Misoprostol for obstetrical and gynecological use will be available in pharmacies

Argentina’s food and drug regulator authorized the sale of misoprostol in pharmacies under a special prescription mechanism. This is a hugely important move for the health of women and persons with the capacity to gestate.

In August 2018, the National Administration of Medication, Food and Medical Technology (ANMAT) authorized Laboratorio Domínguez to produce and sell misoprostol in 200-mcg pills for obstetrical and gynecological use. However, at that time, it restricted their use to hospitals.

CELS, along with Lesbianas y Feministas por la descriminalización del aborto (Lesbians and Feminists for the Decriminalization of Abortion) and the Gender Secretariat of the Nuevo Encuentro political party, demanded in 2016 that ANMAT do a thorough review of the conditions that the state had imposed 20 years earlier on access to that medication.

When the media reported that Laboratorio Domínguez’s request would be approved but only for exclusive hospital use, we recurred once again to ANMAT to request that it review the conditions of sale so the misoprostol could be made available in pharmacies. The UN Committee on Economic, Social and Cultural Rights established that the state must guarantee the widest possible access to abortion medications, eliminating administrative and economic obstacles in order to avoid incurring in discriminatory policies.

ANMAT has now taken a crucial step forward for the sexual and reproductive health of women and others with the capacity to gestate by authorizing Laboratorio Domínguez to sell misoprostol in pharmacies, available in boxes of 12 vaginal suppositories, which is the number recommended for safe abortions.

Misoprostol is one of the drugs that the World Health Organization (WHO) recommends, along with mifepristone, for safe abortions and it is used in post-abortion care, as well as for births and post-partum purposes in distinct doses. These two medications are listed by the WHO as essential medicines and, as such, they must meet specific requirements regarding availability, accessibility and affordability.

While ANMAT’s decision marks significant progress, issues remain regarding the conditions for sale of misoprostol and the fact that a special prescription mechanism continues to be required. In addition, the approval of mifepristone by ANMAT is still pending, along with the public production of both medications.