1. ICA FOUNDATION International Contraceptive Access March 2011 1

2. ICA FOUNDATION 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 Public-private partnership between Population Council and Bayer Healthcare Pharmaceuticals 2

3. ASPIRATIONS OF ICA Learn from experiences on introduction strategies and service models Gain insight into transitions to new generation of products Understand role of health benefits in acceptability and use of IUS 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), with pending registrations in several more 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 Effective: rate of unplanned pregnancy ~0.1% at 1year and less than 1% at 5 years High continuation rate: up to 85% at one year Significantly reduces menstrual blood loss Return to fertility after removal is 80% at 1year More cost-effective than oral contraceptives, condoms and injectable contraception over five years 5

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* 6 * There is no evidence that the LNG-IUS can prevent implantation

7. ALTERNATIVE TO STERILIZATION Where sterilization services not available or not acceptable, IUS is as, or more, effective than sterilization (8 vs. 13 failures per 1000 procedures at 5 years) Reversibility reduces risk of regret among younger women Currently complementing female sterilization in northern Europe Sources: Sivin, 2007; Mansour, 2007; Inki, 2007 7

8. TREATMENT FOR MENORRHAGIA Use of LNG IUS makes periods lighter, shorter and less painful (and may include dysmenorrhea) Over 12 months, blood loss reduced by 80-96% in women with menorrhagia 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: Luukkainen 1987; Rezan and Chi, 2007; Sitruk-Ware, 2007 8

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

10. ICA FOUNDATION INVENTORY The ICA Foundation offers donations of LNG IUS to public sector Donations of LNG-IUS make up to 1% of non-US market sales of Mirena ® 10

11. Client Health system policies, programs and providers Family and community relationships Method characteristics CONCEPTUAL FRAMEWORK 11

12. PRIORITY CLIENT GROUP Women who want long-term effective and reversible contraception Women with heavy menstrual bleeding or for whom Copper IUDs are unsuitable 12

13. DONATION PROCEDURES Service delivery organization submit proposal to Foundation LNG IUS is registered or special permission to import 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 13

14. ICA CUMULATIVE DONATIONS: 40 740 LNG IUS ( Dec 2011 ) 14

15. COUNTRY PROJECTS Latin America Brazil Curacao Dominican Rep. Ecuador El Salvador Paraguay Saint Lucia Africa Ethiopia Ghana Kenya Nigeria South Africa Zambia Asia Bangladesh Indonesia Upcoming Donations Lesotho Nepal Philippines Senegal Uganda Zimbabwe 15

16. ROLE OF NETWORKS Partnerships with service delivery networks, such as Marie Stopes International (MSI) or the International Planned Parenthood Federation (IPPF) 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 HealthCare Pharmaceuticals Demet Gural Caroline Crosbie (Deputy Member) Pathfinder International Vanessa Cullins Planned Parenthood Federation of America (PPFA) Michael Holscher Tracey Brett (Deputy Member) Marie Stopes International (MSI) Pamela Barnes Roy Jacobstein (Deputy Member) EngenderHealth James Sailer Rebecca Brodsky (Deputy Member) Population Council David Smith Toan Tran (Deputy Member) International Planned Parenthood Federation (IPPF) Johanna Kouru Bayer Oy Annette Velleur (Deputy Member) Bayer HealthCare Pharmaceuticals ADVISORY MEMBERS Luis Bahamondes Unicamp Annette Gabriel KfW Claus-Peter Janisch Medical Consultant Katherine Williams Jeff Spieler United States Agency for International Development (USAID) Robert Zinser Rotary International SECRETARY Joanna Holopainen Bayer Oy 17

18. 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 18