Reproduction and Responsibility:

The Regulation of New Biotechnologies

The President's Council on Bioethics
Washington, D.C.
March 2004
www.bioethics.gov

Preface

Reproduction and Responsibility: The Regulation of New Biotechnologies is a report of the President's Council on Bioethics, which was created by President George W. Bush on November 28, 2001, by means of Executive Order 13237.

The Council's purpose is to advise the President on bioethical issues related to advances in biomedical science and technology. In connection with its advisory role, the mission of the Council includes the following functions:

• To undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology.
  
• To explore specific ethical and policy questions related to these developments.
  
• To provide a forum for a national discussion of bioethical issues.
  
• To facilitate a greater understanding of bioethical issues.

In his executive order, the President specified several areas for possible attention by the Council, including "embryo and stem cell research, assisted reproduction, cloning, uses of knowledge and techniques derived from human genetics or the neurosciences, and end of life issues," and added that the Council may "study broader ethical and social issues not tied to a specific technology, such as questions regarding the protection of human subjects in research, the appropriate uses of biomedical technologies, the moral implications of biomedical technologies, and the consequences of limiting scientific research." The President left the Council free to establish its own priorities among the many issues encompassed within its charter, and to determine its own modes of proceeding.

The inquiry that led to the present report began at the first Council meeting in January of 2002, when, in his maiden comments to the Council, Professor Francis Fukuyama proposed that the group pursue a study of how new biotechnologies are currently regulated, in hopes of advising the President on new regulatory institutions and principles that might outlive the Council.

In a memo to the Council dated April 10, 2002, Professor Fukuyama argued that

broad legislative bans will not be an appropriate approach for dealing with a number of foreseeable future technologies. For this, a regulatory model (that is, where Congress delegates authority to a regulatory body under broad guidelines) will be necessary. But the current regulatory system in the United States for human biotechnology is inadequate to make some of the decisions that will have to be made.ⁱ

Detailing what he regarded as the gaps in the U.S. regulatory system, Fukuyama suggested that new institutions are necessary, but added that "a great deal may be achievable through self-regulation," citing as an example the Recombinant DNA Advisory Committee (RAC), created as a tool for self-policing by scientists after the Asilomar Conference of 1975. And he named five specific areas for possible regulation: preimplantation genetic diagnosis (PGD); germ-line engineering; the creation of human-animal hybrids and chimeras; novel research techniques (as, for example, research cloning or creating female embryos in order to harvest eggs from their ovaries); and security against bioterrorism.

The Council's interest in the general topic of the regulation of biotechnology soon became focused on the area of human reproduction, and in particular, on the intersection of assisted reproduction, genetic testing and selection, and embryo research. In its July 2002 report on human cloning, in addition to recommending a permanent nationwide ban on cloning-to-produce-children and a four-year moratorium on cloning-for-biomedical-research, a majority of the Council called for "a federal review of current and projected practices of human embryo research, preimplantation genetic diagnosis, genetic modification of human embryos and gametes, and related matters, with a view to recommending and shaping ethically sound policies for the entire field." And it offered itself to "undertake the preliminary steps of such a process and to provide advice on further steps."ⁱⁱ

In October 2002, staff produced a memo that set forth some tentative findings to date:

1. The need for some system of regulation has been widely felt around the world.
   
2. Most countries focus their debate and regulation on questions of assisted reproduction and genetics.
   
3. The experience of other countries shows that diverse approaches are possible, each in line with the character and history of the particular society.
   
4. Designing and establishing systems of regulation takes a great deal of time and effort.
   
5. In the United States, existing institutions appear to be insufficient to handle the questions raised by the new biotechnologies.ⁱⁱⁱ

After discussing the memo, the Council charged staff with the task of coming back in six months with a thorough description of the entire range of regulatory institutions and activities-governmental and professional-that monitor, oversee, and regulate the uses of biotechnologies touching the beginnings of human life, and perhaps also with some policy options for consideration. In addition, the Council continued to hear invited presentations on various aspects of the subject, including, among others, the activities of the Food and Drug Administration and institutional review boards (IRBs); the patenting of living organisms; professional self-regulation; the concerns of patients with infertility or with children suffering genetic diseases; and the regulatory activities of other countries, with special presentations regarding institutional arrangements in Canada, Germany, and Great Britain. And the Council also received and considered voluminous written submissions in response to its call for public comment, posted in the Federal Register.^iv

At the June 2003 meeting, staff presented the requested diagnostic overview of all current oversight and regulatory activities, in the form of a 132-page discussion document. Further discussion documents were subsequently produced: a summary of the diagnostic findings and an overview of some possible policy options (July); draft recommendations covering data collection, monitoring, oversight, professional self-regulation, and targeted legislative measures (September); revised recommendations for the targeted legislative measures (October); and all recommendations, revised once more (January 2004). All told, twenty-six sessions, of ninety minutes each, were devoted to this topic at public meetings. Transcripts are available on-line at www.bioethics.gov. The present report draws directly upon those transcripts, as well as on writings of Council members, staff, and invited consultants; comments by interested members of the public and outside experts^v; and the written submissions responding to the Council's call for public comment.

As noted in Chapter 1, this report does not go so far as Professor Fukuyama had originally recommended. It does not advocate new regulatory structures or institutions; neither does it recommend any major changes or increased responsibility for existing regulatory institutions. It does, however, set forth detailed findings about the regulatory status quo. It lays out possible policy options, for future examination and study. And it makes interim recommendations, to be followed as the investigation seeking improved regulatory institutions and activities proceeds. We view this report as a first step in a continuing national conversation.

We hope this document, with its detailed diagnostic survey of the regulatory status quo, will serve as a source of clear, intelligible, and useful information for both policymakers and the general public. We also hope that policymakers will take action soon to implement the interim recommendations, set forth in Chapter 10, even as that conversation continues.

In creating this Council, President Bush expressed his desire to see us

consider all of the medical and ethical ramifications of biomedical innovation. . . . This council will keep us apprised of new developments and give our nation a forum to continue to discuss and evaluate these important issues. As we go forward, I hope we will always be guided by both intellect and heart, by both our capabilities and our conscience.

It has been our goal in the present report, as in all of our work, to live up to these high hopes and noble aspirations.

Leon R. Kass, M.D.

Chairman