1. ICA FOUNDATION International Contraceptive Access June 2015 1

2. ICA FOUNDATION Public-private partnership between Population Council and Bayer Not-for-profit registered in Finland in 2004 Provides contraceptive products, e.g., levonorgestrel releasing intrauterine system (LNG IUS) to public health organizations such as multilaterals, governments, or NGOs for use in their programs Aims to serve the reproductive needs of women and families in resource-poor settings in developing countries Member of the Reproductive Health Supplies Coalition 2

3. ASPIRATIONS OF ICA Increase the well being of women and families in resource-poor settings ICA Foundation will generate value by ensuring public benefit by providing LNG IUS contraceptive devices (new contraceptive technology) on a not- for- profit basis and serving the reproductive needs of women and families in poor and vulnerable populations in developing world 3

4. Product consists of a T-shaped plastic frame and white cylinder shaped hormone reservoir around the vertical arm of the frame, with two nylon threads for removal. The system contains 52 mg of the hormone levonorgestrel (LNG) and releases 20µg/24h in the uterus for up to five years of protection. Registered in 3 countries (Ghana, Kenya and Nigeria) Mirena® has been commercially available since 1990, currently registered in over 120 countries LEVONORGESTREL INTRA-UTERINE SYSTEM The LNG IUS contraceptive was developed in the 1970s by Population Council and Bayer Oy, combining the best features of both oral contraceptives and the IUD. 4

5. CHARACTERISTICS OF LNG IUS 5 Highly effective: failure rate ~0.2% at 1year and cumulative failure rate 0.7% at 5 years High continuation rate: more than 90% of users continue each year of use Significantly reduces menstrual blood loss Approved treatment for women suffering of heavy menstrual bleeding Rapid return to fertility after removal More cost-effective than oral contraceptives, condoms and injectable contraception over five years Sources: Bayer AG: LNG IUS Corporate Core Data Sheet Jan 2014 Backman T, Huhtala S, Blom T, et al. Length of use and symptoms associated with premature removal of the levonorgestrel intrauterine system: a nation-wide study of 17,360 users. BJOG 2000;107:335–9 Andersson K, Batar I, Rybo G. Return to fertility after removal of a levonorgestrel releasing intrauterine device and Nova T. Contraception 1992;45:575–84 Trussell J. Update on the cost-effectiveness of contraceptives in the United States. Contraception 2010;82:391

6. LNG IUS MECHANISMS OF ACTION Thickens cervical mucus Inhibits sperm function in uterus Reduces monthly growth of the lining of the uterus making periods lighter and shorter * No evidence of any interference in the fertilization process 6 * There is no evidence that the LNG IUS can prevent implantation Sources: Bayer AG: LNG IUS Corporate Core Data Sheet Jan 2014

7. ALTERNATIVE TO STERILIZATION 7 The contraceptive efficacy of LNG IUS is similar to that of female sterilization, with full reversibility of fertility upon removal (unlike sterilization) Up to 40% of women sterilized at age 30 or younger, will regret their decision or request reversal of the surgery Heavy menstrual bleeding increases in late reproductive years: In contrast to sterilization which does not have an effect on periods, LNG- IUS offers the benefit of shorter and lighter periods Sources: Grimes and Michell: Intrauterine contraception as an alternative to interval tubal sterilization. Contraception 2008;77:6-9 Bayer Ag: LNG IUS Corporate core data sheet Jan 2014

8. TREATMENT FOR HEAVY MENSTRUAL BLEEDING Use of LNG IUS makes periods lighter, shorter and less painful Over 12 months, blood loss reduced by 80-96% in women with heavy menstrual bleeding Clinical improvement in associated anemia Hemoglobin levels rise 1.8g/L in one year of use with LNG-IUS, compared to a decrease of 1.2g/L with Copper-T. Irregular bleeding or spotting common in first 3-6 months; 20% with amenorrhea at 12 months Sources: Bayer AG: LNG IUS Corporate Core Data Sheet Jan 2014 Luukkainen 1987; Rezan and Chi, 2007; Sitruk-Ware, 2007 8

9. SUBSTITUTE FOR WOMEN AWAITING HYSTERECTOMY Source: Lahteenmaki et al, 1998 9

10. Client Health system policies, programs and providers Family and community relationships Method characteristics CONCEPTUAL FRAMEWORK 10

11. PRIORITY CLIENT GROUP Women who want long-term effective and reversible contraception Women with heavy menstrual bleeding or for whom Copper IUDs are unsuitable Women with contraindications to use estrogen; Women who need endometrial protection due to estrogen therapy Potential target groups: Post partum and post abortion women 11

12. LNG IUS DONATION PROCEDURES Service delivery organization submit LNG IUS project proposal to ICA Foundation LNG IUS is registered or special permission to import and use the product is sought from country of donation Training materials are provided regarding LNG IUS insertion/removal and comprehensive family planning provision and counseling LNG IUS is incorporated into existing service delivery strategy Donation recipient provides updates on numbers of insertions as well as progress and possible challenges of distribution 12

13. Who can apply for LNG IUS? International development and public health organizations, such as multilateral, governmental, or non-governmental organizations for use in their programs. LNG IUS donations are not available for biomedical research purposes, including clinical trials. How to apply? Interested applicants should complete a project proposal form on ICA Foundation’s website and submit it for assessment and approval. For more information please contact ICA Foundation: Mailing address: ICA Foundation, PO Box 581, FI-20101 Turku, Finland E-mail: information@ica-foundation.org Website: http://www.ica-foundation.org 13

14. 14 ICA CUMULATIVE DONATIONS: 71,240 LNG IUS (June 2015)

15. COUNTRY PROJECTS Latin America Bolivia Brazil Colombia Curacao Dominican Rep. Ecuador El Salvador Haiti Mexico Paraguay Saint Lucia Africa DR Congo Ethiopia Ghana Kenya Lesotho Malawi Nigeria South Africa Uganda Zambia Zimbabwe 15 Asia Afghanistan Bangladesh Cambodia Indonesia Mongolia Sri Lanka

16. ROLE OF NETWORKS Partnerships with service delivery networks, such as Marie Stopes International (MSI), International Planned Parenthood Federation (IPPF), AmeriCares and Partners In Health (PIH) allow for efficient delivery of LNG IUS in multiple countries through existing infrastructures, and assist in meeting the Foundation’s objectives. They potentially have greater capacity for training, supervision and logistics management as well as meeting reporting requirements. 16

17. BOARD MEMBERS John Townsend (Chairman) Population Council Klaus Brill (Vice-Chairman) Bayer Pharma AG Demet Gural Caroline Crosbie (Deputy Member) Pathfinder International Vanessa Cullins Planned Parenthood Federation of America (PPFA) Sarah Onyango Maria Cristina Ramirez (Deputy Member) International Planned Parenthood Federation Pamela Barnes Yetnayet Asfaw (Deputy Member) EngenderHealth James Sailer Rebecca Brodsky (Deputy Member) Population Council Johanna Kouru Bayer Oy Annette Velleur (Deputy Member) Bayer Pharma AG ADVISORY MEMBERS Luis Bahamondes Unicamp Annette Gabriel KfW Claus-Peter Janisch Medical Consultant Jeff Spieler United States Agency for International Development (USAID) Robert Zinser Rotary International Roy Jacobstein IntraHealth SECRETARY Joanna Holopainen Bayer Oy OFFICER Heather Chadwick Population Council 17