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• W2312285087 abstract "In November 2014, the Japanese government enacted the Act on the Safety of Regenerative Medicine (ASRM) to regulate the use of stem cells and cell-based products within the context of clinical research and medical practice (Konomi et al., 2015Konomi K. Tobita M. Kimura K. Sato D. Cell Stem Cell. 2015; 16: 350-352Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar). The government introduced this law as part of a wider framework to promote the clinical translation of stem cells, particularly induced pluripotent stem cells (iPSCs), for which Shinya Yamanaka received the Nobel Prize for Physiology and Medicine in 2012. While the law primarily aims to ensure the safety of these products, it also seeks to address concerns about the country’s growing reputation as a destination for medical tourists pursuing unproven stem-cell-based interventions. Prior to 2014, Japanese law did not explicitly regulate the use of stem cells in clinical practice, but instead, oversight fell broadly under the Medical Practitioners Law (1948), which considers a practitioner’s act of producing a medicinal product and administering it to a patient as “physician discretion” (Lysaght et al., 2013Lysaght T. Kerridge I. Sipp D. Porter G. Capps B.J. Cell Stem Cell. 2013; 13: 647-651Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar). The ASRM now requires private clinics and medical institutions to obtain these products from facilities that are licensed or accredited to process cells according to Good Cell and Tissue Practice (GCTP) standards (Konomi et al., 2015Konomi K. Tobita M. Kimura K. Sato D. Cell Stem Cell. 2015; 16: 350-352Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar). These standards are similar to those set out in the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act 2014), which regulates clinical trials that are aimed at evaluating the safety and efficacy of a product for market distribution, but are applied with less rigor (Azuma, 2015Azuma K. Curr Stem Cell Rep. 2015; 1: 118-128Crossref Scopus (51) Google Scholar). Clinics must then obtain an approval from a review committee to use the cells according to a risk-based classification system (see Supplemental Information, available online). This system reserves the highest level of review from the Ministry of Health, Labour, and Welfare (MHLW) in the case of cells derived from pluripotent lines and allogeneic sources. The introduction of the ASRM is laudable in terms of setting minimal quality assurance standards for cell processing; such standards are not required in other countries, such as Australia (McLean et al., 2015McLean A.K. Stewart C. Kerridge I. Stem Cell Res. Ther. 2015; 6: 33Crossref PubMed Scopus (14) Google Scholar), where practitioners are allowed to use autologous cells in private clinical practice. However, as with any statutory law, the devil is in the detail of its implementation. The requirements for GCTP are limited to controlling contaminants and the spread of infection; there are no requirements for characterizing cells, controls for population homogeneity, or standardized procedures for the administration of cells to patients or research subjects. Practitioners must report serious adverse events, although it is unclear if and how they will measure and report other safety and efficacy outcomes. Consideration of these issues will presumably fall under the purview of review committees that will approve the use of the cells. The ASRM has established two types of committees for this purpose. Certified Special Committees for Regenerative Medicine (CSCRMs) review plans for cells classified in high and medium risk categories, while Certified Committees for Regenerative Medicine (CCRMs) will review the provision of cells classified as low risk (Azuma, 2015Azuma K. Curr Stem Cell Rep. 2015; 1: 118-128Crossref Scopus (51) Google Scholar, Konomi et al., 2015Konomi K. Tobita M. Kimura K. Sato D. Cell Stem Cell. 2015; 16: 350-352Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar). The MHLW certifies these committees, but they act autonomously from the regulator in the review of provision plans for the use of stem cells in research as well as clinical practice. The MHLW will only review proposals for Class I (high risk) cells: once approved, relevant committees submit plans for Class II and III (medium and low risk) provisions to the Ministry without any further review. Oversight of these provisions is, therefore, highly decentralized, with the Ministry’s role limited to certifying the committees and auditing their activities rather than the practices of clinics and institutions that use the cells. This oversight model places enormous power and authority over the regulation of stem-cell-based interventions with these review committees, which are independent of the MHLW and may be established within hospitals or the private clinics that submit the provision plans. This model raises important questions of independence and transparency. The MHLW certifies committees according to the size and composition of their membership: the CSCRM must have a minimum of eight members and include specialists with expertise in a relevant field of science (e.g., molecular/cell biology) and regenerative medicine, as well as a clinical practitioner, a biostatistician, and a bioethicist; whereas the CCRM has a minimum of five members with only generalized expertise in clinical medicine and bioethics or law. While restrictions specify the proportion of members that must be external to the institution whose provision plan is under review, clinics that operate within networks or outsource their reviews to for-profit committees could easily circumvent these stipulations, as evidenced by similar practices observed in the United States (Turner, 2015Turner L.G. Regen. Med. 2015; 10: 397-402Crossref PubMed Scopus (18) Google Scholar) and Australia (McLean et al., 2015McLean A.K. Stewart C. Kerridge I. Stem Cell Res. Ther. 2015; 6: 33Crossref PubMed Scopus (14) Google Scholar). Responsibility for classifying cell therapies as high (Class I), medium (Class II), and low risk (Class III) falls under the discretion of individual committees, which could lead to inconsistencies in how similar provisions are reviewed. For example, autologous cells derived from adipose tissue using stromal vascular fractionation (SVF) could be categorized as Class II or III depending on their intended uses as homologous or non-homologous: if homologous, the clinic needs to seek approval only from the CCRM that has classified it. While the MHLW provides a definition of homologous use in its ministerial ordinance, administrative guidance documents such as this do not have the force of law, and compliance is merely voluntary. In addition, as of January 2016, the MHLW has certified 35 CSCRMs and 93 CCRMs, and 2,634 provision plans have been submitted (http://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000085941.pdf). This decentralization leaves considerable scope for variation in how the regulatory guidance is interpreted and applied to specific provisions. Indeed, during a recent visit to Japan, the authors anecdotally found much confusion and uncertainty in how the ASRM will work and whether it will achieve its stated aims or create even bigger problems than those it intended to solve with the use of unproven therapies in clinical practice. For example, an institute affiliated with the South Korean company previously implicated in the deaths of two patients (Cyranoski, 2010Cyranoski D. Nature. 2010; 468: 485Crossref PubMed Scopus (73) Google Scholar) has received an approval from a CSCRM for an autologous SVF Class II treatment of autoimmune diseases (http://en.stemcellbio.com/news/). These cells have not been approved for such use in South Korea. Thus, while it may be premature to dismiss the laws as ineffectual, they are unlikely to either ensure the safety of cell therapies or promote the wider field of regenerative medicine unless the MHLW is better able to monitor the practices of clinics themselves and enforce key regulations to discourage the exploitation of patients for the profit of a few. For this regulatory framework to work as intended, Japan needs to devote more significant planning efforts and resources to structuring effective implementation and oversight. S.S. is a cofounder and shareholder of Adigenics Pte Ltd, which has not had any influence on authors’ views in this article. Download .pdf (.1 MB) Help with pdf files Document S1. Table S1" @default.
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• W2312285087 title "Uncertain Oversight of Regenerative Medicines in Japan under the ASRM" @default.
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