The aim of the Initiative on Public-Private Partnerships ...announcementsfiles.cohred.org/gfhr_pub/assoc/s14819e/s14819e.pdf · Health Research, an independent international foundation

TING THE HEALALLEVIA TH CONSEQUENCES OF POVERTYBY ENHANCING PUBLIC-PRIVATE COLLABORATION

Impact of Public-PrivatePartnerships AddressingAccess to Pharmaceuticalsin Low Income Countries

Uganda Pilot Study

OPERATIONAL ISSUES OF HEALTHPUBLIC-PRIVATE PARTNERSHIPS

The aim of the Initiative on Public-Private Partnerships for Health is to increase the effectiveness of public-private collaboration, particularly by helping those seeking to develop health products,or to improve access to such products needed to fight neglected diseases and other health problems in developing countries.

Created in 2000 in Geneva, Switzerland, the Initiative on Public-Private Partnerships for Health is sponsored by the Bill and Melinda Gates Foundation, the Rockefeller Foundation and the World Bank. It operates under the aegis of the Global Forum for Health Research, an independent international foundation helping to correct the 10/90 gap in health research, from which it also receives support (www.globalforumhealth.org).

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couv. ok 9/12/03 19:26 Page 1

Impact of Public-Private Partnerships AddressingAccess to Pharmaceuticals in Low Income

Countries: Uganda Pilot Study

Karen CainesInstitute for Health Sector Development, London

Julie BataringayaHealth Consultant, Uganda

Louisiana LushLondon School of Hygiene and Tropical Medicine

Grace MurindwaMinistry of Health, Uganda

Hatib N’jieInstitute for Health Sector Development, London

and former WHO Representative to Uganda

ICC (Block G, 3rd Floor)Route de Pré-Bois 20P.O. Box 18261215 Geneva 15Switzerland

E-mail: [email protected]: www.ippph.org

Impact of Public-Private Partnerships Addressing Access to Pharmaceuticals inLow Income Countries: Uganda Pilot Studyby Karen Caines, Julie Bataringaya, Louisiana Lush, Grace Murindwa, and Hatib N’ jie

© Initiative on Public-Private Partnerships for Health, Global Forum for Health ResearchPublished by The Initiative on Public-Private Partnerships for Health,Global Forum for Health Research, October 2003ISBN 2-94 0286-10-8

The reproduction of this document is regulated in accordance with the provisions of Protocol 2 of theUniversal Copyright Convention. All rights are reserved by the Initiative on Public-Private Partnerships forHealth, Global Forum for Health Research. The document may be freely reviewed and abstracted, with theusual acknowledgement of source, but not for sale or for use in conjunction with commercial purposes.Requests for permission to reproduce or translate the report, in part or in full, should be addressed to theInitiative on Public-Private Partnerships for Health where information on any translations or reprints iscentralized (see address below).

The named authors alone are responsible for the views expressed in this publication.

The Initiative on Public-PrivatePartnerships for Health

Additional copies of this publication are available (at no charge) from:

IPPPH SECRETARIAT

Roy Widdus, Project ManagerArmelle Armstrong, Communications OfficerPamela Atiase, Administrative AssistantAlessandra Botta, Information Research SpecialistKarin Holm, Senior Programme OfficerOlive Nakakeeto, Research Assistant

Some of the information contained in the paper may be based on interviews, studies, research, literaturereview, professional advice and/or opinion; some information is supplied by third party sources. The authorhas used his/her best efforts to accurately interpret and report this information and to allow contributors toreview/correct/add when possible but cannot guarantee that the original information as supplied by othersis correct or complete, or that it was accurately portrayed. The author and IPPPH make no representationregarding the completeness, accuracy, up-to-dateness, or adequacy of the information or materials it contains.

Foreword by Roy Widdus, Ph.D.

Executive Summary 1

Abbreviations 4

1. Introduction 5

2. Health Challenges and the Health System in Uganda 8

3. Drug Access PPPs in Uganda for Four Tropical Diseases: Leprosy,

Lymphatic Filariasis, Onchocerciasis, and Sleeping Sickness 13

4. Drug Access PPPs in Uganda for HIV/AIDS 25

5. Pilot Testing the Study Protocol and Tools for Future Studies 37

Annexes

Annex 1 Pilot Study Protocol for Uganda, May 2003 41

Annex 2 Approach to Uganda Pilot Study Fieldwork: Selection of Districts 45

Annex 3 Acknowledgements and List of Interviewees 47

Annex 4 Ministry of Health Organization and Staffing for Study Programmes 50

Annex 5 National TB/Leprosy Control Programme (NTLP) 52

Annex 6 National Programme to Eliminate Lymphatic Filariasis (PELF) 58

Annex 7 National Onchocerciasis Control Programme (NOCP) 63

Annex 8 National Sleeping Sickness Control Programme 71

Annex 9 HIV/AIDS Drug Access Initiative (DAI) and the

Accelerated Access Initiative (AAI) 75

Annex 10 Viramune® Donation Programme 82

Annex 11 Diflucan® Partnership Programme 84

Annex 12 List of References 86

Annex 13 Generic Study Protocol and Materials for Future Studies 89

ContentsContentsContentsContentsContents

Tables

Table 1 Health indices for Uganda 8

Table 2(a) Tropical disease PPP programme objectives and performance(Global programmes) 14

Table 2(b) Tropical disease PPP programme objectives and performance(National programmes) 15

Table 3 Cycle of drug ordering, receipt and distribution: Uganda, May 2003 19

Table 4 Establishment of HIV/AIDS PPP programmes in Uganda 26

Table 5 Service delivery issues of HIV/AIDS PPP programmes in Uganda 28

Table 6 Number of patients on ARVs and costs in Uganda (1996-2001) 34

Table 7 Brand and generic ARVs available in Uganda 35

ForewordForewordForewordForewordForeword

byRoy Widdus, Ph.D.Project ManagerInitiative on Public-Private Partnerships for HealthGlobal Forum For Health Research

The Initiative on Public-Private Partnerships for Health (IPPPH) was established in 2000, in part todevelop a solid evidence base on public-private ‘partnerships’ for health so that the benefits of suchcollaboration for populations afflicted by poverty could be maximized and potential risks ameliorated.

IPPPH identified the need for the type of study described in this report in response to a range ofquestions being raised about ‘partnerships’ addressing drug access in low income countries that includeddonations or discounted pricing from pharmaceutical companies. Funding was provided by the UKDepartment for International Development (DFID) with supplementary support from the generalcontributors to IPPPH, namely, the Bill & Melinda Gates Foundation, The Rockefeller Foundation,and the World Bank.

The study design benefited from wide input, including staff of the World Health Organization and theStudy Advisory Committee. A team of consultants was selected with assistance from the Institute forHealth Sector Development, London, an organization specializing in evaluation of health systems issuesin developing countries. Ultimate approval of the study protocol rested necessarily with the IPPPH asthe agent responsible to the principal funder, DFID.

All members of the consultant team are independent of the pharmaceutical industry and IPPPH. Neitherof the national consultants had any programmatic or managerial responsibility for any of the programmesexamined; however, their knowledge of the Ugandan health system and key informants greatly benefitedthe study.

IPPPH is pleased to publish the consultant team’s report, in its entirety and without modification, as amajor contribution to understanding the actual impact at national and field level of these diversecollaborative ventures.

This study can stand alone but is part of an ongoing IPPPH programme of activities related to theoverall goal of assessing public-private collaboration to improve access to pharmaceuticals for thoseaffected by diseases associated with poverty. Additional, carefully designed studies in other selectedcountries, taking into account the suggestions of the consultant team, are desirable to broaden theevidence base on which ultimately to formulate suggestions for “good practices”.

IPPPH thanks the UK Department for International Development for its financial support, and theexcellent consultant team, particularly Karen Caines of the Institute for Health Sector Development,and Louisiana Lush of the London School of Hygiene and Tropical Medicine for their outstandingleadership of this study overall and of the HIV/AIDS component, respectively.

Special thanks must go to the many individuals in Uganda who gave generously of their time to theconsultant team. We trust the insights of the study, especially into areas needing more external technicaland financial assistance, will prove useful to them, as well as the broader international community.

IMPACT OF PPPs ADDRESSING ACCESS TO PHARMACEUTICALS IN LOW INCOME COUNTRIES: UGANDA PILOT STUDY 1

The UK Department for InternationalDevelopment (DFID) funded the Initiative onPublic-Private Partnerships for Health (IPPPH)1

to conduct a pilot study in Uganda to assess thehealth and health systems impact of public-privatepartnerships (PPPs) for improving access topharmaceuticals in relation to leprosy, lymphaticfilariasis, onchocerciasis, sleeping sickness, andHIV/AIDS. The specific remit was to examineissues of ownership, integration, coordination,implementation and impact, with a particular focuson the unique strengths and problems of theseaccess PPPs as distinct from other comparableprogrammes where drugs are competitivelyprocured.

Given its time and resource limitations, this was arapid and largely qualitative study making extensiveuse of semi-structured interviews with keyinformants at national and district levels. Fieldworkvisits were made to five districts in Uganda –Hoima, Kampala, Katakwi, Masaka and Soroti –selected on the basis of active implementation ofthe PPP programmes, ensuring that eachprogramme was visited in at least one district;regional and socio-economic representation; andsecurity and accessibility within the timescale of thestudy. All members of the study team areindependent of the Initiative on Public-PrivatePartnerships for Health and the pharmaceuticalindustry.

Tropical disease drug access PPPs andTropical disease drug access PPPs andTropical disease drug access PPPs andTropical disease drug access PPPs andTropical disease drug access PPPs andnational programmesnational programmesnational programmesnational programmesnational programmes

• Drug donation partnerships are perceived asproviding real benefit to the Ugandan nationalprogrammes for leprosy, lymphatic filariasis,

onchocerciasis and sleeping sickness, all of whichare serious public health problems in thosedistricts in which they are endemic. The major,widely appreciated benefit is the assurance of asustained and consistent supply of free, high-quality drugs with no unreasonableconditionalities.

• In most though not all cases, the national diseaseelimination programmes have been kick-startedor revitalised by the drug donations plus thebroader WHO-led partnerships. There isnonetheless a strong sense of national ownershipof the programmes, and an excellent fit betweenthe PPP objectives and priorities and plans inUganda. Onchocerciasis and leprosy are includedin the National Minimum Health Care Package,while sleeping sickness and filariasis aredesignated district-specific priorities. All qualifyfor funding from the Primary Health CareConditional Grant. The study team found noevidence of any skewing of national or districtpriorities, nor of unhelpful diversion of humanand financial resources at central, district orcommunity levels.

• National programme managers relate mainly tothe WHO-led global partnerships of which thedrug donation programmes are part, and havehad little if any direct interaction withpharmaceutical companies, except for TheMectizan® Donation Programme. They perceive(rightly or wrongly) greater pharmaceuticalcompany interest in research for neglecteddiseases like sleeping sickness, and welcomeevidence of a willingness to invest in packagingand formulations more appropriate to localhealth system needs.

• Three of the four programmes are alreadyproviding nationwide coverage of endemic areas,subject only to problems caused by recurrentinsecurity in some districts; the fourthprogramme (lymphatic filariasis) was launchedonly in 2002.

Executive Summary

1 An Initiative operating under the legal auspices of the GlobalForum for Health Research, an independent, internationalfoundation created under the Swiss legal code.

2 INITIATIVE ON PUBLIC-PRIVATE PARTNERSHIPS FOR HEALTH (IPPPH)

• Considerable health impact has been achievedby the mature programmes. In the absence ofroutine socio-economic data on the clients, it isassumed in Uganda that these programmesbenefit the poor particularly, because the drugsare provided free in unlimited amounts andbecause these diseases afflict the poor inparticular (subsistence farmers, herdsmen orfishing communities resident in remote areas andthose in the urban fringes, where the diseasevectors are a part of the habitat and wheresusceptibility is exacerbated by poor sanitary andenvironmental conditions, overcrowded housing,and poor access to social services includinghealth).

• Support for operations as well as assured drugsupplies will be critical in the maintenance, aswell as the intensive, phase of these eliminationprogrammes. The onchocerciasis and leprosyprogrammes are making encouraging movestowards sustainability. However, the ability ofUganda to take on the burden of theseprogrammes has to be seen in the context of ashortfall in funding, notable a resource envelope(excluding private spending) of US$9 per capitaper year compared with an estimated US$28 percapita per year required for delivering thegovernment’s National Minimum Health CarePackage.

• Better coordination across these programmes andgreater integration within the district healthsystems is desirable. The study found no evidenceto suggest that these issues were affected by theinvolvement of a pharmaceutical donor ascompared with any other donor and noted thatseveral of the global PPPs of which they are partpositively encourage integration. Comparisonwith the Schistosomiasis Control Initiative,which provides funding rather than drugs,suggests few substantive differences in the rathervertical operation of the programmes. Any moveto distribute drugs from donation programmesto districts through the National Medical Storesshould wait until its current operational changeshave bedded down.

HIV/AIDS drug access PPPsHIV/AIDS drug access PPPsHIV/AIDS drug access PPPsHIV/AIDS drug access PPPsHIV/AIDS drug access PPPs

• The Drug Access Initiative (DAI) reduced pricesof branded medicines and catalysed the trainingof health workers, accreditation of facilities anddevelopment of secure drug distribution systems.The Accelerated Access Initiative (AAI) has

continued to provide access to cheaper brandedmedicines but its profile in Uganda is low.

• However, the DAI raised expectations aboutdrug access which it was unable to meet. Thereduced prices it did achieve were still too highfor the vast majority of people and its impactwas low. Further price reductions wereattributable more to the introduction of genericdrugs into the Ugandan market than to the DAI.

• The policy environment for ARVs remainsinsecure – MOH officials have not yetparticipated in regulating pharmaceutical marketsfor these drugs. Neither have they played astrong role in developing an intellectual propertyregime which will protect public health byensuring the ongoing availability of genericmedicines.

• The Viramune® Donation Programmeenhanced the availability of a much needed drugand stimulated prevention of mother to childtransmission (PMTCT) expansion. The initiativewas welcomed by policy makers and providers,and the involvement of the pharmaceuticalcompany in management of the programmewithin the Ugandan health system was minimal.

• The programme could be scaled up more rapidlybut, although the drug is free, infrastructure anda wide range of services are required. It has thepotential to be better integrated into existingdrug distribution systems, provided their securitymeasures against diversion improve.

• As for Viramune®, the Diflucan® PartnershipProgramme is much appreciated by those in thefront line of providing HIV/AIDS care. Theprogramme specifically targets the poor andassures unlimited supplies of a quality brandedmedicine for an unlimited time.

• While Diflucan® distribution is alreadyintegrated into the National Medical Stores/district system, security problems have createdconfusion and delayed regular access to the drug.

Future StudiesFuture StudiesFuture StudiesFuture StudiesFuture Studies

• If there is to be another full-fledged study onthe Uganda model, the country should beselected carefully as a contrast to Uganda in termsof national organisational capacity and the extentof the role of ‘big pharma’ in country in thetropical disease programmes. Any such studywould also benefit from an extension to


examining the role of the WHO-led globalpartnerships.

• There is scope for further examination of therole of pharmaceutical companies in the marketfor high value, AIDS-related drugs, pricing andprocurement issues, security of drugmanagement, and equity in access to treatmentand care.


AAI Accelerated Access InitiativeAPOC African Onchocerciasis Control ProgrammeART Antiretroviral therapyARV AntiretroviralAZT Azidothymidine; generic name, Zidovudine; brand name, Retrovir®CDD Community drug distributorCDT Community-directed treatmentDAI Drug Access InitiativeDDHS District Director of Health ServicesDFID UK Department for International DevelopmentGAEL Global Alliance to Eliminate LeprosyGAELF Global Alliance to Eliminate Lymphatic FilariasisGAVI Global Alliance for Vaccines and ImmunizationGFATM Global Fund to Fight AIDS, TB and MalariaGoU Government of UgandaGSK GlaxoSmithKlineHAI Health Action InternationalHMIS Health Management Information SystemHPAC Health Policy Advisory CommitteeHSSP Health Sector Strategic PlanIPPPH Initiative on Public-Private Partnerships for HealthJCRC Joint Clinical Research CentreJMS Joint Medical StoresLF Lymphatic FilariasisMAP Multicountry AIDS ProjectMAUL Medical Access Uganda LtdMDA Mass drug administrationMDP Mectizan® Donation ProgrammeMDT Multi-drug therapyMEC Mectizan® Expert CommitteeMoH Ministry of HealthMoU Memorandum of UnderstandingNACP National AIDS Control ProgrammeNGDO Non-governmental Development OrganizationNGO Non-governmental OrganisationNMS National Medical StoresNOCP National Onchocerciasis Control ProgrammeNOTF National Onchocerciasis Task ForceNTLP National TB/Leprosy ProgrammeOCP Onchocerciasis Control ProgrammePAF Ugandan national Poverty Action FundPELF Programme to Eliminate Lymphatic FilariasisPLWHA People living with HIV/AIDSPMTCT Prevention of mother-to-child transmissionPPP Public-private partnershipSCI Schistosomiasis Control InitiativeSSA Sleeping Sickness AssistantSWAp Sector-wide approachTDR Special Programme for Research and Training in Tropical DiseasesUNMHCP Ugandan National Minimum Heath Care Package

Abbreviations


BackgroundBackgroundBackgroundBackgroundBackground

In a vicious cycle, poverty is a major cause of healthinequity in developing countries, and ill-healthperpetuates poverty. Many health problems amongpopulations disadvantaged by poverty have beenneglected because of lack of commercial incentivesor have proven intractable when tackled by thepublic sector or NGOs independently.

In recent years, a number of public-privatepartnerships (PPPs), usually targeted on specificproducts, diseases or technologies, have arisen totackle particular health problems. One group ofPPPs addresses access to pharmaceuticals critical totreatment or care for diseases disproportionately oruniquely affecting the poor in developing countries.This category of partnerships for drug access isusually based around the provision of products thatare donated or heavily discounted (usually a ‘solesource’). They entail a multi-partner effort at fieldlevel to ensure the distribution and proper use ofthe medications.

These drug ‘access partnerships’ are in manyinstances the only initiatives likely to be mountedfor some diseases, especially those that do not risehigh on the political visibility scale (e.g. lymphaticfilariasis, trachoma and sleeping sickness) ascompared with HIV/AIDS, tuberculosis, andmalaria which have attracted global attention.

However, they have given rise to a number ofquestions, mostly relating to their integration with,

and impact upon, the broader development ofhealth services in countries in which they operate.Other questions concern the feasibility of takingsuch initiatives to scale, and their sustainability. Thisrange of questions becomes of greater importanceas the number of targeted partnerships in individualcountries increases and as countries attempt toimplement broader approaches such as debt relief,sector-wide approaches (SWAPs) in health, andmulti-sectoral Poverty Reduction Strategies (PRSs).

Through evaluating national impacts of existingpublic-private partnerships for drug access in anumber of countries, it should ultimately bepossible to develop good practices for suchinitiatives to maximize health benefits for the poorand minimize unintended negative consequences.The presumption was that this would probablyrequire studies across a range of access partnershipsand countries.

The pilot studyThe pilot studyThe pilot studyThe pilot studyThe pilot study

The UK Department for InternationalDevelopment (DFID) funded the Initiative onPublic-Private Partnerships for Health (IPPPH),part of the Global Forum for Health Research, toconduct a pilot study in Uganda in preparation fora larger study or studies. This study can stand alonebut is part of an ongoing IPPPH programme ofactivities related to the overall goal of assessingpublic-private collaboration to improve access topharmaceuticals for those disadvantaged by poverty.

1. Introduction

Pilot Study Terms of Reference

To assess the health and health systems impact in Uganda of public-private partnerships for improvingaccess to pharmaceuticals in relation to leprosy, lymphatic filariasis, onchocerciasis, sleeping sickness,and HIV/AIDS.

Specifically, to examine issues of ownership, integration, coordination, implementation and impact,with a particular focus on the unique strengths and problems of these access PPPs as distinct from othercomparable programmes where drugs are competitively procured.


Key issues for examination have included:Key issues for examination have included:Key issues for examination have included:Key issues for examination have included:Key issues for examination have included:

• the respective roles of PPP programme partners,governments and local interests in developingprogramme proposals, decision-making,conditionalities and governance;

• the fit between the programme and national/localpriorities and plans or individual needs;

• the extent of the PPP programme’s integrationwith national disease programmes and broaderhealth planning, and identification of the specificbenefits and challenges, if any, arising from theinvolvement of the private sector in disease-specific PPPs;

• the programme’s involvement in, and theeffectiveness of, coordinating mechanisms(formal and informal) with other PPPs;

• views on the optimal scale of the programme’soperations within the country, and any plans fortaking the programme to scale and for longer-term sustainability;

• the impact of inclusion in the PPP programmedesign of efforts specifically to reach poorerpopulations, women and children, andmeasurement of coverage by socio-economicstatus, rural/urban mix, gender and age;

• the inclusion in PPP programme design of aspecific objective to strengthen health systems,and the outcome to date.

ObjectivesObjectivesObjectivesObjectivesObjectives

The objectives of this study were to:

• pilot test a study protocol and researchinstruments addressing critical benefit and healthsystem impact questions in preparation for alarger study or studies;

• identify issues unique to drug access PPPs inUganda that include the involvement ofpharmaceutical companies at some stage ofdecision-making and/or implementation.

MethodMethodMethodMethodMethod

Details of the study approach are given in SectionV of this report. The study was overseen by a StudyAdvisory Committee and the country fieldwork wasundertaken in Uganda from 5-23 May 2003 by twonational and three international consultants:

• Karen Caines (study team leader), Institute forHealth Sector Development, London

• Julie Bataringaya, Health Consultant, Uganda(from 1 June 2003 employed by WHO)

• Louisiana Lush, London School of Hygieneand Tropical Medicine, London

• Grace Murindwa, Ugandan Ministry of Health

• Hatib N’jie, Institute for Health SectorDevelopment, London and former WHORepresentative to Uganda

All members of the study team are independent ofthe Initiative on Public-Private Partnerships forHealth and the pharmaceutical industry. Neitherof the national consultants has had programmaticor managerial responsibility for any of theprogrammes examined in the study, which benefited- particularly given the tight timescale - from theirdetailed knowledge of the health system and keyinformants.

It was recognised in the terms of reference that thestudy would not be able to examine all relevantpartnerships in Uganda in the detail ideally desirablenor encompass community focus group work, giventiming and budgetary limitations on the study.These restrictions precluded live data-gathering inthe field. In line with the views of a technicalconsultation meeting held in January 2003 to adviseon study design, this was a rapid and largelyqualitative study making extensive use of semi-structured interviews with key informants.

Fieldwork visits were made to five districts inUganda – Hoima, Kampala, Katakwi, Masaka andSoroti – selected on the basis of activeimplementation of the PPP programmes, ensuringthat each programme was visited in at least onedistrict;regional and socio-economic repre-sentation; and security and accessibility within thetimescale of the study.

AcknowledgementsAcknowledgementsAcknowledgementsAcknowledgementsAcknowledgements

The study team is greatly indebted to all those inUganda who gave so much of their time and energyto provide key information and thoughtfulcommentary on the study issues. We are the moregrateful, given the many other demands oninterviewees during the period of the study. We areparticularly appreciative of the contributions - andkindly patience - of Professor Omaswa and hiscolleagues in the Ministry of Health on whom wenecessarily relied for much of the substantive datareflected in this report.


We acknowledge with thanks that we havethroughout, (and particularly in Section II on theHealth Challenges and Health System in Uganda),drawn heavily on a series of key governmentdocuments including the Ugandan National HealthPolicy, the Health Financing Strategy, the HealthSector Strategic Plan and the very timely report ofthe latter’s Mid-term Review.


The country contextThe country contextThe country contextThe country contextThe country context

Socio-economic characteristics

Uganda has a population of almost 25 million, withan average population growth rate of 3.5%.Approximately 11.3% of the country’s populationis resident in urban centres2.

From 1992-1997, the country achieved markedeconomic growth of an average of 6.5% per annumwith per capita income estimated at US$ 330 overthe period (MoFPED, 1997) along with single-digit inflation. Private sector investment increasedfrom 8.6% of GDP in 1992/93 to 14.6% of GDPin 2001/02. Despite these economic achievements,household incomes have remained low, thoughthere has been an overall reduction in the level ofabsolute poverty from 66.3% in 1994/95 to 35%in 2000. Poverty continues to be a ruralphenomenon, with 96% of the poor living in ruralareas in 2000, and regional concentrations in thenorth and east (MoFPED, 2001). In the North,poverty rose by 8% between 1997 and 2000,leaving two-thirds of its population below thepoverty line. Poverty is recognized to be the mainunderlying cause of the poor health situation within

Uganda. Associated factors are the low level ofliteracy, high prevalence of communicable diseases,emergence of lifestyle diseases, inadequate provisionand inequitable distribution of social services andamenities, protracted civil unrest in the North andWest of the country resulting in mass movementof populations, and underdevelopment of serviceinfrastructure3.

Epidemiological informationEpidemiological informationEpidemiological informationEpidemiological informationEpidemiological information

The leading causes of morbidity and mortality inUganda are mainly communicable diseases.According to the Uganda Burden of Disease study(MoH 1995), over 75% of the life years lost dueto premature deaths were from ten preventablediseases. Perinatal and maternal conditions(20.4%), malaria (15.4%), acute respiratoryinfections (10.5%), HIV/AIDS (9.1%) anddiarrhoea (8.4%) together account for over 60%of the total disease burden. There has also been amarked upsurge in non-communicable diseasesincluding hypertension, diabetes and cancer, mentalillness and chronic degenerative cardiovasculardiseases.

2. Health Challenges and the HealthSystem in Uganda

Table 1: Health indices for Uganda

Source: Uganda Demographic and Health Surveys 1995, 2000-2001

2 Population Census 2002, Uganda Bureau of Statistics.3 National Health Policy, Ministry of Health, Uganda,

September 1999.

1995 2000-2001

Life expectancy (at birth) 52 47

Infant Mortality Rate (IMR) 81 88

Under 5 Mortality Rate 147 152

Maternal Mortality Ratio (MMR) 506 505

Total Fertility Rate (TFR) 6.9 6.9

Contraceptive Prevalence Rate (CPR) 15 25

Access to safe water 48% 51.8%

IMPACT OF PPPS ADDRESSING ACCESS TO PHARMACEUTICALS IN LOW INCOME COUNTRIES: UGANDA PILOT STUDY 9

The health system in UgandaThe health system in UgandaThe health system in UgandaThe health system in UgandaThe health system in Uganda

During the 1970’s and early 1980’s, militarydictatorship, economic crisis and brain drain leftthe health sector depleted and disorganized. WhenUganda emerged from conflict in 1986, there werevast needs for basic services in all sectors, especiallyeducation and health. In the absence of a coherenthealth policy, a proliferation of international andnational agencies and NGOs developed healthprojects outside the government system. Ugandahas since introduced reforms and policies targetingimprovement in economic performance, publicsector performance in general and health sectorperformance through increased efficiency andeffectiveness in the delivery of health services.

Politico-administrative and health systemstructure

Uganda currently consists of 56 districts, withfurther subdivision into 167 counties, 930 sub-counties, 4,517 parishes and 39,692 villages.Delivery of social services has been decentralisedfrom central government to districts. Both theConstitution of the Republic of Uganda (1995)and the Local Governments Act (1997) spell outthe roles and responsibilities of the centre and thedistrict. Key functions for the Ministry of Health(MoH) include policy formulation, settingstandards, and quality assurance; resourcemobilization; capacity development and technicalsupport; provision of nationally coordinatedservices, e.g. epidemic control; co-ordination ofhealth research; monitoring and evaluation of theoverall sector performance. District health careresponsibilities include implementation of theNational Health Policy; planning and managementof district services; provision of disease prevention,health promotion, curative and rehabilitativeser vices; vector control and control ofcommunicable diseases; health education; ensuringprovision of safe water and sanitation; and healthdata issues.

In the National Health Policy (1999), theresponsibility for delivery of health services wastransferred from the district to health sub-district –a near self-contained service zone that brings basichealth care, including essential referral services,closer to the community but is not in itself asubstantive new administrative unit.

National Health Policy, Health Sector StrategicPlan and the UNMHCP

Accelerating the improvement of the health of thepopulation is one of the key pillars of theGovernment’s Poverty Eradication Action Plan(PEAP). A National Health Policy (1999) and aHealth Sector Strategic Plan (HSSP, 2000/01 –2004/05) with a specific development goal weredeveloped as a collaborative undertaking of theGovernment of Uganda (Ministry of Health andrelated ministries), development partners and otherstakeholders. A primary theme of the NationalHealth Policy is greater equity, with specialconsideration for the welfare of the poor, the mostvulnerable and the most disadvantaged. With 100females for every 96 males in the population, it alsostresses the need to mainstream genderconsiderations in the planning and implementationof all health programmes.

Among the more fundamental approachesintroduced by the HSSP are the adoption of asector-wide approach in health, introduction of theUganda National Minimum Health Care Package(UNMHCP) for all (again with emphasis on poorpeople, women and children), furtherdecentralisation of health service delivery to thehealth sub-districts, and strengthened collaborationwith the private sector.

In August 2000, the Government of Uganda(GoU) and its Development partners in the healthsector signed a Memorandum of Understanding(MoU) to guide the implementation of the HSSPthrough a SWAp. Currently nine donors (UK,Ireland, EU, Norway, Sweden, Belgium,Netherlands, World Bank, DANIDA) in the healthsector have moved to some degree of budgetsupport through the Ministry of Finance, Planningand Economic Development (MoFPED).

The Uganda National Minimum Health CarePackage (UNMHCP), one of the HSSP’s fiveprogramme outputs, consists of interventions thatare demonstrably cost effective and have the largestimpact on reducing mortality and morbidity. It wasdesigned4 to be implemented countrywide anddelivered in an integrated manner at all levels ofthe health care system. An important factor for thiscurrent study is that the package includes control

4 UNMHCP designed using data from Burden of Disease andCost Effective Study (1995), the Uganda Participatory PovertyAssessment Project (UPPAP 1998) and analysis of Ministryof Health HMIS.


of communicable diseases such as STD/HIV/AIDS, and interventions against diseases targetedfor elimination as a public health problem, such asonchocerciasis and leprosy. The HSSP also makesclear that districts have the flexibility to add district-specific priorities not in the national minimumpackage, citing sleeping sickness, bilharzia(schistosomiasis) and filarial hydrocele of the testisas examples.

The Mid-term Review Report of the HSSP in April20035 raised an issue about assuring effectivedelivery of the minimum package, withoutreintroducing verticality. It described one constraintas that some Ministry of Health programmes werenot able to separate the roles of facilitator,(appropriate to the national level), and implementer(appropriate to the district level) and thereforecontinued to undertake activities that rightfullybelong to the district or health sub-district levels.Resources provided by the Global Fund to FightAIDS, TB, and Malaria (GFATM) and GAVI wereseen as exacerbating the problem by encouragingthe maintenance of vertical service delivery systems.The tropical disease programmes examined in thisstudy have traditionally been managed in a verticalway.

The Mid-term Review also noted that the improvedpolicy environment provided by the NationalHealth Policy and HSSP, the increase in the healthresource envelope and the abolition of user chargesin March 2001 have all contributed to significantgrowth in the utilisation of primary care services,particularly by the poor. However, it highlightedthe mismatch between the aspirations of the HSSPand available resources, a shortage of trainedpersonnel, an inadequate network of functionalhealth infrastructure and serious shortages in drugsupply. Physical access to a health facility remainslow, with an estimated 57% of the population livingwithin a 5 km radius of an existing facility. Only42% of approved posts are filled by qualified staff,with a consequent impact on quality of service. TheReview suggests that reports of a massive rise inoutpatient attendance following abolition of userfees, and the high level of priority given by ruralcommunities to health centre construction underthe highly discretionary Local GovernmentDevelopment Programme, are indicative of largeunmet needs for basic health care services.

The private sector (NGOs, private practitioners andtraditional medicine practitioners) already plays avery significant role in health care in Uganda.Strengthening collaboration and partnershipbetween the public and private sectors in health toaccelerate health care coverage is a key principle ofthe National Health Policy. GoU financial supportto this sub-sector jumped from Ug Shs 1.0 billionin FY 1997/98 to Ug Shs 16.5 billion in FY 2002/03.

Funding for the health sectorFunding for the health sectorFunding for the health sectorFunding for the health sectorFunding for the health sector

In 1998 the Government of Uganda was granteddebt relief from donor countries and multilateralagencies under the Highly Indebted Poor Countries(HIPC) initiative. A Poverty Action Fund was setup to mobilize and channel additional fundstowards the key sectors, including health, identifiedin the Government’s Poverty Eradication Actionplan (PEAP).

Current Government expenditure on health isapprox. 9.6% (excluding projects, 12.6% includingprojects) of total Government expenditure andabout 0.8% of Gross National Product (MoFPED,2002). The sector has benefited from budgetgrowth averaging 9% per annum from 2000/01 to2002/03. Even so, the resource envelope (excludingprivate spending) is only US$9 per capita comparedwith the estimated minimum of US$28 per capita6

required for delivering the UNMHCP. The lowlevel of health sector funding poses major challengesfor government in achieving a more balancedallocation of the health budget – for example, inrelation to HIV/AIDS, malaria, and reproductivehealth versus the tropical diseases which are endemicin only parts of the country but are there the causeof serious problems. As an act of policy, theproportion of the overall sector budget directlyallocated for district services, (including not forprofit providers), has increased from 32% in 1999/2000 to 54% in 2003/04 at the expense of thecentral MOH and referral hospitals.

The Global Fund to Fight AIDS, TB, and Malaria(GFATM) will provide additional funding up to atotal of US$97.7 million dollars over three years.This funding will be split between the GoU budgetand a project funding mechanism, and utilised byboth public and private entities at central anddistrict levels. Of the total sum available, US$36.3

5 Health Sector Strategic Plan 2000/01-2004/05 Mid-term ReviewReport, April 2003, Ministry of Health, Uganda.

6 The Health Financing Strategy, Ministry of Health, Uganda,2002.

IMPACT OF PPPS ADDRESSING ACCESS TO PHARMACEUTICALS IN LOW INCOME COUNTRIES: UGANDA PILOT STUDY 11

million dollars has been confirmed for a project tofinance the first two years of the implementationof Uganda’s Comprehensive programme for ScalingUp the National Response to HIV/AIDS. A thirdyear HIV/AIDS tranche of US$15.6 million willbe disbursed dependent on results.

The shift from project mode to SWAps and budgetsupport, the longer time horizons of commitmentsfor external support and the global initiativestargeting priority diseases - including previouslyneglected diseases – should help to promote greatersustainability.

Drugs policy, procurement andDrugs policy, procurement andDrugs policy, procurement andDrugs policy, procurement andDrugs policy, procurement andmanagementmanagementmanagementmanagementmanagement

Drugs policy and funding

The HSSP sets out to achieve a comprehensiveapproach to drugs and medical supplies, includingdrug policy development, coordinated selection andquantification of needs, procurement, storage anddistribution, rational drug use, cost recovery, qualitycontrol and drug regulation.

A new National Drug Policy was completed inOctober 2001 though it has yet to be endorsed,and a 5-year National Pharmaceutical SectorStrategic Plan 2002/3-2006/7 has been developedand costed. Funding for drugs and health supplieshas increased from less than US$ 0.8 per capita atthe start of the HSSP to US$1.2 per capita in FY2002/03, which still represents only one-third ofthe estimated requirement of US$3.5 per capita7

(excluding the pentavalent vaccine currentlydonated through GAVI and antiretrovirals(ARVs)). The Mid-term Review concludes that thisshortfall poses a serious threat to sustainedavailability of essential drugs and health supplies,and hence to the delivery of the UNMHCP.

Drug budgets have been decentralized, withguidelines to protect them at all service deliverylevels. However, demand for essential drugs farexceeds supply, not least because of the rapidincrease in service utilisation following the abolitionof cost sharing. Additional funding and a policyrecommendation to dedicate 50% of the non-wagebudget to essential drugs at the lower levels of carehave not been enough to stem high stock-out rateswhich compromise the quality of care8. Resources

for drugs (ARVs, antimalarials, anti-TB) have beenidentified from the World Bank’s Multi-countryAIDS Project (MAP) and the Global Fund to FightAIDS, TB, and Malaria (GFATM).

Drug regulation

There are two regulatory bodies in this sub-sector:the National Drug Authority and the PharmacyCouncil. The drug regulatory system is to bestrengthened through a new Uganda MedicinesControl Authority Bill.

Procurement, storage and distribution

Procurement has been decentralised to lineministries but the Mid-term Review findsweaknesses in unfilled posts in the MoHprocurement unit, undefined roles between variousinterested bodies, the lack of a comprehensiveprocurement plan for the Ministry, and conflictinglegislation, particularly in relation to the NationalMedical Stores (NMS).

The NMS was established with a mandate toprocure, store and distribute drugs and healthsupplies to the entire public sector in Uganda, withan emphasis on a social service rather thancommercially oriented role. While the expectationof social good has remained, it is no longerguaranteed business from the public sector andincreasingly operates in the market like any privatecompany. Parliament has currently suspended theprocess of privatization of the NMS initiated underthe government’s programme of divestiture ofpublic enterprises.

Despite some self-admitted operational difficultiesat the NMS and a need to improve its credibility9,the Mid-term Review finds that variousachievements in the procurement and managementof drugs can be attributed to the NMS’ improvedefficiency. It has introduced standard procurementprocedures in the interests of transparency,responsiveness to fluctuations in demand, andcustomer service. The organisation is currentlyhandling some substantial operational challenges,including the transition from a ‘push’ to a ‘pull’(order-based) supply system to districts,distribution to a multiplicity of health units and amajor IT upgrading.

There is an argument that ideally all drugs fromdonation programmes should be distributed

7 The Health Financing Strategy, Ministry of Health, Uganda,2002.

8 Drug Tracking Study, UPPAP2 report.

9 Note of Health Supplies Procurement Meeting 19 March 2003,Ministry of Health, Uganda, March 2003.


through the NMS system to promote integration,though there are divided views about this withinthe Ugandan Ministry of Health. Whatever thedecision of principle, the study team was advisedthat, as a matter of practicality, consideration ofsuch a move should be left until the new changesin NMS systems have bedded down.

During the study field visit, the NMS was thesubject of MOH and public attention over acontract with Landmark Pharmaceuticals (Uganda)Ltd, under which NMS would procure drugs,mainly antiretrovirals, and sell them to Landmarkwhich would be free to re-sell the drugs elsewhere.According to press reports, GlaxoSmithKline,which sells AIDS drugs to Uganda at subsidisedrates, warned the NMS against selling its productsfor re-export. The NMS maintained that discounteddrugs were not involved. In the event, the deal wasaborted after intervention by the Ministry of Health.

A well-regarded NGO, the Joint Medical Stores(JMS), supplies drugs to mission hospitals andother not for profit providers, plus to somegovernment centres. For example, it serves as thesecond supplier for government when the NMS isout of stock, though there is need for better linkagebetween the NMS and JMS over supply forecasts.The JMS has no distribution system and operateson a cash and carry basis.

In addition, a number of private for profitcompanies import and sell drugs for the privatemedical system, including branded ARVs. Agovernment health research institution specialisingin HIV/AIDS, the Joint Clinical Research Centre(JCRC), also imports drugs directly and has been amarket leader in importing generic ARVs. Otherhealth providers such as the Mildmay Centre andthe Masaka Healthcare Centre are currentlyconsidering importing generic drugs.


Scope of the studyScope of the studyScope of the studyScope of the studyScope of the study

Uganda benefits from public-private partnershipsfor improving access to pharmaceuticals inrelation to four tropical diseases: leprosy, lymphaticfilariasis, onchocerciasis and sleeping sickness. TheInternational Trachoma Initiative does not operatein Uganda.

In each case, the drug donation programmesestablished by the pharmaceutical companies areoperating within and/or alongside a wider disease-focused global partnership under the aegis of WHO.And again in each case, the Ministry of Health inUganda has established a national programme,albeit at varying stages of development. The keyobjective of this country level study has thereforebeen to assess the health and health systems impactof these four national tropical disease programmes,acting in partnership with the global drug accessPPPs. Given strong national ownership of thetropical disease programmes and the general lackof involvement and influence of pharmaceuticalcompanies on local implementation beyond thecrucial step of providing free drugs, it has notproved possible to assess the drug donationprogrammes in isolation at country level.

Since the terms of reference were to examine issuesof ownership, integration, coordination,implementation and impact, with a particular focuson the unique strengths and problems of theseaccess PPPs as distinct from other comparableprogrammes where drugs are competitivelyprocured, the study also examined one comparableprogramme – the Schistomiasis Control Initiative(SCI) - for which Uganda is currently providingthe global pilot. The Ugandan nationalschistosomiasis programme, which is combinedwith the programme for soil-transmitted helminths,has important similarities to the four studyprogrammes. It is tackling a vector borne diseaseendemic in some but not all districts of Uganda.There is a national programme, run from theMinistry of Health, and supported by an

international partnership. But the key distinctionfor this study is that “big pharma” is not involvedin the SCI, either in programme design or in drugdonation. In the case of schistosomiasis control,the global initiative is providing not drugs butfunding for national procurement of drugs, as wellas for training and operational support10.

MethodsMethodsMethodsMethodsMethods

For the four study programmes, members of thestudy team:

• analysed global, national and district programmestrategies, plans and reports, together with widerliterature;

• within the Ministry of Health, interviewed theDirector-General of Health Services, theCommissioner for National Disease Control/Secretary to GFATM Country CoordinatingMechanism, the Assistant Commissioner forVector-borne Diseases Control, the individualProgramme Managers, and Essential Drugspersonnel (see MOH organigram in Annex 4);

• interviewed a range of partners and stakeholders,including multilateral and bilateral agencies, andNGOs (see Annex 3);

• visited district level operations for eachprogramme:

— leprosy (Soroti District)

— lymphatic filariasis (Katakwi District)

— onchocerciasis (Hoima District)

— sleeping sickness (Soroti District)

— schistosomiasis (Hoima District).

3. Drug Access PPPs in Uganda for FourTropical Diseases: Leprosy, LymphaticFilariasis, Onchocerciasis and SleepingSickness

10 The Schistosomiasis Control Initiative (SCI) based atImperial College, London, is supported by a $29.8 millionaward from the Bill & Melinda Gates Foundation’s GlobalHealth Programme. A key objective is to encouragedevelopment of a sustainable schistosomiasis controlprogramme in Sub Saharan Africa.


Further details on district selection are given inAnnex 2.

Background information on theBackground information on theBackground information on theBackground information on theBackground information on theprogrammesprogrammesprogrammesprogrammesprogrammes

Detailed information on each of the four coretropical disease programmes studied is given in:

Annex 5 : National TB/Leprosy Control Programme

Annex 6 : National Programme to EliminateLymphatic Filariasis (PELF)

Table 2(a): Tropical disease PPP programme objectives and performanceTable 2(a): Tropical disease PPP programme objectives and performanceTable 2(a): Tropical disease PPP programme objectives and performanceTable 2(a): Tropical disease PPP programme objectives and performanceTable 2(a): Tropical disease PPP programme objectives and performance

Annex 7: National Onchocerciasis ControlProgramme (NOCP)

Annex 8: National Sleeping Sickness ControlProgramme

Table 2(a) below summarises the programmeobjectives and key conditionalities of the globalpublic-private partnerships.

Table 2(b) summarises the programme objectivesand current performance of the nationalpartnership programmes.

*Note: Merck and Co. announced in 1987 a commitment to donate as much Mectizan® as necessary to treat onchocerciasis to bring the diseaseunder control as a public health problem globally. In 1999 the donation was expanded to the treatment of lymphatic filariasis in Africancountries where onchocerciasis and lymphatic filariasis co-exist.

Global PPP programmesGlobal PPP programmesGlobal PPP programmesGlobal PPP programmesGlobal PPP programmes

COUNTRY:UGANDA

GLOBAL PPP PROGRAMME AND OBJECTIVE

DRUG DONATION

CONDITIONALITIES

LEPROSY

Global Alliance toEliminate Leprosy (GAEL)

Elimination by 2005by "ensuring that allpatients, wherever they may be, will have free and equalaccess to the mostmodern treatment available".

Novartis MDT free to all countries until end 2005.

Support likely to continue over the maintenance phase

Nothing unreasonable

LYMPHATIC FILARIASIS

Global Alliance toEliminate LF (GAELF)

Elimination by 2020

GSK Albendazoledonation

As above.

Mectizan® DonationProgramme

Objective is to ensureMectizan treatment isavailable to those inneed via community-based programmes.

i) GSK: all the albendazole required

ii) Merck/MDP: all theMectizan® required foras long as required*.

Appropriate use of thedrugs.

ONCHOCERCIASIS

African Programme forOnchocerciasis Control(APOC)

To bring the diseaseunder control as apublic health problemand socio-economicproblem throughoutAfrica. 12-year perspective.

Mectizan® DonationProgramme

Merck/MDP: all theMectizan® required for as long as required

Appropriate use of the drugs.

SLEEPING SICKNESS

WHO Programme toEliminate SleepingSickness (WPESS)

Elimination of sleepingsickness.

i) Aventis: pentamidine,melarsoprol, eflornithine - 5 years to 2006, plus funding.

ii) Bristol Myers Squibb: raw materials for 1 year eflornithinesupply, plus funding.

ii) Bayer: suramin, nifurtimox- 5 years to2007, plus funding.

Nothing unreasonable.


Table 2(b). Tropical disease PPP programme objectives and performanceTable 2(b). Tropical disease PPP programme objectives and performanceTable 2(b). Tropical disease PPP programme objectives and performanceTable 2(b). Tropical disease PPP programme objectives and performanceTable 2(b). Tropical disease PPP programme objectives and performance National programmes National programmes National programmes National programmes National programmes

COUNTRY:UGANDA

DISEASE A NATIONAL/DISTRICT HEALTHPRIORITY

NATIONAL PROGRAMME OBJECTIVE

CURRENT NATIONALPROGRAMME INITIATED

POPULATION AT RISK

NATIONAL PARTNERS

CURRENT NATIONALBUDGET CONTRIBUTION

CURRENT NATIONALCOVERAGE

PERFORMANCEAGAINST TARGETS

SUSTAINABILITY

NATIONAL TB/LEPROSY CONTROLPROGRAMME

YesIncluded in nationalhealth policy and plan,and in district healthplans.

Achieve and sustain elimination in all districts by 2005

1990

Total population, i.e. 25 million

MOH, districts, German Leprosy Relief Association(GLRA), faith-basedNGOs

GoU already meets operational costs for50% districts and 100% staff costs.

Total national coverage with MDT, and elimination at the national level, achieved 1994 and sustained to date.

2002 nat. prevalencerate of 0.4, against target of 1, per 10,000. 9 districts notachieved target.

Declining no. of casesand clinicians with relevant skills points to integratingdetection/treatment ingeneral district system.Integration plan developed; all districts mapped; sensitisation of districtsinitiated.

NATIONAL PROGRAMMETO ELIMINATELYMPHATIC FILARIASIS

YesCited in national healthplan, and included in district health plans.

Eliminate LF as a publichealth problem via CDT,and ultimately interrupttransmission

2002

Mapping underwayMay 2003.

MOH, districts, communities, WHO,GSK, Merck/MDP

GoU funding in 2002 foradvocacy meetings, drugtransportation andsupervisory visits.

2 pilot districts 2002.Planned scale up to 10in 2003 (4.2m people)subject to operationalfunding.

Treatment coverage of70% of total populationin 2 districts to date,against target of 80%

Achieving and sustainingfull scale coverage forthe 5 to 6 years necessary to interrupttransmission is whollydependent on an assured source offunding.MOH special request toMinistry of Finance forfunding for 2003 programme is pending.

NATIONALONCHOCERCIASISCONTROL PROGRAMME

YesIncluded in nationalhealth policy and plan,and in health plans ofaffected districts.

Develop sustainableCDTI in all endemicareas; eradicate vector in 2 main transmissionreservoirs.

1997

22/56 districts2 million people

MOH, districts, APOC,Merck/MDP, Global 2000River Blindness Program,Christophel BlindenMission, GTZ,Sight Savers Int'nal,

All staff salaries (except3 central support staff)and c.20% of non-drugoperational costs fromMoH budget and PHCconditional grant.

Target of 100% geographical coverage of endemic districtsachieved in 2001 andsustained.

NOCP target of 80%treatment coverage ofaffected communitiesbeing met. APOC targetof 85% by 2005.

Programme is in transition away fromAPOC operational support (limited to 5years per district). Phase1 districts already selfsustaining. Some laterphase districts includingCDTI in 2003/4 workplans. PHC conditionalgrant, district devt.grant, and NGO supportshould close the gap.Move to greater PHCintegration.

NATIONAL SLEEPINGSICKNESS CONTROLPROGRAMME

YesCited in national healthplan, and included in district health plans.

Establish sustainablecontrol, reduce incidence to


Key findingsKey findingsKey findingsKey findingsKey findings

Common characteristics

These four programmes share a number ofcommon characteristics:

• Elimination programmes: all are global and (withthe exception of sleeping sickness) nationalprogrammes to eliminate the disease as a publichealth problem, with some presumption of a timelimit for the most intensive activities.

• Free drug donations: in each case, the drugs arebeing donated free, not offered at discountedprices. In the case of onchocerciasis andlymphatic filariasis, the pharmaceuticalcompanies concerned (Merck & Co. andGlaxoSmithKline) have made a commitment tosupply as much as is needed, for as long as isneeded to achieve elimination. In the case ofleprosy and sleeping sickness, the companies(Novartis, Aventis and Bayer AG) have to dateput a time limit on free supplies though thereare indications that Novartis’ support for leprosyat least will be extended for the maintenancephase.

• Little direct interaction between government andpharmaceutical partners: for the Ugandangovernment, the prime interface is with WHOor WHO/APOC, as the secretariat for a globalor regional partnership, rather than with thepharmaceutical company direct except for theMectizan® Donation Programme’s more activiststance in visiting Uganda periodically. This lattermay stem from the fact that the MectizanDonation Programme was established in 1987and active in Uganda through NGDOs severalyears before APOC was established as theumbrella partnership for Africa. Overall,however, interviewees have had little, if any,interaction with pharmaceutical companypartners.

• Operational funding a prerequisite for a nationalprogramme: a key common finding is that thefree drug donation is necessary but not sufficientto initiate and support a full national eliminationprogramme for these kind of diseases in its activephase. Given Uganda’s limited resources, somesource of extra-government funding foroperational costs has also been required.

For example, despite the availability of freeMectizan® from 1987 and the development of two

national plans, a government-led, integratedUgandan National Onchocerciasis ControlProgramme (NOCP) was not implemented untilthe establishment of APOC in 1996 provided asource of technical and financial support. Similarly,notwithstanding the availability of free albendazoleand Mectizan® to treat lymphatic filariasis since1999, the Ugandan national Programme toEliminate Lymphatic Filariasis (PELF) waslaunched in two districts only in 2002 withsubstantial operational funding contributed byWHO and DFID.

By contrast, the National Leprosy ControlProgramme achieved national coverage ofmultidrug therapy (MDT) in 1994, and indeedelimination at a national level in that year, on thebasis of contributions from partners sufficient tofund both drugs and operations. The advent of thefree drug donation from Novartis in 1999 enabledthe programme to deploy more funds intooperational support, including at the centre.

National/district priorities and the healthSWAp

All four diseases are serious public health problemsin those districts of Uganda in which they areendemic. Ministry and district interviewees areadamant that, irrespective of drug donations, theprogrammes are clear national or district prioritiesincluded in key policy documents. At national level,the Uganda National Minimum Health CarePackage specifically includes diseases targeted forelimination such as onchocerciasis and leprosy. TheHealth Sector Strategic Plan (2000/2001-2004/2005) makes clear that districts have the flexibilityto add district-specific priorities such as sleepingsickness, bilharzia (schistosomiasis) and filarialhydrocele of the testis. In each district visited, therelevant programme was included in the districtplan.

The Health Sector Strategic Plan is beingimplemented through a Sector-wide Approach(SWAp). The MoU establishing the SWAppartnership calls for budget support as the preferredoption. In any event, the budget developmentprocess in Uganda requires that all funding for thesector (Government budget including donorbudget support and donor funding throughprojects) be included in the resource envelope foreach budget year. The allocations are made inaccordance with priorities agreed upon by thebroader partnership.


One of the implications of this arrangement is thatmany of Uganda’s health development partners nolonger directly support specific programmes suchas those tropical diseases programmes beingstudied. Nonetheless, the study programmes, as partof the jointly developed common developmentframework of the SWAp partnership – the HealthSector Strategic Plan, are of direct concern to thepartnership. All qualify for support from thePrimary Health Care Conditional Grant of theNational Poverty Action Fund, which is the mainconduit for channelling donor budget support andproceeds of debt relief arrangements such as HIPC1 and 2.

In order to reduce the high transaction costs of themultiple partnerships for the different nationalprogrammes, the SWAp operates through variousjoint government/partner structures such as theHealth Policy Advisory Committee (HPAC),Biannual Joint Review Missions, and JointTechnical Working Groups. Individual inter-agencycoordination committees for priority programmesreport periodically to HPAC and to the BasicPackage Working Group. Although none of thetropical disease programmes for this pilot studyfeature in the core set of indicators for the SWAp,they are included in the annual reporting by theMOH and are therefore subject to scrutiny byHPAC and the Joint Review Missions. Indeed,during the recent Mid-term Review of the HSSPcompleted in April 2003, many partners called forincreased attention to these eliminationprogrammes.

The study team’s conclusion is that, in relation tothese four tropical disease programmes, there is anexcellent fit between the PPP objectives and bothnational and local priorities and plans. One agencypartner told us “Rather than skewing governmentpriorities, [the donation programmes] enablegovernment to do what it would like to do”.

Ownership and governance

“Ownership of these programmes rests unequivocallywith the Ministry of Health. We are implementingthem. There is no issue about skewed priorities”, theDirector General of Health Services, UgandaMinistry of Health.

Against the background of the SWAp, intervieweesunanimously regarded governance of, and decision-making within, these programmes as a nationalmatter, accepting the need to comply with general

criteria for the global partnership programmes. Insome cases, there are specific governance bodies,for example, the Uganda Trypanosomiasis ControlCouncil and its Technical Committee, and theNational Onchocerciasis Task Force whosemembers are drawn from implementing partners.

In all cases, day to day programme managementrests firmly within the Ministry of Health (theDepartment of Community Health or theDepartment of National Disease Control) and thedistricts, operating within the guidelines of theglobal/regional partnerships. Given thedecentralised nature of the Uganda health system,Ministry and district officials undertake jointplanning and most of the activities are carried outby districts.

Most external interactions are with WHO as theleader of global or regional partnerships and thereis little direct contact with the drug donationcompanies. This marks a contrast with the newly-launched Schistosomiasis Control Initiative (SCI)where the global director, Dr Alan Fenwick, is atpresent very actively involved in working with theMinistry of Health programme manager. This isno doubt because Uganda is currently engaged inundertaking the pilot for the overall global SCIprogramme which aims to assist at least four sub-Saharan African countries to establish nationwideroutine control involving identifying districts withheavy infections, providing appropriate healtheducation, and procurement of the required drugs.SCI identifies local and international partners toprovide training, and then support the delivery ofthe drug. SCI itself will monitor the effect of theprogramme to demonstrate the impact thattreatment can achieve, in particular by recordingthe reduction in people with heavy infections, thereduction in symptoms, and improvement innutritional status.

For the four core tropical disease PPPs beingstudied, respondents in Uganda noted only onesubstantive example of national intentions beingamended after discussion with the globalpartnership. The Ministry of Health’s originalproposal to WHO and the Mectizan® DonationProgramme in 2000 was that their nationalProgramme to Eliminate Lymphatic Filariasis(PELF) should be launched in three districts(Soroti, Katakwi and Lira). The initial responsewas a recommendation to start MDA in only onedistrict but, after further exchanges with theMinistry and a country visit, it was mutually agreed


that the programme should be initiated in twodistricts (Katakwi and Lira).

There was no evidence or mention of unreasonableconditionalities specified for the drug donationprogrammes (eg in relation to scope of programme,drug indications, modes of operation or reporting).The nature of the reports for the drug donationprogrammes (as distinct from the globalprogrammes) was not seen as unduly onerous. Forexample, for the onchocerciasis programme, theMectizan® Donation Programme has a 3-pagereport with only one mandatory item, the reportingof serious adverse reactions, compared with anannual report to APOC of up to 40 pages. MOHprogramme managers felt strongly that, where theprogrammes were included in the HealthManagement Information System (HMIS), theroutine data provided were not sufficient for theirown programme management purposes.

Integration with national and districtsystems

At Ministry level, there is full integration of thefour PPP-supported programmes with customaryMOH systems for vector control programmes.However, it should be noted that for suchprogrammes, the MOH has typically operated inproject mode (eg in relation to financing,management, drug distribution and reporting). Asone example, vertical programmes of this kind donot at present advise the MOH’s Essential DrugsManagement personnel of drug supply figures. Asimilar vertical approach is taken to other MOHprogrammes such as TB and EPI, the latter – likethe National TB and Leprosy programme -havingits own store and distribution system, managed byEPI from the National Medical Stores site.

The SCI - which requires procurement activity, sincethe Initiative provides the funding for praziquantelrather than the drug itself - is using the NationalMedical Stores to handle procurement and storage.However, the districts then collect supplies for theMass Drug Administration from the Stores on theauthorisation of the MOH programme managerin the Vector Borne Diseases Control department;supplies are not sent out with the NMS districtdeliveries. Table 3 (next page) gives an overview ofthe cycle of drug ordering, receipt and distributionfor all the tropical disease programmes studied.

During our interviews, there were divided viewsabout the best approach in the future. Some central

managers of programmes being funded via theproject mode were reluctant to let go what they seeas their programmes and hence control of thebudget. They argued that control initiatives, whennew, need the intensive oversight provided byvertical programmes of this kind. There is a similarargument that the same detailed attention is neededwhen elimination programmes reach their final,often most challenging, stages.

Others, however, felt that sustainability requiredfull integration at all levels. For example, it wassuggested that the declining number both of leprosycases and of clinicians with the relevant skills totreat them, pointed to integrating detection andtreatment into the general district system with theappropriate training of those concerned. Thenational onchocerciasis task force is workingtowards stronger integration with the nationalprimary health care programme: ivermectin hasbeen incorporated in the current version of thenational essential drug list, and discussions aboutincluding onchocerciasis in the national HealthManagement Information System (HMIS) havebeen initiated.

So far as distributing all drugs from donationprogrammes through the National Medical Storesis concerned, section II has already noted thepressures currently facing that organisation and thegeneral advice that, as a matter of practicality,consideration of such a move should be left untilthe new changes in NMS systems have beddeddown.

Whatever the outcome, the key finding for thisstudy is that the issues of integration are no differentbecause these are programmes with pharmaceuticalcompany involvement rather than any other donor.On the contrary, the global PPP programmesgenerally advocate integration.

Impact

Health impactHealth impactHealth impactHealth impactHealth impactAs foreseen in advance of the country visit, it isdifficult to map the programme outcomes in aresource- and time-limited study of this kind. Forsuch information as is available, Table 2(b) , Tropicaldisease PPP programme objectives and performance:national programmes (page 15), summarisesperformance against targets and Annexes 5 to 8 onthe individual programmes give greater detail.

The health impact of the drug access PPPs asmediated by the national disease programmes varies


Table 3: Cycle of drug ordering, receipt and distribution: Uganda, May 2003Table 3: Cycle of drug ordering, receipt and distribution: Uganda, May 2003Table 3: Cycle of drug ordering, receipt and distribution: Uganda, May 2003Table 3: Cycle of drug ordering, receipt and distribution: Uganda, May 2003Table 3: Cycle of drug ordering, receipt and distribution: Uganda, May 2003

NOTF – National Onchocerciasis Task ForceSCI – Schistosomiasis Control InitiativeWR – WHO Country Representative

ABBREVIATIONSCDD - Community Drug DistributorCDT – Community-directed TreatmentDDHS –District Director Of Health ServicesMDP – Mectizan® Donation Programme

MEC - Mectizan® Expert CommitteeMOH – Ministry of HealthNMS – National Medical StoresNOCP – National Onchocerciasis Control Programme

COUNTRY:UGANDA

ESTIMATION OF DRUG REQUIREMENTS

APPLICATION PROCESS

ORDERS FOR DRUGS

RECEPTION OF DRUG IN COUNTRY

STORAGE

DISTRIBUTION TO DISTRICT LEVEL

DISTRIBUTION TO COMMUNITY LEVEL

DISTRIBUTION TO INDIVIDUALS

COMMUNITY INVOLVEMENTIN DECISIONS ON DISTRIBUTION AND CHOICE OF CDDS

LINKS WITH OTHER PROGRAMMES

LEPROSY

By programme manager based on returns of the previous year, and drug consumption.

By programme managerthrough WR to WHOHQ.

Annually by programmemanager through WR toWHO HQ.

WHO

MOH programme managerNTLP Stores.

Quarterly delivery tozonal stores; zonalsupervisors deliver toDDHS stores quarterly.

Patient collects monthlysupply from supervisinghealth unit duringmonthly visit to theunit.

Little if any choice at themoment.

Integrated leprosy/TB programme.

No linkage with other programmes.

LYMPHATIC FILARIASIS

By programme manager based on district populationestimates, (80% treatment coverage).

By programme managerthrough WR to WHO HQand MDP/MEC.

MOH programme manager through WR toWHO HQ and MDP.

WHO

MOH programme manager.

Collected from MOH programme manager byDDHS.

DDHS Office coordinatordelivers to CDTI commu-nity supervisors, whodistribute to each CDDin their area.

CDTI mass distributionor house to house,according to communitypreference.

Decision rests entirelywith each community.

Integrated CDT for oncho,schisto and intestinal helminths planned in 6 districts.

ONCHOCERCIASIS

By the national NOCPCoordinator based on the census of the communities at riskand drugs dispensed.

NOTF applies to MDP,for MECevaluation/approval.

NOTF secretariat to MDP which orders fromMerck.

WHO

MOH programme managerNOTF stores.

Collected from NOTF stores by DDHS.

District oncho coordinatordelivers to CDTI commu-nity supervisors, whodistributes to each CDDin their area.

CDTI mass distributionor house to house,according to communitypreference.

Decision rests entirelywith each community.

District Oncho coordinatorsare district focal point forvector borne diseases.Many CDDs involved inother health activities.Integrated CDT foroncho, schisto andintestinal helminthsplanned in 6 districts.

SLEEPING SICKNESS

By programme manager based on district estimates/returnsof the previous year.

By programme managerthrough WR to WHO HQReview Comittee.

MOH programme manager through WR toWHO HQ.

Drugs shipped by MSFFrance and collectedfrom airport by WHO.

MOH programme manager.

Collected from MOH programme manager byDDHS.

None.

Only as in-patients in designated treatmentcentres.

N/A

None except with related agriculture and veterinaryprojects.

SCHISTOSOMIASIS (SCI)

By national co-ordinatorbased on census of at risk communities, drugs dispensed & expansionplan.

Districts apply toVCD/SCI and through toSCI London.

With SCI London appro-val, VCD requests NMSto place an order.

National Medical Stores(NMS).

National Medical Stores.

DDHS collects from NMSwith authorisation fromNational Coordinator.(NB praziquantel maybe added to USAID'sDELIVER list).

Drugs are issued toteachers and selectedCDDs by DDHS andVCD district representatives.

By trained teachers andCDD (community wishesrespected).

Community leaders sensitized by trained trainers CDD selected bythe communities.

Integrated CDT for oncho,schisto and intestinal helminths planned in 6districts.


from programme to programme. The leprosyprogramme is long-standing and can point tosubstantial achievements, with national coverageand elimination at national level having beenachieved as long ago as 1994. However, thisantedates the 1999 Novartis free drug donationwhich is the subject of this study. With the assistanceof the Novartis donation, coverage has beenmaintained and the national prevalence rate ofleprosy reduced to 0.42 per 10,000 by the end of2001 down from 0.9 in 1994 and 17.7 in 1983. Itwas however still above the target of 1 per 10,000in nine of the then 39 districts in Uganda. Thedetection rate of new cases was 0.31 per 10,000 in2001, down from 0.37 and 0.42 for 2000 and 1999respectively. The treatment completion rate for bothtypes of leprosy was 69% in 2001, still below thenational target of at least 85%.The NationalOnchocerciasis Control Programme becameoperational in 1997 with support from theMectizan® Donation Programme and APOC,building on the significant coverage alreadyachieved by NGDOs, again with Mectizan®Donation Programme support. Total coverage ofthe communities at risk was achieved in 2001 andhas since been sustained. In 2002 the percentageof those eligible being treated annually in at riskcommunities ranged from 65% to 93%, with anational average of 80%. The target for 2005 isover 85%.

Pharmaceutical company drug donations forsleeping sickness have been available only since2001 (Aventis) and November 2002 (Bayer AG),though these were preceded by other partnerships,often district-based. Under the national plan torevitalise sleeping sickness control launched inUganda in 2001, services are now being providedto all 14 districts affected by the disease. The WestNile foci had been brought well under control suchthat in October 2002, MSF France were able towithdraw support to the Trypanosomiasis controlprogramme in that area. However, an increasingnumber of new cases is again being reported in theWest Nile (data from the follow-up surveillance byEpicentre are yet to be released).

The programmes for lymphatic filariasis andschistosomiasis have each been operating less thana year and are still building to scale so the impact isas yet relatively limited. To date, PELF has heldMDAs in only two districts where over 733,000people were treated. In Lira, some parts of thedistrict affected by insecurity were not covered.

Schistosomiasis and concurrent intestinal helminthtreatment is even more recent, having been launchedon March 4th 2003. During the first 6 monthspraziquantel and albendazole sufficient to treat300,000 children and high prevalence communitieswill be delivered to the 18 worst affected districts.By the end of May 2003, over 100,000 people hadbeen treated in 7 districts on Lake Albert and theNile (Adjumani, Arua, Hoima, Kibale, Lira, Moyo,and Nebbi).

Health systems impactHealth systems impactHealth systems impactHealth systems impactHealth systems impactAn implicit concern of the terms of reference forthis study was that drug access partnerships of thekind studied might have a deleterious impact onthe broader health system of participating countries.In the case of Uganda, interviewees at all levels wereadamant that the impact was beneficial. The studyteam found no evidence of any skewing of nationalor district priorities, nor a consequent unhelpfuldiversion of human and financial resources atcentral, district or community levels. While therewere some specific staff in central units, none ofthe districts visited needed to recruit additional staffto manage these tropical disease programmes. Staffin place there welcomed the fact that the availabilityof drugs and some operational funding had enabledthem to undertake their functions more effectively,and in many cases increased their credibility withthe communities they serve.

While the PPPHs share the wider difficulties ofprioritisation within an environment of severebudget constraints, the drug donation programmestend to act as stimulus for more equitable allocationsfor the affected communities from the alreadystrained budgets at both the centre and districts, solong as the diseases remain priority concerns.

Several interviewees noted the sheer value of theadditional resources brought to health. While it isdifficult to access estimates of the dollar value ofdrug donations by big pharma, they are clearlysubstantial. This must be seen for the greater partas additional funding that would not otherwise havecome to the sector. In some cases, the partnershipsprovide further finance for operations or training,as well as technical support. There is no estimate ofthe resources mobilised on the back of the drugdonation programmes.

One issue that has proved problematic, given thepilot study’s tight time limits, is international levelconcern about the ‘hidden’ operational costsassociated with drug access programmes, eg inrelation to reporting load. Ideally it would have


been preferable to undertake more detailed live datagathering to elucidate the issue than was possiblewithin the constraints of this study. This reportfaithfully reflects the views of country levelinterviewees that this is not a justified concern inrelation to the tropical disease donationprogrammes in Uganda. The diseases are felt to bereal national or district priorities, and the associatedcosts are not inflated by external requirements frompharmaceutical donors.

Health systems strengthening is explicitly anintegral part of the new generation of PPPs forhealth such as APOC, the Schistosomiasis ControlInitiative, the Global Alliance to EliminateLymphatic Filariasis and now the leprosy ‘FinalPush’ programme. All advocate for integration ofprogrammes into the mainstream of primary healthcare activities.

CDTI, TB DOTS and Polio eradication haveinfluenced many other programmes in Uganda intheir approach to communities. Leprosy is nowapplying the Accompanied MDT approach, Malariathe Home based Management of Fever, andReproductive Health is reawakening to TraditionalBirth Attendants. This must be seen as capacitydevelopment across the system with regard tocommunity empowerment for self healthdevelopment.

The PPPs for health also contribute towardsnational capacity development in the areas of policyand planning, for example, in the application ofevidence-based strategies, national mapping ofdisease prevalence using tools such as GIS, cleartargeting of beneficiaries, the routine use ofinformation for management, a focus on time-bound outputs and health outcomes, and a greaterconsciousness of the need for programmesustainability.

Scale and sustainabilityScale and sustainabilityScale and sustainabilityScale and sustainabilityScale and sustainability

Scaling up

Of the four core tropical disease programmesstudied, three (leprosy, onchocerciasis and sleepingsickness) are already providing nationwide coverageof endemic areas, subject only to problems causedby recurrent insecurity in some districts.

The fourth programme, lymphatic filariasis, hasambitious plans for going to scale rapidly to provideMDA in all endemic districts by 2005 – a targetpopulation of nearly 9.5 million people11. Achievingand sustaining this latter for the 5 to 6 yearsnecessary to interrupt transmission is, however,wholly dependent on an assured source of fundingfor operational activities in addition to the existingcommitments by GlaxoSmithKline and Merck &Co. to donate the necessary supplies of drugs(respectively albendazole and Mectizan®). At thetime of the study, the Ugandan Ministry of Financewas considering a special request from the Ministryof Health to fund the planned expansion of theprogramme to 10 districts in 2003.

The Schistosomiasis Control Initiative plansconcurrent scaling up in the 18 worst affecteddistricts. As each District Director of HealthServices reports successful treatment in one sub-county, the drug will be available for a second subcounty as required. The target for 2003 is treatmentof up to 800,000 (50% through schools and 50%through CDD). In 2004, those treated in 2003 willbe retreated, and an extra one million included.Monitoring and evaluation of the programme willbe by independent assessors.

In interviews, the argument was advanced that along-term assurance of all necessary donated drugsfacilitated the rapid scaling-up of a tropical diseasecontrol programme.

Sustainability

Sustainability has different dimensions for thevarious programmes. As stressed throughout,assured funding for operations to complementdonated drugs is a prerequisite for all. This will beassisted by the eligibility of these programmes forfunding from the national Primary Heath CareConditional Grant. The transition of the nationalleprosy and the onchocerciasis programmes togreater self-sufficiency in operational funding isencouraging, though interviewees saw a continuedfree drug supply as critical.

The lesson of history from this study is the vitalneed for continued support during the maintenancephase of these programmes if relapse is to beavoided. Given the financial challenges facingUganda’s health sector, the cumulative demandscould tax central and local government, even givena clear recognition of the priority attached to theprogrammes.11 PELF Annual Report for 2002, Vector Control Division,

Ministry of Health, Uganda


There are wider issues. As described above, boththe leprosy and onchocerciasis programmes seeintegration at all levels of these hitherto verticalprogrammes as a key to long-term sustainability,notwithstanding the challenges posed in terms oftraining and informed oversight. This is beingcomplemented by moves to greater coordinationand collaboration across programmes: leprosy haslong since been managed alongside TB, anddiscussions are underway between the NationalOnchocerciasis Control Programme, PELF and SCIon how best to integrate activities such as training,supervision, advocacy, registration and drugdistribution.

Sustainability for the SCI will be measured by thedegree to which a grass-roots demand for treatmenthas been generated.

Perceived benefits of tropical disease drugPerceived benefits of tropical disease drugPerceived benefits of tropical disease drugPerceived benefits of tropical disease drugPerceived benefits of tropical disease drugaccess PPPsaccess PPPsaccess PPPsaccess PPPsaccess PPPs

The tropical disease drug access PPPs operating inUganda were universally welcomed by all relevantinterviewees in the study, who were specificallyasked to cite disadvantages as well as advantages.

Perceived benefits included the following:

• The actual and forecast health impact of theprogrammes.

• Access to free and necessary drugs when neitherthe MOH nor poor individuals can afford themand when, for three programmes out of fourstudied, there was historically no other donor(s)able or willing to fund drugs for nationalcoverage.

• In the absence of routine socio-economic dataon their clients, it is assumed in Uganda thatthese programmes benefit the poor particularly,because the drugs are provided free in unlimitedamounts and because these diseases afflict thepoor in particular (subsistence farmers, herdsmenor fishing communities resident in remote areasand those in the urban fringes, where the diseasevectors are a part of the habitat, and wheresusceptibility is exacerbated by poor sanitary andenvironmental conditions; overcrowdedhousing; and poor access to social servicesincluding health). In the Uganda ParticipatoryPoverty Assessment Report (the first publishedin 2000 and the second in 2002), the poorindicated ill-health was the most significant causeof, and contributor to, poverty.

• The assurance of a susta

Documents

The aim of the Initiative on Public-Private Partnerships ...announcementsfiles.cohred.org/gfhr_pub/assoc/s14819e/s14819e.pdf · Health Research, an independent international foundation