Woman's Condom achieves WHO/UNFPA prequalification

Contact:
Claire Hudson, PATH, media@path.org, 206.302.4521.

Seattle, United States, and Shanghai, China, March 3, 2016–The Woman's Condom, a new female condom designed to be easy to use and more acceptable to women and their partners, has been prequalified by the World Health Organization (WHO)/United Nations Population Fund (UNFPA). The approval marks a critical step forward in expanding options for female-initiated dual protection from pregnancy and sexually transmitted infections (STIs), including HIV.

WHO/UNFPA prequalification represents an important step in increasing access to the Woman's Condom. The WHO/UNFPA decision allows United Nations agencies and other international purchasers to procure the product for public-sector distribution. Prequalification also serves as an endorsement of quality, efficacy, and safety. In addition to WHO/UNFPA prequalification, the Woman's Condom is approved in China, Europe, Malawi, South Africa, and Zambia.

"This milestone is a testament to the power of cross-sector collaboration," said Steve Davis, president and CEO of PATH. "Through the combined expertise of our partners and the Protection Options for Women Product Development Partnership (POW PDP), we successfully advanced the Woman's Condom from product development to market introduction, and achieved critical approval from WHO. By expanding the method mix for contraception and STI/HIV prevention, our partnership has achieved an important legacy for women's reproductive health."

The Woman's Condom was developed by PATH, CONRAD, and local research partners through a user-centered process across four countries. It has innovative features that enable easy insertion, secure fit during use, and good sensation and comfort for both partners. Clinical studies in multiple countries confirm the Woman's Condom is safe, acceptable, easy to use, and that it performs well. In 2008, PATH transferred production to the Dahua Medical Apparatus Corp. Ltd. (DAHUA) of Shanghai, China.

"DAHUA and our partners celebrate this shared success in advancing the Woman's Condom, known in China as the O'lavie Female Condom," said Mr. Chen Hua, president of DAHUA. "As the manufacturer, we are committed to developing a high-quality product and increasing method choice for dual protection, and are honored that more women and men across the world may have expanded access to this new tool."

WHO/UNFPA prequalification comes at a time when additional options for dual protection are urgently needed. According to recent estimates, more than 350 million new cases of curable STIs occur every year. In 2014, there were two million new HIV infections globally. Women account for slightly more than half of all people living with HIV in low- and middle-income countries. An estimated 225 million women worldwide want to avoid pregnancy but are not using modern contraception, primarily because they want methods that do not have side effects and can be used only when needed.

"The Woman's Condom has great potential to address unmet need and improve reproductive health for women, men, and young people," agreed Mags Beksinska and Jenni Smit, research directors at the Maternal, Adolescent and Child Health Unit (MatCH Research) in South Africa. "Our recent market studies in South Africa showed that women and men–especially young people–are excited about this innovative and pleasurable female condom. MatCH Research looks forward to working with DAHUA and the POW PDP to increase awareness and availability."

Over a five-year period (2011–2015), PATH, DAHUA, CONRAD, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development worked together to bring the Woman's Condom to market through their Protection Options for Women Product Development Partnership (POW PDP). Established by PATH with funding from the Netherlands Ministry of Foreign Affairs, the POW PDP focused on generating clinical evidence, building product supply, gaining product registrations and approvals, shaping new markets, and conducting advocacy. WHO/UNFPA prequalification is a culminating achievement that puts the Woman's Condom in an ideal position for introduction into a variety of countries.

Read more about the Woman's Condom and the POW PDP project (2011-2015).

Dahua Medical Apparatus Co. Ltd. (DAHUA) of Shanghai, China, is a high-quality, large-volume manufacturer with more than 25 years of experience in the medical device business. Dahua has specific capability in film production and welding, plastics molding, and assembly. The company is compliant with general medical device good manufacturing practices (GMP) and has ISO 9000 series and ISO 13485 registration. DAHUA is committed to improving reproductive health and expanding protection options for women and men globally. For more information, visit www.femalecondom.cn.