Genetic Engineering Limits—A Planet Responds (2008, Dec 22)

Genetic Engineering Limits—A Planet RespondsRichard Hayes December 22nd 2008 Cutting Edge Genetics Analyst Over the past half century, the world has been transformed through rapid developments in communications, transportation, weaponry, and trade. A vast infrastructure of intergovernmental institutions has been established to help ensure that these and related developments generate more benefit than they do harm. These include global institutions such as the United Nations and the World Bank, regional groups such as the European Union and the African Union, and those with issue-specific agendas such as the Intergovernmental Panel on Climate Change and the World Health Organization. Although the record of these institutions is far from perfect, a world without them would be fraught with even more risk than it is today. The rapid development of powerful new human biotechnologies raises precisely the sort of questions that such intergovernmental institutions are positioned to address. If developed wisely, these technologies could help prevent and cure diseases that have afflicted humanity for millennia; if misapplied, they could pose new and profoundly consequential risks. Detailed knowledge of the human genome might lead to improved medical diagnostics, but could also lead to a Gattaca-like world in which affluent couples genetically modify their embryos in an attempt to create “designer babies.” The creation of clonal human embryos gives researchers tools to help investigate the developmental origin of congenital diseases, but brings us closer to the day when rogue scientists might attempt to create live-born human clones. Genetic interventions intended to help those suffering from degenerative muscular diseases could be used by athletes to illicitly enhance their strength and endurance. Many countries are adopting comprehensive national policies that establish guidelines, regulations, and laws stipulating which applications of the new human biotechnologies are permitted and which are not. But the greater majority of the world’s countries have not adopted policies regarding these technologies. Intergovernmental institutions are in a position to play major leadership roles in ensuring the proper use of the new human biotechnologies. They can promote greater understanding of both the benefits and the risks that these technologies pose; develop statements of principles to guide national policies; prepare model national legislation; and take the lead in negotiating binding multilateral treaties and conventions.

It will not be an easy task to come to formal agreement on even a minimal set of international principles and policies. These technologies are new and the issues involved are complex. But the encouraging news is that many key intergovernmental institutions have already begun taking steps to address the new human biotechnologies, and broad areas of at least implicit agreement are evident. 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 the use of cloning for research purposes. 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 introduced and received a plurality of votes (46 percent), which under UN rules makes it the official UN position. However, the lack of a clear consensus rendered moot any proposals to promote this position further. In the absence of a formal global treaty, individual countries have proceeded to adopt their own policies addressing human cloning. By 2007 human reproductive cloning had been banned by 59 countries—including the great majority of those with robust biomedical research sectors—and approved by none. In 2007 scholars associated with the United Nations University noted that the prohibition of reproductive cloning might be considered to have attained the status of customary international law. This was not the case for cloning for research purposes, however, as policies adopted by individual countries varied widely. UNESCO The United Nations Educational, Social and Cultural Organization (UNESCO) is a specialized agency of the United Nations working to promote international collaboration through education, science, and culture. In 1993 UNESCO established a Bioethics Programme within its Division of the Ethics of Science and Technology. The Programme is led by the International Bioethics Committee (IBC), consisting of 36 outside experts, and the Intergovernmental Bioethics Committee (IGBC), consisting of representatives from 36 member states. The Bioethics Programme has sponsored three major nonbinding international agreements. 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 (WADA), which had been established earlier by the International Olympic Committee. The Convention includes language banning the use of genetic technology to enhance athletic performance in official athletic events, referred to as "gene-doping." It entered into force on February 1, 2007, and has been ratified by 86 countries. The earlier Copenhagen Declaration on Anti-Doping in Sport has been signed by 192 countries. Council of Europe The Council of Europe is an international organization of 47 member countries working to foster democracy and human rights. It 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 had 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, banning human reproductive cloning through an Additional Protocol on the Prohibition of Cloning Human Beings, which went into force in 1998. 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." Importantly, the EU disburses some $5 to 6 billion U.S. every seven years for biomedical and health-related research, and sets policies on the use of these funds. Under the current programme, which runs from 2007 to 2013, these funds cannot be used for research that involves human reproductive cloning, inheritable genetic modification, the creation of human embryos solely for research purposes, or the destruction of human embryos.

African Union The African Union (AU) is an intergovernmental organization consisting of most African nations. At its 1996 Assembly of Heads of State, the AU (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." World Health Organization The World Health Organization (WHO) and its governing body, the World Health Assembly, are specialized agencies of the United Nations that address issues of international public health. In 1997 the WHO called for a global ban on human reproductive cloning. 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 Dr, Gro Harlem Brundtland reiterated opposition to human reproductive cloning. 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. Group of Eight The Group of Eight (G-8) is an international forum for the governments of Canada, France, Germany, Italy, Japan, Russia, the United Kingdom and the United States. It convenes annual summits to consider issues of common concern, typically of an economic or military nature. 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." The Consensus There appears to be broad support for applications intended to prevent or cure disease, but strong opposition to applications that involve selecting or modifying the genes of future generations for non-medical purposes. There is wide opposition as well as to human reproductive cloning and to non-medical genetic modification, including athletic “gene doping.” The one practice for which a consensus does not appear to be in the cards is medical research involving human embryos. Some intergovernmental institutions explicitly support this and others oppose it. Real opportunities exist for one or more respected intergovernmental institutions to mount a global initiative to clarify, codify and promote—indeed, to universalize—those human biotech policies about which broad agreement exists, while agreeing to disagree on the fewer number about which disagreements persist. Such an initiative would go a long way towards ensuring that these powerful new technologies are used in the best interests of all humanity. Cutting Edge Genetic Analyst Richard Hayes is executive director of the Center for Genetics and Society and can be found at www.geneticsandsociety.org. This article draws on an appendix of an article published by Science Progress, and on data compiled on CGS's BioPolicyWiki.

For a full account of the state of policies among individual countries see The Quest for Global Consensus on Human Biotechnology in The Cutting Edge News Nov 24, 2008.