Japan: A Better Environment

By Chia-Feng Lu

In the past few years, from the policy statement in 2013, “Japan is back,” to the proposed policy statement in 2017, “Japan revitalization strategy 2017,” the Japanese government’s determination to revitalize its life sciences industry is unquestionable. Japan continues to promote its healthcare industry by attracting more clinical development activities and facilitating the discovery and development of novel therapies. The government advocates providing a friendly regulatory environment to champion innovation while increasing enforcement to assure stakeholder adherence to desired practice.

Thus, the Japanese government has become more proactive in responding to the increased frequency of noncompliant practices in clinical studies. In the wake of a series of past incidents in Japan, the prompt responses of both the government agency and the industry association reflect a more active stance of proceeding with enforcement actions and discovering noncompliant activities. The overhaul of the regulatory framework overseeing medical products through the introduction of the Pharmaceutical and Medical Device Act (PMD Act) has been completed. Additionally, numerous initiatives launched by the regulatory agencies, such as the Sakigake system and compassionate use, are progressively making the regulatory scheme in Japan more robust. This year, the relevant reforms in Japan are related to improving the regulatory environment by clearing unnecessary regulatory hurdles and by providing more guidance to mitigate the regulatory uncertainty regarding the gray areas in this complex regulatory structure.

Two recently enacted laws related to the life sciences industry are indicative of the theme of the first half of 2017 in Japan.

Clinical Research Act

The Clinical Research Act (CRA) was enacted on April 7, 2017, and was promulgated on April 14, 2017; it will be implemented in April 2018. In connection with the CRA, a number of ministerial ordinances, including Good Clinical Practice (GCP) type regulations and additional standards are under discussion at this time, and their drafts are expected to be released by the Ministry of Health, Labor, and Welfare (MHLW) by the end of 2017. These ministerial ordinances will specify the details for parties to carry out clinical studies governed by the CRA.

Generally, the CRA will address clinical research activities that do not fall under the statutory definition of clinical studies or trials regulated under the PMD Act (i.e., clinical trials conducted for marketing authorization application). The CRA will provide the legal basis for the MHLW to regulate clinical research activities for drugs, medical devices, or human cell therapy and gene therapy products that are not approved under the PMD Act or off-label studies. It stipulates the approval process for conducting this type of clinical research, and imposes certain obligations on the manufacturers or academic researchers, in particular with respect to informed consent, data confidentiality, record keeping, adverse events reporting, clinical research monitoring activities, auditing, management of conflicts of interest, and certified clinical research ethics committee hearings for clinical research plans.

The sensitivity of the relationship between the manufacturer and the investigator is also factored into the formulation of the CRA and related ministerial ordinances. The CRA requires manufacturers that fund clinical research conducted by academia or medical institutions to execute agreements and to disclose required information about funding.

Academic researchers conducting clinical research regulated by the CRA are required to submit study protocols to the MHLW, observe the GCP regulations and the study protocol, consider opinions of an accredited ethics committee (EC), obtain informed consent from the study subjects in due course, report serious adverse event information to the MHLW and the EC, ensure the protection of personal information, and preserve the specified documents in accordance with the forthcoming ordinances.

Medical Care Big Data Act

The incorporation of medical data in medical practice decisions and R&D for medical products is becoming the trend and will prove to be critical for healthcare service delivery. In 2016, Japan’s Ministry of Economy, Trade and Industry also stressed the importance of utilizing medical data in bio-industry under the concept of big data in its policy proposal “Institutional reform for the Fourth Industrial Revolution.” However, the sensitive nature of medical data, which is appreciated by the old paradigms for personal data protection, results in the inefficient sharing of medical data. In many cases, the sharing of medical data across numerous data bases or data sources is strictly prohibited. In addition, the medical data storage and processing systems operated by individual medical institutions lack standardization in Japan. These issues could create an unfriendly environment to advance R&D and business development in connection with healthcare delivery and medical research innovation.

During parliamentary debate, the Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field, also called “Next Generation Medical Infrastructure Act” or “Medical Care Big Data Act” (NGMA), was found to address those considerations. The NGMA was enacted in Japan on April 28, 2017, promulgated on May 12, 2017, and will come into force within a year.

In sum, the NGMA facilitates the utilization or sharing of anonymized medical data for the purpose of medical research without the subject’s consent unless the subject expresses a desire to “opt-out.” The NGMA establishes a system that certifies business operators that can properly and reliably anonymize medical data through advanced technical and management capabilities as certified anonymized medical data agents (certified agents). Certified agents can legally receive patient medical data directly from medical institutions if the medical institutions give upfront notice to the patients and the patients do not object.

As Japan continues to position itself as a growth market for the healthcare industry, life sciences companies’ ability to align their practices with the country’s rapidly evolving standards is critical to their ongoing success. Dedicated efforts to incorporate the insights of the newly introduced scheme will ensure that life sciences companies capitalize on the improved regulatory environment and prepare themselves to tackle any headwinds generated by increased enforcement trends.