WomanCare Global and PSI's Official Update

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WomanCare Global and PSI's Official Update
Publication Date: 10/13/2015

WomanCare Global and PSI provided the following updates on progress in achieving its FP2020 commitments:

Expanding access to an array of reproductive health products and managing large-scale distribution: Under the USAID-funded, Expanding Effective Contraceptive Options (EECO) project, WCG and PSI are working together to introduce new methods of contraception. Large-scale pilots in Zambia, Malawi, Madagascar and India will provide women with greater choice to prevent unplanned pregnancy. New methods supported under EECO include four new product lines: a contraceptive gel; new barrier methods; a hormonal intrauterine system (IUS) and intra-vaginal rings (IVR).  

  • Globally, 110 million women cite method-related reasons for non-use of contraception. Each product in the EECO project possesses important benefits that address one or more method related reasons for non-use, e.g., they are non-hormonal, appropriate for breastfeeding women, discreet. Additionally, because most are woman-initiated, these products have the potential to overcome access barriers related to the limited number providers and/or provider or partner bias against contraceptives.
  • As of June 2015, the project has registered the PATH-developed SILCS Diaphragm and Woman’s Condom in Malawi and Zambia. A background research review was performed for all EECO products, and formative and market research were completed in Malawi and Zambia for the SILCS Diaphragm and the Woman’s Condom. Marketing plans and country-specific branding and packaging were developed for both products and countries.  Distribution and promotion of the Woman’s Condom will launch in Malawi and Zambia in Q3/Q4 2015.  Distribution and promotion of the SILCS Diaphragm will not take place until 2016.
  • In April 2015, WCG completed a regulatory assessment for the SILCS Diaphragm and Amphora Contraceptive Gel in India. PSI will initiate market research in India in Q4 2015 and WCG regulatory activities are expected to commence in Q2 2016, pending U.S. FDA approval of Amphora Contraceptive Gel.
  • Under the EECO project, WCG is also working closely with the Population Council and USAID to advance regulatory work with the progesterone contraceptive vaginal ring developed by the Population Council and currently on the market in eight Latin American countries.

Increasing the usage of long-acting, reversible contraceptives: In Q3 2015, under the USAID-funded Expanding Effective Contraceptive Options project, WCG and PSI will begin planning for the pilot introduction of Medecine360/Actavis’ levonorgestrel intrauterine system (LNG-IUS), Liletta.  WCG and PSI will commence regulatory activities for the product in Malawi, Zambia and Madagascar before the close of 2015.  Registration will take between six and twelve months, depending on the country. 

Monitoring the quality of products and evaluating programs: Under the USAID-funded, Expanding Effective Contraceptive Options project, WCG is responsible for quality assurance/quality control for each of the project’s focus products, including: a contraceptive gel; new barrier methods; a hormonal intrauterine system (IUS) and intra-vaginal rings (IVR).  

  • In 2014, WCG and USAID established the QA requirements necessary for the first set of products to be launched under EECO. As part of this agreement, WCG performed an on-site cGMP compliance audit with three product manufacturers, established an agreement with an ISO-certified, independent test laboratory for pre-acceptance testing of all lots procured under EECO and reviewed evidence of compliance with manufacturer specifications.
  • In addition, as launch of the first product (the Woman’s Condom) approaches, WCG and PSI are working to establish agreements pertaining to pharmacovigilance, including monitoring, managing and reporting adverse events and complications.

Providing training and other forms of support: Under the Expanding Effective Contraceptive Options (EECO) project, PSI and WCG will commence medical detailer training and provider/retailer orientation for the first product launch (the Woman’s Condom) in Malawi and Zambia in Q3/Q4 2015. Additional product training will take place in 2016 and 2017 in Malawi, Zambia, Madagascar and India prior to the launch of the other EECO products (e.g. the SILCS Diaphragm, Amphora Contraceptive Gel and the LNG-IUS). 

Utilizing existing wholesale and retail distribution infrastructure to make products widely available, supplemented by outreach events and the engagement of community-based health workers: As of June 2015, under the USAID-funded Expanding Effective Contraceptive Options (EECO) project, WCG and PSI have registered the PATH-developed SILCS Diaphragm and Woman’s Condom in Malawi and Zambia. The Woman’s Condom will launch in 2015 via private sector outlets (pharmacies, clinics and select fast moving goods outlets) in Malawi and Zambia.  In both countries, PSI and WCG will promote the EECO products via interpersonal communication agents acting at the community level and via medical detailers who will target providers and retailers.

Focusing on an integrated pilot effort in four markets in Africa: Under the USAID-funded Expanding Effective Contraceptive Options (EECO) project, WCG and PSI are working together to introduce new contraceptive methods via integrated pilots in three African countries—Malawi, Zambia and Madagascar—as well as in India.

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WomanCare Global and PSI's Official Update