Defying Definitions and Breaking Down Barriers: Lessons from Medicines360’s Nonprofit Journey

Medicines360 has the unique distinction of being the longest-standing nonprofit pharmaceutical organization that has product available in the U.S. market. Its inception was an industry innovation, and its survival has required it to push boundaries and defy traditional definitions — all in service of improving health equity.

For the Medicines360’s team, the value of this work lies in having broadened women’s access to one of the most effective forms of reversible contraception — access that the market was simply not delivering. The proof is in the numbers: as of January 2022, more than 369,000 units of our hormonal IUD product have been distributed at a deeply discounted price to approximately 2,500 safety net clinics and hospitals in the US. And patients without insurance have saved nearly $200 each when prescribed our product instead of another hormonal IUD[i], helping to create more equitable access for historically underserved communities across the country and enabling increased autonomy over their health, their lives, and their futures.

Over our 13-year history, we have always held our mission as our north star. Along the way, we have proven to the U.S. pharmaceutical industry, lawmakers, safety net providers, and — most importantly — patients, what a nonprofit pharmaceutical organization can achieve for public benefit. As a values-led organization, we believe in the virtues of collaboration and transparency. Because of this, we are excited to report how we achieved our goals and the hurdles we faced along the way. While we are proud to have catalyzed a new path for nonprofit pharma in the U.S., our dream is for many more organizations that develop their own innovative solutions to emerge and expand the potential of the nonprofit pharmaceutical model further than we have yet to imagine.

That’s why today, we are proud to release the case study documenting our journey to this point, “Nonprofit Pharma, Advancing A New Model for Equitable Access to Medicines .” Developed in collaboration with our partners at Waxman Strategies, this case study demonstrates critical lessons learned from bringing a branded product to market in the U.S., highlights barriers in the current healthcare system that impede the sustainability of nonprofit pharma, and lays out policy solutions that can unleash the industry’s full potential.

 Specifically, this report:

  1. Describes each phase of Medicines360’s process — from responding to a market need through product commercialization — to help readers better understand the strategy, effort, and cost required to bring a branded drug to market in the U.S.
  1. Examines major barriers encountered in the drug development and approval process and identifies if/how those barriers are unique to nonprofits
  1. Presents policy recommendations to address identified issues in the current U.S. drug development system that would allow nonprofit pharmaceutical organizations to better fulfill their missions to both increase access to drugs and lower drug prices

We invite you to learn more by reading the M360 case study and reaching out with any questions that may arise.

Medicines360 conducted this research in collaboration with Waxman Strategies with support from Arnold Ventures. Medicines360 is a nonprofit global pharmaceutical company focused on expanding healthcare access for women and is the developer of a hormonal IUD approved for use in the U.S. and 7 countries around the globe.


[i] Internal M360 data on file.


About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical organization with a mission to catalyze equitable access to medicines and devices through product development, policy advocacy, and collaboration with global and US partners. Medicines360, through its subsidiary Impact RH360, launched the Avibela Project to expand access to hormonal IUDs in low- and middle-income countries. For more information, visit medicines360.org

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AVIBELA can be made available in the following 88 countries

  1. Algeria
  2. Angola
  3. Bangladesh
  4. Belize
  5. Benin
  6. Bhutan
  7. Botswana
  8. Burkina Faso
  9. Burundi
  10. Cambodia
  11. Cameroon
  12. Cape Verde
  13. Central African Republic
  14. Chad
  15. Comoros
  16. Costa Rica
  17. Cuba
  18. Democratic Republic of the Congo
  19. Djibouti
  20. Dominica
  21. Dominican Republic
  22. Egypt
  23. El Salvador
  24. Equatorial Guinea
  25. Eritrea
  26. Ethiopia
  27. Gabon
  28. Ghana
  29. Grenada
  30. Guatemala
  31. Guinea
  32. Guinea-Bissau
  33. Haiti
  34. Honduras
  35. India
  36. Indonesia
  37. Ivory Coast
  38. Jamaica
  39. Kenya
  40. Lao PDR
  41. Lesotho
  42. Liberia
  43. Libya
  44. Madagascar
  45. Malawi
  46. Malaysia
  47. Maldives
  48. Mali
  49. Mauritania
  50. Mauritius
  51. Mayotte
  52. Morocco
  53. Mozambique
  54. Myanmar
  55. Namibia
  56. Nepal
  57. Nicaragua
  58. Niger
  59. Nigeria
  60. Pakistan
  61. Panama
  62. Papua New Guinea
  63. Philippines
  64. Republic of the Congo
  65. Rwanda
  66. Sao Tome and Principe
  67. Senegal
  68. Seychelles
  69. Sierra Leone
  70. Somalia
  71. South Africa
  72. South Sudan
  73. Sri Lanka
  74. Kitts and Nevis
  75. Lucia
  76. Vincent & the Grenadines
  77. Sudan
  78. Swaziland
  79. Tanzania
  80. Thailand
  81. The Gambia
  82. Timor-Leste
  83. Togo
  84. Tunisia
  85. Uganda
  86. Vietnam
  87. Zambia
  88. Sri Lanka

Tina Raine-Bennett, MD, MPH, FACOG

Chief Executive Officer

Tina Raine-Bennett, MD, MPH, is CEO of Medicines360. Previously, she served as a senior research scientist at the Kaiser Permanente Northern California Division of Research and the research director of the Women’s Health Research Institute. She is a Board-Certified Obstetrician Gynecologist who received her medical training at the University of California, San Diego, and post-graduate residency training and MPH at the University of Washington in Seattle, where she also completed a Robert Wood Johnson Clinical Scholars Fellowship. She was also senior staff physician at Kaiser Permanente and has a special interest in family planning and adolescent reproductive health.

As the director of the Women’s Health Research Institute, Dr. Raine-Bennett focused on expanding research on women’s health within the Division and translating women’s health research into clinical practice and policy within the Ob/Gyn departments in Northern California. She also promoted the involvement of clinicians in research designed to improve the health outcomes and healthcare experiences of women at Kaiser Permanente and women in general.

Prior to Kaiser Permanente, Dr. Raine-Bennett was a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Francisco (UCSF). She was based at San Francisco General Hospital where she was also the medical director of the New Generation Health Center, a UCSF affiliate site that provides community-based reproductive health services. Dr. Raine-Bennett’s research has focused on contraceptive methods and on elucidating factors that influence contraceptive choice and continuation, and she was principal investigator on NIH grants to assess hormonal contraceptive use predictors and develop interventions to improve contraceptive access.

Her past and current research on emergency contraception has focused on the safety of making emergency contraception more accessible and she conducted a pivotal clinical trial to make emergency contraception available to teens without a prescription. She served on the editorial board of Obstetrics and Gynecology and has over 100 peer-reviewed publications. She was the Treasurer of the Board of Directors for the Society of Family Planning and Society of Family Planning Research Fund. She has also served as an examiner for the American Board of Obstetrics and Gynecology, and on national committees for the American College of Obstetrics and Gynecology and the National Medical Board of Planned Parenthood Federation of America.