Reproduction and Responsibility:
The Regulation of New Biotechnologies
The President's Council on Bioethics
Washington, D.C.
March 2004
www.bioethics.gov
Executive Summary
Advances in biotechnology in recent decades have made available
an increasing capacity to intervene in the beginnings of human
life, especially life initiated outside the body, whether
in the clinic or in the laboratory. This capacity emerges
from a confluence of work in reproductive biology, developmental
biology, and human genetics, and raises ethical issues involving
a number of important human goods. There is little question
that the way these new technologies are used could have far-reaching
consequences, not only for the individuals involved but also
for society as a whole.
Yet it is not clear just how the interests of those individuals
and of the public at large can best be served as these new
technologies are developed and applied. What challenges and
public policy concerns arise together with the use of new
technologies affecting human reproduction? Whose responsibility
is it to monitor, review, and offer guidance where guidance
is needed, in order to safeguard the diverse human goods at
stake? Should there be more or less oversight and regulation?
Should there be any? Just how much is there now? Only partial
answers are available to these questions, and much basic data
remain to be gathered before they could be answered.
Since its very first meeting, in January of 2002, the President's
Council on Bioethics has taken an interest in these subjects,
and the Council has sought a way to advance public understanding
of the challenges that confront us in this arena-beginning
with the most basic information regarding what is being done
and with what results. In the Council's report, Human Cloning
and Human Dignity (2002), members observed that, with
regard to assisted reproduction, genetic testing, and human
embryo research,
we lack comprehensive knowledge about what is being done,
with what success, at what risk, under what ethical guidelines,
respecting which moral boundaries, subject to what oversight
and regulation, and with what sanctions for misconduct or
abuse. If we are to have wise public policy regarding these
scientifically and medically promising but morally challenging
activities, we need careful study and sustained public moral
discourse on this general subject, and not only on specific
narrowly defined pieces of the field.
Following the release of that report, the Council decided
to undertake a thoroughgoing inquiry into the current regulation
of those biotechnologies that touch on human reproduction.
This report is the fruit of that inquiry. Its principal aim
is to describe and critically assess the various oversight
and regulatory measures that now govern the biotechnologies
and practices at the intersection of assisted reproduction,
human genetics, and human embryo research.
I. WHAT IS AT STAKE?
The Council saw a number of powerful reasons for taking
up this subject. It involves some of the key concerns of bioethics
and is likely to be an area of increasing importance, one
in which both public understanding and public policy lag well
behind the rapid advance of technological developments. Among
the goods and ideals that are at stake, and that led the Council
to point the public's attention toward this subject, are the
following:
- The health and well-being of the human subjects directly
affected by these technologies, not only the individuals
or couples seeking their use, but also and especially the
children who may be born with their aid.
- Relief of the suffering and sorrow of those afflicted
with infertility.
- Compassion for children with serious genetic diseases,
and relief of the sorrows and burdens that they and those
who love and care for them must bear.
- The intrinsic value of new knowledge of human development
and genetic function in addition to the inestimable practical
value of new treatments for diseases and disabilities.
- Privacy of genetic information and reproductive practice.
- The foundational value of human life and the respect
owed to it in its various stages.
- Several expressions and avenues of human freedom, including
the freedom of parents to make their own reproductive decisions
or to use or refuse genetic screening, and the freedom of
scientists to conduct research. As important, as well, is
the necessity to protect the freedom of children from improper
attempts to manipulate their lives through control of their
genetic make-up or from unreasonable expectations that could
accompany such manipulations.
- The promotion of justice and equality, including equitable
access to the use and benefits of new technologies, equal
respect and opportunity in a world that places great emphasis
on genetic distinctions, and the prevention of discrimination
against or contempt for genetic "defectiveness" or "inferiority."
- The protection of human dignity, including the dignity
of the human body and its parts, the dignity of important
human relationships (parent and child, one generation and
the next), and the humanity of human procreation.
The Council's review of the field has been guided and motivated
by these concerns.
II. A DIAGNOSTIC OVERVIEW
This report is fundamentally a diagnostic document, and
even most of the recommendations with which it concludes aim
largely at improving the nation's capacity for future diagnosis
of the state of this field. The diagnosis begins by
examining policies and practices related to assisted reproduction.
This is our starting point because assisted reproduction is,
in practice, the necessary gateway to all the newer technologies-present
and projected-that affect human reproduction. Preimplantation
genetic diagnosis (including sex selection), germ-line genetic
modification, human embryo research, and similar techniques
all presuppose in vitro fertilization and the existence of
developing human life in vitro. As a consequence, any oversight
or regulation of the use of genetic technologies in human
reproduction will necessarily depend on the systems that oversee
and regulate assisted reproduction itself. Also, the addition
of genetic technologies to existing techniques of assisted
reproduction has made it clear-if it had not been clear before-that
we are dealing here with a most unusual branch of medicine.
In no other area of medicine does the treatment of an ailment-in
this case, infertility-call for the creation of another human
being. Our deep concern for the safety and well-being of children
suggests to us the need for special attention to the uses
and outcomes of these new biotechnologies.
The report then proceeds to review the regulatory policies
and practices involved in screening and selecting for genetic
conditions and traits; modification of traits and characteristics;
research involving in vitro human embryos; and commercial
and financial interests in this arena.
In discussing each area we review the relevant techniques
and practices, the principal ethical issues, and (especially)
the existing regulatory activities. This extended diagnostic
discussion explores in detail precisely who currently provides
oversight and guidance in each area, pursuant to what authority,
according to what principles and values, and with what ultimate
practical effect.
III. THE COUNCIL'S FINDINGS
The Council's diagnostic review of these areas has led us
to several general conclusions:
- The fields of assisted reproduction, human genetics,
and embryo research are increasingly converging with one
another.
- There is no uniform, comprehensive, and enforceable system
of data collection, monitoring, or oversight for the biotechnologies
affecting human reproduction.
- There is minimal direct governmental regulation of the
practice of assisted reproduction.
- There is extensive professional self-regulation of the
practice of assisted reproduction, but compliance with the
standards invoked is purely voluntary.
- There is no comprehensive, uniform, and enforceable mechanism
for data collection, monitoring, or oversight of how the
new reproductive biotechnologies affect the well-being of
the children conceived with their aid, the egg donors, or
the gestational mothers.
- There are no nationally uniform laws or policies relating
to access to assisted reproduction.
- Given the present framework of regulation, novel technologies
and practices that are successful move from the experimental
context to clinical practice with relatively little oversight
or deliberation. Once in practice, these techniques are
used at clinicians' discretion, with little or no external
oversight. Use of effective technologies becomes widespread
rapidly.
- As in other areas of medicine, there is no uniform system
for public review and deliberation regarding the larger
human or social significance of new reproductive biotechnologies.
- Preimplantation genetic diagnosis is an unregulated practice.
- Gene transfer research, by contrast, is regulated robustly.
- There is no comprehensive, uniform, and enforceable mechanism
for data collection, monitoring, or oversight regarding
the use and disposition of in vitro human embryos in the
context of clinical practice or research.
- There is no comprehensive mechanism for regulation of
commerce in gametes, embryos, and assisted reproductive
technology services.
- Patenting of embryonic or fetal human organisms is prohibited
for the fiscal year 2004.
The Council does not take these findings in and of themselves
to mean that any public policy response is called for, but
any consideration of potential public policies in this area
must take these basic facts into account.
IV. POLICY OPTIONS AND
RECOMMENDATIONS
The Council's findings, combined with the concerns that
animate our interest in this area, point toward a fairly wide
array of possible regulatory approaches. In this report, the
Council considers these options in some detail, laying out
a range of potential institutional options-from doing nothing
to developing entirely new regulatory institutions-and offering
a number of possible aims and principles that might guide
future regulators.
However, given the preliminary character of this report,
and the fact that our review of the field has turned up a
number of areas where crucial data are simply lacking, the
Council was not prepared to recommend any sweeping institutional
reform or innovation. Rather, members agreed upon a series
of modest measures to alleviate some clear and significant
present problems, including especially the lack of information
on certain key practices and their consequences.
The report concludes, therefore, with a set of recommendations
that the Council agrees should be adopted immediately. These
recommendations are not for structural or institutional changes;
we do not propose the wholesale creation of new regulatory
institutions or even the reform of existing ones. Rather,
we offer these recommendations as interim measures with two
goals in mind: first, to strengthen existing legislation and
regulatory mechanisms in order to gather more complete and
useful information; and, second, to erect certain legislative
safeguards against a small number of boundary-crossing practices,
at least until there can be further deliberation and debate
about both the human goods at stake and the best way to protect
them.
The recommendations fall into three general categories:
studies and data collection, oversight and self-regulation
by professional societies, and targeted legislative measures.
In each case, the Council has detailed its precise recommendations
in the report and has offered extensive supporting arguments
and reasons. The recommendations are as follows.
A. Federal Studies, Data Collection,
Reporting, and Monitoring Regarding the Uses and Effects of
These Technologies
As the Council's findings demonstrate, the incompleteness
of basic information on the uses and impact of new reproductive
technologies makes any conclusive policy judgments very difficult
to formulate. The Council therefore recommends that the federal
government take a number of specific steps to improve our
knowledge and understanding:
- Undertake a federally funded longitudinal study of the
impact of assisted reproductive technologies on the health
and development of children born with their aid.
- Undertake federally funded studies on the impact of assisted
reproductive technologies on the health and well-being of
women.
- Undertake federally funded comprehensive studies on the
uses of reproductive genetic technologies, and on their
effects on children born with their aid.
- Strengthen and augment the Fertility Clinic Success Rate
and Certification Act to better protect consumers and patients:
- Provide more user-friendly reporting of data.
- Require the publication of all reported adverse health
effects.
- Require the reporting of the average prices of the
procedures and the average cost (to patients) of a successful
assisted pregnancy.
- Include information on novel and experimental procedures.
- Require more specific reporting and publication of
the frequency of, and reasons for, uses of specialized
techniques such as ICSI, preimplantation genetic diagnosis,
and sperm sorting for sex-selection.
- Provide model forms for decision-making.
- Provide stronger penalties to enhance compliance
with the Act's reporting requirements.
- Increase funding for implementation of the Act.
B. Increased Oversight by Professional
Societies and Practitioners
Most oversight in this area currently takes the form of
self-regulation by professional societies, and as far as the
Council can determine the vast majority of practitioners abide
by these guidelines and standards and are dedicated to the
welfare of their patients. Yet the Council has identified
a few ways in which self-regulation could be meaningfully
improved:
- Strengthen informed patient decision-making.
- Treat the child born with the aid of assisted reproductive
procedures as a patient.
- Improve enforcement of existing guidelines.
- Improve procedures for movement of experimental procedures
into clinical practice.
- Create and enforce minimum uniform standards for the
protection of human subjects affected by assisted reproduction.
- Develop additional self-imposed ethical boundaries.
C. Targeted Legislative Measures
In the course of its review, discussion, and findings, the
Council encountered and highlighted several particular practices
and techniques (some already in use, others likely to be tried
in the foreseeable future) touching human reproduction that
raise new and distinctive challenges. Given the importance
of the matter, we believe these require special attention,
and we therefore recommend that Congress should consider some
limited targeted measures that might institute a moratorium
on certain particularly questionable practices. The report
includes an extensive discussion of the reasons for these
recommendations as well as the aims we hope they might serve.
The Council recommends that the Congress should, at least
for a limited time:
- Prohibit the transfer, for any purpose, of any human
embryo into the body of any member of a non-human species.
- Prohibit the production of a hybrid human-animal embryo
by fertilization of human egg by animal sperm or of animal
egg by human sperm.i
- Prohibit the transfer of a human embryo (produced ex
vivo) to a woman's uterus for any purpose other than to
attempt to produce a live-born child.
- Prohibit attempts to conceive a child by any means other
than the union of egg and sperm.ii
- Prohibit attempts to conceive a child by using gametes
obtained from a human fetus or derived from human embryonic
stem cells.ii
- Prohibit attempts to conceive a child by fusing blastomeres
from two or more embryos.ii
- Prohibit the use of human embryos in research beyond
a designated stage in their development (between 10 and
14 days after fertilization).iii
- Prohibit the buying and selling of human embryos.iv
- Prohibit the issuing of patents on claims directed to
or encompassing human embryos or fetuses at any stage of
development; and amend Title 35, United States Code, section
271(g) (which extends patent protections to products resulting
from a patented process) to exclude these items from patentability.v
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Footnotes
i.
It bears noting that, in testing for male-factor infertility,
practitioners of assisted reproduction now use hamster eggs
to test the capacity of human sperm to penetrate an egg;
yet there is no intent to produce a human-animal hybrid
embryo, and there is negligible likelihood that one might
be formed, given the wide genetic gap between the species.
Thus, we do not believe that such procedures run afoul of
the letter or spirit of the above recommendations.
ii.
Operationally, in each of the three cases listed, the prohibited
act comprises the creation ex vivo of any such human embryo
with the intent to transfer it to a woman's body
to initiate a pregnancy.
iii.
Some members of the Council are opposed to any experimentation
that harms or destroys human embryos, but, recognizing that
it is legal and active, they see the value in limiting the
practice. Other members of the Council favor allowing such
experimentation during the early stages of embryonic development,
but nonetheless recognize the need to establish an upper
age limit beyond which such research should not proceed.
Some Council members believe that this upper limit should
be 14 days after the first cell division; others favor 10
(or less).
iv.
This provision is not intended to preclude patients who
receive donated embryos from reimbursing donors for reasonable
expenses, storage costs, and the like. Also, because the
compensated giving of sperm is a long-established practice,
and because payment to egg donors is now also fairly common,
efforts to ban payment to gamete providers would likely
prove controversial and untenable for purposes of actual
legislation. Thus, we decline to recommend such a
ban here. That is not to say, however, that the Council
approves of the buying and selling of gametes. Indeed, many
Council members have raised serious concerns regarding this
species of commercialization in the domain of human reproduction.
v.
The language of any such statute would in our view need to
take some care not to exclude from patentability the processes
that result in these items, but only the products themselves.
Similar language has been included in a component of the federal
budget for fiscal year 2004 (the Consolidated Appropriations
Act of 2004, H.R. 2673, 108th Congress [January 23, 2004],
Division B, §634), but we believe this provision should also
be made a clear and permanent element of the patent law.
