At Merck, our commitment to providing access to reproductive health starts with our research and development, which has resulted in a diverse portfolio of contraceptive products.
Beyond our research, we continue to work hard to develop sustainable business models that will help improve access to our products for the people who need them most. Our partnerships with governments, international organizations and nongovernmental development organizations help support and implement programs that improve access and promote capacity-building by helping to train healthcare professionals and address other barriers to care.
Research & Development
Merck has a strong legacy of research and development of contraceptive products that have supported women’s family planning efforts. Over the years, we have been responsible for the development of a wide range of contraceptive options, including a single-rod contraceptive implant, a once-monthly vaginal contraceptive ring, and progestin-only and combined oral contraceptives.
In 2012, Merck researchers continued to develop new formulations of our existing women’s health products to better meet conditions in developing countries, including heat-stable formulations, and to develop innovative long-acting reversible contraceptive solutions relevant to the needs of women in low- and middle-income markets.
Sustainable Business Model to Promote Access
Merck is committed to making its contraceptive products available to women around the world. We take a comprehensive approach to access that includes high-quality manufacturing and supply chain management; extensive registration and World Health Organization (WHO) prequalification of our family planning products; responsible commercialization that incorporates training and capacity-building; and community investment.
Merck supports the ambitious, but we believe achievable, goal set out by the global reproductive health community in 2012 of ensuring that voluntary life-saving family planning information, services and products reach an additional 120 million women and girls in the world’s poorest countries by 2020. We also support the UN Commission on Life-saving Commodities for Women and Children’s call to improve equitable access to 13 overlooked commodities, including contraceptive implants.
In developing countries that have high rates of maternal mortality and low rates of contraceptive prevalence, our Institutional Family Planning Services division has created a sustainable business model to promote access to contraceptive health programs. These activities are focused primarily on sub-Saharan Africa and markets in Asia and Latin America with high unmet need.
High-Quality Manufacturing & Supply Chain Management
We work to ensure that we have sufficient manufacturing capacity to meet short-, medium- and long-term availability of our contraceptive products for reproductive health programs conducted by governmental and nongovernmental organizations and other customers.
In 2012, we dedicated resources to examining our supply chain to reduce inefficiencies, optimize yields and lower costs of production. We have passed these savings on to our customers in the form of lower prices, particularly in lower-income markets. We also invested in new technologies to increase the efficiency of our operations and to be able to produce more affordable product at the same high quality to meet increasing demand.
Registration & Prequalification
We seek to ensure global access to our contraceptive products by obtaining and maintaining up-to-date product registrations around the world. In addition to existing and in-process registrations, numerous registrations are planned for products in countries of various income levels.
Note: For World Bank country classifications, please click here.
In order to facilitate institutional purchases of family planning products and provide quality assurance, Merck has secured WHO prequalification for EXLUTON® (lynestrenol), IMPLANON® (etonogestrel implant), IMPLANON NXT® (etonogestrel implant) and MARVELON® (desogestrel-ethinyl estradiol).
The success of reproductive health programs in the developing world relies upon the close cooperation and coordination of many partners. They include pharmaceutical companies like Merck that discover, develop and manufacture contraceptive products; national governments that seek to support family planning by increasing the use of contraception; international, bilateral and multilateral donors that finance the purchase of reproductive health commodities and invest in service delivery management and implementation; nongovernmental organizations that support implementation of such programs; and healthcare professionals and health extension workers who counsel and provide care for women around the world.
As one of many partners, Merck takes the following steps to support family planning programs and to help increase awareness and access to a broad choice of contraceptive products.
Requests for Quotation
Merck receives and responds to “Requests for Quotation” from developing countries’ governments seeking supplies for their own programs (financed by government funds, by multilateral organizations like the World Bank, or through bilateral aid); from donor country aid agencies (e.g., USAID, DfID, KfW) seeking to purchase reproductive health commodities that will be donated to programs in one or more countries; from multilateral agencies such as the United Nations Population Fund (UNFPA) donating to one or more countries; or from nongovernmental agencies seeking supplies for programs that they manage in one or more countries.
In responding to these requests, Merck adheres to the specific guidelines of each proposal and acts in full compliance with local and international laws and requirements.
For contraceptive product pricing, we consider a nation’s level of economic development and other relevant factors, including the type of family planning programs implemented by the local government.
In upper-middle-income and high-income countries, we provide our products at prices that take into account the innovation and value they represent. With a commitment to making our contraceptive products available to the public sector, we also offer discounts to organizations that serve women of all income levels, like Planned Parenthood affiliates, so that the women who rely on their services have routine access to contraceptive options that include nondaily and long-acting reversible methods.
In order to facilitate the purchase of our products for use in institutional family planning programs in low-income and lower-middle-income countries, we price our reproductive health commodities at their lowest access prices when selling them to qualified buyers.
We believe that our pricing approach will help improve product availability while also allowing the company to continue to invest in research, development, production, and the training and education necessary to help ensure appropriate counseling and use of our products.
In July 2011, Merck and the Reproductive Health Supplies Coalition (RHSC) announced a partnership to enhance access and appropriate and effective use of IMPLANON® (etonogestrel implant) for qualified buyers in developing countries. Under the initiative, IMPLANON is available at Merck’s lowest access price to donor agencies and family planning members of RHSC in sub-Saharan Africa, and in all other Low Income countries as defined by the World Bank1 and Lower Middle Income countries1 with maternal mortality ratios of >200 according to UN data.2
Less than one year later, in November 2012, RHSC announced that the initiative had met its initial target of supplying 4.5 million units of the product, triggering a further credit rebate for the eligible recipient countries.
In May 2013, building on the company’s previous price announcement, Merck and a group of public- and private-sector partners announced an agreement to further expand contraceptive access and options for millions of women in some of the world’s poorest countries. The increased volume generated from the success of the initial initiative with RHSC and the guarantee of continued volume has allowed Merck to achieve improved economies of scale making the further price reduction possible. Under the agreement MSD will reduce the cost of IMPLANON and its next-generation implant, IMPLANON NXT® (etonogestrel), by approximately 50 percent for the next six years in the targeted poorest eligible countries of focus for the reproductive health community. Learn more.
Partnering for Implementation
For family planning programs in the developing world involving Merck’s contraceptive implant IMPLANON, the company requires the recipient governments and partnering NGOs to sign a Cooperation Agreement for the Receipt and Use of IMPLANON (CARUI). The cooperation agreement includes:
- Merck’s commitment to a comprehensive service approach that provides and/or supports capacity-building in service delivery, including pre- and post-insertion counseling and insertion/removal training
- Distribution requirements that must be met by Merck and local partners to ensure that all clinics/providers meet training and quality assurance requirements, provide sustained services over the duration of the product’s life (three years), and can access referral centers in case more specialized care related to IMPLANON is required
- Merck’s commitment to “training of trainers” and providing training materials, including audiovisual materials, training kits, artificial arm models and placebos; Merck may provide additional technical assistance for direct and cascaded training activities of healthcare providers with our local partners on a case-by-case basis
- Procedures to report product complaints and adverse events
- Provisions regarding compliance with the applicable laws of the U.S. and the recipient country, and Merck’s ethical and business compliance policies
In the countries where Merck products are included in family planning programs, we work closely with ministries of health and local implementing partners, who play a pivotal role in supporting training, counseling and other related activities. Our local implementing partners have included Jhpiego, EngenderHealth, Marie Stopes International, International Planned Parenthood Federation, Population Services International, Pathfinder International and DKT. Such collaboration ensures that countries have the expertise and support they need to achieve their reproductive health objectives.
In 2012, we worked with more than 30 countries in sub-Saharan Africa, Asia and Central America to provide contraceptive products through numerous partnerships with governments, donors and NGOs. Some of the countries where our Institutional Family Planning Services engaged in partnerships in 2012 include Madagascar, Ethiopia, Kenya, Uganda, Tanzania, Nigeria, Bangladesh, Vietnam and Cambodia.
As part of our capacity-building and training commitment, Merck provided support and educational grants for governments and/or local implementing partners to train more than 15,000 healthcare providers in sub-Saharan Africa, Asia and Central America in 2012. Merck also trained and/or provided medical education to many healthcare providers around the world.
Merck supports the ambitious, but we believe achievable, goal set out by the public health community in 2012 of ensuring that voluntary lifesaving family planning information, services and products reach an additional 120 million women and girls in the world’s poorest countries by 2020.
We were pleased to have been asked to participate in the London Summit on Family Planning in July 2012, at which we affirmed our partnership with RHSC to make IMPLANON available at our access pricing.
We also participated in the September 2012 launch of a report by the UN Commission on Life-Saving Commodities for Women and Children that recognized the importance of contraceptive implants and of women’s choice in deciding which method and product is right for them. Merck Chairman and Chief Executive Officer, Ken Frazier, was one of the Commission’s 19 commissioners. And we continued to engage with partners and donors to ensure that multiple options are available to countries as they seek to address the unmet contraceptive needs of women.
1 World Bank Classification of countries as of 18 July 2011, Atlas Method
2 WHO/UNICEF/UNFPA/The World Bank, Estimates of Maternal Mortality 2008
Last Updated November 25, 2013