Supplementary Appendix Tables SA1-SA6: Policy Documents for Six WHO Regions
Baylis, Françoise, Marcy Darnovsky, Katie Hasson, and Timothy M. Krahn. 2020. “Human Germline and Heritable Genome Editing: The Global Policy Landscape.” The CRISPR Journal 3(5). DOI: 10.1089/crispr.2020.0082
Supplementary Appendix Table SA1: Policy Documents for the African Region
Nation | Legislation | | Relevant excerpts | Germline Genome Editing research | Heritable Genome Editing research (for reproduction) |
Benin | ||||
Art 59 Law no. 2015-08 of 8 December 2015 on the Children's Code in the Republic of Benin | SECTION II MEDICAL ASSISTANCE TO PROCREATION Article 51: Regulations Medically assisted procreation is authorized in the Republic of Benin. It designates all of the methods allowing procreation when this cannot be carried out under natural conditions, namely, inter alia, in vitro conception, embryo transfer and artificial insemination, as well as all techniques of equivalent effects allowing procreation outside the natural process. Article 60: Prohibition of other methods of medically assisted procreation Any other mode of medically assisted procreation not referred to in the provisions of this law is formally prohibited in the Republic of Benin. Article 61: Prohibition of the production of embryos for commercial purposes An embryo cannot be conceived nor used for commercial or industrial purposes. Any offender is punished with the penalties referred to in article 354 of this law. | prohibited | ||
Burkina Faso | CHAPTER I: GENERAL PROVISIONS ARTICLE 2: The Ethics Committee for Health Research in Burkina Faso is a decision-making body responsible for monitoring compliance with the principles set out in the National Code of Ethics in Health Research. It is independent. |
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[DRAFT] | TITLE I: GENERAL PROVISIONS Chapter 2: Biomedical Research Section 2: Biomedical research using biological reproductive material Article 16: Biomedical research using biological reproductive material means research carried out with human gametes, embryos, fetuses and fetal tissues. It can only be done within the framework of medically assisted procreation or for therapeutic purposes and within the limits of this law. Article 20: Cloning for reproductive purposes is strictly prohibited. Cloning for therapeutic purposes is authorized within the framework of the legal provisions in force. | indeterminate † | indeterminate † | |
Burundi | Law No. 1/012 of May 30, 2018 on the Code of the Offer of Health Care and Services in Burundi | CHAPTER III: GENETIC MANIPULATION, MEDICALLY ASSISTED PROCREATION AND CLONING Article 234: Any genetic manipulation in humans can only have the purpose of diagnosis, treatment, prevention and medical research. Article 235: No genetic manipulation, no medically assisted procreation, no cloning must neither denature the human species nor contribute to a programmed selection of individuals. Article 236: Any reproductive human cloning is prohibited. A decree sets the conditions for carrying out therapeutic human cloning on the proposal of the ministers having public health and scientific research in their attributions. Article 237: On the proposal of the national bioethics committee, the minister in charge of public health sets the rules and procedures relating to genetic manipulation and assisted procreation in humans | permitted | prohibited |
Central African Republic | CHAPTER III THE EXPOSURE OF OTHERS TO A RISK OF DEATH AND ILLICIT BIOMEDICAL RESEARCH Article 254: Shall be punished with one month to three years' imprisonment and a fine of 500,000 to 5,000,000 francs: 1. The fact of carrying out or having carried out biomedical research on others without their consent; 2. Obtaining from another one of its organs or the removal of tissue, cells or products of its body against payment, whatever the form; 3. Obtaining human embryos for payment in any form. | |||
Law N ° 06.005 of June 20, 2006 Bangayassi Relating to Reproductive Health | ||||
Congo | ||||
Guidelines for the Ethical Evaluation of Research Involving Human Subjects in R. D. Congo [n. d.] | Section 4: Genetic manipulation, assisted reproduction and cloning Article 76 Any genetic manipulation in humans can only have the purpose of diagnosis, treatment, prevention and research on diseases. Article 77 No genetic manipulation, no assisted procreation, no cloning can either denature the human species or contribute to a programmed selection of individuals. Article 78 Any reproductive human cloning is prohibited. Article 79 On the proposal of the National Bioethics Committee, an order of the Minister having public health in his attributions sets the rules and procedures relating to genetic manipulation and assisted procreation in human subjects. | permitted | prohibited | |
Guinea | CHAPTER IV: ETHICAL EXAMINATION Article 303: Any health research project involving human subjects must be submitted before its execution to the appreciation of the National Committee of Ethics for Health Research (CNERS) which expresses itself in full independence. In any case, the CNERS opinion does not release the promoter or the investigator of his ethical and scientific responsibilities. | |||
Kenya | PART III __ PROHIBITED ACTIVITIES 21. A person shall undertake assisted reproductive technology only for procreation purposes. … 23. A person shall not undertake assisted reproductive technology for – (a) any purpose other than human procreation; (b) experimental purposes aimed at modifying the human race; or (c) purely speculative purposes | prohibited | ||
An Act of Parliament to regulate activities in genetically modified organisms, to establish the National Biosafety Authority, and for connected purposes. PART 1 PRELIMINARY 2. Interpretation In this Act, unless the context otherwise requires— “genetically modified organism” means any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques; | ||||
Namibia | Access to Biological and Genetic Resources and Associated Traditional Knowledge Bill Act 2 of 2017 | Definitions "biological resources" includes organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity; "genetic resources" means any material of plant, animal, microbial or other origin containing or derived from functional units of heredity and which has actual or potential value which may be found in in situ or ex situ conditions under the control of the State; Application of Act 3. This Act applies to – (a) biological and genetic resources in both in situ and ex situ conditions; (b) the derivatives of biological or genetic resources; (c) associated traditional knowledge; (d) benefits arising from the use of biological and genetic resources, their derivatives and associated traditional knowledge; and (e) the discovery or commercialization phase of bioprospecting. | ||
Nigeria | PART VI—CONTROL OF USE OF BLOOD, BLOOD PRODUCTS, TISSUE AND GAMETES IN HUMANS Prohibition of reproductive, therapeutic cloning of human kind. 50.—(1) A person shall not— (a) manipulate any genetic material, including genetic material of human gametes, zygotes or embryos ; or (b) engage in any activity including nuclear transfer or embryo splitting for the purpose of the cloning of human being ; (c) import or export human zygotes or embryos. | indeterminate | indeterminate | |
Commencement of a Clinical Trial 3. … e. No gene therapy trials shall be carried out which result in modifications to the participant's germ line genetic identity. | prohibited | |||
21. NEW FRONTIERS OF KNOWLEDGE AND PRACTICE It is mandatory for registered practitioners to be aware of new frontiers in the advancement of medically related scientific knowledge and actions. In view of the potential significance of these high-tech based advances, registered practitioners are advised to be cautiously involved in such new fields as cloning, genetic engineering, genomics etc. Certainly, specific guidelines on such and similar terrain of knowledge and practice will have to be made available in due course by the Council.
23. ASSISTED CONCEPTION AND RELATED PRACTICES High-technology based human reproductive processes are now being employed by registered practitioners in Nigeria. These techniques embrace wide professional practices that include in-vitro fertilization, sperm donor and egg donor techniques, embryo donation, gestational surrogacy, full surrogacy and other emerging procedures. Whilst the necessary statutes to govern these desirable practices in the society are yet to be enshrined, ethical considerations show the essence for care and attention to the several needs of donor, recipient, and offspring at every step in these practices. Whilst the Council is devoting particular attention to necessary and continuous development of the ethical guidelines in assisted conception and all its professional practice implications, practitioners are expected to resolve certain matters of ethical significance that may arise. While both sperm and egg donations in in-vitro fertilization are accepted as ethically sound practices, in embryo donations, gestational surrogacy or full surrogacy, the practitioner will need to resolve ethical matters in respect of the following:
(F) Embryo donation for research There is the ethical risk of trading in embryos that are neither used to - initiate pregnancy nor discarded. Such issues as donor recruitment methods, monetary transactions, and types of researches to be applied to embryos certainly need statutory regulation. The Medical and Dental Council of Nigeria calls for appropriate legislation on the matter. | indeterminate | |||
South Africa | CHAPTER 8 CONTROL OF USE OF BLOOD, BLOOD PRODUCTS, TISSUE AND GAMETES IN HUMANS Prohibition of reproductive cloning of human beings 57.(1) A person may not— (a) manipulate any genetic material, including genetic material of human gametes, zygotes or embryos; or (b) engage in any activity, including nuclear transfer or embryo splitting, (2) The Minister may, under such conditions as may be prescribed, permit therapeutic cloning utilising adult or umbilical cord stem cells. (6) For the purpose of this section— (a) “reproductive cloning of a human being” means the manipulation of genetic material in order to achieve the reproduction of a human being and includes nuclear transfer or embryo splitting for such purpose; and (b) “therapeutic cloning” means the manipulation of genetic material from either adult, zygotic or embryonic cells in order to alter, for therapeutic purposes, the function of cells or tissues. | |||
Tanzania, United Republic of | Part XI Miscellaneous Provisions 71— (2)…the Minister shall make regulations prescribing for… (l) management and use of gene therapy | |||
Uganda | National Guidelines for Research Involving Humans as Research Subjects (2014) | |||
Zambia | Prohibition of reproductive cloning of human beings 46. (1) A person shall not — (a) manipulate any genetic material, including the genetic material of humans for the purpose of cloning a human being; or (b) engage in any activity, including nuclear transfer or embryo splitting, gametes, zygotes or embryos for the purpose of reproductive cloning of a human being. (2) A person shall not export or import human zygotes or embryos without the prior written approval of the Minister. … (4) The Minister may, in consultation with the Authority, if it is consistent with this Act and any other written law, and upon such terms and conditions as the Minister may consider necessary, by notice in the Gazette, exempt any person or category of persons from any or all of the provisions of this section. |
† Proposed or draft policy, not in effect
Supplementary Appendix Table SA2: Policy Documents for the Region of the Americas
Nation | Legislation | | Relevant excerpts | Germline Genome Editing research | Heritable Genome Editing research (for reproduction) |
Antigua and Barbuda | The Antigua and Barbuda Medical Council Code of Ethics in the Practice of Medicine [n.d.] | Human Reproductive Cloning The Antigua and Barbuda Medical Council endorses the viewpoint of the international community which declared human reproductive cloning to be ‘contrary to human dignity and not to be permitted’ in 1997 at the United Nations Educational, Scientific and Cultural Organization (UNESCO) General Conference. | ||
Policy on Research Ethics (University of the West Indies) (2010) | ||||
Argentina | Article 57. Prohibited practices Any practice aimed at producing a genetic alteration of the embryo that is transmitted to its offspring is prohibited. | prohibited | ||
Barbados | Policy on Research Ethics (University of the West Indies) (2011) | |||
Brazil | CHAPTER I PRELIMINARY AND GENERAL PROVISIONS Article 6.The following is prohibited: III - genetic engineering in a human germ cell, human zygote and human embryo; | prohibited | prohibited | |
Canada | Assisted Human Reproduction Act (S.C. 2004. c. 2 as amended 2019) | Prohibited Activities Prohibited procedures 5 (1) No person shall knowingly (f) alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants | prohibited | prohibited |
Chile | Article 1 - This law has the purpose of protecting the life of the human beings, as of their conception, their physical and psychic integrity, as well as their diversity and genetic identity in relation to the scientific biomedical investigation and its clinical applications. Article 3 - All eugenic practices are hereby prohibited, except for the genetic counseling. | prohibited | ||
Colombia | SECOND BOOK SPECIAL PART OF THE CRIMES IN PARTICULAR TITLE I CRIMES AGAINST LIFE AND PERSONAL INTEGRITY EIGHTH CHAPTER On genetic manipulation Article 132. Genetic Manipulation. Whoever manipulates human genes by altering the genotype for purposes other than treatment, diagnosis, or scientific research in the fields of biology, genetics and medicine, aimed at relieving suffering or improving the health of the person and humanity, risks imprisonment of one (1) to five (5) years. | prohibited with exceptions | prohibited with exceptions | |
Costa Rica | Executive Decree No. 24029-S Regulation on in vitro Assisted Reproduction Techniques or IVF (1995) | Article 11.- Manipulation of the genetic code of the embryo, as well as every form of experimentation on it remain absolutely prohibited. | prohibited | prohibited |
Cuba | SECTION II Aims ARTICLE 3.- Human genetic data may only be collected, processed, used and preserved for the following purposes: a) Diagnosis and medical assistance, which includes carrying out landscapes and predictive tests. b) Medical research and other forms of scientific research, including epidemiological studies, especially population genetics, as well as anthropological or archaeological studies. c) Forensic medicine and civil or criminal procedures or other legal actions. d) Any other purposes as long as they are compatible with the Universal Declaration on the Human Genome and Human Rights, and the international law relative to human rights and receive due authorization from the Ministry of Public Health. | |||
THIRD: The Health Research Ethics Committees (CEIS), for their proper performance, they will be independent of the researcher, promoter, sponsor or any other type of ethically unacceptable influence, but always in accordance with laws and regulations in force in the country. | ||||
Guyana | Medical Research Involving Human Subjects Regulations (2007) | |||
Jamaica | Policy on Research Ethics (University of the West Indies) (2010) | |||
Guidelines for the Conduct of Research on Human Subjects (revised 2002, updated 2010) |
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Mexico | Regulation of The General Health Law on Health Research (1987 as amended 2014) | SECOND TITLE On the Ethical Aspects of Research in Human Beings CHAPTER IV Research on Women of Fertile Age, Pregnant Women, during Labor, Puerperium, Lactation and Newborns; of the use of Embryos, Deceased Fetuses and Assisted Fertilization ARTICLE 55.- The investigations with embryos, deaths, fetuses, stillbirths, macerated fetal matter, cells, tissues and organs extracted from them, will be carried out in accordance with the provisions of Title Fourteen of the Law and in these Regulations. ARTICLE 56.-Research on assisted fertilization will only be admissible when it is applied to solve sterility problems that cannot be solved otherwise, respecting the couple’s moral, cultural, and social point of view, even if these differ from those of the researcher. | prohibited | |
TITLE FOURTEEN Donation, Transplants and Loss of Life CHAPTER I Common provisions Article 314 VIII Embryo, the product of conception from the moment of it, and until the end of the twelfth gestational week CHAPTER III Transplant Article 330.-Transplants of organs, tissues and cells in living human beings may be carried out when the results of the investigations carried out for this purpose have been satisfactory, represent an acceptable risk to the health and life of the donor and recipient, and as long as there are therapeutic justifications. Is prohibited: I. The transplantation of gonads or gonadal tissues, and II. The use, for any purpose, of embryonic or fetal tissues resulting from induced abortions. | ||||
Panama | DECREE: Article 8. The creation of an embryo is prohibited in the following cases: 1. With the sole purpose of obtaining stem cells or other derivatives. 2. For the transfer of cell nuclei or other components of human somatic cells. Article 9. Until the issue of assisted reproduction is regulated by the competent health authorities, the embryo cannot be destroyed for the sole purpose of using its cells. | |||
Criminal Code of the Republic of Panama (2007 as amended 2010) | Chapter II Reproduction and Genetic Manipulation Article 145. Whosoever manipulates human genes for a purpose other than the elimination or reduction of a genetic defect or serious illness and thereby alters the genotype shall be punished with imprisonment of two to six years. If the genetic modification occurred through negligence, the sanction will be a fine of 30 to 100 days [of salary]. There will be an increase of up to half of the maximum penalty for whomever uses genetic engineering to create identical human beings by cloning or other procedure for race selection. | prohibited with exceptions | prohibited with exceptions | |
Peru | TITLE I OF THE RIGHTS, DUTIES AND RESPONSIBILITIES CONCERNING INDIVIDUAL HEALTH Article 7.- ...The fertilization of human eggs for purposes other than reproduction is prohibited, as is the cloning of human beings. | |||
Trinidad and Tobago | Policy on Research Ethics (University of the West Indies) (2011) | |||
United States of America | TITLE V GENERAL PROVISIONS (TRANSFER OF FUNDS) SEC. 508. (a) None of the funds made available in this Act may be used for— (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). (b) For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 (the Human Subject Protection regulations) . . . that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes (sperm or egg) or human diploid cells. TITLE VII GENERAL PROVISIONS (including rescissions and transfers of funds) Sec. 745. None of the funds made available by this Act may be used to notify a sponsor or otherwise acknowledge receipt of a submission for an exemption for investigational use of a drug or biological product under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a)(3) of the Public Health Service Act (42 U.S.C. 262(a)(3)) in research in which a human embryo is intentionally created or modified to include a heritable genetic modification. Any such submission shall be deemed to have not been received by the Secretary, and the exemption may not go into effect. | permitted (federal funding prohibited) | prohibited | |
Uruguay | ASSISTED HUMAN REPRODUCTION TECHNIQUES REGULATION CHAPTER III ON THE DONATION OF GAMETES AND EMBRYOS Article 18. (Research with gametes and embryos).- Gametes may be used for research or scientific experimentation for the improvement of assisted reproduction techniques. In such cases, gametes cannot be fertilized in order to obtain embryos. Scientific research or experimentation with embryos generated to develop pregnancies with assisted human reproduction techniques regulated by this law is prohibited. Article 19. (Cloning and alteration of the human species). - The cloning of human beings as well as any procedure aimed at the transformation or alteration of the human species, from biological material obtained in the application of assisted human reproduction techniques authorized by law is prohibited. | prohibited | prohibited |
Supplementary Appendix Table SA3: Policy Documents for the Eastern Mediterranean
Nation | Legislation | | Relevant excerpts | Germline Genome Editing research | Heritable Genome Editing research (for reproduction) |
Bahrain | ||||
Chapter 4 Medical techniques that aid in artificial insemination and fertilization and the controls of their use Article (7) It is prohibited for the health institution, consultant, specialist, or technician to carry out the following actions: E- Obtaining embryos for the purpose of conducting studies and research. I- Using medical technologies for the purpose of donating or selling gametes or embryos. K- Conducting clinical trials except within the legal framework established for this and in accordance with the rules and regulations applicable to the Authority. | prohibited* | prohibited* | ||
Egypt | Chapter Three: Public Rights, Freedoms and Duties Article 60: Inviolability of the human body. The human body is inviolable. Any assault, defilement or mutilation thereof is a crime punishable by law. Organ trafficking is forbidden, and no medical or scientific experiment may be performed thereon without the documented free consent of the subject, according to the established principles of the medical field as regulated by law. | |||
Part Three Medical Interventions of Special Nature Second : Assisted Reproductive Operations Article 44 : The assisted reproductive operations for the wife’s ovum from the husband’s sperm inside or outside the wife’s body (laboratory reproductive techniques or intra cytoplasmic sperm injection) shall be subject to the moral guidelines which aim at preserving the human race and treating infertility, while observing the purity of lineages and the legal criteria issued by the competent quarters. Part Four Conducting Medical Research & Experiments On Human Beings First : General Provisions Article 52 : The physician shall comply with observing the implementation of all moral criteria and guidelines as well as the social and religious values laid down by the competent authority for conducting medical research on human beings. Article 53 : The physician shall be prohibited from conducting any experiments for drugs and techniques on human beings prior to being endorsed by the competent quarters. Article 60 : The researcher shall be prohibited from conducting researches and practices that involve the suspicion of mixing lineages, or participating in them in any way. He shall also be prohibited from carrying out or participating in medical research which aim at cloning the human being. |
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Iran (Islamic Republic of) | Chapter 5 Ethical guideline for research related to genetic manipulation in regenerative medicine 5.1 Ethical considerations on genetic manipulation of human embryo, fetus and cells 5.1.1 Studies on genetic manipulation of embryos and gametes can help expanding knowledge on the prevention of genetic diseases. However, until the safety of the scientific methods is ensured, it is only permitted to carry out genetic manipulation on human embryo up to 14 days in surplus or non-transferable in vitro fertilized (IVF) embryos due to infertility treatments or pre-implantation genetic diagnosis. It is not allowed to transfer this embryo to the uterus and the manipulated human embryo should only be allowed to survive for 14 days after in vitro fertilization and must be discarded after this period. 5.1.4 Genetic manipulation for the purpose of human enhancement and eugenics is prohibited. | permitted | prohibited | |
Lebanon | ||||
Law no. 240 October 2012, Amending Law No, 288 of February 22, 1994 | Chapter II Physician’s Duties to Patients Human Experiments, Transplants, Artificial Insemination and Abortion Article 30 8- The targets, conditions and procedures of research on the fetus, the ethics of research, the authorization to use the embryo cells, the use of the frozen embryos for research, or their disposal shall be determined by a decree issued by the Cabinet, upon proposal of the Minister of Public Health after consulting with the National Advisory Committee for the Ethics Health and Life Sciences. | indeterminate | indeterminate | |
[DRAFT] | The Law Regarding ART Article 8: The use of embryo for commercial or research purposes or to do genomic editing or to choose the gender of the except in scenarios where the genetic defect goes hand in hand with the gender of the infant infant is prohibited. | prohibited † | prohibited † | |
Chapter 1 Article 4: It is not allowed for research considerations related to genetics and its biologic and medical applications to take precedence over human rights, basic freedoms and human dignity for the individual or the society. As such, it is absolutely prohibited to perform any procedures or tests that violate human dignity. | ||||
Oman | Fertility Centre Standards and Regulations for Private Sector (2017) | Introduction 2. Scope All fertility services and centres in Oman HEALTH INFORMATION AND CONSENT v. The prohibited practices at the Centre, such as using the fertilized and unfertilized ova or sperm for commercial purposes, introducing genetic modifications to the features of foetuses, taking the unfertilized or fertilized ova and sperm specimens that have been prepared inside the Country abroad and bringing such specimens into the Country if they have been prepared abroad or dealing with embryo banks without permission of the supervising and control committee. | prohibited | |
Pakistan | Protocol / Guidelines for Stem Cell Research / Regulation in Pakistan [n.d.] | 3. GUIDELINES 3.14 Prohibited Research …
| prohibited | prohibited |
Qatar | IV. Other Non—Allowable Research A. The derivation of stem cells from viable human embryos. B. Research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or in Vitro Fertilized embryos created specifically for research purposes. C. Research using imported cells from sources in other countries that generate these cells as described in A or B. D. Research using human embryonic stem cells obtained by harvesting stem cells from human embryos where the embryo is destroyed. | |||
I. General guidelines for gene therapy research involving humans
| prohibited | |||
Policies, Regulations and Guidelines for Research Involving Human [n.d.] | ||||
Saudi Arabia | Chapter Eleven: Dealing with Genetic Material and its Banks Article 32 When setting up local data banks for the preservation of genetic material, establishments conducting research on such genetic material shall comply with conditions and procedures specified by the Regulations. Article (32.4) 1. In case of conducting therapeutic research on the genetic material of animals or humans, the research objective shall be limited to finding treatment for genetic defects or diseases, provided the research is conducted on somatic and stem cells only; 2. In all cases, no research may be conducted on reproductive cells for the purpose of modifying natural human characteristics; 3. Except for the provisions set forth in paragraphs 1 and 2 above, the genetic treatment research shall be subject to controls and rules applied to clinical research as well as laws and controls issued by the National Committee. | prohibited | prohibited | |
Tunisia | FIRST CHAPTER General provisions Art. 7. - It is forbidden to conceive a human embryo, or to use it for commercial, industrial or eugenic purposes. | indeterminate | prohibited | |
United Arab Emirates | Article 14 – Prohibitions Concerning the Usage of the Oocytes and Sperms 1- The Centres shall not use the fertilised or unfertilised eggs and the frozen sperms for commercial purposes, and they shall not introduce any non-therapeutic genetic modifications thereto or transfer them to third parties, even with the consent of both spouses. | prohibited with exceptions |
* Prohibited insofar as all embryo research is prohibited
† Proposed or draft policy, not in effect
Supplementary Appendix Table SA4: Policy Documents for the European Region
Nation | Legislation | | Relevant excerpts | Germline Genome Editing research | Heritable Genome Editing research (for reproduction) |
Albania | Chapter IV – Human genome Article 13 – Interventions on the human genome An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Chapter V – Scientific research Article 18 – Research on embryos in vitro 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
| CHAPTER V TECHNIQUES OF ASSISTED MEDICAL REPRODUCTION Article 30 Assisted medical reproduction has the purpose of meeting the request of an individual or a couple to have a child. It aims at treating one or more medical instances of infertility, that make a couple not able to achieve a pregnancy in the natural way. Article 31 Assisted medical reproduction includes clinical and biological practices, which enable conception in vitro, the transfer of embryos and artificial insemination, as well as all other equivalent techniques that permit reproduction outside the natural process. Article 33 The techniques of reproduction are used only in the cases when: a) other methods of treatment of the infertility of the man or the woman are not productive or appropriate and do not guarantee the desired result; b) they prevent the transmission to the child of genetic illnesses, or other illnesses that would produce premature death, mental retardation or serious invalidity; c) they are considered as an alternative to a natural birth. CHAPTER VI ARTIFICIAL INSEMINATION Article 38 The human embryo is prohibited from being used for any other kind of commercial, industrial or experimental purpose. | prohibited* | prohibited* | |
Armenia | Article 11. Application of assisted reproductive technologies … Article 12. Legal relations related to the use of assisted reproduction technologies | |||
Austria | Section 4 Use, Examination and Treatment of Cells General provisions §9. (3) Interventions in the germ cell pathway are not permitted. In addition to the cases regulated in Section 2a [preimplantation diagnosis], this also applies to genetic examinations of viable cells before they are introduced into a woman's body. | prohibited | prohibited | |
Belarus | CHAPTER 4 RIGHTS OF THE PATIENT AT APPLICATION AUXILIARY REPRODUCTIVE TECHNOLOGIES Article 18. Restrictions on the use of germ cells, embryos The use of embryos for research purposes is prohibited. | prohibited* | prohibited* | |
Belgium | Law on Research Involving In Vitro Embryos (2003 as amended 2014) | Page 29288 Art. 5. It is forbidden: 2° to implant embryos that have been used for research unless the research was for a specific therapeutic purpose for the embryo itself or involved observational research that does not affect the integrity of the embryo; 4° to perform research or treatments of a eugenic nature, that is to say focused on the selection or amplification of non-pathological genetic characteristics of the human species; | prohibited with exceptions | |
Bosnia and Herzegovina | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Bulgaria | Chapter Four. HEALTH PROTECTION OF CERTAIN POPULATION GROUPS Section III. Assisted reproduction Art. 135. (4) Any intervention aimed at modifying the human genome may be undertaken only for preventive or therapeutic purposes and not for the purposes of introducing the modification into the genome of the progeny. | prohibited | ||
| Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Croatia | VI. STORAGE OF REPRODUCTIVE CELLS, TISSUES AND EMBRYOS Embryo protection Article 36 (3) Scientific or research work on the embryo shall be prohibited. | prohibited* | prohibited* | |
7. The Human Genome Article 7. 3. Interventions aimed at altering the human genome may only be carried out for preventive, diagnostic and therapeutic purposes, provided that such alterations are not transmitted to posterity. | prohibited | |||
Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | |||
Cyprus | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Czech Republic | ||||
Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | |||
Denmark | Does not apply in Greenland or the Faroe Islands | Chapter 2 Chapter 7 Prohibition of research and experimentation Section 27. Fertilized human eggs that have been used for scientific health research, including quality assurance research, may only be placed in a woman's womb if the fertilized egg is genetically unchanged (unmodified) and if the prior research, based on professional assessment, is believed not to have damaged the egg in its further development. Chapter 9 Entry into force, etc. Section 32. The law does not apply to the Faroe Islands and Greenland… | prohibited | |
| Oviedo Convention | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | |
Estonia | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Chapter 4 PROTECTION OF EMBRYOS CREATED IN VITRO § 33. Prohibition on transfer of embryos used for scientific research Transfer of an embryo which has been used for scientific research to a woman is prohibited. | prohibited | |||
Finland | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Chapter 1 General provisions Section 4 General restrictions on use of gametes and embryos The following may not be used in assisted fertility treatment: 1) genetically manipulated gametes and embryos, … 3) gametes and embryos which have been used in research. | prohibited | |||
Chapter 3 Research involving embryos and foetuses Section 13 Restrictions on research on embryos Embryos that have been used for research may not be implanted in a human body or be kept alive for longer than 14 days from their formation, not including any time during which they have been kept frozen. Section 15 Prohibited research Research on embryos and gametes for the purpose of developing procedures for modifying hereditary properties shall be prohibited, unless the research is for the purpose of curing or preventing a serious hereditary disease. | prohibited with exception(s) | prohibited | ||
France | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Public Health Code (2000 as amended 2016 [and consistent with proposed revisions of 2019]) | Public health code Legislative part Part 2: Sexual and Reproductive Health, Women's Rights and Child Health Protection Book I: Protection and Promotion of Maternal and Child Health Title V: Embryo and embryonic stem cell research Article L2151-5 II -Research can only be carried out on embryos conceived in vitro as part of assisted reproduction that are no longer the subject of a parental project. | prohibited | ||
Civil Code Book I: People Title I: Civil Rights Chapter II: Respect for the human body Article 16-4 No one can undermine the integrity of the human species. Any eugenic practice of organizing the selection of persons is prohibited. Any intervention aimed at bringing a child genetically identical to another living or dead person is prohibited. Without prejudice to research aimed at the prevention, diagnosis, and treatment of diseases, no transformation can be made to genetic traits in order to modify the offspring of the person. | prohibited | |||
Georgia | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
| Chapter VI. Rights in the Sphere of Generic Consultations and Gene Therapy Article 33 An intervention intended to modify a human gene shall be permissible only for diagnostic, treatment and prevention purposes, unless it is intended to modify the genome of a patient’s descendants. | prohibited | ||
Germany | §5 Artificial alteration of human germline cells (1) Anyone who artificially alters the genetic information of a human germline cell will be punished with imprisonment of up to five years or a fine. (2) Anyone who uses a human germ cell with artificially modified genetic information for fertilization will also be punished | prohibited | prohibited | |
Greece | CHAPTER 1 SPECIAL ISSUES Article 34 The protection of genetic identity 1. Medical interventions seeking to modify the human genome may only be undertaken for preventive, diagnostic, or therapeutic purposes. Under no circumstances can this modification be transferred to the genome of any descendants. 2. Genetic technology cannot be used for political or military purposes. | prohibited | ||
Law 3305/2005 Application of medically assisted reproduction (2005) | CHAPTER F – PENALTIES Article 26 Criminal penalties 1. Anyone who violates articles 1455 AK [Civil Code] and 2, paragraph 3 of the current article and does reproductive cloning, sex-selection for non-medical reasons, creation of chimeras and hybrids, modification of the genome of the human gametes and fertilized eggs, transfer of human fertilized egg into an animal or generation of human fertilized eggs outside of the human body beyond fourteen (14) days post-fertilization, is subject to imprisonment up to (15) years. | prohibited | prohibited | |
Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | |||
Hungary | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Iceland | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
[Research on embryos in connection with in vitro fertilisation treatment.]1) 1) Act No. 27/2008, Article 4. [Article 11 A health institution which has been granted a licence under paragraph 1 of Article 2 may, with the informed consent of the gamete donors, perform research, experiments and procedures on embryos which have been created by in vitro treatment, and are a part of that, or have been created in order to diagnose hereditary diseases in the embryos themselves. The same applies to research which aims to advance treatment for infertility, or to enhance understanding of the causes of congenital diseases and miscarriages.]1) 1) Act No. 27/2008, Article 4 [Article 14 It is prohibited to: a. cultivate or produce embryos solely for research purposes, …] | ||||
Ireland | [DRAFT] General Scheme of the Assisted Human Reproduction Bill (2017, pending, Last updated July 2019) | PART 7 EMBRYO AND STEM CELL RESEARCH Head 61 - Prohibition of modification of the human genome This Head provides that: (1) Where the genome of a human gamete or embryo has been modified such that the modification could be inherited by children born from that gamete or embryo or their descendants it is prohibited to place that gamete or embryo into the body of a woman in an attempt to achieve a pregnancy. Head 63 - Authorised research This Head provides that: (1) Research applications shall be made to the Regulatory Authority for authorisation on: (a) research involving embryos, or (b) research involving the derivation, collection, storage or use of— (i) embryonic stem cells or stem cell lines, or (ii) induced pluripotent stem cells or stem cell lines. (2) The Regulatory Authority may only authorise the types of research referred to in Subhead (1) where the Authority is satisfied that— (a) if the research involves embryos- (i) it will only involve supernumerary embryos that were donated for use in research in accordance with the relevant provisions in Part 3, and (ii) the proposed use of the supernumerary embryos is in accordance with the consent of the donors of those embryos. (b) the research is likely to lead to advances in— (i) knowledge, treatments or other procedures relating to assisted human reproduction, or (ii) the knowledge or treatment of serious diseases or other serious medical conditions. | permitted † | prohibited † |
Israel | Prohibited actions 3. Throughout the period during which this Law is in force, no person shall perform any of the following acts: (2) Using reproductive cells that have undergone a permanent intentional genetic modification (germ line gene therapy) in order to cause the creation of a person. | prohibited | ||
Italy | Norms regarding Medically Assisted Reproduction (2004 as amended by court decisions up to 2015) | CHAPTER VI PROTECTION MEASURES FOR EMBRYO ART. 13. (Experimentation on human embryos) 1. Experimentations on human embryos are prohibited. 2. Clinical and experimental research on human embryos is permitted provided it pursues only therapeutic and diagnostic purposes, aimed at protecting the health and development of the embryo itself, and where alternatives are not available. 3. The following are in any case prohibited: … b) any form of eugenic selection of embryos and gametes or interventions that, through selection techniques, manipulation or artificial procedures, aim at altering the genetic heritage of the embryo or the gamete, or set genetic features, with the exception of interventions for diagnostic and therapeutic purposes, as per paragraph 2 of this article; | prohibited with exceptions | prohibited with exceptions |
Latvia | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Lithuania | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Law on biomedical research ethics of the Republic of Lithuania (2000 as at 2019) | SECTION I GENERAL PROVISIONS Article 3. Subject of biomedical research 7. Biomedical research involving the modification of the human genome may only be carried out for prophylactic, diagnostic or therapeutic purposes and only when it does not seek to modify the genome of the offspring. | prohibited | ||
Luxembourg | NOTICE 24: Research on supernumerary embryos in Luxembourg (2013) | "However, no one was opposed to the idea of banning the production of human embryos solely for research purposes." (page 7) | ||
Malta | Prohibition of artificial alteration of human germ line cells. 13. (1) Subject to the provisions of sub-article (3), whosoever shall willfully alter in an artificial way the genetic information of a human germline cell shall be guilty of an offence and, on conviction, shall be [sic] liable to the punishment of a fine (multa) of not less than ten thousand euro (€10,000) and not exceeding twenty-three thousand euro (€23,000) or to imprisonment not exceeding five years or to both such fine and imprisonment. (2) Whosoever knowingly uses a human germline cell with artificially altered genetic information for fertilization shall be guilty of an offence and shall be liable to the same punishment laid down in sub-article (1). Prohibition of experimentation on human embryos. | prohibited | prohibited | |
Moldova, Republic of | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Montenegro | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Netherlands | Section 6. Prohibited acts with germ cells and embryos Article 24 It is forbidden:
…
| indeterminate | prohibited | |
North Macedonia | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Norway | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Chapter 3. Research on redundant fertilized eggs, cloning etc. § 3-1. Use of redundant fertilized eggs for research Excess fertilized eggs and cells derived from excess fertilized eggs can only be used for research when the purpose is: 1. to develop and improve methods and techniques for in vitro fertilization with a view to achieving pregnancy 2. to develop and improve methods and techniques for the genetic examination of fertilized eggs with a view to determining whether there is a serious monogenic or chromosomal inherited disease (preimplantation diagnostics) 3. to acquire new knowledge with a view to future treatment of serious illness in humans. § 3-2. Terms for the use of redundant fertilized eggs for research Research as mentioned in § 3-1 is only permitted on fertilized eggs that have become redundant after fertilization outside the body with a view to fertility treatment or preimplantation diagnostics. It is not permitted to fertilize eggs for research purposes alone. … Fertilized eggs that have been the subject of research, and gametes that have been the subject of research, must not be inserted into a woman, but must be destroyed. Research that causes genetic changes that can be inherited in humans is not allowed.
Chapter 6. Gene therapy § 6-2. Terms for gene therapy etc. Gene therapy can only be used to treat disease or to prevent disease from occurring. Gene therapy and other transmission of genetic material to human cells, fetuses and fertilized eggs that cause genetic changes that are inherited in gametes are prohibited. | permitted | prohibited | ||
Poland | Chapter 3 Handling of reproductive cells and embryos in the procedure of medically assisted procreation Art. 25. 1. It is unlawful to create human embryos for purposes other than the medically assisted procreation procedure. 2. It is unlawful to create, using medically assisted chimeric or hybrid procreation techniques, an intervention that has the purpose to create hereditary changes in the human genome that can be passed on to future generations. Chapter 12 Art. 86. Who creates, using medically assisted procreation techniques, a chimera or hybrid, or carries out an intervention that has the purpose to create heritable changes in the human genome that can be passed on to future generations, is punishable by imprisonment from 6 months to 5 years. | prohibited | ||
Portugal | SUMMARY Medically assisted procreation CHAPTER 1 General Provisions Article 7. Prohibited purposes 2. - MAP [medically assisted reproduction] techniques cannot be used to improve certain non-medical characteristics of the unborn child, namely the choice of sex. Article 9. Research using embryos 1. - The creation of embryos through MAP with the deliberate purpose of their use in scientific research is prohibited. | indeterminate | ||
| Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Romania | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Russian Federation | Thus, it should be noted that any clinical use of editing technologies of the genome of human embryos and germ cells is premature and there is a need for a comprehensive study and evaluation of this issue in all its aspects. The existing legal regulation in the field of healthcare does not allow the use of such technologies in the provision of medical care, ensuring the safety of the methods used. At the same time, the Ministry of Health of Russia is carrying out relevant work to comprehensively resolve issues of editing the human genome, including in the framework of the formation of a global consensus position on this issue. | prohibited | ||
Appendix No. 1 Procedure for the use of assisted reproductive technologies, contraindications and restrictions on their use I. General Provisions 2. Assisted reproductive technologies are methods of treating infertility, in which some or all stages of conception and early development of embryos are carried out outside the mother's body (including using donor and (or) cryopreserved germ cells, tissues of reproductive organs and embryos, and also surrogacy) *(1). III The procedures for using ART. The basic program of ART (in vitro fertilization) 20. Indications for the basic program of in vitro fertilization (hereinafter referred to as IVF) are: 22. Restrictions on the use of IVF program are: a) a decrease in the ovarian reserve … b) conditions in which treatment using the basic UIVF program is ineffective and the use of donor and (or) cryopreserved germ cells and embryos, as well as surrogacy is indicated; c) hereditary sex-related diseases in women (hemophilia, Duchenne muscular dystrophy, ichthyosis associated with the X chromosome, Charcot-Marie neural amyotrophy and others) (according to the conclusion of the geneticist, it is possible to conduct a basic IVF program using their own oocytes with mandatory preimplantation genetic diagnosis). 24. The implementation of the basic IVF program consists of the following stages: a) stimulation of superovulation ...; b) follicular puncture ... to obtain eggs ...; c) insemination of oocytes ...; d) cultivation of embryos; e) intrauterine administration (transfer) of embryos ... * (1) - Part 1 of Article 55 of the Federal Law of November 21, 2011 No. 323-ФЗ "On the Basics of Protecting the Health of Citizens in the Russian Federation". | prohibited | |||
| Article 55. The use of assisted reproductive technologies 1. Assisted reproductive technologies are methods of infertility treatment, in which some or all stages of conception and early development of embryos are carried out outside the mother's body (including using donor and (or) cryopreserved germ cells, tissues of reproductive organs and embryos, as well as surrogacy). 2. The procedure for using assisted reproductive technologies, contraindications and restrictions on their use are approved by the authorized federal executive body. … 4. When using assisted reproductive technologies, the choice of the sex of the unborn child is not allowed, with the exception of cases of the possibility of inheritance of diseases associated with sex. 5. Citizens have the right to cryopreservation and storage of their sex cells, tissues of the reproductive organs and embryos at the expense of personal funds and other means provided for by the legislation of the Russian Federation. 6. Sex cells, reproductive organs and human embryos cannot be used for industrial purposes. | |||
| Federal Law No. 86- ФЗ On state regulation in the field of genetic engineering (1996 as amended in 2000 by Federal Law No. 96- ФЗ and as amended in 2016) | ARTICLE 1. SCOPE OF THIS FEDERAL LAW ARTICLE 2. BASIC CONCEPTS The main concepts used in this Federal Law: gene therapy (gene therapy) - a combination of genetic engineering (biotechnological) and medical methods aimed at making changes to the genetic apparatus of human somatic cells for the treatment of diseases; | ||
San Marino | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Serbia | IV PROHIBITED ACTIVITIES IN BMPO [biomedically assisted fertilization] ACTIVITIES Prohibited activities in BMPO activities Article 49 In the BMPO procedure, it is prohibited to: 10) insert of a sequence of nucleotides into the genome of a human embryo, whether it is a sequence of nucleotides of a human species or any other being, including a synthesized nucleotide sequence | prohibited | ||
Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | |||
Slovak Republic | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Slovenia | Law on infertility treatment and fertilization procedures with biomedical assistance (2000) | VII. Management of germ cells or early embryos Article 33 With infertility treatment and biomedical fertilization it is prohibited: - to allow the production of human embryos from the germ cells by causing a change in the hereditary conception and to transfer such embryos into the human or animal body; … - to intentionally alter the hereditary design of embryonic cells. | prohibited | |
Oviedo Convention | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Spain | TITLE VI Offenses, penalties and compensation for damages Article 74. Offenses. 1. The infractions will be classified as minor, serious, or very serious, based on the harmfulness of the event, the anticipated future benefits, the health and social alteration produced and the degree of intentionality. 2. … the following are considered as minor, serious and very serious infractions: C) They are very serious infractions: a) The performance of any intervention aimed at the introduction of a modification in the genome of the offspring. | prohibited | ||
| CHAPTER IV Research with gametes and human pre-embryos Article 14. Use of gametes for research purposes. 1. Gametes may be used independently for research purposes. 2. Gametes used in research or experimentation may not be used for transfer to women or to cause pre-embryos for procreation. | prohibited | ||
| Art.13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Sweden | Chapter 2. Genetic investigation and information and gene therapy Gene therapy Section 3 Experiments for the purposes of research or treatment that entail genetic changes that can be inherited in humans may not be carried out. Section 4 Treatment methods that are intended to bring about genetic changes that can be inherited in humans may not be used. Section 5 If a fertilised egg has been used for an experiment for purposes of research or treatment, the egg may not be introduced into a woman’s body. The same applies if the egg, before fertilisation, or the sperm used for fertilisation have been used for such an experiment or if the egg has been subject to somatic nuclear transfer. | prohibited | prohibited | |
Switzerland | Art. 13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | ||
Federal Constitution of the Swiss Confederation (1999 as at 2018) | Title 3 Confederation, Cantons and Communes Chapter 2 Powers Section 8 Housing, Employment, Social Security and Health Art. 119 Reproductive medicine and gene technology involving human beings 2 The Confederation shall legislate on the use of human reproductive and genetic material. In doing so, it shall ensure the protection of human dignity, privacy and the family and shall adhere in particular to the following principles: a. All forms of cloning and interference with the genetic material of human reproductive cells and embryos are unlawful. c. The procedures for medically-assisted reproduction may be used only if infertility or the risk of transmitting a serious illness cannot otherwise be overcome, but not in order to conceive a child with specific characteristics or to further research; the fertilisation of human egg cells outside a woman’s body is permitted only under the conditions laid down by the law; no more human egg cells may be developed into embryos outside a woman’s body than are required for medically-assisted reproduction. | prohibited | prohibited | |
Federal law on medically assisted procreation (1998 as amended 2017) | Chapter 4 Penal Provisions Art. 35 Intervention in the germline 1 Anyone who genetically modifies human germ cells or human embryonic cells is punishable by up to three years imprisonment or a fine. 2 Anyone who uses genetically modified gametes or a genetically modified fertilized egg that is allowed to develop into an embryo for impregnation is subject to the same penalty. | prohibited | prohibited | |
Turkey | Regulation on reproductive treatment practices and reproductive treatment centers (2014) | FIRST PART Purpose, Scope, Basis and Definitions Goal ARTICLE 1 - (1) The purpose of this Regulation; To arrange the principles of the application to be done for married couples who cannot have children to have children through the methods of reproductive treatment that are medically appropriate, and the procedures and principles regarding the establishment, operation and supervision of the centers that will perform this practice. | ||
Art.13: Interventions on the human genome. An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Art. 18: Research on embryos in vitro. 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited. | prohibited | |||
Ukraine | Fundamentals of the Legislation of Ukraine on health care (1993 as amended 2020) | CHAPTER IV PROVISION OF HEALTHY AND SAFE CONDITIONS OF LIFE Article 29. Conservation of the gene pool of the people of Ukraine: In the interests of preserving the gene pool of the people of Ukraine, preventing the demographic crisis, ensuring the health of future generations and preventing hereditary diseases, the state implements a set of measures aimed at eliminating factors that adversely affect the human genetic apparatus, as well as creates a system of state genetic monitoring, organizes medical and genetic care, promotes the enrichment and dissemination of scientific knowledge in the field of genetics and demography. Medical intervention, which can cause a disorder of the human genetic apparatus, is prohibited. | indeterminate | |
United Kingdom of Great Britain and Northern Ireland | The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations (2015) | PART 2 Permitted eggs and permitted embryos Permitted embryo 6. An embryo (“embryo P”) is a permitted embryo for the purposes of section 3(2)(a) of the Act if— (b) that process has been applied to those embryos in the circumstances specified in regulation 8; and (c) since embryo P was created by means of the application of that process— (i) there have been no alterations in the nuclear or mitochondrial DNA of any cell of embryo P, and (ii) no cell has been added to embryo P other than by the division of embryo P’s own cells. Permitted embryo: circumstances 8. The circumstances referred to in regulation 6(b) are that— (a) the Authority has issued a determination that— (i) there is a particular risk that any embryo which is created by the fertilisation of an egg extracted from the ovaries of a woman named in the determination may have mitochondrial abnormalities caused by mitochondrial DNA; and (ii) there is a significant risk that a person with those abnormalities will have or develop serious mitochondrial disease; and (b) embryo B was created by the fertilisation of an egg extracted from the ovaries of the woman so named. | prohibited with exception for “mitochondrial donation” | |
Human Fertilisation and Embryology Act (1990 as amended 2008) | PART 1 Section 3 Prohibitions in connection with embryos (2) No person shall place in a woman— (a) an embryo other than a permitted embryo (as defined by section 3ZA) Section 3ZA Permitted eggs, permitted sperm and permitted embryos (4) An embryo is a permitted embryo if— (a) it has been created by the fertilisation of a permitted egg by permitted sperm, (b) no nuclear or mitochondrial DNA of any cell of the embryo has been altered, and (c) no cell has been added to it other than by division of the embryo's own cells. SCHEDULE 2 ACTIVITIES FOR WHICH LICENSES MAY BE GRANTED 3(1)A licence under this paragraph may authorise any of the following—
for the purposes of a project of research specified in the licence. | permitted | prohibited | |
The Vatican/ Holy See | Instruction Dignitas Personae on Certain Bioethical Questions (2008) | Third Part: New Treatments which Involve the Manipulation of the Embryo or the Human Genetic Patrimony 26. … Whatever genetic modifications are effected on the germ cells of a person will be transmitted to any potential offspring. Because the risks connected to any genetic manipulation are considerable and as yet not fully controllable, in the present state of research, it is not morally permissible to act in a way that may cause possible harm to the resulting progeny. In the hypothesis of gene therapy on the embryo, it needs to be added that this only takes place in the context of in vitro fertilization and thus runs up against all the ethical objections to such procedures. For these reasons, therefore, it must be stated that, in its current state, germ line cell therapy in all its forms is morally illicit. 34. … “[T]he use of human embryos or fetuses as an object of experimentation constitutes a crime against their dignity as human beings who have a right to the same respect owed to a child once born, just as to every person” [citation from John Paul II, Encyclical Letter Evangelium vitae, 63: AAS 87 (1995), 472-473] | prohibited | prohibited |
* Prohibited insofar as all embryo research is prohibited
† Proposed or draft policy, not in effect
Supplementary Appendix Table SA5: Policy Documents for the South-East Asia Region
Nation | Legislation | | Relevant excerpts | Germline Genome Editing research | Heritable Genome Editing research (for reproduction) |
India | National Guidelines for Gene Therapy Product Development and Clinical Trials (2019) | 4. Classification of Gene Therapy 4.1 Germ-line gene therapy… germline or in utero gene therapy is prohibited in India, due to ethical and social considerations. | prohibited | |
National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) | Section 10 Human genetics testing and research 10.14 Gene therapy 10.14.7 Germ line therapy is prohibited under the present state of knowledge. 10.14.8 Eugenic genetic engineering for changing/selecting/altering genetic characteristics and creating so called designer babies is prohibited. These should not be attempted, as we possess insufficient information at present to understand the effects of attempts to alter/enhance the genetic machinery of humans. It would be unethical to use genetic engineering for improvement of intelligence, memory, formation of body organs, fertility, physical, mental and emotional characteristics, etc. even if specific gene/genes are identified in future. 10.15 Use of newer technologies 10.15.3 Gene editing technology – Clustered, regularly interspaced, short palindromic repeat (CRISPR) Today therapeutic applications are possible for a wide range of indications, in preclinical models or in clinical settings through clinical trials in humans. There are some considerations related to the use of this technology.
| prohibited | ||
8.0 Categorization of Research 8.2 Restrictive Areas of Research 8.2.8 Genome modification including gene editing (for example by CRISPR-Cas9 technology) of stem cells, germ-line stem cells or gamete and human embryos is restricted only to in vitro studies. It will require thorough review by the IC-SCR, IEC and IBSC, and finally by Review Committee on Genetic Manipulation (RCGM). 10. Stem Cell Research: Basic Research The guidelines for basic studies are summarized below: … 10.6 …no in vitro manipulated cells shall be implanted in human/animal uterus with the intent of developing a whole organism. | permitted | prohibited | ||
Thailand | Protection of a Child Born by Medically Assisted Reproductive Technology Act, B.E.2558 (2015) | Section 36. No person shall form an embryo for using in any affair except for using in infertility treatment of lawful husband and wife. Section 37. A medical practitioner who intends to use a leftover embryo from infertility treatment of lawful husband and wife for a conduct of research shall receive permission from the Committee. Rules, procedures, and conditions for applying for permission and the granting of permission shall be as prescribed by the Committee through publication in the Government Gazette. … Section 38. No person shall carry out any act for the purpose of creating human being by other method in addition to the fertilization between sperm and an oocyte. Section 40. No person shall form, store, sell, import, export or use an embryo having human’s genetic materials of more than two persons or an embryo having cell or an element of human’s cell with other species being included. | permitted | prohibited |
Supplementary Appendix Table SA6: Policy Documents for the Western Pacific Region
Nation | Legislation | | Relevant excerpts | Germline Genome Editing research | Heritable Genome Editing research (for reproduction) |
Australia | Prohibition of Human Cloning for Reproduction Act (2002, as amended 2017) | Part 2—Prohibited practices Division 1—Practices that are completely prohibited 15 Offence—heritable alterations to genome (1) A person commits an offence if: (a) the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and (b) in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered. (2) In this section: human cell includes a human embryonal cell, a human fetal cell, human sperm or a human egg 20 - Offence - Importing, exporting or placing a prohibited embryo (3) A person commits an offence if the person intentionally places an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo. (4) In this section: prohibited embryo means: … (f) a human embryo that contains a human cell (within the meaning of section 15) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; | prohibited | |
11 Offence—use of embryo that is not an excess ART embryo A person commits an offence if: (a) the person intentionally uses, outside the body of a woman, a human embryo: (i) that was created by fertilisation of a human egg by a human sperm; and (ii) that is not an excess ART embryo; and (b) the use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact. | ||||
China | Civil Code of the People’s Republic of China (Effective January 1, 2021) | Part IV Personality Rights Chapter II The Right to Life, Body and Health Article 108 [Human Clinical Trials] For the development of new drugs, medical devices, or the development of new prevention and treatment methods, clinical trials shall be approved by the relevant authorities in accordance with the law and reviewed and approved by the ethics committee to report to the subjects Or the subject’s guardian shall inform the test purpose, use and possible risks and other details, and obtain written consent from him. In conducting clinical trials, no trial fees shall be charged to the subjects. Article 109 [Obligations when engaging in medical and scientific research activities related to human genes and human embryos ] To engage in medical and scientific research activities related to human genes, human embryos, etc., you shall abide by laws, administrative regulations and relevant national regulations. Must not endanger human health, must not violate ethics, and must not harm public interests. | ||
Regulations of the People's Republic of China on the Administration of Human Genetic Resources
Chapter One General Provisions Article 2: Human genetic resources mentioned in these Regulations include human genetic resource materials and human genetic resource information. Human genetic resource materials refer to organs, tissues, cells and other genetic materials that contain human genomes, genes, and other genetic materials. Human genetic resource information refers to information such as data generated by using human genetic resource materials.
Article 9: The collection, preservation, utilization, and external provision of China's human genetic resources shall comply with ethical principles and conduct ethical review in accordance with relevant national regulations. The collection, preservation, utilization, and provision of human genetic resources in our country shall respect the privacy rights of the providers of human genetic resources, obtain their prior informed consent, and protect their legitimate rights and interests.
Article 20: Those who use China's human genetic resources to carry out biotechnology research and development activities or conduct clinical trials shall comply with the relevant laws, administrative regulations and relevant national regulations on biotechnology research and clinical application management. | ||||
[DRAFT] | Article 7 Clinical research of new biomedical technologies shall be managed in stages. Clinical research of new and low-risk biomedical technologies is managed by the provincial health authority, and clinical research of new high-risk biomedical technologies is managed by the health authority of the State Council. New high-risk biomedical technologies include, but are not limited to, the following scenarios: (1) Involving changes in genetic material or regulation of genetic material expression, such as gene transfer technology, gene editing technology, gene regulation technology, stem cell technology, somatic technology, mitochondrial replacement technology, etc.; | indeterminate † | ||
Ethical Guiding Principles on Human Embryonic Stem Cell Research (2003) | Art. 6: All research activities related to human embryonic stem cells shall comply with the following norms: 1) Embryos obtained from IVF, human somatic cell nuclear transfer, parthenogenesis or genetic modification techniques, its in vitro culture period shall not exceed 14 days starting from the day when fertilization or nuclear transfer is performed. 2) It shall be prohibited to implant embryos created by means described above into the genital organ of human beings or any other species. | permitted | prohibited | |
Regulatory document of MoH No.176 Ethical Principles for Human Assisted Reproductive Technology and Human Sperm Bank (2003) | I. Ethical principles of human assisted reproductive technology (3) The principle of protecting future generations 3. If there is evidence that the implementation of human assisted reproductive technology will cause serious physical, psychological and social harms to future generations, medical professionals have an obligation not to implement the technology; 7. Before the safety of human egg cytoplasmic transplantation and human egg nucleus transplantation technology has been solved, medical personnel shall not implement human egg cytoplasmic transplantation and human egg nucleus transplantation technology for the purpose of treating infertility; (4) The principle of social welfare 5. Medical professionals are not allowed to carry out various experimental research and clinical practice on gametes and embryos that violate ethical and moral principles. | indeterminate | indeterminate | |
Article 336 Whoever, without obtaining the qualification for practising medicine, unlawfully practises medicine, if the circumstances are serious, shall be sentenced to fixed-term imprisonment of not more than three years, criminal detention or public surveillance and shall also, or shall only, be fined; | Court decision in case involving He Jiankui | |||
Japan | Guidelines for Research Using Gene-altering Technologies on Human Fertilized Embryos (2019) | Chapter I General Provisions Section 1 Purpose These Guidelines pertain to basic research using gene-altering technologies in Human Fertilized Embryos (…hereinafter referred to as “research”); the purpose of these Guidelines is for this research to be conducted appropriately by stipulating the matters to be observed by persons involved in such research, based on such ethical viewpoints as the respect for Human Fertilized Embryos and impact on genetic information. Chapter II Handling of Human Fertilized Embryos Section 3 Prohibition of Transplantation into Uteri (1) Human Fertilized Embryos used in research shall not be transplanted into a human or animal uterus. (2) Research shall not be conducted in a room that is equipped with facilities allowing Human Fertilized Embryos to be transplanted into a human or animal uterus. | permitted | prohibited |
Korea, Republic of | Bioethics and Safety Act [Law No. 16372, April 23, 2019, partial revision] | Chapter 1 General provisions Article 2 (Definition) The meanings of terms used in this Act are as follows. <Revised Dec. 29, 2015> 16. "Genetic therapy" means a series of acts that cause genetic variation in the human body or deliver the genetic material or cells into which the genetic material has been introduced into the human body for the purpose of preventing or treating a disease. 3.Residual Embryo Research Article 29 (Residual Embryo Research) (1) Residual embryos, which have passed the preservation period of embryos under Article 25, may be used in vitro for research purposes only until the development of primitive glands. Article 30 (Approval of Embryo Research Proposal) (1) To conduct research on the remaining embryos, an embryo research institute must submit an embryo research proposal to the Minister of Health and Welfare in advance for approval. The same shall also apply to any changes in the contents of the embryo research plan prescribed by Presidential Decree. Chapter 6 Gene Therapy and Testing Article 47 (Gene Therapy) (3) Gene therapy should not be performed on embryos, eggs, sperm and fetus. <Revised Dec. 29, 2015> | prohibited | |
Malaysia | Guideline of The Malaysian Medical Council – Assisted Reproduction (MMC Guideline 003/2006) | 15. PROHIBITED / UNACCEPTABLE PRACTICES The following practices are ethically unacceptable and are prohibited under this Guideline:
| prohibited | prohibited |
New Zealand | Human Assisted Reproductive Technology Act (2004 Reprint as at 1 October 2018) | Part 1 Preliminary provisions 5 Interpretation human reproductive research means research that uses or creates a human gamete, a human embryo, or a hybrid embryo Part 2 Prohibited and regulated activities 8 Prohibited actions
Schedule 1 8 Implant into a human being a genetically modified gamete, human embryo, or hybrid embryo. Subpart 2—Activities requiring approval of ethics committee 19 Approval of assisted reproductive procedure or research (1) The ethics committee may give its written approval— (b) for the conduct of human reproductive research by a nominated person. | prohibited | |
Singapore | Licensing Terms and Conditions on Assisted Reproduction Services 2020 | 5.39 AR [Assisted Reproduction] Centres shall only store gametes and embryos if such storage is medically indicated or where the gametes and embryos have been donated for research. 5.54 AR Centres shall not carry out any of the following activities:
9. RESEARCH 9.1 AR Centres conducting research on sperm, oocytes or embryos shall comply with all applicable requirements under the Human Biomedical Research Act 2015 (Act 29 of 2015) and its subsidiary legislation. | ||
No. S 622 Human Biomedical Research (Restricted Research) Regulations 2017 | PART 3 RESEARCH INVOLVING OOCYTES AND EMBRYOS Release of oocytes or embryos for research 15.—(1) Every researcher conducting or intending to conduct restricted research involving the use of oocytes or embryos must apply to the Director, through his or her research institution, for approval for the relevant tissue bank, if any, to release oocytes or embryos or both. (3) In determining whether to grant any approval for the release of oocytes or embryos or both, the Director may consult the advisory committee established under section 5(2) of the Act. (4) The advisory committee established under section 5(2) of the Act must, in advising the Director on whether to approve the release of oocytes or embryos or both — (a) review the scientific merit of the research proposal; and (b) consider the ethical issues and concerns with regard to conducting such a research at the wider societal level. | |||
PART 1 PRELIMINARY 3. Meanings of “human biomedical research” and “supervision and control” (3) Any research that involves — (a) human gametes or human embryos; PART 5 REGULATION OF HUMAN BIOMEDICAL RESEARCH Restricted human biomedical research 31.—(1) No research institution or person can conduct, supervise or control any restricted human biomedical research specified in the Fourth Schedule except in accordance with such requirements as the Minister may prescribe and such prescribed requirements are in addition to and not in lieu of the requirements in this Act. FOURTH SCHEDULE RESTRICTED HUMAN BIOMEDICAL RESEARCH 1. Human biomedical research involving human eggs or human embryos | indeterminate | indeterminate | ||
Viet Nam | Article 5. Protection of the marriage and family regime 2. The following acts are prohibited: … g/ Giving birth with assisted reproductive technology for commercial purpose, commercial gestational surrogacy, prenatal sex selection, cloning; |
† Proposed or draft policy, not in effect