This is the companion website for Boggio A./Romano C./Almqvist J. (eds.), Human Germline Genome Modification and the Right to Science: A Comparative Study of National Laws and Policies, Cambridge University Press, 2019 (ISBN: 9781108499873).
You can find here the legal instruments referred to in the various chapters of the book. The instruments have been made available by the authors of the various chapters and they are solely responsible for the accuracy of the documents provided. Whenever possible, they provided an English version of the relevant instrument.
Ch. 2 (Cesare Romano, Andrea Boggio, Jessica Almqvist) The Governance of Human (Germline) Genome Modification at the International and Transnational Level
- International Covenant on Economic, Social and Cultural Rights
- Optional Protocol to the International Covenant on Economic, Social and Cultural Rights
- UN, ECOSOC, Human Rights Commission – Human rights and the human genome (2005)
- UNESCO Universal Declaration on the Human Genome and Human Rights (1997)
- UNESCO International Declaration on Human Genetic Data (2003)
- UNESCO International Declaration on Bioethics and Human Rights (2005)
- UNESCO Recommendation on Science and Scientific Researchers (2017)
Ch. 3 (Erika Kleiderman) Canada
- Constitution Act of 1867, Sections 91 and 92
- Assisted Human Reproduction Act 2004 (current to May 9, 2018)
- Act respecting clinical and research activities related to procreation 2010 (updated to 1 March 2018)
- Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (2014)
Ch. 4 (Kerry Macintosh) United States of America
- S. Constitution
- Consolidated Appropriations Act, 2018, with Dickey-Wicker Amendment
- Animal Welfare Act
- Federal Food, Drug, And Cosmetic Act
- Public Health Service Act, Licensing of Biological Products and Clinical Laboratories
- FDA, Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, Guidance for Industry #187
- FDA, Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA (Proposed Revised Guidance for Industry)
- FDA, Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products, 1993
- NIH, Guidelines For Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2016)
- NIH, Guidelines For Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Proposed Revisions)
- The Common Rule and related regulations
- UD DHHS, PHS Policy on Humane Care and Use of Laboratory Animals
Ch. 5 (María de Jesús Medina Arellano) Mexico
- Political Constitution of the Mexican United States, (Constitución Política de los Estados Unidos Mexicanos) (1917, last amended August 2018).
- General Health Law (Ley General de Salud) (1982, last amended July 2018).
- Regulation on the Sanitary Disposal of Human Organs, Tissues and Corpses ‘Tissue Regulation’, (Reglamento en Materia de Control Sanitario de la Disposición de Órganos, Tejidos y Cadáveres de Seres Humanos) (1985)
- 1987 Regulation on Health Research (Spanish)
- Law on Biosafety of Genetically Modified Organisms (Spanish)
Ch. 6 (Jessica Almqvist, Cesare Romano) Europe (EU and Council of Europe)
Council of Europe
- Convention on Human Rights and Biomedicine (Oviedo Convention)
- Convention on Human Rights and Biomedicine (Oviedo Convention) – Explanatory Report
- Steering Committee on Bioethics (CDBI) – Convention on Human Rights and Biomedicine, Preparatory work of the Oviedo Convention
- CDBI – Preparatory work of the Oviedo Convention, Addendum 1.pdf
- CDBI – Preparatory work of the Oviedo Convention, Addendum 2.pdf
- CoE, Parliamentary Assembly, Recommendation 2115 (2017) on the use of new genetic technologies on human beings
- CoE, Parliamentary Assembly, Pre-Assembly Report, The use of new genetic technologies in human beings (2017)
- CoE, Parliamentary Assembly, Motion for Assembly – Genetically engineered human beings (2017)
European Union
- Directive 2001-20-EC regarding good clinical practice in the conduct of clinical trials on medicinal products of human use
- Directive 2001-83-EC on the Community Code Relating to Medicinal Products for Human Use
- Regulation 1394-2007 on advanced therapy medicinal products, amending Directive 2001-83
- ECDirective 2004-23-EC on standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
- Directive 2006-17-EC regarding certain technical requirements for the donation, procurement and testing of human tissues and cells
- Directive 2006-86-EC regarding the coding, processing, preservation, storage and distribution of human cells
- Directive 2010-63-EU on the protection of animals used for scientific purposes
Ch. 7 (James Lawford Davies) United Kingdom of Great Britain and Northern Ireland
- Human Fertilisation and Embryology Act 1990.
- Human Fertilisation and Embryology Act 2008.
- The Human Fertilisation and Embryology (Research Purposes) Regulations 2001, No. 188.
- Human Fertilisation and Embryology Authority, Code of Practice (8th edition, October 2017)
- The Human Fertilisation and Embryology (Special Exemptions) Regulations 1991, No. 1588.
- Animals (Scientific Procedures) Act 1986.
- Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012, No.3039.
- The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015
Ch. 8 (Timo Faltus) Germany
- Basic Law for the Federal Republic of Germany (Arts. 1, 2 and 103)
- German Criminal Code (excerpts)
- Gesetz zum Schutz von Embryonen (ESchG) – Law for the Protection of Embryos (1990 with updates through 2011)
- Law for the protection of Embryos (English translation)
Ch. 9 (Guido Pennings) Belgium
- Belgian Constitution (updated to constitutional revisions of 6 January 2014)
- Loi relative à la procréation médicalement assistée et à la destination des embryons surnuméraires et des gamètes (6 July 2007)
- Loi relative à la recherche sur les embryons in vitro (11 May 2003)
Ch. 10 (Heidi C. Howard and Santa Slokenberga) Sweden
- Instrument of Government (SFS nr: 1974:152) / Kungörelse om beslutad ny regeringsform (1974:152).
- Swedish Church Act (SFS nr: 1998:1591) / Lag om Svenska kyrkan (1998:1591).
- Law on the European Convention for the Protection of Human Rights and Fundamental Freedoms (SFS 1994:1219) / Lag om den europeiska konventionen angående skydd för de mänskliga rättigheterna och de grundläggande friheterna (1994:1219).
- Genetic Integrity Act (SFS 2006:351) / Lag om genetisk integritet m.m. (2006:351) (Note that the act has been amended in 2019 but the changes do no relate to the content of the chapter in the book).
- The Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460) / Lag om etikprövning av forskning som avser människor (2003:460).
- Law with supplementary provisions to the EU Data Protection Regulation (SFS 2018:218) / Lag med kompletterande bestämmelser till EU:s dataskyddsförordning (2018:218).
- Publicity and Privacy Act (SFS 2009:400) / Offentlighets- och sekretesslag (2009:400) (Note that the act has been amended in 2019 but the changes do no relate to the content of the chapter in the book).
- Law on biobanks in health care, etc., (SFS 2002:297) / Lag om biobanker i hälso- och sjukvården m.m. (2002:297) (Note that the act has been amended in 2019 but the changes do no relate to the content of the chapter in the book).
- The Animal Welfare Act (SFS 1988:534) / Djurskyddslag (1988:534) (The analysis of research on animals in Sweden in the book is based on this act. From 1 April 2019 a new act applies. The new act is mentioned in the chapter).
- The Animal Welfare Act (SFS 2018:1192) / Djurskyddslag (2018:1192) (It entered into force on 1 April 2019. This is the new Animal Welfare Act).
- Ordinance with instruction to the National Board of Health (SFS 2015:284) / Förordning (2015:284) med instruktion för Socialstyrelsen.
- Animal Welfare Ordinance (SFS 1988:539) / Djurskyddsförordning (1988:539) (The analysis of regulations protecting animals used in research in the book was based on this ordinance. On 1 April 2019 a new ordinance replaced this ordinance (see 13 below)).
- Animal Welfare Ordinance (SFS nr: 2019:66) / Djurskyddsförordning (2019:66).
- Swedish Board of Agriculture’s regulations and general guidelines on laboratory animals (SJVFS 2017:40) / Statens jordbruksverks föreskrifter och allmänna råd om försöksdjur; (SJVFS 2017:40) (The analysis of regulations protecting animals used in research in the book was based on these guidelines. From 1 April 2019 new guidelines apply (see 15 below).
- Swedish Board of Agriculture’s regulations and general guidelines on laboratory animals (SJVFS 2019:9) / Statens jordbruksverks föreskrifter och allmänna råd om försöksdjur (SJVFS 2019:9).
Ch. 11 (Britta van BeersCharlotte de KluiverRick Maas) Netherlands
- Constitution of the Kingdom of the Netherlands (2002) (English)
- Medical Research involving Human Subjects Act (20 March 2006) (English)
- Act containing rules relating to the use (Embryos Act) (English)
- Amendments to the Embryo Act (2013) (English)
- Dutch Civil Code (excerpts) (English)
- Wet donorgegevens kunstmatige bevruchting (Artificial conception donor data Law) (Dutch)
- Wet medisch-wetenschappelijk onderzoek met mensen (Medical Research on People Act) (Dutch)
Ch. 12 (Ludovica Poli) Italy
- Italian Constitution (English).pdf
- Law 40-2004 (Italian).pdf
- Law 40-2004 (English text).pdf
- Legislative decree 26-14 on the implementation of EU directive 2010 63 on protection of animals used in research (Italian)
- Industrial Property Code (Legislative decree 30-05) (English)
- Legislative decree 211-03 on the implementation of EU directive 2001-20 on clinical experimentation (Italian)
- Legislative decree 211-03 on the implementation of EU directive 2001-20 on clinical experimentation (English Translation)
- Law 3-2018 on clinical trials of medicines (Italian)
- Law 145-2001 ratifying the Oviedo Convention (Italian)
- Law 189-2012 (Italian)
- Law 194-1978 on protection of maternity and voluntary interruption of pregnancy (Italian)
- Law 194-1978 on protection of maternity and voluntary interruption of pregnancy (English translation)
- Ministry of Health Decree of 8 February 2013 (Italian)
- Ministry of Health Decree of 1 July 2015 (Italian)
Ch. 13 (Iñigo de Miguel Beriain and Carlos María Romeo Casabona) Spain
Ch. 14 (Alessandro Blasimme, Effy Vayena and Dorothée Caminiti) France
- Regulation 536-2014
- Directive 2010-63-EU
- Regulation 1394-2007 on advanced therapy medicinal products, amending Directive 2001-83-EC
- Directive 2001-83-EC on the Community Code Relating to Medicinal Products for Human Use
- Constitution 4 October 1958
Ch. 15 (Alessandro Blasimme, Effy Vayena and Dorothée Caminiti) Switzerland
- CC 101 Federal Constitution of 18 April 1999 of the Swiss Confederation
- CC 810.11 Federal Act of 18 December 1998 on Medically Assisted Reproduction (LPMA)
- CC 810.31 Federal Act of 19 December 2003 on Research Involving Embryonic Stem Cells (LRCS)
- CC 810.12 Federal Act of 8 October 2004 on Human Genetic Testing (LAGH)
- CC 810.21 Federal Act of 8 October 2004 on the Transplantation of Organs, Tissues and Cells (Loi sur la transplantation)
- CC 810.30 Federal Act of 30 September 2011 on Research involving Human Beings (LRH)
- CC 420.1 Federal Act of 14 December 2012 on the Promotion of Research and Innovation (LERI)
- CC 812.21 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (LPTh)
- CC 814.91 Federal Act of 21 March 2003 on Non-Human Gene Technology (Gene Technology Act, GTA)
- RS 455 Loi fédérale du 16 de Décembre 2005 sur la protection des animaux (LPA)
- CC 810.112.2 Reproductive Medicine Ordinance of 4 December 2000 (OPMA)
- CC 810.311 Ordinance of 2 February 2005 on Research involving Embryonic Stem Cells (ORCS)
- RS 810.122.1 Ordonnance du 14 février 2007 sur l’analyse génétique humaine (OAGH)
- RS 810.211 Ordonnance du 16 mars 2007 sur la transplantation d’organes (Ordonnance sur la transplantation)
- CC 810.301 Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (ORH)
- CC 810.305 Ordinance of 20 September 2013 on Clinical Trials in Human Research (OClin)
- RS 810.113 Ordonnance du 4 décembre 2000 sur la Commission nationale d’éthique dans le domaine de la médecine humaine (OCNE)
- RS 420.11 Ordonnance du 29 novembre 2013 relative à la loi fédérale sur l’encouragement de la recherche (O-LERI)
- CC 814.912 Ordinance of 9 May 2012 on Handling Organisms in Contained Systems (OUC)
- RS 455.1 Ordonnance du 23 avril 2008 sur la protection des animaux (OPAn)
- RS 455.163 Ordonnance de l’OSAV du 12 avril 2010 (Ordonnance sur l’expérimentation animale)
- RS 455.61 Ordonnance du 1 septembre 2010 sur le système informatique de gestion des expériences sur animaux (O-SIGEXPA)
Ch. 16 (Tetsuya Ishii ) Japan
- Human Cloning Regulation Act (2000) (Japanese)
- 2009 MEXT Guidelines on the Handling of Specified Embryos (Japanese)
- 2009 MEXT Ordinance for Enforcement of the Act on Regulation of Human Cloning Techniques (Japanese)
Ch. 17 (Lingquiao SongRosario Isasi ) People’s Republic of China
- Decision to Ratify the Covenant on Economic. Social and Cultural Rights (CESCR) (2001, the Standing Committee of the National People’s Congress) (全国人民代表大会常务委员会关于 批准《经济、社会及文化权利国际 公约》的决定) (2001, 2, 28 )
- Administrative Measures for Gene Engineering Safety (1993, MoST) (基因工程安全管理办法) (1993)
- Interim Administrative Measures for Human Genetic Resources (1998, MoH and MoST) (人类遗传资源管理暂行规定(1998))
- Guiding Principles for Human Gene Therapy Research and Quality Control of Preparation (2003, CFDA) (人基因治疗研究和制剂质量控制技 术指导原则) (2003)
- Ethical Guiding Principles for Research on the Human Embryonic Stem Cells (2003, Former MoH and MoST) (人胚胎干细胞研究伦理指导原则) (2003)
- Management Ordinance for the Quality of Drug Clinical Trial (2003, CFDA) (药物临床试验 质量管理规范) (2003)
- Technical Norms on Human Assisted Reproduction (2003, MoH) (人类辅助生殖技术规范) (2003)
- Administrative Measures for the Clinical Application of Medical Technology (2009, MoH) (医疗技术临床应用管理办法) (2009)
- Guiding Principles for Quality Control and Preclinical Research of Stem Cell-Based Medical Products Formulation and (Trial) (for public deliberation) (CFDA, 2013) (干细胞制剂质量控制及临床前研 究指导原则（试行）) (2013)
- Ethical Review Guidelines for Biomedical Research Involving Humans (2016, HFC) (涉及人的生物医学研究伦理审查办 法)(2016)
- Administrative Safety Measures for Biotechnology Research and Development (2017, MoST) (生物技术研究开发安全管理办法) (2017).
Ch. 18 (Hannah Kim and Yann Joly) Republic of Korea (South Korea)
- Constitution of the Republic of Korea (English)
- Bioethics & Biosafety Act (2005) (English)
- Pharmaceutical Affairs Act (as amended through 2010) (English)
- Ministry of Food and Drug Safety, Guide to Drug Approval System in Korea
Ch. 19 (Calvin Ho) Singapore
Ch. 20 (Dianne Nicol ) Australia
- Research Involving Human Embryos Act 2002 (including amendments up to Act No. 61, 2016)
- Prohibition of Human Cloning for Reproduction Act 2002 (including amendments up to Act No. 93, 2017)
- Gene Technology Act 2000 (including amendments up to Act No. 33, 2016)
Ch. 21 (Vardit Ravitsky and Gali Ben-Or) Israel