Anvisa, retire as restrições ao uso e comercialização do misoprostol no Brasil!
(Anvisa, remove restrictions on the use and marketing of misoprostol in Brazil)! 

Brazil has one of the most restrictive regulations in the world regarding the use of misoprostol. Among countries in Africa, Asia and Latin America, Brazil is second only to Vietnam among those with the greatest restrictions on access to medical abortion in the world. However, in Vietnam, there is a registration of mifepristone, unavailable in Brazil, which makes the Brazilian regulation even more restrictive…

In South America… Brazil is also the only country that does not make misoprostol available directly to women in pharmacies or from primary health care services. Restrictions on the use and marketing of misoprostol date back to the 1990s. In 1998, the first regulation of misoprostol as a special, controlled drug was published, Ordinance 344/1998, in force until the present day. At that time, it may have been understandable to restrict the sale of misoprostol to accredited health establishments, given the limited scientific knowledge about it. However, there is now a robust body of scientific evidence supporting its efficacy and safety, and it has long been on the WHO List of Essential Medicines. In the 2019 revision of that list, WHO removed the need for expert supervision for the administration of the mifepristone/misoprostol combination.

These restrictions have not reduced its use by women, since half of the illegal abortion in Brazil are carried out with misoprostol. The barriers, however, feed the underground market, in which women resort to unregulated medicines that are too often of dubious quality, putting lives at risk. In Brazil, more than 200,000 women are hospitalised each year for the treatment of complications related to clandestine abortion. The elimination of barriers to accessing misoprostol would reduce costs both for the Unified Health System (SUS) due to hospitalisation, and for women, who would not need to be hospitalised but could receive adequate care in local health units.

In light of this, we, the undersigned, request the removal of disproportionate restrictions on the availability, marketing and use of misoprostol, an essential drug for the sexual and reproductive health of Brazilian girls and women. The current restrictions disrespect the constitutional guarantees such as the right to health and life of Brazilian women (Arts. 5 and 6 of the Federal Constitution of 1988) and established in international treaties.


We request that misoprostol be made available to health services in Brazil at all levels of care (basic health and family health units, emergency care units, hospitals and maternity hospitals), without any restrictions other than those relating to controlled medications, i.e. the prescription in two copies, with retention of one copy in the pharmacy and the ability to identify doctors and prescribing doctors.