Argentina approved gynecological misoprostol for sale in pharmacies: A precedent for women in South America?

19/12/2018 - Daniel Salman
The National Administration of Medicines, Foods and Medical Technology (ANMAT) of Argentina, enabled a laboratory to sell misoprostrol for gynecological purposes. This is a significant and relevant measure because this drug is used to interrupt pregnancies and is recommended for this purpose by the World Health Organization (WHO).
The ANMAT had two fundamental aspects regarding this medicine: the sale in 12 tablets (exact dose to interrupt a pregnancy) and the possibility of acquiring it under a prescription filed in pharmacies. The latter extends its access since originally it was only for hospital and institutional use.
The measure takes place in a particular context for the country member of UNASUR. In August of this year the Argentine Senate rejected the bill that guaranteed legal, safe and free abortion until week 12 of pregnancy for all women and pregnant people. However, since 1921 in Argentina there are legal abortions, also called “non-punishable” and that are contemplated in the Criminal Code of that country.
In Argentina, “non-punishable” abortions are allowed when the pregnancy is the product of rape; the physical and / or mental health of the mother is in danger; or there is extrauterine infertility of the fetus. In addition to Argentina, in South America, the countries where this practice is allowed, for these or other reasons, are: Chile, Colombia, Brazil, Ecuador, Paraguay, Venezuela, Bolivia and Peru. Only Uruguay and Guyana have legal abortion in the South American region.
Abortion, a public health problem
The Secretary of Health of Argentina, Adolfo Rubinstein, in his speech at the Senate when the subject was discussed, pointed out that “abortion is a public health problem because it produces avoidable deaths, especially in women with high social vulnerability. Restrictive countries do not reduce death due to abortions and as a consequence, this practice increases clandestinely. In addition, it implies higher costs for the health system”.
In turn, in statements to the Argentine press, Rubinstein said that the novelty of the measure on the drug is that “there is a laboratory that submitted a record so that, instead of making misoprostol mixed with an anti-inflammatory, it can be sold alone and in the right dose that is needed to interrupt a pregnancy. ”
From now on, legally any health professional who considers that there are conditions to terminate a pregnancy, may carry out the abortion with the consent of the pregnant person. This professional may prescribe misoprostol directly so that it can be purchased at the pharmacy.
In a conversation with Health to the South, the Argentinian journalist Estefanía Pozzo, said that it is “an advance of rights in people who are pregnant in Argentina because there was no medication aimed at that end, to interrupt a pregnancy. The measure is ensuring that, in the Argentine vademecum, we have a drug that is specifically to contemplate a situation that in the Penal Code is guaranteed since 1921. ”
A measure achieved thanks to popular mobilization
The decision made by the Argentine government was largely a result of the struggle of the women’s movement; justice and human rights organizations such as the Center for Legal and Social Studies (CELS); civil society, among others.
Ángela Acosta, specialist in medicines and health technologies of the South American Institute of Government in Health (ISAGS), belonging to the UNASUR, salutes the decision of the Argentine government to facilitate access to this drug, although warns that “although the possibility of accessing it is an option, it is still a risk that women are not always accompanied throughout this complex process. Even in cases where abortions are contemplated in the respective regulations of each country, access barriers still exist, as could be, among others, the objection of conscience on the part of health professionals”.
Luli Sanchez, lawyer of the Argentinian Lesbian and Feminist Association for the Legalization of Abortion also spoke with Health to the South and said that “until now what happened was that it was in pharmacies combined with diclofenac and was a medicine produced by a single laboratory. That made the price very high. Thus, together with other agencies, we filed a complaint for abuse of a dominant position in the National Secretariat of Commerce, and now there are at least two laboratories producing it”.
A precedent for South America?
The Argentine decision sets an important precedent for most of the countries of South America. “Although it has been available for a long time, in several countries of the region, the pharmaceutical industry exerts a lot of pressure with different arguments to restrict and stigmatize it,” says Sánchez. And she adds, “we want the international organizations to position themselves in this regard. We see that little by little they are doing it, but it is a slow road”.
The Argentine decision is transcendent also because situations like these would favor the production of the drug in public laboratories. “We understand that the Pharmaceutical Industrial Laboratory (LIF) of the Argentine province of Santa Fe, is producing it for a year, but still do not release it to the market. Maybe this measure drives it. There is a lot of stigma on the part of those who produce it, there is fear of being denounced. Fear a little absurd maybe, because it is a drug that circulates many decades ago, “emphasizes the lawyer Sánchez.
It is the role of the State as executor of public policies, which is also highlighted by Angela Acosta from ISAGS, “if that encourages production in public laboratories, it is very good. What countries should not do, and Argentina in particular with this measure, is to believe that the monopoly breaks down with the appearance of a new private laboratory. We still see that there are only two suppliers in the Argentine market, both for hospital and outpatient use. ”
The Latin American Consortium Against Unsafe Abortion (CLACAI) directed a study that surveys the registration and availability of mifepristone and misoprostol in six countries in South America: Argentina, Bolivia, Brazil, Colombia, Peru and Uruguay.
“Since its inception, CLACAI has promoted a variety of actions to support national processes so that countries have protocols and regulatory frameworks that facilitate access to medical abortion, especially in those countries where the normative framework allows abortion in different situations (…) However, in most Latin American countries, the necessary supplies are not yet available, such as misoprostol in obstetric presentation and mifepristone. This situation negatively affects the effectiveness of the induction of abortion with medications, imposes higher costs on services and difficulties for health teams to ensure quality care, generates stress for women and affects the possibility of making safe decisions, to the point to force them to continue the pregnancy “, the authors of the investigation point out.
Exercise citizen control, the contribution of ISAGS
As a government institution in health, ISAGS, in its eagerness to contribute to the democratization of access to knowledge and information, highlights the prioritization that countries have given to social participation and citizen control.
In this sense, the ISAGS specialist suggests consulting the medicines registered with ANMAT. “With just accessing this link, citizens can see what is the maximum recommended price for sale by that agency, complain if there is price abuse in pharmacies and compare the different versions (and economic cost) of a single drug”.
Finally, it is about generating and disseminating critical, innovative and transformative knowledge of health policies and systems for the reduction of social inequalities. “Exercise citizen control and make well-informed decisions, aims to not favor interests beyond social and dignifying rights, in this case, women’s and their autonomy”, Angela concludes.
Daniel Salman
Communication & Information Analyst do ISAGS -UNASUR