Medicines360 is a non-profit that holds the rights to distribute an intrauterine contraceptive device (IUD) in multiple jurisdictions around the world, including in sub-Saharan Africa. Medicines360 has a number of partners in the U.S. and U.K. that in turn have offices all over sub-Saharan Africa. Arnall Golden Gregory created a framework by which the clients’ rights in distributing the IUD would be recognized and approved in the sub-Saharan countries, beginning with Madagascar.
Arnall Golden Gregory became involved in the project through FDA work conducted by Food and Drug Practice Chair Alan G. Minsk. AGG developed a process that made it possible for the local offices to apply for drug approval and marketing authorizations in those countries. Following that, AGG drew up distribution agreements, quality agreements and pharma co-vigilance agreements between the client and the local African entities. The agreements cover purchases from the client, shipping to the countries and training for proper use and storage of the product. The goal is to provide effective birth control in areas in which access to birth control has been extremely limited.
The World Health Organization states that increasing access to voluntary contraception has significant health, economic and social benefits for families and communities, improving women’s opportunities for education, employment and full participation in society. The introduction of this hormonal IUD will help the global health organizations Population Services International and WomanCare Global deliver on a joint family-planning commitment to increase the usage of voluntary, long-acting, reversible contraceptives by 2020.