Population Council Official Update

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Population Council Official Update
Publication Date: 10/13/2015

The Population Council provided the following updates on progress in achieving its FP2020 commitments:

 The  Council is examining how service delivery options outside of the formal health systems, such as pharmacies and drug shops, and workplace settings, can play an increased role in the provision of an expanded range of contraceptive methods. Expanding the range of contraceptive products available in markets not only increases uptake but simultaneously influences the supply side of service delivery as additional methods offered by providers serves to  strengthen the supply chain and health system.

  • To assist the many countries that are working to diversity their method mix, the Evidence Project is drafting a working paper that explores the history of how the methods came into a better balance over time. The project analyzed existing demographic data across 123 low- and middle-income countries to provide insights into the dynamics of method-mix transitions. Drawing on this data, a set of 15 countries has been identified where notable positive changes in the composition of the method mix have occurred over time. Results suggest certain patterns in the path to an improved method mix. This analysis provides a useful perspective for better understanding the dynamics of past method-mix transitions, which can ultimately offer insights for future efforts to expand contraceptive method access and choice.

Developing and testing the effectiveness, safety and acceptability of new reproductive health technologies designed to benefit women and men in developing countries: The Population Council, with support from the USAID Office of Population and Reproductive Health, has developed two innovative contraceptive vaginal rings: a one-year contraceptive vaginal ring that can be used by women to plan their pregnancies and a three-month vaginal ring that can be used by breastfeeding women. Long-acting vaginal rings represent an important advance in contraceptive development. These methods are especially beneficial for women in low-resource settings since they are designed to be under the woman’s control and do not require insertion by a healthcare provider or regular visits to a pharmacy. Both of these factors stand to dramatically expand access to family planning options.

  • The one-year contraceptive vaginal ring contains ethinyl estradiol, an approved, marketed hormonal product, and Nestorone®, an investigational progestin that has been shown to be highly effective in preventing ovulation. Because it is intended to be effective for 13 cycles and does not require refrigeration, it may be an attractive option for women in developing countries who lack access to a healthcare facility or pharmacy, and where access to reliable electricity is lacking. The Council will submit a New Drug Application to the US Food and Drug Administration and seek to introduce the vaginal ring in USAID priority countries.
  • The progesterone CVR is an intravaginal ring that provides women who breastfeed at least four times a day with a contraceptive option as early as four weeks after giving birth. Each ring can be used continuously for three months, and rings can be used successively for up to one year. The progesterone CVR is an effective, user-controlled method that can aid in spacing pregnancies as it does not affect a woman’s ability to produce breast milk and does not require insertion by a healthcare provider. Fertility returns shortly after discontinuing use. The WHO and UNICEF recommend that women breastfeed exclusively for the first six months after birth and continue breastfeeding up to two years of age. However, the proportion of women who breastfeed exclusively varies greatly by culture, economic context, and time since giving birth. And once a woman stops breastfeeding exclusively or resumes regular menstruation, she is at risk of pregnancy before she may be ready to have another child. Short intervals between births can put a mother, her baby, and its siblings at risk of health complications and death.
  • The progesterone CVR works by releasing a continuous low dose of the natural hormone progesterone, which reinforces the contraceptive effect of breastfeeding. Clinical trials have demonstrated that the ring is 98.5% effective in preventing pregnancy when used correctly, is safe for mother and baby, and does not affect a woman’s ability to produce breast milk, unlike estrogen-containing oral contraceptives. Once a woman receives an initial examination and orientation to the method by a healthcare provider, she can insert and remove the ring by herself, reducing the need for frequent visits to her provider. The ring does not require refrigeration or special storage conditions, an advantage in countries that do not have a strong health system infrastructure.
  • The three-month progesterone CVR is approved for use in eight Latin American countries: Bolivia, Chile, Dominican Republic, Ecuador, El Salvador, Guatemala, Panama, and Peru. Although not yet approved for use in other countries, efforts are underway to determine the feasibility and likely impact of introducing the ring in Kenya, Nigeria, and Senegal, and results are expected soon from a clinical study of the ring required for registration of the progesterone CVR in India.
  • In addition to developing CVRs, the Council is also investigating multipurpose prevention technologies to protect against HIV and other sexually transmitted infections, and in some cases also provide contraception, with a single product. Beyond multi-purpose technologies, our Center for Biomedical Research has begun developing male contraceptive methods including a one-year implant that is placed under the skin of the upper arm. This work relies on MENT® acetate (7α-methyl-19-nortestosterone) which is created from a synthetic steroid that resembles testosterone. If approved by regulatory authorities, MENT would be the first long-acting reversible male contraceptive. Through the development of MENT, the Council has pioneered an approach to suppress or inhibit sperm cell development without impairing a man’s sexual drive (libido). This approach reduces sperm count by administering an androgen (a male sex hormone) alone or in combination with synthetic progestins.

Engaging pharmaceutical companies to license, register and/or manufacture technologies developed by the Population Council to expand choice in developing country markets: In 2014, Population Council researchers completed studies required for the registration and introduction of the progesterone CVR in counties in Kenya, Nigeria, and Senegal. In India, the Council and the Indian Council of Medical Research evaluated the safety and efficacy of the progesterone CVR compared to the Copper T IUD in breastfeeding women who wish to space their pregnancies.

  • The Council is also working with a Chilean manufacturer to expand the potential markets for the progesterone CVR, by increasing its license territory and encouraging the partner to invest more in marketing and distribution for the ring in its existing territory.
  • Recently, the Council provided evidence on the safety and efficacy of the progesterone CVR to the World Health Organization, which has added the ring to its 2015 updated Essential Medicines List. The WHO established the Essential Medicines List to satisfy priority health care needs. Medicines are selected for their public health relevance, efficacy, safety, and comparative cost-effectiveness. They are intended to be available within health systems at all times in adequate amounts, appropriate doses, with assured quality and adequate information on their use, and at a price that individuals and communities can afford. The WHO’s Essential Medicines List is considered a model to help guide the development of national and institutional essential medicine lists. To complement the Essential Medicines List, WHO has also added guidance to its Medical Eligibility Criteria to ensure that providers understand the method and how to counsel women about it as a contraceptive option. This is important, because when providers are familiar with a method, they are more likely to provide it as an option to their patients.
  • The Council is planning to file a New Drug Application in the United States for a one-year contraceptive ring in 2016. Once the one year ring is approved by the US FDA, the Council will work through partners to register the ring in the developing world, and will seek additional partnerships to facilitate the introduction of the product.

Additionally, the International Contraceptive Access (ICA) Foundation is a priority initiative for the Council. The ICA Foundation, a public–private partnership between the Council and Bayer OY, is helping expand access to long-acting reversible contraception in low-resource settings. The objective of the Foundation is to provide local service-delivery organizations with the levonorgestrel releasing intrauterine system (LNG IUS) contraceptive devices on a not-for-profit basis and ultimately serve the reproductive needs of women in resource-poor settings, primarily in developing countries. To date, the Foundation has provided over 67,000 LNG IUS and training materials to projects in 28 low- and middle-income countries. Since 2012 alone, the foundation has donated more than 19,000 units of LNG IUS and related education materials. Country projects include collaborations with local not-for-profit organizations, hospitals, and global partners with a network of service delivery facilities in developing countries.

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