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Japan initiates a groundbreaking market test of over-the-counter emergency contraceptive pills with pharmacies as a first access point
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  1. Hayase Hakariya1,2,
  2. Takanao Hashimoto3,
  3. Yosuke Suzuki4,
  4. Tamae Hamaki5,6,
  5. Tetsuya Tanimoto5,6
  1. 1 Eberhard Karls University Tübingen Interfaculty Institute of Biochemistry, Tübingen, Germany
  2. 2 Institute for Pharmaceutical and Social Health Sciences, Kyoto, Japan
  3. 3 Kenkodo Pharmacy, Osaki, Miyagi, Japan
  4. 4 Department of Obstetrics and Gynecology, Tone Chuo Hospital, Numata, Gunma, Japan
  5. 5 Medical Governance Research Institute, Minato-ku, Tokyo, Japan
  6. 6 Navitas Clinic, Tokyo, Japan
  1. Correspondence to Dr Hayase Hakariya, Eberhard Karls University Tübingen Interfaculty Institute of Biochemistry, Tübingen 72076, Germany; hayase.hakariya{at}uni-tuebingen.de

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On 28 November 2023, the Japanese Ministry of Health, Labor and Welfare (MHLW) initiated a market test to allow designated pharmacies to sell emergency contraceptive pills (ECPs), levonorgestrel (approved in 2011 in Japan) or its generic product, behind the pharmacy counter without a prescription.1 The test, commissioned by the MHLW and conducted by the Japan Pharmaceutical Association, will run until at least March 2024, evaluating the future possibility of switching ECPs to either behind-the-counter (BTC) or over-the-counter (OTC) medication. Individuals who consent to participate in the investigative research can administer the pill in front of the pharmacist subsequently after the instruction. The official website estimates the ECP to cost around Japanese yen ¥7000–9000 (US$47–62), which is not covered by health insurance.

This BTC framework is epoch-making given that access to ECPs in Japan was previously limited to prescription drugs with expensive costs ranging from ¥6000–20 000 (US$40–136), which is unacceptable for many young individuals.2 Understandably, the market test was initiated under specific circumstances. First, the trial set the limitation of the age of sexual consent at over 16 years. Second, minors (aged 16 or 17 years) are required to obtain parental consent. Participants are also required to consent to participate in the research and answer two questionnaire surveys, once before administration and again after 3–5 weeks. These conditions may potentially limit certain individuals’ access to the drug, such as minors who are abused or neglected by their parents.

Nonetheless, initiation of this trial has paved the way for Japan to take a large step towards catching up with global standards in birth control. Currently, 19 countries allow direct access to ECPs OTC, and 76 countries from a pharmacist BTC without a prescription, with Japan initiating the BTC method in this trial.2 Given that 120 000 abortions were performed in Japan in fiscal year 2022, with more than half being done by means of curettage and vacuum aspiration, it is reasonable to provide ECPs BTC via a pharmacist as an alternative method.3

Japan has a historical background that lags behind many other countries in terms of women’s health and rights. The country struggled to approve low-dose oral contraceptives in 1999 with over 35 years of debate due to potential concerns from the authorities concerning adverse effects, declining birth rate, and deterioration of sexual morality.4 5 Similarly, this market test framework has waited 6 years due to the initial review committee declining to switch ECPs to pharmacist-assisted BTC medication.6 However, during these 6 years, individuals or voluntary groups including medical practitioners performed questionnaire surveillance, ran promotional campaigns, discussed achieving easier access to ECPs with the authorities, and made policy recommendations, with civil grassroots campaigns successfully obtaining more than 107 000 signatures. Eventually, the current market testing was initiated. In this way, the Japanese Government has hesitantly taken the first step towards securing sexual and reproductive health and rights by means of this framework.

With the availability of an easier birth-control option, Japan will be able to encourage women to fulfil their roles within society. To achieve a gender-equalised society, pharmacists should take advantage of this market testing as a first opportunity that enables them to directly communicate with individuals to empower sexual literacy among Japanese citizens. Establishing successful sexual education opportunities and supporting socially vulnerable individuals in obtaining appropriate medical access could be further possible measures. Although the current market test involves only 145 (<0.24%) pharmacies, a full-scale rollout would potentially enable more than 60 000 pharmacies in Japan to play a part in being the first access point for individuals. Grassroots activities outside hospitals would reinforce pharmacies’ function as an individual's first point of access, ultimately progressing towards achieving a society without unintended pregnancies.

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  • X @hayase_hakariya

  • Contributors HH conceptualised, collected information required for the project, and completed the original manuscript with help from all the listed authors. TT, YS, and THashimoto supervised. All the listed authors contributed to writing the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests TT receives personal fees from MNES Inc. and Bionics Inc., outside the submitted work. HH is supported by the TOYOBO Biotechnology Foundation Fellowship, outside the submitted work. The other authors (THashimoto, YS and THamaki) have no relevant financial or non-financial interests to disclose.

  • Provenance and peer review Not commissioned; externally peer reviewed.