PrintThe newest 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 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 (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.
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.
In most OECD countries and many others, their policies 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.
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.
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.
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.
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.
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.
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. 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. Jesse Reynolds, Jamie D. Brooks and Pete Shanks collected much of the data for this article, which was adapted from one originally published in Science Progress.
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