We support the ambitious—but, we believe, achievable—goal set 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.
Our commitment to providing access to reproductive health starts with our research and development, which has resulted in a diverse portfolio of contraceptive products.
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.
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 organizations (NGOs) help support and implement programs and policies that improve access and promote capacity-building by helping to train health care professionals and address barriers to care.
SUSTAINABLE BUSINESS MODEL TO PROMOTE ACCESS
We are committed to making our 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 for a wide variety of our family-planning products; responsible commercialization that incorporates training and capacity-building; policy advocacy; and community investment.
In developing countries that have high rates of maternal mortality and low rates of contraceptive prevalence, we have created a sustainable business model to promote access to contraceptive health programs. These activities are focused primarily on sub-Saharan Africa and countries in Asia and Latin America with high unmet need. Through this model, we work closely with core global partners and their regional and local affiliates—including the United Nations Population Fund (UNFPA), U.S. Agency for International Development (USAID), Department for International Development (DFID), Marie Stopes International, the International Planned Parenthood Federation, DKT International, the Clinton Health Access Initiative, the Bill & Melinda Gates Foundation, and Population Services International—to help expand access to our products.
We also work to raise awareness and improve equity in access to contraception in other parts of the world. In Europe, we are working to support efforts to launch our “Call to Action for Access to Effective Contraception” at the EU and country levels, and are liaising with stakeholders to elevate awareness and generate potential solutions for improvement.
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 to meet customer needs globally.
The majority of our production of our long-term reversible contraceptive implant is for developing countries. When we face supply constraints in these markets due to unforecasted demand, we work in close collaboration with our customers and partners to allocate supply to those countries most in need in the fairest and most transparent manner.
We continuously examine our supply chain, seeking to reduce inefficiencies, optimize yields, and lower costs of production, and have passed these savings on to our customers in the form of lower prices, particularly in lower-income markets. We also invest in new technologies to increase the efficiency of our operations and to be able to produce more affordable products at the same high quality to meet increasing demand.
As we continue to see demand grow for our long-term reversible contraceptive implant, particularly in developing markets, we will continue to analyze potential investments in our production capacity.
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.
The following metrics are for our family-planning products intended for underserved segments of the world’s poorest countries (defined as Family Planning 2020 or FP2020 countries) that are supplied through the public sector and social-marketing organizations. In 2017, IMPLANON NXT® (etonogestrel implant) was approved in India.
Note: For World Bank country classifications, please click here.
|IMPLANON NXT®||EXLUTON®||MARVELON 28®|
|Product is WHO Prequalified||Yes||Yes||Yes|
|FP2020 countries where product is registered1||45||30||29|
|FP2020 countries in which we supplied product||34||4||3|
|Women reached in FP2020 countries2||3,485,179||195,622||385,676|
|1. There are additional unregulated markets where our products may be available that are not represented by these numbers.|
2. Number represents potential number of women who could be reached based on number of products provided.
In order to facilitate institutional purchases of family-planning products and provide quality assurance, we have secured WHO prequalification for EXLUTON (lynestrenol), IMPLANON NXT (etonogestrel implant) and MARVELON 28 (desogestrel-ethinyl estradiol).
IMPLANON NXT is also included on the WHO Model List of Essential Medicines. The WHO list, updated every two years, serves as a guide for the development of national and institutional essential medicine lists. Medicines for inclusion are selected by WHO based on a rigorous review process by an Expert Committee of public health and clinical experts.
|International Nonproprietary Name (IN)||Date of Prequalification|
|MARVELON 28||Ethinylestradiol + Desogestrel||October 21, 2010|
|EXLUTON||Lynestrenol||June 18, 2010|
|IMPLANON NXT||Etonogestrel||May 23, 2013|
The success of reproductive health programs in the developing world relies upon the close cooperation and coordination of many partners. Those include pharmaceutical companies like ours that discover, develop and manufacture contraceptive products; national governments that seek to support family planning through policies that increase the use of contraception and through investment in both procurement and capacity-building; international, bilateral and multilateral donors that finance the purchase of reproductive health commodities and invest in service delivery management and implementation; NGOs that support implementation of such programs; and health care professionals and health extension workers who counsel and provide care for women around the world.
As one of many partners, we take the following steps to support family planning programs and to help increase awareness of and access to a broad choice of contraceptive products:
- Requests for quotation
- Partnering for implementation
- Public advocacy
REQUESTS FOR QUOTATION
Our company 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 and KfW, a German government-owned development bank) seeking to purchase reproductive health commodities that will be donated to programs in one or more countries; from multilateral agencies, such as 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, we adhere to the specific guidelines of each proposal and act in full compliance with local and international laws and requirements, as well as with our own high ethical standards.
For contraceptive product pricing, we consider a nation’s level of economic development and other relevant factors, including the types 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 non-daily and long-acting reversible methods.
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 on and use of our products.
We are extending our access pricing to targeted countries through 2023, an additional five years beyond the expiration of our 2013 agreement.
In May 2013, our company and the Bill & Melinda Gates Foundation announced an agreement to expand contraceptive access and options for millions of women in some of the world’s poorest countries. Under the agreement, we reduced the cost of IMPLANON and IMPLANON NXT by approximately 50 percent through 2018 in the targeted poorest eligible countries of focus for the reproductive health community.
Since 2013, we have supplied more than 20 million implants, bringing greater choice to millions of women in the world’s poorest regions.
In November 2015, we announced our decision to extend our access pricing to these same targeted countries through 2023, an additional five years beyond the expiration of the 2013 agreement.
PARTNERING FOR IMPLEMENTATION
For family planning programs in the developing world involving our contraceptive implants IMPLANON and IMPLANON NXT, the company requires the recipient governments and partnering NGOs to sign its Cooperation Agreement for the Receipt and Use of IMPLANON (CARUI).
The cooperation agreement includes:
- Our 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 our company 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
- Procedures to report product complaints and adverse events
- Provisions regarding compliance with the applicable laws of the U.S. and the recipient country, and with our ethical and business compliance policies
In the countries where our 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, the Clinton Health Access Initiative, Marie Stopes International (MSI), the International Planned Parenthood Federation (IPPF), Population Services International, DKT and Pathfinder International. Such collaboration ensures that countries have the expertise and support they need to achieve their reproductive health objectives.
In February 2015, we announced, as part of our commitment to health care provider training, that we would provide IMPLANON NXT training applicators at no cost in FP2020 countries through 2018 as part of product launch. During 2017, we provided approximately 54,912 placebos, and supported “training of trainers” by providing other training materials, including audiovisual materials, training kits and artificial arm models.
In 2017, we worked with more than 48 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 we engaged with were Mozambique, Malawi, the Gambia, Bangladesh, Uganda, Zambia, Zimbabwe and Niger.