Assisted Human Reproduction Internationally

Canada's Assisted Human Reproduction Act is one of the world's most comprehensive legislative initiatives in the area of AHR. It draws on the best practices and experiences from other countries, yet is uniquely Canadian. The legislation speaks to the growing problem of infertility and our increasing reliance on AHR here in Canada.

The following provides a brief description of how some other countries are addressing AHR.

Australia

Updated - March 2004

The Australian constitution devolves the responsibility for most health legislation to its states. At the national level, the practice of medicine is overseen by the Australian National Health and Medical Research Council (NHMRC).

The states of Victoria, South Australia and West Australia have legislation governing AHR procedures and have also established statutory oversight bodies. Where there are no specific state legislative arrangements, the NHMRC's ethical guidelines on AHR, established in 1984, are used. In 1987, the Fertility Society of Australia (FSA) established an accreditation committee, the Reproductive Technology Accreditation Committee (RTAC), to oversee the practice of IVF throughout the country. State legislative bodies such as the Infertility Treatment Authority (ITA) in the State of Victoria, will not issue licences to IVF clinics unless the clinics have been accredited by the RTAC.

Australia's Research Involving Human Embryos Act 2002 and Prohibition of Human Cloning Act 2002 prohibit human cloning, both therapeutic and reproductive, and regulate uses of supernumerary human embryos created though AHR procedures. The Acts are applicable nationally and are administered by the NHMRC.

The issue of surrogacy is addressed at the state level to varying degrees. For example, only altruistic surrogacy is allowed in Victoria, whereas Queensland prohibits both altruistic and commercial surrogacy.

France

Updated - July 2004

France passed three bills in 1994 grouped under the heading of bioethics legislation - Loi santé, Loi justice and Loi recherche. These Bioethics Laws define the civil status of the human body, list prohibited activities and specify conditions under which regulated activities such as AHR procedures can be undertaken. The National Council on Reproductive Medicine and Biology advises the Minister regarding the approval, renewal and withdrawal of licence applications to perform AHR procedures.

In 2002, the French National Assembly revised its Bioethics Law of 1994 with the Projet de loi relatif à la bioéthique,2002. This draft bioethics legislation became law on July 9, 2004, and allows for embryonic stem cell research on supernumerary embryos for a period of five years. Both therapeutic and reproductive cloning remain banned and are subject to severe penalties. The law qualifies human reproductive cloning as a "crime against the human species." It is anticipated that a new national biomedicine agency to legislate matters relating to embryology and reproduction will become operational by early 2005. All types of surrogacy arrangements remain prohibited in France.

Germany

Updated - March 2004

The Embryo Prohibition Act 1992 prohibits all forms of research on human embryos that is not explicitly designed to preserve the embryo and facilitate implantation in a woman's uterus. Those contravening the Act face up to five years imprisonment. The Act also creates a number of criminal offences for engaging in certain practices involving AHR. For instance, it is an offence to attempt to fertilise an egg for any purpose, other than bringing about pregnancy in a woman from whom the egg originated, or attempt to fertilise more eggs than may be transferred within one treatment cycle (ie. all fertilised eggs must be transferred to a woman's uterus; none can be put in storage for future use).

In 2002, following intense debate, the German Parliament voted to allow human embryonic stem cells to be imported for medical research. Cloning for any purpose is prohibited in Germany, as are all forms of surrogacy.

Italy

Updated - March 2004

In Italy, the area of fertility treatment has been largely unregulated for the last 20 years. This changed in December 2003 when the Italian Senate passed legislation regulating many aspects of fertility treatment. The new legislation limits the use of assisted human reproductive procedures to 'stable heterosexual couples who live together and are of childbearing age'. As a result, single parents, same-sex couples and women beyond child-bearing age are banned from using assisted reproduction techniques. Additionally, the legislation bans the use of donor sperm or eggs and forbids the freezing of embryos for use at a later date (including after a spouse has died) or for scientific research. It allows a maximum of three eggs to be fertilised at one time and would require them all to be transferred to the womb at the same time. Pre-implantation genetic diagnosis (PGD) and prenatal screening for genetic disorders will also been banned, even for couples with a history of genetic disease. Existing frozen embryo storage facilities will be closed down and suitable donors will be found for the almost 24,000 embryos in storage.

The legislation forbids research on human embryos, such as cloning and stem cell derivation. Scientists found involved in cloning or the manipulation of human embryos risk jail sentences of between 10 and 20 years. Cloning will also be subject to a one million euro fine. Doctors who use donated gametes in treatment will be fined up to 600,000 euros and those providing assisted human reproduction procedures for single women or same-sex couples could be fined up to 300,000 euros. Surrogacy is also prohibited under the new legislation.

Japan

Updated - March 2004

The government of Japan passed "The Law Concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques" in November 2000. The law permits, for research purposes, human-animal chimeric combinations and the creation of human embryos through cloning (i.e. somatic cell nuclear transfer). However, it prohibits the transfer of such embryos into the uterus of a woman or an animal. Japan has no legislation governing other AHR activities such as IVF, but abides by guidelines issued by the country's Society of Obstetricians and Gynaecologists.

Japan's Guidelines for Derivation and Utilization of Human Embryonic Stem Cells, 2001, allows for the derivation of stem cells using embryos in excess of reproductive needs. Stem cell research is only permitted where certain requirements are satisfied: "the purposes of research contribute to the clarification of human development, differentiation, regeneration and the development of new methods to diagnose, prevent or treat diseases or of medicines and drugs." Also, the research must be "scientifically necessary and rational."

Singapore

Updated - March 2004

There is currently no legislation governing assisted human reproduction or embryonic stem cell research in Singapore. However, in 2000, Singapore's Cabinet appointed the Bioethics Advisory Committee (BAC) to examine the ethical, legal and social issues arising from biomedical research and development. In 2002, BAC published its report entitled Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning. The report recommends a complete ban on human reproductive cloning but suggests that human embryonic stem cell research and therapeutic cloning be permitted under strict regulation. According to the BAC report, the proposed regulatory framework should require the informed voluntary consent of donors, prohibit the commerce and sale of donated materials, particularly supernumerary embryos, and stipulates that "no one shall be under a duty to participate in any manner of research on human stem cells....to which he has a conscientious objection." The Singapore government has accepted BAC's recommendations and the Ministry of Health has prepared a draft Bill which has been made available for public consultation.

With regards to the provision of AHR services in Singapore, it is overseen by the Guidelines for Private Healthcare Institutions Providing Assisted Reproduction Services, issued by the Ministry of Health. The guidelines address various aspects of the AHR field, including the licensing of AHR centres, gamete donation and the provision of counselling to patients.

Sweden

Updated - March 2004

The In Vitro Fertilisation Act,1988 regulates the practice of IVF in Sweden and also contains provisions regarding gamete donation and the storage of and access to identifying donor information. The Act Concerning Measures for Research or Treatment Involving Fertilised Human Ova,1991, by contrast, regulates reproductive research and research on embryonic development, covers storage of embryos and allows for embryos to be cryopreserved for five years. Under this Act, research must be performed within 14 days of fertilisation and only with the consent of the donors. Any research that seeks to genetically modify the embryo is prohibited. The Act stipulates that once research is completed, the embryo cannot be used for reproductive purposes and must be destroyed.

Sweden has no legislation specifically directed at stem cell research. The Swedish Research Council issued guidelines in December 2001 covering stem cell research. The use of supernumerary embryos for research is permissible if "the project is judged necessary in order to advance the research on stem cells." Only supernumerary embryos can be used for research purposes and the donors must give informed consent. The Council did not endorse the creation of embryos solely for research. The Council considered the derivation of stem cells from embryos created by somatic cell nuclear transfer to be 'ethically justifiable' but cannot be allowed, due to present laws in Sweden. The Council recommended a review to enable such research to be undertaken and also recommended the banning of reproductive cloning.

United Kingdom (UK)

Updated - August 2004

In 1990 the UK Parliament passed the Human Fertilisation and Embryology Act (HFE Act). The Act banned certain activities, such as reproductive cloning, and established the world's first national regulatory body to oversee licensable activities, such as in vitro fertilisation (IVF). Clinics in the UK offering assisted reproductive procedures, storage of sperm, eggs, or embryos, or those undertaking human embryo research were required by law to be licensed by the Human Fertilisation and Embryology Authority (HFEA).

The HFEA licenses, inspects and monitors all assisted human reproduction (AHR) clinics in the UK (over 100). The Authority also maintains a Code of Practice for AHR clinics governing licensed activities.

Since 2000, changes have been made to the HFE Act and therapeutic cloning is now a licensed activity. As a result, cloned embryos can now be created, under licence, in order to derive stem cells for research. In early August, 2004, the HFEA Licence Committee granted its first therapeutic cloning research licence to the International Centre for Life at Newcastle University. The one-year licence permits the creation of human embryonic stem cells using somatic cell nuclear transfer. British scientists will use the stem cells from the cloned human embryos for research towards the development of treatments for serious diseases such as diabetes, Parkinson's or Alzheimers. While therapeutic cloning has been legal in Britain since 2001, each research project must be licensed by the HFEA. Reproductive cloning is illegal in the UK and penalties include a 10-year prison sentence and unlimited fines.

Commercial surrogacy is prohibited in the UK by the Surrogacy Arrangements Act 1985.

United Nations (UN)

Updated - October 2004

In 2001, at the request of France and Germany, the UN General Assembly established an Ad Hoc Committee to consider the development of an international convention "against the reproductive cloning of human beings". Discussions have been at an impasse since 2001 as member states have been unable to agree upon the scope of a negotiating mandate for the development of a convention. At issue is whether an international convention on human cloning should prohibit both reproductive and therapeutic cloning, or should countries be provided the opportunity to address therapeutic cloning through a ban or alternative means - a moratorium or regulation. Achieving a broad international consensus is hindered by the fact that some countries already allow regulated therapeutic cloning for research purposes; whereas other countries remain firm in their position that no cloning, regardless of the purpose, should ever be considered. The 2004 discussions are still ongoing.

United States (US)

Updated - April 2004

In 1992, the Fertility Clinic Success Rate and Certification Act of 1992 was passed. Under the Act, fertility clinics must report pregnancy success rates and this information is published annually by the Centre for Disease Control. Although some states have legislation addressing AHR procedures, there is no national legislation. The sector is primarily self-regulated through voluntary adherence to laboratory guidelines and clinical standards published by the American Society for Reproductive Medicine (ASRM).

Since 2001, federal funding for embryonic stem cell research has been restricted to 15 pre-approved stem cell lines derived before August 9, 2001. In 2002, California became the first state to allow researchers to use state funds for research involving the derivation and use of human embryonic stem cells from any source, including somatic cell nuclear transfer (ie. cloning), for the purpose of developing new medical treatments. More recently, in January 2004, New Jersey enacted legislation similar to that of California.

With respect to human cloning, there are a number of federal bills being debated. Some bills propose banning both reproductive and therapeutic cloning, while others seek to ban only reproductive cloning. It is not anticipated that any bill will pass before the 2004 US election.

The issue of surrogacy is addressed at the state level. Commercial surrogacy is forbidden in some states while others permit it with varying degrees of state intervention.

In April, 2004, a report entitled "Responsibility and Reproduction" was issued by President's Council on Bioethics, urging more federal funding for research and studies on the long-term health affects of assisted reproduction techniques on mothers and their offspring.