JAPAN Trends and Developments Contributed by: Satoshi Ogawa, Yuto Noro, Hitoshi Fujimaki and Yuka Hirata, TMI Associates
In 2025, a ten-year fund is scheduled to be launched to support drug discovery start-ups, with the goal of accelerating the development of innovative pharmaceuticals. In parallel, research and development support programmes for healthcare start-ups – primarily led by the Japan Agency for Medical Research and Development (AMED) – are ongoing and continue to play a central role in fostering innovation in the sector. Expansion of remote medical care Background Previously in Japan, medical services were basically administered in a face-to-face man- ner, while remote medical care was regarded as a supplement to face-to-face treatment and its use was limited. Face-to-face guidance on the administration of medication has tradition- ally been mandatory; however, in recent years, in addition to the development of information and communication devices, there has been a temporary relaxation of related regulations as a response to the increased demand for online medical treatment and online medication guid- ance during the COVID-19 pandemic. This has resulted in the widespread use of telemedicine and online medication guidance in Japan. Telemedicine Telemedicine in Japan has long been constrained by Article 20 of the Medical Practitioners’ Act, which prohibits physicians from providing medi- cal treatment without a physical examination. To address this, the MHLW released its Telemedi- cine Guidelines in March 2018, outlining mini- mum compliance requirements and clarifying that adherence to the Guidelines does not vio- late Article 20. Initially, the Guidelines mandated that the first medical consultation be conducted in person, limiting the expansion of telemedicine. However,
in response to the increased reliance on remote healthcare during the COVID-19 pandemic, the MHLW revised these Guidelines in January 2022 and March 2023. Subsequently, in June 2023, the MHLW published its “Basic Policy for Pro- moting Online Medical Treatments and Other Forms of Telemedicine” to facilitate the wide- spread and appropriate promotion of telemedi- cine services. However, as of 2025, the temporary measures that permitted telephone-only initial consulta- tions during the COVID-19 pandemic have been rescinded. These consultations, which were cov- ered by health insurance until July 2023, are no longer authorised or reimbursed. Nevertheless, telephone-based follow-up consultations con- tinue to be eligible for health insurance cover- age. In addition, to qualify for additional reim- bursement under the National Health Insurance system for online medical services, medical institutions must submit a notification confirming compliance with the required facility standards. In terms of clinical practice, the Telemedicine Guidelines impose certain limitations, such as restricting initial consultations for specific symptoms and prohibiting the prescription of certain medicines during first-time remote con- sultations. In addition, consultations conducted solely via telephone or written correspondence are not permitted. Moreover, telemedicine must utilise both visual and auditory communication. While only licensed physicians can provide tel- emedicine services, non-physicians may offer health consultations that do not involve medical judgements. These services, not governed by the Medical Practitioners’ Act or the Telemedi- cine Guidelines, serve as a preliminary step to telemedicine, facilitating early disease detection and offering low barriers to entry.
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