Was ANMAT expecting a different result? Despite the Senate’s rejection of the bill to legalize abortion last week, the National Administration of Drugs, Foods and Medical Devices (ANMAT) has authorized the national production of misoprostol, more commonly known as the drug recommended by the World Health Organization (WHO) for safe medical abortions. The proposal was approved on July 2nd and authorizes national laboratory Laboratorio Domínguez to produce and supply the drug for gynecological use, although sales will be strictly limited to hospitals only.
The laboratory’s technical director, Sandra Rismondo, said that production could begin before the end of this year. She also said that in early August, Laboratorio Domínguez asked ANMAT for a change in sale conditions so that the general public can buy the drug directly from pharmacies, though given the continued illegality of most abortions, it seems unlikely that this will be approved.
“This file is under evaluation and we hope that before the end of the year, if it is approved as soon as possible, we can commercialize the product in pharmacies at a substantially cheaper price than what is currently available on the market,” she told El Cronista.
During the debate over the legalization of abortion, the devaluation of the peso against the dollar meant that the price of misoprostol had risen steeply, while clandestine abortions, also priced in dollars, had become even more expensive than before.
In the last month, the price of the drug in pharmacies increased from AR $3,200 in mid-June to AR $3,427 in August, while clandestine procedures are priced at US $1,000, around AR $30,000. Meanwhile, average wages for women increased below the inflation rate, reducing their access to health services in a marked feminization of poverty.
The WHO defines Misoprostol as a medicine first used to treat stomach ulcers, and so it is often available for this purpose in countries where abortion is illegal. In Argentina, it has only been available in pharmacies in the form of Oxaprost, a medicine for gastric ailments which sees it combined with the drug diclofenac.
Dr. Viviana Mazur, who works at the Sexual Health, HIV and Sexually Transmitted Diseases coordination team for the Ministry of Health for Buenos Aires, told Clarín that pure misoprostol will be much cheaper to access. “This is a slight improvement, because we are going to have misoprostol without diclofenac,” she said. “The advantage is that this will reduce its cost, because in recent months, the price of Oxaprost has increased 10 times.”
Misoprostol provokes uterine contractions that induce miscarriage, meaning that it is considered as a more ‘natural’ way to abort than a surgical procedure. It is also favored as it carries a very low risk of complications, making it much safer than other abortive methods. Misoprostol can be taken by itself, but the effectiveness is significantly decreased and the dosage has to be changed by the doctor, depending on the patient’s age, weight and stage of gestation.
It is normally used in a combined regimen, which studies have proven makes it more effective. The most common drug combination is with mifepristone, which is illegal in many countries where abortion has not yet been legalized. This combination is 95 percent effective in the first trimester of pregnancy.
(Photo via Mercurial blog).
As part of the conditions for the drug’s approval, ANMAT requested that the laboratory present a tripartite Risk Management Program that ensures the following:
1. Sales are made exclusively to hospital institutions that have an obstetrics service
2. Hospitals must complete special forms for the purchase of the medication detailing the use of the product and the average number of deliveries to the institution
3. The head laboratory informs ANMAT of the movements of the product and the data collected in the medication purchase forms.
This is not the first move to produce pure misoprostol in Argentina. In March, the government of Santa Fe began producing misoprostol for use in legally-permitted abortions. The drug is being produced by Laboratorio Industrial Farmacéutico Sociedad del Estado (LIF), and they predict that it will commercially available in December.
While this move will make legal abortions much cheaper for the national health service, it will be unlikely to affect the exorbitant price of misoprostol on the black market as it will theoretically only be available for certain hospital services, and even then, their order quantities will be strictly monitored.