Japanese Journal of Clinical Oncology, 2015, 45(3) 311–312 doi: 10.1093/jjco/hyu225 Advance Access Publication Date: 22 January 2015 Letter
Letter Pros and cons of legislation on allogeneic hematopoietic stem cell transplantation Satoshi Nishiwaki* Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
To the Editor: The Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantations (2012) (1) was put into operation in January 2014. The act is summarized in Table 1. Generally, the government introduces legislation when a serious problem exists to be regulated (2). Fortunately for Japan, no serious accident has prevented the growth of allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, concerned parties such as physicians, patients and volunteers urged the legislature to regulate allo-HSCT. These parties expect the act to improve and maintain the infrastructure for allo-HSCT, especially regarding its financial aspects. Articles 28 and 42 stipulate that the government may provide partial subsidies, within budgetary limits, for the expenses of bone marrow, peripheral blood stem cell and cord blood supply to the agencies involved. However, these agencies must fully justify their operations due to their receipt of tax funds. Although the provision of unrelated sources is in public interest, the activity must be justified from a cost perspective (3). Safety is another issue. The act states that bone marrow and peripheral blood stem cell agencies and cord blood suppliers must be licensed by the Minister of Health, Labour and Welfare (Article 17 and 30). Article 32 also stipulates that cord blood suppliers must comply with the relevant standards specified by the Ministry of Health, Labour and Welfare ordinances in regard to how cord blood supply services are performed. Complying with these standards is necessary to ensure the safety and quality of the cord blood used in transplantation. This quality assurance is desirable for patients, but it requires additional manpower and facilities along with strengthened checking systems and record integrity. It may be necessary to meet the needs of higher quality to ensure the safety of allo-HSCT, just as the hemovigilance system is employed with blood transfusion (4). Government officials will likely focus most of their attention on regulation. However, allo-HSCT cannot be improved without
research, and excessive regulation impedes medical development. Article 14 stipulates that the national government shall take necessary measures to encourage research and development that will contribute to promoting the appropriate provision of hematopoietic stem cells for use in transplantations, as well as the dissemination of the results of that research and development. Bone marrow, peripheral blood stem cell and cord blood suppliers should actively provide unrelated sources for researchers despite the regulations of the act. Government regulators should handle the authority of managing allo-HSCT. Under the government surveillance system, accidents due to systematic flaws can be prevented in advance. Also, these officials can take a comprehensive, panoramic view of allo-HSCT, which may have benefits such as the centralization of information management. However, highly specialized, constantly advancing field of allo-HSCT requires administrative officials to possess specialist knowledge and capabilities. A complete understanding of allo-HSCT is difficult to obtain without adequate practical experience. Therefore, the government must encourage expert input or risk enacting rules that are out of touch with clinical practice. Since the act may directly affect the clinical practice of allo-HSCT, clinicians should understand its possible effects. A good thing for patients is that safe stem cell sources that meet the national standards can be provided for allo-HSCT all over Japan. On the other hand, tight control of sources, donors and patients, such as paper management, will be required in performing allo-HSCT. The pros and cons of the legislation are summarized in Table 2. The act may have both positive and negative impacts, but its benefits will be maximized if all parties play their own roles appropriately while understanding the act’s limitations. The views expressed are those of the author and do not necessarily reflect the policy of the Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare.
© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected]
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*For reprints and all correspondence: Satoshi Nishiwaki, Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki Chiyoda-ku Tokyo, 100-8916, Japan. E-mail: [email protected]
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Table 1. Summary of the act for appropriate provision of hematopoietic stem cells to be used in transplantation
HSC, hematopoietic stem cell; HSCT, hematopoietic stem cell transplantation; BM, bone marrow; PBSCs, peripheral blood stem cells; CB, cord blood.
Table 2. Pros and cons of legislation on allo-HSCT Pros • Infrastructure for allo-HSCT is improved and maintained • Agencies gain financial security • Safety and quality of sources are ensured • Accidents due to systematic flaws can be prevented in advance • Regulatory officials can take a comprehensive view of allo-HSCT
Cons • Rationalization of operations is required (activity must be justified from a cost perspective) • Additional manpower and facilities are required for quality assurance • Higher quality may be required • Cooperation with researchers may be hampered due to narrow interpretation of the act • Regulatory officials may lack specialist knowledge of allo-HSCT
Conflict of interest statement The authors have no commercial, proprietary, or financial interest in the products or companies described in this article.
References 1. The Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantations. 2012 http://www.jshct.com/english/pdf/act_en.pdf.
2. Weinberg PD, Hounshell J, Sherman LA, et al. Legal, financial, and public health consequences of HIV contamination of blood and blood products in the 1980s and 1990s. Ann Intern Med 2002;136:312–9. 3. The Cost of Blood Consensus Conference. The cost of blood: multidisciplinary consensus conference for a standard methodology. Transfusion Med Rev 2005;19:66–78. 4. René R, De Vries P, Faber J-C. Hemovigilance: an effective tool for improving transfusion safety. Wiley 2012. doi: 10.1002/9781118338179.
Downloaded from http://jjco.oxfordjournals.org/ at North Dakota State University on June 9, 2015
1. Basic principles (Article 3) 1. Effort shall be made to promote the provision of HSCs for use in transplantation. 2. HSCs used in transplantation shall be provided voluntarily. 3. Opportunities to receive HSCT shall be granted fairly. 4. The safety of HSCs used in transplantation shall be ensured. 5. The health of people who provide BM or PBSCs shall be protected. 6. The quality of CB used in transplantation shall be ensured. 2. Responsibilities (Article 4–Article 8) 1. The national government shall formulate and implement measures and policies to promote the proper provision of HSCs used in transplantation. 2. BM banks and CB banks shall contribute to promoting the appropriate provision of HSCs for use in transplantation. 3. Healthcare professionals shall provide information necessary for the efforts to monitor and analyze the health status of donors and patients. 3. Basic policy (Article 9) The Minister of Health, Labour and Welfare shall establish the basic policy to promote the appropriate provision of HSCs for transplantation. 4. Measures to promote the proper provision of HSCs used in transplantation (Article 10–Article 16) 1. National and local government authorities shall promote better public understanding. 2. The national government shall provide information on the provision of HSCs in an integrated manner. 3. The national government shall take necessary measures to support efforts to monitor and analyze the health status of donors and patients. 4. The national government shall take necessary financial and other measures to ensure the stable operation of HSC related businesses. 5. The national government shall promote research that will contribute to promoting the appropriate provision of HSCs for use in transplantation. 6. The national government shall promote international cooperation for the provision of HSCs used in transplantation. 7. The national government shall develop healthcare delivery systems related to the collection of BM and PBSCs. 5. Intermediaries in the provision of BM and PBSCs (BM banks) (Article 17–Article 29) 1. A licensing system shall be made for BM banks. 2. Licensed BM banks shall not conduct the business for the purpose of profit. 3. Measures must be adopted to ensure the safety of BM and PBSCs and to protect the health of donors. 4. Appropriate explanations shall be given to people who are considering donations, and their consent obtained. 5. The national government may provide partial subsidies for the expenses necessary for BM banks in the provision of BM and PBSCs. 6. Umbilical cord blood supply business (CB bank) (Article 30–Article 43) 1. A licensing system shall be made for CB banks. 2. Licensed CB banks shall not conduct the business for the purpose of profit. 3. CB banks shall meet the standards specified in Ministry of Health, Labour and Welfare ordinances for matters necessary to ensure safety of CB. 4. Appropriate explanations shall be given to people who are considering donations, and their consent obtained. 5. CB may be used by the CB bank or provided to others for research. 6. The national government may provide partial subsidies for the expenses necessary for CB supply businesses. 7. Hematopoietic stem cell provision support organization (Article 44–Article 52) 1. The support organization shall: 1) resister donors for BM and PBSCs and cooperate with other service providers, 2) liaise and coordinate among entities involved in HSC provision, 3) provide unified management and supply of information related to HSCs used in transplantation and 4) disseminate information and raise awareness of providing HSCs for use in transplantation. 2. The national government may provide partial subsidies for the expenses necessary for the support organization.
Letter Pros and cons of legislation on allogeneic hematopoietic stem cell transplantation Satoshi Nishiwaki* Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
To the Editor: The Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantations (2012) (1) was put into operation in January 2014. The act is summarized in Table 1. Generally, the government introduces legislation when a serious problem exists to be regulated (2). Fortunately for Japan, no serious accident has prevented the growth of allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, concerned parties such as physicians, patients and volunteers urged the legislature to regulate allo-HSCT. These parties expect the act to improve and maintain the infrastructure for allo-HSCT, especially regarding its financial aspects. Articles 28 and 42 stipulate that the government may provide partial subsidies, within budgetary limits, for the expenses of bone marrow, peripheral blood stem cell and cord blood supply to the agencies involved. However, these agencies must fully justify their operations due to their receipt of tax funds. Although the provision of unrelated sources is in public interest, the activity must be justified from a cost perspective (3). Safety is another issue. The act states that bone marrow and peripheral blood stem cell agencies and cord blood suppliers must be licensed by the Minister of Health, Labour and Welfare (Article 17 and 30). Article 32 also stipulates that cord blood suppliers must comply with the relevant standards specified by the Ministry of Health, Labour and Welfare ordinances in regard to how cord blood supply services are performed. Complying with these standards is necessary to ensure the safety and quality of the cord blood used in transplantation. This quality assurance is desirable for patients, but it requires additional manpower and facilities along with strengthened checking systems and record integrity. It may be necessary to meet the needs of higher quality to ensure the safety of allo-HSCT, just as the hemovigilance system is employed with blood transfusion (4). Government officials will likely focus most of their attention on regulation. However, allo-HSCT cannot be improved without
research, and excessive regulation impedes medical development. Article 14 stipulates that the national government shall take necessary measures to encourage research and development that will contribute to promoting the appropriate provision of hematopoietic stem cells for use in transplantations, as well as the dissemination of the results of that research and development. Bone marrow, peripheral blood stem cell and cord blood suppliers should actively provide unrelated sources for researchers despite the regulations of the act. Government regulators should handle the authority of managing allo-HSCT. Under the government surveillance system, accidents due to systematic flaws can be prevented in advance. Also, these officials can take a comprehensive, panoramic view of allo-HSCT, which may have benefits such as the centralization of information management. However, highly specialized, constantly advancing field of allo-HSCT requires administrative officials to possess specialist knowledge and capabilities. A complete understanding of allo-HSCT is difficult to obtain without adequate practical experience. Therefore, the government must encourage expert input or risk enacting rules that are out of touch with clinical practice. Since the act may directly affect the clinical practice of allo-HSCT, clinicians should understand its possible effects. A good thing for patients is that safe stem cell sources that meet the national standards can be provided for allo-HSCT all over Japan. On the other hand, tight control of sources, donors and patients, such as paper management, will be required in performing allo-HSCT. The pros and cons of the legislation are summarized in Table 2. The act may have both positive and negative impacts, but its benefits will be maximized if all parties play their own roles appropriately while understanding the act’s limitations. The views expressed are those of the author and do not necessarily reflect the policy of the Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare.
© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected]
311
Downloaded from http://jjco.oxfordjournals.org/ at North Dakota State University on June 9, 2015
*For reprints and all correspondence: Satoshi Nishiwaki, Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki Chiyoda-ku Tokyo, 100-8916, Japan. E-mail: [email protected]
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Letter
Table 1. Summary of the act for appropriate provision of hematopoietic stem cells to be used in transplantation
HSC, hematopoietic stem cell; HSCT, hematopoietic stem cell transplantation; BM, bone marrow; PBSCs, peripheral blood stem cells; CB, cord blood.
Table 2. Pros and cons of legislation on allo-HSCT Pros • Infrastructure for allo-HSCT is improved and maintained • Agencies gain financial security • Safety and quality of sources are ensured • Accidents due to systematic flaws can be prevented in advance • Regulatory officials can take a comprehensive view of allo-HSCT
Cons • Rationalization of operations is required (activity must be justified from a cost perspective) • Additional manpower and facilities are required for quality assurance • Higher quality may be required • Cooperation with researchers may be hampered due to narrow interpretation of the act • Regulatory officials may lack specialist knowledge of allo-HSCT
Conflict of interest statement The authors have no commercial, proprietary, or financial interest in the products or companies described in this article.
References 1. The Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantations. 2012 http://www.jshct.com/english/pdf/act_en.pdf.
2. Weinberg PD, Hounshell J, Sherman LA, et al. Legal, financial, and public health consequences of HIV contamination of blood and blood products in the 1980s and 1990s. Ann Intern Med 2002;136:312–9. 3. The Cost of Blood Consensus Conference. The cost of blood: multidisciplinary consensus conference for a standard methodology. Transfusion Med Rev 2005;19:66–78. 4. René R, De Vries P, Faber J-C. Hemovigilance: an effective tool for improving transfusion safety. Wiley 2012. doi: 10.1002/9781118338179.
Downloaded from http://jjco.oxfordjournals.org/ at North Dakota State University on June 9, 2015
1. Basic principles (Article 3) 1. Effort shall be made to promote the provision of HSCs for use in transplantation. 2. HSCs used in transplantation shall be provided voluntarily. 3. Opportunities to receive HSCT shall be granted fairly. 4. The safety of HSCs used in transplantation shall be ensured. 5. The health of people who provide BM or PBSCs shall be protected. 6. The quality of CB used in transplantation shall be ensured. 2. Responsibilities (Article 4–Article 8) 1. The national government shall formulate and implement measures and policies to promote the proper provision of HSCs used in transplantation. 2. BM banks and CB banks shall contribute to promoting the appropriate provision of HSCs for use in transplantation. 3. Healthcare professionals shall provide information necessary for the efforts to monitor and analyze the health status of donors and patients. 3. Basic policy (Article 9) The Minister of Health, Labour and Welfare shall establish the basic policy to promote the appropriate provision of HSCs for transplantation. 4. Measures to promote the proper provision of HSCs used in transplantation (Article 10–Article 16) 1. National and local government authorities shall promote better public understanding. 2. The national government shall provide information on the provision of HSCs in an integrated manner. 3. The national government shall take necessary measures to support efforts to monitor and analyze the health status of donors and patients. 4. The national government shall take necessary financial and other measures to ensure the stable operation of HSC related businesses. 5. The national government shall promote research that will contribute to promoting the appropriate provision of HSCs for use in transplantation. 6. The national government shall promote international cooperation for the provision of HSCs used in transplantation. 7. The national government shall develop healthcare delivery systems related to the collection of BM and PBSCs. 5. Intermediaries in the provision of BM and PBSCs (BM banks) (Article 17–Article 29) 1. A licensing system shall be made for BM banks. 2. Licensed BM banks shall not conduct the business for the purpose of profit. 3. Measures must be adopted to ensure the safety of BM and PBSCs and to protect the health of donors. 4. Appropriate explanations shall be given to people who are considering donations, and their consent obtained. 5. The national government may provide partial subsidies for the expenses necessary for BM banks in the provision of BM and PBSCs. 6. Umbilical cord blood supply business (CB bank) (Article 30–Article 43) 1. A licensing system shall be made for CB banks. 2. Licensed CB banks shall not conduct the business for the purpose of profit. 3. CB banks shall meet the standards specified in Ministry of Health, Labour and Welfare ordinances for matters necessary to ensure safety of CB. 4. Appropriate explanations shall be given to people who are considering donations, and their consent obtained. 5. CB may be used by the CB bank or provided to others for research. 6. The national government may provide partial subsidies for the expenses necessary for CB supply businesses. 7. Hematopoietic stem cell provision support organization (Article 44–Article 52) 1. The support organization shall: 1) resister donors for BM and PBSCs and cooperate with other service providers, 2) liaise and coordinate among entities involved in HSC provision, 3) provide unified management and supply of information related to HSCs used in transplantation and 4) disseminate information and raise awareness of providing HSCs for use in transplantation. 2. The national government may provide partial subsidies for the expenses necessary for the support organization.
