The government has officially announced the introduction of the abortion pill mifepristone, aiming for its domestic availability as early as the first quarter of next year. This decision comes seven years after the Constitutional Court ruled that the abortion law was unconstitutional.
Mifepristone is an oral medication used in the early stages of pregnancy. The version being introduced in the country, known as mifepristone-misoprostol, is a combination of mifepristone and misoprostol. The term 'mifepristone' typically refers to the single-component medication.
Abortion pills are already in use in several countries. The World Health Organization (WHO) recognizes the medical abortion method using mifepristone and misoprostol within healthcare systems. Due to the difficulty in legally obtaining abortion pills in the country, illegal online distribution has persisted. The Ministry of Food and Drug Safety reported that from 2021 to May of this year, it identified 3,189 cases of illegal online sales and advertisements for abortion medications.
The issues arose during the transaction process. Buyers typically sought sellers through platforms like Telegram and X, disclosed their pregnancy weeks, and sent money to receive the medication. It was often challenging to verify the source or storage conditions of the drugs, and many users did not receive proper instructions on dosage or precautions. Given that these transactions occurred outside the legal framework, seeking medical assistance for adverse symptoms was also difficult.
To combat illegal distribution, the government plans to manage the initial two years of mifepristone's introduction through prescriptions and dispensing by medical institutions. The products currently under review are intended for use within 63 days of pregnancy, or nine weeks. The government has also proposed a phased approach to transition to pharmacy dispensing based on safety management evaluations.
However, the arrival of the medication does not complete the system. Challenges remain, including whether to include health insurance coverage, how to ensure access for minors and vulnerable women, and defining the scope of responsibility for medical professionals during the prescription and dispensing process. There is also a need to clarify how to connect emergency medical care and follow-up management in cases of adverse symptoms or complications after taking the medication.
The nine-week usage limit set for the medication is another point for future discussion. The current domestic approval application is based on clinical trial data that assumes use within nine weeks. In contrast, the WHO provides separate guidelines for medical abortion methods and medical management based on gestational age. Ultimately, the extent of what will be permitted domestically will need to be discussed not only in terms of drug approval but also in the future design of the system.
Debate also surrounds the dispensing method. While the government has established hospital-based prescriptions and dispensing as the principle for the initial two years, transitioning to pharmacy dispensing will require adjustments to relevant laws and systems. Pharmacy associations have also advocated for legislative measures regarding pharmacy dispensing of abortion medications. Considering past instances where nurses or nursing assistants were involved in the dispensing process, it is essential to clarify the entities responsible for prescriptions and dispensing.
The introduction of abortion pills marks not an end but a beginning. Simply bringing the medication into the country does not complete the system. Legal standards for abortion, the scope of medical professionals' responsibilities, and emergency medical care and follow-up management for adverse symptoms must be clearly established. Equally important is developing a system that can ensure patient safety within the legal framework.
* This article has been translated by AI.
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