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An Emerging Consensus

Human Biotechnology Policies Around the World
by Richard HayesScience Progress
November 6th, 2008

Source: NHGRI

The new human biotechnologies have the potential for both great good and great harm. If used responsibly they could lead to medical advances and improved health outcomes. If misapplied they could exacerbate health disparities and generate new forms of discrimination and inequality. If we are to realize their benefits yet avoid their risks we will need regulations, laws, and guidelines at both national and international levels.

But how and where should the lines be drawn? If drawn too tightly they could constrain valuable medical research. If drawn too loosely they could open the door to a Gattaca-like world of neo-eugenic practices and ideologies.

In the United States serious discussion of these questions has been thwarted for the past eight years by partisanship and polarization, and constructive engagement by the Bush administration at the international level has been effectively nil.

The good news, however, is that during this same period many countries have been developing comprehensive human biotech policies that strike a practicable and socially responsible balance between being overly restrictive and overly permissive. A survey of all 192 countries and eight major intergovernmental organizations suggests that:

  • There is widespread support for human embryonic stem cell research involving embryos created but not used in the course of assisted reproductive technology, or ART, procedures.
  • There is similarly widespread support for embryo screening to avoid passing serious diseases to one's offspring.
  • There is strong opposition to human reproductive cloning, inheritable genetic modification, and embryo screening for non-medical purposes.
  • There is widespread concern about the commercialization of human reproductive activities and about the use of genetic technologies for so-called "enhancement" purposes.

One practice about which there is no clear consensus is the creation of clonal human embryos for research purposes. Most countries that have adopted policies addressing this practice have prohibited it, but more than a quarter explicitly support it.

This map [developed by Science Progress] provides an overview of selected human biotechnology policies around the globe [1]:



It is instructive to note that of the thirty member countries of the Organization for Economic Cooperation and Development, which together account for 84 percent of world GDP and have the most fully developed biomedical research sectors, fully twenty-six (87 percent) allow human embryonic stem cell research using ART embryos. At the same time, 97 percent of OECD countries have banned human reproductive cloning; 87 percent have banned inheritable genetic modification; and 80 percent have banned embryo screening for non-medical purposes. None have approved these. And those few OECD countries that don't yet have formal policies appear to be unsupportive of these practices.

Countries with explicit national policies on selected human biotechnology applications

(of 192 total UN countries surveyed)

Countries with explicit policies on selected human biotechnology applications

The table shows the status of selected key policies in all 192 countries. Detailed descriptions of policies within each country can be found in the BioPolicyWiki. Summaries of policies adopted by nine major intergovernmental bodies-the United Nations, UNESCO, the World Health Organization, the European Union, the Council of Europe, the World Anti-Sports Doping Agency, the African Union and the Group of Eight-are available here and in the BioPolicyWiki. Data for embryonic stem cell research using ART embryos is based on surveys by the United Kingdom's Human Fertility and Embryological Authority and by the Hinxton Group.

In most OECD countries and many others, the policies just noted are part of comprehensive regulatory regimes established at the national level that also address important safety, privacy, consent and other concerns. Several countries have established national regulatory agencies, such as the United Kingdom's Human Fertility and Embryological Authority and Canada's Assisted Human Reproductive Agency. These allow valuable medical research to proceed in an accountable and socially responsible manner while taking dangerous or otherwise undesirable applications off the table. They also facilitate public participation in the ongoing review and modification of human biotechnology policies.[2]

It's important to note, however, that the majority of countries worldwide have not yet adopted any meaningful policies regarding the new human biotechnologies. Recent scandals involving stem cell research in South Korea and Austria should be a wake-up call concerning the need for responsible regulatory oversight if such research is to retain public support.[3] In addition, the current policy deficit is an open invitation to rogue nations and scientists intent on creating genetically enhanced bioweapons or conducting human genetic experiments that cross ethical boundaries.

If the emerging policy consensus is to make good on its promise, all countries will need to be part of it in one manner or another. Little is resolved if 189 countries ban human reproductive cloning while three promote themselves as safe havens for the creation of human clones.

Fortunately, discussions about the sorts of instruments that might facilitate meaningful global agreements have been underway for some time. In 2001 legal experts suggested that the 1997 Ottawa Treaty on the prohibition of antipersonnel landmines, and other existing treaties, might serve as models for global agreements addressing the new human biotechnologies.[4] A 2002 proposal by law and bioethics scholars George Annas, Lori Andrews, and Rosario Isasi called for an international "Convention on the Preservation of the Human Species." It would prohibit reproductive cloning and inheritable genetic modification, and mandate national systems of oversight ensuring that the use of human gametes or embryos for experimental or clinical practices meet consent, safety, and ethical standards.[5]

In 2007 scholars associated with the United Nations University argued that the prohibition of human reproductive cloning may by now have attained the status of customary international law, and that measures to formalize this, perhaps negotiated under the auspices of UNESCO's International Bioethics Committee, would stand a good chance of success.[6] In early 2008 Asia Society Executive Vice-President Jamie Metzl, who served in the State Department under former President Bill Clinton, proposed a "Genetic Heritage Safeguard Treaty" modeled on the 1970 Nuclear Nonproliferation Treaty. He argued that such a treaty could serve the dual function of encouraging responsible applications of human genetic research and specifying limits on those applications deemed undesirable.[7]

There are other possibilities as well. The Council of Europe's 1997 Convention on Biomedicine and Human Rights allows countries other than Council members to ratify it, suggesting that well-crafted regional agreements might serve as foundations for global agreements.[8] Alternatively, regional agreements might be crafted that harmonize those provisions having profound implications for humanity as a whole, while allowing other provisions to vary in accordance with regional social and cultural differences.

Development and enforcement of such global agreements will not be easy. For some practices, such as genetic testing and screening, the boundaries between acceptable and unacceptable uses are often unclear, and people are understandably reluctant to forego possible benefits without good reason. Countries may fear that constraints of any sort on biotech research or commerce could leave them at an economic disadvantage. And in a world still rife with nationalist conflict, some countries will want to reserve the option of using these technologies for hostile purposes.

But these challenges can be met. People intuitively understand that the ability to manipulate the human genome holds great potential for abuse. The current global financial crisis has served as a powerful reminder of the need for responsible oversight and regulation in a complex, interdependent world. And the emerging international consensus regarding human biotechnology is remarkably consistent across regions and cultures. Western European countries widely regarded as bastions of secular liberalism, for example, have adopted some of the most comprehensive controls over human genetic technology in the world. This derives from their generally social-democratic political ethos and their first-hand experience in the 20th century with eugenics, euthanasia, and genocide. Europeans know all too well what can happen when ideologies and policies that valorize the creation of "genetically superior" human beings come to the fore. For different but related reasons, developing countries such as South Africa, Vietnam, and Brazil have likewise established regulatory controls over human biotech research and applications.

There is no reason that the human community cannot come to agreement on where and how to draw lines on the most critically consequential new human biotechnologies. But this will require enlightened and committed social and political leadership, and very soon.

Richard Hayes, PhD, is Executive Director of the Center for Genetics and Society. This article is based on testimony presented at a hearing of the House Foreign Affairs Committee Subcommittee on Terrorism, Nonproliferation and Trade on June 19, 2008.

Acknowledgements: Jesse Reynolds, Jamie D. Brooks and Pete Shanks collected much of the data on which this article draws, and which is displayed in the BioPolicyWiki.

Appendix: Policies Adopted by Intergovernmental Organizations

1. The United Nations

In 2001 France and Germany proposed a binding UN treaty calling for a prohibition on human reproductive cloning. An early procedural vote suggested unanimous support for this measure. A significant number of countries subsequently expressed opposition to banning reproductive cloning without simultaneously banning research cloning. This led to extended controversy, and the debate became, essentially, a debate over the acceptability of research cloning. By 2003 it became clear that a consensus concerning research cloning could not be achieved. In 2005 a non-binding declaration opposing both research cloning and reproductive cloning was brought to a vote. It received a plurality of votes, 46 percent, which under UN rules makes it the official UN position. Both opponents and supporters of research cloning claimed vindication of their positions. Supporters of research cloning noted that as the declaration was non-binding, and as 18 percent of UN member states supported research cloning, the vote was of questionable significance. Opponents of research cloning noted that a larger number of countries had expressed strong opposition to research cloning than had initially been anticipated.[9]

2. UNESCO

The United Nations Educational, Scientific, and Cultural Organization (UNESCO) Bioethics Programme is led by the International Bioethics Committee, or IBC, consisting of 36 outside experts, and the Intergovernmental Bioethics Committee, or IGBC, consisting of representatives from 36 member states. The Bioethics Programme has sponsored three major nonbinding international agreements:[10]

The Universal Declaration on the Human Genome and Human Rights was adopted unanimously by the UNESCO General Conference in 1997 and ratified by the UN General Assembly in 1998. The declaration calls for member states to undertake specific actions, including the prohibition of "practices which are contrary to human dignity, such as reproductive cloning of human beings." It also calls on the IBC to study "practices that could be contrary to human dignity, such as germline interventions."

The International Declaration on Human Genetic Data was adopted in 2003. The declaration is intended "to ensure the respect of human dignity and protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic and proteomic data, and of the biological samples from which they are derived, in keeping with the requirements of equality, justice and solidarity, while giving due consideration to freedom of thought and expression, including freedom of research."

The Universal Declaration on Bioethics and Human Rights was adopted in 2005. The
declaration used a human rights framework to establish normative principles in fifteen areas, including human dignity and human rights; equality, justice, and equity; and protecting future generations. These principles cover a wider range of issues than did the previous two bioethics declarations.

UNESCO took the lead in negotiating the International Convention Against Doping in Sports, in collaboration with the World Anti-Doping Agency, which had earlier been established by the International Olympic Committee. It includes language banning the use of genetic technology to enhance athletic performance in official athletic events, referred to as "gene-doping." The convention entered into force on February 1, 2007, and has been ratified by 86 countries (not including the United States).[11] The earlier Copenhagen Declaration on Anti-Doping in Sport has been signed by 192 countries, including the United States.[12]

3. Council of Europe

The 47-member Council of Europe maintains a Bioethics Division, guided by a Steering Committee on Bioethics. The Council's Convention on Biomedicine and Human Rights was opened for signatures in 1997 and went into force in 1998. As of March 2008 it has been signed or ratified by 34 countries. It explicitly prohibits inheritable genetic modification, somatic genetic modification for enhancement purposes, social sex selection, and the creation of human embryos solely for research purposes. The Convention is perhaps the single most well-developed intergovernmental agreement extant addressing the new human biotechnologies. Human reproductive cloning was banned by an Additional Protocol on the Prohibition of Cloning Human Beings, which went into force in 1998.[13]

4. European Union

With 27 member states, the European Union and its constituent bodies play a major and growing role in European policy integration. Article 3 of the EU's Charter of Fundamental Rights, entitled "Rights to the Integrity of the Person," prohibits human reproductive cloning, "eugenic practices, in particular those aiming at the selection of persons," and "making the human body and its parts as such a source of financial gain."[14]

5. African Union

At its 1996 Assembly of Heads of State, the African Union (then called the Organization of African Unity) approved a Resolution on Bioethics that affirmed "the inviolability of the human body and the genetic heritage of the human species" and called for "supervision of research facilities to obviate selective eugenic by-products, particularly those relating to sex considerations."[15]

6. World Health Organization

In 1997 the WHO called for a global ban on human reproductive cloning.[16] In 1999 a Consultation on Ethical Issues in Genetics, Cloning and Biotechnology was held to help assess future directions for the WHO. The draft guidelines prepared as part of this consultation, Medical Genetics and Biotechnology: Implications for Public Health, called for a global ban on inheritable genetic modification. In 2000 WHO Director-General Gro Harlem Brundtland reiterated opposition to human reproductive cloning.[17] In September 2001 the WHO convened a meeting to review and assess "recent technical developments in medically assisted procreation and their ethical and social implications." The review covered, among other items, preimplantation genetic diagnosis, intracytoplasmic sperm injection, and cryopreservation of gametes and embryos. In February 2002 the WHO repeated its opposition to human reproductive cloning and cautioned against banning cloning techniques for medical research. In October 2002 the WHO established a Department of Ethics, Equity, Trade, and Human Rights to coordinate activities addressing bioethical issues.[18]

7. Group of Eight

At its June 1997 summit in Denver, Colorado, the G-8 called for a worldwide ban on human reproductive cloning. According to the Final Communique of the Denver Summit of the Eight, the leaders of the G-8 nations agreed "on the need for appropriate domestic measures and close international cooperation to prohibit the use of somatic cell nuclear transfer to create a child."[19]

Notes

[1] The map displays data available in the BioPolicyWiki as of 28 October 2008. The categories used in the BioPolicyWiki to describe policies are broad ones, and policies are subject to change. Consult the BioPolicyWiki for more background and updates.

[2] The Canadian Assisted Human Reproduction Act (AHRA), approved by the Canadian Parliament in 2004, is exemplary. It grounds its provisions in an explicit statement of principles, prohibits objectionable procedures such as reproductive cloning, and establishes a federal regulatory agency to ensure that permitted procedures are safe and used in an equitable manner. The agency licenses and monitors all private and public fertility clinics, research facilities and other institutions whose activities involve human gametes or embryos. The agency is governed by a 13-member board, half of whose members are encouraged to be women. See more on the AHRA and on the UK's HFEA in BioPolicyWiki.

Comprehensive regulatory structures for the United States have been proposed by Eric Parens and Laurie Knowles in "Reprogenetics and Public Policy: Reflections and Recommendations," Hastings Center Report, July-August: 2003., http://www.thehastingscenter.org/pdf/reprogenetics_and_public_policy.pdf, and by Francis Fukuyama and Franco Furger in Beyond Bioethics: A Proposal for Modernizing the Regulation of Human Biotechnologies; The Paul H. Nitze School of Advanced International Studies, Washington DC; available at http://www.biotechgov.org/

[3] For Korea, see: "Reflections on South Korea's stem cell scandal," US News & World Report, 3 Jan 2006, at http://health.usnews.com/usnews/health/articles/060103/3book.htm and "So. Korean scandal rocks stem cell community," Nat Med. 2006 Jan;12(1):4. For Austria, see "Rector sacked in Austrian stem-cell scandal," 27 August 2008 | Nature 454, 1041 (2008).

[4] See "Health & Human Rights Leaders Call for Global Ban on Species-Altering Procedures," Genetic Crossroads, October 2, 2001; available at http://www.geneticsandsociety.org/article.php?id=2809

[5] George J. Annas, Lori B. Andrews and Rosario M. Isasi, "Protecting the Endangered Human: Toward an International Treaty Prohibiting Cloning and Inheritable Alterations," American Journal of Law & Medicine, Vol. 28, Nos. 2 & 3, pp. 151-178 (2002), available at http://geneticsandsociety.org/downloads/2002_ajlm_annasetal.pdf

[6] Chamundeeswari Kuppuswamy, Darryl Macer, Mihaela Serbulea and Brendan Tobin, Is Human Reproductive Cloning Inevitable: Future Options for UN Governance, United Nations University - Institute of Advanced Studies, Yokohama, Japan, 2007; available at http://www.ias.unu.edu/resource_centre/Cloning_9.20B.pdf

[7] Jamie Metzl, "Brave New World War," Democracy, Spring 2008; available at http://www.geneticsandsociety.org/article.php?id=3985. Metzl is Executive Vice President of the Asia Society, and served as Director for Multilateral and Humanitarian Affairs for the National Security Council during the Clinton Administration.

[8] Council of Europe, "Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine," 4 April, 1997; available at http://conventions.coe.int/treaty/en/treaties/html/164.htm

[9] See Center for Genetics and Society, "The United Nations Human Cloning Treaty Debate, 2000-2005," June 1st, 2006, available at http://www.geneticsandsociety.org/article.php?id=338

[10] See UNESCO, "Bioethics," at www.unesco.org/shs/bioethics

[11] UNESCO, "International Convention against Doping in Sport 2005," http://portal.unesco.org/en/ev.php-URL_ID=31037&URL_DO=DO_TOPIC&URL_SECTION=201.html

[12] World Anti-Doping Agency, "Copenhagen Declaration on Anti-Doping in Sport," 2003, linked from and overview at http://www.wada-ama.org/en/dynamic.ch2?pageCategory.id=272

[13] Council of Europe, "Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine," 4 April, 1997; available at http://conventions.coe.int/treaty/en/treaties/html/164.htm
"Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings," 12 January, 1998; available at http://conventions.coe.int/Treaty/EN/Treaties/Html/168.htm

[14] The Charter of Fundamental Rights of the European Union, Article 3, text available from http://www.europarl.europa.eu/charter/default_en.htm

[15] Organization of African Unity, Assembly of Heads of State and Government, 32nd Ordinary Session, Cameroon, July, 1996, "Resolution on Bioethics" (AHG/Res.254[XXXII]), paragraphs 3b and 3f; available at http://www.africa-union.org/root/au/Documents/Decisions/hog/6HoGAssembly1996.pdf

[16] World Health Assembly, Resolution 50.37, on "Ethical, Scientific and Social Implications of Cloning in Human Health," Geneva, 1997; not currently available on the web. The resolution was reaffirmed in 1998, in Resolution WHA51.10 (same title), available at http://www.who.int/ethics/en/WHA51_10.pdf

[17] Cloning in Human Health: Report by the Director-General, World Health Organization, May 10, 2000; available at http://www.who.int/ethics/en/A53_15.pdf

[18] See "Ethics and Health at WHO," http://www.who.int/ethics/about/en/

[19] Final Communique of the Denver Summit of the Eight, June 22, 1997; available at http://www.g7.utoronto.ca/summit/1997denver/g8final.htm




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