The ANMAT Provision that authorized the sale of Misoprostol in pharmacies is suspended

The judge in the Federal Administrative Litigation No. 11, Cecilia Gilardi de Negre, issued on Thursday a precautionary resolution within the framework of the collective protection initiated by the Association for the Promotion of Civil Rights and by the Civil Association Portal de Belén.

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In the case, initiated in 2018, organizations question the constitutionality of the Protocol for the comprehensive care of people entitled to the Legal Interruption of Pregnancy of the Ministry of Health and Social Development, and Provision No. 946/2018 of the National Administration of Medicines, Food and Technology (ANMAT), issued on 12/10/2018, while authorizing Laboratorios Domínguez SA a new condition of sale (under archived prescription).

Suspension of sale in pharmacies

The precautionary measure orders the suspension of article 2 of the provision, and is based on the reading of the MISOP 200 leaflet, as it indicates that its improper use or outside of the recommended indications may be harmful to health.

However, as indicated by the Ministry of Health and Social Development when appearing before the Court in the context of the case, Misoprostol presents security for ambulatory use with medical follow-up, without risks for the person entitled to access the interruption if It is done during the first trimester of pregnancy. Likewise, the availability of the drug in pharmacies, under an archived prescription, allows the pregnant person, together with their doctor, to decide how and where to carry out the termination of pregnancy in the cases allowed by law, without the need to attend the system Health public

Likewise, as we affirmed in our amicus, access to the medicines necessary for the termination of pregnancy, classified as essential by the World Health Organization, is part of the fundamental human rights in health matters to which the Argentine State is bound by Your international commitments. The Committee on Economic, Social and Cultural Rights, in its General Comment No. 22, on the right to sexual and reproductive health, establishes access to essential medicines as a standard for States parties. In this regard, when describing the elements of sexual and reproductive rights, and developing the concept of availability, the Committee states that: “Essential medicines must also be available, including a wide range of contraceptive methods, such as condoms and contraceptives emergency, medications for assistance in cases of abortion and after abortion, and medications, including generic drugs, for the prevention and treatment of sexually transmitted infections and HIV ”.

The attack attacked, and now suspended, aimed at ensuring the rights of people who require access to this medicine for the practice of legal termination of pregnancy. There are no technical, medical or therapeutic reasons to prevent the pharmaceutical circulation of misoprostol in its presentation of 200 mcg pills, and, consequently, restrict this medication only to hospital use as intended.

Soup again

The protection presented by these organizations is only another attempt to impede rights. We recall that there is a systematic practice by these groups to prosecute each of the advances that are achieved in our country in terms of sexual, reproductive and non-reproductive health. They already did it locally: Portal de Belén got the local protocol for the care of non-punishable abortions to be suspended for more than 7 years. In that case, Prodeci had introduced himself as amicus curiae. Now, their efforts are focused on the federal order.

ILE is still right

It is important to clarify that the resolution only suspends the application of article 2 of Provision No. 946/18 of ANMAT, which authorized the sale of MISOP 200 of Domínguez Laboratories in pharmacies, under archived prescription. The precautionary request of organizations to suspend the national protocol was rejected, so its application remains in force.

Nor does the availability of MISOP 200 change for gynecological use in hospitals and health centers, nor the availability in pharmacies of misoprostol in its other commercial form, Oxaprost, from Beta Laboratory.

It is unfortunate a resolution of these characteristics, taking into account that in our country the legal abortion due to causes is a right since 1921, and the Argentine State has been repeatedly recommended to facilitate access to the practice in safe conditions.

In addition to the pending resolution of the merits, the legislative treatment of the Voluntary Interruption of Pregnancy is imminent, for which the discussion on the availability of essential medicines for practice should be resumed.


Mayca Balaguer, maycabalaguer@fundeps.org