Human Genetic Engineering: Chapter 12, Regulation? What Regulation?

The US does have some regulations about Human GE. But they are deeply confusing, incoherent, and filled with such enormous loopholes that the Food and Drug Administration (FDA), desperate to exert some kind of control, has even been reduced to pretending that cloning is a drug (see Box 12.1).

The system is a mess. In fact, system is the wrong word: The US not only lacks a comprehensive oversight mechanism, it lacks any effective process for developing the rules needed to handle the continually changing issues around these technologies. As law professors Lori Andrews and Nanette Elster put it, with academic understatement, “The United States notably lacks an adequate structural mechanism for assessing genetic and reproductive technologies.” That’s why, as the Center for Genetics and Society has noted, in the absence of either adequate laws or strong regulations, we have seen that:

In 1999 the University of California at San Francisco began secret experiments to clone human embryos, and did not acknowledge this until 2002 when reporters using the California Public Information Act forced disclosure of lab reports.
In 2000 Advanced Cell Technologies in Massachusetts began creating clonal embryos under wraps of corporate secrecy, with no prior review except by an internal “ethics advisory board” known in advance to support research cloning.
In 2001 the Jones Institute for Reproductive Medicine in Virginia broke a widely-observed ethical restraint and harvested 162 eggs from 12 women to create 40 viable embryos to be used exclusively for research purposes, again without going through any process of public review and approval.

Each of those activities is problematic in itself, but the more general issue is that there is no standard forum in which to debate them. That means that reputable scientists cannot be confident that their research will be supported, and rogues can blithely ignore anyone else’s opinion.

These are issues with which every developed country is grappling. Many countries have passed laws about specific issues such as cloning; others have signed multi-national agreements, notably that of the Council of Europe; and a few, including Britain, Canada, Germany and Australia, have established comprehensive policies and systems from which the US might learn. ...

	CHAPTER 12 REGULATION? WHAT REGULATION?

	Every society in the world that is not completely consumed by poverty is grappling with the issue of how to regulate Human GE. Some have quite well-developed procedures — Canada's 2004 Assisted Human Reproduction Act (AHRA) is probably the state of the art — while others are just starting the necessary discussions. The US is falling far behind. Worse, polarization of opinion has led not only to congressional stalemates (and therefore enormous regulatory holes that the unscrupulous can exploit) but to state laws that contradict each other. It's a mess and getting worse. This chapter describers the confusing state of affairs, nationally and internationally, and points towards some examples of ways we might move forward. The chapter's section titles, below, are followed by a list of the text boxes the chapter's introduction the annotated FURTHER READING list, which includes links to Free Documents from the Web and a short list of recommended Books There are many more resources in the Appendix.

	INTRODUCTION THE STALEMATE IN WASHINGTON STATE LAWS FUNDING AS A FORM OF REGULATION PATENTS THE NIH, RAC, CDC AND FDA PROFESSIONAL SELF-REGULATION SPECIFIC LAWS IN OTHER COUNTRIES THE COUNCIL OF EUROPE THE EUROPEAN UNION UNESCO THE WHO THE UN THE UK HFEA THE CANADIAN AHRAC FURTHER READING BOX 12.1 Is Cloning Really a Drug? BOX 12.2 Experiments on Humans

	INTRODUCTION The US does have some regulations about Human GE. But they are deeply confusing, incoherent, and filled with such enormous loopholes that the Food and Drug Administration (FDA), desperate to exert some kind of control, has even been reduced to pretending that cloning is a drug (see Box 12.1). The system is a mess. In fact, system is the wrong word: The US not only lacks a comprehensive oversight mechanism, it lacks any effective process for developing the rules needed to handle the continually changing issues around these technologies. As law professors Lori Andrews and Nanette Elster put it, with academic understatement, “The United States notably lacks an adequate structural mechanism for assessing genetic and reproductive technologies.” That’s why, as the Center for Genetics and Society has noted, in the absence of either adequate laws or strong regulations, we have seen that: In 1999 the University of California at San Francisco began secret experiments to clone human embryos, and did not acknowledge this until 2002 when reporters using the California Public Information Act forced disclosure of lab reports. In 2000 Advanced Cell Technologies in Massachusetts began creating clonal embryos under wraps of corporate secrecy, with no prior review except by an internal “ethics advisory board” known in advance to support research cloning. In 2001 the Jones Institute for Reproductive Medicine in Virginia broke a widely-observed ethical restraint and harvested 162 eggs from 12 women to create 40 viable embryos to be used exclusively for research purposes, again without going through any process of public review and approval. Each of those activities is problematic in itself, but the more general issue is that there is no standard forum in which to debate them. That means that reputable scientists cannot be confident that their research will be supported, and rogues can blithely ignore anyone else’s opinion. These are issues with which every developed country is grappling. Many countries have passed laws about specific issues such as cloning; others have signed multi-national agreements, notably that of the Council of Europe; and a few, including Britain, Canada, Germany and Australia, have established comprehensive policies and systems from which the US might learn. ...

	FURTHER READING Free Documents from the Web Links were checked and functioning as of 5/09/05; they are supposed to open in new windows. Please report broken ones. The Global Lawyers and Physicians for Human Rights Database of Global Policies on Human Cloning and Germline Engineering is an invaluable resource. Reproduction and Responsibility: The Regulation of New Biotechnologies, by The President’s Council on Bioethics, is a 305-page report, available as a single pdf (2.2mb) or a series of web pages. A pdf of the Executive Summary is also available, as is a pdf of the Recommendations and even the whole document in one enormous web page. M. Asif Ismail, “In Congress, a Cloning Stalemate,” Center for Public Integrity, 06/02/04, is one of a six-part series, all linked from it and their Genetics Project Home Page. David Appell, “The New Uncertainty Principle,” Scientific American, 01/01 Mark Dowie, “God and Monsters,” Mother Jones, 01–02/04. This entertaining article describes the efforts of Stuart Newman and Jeremy Rifkin to patent a chimera, an animal-human hybrid, specifically in order to ban its production. They later declared victory and quit, when the Patent Office rejected the application.

	Books Andrew Kimbrell, The Human Body Shop, Regnery Publishing, 1997 William Kristol and Eric Cohen, eds., The Future Is Now: America Confronts the New Genetics, Rowman & Littlefield, 2002; an extensive collection of short pieces, from a generally conservative point of view, including much testimony from the 2001 Congressional debates Sheldon Krimsky, Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? Rowman & Littlefield, 2003; the answer to the question in the subtitle is: Yes.