Female condom - Reproductive Health Supplies Coalition

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CAUCUS ON NEW AND UNDERUSED REPRODUCTIVE HEALTH TECHNOLOGIES PRODUCT BRIEFCurrent program/sector useSince 1993, female condoms have been distributedin 130 countries, and public-sector programs areunderway in several of these countries.The FC2® is purchased for public-sector programs byorganizations such as the US Agency for InternationalDevelopment (USAID), the United NationsPopulation Fund (UNFPA), and governmental healthministries. The Female Health Company reportedsales of 60 million units of FC2® in 2012. 6The Cupid female condom has recently been WHOprequalified and approved for bulk procurement byUN agencies. Until now, the Cupid was distributedthrough limited channels in Brazil, India, Indonesia,Kyrgyz Republic, Mozambique, the Netherlands, andSouth Africa. Between 2010 and 2013, Cupid Ltd.reported that over 2.5 million units of the femalecondom were sold.The Woman’s Condom and Phoenurse® are newerproducts with limited distribution in China. TheWoman’s Condom, branded O’lavie for the Chinesemarket, has been available in China in limitedchannels since late 2011. It is expected to becomeavailable in South Africa in 2013.According to the Reproductive Health Interchange,female condoms worth US$28.2 million wereprocured and distributed globally in 2012, by majorprocurement agencies. 7Manufacturers and distributionIncluded below is key information on the manufactureand registration status of the five female condomproducts that are currently on the market.PRODUCT MANUFACTURER REGULATORY STATUS DISTRIBUTION PRICEESTIMATES***FC2® female condom (alsoknown under the brand nameFemidon, Protectiv, Care, andmany other names)Made of nitrile (syntheticlatex), pre-lubricatedCupid female condomMade of rubber latex,pre-lubricatedFemale HealthCompanyCupid Ltd., IndiaCE marking;***WHO prequalified 2007, 2012;USFDA approved 2009CE marking;WHO prequalified 2012;USFDA registration processinitiated in 2012Available in 130countriesBrazil, India,Indonesia,Kyrgyz Republic,Mozambique, theNetherlands, andSouth Africa$0.55/unit$0.45/unit at 5million unitsWoman’s Condom (alsoknown as O’lavie for theChina market)Pouch, ring, and foam shapesmade of polyurethane;dissolving insertion capsulemade of polyvinyl alcohol;Shanghai DahuaMedical ApparatusCompany, ChinaCE marking;Under WHO review forprequalification;Undergoing contraceptiveeffectiveness study needed forUSFDA approvalLimited privatesectordistributionin China$0.87/unit at 5million units,volume discountsmay applyNon-lubricated, packaged withwater-based lubricantPhoenurse® female condomMade of polyurethane,pre-lubricated withsilicone-based lubricantTianjin CondombaoMedical PolyurethaneTech. Co. Ltd,Tianjin, ChinaCE markingBrazil, China,Kenya, Mexico, andSri Lanka0.59/unit; volumediscounts mayapply*** Pricing information in this table is based on the most accurate information and/or estimates provided by the manufacturer. Prices may fluctuate dependingon various procurement conditions, including volume and contractual stipulation.**** The manufacturer of a product affixes the CE marking to it, assuring the product meets European Economic Area regulations. However, the manufacturersdo have to take certain obligatory steps before the product can bear the CE marking: they must complete a conformity assessment, set up a technical file, and signa European Community declaration of conformity. The document has to be made available to authorities on request.2
CAUCUS ON NEW AND UNDERUSED REPRODUCTIVE HEALTH TECHNOLOGIES PRODUCT BRIEFRegistration statusThe FC2®, Cupid, Phoenurse®, and Woman’s Condomall have a CE marking, which certifies that the producthas met European Union consumer safety, health, andenvironmental requirements.In addition to being WHO prequalified and USFDAapproved, the FC2® is registered in 30 countries and iscurrently pending registration in four countries. Afterreceiving WHO prequalification in 2012, Cupid Ltd.has initiated the female condom registration processwith USFDA. Cupid female condom is currentlyregistered with the Brazilian Regulatory Agency(ANVISA), Indian Drug Control Authority, and SouthAfrican Bureau of Standards. The Woman’s Condom isregistered in China and registration in South Africa isunderway. Phoenurse® is currently registered in Braziland China.Public-sector price agreementsAt the 2012 Family Planning Summit in London, theFemale Health Company pledged to increase access toFC2® female condom for the world’s poorest countriesand announced a prospective pricing arrangementbased on aggregate purchases and 5 percent freegoods based on the prior year’s purchases, togetherwith a multiyear agreement to provide $14 million intraining and education by FHC over the next six years.The Cupid female condoms have been sold in KyrgyzRepublic through UNFPA for their public distributionsystem. The Woman’s Condom has been sold to thepublic sector in China. Phoenurse® female condomshave not been sold to public-sector purchasers as ofthe date of this publication.Globally, it is acknowledged that further pricereductions are necessary to achieve universal accessto female condoms. Based on market analysis it isexpected that sustainable price reductions are feasible.References1. World Health Organization (WHO) Department ofReproductive Health and Research, Johns Hopkins BloombergSchool of Public Health/Center for Communication Programs(CCP) INFO Project. Family Planning: A Global Handbook forProviders. Geneva and Baltimore: WHO and CCP; 2007.2. US Food and Drug Administration. Summary of Safety andEffectiveness Data – FC2 Female Condom. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080002. Accessed February 13, 2013.3. Joanis C. A Randomized Controlled Trial of the FunctionalPerformance of New Female Condoms: An Evaluation of theWoman’s Condom (WC), FC2, VA w.o.w. and Cupid: FinalReport. Joanis Consulting: Kennesaw, Georgia; 2012.4. Cecil H, et al. The female condom: what we have learned thusfar, AIDS and Behavior. 1998;2(3):241–256.5. WHO. The Female Condom: A Review. Geneva: WHO; 1997.6. The Female Health Company website. Available at: www.femalehealth.com.7. Reproductive Health Interchange website. Available at: http://www.myaccessrh.org/rhi-home. Accessed March 11, 2013.For more information on the Caucus on New and Underused RH Technologies, please visit our web page athttp://www.rhsupplies.org/working-groups/caucus-on-newunderused-rh-technologies.html.This publication forms part of a series of technical briefs, written by members of the Caucus on New and Underused Reproductive HealthTechnologies, a thematic group established under the auspices of the Reproductive Health Supplies Coalition. The Caucus’ aim is tobroaden the discussion within the Coalition of reproductive health technologies that are not well integrated into the public or commercialhealth sectors. Responsibility for the selection and contents of the product briefs rests solely with the Caucus and does not implyendorsement by the Coalition or its wider membership. For additional information, please contact secretariat@rhsupplies.org.This brief was last updated May 20133
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Female condom - Reproductive Health Supplies Coalition

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