Supplementary Materials for

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1 Supplementary Materials for Editing policy to fit the genome? R. M. Isasi,* E. Kleiderman, B. M. Knoppers *Corresponding author. Published 22 January 2016, Science 351, 337 (2016) DOI: /science.aad6778 This PDF file includes Table S1 References

2 Table S1. Compendium of normative and legislative documents regarding genomic technologies. Country Australia Document Title Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act (2006) Prohibition of Human Cloning for Reproduction Act (2002, last amendment 2008) Research Involving Human Embryos Act (2002, last amendment 2014) Therapeutic Goods Act (1989, last amendment 2015) National Health and Medical Research Council (2007, updated 2015), National Statement on Ethical Conduct in Research Involving Humans National Health and Medical Research Council (2004, updated 2007), Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research Belgium Act on Research on Embryos in Vitro (2003) / Loi relative à la recherche sur les embryons in vitro (2003) Brazil Biosafety Law (2005) Canada An Act Respecting Assisted Human Reproduction and Related Research [Assisted Human Reproduction Act] (2004) Tri Council Policy Statement Ethical Conduct for Research Involving Humans (1998, last amendment 2014) China Guidelines on Human Assisted Reproductive Technologies (2003) (available only in Chinese) China Food and Drug Administration (CFDA) (2003), The principle of research on human genetic therapy and quality control of formulation China s Ministry of Science and Technology, and Ministry of Health (2004), Guidelines for Research on Human Embryonic Stem Cells [Ethical Guiding Principles on Human Embryonic Stem Cell Research] Expert Committee of the Stem Cell Research of the China National Health and Family Planning Commission and the China Food and Drug Administration, Draft Document on Administrative Management on Clinical Research of Stem Cells (for public comments) available only in Chinese Ministry of Science and Technology of the People's Republic of China; of China (2003), Human stem cell embryo research ethics China available only in Chinese

3 of China; China Food and drug Administration (CFDA) (2013) Measures for stem cell clinical trial (for Trial Implementation) Measures for Lab Facility for stem cell clinical trial (for Trial Implementation) Principle of Quality Control for Stem Cell Formulation and Preclinical Study (for Trial Implementation) of China (2015), Measures for stem cell clinical application (for Trial Implementation) of China (1993), Quality control principle of clinical research on human somatic cell therapy and gene therapy available only in Chinese France Germany Bioethics Law / Loi n du 6 août 2004 relative à la bioéthique (2004, last amendment 2009) Code civil (1804, last amendment 2015) Loi n du 7 juillet 2011 relative à la bioéthique (2011) Loi n du 29 juillet 1994 relative au don et à l'utilisation des éléments et produits du corps humain, à l'assistance médicale à la procréation et au diagnostic prénatal (1994, last amendment 2000) Basic Law for the Federal Republic of Germany (1949, last amendment 2010) Embryo Protection Act (1990, last amendment 2012) Medicinal Products Act (The Drug Law) (1976, last amendment 2014) Stem Cell Act (2002, last amendment 2008) Bundesministerium für Bildung und Forschung (2011), Second Guideline Paper of the Federal Government for the Forthcoming Framework Programme for Research and Innovation Thematic Positions German Doctor s association Bundesärztekammer (BÄK) (2006), Forschungsklonen mit dem Ziel therapeutischer Anwendungen available only in German German Doctor s association Bundesärztekammer (BÄK) (2003), Stellungnahme der Zentralen Ethikkommission zur Stammzellforschung available only in German German National Ethics Council (Geschäftsselle des Nationalen Ethikrates) (2014), Stem cell research new challenges for the ban on cloning and treatment of artificially created germ cells? Ad hoc Recommendation German National Ethics Council (Geschäftsselle des Nationalen Ethikrates) (2004), Cloning for reproductive purposes and cloning for the

4 purposes of biomedical research, Opinion German Research Foundation (Deutsche Forschungsgemeinschaft) (2006), Stem Cell Research in Germany Possibilities and Perspectives available only in German German Research Foundation (Deutsche Forschungsgemeinschaft) (2003), Research with Human Embryonic Stem Cells, Positions German Research Foundation (Deutsche Forschungsgemeinschaft) (2001), Research Involving Human Stem Cells available only in German Interdisciplinary Research Group Gene Technology Report & Berlin Bradenburg Academy of Sciences and Humanities (2012), Gene Therapy in Germany. An Interdisciplinary Survey Supplement of the Interdisciplinary Research Group Gene Technology Report Summary Interdisciplinary Study Group Gene Technology Report & Berlin Bradenburg Academy of Science and Humanities (2008), Gene Therapy in Germany. An Interdisciplinary Survey Supplement of the German Gene Technology Report Summary Précis: Summary and Recommendations by the DFG on Stem Cell Research in Germany Possibilities and Perspectives (2006) available only in German India Israel Japan The Pre Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act (1994, last amendment 2003) Indian Council of Medical Research (2013), National Guidelines for Stem Cell Research Indian Council of Medical Research (2000, last amendment 2006), Ethical Guidelines for Biomedical Research on Human Participants Prohibition of Genetic Intervention (Human Cloning and Genetic Manipulation of Reproductive Cells) Law (1999, valid until May 23, 2016) Bioethics Advisory Committee of the Israel Academy of Sciences and Humanities (2001), Report of the Bioethics Advisory Committee of the Israel Academy of Sciences and Humanities: The Use of Embryonic Stem Cells for Therapeutic Research Act on Regulation of Human Cloning Techniques (Act No. 146 of 2000, last amendment 2014) Guidelines of Clinical Research Regarding Gene Therapy (2002, last amendment 2008) PFSB Director Notice 0907 No. 1 (2012) Japan Society of Human Genetics (2004), Guidelines for Genetic Testing Ministerial Notification of MEXT and MHLW (2004), Guideline for Gene Therapy Clinical Research available only in Japanese

5 Ministerial Notification of MHLW (2006), Guideline for Human Stem Cell Therapy Clinical Research available only in Japanese Mexico General Health Law (1984, last amendment 2015) [Penal Code of the Federal District of Mexico (Mexico DF)] Código Penal Distrito Federal de México (2002, last amendment 2014) [Regulation to the General Health Law on Sanitary Controls and Disposition of Human Organs, Tissues and Cadavers] Reglamento de la Ley General de Salud en Materia de Control Sanitario de la Disposición de Organos, Tejidos y Cadáveres de Seres Humanos (1985, last amendment 2014) [Regulation to the General Health Law on Health Research] Reglamento de la Ley General de Salud en Materia de Investigacion para la Salud (1987, last amendment 2014) The Netherlands Singapore Act Containing Rules Relating to the Use of Gametes and Embryos [The Embryos Act] (2002, last amendment 2009) 2013 amendment available only in Dutch Human Cloning and Other Prohibited Practices Act (2004, last amendment 2005) Bioethics Advisory Committee of Singapore (2015), Ethics Guidelines for Human Biomedical Research South Korea Bioethics and Safety Act (2013) United Kingdom Human Fertilisation and Embryology Act (1990, last amendment 2008) Human Fertilisation and Embryology (Mitochondrial Donation) Regulations (2015) Human Fertilisation and Embryology (Research Purposes) Regulations (2001) Medical Research Council (2010, last amendment 2015), HFEA Code of Practice for the Use of Human Stem Cell Lines United States Omnibus Appropriations Act (2009) [Dickey Wicker Amendment, 1996] Human Embryonic Stem Cell Research Advisory Committee (2010), Final Report of the National Academies Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies Guidelines for Human Embryonic Stem Cell Research; National Academies of Science National Institutes of Health (2015), Statement on NIH funding of research using gene editing technologies in human embryos National Institutes of Health (2013), Guidelines for Research Involving

6 Recombinant or Synthetic Nucleic Acid Molecules National Institutes of Health (2009), Guidelines for Research Using Human Stem Cells White House Office of Science and Technology Policy (2015), A Note on Genome Editing

7 REFERENCES AND NOTES 1. J. S. LaFountaine, K. Fathe, H. D. Smyth, Int. J. Pharm. 494, 180 (2015). 2. J. A. Doudna, E. Charpentier, Science 346, (2014). 3. D. Cressey, A. Abott, H. Ledford, Nature (2015) /nature Regulation No. 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. (2014). 5. Australia, Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act, Act no. 172 (2006). 6. Australia, Prohibition of Human Cloning for Reproduction Act 2002 (last amended by Act no. 144) (2008). 7. R. M. Isasi, B. M. Knoppers, Hum. Reprod. 21, 2474 (2006). 8. R. M. Isasi, B. M. Knoppers, Eur. J. Health Law 13, 9 (2006). 9. Israel, Prohibition of Genetic Intervention (Human Cloning and Genetic Manipulation of Reproductive Cells) Law (1999) (last renewed) (2009). 10. United Kingdom, Human Fertilisation Act (1990) (last amended) (2008). 11. Belgium, Act on Research on Embryos in Vitro Loi du 11 Mai Relative a la Recherché sur les Embryons in Vitro (2003). 12. France, Bioethics Law/Loi No du 6 août 2004 relative à la bioéthique (last amended) (2009) 13. France, Code Civil (1804) re the Bioethics Law (last amended) (2015). 14. D. Baltimore et al., Science 348, 36 (2015). 15. E. Lanphier, F. Urnov, S. E. Haecker, M. Werner, J. Smolenski, Nature 519, 410 (2015). 16. Organizing Committee for the International Summit on Human Gene Editing, International Summit Statement (December, 2015); A. L. Caplan, B. Parent, M. Shen, C. Plunkett, EMBO Rep. 16, 1421 (2015). 18. J. Sugarman, EMBO Rep. 16, 879 (2015). 19. B. M. Knoppers, R. M. Isasi, Hum. Reprod. 19, 2695 (2004). 20. Penal Code of the Federal District of Mexico (Mexico DF) (2002) (last amended) (2014). 21. Bioethics Advisory Committee of Singapore, Ethics Guidelines for Human Biomedical Research, (Singapore, 2015). 22. B. M. Knoppers, S. Bordet, R. M. Isasi, Annu. Rev. Genomics Hum. Genet. 7, 201 (2006). 23. The Hinxton Group, Statement on Genome Editing Technologies and Human Germline Modification (2015);