The Law Concerning Regulation Related to Human Cloning Techniques and Other Similar Techniques Table of Contents Article 1. Purpose of the Law Article 2. Definitions Article 3. Prohibited Acts Article 4. Guidelines Article 5. Duty of Compliance Article 6. Notification of Production, Assignment or Import of a Specified Embryo Article 7. Order for a Plan to be Altered or Changed Article 8．Limitation on Execution Article 9．Notification of Production of Specified Embryos by Contingent Causes Article 10. Record Article 11．Notification of assignment of Specified Embryos to others, and the like Article 12．Order for measures to be taken in relation to method of handling Specified Embryos Article 13．Protection of Private Information Article 14．Asking for Reports Article 15．Access and Inspection Article 16．Penalties Article 17. Article 18. Article 19. Article 20. SUPPLEMENTARY PROVISIONS Article 1. Enforcement Date Article 2. Study and Examination　 Article 3．Transitional Measures Article 4．Amendment to a Part of the Law for Punishing Collective Crimes and for Regulation Relating to Gain from Crimes Article 1. Purpose of the Law 　　　　The cloning techniques and other similar techniques included in　 techniques for manipulating embryos or germ cells of a human or an animal　could, depending on the way they are applied, artificially create an　individual with the same genetic structure as a certain individual　(hereinafter referred to as "human clone individual") or an individual which　cannot be clearly classified as a human or an animal (hereinafter referred to　as "amphimictic individuals"), or other similar individuals. This could have　a severe influence on preservation of human dignity, safety for human life　and body, and maintenance of social order. Based upon these understandings,　the purpose of this law is to prevent and restrain creation of a human clone　individual and an amphimictic individual, and to regulate artificial creation　of individuals similar to such individuals set forth herein, by means of　 prohibiting transfer of embryos produced by the cloning techniques or the Specific Fusion/Aggregation Techniques into a human or an animal uterus,　by means of regulating production, assignment and import of such embryos,　and by means of taking other necessary measures to secure appropriate　handling of such embryos. Article 2. Definitions (1) In this Law, the terms stated in each of the following paragraphs　have the meanings defined therein: 1. Embryo A cell (except for a germ cell) or cells which has/have potential to grow into an individual through the process of development in utero of a human or an animal and has/have not yet begun formation of a placenta. 2. Germ cell A spermatozoon (including a spermatid, and a spermatocyte whose number of chromatids is equivalent to the number of chromatids of a spermatid; hereinafter defined the same) and an unfertilized egg. 3. Unfertilized egg An unfertilized ovum and an oocyte (limited to an oocyte whose number of chromatids is equivalent to the number of chromatids of an ovum). 4. Somatic cell A cell (except for a germ cell) extracted from an individual (including a dead individual) or a fetus (including a dead fetus) belonging to the Mammalia, or a cell produced by a division of such a cell, excluding an embryo or a cell composing an embryo. 5. Embryonic cell A cell collected from an embryo, or a cell produced by a division of such a cell, excluding an embryo. 6. Human fertilized embryo An embryo produced by fertilization between a human spermatozoon and a human unfertilized egg (including each embryo which is produced successively by not less than one split of such an embryo and is not a human split embryo). 7. Fetus Cells lying in utero of a human or an animal which have potential to grow to be an individual through the process of development in utero and have begun formation of a placenta, including a placenta or other attachment. 8. Human split embryo An embryo produced by a split of a human fertilized embryo or a human embryonic clone embryo outside a human uterus. 9. Human embryonic clone embryo An embryo produced by fusion between a human enucleated egg and a human fertilized embryo or a human split embryo at the one-cell stage, or an embryonic cell with a cell nucleus of a human fertilized embryo, a human split embryo or a human-human chimeric embryo. 10. Human somatic clone embryo An embryo produced by fusion between a human somatic cell with a cell nucleus and a human enucleated egg (including each embryo produced successively by not less than one split of such an embryo). 11. Cloning techniques The techniques to produce a human somatic clone embryo. 12. Human-human chimeric embryo An embryo specified in any of the following (including each embryo produced successively by not less than one split of such an embryo): a. An embryo produced by unification as a result of aggregation of not less than two embryos belonging to a human fertilized embryo, a human split embryo, a human embryonic clone embryo or a human somatic clone embryo (including an embryo produced by unification as a result of aggregation of such an embryo and a human somatic cell, or an embryonic cell of a human fertilized embryo, a human split embryo, a human embryonic clone embryo or a human somatic clone embryo). b. An embryo produced by unification as a result of aggregation of a human fertilized embryo, a human split embryo, a human embryonic clone embryo, or a human somatic clone embryo and a human somatic cell or an embryonic cell of a human fertilized embryo, a human split embryo, a human embryonic clone embryo or a human somatic clone embryo. 13. Human-animal amphimictic embryo An embryo specified in any of the following (including each embryo produced successively by not less than one split of such an embryo): a. An embryo produced by having a human germ cell and an animal germ cell fertilize with each other. b. An embryo produced by fusion between a human or an animal enucleated egg and an embryo specified in (a) or an embryonic cell with a cell nucleus of an embryo specified in (a). 14. Human-animal hybrid embryo An embryo specified in any of the following (including each embryo produced successively by not less than one split of such an embryo): a. An embryo produced by fusion between an animal enucleated egg and a human somatic cell or an embryo at the one-cell stage belonging to a human fertilized embryo, a human split embryo, a human embryonic clone embryo or a human somatic clone embryo, or an embryonic cell with a cell nucleus of a human fertilized embryo, a human split embryo, a human embryonic clone embryo, a human somatic clone embryo or a human-human chimeric embryo. b. An embryo produced by fusion between a human or an animal enucleated egg and an embryo at the one-cell stage specified in (a) or an embryonic cell with a cell nucleus of an embryo specified in (a). 15. Human-animal chimeric embryo An embryo specified in any of the following (including each embryo produced successively by not less than one split of such an embryo, but excluding an embryo which belongs to a human-human chimeric embryo, an animal embryo or an animal-human chimeric embryo). a. An embryo produced by unification as a result of aggregation of not less than two embryos (including an embryo produced by unification as a result of aggregation of such an embryo and a somatic or an embryonic cell). b. An embryo produced by unification as a result of aggregation of an embryo and a somatic or an embryonic cell. c. An embryo produced by fusion between an embryonic cell with a cell nucleus of an embryo specified in (a) or (b), and a human or an animal embryonic enucleated egg. 16. Specified Fusion/Aggregation Techniques Techniques to produce a human-animal amphimictic embryo, a human-animal hybrid embryo or a human-animal chimeric embryo. 17. Animal An individual which belongs to the Mammalia (except for Homo sapiens). 18. Animal embryo An embryo specified in any of the following (including each embryo produced successively by not less than one split of such an embryo): a. An embryo produced by fertilization between an animal spermatozoon and an animal unfertilized egg. b. An embryo produced by fusion between an animal enucleated egg and an animal somatic cell, an embryo at the one-cell stage specified in (a), or an embryonic cell with a cell nucleus of an embryo specified in (a). c. An embryo produced by unification as a result of aggregation of not less than two embryos specified in (a) or (b) (including an embryo produced by unification as a result of aggregation of such an embryo and an animal somatic cell or an embryonic cell of an embryo specified in (a) or (b)). d. An embryo produced by unification as a result of aggregation of an embryo specified in (a) or (b) and an animal somatic cell or an embryonic cell of an embryo specified in (a) or (b). 19. Animal-human hybrid embryo An embryo specified in any of the following (including each embryo produced successively by not less than one split of such an embryo): a. An embryo produced by fusion between a human enucleated egg and an animal embryo at the one-cell stage or an embryonic cell with a cell nucleus of an animal embryo. b. An embryo produced by fusion between an animal enucleated egg and an embryo at the one-cell stage specified in (a) or an embryonic cell with a cell nucleus of an embryo specified in (a). 20. Animal-human chimeric embryo An embryo specified in any of the following (including each embryo produced successively by not less than one split of such an embryo): a. An embryo produced by unification as a result of aggregation of not less than two animal-human hybrid embryos (including an embryo produced by unification as a result of aggregation of such an embryo and a somatic or an embryonic cell). b. An embryo produced by unification as a result of aggregation of not less than one animal-human hybrid embryo and not less than one animal embryo or a somatic or an embryonic cell. c. An embryo produced by unification as a result of aggregation of not less than one animal embryo and a human somatic cell or an embryonic cell of a human fertilized embryo, a human split embryo, a human embryonic clone embryo, a human somatic clone embryo, a humanー-human chimeric embryo, a human-animal amphimictic embryo, a human-animal hybrid embryo, a human-animal chimeric embryo or an animal-human hybrid embryo (including an embryo produced by unification as a result of aggregation of such an embryo and an animal somatic cell or an embryonic cell of an animal embryo). d. An embryo produced by fusion between a human or an animal enucleated egg and an embryonic cell of an embryo of a cell specified in (a), (b) and (c). 21. Fusion Production of a single cell through combination of more than a single cell without fertilization; including transfer of a cell nucleus of a single cell to another enucleated cell. 22. Enucleation Removal or destruction of a cell nucleus from a cell. 23. Human enucleated egg An enucleated human unfertilized egg or an embryonic enucleated embryo at the one-cell stage belonging to a human fertilized embryo or human split embryo. 24. Animal enucleated egg An enucleated animal unfertilized egg or an enucleated animal embryo at the one-cell stage. (Note: Definitions in Article 2 are effective only in this law and may differ from general or academic definitions.) (2) An embryo(s) or a cell(s) shown in (B) of the following table shall be regarded as an embryo(s) or a cell(s) shown in (C) when the provisions shown on (A) are applied. (A) (B) (C) 1 (1)-8 a human split embryo a human fertilized embryo 2 (1)-9 a human embryonic clone Embryo a human fertilized embryo 3 (1)-10 a human somatic clone embryo at the one-cell stage, or an embryonic cell of a human somatic clone embryo a human somatic cell 4 (1)-12 a&b an embryonic cell of a human-human chimeric embryo a embryonic cell of a human somatic clone embryo 5 (1)-13 b a human-animal amphimictic embryo an embryo specified in (1)-13 a 6 (1)-14 a a human-animal hybrid embryo a human somatic clone embryo 7 (1)-14 b a human-animal hybrid embryo an embryo specified in (1)-14 a 8 (1)-18 b an animal embryo an embryo specified in (1)-18 a 9 (1)-18 c&d an embryonic cell of an animal embryo an embryonic cell of a embryo specified in (1)-18 a 10 (1)-19 a an animal-human hybrid embryo an animal embryo 11 (1)-19 b an animal-human hybrid embryo an embryo specified (1)-19 a 12 (1)-20 c an embryonic cell of an animal- human himeric embryo an embryonic cell of an animal embryo 13 (1)-23 a human embryonic clone embryo or a human somatic clone embryo a human fertilized embryo 14 (1)-24 a human-animal amphimictic embryo, a human-animal hybrid embryo or an animal-human hybrid embryo an animal embryo Article 3. Prohibited Acts No person shall transfer a human somatic clone embryo, a human-animal amphimictic embryo, a human-animal hybrid embryo or a human-animal chimeric embryo into a uterus of a human or an animal. Article 4. Guidelines (1) Under the circumstances where there is apprehension that a human split embryo, a human embryonic clone embryo, a human somatic clone embryo, a human-human chimeric embryo, a human-animal amphimictic, a human-animal hybrid embryo, a human-animal chimeric embryo, an animal-human hybrid embryo or an animal-human chimeric embryo (hereinafter referred to as "a Specified Embryo") transferred into a human or an animal uterus could develop to an individual similar to a human clone individual or an amphimictic individual, or affect preservation of human dignity, safety for human life and body, and maintenance of the social order, the Minister of Education, Culture, Sports, Science and Technology (hereinafter referred to as "the Minister") shall prescribe guidelines in relation to handling of Specified Embryos (hereinafter referred to as "Guidelines" in order to secure appropriate production, assignment or import of Specified Embryos and in handling Specified Embryos after such acts (hereinafter referred to as "Handling of Specified Embryos"), taking into consideration scientific knowledge related to the clarification of the phenomenon of life. (2) The Guidelines shall contain the following items: 1. An acquirement of consent by a donor of embryos or cells necessary to produce a Specified Embryo, and other items related to the requirements for allowed production of Specified Embryos. 2. Items related to the requirements for allowed handling of Specified Embryos, in addition to the items specified in the previous section. 3. Items concerning procedures and other matters to be considered in the handling of a Specified Embryo, in addition to the items set forth in each section hereof. (3) The Minister shall consult the chief officers of the administrative organs concerned and hear the opinions of the Council for Science and Technology Policy, Cabinet Office, prior to an establishment of or possible modification to the Guidelines. (4) The Minister shall, when the Guidelines have been established or modified, announce such establishment or modification without delay. Article 5. Duty of Compliance Any Specified Embryo shall be handled in accordance with the Guidelines. Article 6. Notification of Production, Assignment or Import of a Specified Embryo (1) A person who will produce, be assigned or import a Specified Embryo shall notify the following items to the Minister pursuant to the provisions under an ordinance of the Ministry of Education, Culture, Sports, Science and Technology (hereinafter referred to as "the Government Ordinance"). 1. The full name or trade name and permanent address and, in the case of a legal entity, the full name of its representative. 2. The category of the embryo to be produced, assigned, or imported. 3. The purpose of production, assignment or import, and, in the case of production, its system or method. 4. Date of production, assignment or import. 5. The method of handling the Specified Embryo after production, assignment or import. 6. Other requirements provided under the Government Ordinance, in addition to the items set forth in each section hereof. (2) A person who has given notice under the provisions set forth herein shall, if any modification to the items related to the notice arises, notify such modification to the Minister according to the Government Ordinance. Article 7. Order for a Plan to be Altered or Changed (1) In the case that a method of handling a Specified Embryo described in the notice given under Article 6 Paragraph 1 or 2 is not deemed to comply with the Guidelines, the Minister may, within sixty days from the date of acceptance of the notice, order the person who gave the notice to alter or cancel the plan, or to take other necessary measures for the method of handling such a Specified Embryo. (2) In the case that the description of the notice given under Article 6 Paragraph 1 or 2 is deemed appropriate, the Minister may shorten the period fixed thereby. In this case, the Minister shall notify, without delay, the person who gave the notice of the shortened period. Article 8．Limitation on Execution A person who has given notice under Article 6 Paragraph 1 or 2 shall not produce, be assigned from others or import any Specified Embryo related to the notice, or modify the items related to the notice until sixty days have passed from the date of acceptance of the notice (or until the expiration date of a period advised under the provisions specified in the latter part of Article 7 Paragraph 2). Article 9．Notification of Production of Specified Embryos by Contingent Causes A person who has given notice under Article 6 Paragraph 1 shall immediately notify the Minister of the following items according to the Government Ordinance when the Specified Embryo related to the notice has produced another Specified Embryo by any contingent causes. Provided that, the same shall not apply to the case where another such Specified Embryo is discarded immediately after production. 1. The full name or trade name and permanent address, and, in the case of a legal entity, the full name of its representative. 2. The category of the produced embryo. 3. The date of the production. 4. Other requirements provided under the Government Ordinance, in addition to the items set forth in each section hereof. Article 10．Record (2) A person who has given notice under Article 6 Paragraph 1 or Article 9 shall record the following matters in connection with the Specified Embryo related to the notice under the Government Ordinance. 1. The category of the embryo which has been produced, assigned or imported. 2. Date of production, assignment or import. 3. The process of handling of the Specified Embryo after production, assignment or import. 4. Other requirements provided under the Government Ordinance in addition to the matters set forth in each section hereof. (2) A person who has given notice shall keep the records specified above according to the Government Ordinance. Article 11．Notification of assignment of Specified Embryos to others, and the like A person who has given notice under Article 6 Paragraph 1 or Article 9 shall notify the Minister of the following items without delay according to the Government Ordinance when the Specified Embryo related to the notice is assigned to others, exported, lost or discarded. 1. The full name or trade name and permanent residence or establishment, and, in the case of a legal entity, the full name of its representative. 2. The category of the embryo which has been assigned to others, exported, lost or discarded. 3. The date of the assignment, export, loss or discarding, and, in the case of loss or discarding, the state at that time. 4. Other requirements provided under the Government Ordinance, in addition to the items set forth in each section hereof. Article 12．Order for measures to be taken in relation to method of handling Specified Embryos In the case that a method of handling a Specified Embryo described in the notice given under Article 6 Paragraph 1 or Article 9 is not deemed to comply with the Guidelines, the Minister may order the person who gave notice to suspend handling the Specified Embryo, to improve the method of handling or to take other necessary measures. Article 13．Protection of Private Information A person who has given notice under Article 6 Paragraph 1 or Article 9 shall endeavor to take measures necessary to restrain and prevent leakage of any private information of a donor of embryos or cells used to produce the Specified Embryo related to the notice. Such private information means information concerning an individual including the name, date of birth and other description from which the individual may be identified (including information from which the individual may be identified by crosschecking with other information). Article 14． Asking for Reports The Minister may, to the extent necessary to enforce this Law, ask a person who has given notice under Article 6 Paragraph 1 or Article 9 for reports concerning the conditions in which the Specific Embryo was handled and other necessary items related to the notice. Article 15．Access and Inspection (1) The Minister may, to the extent necessary to enforce this Law, have a Ministry official access and enter the office or laboratory of a person who has given notice according to the provisions under Article 6 Paragraph 1 or Article 9, inspect documents and other necessary property, and ask questions of the participants. (2) Any official who accesses and entries the office or laboratory under the provisions set forth herein shall carry an identification card and show it to a participant when requested. (3) No authority under Paragraph 1 hereof shall be constructed as approved for the purpose of investigation of a criminal offense. Article 16．Penalties A person who has violated the provisions under Article 3 shall be punished with imprisonment for not more than ten years or a fine of not more than ten million yen, or with both of these penalties cumulatively. Article 17. A person who is pertinent to any of the following shall be punished with imprisonment for not more than one year or a fine of not more than one million yen. 1. A person who has not given any notice provided under Article 6 Paragraph 1, or has produced, assigned from others or imported a Specified Embryo with a false notice. 2. A person who has not given any notice provided under Article 6 Paragraph 2, or has modified the description provided therein with a false notice. 3. A person who has violated the order provided under Article 7 Paragraph 1. 4. A person who has violated the order provided under Article 12. Article 18. A person who has violated the provisions under Article 8 shall be punished with imprisonment for not more than six months or a fine of not more than five hundred thousand yen. Article 19. A person who is pertinent to any of the following shall be punished with a fine of not more than five hundred thousand yen. 1. A person who has not given any notice provided under Article 9, or has given a false notice. 2. A person who has not drafted the documents provided under Article 10 Paragraph 1, or has drafted a false document. 3. A person who has violated the provisions under Article 10 Paragraph 2. 4. A person who has not given any notice provided under Article 11, or has given a false notice. 5. A person who has not given any reports provided under Article 14, or has given a false report. 6. A person who has defied, obstructed or evaded access or an inspection, or has refused to answer or has given a false answer to the question(s) provided under Article 15 Paragraph 1. Article 20. In the case that a representative of a legal entity, or an agent, a trade employee or other employees of a legal entity or a person has/have committed an act in violation of the provisions from Article 16 to Article 19, the perpetrator shall be punished and the legal entity or the person itself shall be punished with a fine. SUPPLEMENTARY PROVISIONS Article 1. Enforcement Date This Law shall come into force in six (6) months from the date of its promulgation, provided that the following provisions shall come into force as of the date specified in each section: 1. The provisions under Article 4 Paragraph 3, and Article 3 of Supplementary Provisions: the date of the promulgation. 2. The provisions under Article 4 Paragraph 1, 2 and 4, from Article 5 to Article 15, from Article 17 to Article 19, and Article 20 (the parts concerning from Article 17 to Article 19 only): the date prescribed by Cabinet Order within the period not exceeding one year counting from the date of the promulgation. Article 2. Study and Examination The Government shall, within three years of enforcement of this Law, take necessary measures in accordance with the results of its study and examination on the provisions under this Law, on the basis of the results of the study and examination by the Council for Science and Technology Policy, Cabinet Office concerning the method of handling of a human fertilized embryo as the beginning of a human life with consideration to the circumstances in which this Law is enforced or to any change of the situation surrounding the cloning techniques and other similar techniques. Article 3．Transitional Measures In applying the provisions under Article 4 Paragraph 3, the term "the Minister of Education, Culture, Sports, Science and Technology" shall be replaced by "the Prime Minister", and the term "the Council for Science and Technology Policy, Cabinet Office" shall be replaced by "the Council for Science and Technology" from the date of promulgation of this Law to the previous day of the enforcement date (January 6, 2001) of the Law for the Amendment to a Part of Cabinet Law (Law No.88, 1999). Article 4．Amendment to a Part of the Law for Punishing Collective Crimes and for Regulation Relating to Gain from Crimes A part of the Law for Punishing Collective Crimes and for Regulation Relating to Gain form Crimes (Law No. 136, 1999) shall be amended as follows: The following item shall be added to the Exhibit: 61. The Law Concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques (Law No. 146, 2000) Article 16: (Crimes of transfer of a human somatic clone embryo and other specified embryos into a human or an animal uterus) Source: Cabinet Office of the Japanese Government. The formatting, indexing and hyperlinking of the text are copyrights of the Jouhou Koukai Services LLC Worldwide Copyright (c) 2001-2003 by JKS LLC Reproduction in whole or part without permission is forbidden. www.jouhoukoukai.com Law on Human Cloning and Other Similar Techniques Japan Legislation Series Copyright (c) 2001-2003 by JKS LLC Page 1 of 17