Bill & Melinda Gates Foundation

Generic Manufacturers for Reproductive Health: Closing the Gap to Reaching 120 Million More Women

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July 29, 2013

One year ago, the world witnessed a palpable surge of energy and momentum around family planning and meeting the unmet need of millions of women around the world. The London Summit on Family Planning united civil society organizations, governments, private sector and foundations around the promise to provide 120 million more women in developing countries with access to contraceptives information, services and supplies by 2020. The commitments and coordination were unprecedented.

In the year since, and with the formation of the new Family Planning 2020 (FP2020) global initiative, commitment makers have turned their focus from what is our goal?, to how will we reach this goal? Our community is asking critical questions like: How do we turn these commitments into concrete results? What is needed to fill the gap, and deliver high-quality products to the women and families who need them most?

We know that all sectors have an important role to play. More importantly, we can only reach our shared goal if global leaders and the reproductive health community are open to considering innovative approaches, sharing information more broadly, and inviting new players and partners to join the effort.

In this spirit, a select group of generic manufacturers of reproductive health supplies inspired by the concerted focus that emerged during the London Summit, have come together under the auspices of the Reproductive Health Supplies Coalition (RHSC) to do their part to realize the FP2020 goal. The Generic Manufacturers for Reproductive Health (or GEMS Caucus) is a new community of practice comprised of a select group of generic manufacturers that collectively distribute family planning products to more than 50 countries. They are united in their commitment to provide the safe, quality-assured family planning products that enable women to make choices about their reproductive health – a key driver in the social and economic health of their families, communities, and country.

The GEMS Caucus currently includes seven select pharmaceutical companies from Asia, Africa, and Europe. They include: Cipla Limited (India); Famy Care, Ltd. (India); HELM AG (Germany); Naari AG (Switzerland); PT. Tunggal Idaman Abdi (Indonesia); Shanghai Dahua Pharmaceuticals Co., Ltd. (China); and China Resources Zizhu Pharmaceutical Co., Ltd. (China). Caucus members manufacturer and distribute the full range of essential hormonal contraceptives and most of the key maternal health medicines – and they are united in their commitment to the long-term objectives of FP2020. This is not, however, a closed group, and its membership is expected to grow as new partners demonstrate their steadfastness to quality.

For GEMS Caucus members, this commitment is demonstrated through their diligent efforts to meet expert review panel (ERP) and World Health Organization (WHO) Pre-qualification Programme product guidelines – the most vigorous standards base. Currently three out of the seven GEMS Caucus members have met WHO pre-qualification standards for at least one of their products.

In 2011, Cipla earned prequalification for a combined oral contraceptive. Earlier this year, two other companies also attained this high standard. First, China Resources Zizhu Pharmaceutical Co Ltd (China) became the first reproductive health manufacturer to receive prequalification from WHO Prequalification of Medicines Programme for the API (active pharmaceutical ingredient) ethinylestradiol. This is one of the main ingredients found in the most commonly-used combined oral contraceptive (COC) pills. High-quality APIs are vital to the production of high-quality medicines. Then, Famy Care Ltd., which already has a prequalified combined oral contraceptive, also received pre-qualification for the first generic emergency contraceptive product.

Looking down the road, Caucus members have many more products in the pipeline. Some of these supplies may soon become available should they receive a positive recommendation from the Expert Review Panel for Reproductive Health (ERP/RH), which meets later this month.

In this age of austerity – as public health procurers increasingly look for family planning products meeting international standards, and governments seek to do more with fewer resources – GEMS Caucus members represent a clear alternative. These manufacturers can meet the demand in high-need countries for lower-cost family planning supplies without sacrificing the quality that all women deserve. As consumers in the U.S. and developed markets increasingly trust and rely on generic medicines, Caucus manufacturers realize they can fulfill an important social need while also maintaining a viable business model. But GEMS companies are also motivated by what they have seen first-hand:  when women can choose if and when to have a family with confidence, everyone benefits. Women who are able to control their reproductive health are more likely to get an education, earn higher wages and be more productive members of their community.

The GEMS Caucus recently joined forces with the RHSC to support a focused initiative in a few high-need countries to shape markets and reduce stockouts. Working together with other RHSC partners provides Caucus members with access to a range of shared resources, including research, data and stakeholder networks that help foster deeper connections at the country level. The Concept Foundation serves as the RHSC's coordinating partner, working closely with this Caucus and other Coalition members to elevate the role of generic manufacturers globally.  

As individual companies and in tandem with the RHSC, members of the GEMS Caucus have the capacity to provide millions more women with quality reproductive health supplies. The Caucus is ready to do its part to advance the goals of FP2020, and to work together with all who are committed to reaching 120 million additional women with the products needed to meet their family planning needs.  

 
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