JAPAN: An Introduction to Life Sciences
Regulatory Developments in the Life Sciences Sector in Japan
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, comprehension of the legal and regulatory landscape in Japan requires accurate information on current discussions and developments concerning the rules and regulations affecting the Japanese life sciences industry. We set out below some of the key recent developments.
Amendment of the Act on the Safety of Regenerative Medicine and the Clinical Trials Act
A bill to amend the Act on the Safety of Regenerative Medicine and the Clinical Trials Act was promulgated in June 2024. The amendments under the bill are scheduled to take effect within one year from the promulgation. The bill stipulates various amendments to the regulatory framework for gene therapy and clinical research provided under these acts.
One notable amendment is the addition of in vivo gene therapy to the scope of regulated gene therapy under the Act on the Safety of Regenerative Medicine. The current Act applies to ex vivo gene therapy, but does not provide for a regulatory framework covering gene therapy that does not use processed cells, such as gene transfer and genetic modification (ie, in vivo gene therapy). The amendment will expand the scope of the Act to include such in vivo gene therapy.
The Clinical Trials Act will also be amended to clarify the scope of clinical research regulated under the said Act. Under the amendment, if tests that entail a substantial burden on research subjects are conducted for the purpose of studying the effectiveness of drugs which are used as part of ordinary medical care, such research will fall within regulated clinical research under the said Act.
Updated regulatory guidance on the provision of comparative drug information and off-label/pre-approval drug information
In February 2024, the Japanese health authority (ie, MHLW, or the Ministry of Health, Labour and Welfare) published a new set of FAQs concerning its guidelines on the provision of marketing information regarding prescription drugs. While the Japanese Pharmaceuticals and Medical Devices Act provides for statutory regulations on drug advertising, the MHLW guidelines set out detailed guidance on what the MHLW considers permissible or non-permissible provision of drug information. The updated FAQs provide guidance concerning the provision of comparative drug information and off-label/pre-approval drug information. According to the updated FAQs, providing information comparing a company’s own products with those of other companies will be permissible if it satisfies certain prescribed conditions, which include, for example: (i) the information must be limited to that requested by doctors or pharmacists, and the information must, in general, be provided to only such requesting doctors/pharmacists; (ii) the information must not be false or exaggerated, and must be based on scientific and objective grounds; and (iii) the information must not be arbitrarily selected in a manner that is disadvantageous to the other company’s products. The updated FAQ also provides guidance for cases where comparative drug information may be provided without a request from the doctors/pharmacists, and the conditions that need to be satisfied in order to provide off-label or pre-approval drug information.
Government initiatives to strengthen Japan’s Healthcare Startup Ecosystem
In June 2024, the MHLW issued its White Paper on Strengthening Japan’s Healthcare Startup Ecosystem, which sets out a total of 25 policy recommendations for promoting and supporting healthcare start-ups, along with a timetable for their implementation. These policy recommendations are comprised of a wide variety of proposals relevant to diverse roles relating to healthcare start-ups (such as academia, and business incubators, entrepreneurs and investors), ranging across five fields: “General”, “Biotechnology and Regenerative Medicine”, “Medical Devices and SaMD”, “Medical DX and AI”, and “Age Tech”. To support the Japanese start-ups’ potential to lead global innovation in healthcare, the White Paper proposes specific measures to invite top-tier global VC investors in the healthcare sector to further engage in the Japanese market, as well as policy measures to invite world-class contract development and manufacturing organisations to Japan. The White Paper also contains detailed proposals to amend and clarify current Japanese regulations, to further support and promote the growth of healthcare start-ups in Japan. These include: deregulating certain business licence requirements and advertising regulations relating to the development and commercialisation of software as a medical device (SaMD); clarifying rules and regulations regarding healthcare and AI; and providing clarity on regulations concerning non-clinical direct-to-consumer testing services.
Policy measures to revitalise the generic drug industry in Japan
In May 2024, the MHLW published a report on policy measures discussed by its Review Committee on the Industrial Structure for Realization of a Stable Supply of Generic Drugs. While generic drugs now comprise approximately 80% of the overall use of pharmaceuticals in Japan, a serious supply crisis of generic drugs has continued for about three years. The supply shortage was originally triggered by a number of business suspension orders issued to the manufacturers for their violation of current good manufacturing practices, but there also seem to be various problems inherent in the Japanese generic drug industry. The report proposes various policies and measures to: (i) ensure effective manufacturing and quality control systems; (ii) secure stable supply capacity; and (iii) realise the sustainable industrial structure of the generic drug industry. The proposed measures include, among other things: implementing intensive “dawn raid” inspections by the authorities; requiring manufacturers to establish governance systems to ensure a stable supply; simplifying regulatory procedures for changes in the manufacturing process; and introducing incentives for a stable supply in the drug reimbursement price mechanism. The report also suggests that collaboration and restructuring among generic drug manufacturers should be promoted through alliances and M&As, which could entail potential antitrust issues that need to be carefully considered and addressed.
Amendment of the rules on the advertising of medical services
In March 2024, the MHLW published an amendment to its guidelines on medical advertising, which set forth detailed guidance on the regulations provided under the Medical Care Act with respect to advertising concerning medical services and healthcare institutions. The amendment was made in response to recent issues in Japan involving the off-label use of pharmaceuticals for cosmetic and slimming purposes (such as those pertaining to GLP-1 receptor agonists approved for the treatment of type 2 diabetes in Japan). The Medical Care Act generally restricts the information that can be contained in medical advertisements to that listed in the Medical Care Act and the ministerial ordinance thereunder. Although there are certain exceptions to such prescribed limitation of advertisable information, even where such exceptions apply, pursuant to the amendment of the medical advertising guidelines, if an advertisement pertains to medical treatment that is not covered under the Japanese universal healthcare plan, the advertisement is required to contain certain prescribed information concerning off-label use, such as: (i) drug safety information available outside of Japan; (ii) whether or not there are other pharmaceuticals with the same ingredients and efficacy that have been approved in Japan; and (iii) indication that the purported use is off label and that the statutory relief system for adverse health effects will not be available for such off-label use.