Planning for Microbicide Access in Developing Countries
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Planning for Microbicide Access in Developing Countries

PLANNING FOR MICROBICIDEACCESS IN DEVELOPINGCOUNTRIES:Lessons from the Introduction ofContraceptive TechnologiesGeorge F. BrownVimala RaghavendranSaul WalkerJULY 2007

ACKNOWLEDGEMENTSThis paper was written by Dr. George F. Brown (international health consultant), Vimala Raghavendran (InternationalPartnership for Microbicides) and Saul Walker (International Partnership for Microbicides).The authors wish to thank Kristin Bergantz and the staff at Population Services International; Philip Harvey at DKT International;and Jeffrey Spieler at the US Agency for International Development for providing valuable information andclarification. The authors would also like to thank the following people for their review and comments: Carol Bradford(consultant); Elizabeth McGrory (consultant); Jane Rowley (consultant); Mitchell Warren (AIDS Vaccine Advocacy Coalition);Susan Perl (consultant); and Sydney West (Global Campaign for Microbicides). Finally, special thanks to AllisonClifford; Jennifer Nadeau; Jocelyn Riley; Pamela Norick and Youssef Tawfik at IPM; and Barbara Shane (consultant) fortheir review, editing and production assistance.

devices (IUDs), became available. Many publichealth and population experts expected thatadoption of these methods would quicklyreduce fertility rates (Freedman 1966).As Figure 1 makes clear, however, widespreaduse of contraception took decades to achieve,particularly in some of the sub-SaharanAfrican countries. At present, despite nearlyhalf a century of modern family planningprogramming, 201 million women globally– 30 percent of women at risk of unintendedpregnancy – need family planning services tomeet their reproductive goals but are not usingany contraceptive method (Singh et al. 2004).Providing a wide range of contraceptiveoptions expands choices for women and hasbeen shown to increase overall contraceptiveuse. However, the contraceptive methodmix among countries varies enormously,and at least 34 countries rely on a singlemethod for more than 50 percent of all use(Sullivan et al. 2006). Many country-specificreasons explain these skewed patterns of use,including user preferences, provider biasesand restrictive government policies. Thesesame factors will influence use of existing andfuture HIV-prevention technologies, includingmicrobicides.The way a product is initially introduced has asignificant impact on its future market share,which, in part, explains the widely differentpatterns of contraceptive method choicefrom country to country. The introductionhistories of three contraceptive technologies– IUDs, implants and female condoms – offerlessons for future microbicide access efforts.These three methods were chosen becauseeach presented a novel form of contraceptionat the time of introduction; was introducedwith a planned and sustained internationalaccess effort; experienced and documentedsuccesses, challenges and failures; and saw theintroduction of next-generation technologieswithin the same product line.The channels through which a product reachesconsumers also affects end-users’ access to anduse of the product. This paper will examinefour delivery approaches that have been usedin contraceptive distribution – public sector,civil society, social marketing and the privatesector – for their applicability to microbicideintroduction.3. PRODUCT INTRODUCTIONSINTRA-UTERINE DEVICES (IUDS)The IUD is the most popular reversible moderncontraceptive method in the world (UN 2004),but its use varies greatly by region and bycountry. The Copper T380A IUD is a T-shapedplastic device covered with copper. Insertedinto the uterus by a minor gynaecologicalprocedure, it is highly effective for up to 12years. Its side-effects include inter-menstrualbleeding and cramping. Expulsion can alsosometimes occur. The device is probably theworld’s most cost-effective contraceptive,costing about US$1.50 for public sector use(Appendix 1), and is available in most parts ofthe world. In 2003, the United Nations (UN)estimated there were 145 million IUD usersworldwide. This number is heavily influencedby China, which has 96 million IUD users, ortwo-thirds of the world’s total. Notably, Indiaand sub-Saharan Africa have very low rates ofIUD use (see Table 1).4 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

Table 1: Percentage of women of reproductiveage in married or consensual unions usingIUDs (Source: UN 2003)High UseChina and Vietnam (36 - 38%)Former Soviet Union (9 - 56%)Scandinavia, France (20 - 36%)Egypt, Lebanon, Syria, Turkey, Jordan,Tunisia (15 - 36%)Cuba (44%)Moderate UseEight Latin American countries (10 - 14%)Iran, Indonesia (8%)Negligible UseSub-Saharan, East and West Africa (1 - 4%)Asia, excluding China and Vietnam (0 - 5%)India (2%)Brazil (1%)North America (1%)History of IntroductionAs the first national family planningprogrammes were being established in theearly 1960s, the first modern IUD – the LippesLoop, an inert plastic device – was introduced.Many international and national policy makersbelieved that the IUD, requiring a singleinsertion and no need for repeated action bythe user, was the key to family planning successin countries with low literacy (Freedman1966). While early programmes promoted the“cafeteria approach” to contraceptive services,ostensibly making all methods available,special efforts were made to accelerate IUDuse. International conferences on the IUD tookplace in 1962 and 1964 to mobilise the supportof key international policy makers and healthofficials. By 1970, improved copper-bearingIUDs became available, culminating in theCopper T380A.The IUD was popular in the United States (US)in the 1960s, but use declined substantiallyin the 1970s following the introduction of adefective device, the Dalkon Shield, whichcaused uterine infections and some deaths.Although this device was withdrawn from themarket by the late 1970s, negative attitudesabout IUDs, including the misconceptionthat all IUDs carry a risk of pelvic infection,have lingered (Espey and Ogburn 2002). TheDalkon Shield experience also had a rippleeffect in some developing countries, raisingfears of infection with IUD use. However, mostEuropean countries continue to have moderateto high levels of IUD use (UN 2004).A newer, progestin-releasing IUD, Mirena, wasintroduced in 1990. It is as effective as theCopper T, but causes less bleeding. As it is moreexpensive than the T380A (about US$22.00 in thepublic sector), it has had limited use in developingcountries. The possibility of lowering the pricethrough bulk or generic manufacture is underconsideration, and other progestin-releasing IUDsare being developed. Several donor agencies arecurrently supporting efforts to increase IUD usein selected African countries, with some initialsuccess (Jacobstein and McGinn 2005).PLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 5

Factors Affecting the Skewed Use of IUDsAs one of the few modern contraceptivesavailable in the 1960s, the IUD, along withoral contraceptives and female sterilisation,became institutionalised in more maturefamily planning programmes (Bulatao 1998b).However, as seen in Table 1, IUD use variessubstantially by region. Factors contributing tothis skewed uptake include:Country-specific and cultural factors: The IUDis popular in certain countries for specificreasons. For example, in China, thegovernment’s population limitation policiesplay a major role in urging, and sometimesrequiring, IUD use. In Egypt, the Islamicobjection to sterilisation contributes torelatively greater use of IUDs. A negativeattitude towards oral contraceptives, deemedunsafe during Soviet times, has carried overin several former Soviet republics in CentralAsia and has resulted in high IUD use, despiteefforts by the government to promote othermethods (Sullivan et al. 2006). Similarly, inVietnam, misconceptions about other productspreclude their uptake and favour use of IUDs(Do Trong et al. 1995).Health care provider support and training:Studies in low-use countries, includingGhana, Guatemala and Kenya (Osei et al.2005; Population Council 2004; Stanback andOmondi-Odhiambo 1995), show that healthcare providers are often biased against the IUD,lack adequate training in insertion techniques,and may provide IUD patients with poor careand inadequate counselling about side-effects.In Egypt, on the other hand, the availability of alarge pool of physicians trained in performingIUD insertions contributed to greater use ofthe method. In general, while programmemanagers tend to like the IUD for its costeffectiveness,overworked providers often seeit as cumbersome due to the relatively timeconsuminggynaecological procedure required.Popularity of competing products: In muchof Africa, injectable hormonal contraception(primarily Depo-Provera) has supplanted theIUD as the long-acting method of choice. InKenya, for example, IUD use among marriedwomen dropped from 3.7 percent in 1989to 2.4 percent in 2003, while injectable useincreased over the same period from 3.3percent to 14.3 percent (Ross, Stover andAdelaja 2005).From the history of IUD introduction, thefollowing lessons can be learned:• Cost matters. The cost-effectivenessof the IUD drove its substantial earlysupport, particularly among programmemanagers and donors, and led to theinstitutionalisation and continuedpopularity of the method among manyof the family planning programmesestablished in the 1960s.• Strong, sustained stakeholder support isneeded at many levels. While programmemanagers and donors like the IUD, a lack ofcommitment or inadequate training amonghealth care providers has limited its use inmany settings.• Real and perceived method side-effects canlimit uptake of a method for many years,and may have ripple effects, as in the caseof the Dalkon Shield.6 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

• Every country and cultural setting isdifferent and methods may need to bepositioned differently in different contexts.• Second-generation products, like Mirena,may have benefits appealing to new users,but can also present new barriers (such ascost).• Expect the unexpected and be quick torespond. The Dalkon Shield experiencecontinues to taint user perceptions of allIUDs, even 30 years later.IMPLANT CONTRACEPTIONNorplant, the first hormonal implantcontraceptive, consists of six plastic capsulesfilled with levonorgestrel, a progestincommonly used in oral contraceptives. Thecapsules are inserted under the skin on theinside of the upper arm in a simple clinicalprocedure using local anaesthesia. The deviceis highly effective for up to seven years, and canbe removed at any time by trained personnel.Side-effects include spotting, bleeding andamenorrhea. While more expensive thanthe IUD (US$23 per set in the public sector),Norplant is another highly effective, longactingand reversible contraceptive method(see Appendix 1).Although enthusiastically introducedinternationally in the late 1980s and 1990s,Norplant currently accounts for less thanone percent of overall contraceptive use inmost parts of the developing world, with theexception of Indonesia, where the method isused by almost five percent of married women(ORC Macro 2006).History of IntroductionThe concept of a long-acting contraceptiveimplant was first proposed in 1966. After17 years of development by the PopulationCouncil, Norplant was approved in Finland, thecountry of manufacture, in 1983. Programmemanagers, international agencies, donors andclinicians were enthusiastic about Norplantbecause it is highly effective, requires only asingle clinic visit and demands no repeatedaction by the user. Unlike inserting an IUD,inserting Norplant requires no gynaecologicalprocedure, and early acceptability studiesindicated that women were generally positiveabout the method. For all these reasons, itwas widely thought that Norplant wouldmake a major contribution to family planningprogrammes in developing countries.Extensive international clinical trials andacceptability studies were followed by avigorous international access programme,led by the Population Council, FamilyHealth International, other internationalnongovernmental organisations (NGOs) and theWorld Health Organization (WHO). Beginningin 1984, a series of thirty “pre-introductionstudies” were conducted in all regions of thedeveloping world, with countries selected onthe basis of their interest, viable clinic capacity,potential to serve as models within their regionand provision of a range of contraceptivechoices. These novel studies, lasting severalyears, tested the product under local conditionsand measured acceptance, continued use,safety and efficacy. The transfer of clinical andcounselling skills was a key component, andprototype training materials were developed(Population Council 2007; Grubb, Moore andAnderson 1995; Harrison and Rosenfield 1998).PLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 7

User acceptability studies revealed somecountry- and cultural-specific concerns. Forexample, in some Muslim countries, irregularbleeding was a problem for women whowere expected to abstain from intercourseduring menses. In addition, in some settingshealth care providers were seen to be overlydirective in encouraging women to adoptthe new method. Overall, however, thesepre-introduction studies were consideredto be successful, and in several countriesserved as the basis for subsequent larger-scaleintroduction (Grubb, Moore and Anderson1995).By 2002, 62 countries had given regulatoryapproval to Norplant, three internationaltraining centres had been established andseveral countries began expansion of servicesto the national level. A major post-marketingsurveillance survey, undertaken by WHO, washighly positive (Meirik et al. 2001).However, problems and constraints emergedover time: lack of trained personnel, weakcounselling about side-effects, problemswith removal, occasional reluctance by someclinicians to remove Norplant at the client’srequest and user complaints that side-effectswere sometimes ignored or minimised byproviders. It was also sometimes difficult totrack clients to ensure they returned to havetheir implants removed after five to sevenyears.The US Food and Drug Administration (FDA)approved Norplant in 1990, and the methodwas introduced in the US in 1991 by the USmanufacturer, Wyeth-Ayerst. Wyeth adaptedelements of the international introductionexperience in its marketing efforts, and highlevels of enthusiasm and rapid roll-out resultedin the training of many physicians and highinitial uptake totalling over one million unitsin the first year. However, significant negativepublicity was generated by isolated instancesof legal attempts to require Norplant useas a part of court sentences and proposedmandatory use by several states. 1 Bleeding andremoval problems and other real or imaginedside-effects were also magnified by the media.Major lawsuits resulted and, although nonewere successful, Norplant was nonethelesswithdrawn from the US market in 2002. 2Following litigation in the United Kingdom,Norplant was withdrawn from that market aswell (Harrison and Rosenfield 1998).The Population Council began testing a secondgeneration implant, Jadelle, in 1977. Jadellewas approved in Finland and by the FDA in1996, initially as a three-year method, andthen extended to five years in 2001. Consistingof two solid plastic rods impregnated withlevonorgestrel, Jadelle is easier to manufacture,insert and remove than Norplant, but hasthe same effectiveness and duration of use(Population Council 2007). Jadelle’s publicsector price is similar to that of Norplant. Wyeth1 A few judges and legislators seized upon the opportunity presented by Norplant to employ the product coercively by requiring that certain individualshave Norplant inserted in lieu of jail sentences.2 Bleeding problems and difficulty in removal of improperly inserted capsules were picked up in the media. Lawyers seized on these issues, as well asimagined auto-immune problems linked to the silicone in the capsules. (The launch of Norplant followed soon after major legal action against companiesmanufacturing silicone breast implants, and the same group of lawyers led the litigation against Norplant.) Thousands of lawsuits resulted and negativemedia accounts played up the controversy. While none of the lawsuits were successful in court, the burden on the company in defending them, and thedamage done to the reputation of Norplant were devastating.8 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

has declined thus far to introduce Jadelleinto the US market, but the product has beenapproved in Europe and has significant levelsof acceptance in several European countries. Anew programme to introduce Jadelle at no costinto developing countries has been initiatedby the provider, through a new entity, the ICAFoundation.Another second-generation implant, Implanon,was approved by the FDA in 2006. It is a singlerod device containing another progestin,etonogestrel, and is effective for threeyears. As a single implant pre-loaded in itsinserter, it is easier to use. A Chinese implant,Sinoplant, which is similar to Jadelle has alsobeen developed. It is available in China andIndonesia. Side-effects of all three types ofimplant are similar.From 1984 to 2002 an estimated 10.5 millionNorplant sets had been used. Jadelle hasnow largely displaced Norplant in developedcountries. Limited efforts are ongoing toexpand Jadelle, Implanon and Sinoplant use indeveloping countries. It is possible that thesethree improved implants could renew interestin implant contraception and expand use insome developing countries, but this remains tobe seen.Factors Hampering the Uptake of ImplantsMost of the problems and constraints inherentin the application of implant technology indeveloping countries were identified beforewide-scale use. However, overall enthusiasmfor the method was so strong that positivemomentum was maintained for many years.The major constraints were:Cost: The cost of Norplant was a major issuefrom the outset, but donor enthusiasm andfinancial support for introduction activitiesenabled the work to go forward, andminimised initial governmental concerns aboutthe high cost of Norplant and the substantialprogrammatic costs for training. Over five toseven years, it was argued, the cost of Norplantwould approach that of oral contraceptivesover a similar period. In practice, however,average duration of use ranged from 2.5 to 3.5years.Health care provider support and training:Like the IUD, implants must be inserted bya health professional. Many countries havehad difficulty training sufficient numbers ofproviders. In addition to insertion techniques,providers need training in good counsellingskills and positive provider-client relations.Side-effects: While side-effects were wellknownand carefully measured, they were notconsidered to be major problems in the earlyphase of research and initial introduction, aslong as women were thoroughly counselledbefore accepting the method. This proved tobe difficult in many settings, and side-effects– while generally mild – still remain limitingfactors in some countries.Directive and coercive behaviour: While thesponsoring agencies made every effort to ensurevoluntary acceptance and informed choice,isolated instances of coercive use resultedin much negative publicity. In developingcountries, the sponsoring agencies insisted thatimplants be offered by well-trained providers ina voluntary fashion as one of several availablecontraceptive options. However, high levels ofPLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 9

enthusiasm by health providers occasionallyresulted in overly directive actions.Failure to manage expectations: This novelcontraceptive technology attracted a greatdeal of media attention, and initial effortswere made to ensure that careful, balancedinformation was provided to the media. AsNorplant began to be made available, however,overly enthusiastic publicity quickly emerged,some of it dramatically overselling the method.This was followed by highly negative mediacoverage as the problems described abovesurfaced.From the history of Norplant introduction, thefollowing lessons can be learned:• Beware the “magic bullet syndrome.”Norplant was heralded at the outset as amajor breakthrough, which heightenedexpectations and thus magnifieddisappointments as the method ran intodifficulties.• Cost matters. Despite initial enthusiasm andwillingness to pay on the part of donorsand programme managers, the relativelyhigh initial cost of Norplant remains asignificant hurdle.• Choice matters. Concerns that healthcare providers and legal authorities werepressuring women to choose Norplant haveresulted in negative publicity and resistanceto the method.• Real and perceived method side-effectsshould be taken seriously, and healthcare providers must be well-trained incounselling women in what to expect whenusing a method (not simply in insertion andremoval).• Second-generation products, such asJadelle and Implanon, may provideopportunities to attract new users.• Expect the unexpected and be quick torespond. Despite careful pre-introductionstudies, new and magnified concerns aroseas Norplant services were expanded.FEMALE CONDOMThe female condom is the first HIV-preventiontechnology developed since the onset ofthe AIDS epidemic. It provides the onlyfemale-initiated means to prevent bothsexually transmitted infections (STIs) andpregnancy. The most widely available type 3 ,FC, is a thin polyurethane sac with a flexibleinternal ring inserted into the vagina, andan outer ring used to hold it in place outsidethe vagina. When properly and consistentlyused, it is highly effective in preventing HIVand STI transmission, and is also an effectivecontraceptive (see Appendix 1). It has virtuallyno side-effects. FC has a public sector price ofapproximately US$0.68 per unit (PATH 2006).History of IntroductionThe FC female condom was approved asa contraceptive by the FDA in 1993. Sincethe mid-1990s, FC has been marketed in 903 Two other female condoms, the V’Amour Female Condom and the Natural Sensation Panty Condom are in limited distribution but have not been approvedby the FDA and are not procured by major donors.10 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

Figure 2: Number of female condoms in public and private sectors by region, 2000-2005(Source: UNFPA 2006)developing countries by its manufacturer, theFemale Health Company; by social marketingorganisations; and by national health and AIDSprogrammes, with the support of UNAIDS andseveral donor institutions. More than 100 millionfemale condoms have been distributed, ofwhich approximately 12 million were distributedannually in developing countries in recent years(see Figure 2). In contrast, six to nine billion malecondoms are distributed each year.Research has demonstrated high initialacceptability in a number of different culturesand social groups (Cecil et al. 1998; VanDevanter et al. 2002; Choi et al. 2003). Evidenceon longer-term acceptability is less clear.Various studies have also shown an increasein protected sex acts when female condomsare added to the method mix (Musaba et al.1998; Fontanet et al. 1998; Hatzell Hoke 2005).Commercial sex workers have successfullyused female condoms, often as an alternativeto male condoms. Gender power relationsare a critical aspect of negotiating femalecondom use, and require special attentionin each cultural setting (Mantell et al. 2001).Limited acceptability studies of female condomuse among men have also been generallyencouraging.By far the most successful programmes arein Brazil, South Africa and Zimbabwe (Warrenand Philpott 2003; PATH 2006). Modest socialmarketing efforts continue in Venezuela,Zambia and Tanzania. In other countries, lack ofsustained programme support and funding hasPLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 11

esulted in very poor access and low levels ofuse. Donor support has been uneven and rarelysustained over several years.Efforts have been made to lower the per-usecost of the female condom by bulk purchase,reuse or new product design. Reuse of thefemale condom by washing with a detergenthas been successfully tested (Beksinska et al.2001). Whether reuse could be successfullyimplemented on a large scale is unclear, but itwould certainly bring down the cost per coitalact. WHO does not recommend reuse but saysthe final decision should be made locally andhas issued guidelines for safe and effectivereuse.A second-generation product, FC2, made ofsynthetic latex, is easier to mass produce. Withvery large bulk orders (200 million units), theprice of the FC2 could drop to US$0.31 per unit,although such large orders seem unrealistic atthis time (PATH and UNFPA 2006).Other female condoms under developmentinclude the Woman’s Condom, a new V’Amourcondom, the Silk Parasol Female PantyCondom and the Belgian Female Condom(PATH 2006). However, all depend on fundingfor several more years of research. It is not clearwhether these alternative female condomswill be significantly cheaper than the currentlyavailable model (though the product designmay potentially be more acceptable to someusers).Periodic international and national advocacyefforts in support of female condoms havebeen undertaken over the past decade, withthe Joint United Nations Programme on HIV/AIDS (UNAIDS), WHO, European Union andother international and national groups callingfor increased availability of female condoms.In 2005, the United Nations PopulationFund (UNFPA) launched the Global FemaleCondom Initiative which aims to scale-upfemale condom programming in 28 countries(PATH and UNFPA 2006). NGOs and grassrootscampaigns have also contributed, as in thecase of Zimbabwe where women’s groupsorganised a petition with 30,000 signaturesto pressure the government into introducingfemale condoms in the country. A recentinternational meeting on female condomscalled for another round of advocacy and ledto the development of a document, “FemaleCondom: A Powerful Tool for Protection,” topromote the method (PATH 2006). Despitethese substantial efforts, thus far there has notbeen sustained acceptance of female condomsas an important component of internationalHIV-prevention efforts.Factors Hampering the Uptake of the FemaleCondomDespite the great promise of the femalecondom as a female-initiated way to preventboth STIs and unwanted pregnancies, in mostsettings, the method has not taken hold. Someof the problems have been:Cost: The public sector unit price of femalecondoms is many times that of a male condom.However, cost-effectiveness analyses havedemonstrated that female condoms offersubstantial health care savings. A South Africanmodelling analysis showed that a relativelymodest investment in distributing femalecondoms to sex workers would be less thanhalf the otherwise resulting cost of treatmentof HIV and other STIs. The comparison of the12 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

unit costs of female and male condoms isvery large, but when full programme costs areincluded the difference between the two isdramatically reduced (PATH and UNFPA 2006).Usability factors: The physical appearance offemale condoms sometimes evokes an initialnegative reaction, as it is perceived to becumbersome and difficult to insert, and someusers complain about noise during coitus.Female condoms also face the stigma attachedto any barrier method for HIV prevention or anyvaginal product. Although the female condomis a female-initiated method, it is visible andtherefore requires partner concurrence. Thiscan be a negative feature, but also presents anopportunity for male involvement. As with allbarrier methods, the need for insertion beforeintercourse is a significant challenge, although,unlike the male condom, the female condomis not coitally dependent and can be insertedseveral hours prior to intercourse.Provider reactions: The technology itselfseems to engender negative initial responseson the part of many donors, programmemanagers and providers, who ignore morepositive acceptability studies and the fewsuccessful country experiences.Comparison with male condoms: Negativeviews of male condoms are often similarlylevelled at female condoms. While male andfemale condoms do share many characteristics,the female condom is nonetheless the onlyfemale-initiated product available for HIVprevention. Yet, with a few country exceptions,female condoms have not benefited fromsustained introduction, marketing andfinancing programmes.Lack of strategic programme introduction:In the few countries that have seen sustaineduptake, the governments have made long-termcommitments to providing female condoms.Grassroots and women’s groups also gavesupport, strong social marketing programmeswere established and donors – as well as thegovernments themselves – provided sustainedfinancial support. The most successfulprogrammes have been sensitive to localattitudes and conditions. Marketing strategies,in some cases, have emphasised enhancedsexual pleasure with female condoms, anapproach that has also been used successfullywith male condoms and vaginal spermicides.From the introduction history of the femalecondom, the following lessons can be learned:• Cost matters. The expense of the femalecondom relative to male condoms has beena significant barrier to uptake. In additionto ongoing efforts to reduce costs, costeffectivenessanalyses showing the longertermpotential for savings should be used toinform policy and programming decisions.• Choice matters. Even though billions moremale than female condoms are distributedeach year, adding the female condom to themethod mix has successfully increased theproportion of sex acts that are protected,suggesting that offering another optionattracts users who would otherwise not beusing any method of protection.• Strong, sustained stakeholder support isneeded at many levels. A lack of enthusiasmamong donors, programme managers andproviders, despite positive acceptabilityPLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 13

studies, has been a significant problem for thefemale condom.• Perseverance is essential. The countriesthat have seen the greatest success withthe female condom have made long-termcommitments to providing the method.It is hoped that ongoing efforts amongadvocates and NGOs to promote themethod will, over time, broaden access andfunding.4. CONTRACEPTIVE PROVISIONA critical element in the introduction andongoing success of any product is havingadequate capacity to get relevant and highquality information, supplies and servicesto users. In the case of family planning, fourmain sectors – civil society, government, socialmarketing and private – have responded tothe information and service needs of differentpopulations. Reviewing the roles thesedifferent sectors have played in contraceptiveservice provision offers some useful lessonsfor potential roles in developing access formicrobicides.CIVIL SOCIETYAdvocacy and Demonstration of Demand andQualityThe idea that contraceptives should be madewidely available for women’s use emergedin the US and Europe in the first half of thetwentieth century, through the work ofpioneers like Margaret Sanger, whose effortsled to the creation of the International PlannedParenthood Federation (IPPF). The growth offamily planning in the developing world wasinitially driven by the advocacy and consensusbuildinginitiatives of civil society organisationssuch as IPPF, the Ford and RockefellerFoundations and the Population Council(Seltzer 2002). These initial efforts were crucialin demonstrating the need for family planning(in terms of women’s expressed desires to limitfamily size or space pregnancies) and buildingdemand among women in many countries.Overcoming stigma, government inertia andreligious opposition to family planning havebeen enormous and ongoing struggles in manycountries, with civil society groups always inthe forefront. Civil society groups have alsobeen important in directly providing highqualityservices. In Colombia, for example,Profamilia, the local IPPF affiliate (with tacitsupport from the government), establishedan effective national family planningprogramme and became the primary providerof reproductive health services throughout thecountry because the government was unwillingto take on religious opposition and initiate aprogramme itself.However, in most cases, civil society groupshave not been able to provide high-qualityservices on a large scale. And cultural andreligious beliefs can make the provision offamily planning services sensitive for some civilsociety organisations. For example, in Tanzania,where faith-based groups provide around40 percent of healthcare services, condomsare not provided in faith-based hospitals andclinics (Strategies for Enhancing Access toMedicines 2001).14 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

Similarly, many civil society groups have beenestablished to advocate for greater politicalattention to AIDS, and to provide healthcareand support. Treatment advocacy groups,organisations of people living with HIV,women’s groups and faith-based organisationshave been key actors. The early advocacywork of ACT/UP in the US was extremelyeffective, and has led to the creation ofmany similar advocacy groups, including theTreatment Action Campaign in South Africa,The AIDS Support Organisation (TASO) ofUganda, the International HIV/AIDS Alliance,the International Council on AIDS ServiceOrganizations (ICASO) and the Society forWomen and AIDS in Africa (SWAA).To date, there has been limited integrationof civil society provision of family planningand broader sexual and reproductive health(SRH) services with HIV/AIDS advocacy andservices. The existence of different fundingstreams, an initial focus among HIV/AIDSorganisations on care for people living with HIVand, in some instances, a focus on work withmarginalised communities who are not alwayswell-served by SRH-focused organisations allhelped institutionalise a new, separate set oforganisations and activities to address HIV/AIDS in some countries. Donor conditionalitieson funding (e.g., the US “Mexico City policy,”which denies funding to organisationsproviding abortion counselling or services) mayhave also encouraged the separation of SRHand HIV/AIDS services. However, despite someoperational challenges and different emphasesbetween the two fields, links between SRHand HIV/AIDS are now being made (InteractWorldwide 2006; IPPF 2006).Microbicides will be used by reproductiveagewomen, who are often already servedby family planning and reproductive healthorganisations. Microbicide introduction willrequire community mobilisation and support,and would benefit from improved civil societycoordination on SRH and HIV/AIDS.GOVERNMENT PROGRAMMESProviding Access to Services for the PoorGovernment health services play an importantrole in providing family planning services (seeFigure 3). The first government-led nationalfamily planning programme was launchedin India in 1959, followed by other countriesin the 1960s and 1970s. By 1976, seven inten developing country governments (109countries) provided some form of supportfor contraception. By 2001, this number hadincreased to 184 countries (UN 2003).In addition to establishing programmes todirectly provide services, governmental supporthas facilitated access to contraceptives bypublicly legitimising family planning, educatingthe public, addressing cultural or professionalopposition and supporting a range of nationalpolicy initiatives, such as increasing theminimum age-at-marriage, allowing tax-freeimportation of supplies and removing lawsthat might inhibit programme implementation(e.g., regarding provision of family planninginformation to key populations).Historically, the majority of international donorsupport for reproductive health and familyplanning has gone to governments. Initially,donors supported independent verticalPLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 15

Figure 3: Source of supply of modern contraceptive methods in select countries, % public sector(survey year) (Source: ORC MACRO 2006)government family planning programmesbecause Ministries of Health were often slowto accept family planning and governmentsstruggled to include it in existing healthservice structures. A prominent example isthe Indonesian National Family PlanningBoard, which was created as a cabinet-levelentity with a successful national programmeoperating independently from the Ministry ofHealth. While the vertical approach permittedthe rapid development of dedicated nationalprogrammes and made it easier to measurefamily planning efforts, it often failed tointegrate family planning into broader healthprogrammes and infrastructure, and madeprojects vulnerable to changes in donorpriorities. Over time, maternal and child healthservices incorporated family planning into theirlarger programmes and, following the CairoConference in 1994, integration of reproductivehealth/family planning into national healthsystems became the norm.However, public health systems andgovernment programmes, particularly in sub-Saharan African and South Asia, are oftenhighly constrained by inadequate funding(compounded by unreliable donor support),weak infrastructure and severe staff shortages.These constraints result in low servicecoverage (especially in rural areas), stock-outsand poor quality of care. Low expectationsof public sector services often lead to lowservice utilisation rates, with many peopleresorting to faith-based and other civil societyorganisations or private sector providers for16 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

health commodities or services (Mendis et al.2007; Ewen and Dey 2005).In the government sector, just as within civilsociety, much HIV funding and programmingis being delivered vertically and in parallel toother health financing and funding. While thishas supported rapid increases in HIV services,concerns have been raised regarding thesustainability of these new structures, andabout the risk of diverting resources awayfrom existing broader and already strainedsystems. In recognition, more emphasis isnow being placed on approaches to scaleup HIV-prevention and treatment servicesin ways that can strengthen health systems(WHO 2003), including greater linkages withSRH services (WHO/UNFPA/IPPF 2005). Theoutcome of these approaches will be importantfor decisions on the initial introduction, scaleupand long-term sustainability of microbicideaccess.SOCIAL MARKETINGNiche between Public and Private SectorsSocial marketing occupies a niche betweenthe public and private sectors, using privatesector marketing methodologies anddistribution channels to promote publichealth. Social marketing programmes focuson creating demand for services, brands orhealth in general, and behaviour change. Byproviding easy and reliable access to low-cost,quality-assured products, social marketingprogrammes have increased coverage andconsistency of service use or behaviour changein its target populations.Social marketing for family planning beganin the 1960s to promote wider condom use.It spread throughout South Asia in the 1970sand in other regions during the 1980s. Socialmarketing organisations – both national andinternational – proliferated following theadvent of the HIV/AIDS epidemic. Today, thefocus on family planning and HIV and STIprevention remain, but the social marketingfield has broadened to include products formalaria prevention, nutrition, water treatmentand other health issues (Population ServicesInternational 2006).Social marketing product and programme costsare usually subsidised by international donors,who invest approximately US$350 millionannually in social marketing programmes(Institute for Health Sector Development2004). In 2005, social marketing providedapproximately five percent of all couple yearsof contraceptive protection in developingcountries excluding China (DKT International2006). However, social marketing’s share ofthe contraceptive market varies widely fromcountry to country, from 86 percent in Nigeriato just 2.5 percent in South Africa (Meadley2003).Social marketing has been most successfulat delivering over-the-counter products, likecondoms, but innovative methods have beendeveloped to provide prescription products.For instance, in Sri Lanka, where pills wereto be provided only with a prescription,“prescriptions” were printed in newspaperswith all the necessary information that womencould take to their doctors for signature(Harvey 1997).PLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 17

Social marketing organisations have begun todevelop franchising initiatives to expand accessto provider-dependent methods that mustbe distributed in a clinic. In social franchising,the central organisation provides training,marketing support and branding to retail outletsand clinics, and the outlets (franchisees) agreeto provide quality products and services atlow prices. For example, in Pakistan the “GreenStar” network of family planning clinics andretail outlets provide IUD services to the urbanpoor. Voucher schemes are also often used toencourage vulnerable clients to visit a clinicfor specific services (such as providing subsidyvouchers for insecticide treated nets for malariaprevention to new mothers at antenatal clinics).A prescription-only microbicide may benefitfrom social marketing innovations such as these.Social marketing programmes can be lesseffective at reaching people in rural areas, wherelow population densities and poor infrastructureincrease costs. Some commentators haveargued that co-payments usually required bysocial marketing programmes can providea barrier to access for the very poor (Sachs2006), although evidence on the equity ofsocial marketing programmes for differentcommodities is mixed (Chapman and Astatke2003). Even with co-payments, however, socialmarketing programmes require long-terminvestment by governments and/or donors.Social marketing excels at identifying anddeveloping market segments, skilful productpositioning, market research and demandgeneration,all of which are critical componentsfor introducing a new category of product andmaking such approaches particularly attractivefor microbicides. In addition, social marketingorganisations already work in the areas of SRHand HIV prevention, two important entry pointsfor microbicides.PRIVATE SECTORKey to Sustainability?In many medium- and low-income countries,private expenditure significantly exceedspublic spending on health (see Figure 4). Mostprivate spending is for acute treatment ratherthan preventive services, and as much as 90percent of out-of-pocket expenditure is forpharmaceuticals (Institute for Health SectorDevelopment 2004).The private sector could be an attractivedelivery channel in certain instances. Onestudy shows that the private sector is preferredto the public sector by young women andadolescents for family planning services inseveral African countries (Murray et al. 2005).However, it is important to note that moregenerally, poor women are less likely to useprivate healthcare services compared to poormen, especially if they do not earn an income(Rakodi 2002).A country’s income is not necessarily apredicator of a vigorous private sector, asevidenced by the robust private sector healthactivity in poor countries like India andBangladesh. More important determinantsare potential market size, the availability ofdistribution and promotion channels, and afavourable regulatory and business climate.The concentration of population in urbanareas also facilitates commercial sector activitybecause it reduces distribution and promotion18 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

Figure 4: Private expenditure on health as % of total health expenditure in 2001(Source: WHO 2004a)costs (Bulatao 2002). Many developmentagencies, especially US Agency for InternationalDevelopment, have made efforts to expandthe role of the commercial sector inproviding contraceptives in order to promotesustainability.However, the private sector is not a panacea.Regulatory capacity, quality assurance andenforcement are weak in most developingcountries (Institute for Health SectorDevelopment 2004). Low quality of drugs andpoor prescribing and dispensing are pervasiveproblems in the private sector (WHO 2004a).This is particularly true in rural and peri-urbanareas, where medicines are primarily sold bychemical sellers and general stores that areoften unlicensed and have staff with littleor no training. Counterfeit drugs also pose aproblem: 70 percent of antimalarials in SouthEast Asia and over 50 percent of all drugstested in Nigeria were found to be counterfeit(Institute for Health Sector Development 2004)and contained little, no or the wrong activeingredients. In addition, high price markupsare common and can present a seriousaffordability barrier to the poor (Ewen and Dey2005).The private sector already plays a major rolein the delivery of health commodities andprovides important distribution outlets forPLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 19

eventual microbicide access, but improvedregulation, quality control and enforcement areneeded. Strategies are also needed to betteralign public health goals and commercialincentives, particularly to improve affordabilityand rural accessibility.5. LESSONS FROMCONTRACEPTIVE UPTAKEEXPERIENCESEncouragingly, substantial new resources areflowing to the health field, much of it spurredby the HIV/AIDS epidemic. Funding for HIV andAIDS efforts in developing countries increased28 fold between 1996 and 2005, reaching anestimated total of US$8.3 billion last year (Piot2006). Innovative health financing mechanisms– such as the Global Fund for AIDS,Tuberculosis and Malaria, the US President’sEmergency Plan for AIDS Relief, and the GlobalAlliance for Vaccines and Immunization – thatcan commit large sums over longer periodsthan traditional bilateral funding, could greatlybenefit microbicide introduction and scale-upthrough a variety of distribution channels.part of broader HIV and SRH programmes willbe essential.The experiences of family planning andreproductive health programmes also suggestthat the most effective mix of distributionchannels will differ from country to country.And new channels and approaches will alsobe needed in some countries – particularly toreach populations that are currently poorlyserved, including the many women in sub-Saharan Africa, who lack access to familyplanning and SRH services.HIV/AIDS has transformed what is perceivedto be achievable in delivering health servicesin developing countries. Although at anearly stage, attention is now being paid tothe potential of these HIV resources to buildbroader health system capacity, and to betterintegrate HIV and SRH services. The long-termsustainability of microbicide access will dependon supporting existing health structures andcapitalising on what is already in place.The experiences of family planningprogrammes suggest that civil society,government, social marketing and privatesectors could have mutually supporting rolesfor microbicide access. Further, it is importantto keep in mind that an eventual microbicidewill be introduced into settings where somemix of contraceptive products, as well asexisting HIV-prevention tools, are already beingsuccessfully distributed. Thus, whatever the mixof delivery channels mobilised, joint planningfor microbicide introduction and scale-up as20 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

LEARNING FROM THE PAST, LOOKING TO THE FUTURE: LESSONS FOR MICROBICIDESMany lessons for microbicide access can be drawn from the international family planning/sexualand reproductive health movement and its successes and difficulties in reducing fertility ratesthroughout the world: the “Magic Bullet Syndrome.” The frequent tendency of sponsoring agencies,researchers and providers to become highly enthusiastic about their newly developedtechnology can result in great optimism, overselling of the product and insufficient attentiongiven to limitations and constraints. This can lead to disappointment, negative reactions andeven abandonment of the method. It is essential to proceed cautiously, recognise productlimitations early and examine the potential market in light of existing methods.Cost Matters. The unit price of a reproductive health commodity greatly influences consumerand donor decision making. Product price is, however, only one element of total cost: theprogrammatic costs required to get the product to users are usually several times greater.Cost-effectiveness studies will be essential to determine the true value of microbicides indifferent settings. Strong and sustained donor and government support, akin to supportfor male condoms, will be needed if microbicides are to be made widely accessible. Recentinterest in international financing mechanisms for new health products may help to offset theapparent burdensome costs of procurement.Choice Matters. The family planning field has shown the importance of providing choice tomeet individuals’ changing needs and preferences. A variety of contraceptive technologies arenow available, although local preferences and provider biases have contributed to substantialvariations in uptake patterns in different countries. As HIV-prevention options expand, they,too, must respond to different country contexts and changing personal needs. Unlike thegradual growth of contraceptive technologies, the HIV-prevention field faces the prospect ofan expansion of options over the next few years, with the potential advent of approaches asdiverse as male circumcision, pre-exposure prophylaxis (PrEP) and microbicides. Managingsimultaneous introductions of new technologies into existing HIV-prevention and SRHservices will require considerable strategic planning and coordination.Secure Strong, Sustained Stakeholder Support. The history of the family planningmovement emphasises the fundamental importance of building and sustaining supportamong multiple constituencies and stakeholders, from donors and developing countrypolicy makers to civil society organisations and community leaders. Full understanding of theimportance of microbicides by key opinion leaders is essential to long-term success.PLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 21

The strong and ongoing support of international agency leaders and donors is crucial, asmicrobicides will require substantial long-term subsidisation. Developing products thatwomen and their partners will want to use, building sustained, broad-based support amongpolicy makers and health providers, and generating demand for an eventual product are allcrucial to success. Is Essential. New technologies can take years, even decades, before theyare fully accepted. After more than 30 years, the IUD is still not commonly accepted insub-Saharan Africa, although it is widely used elsewhere. Widespread demand generation,especially for a new category of product like microbicides, takes time. Inevitably, setbackswill occur. Long-term planning for full access is essential from the outset, and all stakeholdersmust understand that overnight success is highly unlikely.Pay Close Attention to Real and Perceived Side-Effects and Media Response. Side-effectsperceived to be minor or manageable in the development stage can become major problemsin full-scale access efforts. Rare events that were not detected in the development phase canemerge later, and need close and immediate attention. Media can quickly highlight real orperceived problems – even in other countries. Legal challenges can emerge and these attackscan be costly, effectively destroying markets and forcing manufacturers to withdraw products.International Procurement and Logistics Systems Are Essential. Donors need to developprocurement systems, or include microbicides in existing ones, to assure value in bulkpurchasing, predict current and future needs, and ensure timely, efficient and sustaineddistribution to countries. Effective national logistics and supply systems are needed to ensureeffective, low-cost distribution of microbicides and avoid stock-outs.Every Country and Cultural Setting Is Different. Market research is essential toappropriately position and price microbicides in each market segment. Special attentionneeds to be given to gender power relations in different cultural settings. A positive message(e.g., improving family life, sexual pleasure and lubrication) is more effective than a negativeone focusing on disease and death. Stigmatising a product by associating it with a particulargroup, such as sex workers and their customers, may limit more widespread use.Build on Existing Health Structures. While introduction strategies will require some level ofspecificity to establish microbicides and deliver them quickly to key populations, integrationwith existing HIV and SRH programmes and use of many of the same delivery channels will becrucial to securing widespread use. Public, private and non-profit sectors can all play a role inreaching different populations and in ensuring reliable, affordable, accessible and acceptablemicrobicide programmes. All possible mechanisms for providing access to microbicidesshould be exploited, including government health systems, local NGOs, faith-based groups,22 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

community organisations, industry, the police and military, commercial sales throughpharmacies and social marketing. The variety of delivery approaches is important, but theyrequire strengthening of regulatory and accountability systems.10. Plan for Scale-Up. The history of contraceptive introduction emphasises the importanceof planning for both introduction and scale-up. Funding and support for pilot programmesdoes not necessarily translate into longer-term, widespread adoption and use. Success in firstadoptercommunities and countries plays an important role in supporting subsequent uptake.For microbicides, initial introduction should be planned to maximise uptake and demonstrateimpact. As importantly, defining what counts as “successful introduction” will be essential tomaintaining momentum for scale-up.11. Second-Generation Products Offer New Access Opportunities. Improved, secondgenerationproducts offer important opportunities to expand the initial programme. Thisis particularly important because the first microbicides to be introduced will likely besuperseded relatively quickly, both by more effective products and increased variety inpresentation and delivery method (e.g., both coitally and non-coitally dependent products).If the second-generation product is more expensive than the original the advantages of thenew product must be marketed effectively to offset the price differential.12. Expect the Unexpected: the Roller-Coaster. Despite the most carefully planned microbicideaccess strategy, unanticipated events are likely to occur. These could include known sideeffectsbeing misrepresented in the media, rare or unanticipated side-effects, religiousopposition, false rumours, legal actions, ethical questions, donor fatigue and change inpolicies, financial mismanagement and changes in government leadership, among others. Aswith the introduction of contraceptives, these problems can lead to loss of confidence in themethod, negative media reports, lawsuits and loss of stakeholder support. Quick response tounexpected events is crucial.PLANNING FOR MICROBICIDE ACCESS IN DEVELOPING COUNTRIES: Lessons from the Introduction of Contraceptive Technologies 23

APPENDIX 1Comparative data on the IUD, implant and female condom contraceptive methods% of womenexperiencingReplacement an unintendedIllustrative Cost per Couple-Year of ProtectionFrequencypregnancy Public(product and programming costs) 5Public Procurement -# of units (in000s) 6within the firstProductyear of use 4 SectorCostperunit 4Typical FDA ApprovedUse UseTypical PerfectUseKenya Ghana UgandaSouthAfricaIndia 2000 2001 2002 2003 2004TCu380A 3.5 years 1 10 years 3 0.8 0.6 $1.55 $0.72 $0.54 $0.77 $0.93 $0.66 3328 7087 5945 6304 6642IUDNorplant 3.5 years 1 5 years 3 0.05 0.05 $23.80 $7.76 $7.58 $7.81 $7.98 $7.70 260 272 232 155 175Female There is each sex 21 5 $0.59 $119.00 $118.55 $119.12 $119.53 $118.85 ~ 3950 6770 4729 8971Condom evidence actthat FCs arere-used butnot enoughresearch toascertain theextent of thepractice 21 Janowitz et al 19992 Francis-Chizororo and Natshalaga 20033 USAID 20064 Trussel 20045 UN Millennium Project 2003. Does not include follow-up programming costs for implant and IUD beyond initial insertion. For implants, this estimatedoes not include removal costs.6 UNFPA 200524 INTERNATIONAL PARTNERSHIP FOR MICROBICIDES - JULY 2007

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IPM MISSION:The mission of IPM is to prevent HIV transmission by accelerating the development andavailability of safe and effective microbicides for use by women in developing countries.HEADQUARTERS:8401 Colesville RoadSuite 200Silver Spring, MD 20910USAIPM BELGIUM:Rue du Trône, 98, 7 th floor1050 BrusselsBelgiumIPM SOUTH AFRICA:Zomerlust EstatePricewaterhouseCoopers BuildingBergriver Boulevard, Paarl, 7646P.O. Box 3460, Paarl, 7620South

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