JAPAN: An Introduction to Life Sciences
Recent Developments in Life Sciences Regulations
The legal regime regulating the life sciences sector in Japan consists of a wide range of rules and regulations stipulated in statutes enacted by the diet guidance published by relevant regulatory authorities and industry rules established by industry organisations. These rules and regulations undergo constant review and updating; thus, accurate comprehension of the legal and regulatory landscape in Japan requires a correct understanding of the most current rules and regulations affecting the Japanese life sciences industry. In this regard, there have been quite a number of significant developments recently in Japan, especially in relation to use of data and technology. Set out below are some of the key recent developments.
Updated rules on SaMD (Software as a Medical Device)
Until relatively recently, whether a SaMD product should be considered a regulated medical device subject to product marketing authorisation and business licensing requirements for product manufacturing, marketing and distribution under the Japanese medical device regulations remained a constant point of debate due to the lack of sufficient regulatory clarification or guidance. To resolve this matter, the Japanese health authority (ie, MHLW, or the Ministry of Health, Labour and Welfare) issued a guideline concerning medical device software programs which provides detailed guidance on what constitutes a regulated SaMD. This MHLW guideline was substantially updated and revised in March 2023 to reflect recent cases where MHLW considered whether certain software products constitute regulated medical devices. The updated guideline also provides a user-friendly flowchart that serves as practical reference for determining the regulatory status of a health-related software product.
Introduction of rules addressing DCT (Decentralised Clinical Trial)
The Japanese GCP (Good Clinical Practice) ordinance has been premised generally on the traditional face-to-face clinical trial setting where patients physically visit the trial site to participate in a clinical trial. With an aim to facilitate and encourage decentralised clinical trials in Japan, MHLW issued various guidance to allow for clinical trials to be performed remotely using technologies and interactive telecommunication systems. As part of this initiative, MHLW issued a regulatory notice in March 2023 concerning electronic consent or e-consent of clinical trial participants, which provides guidance on the circumstances where informed consent of the trial participant can be obtained remotely using digital means. For e-consent to be used, this 2023 MHLW notice requires that the explanation provided remotely by the physician and the communication between the physician and trial participant using interactive telecommunication systems be substantially equivalent to that provided or experienced in a traditional face-to-face setting.
Reform of legal framework for utilising processed medical data
The Act on Protection of Personal Information (APPI) is the primary statute regulating the handling of personal information in Japan; however, the APPI is a general law that applies across various industries and does not focus specifically on the life sciences sector. In this regard, there is a separate statute, generally known as the Next Generation Medical Infrastructure Act, which provides for a special legal framework to facilitate utilisation of processed medical data by anonymising patient data. This Act requires, among other things, that the anonymised data does not contain any outlier data (ie, unusual values in a dataset) and is not capable of restoring personally identifiable information. A new law reforming this Act was passed and promulgated in May 2023, and is scheduled to take effect by May 2024. The reform introduces the concept of pseudonymised medical data, and allows for a new alternative pathway to facilitate utilisation of processed medical data by pseudonymising patient data through prescribed means. Pseudonymised medical data can include outlier data, which is expected to facilitate use of processed medical data pertaining to rare disease cases. Pseudonymisation also allows for the processed medical data to be restored to personally identifiable information, which is expected to promote use of processed medical data for broader purposes such as for drug marketing authorisation application purposes.
Amendment of rules on life science research activities
There are various rules in Japan that apply to life sciences research activities, and the applicable rules differ depending on the type and details of the research to be conducted. MHLW, together with METI (Ministry of Economy, Trade and Industry) and MEXT (Ministry of Education, Culture, Sports, Science and Technology) have issued an ethical guideline concerning life science research activities on human subjects, which sets out detailed guidance on informed consent requirements and other rules regulating those research activities. The ethical guideline is frequently amended, and was recently amended in March 2023. The 2023 amendment includes, among others, various changes to the informed consent process required to be taken in respect of research subjects, as well as changes to the opt-out mechanism that can be implemented under the ethical guideline.
Revision of industry guidance on promotional materials for ethical drugs
The Japanese Pharmaceuticals and Medical Devices Act stipulates regulations on advertisements of various categories of drugs, but the rules on promotional activities of ethical drugs are prescribed in a guideline issued by MHLW, and also in industry guidance issued by the relevant industry organisation. In October 2023, JPMA (Japan Pharmaceutical Manufacturers Association) published a revised guidance on promotional materials to be used for the marketing of ethical drugs. The 2023 revision includes various changes made to ensure accuracy of the message to be conveyed through promotional materials and to prevent misleading information from being provided to healthcare professionals through promotional materials.
Amendment of rules on telemedicine
In Japan, as a general principle, medical diagnosis must be performed by a physician through in-person medical examination with a patient. However, a guideline issued by MHLW provides guidance on the permissible scope of telemedicine services. The use of telemedicine expanded during the COVID-19 pandemic, and there have been substantive amendments made to this guideline to clarify the circumstances in which telemedicine is allowed in Japan. The MHLW telemedicine guideline was recently amended in March 2023 to provide for, among other changes, various enhanced requirements concerning cyber security risks and telecommunication systems used for telemedicine. The 2023 amendment includes new requirements on the healthcare provider to provide sufficient explanation to the patient on cyber security risk, and to obtain the patient’s consent to the telecommunication system used for telemedicine.
Amendment of guidelines on security measures concerning medical data
The APPI establishes general requirements on business operators to take appropriate security measures when handling personal data of individuals in Japan. In the life sciences sector, a guideline issued by MHLW and another guideline jointly issued by METI and MIC (Ministry of Internal Affairs and Communications) provide for detailed guidance on the security measures to be taken when handling personal medical data of individuals. The MHLW guideline was amended in May 2023, and the METI/MIC guideline was amended in July 2023. As part of the 2023 amendment of these guidelines, the MHLW guideline was restructured into four sections (overview, governance, management and control), and various changes were made to, for example, the rules concerning outsourcing and use of external vendors.