The Ministry of Health has allowed the free sale of popular emergency contraceptives

The popular emergency contraceptives Postinor and Escapelle will now be sold in pharmacies without a prescription. Moreover, they can even be purchased online. The company Gedeon Richter, which produces these products, said that Russian regulatory authorities assessed international experience in use, as well as their own research from the point of view of the safety of taking the drug without a doctor’s prescription. This decision was made against the backdrop of a tightening last year in the circulation of mifepristone, which is also used in low dosages as an emergency contraceptive. The Ministry of Health explained to Kommersant that Postinor and Escapelle do not meet any of the requirements for prescription drugs, and comparison of control measures for drugs belonging to different pharmacotherapeutic groups is incorrect.

At the end of last year, the Ministry of Health banned the sale of a number of contraceptives without a prescription. Mifepristone and misoprostol were included in the List of Medicines for Medical Use Subject to Quantitative Accounting. The mentioned drugs are used for medical abortion, and low-dose mifepristone drugs are also used as a means of emergency contraception. At the same time, at the beginning of 2024, the Ministry of Health allowed the Hungarian Gedeon Richter to make over-the-counter emergency contraceptive drugs Postinor and Escapelle – INN levonorgestrel (synthetic progestogen hormone). They differ in dosage, but have the same effect.

Anna Pokhitonova, head of the communications department at Gedeon Richter in Russia, noted that when changing the status of drugs from prescription to over-the-counter according to current practice, Russian regulatory authorities evaluate international experience in use, as well as their own research from the point of view of the safety of taking without a doctor’s prescription. At the moment, levonorgestrel is available over-the-counter in Germany, France, the Netherlands, Sweden, Finland, as well as in the EAEU and CIS countries (Georgia, Uzbekistan, Kyrgyzstan, Belarus and Armenia). “According to the instructions, in order to avoid the development of an unwanted pregnancy, emergency contraception must be taken within the first 72 hours after unprotected sexual intercourse. And since time is a decisive factor related to the effectiveness of the drug, not having to write a prescription allows a woman to act faster,” explained Ms. Pokhitonova.

RNC Pharma Development Director Nikolay Bespalov points out a complex procedure that involves providing documents confirming the safety of the drug. According to him, there are few examples on the market of drugs changing their status. The precedent itself causes Mr. Bespalov “at least bewilderment.” “It turns out that the Ministry of Health with one hand is transferring some drugs for emergency contraception to the category of products subject to substantive and quantitative accounting, seriously limiting their availability to consumers, while with the other hand it is transferring drugs similar from a pharmacotherapeutic point of view into the category of over-the-counter products, opening access to them to everyone, including online trading, since the sale of such drugs on the Internet is not prohibited in our country,” he comments. “In fact, we are talking about providing some market players with more favorable conditions.”

The Ministry of Health of the Russian Federation explained that, according to the instructions, levonorgestrel belongs to hormonal contraceptives for systemic use and drugs for emergency contraception. At the same time, mifepristone belongs to another pharmacotherapeutic group (other sex hormones and modulators of the reproductive system, progesterone receptor modulators). “Thus, comparison of control measures for drugs belonging to different pharmacotherapeutic groups is incorrect,” the department said. They emphasized that Postinor and Escapelle do not meet any of the requirements for prescription drugs. In particular, the latter, even when used correctly, but without medical supervision, can cause direct or indirect harm to human health or are often used incorrectly. “At the same time, increased control over the drugs mifepristone and misoprostol, which are used for medical termination of pregnancy, is associated with a high risk of negative effects on health and even a threat to life when using these drugs without the supervision of a doctor,” the Ministry of Health concluded.

Obstetrician-gynecologist, public health and health specialist, WHO expert Lyubov Erofeeva sees logic in the actions of the Ministry of Health: the department has tightened control over the circulation of drugs used to terminate pregnancy, so that such procedures take place only in hospitals. She considers the decision to make drugs with the INN levonorgestrel over-the-counter long overdue: “These drugs are needed urgently, there is no time to go to the doctor, a woman has three days to avoid an unwanted pregnancy and then not to have an abortion.” Ms. Erofeeva notes that the drugs are more than 35 years old, during which time they have been used more than 200 million times, and, according to her assessment, they are absolutely safe. Moreover, the expert adds, in situations where “a woman in hysterics” ran to the pharmacy and asked for the drug, concessions were made – so that it could eventually be purchased without a prescription.

Secretary of the Hippocratic Medical Forum Inna Yambulatova confirms this fact. In her opinion, this is, in fact, an attempt to bring drugs out of the gray zone: “The state had two ways to take control of this process: either legalize what exists, or introduce a strict reporting form and monitor the volume of drugs sold and produced or imported. The Ministry of Health decided to take a liberal path, but then it must be clearly understood that 13- and 15-year-old girls will be able to safely buy Postinor. I’m not sure that pediatric obstetricians and gynecologists will welcome this news.”

According to Ms. Yambulatova, it should be prohibited to sell Postinor and Escapelle to minors without a doctor’s prescription. “As for mifepristone and misoprostol, we would recommend switching them from the PKU to a regulatory act that registers the dispensing of drugs only in a medical institution in order to avoid abortion at home,” she added.

The Patriarchal Commission on Family Issues, Protection of Motherhood and Childhood referred to the document “On the inviolability of human life from the moment of conception” adopted by the Synod at the end of December. There, in particular, it says that the church recognizes the use of contraceptives that are abortifacient in nature as unacceptable, since their action “leads to the death of the embryo in the early stages of its development, and … such actions are not fundamentally different from abortion.” In addition, the use of such drugs can cause irreparable harm to a woman’s health, therefore, medications that have an abortifacient nature must be labeled accordingly, the document states.

Natalia Kostarnova