Access to Family Planning

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Technical Assistance

Provision of technical assistance to manufacturers of generic family planning products

Under its ongoing Bill and Melinda Gates Foundation (BMGF) grant to address the barriers to making quality-assured, three-monthly injectable contraception widely available, Concept Foundation is working with manufacturers of generic intra-muscular depot medroxyprogesterone acetate (DMPA) FPPs and medroxyprogesterone acetate (MPA) APIs towards achieving WHO Prequalification (PQ) of their products. (More information on WHO PQ can be found on our Resources page)

Technical support is being provided to manufacturers of MPA API to ensure that adequately documented quality ingredients are available to manufacturers of generic DMPA, in order to both support WHO PQ and ultimately serve the market. In addition to these activities, Concept Foundation has continued working with selected oral contraceptive manufactures, however due to a lack of donor funding for this activity, agreements have been made with the manufacturers to receive technical assistance on a fee paying basis.

Technical assistance is provided as follows:

Finished Pharmaceutical Products (FPPs)
Active Pharmaceutical Ingredients (APIs)
Research

On-going country-level research for generic RH medicines

Quality generics offer value for money and many procurers and country-level decision-makers are either not aware of their existence or often perceive generics in a negative light, often due to a history of bad experiences relating to quality issues with products that are not quality assured (QA). As a result, increased availability of WHO prequalified products does not necessarily translate to access. Procurers who do buy generics are often faced with a lack of choice of QA generic products and often are forced to purchase lower-cost non-QA generics, thereby feeding into the negative perceptions by increasing risks relating to safety and efficacy.

Under its ongoing BMGF grant, Concept Foundation has contracted research in target countries to inform the development of tools and materials for country-level messaging and communications for stakeholders involved in decision-making and procurement processes of RH medicines. These advocacy materials will be developed for dissemination in target countries, with the goal of increasing the likelihood of and improving the timeline for the uptake of generic reproductive health products among procurers, service providers, and consumers.

Access to Markets

DMPA forecasting

To ensure that the current and future production capacities of manufacturers of generic DMPA are adequate to meet the forecasted need, Concept Foundation is working with the William Davidson Institute to reassess the forecasted market demand for DMPA over coming years. This work is being conducted in parallel with the on-going activities with manufacturers of generic DMPA to achieve WHO prequalification of their products.

The forecasting datasets will be published formally through the RHSC DMPA Advisory Committee and other appropriate channels.

In addition to the forecast, this exercise will also focus on the development of a DMPA forecasting model which will be made available to other relevant institutions as required.

Provision of regulatory support to manufacturers of generic DMPA

Registration of reproductive health products remains a significant barrier to market entry for many generic manufacturers, further contributing to the continued lack of availability of affordable quality assured injectable contraception at the country level. Once WHO-prequalified, products have to go through country-level regulatory processes in order for them to be accessible within national markets. Under its ongoing BMGF grant, Concept Foundation is assisting manufacturers of generic DMPA to support market entry once WHO Prequalified to make these contraceptives widely available. These activities will focus on establishing the strategy and pathways for fast-tracking registration of generic DMPA in target countries where there is a high need for DMPA.  This effort will be coordinated with the existing WHO Collaborative Registration procedure and the Nepad African Medical Regulatory Harmonization (AMRH) group.

Countries that are currently participating in the WHO Collaborative Procedure are:

  • Armenia, Botswana, Burkina Faso, Burundi, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Georgia, Ghana, Kenya, Kyrgyzstan, Madagascar, Malawi, Mozambique, Namibia, Nigeria, Philippines, Senegal, Sierra Leone, Tanzania, Uganda, Ukraine, Zambia, Zanzibar, Zimbabwe.

The aim of these activities is to ensure that a competitive choice of DMPA product is registered and available for potential procurement.

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