Genetics & Public Policy Center
Newsletter Signup
Text Size:   Decrease text size Increase text size
International Law Search

The Genetics and Public Policy Center commissioned a survey of laws related to reproductive genetic testing, specifically prenatal genetic testing and preimplantation genetic diagnosis in 16 countries. Bartha M. Knoppers and Rosario M. Isasi of the University of Montreal conducted the survey.

The results of the survey form the basis of an article in the journal Human Reproduction. The article, "Regulatory Approaches to Reproductive Genetic Testing", analyzes the ethical and legal aspect of the laws in these countries by examining the substantive requirements of the laws and the procedural safeguards in place. The authors describe differences and similarities across countries and argue that the countries' broad range of approaches reflect the legal, social and religious cultures and beliefs of each country.

The results of this survey are available below. The information in this database was most recently updated in January 2004 and will be updated again soon. We would welcome input on the accuracy of this chart. Please send comments to sbaruch2@jhu.edu.


Search Laws:
Select categories and countries you would like to locate laws for. To select multiple items in each menu,
Windows users use CTRL + click, Mac users use CMD (Apple key) + click. Results will display below.




Show all laws»


Cloning (View PDF of all Cloning laws)

[Australia] Research Involving Human Embryos Act and the Prohibition of Human Cloning Act
In 2002, the Australian Government adopted federal legislation to regulate cloning and embryonic stem cell research under the Research Involving Human Embryos Act and the Prohibition of Human Cloning Act. These two acts limit research on...

[Canada] Act Respecting Assisted Human Reproduction and Related Research
The Act Respecting Assisted Human Reproduction and Related Research defines an embryo as "a human organism during the first 56 days of its development following fertilization or creation and includes any cell derived from such an organism...

[China] Human Reproductive Technology Ordinance
The Human Reproductive Technology Ordinance enacted by the Government of the Hong Kong Special Administrative Region, though not yet in operation, regulates the creation, use and manipulation of an embryo, whether or not the embryo is to be implanted...

[France] Bioethics Law
Under the Bioethics Law it is prohibited to create embryos for research purposes or for the creation of stem cells. Therapeutic cloning is thus prohibited while reproductive cloning is considered a “crime against the human race.” Both...

[Germany] Embryo Protection Law
Under German Law, human cloning (therapeutic or reproductive) is criminalized by the Embryo Protection Law. Furthermore, the use of human embryos for research purposes is not allowed.

Article 6 of this law states, “any person who...

[India] Ethical Policies on the Human Genome, Genetic Research and Services
Cloning in India is not regulated by legislation but by ethical guidelines adopted by authoritative bodies. The Department of Biotechnology of the Ministry of Science and Technology has adopted ethical policies on the human genome, which have laid...

[Israel] Law on Genetic Interventions in Humans
The Law on Genetic Interventions in Humans prohibits the creation of a “complete human being” by reproductive cloning; however, this law does not rule out producing cloned embryos that will not be implanted. For the purpose of the law,...

[Japan] Law Concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques
“The Law Concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques” prohibits the transfer of embryos created by human cloning techniques as well as those created by xenotransplantation. However, it allows the...

[Mexico] General Health Law
Mexican legislation does not regulate explicitly cloning for reproductive and/or therapeutic purposes. The General Health Law and its Regulation on Scientific Research have been interpreted as implicitly prohibiting human reproductive cloning. The...

[Singapore] Human Cloning and Other Prohibited Practices Act
The Human Cloning and Other Prohibited Practices Act prohibits placing a human embryo clone in the body of a human or the body of an animal. It also prohibits the import and export of any human embryo clone into or out of Singapore. Under this Act, a...

[South Africa] National Health Act
The National Health Act prohibits both human reproductive and therapeutic cloning (the latter allowed only from adult or cord blood stem cells) as well asthe genetic manipulation of gametes, zygotes or embryos (“a human embryo is a human...

[South Korea] Bioethics and Biosafety Act
The Bioethics and Biosafety Act regulates research development in biotechnology in accordance with principles of bioethics. The Act defines an embryo as “a fertilized egg (or segmented cell) from the moment of fertilization to the point of time...

[Switzerland] Embryonic Research Act
The Federal Constitution of Switzerland, at article 119, protects persons against abuse related to assisted procreation and gene technology. This article stipulates that the Swiss Constitution will ensure “the protection of human dignity, of...

[The Netherlands] Embryos Act
The Embryos Act, which contains rules relating to the use of human gametes and embryos, allows the use of spare embryos for scientific research (including obtaining stem cells from such embryos for the purposes of research), subject to review of the...

[United Kingdom] Fertilisation and Embryology Act 1990
Embryo research is regulated by both the Human Fertilisation and Embryology Act 1990, which makes general provisions in connection with embryo research, and the Human Reproductive Cloning Act 2001, which bans human reproductive cloning by and renders...

[United States] Dickey-Wicker Amendment
In the United States there is no federal legislation prohibiting cloning for either reproductive and therapeutic purposes. However, under the 1996 Dickey-Wicker Amendment it is illegal to use federal funds to support research “in which human...


Human Genetic Modification (View PDF of all Human Genetic Modification laws)

[Australia] Prohibition of Human Cloning Act
The Australian government has banned germline therapy, making it an offense subject to criminal sanctions under the Prohibition of Human Cloning Act (Section 18). Any "human embryo that contains a human cell (within the meaning of Section...

[Canada] Act Respecting Assisted Human Reproduction and Related Reseach
According to the Act Respecting Assisted Human Reproduction and Related Research 2004, germline genetic alteration is banned and sanctioned by penal clauses (SS.5(1f) and 60). Under this Act, germline genetic alteration is defined as "altering...

[China] State Drug Administration
In China, a regulatory system governs clinical trials in humans and gene therapy products. The State Food and Drug Administration (SFDA), established in 2003 as a successor to the State Drug Administration (SDA), is the national regulatory authority...

[France] Law no.94-654 governing the donation and use of elements and products of the human body, medically assisted reproduction, and prenatal diagnosis
In France, the Law no.94-654 governing the donation and use of elements and products of the human body, medically assisted reproduction, and prenatal diagnosis (1994), which was been amended in 2004 by the Bioethics Law no.2004-800, regulates gene...

[Germany] Embryo Protection Law
The artificial alteration of the human germline is criminalized by the Embryo Protection Law (art. 5, par. 1). Likewise, the law punishes anyone who uses or attempts to use a human germ cell with artificially altered genetic information for...

[India] Drugs and Cosmetics Act
Although there is no specific legislation in India governing gene therapy, the Indian Council of Medical Research (ICMR) states that gene therapy should be subject to ethical codes that apply to research involving human patients. Therefore, the...

[Israel] Prohibition of Genetic Interventions (Human Cloning and Genetic Modification of Reproductive Cells) Act
In 1999, the Israel government adopted the Prohibition of Genetic Interventions (Human Cloning and Genetic Modification of Reproductive Cells) Act to prescribe a five-year period during which certain genetic interventions on humans are banned in order...

[Japan] Guidelines for Genetic Testing
The Japanese law regulating human cloning and other techniques (2001) states that any technique that manipulates embryos or germ cells of a human could “have severe influence on the preservation of human dignity, safety for human life and body,...

[Mexico] General Health Law
Mexican federal legislation does not regulate explicitly human genetic modification. The General Health Law (GHL) and its Regulation on Scientific Research (RSR) and Regulation on the Sanitary Control of Organs, Tissues and Human Cadavers (RCOTHC),...

[Singapore] Medicines Act
In Singapore, no laws exist that regulate gene therapy explicitly; however, there is a regulatory system in place for ethical governance of clinical trials. Concerning drug trials, three main legislations provide the current formal regulatory...

[South Africa] National Health Act
In South Africa, human genetic modification technologies are regulated by the National Health Act and the ethics research guidelines issued by the Minister of Health. Under the Act, “the manipulation of any genetic material, including human...

[South Korea] Bioethics and Biosafety Act
In South Korea, the Bioethics and Biosafety Act establishes the regulatory process for biomedical practices and includes provisions regulating gene therapy. This Act interprets gene therapy as “procedures involving genetic mutation that are...

[Switzerland] Embryonic Research Act
One of the main principles of the Swiss Constitution is the protection of human dignity and personality as well as a person’s “genetic heritage.” The ban on any manipulation of germ cells of human gametes and embryos in the...

[The Netherlands] Embryos Act
The Embryos Act prohibits and criminalizes any “intentiona[l] modif[ication] [of] the gene material of the nucleus of human germ-line cells with which pregnancy is to be indicated,” (Section 24(g) and 28(1)).

Although there are...

[United Kingdom] Medicines for Human Use (Clinical Trials) Regulations 2004
In 1989, the UK government established the Committee on Ethics of Gene Therapy, a non-statutory body, to provide ethical guidelines for research on the treatment of genetic disorders in adults and children through genetic modification of the cells of...

[United States] Federal Food, Drug and Cosmetic Act
The United States has no federal legislation specifically addressing human genetic modification (either germline and somatic). However, the Federal Food, Drug and Cosmetic Act and the Public Health Service Act have been interpreted as providing...


Reproductive Genetic Testing (View PDF of all Reproductive Genetic Testing laws)

[Australia] Regulation of Assisted Reproductive Technologies
In Australia, the regulation of assisted reproductive technologies (ART), as well as PGD, is complex and not uniform among the different states. For example, PGD is allowed under strict conditions in all Australian states except Western Australia....

[Canada] Assisted Human Reproduction Act
In Canada, PGD was not regulated until the enactment of the Assisted Human Reproduction Act (AHR Act) in 2004. This Act provides, "No person shall knowingly for the purpose of creating a human being, perform any procedure or provide,...

[China] Law on Maternal and Infant Health Care
China's Law on Maternal and Infant Health Care regulates genetic disease diagnosis and pre-natal diagnosis. Under this law, PND is explicitly permitted but sex identification of the fetus by technical means is forbidden unless it is positively...

[France] Law no. 94-654 governing the donation and use of elements and products of the human body, medically assisted reproduction, and prenatal diagnosis
Reproductive genetic technologies are regulated under the Law no. 94-654 governing the donation and use of elements and products of the human body, medically assisted reproduction, and prenatal diagnosis (1994) which was revised in 2004 by the...

[Germany] Embryo Protection Act of 1990
Germany’s Embryo Protection Act of 1990 defines an embryo as a “fertilized human egg capable of developing from the time of fusion of the nuclei, and each totipotent cell removed from an embryo that is capable of dividing or developing...

[India] Law on Pre-natal Diagnostic Techniques
In India PGD is prohibited except to detect specific genetic and chromosomal abnormalities or sex-linked genetic disorders. The Law on Pre-natal Diagnostic Techniques “provides the prohibition of sex selection, before or after conception,”...

[Israel] National Health Law
As in many other industrialized countries, PND in Israel is considered an element of standard medical care. There is no specific legislation on PND in Israel, but it falls under the authority of the director general of the Ministry of Health.
...

[Japan] Guidelines for Genetic Testing
PGD and PND in Japan are not regulated by law but are governed by professional guidelines.
In 2003, ten genetic-medicine-related societies published a comprehensive guideline to incorporate and expand on previously established guidelines. The...

[Mexico] General Health Law
Mexican legislation does not explicitly regulate PGD or PND. The General Health Law and the Regulation on Scientific Research establish that it is only permissible to conduct assisted reproduction in order to solve infertility problems which cannot be...

[Singapore] Bioethics Advisory Committee
The report on genetic testing issued by the Bioethics Advisory Committee (BAC) states that PGD is a valuable option for couples since it allows the detection of certain genetic diseases. However, the process remains ethically debatable because of...

[South Africa] Genetic Policy Guidelines
South Africa does not regulate PGD explicitly by legislation or professional guidelines. However, the Medical Research Council of South Africa states that the use of recombinant technology in selecting fetal sex is unethical if done for non-medical...

[South Korea] Bioethics and Biosafety Act
The Bioethics and Biosafety Act regulates biotechnologies in general with no specific mention of PGD or PND. However, under the Act, tests on embryos or fetuses can only be performed to diagnose muscular dystrophy or other DNA-related diseases as...

[Switzerland] Federal Constitution of the Swiss Confederation
The Federal Constitution of the Swiss Confederation and the Federal Law on Medically Assisted Reproduction prohibit PGD. The federal law states, “the removal of one or several cells in embryo in vitro and their analysis are prohibited.”...

[The Netherlands] Embryos Act
PGD in the Netherlands is offered within the framework of medical research, according to the Health Council of the Netherlands (“IVF-related research”, 1998), and is strictly regulated by law under the Embryos Act (2001). Under the Embryos...

[United Kingdom] Human Fertilization and Embryology Act
The regulation of reproductive technologies in the United Kingdom falls under the Human Fertilization and Embryology Act (HFE Act) (1990), which covers, among other techniques, in vitro fertilization and donor insemination, but does not address PGD or...

[United States] A regulatory patchwork
In the United States, there is no uniform or comprehensive system for the regulation of assisted reproductive technologies, including reproductive genetic testing. The federal government does not have direct jurisdiction over the practice of medicine....