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National Polices on Human Genetic Modification: A Preliminary Survey

November 15th, 2007

Humanity is facing a policy deficit at both national and international levels concerning social oversight and control of the new technologies of human genetic modification.

In the ten years since the birth of Dolly the sheep alerted the world to the prospect of human cloning and a new, high-tech eugenics, few countries have adopted the policies needed to bring human genetic technology under responsible societal governance.

A survey of national policies shows that as of November 2007:

71% of countries have still not taken action to ban reproductive human cloning;

79% of countries have still not taken action to ban the creation of "designer babies."

Table 1 (below) shows policies by region and world. Tables 2 through 7 (following) show policies for individual countries. An expanded survey (in preparation) analyzes the state of policies adopted or under consideration by international bodies.

A note on the survey

The information shown in this preliminary survey represents our best knowledge as of November 2007. Lead researcher was Rosario Isasi, J.D., CGS Program Associate for International Policy. Additional research was conducted by Jesse Reynolds of CGS. See sources and citations.

Policies on human genetic technologies are undergoing rapid development. If you have information on changes in existing policies or the adoption of new policies, please contact us.

Table 1. Summary

Region
Countries
Reproductive Cloning
Research Cloning
IGM
- -
Prohibited
Prohibited
Allowed
Prohibited
-
#
#
%
#
%
#
%
#
%
Africa 53 2 4% 2 4% 0 0% 1 2%
Middle East 23 1 4% 0 0% 1
4% 1 4%
South Asia / East Asia / Pacific 33 11
33% 2
6% 8 24% 7 21%
Europe - Eastern 26 15 58% 11 42% 0 0% 11 42%
Europe - Western 22 17 77% 12 55% 4 18% 15
68%
Americas & Caribbean 35 10
29% 8 23% 1 3% 1 3%
World 193 56 29% 35 18% 14 7% 40 21%

Key to the tables:

Reproductive cloning: using a clonal embryo to initiate a human pregnancy

Research cloning: creating a clonal human embryo to be used for research or possible therapeutic purposes

IGM: inheritable genetic modification ("designer babies"); modification of the genes passed from one generation to the next

  • prohibited: This practice is prohibited by law or by measures having the force of law.
  • ALLOWED: This practice has been affirmed to be acceptable by an authoritative public body, or is otherwise allowed.
  • blank cell: no policy has been adopted or that the policy is unknown.

Council of Europe Convention:

  • signed: has signed the Convention on Biomedicine and Human Rights
  • RATIFIED: has both signed and ratified the Convention on Biomedicine and Human Rights
  • blank cell: has not signed the Convention
  • N/A: is not a member of the Council of Europe

Policy on UN cloning treaty, 2003:

  • FULL BAN: supported the 2003 proposal by USA/Costa Rica to ban both reproductive and research cloning
  • partial ban: supported the 2003 proposal by Belgium to ban reproductive cloning and allow national discretion on research cloning

Vote on UN cloning treaty process, Nov. 6, 2003:

  • Y: voted in favor of Iran's motion to postpone further discussion for two years
  • N: voted against Iran's motion to postpone further discussion for two years
  • A: abstained from voting on Iran's motion
  • 00: present and not voting, or not present

Table 2. Nations of Africa

- Reproductive Cloning Research Cloning IGM Policy on UN Cloning Treaty, 2003 Vote on UN Cloning Treaty process, 2003
Algeria - - - - Y
Angola - - - - N
Benin - - - FULL OO
Botswana - - - - Y
Burkina Faso - - - - A
Burundi - - - - N
Cameroon - - - - A
Cape Verde - - - - A
Central African Republic - - - - N
Chad - - - - OO
Comoros - - - - Y
Congo - - - - OO
Cote d'Ivoire - - - FULL OO
DR Congo (Formerly Zaire) - - - - OO
Djibouti - - - - Y
Egypt - - - - Y
Equitorial Guinea - - - - N
Eritrea - - - FULL N
Ethiopia - - - FULL N
Gabon - - - - Y
Gambia - - - FULL N
Ghana - - - - OO
Guinea - - - - N
Guinea-Bissau - - - -
OO
Kenya - - - FULL N
Lesotho - - - - N
Liberia - - - - OO
Libya - - - - OO
Madagascar - - - FULL N
Malawi - - - - N
Mali - - - - Y
Mauritania - - - - Y
Mauritius - - - - Y
Morocco - - - - Y
Mozambique - - - - OO
Namibia - - - - Y
Niger - - - - Y
Nigeria - - - FULL N
Rwanda - - - - N
Sao Tome and Principe - - - - N
Senegal - - - - Y
Seychelles - - - - OO
Sierra Leone - - - FULL N
Somalia - - - - N
South Africa prohibited prohibited prohibited partial Y
Sudan - - - - Y
Swaziland - - - - Y
Tanzania - - - FULL N
Togo - - - - OO
Tunisia prohibited prohibited - - Y
Uganda - - - FULL N
Zambia - - - FULL N
Zimbabwe - - - - Y
Total: 2
2 1 - 18 / 20 / 15

Table 3. Nations of Middle East

- Reproductive Cloning Research Cloning IGM Policy on UN Cloning Treaty, 2003 Vote on UN Cloning Treaty process, 2003
Afghanistan - - - - OO
Bahrain - - - - Y
Bangladesh - - - - A
Bhutan - - - - A
Brunei-Darassalam - - - - Y
Iran - - - - Y
Iraq - - - -
OO
Israel prohibited ALLOWED prohibited - N
Jordan - - - - Y
Kazakhstan - - - FULL N
Kuwait - - - - Y
Kyrgystan - - - FULL N
Lebanon - - - - Y
Oman - - - - Y
Pakistan - - - - Y
Qatar - - - - Y
Saudi Arabia - - - - Y
Syria - - - - Y
Tajikistan - - - FULL N
Turkmenistan - - - - OO
United Arab Emirates - - - - Y
Uzbekistan - - - FULL N
Yemen - - - - Y
Total: 1 0 1 - 13 / 5 / 5

Table 4. Nations of South Asia/East Asia/Pacific

- Reproductive Cloning Research Cloning IGM Policy on UN Cloning Treaty, 2003 Vote on UN Cloning Treaty process, 2003
Australia prohibited ALLOWED prohibited - N
Cambodia - - - - Y
China prohibited ALLOWED - partial Y
East Timor - - - FULL N
Fiji - - - FULL N
India prohibited ALLOWED prohibited - Y
Indonesia - - - - Y
Japan prohibited ALLOWED prohibited partial Y
Kiribati - - - - OO
Laos - - - - OO
Malaysia - - - - Y
Maldives - - - - Y
Marshall Islands - - - FULL N
Micronesia - - - FULL N
Mongolia - - - - OO
Myanmar - - - - Y
Nauru - - - FULL N
Nepal - - - - N
New Zealand prohibited prohibited prohibited
- Y
North Korea - - - - Y
Palau - - - FULL N
Papua New Guinea - - - - N
Philippines prohibited - - FULL N
Samoa - - - - N
Singapore prohibited ALLOWED prohibited - Y
Solomon Islands - - - - N
South Korea prohibited ALLOWED prohibited - Y
Sri Lanka - - - - Y
Taiwan
prohibited ALLOWED

n/a
Thailand prohibited
ALLOWED
- - Y
Tonga - - - - Y
Tuvalu - - - - N
Vanuatu - - - FULL N
Viet Nam prohibited prohibited prohibited - Y
Total: 11
2 / 8 6
- 16 / 14 / 3

Table 5. Nations of eastern Europe

- Reproductive Cloning Research Cloning IGM Council of
Europe
Convention
Policy on UN Cloning Treaty, 2003 Vote on UN Cloning Treaty process, 2003
Albania - - - - - N
Armenia - - - - - Y
Azerbaijan - - - - - Y
Belarus - - - N/A partial Y
Bosnia and Herzegovina - - - RATIFIED
- N
Bulgaria prohibited - prohibited RATIFIED - Y
Croatia - - - RATIFIED - Y
Cyprus prohibited prohibited
- RATIFIED - Y
Czech Republic prohibited prohibited prohibited RATIFIED partial Y
Estonia prohibited prohibited prohibited RATIFIED - Y
Georgia prohibited prohibited prohibited RATIFIED FULL N
Greece prohibited prohibited - RATIFIED - Y
Hungary prohibited prohibited prohibited RATIFIED - Y
Latvia prohibited - - signed - Y
Lithuania prohibited prohibited prohibited RATIFIED - Y
Macedonia



signed
A
Moldova prohibited - prohibited RATIFIED - A
Montenegro




n/a n/a
Poland prohibited - - signed - N
Romania prohibited prohibited prohibited RATIFIED - A
Russia
- - - - - Y
Serbia
- - - signed - A
Slovakia prohibited prohibited prohibited RATIFIED - N
Slovenia prohibited prohibited prohibited RATIFIED - Y
Turkey prohibited - prohibited RATIFIED - Y
Ukraine - - - signed - A
Total: 15 11 11 14 / 4
- 15 / 5 / 5

Table 6. Nations of western Europe

- Reproductive Cloning Research Cloning IGM Council of
Europe
Convention
Policy on UN Cloning Treaty, 2003 Vote on UN Cloning Treaty process, 2003
Andorra - - - - - N
Austria prohibited prohibited prohibited - - N
Belgium prohibited ALLOWED prohibited -
partial
Y
Denmark prohibited prohibited prohibited RATIFIED
partial
Y
Finland prohibited - prohibited signed
partial
Y
France prohibited prohibited prohibited signed - Y
Germany prohibited prohibited prohibited - - Y
Iceland prohibited prohibited prohibited RATIFIED
partial
Y
Ireland prohibited prohibited - - - N
Italy prohibited prohibited prohibited signed
FULL
N
Liechtenstein - - - -
partial
Y
Luxembourg prohibited prohibited - signed - Y
Malta - - - - - N
Monaco - - - N/A - Y
Netherlands prohibited prohibited prohibited signed - Y
Norway prohibited prohibited prohibited RATIFIED - N
Portugal prohibited prohibited prohibited RATIFIED
FULL
N
San Marino - - - RATIFIED
FULL
N
Spain prohibited prohibited prohibited RATIFIED
FULL
N
Sweden prohibited prohibited prohibited signed
partial
Y
Switzerland prohibited prohibited prohibited signed
partial
Y
UK prohibited ALLOWED prohibited -
partial
Y
Total: 17 12 / 4 15 6/7 - 15 / 9 / 0

Table 7.Nations of the Americas and the Caribbean

- Reproductive Cloning Research Cloning IGM Policy on UN Cloning Treaty, 2003 Vote on UN Cloning Treaty process, 2003
Antigua and Barbuda - - - FULL N
Argentina prohibited prohibited - - Y
Bahamas - - - - Y
Barbados - - - - N
Belize - - - - N
Bolivia - - - - N
Brazil prohibited prohibited prohibited partial Y
Canada prohibited prohibited prohibited - A
Chile - - - - N
Colombia prohibited prohibited prohibited - A
Costa Rica prohibited prohibited prohibited FULL N
Cuba prohibited ALLOWED - - Y
Dominica - - - FULL N
Dominican Republic - - - FULL N
Ecuador prohibited prohibited - - N
El Salvador - - - FULL N
Grenada - - - FULL N
Guatemala - - - - N
Guyana - - - - N
Haiti - - - FULL N
Honduras - - - FULL N
Jamaica - - - - A
Mexico prohibited - - - Y
Nicaragua - - - FULL N
Panama prohibited
prohibited
- FULL N
Paraguay - - - FULL N
Peru prohibited prohibited prohibited - A
Saint Kitts & Nevis - - - FULL N
St. Vincent & Grenadines - - - FULL N
Santa Lucia - - - - N
Suriname - - - FULL N
Trinidad & Tobago - - - - N
United States - - - FULL N
Uruguay - - - - A
Venezuela - - - - N
Total: 10
8 / 1 5 - 5 / 25 / 5

Notes:

Austria: IGM prohibition is implicit

China: Policy on IGM is unclear. The only provision pertaining to germ line modification reads as follows: "It shall be prohibited to hybridize human germ cells with germ cells of any other species".

Colombia: IGM prohibition is implicit

Finland: IGM prohibition is implicit

France: PGD for sex selection is only allowed for medical reasons and prohibited for cultural reasons or for family balancing.

Iceland: IGM prohibition is implicit. Embryo research allowed only if the intention is to diagnose hereditary diseases in the embryos themselves,

India: There is no specific legislation in India governing human genetic modification. Under guidelines issued by the ICMR and the Ministry of Science and Technology, IGM is explicitly prohibited.PGD is prohibited, except for detecting specific genetic and chromosomal abnormalities or for sex-linked genetic disorders. Sex selection "at any stage of fertilization, except to avoid the risk of transmission of a genetic abnormality assessed through PGD."; Sex selection "at any stage of fertilization, except to avoid the risk of transmission of a genetic abnormality assessed through PGD."

Israel: IGM prohibition is a moratorium. Sex selection is permissible in principle only for medical purposes, however in some very exceptional circumstances; sex selection may be approved for social reasons or "family balancing"

Italy: PGD allowed exceptionally by Court order on a case-by-case basis

Lithuania: IGM prohibition is implicit. Sex selection is implicitly permitted

Peru: IGM prohibition is implicit

Russia: Moratorium on reproductive cloning expired

Serbia: UN votes were as Serbia and Montenegro

South Africa: 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 foetal sex is unethical if done for non-medical purposes. It is the Council's opinion that gender testing may be beneficial in connection with sex-linked diseases and therapeutic abortion, but should be subject to the general guidelines and laws that exist in South Africa

South Korea: 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 for the diagnosis of fetus muscular dystrophy or other DNA-related diseases as stipulated by the President. The Act also bans sex selection as well as obtaining personal benefits (monetary or non-monetary) for the use of sperm or oocytes.

Taiwan: Allowance of research cloning is unclear

Sources and Citations:

Argentina: Decree No. 200/97: A Prohibition on Human Cloning Research, 7 March 1997.

Australia: Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill, approved by the House 6 December 2007. Prohibition of Human Cloning Act No. 144-2002, 7 January 2003 "An Act to prohibit human cloning and other unacceptable practices associated with reproductive technology and for related purposes". Research Involving Embryos Act No. 145-2002, 7 Jan. 2003. National Health and Medical Research Council, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research, September 2004.

Austria: Austria/Government, Federal Law of 1992 (Serial No. 275) regulating medically assisted procreation (the Reproductive Medicine Law), and amending the General Civil Code, the Marriage Law, and the Rules of Jurisdiction, June 4 1992.

Belgium: Law regarding Assisted Medical Procreation and the purpose of supernumerary embryos and gametes, July 6 2007.

Brazil: Law on Biosafety PL. 2401-C/03, March 2, 2005.

Bulgaria: The law on Public Health

Canada: An Act Respecting Assisted Human Reproduction and Related Research, March 29, 2004.

China: Ministry of Science and Technology and Ministry of Health, Ethical Guidelines on Human Embryonic Stem Cell, January 2004; Ministry of Health, Regulation on Human Assisted Reproductive Technologies, 2001

Colombia: Criminal Code, July 24 2000.

Costa Rica: Decree No. 24029-S: A Regulation on Assisted Reproduction, February 3 1995.

Cyprus: L. 31(III)/2001 article 38 (ratification European Convention on Human Rights and Biomedicine).

Czech Republic: Act No. 227 on Research on Human Embryonic Stem Cells and Related Activities and on Amendment to Some Related Acts, 26 April 2006.

Denmark: Act No. 460/97 on Medically Assisted Procreation in Connection with Medical Treatment, Diagnosis and Research (June 10 1997, amended 2003); Order No. 758 on the reporting of in vitro fertilization treatments, etc., and pre-implantation diagnosis, 30 September 1997.

Ecuador: Constitution of 5 June 1998 prohibits research on human embryos (Article 49 par. I.).

Estonia: Embryo Protection and Artificial Fertilisation Act, 1997; Penal Code (Consolidated 2007); Patents Act (16 March 1994, amended by Act RT I 2003, 18, 106; 29 January 2003)

Finland: Medical Research Act No. 488/1999; Act on Assisted Conception Treatments No. 1237, December 22 2006.

France: Bioethics Law No. 2004-800, August 6 2004.

Georgia: Law on Health Care, 1997; Law on the Rights of Patients, 2002.

Germany: Act for the Protection of Embryos, 1990.

Greece: Law 3089/2002 on Medically Assisted Human Reproduction, 2002; Ministerial Decision Φ.0546/1/ΑΣ 723/ Μ.4898, 1998; National Bioethics Commission, Recommendation on Pre-Natal and Pre-Implantation Genetic Diagnosis, 2007. (Ratification Biomedicine Convention)

Hungary: Law No. 154 on Public Health, 15 December 1997.

Iceland: Artificial Fertilisation Act no. 55/1996, and Iceland Ministry of Health and Social Security, Regulation no. 568/1997 on Artificial Fertilisation, September 30 1997.

India: Department of Biotechnology, Ministry of Science and Technology, Ethical Policies on the Human Genome, Genetic Research and Services, June 2001; The Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Act, 2001 (amended 2003); Indian Council of Medical Research, National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India, 2004, Guidelines for Stem Cell Research and Therapy, 2007, Statement on Specific Principles on Human Genetics Research, July 2000.

Ireland: Constitution of Ireland (Article 40, paragraph 3).

Israel: Law on the Prohibition of Genetic Intervention Act 1999-5759 (Human Cloning and Genetic Manipulation of Reproductive Cells), 1999 and 2004 (renewed); National Health Regulations on IVF, 1987; Recommendations issued by the Bioethics Committee of the Israel National Academy of Sciences and Humanities and the National (Helsinki) Committee on Medical Experimentation in Human Beings), 2006.

Italy: Medical Assisted Procreation Law No. 40, February 19, 2004.

Japan: Law Concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques, June 2001; Japan Society of Human Genetics, Japan Society of Obstetrics and Gynecology (Guidelines on Preimplantation Genetic Diagnosis, October 1998), Japan Society for Pediatric Genetics, Japanese Society for Familial Tumor, Japanese Society for Gene Diagnosis and Therapy, Japanese Society for Genetic Counselling, Japanese Society for Inherited Metabolic Diseases, Japanese Society of Laboratory Medicine, Japanese Society for Mass-screening, and Japanese Teratology Society, Guidelines for Genetic Testing, August 2003.

Latvia: Law on Sexual and Reproductive Health, July 2002.

Lithuania: Law on Ethics of Biomedical Research No. VIII-1679, May 11 2000.

Luxembourg: Law No. 4567 on medically assisted procreation. Minister of Health, Committee for Research Ethics (1995).

Mexico: The General Health Law of 7 May 1997. Regulation to the General Health Law on Scientific Health Research (1985).

Netherlands: Act containing rules relating to the use of gametes and embryos (Embryos Act), September 1st 2002.

New Zealand: Human Assisted Reproductive Technology Act No. 92, 2004; Advisory Committee on Assisted Reproductive Technology, Guidelines on Preimplantation Genetic Diagnosis, March 2005.

Norway: Law on the Medical Use of Biotechnology, 1995, revised 2007

Panama: Law No. 3 Human Cloning Prohibition, 15 January 2004.

Peru: Law No. 26842, General Health Law, July 9 1997; Law No. 27636, Criminal Code: Genetic Manipulation, January 16 2002.

Philippines: National Ethical Guidelines for Health Research, 2006

Poland: Law of January 1993 on family planning, protection of human fetuses, and the conditions under which pregnancy termination is possible (1993)

Portugal: Law No. 32/2006 concerning Medically Assisted Reproduction, July 26th 2006.

Russia: Law on Temporary Prohibition of Human Reproductive Cloning, 2002 (moratoria expired in 2006)

Singapore: Human Cloning and Other Prohibited Practices Act, September 2 2004; National Medical Ethics Committee, Ethical Guidelines for Gene Technology, 2001; Bioethics Advisory Committee of Singapore, Genetic Testing and Genetic Research, 2005.; Ministry of Health, Licensing & Accreditation Branch, Directives for Private Healthcare Institutions Providing Assisted Reproduction Services: Regulation 4 of the Private Hospitals and Medical Clinics Regulations (CAP 248, Reg 1), March 2006.

Slovakia: Act No. 576/2004 Coll. on healthcare, healthcare-related services and on the amendment and supplementing of certain laws, 22 September 2004; Penal Code (Amended September 2003).

Slovenia: The Law on Medically Assisted Reproduction, 2001; Penal Code, 2002.

South Africa: National Health Act December 31, 2003; Medical Research Council of South Africa, Guidelines on Ethics for Medical Research (General Principles/Reproductive Biology and Genetic Research - Book 1 & 2), 2002-2005.

South Korea: Ministry of Health and Welfare, Guidelines on the Safety of Biotechnology Research, 2000.; Bioethics and Biosafety Act, 2005.;

Spain: Law No. 14/2006 on Assisted Human Reproduction Techniques, May 26 2006; Biomedicine Law, 2007.

Sweden: Law No. 115 of March 14 1991, Act concerning measures for the purposes of Research or Treatment in connection with Fertilized Human Oocytes (amendment in force 1 April 2005). In Vitro Fertilization Act, 1998.

Switzerland: Federal Constitution of the Swiss Confederation, September 2001; Federal Act on Research on Surplus Embryos and Embryonic Stem Cells (Embryonic Research Act), (Approved by Referendum November 2004); Federal Law on Medically Assisted Reproduction, December 8 1998.

Taiwan: Ethical Regulations for Embryonic Stem Cell Research, 2004

Thailand: Medical Council of Thailand, Regulations on Human Cloning No. 21/2544, June 2002.

Tunisia: National Medical Ethics Committee, Opinion No. 3, 1997.

Turkey: Code of Public Health, Law No. 94-654, 29 July 1994; Regulation on In Vitro Fertilization and Embryo Transfer Centers, 1996.

United Kingdom: Human Reproductive Cloning Act (2001). Human Embryology & Fertilization Act (1990).

Vietnam: Government Decree banning human cloning and surrogacy, May 2003.


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