Misoprostol: We ask that ANMAT recognize it as an obstetrical drug and guarantee access

Today we are asking ANMAT to amend a ruling governing conditions of sale for drugs containing misoprostol and that the entity establish an appropriate mechanism to ensure access to this medication.

Today, we are asking ANMAT (Argentina’s national administration of drugs, food and technology) to amend the ruling 3646/98, which is nearly 20 years old, governing the conditions of sale for drugs containing misoprostol and to establish an appropriate mechanism to ensure access to this medication.

Since the drafting of the provision, there has been new scientific evidence that recognizes other uses for misoprostol, such as for obstetrics, and its use as an effective and safe abortion drug. The World Health Organization considers it as an “essential medicine” for sexual and reproductive health given its applications for safe abortions and post-abortion care, in addition to its childbirth and postpartum practices. The WHO also noted that accessibility to abortion drugs is important and that their administration should lie not only on doctors but also healthcare providers, even at basic levels. On the other hand, the UN Committee on Economic, Social and Cultural Rights, in its General Comment No. 22, established that the State must guarantee as-free-as-possible access to medicine for abortions, without administrative or economic obstacles or barriers; on the contrary, it would result in discriminatory policies.

Misoprostol in Argentina is produced and marketed by a single pharmaceutical company. It is formulated in combination with sodium diclofenac, under the name Oxaprost. ANMAT has approved its use for gastric treatments only. Obstetric use is not recognized and a restrictive form of prescription was established, requiring that a prescription be kept on file, making it difficult to access. The pharmaceutical company Beta, on the other hand, has a monopoly on production and marketing. It abuses its dominant position and imposes high prices. More than one year ago, the Secretariat of Commerce had to rule on a complaint that CELS filed against Beta.

In Argentina, the health authority does not formally recognize any medicines for abortions, despite the fact that article 86 of the Criminal Code establishes some abortions as legal, the Supreme Court has recognized them as a right, and the Ministry of Health recommends medical abortion practices.

CELS, Lesbianas y Feministas por la descriminalización del aborto and Nuevo Encuentro’s Secretariat for Gender in the city of Buenos Aires ask ANMAT to lift the restrictions on the sale of misoprostol tablets that are not based on health reasons and to ensure the widest possible access, in accordance with international human rights standards. We also ask that it repeal the old provision that establishes the requirement that a prescription be kept on file for its sale; that it acknowledge misoprostol’s indications in the practice of obstetrics according to the specifications of the WHO’s list of essential medicines; and that it analyze and update patient information leaflets to include information about the proper indications for ambulatory and domiciliary obstetric procedures.

Preventing or restricting access to a medication that is essential to the health of women and transgender persons is a violation of their human rights. The State is responsible for these violations before the national and international community.