External review of the Oncocerciasis Control Programme, October 1990

Onchocerctasis Control Programme ln West Africa Prognamme de Lutte contre l'Onchocercose en Afrique de I'Orest. t I 1 t JOINT PROGRAMME COMMITTEE Office of the Chairman JPC-CCP E"YTERNAL REVIEId OF fiIE ONCHOCERCIASIS CONIBOL PROGRAII{T{E COMME CONJOINT DU PROGRAMME Bureau du Prdsident JPCl1 . g ORIGINAL: ENGLISH November 1990 JOIM PROGRAMME COMMITTEE Eleventh session , 3-6 December 1990 Provisional agenda iten 11 F t I i I IETTERNAL REVIEU ()F THE ONCHOCERCIASIS C()NTR()L PR()GRAII October 1990 Dr. Gerald llebbe, Medl.cal Parasitologl.st, Team Leader Dr. John IILIson, Anthropologlst, Ersqutl.ve Secretary Dr. EasLle AdJou-Houroouni, Public Eealth Specialist Dr. Paul Lechuga, Epidemrologist Dr. Steveu Smits, Tropical Dlseases Specialist Dr. George TsallkLs, Institutl.onal Management Speciallst I ABBREVIATIONS United States Agency for International Development Annua1 Transmission potential Volta Valleys Development Agency Courorunity Microf ilarial Load Committee of Sponsoring Agencies Expert Advisory Cosxrlittee Ecological Group Food and Agriculture Organization of the United NationsInternational Bank for Reconstruction and DevelopmentMicrofilariae National Onchocerciasis CotrElittee Organizatlon for coordination and cooperation in the campaignAgainst Endemic Diseases Onchocerciasis Control program Onchocerciasis Chemotherapy proj ect Onchocerciasis Fund AgreementOffice for Scientific and Technical Research OverseasPreparatory Assistance to Governments MissionPreclinical Drug Development Team IINDP/world Bank/wlIO special program for Research and rraining inTropical Diseases United Nations Development program World Health Organization Africa Region Office of the l{orld Health Organization a USAID ATP Avv CMFL csA EAC EG FAO IBRD Mf NOC OCCGE ocP ocT OFA ORSTOM PAG PDDT TDR UNDP !mo wlro/AFRo I TABLE OF CONTENTS Acknowledgements . Preface Executive Surmary I. Achievements of the Program..... ....... 1 A. Progress in OCP Operations 1 B. Reasons for Success and Lessons Learned. ....... 5 II. Devolution. III. IV. v. Annexes A. Background B. Requirements for Maintaining Onchocerciasis Control C. Institutional Aspects of Devolution. The Onchocerciasis Chemotherapy Project... Socioeconomic Development of the Onchocerciasis Areas Conclusions and Recommendations References. . . . 9 9 9 13 t7 2L 24 27 Annex 1 Annex 2 Annex 3 Annex 4 External Review Terms of Reference.... National Devolution Plans Socioeconomic Development: Individual Country Plans. The Onchocerciasis Chemotherapy Project 30 34 38 47 1 a ACKNOI.JLEDGEMENTS The Erternal Review wishes to thank Dr. E. M. Samba, Director of the Onchocerciasis Control Prograume (OCP), who assisted in every way to facilltate our task. lle also wish to thank all of the OCP staff for their valuable dlscussions and patient understanding of our enquiries and sometimes persj.stent questioning,. In particular, we are grateful to Drs. F. Adwadzi, D. Ba1dry, C. Ginger, D. Carvalho, K. Dadzie, G. de Sole, J. I{alsh, P. Guillet, D. Quillevere, J. Resme, 0. Ba, A. Seketeli, Y. Bissan, and I. Bogui, as well as Messrs. G. Koullscher, L. Yameogo, J. Zongo, and D. Boakye. We are eepecially grateful to Mr. P. Chopin and his staff who diligently saw to our complex travel arrangements. Special thanks, also, to our skilled Evergreenpilot, Ms. E. Halerryn. I{e are also indebted to Mr. B. Benton and Dr. B. Liese of the l{orld Bank for their constructive advice and to Ms. E. Skinner, and Ms. M. Cornejo of the llorld Bank for their essential administrative support. We also wish to thank Dr. P. de Raadt, Control of Tropical Diseases/ world Hea1th Organization (CTD/}III0), Dr. T. Godal, Special Progranme for Research and Training ln Tropical Diseases (TDR)/WHO, and Dr. A. Mu1ler and all the members of the Expert Advisory Couulittee (EAC), for most useful discussions. We must also thank Mr. J. D. Marr for sharing his valuable perspective on the Program. This report and eny errors it may contain, however, are wholly the responsiblllty of the authors. 11 PREFACE The objectives and tersrs of reference (Annex 1) of the External Revlew cover a broad range of lssues but focus, in particurar, on progress made towards devolution. This report assesses OCP's achievements and institutional arran8ements and hlghlights relevant issues; looking to the future anddevolution, we have identified specJ-fic technical inputs and institutional arrangements that should help ensure that the Program eventually reaches a successful conclusion. lle have also examined the work of the Onchocerciasis Chemotherapy Project (oCT) and issues concerning the socioeconomic development of the onchocerciasis areas. The External Review team met with the Cosulittee of Sponsoring Agencies(cSA) in weshington, D.c.r prlor to making field visits to the ocp program area, and had the benefit of an early briefing by the Progrnrq Director, Dr. E.M. Sanba. Field visits were carried out between May 2 and June 23, lgg}. AIl eleven Partlclpating Countries were visited by one or more members of the tean. upon arrival in ouagadougou, the team lras furly briefed at ocp Headquarters before undertaking fleld vlslts. The brieflng covered all aspects of ocP operatlons lncruding adminlstratlon, vector control, epldemiology, data analysis and computer support. Further briefings anddlscussions were held with oCP operational unlts at headquarters "nd ,ith ocppersonnel in Bamako (MaIi), Kara (Togo), Odj.enne and Bouake (cote d'rvoire), Hohoe (Ghana), Niamey (Niger), and with national personner involved in ocp operatlons In Guinea, Guinea-Bissau and sierra Leone. The frank andlnformative discusslons held in the field were of great value to our understandlng of the achlevements and problems of the program. Whlle in the Particlpatlng Countries, the tean dlscussed the program wlth ministers of health and members of the Natlonal onchocerclasisCoststittees, wherever possible. Members of the team elso met with country representatives of the World Bank, the United Nations Development progran(ITNDP), the Food and Agriculture organlzation of the United Nations (feo) anathe llorld Heelth organization (uHo). rn the field, the tean intervlewed netionelE employed by OCP and Program beneficlaries in local villages. The opportunlty to attend the National Onchocerclasis Corurittees meeti;g and theExpert Advisory Couurlttee meeting provided iurportant lnsights into ihe workingof these coslstittees and their decislon making processes. Members of the teamalso attended the flrst meeting of a task force on accelerated ivermectindlstrlbution for the northern part of the lrestern Extension. The team leader el8o ettended a Steering Costslittee meeting of the Onchocerclasis ChenotherapyProject in Geneva and met with members of the Preclinical Drug DevelopmentTean (PDDT). Members of the team interviewed representatj.ves of the sponsoring agencies and of several donor countries including Belgium, Canada, Fraice, theUnited Klngdom, the Netherlands, Swltzerland and the United States. prior to completion of the report, the External Revierf, team held a finat neeting inlrashlngton, D.c. from August zl to August 31, 1990 and met with the cse todiscuss preliminary findings. iii EXECUTIVE SUMI.,'ARY The Onchocerciasis Control Program has virtually eliminated transmissionin the core area of the Program overcoming the major obstacles of resistance and reinvasion. It has made significant achievements in improving larviciding technology, in ecological monitoring to minimize environmental impact, in entomological research on the vector species, in epidemiological surveillance and assessment and in treatment of the disease. Protection of the ocp's achievements will require the continued comslitment of the donors to the Progran strategy based on vector control for a minimum of 14 years from the start of larvlciding ln any given area. The critical areas are the sources of reinvasion in the Western Extension and selected pockets in the core and Southern Extension arees. Maintaining the continued success of the Program will require continued support for the effective institutional arrangements that have allowed the Program to successfully pursue its mandate with autonomy and flexibility ltithin a framework of internal checks and balances through independent expert review and oversight from the sponsoring agencies, donors, and Participating Countries. The success of the Program can be attributed to: clearly defined objectives; a realistic ti-rreframe; choice of the best technology available for the tasks at hand; the high susceptibility of onchocerciasis to vector control due to the breeding hablts of the vector; contracting out of highly specialized tasks; the priority given to operational research; the high degree of autonomy of the Program; the delegation of authority within the governing structure which has permitted timely response to changing requirements in thefield; long-term commitment from donors, sponsors and Participating Countries withln six-year flnanclal planning cycles which have specified medium-term operational goals; an effective system of checks and balances characterized by transParency and free flow of information between the Program, its statutory review bodies, and the governing structure - the CSA and the Joint Programme Cosurlttee (JPC); and finally, strong vertical management and high quality staff. The Program and its sponsors, donors and Participating Countries must now turn their fuII attention to devolution. The future of the Program is clearer today given the availability of an effective microfilaricide, Lvermectin. However, the institutional dimensions and the financing mechanisms to assure successful devolution need to be spelled out and made operational, as the Program enters lts fourth financial phase. The technological underpinnings for devolutlon will be epidemiological surveillance and ivermectin distribution for disease treatment and recrudescence control. The effective implementation of these activities will require appropriate institutional strengthening in the Participating Countries with special attention to tralning and management. OCP can contribute further to devolution through creation of a new Devolution Unit, rrith three or four professionals (a social scientist, epidemlologist, public health/management specialist, and training specialist), whlch would: (i) assist the Participating Countries in preparation of hunan resource development plans; (ii) design and manage training and in-service training in multi-disease surveillance and drug distribution; (iii) undertake 1V , a tnanagement training prog,ran for mid- and upper level national personnel;(iv) promote g,reater involvement of national team personnel, at all levels, in strategic planning, supervision, and evaluation; (v) sensitize Participating Country governments to the need to establish onchocerciasis as a high priority in public health, to plan for the eventual absorption of OCP trained personnel in national structures and to promote relevant couurunity education and mobilization actlvities; (vi) support operational research on topics relevant to devolutlon; and (vii) provide technical assistance to Participating Country governments in order to strengthen organization and management of disease control. In regard to devolution, there are e number of research topics that should be pursued: the impact of ivermectin on transmission ln real recrudescence situations; the relative effectiveness of alternative ivermectin distribution systemo; the safety of lvermectin on more frequent dosage schedules; potentiel resistance to ivermectin and appropriate tools to detect such resistance; general health systems research in the Participatlng Countrj.es; and development of a highly sensitLve and speclfic luurunodlagnostic te6t to detect low levels of infection. The Onchocerclasls Chemotherapy Project (OCT) has been of greet value. The field trials for lvermectl.n rrere instrumental ln preparlng for selective mess treatment of onchocerciaeis. Its primary objective, however, is to search for a safe and effectlve macrofllerlclde and an increased number of compounds from as many pharmaceutical sources as possible should be screened. The new OCP/TDR Macrofil Project, combining the efforts of OCT and the Speclal Prograrme for Research and Trainlng in Tropical Dlseases (TDR) ts a positive step but mu6t not be allowed to dilute the OCT objectlve nor to reduce itsflexibllity, within the bureaucratic framework of TDR. Towards the conclusion of 0CP, preparation of an intercountry facility will be necessary to provlde a framework for intercountry cooperetlon and for activitlee whlch are beyond the capacity of the Partlcipating Countries. Such a facllity would: monitor epidemlological trends throughout the Progran area; coordlnate the efforts of regional institutes lnvolved in onchocerciasis reeearch; asslst in data processlng and provlde a long-term memory for analysls of trends; help countriee deteranine needs and prlorities; undertake trainlng, review research and disseminate inforxratLon. PartlciPatlng Country capacity for development of the onchocerciasls areas ls very rlsrited and separate planning for these areas, outside the national economic context, is lnefficient. lle recomrend that the CSA, intereeted donors, and Participsting Countriee, taking lnto account the various conclu8ions of the socioeconomic reports produced by the CSA, jolntly support socloeconomic development planning and programs for the onchocerciasis-freed areas and ensure the integratlon of euch planning lnto the broader nationel development Btrategy of each of the participating Countries. v , 1I. ACHIEVEMENTS OF THE PROGRAI'T A. Progress in OCP Operations 1. Few programs can claln the kind of success that the OCp, in spite of serlous obstacles, has achieved in the past 16 years. In all of the original Program area the disease has ceased to be a pubric health problem. Today, over 30 million people (including the populations of both the l{estern and southern ertenslon areaB) are protected from the transml.ssion of onchocerclasls and its symptoms because of the OCP. Slnce the Progran began, about seven milllon children have been born virtuarly free of risk of onchocercar blindness. some L.25 slilrion people who were at one time seriously infected are today completely free of the paraslte. Furthermore, there are about L00,000 people in the Progrnm area who still have thelr sight today because of the OcP. The ocp is also having significant net socioeconomic benefits which can be quantified (Benton and Skinner 1990). TheProgran's accomplishslents have been many, In perticular, lt has made advancesin: (i) vector control and larviclding; (li) ecorogicar monltoring (iii) entomological research; (iv) epidemiologicar aBsessment; and (v) disease treatment. Vector Control 2. OCP vector control operetions have been h1ghly succeseful, in spite ofthe great difficultiee posed by reslstance to larvLcldes and reinvasion of controlled erea8. These rrere no snal1 obstacles, but with the backing of a comritted donor coururunity, strong progrsm management and operatlonalflexibllity based on appried research, the goals of the prograrn were not conpromlsed. A highly effective radio network maintained by the program throughout the Program area has been fundamental to the efficlent management of vector control; this cosurunications system shourd be useful to theParticipating Countries (and to an intercountry facility) for onchocerciasis and other dlsease control efforts for many yeers to come. Today, wlth the exception of some pockets of resistance or reinvasion, the follorrl.nglndl'cators 8PPly throughout the original Progran area: (i) annual blting rateis below 100 and annual transmiesion potentlal is less than ten (these messure8 indlcate that there is no significant risk of onchocerciasie transml.ssion); (ii) costglunity ml.crofilarial load (CMPL - the mean nunber of microfllariae per skln snip for a given populatlon) has reached a very lowlevel (between 1 and 4); (iv) prevalence of blindness due to onchoceriiasis isclearly in decline; and (v) prevalence of onchocerclasis ls in marked decline.Thus, there are grounds for optlmlsm and the orlglnal area Is in an excellentposl.tion to begin devolution. 3. The vector control strategy should be able to achieve simllar results inthe extension areas, elimLnating the sources of reinvasion of the original area. In the Southern Extension area, vector control is now in its 3rd year and has had good results lrith the exception of two problem arees located onthe Benin/Nigeria and Ghana/Togo borders. Vector control operations are norr I i l I ( 2underway throughout the Western Extension with the exception of the northern part (trestern Mali, Senegal, and Guinea Bissau) where larviciding operations have been discontinued. Larvlciding 4. The OCP's rotatLonal larvicide use has successfully prevented any serious interruption of operetions due to blackfly resistance to larvicides and the search for new compounds (especially from groups unlikely to give crosB-reoistance) has been diligently pursued. In addition, the Program has funproved larvicidlng operations in two respects: (i) it has irnproved accuracy in larvicide application and consequently, cost-effectiveness; and (ii) it has lmproved its capacity to judge vhen spraying may be safely discontinued. 5. The OCP has upgraded larviciding operations with the introduction of a computer program (PERIES), developed by ORSTOM hydrologists in 1989. This program optlmizes larvicide and application costs by embracing simultaneously all relevant larvicide, river (discharge) and aircraft parameters.l Using thie technology, the Program has reallzed conslderable savings in larvicide and appllcation costs. 6. For the orlginal area, OCP's attention is focused largely on defining the parameters on which the decision to stop larviciding can be based. Epidemlologlcal mapping and entomological surveillance ectivities are belng complemented by another computer model, ONCHOSIM, which predicts long-term epidemiological trends given control methods based on specific combinations of vector control and ivernectin treatment. The Program's technical staff hold that larvicidlng can be stopped after 14 years if the following criteria are met: (l) trends ln CMFL and trends in prevalence of cohorts in the indicator villages ehould be the sane as or faster than the trends predicted assuming complete interruption of transmission; (ii) in lndlcator villages, there should be no Lncldence ln children born since the beginning of vector control or ln persons skln snipped twice with negative results on both occasions. For non-lndicator villages, prevalence and distribution of microfilariae (mf) should be consistent rrith that found in the lndicator villagesz. Ecological Monitoring 7. The Progran, guided by the independent advice of the Ecological croup, has continually conducted tests to detemine the impact of new larvicides and new forsruletions on the environment and has evaluated the long-term impact of 1 Th" program is based on nGraph and Network" mathematicat theory and on OCP's prediction models for the carry of larvicides in irater-courses under aII conditlons occurring ln the program area. These models were developed for larvlcldes in use on the basls of experimental river applicatlons, use of fluorescent tracer, and bioassays. 2 ocP will continue entomological surveillance and evaluation for two years after larviciding, stops in order to determine the proportion of infective parous flies (OCP 1990a). 3vector contror operations on the non-terget fauna. Thus far, no long-term effect on the fauna has been revealed by analyses of available data. OCP is currently working on development of a technique by which long term effects canbe determined by short term observations and steps have been taken to irnprove the processlng, analysis and presentation of hydrobiological data (Yameogo et al. 1988; OCP 1990b). Entomolosl Research 8. The oCP has made considerable inprovements ln its ability to detect resistance to larvlcides. Thresholds of resistence for s. damnosum s.r.populations have been reassessed and a computerized cytotaxonomlc data bank hae been developed. The cytotaxonomic data can thus be correlated with known resistance patterns. This facllltates redeflnition of the range of susceptibillty of the varl.ous members of the s.damnosum complex. 9. Operatlonal research on the vector continues to improve OCp,s ability totarget vector control. OCP continues to seek a better understanding of thedlstribution of vector species and to add to its knowledge of thelr respective roles ln transmisslon. Studies of vector species distribution have been concentrated ln southern Slerra Leone and nine specles or forms have now beenidentified. Pending the separation of infective larvae recovered from man-bitlng vectors into bllnding and non-blindlng strains, the decisions on which vectors should be targeted for control wIll depend on ncross-transmission etudies and knowledge of nan-biting rates, anthropophily, survlval rates, natural infectlon levels and aseociations with blindlng focin (OCp 1990a). Eoldemlologlcal Aesessment 10. oCP etudies of the epideniological inpact of ivermectin treatment have established that Lvermectin cannot effectively control onchocerciasis transmission on an annual treatment schedure (in hyper and holo-endemic areas). More research is undenray to asBess its epidemiological impact at more frequent dosage schedules (e.g. several yeers of treatments at 3 to 4 month intervals). OCP also recognizes that lt may not be possible to measurethe lnpact on tran8niesion untlI after 7 to I years of Lvermectl.n treetments(OCP 1990a; OCP 1990c). 11. OCP has completed epidemlological mapping throughout the original and extenelon 8rea8. These suneys ere essential to etraieglc plannin!, includingthe selection of couurunlties for chemotherapy delivery. L2. The ocP's epldemiorogical surveys show that priority areao rn theWestern Exteneion area (areas of hlgh endemiclty and high risk of blindness), are sltuated In the upper Nrger Basin, the Ganbia Basln in senegal, upper Bakoye Basln, and the Tienfala focus along the Niger Rlver tn uirr. -- 13. In addltion, studLes of ocular disease patterns (through ophthalmologlcal examLnatlons) ln selected villages in the Upper Niger basinln Gulnea and Sierra Leone have red to I better understanding- of the relationship between the prevalence of severe eye lesions, onchocercal 4blindness, and CMFL.3 These findings have helped OCP to better target vector control by determining the southern lfurit of the transmission of blinding forms of the parasite and, therefore, the southern limit for vector control and targeted ivermectin delivery.q 14. The ONCHOSIM computer model, mentioned above, also permits the separate slmulation of lesions of the anterlor and posterior segments of the eye. It mey, therefore, facilitate more realistic simulation of morbidity control following treatment with ivermectin. Two inportant sensitivity analyses were carried out by the University of Rotterdam, which has been collaborating with the OCP on epidemiological research. The first of these concerned a detailed analysis of the parameters which control the distribution of the lifespan of O. volvulus. The main conclusion was that the mean reproductive lifespan of0. volvulus is between 9 and J.l years and that 95t of the adult lrorrns terminate their reproductive period before the woru age of 13 to 14 years. The second sensitivity analysis addressed the risk of recrudescence in relation to duration of vector control. The results confirmed previous estirnetes that the risk of recrudescence continued to be too great after 13 years of control, end that a minimum of 14 years of interrupted transmissionls requlred. Further refinements with combinations of different perameterquantlfications lndlcated that some risk of transmission existed even after 14yeers. Further nodelling considerations related to dete analysis and operational planning have been made, including: quantification and testing of the ocular disease module; simulation of regional variations in transmission dynarnics; and surveillance and recrudescence control under devolution (OCP 1989; Reume et al. 1986). 15. It may soon be easier to distinguish blinding from non-bllnding strains of the parasite if a DNA probe, currently under study by the OCp and the University of Alabama, is validated. It mey also be of value in distinguishing hunan and animal strains of the parasite. Disease Treatment 16. Clinical trials conducted by the OCP (Tamale/Hohoe) have established that ivermectin has a profound microfilaricidal action, reducing mf loads for uP to one year. The safety of ivermectin (following individual treatments) 3 Th" comnunlty patterns of ocular onchocerciasls in these areas rf,ere compared with patterns found ln the sevanna zone of the original area. The result lras that at similar levels of CMFL, the corneal microfilarial load in the cosutunity and the prevalence of advanced sclerosing keratitis proved to be much lower in Guinea and Slerra Leone. In northern Sierra Leone, patterns of lnfection suggested the presence of another non-blinding strain and further ophthalmologlcal lnvestigations are being undertaken by the OCP. 4 In Si"rra Leone there lras a linear relationship between CMFL and severity of eye lesions. Although incidence of blindness was lower than in the origlnal OCP area, onchocercal blindness reached significant levels (4 to 6Z) where CMFL levels lrere high. 5has been establlshed ln clinlcal trials and through observations made in the erecution of targeted ivermectin treatment. L7. The potential role of lvermectin in the prevention of disease may be much greater than earlier believed. Annual treatment with ivermectin has been sholrn (in the savanna area) to cause regression of iridocycritis and sclerosing kerstitis, and to arrest optic atrophy and choroidoretinitis. Thepositlve cllnlcal results of ivermectln treatment suggest that exclusion crlteria should be revised to make the drug available to more heavily infectedpatients (OCP 1990a; Reume et al.1989; Dadzie et al.1996,1989). B Reasons Success and Less s Learned 18. There are qany lnterdependent characteristics of the OCP which are clearly factors that have allowed the program to achieve what has been achleved to date -- the near eradlcation of a serious public health problem from a large end often lnaccessible area. The success of the program can be ettributed to: (1) clearly defined objectives; (ii) a realistic ana feasibletine fragle; (lil) choice of the right technology; (iv) the susceptibllity of onchocerclasl.s transmission to contror; (v) contracting out of hlghly speclalized operations; (vi) a strong emphasls on operational research; (vii) a hlgh degree of autonomy fron I{HO and its governing structures; (vlii) clearderegation of authority allowing operational fleribility; (ix) medium-termprannlng and suetalned donor cosrmitment; (x) an unrestricted ftow ofinformation between all parties concerned rrhlch has helped to meintein a system of internal checke and balances and clear accountability; and (ri) strong nanagement and high quallty staff. Clearlv Deflned Oblectives 19. since lts inceptlon the ocp has herd to a rimited, well-defined objectlve that hae been shared equally by Program staff, beneficlarlee, donors and sponsorlng agencles. Thls has given the Program a clear mandate and thelegltimacy to pursue Lt. consequently, the program'e hlghly focused naturehelped ensure thet lt was guided by rigorously technlcat, not politlcal, conslderationa. such slngle-mindednees of purpose hae been a crl.ticaldlnenelon ln the successful inplementatlon and day-to-day manag,ement of the Program. Reall.stic Tiglefreme 20. The ocP and the donors agreed at the beglnnlng of the program on a reall'stic timefrane for achievement of Progran obJectives. The request for a 2O-year couutLtment from the donors rras unprecedented and dld not meet t ithfumedlate approval from the potentisl donors. Nonetheless, the proponents ofthe Program remained fi n in their assessment that thie timeframe wis appropriate and reallstic based on epidemiological facts (principally the rhen conceLved 15 to 18 year llfespan of the adult worm). 6Choice of Technology 2L. Part of the Program's success can be attributed to its conscientious pursuit of the best technology available. This has el-lowed a sophisticated level of operational control hardly inagined possible in ![est Africa. Accordingly, aircraft have been used to apply larvicides and, more recently, water level data have been transmitted using state of the art methods via satellite enabling more accurate spraying levels and reduced environmental impact. Computer nodelling of onchocerclasis transmission has been developed and ls used in forecastl.ng the progress of operations. Chromosome reading was introduced to ldentify species of the S. damnosum complex more efficiently and the separation of vector and non-vector species. This reliance on the most advanced tools avallable has helped maintain the cost-efficiency of operations. 22. In part, the Progratrl's success must be attributed to the nature of onchocercl.asiB transmlseion. The disease proved highly susceptible to the control stretegy applied because it was possible to pinpolnt very precisely the locatlons of vector breedlng sites, the characteristics of vector migratlons, and the pattern of fluctuations in the hydrographic network. Other vector-borne diseaee control efforts (malaria, for example) have not Bhared thls klnd of advantage. Co4trecti.ng Out lllghly Speciallzed Tasks 23. Aerial spraying operations, the key element in the OCP strategy, were contracted out to prJ.vate companies especially qualified for the task. The OCP accepted early on that it lacked the expertise to undertake such a large and complex spraying effort involving a fleet of helicopters and sophisticated spraylng equlpment. Operational Research 24, Much of the Program's success can be attributed to the importance granted to operational research. Since the Progran began from a position of relative ignorance and inexperience, operational research was a key element in the development and evolution of the OCP's dlsease control strategy. OCP has spent about 152 of its budget on operational research. Results of operational re8earch have gulded operations and helped improve efficiency. Operational regearch has focused on a renge of relevant problems such as: larvicide development and application technologies, vectorial capacity and vector specles identlficatlon, the relatlonship between intensity of infection and bllndness, the epidemlologlcal lrpact of control efforts, and clinical ivermectin field trials. Autonomy of the Proqrarn 25. The Program rras set up with a high degree of autonomy. This has helped OCP avold WIIO administrative procedures, enabllng it to adjust operations quickly when necessary. OCP's autonomy has sheltered the Program from Susceptibilitv of Onchocerciasis Transmission to Control 7competition lrith other WIIO priorities during a time when attention to tropical diseases has clearly declined. Governance of the ProEram 26. Delegation of authority to those most closely involved in the Program has been crucial to assuring its ongoing success. The Cosulittee of Sponsoring Agencies (CSA), which meets three to four tines per year, has proven a useful,persistent referee of the ocP since the beginning. The delegation of responsibllity for policy development and financial supervision to the CSA has enabled cruclal decislons to be taken between ennual meetings of the JpC. This has allowed the Program to respond ln tinely fashion to changing operational and financial requirements. Medlum-Term Plannins and stained Donor Corunitment 27. Faced with the dlfficulty of sustalning donor support over a longperlod, the Progran was dlvided into a series of six-year phases. A detailedplan of oPeratlons lras prepared for each phase outlining the objectives to be reached during that period, any modifications necessary and the estimated cost of the operations. The onchocerciasis Fund Agreements, based on approved Plans of Operatlons, blnd the Progran to lrhat it should accomplish in the six-year period, obligate the donors to an agreed upon level of financial support, and tle the Participatlng Countrles to their responsibilities. Trensparency - Informatlon Plow 28. The Progran has beneflted greatly from the transperency achieved by meintalninS, an unrestricted flow of lnformation about the program amongst a1lparties I'nvolved. It h8B also benefitted from its ornr openness to inspection and revlew. The Program has undergone annual technical audits by the iAC which has reported lts findlngs in frank annual reports to the Jpc. periodic analyses and reviews by the EAC and the Ecological Group have strengthened the Program by providing independent, credible evaluation of activities andprogre88. They have also endorsed necessary modifications in strategy ortactics. The oversight provided by these statutory bodles have enabilO tn" JPC to malntain donor confidence and support. Another lmportent input has come from lndependent reviews lncluding the Independent Cosrnlssion ieport in1981 (I{HO 1981), the USAID Inpact Review in 1985 (USAID 1986) and the presenrErternal Review. Strong Management and His,h Qualitv Staff 29. OCP management of human, material and financlal resources is rigorous and strict and almost rrilltary ln character. Thls yields a certaln ottirigm wLth respect to the achlevement of program goals, a sense of urgency io ""tand to succeed, and an overrlding sense of the importance of discipilne andorder. There is arso a sense of honor and pride in one's work and in the mandate of the Progran as a whole. Out of thls develops e sense of family andtean spirit. Disciprlne ts high and ocp personnel take their jobs very serl'ous1y; each staff member Ls aware of how important his pariicular Lask isto the success of the Progran. 8Lessons Learned 30. Goals must be set within a realistic timeframe. A key factor in sustaining donor cosmitment over the long term was the acceptance, at the verybeginning of the Program, of a long-term perspective and couulitment, which wasbased on epidemiologicar fact (the lifespan of the adult worm). 31. Maintainlng this level of coruritment over time requires that goals be clear and unambiguous and that progress torrerds them be updated fref,uently and assessed regularly by independent reviews. 32. The legal nature of the formal Onchocerciasis Trust Fund Agreements(covering six-year periods) has also been very importent in mainiaining donor coEmitment and ln maintaining the organizational integrity of the progian. Inaddition' the dlvision of the corresponding six-year financial phases into annual budget cycles has enhanced transparency and accountability and further maintained the confidence of the donors. 33. Operatlonal research is essential. It can increase efficiency and reduce costs, and ensure survlval of a program when critical technital challenges arise (the rapid spread of resistance to larvicides, for example). 34. Under certain circuglstances, technologically advanced alternatives canbe more cost-effective than others. In the Progran's experience, the highly eophisticated aerial larvlciding operations have proven to be a great deallees costly, and certainly more effective, than ground larviciding would havebeen. 35. The Prograur has been able to malntain better control and demand higherquality in vector control operations by contracting out aerial larviciding to competent' specialized firms. Better results can be achieved more efficiently when highly specialized tesks, beyond the expertise of the executlng agency, are contracted out in this way. 36. The Progranr'6 autonomy from IJIIO and its governing bodies helped insulatethe Program from competltion rrith other health development trends in Afrlca and a useful lesson can be drar*a from the fact that the Program has prospered et a tlme rrhen attention to tropical diseases, in general, has been in seriousdecline. 9II. DEVOLUTION A. Background 37. The idea that the Particlpating Countries would eventually assune full responsibility for maintenance of onchocerciasis control was first discussedin the PAG misslon report in 1973 (I,NDP/FAO/IBRD/!,HO tg73). The concept ofndevolutionn, or the process by which responsibillty for onchocerciasis contEol would be transferred to the participating countries, was first articulated as such by the Independent Cosulission in 198L (WHO 1981). TheLong Term Strategy PaPer (OCP 1984) went further to define devolution as along term objective of the Program which would be carried out jointly by theProgram and the Partlcipating Countries. Translating the conc-pt into action,however, proved difficult due to the program's reliance on highiy sophisticated technology and on strong, vertical management. Technological and instltutional constralnts have made it impossible to transfer much of what ocP doee to any one of the partlcipating countries. However, with thelntroduction of ivenrectin, devolution and its objectives could be moreclearly defined in operational terms. Devolutlon is now understood to meanprogressive natLonal participatlon in activities to detect and suppress recrudescence and ln the dlstributlon of lvermectin to reduce moriidity (Ocp1988:1). Thus far, devorution plans have been approved by the Jpc for Marl,Niger, and Burkina Faso (see Annex 2) end draft pl"n. are soon to be submittedfor Benl.n, Ghana, Cote d,Ivolre, and Togo. 38. Preeently, the Prograture's contribution to devolution includes: (i) thedevelopment of technlcal standarde and evaluation of entomological and epldemiologlcal eurveillance; (il) advisory and coordination activitleg regardlng the develoPment of natlonal plans for devolution, includlng effortsfor attractlng external flnancl.ng; and (tii) training of nationals In fieldsrelatlng to ocP operationE. The ocP draft Plan of operations for Lgg2-t997 adds training and reeearch in new flelds relating to health care systeme and management to these actlvlties. 39. The Participating countries already take part in epidemiological evaluation and ivermectin distribution under oci supervtston. ThJy alsoposses8 the capabllity to carry out ground larvicldlng and entonologlcalsurvelllance. In additlon, with technical asslstance they could asfune fullresponslblllty for ecologlcal monitoring. The speclfic OCp actlvltiee whlch cannot be devolved (and which would have to be passed on to a succeosor agencyto ocP) are aerial larvicidinSr rre!f, larvicide development, and macrofilaricideresearch. The Partlcipating countries do not have and are unlikety toachleve, in the foreseeable future, the technological, institutiorr"l, o,financial capacity to take on these specific activities. B. Requirements for Ma Onchoce rciasis Control In order to maintaln onchocerciasl.s control, the partlcipating Countries must have the capacity to: (i) detect recrudescence througtr epiAemiJlogical surveillance; (ii) suppress recrudescence (i.e. renewed tiansmission) irr r"ry 10 limited foci using ivermectin; and (iii) carry out ivermectin treatment to reduce morbidity (i.e. for disease control). Detecting Recrudescence 40. The eristlng system to detect recrudescence consists of: (i) passive screening at public and private health centers in order to detect infected cases among patients presenting spontaneously; (ii) if high levels of l.nfection rrere detected, skin-snip surveys would be carried out by mobile teams in areas of suspected recrudescence (migration studies would complementthis eystem); and (lii) sronitoring levels of infection through skin-snip surveye ln randomly selected lndicator villages every three years. Nationals are already involved in thls surveillance 6ystem, under the close supervision and wlth the logistic and financial support of the OCP. Under devolution, these activitiee will become the full responsibility of the Participating Countries. l Suppresslng Recrudescence with Ivermectin 41. There are still eome major questions about this particular aspect of devolutlon and maintenance of onchocerciasls control which cannot be answered today and which w111 requlre, at least, several years of observations of the epideurlologlcal impact of ivernectin usez. The EAC has sumarlzed the question of ivermectin and recrudescence (transmission) control thus: nthe OCp 8t111 needs to determine the degree to which ivermectin can control transmissLon in e true recrudescence focus, what critical threshold should be reached before Lvermectin delivery should be undertaken, and the best dosage frequency to achl.eve control. such a focus has yet to be found in the ocp arean (OCP 1990a:6). The available evidence suggests that ivermectin does not have a slgnlficent inpact on transmission when given on a yearly dosage schedule and under present exclusion criteria (which so far has permitted coverage of about 50-652). In order to assess its usefulness as a 1Ir, .r"ae at risk where vector control is not carried out (such as the northern part of the Western Ertension area) surveillance activitles rrould not ain to detect recrudescence but would focus on detecting persons at risk ofblindness or serLous skln disease uslng clinical methods. This could be doneby screening for corneal leeions lrith e uragnlfying glass which, according to oPhthalmologists, would be possible for health workers wlth li$ited training. The skln-snip method could still be used to deternine severity of infection inindlviduals. 2Computer simulations using the ONCHOSIM epidemiological model quantified the effect of ivernectin, baeed on resurts from the couurunity trlar in Aeubende, and concluded that large scale lvermectin treatment alone cannotprogreBsively ellminate the paraslte resevoir in endemic arees in I{est African aavanna. This was supported by the latest field observations from the Asubende focus. There are still uncertainties about long term impact of ivermectLn treatment, mf repopulation dynamics after treetment, and the cunulatl.ve effect of repeated treatment on mf production. 11 transmission control tool, there is a need for an evaluation of the results on transmission of several years of ivermectin treatments et 3 to 4 monthintervals. Although the OCP lacks experience in the use of ivermectin to suPpress recrudescence, Lt will hopefully collect relevant information on the epidemiologlcal lrpact of iveranectin in the northern part of the llestern ExtensLon where vector control is being discontinued and ivennectindistribution intensified. A review of the epidemiological irnpact ofivermectin, as well as of drug delivery systems and of the safety of repeated treatments at more frequent intervars, should be made in 5 to 6 years, ifposslble, to reassess its role ln transmisslon and disease control strategy.3 42. rn any event, the Participating countries will have to be prepared to respond to recrudescence situations wlth the tools available, i.e. through elther tergetted lve nectin delivery or, where feaslble, liglited groundlarviclding. rn splte of the uncertainties regarding ivermectin and suppression of recrudescence, Participating Country capability to undertakethese actl.vitl.es must be strengthened in the course of devolution. Ivermectin Distributlon to Control Disease 43. The,.ProsPect for control of disease menlfeBtstlons with LvermectLn is very goodr. About 35,000 peopre are being treated per yeer in alr high risk ereas (defined as sreas where the courmunity uricrofilarial load, CMFL, is foundto be greater than 10 glicrofllariae per skin-snip). Selective ivermectindistribution for disease control is being carried out primarily in the extension arees where larviclding ls still underway or where larviciding will not be carried out. Drug distribution is carried out by nationals under thedlrect supervision and rvlth financial and logistic support of the OCp. Thisls expected to continue for as long es the Ocp is in Lperation. In devolutlon 3 It th" llestern Extension erea there are Ilkely to be sone difflcultiesln assessing epideuriologlcal inpact due to the presence of animal(onchocerclasis) larvae in the vectors throughout the area. Further:nore, a reductlon ln incidence nould be difficult to deter:nine durlng the initial 4 to5 years of treatments due to the length of the pre-patent p"iioa (the periodbefore the adult lronns begin producing microfilariael, the lorv eensitivlty ofskin-snrps to light infectlons, and the rack of a contror group. rt may, infact, onry be possibre to clearly observe the epidemiologi-af irp""t ofivermectln on transmissl.on after 7 to g years oi treatment (ocp 1990c). 4 Obt"t "tlons in the savanna area ehowed that annual treatment lrithivermectin caused regreesion of iridocyclitls and sclerosing keratitis, andarreBt of optlc atrophy and choroidoretlnitls. Clinical results from two rounde of ivermectin treatment have shown ilrprovement or stabllization of eyelesl'ons. This Euggests that the erclusion criterla should be reviewed to enable maxi-nusr availability of euch beneflte to more heavily infected patients and, ln holo-endemLc areas, annual treatment may be recouurended (OCp t-ggOa; Resme et al 1989; DadzLe et al. 1989). L2 this activity wi]l, in most of the Participating Countries, be horizontally integrated with other disease control activities. The Participating Countries must now begin to consider and experiment with alternative distribution mechanisms in order to optiarize the potential benefits of the drug to affected populations. Research to Define the Parameters of Ivermectin Use 44. There are a number of operational research tasks which would help answer some of the major questions related to successful maintenance of onchocerclasis control. lle have already mentioned the need for studies of the impact of ivermectin on transmission at more frequent dosages (e.9. 3 to 4 month intervals). In addition, further research is needed to determine the lncidence level at which recrudescence control using ivermectin must be initiated. The mlnimum safe lnterval between ivermectin treatments also needs to be established. It is possible that ivermectin may be less effective in early infections; if so, this needs to be better understood and its lmpllcations for detecting recrudescence considered. More needs to be known about the efflcacy of ivermectin treatment over a prolonged period in preventing, halting or reversing eye disease. Since there is known resistance to ivermectin in veterinary medicine and since ivermectin will assugle a greeter role in onchocerciasis control (e.g. the northern part of the Western Extenslon) research on potential resistance to ivermectin should be pursued through the OCP/TDR Macrofil Project. 45. Research on alternative ivermectin delivery systems, within the specific context of each of the Participating Countrys'existing health systems, is especially important and should: (i) determine the actual logistic requirements for ivermectin delivery through active (seeking out infected individuals and treeting them) and passive (making the drug available to patients seeking treatment) distribution mechanisms; (ii) Provide an estimate of the actual need (i.e. the nunber of patients that will require treatment)(iii) exanine different methods of organizing drug delivery (e.9. elternating distribution from fired and mobile facilities, inventory menagement and storage systems, recordkeeping systems on individuals and cotnnunlties, supervision/monltoring systems); (iv) examine si:nultaneous distrlbution, in the course of the same round, of various theraPeutic agents; (v) attemPt to determine the optlmal length and frequency of rounds; (vl) examine behavioral issues concerning the acceptance and use of the drug, for example, will use of the drug for treating human intestinal parasites, or for treating bovine parasites affect lts use for onchocerciesis? In the absence of reinfection, treatment must be repeated annually until all adult t orrns have died (an estimated 14 years); will patients comply throughout this extended period, however, in the probable absence of symptoms?. 46. The JpC should also seek increaeed support for ongoing research and development of an approprl-ate isulunodiagnostic test t hich can better detect of low leve]s of lnfectlon. Several universlty laboratories are already involved in this research which is especially important in terms of the capability to detect recrudescence. If it is possible to suPPress recrudescence through ivermectin treatment, then the OCP's epidemiological modelling studles suS,gest 13 that the eooner intervention begins the greeter the chances of success (OCP 1989:7). c t ional cts of Devolut 47. Devolution is essentially the process of strengthening Partlcipating Country capabilitiee in epldemiological surveillance and ivermectindlstrlbution, with the goals of detecting and suppressing recrudescence of onchocerciasls. The sustalnabllity and impact of devolutLon can be better assured and anplifled lf lt ls carrled out as part of general health systems development In the Partlclpating Countries. OCP can meet the needs of devolutl.on and contribute to health systems development by undertaklng actlvities ln two general areas where it already has considerable experlence:(i) tralning and in-service training; and (ii) technical asslstence, especially ln regard to planning, management and operetional research. Creating an OCP Devolutlon Unit 48. The Program can begln by creating a Devolution Unit to undertake actlvitles in these areas. Speclflcally the unit would: (1) asslst the Partlcipating Countries ln the preparation of human resource development prans based on an in depth essessment of existing huslan resourceg and projected needs (the ocP has already contracted two consultants to begln this work); (ii) destgn and menage training and in-service training programs forfield personnel involved in nu1tl-disease surveillance and drugdistribution actlvities ; (lil) undertake a tnanagement tralning progran for mid- and upper level national personnel with a focus on personnel management ski1ls,instilling dlscipllne and positive work attitudes; (iv) promote greater involvement of national team personnel, at allIevele, in strategic planning, supervision, and evaluation; (v) seneitize Particlpating country governnentB to the ilrportance of onchocerclasis control malntenance, promote its establlshment as a highpriority ln publlc health, and make Participating country governments arrare of the human resources thet are being tralned by ocp and the needfor Participatlng countries to make approprlate plens for the eventual absorptlon of these hlghly qualified personnel; (vi) seneitize Participating Countries to the increasing inportance of coumunity educatlon and moblllzation efforts ee disease control efforts rely increaslngly on epideniological surveilrance and ivermectintreatment. rn each country, corrrunity mobilization plans are needed; knowledge, attitude, and practice (KAP) surveys could usefully identify gaps in knowredge about onchocerciasis, attitudes tot ards the dlsease and in those who are afflicted, and the appropriate content and vehicresfor dlssemlnatlng public health messages; 14 (vii)supportoPerationalresearchontopicsrelevanttodevo].utionsuch as health systems research (inventories of what actually exists in the Participatingcountriesneedtobeupdated);elternativeivermectin delivery ,yrI"r.; ivermectin's epidemiological i-npact and long term safety; new igElunodiagnostic tools; drug resistance; and cotrmunity parti;iPation ln onchocerciasis control; (vlii) provide technical assistance to Participating Country governments to help- them strengthen the organization and management of disease control. 49. The initial size and professional composition of such a unit should be determlned by OCP management on the basis of what the institution can effectlvely absorb, assunlng that there will be additional funding from the donors to tover the costs of the new unit's personnel and activities. It should, however, aim for a comPlement of three or four higher leve} professionals in Ouagadougou (a social sclentist, an epidemiologist, a public irealth/management speclalist, and a training specialist) ' B ing and Strenethenlng EAC 50. Ife have proposed coneiderable additions to the responsibilities and structure of the OCP so that it cen better address technical and lnstitutional aspects of devolution and maxlmlze it's potential i-urpact on health systems development. Ife therefore Propose' eB !re11, that the JPC suPPort en expended E11C Bembershlp which reflects the growing importance of social and managerial issuee to the future of onchocerciasis control in the region. Specifically' the couurittee should be etrengthened by the addition of new members wlth extengive experience in public health management (especially chemotherapy delivery systems), training and institutionel development, and the social sciences llspecially with regard to cosmunity involvement ln public health). IIHO/AFRO and Devolution 51. Because devolution is of necessity linked to general health systems development, there has been a demand for WIIO/AFRO participatLon in planning for devolution. In collaboration with the OCP, !ffiO/AFRO recently prepared a planning docunent which dlscusses devolution in the wider context of health development strategy for the reS,ion (see WHO/APRO/OCP 1989). This document is useful as a checktist of some prerequisites for successful devolution and it conflrmg the need for considerable external financing to begin setting these eupportLng structures and processes ln place. The NOCS tere not involved in the draftlng of this document but it could be of value to each of theparticlpatlng Countries to gulde their oun review of country speciflc neede for devolutlon ln the contert of general health systems development. Although Its potential financiel contributlon is limited, I&Io/AFRO is encouraging theparticlpating Country g,overilnents to specifically earmark for devolution some of the ifUO/efnO resources at their disposal. IIHO/AFRO can thereby help to highlight the maintenance of onchocerclasis control as an irnportant national health prlority. 15 The Intercountrv Facility 52. Towards the conclueion of OCP, the preparation of an intercountry facillty will be necessary to suppoEt intercountry cooperation and maintain a regional perspective on onchocerciasis control. In particular, this facility will be needed to carry out essential activities that are not within the capabllity of any one of the Participating Countrles acting alone. 53. In functional terms the intercountry facility should: (i) serve as a major infornation system to monitor onchocerciasis on a regular and regional basis in all of the Participating Countries in order to identify changing trends in the pattern of the disease and its recrudescence (it can make use of the extensive radio-network set in place by the OCP which has functioned very effectively); (ii) possess an active Long-term memory against which to evaluate current action progrems and each year it should generate a summary of surveillance results and steps taken for disease control; (iii) coordinate the efforts of different participants ln a network of regional researchinstitutions and disseminate informatj.on to the internetional coumunity; and(v) undertake the tralning and technical assistance functions of the OCp Devolution Unit (es OCP eventually phases out its own actlvities). 54. In term6 of structure, the existing options are few. In 198J., the Independent Comnlssion indicated the OCP as the ideal base from which to develop an intercountry facility and some OcP professionars agree that a leaner OCP, with a nerr mandate, could do the job. Others have suggested that the OCCGE essune the role of intercountry facility, using the pAHO/WHO caribbean Epidemiology center as a model. At present, however, none of the Unlted Nations organizations or intercountry technical cooperation agencies could be expected to provide the same quality and capability in onchocerciasis control as the ocP. one possible solution, therefore, mey be to create annonchocerciasis monltoring agencyn, to be operated by a small international team of disease contror experts, which can conbine the capabirities and coordinate the actions of existing regional research institutions andinterested international agencies. The OCCGE Institutes, which are already used by OCP to train techniciqns and provide expert services, are possible candidates for such a networkS. The Role of t.he Participatins Countries in Devolution 55. 0n the whole, economies in the region are deteriorating and fiscal cutbacks have been especially danaging to health and social services. Effortsto reforn health care in the spirit of Alma Ata, have not proven successful. There ls a large gap between national governments and the needs of ruralpopulations (Azarya and Chazan 1987; Decosae 1990) and health services have tended to have a row prlority in the nationar budgets. consequentry, thePartlclpating countrles have repeatedry called for external support of 5 Th"t" include: the Institute of Tropical Ophthalmology in Bamako, thePierre Rlchet Institute ln Bouakd, National Institutes of Public Health in theParticlpatlng Countries, and several reglonal universities. a 16 national health systems so that they can absorb and sustain the activities of devolution. 55. In this context, the potential fiscal contribution to devolution from the Participating Countries is clearly ljmited. Nonetheless, they can contribute significantly to the process of devolution. First, they can undertake the political task of making onchocerciasis a national priority. ?his is especially important in the core area where the success of the Program can work against it to the extent that onchocerciasis is no Longer perceived as a problem. Public health authorities and the beneficiaries need to be firmly reminded that while the disease may be absent, the risk of recrudescence Is not. Seeond, the Participating Countries must take steps to revitalize the NOCs. The need for this was a key conclusion of the 14th NOC meeting in Ouagadougou (May 1990). The NOCs should solicit assistance from the OCP Devolution Unit to help them identify lssues and problems and to take steps to revitalize and strengthen thelr own efforts and participation in devolution. Third, members of the NOCs and other health ministry personnel can work with the OCP Devolution Unit to prepare the groundwork for health systems research and for later elaboration of hunan resource development plans. The Partlcipating Countries can already begin to prePare inventories of what exists in terms of facilities, programs and human resources. i L7 III. THE ONCHOCERCIASIS CHEMOTHERAPY PROJECT 57. The onchocercLasis chemotherapy Project (ocr) was con6tituted in 1983, followlng e recorulendatlon by the lillO Independent Couurission (I,IHO 1981) that a safe and effective macrofirariclde rrould contribute slgnificantly to future strategic planning of oCP. It was recouurended thatthe JPC provlde the necessary reoources from the Onchocerciasis Fund anddelegate responslbility for the prog,ram to TDR. rn December 19g1, the Jpc requested that I'lHo estabrish the ocr on behalf of ocp. I{hen ocr wasformally eetablished in 1983, Lt was arlocated a budget of usg3.45 millionper annum for five years. 58. The stated objective of ocr is: to accelerate the drscovery and development of a safe, effective, low-cost and easily administeied drug for onchocerciasls, whlch lgill be sultable for large-scale use and which will meet the following criteria: (1) it must kill or permanently sterilize the adult female worms of Onchocerca volvulus, wl.thout at the sane ti-ne causing severe allerglc reactions ln reclplents from microfilaricidal action; and(it) if lt has a mlcrofilaricidal action this should be of long duration, and reactions in the host should be mlninal. OCT's Maior Activities 59. One of the OCT's most important actlvities has been collaboration with the pharmaceutical industry. OCT hae supported two multldlsclplinary research Sroups wlthln drug companies (Welcome Resesrch Laboratorles andUpjohn Co.) and has collaborated with three pharmaceutical companles onpotential antl-onchocerca compounds: Merck, sharp, and Dohne 1us1, JanssenPharmaceutica (Belglun), and ciba-Geigy (swltzerrand) (see Annex 4). 60. rn collaboration wlth Merck, sharp and Dohme, phase r and rr cllnicaltrials of ivermectin were lnitiated against onchocerciasis. ocr arsofunded additionar assays to explore potential problems of toricrty lnlaboratory LnfectLons of bacterlal meningltis in dogs, and Trvpanlsoma rhodesiense infections in priarates. Studies were aieo *0" oFff,iiii'slbleprophylactic effect of ivermectln against developing larvae of Onchlcerca volvulus in the chfurpanzee (no such activity was apparent). rr,- colraboratlon lrlth clba-Gelgy Ltd., two compounds, ccp 6140 and cGp 20376, nhlch have macrofilarlcldal activlty agalnst onchocerca sibsoni In cattle,lrere I'ntroduced Lnto Phase I cllnical trials eor orrctrocerctasis (ccp 6140) and lymphatlc filariasis (cGp 20316) in 1985. rn addition, ocr has collaborated with Janssen Pharmaceutica which has attempted to urodlfyformulations of benzlnldazore for either ilrproved bioavarlabrrty(mebendazole) or painless Lntramuscular injection (flubendazolej (nelther of these objectives was achieved). 18 61. During the past t\ro years, OCT has made a critical appraisal of all fundamental research projects, and only those essential to drug screening, or having potential for identification of drugs in the short term have been retained. Thus, the contracts with the lilelcome Research Laboratories and the Upjohn Company consortium were terminated ln June 1989, when leads showed toxicity and insufficient efficacy. Projects currently funded are directly related to drug screening, preclinical development and clinical trials. 62. The OCT has built up e netlrork of in vivo screening facilities utilizing model filarlal infections in rodents, end g-3!@gi and O. gutturosa in cattle. Laboratories were also encouraged to improve j.n vitro cultivatlon of Onchocerca speci.es and other filariae to provide in vitro drug-screening facilities. As detailed in the Chemotherapy Project Progress Report in 1985 (!mO 1985), basic research was also carried out in varl.ous biochemical areas (see also l{tlO 1990a). 53. Furthermore, the OCT has funded the Onchocerciasis Chemotherapy Research Centre (OCRC) (originally located ln Tanale, Ghana it is now in Hohoe), 8nd has supported a mobile cllnical research team, based in the Unlted Stetes which hae conducted clinical trials in Liberia. 64. SLnce 1983, OCT has funded 73 projects, and the total cost of the prograrn (to Decenber 1989) is approximately US$15.9 million. Many scientiflc publications of high quality on basic biology and chemotherapy, funded by OCT, have been produced during this ti.ure (WHO 1990e). At present, OCT's most inportant contribution has been to assist in ivermectin development, ln particular, in clinical trielB. I{hile not a macrofllarlcide, this product has changed the prospects for Bhort-term dleease control, facilitated changes in on-going strategy, and has made feaslble the planning and execution of devolution. Earlier Reviews of OCT 65. In 1987, an Independent Review of OCT (I{HO 1988a) drew several i-Eportant concluslons and recosurendations. It noted that the discovery of ivermectin as a long-acting microfilaricide had necessarily diverted a substantial proportlon of OCT resources 1/. The review also noted that oCT had proven to be a good mechanism for promoting drug development in collaboration with industry and that a substantial scientiiic and financial investment was being made. Concludlng that the general momentum gained should not be lost, the revl.ew recosurended that, by 1991, alternative means of support be identified sithln TDR to ensure continulty ln the long-term development of drugs against filarial lnfections. 66. In 1988, the CSA also undertook a review of the OCT to re-examine the OCT's mandate, management, and financing. Members of the donor coumunlty and the Expert Advlsory Couurittee (EAC) pertlcipated in this review which reafflrmed thet, lrlth approprlate changes, the OCT would 1/Iversrectin was registered as "Mectlzann for use against onchocerciasis in 1987, and subsequently, OCT handed over all other development of the drug at comunity level to oCP. 19 contl.nue to provide the most satisfactory vehicle for support of macrofllaricide developrnent and that the principal objective of ocr infuture years should be the development of a safe and effective nacrofllaricide consistent with feasible public health delivery. The review recogmended that more pharmaceutical companies should be involved and that OCT procedures for drug discovery and development be changed topemrit a more focused yet flexibre nanagement structure. rt also recomrended that Eore responslbility and authority (especially regarding collaboratlon trith lndustry) be shifted from the OCT's Steering Comsritteeto the OCT Secretariat. The review recoursrended that the function of theSteering Comsrittee should be to evaluate scientiflc merlt, progress and thelever of funding of research contracts. rt also recogmended that us$7 milrion constitute the maxi-slrur ln Ocp support over the period 19g9-1991, and. that such support be fully integrated into the overall ocp budget. 67. The CSA review also recoursrended that future technical reviews of OCTbe made by the EAC (rather than by TDR's technical advisory cosglittee), andfor:ar part of the EAC's Annual Report to the JPC. It therelore recosmended.Btrengthening of the EAC in the area of drug development. rn December1989' JPc 10, on the recosulendation of EAC 10, which favored furtherintegration of OCT into the TDR structure, requested that OCp, SecretaryOcr' and rDR, jointly prepare a scientific plan for macrofilaricidedevelopment for EAC 11 in 1990. 68. Forlowing the csA review of ocr activities ir was decided to amargamate the drug development resources of ocr with those of TDR forFilariasis (?DR/FiI), in order to improve the chances of success and reduceoverall costs. The Preclinical Drug Development Team (PDDT) was therefore established which deals with matters of drug screening and development outslde the usual steering cosmittees. This has proven to be " rrlrypositive and valuable development. The OCP/TDR Macrofil proiecr 69. At EAC 11 (1990), the Dl.rectors of OCP and TDR recogrsrended that ajoint OCP/TDR project be estabrished for the deveropment of amacrofLlarlcldal drug. The recourendatLon stated: "the activity must befocused on the search for a macrofilarlcide, and not be diluted Ly otheractivities; that 8 streanlining galn must be achieved; and unnecer".ry changes be avoided". The proposal merges all macrofilaricide activitiesfor both onchocerciasl.s and fllariasls-into one project nanagement group.The OCP/TDR Macrofir Project is to be funded 5orntr! by ocp ind roRl eachnaklng contributions that will be managed r"p.r"t"ty, i.e. there will be nochange in present financial reporting, or oct-r".o,rrl"r, and rDR willestablish I ne!, budger llne for ocp/TDR Macrofil. The ocp/TDR MacrofilProject will be, as in OCT, under the technical supervision of the Directorof TDR. rn order to avoid duplication of reports, a singre report ,,irr beprepared annually whlch w111 go to the EAC and to TDR's technlcal advisorybody (sTAC). The Dlrectors of ocP/TDR are satisfled that the arrangemenrsoutlined will facilltate any procedures necessary for the rapid developmentof a macrofilariclde, and 8t the same ti-me proviie accountability for the ocP/TDR Macrofil to both ocP and TDR. These arrangements lrere endorsed byEAC 11 in June 1990 (I{tsO 1990a). 20 Conclusions and Reconrmendations 70. Ivermectin was e serendipitous windfall from veterinary medicine which has now emerged as an acceptable microfilaricidal agent. The search for a macrofilaricide suitable for mass chemotheraPy is, however, the prinicipal objective of OCT's endeavour and must continue to be addressed through screening of many more compounds from a larger range of pharmaceutical sources. 7L. The urgency to find and develop a macrofilaricide may generate undue pressures on ocT, and lt is understandable that every opportunlty is taken, therefore, to screen compounds showing potential anti-onchocercal ectivity, partlcularly when preclinical work is undertaken by the pharnaceutical source. However, clinLcal triale of any compound, including CGI 18041 and CGP 6140 (see Anner 4) should not be pursued unless an acceptable toxicological profile is available. 72. Care should be taken that the goal of OCT to develop a macrofllaricide is not in any way diluted ln the proposed future amalgamatlon of oCT with TDR Filariasls. Therefore, the Etatus of the OCP/TDR Macrofil Project should be carefully monitored vis-a-vis future developments within TDR. 73. OCP/TDR should adopt a flerible financial policy with regard to apeclal research and development costs which may arise in relation to e novel compound. In the event that a compound is found, the new OCP/TDR Macrofil Project ehould have the capaclty to undertake the requisite precllnical and clinical trials. It may even be necessary to essist financially in research and development with respect to toxicological requl.rements such ae carcinogenicity teeting,. Development costs of a novel compound w111 depend on paralleI interests which the respective pharmaceutlcal source might have. It w111, however, probably be necessary to provLde extra budget to meet special screening needs. 74. OCt should continue to pursue development of a sensitlvity assay for microfilariae of O. volvulus to ivermectin in order to detect possible resistance to the drug, especially in llght of expanded populatlon chemotherapy ln the l{estern Extension and throughout the OCP area. 75. Industry should be made alrare of known drug targets in filarial lnfections, and that drugs whlch may be produced for other purposes' particularly veterLnary products, should be tested for antiparasitic actlvity Ln hunan Lnfections. There is lnsufficient funding available to address basic research and rational chemotheraPy development, lrithout additional industrial input. Continued support for research on specific blochemlcal pathways is also inportant as well as efforts to identify ne\f, blological drug targets in filariae. 76. Representativeo of the drug industry should be lnvited to participete in appropriate OCT meetings in order to encourage dialogue with industry. 2t IV SOCIOECONOMIC DEVELOPMENT OF THE ONCHOCERCIASIS AREAS Major Issues 77, The capacity for economlc development of the onchocerciasls areas islimlted ln every country, therefore no country ls now planning or lmplementingprogratns commensurete wlth the potential of the onchocerciasis areas. 78. In all eleven countries efficient allocation of investment resources cannoE be undertaken outslde the context of the national economy; independentplanning for the onchocerciasls areas is probably inefficient and counterproductive. The particlpating countries should be encouraged toincorporate planning for onchocerciasis ereas ln overall country flanning. 79. In all countries, fundamental requirements for effective economicdevelopment of the onchocerciasis zones are generally absent and need to befi11ed. 80. The questlon of adequacy of plans and actions can be approached with respect to the considerable efforts made by the csA which inspired andassisted in onchocerciasie area studles undertaken by the pariicipating countries, the nHuntlngn report, the Land settlement Revlew and the socioeconomic development consultations between each participating Country andthe CSA, Ied by the l{orld Bank, as well as the comprehensive or"rill nationaldevelopment plans, actions, budgets and resour"". Lf the participatingcountries. Alternatively, the guestlon may be approached lrith rlrp""I to theactual development plans and activities in the onchocerciasj.s rorr"a, in thespecific context of the overall national plans and development actions in eachcountry. 81. Are the Participating Countries pursuing development opportunities inthelr onchocercl-asis zones coErrnensurate with itre potentiat, iLtative to otherlnvestment options ln the country in the context or tn" country,s resources(including those avallable from external sources) and the eocial and political consideratLons confronting the decision-makers? 82. The answer to thls queston is that the respective country euthoritles are undertaking the optimal choicee in their cirlumstances. Tirls response is,ln a sense trivial, but in another, quite revealing: national pranneis andinvestment declsion makers are aware of the potentlals of their onchocerciasis aress and the prlorlties in the national schemes. National authorltles may beoverly lnformed, insofar as the ocp and csA instst on focueing, perhaps too much, on onchocerciasis areas whlch rnay be relatively poor developr"rri cholcesin the national context. In other cases the onchoceiciasis zones are the onlyalternative ereas for development and in these instances the csA/ocp effortsto steer development towards them may be irrelevant. Responslble lnvestments are not undertaken just because certain sites are onchocercLasls-freed. z2 83. The OCP countries have often been overwhelmed by advice from donor international agencies and NGOs who insist on one or another development actlvl.ty. This advice, which may come from the OCP as well, is based on objectives (motives) whlch may or may not be compatible with overall country goa1e. 84. Since the beginning of the Program, the CSA and the oCP have been preoccupied vith development of the onchocerciasis zones. These efforts resulted first in a serles of national impact studies (circa 1985) undertaken by the NOCs to identify (economlc) effects and opportunities arising from successful control of onchocerciasis. These varied in quality but, in general, the results lrere poor. The CSA folloned up wlth several major studl.es: The Huntlng Report (Socloeconomic Development Studies in the OCP Areas), the Land Settlement Review and the Natlonal Oncho-Zone Development Studles. On the whole, these studies usefully contribute to a better understanding of the onchocerciael,s zones as rrell as to relevant socio- denographlc proceeses (e.9. land settlement). However, they ehould not be ueed to Justtfy prlvileged development of the onchocerciasis areas. Rather, they ought to be incorporated lnto each country'B over811 natlonal development plans Ln a reallstic fashlon. 85. At thie point the Participatlng Countries have in hand a considerable amount of lnformation about the onchocerciasis areas produced by themselves or by the CSA, ae well ae other studies, plans, and prograsls of natlonal scope which are also of relevance to the onchocerciasis areag. Assessment of potential productive activitleq 86. Both the Huntlng etudiee and the World Bank-Ied CSA mlsslons on socioeconomJ.c development have addressed the question of development prlorJ.tles in some detail. The Hunting studl.es generated a nuurber of proposals and suggeetions for National Oncho-Zone Development Studies and a prlority development project for each of the seven original Participating Countrl.es. The Bank'e eocloeconomic development mlssions reviewed these and further narrowed the choices. The Land Settlement Revierv provided useful insights and recomendations to additionally refine the possiblllties. This Erternal Review cannot Ln the tlme availeble do much to enhance what has already been done. We note however that lt appears that the socioeconomlc development progran, proposed and carried out by the CSA since 1987, has accomplished just about all it cen in attempting to promote economlc development in the zone. Each of the preparatory studLes and reconsrendations nay well be justified ln terms of its internal merits, but they can only be properly appralsed ln the natlonal context and this has, generally, not been and probably cannot be done by the CSA/OCP or thelr varloue technical consultants. Development proposals in the onchocerclasis zone can only be properly addreseed a8 a component of the country's overall investment planning. It ls time for the Participating Countries to integrate the data, analyses and recouurendations into their national planning and investment allocation processes. 87. we have attempted, in the country specific analyses in Annex 3, a subjective assessment of the possibility for significant development in the onchocerciasis zone given current economic conditions in each country, a sortof necessary 'condltions precedent" for successful development in th; zones, and the level of development actlvity underway or planned. Having done this,the Lnteresting question becomes: Given the conditions of the refpective national economies, the global priorities of the Particlpating Countries andthe constraints confronting development of the onchocerciasis-zones, what would be the most constructlve actlvities for development of the zones at thistlne? lJtrile eech economy has a different mix of constraints, there are some obstacles which are frequent and of possibly decisive importance. In order to expedite development ln the onchocerciasis zone the Participating Countries shourd assure, as prlorities, that: (a) agricultural price porlc! and marketing regulations must be consistent with free maiket piinciptes, (b) Iandtitllng and transfers should be standardized and secure, (c) there is adequatephyslcal access to areas appropriate for development and (d) the regulations and training necessary to assure environrnental itability are in plafe. Thesewill provide the minimal incentives to facilitate access and enclurageindividual initLative for sustainable development. Complementary prioritylnputs required in addition to these are! (a) adult literacy and rlleventprinary schools, (b) convenient water points for domestic use and (c) healthcere services. 23 88. Authorities in the participatlng countries must make their onchocerclasie zone declsione in the national socLoeconomic developmentcontext. The best (and most efficient) contribution that the oCp can make tothe economic development of the onchocerciasis zones is to conti.nue itssuccessful dj.sease control efforts and to continue promoting general healthservices development through its involvemen! with llcal Ministrles of Health. 24 V. CONCLUSIONS AND RECOMMENDATIONS Protection of the Program's Achievements 89. In order to protect the oCP's achievements in the core area, the JPC must continue to support fulI-scale vector control operations in the extension areas, in particular, in areas which rrere sources of reinvasion of the original area. Operational research has confirmed that a minimum of 14 years of continuous larviciding is necessary to eliminate transmission of onchocerciasis. Therefore, larviciding should continue in these areas for at least that perlod of tlme. OCP can thus leave the Participating Countries in the best possible position to assume responsibility for maintaining onchocerciaisis control. Research To Deflne the Pa ters of Ivermectin Use 90. The following research questions ere essential to the future of onchocercLasis control. The JPC should consi.der the research needs identified here and adopt a llst of research priorities. It must also consider and determine how these studies will be financed. Research is needed on: (i) the precise timing of lnterventlon with ivermectin distribution to control recrudescence; (ii) the impact of ivermectin on transmission at more frequent dosages (e.g. 3 to 4 month intervals)i (iii) the minimum safe interval between ivermectin treatments; (iv) the efficacy of ivermectin treatment over I prolonged period J.n preventing, halting or reversing eye disease; (v) the possible lesser impact of ivermectin in early infections and the implications for detecting and controlling recrudescence; (vi) all aspects of ivermectin delivery systems including behavioral/cultural aspects; (vii) development of an lgulunodiagnostic test to detect low levels of infection; and (viii) basic health systems research on the existing structures and capabilities in the Participating Countries in order to determine what wIll be needed to effectively implement ivermectin delivery and epidemiological surveillance. In addition, the Program should bear in mind the need for a future review of the epideniological impact of ivermectin use ln order to rea8sess its role In onchocerclasis control strategy. Continue SuDDort for Mac rof ilaricide Development 91. The OCP efforts, through the oCT, in drug development have been of great value. The field trials for ivermectin were instrumental ln preparing for use of the drug in selective mass treatment to alleviate the symptoms of onchocercLasls. The need for a safe and effective macrofilaricide has not dlsrinished, however. The new OCP/TDR Macrofil Project whlch will join OCT and TDR efforts in drug development for filariasis is a positive step which can enhance the search for a macrofilaricide. This effort should be fully supported so that an increased nunber of compounds from as many pharmaceutical sources as possible can be screened. OCP/TDR should adopt a flexible financial pollcy with regard to special research and development costs whlch 25 may arise in relation to a novel compound (e.g. toxicology testing). In addition, industry should be invited to participate in future Steering Cormittee meetings. Efforts should be made to increase industry awareness of knorm drug targets in fllarial infections. Industry should be encouraged totest drugs produced for other purposes (e.g. veterinary products) for antiperasitic activity in human infections. Maintain OCP's Successful Institut ional Arrangements 92. The present institutional arrangements of the Program including each ofits statutory decision rraking and advisory bodies should be maintained becat sethey have been criticar to the Prograrn's success. The autonomy andflexibllity of the Program, coupled with its checks and balances, have been essential in allowing lt to plan effectively and implement efficiently while responding quickly to changing conditions and needs. An OCP Devolution Unit 93. we recormend broadening the scope of ocp's functions through the creation of a Devolutlon Unit within OCP. This unit should employ at least 3 or 4 professionals (a social scientlst, an epidemiologist, a public hearth/management speciarist, and I training speciarist) to: (i) assist theParticipating Countries in preparation of htrman resource development plans;(ii) deslgn and manage training and in-service training in multi-disease surveillance and drug distribution; (1ii) undertake a management trainingprogram for mid- and upper level nationar personner; (iv) promote g,reater involvement of nationel team personnel, at all leveIs, in strategic planning, supervision, and evaluation; (v) sensitize Participating Country gorr-rrrmentsto the need to establish onchocerclasis as a high priority in pubiic health,to plan for the eventual absorption of OCP trained personnel jn national structures and to promote relevant couurunity education and mobilization activities; (vi) support operational research on topics relevant todevolution; and (vii) provide technical assistance to Participating Countrygovernments ln order to strengthen organization and management of disease control. An Intercoun try Facility 94. The JPC must consider how to organize and finance the proposed inter- country facility which would function to: (i) coordinate onchocerciasis surveillance at a regional level; (ii) coordi.nate efforts of a network of regional research institutions involved in onchocerciasls research; and (iii) undertake the training and technical assistance functions of the ocpDevolutlon unit rrhen OcP eventually phases out lts own activitles. Strengthening the Expert Adv isory Conrnlt,tee 95. We also proPose that the JPC support an expanded EAC membership which reflects the growing lmportance of social and managerial lssues to the future of onchocerciaisis control in the region. Specifically, the cosrulittee shouldbe strengthened by the addition of new members wLth extensive experlence inpublic health menagement (especially chemotherapy dellvery systems), training and institutional develoPment, to cosurunity mobilization) . 26 and the social sciences (especially in regard Soc ioeconomic Development 96. The CSA preparatory program on socioeconomic development, approved by JPC.7 in Accra in 1986, is nearing completion. We recogutend that the CSA, interested donors, and Participating Countries, taking into account the various conclusLons of the socioeconomic reports produced by the CSA' jointly support socloeconomic develoPment planning and programs for the onchocerciasis-freed arees and ensure the integration of such planning into the broader national development strategy of each of the Participating Countrles. 27 REFERENCES Azerya, v. and chazan, N. 1987. Disengagement from the state in Africa: Reflections on the Experience of Ghana and Guinea. In Comparative Studles in Soclety and History, January 19g7:106_131. Benton, B. and Skinner, E. 1990. Cost-Benefits of OnchocerciasisControl. In Acta Leidensia 59(1,2):405-411. Burkina Faso Minlstry of Health. 1988. Burkina Faso: Husun Trypanosomiasls Surveillance and Control. Faso Minlstry of Health. Onchocerci.asis and Ouagadougou: Burkina Dadzie, K.Y., Remme J., Rolland, A., Thylefors, B. 1996. The effect of 7-8 years of Vector Control on the Evolution of Ocular Onchocerciasisin IJest African Savanna. Tropical Medicine and Parasitoloev 37:263-270 1989. Ocular Onchocerciasis and Intensity of Infection in the ConnunityII. Tropical Medicine and Parasitolosv (no. 3) 40:348-354. Davis, A. L982. In Schistosomiasis: Epidemiology, Treatment and Control,Jordan, P. and G. I{ebbe, eds. London: Heinemann t{eaicar sooks Lta. Decosas, J. 1990. Planning for primary Hearth care: the case of theSierra Leone National Action PIan. In International Journal of HealthServlces, 20 (1) : L67-L77 . Guinea-Blssau. 1988. Plano Quadrienal de Desenvorvimento EconomicoSocial, 1989-92, Bissau. Huntlng Technical Servl.ces, Ltd. 199g. socloeconomic DevelopmentStudles ln the Onchocerciasis Control Prograrure Area. Volusre 1. MalnReport. Hemel Hempstead, Herts, Eng1and. Koenlg, Dolores. 1990. Land settrement Review, country case study: Mall.Binghamton, N.Y. ! Institute for Development enthropology. Mali Mlnistry of Health. 1989. MaLi: surveilrance and control ofOnchocercj.asis, Trypanosomiasl.s and Other Blinding Dlseases: Devolution P1an. Niger Ministry of Public Health. 1989. Niger: plan for Devolution ofthe onchocerciasis and Leprosy surveillance and control program. Onchocerclasis Control Prograrme (OCp).Strategy. Docunent OCp/84.4. 1984. Proposal for a Long-Term 1988. A CSA Progress Report on nDevolutionn. OCp/JpC 9.98. 28 1989. Prospective Evaluation of Onchocerciasis Control in the OCP: The Application of a Transmission Model. Information document for donors' seminar, Paris, 18-19 October, 1989. 1990a. Report of the Annual Internal Technical Review Meeting ocP/EAC/11.4. 1990b. Report of the Eleventh Session of the Ecological croup. ocP /EAC / r.1 . 1 l-990c. Task Force on Ivermectin Treatment in the Northern Part of the Western Extension (unpublished report) . Reume J., Ba, O., Dadzie, K.Y., Karam, M. 1985. A Force of Infection Model for Onchocerciasis and its Application in the Epidemiological Evaluation of the Onchocerciasis Control Prograuune in the Vo1ta River Basin Area. Bulletin of the World Health Organization 64 2667 -68L Remne, J., Dadzie, K.Y., Rolland, A. and Thylefors, B. 1989. Ocular Onchocerciasis and Intensity of Infectlon in the Comnunity I. Tropical Medicine and Parasitology (no. 3) 40:340-347. United Nations Development Program (ITNDP). 1988. Quatrieme Prograume du Benin. Document DP/CP/BEN/4. IrNDP/FAO/IBRD/!IHO. 1973. Onchocerciasis Control in the Volta River Basin Area: Report of the Preparatory Assistance Mission to the Governments of Dahomey, Ghana, Ivory Coast, Mali, Niger, Togo, and Upper Volta. Docuslent OCP/73.1. United States Agency for International Development (USAID). 1986. Impact Review of the Onchocerclasis Control Prograrune. Washington, D.C.:USAID World Health Organization (l{HO). 1970. IITIO, Onchocerciasis Control, Volta River Basin, Report of an Inter-egency Planning Meeting, 6-7 JuIy, 1970. 1981. WHO Independent Cosulission on the Long Term Prospects of the Onchocerciasis Control Program, Final Report. L985. Report on the Onchocerciasis Chemotherapy Project. Document ocP/8s.3. 1988a. Independent Review of the Onchocerciasis Chemotherapy Project Document JPC 8(b) /1988. 1988b. Report of the Steering Corurittee of the Scientific Working Group on Filariasis. Docugrent TDR/Fi1/SC.SG (83-88) 188.3. 1989. Report of the Tenth Session of the Expert Advisory Corurittee. ocP/EAC/8e.1 29 1990a. Report of the Eleventh Session of the Expert Advisory Committee Document oCP/EAC/11.. 1.. 1.990b. rDR Product Development unir (pDU). Document rDR/srAc -t2lgo.4. 1990c. Fifteenth Steering Corulittee of the Onchocerciasis ChemotherapyProject. Docunent OCT/SC - SlgO, 1990d. Report of the Onchocerciasis Chemotherapy project. ocP/EAC/11.3 . 1.990e. Report of the Onchocerciasis ocP/EAC/11..3. Chemotherapy Project (Appendix 3) I{Ho/AFRO/OcP. 1989. Devolution of the onchocerciasis Control prograrune ln the Framework of the Three Phase Health Development Scenaiio for theAfrlca Reglon. Document prepared by I.llIO/AFRO/OCP, Brazzaville, November 1989. llor1d Bank. 1988. Togo, Third Structural Adjustment program. Report No. P-4765-T0, March 1988. YFrneogo, L., Levequ€, C., Traore, K. and Fal.rhurst, C.p. 1 Dlx Ans de Surveillance de la Faune Aquatiques des Ri L'Ouest Traitees Contre les Si^glulies (Diptera: Si_muli Vecteurs de L'Onchocercose Humaine - Naturaliste can. LLS:287 -298 . 988. vieres D'Afrique de idae), Agents Rev. Eco1. svst.

30 Onchocerciasis Control Programme rn West Africa Programrne de Lutte contre I'Onchocercosc en Afriquc de t'Ouest. JOINT PROGRAIITIVTE COMMITTEE Officc of the Chairman JPC .CCP COMITE CONJOINT DU PROGRI"\'IME Bureau du Pr€sident JPC10.9 ORIGINAL: ENGLISH Novenber 1!8! JOINT'366P6}{ME COMMITTEE Tent.h session The Hanre, 4-7 Decenber 1Q8q Provisional agenda iten 14 COI'ERING NOTE ONCBOCERCIASIS CoNlRoL PROGRAIt{E r DRAFT TERTS OF REFERENCE FOB AII EXIEBNAL REI'IET 1. It rras suggested by a urenber of the Joint Programre Cosmittee(JPC) durlng the Nlnth Sesslon of the JPC in Dakar in Decenber 1988. thrt 'an external evaluation be conducted before the end of thc Third Financlal Phase to assess protrees torrards achleving Programre obJectlver end towerds devolution and socioecononic development'. Bcsed upon thst sugg,estion, the Cosflrittee of Sponsoring Agencies has prepared the attrched draft temrs of reference (TORs) for an erternal revies. 2. The CSA has agreed to assusre responslbllity for organizlng the tean of consultants who will conduct the external review and to assist in coordinating their actlvities. This team will be selected from candldates nominated by JPC members based upon the profiles of the tean positions described in Section V of the attached TORs. 3. The upper li.srit of the cost of the external review is esti-nated to be USS300.000. It is expected that this cost will be borne by voluntary contributions from lnterested donors. Several donors have lndicated s willlngness to aseist in thk flnancing. It is proposed that funde for the external review bc untied and channeled through a separate trust fund to be adninistered by the lIorld Bank. 4, Once the attached tORs have been approved by th€ JPC, the CSA will begln the process of solicitlng candidate nomlnations for the external review tean. The obJective uill be to assemble a tealr !s soon as possible following approval by the JPC. The timefrane for completlon of the erternal revien would entail having the flnal report submitted for consideration at JPC.11. 30 a ANNEX 1 Page 1 of 4 TERI.IS OT' REFERENCE ONCBOCERCIASIS CONTROL PROGRAMME ttoERItAL REVIEw, 1990 I. Background L. The Onchocercissls Control Prograume (OCP) is a multi-donor regional disease control effort set up in 1974 at the request of seven countries in the Volta River Basin: Benin, Burkina Faso, Ghana, COte d'Ivoire, Mali, Niger and Togo. Four other countries joined the Progranure in 1985: Guinea, Guinea- Bissau, Senegal and Sierra Leone. The OCP area presently covers about 1,300,000 km2, wlth a population of 30 million. The Progranrne has been treeting, approximately 50,000 km of rivers throughout the OCP area. 2. The World Health Organization is the executing agency for OCP. Overall decisions regarding policy and planning for the Programme ere made by a Joint Prograrme Couurittee (JPC) consisting of representatj.ves of the 11participating African countries, 23 donors and the four Sponsoring Agencies: the United Nations Development Programme (UNDP), the Food and Agriculture Organization (FAO), the World Bank, and the l{or1d Health Organization (I{HO) . The l{orld Bank mobilizes funding for OCP, manages the Prograume's trust fund, and is the principal contact rrith the participating donor coumunity. 3. The Cosurittee of Sponsoring Agencies (CSA), which is comprised of ITNDP, FAO, World Bank, and WIIO, acts as nsteering couurittee' for the Prograrrne. It meets quarterly to review work plans and budgets, monitor OCP operations, and examine reports prepared by the Programme's advisory bodies(described below). The CSA was assigned by the 1985 JPC the speciflc responslbility for coordinating preparatory socioeconomic development activities in collaboration with the 1.1 Participating Countries in areas where onchocerclasio control is underway. In response, the CSA has initiated a serLes of socloecononic development studies to identify development opportunities and to propose follow-up actions in the onchocerciasis controlled eree6 of the Participating Countries. 4. The Programe Ls evaluated annually by an independent Expert Advlsory Couurlttee and an Ecological Group which provide guidance on scientlflc, technical and ecological matters. The members are experts in their fields who are selected by the Prograuure's Sponsoring Agencies. 5. In 1981 an Independent Cornrission reviewed the Onchocerclasis Control Programe and submitted to the Joint Prograume Couurittee recorrnendations regarding the Prograuure's long-tenn pro6pects. 6. In 1985, the USAID undertook an evaluation mission on the Progrerilne and prePared a report which was subsequently circulated to all members of the JPC endorsing the operational management and the success achieved by then. 31 ANNEX 1 Page 2 of 4 7. At JPC.9 in Dakar a suggesti.on was made that nan external evaluation be conducted before the end of the Third Financial Phase to assess progress towards achieving Programme objectives and towards devolution and socioeconomic development. i 8. In response, thls paper draws up the Terms of Reference for an external review with a view to having a final report presented to JPC.11 in December 1990. II. 0bi ectives 9 The objectives of the external review are aB follows: (e) to take stock of ocP's progress to date, examine the reasons for ocP'e achievements, and draw ressons whlch mlght have applicabilityto other projects and prograuures; (b) to assesB progress torrarde devolvlng responsibiritles to thePartlclpatlng Countrles for ensuring that there ls no recrudescence of onchocerciaels, including strengthening national epldemiological surveillance and training capacities ; (c) to assess progress towards promoting future socioeconomic development of areas where onchocerclaeis is now or soon wlrl be under "ont.tl;and (d) to hlghlight relevant lssues for the future of the prograrune, to make appropriate recoErnendations for attaining ocp's objective, and to eranine ocP'e potential long-run contrlbution to health systemdevelopment in the Participating Countries. III. 10. and re on 80c evalua 11 (a) (b) Terms of Reference The erternal revlew should take into eccount prior concluslons cosmendatlons of the Erpert Advisory committee and the work of the csAioeconomlc development, as well as the findings of previous reviews andtions. The external review team shall: take stock of ocP operations to date and the progress made in boththe original area and extension areas in reducin[ tt" disease to alever where lt ls no longer of public health and socioeconomic irnportance; exrmlne ocP's institutional arrangements and structure, Lncluding mechanisms for intercountry cooperation; 32 ANNEX 1 Page 3 of 4 (c) assess the reasons for OcP's achievements and draw ressons which might have applicability to other projects and progranrmes; (d) assess plans and mechanisms in place to distribute i.vermectin, the effectiveness of the Progranune's means for evaluating the epidemiological impact of ivermectin distribution, the cost of ivermectin treetment and its future budgetary implications, and the requi.rements for drug distribution mechanisms in the devolution phase; (e) assess OCP and Particlpating Country activities currently underway orplanned for strengthening the capacity of the Participating countriesto esBusle responsibilities for maintaining control of onchocerciasis; (f) assess ocP's present and potentiar role in contributing to health care system development of the participating Countri.es; (g) assess the lmpllcations, both structural and financial, including an estinate of rong-tenn recurrent costs, of malntaining contror of onchocerciasis post-ocP, taking lnto account the difference i.n approaches required in the extension areas as opposed to the original area in view of the ismediate ective natl-onal involvement in ocp oPeretions in the extension countries. Thls asses6ment would include studying the poeslbility of the need for some form of post_OCpinstitutl.onar mechanism for coordinating control maintenance activlties throughout the prograuure area; (h) revlew the progress and achievements of the onchocerciasis Chemotherapy Project; (i) assess the adequacy of the actions undertaken and planned to promote environmentally sound, sustainabre socioeconomic deveropment of the area6 already, or soon to be, freed from onchocerciasi_s; and asseEs the potentlal of various posslble productive activities within( j ) the onchocerclaers-controlled areas for future socioeconomic development. IV. Coordination L2. The CSA will be responsible for organizing the external review team and assisting in coordinating its activities. 33 ANNEX 1 Page 4 of 4V. Composition of the Revlew Team 13. The CSA w111 select the external review teasr including the teamleader. JPC members w111 be invited to propose candidates with relevant curriculum vitae for the team positions. The core team would consist of the followlng positJ.ons: (a) Health Administrator. Must be qualified in public health administration with relevant experience in project and/or progranme evaluatlon, as well as working on large health progrelrnes and/or other multidisclplinary prograsmes in developing countries. Must befluent ln Engrish or French and have a good worklng knowledge of the other. (b) Tropical Disease Specialist. Must be quallfied in public health and have experlence In the epidemiorogy of tropicar diseases and in the control of such diseases through large-scare control prograrns. Must have adequate experience ln Africa. Must be fluent in English or French and have a good working knowledge of the other. (c) Economist. Must be quarified generar economist with relevant experience ln project analysls, land/resource use, and rural development ln developlng countrles. Must be fluent in English or French and have a good working knowledge of the other. (d) rnstitutlonar Management specl.alist. Must have experl.ence with assessment of publlc lnstltutions, and background ln instttutlonal management and lnternational aid coordination, as well as knowledge of United Nations family of organizatlons and extensive experience inproject/programne evaluation. Must be fluent in Engllsh oi French and have a good worklng knowledge of the other. (e) Executive secretary. Must be quarlfied professional-Ievel coordlnator of activLties, have familiarity with the United Natlons system, and have had similar associatlon wlth the plannlng and suPport of large-scale health prograuures in developing countrles. Must be fluent in English with a good working knouledge of French. The team leader would be selected from one of the above candldates. He or she must be fluent ln both Engllsh and French and nust be accustomed to worklng with senior-level pollcy makers in African countries, United Natlons agencies, and donor countriee/agencles. In addition, the teasr leader would have theeuthority to recruit short-term highly speclalized technical aseistance, as requl.red. October 1989 34 ANNEX 2 Page 1 of 4 COI]NTRY DEVOLUTION PLANS : BIIRKINA FASO, I{ALI AND NIGER BurkLna Faso 1. Transmission of onchocerciasis has been interrupted in Burkina with the erception of e stretch of the Dienkoa river around the village of Pendie. The parasite reservoir has not yet been elisrinated in the country but it is declining fast and ls expected to become insigniflcant by the turn of the century. Larvlclding may be lnterrupted at that point subject to the findings of ertensive epidemiological surveillance. Burkina Faso's devolution plans provlde for this surveillance in combination with detection of other diseases, trypanosomlesis, in particular. The plan also includes passive and active(nas6) treatment with lvernectin. 2. Epidemiological surveillance will be carried out by mobile teams based in the provlnces wlth the partlcipation of fixed departmental health facillties and PHC posts served by volunteers (a male health worker, equipped wlth a bicycle, and a midwife). Distrlbution of ivermectln will be carried out vertically by the departmental leveI. The plan provides for mass treatment Et least once a year and continuing passive treetment. It is anticLpated that passive treatment rrill be problematic since beneficiaries would have to travel 10-15 kms to reach a distributlon point. If this does not work the patient will also have to be reached vertically in villages which are not to be covered by mass treatment. 3. Under the present circumstences, this seems the most appropriate plan. As ln other countries of the region, the integration of vertical and horLzontal progrdlrnes will remain an ideal for the foreseeable future. Burkina, one of the poorest of the OCP countries, has established 5,704 PHC posts. Many do not operete and those which do are uncertain and problematic. Only half of the country's population is covered. Frequent abandonment of health poots may be due in part to the fact that staff are volunteers. The posts are lnsufficiently supervised and poorly equipped. Essential medicines are poorly supplled and stocks are often not replenished. There ls a lack of accountabillty and coursrunicetion with supervisory authorities. Counrunity partlcipation is insufflcient or absent. The 57 medical centers operatlng at the departmental level under physlclans are also poor in human and material resourceg. The aame can be said of the Provlncial Directorates of Health and Soclal Actlon. Generally the publlc health syetem, from the center to the village, has a weak structure end is poorly planned, adninistered and coordlnated. 4. Devolution of OCP activities has been seen in Burklna (and in other countries in the same situatlon) as an opportunity for strengthening the national PHC system. In this case the devolution plan "falls within the frame-work of a policy of globaI development" (Burklna Faso 1988). The plan 35 ANNEX 2 Page 2 of 4 wae costed at about 600 million CFA in 1988 (roughly US$2.3 urilllon) and is expected to be financed by external aid. Recurrent costs account for about 242 of the total. The cost of the plan is relatively low for a prograxn thatle so highly valued. However, plans are usually assessed not only with reference to thelr cost and value but also according to thelr potential effectiveness in the long term. In thls respect Burkina has set a precedent whlch potential donors may hope to see in other countries. Devolution startedin Burklna rsith erternal funding. The OCP, to promote devolution, contributed $CFA 5.0 million for the tralning of 195 nationals ln epidemlological surveillance and drug distribution. Burkina has already established three out of slx tearno provided for ln its devolution plan. Devolution will thus evolveln stages lrith fornal evaluatl.ons propoeed for each stage. The plan was to begin ln 1989 but due to the lack of external funding it was postponed for tlro year8. 5. The Ministers of Health and Planning have sought funding from several countries and internatlonal agencies but so far neither bilateral nor multllateral aid has been recelved. It seem6 that initially potential donors rrere not approached through the right channels and procedures and advice on these metters from OCP and internatl.onal agencies did not come until recently. oCP hae proposed thst UNDP Bet up roundtable discussions with potential donors and UNDP has recently hired a consultant for this purpose. Generally, there hae been a feeling of uncertainty about the lntentions of donor countries andinternationar agencies since the adoption of Burklna's plan. rt now seems unlikely that the governnent w111 move ahead with devolutlon wlthout external ald. MaIl 6. l'[81i's devolution plan covers the original area of OCP activities whlch repre8ents about 402 of the country's territory snd which has a high potentlatfor socioeconomlc development. Disease transmlsslon is under control in this area with the exceptlon of four dletricts rrhere blackfly relnvasion occurred. The llberated zonee heve seen considerable economlc developnent sl.nce the end of the drought. Signtficant irurlgratlon has followed and lt is likely tolncrease. Thie, together wlth favorable clisratlc condltions and the termination of larvlcidlng pose a serloue threat of recrudescence of thedlsease (Mall 1989:9). 7. The whole of the orlglnal OCP area ln l,tali faces increaslng prevalence of dlseases such aB trypanosomlasis and other bllndlng diseasee. The control of these dlseases w111 be combined with the actlvlties to be devolved from the ocP. 8. Like Burkina, Mali has seen severe economic hardship over the pastflfteen years. Thls is reflected in the country's poor demographic and healthindlcators. only 252 of the population hae accesc to hearth care (Mari1989:11). servlces ere provided mainly at the dtstrlct level and they arepoorly financed, supplied, adminietered and staffed. I 36 ANNEX 2 Page 3 of 4 g. Mali's devolution plan proposes epidemiological surveys, active (mass) and passive treatment with ivermectin and monitoring of indicator villages every three years. Passive treatment with ivermectin is to be provided by district health centere whlch will be responsible for all activities concerning the control of onchocerciasis, trypanosomiasis and other blinding diseases. The proposed Progralflne is a vertical one and basically sati.sfactory. It ls to be evaluated in the third and fifth year of its operation. Its cost is relatlvely at the sane level as that of Burkina's plan. 10. It mu6t be noted that Mali's plan contains I Ti$e-table of Activitles which does not show any specific years. This is an indication of the country's reluctance to begin implementation of the plan before obtaining external aid. Attempts have been made to attract bilateral and multilateral funding but Mali has had no more auccess than Burkina in this respect. Progress torrards devolution wlthout such funding is doubtful. Nlger 11. Un1ike the other countries of the orlginal OCP area, Nlger rras not greatly affected by the disease when operatlons began. Only two regions, Say and Tera, along the Niger river were affected. The population exposed to the disease wae 224,000 but only about 300 people were found to have impaired vl.sion. Epideuriological surveyB have ehown that trsnsmission of onchocerciasis i6 virtually J.nterrupted in the whole area covered by the OCP. Although the reservoir of the disease has not been ellminated it is expected to decreese to lnsignlficant levels after about fifteen years of control. LZ. Niger is one of the poorest countries in the rrorld and one of the first to establish a voluntary PHC network in the 1960's (about ten yeers before the Alma Ata Declaratlon). The country'e devolution plan recorded this fact and declared that "Niger subecribes fully to the IIHO's Bocial goaI, health for all by the year 2000' (Niger 1989:8). However, the country's vital statistlcs on the same page shov a bleak picture which indlcates that Niger is far from that goal. 13. The PHC system described In the plan is highly questionable. Information gathered during this revie!, at the Minlstry, and at the WHO repregentatlve's and in the field, indicates that the vast majority of the village health team6 established in the country do not oPerete. About 802 of the populatlon do not have ecceos to care. Even ln the relatively affluent region of Say about 151 of the village health po6t6 have been abandoned. It is apparently for this reason that the country sees devolutlon of onchocerciasis control as a means for strengthening PHC (Niger 1989:13). A large part of the zone liberated from onchocerciasis, aB many other Parts of the country, have experienced environmental disasters due to erratlc population movements and exploitation of resources. The government has planned a nunber of projects to address these issues but so far most of them resEin on paper. r 37 ANNEX 2 Page 4 of 4 14. Nlger's disease survel.llance and treatment services have serious fiscal and administrative problems. The country relies heavily on external aid and/or ncltLzen participatlon' (prlvatlzation). The devolution plan presented by Nlger has merit and combines onchocerciasis and leprosy control. It provi.des for vertl.cal epldemiologlcal surveillance and passive treetment lrith Lvermectln at the local level. Survelllance ls proposed only for penunent reeidents to be identified with the help of an interpreter, I hlghly problenatic operatl.on in areas with nany nomads. Paesl.ve treatment is to be promoted by manuale and posters whlch are hardly approprlate means for rural populations. Although the plan declares that 'special furportance is ettached to the management problems of pubIlc health servicee...n (Niger 1988:10) it does not make any provision for training in management (traLning and retraining ls llslited to technLcal staff). 15. The national budget lncludes no flnancl.ng for the devolutlon plan. The Minlster of Health applied to the IINDP for aid but the request rra8 not proceesed eince lt ie supposed to come frorn the MLnleter of Planning. Thie proceedure was only erplained to the NOCs at the 1990 NoC areeting. Niger's devolution plan wae to begin thls year but, again, Iack of erternal fundlng hae delayed the procese. Ae the area Lnvolved ls relatively smalI, lt is likely that the government w111 begin lmplementing the plan in order to attract erternal support. .t 38 ANNEX 3 Page 1 of 9 socroEcoNoMrc DEVELOPMENT: INDIVIDUAL COI'NTRY PLANS 1. The situation in each of the eleven OCP countries differs in regard to the quallty of data avallable, development Progress to dete, the kind and levei of oiportunitles preBented by the onchocerclasis zones, and the relative economlc importance of these arees in the national context. Z. This report essesses the nadequacy' of development planning (formal or irnplicit) for the whole of the onchocerciaeis zone in each country using eeveral criteria which refer to the provision of basic conditlons and inputs. Theee criteria are:(a) lncentive agricultural price and marketing regulations;(b) secure land tenure; (c) road/track access; (d) domestic water supplies;(e) schools and health posts; and (f) environslental protection. 3. Theee criterie are particularly relevant to nnew lands' exploltation; they epply especially to the portions of the onchocerciasis zone which are refittvlfy underpopulated, but obvlously not exclusively so. I{hile fulflllment of these criterla alone would not be sufficient to attrect ag,rlcultural development, lre will assr.rgre that it is neces6ary. Therefore, ad"qoa"y of provJ.slon of the above lnputs will be taken to indicate the "adequacy" of preparation for onchocerciasis zone development, regardless of the national economic context. Benl.n 4. Benin appears to be taklng some initiel steps tolrerds the trensformation of e centrallzed economy into a more liberal and market-oriented one. The country does not have any unusual physical constraints to develoPment. On the corrtr.iy, lt poseesses many advantages not enjoyed by its neighbors such as tow popltatlon pressure, favorable climate, reliable rainfa11, traditional food sufflclency, and a comfortable ratio of arable land per capita. Comlng out of a bad economic situation, it is now, like urany other developing countrles, saddled with a huge external debt. There are other problems: The Minlatry of Planning reported some 163 donor-funded projects currently (May 1990) at some stage of execution, in additlon to those being planned or negotiated. Ottei observers report redundancy and lraste or slmply too much ""[trlty to the extent that nno one really knowe what ls g,oing on. i There is road construction but only linited maintenance, wells but no pump repairs, brush flree and limited land use planning. Internally, it is clearly in need of economlc and regulatory reform. This will take tine but already salutary effects are discernible. 5. With respect to the onchocerclasis zone (which here includes most of the country) developurent is lntegrated into the national plan. The Beninoise do not dlscuse "development of the onchocerciasis zone" pry (nor do the LNDP, PAQ, or the Wor]d Bank). However, there is a great deal of ongoing rural development activity ln Benln. Hundreds of kllometer8 of secondary roads, feeder roads and traile have been constructed or improved; hundreds of rrells ? 39 ANNEX 3 Page 2 of 9 and many dams have been built and market cooperatives organized; thousands of animal tractlon units are in use and more are being prepared. A11 this in the Ilberalization context which peruits food exports through private cosmercl.al intermedlaries, decontrol of some prices, (reduction or elimination of input eubsidiee) and efforts to i.nprove rural incomes fron food and export crop productlon. Overall, Benin appears to be well on the way to effectively erploitlng the advantages provided by OCP (ITNDP 1.988). Burklna Faso 6. Ae an orlginal core country and the economy rvhich has most to gain in economic terms (thet Is, proportionally, havlng had more land area affected by onchocerciasis than any other), Burklna Faso ls both an example of the economic effects of the Onchocerclasls Control Progran and, perhaps, the most crucial test of the ultlsrate utility of the Program. As elsewhere, onchocerciasis, when it was at its height, wee not the onJ.y or even the most funportant factor underlylng the elemental poverty whlch pervades the country; nor was it the most inportant constralnt to grolrth and economic security. But the dlseaae, ln conjunction with the usual collection of other obstaclee to economic improvement found in l{est Africa (in this case Sahelian W. Africa) rra8 inportant. Moreover, the succese so far of OCP in Burkina Faso, which has rendered essentially the whole country free from transmission of the disease, has occurred at e most opportune tine. 7, Burkina Faso endured the droughts and after-effects of 1973-76 and 1983- 84, the years of declining lncomes, lncreasing populatlon, emigratlon, environmental deterloration and polltical instabillty, economlc deprivation, starvation and lnsecurity: the period which, more-or-Iess overlapped with the flret decade of the OCP. It may be fortuitous coincidence that in Burkina Feso substantial economlc improvement which began in about 1.982, has continued into the preeent (1990) and appears to be continulng. In 1979, flve years into OCP, the population was lncreasing, relatively modestly at about 2.32 but only due to substantial emlgratl.on, especially of productive young men. The najor agricultural production area, the Mossi Plateau, was under increasing presoure from populatlon, drought, reduced fallow, deforestatlon, and erosion. The better lands to the south, wlth higher ralnfall, more permanent rratet$ays, better forests and vegetation, and avallable underexploited arable land were not bel.ng eurployed (for a variety of reasons, one of which, of course, was onchocerclasis) . 8. In comparlson, ln 1988 at least five hundred thousand additional hectares were under cultivatlon (60,000 ha. of whlch was reclaimed land); the area cultlvated increasing at an average of 3Z per annum. In the interval L982-87 the area of irrigated surface doubled, increasing at an average of 2000 ha./annu^ut, and these investmente lrere nostly private sector initiatives. Exploitatlon of new lends increased in the south of the country, the area historically most affected by onchocerciasis. Interesting and encouragl.ng events have been emerging in Burkina Faso, concurrent with the successful eradicatlon of the disease. I 40 ANNEX 3 Page 3 of 9 9, There is no direct cause/effect link; although Burkina has, since 1974, been quite actively promoting development of its underutilized agricultural potential. The Volta Valley Authority (AW) was given the responsibility for promotion of exploitation of the relatively sparsely populated and better- watered lands drained by the nunerous permanent and seasonal rivers and streams in the south of the country. (At the same time substantial amounts of spontaneous, unassisted settlement lras undenray in the same broad area.) Much is being done, perhaps too much, in the sense that there are literally hundreds of projects under !ray, some 100 NGOs active in the country which tends to overwhelm official capacit.y to coordinate and efficiently allocate reeources. Thls suggests that the donors need to explore the option of fJ.nancing less and coordinating more their development Bupport. In sutrmery, however, the outlook for the economl, in part due to the success of OCP, is optimistic. Ghana 10. Including the extenslon zone, the OCP covers some 2/3 of the surface of Ghana. Overall the zone ls underpopulated and poor but has substantial agrlcultural potential. Since 1984 the government and lts special National Onchocerciasis Secretariat, along with the FAO and IINDP, inter alia, have focused considerable effort on preparatlon for economic development of the zone. At thls juncture, 1989, three observatlons mlght sutrErarize the overall stetus: (a) There are not yet adequate data, analyses, understanding or ldentificatlon of objectives (see Hunting 1988:146) to undertake investment in the zone; (b) The proposals whlch have emerged and the development measures even now undenray are questlonable; and (c) None of the studles or recosrsrendatlons for the zone refers to the national context, the problems, reoources, prlorJ.ties and constralnts to develoPment of Ghana, as a who1e. Nonetheless, the National Onchocerciasis Secreteriat has prepared a "Planning Project' (SP 004/86) for the L99O-92 investment plan. This plan provides for road and bridge construction to access the nOverseasn areas from the north, health posts (partly to accosulodate the devolution requirements for onchocerclasis) and water supply. (According to the National Onchocerciasis Secretariat, the roads portion has been funded. ) The nPlan' does not address prlmary schools, land tenure (a chronic Lssue in the North) or environmental protection. This first phase pilot will cost some US$12 million and the outline for the long term envisioned by the National Onchocerciasis Secretariat would require an additional USS45-50 million over 12 year6 and is small ln comparison wl.th the recent annual national lnvestment budgets (order- of-magnltude, US$200 urillion). I{trile the National Onchocerciasis Secretariat identifies the zone as nthe last remalning significant area in the Ghana/West Africa subregion which has not been exploited', it is not at all clear that the GOG itself belleves this to be true and, lf eo, that natlonsl resources will be diverted accordingly. 11. Ghana is ettempting to implement decentralization of development planning and operatlons. It has an established Northern Region development appsratus, nascent and flawed as it may be, and a nr:nber of special, donor- funded developrnent instltutlons operating in the North which have defined I 41 Page roles in the national development scheme. There is no obvious need for a separate National OnchocerciasLs Secretariat. Ghana's planning for the onchocerciasis zone must be part and parcel of the national development process; it cannot be efficlent otherwise because it is not being designed in the appropriate context. Gulnea 12. There waa no way to go but up for Guinea ln terms of natlonal product and per capita lncome, slnce the country had decllned to such a basic leve1 by the nid 1980s when the Second Republic was organized. Very substantial improvemente have already been achieved slnce reforms baeed upon e market orl.entatlon rrere begun in L985. It appears that the necessary transformation will be pursued: the eseential regulatory obstacles to agricultural productJ.on have been removed, producer prices are market-based, most subsidies eliminated such that food prices are not undercut by iurports and farmers are free to make their orrn productlon decisl.ons. Guinea has an endowment of husran and natural resources that augur selI for the future. ReaI and substantial growth has resumed; the problem le that there ls eo much to be done that the more remote rural areas, shich comprlse much of the onchocerciaeis zone, are not likeIy to be given high priorlty. 13. The Governnent's development Btrategy is concentrating on global issues: research and ertension, rural roads, water supply, encouragement of cooperatives and baslc health and educatlon. Resources are lfunlted; the natl.onal accounts are oversubscrlbed and the erternal debt overburdening. In the onchocerclasls zone there are many projects underway and many donors and NGOo In the fleld. In the circumstances discretlon may be the optinal strategy: to essure that the private initiative of the farurere ls glven reasonable play (while attempting, to assure sustainable systems of production) and to undertake to understand just what and where the development opportunltLee are 1.e. (as suggested by the Hunting studiee) to ascertaln the Iand use Patterns and ldentlfy their potential before corurltting subetantial invegtment regources. Guinea Blssau 14. Bl.ssaun officials describe the present condition of the economy as tranel.tional: from a very recent colonial experience and, more lmportantly, aprotrected and extremely damaging, lrar of lndependence. Ihe country is undeveloped and, except for modest agrlcultural potential, resource-poor. The authorlties intend to "rededlcate to fanily and private agricultural productionn and to reorganize and decentralize the Ministry of Agrlculture and Rural Development. Under the reform progran, rice import subsidies have been removed and domestic food prLce regulation has been largely ellmlnated. ANNEX 3 4of9 42 ANNEX 3 Page 5 of 9 15. The country is now well into lts second four-year plan (the first having falled) and the second euccessive IMF/I{orld Bank stabilization and regtructuralization egreement. The National Development Plan in that section whlch addresses agricultural and rural development in the onchocerciasis zone(Reglon II, Bafata and Gabu plus a part of Olo) identlfies the usual problems: acces6, urarkets, migration of young men, llllteracy' rudimentary technology and absence or inedequate supply of i-urportant inPuts (seeds, improved fertllizer, i.rnplements' etc.) (Guinea Bissau 1988). As a result of liberallzation of regulations agriculture has been growing rapidly recently. The dominant asset aPpeers to be a substantial surplus of arable land, of whLch, psrticularly, the !re11-!ratered river valleys have promise. As Part of the reorganizatlon of the Minletry of Rural Development and Agriculture, the Ministry hae ldentlfied the need for coordination of plannlng and execution of the many donor and NGO development ectivities ln the region. Of the country's planned total investment in agriculture in the present plan, more than 502 is intended for the onchocerciasls zone. This would amount to the sr:n of approximately USS12 milllon for the four years of the plan. (In terns of per capita dlstributlon, approxinately, one-third of the total population lives in the zone.) These inve8tments are intended for improved seeds, extension training, integrated rural development, cereal, honey and livestock production, ecceg6 roads and irrigated rlce (bas fond). Underlying this t ell-meaning and intense sctivity is a basic ignorance of resources and potentl.als, of actual land uee and avallability, of stream flows and t ater tablee, topography and physical accessiblllty, demographics and population movementB, cotrrnerce and markets (see Huntlng 1988). This is acknowledged by the authorities wtro are promlslng to undertake the required surveys and cenguses. (OCP has helped already in, e.g. monltoring streems and the carrylng out of the base-Ilne epidemiologlcal census.) In the circunstances, there appears to be no lray to Lntensify J.nvestment at this time; absorptive capacJ.ty ls extremely limited relatLve to the many lnltlatlves already undeErray. Cote d'Ivolre 16. The country has had, overall, relatively good grollrgh (with serious Betbacks, en route) into 1990. There are at this tfure major problems of external debt, debt service, high rate of growth of population and severe income dlsparlties (modern versus developing sectors; urban and rural). Most of the grolrth and the wealth le in the south; the development Problemo end potentlal are Ln the center and north, the original core and extension zones of the oCP in the aggregate constituting two-thirds of the country. More than half the country is ln the savanna zone, where the population Erowth has been mlnigral (as people have moved to the south). That Portion of the country whlch t aB in the core area has the nost sparse population density (exceptlng Ferkessedougou and Bouake) but lt is endowed with some very attractive agricultural potentlal. In fact, presently it contributes a very substantisl 43 ANNEX 3 Page 6 of 9 proportion of the country's agricultural output: 1/3 of the rice, all of the sorghum and mlllet, all of the maize, 213 of the yanrs and the major portion of anlslal producte. Cote d'Ivoire has done much already to improve output and Lncomes ln the onchocerciasis zone; in addltion, a considerable portion of the country's current Lnvestment progrem is channeled to the upper half of the country. The area of llkeIy most rapid future agricultural growth is in the North (this has certainly been helped by the success of OCP) and it is here that the least developed, most 'openn lands for settlement can be found. The considerable preparation of basic analyses already echieved by the CSA and wlth the time available now to complet other data requirements (e.g. maps and land use) the country will be in e better position to exploit the opportunities conferred by the success of OCP once macroeconomic stabilization and reform are achieved. 17. The Goverrunent does not single out the onchocerciasis zones for special planning but (quite properly) incorporates the zone into the country's natlonal development planning process for which it has effective capability(see Hunting 1988). Ma11 18. The restructuring whlch was inltiated in 1981 has deflnltely yielded benefits to the economy. Nonethelees, significant ratlonalization (i.e.llberalization) remains to be achieved. In the 1980's, the country was ableto attaln a rnodest positive real average per capita growth. That achievement vindlcates the reforms that had been implemented and justifies continued Perseverance and discipline on all fronts. Even in the best conceivableinstitutional and regulatory envLronglent, the economy is constrained by itslack of physlcal resources, climatic vulnerability and the present technological capacity of the population. 19. Mali has undertaken decentrallzed planning (through the reglonal development coststittees) and implementation of development lnitiatives.(However, only about 5l of the nationar development program is channeled through the regional entlties.) Much of the extension zone is consldered unfit for cultlvatlon; the core area in the Segou region ls relatively more densely populated while having both poor Eggregate cultivation potential andthe shorter growing season. The sikasso region portion of the core has received a good deal of attention; it is the focus for development of cottonproduction (under the World Bank financed Mali Sud I & II & III projects) as well as llvestock development, roads projects and numerous complementary actlvities. rn the east of the onchocerciasis zone the potential for agrlculture ls relatively good (while the western half of the reglon has more moderate potentisl with mostry low Buitabirity for cultivation). rt is lmportant to note that opinlons differ on the availability of un or under- utilized arable lands. The Plan Quinquennal observes that level of exploltatlon ln Sikasso Region is very high and dangerously close to overexploltation. Development plans for the reglon 44 ANNEX 3 Page 7 of 9 provide for construction and rehabilitation of major national north-south routes which traverse the area as-well-as a quantity of secondary roads and feeders. It is also important to observe that the Government of Mali does not, at this tine, wish to encourage migration Lnto the Sikasso region. (See Land Settlement Review, MaIi Case Study) No provisions are being made for settlement into the core erea. Niger 20. The River Niger, which has ceased to flow at certain times ln the recent past, is the only significant source of water in Niger and its banks are the beet bet for cultivatlon in this desert and sub-desert country. Beyond mineral exports, agriculture (including livestock) serves as the base of the economy even though the agrlcultural potential in Niger is limited. Priority for development is given to enhancement of the river banks through irrigation development, etc. The only other possibility for cultivatlon is that small fraction of the country to the south and rrest of the river and the capital, Niaurey. This area coincldes, essentially with the onchocerciasis zone in Nlger. It is not an especially attrective agricultural prospect. The land is generally open upland woodland with soils which are preponderantly classified as 'rnarglnal' or unsuitable for agriculture. Interspersed are alluvlal valleys rrl.th seasonal streams and good potential. The region is attracting some sponteneous lmmigratlon. lrmigration and natural growth increased the population from 60,000 in 1979 to 240,000 today. Onchocerciasis had been endemic in the area before OCP but et a low level; only about three hundred people were seriously affected. The li-mited soil ferttlity can reportedly be enhanced with additlons of phosphates, some of which ls available IocaIIy or nearby In Burklna Faso. The Goverrurent's plan for the area (Projet de mise en valeur des zones llberees de 1'onchocercose), J.s comprehensive and includes ecological, agricultural, llvestock, social services, education and lnfrestructure components. But there are many problems reflecting the distressed status of the national economy, making it difficult to invest public resources in this area in the short term. It seems likeiy, however, that the onchocerciasls zone wl11 ultislately receive the lnvestment attentlon which it merits. Niger has in the past demonstreted a capability for getting thlngs done. Senegal 2L. The southeast quarter of the country, the Orlentale, is in many senses the most remote and least appreciated section of the country; this (including a substantial portion of Bakel Provlnce) ls also the onchocerclasie zone. It is an area of endemic onchocercl.asis. However, Senegal Orientale has not, hlstorlcally, figured as an important region in the economy of Senegal and onchocercaisis has not been a major factor ln its economic dynamics. I{hile the operations of OCP have led to an effective national onchocerciasis team headquartered in Tanbacounda, and this undoubtedly will yield lmproved rural public health servlces in the region, it is doubtful that the onchocercj.asis control activities will have a significant impact on the economic development of the region. 45 ANNEX 3 Page 8 of 9 22. The national economy of Senegal has been undergoi.ng serious restructuralization since the crisis of the early 1980's. The country will neceesarily concentrate on the principal problems and the long neglectedOrientale region will probably continue to receive lesser attention. There is a regional development plan (1987) which incorporates actlvities of a number of donors and the cotton productlon parastatal, SODEFITEX. At the moment thispolicy of lesser attention to the Orientele may be approprlate. Although over the years there has been much discussion of need and a number of attempts to do eomething for the development of the East, it seems that there ere not enough data in hand to decide what, lf anything, should be done to initiate improvements (Hunting 1988 tF327 -329) . 23. rn senegal, then, ocP operations have very little effect other thandlrectly ln public health and ln the externaltties resulting from the collaborative Participation of the National Team. There is evidently llttle,if any, output from the National Onchocerciasis Corurittee and llttle evidence of consideration of the effects of onchocerciasls control in natlonal or regional economic development. The GOS doee appear, in principle, to be encouraging development of mining induetry, but thls is largely unrelated to onchocerclasls plannlng. Sle rra Leone 24. The Onchocerciasis zone has major agricultural potential, for rice andfood crops. It is, on the whole, underpopulated, with promising strean valley sl.tes unlnhabited. The zone's populatlon, which is, at most, only flfteenpercent of the country total, has been growing modestly (less than 2l/annurn) and has been receiving new settlers. There is a net out-migration, reportedly young males, and seasonal labor shortages have been cited (The Hunting etudies) as a constraint to the Buccess of some agricultural development. 25. Sierra Leone has much larger problems, and priorities, than the remote,North. The economic house has been out of order, not only in termg of externel debt, arrearages, balance of payments and donor participatlon but with respect to Lssues basic to agricultural development and lnvestment, such as, food prlce policlee and land titling, and infrastructure. Real reform isjust nos, belng put on track. At this juncture, since development of (at leastthe upper) onchocerciasis zone is not all that pressing, certain activitieg necessary to prepare for future actions can be undertaken, Buch as, implementatlon of lncentive regulations regarding agrlcultural productlon(price and marketing policies, land tenure) and basic studles of land use andplannlng (eee the Huntlng studies). There is as yet no development plan for the reglon. t 46 ANNEX 3 Page 9 of 9 Togo 26. The Onchocerciasis zone, including the extension, covers at leest 902 of the country. Almost all development of agrlculture in Togo, hence, all development planning is, effectively, planning for the onchocerciasis area. A fair aseessment of the adequacy of the development effort in the onchocerciasis zone becomes an evaluation of Togo's overall development effort, which, perforce, must be addreesed in the context of the country's access to resources i.e. its overall economic situatlon. Since 1983, Togo has been i-urplementing stabilization and restructuring in cooperation with the IMF and the I{orld Bank, ln order to resolve excessive erternal debt obligations and to reform lnefficlent and counterproductive instltutions and policies to optlmal inveBtment and exploitstion of available resources. The effort has been paying off and some reforsls are eliclting the desired responses. 27. In agriculture offlcial measures to set prices for export cosmodities and food producte have been eased. The Togolese governnent has abolished certaln marketing monopolles, particularly for food crops (although the prlnciple has not been abandoned). The result has been rapid growth in export and food productlon. (The Bank/Fund are urging ceseation of taxation of export crop6 rrhich have been an important Eource of official revenues.) The overall Btrategy for agriculture is to lmprove services lncludlng research, ertension, lnput supply and improved seeds and to suPport the formation of cooperatlves for credit, inputs, storage and marketlng. Implementation of agricultural development lnltiatives, including projects, is through decentralized structures. Togo has significant unexploited agricultural potential 8nd, overall, relatively mild populatlon density (160 persons/sq. km of arable land) (I{orld Bank 1988:37). Through the years agriculture has recelved much attentlon and donor investment. Currently there are literally hundreds of development projects in the rural areas, suggesting redundancy and inefficiency and overextension of official personnel and management capacities. Nonetheleee, lt seems that virtually all obstacles to agrlcultural development are someho!, and somewhere being confronted; about 352 of the public investment program is earmarked for the sector. In sumrary, Togo'e planning and priorltiee for development in the onchocerciasis zone are conslstent lrith the problems, having removed a number of policy and inetitutional obstacles. A najor near-term constraint may be degradation reeultlng from Lnadequate conservation measures arising from lnsecurity of land tenure. t) t47 ANNEX 4 Page 1 of 2 THE ONCHOCERCIASIS CHEMOTHERAPY PROJECT (OC?) Mac rof ilaric idal Development 1. CGI 18041. The benzothiazole derivative CGI 18041 is considered by OCTto be the most promising compounded from Ciba-Geigy at present. It is related chemically to both the earller compounds CGP 6140 and CGP 20376. It ls, however, more lipophilic, has different pharmacological properties to the other compounds, and does not produce the sane high levels of the potentially toric isothiocyanate metabolite. It has shown macrofilaricidal activity agalnst Brugla malavl in the leaf monkey, uslng singl-e oral doses of 25 or 50 ng/kg. It is lntended that preclinical development work by Ciba-Geigy will befollowed by Phase r cllnical tralls ln man, provided that satisfactorypreclinical toxicologlcal data are available. 2. CGP 6140. This N-methyl piperazine adduct of amoscanate, was put intotrlals in Mali and Ghana. Htrile interi-sl reports from Ciba-Geigy relating tolts own trials of CG 6140 in Latin Anerica, indicate that multi-dose schedules of cGP 6140 (3mg/kg twice a day on three consecutive days) kill 70-752 of adult female worms, a slightly different dosage schedule in the clinicaltrials ln Ghana and Mali resulted in neurotoxicity rrithout macrofi.laricidal sctivity (Dr. Awadzi, Hohoe, personal couurunication). Si-mllar results were reported from Mali. The report of the Onchocerciasis Chemotherapy Project(!rHO 1990d), however, stated that while the above mentioned dosing schedule, together wlth the low therapeutic ratio of the drug, make it unacceptable for routlne couurunity therapy, there is a possible role for the drug in combination with ivermectin in control of disease recrudescence in isolatedfoci within oCP. This is, lndeed, an astonishing stetement in vlew of the avallable toxicological evidence relating to the drug, and its low therapeutic1ndex. Amoscanate and varlous formulations of nithiocyarninr:.n have shorrn high efflcacy in the treatment of schistosomiasis and macro- and microfilaricidalproperties in appropriate test systems (Davis 19g2). side-effects of treatment, however, lncluded central nervous system reactions and post- therapeutlc jaundlce of mixed cholestatic and hepatotoxic cause. Wtrile a substantial number of treatments for schistosomiasis were carried out inChina, the drug has not been developed further for use in Western Medlclne.It ls, surprising' therefore, that clinical trials have been pursued using CGp6140, even in light of the known unacceptable toxicology of amoscanate and related compounds. 3. cGP 20376. The compound cGp 20376, showed good macrofilaricidal activity in anlslal models of filariasis, but metabolism to an lsothiocyanate metabolite produced problems of renal and hepatotoxlcity. In clinical trials of patlents infected with Wuchereria_ bancrofti, poor efficacy r,ras found as a mlcrofilarlcide, together rith r""ersible hepstotoxicity, ani positlve actlvity was detected ln vitro tests for mutagenicity. The company and I{IIOtherefore recently decided to terminate any further clinical trials with CGp 20376. a , t 48 Page ANNEX 4 r2of2 4. Suramin. Suramin, which is the only currently available macrofilaricide for irrffif[,r"l patient therapy, has been used to treat a series of onchocerciasis patents at the Oncho Unit, Hohoe, Ghana. This was done using a stanciard mutti-dose intravenous regimen of suranin. The condition of palpable nodules was monitored by ultrasound scanning, and these nodules lrill be removed at intervals throughout the period of a year for histopathological scrutiny. Blood and urlne semples were taken for storage in the TDR/Fi1 Serum Bank, bling tested for antigen and/or antibody changes. It is, therefore, top"a that such physical or irglunological parameters may Permit more precise "rtia"t". of rrorm damage, as a complement to the time-consuming histopathological technique. The eventual application of any such successful new srlthodology would certainly be a valuable adjunct in determining macrofilaricidal activity of new experimental compounds. 5. Other comDounds. These have lncluded benzimidazole and thiophanete arr.logffifi"rS of Michigan, U.S.A.), supported by TDR/Fil. The resulis, however, "rL dir"ppointing and it seems unlikely that any of the novel benzisridazole/thiophanates ere suPerior macrofilaricides to the presently registered benzirnidazole such as albendazole, mebendazole or ituUerrOatolel whtch show only pertical macrofilaricidal activity in man (WHo 1990d) . to be selected and tested at l{alter Reed Army as are guanidine compounds from Parke-Davis, Other Studies SuPPorted bv ocT 7. Additional studies necessary to the drug development process, and previously carried out rrithin the industrial groups are nol necessarily supported separately by OCT (I.IHO 1990d). Prirnary, secondary and tertiary s"re"rri.rg in animals is supported in collaboration with the Justus-Liebig University Giessen, PRG, th; CAB International Instl'tute of Parasitology' St' Albans, U.X., the Institute for Medical Research, Kuala Lumpar, ttalaysia, and the James Cook University' Queensland, Australla. Additionally in vitro drug assays are supported beciuse of the lack of suitable animal models for Onchocerca inilctions. Such assays are carried out at the Institute of P"."rit"1"gy, St. Albans, U.K. and at the Bernard Nocht Institute. HamburS' FRG, lrith alaitionat field work on 0. volvulus being done in Ghana, Liberia and Guatemala. 6. Other comPounds continue Institute of Research (IIBAIR) ' u. s.A. t I t ,