- Initiated a significant expansion project for our IMPLANON NXT® (etonogestrel) manufacturing capabilities
- Pledged to provide IMPLANON NXT training applicators available at no cost during product launches in a country
- Together with the Bill & Melinda Gates Foundation, we extended our commitment to Family Planning 2020 (FP2020) for an additional two years through the end of 2025
- Added 2D matrix and serialization to the packaging of IMPLANON NXT; surpassing the request to complete serialization by June 2022
- Support efforts to accelerate access to our products and ensure that reproductive health and rights are included in global, regional and country strategies
- We seek to ensure global access to our contraceptive products by obtaining and maintaining up-to-date product registrations around the world
While progress regarding women’s health has been made since the launch of the Millennium Development Goals, rates of maternal mortality and unintended pregnancy remain high in many countries, and access to modern contraceptive methods remains limited, especially among the poorest and most vulnerable women and girls.
As the global community embraces the UN SDGs, we continue to support efforts to accelerate access to our products and ensure that reproductive health and rights are included in global, regional and country strategies.
In February 2020, our company announced its intention to spin-off products from its women’s health, trusted legacy brands and biosimilars businesses into a new, independent, publicly traded company (Organon & Co.).
Access to reproductive health
Enabling couples to determine whether, when and how often to have children is vital to helping achieve safe motherhood, healthy families and healthy communities. Voluntary family planning and broadening the method mix of family planning options help protect the health of women by reducing high-risk pregnancies, and help protect the health of children, adolescents and mothers by allowing sufficient time between pregnancies.
Research has shown that appropriately spacing pregnancies helps improve both mother and child survival rates and reduces the risk of preterm birth.2 The use of family-planning methods can also reduce the number of unsafe abortions and associated complications.3
Access to modern contraceptives is an important aspect of family planning. Our multifaceted approach supports efforts to improve access to family-planning services and contraceptives for the women most in need of them. We are actively engaged in areas where maternal mortality is high, and the prevalence of contraceptive use is low.4
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, and progestin-only and combined oral contraceptives.
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 WHO prequalification for a variety of our family-planning products, responsible commercialization that promotes training and capacity-building, policy advocacy and community investment.
We support the ambitious goal set by the public health community in 2012 of ensuring that the reach of voluntary lifesaving family planning information, services and products is increased in the world’s poorest countries. Strong progress has been made towards this target with information, services and products reaching 53 million additional women5 since the initiative began.
In developing countries that have high rates of maternal mortality and low rates of contraceptive prevalence, we have created a sustainable public-private partnership model, with first-quality products made available at access pricing 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.
Manufacturing and supply chain management
We work to ensure that we track changes in the markets to support short-, medium- and long-term availability of our contraceptive products to meet customer needs globally.
The majority of production of our long-term reversible contraceptive implant is for developing countries. When we face supply constraints in these markets due to un-forecasted 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 with aligned focus on existing programs.
As we continue to see demand grow for IMPLANON NXT, we have analyzed the investment needs required to significantly expand our production capacity. This resulted in a renewed long-term capacity plan that was finalized in 2019. As a result of this new long-term plan, our company has now initiated a significant expansion project for our IMPLANON NXT manufacturing capabilities. This project will result in annual available volumes for the FP2020 markets to grow year on year, with the goal of significantly increased volumes made available to FP2020 markets over the next four years. The first increases in volumes are expected to become available from 2021.
In order to facilitate institutional purchases of family-planning products and provide quality assurance, we have extended our WHO prequalification in 2019 for EXLUTON® (lynestrenol), IMPLANON NXT 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.
|IMPLANON NXT®||EXLUTON®||MARVELON 28®|
|Product is WHO prequalified||Yes||Yes||Yes|
|FP2020 countries where product is registered6||43||26||23|
|FP2020 countries in which we supplied product||32||6||6|
|Women reached in FP2020 countries7||5,246,000||4,921,000||1,816,000|
|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|
Registration and 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, we continue exploring options to expand the number of registrations for products in countries of various income levels.
The following 2019 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.
Pricing and commercialization
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
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 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 and maternal mortality rates.
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 and production of our products.
Programs and initiatives
Health care provider training
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 the product launch in these countries. Also, in 2019, our company pledged to make these training applicators available at no cost during product launches in a country. In cases not related to a product launch, IMPLANON NXT training applicators were made available at a reduced price.
Partnering for implementation
Given the scope and complexity of resolving the enormous unmet needs for contraceptives in the access markets, partnership with the international community is of huge importance. For example, to ensure the most efficient use of available products and funding, cooperation and alignment is needed to avoid overstocking in certain countries and leaving other countries without product. We continue to work with partners such as UNFPA, USAID, Collaborative Supply Planning Group/RHSC and many others to avoid such unbalances and ensure reproductive health supply chain security.
We support the European Patients Forum and their efforts with the European Parliament to raise awareness and improve equity in access to contraception in Europe where access to modern contraception continues to vary significantly throughout the continent.
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.
Throughout the world, we have partnered with organizations and supported projects that work to increase women’s access to health services, reduce maternal mortality, increase awareness of reproductive/sexual health among adolescents and vulnerable populations, prevent mother-to-child transmission of HIV/AIDS, and promote women’s empowerment and access to economic opportunities.
Through these partnerships we help to expand access to highly effective modern contraception and ensure that health care workers gain access to contraception training.
Family Planning 2020
FP2020 works with governments, civil society, multilateral organizations, donors, the private sector and the research and development community to enable 120 million more women and girls to use contraceptives by 2020. It is based on the principle that all women, no matter where they live, should have access to contraceptives, and supports the UN Secretary-General’s global effort for women’s and children’s health.
In May 2013, together with the Bill & Melinda Gates Foundation, we 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.
In November 2015, we extended this commitment to FP2020 by an additional five years, through 2023, to offer access pricing for IMPLANON NXT to eligible countries. Additionally, in 2019 our company entered into a new agreement with the Bill & Melinda Gates Foundation to increase production capacity for these eligible countries and continue our access price for an additional two years through the end of 2025. This reinforces our commitments to support the broadening of access for many years to come.
Throughout 2018, IMPLANON NXT volumes for FP2020 countries exceeded 400 percent of the threshold volume agreed in the Implant Access program—a clear reflection of the increased availability this agreement had for the access markets.
In addition, the volume of IMPLANON NXT supplied to the FP2020 countries increased to the level of approximately 126 percent of the 2016/2017 annual average, which creates access for approximately 26 percent more women compared to the previous two years. In 2019 this volume again increased compared to 2018 by another 12 percent.
Reproductive Health Supplies Coalition (RHSC)
The RHSC is a global partnership of public, private and nongovernmental organizations (NGOs) dedicated to helping all people in low- and middle-income countries gain access to and use affordable, high-quality supplies that ensure better reproductive health.
The coalition brings together diverse agencies and groups with critical roles in providing contraceptives and other reproductive health supplies. These include multilateral and bilateral organizations, private foundations, governments and civil society and private-sector representatives.
Reproductive Health Global Traceability Advisory Group
Throughout 2019, we continued to participate in the Reproductive Health Global Traceability Advisory Group, convened by USAID and UNFPA. In 2018, all our company’s contraceptive products supplied to USAID received global standardized Global Trade Item Number (GTIN) reference, which was added to individual packs and shipper boxes from mid-2019 onwards. We also added 2D matrix and serialization to the packaging of IMPLANON NXT from mid-2019 onwards, thus surpassing the request to complete serialization by June 2022. This standardization, together with 2D matrix and serialization, strengthens traceability throughout the supply chain.
Global Implant Removal Task Force
Since 2015, we have participated in the Bill & Melinda Gates Foundation-convened Global Implant Removal Task Force, which brings together multiple organizations to deliver clear evidence and best practices and offer tangible solutions for identified problems in implant removal services. This participation is still ongoing. Educational materials that include a training video with on-line access for health care professionals is being used for information and education. The medical toolsets required for both simple and complex removals are available on demand. The taskforce is also conducting studies to obtain numerical information on the number of removals and evaluate experiences.
European Parliamentary Forum for Sexual & Reproductive Rights
Access to contraception should be a key concern of governments in empowering citizens to plan their families and lives. Yet every country analyzed by the 2019 Contraception Atlas needs to do more to improve access. The findings show that for many European countries, ensuring that people have choice over their reproductive lives is not a priority.
We have established a partnership with the European Parliamentary Forum for Sexual & Reproductive Rights (EPF) to support their efforts to raise awareness of inequities in access to contraception and family-planning services among European countries.
Our company provided EPF with support to create the European Contraception Atlas, a unique new online map that scores 46 European countries on access to modern contraception, focusing on access to information and contraceptive supplies.
With criteria established by a multi-stakeholder group of experts in sexual and reproductive health and rights, the Atlas aims to provide a dynamic and robust tool to help improve access to modern contraception.
As a result of this research, the group of experts supported by EPF published a whitepaper, representing a call-to-action and providing recommendations on how to improve access to contraception in Europe. The whitepaper was launched at the European Parliament on September 26, 2018, World Contraception Day.
Now in its third edition, the Atlas keeps tracking progress in government policies on access to contraceptive methods, family planning counseling and the provision of online information on contraception across the European region. Our company continues to support the work of EPF, awaiting the 4th edition of the Atlas in 2020.
2 http://www.marchofdimes.com/news/jul19b_2011.html, https://www.guttmacher.org/sites/default/files/report_pdf/AddingItUp2009.pdf
3Singh, S., et al., Guttmacher Institute and United Nations Population Fund; 2009.
5Source Family Planning 2020.org
6There are additional unregulated markets where our products may be available that are not represented by these numbers.
7Number represents potential number of women who could be reached based on number of units provided.
Though the numbers of product supplied are substantial, the impact of these supplies are even more significant. As an example, the potential impact of the volumes of IMPLANON NXT supplied to FP2020 countries in 2019 are reflected by the following table (Data reflects estimates, based on the MSI Impact 2 v5 tool).
|IMPLANON NXT in FP2020 markets||2019|
|Unintended pregnancies averted||6,000,000|
|Live births averted||3,000,000|
|Maternal deaths averted||14,000|
|Child deaths averted||111,000|
|Unsafe abortions averted||1,700,000|
|Note: The figures above are estimates, based on the full-service lifespan (2.7 years) impacts. These estimates are based on 2019 supplies (5,053,090 units), using the Impact 2 v5 tool (2016) provided by Marie Stopes International (MSI).|