The Ministry of Health issued an order to control drugs for medical abortion

The Ministry of Health published order No. 459n on approval of the list of medicines for medical use that are subject to subject-quantitative accounting (PKU). The list includes the drugs mifepristone and misoprostol, used for medical abortion. Experts say the use of these abortifacient drugs has been strictly controlled in the past. The problem, in their opinion, is that the order does not specify the dosage, and drugs for the treatment of uterine fibroids and emergency contraceptives containing mifepristone may fall under the PCU. The Ministry of Health insists that the registration will only affect drugs for abortion.

As Kommersant told, the draft updated list became available for public discussion in mid-July. In total, the list of medicines subject to registration includes over 130 items – for example, diazepam, ketamine, cocaine, morphine, pseudoephedrine, fentanyl, bee venom, chloroform. Among other things, the department decided to add drugs for medical abortion: mifepristone and misoprostol. This happened against the backdrop of a discussion by United Russia about ways to improve demographics in the country and a statement by Health Minister Mikhail Murashko about the need for “strict control” of such drugs. The document will come into force in April 2024. In addition, the department promises to consider the proposal of a number of deputies to ban abortions in private clinics.

Despite the protests of the professional community, which Kommersant wrote about, the order does not contain any instructions on the dosage of medications that require PCU. At the same time, mifepristone in a dosage of 50 mg is also used to treat uterine fibroids; some emergency contraceptives are also produced on its basis. And although earlier Minister Mikhail Murashko assured that the restrictions would apply only to abortion drugs, and not to emergency contraception, it follows from the document that all drugs containing misoprostol and mifepristone will come under enhanced control.

Natalia Dolgushina, chief freelance specialist on women’s reproductive health at the Russian Ministry of Health, said that the new rules for dispensing drugs for medical abortion will not affect their availability. According to her, in medical organizations the work with such means is streamlined and does not cause any problems. “Medical abortion drugs can be dangerous when used independently. That is why their transfer to drug-quantitative registration is completely justified,” said Ms. Dolgushina. “The measure is aimed at preserving the health of women, since in order to prevent complications of medical abortion, consultation and a doctor’s prescription are necessary.”

However, in the professional community there is a different opinion. Earlier, Kommersant talked about a survey conducted among 1.6 thousand doctors by the professional service Doctor’s Directory. As it turned out, 59% of the doctors surveyed were against restricting the free sale of abortion drugs. Doctors believe that this will lead to an increase in criminal abortions, a surge in “medical tourism” and a high percentage of child abandonment. Kommersant asked several gynecologists to comment on the survey, but they all refused, saying that the topic had a “political context.” One of the experts, speaking on condition of anonymity, said that “the data obtained by colleagues probably does not fully reflect the true position of doctors, since the answer of an experienced doctor is more complex and not always unambiguous.” Kommersant’s interlocutor also noted that any ban on the circulation of medicines gradually shifts sales of drugs to the shadow sector. As a result, statistics are distorted, and decisions affecting the country’s demographic policy are made on the basis of incorrect data. The gynecologist recalled that the WHO position does not exclude the free circulation of drugs for medical abortion. At the same time, special attention is paid to fully informing patients purchasing the drug about the risks and actions in case of complications.

Deputy General Director of AlphaRM (specializing in pharmaceutical industry research) Tatyana Kovalchuk emphasized: drugs for abortion are already used “exclusively in clinics” – they are already prescription and purchased for their intended purpose. And the changes will only manifest themselves in the fact that now special forms will be used for them. Obstetrician-gynecologist, public health and health specialist, WHO expert Lyubov Erofeeva does not understand the hype around mifepristone and misoprostol. According to her, they were already registered: “They still can’t be bought at a pharmacy, either with a prescription or without a prescription. They are bought by clinics, both private and public. And they perform abortions under the supervision of a doctor, the packages are not thrown away, all this is registered. That is, instead of strict accounting of the drug, they decided to make the accounting even stricter.”

However, RNC Pharma development director Nikolai Bespalov told Kommersant that misoprostol and mifepristone drugs in dosages intended for abortion are still sold in pharmacies, albeit in small quantities – no more than 2-3% of total volumes (about 23–25 thousand packages per year). According to him, they can be used both for performing abortions at home and for “gray” clinics that perform abortions unofficially.

Lyubov Erofeeva is concerned that the order does not indicate the dosage, which means that drugs for the treatment of uterine fibroids and emergency contraception are also included in the registration: “Since pharmacies are private enterprises, there are owners, and if this is the case, there are also staff, It is not enough for them to fill out additional paperwork, then they simply will not purchase these drugs. Other emergency contraceptives can be banned on the sly.” She points out that even in Catholic Western countries, such as Ireland, barriers to terminating unwanted pregnancies have been removed over the past 25 years, while in Russia, since 2011, “pieces of women’s rights have been biting off.” At the same time, the number of abortions in Russia, she notes, is already low in comparison with global statistics, and Russian women give birth more than citizens of Poland, where artificial termination of pregnancy is prohibited.

Note that, according to the Ministry of Health, in 2022, 395,201 abortions were performed in Russia – 4% less than in 2021. Overall, the number of abortions in the country has been steadily declining since the early 1990s, by an average of 6% per year, and is now more than five times lower than the 1990 level.

Natalia Kostarnova