Reproduction and Responsibility:
The Regulation of New Biotechnologies
The President's Council on Bioethics
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
- 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
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:
- The need for some system of regulation has been widely
felt around the world.
- Most countries focus their debate and regulation
on questions of assisted reproduction and genetics.
- The experience of other countries shows that diverse
approaches are possible, each in line with the character
and history of the particular society.
- Designing and establishing systems of regulation
takes a great deal of time and effort.
- In the United States, existing institutions appear
to be insufficient to handle the questions raised by the
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 expertsv;
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.
Fukuyama, F., “An Overview of Biotech Regulation,” Memo
to the Members of the President’s Council on Bioethics,
discussed at session 6 of the Council’s meeting on April
26, 2002. For more on this theme, see his book Our Posthuman
Future: Consequences of the Biotechnology Revolution,
New York: Farrar, Strauss and Giroux, 2002.
The President’s Council on Bioethics, Human Cloning and
Human Dignity: An Ethical Inquiry, Washington, D.C.:
Government Printing Office, 2002, p. 205 (also pp. x and
The President’s Council on Bioethics, “Regulating the New
Biotechnologies: Observations and Procedural Options for
the Council,” Staff Working Paper discussed at session 7
of the Council’s meeting on October 18, 2002 (available
The President’s Council on Bioethics, “Call for submissions,”
Federal Register 68, no. 56 (March 24, 2003): 14239.
See the Acknowledgments for a list of individuals and organizations
that aided the Council in preparing the report.