland and Zanzibar), Rwanda and Burundi, with the goal of mutual recognition or even establishment of a joint authority in a common market. However, due to different levels of drug regulation in the five countries, Tanzania and Uganda currently being the most advanced, common registration procedures have not been implemented yet (EAC, 2007). 2.7.2

Local production of medicines Whether support of local generic production in developing countries can promote access

to essential medicines has been controversially discussed within the last decades. In the 1970s and 80s, international organizations like the United Nations Industrial Development Organization (UNIDO) strongly supported the establishment of pharmaceutical industries in developing countries. Assisted countries had the goal to reduce dependence on imported medicines, create employment, save foreign exchange and achieve self-sufficiency, leading to improved and sustained access to drugs. Since few of these cases were deemed successful, the approach was soon abandoned by donors. Only middle-income countries with large populations like India or Brazil were considered to have achieved an economically viable pharmaceutical production (UNIDO, 1980). 45

A discussion paper by Kaplan and Laing (2005) critically reviewed some of the assumptions surrounding domestic production and came to the conclusion that in many developing countries domestic pharmaceutical production makes little economic sense. It might even result in less access if many countries begin local production and thus economies of scale get lost. However, the paper also states that the decision whether or not to promote local pharmaceutical industries has to be taken by the countries themselves and should not be imposed by developed countries or donors. Another paper (Guimier et al., 2004) looked at the opportunities and challenges of local pharmaceutical production in the light of increased funding for HIV/AIDS, Tb and malaria. Out of a public health perspective and considering the four dimensions of access, affordability seems to be the only dimension which can be positively affected by local manufacturing. Since local manufacturers in SSA face numerous challenges in terms of technical expertise, access to financial capital, equipment and spare parts, they struggle to meet international quality standards and to compete with international manufacturers. However, under certain conditions – stable political environment, production of a mix of products (those for priority diseases and other basic essential medicines) – financial viability and even improved affordability might be possible if favourable API prices and a significant market share can be achieved. The fact that the first pharmaceutical company based in a least developed country (Uganda) has recently achieved WHO prequalification standards for its manufacturing facility, has strengthened confidence in local production. Potential locational advantages for LDCs due to TRIPS-related exemptions until 2016 support this position (Anderson 2010). In 2009, WHO in cooperation with other partners like UNCTAD and the EU, started a project on “improving access to medicines in developing countries through local production and related technology transfer” with the intention to bring stakeholders together and analyse as well as discuss current trends, case studies and prerequisites for successful local pharmaceutical production (WHO, 2010c).

In Tanzania, promotion of the local pharmaceutical industries, comprising public and private companies, has already been a core element of the National Drug Policy (1991), with the goal of attaining self-reliance. Regarding drug procurement, the policy states that “priority will be given to local manufacturing companies and when feasible to regional manufacturers before considering overseas suppliers”. As a result, local manufacturers get a 15% preferential treatment when participating in MSD tenders (Losse et al., 2007). Currently there are seven registered manufacturers in Tanzania under the umbrella of the TPMA: TPI Ltd, Shelys Pharmaceuticals Ltd, Zenufa Ltd, Tanzansino United Pharmaceuticals Ltd, Keko Pharmaceutical (1997) Ltd, A.A. Pharmaceuticals Ltd and Mansoor Daya Chemicals Ltd. The 46

biggest ones are TPI, Shelys and Zenufa with a variety of products. An evaluation of GMP compliance at the local industries revealed that especially the smaller ones are struggling to meet national GMP standards – a situation which resulted in the closure of one company in early 2009 (Pius, 2009). However, during the last decade, TFDA has noticed improvements in the majority of industries, especially concerning stability testing and analytical controls through HPLC testing (MOHSW, 2006). Over many years, difficulties in accessing capital caused enormous constraints, especially for the older industries. The two government owned companies, TPI and Keko were privatized after the introduction of a market economy in Tanzania. Since 1997, several industries have invested considerably in order to increase their capacity, diversify the product range and achieve GMP status. The fluctuating industrial development and growth, accompanied by a challenging business environment, has led to a market share of only 30% for locally manufactured drugs. Therefore, the national policy of supporting local pharmaceutical production has been reinforced during the last years. A specific strategy document was prepared by stakeholders in the pharmaceutical sector – the “Strategies for promotion of local production of pharmaceuticals in Tanzania 2006 – 2016” (MOHSW, 2006). The goal is to support the local industries so that they can satisfy 60% of the national medicine needs by 2016. This shall contribute to the “National Vision 2025” which aims to achieve economic growth of 8-10%. Taking into consideration the current obstacles for pharmaceutical manufacturers like poor infrastructure, lack of skilled personnel and a weak financial system, the policy strives at: -

Encouraging development partners to invest in pharmaceutical industries

-

Enhancement of TFDA´s capacity to enforce standards for local production

-

Promotion of GMP standards

-

Increasing the number of pharmacy students

-

Integration of TRIPS flexibilities into national patent legislation

-

R&D for pharmaceutical formulation by local manufacturers in cooperation with academia (MOHSW, 2006)

Among the other four EAC member states, only Kenya´s pharmaceutical industry with 26 registered premises (PPB, 2010) is larger than the Tanzanian one. Similar to Tanzania, Kenya favours its local industries with a 15% advantage in the public procurement sector. However, Kenyan pharmaceutical manufacturers cover already 80% of the national needs for essential medicines (excluding ARVs, Tb drugs and ACTs) and export significant amounts to other EAC countries as well (EAC, 2007). 47

2.7.3

Donor strategies and initiatives in Tanzania Since 1999, when Tanzania initiated a health sector reform, most development partners

engaged in the health sector agreed to provide their financial assistance within the framework of a Sector Wide Approach (SWAP), mainly to increase coordination and ownership. Funding mechanisms reach from direct funding of projects and programmes to general budget support; a Health Basket Fund has been established to strengthen particularly district health services and enhance decentralization efforts. Vertical programmes, however, with their disease-specific supply of medicines, remained largely outside the SWAP (Ministry of Foreign Affairs of Denmark, 2007). In the pharmaceutical sector as part of the health sector, a prominent international actor has been Management Sciences for Health (MSH) in recent years. Through its programme “Strategies for Enhancing Access to Medicines” (SEAM), funded by the Gates Foundation, MSH has been active in three areas since 2002: -

To face the problem of substandard medicines and counterfeits on the Tanzanian market, SEAM supported the two-tier quality assurance programme which was implemented by the TFDA in 2003. The initiative included drug inspection and quality testing at the ports of entry and in the marketplace, using the “GPHF Minilab®” (MSH, 2005; Risha et al., 2008).

-

In order to fill the supply gaps of MSD, SEAM together with MEMS, supported by CSSC and the ELCT in Northern Tanzania, tried to assist faith-based facilities to select a reliable alternative commercial supplier since 2003. The goal is to achieve reduced prices through pooled procurement from a prequalified prime vendor. A service fee of 10% is charged by MEMS which is used for training programmes and supervisory visits at the participating health facilities (MSH, 2005).

-

Supervision of small informal drug shops (“Duka la dawa baridi”), especially in poor urban and rural areas, is associated with problems regarding personnel qualification and the illegal sales of prescription medicines. SEAM in cooperation with TFDA started a pilot project to train those drug sellers in selected regions and certify their shops as “Accredited Drug Dispensing Outlets” (ADDO) being allowed to sell selected prescription medicines. The accreditation is coupled with some incentives like access to microfinance services and links to health financing schemes. However, due to financial implications involved, upscaling remains a challenge (Rutta et al., 2009).

48

Further donor initiatives have taken up the support of local pharmaceutical production through GMP assessments at selected manufacturing sites by GTZ/Begeca 25 and the training of pharmaceutical staff at Saint Luke Foundation Moshi, supported by GTZ and UNIDO. A feasibility study on pharmaceutical production in Tanzania argued that there is potential for local manufacturers, considering especially the donor market in Tanzania. However, challenges like quality standards, human resource development and competitiveness in the regional market have to be addressed (Losse et al., 2007; UNIDO, 2010).

3

METHODOLOGY

3.1

Study approach The study was conducted as a rapid appraisal with a focused approach and contained

qualitative as well as few quantitative elements (Hardon et al., 2001). In order to increase validity through triangulation, different data collection methods were applied – semi-structured interviews and anonymous structured questionnaires. Validity refers to the extent of actually measuring what is supposed to be measured (Mayer, 2004). Or, in other words, it may be described as ”trustworthiness” or “scientific rigor” (Ash, 2007). Reliability, closely related to validity, is concerned with repeatability of scientific results and underlying data collected. The validity and reliability of this study have been maximized through reflexivity, triangulation, member checking and saturation in the field (Ash, 2007). 3.1.1

Semi-structured interviews with guided questionnaires Semi-structured

interviews

with

loosely

structured

interview guides

(guided

questionnaires) were conducted to ask stakeholders for their views on and assessment of the activities undertaken by action medeor in Tanzania. The following respondent groups were included: -

Policy makers and partners

-

Customers of AMT

-

Managers of pharmaceutical companies

-

Pharmaceutical key personnel (workshop participants)

Begeca (Beschaffungsgesellschaft für kirchliche, caritative und soziale Einrichtungen) is a German non-profit company procuring goods, including drugs, for overseas projects and partners – e.g. in Congo DRC and Sudan. Pursuing preferably local and regional procurement, Begeca regularly inspected and prequalified several pharmaceutical manufacturers in Kenya and Tanzania according to PIC/S standards (Losse et al., 2007). 25

49

Purposive sampling was used to identify interview partners, meaning that specific criteria were applied to select key informants within the four respondent groups. The objective was to include all different types of action medeor partners, customers and beneficiaries in Tanzania and East Africa to achieve saturation of information and thus provide a complete picture which would allow for some cautious generalization (Mayer, 2004). However, considering financial, logistical and time resources, there was the necessity to strike a balance between feasibility and comprehensiveness. Policy makers and other partners (apart from customers and direct beneficiaries) were selected based on the stakeholder analysis (through reviewing of action medeor project reports), to ensure representation of all relevant institutions: -

National policy makers and partners: TFDA, Pharmacy Council, TPMA, CSSC, MSD, MEMS, MUHAS, MOHSW, SLF

-

Donors and regional partners: GTZ/EAC, InWEnt, EPN

The sampling procedure for customers of action medeor Tanzania considered the following criteria to make sure that different categories of health facilities were represented: urban/rural, public/faith-based, hospital/ health centre/ dispensary. Nine customers were visited (see table 3). Concerning public health facilities, only two hospitals were included in the study since public health centres and dispensaries are not in the customer range of AMT. Public hospitals are mainly located in the urban centres, whereas FBO hospitals are often found in rural settings. Urban (Dar / Bagamoyo)

Rural

Hospital

2 (public)

2 (FBO)

Health centre

3 (FBO)

-

Dispensary

1 (FBO)

1 (FBO)

Table 3: Characteristics of selected AMT customers

Former workshop participants (pharmaceutical key personnel) were sampled in the following way: As participants from Kenya and Tanzania made up the majority of all workshop participants since 2005, the interviews were limited to participants from those two countries. As the respective objective of this study is “to assess if and how East African pharmaceutical manufacturers benefited from action medeor’s capacity building interventions”, the focus was on participants from pharmaceutical industries. (Participants from other institutions like DRAs were not considered.) The participants were selected in a way that different pharmaceutical companies 50

were represented and that most of the workshops were covered (see table 4). In all, seven workshop participants, five from Kenya and two from Tanzania, were interviewed. Five interviewees had attended more than one workshop so far. Workshops

Interviewees from Tanzania

Interviewees from Kenya

Comprehensive GMP Training, Part 1, 2005

1

1

Comprehensive GMP Training, Part 2, 2005

2

1

Compact GMP Training, 2006

1

1

GMP Training “Validation & Qualification”, 2006

1

-

GMP Training “Validation & Qualification”, 2008

2

-

“Granulation, Tabletting & Coating”, 2009

1

3

Quality Control of Drugs, 2009

-

-

Quality Control of Drugs, 2010

1

2

Table 4: Selection of interviewees by type of workshop attended

In addition to the workshop participants, six representatives on management level of three Kenyan and three Tanzanian pharmaceutical companies were approached. The precondition was that they had sent staff members to action medeor workshops already. Two interviewees were at the same time part of other key informant groups. One Kenyan manager had attended action medeor workshops herself, and one Tanzanian manager represented the TPMA. Four of the six companies were suppliers of AMT.

Within institutions, companies and health facilities, those representatives were approached who were most familiar with action medeor activities. Apart from these criteria, interview partners were selected according to availability and convenience.

Semi-structured interviews were conducted in order to get comprehensive reactions, perceptions and views on action medeor activities in Tanzania. However, this means that only those informants were chosen who had interacted with action medeor already, bearing the risk of selfselection and potential bias. Since the interviewer (investigator of this study) is an employee of action medeor and has been strongly involved in implementing the various projects, access to respective stakeholders and open discussions were facilitated. On the other hand, potential interviewer bias had to be overcome (see 3.3).

51

3.1.2

Written self-administered questionnaires In September 2009, an anonymous structured feedback questionnaire was issued from

action medeor Tanzania to all faith-based health institutions participating in the annual general meeting of the Tanzania Christian Medical Association (TCMA)26. These written self-administered questionnaires were filled by health staff representing customers of action medeor Tanzania and those who were not (yet) customers. The questionnaires had not been analysed before, due to time constraints. After checking the questionnaire set-up, it was decided to include the data in this thesis. The questionnaire revealed additional information, especially from “non-customers” who were not approached through interviews. Furthermore, the questionnaire, containing qualitative and quantitative information, complemented data gathered from customer interviews and served as a means for triangulation to increase validity of the results. However, since the questionnaire was conceptualized as a customer feedback questionnaire, it contained only questions directed towards action medeor services. Moreover, in contrast to the semis-structured interviews, wider topics like the comparison with other drug suppliers or challenges of the health facilities were not covered. Similarly, anonymous structured evaluation questionnaires from workshop participants were considered for data analysis. These self-administered questionnaires were filled by the workshop participants at the end of each training module. Participants were asked for their assessment of the training and regarding their plans for implementation of the acquired knowledge. The evaluation questionnaires, containing quantitative and qualitative elements, were included to increase validity of this part of the study and to complement the information gathered through interviews27. Whereas the questionnaires were filled directly after the training courses and thus provided more detailed assessment of specific topics and the organization of the workshops, the interviews were conducted some time (weeks, months or years) after the workshop and focussed more on the actual implementation of the acquired knowledge and challenges encountered.

3.2 3.2.1

Data collection and data analysis Data collection The following tools for data collection were used:

26 27

-

structured questionnaires (for secondary data analysis) – see annexes 4 and 5

-

guided questionnaires for semi-structured interviews – see annex 3

TCMA is an association of health staff working in faith-based health facilities (under the umbrella of CSSC). Only workshop evaluation questionnaires with a comparable set-up were analysed.

52

-

recorder for tape-recording of interviews

The structured self-administered questionnaires which had been filled by AMT customers (annex 4) and workshop participants (annex 5) were used for secondary data analysis. Both questionnaires contained mainly closed questions with predetermined response options but also some open questions. For the majority of closed questions a rating scale was given, e.g. from 1 (“excellent”) to 5 (“poor”). A rating scale is commonly used in standardized and structured questionnaires; however, it bears the risk of favouring the central categories (Mayer, 2004).

Four different types of guided questionnaires for semi-structured interviews were developed targeting the various respondent groups: -

Policy makers and partners (annex 3.1)

-

Customers / health facilities (annex 3.2)

-

Workshop participants (annex 3.3)

-

Pharmaceutical companies (managers) (annex 3.4)

The guided questionnaires were designed in a way to leave room for flexibility during the interviews (Mayer, 2004). They covered the most important themes of the study, tailored to the different respondent groups, namely: -

assessment of the services of action medeor’s drug distribution centre in Dar es Salaam

-

assessment of the GMP workshops conducted by action medeor

-

current and future role of the Pharm R&D Lab – opportunities and challenges

-

integration of action medeor activities in the overall pharmaceutical context, relation to national policies and cooperation with other stakeholders

-

challenges in the health and pharmaceutical sector as perceived by the key informants

-

recommendations for action medeor28

The first interview in each category was considered as pilot test. However, since questionnaires were only slightly modified afterwards, all conducted interviews were included in the data analysis. During the interviews, open-ended questions were used with the option for further probing, based on (theoretical) background knowledge and the information gained from previous interviews (Mayer, 2004). The interviews were conducted by the investigator of the study, all except for one in English. One interview (with a representative of a German partner institution) was conducted in Due to the abundance of data, the themes “challenges” and “recommendations” could not be elaborated on indepth within the scope of this study. Only the most relevant challenges and recommendations related to action medeor activities in Tanzania are covered. 28

53

German and translated into English afterwards. All interviews were recorded after interviewees had given their consent. The audio (MP3) files were then transferred to the computer for transcription. The data collection, specifically the realization of the interviews, was pursued by the investigator in February and March 2010. In total, 31 interviews with key informants were conducted at their workplaces, if possible, to reduce bias (social desirability). A complete list of interviews can be found in annex 6. Visits to health facilities were planned in accordance with the acting branch manager of action medeor Tanzania, who served as a “gatekeeper” in the sense of providing access to this category of interview partners (Mayer 2004). Other interview partners were contacted directly by the investigator. During a visit to Nairobi/ Kenya in mid-March 2010, pharmaceutical companies were visited there, and managers as well as former workshop participants were interviewed. This same tour had also the goal to inform the companies about the services of the Pharm R&D Lab which had just started operations. Therefore, the Pharm R&D Lab manager accompanied the investigator. After thorough consideration, the investigator decided to let the lab manager observe and partly participate in the interviews, if the interviewees had given their consent. The advantage of this participatory approach was seen in boosting the interaction between academic lab personnel and pharmaceutical industry and thus contributing to the sustainability of the Pharm R&D lab project. 3.2.2

Data analysis All tape-recorded interviews were transcribed manually from audio files to word

documents, with a focus on the content and without thoroughly considering language features like pronunciation, breaks etc. This approach is deemed appropriate for key informant interviews (Mayer, 2004). The qualitative data from the semi-structured interviews was analysed using the software programme Atlas.ti. In a first round, transcripts were read and notes were taken. In a second round, the transcripts were coded with Atlas.ti along the themes of the interview questionnaires. Categories and sub-categories were developed and continuously modified during the process of data analysis. Additional emerging issues were included and integrated in the coding system. Transcript sections linked to specific codes were organized in code families which were used for further summarizing, sorting and presentation of the data (Schmidt, 2004). The completed structured questionnaires which were available as secondary data were analysed and aggregated using MS Office software (Word and Excel). 54

3.3

Limitations As already discussed before, one limitation of the study, leading to a potential selection

bias, can be seen in its focus on getting feedback – views and perceptions – from stakeholders, those who have interacted with action medeor already. Views from other players in the pharmaceutical sector, e.g. faith-based health facilities not procuring medicines from action medeor, are only marginally touched (in structured questionnaires). Due to logistical constraints, the number of remote rural health facilities in the sample was quite small and even those visited were still located in the surrounding area of Dar es Salaam (maximum distance 300 km). However, through interviews and observation, the investigator got an impression of the special situation faced by these facilities and tried to consider their challenges in this study. Furthermore, two partners/ policy makers – MOHSW and SLF - could not be reached due to absence of the responsible person in charge (MOHSW) and logistical constraints. During data collection, observer bias and potential effect of the interviewer on the interviewee had to be overcome. Since the interviewer was seen by the respondents as representative of action medeor, interviewees were explicitly asked to express any critique which would come into their mind, in order to provoke critical interview statements. It was explained that this assessment would serve as a basis for future recommendations and improvements. Through triangulation, comparison with anonymously filled questionnaires, it could be confirmed that interview data was not biased due to social desirability. The investigator, who was involved in the implementation of the various projects and activities, had to apply reflexivity and consider the study as some sort of “self-inspection”. Another limitation which the investigator noticed during data collection was that some respondents -mainly lower qualified staff in small health facilities- were not so confident expressing themselves in English. So they had to be assured that language mistakes did not play any role in this study. However, the dialogues with this type of interviewees remained quite short, maybe also caused by the unfamiliar interview situation.

3.4

Ethical considerations In order to clarify whether formal ethical approval was required for this study, the local

partner institution Muhimbili University of Health and Allied Sciences (MUHAS) in Dar es Salaam was consulted. Considering the nature of the study, which does not imply any risk of harming individuals, the decision was taken that no ethical clearance was required. 55

However, during the course of data collection, established ethical principles were applied. Key informants and the respective institutions, organizations or companies were asked for informed consent after thorough explanation of the study purpose. The data obtained will be kept strictly confidential and anonymous. Since key informant interviews, due to their small numbers, bear the risk of re-identification, reporting in this study is aimed at a maximum of anonymity. If anonymization is not possible in specific cases, the respective data will not be presented. Selected key informants will be asked to provide feedback on the results section before completion of the thesis. This “member checking” shall also increase validity of the study. Study results will be disseminated to all participating bodies.

4

RESULTS The findings are presented following the specific objectives of this study – assessment of

action medeor’s activities by policy makers and partners with a focus on integration in the overall pharmaceutical sector, effects of drug distribution on non-profit health facilities, influence of capacity building on regional pharmaceutical manufacturing and opportunities and risks for the newly established Pharm R&D Lab. This will serve as a basis to discuss the NGO’s overall contribution to improved access to medicines in Tanzania.

4.1

Policy makers’ and partners’ views on action medeor activities in Tanzania Policy makers and partners of action medeor - identified through reviewing of project

reports (stakeholder analysis) - were asked to assess action medeor’s activities within the local context. The interviews revealed that stakeholders were familiar with different aspects of the NGO’s activities in the pharmaceutical sector in Tanzania and East Africa. Table 5 shows the list of selected key stakeholders linked to the activities they provided feedback on. Results from interviews with direct beneficiaries (East African pharmaceutical companies and workshop participants) and AMT customers will be presented later on. The following themes were extracted from the interviews with partners and policy makers and will be presented in the following sub-chapters: -

Cooperation with stakeholders and relation to national policies

-

Assessment of AMT drug distribution activities

-

Assessment of GMP training activities

-

Assessment of TPI technology transfer project

56

A further theme, the results related to the Pharm R&D Lab, MUHAS, will be presented in subchapter 4.4. Stakeholder

Description

AMT drug distribution

GMP capacity building

TPI technology transfer project

Pharm R&D Lab, MUHAS

CSSC

FBO umbrella organization / network

X

EPN

FBO umbrella organization / network

X

(X)

GTZ / EAC Secretariat

German partner/ donor

(X)

X

X

X

InWEnt

German partner/ donor

(X)

X

X

X

MEMS

Drug supply organization (DSO)

X

MSD

Drug supply organization (DSO)

X

(X)

(X)

X

MUHAS (2)

MUHAS management

Pharmacy Council

Regulator

TFDA

Regulator

TPMA

Manufacturers Association

X

X

X

X

X

X

X

X

X

X

X

X

X

Table 5: Interlinkeage between stakeholders and action medeor activities in Tanzania X = Stakeholder familiar with action medeor activity; (X) = Stakeholder has only heard of activity

4.1.1

Cooperation with stakeholders and relation to national policies Key informants generally stated that cooperation with action medeor was fruitful and that

they felt that the most important stakeholders were involved in all projects. However, overall collaboration within the pharmaceutical sector could be improved; particularly national policy makers asked action medeor to facilitate this process: “… I think we need to work more on this. For example, currently we import almost 70% […] of our needs. And maybe because the stakeholders have not come together very strongly to convince the government and other partners to invest more in pharmaceutical production in the country. We have few pharmaceutical personnel in the country, we have less than 1000 pharmacists, a country of 40 million people almost. So I think there is really a need to bring different stakeholders together [...]. So if action medeor could take some action to improve this collaboration...” (Interview no.4, regulator)

Most local partners stated that they were trying to cooperate with other institutions and organizations, but that cooperation was still not sufficient, mainly because they were still struggling with their own core tasks.

57

“… All these are also not very old institutions. Some of them just started a few years ago, so they also have teething problems. And therefore we cannot say that our cooperation is very strong, there is room for improvement..” (Interview no. 27, MUHAS management)

International (German) partners requested action medeor to involve WHO and the MOHSW in their projects as well as to cooperate with Saint Luke Foundation in Moshi. One local partner suggested, action medeor should seek collaboration with organizations “which have more experience in operating large-scale”, like MSH, being active in the field of postmarketing surveillance and inspections. When asked whether and how action medeor activities related to national policies, Tanzanian stakeholders mentioned that there is a clear link to the National Drug Policy, the Pharmaceutical Masterplan and the National Health Policy. By making available high-quality generics which are affordable to the needy population, by supporting the local pharmaceutical industry and addressing the shortage of skilled personnel, “they are trying to work on all the factors of the National Drug Policy”. “…At the end of the day, they [action medeor] want to make sure that people are getting access to medicines at affordable prices, but also at the quality which is required to be. So in terms of the policy, they do quite a lot, in terms of fulfilling.” (Interview no. 12, manufacturers association)

4.1.2

action medeor Tanzania – drug distribution centre Only two partners (CSSC and MEMS) directly affected by AMT activities were in a

position to comment in detail on the AMT drug distribution service. Those partners mentioned that the availability and quality of AMT products was very good. However, the problem was seen in the relatively high prices, without any option for discount. Furthermore, 24 out of the 89 FBO hospitals in Tanzania are district designated hospitals (DDH), which means their funds are channelled through MSD, like they are for all public hospitals. The other 65 FBO hospitals, being eligible to procure from MSD, would mostly prefer MSD due to cheaper pricing. All (6) stakeholders – even direct “competitors” – who were familiar with AMT activities to some extent were convinced that a public-private mix of suppliers is required to ensure access to medicines for the whole population. As the only challenging factors related to the involvement of private wholesalers, assuring the quality of medicines in the market and quantification of needs at MSD were mentioned. Positively, private suppliers would complement the public system, and particularly private non-profit suppliers would make items available which are not of interest for commercial suppliers. “So action medeor in that sense is very reputable, because they keep items, even those which you would say that they are not of commercial value. But they are important to the hospital. I will give you an example - Oxytocin injections or Ephedrine injections, you hardly find these being kept by these private suppliers.” (Interview no. 22, DSO)

58

One stakeholder, on the other hand, stated that a real effect by AMT could only be achieved by decentralizing the services and competing with MSD in the rural areas. Other public and private non-profit suppliers (MSD and MEMS) themselves were requesting a closer collaboration with AMT and among regional drug supply organizations in general. “I have been hearing action medeor, action medeor. But it´s just for those few projects which I am aware of… But I think there is a need to improve the cooperation, we can learn a lot from them. And we can see which areas we can collaborate further.” (Interview no. 30, DSO)

The Drug Regulatory Authority emphasized that AMT should try as hard as possible to only import registered medicines into the country, even for special cases like ophthalmologic preparations 29 . If no TFDA registered products are available, the suppliers of these specific products should be asked to apply for TFDA registration.

4.1.3

Capacity building for pharmaceutical manufacturers All stakeholders who were familiar with action medeor’s capacity building activities in the

field of GMP were of the opinion that the trainings “are very relevant in improving quality in manufacturing”, one reason being that curricula for pharmacy students in the past did not contain practical aspects on pharmaceutical manufacturing and GMP. “The problem was, they [the pharmacy graduates] had no practical experience at all. So they had just learnt about a lot of things like when you are talking of a disintegrant, but they don’t know how the disintegrant will work...” (Interview no. 12, manufacturers association)

The trainings were also valued by the regulators (Pharmacy Council and TFDA), having sent their staff to the GMP workshops already. “...From the regulators’ point of view, I am sure they [the workshop participants] will implement whatever they acquired there, through their daily work. And we have already seen significant improvements through trainings, provided through this approach, but also with other partners, for example WHO prequalification.” (Interview no. 4, regulator)

According to the key informants, only few international stakeholders are engaged in this specific field in Tanzania. “...I know WHO has been giving some training on GMP, Quality Assurance… But as far as the pharmaceutical [industries], I don’t think one was giving more than what action medeor is doing in cooperation with InWEnt...” (Interview no. 12, manufacturers association)

For the future, stakeholders recommend to offer further short courses, even weekend courses, since this seems to be the request by the industries. According to the partners, the challenge will

In 2007, AMT became a major supplier of Christoffel Blindenmission / Germany and therefore included a variety of ophthalmologic supplies (approx. 420 items) in the product range. Some of these special products are available from non-registered sources only and are imported case by case under a special import license issued by TFDA.

29

59

be to get the companies to pay for these services and to keep the high level of training – once the international donors step out. Cooperation with Saint Luke Foundation, which has started offering similar courses, is to be sought in order to achieve synergistic effects and to avoid duplication. Specific needs of the industry could be defined through a detailed gap analysis. 4.1.4

Technology transfer and local production of ARVs All key informants who were familiar with the plan for the new ARV production plant to be

established together with TPI in Arusha, were in favour of this project - for the following reasons: -

Increased access to ARVs in Tanzania

-

ARVs will become cheaper (affordability)

-

For DRA it will become easier to follow up (quality, inspections)

-

WHO prequalification will be easier to reach with new facility

-

Employment for pharmacists

Overall, national stakeholders supported their local industry: “Of course, I do support that, because of - you see - now most of the funds are from development partners - Global Fund. And to use Global Fund finances to purchase drugs, we have to follow the quality assurance policy of the Global Fund, where our local manufacturers currently don’t fit. So I think we are not keen enough to utilize those funds for the development of Tanzania as a nation. And also, to have local capacity will also increase the economy of the country, will improve the employment facilities. So, I think it is good to have a plant which will be GMP certified, and maybe also expand the production so that we can export drugs to neighbouring countries.” (Interview no. 30, DSO)

There was only one concern that achieving WHO prequalification would not automatically mean being able to compete on the global market. The question of possible market distortion was raised briefly, but not considered to be problematic: “But I think as the need is so large, you can easily accept that you just help one of the enterprises. In order to make sure that at the end something is coming out at least, anywhere where it is seated.” (Interview no. 5, German partner)

4.2

Effects of drug distribution through action medeor Tanzania As described in the methodology section, nine health facilities representing different

customer groups of AMT (public/ faith-based, hospital/ health centre/ dispensary, urban/ rural) were visited and asked for their feedback and perceptions on AMT services. The following themes emerged from the interviews and will be presented in the next sub-chapters: -

Perception of AMT by customers and first contact

-

Assessment of product range and availability

-

Assessment of quality

-

Assessment of prices

-

Assessment of AMT service – customer care, ordering, transport, payment modalities 60

The results from the previously collected customer feedback questionnaires will be presented in sub-chapter 4.2.6. 4.2.1

Perception of AMT by customers and first contact The interviewed customers perceive AMT mostly as a “company”, a “wholesale pharmacy

associated with the faith-based facilities” which is “trustworthy”. However, some interviewed customers were not aware that the DSO operates in a non-profit way: “But I don’t know if non-profit, because I know it’s a pharmacy. When you go to wholesale pharmacy, they get a profit.” (Interview no. 11, FBO health centre urban)

The nine interviewed customers got to know AMT between 2005 and 2009. When asked how their first contact with AMT was made, they mentioned various reasons (table 6). How was contact with AMT made? FBO

-

received donations from AMT through German partners (3)

facilities

-

was advised by predecessor / colleague to procure from AMT (when joining the health facility) (3)

-

saw advertising of AMT (1)

-

presentation during TCMA meeting in Dar es Salaam (2 hospitals)

Public

-

searching for specific items (emergency procurement) (1)

facilities

-

told by colleague from other public hospital (1)

-

some donations from AMT (1)

-

AMT known from previous workplace (rural district council) (1)

Table 6: First contact between customer (health facility) and AMT

Some health facilities had received donations via action medeor, others got to know the DSO at a meeting or through colleagues. A typical reply from FBO health centres and dispensaries was the following: “And here I met a sister who was running the services... And she had to handle [hand over] all the activities to me, she showed me that we normally get some medicines [from action medeor]. We go there to buy, or sometimes we get them from donors who are helping us, because they know that this place, really those people whom we are giving the services, they are poor. So they cannot afford to pay or to contribute for the services. She told me that the […] brother [from Germany], he has already died.. [that] he was the one who made the contact with action medeor...” (Interview no. 13, FBO dispensary rural)

A public hospital got to know AMT services when searching for emergency procurement: “Actually before, I was passing at Buguruni where action medeor is. I was just looking at those words, but I couldn´t know what was it. But I think two years ago when I had a problem with a medication, I passed through so many shops, I couldn’t get Pancuronium injection. Somebody told me: “Why don’t you go to action medeor?” I went there, I got the drug at action medeor. ... [It was] the pharmacist at [name] hospital - he told me “Oh, we normally get that from action medeor”. So I went there, I found a very good place, so many drugs. So from there on, I used to go there.” (Interview no. 31, public hospital urban)

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4.2.2

Assessment of product range and availability In general, interviewed customers were satisfied with the range and availability of AMT

products, compared to other suppliers. “Actually, what happens now, most of these suppliers are the local pharmacies in Dar es Salaam, of which most of them, they do sell fast-moving drugs like Amoxycillin, Paracetamol, anti-pains, analgesics, anthelminthics, fast-moving drugs in Tanzania. But you cannot find most of these local pharmacies which are selling medical supplies like Magnesium Sulphate, Formalin, so these are always supplied by those organizations which are determined to supply. [...] We get from MSD and action medeor.” (Interview no. 28, public hospital urban) “And Medical Stores, they are supplying the basic drugs only, so you may find some of the drugs are not there. So you have to go to action medeor or anywhere else. […] In action medeor, there is a big number of items. So as you go there, you will meet your whole order.” (Interview no. 14, FBO hospital rural)

However, three customers made some recommendations to increase the range of products and add items like raw materials for hospital production, some more lab equipment and certain medicines like “Metakelfin”30. Concerning the availability of medicines at AMT, customers had different opinions. The majority (5) had almost never experienced out-of-stock at AMT and were quite satisfied: “Regarding the availability, action medeor is always timely when it comes to the issue of drugs and medical supplies. When they promise you that this product will be there, say, on Friday, when you go there, you find it.” (Interview no. 28, public hospital urban) “And if it is out of stock there, also all over the town it could be that the drug is not in place.” (Interview no. 13, FBO dispensary rural)

Few customers (2) had experienced stock-outs and recommended AMT to improve on this: “I think my recommendation is that, action medeor is a big supplier... So you must assure that all the medicines are there. Because sometimes when we order medicines, there is out of stock. So it´s better to get enough stock. Sometimes when we order, they say “we don’t have”... I think even last week, I ordered Ampicillin injection, because we need here a lot of Ampicillin for children with pneumonia. Two months now there is no Ampicillin injection. Sometimes we order Diclofenac injection - out of stock. But it is not all drugs, sometimes few drugs are missing.” (Interview no. 10, FBO health centre urban)

4.2.3

Assessment of quality Eight out of nine interviewed customers were very satisfied with the quality of AMT

products. They based their assessment on the physical appearance of the medicines and the packaging, the warehouse set-up and transport conditions (cold chain), the (perceived) cure rate and incidence of drug reactions, as well as the (perceived) origin of the products (Germany/Europe).

30

Metakelfin (Sulfamethoxypyrazin 500mg + Pyrimethamin 25mg), even though included as an antimalarial drug in the NEML, was banned by TFDA in April 2009 after a serious counterfeit incidence (Rugonzibwa, 2009). Therefore, it cannot be supplied anymore.

62

“… Even the labelling can tell about the quality. […] Most of the items or drugs we are getting from action medeor, they do have a good labelling. Even we have not received any complaint […] that this drug has brought any reaction to any client. And among the forms that we have filled, we have the forms for collection of drug reaction, we have not any report of the drug from action medeor.” (Interview no. 28, public hospital urban) “It is very good quality, I can say. Because, if I go to other shops, for example if I am buying a medication which needs refrigeration, actually normally the coldness at the other shops you cannot compare with the coldness at action medeor. … I once bought a medication which needs refrigeration. Actually, I liked the way they packed, they gave me the ice material, I like the way they did it, compared to other places. … They gave me a box, then they put an ice pack inside... I came from there to here, it was still maintaining the same temperature. … [Other pharmacies] they are not doing. They just tell you: “This is a cold… So go quickly to your place.” (Interview no. 31, public hospital urban)

One customer expressed her concern towards Indian manufacturers: “But I think as the in-charge explained to us, that they are really choosing the good companies from India. Although, we really doubt and dislike Indian companies, because their products are not really durable.” (Interview no. 11, FBO health centre urban)

The superior quality of AMT products was mainly seen in contrast to commercial wholesalers: “The other wholesalers, they are business-oriented. action medeor has more pharmaceutical knowledge. I mean they are doing according to the profession if you compare to the other places where actually the business is overloading.” (Interview no. 31, public hospital urban)

4.2.4

Assessment of prices Most of the customers stated that the prices for at least some AMT products were rather

high. And this was given as main reason for not buying all their medicines from AMT. Especially the smaller FBO facilities (health centres and dispensaries) were concerned about the prices. “Although we are always afraid of the prices - they are high. […] The reason of not coming often to your place, is because of the price.” (Interview no. 11, FBO health centre urban) “We choose action medeor because the price of some of the drugs is low, compared with other town pharmacies. […] You know, [...] we are dealing with the poor people. This health centre is not a profitable. […] That’s why we are looking for a pharmacy who sells the drugs on a low price. And when we take low price, here we are providing drugs on a low price. The aim is everybody to get a treatment. […] But the problem is, sometimes […] the price is high. I can’t afford to buy all the medicines there [at AMT]. That’s why I choose three pharmacies. We are selecting the drugs, some of the drugs we are taking at action medeor, other drugs we are looking for lower prices, we are going to MSD, and others to Salama31.” (Interview no. 10, FBO health centre urban)

The two interviewed FBO hospital representatives realized price differences, but the advantages procuring from AMT seemed to prevail: “…The [...] advantage with action medeor is, once you go there, you meet all of your order. So normally, when you are going to buy a number of items, you may find, some are expensive, some are less expensive. So if you take it as a total, you find that it is not more expensive, because you went there and took a big order.” (Interview no. 14, FBO hospital rural) “The main difference, at the beginning, action medeor their price was high, and MSD the price was a little bit low. But this time, I think the price - there is no difference.” (Interview no. 15, FBO hospital rural) 31

Salama Ltd.: commercial drug supplier of mainly Indian products, based in Dar es Salaam

63

In contrast, the two public hospitals perceived AMT prices as low: “First of all they have a lower price compared to even sometimes MSD, and also their products are of good quality.” (Interview no. 28, public hospital urban) “Actually, I like there, before first of all, it is cheap.” (Interview no. 31, public hospital urban)

One customer was not satisfied with the fact that AMT publishes indicative prices rather than fixed prices (like MSD): “The major problem is the price. Although, sometimes, when we go there, we expect to get the medicines by a certain price. But after filling the forms, they tell us the price is different from those prices which they prepared before. […] Maybe it is better to have a fixed price.” (Interview no. 16, FBO health centre urban)

4.2.5

Assessment of service (customer care, transport, payment modalities) All interviewed customers were positive about the customer care service which action

medeor provides. They mentioned that the communication was good and that the waiting time to get the medicines was much shorter compared to other wholesale pharmacies. “... Compared to other institutions like Medical Stores, in action medeor it is easier. Because you just go there, you place your order and then they give you your order. It doesn’t take long, just few minutes, I mean few hours, compared to other institutions.” (Interview no. 14, FBO hospital rural) “… action medeor is the number 1, because they are communicating well, and there is a good quality service, the quality is 100%.” (Interview no. 13, FBO health centre urban)

Among the customers visited, the predominant way of making orders was through personal visit at the AMT warehouse and the immediate collection of medicines. Even customers staying several hundred km from Dar es Salaam travelled there from time to time to get their medicines. For customers staying nearby, transport was not an issue. Other customers stated that they would prefer transport service to their facility, even though they were not clear about it: “If it is possible they could bring for me, it would be better, instead of me going there. No, but it is better for me to go. Because once I miss some drugs, I have to go somewhere else.” (Interview no. 17, FBO dispensary urban) “action medeor - we must go there. But if we say, “we need drugs, please bring it to us”, they bring it. They use our normal transport or posta.” (Interview no. 15, FBO hospital rural)

Regular customers appreciated the payment modalities of AMT which allow for delayed payment within 30 days after delivery. “I think there are some changes, because you find out-of-stock in the hospital, now it is minimized. Because, we are sure, we can go to action medeor, even without having cash, they can give you some drugs and you pay some days later. So, even if you see it is not enough, the drugs here, we are sure that once we go to action medeor, there is no problem.” (Interview no. 14, FBO hospital rural)

Other customers mentioned financial challenges, like: “Sometimes we are running problems with the cash. In the end of the month, salary together with medicines, it is not easy to afford it to buy. Because we don’t get resources from somewhere else, just from the medicines and from the patients.” (Interview no. 11, FBO health centre urban)

64

Some health facilities could make use of donations, allocated mainly through partners in Germany, to fill the “cash flow gaps”. Due to the weaknesses of the public supply system, public health facilities advocate for being allowed to procure from other sources than MSD: “There is undergoing discussion and comment from HMT, CHMT, regional RHMT32 and other stakeholders, they want the government to amend the laws, to allow the other suppliers to supply the hospital, so that the hospital should decide where to buy the drugs. I think that would be the best. But for the time being, having only one supplier, it is a problem. Because sometimes, when we miss [drugs] there, we don’t have an alternative. So it becomes a problem to the pharmacist, a problem to the hospital, a problem to the patients.” (Interview no. 28, public hospital urban)

Within this context, AMT was asked to “cooperate with the government and help to fill this gap” by promoting the DSO’s services. “They should actually go to these public hospitals and advertise themselves. I know they are not doing business but actually knowing where they are and what they are doing, it’s a good thing.” (Interview no. 31, public hospital urban)

4.2.6

Results from customer feedback questionnaires The feedback questionnaire (annex 4) issued to approx. 200 representatives of faith-

based health facilities at the annual meeting of the Tanzania Christian Medical Association (TCMA) in Dar es Salaam in September 2009 was in this study mainly used for cross-checking data received from the interviews and for getting further information from non-customers. Among the 37 respondents (response rate 18.5%), there were 13 non-customers – 8 of those had never heard of AMT before. 5 respondents were familiar with AMT, however, had not procured from AMT for the following reasons: -

no order form available

-

the nature of their facility (training institution, need of very small medicine amounts)

-

receiving medicines from other suppliers (e.g. MSD)

The 8 respondents who did not know AMT before were interested to get some information on AMT services. This recommendation to disseminate more information and to advertise AMT was made by customers as well. Customers were asked to rate AMT services according to their level of satisfaction, 1 representing “extremely satisfied”, 5 representing “extremely dissatisfied” (see table 7). Average rating for availability, quality and customer care was around 2, rating for price was almost 3. The results of the rating scale show that customers are generally more satisfied with quality, customer

32

HMT= Health Management Team, CHMT= Council Health Management Team, RHMT= Regional Health Management Team

65

care and availability than with price of AMT products. Corresponding results were found in the interviews. AMT services

Availability

Average rating

Quality

2,05

Price 1,86

Customer care 2,86

1,95

Overall satisfaction 2,19

Table 7: Average rating of AMT services by customers (1 best, 5 worst)

4.3

Capacity building for local pharmaceutical manufacturers Seven workshop participants, five from Kenya and two from Tanzania, were asked in semi-

structured interviews for an assessment of the GMP workshops they had attended and how they were able to benefit and possibly implement the acquired knowledge at their workplace. Two interviewees were female, the others male, roughly representing the overall participants distribution. Four of the interviewees were holding a pharmaceutical degree, three were holding a chemical degree. Quality assurance (4), production (2) and quality control (1 Head QA/QC) departments of seven different (smaller and bigger) companies were represented. The following themes were extracted from the interviews with workshop participants and will be elaborated on hereafter: -

Assessment of the workshop organization

-

Benefits and implementation

-

Comparison with other training providers

In addition, the results from structured workshop evaluation questionnaires will be presented in sub-chapter 4.3.4. Furthermore, six managers of pharmaceutical companies (three from Kenya, three from Tanzania) were asked for their perspective on the pharmaceutical activities conducted by action medeor in the region and specifically how these helped the East African pharmaceutical companies (subchapter 4.3.5). 4.3.1

Workshop participants – assessment of the workshop organization The interviewed participants were in general very satisfied with the workshop

organization. “So, I would say so far for the two trainings I have attended, there is well organization, there is good flow of events. And even the topics are well correlated. The arrangement of the topics and the groupworks, they are well organized, so that there is building of knowledge from one topic to the other.” (Interview no. 3, workshop participant Kenya)

66

All interviewees emphasized that the quality of the lectures was very good, since the trainers were industry-experienced international consultants. “… there was this consultant who was very good with inspections. […] And this was because, I believe, he had worked in the industry before. [..] And his illustrations, his examples, his training was so so practical.” (Interview no. 25, workshop participant Kenya)

Furthermore, participants appreciated the “free association and sharing of ideas among the participants” and the practical training part (“hands-on experience”) which was included in all workshops since 2008. The only critique expressed was related to accommodation - “that could be a little better” - and to the environment – “the room was not clean”. Concerning the duration of the training, participants had differing opinions. On the one hand, they would like to extend the workshops and add more practical training sessions and case studies. On the other hand, most participants realized that their employers would not release them for more than one week’s time since “key people have to be around”. Furthermore, four of the five Kenyan workshop participants expressed their desire that action medeor should expand the training services to Kenya. This would save money and time for them. 4.3.2

Workshop participants – benefits and implementation All interviewed participants stated that they benefited in various ways from the workshops

and that the workshops were helpful “both for people who have just started working in the industry and also even for those people who have been there for quite a while”. The overall benefit was seen in an increased GMP awareness and concrete ideas on what to implement in order to achieve and maintain GMP. This would help “assuring the quality of the products […] in Tanzania”. One comment from a participant who had taken part in courses since 2005: “…And in comparison, you can see the changes from where we used to be and where we are. … Like the issues of validation, the issues of qualification. Initially the issues like SOP33 were not very well-known, but nowadays it is something which is well-known to everybody. So these trainings are very helpful.” (Interview no. 2, workshop participant Tz)

Effects were seen on personal and company level. Three participants stated that their move into the quality assurance department was facilitated by the GMP workshops.

33

SOP = Standard Operating Procedure

67

“That is the reason why I am now in QA. Because immediately after taking the course, actually there was a lot of improvement, especially on documentation and on the approach of the matters. And in addition to that, that exposure to international... I mean previously I did not know that there is ICH34, like that... I was only knowing about core GMP. Then I came to know that there is US FDA, how these are related to each other, how we can proceed in GMP in the global level… that was a very good exposure.” (Interview no. 9, workshop participant Tz)

The reason why interviewees wanted to attend the training was mainly their own motivation related to the work they were doing. However, they stated that management support was required to release employees for training and to assist with implementation activities. Most interviewed workshop participants mentioned that their employer’s attitude was supportive: “And the attitude of the employer is very positive, because you know training is expensive, and, like this one, it is so much facilitated by the sponsorship of the organizers. So they find it like they are being helped to build their employees. So it is a very welcome idea to the employers and employees.” (Interview no. 3, workshop participant Kenya)

When asked about implementation of the gained knowledge, interviewees illustrated implementation measures in several areas. Every participant specified at least two different implementation aspects, in the areas of training, documentation, validation and qualification, risk assessment and particular production processes. Concrete examples are shown in annex 7. Since QC personnel were underrepresented in the sample and since the specific “Quality Control workshops” have been conducted only recently (2009/2010), specific implementation effects in this area were not mentioned yet. Almost all interviewees described how they conducted training for their fellows: “…and I have been able to pass the same knowledge to my colleagues at work. […] Where action medeor could not reach, we have reached on behalf of action medeor.” (Interview no. 3, workshop participant Kenya) “And the good thing about it was that we had documentation from that training. And actually, we could use this documentation to train the other people.” (Interview no. 25, workshop participant Kenya)

Even though several interviewees (3) mentioned that they did not face any challenges during implementation of what they had learnt, others listed some issues like financial constraints and required GMP awareness of management. “…financial constraints on the side of the company, because some of the ideas you go there with you find that they go and fight some budgetary constraints. Some of them I have to wait for budgeting because maybe when we are doing the training it is the mid of the financial year, some of the things you are coming with cannot be embedded immediately. So budgeting is an issue.” (Interview no.3, workshop participant Kenya)

ICH = International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (www.ich.org)

34

68

4.3.3

Comparison with other training providers When asked about other training opportunities for pharmaceutical personnel, few

initiatives were mentioned by the participants. E.g. UNIDO had conducted an elementary GMP course more than ten years ago, and WHO had offered some courses. All Kenyan participants had attended mainly one-day trainings of PharmaQ Ltd., a company based in Nairobi which is headed by an experienced Kenyan consultant. Some participants knew Saint Luke Foundation (SLF) in Moshi which started offering own industrial pharmacy courses after the trainings with action medeor had been carried out there (in 2005 and 2006). SLF even acquired a small production unit for practical demonstration. Only one of the interviewees had attended a workshop at SLF recently. He stated: “The kind of training I have been attending in St. Luke is normally two weeks, where you have theory and you have very intensive practical training.” (Interview no. 2, workshop participant Tz)

The main difference between action medeor trainings in comparison with PharmaQ, UNIDO and WHO courses was seen in the practical side: “…So in a hotel, you just get pumped on… and then you go home and implement that. And now here with action medeor, the last workshop we had, we had to go the lab, we met the right qualified people, people who work in the field, I mean it intrigued a lot, compared to the other training which we had at PharmaQ.” (Interview no. 23, workshop participant Kenya) “… there was UNIDO, giving a course only once, but that was more than ten years back, and World Health Organization, yes. […] But the only thing, that they did not concentrate on that practical side of it, so that is the major difference. With action medeor, there is also the practical part of the courses. Because getting that theoretical knowledge, fine, it’s good, but someone would not know how to implement it without getting the practical part.” (Interview no. 9, workshop participant Tz)

4.3.4

Feedback from evaluation questionnaires After each workshop, participants were asked to fill an evaluation questionnaire (annex 5).

The quantitative data relating to five one-week workshops (conducted in 2006, 2009 and 2010) was combined and the results are shown in table 8. Out of 117 workshop participants, 98 returned filled questionnaires, signifying a response rate of 83.8%. The results of the feedback questionnaire show that workshop participants were overall satisfied with the training courses. The highest “dissatisfaction” was seen with “course duration”. As mentioned by several interviewees as well, they would prefer longer training courses – possibly including more practical sessions (theory-practice balance). When asked for their implementation plans, qualitative data contained in the questionnaires revealed that workshop participants intended to train their colleagues at work and that they planned to work on cross-cutting issues like documentation, risk assessment, validation and qualification. 69

Workshop evaluation

++

+

0

-

--

No response

Were the course’s topics and curriculum relevant to your work?

74

24

0

0

0

0

Can you apply your newly acquired skills to your work?

69

27

0

0

0

2

Can you pass on your new expertise to colleagues and others in your working environment?

81

16

0

0

0

1

...the workshop’s methodology and teaching efficiency?

64

32

0

0

0

2

...the quality of course materials (presentations, handouts)?

66

30

0

1

0

1

...the balance between theory and practice?

37

46

5

4

1

5

...the workshop’s overall duration?

28

40

19

7

1

3

…the technical qualification of the tutors?

88

9

0

0

0

1

...co-operation and communication of the tutors?

70

25

1

0

0

2

...the group’s professional experience and skill levels?

41

55

2

0

0

0

...the exchange of information and experience at group level?

36

57

3

1

0

1

...the working atmosphere within the group?

51

41

2

3

0

1

...the overall organisation of the event?

65

22

2

2

0

7

What is your assessment of the training measure?

49

45

0

0

0

4

How do you assess…

Table 8: Feedback from workshop evaluation questionnaires (rating: ++ best, - - worst)

4.3.5

Assessment from pharmaceutical manufacturers The six interviewed management representatives of Kenyan and Tanzanian

pharmaceutical companies who had sent their staff to attend action medeor workshops appreciated the initiative as some “soft side assistance”. Most of the managers, however, were not able to provide detailed feedback on the benefits of the GMP workshops since they were not too much involved in technical issues. Nevertheless, one Tanzanian manager described the effects of the workshops comprehensively: “They have helped quite a lot, because, as I told you, the concept of GMP started only sometime in 1999. So it was really a new concept when they were talking of validation […] because most of these pharmaceutical personnel were coming from the University of Dar es Salaam and a little bit of them from India. But even those from overseas, they did not have any practical experience. And they didn´t know much about the GMP […] So by them [action medeor] conducting these courses, they exposed the pharmaceutical personnel on the knowledge of the Good Manufacturing Practices, Good Laboratory Practice, Validation, Quality Assurance. [...] So they were very useful.” (Interview no. 12, pharm. company Tz)

70

The main reason for the companies to send their staff to GMP workshops was shortage of skilled personnel and pharmacy graduates not being properly qualified. Therefore, the companies conducted in-house training, partly through international experts or and tried to make use of rare external training opportunities. “We keep training our staff ourselves. We have some good managers who have been working with multinational companies and who have been training the personnel. Here [in Tanzania], I believe, in the university still the curriculum does not include the industrial part of the pharmacy. So you don’t really find good people to work for you. So we have been doing these trainings in-house and whenever we find an opportunity, when someone comes up which such training sessions, we send our people to profit from that.” (Interview no. 8, pharm. company Tz) “Otherwise we used to send our staff to India.” (Interview no. 20, pharm. company Kenya)

The companies stated different preconditions for sending staff for training – mainly related to budgeting, time of absence of key personnel and location. “But we have not been able to send our guys there [to SLF Moshi], because that´s out of town and for a longer duration. But here, it is feasible, for three, four days, and it is in Dar es Salaam.” (Interview no. 8, pharm. company Tz)

The advantages of action medeor workshops were seen in the closeness to the companies and the cost-effectiveness due to international sponsorship. “Yes, we appreciate these trainings. There are institutions like from South Africa, private consultants. It is very costly, they charge 600 USD per participant.” (Interview no. 7, pharm. company Tz)

Main challenges for the pharmaceutical companies – not directly linked to the GMP workshops – were seen in the high production cost, the price-sensitivity of the market, the harsh competition with Asian products and how to balance this with upcoming cost-intensive GMP requirements like bioequivalence studies. “…to be able to adhere to GMP and produce a quality product, it means that that product has to be expensive. So, it means that the customer out there must have a paradigm shift, to know that to be able to get a quality product, then quality is costly. So this is a big challenge.” (Interview no. 25, pharm. company Kenya)

Most companies were looking forward to harmonization of regulatory standards within the EAC and emphasized that same standards should be applied by inspectors on all manufacturing sites. Only one Tanzanian company mentioned that this would signify a business disadvantage for them because of the large Kenyan pharmaceutical industry bringing their products in. Some of the visited companies had concrete plans to achieve WHO prequalification, even though this implied huge investments and managers stated that due to missing business assurance on the donor market, some board members would judge the undertaking as too risky. Concerning the TPI ARV project, other manufacturers felt that “if it is a local manufacturer type of project, then all the manufacturers should be considered”. However, they appreciated the capacity building element. 71

4.4

Current and future opportunities and risks for the Pharm R&D Lab In order to assess the current and future role of the newly established pharmaceutical

teaching and development lab at MUHAS in the East African pharmaceutical sector, workshop participants, managers of pharmaceutical companies and Tanzanian key policy makers as well as other stakeholders involved were asked for their views and perceptions on the “Pharm R&D Lab”. The group of workshop participants comprised five interviewees (four Kenyans and one Tanzanian) who had experienced training sessions in the Pharm R&D Lab; the managers of pharmaceutical companies came from Kenya (3) and Tanzania (3). Key policy makers and other stakeholders represented the following institutions/partners: TFDA, Pharmacy Council Tanzania, School of Pharmacy / MUHAS management (2), TPMA, MSD, InWEnt gGmbH and GTZ/ EAC Secretariat (see also 4.1). The representative of TPMA acted at the same time as representative of one pharmaceutical company. These responses were considered in the category which was most applicable. The following themes were established: -

Strengths and opportunities of the Pharm R&D Lab

-

Risks and challenges of the Pharm R&D Lab

-

Recommendations from the stakeholders

An overview of the interview results is given in table 9.

Workshop participants, who attended training sessions held in the lab, were convinced of the lab’s capacity. The only challenge was seen by a Kenyan participant concerning the distance between Dar es Salaam and Nairobi. In contrast, this point was not mentioned by the managers of pharmaceutical companies. The latter were interested in R&D services, especially in the analytical part due to their own capacity constraints; however, whether they will really go for the services, will depend on time, cost and the capacity of the lab. One company suggested, the lab should prepare its own formulations of promising products in the pipeline and then sell those to the industry. Key policy makers and other stakeholders acknowledged the importance of the lab for pharmacy training (undergraduate, postgraduate and continuous professional development) as well as for research and development. The biggest challenges were seen in assuring the sustainability of the lab without external support and being able to maintain the equipment. “… The challenge is the sustainability. Because even before this R&D was there, there were some small machines intended for teaching, small machines, but eventually they all collapsed, because I think of sustainability. So similarly that lab, unless there are concrete plans to have it going on.” (Interview no. 6, regulator)

72

Workshop participants

Strengths/ opportunities

Risks / challenges

Recommendations

- very useful to develop formulations, well equipped; own company doesn’t have big R&D Lab (3)

- location; distance Kenya – Tanzania

- extend services to Kenya (lab set-up)

- financial status of the lab

- lab should develop formulations and then approach industry

- “I will recommend” (2) - practical training was very good (3) Pharmaceutical companies

- “we can cooperate” - lab at MUHAS, easier for clinical trials - profit centre for formulation development - make qualified people available for the industry - interest in analytical services (3) – “we are stuck at the analytical stage” - interest in complementary development service, time aspect - “novel idea” , but real capacity has to be found out through visit - processing of small quantities to save API cost

Key policy makers and stakeholders

- new modern lab - lab to act as mediator to adapt research findings from Western world to local context

- “Everything depends on the cost” - lab capacity (staff & equipment) (2)

- keep track on pipeline of new drugs

- unique formula for individual companies required

- start offering services to Tanzanian companies first

- keep track on advancing processes and equipment - Big companies have their own R&D labs

- Upgrade QC lab (2) - Link to bioequivalence lab

- improving the quality of locally produced medicines, development of good and stable formulations

- Analytical capacity

- manufacturers will use the lab, they want “ready-made” formula for production

- Maintenance, spare parts (4)

- pharmaceutical companies may invest

- Unstable power

- Attract trainees from all over Africa

- academic research and publishing

- Interaction between business and academia

- Needs planning / business plan (2)

- capacity building (hands-on) for industry and regulatory staff, CPD during semester holidays (3) - independent training place for product development, industrial production and quality assurance - undergraduate and postgraduate training up to PhD (3) - cooperation with Pharmacy Council, training provider

- Sustainability if donors step out (3)

- Motivation of lab staff - Lack of awareness and commitment within School of Pharmacy - Limited lab space

- analytical service for other institutions (MSD, USAID)

- Generate funds out of research for manufacturers and training fees (3)

- Stakeholder involvement (round table) – assess and present lab´s capacity - Advertise lab - Transparency within School of Pharmacy, Consultancy Bureau

Table 9: Opportunities and risks for the Pharm R&D Lab as assessed by stakeholders

Recommendations were made for income generation (training fees and R&D services for the industry) and stakeholder involvement, but also regarding the extension of the current lab: 73

“... One challenge of course, in order for that R&D Lab to work well, it needs to be complemented by a good QC lab, to carry out analysis. Because you carry out R&D, but you need to test the products also. So the quality control part of that R&D lab should also be improved to the same standard. That is what I should recommend, if possible.” (Interview no. 4, regulator)

Even though the School of Pharmacy / MUHAS management is aware of the huge challenges involved in maintaining the lab, they are convinced of the impact of this project: “For a very long time we have been struggling to get support to get facilities for training our students as well as our alumni, our former students who are now working in the industry on real-life skills, improved skills in the manufacture of medicines. And therefore, when I heard that this was going to be realized, of course I was very impressed. And I know that in the whole of this region - I have been to Uganda, I have been to Kenya, there is no such facility - so I knew immediately that this would be a very big step in the training of pharmaceutical manpower.” (Interview no. 27, MUHAS management)

As a first step towards income generation, a consultancy bureau has been set up at the School of Pharmacy: “The consultancy bureau is supposed to plan for income generation, because as highly skilled pharmaceutical experts, we should be rendering consultancy services to the public at large. And we should be paid for those services. Because basically as academic staff, we have three roles - to teach, to do research and to offer services or consultancies.” (Interview no. 27, MUHAS management)

5

DISCUSSION In this chapter, based on the study results and the literature findings, the contribution of

action medeor’s activities to improved access to essential medicines in Tanzania will be discussed. The elements of the NGO´s multi-dimensional approach comprising drug supply, capacity building and technology transfer will be elaborated on in the light of the Access Framework, considering national policies and the local context. Existing challenges will be mentioned and possible ways to address them will be discussed. The NGO’s project activities in Tanzania started at a time when increased donor funding was made available to tackle global health concerns, especially HIV/AIDS, malaria and Tb. Synergistic effects for action medeor emerged in the field of capacity building and technology transfer, whereas provision of essential medicines was rather downsized by international donors. The main access gaps in Tanzania can be seen in the low availability of medicines, particularly in the public sector, affordability problems, most severe in private facilities, and quality issues, mainly in the commercial sector. Affordability is strongly determined by the poverty of the patients and the need for out-of-pocket spending. action medeor as an NGO is trying to address all these dimensions, directly or indirectly, even though the public sector could be reached to a limited extent only so far.

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5.1

The NGO’s activities in the light of the access framework Based on the Access Framework (WHO, 2004a), action medeor’s contribution to improve

access to high-quality low-cost essential medicines in Tanzania focuses on two of four key areas: “Reliable health and supply systems” and “affordable prices”. Reliable drug supply is supported through different activities along the supply chain – product development, local manufacturing and distribution of high-quality drugs. The third key element, “rational selection of essential medicines”, is considered as well, since the selection of distributed medicines is based on the WHO EML and NEML. Ensuring “sustainable financing”, however, is mainly the responsibility of the government, in cooperation with and in dependence of multi- and bilateral donor and financing institutions. Considering the “access dimensions” availability, affordability, acceptability, accessibility and quality (CPM, 2003a), the NGO’s activities target availability of medicines at health facility level through drug distribution by AMT, affordability and especially quality. Capacity building (GMP trainings) and technology transfer (Pharm R&D Lab, TPI ARV project) contribute to increasing the quality of locally manufactured drugs and may lead to improved availability and affordability in the long run. Acceptability of rationally selected medicines can be indirectly influenced through provision of high-quality generic drugs and through education and information of health staff at the health facility level. Accessibility of medicines and medical services is only marginally touched through making medicines accessible for the customers (health facilities). However, as previous studies have shown, accessibility of health services in Tanzania improved over the years (CPM, 2003b). Currently, about 90% of the population live within 5 km of a health facility (MOHSW, 2008a) and plenty of small commercial drug shops contribute to medicine accessibility. It does not seem possible to quantify action medeor’s contribution to access to medicines in Tanzania, due to the complex network of various dimensions and due to the mainly qualitative approach of this study. However, the results of this study suggest that the NGO, together with its partners, contributed considerably to the development of the pharmaceutical sector in Tanzania with the ultimate goal of improving access.

5.2

The integration and localization of action medeor’s activities within the overall health and pharmaceutical system in Tanzania Considering the multitude of national and international actors in the health and

pharmaceutical sector in Tanzania, sustainable changes regarding access to medicines are only achievable if the principles of the Paris Declaration – ownership, harmonization and alignment – are followed. 75

The comparative advantage of action medeor being an NGO can be seen in the flexible way of operation which comprises the initiation of innovative approaches like the Pharm R&D Lab, business-like cooperation with a pharmaceutical company (TPI) and the potential to complement the public sector drug supply system through AMT. A review of national policies (National Drug Policy, Pharmaceutical Masterplan, National Health Policy, Health Sector Strategic Plan) as well as feedback from policy makers and partners confirmed that the NGO’s activities in the pharmaceutical sector Tanzania are in line with national priorities. This applies especially to the provision of high-quality essential medicines (particularly generics) and the support for local pharmaceutical production including capacity building to address the shortage of skilled personnel and improve the quality of medicines circulating in the market. All concerned Tanzanian stakeholders who were interviewed were found to be in favour of an efficient public-private mix in the medicine supply system, since private (especially private nonprofit) distributors can compensate the weaknesses of the public supply system, particularly the overall low availability of medicines. At present, AMT serves around 25% of all faith-based health facilities in Tanzania. Access of public health facilities to AMT services is, however, limited due to public procurement rules binding them to MSD. Several stakeholders who were interviewed, especially public facilities themselves as well as previous studies conducted (CPM, 2003b; MOHSW, 2008c) advised the government to allow public facilities to procure up to 30% of their medicines from suppliers other than MSD. From an access perspective, the role of AMT is to fill the gaps of MSD and contribute to a reliable medicine supply. Although there is a competitive element, which could be even stimulating for MSD, cooperation or at least exchange of information between MSD, AMT and alternative nonprofit initiatives like MEMS is required. The literature supports the combination of public and private suppliers to increase access to affordable medicines for the patient. Experiences from Kenya and Uganda have shown that nonprofit drug supply organizations can gain a significant share in medicine supply due to their reliability and efficiency (Quick, 2003). As AMT focuses on essential medicines and does not supply ARVs and anti-TB medicines, there is not a lot of interference with vertical programmes. In fact, AMT targets an area which is often neglected by large donors. However, exchange of information would be useful. Most vertical programmes use MSD for procurement of their medicines. Through donor funding, these programmes are much better off and rarely face availability problems (EHG, 2007).

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As found in national policy documents and confirmed through the interviews, action medeor’s support for local pharmaceutical development and production including capacity building complies with the National Drug Policy, the Pharmaceutical Masterplan and directly contributes to achieving three out of ten explicit objectives laid down in the “Strategies for promotion of local production of pharmaceuticals in Tanzania” (MOHSW, 2006): -

“Development partners encouraged to invest in our local pharmaceutical industries in order to improve their technology by the year 2010” (specific objective 3)

-

“Good Manufacturing Practice standard of local pharmaceutical industries promoted by the year 2010” (specific objective 5)

-

“Research and development for pharmaceutical formulation conducted by local manufacturers in collaboration with higher learning institutions by 2016” (specific objective 10)

Furthermore, the needed support for TFDA to enforce production standards and the required implementation of TRIPS flexibilities are mentioned in this strategy; both areas are supported by action medeor as well. The plan for local ARV production together with TPI Ltd. in Arusha was supported by all interviewed policy makers and partners – though the reasons differed, with “increased access to affordable ARVs” and “achievement of WHO prequalification” corresponding to specific project results. Due to the scarcity of skilled pharmaceutical personnel, “employment for pharmacists” as mentioned by one stakeholder seems not to represent the main advantage of the project. However, as a state-of-the art production facility, TPI ARV Ltd. could serve as a training site for prospective industrial pharmacists. Competing pharmaceutical companies, on the other hand, observed this project in a rather sceptical way. Overall, action medeor’s cooperation with relevant national stakeholders seems to be adequate, as stated by the interviewed key informants. However, some room for improvement exists: -

The contact to and involvement of the MOHSW should be improved; the same applies to collaboration with WHO, especially in the field of capacity building.

-

Cooperation and exchange of information with other international and local nongovernmental initiatives in the pharmaceutical sector should be sought; e.g. MEMS as faith-based drug supply initiative, SLF as pharmaceutical training provider, MSH and USAID/SCMS as international donors and actors in the pharmaceutical field as well as rather vertical disease-specific programmes.

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5.3

Effects of drug distribution through action medeor Tanzania

5.3.1

Achievements The results of the study show that after five years of operations, AMT as a non-profit

DSO is perceived as a reliable alternative source for essential medicines by a range of private non-profit health facilities in Tanzania. Several public hospitals make use of AMT as well; however, public health centres and dispensaries are not in the customer range since they only procure from MSD through the DMO. Through the interview responses, several effects of the DSO’s medicine supply on non-profit health facilities (AMT customers) in Tanzania were identified, contributing to an improved access to medicines: -

The most visible effect was reported to be the increased availability of medicines at the health facility level. This effect was particularly noted by customers who had entered into a special agreement with AMT and were granted the possibility to pay within 30 days after receipt of medicines. Since most of the health facilities visited suffered from financial constraints, especially limited cash at the end of the month, this option for delayed payment seems to make a notable difference.

-

Furthermore, a range of vital products which are needed only in small quantities and which due a to low commercial value are rarely stocked by private wholesalers can be found at AMT. Considering the general availability problems of MSD, AMT has become an important alternative source for these life-saving products.

-

The quality-oriented way of the DSO’s operations leads to improved access to quality products for the patient, especially when comparing with commercial sources which still bear the risk of substandard or even counterfeit products. (Negative experience in this respect led to an aversion against Asian products by one customer.) Customers generally appreciate the quality services (e.g. cold chain) of AMT and are convinced of the high product quality, even though they have limited means for actual verification.

-

Through customer care (e.g. short waiting time) and good communication, customers get easier access to medicines and save time, which seems to be an important factor in the context of overstrained health facilities with scarce health personnel.

-

Due to its rational selection of medicines and provision of generic medicines only, AMT contributes to rational drug use at health facilities. Through continued information and education of customers, the DSO needs to raise awareness for this topic and reject customer requests for inclusion of non-essential medicines in the product list 78

The results of the interviews were congruent with the customer feedback gained from the structured questionnaires35. Concerning availability and range of products AMT, seems to perform quite well in comparison with non-profit DSOs in other SSA countries where range and availability of products varied and substantial weaknesses were addressed by customers in this respect (WHO and EPN, 2006). The effect of increased availability of medicines at health facility level confirms previous studies which argue that flexible ways of procurement (public and private suppliers) increase availability notably (CPM, 2003b; URT, 2005). Based on discussions with district councils, the authors of an external evaluation of the Tanzanian health sector in 2007 strongly argued that MSD’s monopoly in the public sector should be ended and mentioned MEMS and action medeor as potential alternative supplier (Ministry of Foreign Affairs of Denmark, 2007). The implementation of this suggestion remains still open. 5.3.2

Areas for improvement Even though the product range and generally high drug availability of AMT in comparison

to public and commercial suppliers were appreciated, some customers already experienced “outof-stock” situations at AMT. This should be taken seriously and give rise to corrective measures. The examples given were Ampicillin and Diclofenac injections, two products, which, according to the NEML, should be available on hospital level. The fact that this complaint was brought up by a health centre raises the question if and how the NEML recommendations are adhered to. Another problem was seen in the comparatively high prices of AMT36 limiting access to a certain extent. Overall, the DSO’s customers were found to be very price-sensitive and therefore, as well as for availability reasons, used a range of suppliers (MSD, AMT, commercial suppliers) to meet their needs. Interesting enough, public facilities perceived the medicine prices as rather low. The reason could be that they procure AMT medicines mainly in emergency situations or they need rare medicines which might be overpriced by commercial wholesalers, if available at all. AMT prices are up to 30% higher than MSD prices. This figure corresponds to the results found in another study (CPM, 2003b) which revealed that undiscounted prices from private (commercial) wholesalers were about 30% higher than MSD prices. According to the feedback provided by AMT customers, the AMT products seem to be slightly more expensive than those from (some) commercial wholesalers. The reasons for the price difference can be seen in the large

35 Even though a time lag (approx. five months) exists between administering of the written questionnaires and conducting key informant interviews, this was not considered as significant within the scope of this study since the political and regulatory framework remained without considerable changes. 36 International comparison (MSH drug price indicator guide 2009) shows that AMT prices are generally above the median IRP (http://erc.msh.org).

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procurement quantities of MSD and the tender procedures. As MSD is supposed to work on a cost-covering basis with fixed low customer prices, costly emergency procurement for MSD to fill availability gaps is hardly possible. So there seems to be a trade-off between price and availability (EHG, 2007). Commercial suppliers, on the other hand, often limit their range of products to fast-moving items and try to operate as profitable as possible by getting products from the cheapest sources, often on the expense of quality. The pricing study conducted by the Tanzanian government in 2004 showed that end consumer prices at NGO and private facilities are twice as high as at public facilities (URT, 2005). This can only partly be explained by higher procurement prices. Additionally, missing or low government subsidies cause non-public health facilities to use the sales of medicines for income generation. Unfortunately, it was not possible during the course of this study to get price lists from health facilities. However, it was observed that end-consumer prices may vary considerably even among NGO facilities, e.g. the cost for one adult treatment of CoArtem (first-line antimalarial medicine distributed for free to all health facilities) was 500 TSH at one faith-based facility but 1000 TSH at another facility. Considering the poverty of most patients, possibilities for price reductions should be sought by AMT in order to make essential medicines more affordable. However, this seems quite challenging if quality of products and services shall be maintained. One option could be to pursue bulk procurement together with other non-profit DSOs in the region which might become feasible within the context of EAC harmonization. What seems more viable in the short term is to widen the range of customers, to include public facilities as already discussed before, but also to attract more NGOs and faith-based facilities. This could be done through “marketing strategies” like advertisement and regular visits of (potential) customers. It is noteworthy mentioning that several of the interviewed customers got in contact with AMT “accidentally” or by word-of-mouth. Considering the responses of the questionnaires issued to TCMA members during the last annual meeting in 2009 whereby 8 of 37 respondents (22%) had never heard of AMT but were interested in its services, the potential for AMT to attract further customers seems still large. In the long run, larger procurement quantities could lead to more affordable prices for the customers. Furthermore, cooperation with the government and tax exemption should be aspired. In order to increase the affordability of high-quality products in general, the government has to find alternative ways to relieve especially poor patients of their financial burden, either through wider health insurance coverage or through a more comprehensive financial government support for public and private non-profit health facilities – allowing them to offer cheap treatment. Price regulation in the private sector, as implemented in Mali (Maiga and Williams-Jones, 2010) is 80

probably not transferable to Tanzania, since competition and pricing pressure are already high. However, pricing guidance at the health facility and retail level could be advisable. Whether and how customers staying very far from Dar es Salaam appreciate AMT services including transport of medicines could not be evaluated in-depth within the context of this study due to logistical constraints. All customers visited, even those staying in the more rural areas (up to 300 km from Dar es Salaam), travel to the DSO’s premises to pick up the medicines rather than having them delivered to their health facilities. The reasons were not made explicit; however, it seems that most customers combine tasks when traveling to Dar es Salaam and try save the transport costs for the medicines. Secondly, some customers intend to make comparisons at different wholesalers in town. Thirdly, customers might feel that picking up the medicines themselves is more secure than relying on public transport. (Even though, no serious incidences were reported in this respect.) Instead of adding actual transport charges to a shipment, AMT could integrate transport costs in the medicine prices, in order to balance disadvantages experienced by remote health facilities. However, again, affordability has to be attained. The possibility of a decentralization of the DSO’s services, as requested by one stakeholder, needs to be discussed, but feasibility is at least questionable at this stage due to associated financial implications.

5.4 5.4.1

Capacity building for local pharmaceutical manufacturers Effects on workshop participants and manufacturing standards The GMP training courses reached pharmaceutical key personnel from all Tanzanian,

one third of the Kenyan and a few further East African pharmaceutical industries. Even though participants from other institutions (accounting for about 40% of the workshop participants) were not included in this study, participation of experts with different background, especially regulators in charge of setting and enforcing pharmaceutical production standards, seems highly desirable due to increased mutual understanding and exchange. As was stated in the interviews, workshop participants had implemented the acquired knowledge in several key areas like risk assessment, validation/ qualification and stability studies, leading to improved production standards as a precondition for the output of high-quality medicines. Convinced that the GMP workshops had a considerable effect on the performance of their daily work, interviewees described how they had passed the knowledge on to their colleagues, through training sessions within the companies. This confirms that the theoretical concept of “Training of Trainers (ToT)” seems to work in practice. The workshop participants acted as multipliers by 81

actually implementing what they had announced in the evaluation questionnaires (directly after the workshops). Overall, interviewees were very satisfied with the quality and organization of the workshops except for minor issues like accommodation and duration of the training. (This was consistent with the results from the workshop evaluation questionnaires.) However, considering the costs for accommodation (covered by donor contribution), it may not be justifiable to fulfil the high lodging expectations, which probably derive from comparison with other donor-funded projects. The presence of international experienced lecturers seemed to be particularly important as stated by the training participants. This raises the concern whether it will be possible to conduct future high-level workshops by experts in Tanzania on a sustainable basis without international support, considering also the limited willingness-to-pay and the fact that Kenyan companies would prefer trainings conducted in Kenya. The comments of those participants and stakeholders who were involved in the workshops from the beginning (2005) show that the GMP workshops started at a time when GMP awareness was still very low among the East African and especially Tanzanian pharmaceutical industries. This might explain the remarkable boosting effect the GMP trainings had on workshop participants and pharmaceutical companies. Furthermore, there were and are not many alternative training options for this specific target group in the East African region. Above all, the environment for this capacity building initiative has been very conducive since the newly created TFDA (2003) was and is committed to set and enforce higher production standards and the privatized industries started to invest (Bitegeko, 2007; Pius, 2009). action medeor on its own, as an NGO procuring small quantities from regional manufacturers, would probably not have had the authority or commercial power of convincing the industries to implement higher quality standards. 5.4.2

Management views - challenges Regarding the effectiveness of the capacity building interventions, management support

seems crucial and was available for most of the interviewed workshop participants. This, however, may not be representative for all pharmaceutical companies in East Africa. The interviewed management representatives of pharmaceutical companies appreciate action medeor’s capacity building initiative since university education is not sufficient and alternative advanced training options are costly and rare. On the other hand, considering the overwhelming challenges of local pharmaceutical manufacturing, the benefits of implementing GMP are easily overlooked by the management of pharmaceutical companies. From a business perspective, implementation of GMP even adds to the production costs, however, the market share may be 82

increased, e.g. considering donor markets. From an access perspective, quality is an indispensable prerequisite which cannot be compromised. The difficulties and challenges mentioned by local pharmaceutical companies – shortage of skilled personnel, maintenance of equipment and utilities as well as costly import of raw materials – correspond to the concerns addressed in previous studies (Guimier et al., 2004; Kaplan and Laing, 2005; Losse et al., 2007). Considering the very price-sensitive local and regional market, the limited possibilities to achieve economies of scale and the harsh competition with imported Asian products, manufacturers were asking for increased recognition of quality products by the customer and application of uniform quality standards on all products in the market. All manufacturers (except for one Tanzanian company) were in favour of the EAC harmonization process which would lead to harmonized regulatory standards and easier registration and marketing of products in the whole East African region. . 5.4.3

Rationale for support of local manufacturing The interview results show that GMP awareness was raised among workshop

participants and GMP aspects were implemented within the companies. Therefore, the trainings effectively contributed to an increased quality of locally manufactured medicines. Despite all mentioned challenges, it has to be noted that the biggest Tanzanian and Kenyan companies have made quite some progress regarding quality standards and have managed to increase their market share (Pius, 2009). Since locally manufactured products will remain on the market, since they are favoured through national policies and since control of regional manufacturers is much easier for TFDA than auditing and supervising those in Asia, it seems advisable for an NGO like action medeor to support the efforts made in local manufacturing. Other donors (InWEnt, GTZ, UNIDO) share this perspective and are engaged in capacity building and other initiatives to support local pharmaceutical production, e.g. within the EAC harmonization process or through the plans for a regional bioequivalence centre (Ali and Scheidel, 2009). As essential medicines are not regulated to the same extent as priority medicines (through WHO prequalification), it is the joint responsibility of the manufacturer and the distributor to supply highquality medicines. The challenge for manufacturers and suppliers like AMT is to invest in quality and at the same keep prices as affordable as possible. Considering cost and time involved for importation of products, local sources have been found to be more cost-effective and more reliable in many cases (Bonsmann, 2010). For example, required Certificates of Analysis (CoA) are very difficult to get from Indian manufacturers through their Tanzanian middlemen (importers); regional manufacturers, however, comply with this requirement (Roessler, 2009). Furthermore, 83

supplier qualification (auditing and re-auditing) is much easier to implement and to sustain at local and regional manufacturing sites compared to international sources (Bonsmann, 2010).

5.5

Current and future opportunities and risks for the Pharm R&D Lab Considering the various access dimensions, the newly established pharmaceutical

teaching and development lab (Pharm R&D Lab) at MUHAS intends to make a contribution to improved quality through capacity building and optimized drug formulations. In the long run, this may lead to increased affordability and availability of “new” generic medicines. The need for such a lab at the university was clearly expressed by pharmaceutical companies, who expect to recruit highly qualified pharmaceutical personnel, but also by other stakeholders, considering further opportunities like increased quality of pharmaceutical products in the market and adaptation of international research findings to the local context. Workshop participants already benefited from practical sessions in the lab and managers of pharmaceutical companies were interested in the Pharm R&D Lab’s contract services like analytical method development. However, as the pharmaceutical industry is business-oriented and wants to save time and costs, the lab has to convince through its performance and results delivered. As a public research institution located in a least-developed country, the lab should keep track on the pipeline of new drugs which could be manufactured locally. Especially products which are not of commercial interest globally and therefore lack investment in R&D could be focussed on, examples being paediatric formulations or fixed-dose combinations of “new” first-line and secondline generic ARVs, which are not taken up rapidly by international generic firms (Waning et al., 2010). The most advanced product under development in the lab, an ARV triple combination recommended as one of six new first-line regimens by WHO (2009a), is currently sold globally by two companies only – one of those generic combination products being WHO prequalified (MSF, 2010). Project-specific funding for high-priority medicines could be sought from international donors. Interviewed policy makers and partners, all supporting the concept of the lab, addressed major challenges and risks in relation to the economic status and the sustainability of the lab, especially the maintenance of the highly valuable equipment. As recommended by the stakeholders, a well thought-out business model which includes concrete plans for income generation is indispensable. Considering the fact that qualified experts are rare, even in the better paying private industries, the Pharm R&D Lab should take some measures to retain and attract development experts. 84

Since upgrading of the analytical part of the Pharm R&D Lab was included only to a limited extent within the scope of the current project, MUHAS should seek further donor assistance at least for the coming few years. Without well-functioning analytical services, the accomplishment of most product development projects seems at risk. As can be derived from the study results, the success of the project and thus a sustainable contribution towards improved access to medicines will mainly depend on the commitment of MUHAS and the School of Pharmacy, and how the lab’s work is promoted. Within the context of a financially constrained health and education sector, this represents a challenging task for a public institution on its own. Therefore, MUHAS should invite potential investors and discuss various business models. Mixed financing (e.g. private, public, donors) seems to be most promising to ensure long-term sustainability. This approach is followed by other initiatives, too; one example being the planned bioequivalence centre within the EAC region which will be commonly run by a university and the private pharmaceutical industries (Ali and Scheidel, 2009). Overall, the approach of the Pharm R&D Lab seems unique within East Africa and represents an opportunity for attracting stakeholders beyond the borders of Tanzania. Projects of this type differ from one another and cannot be generalized. Their success strongly depends on the surrounding conditions. If for example the regulatory framework for production of generic medicines in East Africa becomes more stringent, manufacturers might be forced to invest in optimized drug formulations for bioequivalence studies, providing further business opportunities for the lab. In order to address the challenges mentioned by interviewed stakeholders, collaboration with different kinds of national, regional and international stakeholders should be aspired, with the goal to perform collaborative research, access funds and shape policies and guidelines in the pharmaceutical sector, aiming at increased drug quality.

5.6

Limitations of this study and recommendations for future research and activities One limitation lies in the fact that this study tried to evaluate the activities and contributions

of a specific NGO within a certain local context and regulatory/policy framework. Therefore, the results cannot be easily transferred to other contexts and situations and generalization seems not possible. However, the study exemplifies the interactions between different stakeholders engaged in ensuring access to medicines in a least developed country and shows lessons learnt. A further limitation refers to potential selection bias since only those stakeholders were approached for interviews that were known to be familiar with action medeor’s activities. Whereas the most relevant Tanzanian players were considered, some international actors like MSH and USAID/SCMS were not included. This means that only a narrow picture of the NGO’s integration 85

in the pharmaceutical sector in Tanzania can be given. In order to get a more comprehensive view, further stakeholders could be approached who may, however, not be in a position to relate to the activities of this specific NGO. Further operational research could be done on the medicine supply systems in neighbouring countries like Kenya or Uganda, to compare the factors which influence the role of non-profit DSOs within a system. Additionally, it would be interesting to get some more quantitative data, especially relating to the services of action medeor Tanzania, in order to find out to what extent increased availability on the supply side (AMT) leads to increased availability of medicines at the health facility level and how factors like forecasting capabilities and payment modalities influence the situation precisely. A more comprehensive study focusing on health facilities (AMT customers) could also include aspects like rational drug use, accessibility and acceptability of health services (including medicine provision) and factors influencing availability and prices/affordability of medicines at the health facility level. If feasible and if demand exists, further activities could focus on providing extended assistance to health facilities, e.g. through training on rational drug use or good storage practices, possibly together with experienced partners like MEMS or MSH. Public health facilities facing drug availability problems due to the weaknesses of MSD need to be reached by the NGO’s services. For this, good cooperation of AMT with the government but also with MSD is required, so that the complementary role of AMT becomes clear, which shall not weaken the efficiency and performance of MSD. However, even though action medeor’s contribution focuses only on a small part of the pharmaceutical and health sector in Tanzania so far, it seems advisable to ensure sustainability of the started projects first before initiating new activities.

6

CONCLUSION The overall objective of this study, to „assess an NGO’s contribution to improve access to

high-quality low-cost essential medicines in Tanzania” exemplified by the case of action medeor was achieved through getting the views from beneficiaries, customers, partners and health policy makers on the NGO’s project activities in the pharmaceutical sector in Tanzania and East Africa. The NGO’s multi-level approach focusing on the “supply side of access” starts from the development of high-quality generic medicines at the Pharm R&D Lab, supports regional production through capacity building and technology transfer and finally supplies quality products 86

to non-profit health facilities in Tanzania. The overall goal is to make available high-quality, affordable, rationally selected medicines to the patient. The results of the interviews, assessing the individual activities, showed that a range of positive effects were visible for direct beneficiaries, customers and partners involved; policy makers appreciated the wide scope of activities taking on board the key aspects of the national drug policy and considering national priorities like local production of medicines. From an access perspective, the main contribution of action medeor activities can be seen in relation to the dimensions of “availability” and “quality”. By complementing the public supply system, action medeor Tanzania as a DSO contributes to ensuring “reliable supply” of “rationally selected essential medicines”. Increased affordability through local production of medicines (including “new” generics) is a longterm goal; however, AMT needs to consider alternative approaches to address the issue of pricing in the near future while maintaining its standards of quality and service. The success of action medeor’s individual activities and their overall impact on access to medicines was and is strongly dependent on the economic, regulatory and policy framework as well as on the commitment and ownership of the local partners, in order to ensure sustainability. Therefore, the attribution gap remains high. When action medeor started its activities in the pharmaceutical sector in Tanzania in 2004/2005, TFDA had become a strong actor trying to enforce registration of medicines and pushing implementation of GMP standards in the local industries. The GMP training series became successful because the environment was conducive. Furthermore, as a small NGO with limited funds available, action medeor needs to seek support from other donors in order to realize large projects like the “Pharm R&D Lab”. However, cooperation and alignment are also crucial in the light of the “Paris Declaration and the Accra Agenda for Action”, considering the multitude of donors. So far, cooperation with local partners and policy makers and alignment with national priorities in Tanzania played an important role in all project activities. The contact with other international actors in the field has, however, been limited and needs to be strengthened, in order to increase exchange and avoid duplications. The efforts of action medeor – supply of basic essential medicines and support for local highquality production – focused on areas which were only marginally considered by large bilateral and multilateral donors. In this niche, the NGO set a stimulus which was supported by national stakeholders and German partners. In recent years, the number of international actors in the field has increased, which leads to new opportunities and synergistic effects. The combined national and international efforts are targeted to achieve the health-related MDGs. As part of these, the NGO’s activities contribute to MDG 8 target 8e – “In cooperation with pharmaceutical companies, 87

provide access to affordable essential drugs in developing countries” – but also to MDG 6 (through development and production of ARVs) and to MDGs 4 and 5, which are not achievable without having medicines available.

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ACKNOWLEDGEMENTS

First of all, I would like to thank all my interview partners for dedicating their time and for openly sharing their views and perceptions on the given topic.

Furthermore, my sincere thanks go to my supervisor, Dr. Florian Neuhann, for his constructive guidance and for providing always prompt and comprehensive feedback.

I am most grateful to my employer action medeor for giving me the opportunity to pursue these Master studies and I am equally grateful for all the support I received from my colleagues.

In addition, I would like to thank Dr. Eliangiringa Kaale, Senior Lecturer at MUHAS, for his extraordinary commitment and Mr. Hiiti Sillo, Acting Director General of TFDA, for his valuable cooperation. My thanks also go to the action medeor Tanzania branch team, especially to Acting Branch Manager Mr. Gerald Masuki, for organizing the field trips. They all assisted me in many ways during my two-month stay in Tanzania and provided very useful information. Ahsante sana!

Particular thanks go to Dr. Julia Micklinghoff, Christoph Bonsmann and Susanne Hübscher who did a great job proofreading this thesis.

Last but not least, I want to thank all my family and friends for their moral support and especially my husband for his patience and encouragement.

89

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ANNEXES Annex 1: Background information on action medeor Tanzania (AMT)

18.5 %

for medicines and consumables on the dispensary/ health centre level (classified as AB according to the NEML)

24 %

for medicines and consumables on hospital level (classified as C)

26 %

for specific items like ophthalmologic products

28 %

for medical equipment and non-consumables

3.5 %

handling fee for donors and foreign payees

+ actual transport charges (above a shipment value of 10 million TSH transport is free) Table 10: Mark-ups on CIF prices AMT 2009

Year

Turnover

2005

160,074 €

2006

578,084 €

2007

988,006 €

2008

1,033,760 €

2009

1,046,928 €

Table 11: Turnover AMT 2005-2009

Product description

Amoxicillin 250 mg Captopril 25 mg Chloramphenicol 250 mg Ciprofloxacin 500 mg Diclofenac 50 mg Doxycycline 100 mg Erythromycin 250 mg Glibenclamide 5 mg Metronidazole 200 mg Nystatin Susp. 100.000 IU/ml

Health facility level A C A C B A A C B A

Unit

1000 caps 100 tabs 1000 caps 100 tabs 100 tabs 1000 caps 1000 tabs 100 tabs 1000 tabs 1 bottle (30 ml)

Price (TSH) MSD 33,000 4,500 27,000 4,800 600 20,000 31,000 1,900 5,700 800

Price (TSH) AMT 26,740 5,820 28,633 5,240 770 26,070 36,600 4,340 7,055 1,030

Price difference (%) -18.97 29.33 6.05 9.17 28.33 30.35 18.06 128.42 23.77 28.75

Table 12: Price comparison AMT-MSD 10 randomly selected medicines of the NEML 2007 as well as the latest price lists (AMT 2009, MSD 2008/09) were taken. Exchange rate (June 2010): 1 € = 1,800 TSH

97

Annex 2: Background information on capacity building (GMP workshops)

Date

Title

Location

Financial

Sponsors

volume 10.-21.10.2005

Comprehensive GMP Training,

SLF, Moshi

59,200 €

InWEnt, TPI

SLF, Moshi

59,200 €

InWEnt, TPI

Part 1 5.-16.12.2005

Comprehensive GMP Training, Part 2

13.-17.11.2006

Compact GMP Training

SLF, Moshi

23,100 €

InWEnt, TPI

20.-24.11.2006

GMP Training “Validation &

TPI, Arusha

23,100 €

InWEnt, TPI

Moshi

28,600 €

InWEnt, EC,

Qualification” 26.-30.11.2007

Workshop on TRIPS

UNCTAD 3.-12.12.2008

28.9.-2.10.2009

7.-11.12.2009

GMP Training “Validation &

MUHAS, Dar es

Qualification”

Salaam

“Granulation, Tabletting &

MUHAS, Dar es

Coating”

Salaam

Quality Control of Drugs

MUHAS, Dar es

36,400 €

InWEnt, EC

18,100 €

InWEnt, EC

20,500 €

InWEnt, EC

19,300 €

InWEnt, EC

Salaam 22.-26.2.2010

Quality Control of Drugs

MUHAS, Dar es Salaam

Table 13: Workshops conducted in Tanzania by action medeor

Workshop participants - countries of origin

14 11 73

Tanzania -89 Kenya -52 Uganda -7 Rwanda -3

52

89

Burundi -1 Congo DRC -4 Malawi -1 Botswana -1

Figure 3: Workshop participants 2005-2010 by countries of origin

98

Workshop participants - workplace

18

4

9 Manufacturers -95 DRAs -18

16

National QC Labs -4 Distributors -9 Academia -16

16

Others -16

95

Figure 4: Workshop participants 2005-2010 by workplace

Number of companies represented in workshops 10 10 8 8 6 4 2

1

1

0 Tanzania

Kenya

Uganda

DRC

Figure 5: Companies from different countries represented in the workshops 2005-2010

99

Annex 3: Interview guides (semi-structured interviews) Annex 3.1 Interview guide for partners and policy makers – regulatory bodies and policy makers (TFDA, Pharmacy Council Tz, MOHSW Tz, EAC secretariat), pharmaceutical associations (TPMA, EPN), DSOs (MSD, MEMS) and donors/international partners (GTZ, InWEnt, SLF)

Interview no. Interviewee: Organization/institution: Qualification/position within the organization/institution: Since when in contact with action medeor: Date and time: Place:

Introduction: I am conducting a study to evaluate action medeor´s activities within the pharmaceutical sector in Tanzania (and East Africa). I would like to get stakeholder´s views and perceptions on these activities in order to formulate recommendations for the future. The results of the study will be included in my Master Thesis International Health. All information will be treated as anonymous as possible. However, if there is any confidential information which you feel should not appear in the thesis, please let me know. On behalf of action medeor I would like to ask you to be as open as possible and express any critique which comes into your mind. This will help action medeor to improve in the future. Your participation in this interview is purely voluntary. You can skip a certain question and interrupt or stop the interview at any point in time. I would like to tape record this interview if you agree. If you do not want to participate or if you choose to end the interview for any reason, there will be no negative consequences for you.

Signature of interviewee (Informed consent): ____________________________________

Thank you in advance for your support.

1. Which action medeor activities in Tanzania are you familiar with or have you heard of? Which of those activities are relevant to your work? 2. Could you please briefly describe the interlinkage with action medeor concerning your field of activity and responsibility? 3. How do you assess action medeor activities so far? a. What do you know about action medeor´s drug distribution center in Dar (Buguruni)? How do you think it contributes to improving drug supply to hospitals (esp. private non-profit customers)? How do you assess the coexistence of public and private (profit and non-profit) drug supply organizations in Tanzania? What do you think are the main challenges in the drug supply sector in Tanzania (East Africa resp.)?

100

b. What do you know about action medeor´s involvement in providing further training (workshops) for pharmaceutical key personnel (industry, DRA, drug distributors) in East Africa? If at all, how do you think the trainings can contribute to improving quality of locally produced medicines? c. What do you know about the newly established pharmaceutical teaching and development lab (Pharm R&D Lab) at MUHAS School of Pharmacy? What do think will be the main future tasks and activities of the lab? (Providing service to for the industry? Students training and further education for pharmacists?) What are the strengths and weaknesses of the lab, what are opportunities and threats? d. What do you know about the EU funded project – setting up a new manufacturing plant for ARVs in Arusha together with Tanzania Pharmaceutical Industries? What do you think of this plan? 4. How in your opinion does action medeor relate to respective national policies? 5. How do you assess cooperation among stakeholders in the pharmaceutical sector? Is action required to improve cooperation/communication? If yes, what could be done, especially by action medeor? 6. Which recommendations do you have for action medeor concerning future activities? Which activities should be focused on? Are there any issues which have not yet been properly addressed and should be considered in the future? Is there anything else you want to raise?

101

Annex 3.2 Interview guide for customers – health facilities Header and introduction see Annex 3.1.

1. Brief information on size of health facility (number of patients/beds), human resources, most common diseases. 2. What do you know about action medeor and the drug distribution center in Dar (Buguruni)? 3. Which are your main sources of drugs and medical supplies? (ranking – most important first) 4. When did you become a customer of action medeor Tanzania? 5. Did you receive any drugs from action medeor Germany before the branch office was opened in Dar es Salaam? (Donations?) 6. How did you become aware of the action medeor drug distribution center in Dar? 7. Why did you choose action medeor Tanzania as your supplier? 8. What is your level of satisfaction with action medeor services regarding a. range and availability of drugs/medical supplies, b. quality of products, c. price, d. delivery/transport, e. communication/assistance? What do you like/ what do you dislike and why?

9. What were the effects for your facility and for the patients regarding availability of drugs/medical supplies, after choosing action medeor as your supplier? 10. What do you think are the main challenges for patients in your area to get access to drugs? 11. What are the main challenges for your facility? (Regarding access to drugs and also in general to provide healthcare?) 12. How do you appreciate the mix of public and private (non-profit and profit) drug suppliers? 13. What do you think, how will your future relationship with action medeor develop and why? 14. Which recommendations do you have for action medeor? Are there any services which you are missing? 15. Is there any other issue you want to raise?

102

Annex 3.3 Interview guide for direct beneficiaries – workshop participants (industry) Header and introduction see Annex 3.1.

1. Which action medeor activities in Tanzania and East Africa are you familiar with or have you heard of or participated? 2. Could you please briefly describe the interlinkage with action medeor concerning your field of activity? 3. Which services of action medeor did you use so far? 4. Some of your colleagues and yourself attended action medeor training workshops on GMP and Quality Control already. Why did you participate in these trainings? What is your employer´s attitude towards sending pharmaceutical personnel to external trainings? 5. How do you assess the organization and quality of action medeor workshops? What did you like / dislike? 6. What were the benefits of the training for yourself, your colleagues and for the company/institution you are working at? 7. Which challenges did you face implementing the newly acquired knowledge? 8. Would you attend further action medeor trainings and would you recommend to your colleagues to attend further trainings offered by action medeor? Why/ why not? What would be the preconditions? 9. Which other organizations do you know that provide training for pharmaceutical staff in the East African Industry? How would you compare those trainings to the ones offered by action medeor? 10. What do you know about the newly established pharmaceutical teaching and development lab (Pharm R&D Lab) at MUHAS School of Pharmacy in Dar es Salaam? Would you consider outsourcing drug development (formulation) to this lab or renting the lab for your drug development? Why / why not? 11. What do you think are the main challenges in the pharmaceutical sector in Tanzania (East Africa), esp. for you as key pharmaceutical personnel and for your company/ institution? 12. Which recommendations do you have for action medeor? Are there any services which you are missing or which should be improved? 13. Is there any other issue you want to raise?

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Annex 3.4 Interview guide for direct beneficiaries – pharmaceutical companies Header and introduction see Annex 3.1.

1. Which action medeor activities in Tanzania and East Africa are you familiar with or have you heard of or participated? 2. Could you please briefly describe the interlinkage with action medeor concerning your field of activity? 3. Which services of action medeor did you use so far? 4. Some of your staff attended action medeor training workshops on GMP and Quality Control already. Why did you send them for these trainings? 5. How do you assess the organization and quality of the workshops? 6. What were the benefits of the training for your staff and for the company? 7. Would you send your staff to further trainings offered by action medeor? Why/ why not? What would be the preconditions? 8. Which other organizations do you know that provide training for pharmaceutical staff in the East African Industry? How would you compare those trainings to the ones offered by action medeor? 9. What do you know about the newly established pharmaceutical teaching and development lab (Pharm R&D Lab) at MUHAS School of Pharmacy in Dar es Salaam? Would you consider outsourcing drug development (formulation) to this lab or renting the lab for your drug development? Why / why not? 10. What do you think are the main challenges in the pharmaceutical sector in Tanzania (East Africa), esp. for you as a manufacturing company? 11. Which recommendations do you have for action medeor? Are there any services which you are missing or which should be improved? 12. Is there any other issue you want to raise?

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Annex 4: Customer feedback questionnaire AMT (September 2009)

ACTION MEDEOR INTERNATIONAL HEALTHCARE TANZANIA CUSTOMER SATISFACTION SURVEY Action Medeor International Healthcare Tanzania, has been operating since August. 2005 We serve as a procurement and distribution unit for essential medicines and medical supplies. We would like to assess ourselves on the products and services that we render to our customers, therefore we are requesting you to fill, comment and suggest on the questionnaire provided and return to us. Do you know Action Medeor International Healthcare Tanzania, and the services it render? Yes

No

Have you ever purchased from Action Medeor International Healthcare Tanzania Yes

No

If Not, What was the reason? Had no contact Had no order form Required item were not available Too expensive Other reasons, Please explain below ……………………………..…………………………………………………………………….. …………………………………………………………………………………………………… …………………………………………………………………………………………………… For how long have you been a customer of Action Medeor Tanzania? Less than one year

One to under two years

Three to under five years

Never

Please list the top three reasons you initially became a member of Action Medeor Tanzania in order of importance. i. ………………………………………………………………………………………………… ii. ………………………………………………………………………………………………… iii. …………………………………………………………………………………………………

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On a scale of 1 to 5 where 1 represents "Extremely satisfied" and 5 represents "Extremely Dissatisfied," how would you rate your level of satisfaction with Action Medeor Tanzania with regard to availability? Please circle or tick the response. 1

2

3

4

5

On a scale of 1 to 5 where 1 represents "Extremely satisfied" and 5 represents "Extremely Dissatisfied," how would you rate your level of satisfaction with Action Medeor Tanzania with regard to overall quality? 1

2

3

4

5

On a scale of 1 to 5 where 1 represents "Extremely satisfied" and 5 represents "Extremely Dissatisfied," how would you rate your level of satisfaction with Action Medeor Tanzania with regard to price? 1

2

3

4

5

Thinking about your most recent experience with Action Medeor Tanzania, on a scale of 1 to 5 where 1 represents "Extremely satisfied" and 5 represents "Extremely Dissatisfied," how would you rate your level of Customer care? 1

2

3

4

5

On a scale of 1 to 5 where 1 represents "Extremely satisfied" and 5 represents "Extremely Dissatisfied," how would you rate your level of overall satisfaction with Action Medeor Tanzania? how would you rate your level of satisfaction? 1

2

3

4

5

Why do you say that? What specifically are you satisfied or dissatisfied with Action Medeor Tanzania? Enter response below… …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… How likely are you to recommend Action Medeor Tanzania to a colleague? Would you say the chances are … 1 Excellent 2 Very Good 3 Good 4 Fair 5 Poor

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How likely are you to repurchase products and services from Action Medeor Tanzania? Would you say the chances are … 1 Excellent 2 Very Good 3 Good 4 Fair 5 Poor How would you rate the Action Medeor Tanzania team on being courteous? Would you say … 1 Excellent 2 Very Good 3 Good 4 Fair 5 Poor How would you rate Action Medeor Tanzania team on helpfulness, in other words, a willingness to assist you? Would you say … 1 Excellent 2 Very Good 3 Good 4 Fair 5 Poor Our records indicate that you were one of our esteemed customers who uses our services, and that you have decline your usage. Is this correct? Yes No Don't Know Is there anything specifically that Action Medeor Tanzania could have done differently to keep you as a customer and to make your service better? Please comment and suggest…. …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… Thank you.

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Annex 5: Workshop evaluation questionnaire

1. General information Programme title Duration You have been participating in the above-mentioned workshop. The organizers of the workshop are conducting an evaluation of the workshop with a view to improving similar training activities in the future. Your assistance in completing this questionnaire will be of great benefit for that purpose. Your answers to the questions will be treated on a confidential basis and will be for internal use only. You may also wish to extend your response beyond the space allocated in the questionnaire or provide supplementary material as relevant. 2. Impact on daily work routine yes

mostly yes

++

+

yes

mostly yes

++

+

can’t say 0

mostly not

no

-

--

can’t say 0

mostly not

no

-

--

Were the course’s topics and curriculum relevant to your work? Please name topics that were not covered, but would have been important for your work!

Can you apply your newly acquired skills to your work? If not, please give your reasons! please tick Do you have any concrete plans to implement your newly acquired skills?

Yes

no

Please explain these plans in brief!

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What support do you need for an efficient implementation? yes

mostly yes

++

+

can’t say 0

mostly not

no

-

--

Can you pass on your new expertise to colleagues and others in your working environment? If not, please give the reason. 3. Methodology / learning effect excellent

good

fairly good

could be improved

poor

++

+

0

-

--

How do you assess - the workshop’s methodology and teaching efficiency? - the quality of course materials (presentations, handouts)? - the balance between theory and practice? - the workshop’s overall duration? 4. Content / topics

Workshop specific 5. Tutors How do you assess

excellent

good

fairly good

could be improved

poor

++

+

0

-

--

excellent

good

fairly good

could be improved

poor

++

+

0

-

--

- technical qualification of the tutors? - co-operation and communication of the tutors?

6. Participants How do you assess - the group’s professional experience and skill levels? - the exchange of information and experience at group level? - the working atmosphere within the group?

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7. Achieved objectives The objective of the workshop was to familiarize participants with current standards and trends in GMP and QC. In your opinion, did the workshop achieve its objective as stated? (Please circle the appropriate answer) YES

NO

Please comment if you chose NO: 8. Organisation excellent

good

fairly good

could be improved

poor

++

+

0

-

--

How do you assess - the overall organisation of the event? - the location?

In your view, which materials or information were omitted? 9. Follow-up Which follow-up activities would you recommend?

10. Overall approval excellent

good

fairly good

could be improved

poor

++

+

0

-

--

What is your assessment of the training measure? please tick Would you recommend this course to others?

Yes

No

Further comments and suggestions for improvements Thank you!

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Annex 6: List of interviews conducted (February - March 2010) Interview no. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Interviewee (Description)

Category

German partner/donor Workshop participant Tz Workshop participant Kenya Regulator German partner/donor Regulator Manager pharm. company Tz Manager pharm. company Tz Workshop participant Tz FBO health centre urban FBO health centre urban Manufacturers Association / Manager pharm. Company Tz

Policy maker / partner Workshop participant Workshop participant Policy maker / partner Policy maker / partner Policy maker / partner Pharm. company Pharm. company Workshop participant AMT customer AMT customer Policy maker / partner / Pharm. Company

FBO dispensary rural FBO hospital rural FBO hospital rural FBO health centre urban FBO dispensary urban Manager pharm. company Kenya Workshop participant Kenya Manager pharm. company Kenya Workshop participant Kenya Drug Supply Organization (DSO) Workshop participant Kenya FBO umbrella organization/ network Workshop participant Kenya / Manager pharm. company Kenya MUHAS management MUHAS management Public hospital urban FBO umbrella organization/ network Drug Supply Organization (DSO) Public hospital urban

AMT customer AMT customer AMT customer AMT customer AMT customer Pharm. company Workshop participant Pharm. company Workshop participant Policy maker / partner Workshop participant Policy maker / partner Workshop participant / Pharm. Company Policy maker / partner Policy maker / partner AMT customer Policy maker / partner Policy maker / partner AMT customer

Table 14: Anonymized list of interviews conducted

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Annex 7: Implementation activities in pharmaceutical companies

Area (number of respondents) Training (5) Documentation, esp. SOPs (4)

Examples of implemented activities

“We came and we formed a class…even on weekends, they [the colleagues] had to come for trainings.” (Interview no.19, workshop participant Kenya) “And then about documentation I have held [training], all writing and this all, to my people, only QA. I just teach them about documentation, I have given training.” (Interview no. 21, workshop participant Kenya)

Validation (3)

“What we have implemented, like for validation we have really used a lot, like risk assessment - this format, we didn’t have it. So we have now put it in our validation documents.” (Interview no. 19, workshop participant Kenya)

Qualification (2)

“A training that was very practical for us, was “qualification of water purification plant”. And after that, we actually installed a water purification plant, and using the information that we got from Moshi, and also part of what WHO gives, and what FDA gives. We were able to qualify the water purification plant, starting from the design, the performance, and all the details that are required in qualification.” (Interview no. 25, workshop participant Kenya)

Risk assessment

“I have just realized, this organization I am working with, I need to carry out risk assessment. I have arranged training with my staff in the QC/QA. We were having several trainings on risk assessment, how to conduct risk assessment, before the production begins.” (Interview no. 23, workshop participant Kenya)

(2) Stability studies (2)

Trouble-shooting (1) Granulation & Coating (2)

Specific techniques (2)

“I learnt about the stability - stability profiling, stability analysis. That one - our products here [raw materials] don’t have an expiry date, so I am using that knowledge that I got from the training. We have already started that - stability testing, I have already put the SOPs in place. With time, maybe by next year, we will have at least enough data that will help us to proceed with everything. And at the end of the day, we will have a stability profile for our products. And then we have to set a retest date for products and also the expiration date of the final product.” (Interview no. 23, workshop participant Kenya) “… this area of trouble-shooting in tablets - this happens because of this, sticking happens because of that.. Nobody can cheat me now. In In-Process [Control], now if it is sticking, I can tell you now - here, you have a lot of water here, moisture..” (Interview no. 19, workshop participant Kenya) “..because also like the granulation, that spray-drying granulation, it is the system which we are also installing. Maybe, in a few months, we will also be adopting that technology. .. Actually, it is just in time. We are very glad, it is really an advantage for us, that we learnt all those things.” (Interview no. 19, workshop participant Kenya) “During one of the groupworks I learnt about the maintenance of the punch, how to keep the punch well from one use to the next one. And I have implemented it at our place. Because it was a challenge…” (Interview no. 3, workshop participant Kenya)

Table 15: Implementation activities by the workshop participants

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