New study explores the realities of registering misoprostol and mifepristone in Latin America

Professional health association support and prior registration for obstetric use were found to be critical factors in securing national regulatory approval of misoprostol and mifepristone for medical abortion, a new study has found. Supportive advocacy by civil society was also seen to be a strong enabling factor. The Latin American Consortium Against Unsafe Abortion (CLACAI) has documented cases of successful and failed registrations of misoprostol and mifepristone in six Latin American countries – Argentina, Brazil, Bolivia, Colombia, Peru, Uruguay. Misoprostol is registered for medical abortion in Bolivia, Brazil and Uruguay, and is approved to induce labour in all five except Peru. It is also registered for the treatment of post-partum haemorrhage and incomplete abortion in Bolivia, Colombia and Uruguay. Mifepristone is only registered for obstetric use in Uruguay.

The analysis also looked at dosage and side effects; points of distribution and ease of access; development of standards and guidelines for treatment of incomplete abortion and post-abortion care; and enabling factors for registration for obstetric use. This work was made possible by a grant by the Innovation Fund, with financial support from the Norwegian Agency for Development Cooperation. For more information, please contact Milka Dinev or Susana Chávez.