533569571
2/17/2016 12:05 PM
ARTICLES
STEM CELLS AND CLONING: WHERE THE
REGULATORY CONSENSUS FAILS
ROGER BROWNSWORD*
INTRODUCTION
If there is a regulatory consensus about anything in bioethics and
biolaw, it is that human reproductive cloning is unethical and that it should
be prohibited. If taking a life is the worst thing that we can do, making a
cloned life, it seems, is a close second. So, for example, Article 1(1) of the
Additional Protocol to the Council of Europe’s Convention on Human
Rights and Biomedicine provides that “[a]ny intervention seeking to create
a human being genetically identical to another human being, whether living
or dead, is prohibited”;1 at the Fiftieth World Health Assembly, it was
resolved that “the use of cloning for the replication of human individuals is
ethically unacceptable and contrary to human integrity and morality”;2 and
*
1.
2.
Professor of Law, King’s College London and Honorary Professor in Law at the
University of Sheffield. A truncated version of this paper was presented at the New
England Law Review’s Symposium, Stem Cell Research and Human Cloning: Where
Do We Draw the Line?, held at the Boston Park Plaza Hotel on November 19, 2004. I
am grateful to the participants for their comments. I am also grateful to the members
of my LLM class in London who offered a constructive sounding board for some of
the ideas in this paper. To avoid any misunderstanding, I should emphasize that the
views expressed here are my own and, in no sense, should be attributed to the
Nuffield Council on Bioethics, of which I am a member.
Convention for the Protection of Human Rights and Dignity of the Human Being with
Regard to the Application of Biology and Medicine: Convention on Human Rights
and Biomedicine, Apr. 4, 1997, Additional Protocol, Europ. T.S. No. 168, at art. I,
para. 1 (Jan. 1, 1998) [hereinafter Additional Protocol]. Article 1(2) of the Additional
Protocol defines “genetically identical” as meaning “a human being sharing with
another the same nuclear gene set.” Id. art. I, para. 2.
World Health Assembly, Cloning in Human Reproduction, WHA Res. 50.37 (1997).
535
533569571
536
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
Article 11 of the United Nations Educational, Scientific, and Cultural
Organization (UNESCO) Universal Declaration on the Human Genome
and Human Rights declares bluntly that “[p]ractices which are contrary to
human dignity, such as reproductive cloning of human beings, shall not be
permitted.”3 Even in the United Kingdom, where the regulatory climate is
extremely supportive of modern biotechnology,4 there was a panic when it
was thought that the law might (inadvertently) permit human reproductive
cloninga panic that was calmed only when legislation was rushed
through to make it a serious criminal offense to place in a woman “a human
embryo which has been created otherwise than by fertilisation.”5
The reasons underlying such a panic are not difficult to detect,
reflecting concerns about safety and risk (without any overwhelming
offsetting benefit);6 about damage to the emotional and psychic welfare of
the child (or, as Lori Andrews has put it, the fear that cloning might
“undermine human dignity by threatening the replicant’s sense of self and
autonomy,” subverting the essential “sense of an independent self”);7 about
the creation of confusion and ambiguity in familial relationships;8 about the
3.
4.
5.
6.
7.
8.
Universal Declaration on the Human Genome and Human Rights, UNESCO, 29th
Sess., at 41, 29 C/Res. 16 (1997) [hereinafter Universal Declaration on the Human
Genome], available at http://unesdoc.unesco.org/images/0011/001102/110220e.pdf.
See Roger Brownsword, Regulating Stem Cell Research in the United Kingdom:
Filling in the Cultural Background, in CROSSING BORDERS: CULTURAL, RELIGIOUS,
AND POLITICAL DIFFERENCES IN STEM CELL RESEARCH (W. Bender et al. eds.,
forthcoming 2005).
Human Reproductive Cloning Act, 2001 c. 23, § 1(1) (Eng.); see Andrew Grubb,
Regulating Cloned Embryos, 118 LAW Q. REV. 358 (2002); Roger Brownsword, Stem
Cells, Superman, and the Report of the Select Committee, 65 MOD. L. REV. 568
(2002) (providing background on the Act).
Alan Colman, who was Research Director of PPL Therapeutics Ltd. at the time of the
successful and dramatic cloning of Dolly the sheep, has argued that human
reproductive cloning should be rejected on ethical grounds as both unsafe and
inefficient. See Alan Colman, Why Human Cloning Should Not Be Attempted, in THE
GENETIC REVOLUTION AND HUMAN RIGHTS 14 (Justine Burley ed., 1999). Colman
suggests that, if human reproductive cloning were to be attempted, it “would quite
likely join thalidomide in the teratogenic hall of infamy.” Id. at 16.
Lori B. Andrews, Is There a Right to Clone? Constitutional Challenges to Bans on
Human Cloning, 11 HARV. J.L. & TECH. 643, 655 (1998); see also Ruth Deech,
Cloning and Public Policy, in THE GENETIC REVOLUTION AND HUMAN RIGHTS 95, 98
(Justine Burley ed., 1999) (writing on the widespread concern for the replicant’s
“individuality”). For a skeptical assessment, see Dan W. Brock, Cloning Human
Beings: An Assessment of the Ethical Issues Pro and Con, in CLONES AND CLONES:
FACTS AND FANTASIES ABOUT HUMAN CLONING 141, 152-55 (Martha C. Nussbaum &
Cass R. Sunstein eds., 1998).
This consideration was highlighted by the House of Lords Select Committee in its
report on Stem Cell Research. House of Lords Select Committee on Stem Cell
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
537
possibly disreputable purposes of cloners;9 about unnatural intervention in
the human reproductive process; and, particularly so in Europe, about the
dignity of human life and, concomitantly, the importance of ensuring that
human dignity is not compromised.10 In any event, we find a “degree of
unanimity in opposition to cloning [that is] astounding, often uniting liberal
and conservative, pro-life and pro-choice, and secular and religious people
of various persuasions.”11 What is more, this plurality of religious and
secular voices not only unites in condemning the very idea of human
reproductive cloning, typically it will not settle for anything less than
outright regulatory prohibition (even carefully controlled permission, it
should be noted, will not suffice).
On closer inspection, it becomes apparent that the reasons backing
this red-light regulatory demand are not only various, but actually of very
different orders. While the variety of reasons speaks to the size and scale of
the consensus, the fact that different (and oppositional) bioethical orders
are (for the time being) drawn together speaks to a potential weakness. As
Cass Sunstein has eloquently explained, in pluralistic democracies, a
working consensus (or common position) might be located at more than
one level—running from abstract principle to a concrete regulatory
position.12 In the case of human reproductive cloning, the consensus is
9.
10.
11.
12.
Research, Report, HL 83(i), at ch. 2 § 2.2 (Feb. 13, 2002) [hereinafter House of Lords
Select Committee Report], available at http://www.parliament.the-stationeryoffice.co.uk/pa/ld200102/ldselect/ldstem/83/8301.htm; see also Lawrence Wu,
Family Planning Through Human Cloning: Is There a Fundamental Right?, 98
COLUM. L. REV. 1461, 1496-1500, 1509-10 (1998). Wu argues that such fears are
speculative and largely unfounded. However, his confidence in the individuation of
the cloned child is aided by assumptions concerning a loving context, the child being
informed as to its cloned status at the right time, and the fact that the child is cloned
not being widely known. Id.
In March 1997, the European Parliament called for a ban on human reproductive
cloning. The preamble to the resolution stated: “[T]he cloning . . . of human beings
cannot under any circumstances be justified or tolerated by any society, because it is a
serious violation of fundamental human rights and is contrary to the principle of
equality of human beings, as it permits a eugenic and racist selection of the human
race. . . .” Resolution on Cloning, EUR. PARL. DOC. (C115) 92 (1997).
As the Preamble to the Protocol puts it, “the instrumentalisation of human beings
through the deliberate creation of genetically identical human beings is contrary to
human dignity and thus constitutes a misuse of biology and medicine.” Additional
Protocol, supra note 1, at pmbl.; see also Rick Santorum, The New Culture of Life:
Promoting Responsible and Appropriate Medical Research, 17 NOTRE DAME J.L.
ETHICS & PUB. POL’Y 151, 154-55 (2003) (“America has never been a nation of strict
utilitarianism . . . [a]nd it is critical that we seek a responsible policy framework that
will protect and enhance human dignity.”).
John Charles Kunich, The Naked Clone, 91 KY. L.J. 1, 3 (2002).
CASS R. SUNSTEIN, DESIGNING DEMOCRACY 49-52 (2001).
533569571
538
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
focused on the agreed concrete regulatory position (one of prohibition);
but, once things move on, the oppositional principles that presently drive
the panic are liable to break free and disrupt the consensus. For example, if
anxieties about safety or reliability could be assuaged, those who presently
cite such concerns in support of a prohibition on cloning might change their
tune, arguing initially for a cautious and controlled permissive position and
then, if and when doubts about safety and reliability have been largely laid
to rest, for an even more permissive position. In other words, the consensus
against human reproductive cloning is less deeply-rooted than it seems.
What we have is a happenstance convergence of essentially oppositional
bioethical constituencies drawn together by the contingencies of the
moment.13
When we turn to the regulation of so-called “therapeutic cloning,”14
or allied procedures involving the isolation and manipulation of human
embryonic stem cells, there is little sign of, or hope for, a consensus.
Nations that are united in condemning human reproductive cloning and
supporting its worldwide prohibition become divided when it is proposed
that therapeutic cloning, too, should be covered by the prohibition;15 and,
13.
14.
15.
For a nice example of “consensus by convergence,” see CALIFORNIA ADVISORY
COMMITTEE ON HUMAN CLONING, CLONING CALIFORNIANS? (Jan. 11, 2002)
[hereinafter CLONING CALIFORNIANS?], available at http://www.scu.edu/ethics/
publications/adbdreport.html. The many arguments against human reproductive
cloning are listed in Part IIB of the report.
“Cloning” may be defined as: “The process of asexually producing a group of cells
(clones), all genetically identical, from a single ancestor. A clone is genetically
identical to its parents and its siblings.” DEPARTMENT OF HEALTH (U.K.), Cm 5791-II,
OUR INHERITANCE, OUR FUTURE 90 (2003), available at http://www.dh.gov.uk/
assetRoot/04/01/92/39/04019239.pdf. The distinction between therapeutic and
reproductive cloning turns not so much on the process of cloning as on the purpose of
the cloner. Putting the matter in my own non-technical way, by “therapeutic cloning,”
I mean the process of engineering an egg that has an imported nuclear gene set
(designed to be compatible with a target patient or patients), such egg then being
stimulated to form an embryo from which embryonic stem cells are isolated.
Embryonic stem cell research involves, inter alia, developing processes for isolating
stem cells and then directing them to perform a specific differentiated cellular
function.
All 191 members of the UN agree in principle that there should be a declaration
banning human reproductive cloning. However, after four years of deliberation,
during which time efforts have been made to achieve a consensus covering the
regulation of all uses of cloning technology (reproductive and therapeutic) in humans,
the nations remain divided. Most recently, on February 18, 2005, the Legal
Committee voted seventy-one in favor and thirty-five against (with forty-three
abstentions) to recommend to the General Assembly that members should be called
on “to prohibit all forms of human cloning inasmuch as they are incompatible with
human dignity and the protection of human life.” Press Release, United Nations,
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
539
around the world, within nation states, a patchwork of regulatory
provisions is to be found. In some jurisdictions, there are outright
prohibitions; in others, the position is permissive but heavily qualified (for
example, restricting researchers to the use of supernumerary human
embryos); in others, the regulation is relatively liberal (notably that in the
United Kingdom);16 and, in yet others, we find a form of regulatory
schizophrenia with prohibition co-existing with permission.17 How are we
to account for the bioethical divisions that underlie these very different
regulatory positions? Why does the consensus supporting a prohibition on
human reproductive cloning evaporate so quickly when the regulatory issue
concerns therapeutic cloning?
One reason is that there is a popular tendency to look more favorably
on ethically questionable technologies that promise to deliver medical
benefits (as is the case with therapeutic cloning) as against those that do not
hold out the promise of such benefits; to be sure, humans value their wealth
but, in the end, it is their health that really matters. This tells against human
reproductive cloningand, in Europe at any rate, there is evidence that it
tells, too, against the genetic manipulation of crops.18 However, within the
bioethical community, the reason why there is no consensus in relation to
therapeutic cloning and stem cells is that the ethical hot-spot has moved on
16.
17.
18.
Legal Committee Recommends UN Declaration on Human Cloning to General
Assembly (Feb. 18, 2005) (U.N. Doc. GA/L/3271), available at http://www.un.org/
News/Press/docs/2005/gal3271.doc.htm. In this light, the hope expressed by the
representative of Germany to the effect that “the current system of anarchy over
human cloning would be overcome in the coming years and that consensus would
again be possible” looks somewhat forlorn. Id.
On February 8, 2005, the Human Fertilisation and Embryology Authority announced
that it had granted a licence to Professor Ian Wilmut (who led the team that cloned
Dolly the sheep) to undertake (non-reproductive) cloning of human embryos in order
to understand more about motor neuron disease and with a view to developing
therapeutic responses. Press Release, The Human Fertilisation and Embryology
Authority (U.K.), HFEA Grants Embryonic Stem Cell Research License to Study
Motor Neuron Disease (Feb. 8, 2005), available at http://www.hfea.gov.uk/
PressOffice/Archive/1107861560.
Such “schizophrenia” might be reflected in funding restrictions that do not map on to
the legislative scheme of permission and prohibition, or in prohibition subject to quite
unprincipled permissive exemption. See Samantha Halliday, A Comparative
Approach to the Regulation of Human Embryonic Stem Cell Research in Europe, 12
MED. L. REV. 40 (2004) (providing a helpful review of the regulatory scene in
Europe); Shawn E. Peterson, A Comprehensive National Policy to Stop Human
Cloning: An Analysis of the Human Cloning Prohibition Act of 2001 with
Recommendations for Federal and State Legislatures, 17 NOTRE DAME J.L. ETHICS &
PUB. POL’Y 217 (2003) (describing the regulatory scheme in the United States).
See generally BIOTECHNOLOGYTHE MAKING OF A GLOBAL CONTROVERSY (Martin
W. Bauer & George Gaskell eds., 2002).
533569571
540
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
to become the treatment (and destruction) of human embryos, not the
possibility of attempts at human reproductive cloning going wrong or being
abused. With the exception of dignitarian bioethicswhich holds
constantly to the view that human cloning, whether for reproductive or
therapeutic purposes, compromises human dignity and, thus, should be
prohibitedthis changes the ethical calculation; and, with that, the
bioethical and regulatory consensus breaks down.
The paper is in three parts. The first part sketches a “bioethical
triangle,” the three points of which capture the three leading bioethical
views in play in this fieldnamely, the views of utilitarians, human rights
theorists, and the dignitarian alliance. Although these views sometimes
generate a dual convergence (as often happens with (rule) utilitarians and
human rights theorists) and, exceptionally, a triple convergence (as with
human reproductive cloning), their default positions are essentially
oppositional. The second part explains how these three views relate to the
received (and, nowadays, regulatory) bioethical wisdom that researchers
should proceed only with the free and informed consent of participants.
Finally, the third part spells out how it is that the three views converge in
supporting a prohibition on human reproductive cloning (albeit that the
consensus might easily crack once what I call “micro reproductive cloning”
for “genetic connection,” rather than for “genetic compatibility” or, a
fortiori, for “genetic characteristics,” is brought clearly into view); why it
is that these views diverge in arguing for a range of regulatory positions in
relation to therapeutic cloning; and how they view the slippery slope
argument that the latter type of cloning must be prohibited lest it opens the
door to the former.
I. THE BIOETHICAL TRIANGLE
The International Bioethics Committee (IBC) of UNESCO has been
in the vanguard of attempts to forge a worldwide bioethical consensus,
publishing its Universal Declaration on the Human Genome and Human
Rights in 1997.19 In 2004, the Committee began work on its most ambitious
project to date, the drafting of a Universal Declaration on Bioethics.
Having gone through several drafts, the Declarationnow published in the
form of a Preliminary Draft Declaration on Universal Norms on
Bioethics20expresses as one of its aims an idea that is axiomatic for the
19.
20.
Universal Declaration on the Human Genome, supra note 3; see also International
Declaration on Human Genetic Data, UNESCO, 32d Sess., at 39, 32 C/Res. 22
(2003) available at http://unesdoc.unesco.org/images/0013/001331/133171e.pdf.
Preliminary Draft Declaration on Universal Norms on Bioethics, UNESCO, Int’l
Bioethics Comm., Extraordinary Sess., SHS/EST/CIB-EXTR/05/CONF.202/2 (Feb.
9, 2005) [hereinafter IBC Declaration], available at http://portal.unesco.org/shs/en/
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
541
IBC, namely: “to recognize the importance of freedom of scientific
research and the benefits derived from scientific and technological
developments, whilst ensuring that such developments occur within the
framework of ethical principles that respect human dignity and protect
human rights and fundamental freedoms.”21
Having articulated a number of general principles (including “full
respect for the inherent dignity of the human person, human rights and
fundamental freedoms”22) as well as seeking to ensure that bio-decisions
and bio-practices “seek to benefit the person concerned and to minimize
[any] possible harm,”23 the Declaration lists a number of more particular
principles including non-discrimination and non-stigmatization, autonomy
and individual responsibility, informed consent, and privacy and
confidentiality.24 There is a long way to go with this Declaration, but
already the influence of the bioethical triangle is evident. First, it is
declared that the benefits of the biosciences need to be recognized; benefits
are to be optimized, harms minimized. Secondly, human rights are to be
taken seriously, and this shines through not only in the general principles,
but also in the more particular principles that flag up autonomy and
responsibility, privacy and confidentiality, non-discrimination and nonstigmatization, and (as we will see further in Part II) consent. Thirdly,
human dignity is not to be compromised. Before taking a more careful look
at each of these three ingredients, it is worth emphasizing that the
Declaration rightly reflects the sense in which today’s bioethics has
developed from being a dialogue to become, as it were, a trialogue.
For the last twenty-five or thirty years, the headline story in bioethics
has concerned the tension between utilitarian promotion of the general
good and the constraints imposed if individual rights are to be taken
seriously, with theorists coming from a human rights perspective seeking to
prioritize individual rights, the costs and inconvenience of compliance
notwithstanding. In particular, it is now axiomatic (in exactly the way that
the Declaration puts it) that best practice demands careful attention to free
and informed consent (consent going hand in hand with the recognition of
human rights), that the capacity for autonomous decision-making should be
respected, that privacy and confidentiality should be protected, and so on.
Moreover, given the historic abuse of persons (particularly the vulnerable)
who have been co-opted into research trials without being told what is
going on, there is a very good reason for human rights bioethicists to be so
21.
22.
23.
24.
file_download.php/10d16a8d802caebf882673e4443950fdPreliminary_Draft_EN.pdf.
Id. art. 3(iii).
Id. art. 4(a).
Id. art 6.
Id. arts. 8-11.
533569571
542
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
insistent about the importance of rights and consent.
In the dialogue between proponents of utilitarian and human rights
perspectives, the opening moves will often involve some trumpeting of the
potential benefits of the particular science or technology with,
concomitantly, a temptation to underplay its downside. For example, in the
United Kingdom, when the House of Lords Select Committee took
evidence on the benefits to be obtained if licences could be granted for
human embryonic stem cell research, estimates as to the availability of the
first transplantation treatments ranged from five to thirty years.25 If
utilitarians can take a more or less optimistic view of the benefits, equally
they can take a more or less pessimistic view of the risks or costs. “Green”
utilitarians, for example, who argue from the precautionary principle, adopt
just such a cautious approach. There are also intra-utilitarian issues about
the timescale within which the relevant cost-benefit calculations are to be
madeutilitarians who take a longer-term view might well arrive at a
different judgment to those who take a shorter-term view. Ultimately,
though, these are matters for debate that are internal to the utilitarian
perspective.
If particular utilitarian judgments are contested, and rejected, not by
reference to a common calculus, but as a matter of principle, then this will
often be for reasons relating to human rights and human dignity or decency.
When it became apparent that modern biotechnology was lining up a new
agenda for regulators, Mary Warnock helpfully spelled out our ethical
options in the following terms:
Technology has made all kinds of things possible that were
impossible, or unimaginable in an earlier age. Ought all these
things to be carried into practice? This is the most general ethical
question to be asked about genetic engineering, whether of
plants, animals or humans. The question may itself take two
forms: in the first place, we may ask whether the benefits
promised by the practice are outweighed by its possible harms.
This is an ethical question posed in strictly utilitarian form. . . . It
entails looking into the future, calculating probabilities, and of
course evaluating outcomes. “Benefits” and “harm” are not self-
25.
House of Lords Select Committee Report, supra note 8, at ch. 2; see also
Brownsword, supra note 5 (discussing the Select Committee’s report); Maureen L.
Condic & Samuel B. Condic, The Appropriate Limits of Science in the Formation of
Public Policy, 17 NOTRE DAME J.L. ETHICS & PUB. POL’Y 157 (2003) (discussing the
need to take a hard look at the scientific pitch, which, characteristically, presents work
as promising, in need of more research and funding, and not aided by regulatory
restriction); Margaret R. McLean, What’s in a Name? “Nuclear Transplantation” and
the Ethics of Stem Cell Research, 53 HASTINGS L.J. 1017, 1031-33 (2002) (regarding
the claims made for stem cell research).
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
543
evidently identifiable values. Secondly we may ask whether,
even if the benefits of the practice seem to outweigh the dangers,
it nevertheless so outrages our sense of justice or of rights or of
human decency that it should be prohibited whatever the
advantages.26
Although utilitarian reasoning is commonly relied on to argue in favor
of facilitating biotechnological research and development (not least in the
patent system), the problem with utilitarian calculations is that they are
capable of outraging our sense of justice particularly by authorizing the
pursuit of the larger benefit at the cost of individual human rights. This
invites a principled resistance to utilitarian pragmatism of the kind that is
familiar, not just in biolaw and bioethics, but right across the board of
practical affairs.27 As John Rawls famously proclaimed, when advancing
his rights-driven account of justice in A Theory of Justice,28 it was the
utilitarian view that was his foil and principal rival.
If bioethics was once a two-way contest between utilitarians and
human rights theorists, this is no longer the case. To be sure, there are some
up-and-coming bio-issueslarge scale genetic databases, such as that
being developed by the UK Biobank, are probably a case in pointwhere
the opposition is still primarily between utilitarian and human rights
considerations. However, the key change is that there is now a new
dignitarian ethic on the block. Moreover, when we are trying to capture
concerns about modern biotechnology, this is the ethic that really matters.
Quite simply, this new perspective condemns any practice, process or
producthuman reproductive cloning being the prime examplewhich it
judges to compromise human dignity. Such condemnation (by reference to
human dignity) operates as a “conversation stopper”;29 but the dignitarians
are not troubledto say that something violates human dignity is the
ultimate condemnation. Of course, it is not just human reproductive cloning
26.
27.
28.
29.
Baroness Mary Warnock, Philosophy and Ethics, in GENETIC ENGINEERING—THE
NEW CHALLENGE 67 (C. Cookson et al. eds., 1993).
See generally RONALD DWORKIN, TAKING RIGHTS SERIOUSLY (rev. ed., London,
Duckworth, 1978).
JOHN RAWLS, A THEORY OF JUSTICE (1971).
See Dieter Birnbacher, Do Modern Reproductive Technologies Violate Human
Dignity?, in IN VITRO FERTILISATION IN THE 1990S 325 (Elisabeth Hildt & Dietmar
Mieth eds., 1998). Cf. NUFFIELD COUNCIL ON BIOETHICS, GENETICALLY MODIFIED
CROPS: THE ETHICAL AND SOCIAL ISSUES 96 (1999), available at
http://www.nuffieldbioethics.org/fileLibrary/pdf/gmcrop.pdf. Those who contend that
genetic modification is intrinsically wrong or unnatural present views that “have
something of an ‘unarguable’ quality, inasmuch as no amount of information,
explanation or rationalisation would move a person with such views from their
position.” Id.
533569571
544
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
that the dignitarians see as compromising human dignity. There is a whole
inventory of practices which they believe should be resisted on just this
ground. For example, they reject germ-line gene therapy or genetic
manipulation, sex selection, and commodification of the human body
(running from prostitution and surrogacy to organ selling). Opponents of
therapeutic cloning and stem cell research also like to appeal to the dignity
of the human embryo.30
The emergence of the new dignitarian view creates a genuinely
triangular contest, the dignitarians disagreeing as much with the utilitarians
as they do with the human rights constituencywith the former because
they do not think that consequences, even entirely “beneficial”
consequences (that is, “beneficial” relative to a utilitarian standard), are
determinative; and with the latter because they do not think that informed
consent cures the compromising of human dignity. A nice illustration is the
French dwarf-throwing case that went to the Conseil d’État in the mid1990s.31 What happened there was that the local police banned dwarfthrowing in clubs in two areas in France. One of the dwarfs, Manuel
Wackenheim, brought a challenge against these bans, claiming that they
were unconstitutional. The appeal worked its way up to the Constitutional
Court where the court confirmed, first, that human dignity is an element of
the French notion of ordre public and, secondly, that dwarf-throwing
compromises human dignity and, thus, is a violation of ordre public. The
bans had been properly imposed.32
Yet, why should this be so? As Manuel Wackenheim argued, he
participated freely; those who threw the dwarfs did so freely; all
participants were adults; there was no forced choice; it was a model of free
and informed consent. Moreover, for those who appeal to human dignity,
how do they justify the indignity of being forced to rely again on State
welfare payments or charity? This is demeaning and degrading and not at
all good for one’s sense of self-esteem. However, the new dignitarians
would say that the Conseil was exactly right. The fact that one might be
30.
31.
32.
Likewise, those who oppose the relaxation of the restrictions on PGD and HLA
tissue-typing make similar appeals. See, e.g., Sarah Boseley, Green Light for
“Designer Babies” to Save Siblings, THE GUARDIAN, July 22, 2004, at 1, 3, available
at http://www.guardian.co.uk/uk_news/story/0,,1266344,00.html (embryos should not
be instrumentalized); see also R. (on the application of Quintavalle) v. Human
Fertilisation and Embryology Authority, [2004] Q.B. 168; Roger Brownsword,
Reproductive Opportunities and Regulatory Challenges, 67 MOD. L. REV. 304 (2004)
(commenting on the Court of Appeal’s decision).
Ville d’Aix-en-Provence, 1996 Dalloz 177 (Conseil d’Etat) req. nos. 143-578; Cne de
Morsang-sur-Orge, 1995 Dalloz 257 (Conseil d’Etat) req. nos. 136-727.
See Marie-Christine Rouault, Note: L’interdiction Par un Maire de L’attraction Dite
de Lancer de Nain, 11 LES PETITES AFFICHES 30, 32 (1996).
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
545
able to justify dwarf-throwing, where no one gets seriously hurt, on
utilitarian grounds is completely irrelevant, as is Wackenheim’s argument
that the participants gave their informed consenthuman rights, too,
misses the point.
In this light, we might pause over the thesis advanced by Francis
Fukuyama in Our Posthuman Future.33 Recalling the dystopian visions
painted by George Orwell in 1984 and Aldous Huxley in Brave New
World, Fukuyama argues that it is modern biotechnology’s pathway to the
latter that should concern us. In his view, we do not need to be unduly
concerned by the Orwellian nightmare because, although we have intrusive
information technology, the Internet in particular is a largely benign
development.34 And, where such technology presents dangers, we are
already on regulatory alert because they are fairly obvious ones. On the
other hand, with biotechnology we are much more at risk, for this is a
dangerous technology which does not advertise its deepest dangers.
According to Fukuyama, whilst we rightly worry about safety, unintended
consequences, unforeseen costs, and the like, the deepest fear that people
express about biotechnology is not a utilitarian one. Rather, it is a fear that,
in the end, biotechnology will cause us to lose our humanitythat is, some
essential quality that has always underpinned our sense of who we are and
where we are going: none other in fact than our human dignity. Or, to put
this another way, the deepest danger presented by modern biotechnology is
not that it might go wrong (as utilitarians fear) or that it might be abused
(as human rights theorists worry), but that it might actually work.
Confusingly, human dignity is a key idea in two corners of this threeway contest.35 Utilitarians can squeeze some disutility out of concerns
about human dignity, but the idea that we should disallow a practice
because human dignity is compromised is not a prominent feature of
utilitarian thinking. With the human rights constituency, however, matters
could scarcely be more different. Human rights theorists believe that the
entire apparatus of human rights is premised on the principle of respect for
human dignity. This premise is written into the historic human rights
instruments of the mid-Twentieth Century. According to the Preamble and
Article 1 of the Universal Declaration of Human Rights, the fundamental
premise is that we each have inalienable and intrinsic human dignity. This
is why we have human rights. The jump from human dignity to human
rights actually bears closer examination but it is the move that is standardly
33.
34.
35.
FRANCIS FUKUYAMA, OUR POSTHUMAN FUTURE 3-17 (2002).
See Roger Brownsword, What the World Needs Now: Techno-Regulation, Human
Rights and Human Dignity, in HUMAN RIGHTS 203 (Roger Brownsword ed., 2004).
See DERYCK BEYLEVELD & ROGER BROWNSWORD, HUMAN DIGNITY IN BIOETHICS AND
BIOLAW 11 (2001).
533569571
546
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
made. If the question is why we have human rights, the stock answer is:
“Because we have human dignity.”36
In the dignitarian corner, too, respect for human dignity is
fundamental but not as the underpinning of human rights and individual
autonomy. Drawing on a mixture of Kantian, Catholic and communitarian
credos, this constituency registers its discomfort with various aspects of
new technology by contending that human dignity is compromised. If we
value a rights-driven conception of autonomy, this is bad news (as Manuel
Wackenheim found to his cost); if we take a utilitarian view, it is also an
annoyance; but if we fear, say, genetic discrimination or if we sense a
certain insouciance about the way in which human embryos are committed
for research, we might find some solace in the protective scope of new
dignitarianism.37
Stated shortly, then, the bioethical triangle, capturing many of the
currents in today’s bioethical debates, is constituted by a utilitarian stream
of thinking, a rights-led human rights perspective (founded on respect for
the inalienable and intrinsic dignity of humans), and a duty-driven
dignitarian view. If we were able to follow Cass Sunstein’s advice, we
would do well to let sleeping dogs lie; a working consensus is consensus
enough even if it is incompletely theorized.38 However, these dogs are light
and restless sleepers; before long, it is inevitable that they will wake.
II. PUTTING CONSENT ON THE BIOETHICAL MAP
It is an axiom of modern bioethics that the principle of informed
consent should be respected. Not surprisingly, Article 10 of the IBC
Preliminary Draft Declaration provides as follows:
(a) Any decision or practice in the field of scientific research
shall only be made or carried out with the prior, free, informed
and express consent of the persons concerned. Such consent may
be withdrawn by the person concerned at any time and for any
reason without any disadvantage or penalty.
(b) Any decision or practice regarding the medical diagnosis and
treatment of a person shall only be made or carried out with the
consent of the person concerned, based on information
appropriate to the decision, and with the ongoing participation of
such person.
36.
37.
38.
Roger Brownsword, Bioethics Today, Bioethics Tomorrow: Stem Cell Research and
the “Dignitarian Alliance,” 17 NOTRE DAME J.L. ETHICS & PUB. POL’Y 15, 21 (2003).
See id. at 33-34.
See SUNSTEIN, supra note 12, at 49-55.
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
547
(c) In any decision or practice involving persons who do not
have the capacity to consent, special protection shall be given to
such persons. Such protection shall be based on ethical and legal
standards adopted by States, consistent with the principles set out
in this Declaration.39
The Declaration does not indicate how the principle of informed
consent (and, concomitantly, the right to withdraw) relates to the more
general principles that are set out in the instrument. And, because consent
now assumes such an importance in bioethics (almost to the point of
becoming a free-standing value), it is essential to understand its derivative
relationship to the higher order trinity of utility, human rights, and human
dignity. In each case, we can consider what the more fundamental principle
would make of (i) the need for free and informed consent, (ii) the right to
withdraw consent, and (iii) the adoption of a best interests test where a
person is not capable of giving consent (assuming that “best interests” is a
generally-adopted test).
A. Utilitarianism and Consent
Utilitarians count utility and disutility; and, for utilitarians, utility and
disutility is all that counts. As such, there is nothing special about consent
or the lack of it. In general, it is easy to see the negatives in relation to
consent collection. Obtaining consent might not always be practicable;
where it is, it nevertheless incurs transaction costs; and, on some occasions,
it might be downright distressful. Waiting for consents to be cleared might
involve opportunity costs. Moreover, policies might be frustrated if, instead
of saying “yes,” those who are asked to consent say “no.” On the other
hand, dealing on the basis of consent might ease matters ex ante, it might
allay concern and weaken opposition, and it might be a convenient
justificatory response ex post. Thus, there is no golden rule requiring that
the consent of those whom an action or decision impacts should be
obtained. For example, requiring researchers or doctors to deal on an
informed consent basis with research participants or others is not
necessarily an improvement on compulsion, ignorance, or paternalism. The
calculation always depends on context, convenience, contingency, and
circumstance. Having said this, in a culture where preferences strongly
favor the currency of consent, even if there is no golden rule requiring
consent, utilitarians might well accept the sense of a general rule to this
effect.40
39.
40.
IBC Declaration, supra note 20, art. 10.
Consent is said to be the fundamental principle underlying the new UK human tissue
legislation. According to a House of Commons Research Paper, the government’s
approach is essentially utilitarian. See generally Research Paper, House of Commons,
533569571
548
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
In the light of this thumbnail sketch, it is clear that utilitarians have no
commitment to consent, even less to any particular specification of an
adequate consent, with all that that entails in relation to unforced and
informed choice, express and unequivocal signaling, and so on. Utilitarians
will not argue for consent through thick and thin; and, if they do argue for
consent, their specification of the conditions of adequacy will be either
thick or thin as circumstances and consequences dictate.
When the draft Declaration says that consenting parties may withdraw
their consent at any time, this conjures up visions of a person withdrawing
from participation in a research trial or discontinuing a treatment or the like
(and, of course, doing so at a time when it is still practically possible to pull
out). From a utilitarian perspective, this will probably be seen as unhelpful
and wasteful of resources. However, it might be much worse. If the
withdrawal relates to tissue or samples that are difficult to substitute and
that are of significant medical benefit or commercial value, this could
really weigh the utilitarian scales against making it easy to withdraw. So,
for example, if there is a shortage of human eggs or donated embryos for
therapeutic cloning purposes, utilitarians might regard advertising the
option of withdrawal as a hostage to fortune. Indeed, from a utilitarian
perspective, the most efficient consent is one that is broadly drafted (so that
researchers do not have to keep returning to the consenting parties to seek
their authorization for variation of the terms of the consent) and one that,
once given, is not retractable.
The case of persons who cannot consent needs a little prior
clarification. In principle, there are many categories of subjects who are not
capable of giving consentthere are those (such as embryos, fetuses and
neonates) who, normal development permitting, will have the capacity to
consent, those whose development has been impaired such that they do not
have the capacity to consent, and those who once had the capacity but who
no longer have it (such as persons suffering from dementia or who are in a
persistent vegetative state). Typically, legal systems handle such cases by
relying on a best interests test or a test involving a substituted judgment.41
41.
The Human Tissue Bill, (Apr. 4, 2004), available at http://www.parliament.uk/
commons/lib/research/rp2004/rp04-004.pdf. The research paper says that the
government believes that the effect of the consent provisions will be to “prevent a
recurrence of the distress caused by retention of tissue and organs without proper
consent,” to “help improve public confidence so that people will be more willing to
agree to valuable uses of tissue and organs” (such as for research and transplantation
purposes), and to “improve professional confidence so that properly authorized
supplies of tissue for research, education and transplantation can be maintained and
improved.” Id. at 4. Quite probably, this is enlightened utilitarian thinking, but the
point is that it is a utilitarian approach to consent.
See Louise Harmon, Falling off the Vine: Legal Fictions and the Doctrine of
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
549
Where such tests bring in representative parties, the worry for a utilitarian
is that they threaten to interfere with the pursuit of utility, particularly
where the representatives refuse to consent to a course of action that is seen
as having beneficial consequences. Accordingly, in the hands of
utilitarians, tests of best interests or the like are liable to become tokens for
utilitarian judgments.42
As for those, such as embryos, fetuses, and young children, who do
not yet have the capacity to consent, utilitarians will distinguish between
those who are sentient and those who are not. If fetuses and young children
can experience pain, then their distress counts as a disutility. However, if
we assume that an embryo experiences no pain, it is neither a subject of
consent nor a subject in distress and it is not, so to speak, a stakeholder in
the ethical calculation. Clearly, this is of some considerable relevance with
regard to the ethics of using embryos for therapeutic cloning and stem cell
research.
B. Human Rights and Consent
Against the utilitarians, human rights theorists hold that what counts
is respect for individual autonomy, entailing recognition of the right of
individuals to make their own choices, to exercise control over their own
person, property, and privacy, and to say “yes” or to say “no.” Taking
individuals seriously and taking rights seriously means taking consents and
refusals seriously.
Viewed from a human rights perspective, consent by A might signal
either a change of position or the creation of a new relationship. There is a
tendency to focus more on the former than the latter, that is, on consent
signalling A’s willingness to modify his or her position in relation to the
particular background scheme of rights and duties, permissions and
immunities, and the like, that regulates his or her relationship with B (the
recipient of the consent). As George Fletcher puts it: “When individuals
consent to undergo medical operations, to engage in sexual intercourse, to
open their homes to police searches, or to testify against themselves in
court, they convert what otherwise would be an invasion of their person or
42.
Substituted Judgment, 100 YALE L.J. 1 passim (1990) (discussing the short step—and
its potential utilitarian capture—from actual consent to fictional consent).
Cf. Re A (Children) (Conjoined Twins: Surgical Separation) 4 All E.R. 961 (2000). In
this case, there was a plausible utilitarian argument for surgical separation: in order to
save the life of one twin when, without separation, both twins would perish. To dress
this up as being in the “best interests” of the twin who is not to be saved, however, is
surely less plausible. For a cross section of academic opinion on this case, see the six
papers in 9 MED. L. REV. 201-98 (2001).
533569571
550
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
their rights into a harmless or justified activity.”43
The latter function (the creation of a new relationship), however,
should not be ignored. Where A signals consent to the creation of a new
relationship with B, this might be by virtue of some simple dynamic (such
as the giving of a promise or agreement to an exchange of goods); or it
might be by virtue of some more complex institutional set (as is the case,
for example, if A invokes the law of contract or the law of marriage) or
regulated scheme (such as one licensing assisted conception or physicianassisted suicide). Where A thus signals consent, then other things being
equal, A is precluded from asserting that B may not justifiably rely on, or
hold A to, the agreed change of position or the terms of the new
relationship. Whether A signals a change of position or agreement to the
creation of a new relationship, consent functions as a procedural
justification (for the benefit of the recipient B) rather than as a full
substantive justification of the kind that would be appropriate if one were
arguing for a particular human right itself.
For consent to operate as any kind of justification it must be
“adequate.” In the human rights community, it has become a mantra to
insist that consent must be free and informed. However, unforced choice
and informed choice are just elementsgranted, very important
elementsin a larger theory setting the criteria for an adequate consent.
Given that consent operates to effect a significant lowering of the rightsholder’s shield (by authorizing the duty-bearer to act in a way that would
otherwise involve a violation of right) or to bring into effect a wholly new
relationship that burdens the power-holder with additional obligations,
human rights theorists will be much influenced by the importance of
ensuring that the party who appears to be consenting really intends to do
just that. This tends towards the adoption of thick conditions of adequacy,44
including a subjectivism that seeks to track the private intentions of the
party who seems to be consenting. However, giving consent is a public act,
set in the context of a transaction with another party, and human rights
theorists cannot ignore the interests of the recipient of the apparent consent.
This tends towards some thinning of the conditions of adequacy and some
movement towards a more objective reading of the signals sent by the party
who is alleged to have consented.
From a human rights perspective, it is tempting to argue that
withdrawal of consent must always be an option so long as the recipient has
not proceeded to the point where reversal is no longer practically possible.
However, on reflection, a distinction probably needs to be drawn between:
43.
44.
GEORGE P. FLETCHER, BASIC CONCEPTS OF LEGAL THOUGHT 109 (1996).
See, e.g., International Declaration on Human Genetic Data, supra note 19, arts.
6(d), 8 (describing consent requirements).
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
551
(i) withdrawing a consent that has authorized a duty-holder to act in a way
that would otherwise violate a right, and (ii) withdrawing a consent that
involves the exercise of power. Whilst in the former case, it must be taken
as understood that the consent is retractable (that is, such is a reasonable
implicit expectation), this is not obviously so in the latter case. For
example, if a person consents to participate in a clinical trial (the first kind
of case), it must be implicit that withdrawal at any time is an option;
whereas, if the person consents to donate tissue, it might be incumbent on
the donor to make an explicit reservation about withdrawalafter all, even
in a human rights community, a gift is normally understood to be a gift
without qualification unless a caveat is expressly mentioned.
This leaves the question of the capacity to consent. To repeat, those
who lack the capacity to consent fall into more than one category: some are
not yet “subjects of consent” (as it would be put by a human rights
theorist), others never will be, and others once were but no longer are. In
general, human rights theorists will try to keep faith with the expressed will
(the autonomy) of those who consented while they had the capacity (in the
form of advance directives and the like); but, otherwise, it is improper to
proceed as though those who are not subjects of consent are consenting. To
deal with these latter cases, human rights theorists need to determine where
the boundaries of the community of rights are drawn.45 If we are dealing
with a rights-holder, albeit one who is not able to consent, respect for the
relevant rights is directly required; such persons, even if not capable of
consenting, are still ethical stakeholders in a community of rights.
However, if we are not dealing with a rights-holder (as might be thought to
be the case in relation to, say, a human embryo or a fetus), respect for
rights is, at most, only indirectly required.46 If human rights theory fails to
provide any protective cover to life-forms that are judged to lack rights, the
45.
46.
Cf. Vo. v. France, App. No. 53924/00 (Eur. Ct. H.R. 2004), available at
http://www.echr.coe.int. In this case, the applicant challenged a decision of the Cour
de Cassation in which the court refused to treat a doctor’s unintentional termination
of the applicant’s six-month pregnancy as a criminal act and, thus, declined to treat
the fetus as a life protected by the criminal law. The majority of the court held that the
French decision was compatible with Article 2 of the Convention (concerning the
right to life). According to the court, there was no consensus in Europe on the nature
and status of the embryo and/or fetus. At best, it could be regarded as common
ground between states that the embryo/fetus belonged to the human race. Its potential
and capacity to become a person required protection in the name of human dignity,
without making it a person with the right to life for the purposes of Article 2. In other
words, rights-bearing humans must at least be born; for unborn humans, it is human
dignity that does the protective work.
The force of such indirect protection, however, is not to be discounted. See
BEYLEVELD & BROWNSWORD, supra note 35, at ch. 6 (suggesting a radical approach,
combining precaution and proportion to generate a possible—direct—rights claim).
533569571
552
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
scope of its constraints is much narrower than that of the utilitarians and the
dignitarians. On this account, we might say that, while human rights sets a
demanding standard for the ethics of corporate social responsibility, it
recognizes a relatively restricted class of stakeholders who are direct
beneficiaries of this approach.
C. Dignitarians and Consent
The third constituency is the dignitarian alliance, whose fundamental
axiom is that human dignity must not be compromised. It is an “alliance”
because, as I have said, there is more than one pathway to this
ethicKantian and communitarian as well as religious. So, for example, if
we were to express the dignitarian perspective in communitarian terms, we
would say that human dignity is a good which must not be compromised by
our actions or practices and that any action or practice that compromises
this good is unethical irrespective of welfare-maximizing consequences and
regardless of the informed consent of the participants.
For the dignitarians, it is the duty to respect human dignity that is
fundamental. Because it takes such a duty-led approach, rights are a reflex
of the prior duties; and transactions with rights-holders are governed by the
duty side of the relationship not by the rights side. So, for example, if
dignitarians hold that there is a duty not to engage in prostitution, because
the commodification of the body compromises human dignity, it follows
that humans have both a right not to be pressed into prostitution as well as a
duty not to engage in the trade. The fact that a person consents to
participate in the trade does not release them from the duty. They remain
duty-bound not to compromise human dignity; and this is something that is
simply not negotiable or waivable.
The well-known German Peep-Show Decision,47 handed down by the
Federal Administrative Tribunal, provides a forceful exemplification of the
way that dignitarians subordinate consent given by individuals to the larger
responsibilities of subjects. There, the Tribunal denied a licence for a
mechanical peep-show on the ground that the performance would violate
Article 1(1) of the Basic Law. Having affirmed that “respect for and
protection of human dignity are constituent principles of the Basic Law,”
and, having said that in the peep-show, “the woman is placed in a
degrading position [and] treated like an object,” the Tribunal continued:
The consent of the women concerned can only exclude a
violation of human dignity if such a violation is based only on
the lack of consent to the relevant actions or omissions of the
47.
BVerwGE 64 (1981) 274; see also Shayana Kadidal, Obscenity in the Age of
Mechanical Reproduction, 44 AM. J. COMP. L. 353 (1996).
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
553
women concerned. However, this is not the situation here
because in the case at issue . . . the human dignity of the women
concerned is violated by the exposition typical of these
performances. Here, human dignity, because its significance
reaches beyond the individual, must be protected even against
the wishes of the woman concerned whose own subjective ideas
deviate from the objective value of human dignity. 48
In other words, human dignity represents an “objective value” or
good (reaching beyond the individual) such that, if an act violates this
value, human dignity is compromised irrespective of whether the party so
acting freely agrees to perform the act in question. Where human dignity so
conceived is at stake, free choice (including free consent) is irrelevant.
The force of the dignitarian position can be drawn out in another way.
When dignitarians complain about a person being “instrumentalized,” or
(as it might be expressed in Kantian language) “used merely as a means,” it
is sometimes responded that the person has not been so instrumentalized or
used because consent was given. From a rights-led perspective, this signals
that the (consenting) party is also being treated as an end and all is well.49
However, from a dignitarian duty-driven perspective, all is not well. Far
from itif instrumentalization is involved, this is being used as a mere
means; where human dignity is compromised, it cannot be squared by
consent.
In the light of these remarks, it will be apparent that the giving of
consent, the withdrawing of consent and, indeed, the capacity to consent
are simply not focal ideas for dignitarians. The giving or withdrawing of
consent (whether by the principal or by a representative) makes no
difference to the duty not to compromise human dignity; the duty is not
switched off by the obligee’s consent or switched on again by the obligee’s
withdrawal of consent. In the same way, the duties do not vary according to
whether the duty-holder is dealing with one who has the capacity to
consent or with one who does not. The duties are owed to members of the
human species (or, in a communitarian account, to members of the
community) and it is the interests of all members that count, not merely
those of the consenting community. Crucially, this means that dignitarians
stand up for the interests of the human embryo even if this is not yet a
person with the capacity to consent or to experience pain and distress.
48.
49.
BVerwGE 64 (1981) at 277-79.
Cf. Howard Florey/Relaxin, (opposition by Fraktion der Grunen Im Europischen
Parlament; Lannoye), 1995 E.P.O.R. 541 (Germany); Roger Brownsword, The
Relaxin Opposition Revisited, 9 JAHRBUCH FÜR RECHT UND ETHIK 3 (2001).
533569571
554
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
D. The Integrity of Consent
These remarks can be drawn together by focusing briefly on the
integrity of consent. In principle, the integrity of consent (understood as a
correlate of human rightsthat is, as a categorical consideration but one
that is parasitic on the background scheme of rights, duties and powers)
might be challenged from two directions, from the direction of those who
undervalue it and from the direction of those who overvalue it.
In terms of the bioethical triangle, it is the utilitarians and dignitarians
who represent the threat of undervaluation. Utilitarians do so by treating
consent as a contingent requirement; while, for the dignitarian alliance,
consent is never conclusive and it might not even be relevant.
The opposite threat, that of overvaluation, arises where consent
becomes a fetish or a fixation.50 At worst, this treats consent as a freestanding ethic; but this is not a mistake that we can yet accuse the drafters
of the Declaration of making. Nevertheless, we need to be alert to the risk
that consent slips its moorings in human rights theory and that too much is
claimed in consequence of its presence (consent being claimed to remove
all objections) or in consequence of its absence (lack of consent being
claimed to entail that action is ethically problematic). There are already
enough fictions and fallacies concerning consent and we should not add to
them.51 If the integrity of consent is to be maintained, it must not only be
confined to the bioethical triangle, but anchored specifically to the human
rights point of the triangle.
III. REGULATING CLONING: CONVERGENCE AND DIVERGENCE
Having set out the terms of the bioethical triangle and related its three
pointsthe utilitarian, human rights, and dignitarianto the idea of
consent, much of the hard analytical work has been done. To be sure, we
still have to draw some distinctions that encourage thinking about cloning
in a more fine-tuned way, inviting the view that there is, as it were, cloning
and “cloning.” However, the principal purpose of this part of the paper is to
apply the background bioethical analysis to the regulation of cloning,
human reproductive and therapeutic, and then to the argument that
therapeutic cloning, even if not ethically objectionable in itself, needs to be
prohibited lest the way is paved for human reproductive cloning.
50.
51.
See ONORA O’NEILL, AUTONOMY AND TRUST IN BIOETHICS 47-48 (2002) (making
some critical remarks on the modern tendency towards a “fixation” with consent).
See Roger Brownsword, The Cult of Consent: Fixation and Fallacy, 15 KING’S C. L.J.
223 (2004).
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
555
A. Human Reproductive Cloning
Broadly speaking, in relation to human reproductive cloning, there is
a double consensus, namely: (i) that it is unethical; and (ii) that it needs to
be prohibited. This seems clear enough; and, without doubt, the consensus
straightforwardly reflects the dignitarian position, according to which
human reproductive cloning—in any of its possible manifestations—
compromises human dignity. Yet, are all acts of human reproductive
cloning to be likened to one another in this sweeping fashion? In
condemning human reproductive cloning tout court, is there any possible
danger that we might be throwing out the (legitimate cloned) baby with the
(illegitimate) bathwater?
Consider the following two distinctions. First, there is a distinction
between, so to speak, micro and macro cloning; a distinction between
cloning just one person (micro) as opposed to cloning many persons,
groups, classes, or even whole populations (macro). Secondly, there is a
three-way distinction between cloning for genetic connection, cloning for
genetic compatibility, and cloning for genetic characteristics. In the first
case, the cloners simply want to maintain a genetic lineage (regardless of
its particular genetic makeup); in the second case, lineage is not enough, it
is the genetic compatibility of the clone with the cloner that mattersfor
example, a person with leukaemia wishes to clone herself in order to
produce a tissue compatible clone to serve as a bone marrow donor.52 In the
third case, it is the substantive genetic specification that matters, not its
pedigree.53 To repeat, for dignitarians, such distinctions are immaterial;
52.
53.
For this example, I am indebted to Ronald Chester. See Ronald Chester, Cloning for
Human Reproduction: One American Perspective, 23 SYDNEY L. REV. 319, 339
(2001).
Cf. John A. Robertson, Liberty, Identity, and Human Cloning, 76 TEX. L. REV. 1371
(1998). Robertson places his heaviest emphasis on the distinction between couples
who want a cloned child that they intend to rear and couples who have no such
intention to rear the child, his position being that the claims of the former are far more
compelling than those of the latter. Id. at 1395-1401. However, even if a couple
intends to rear their cloned child, it matters (so I would contend) whether they are
seeking to maintain a genetic connection or whether they are more concerned with the
genetic characteristics of the child. If the latter, then it matters whether they are
concerned to eliminate a serious disease that runs in the family or whether they are
interested in other characteristics. If the latter, then a very hard look needs to be taken
at their case for cloning a child. Robertson (rightly, I think) indicates his reservations
thus:
A pervasive concern about cloning is the risk that choosing the child’s
DNA will turn the child into a mere instrument or object to satisfy
parental agendas that conflict with treating the child as an end in herself.
Although responsible families can successfully negotiate those dangers,
533569571
556
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
human reproductive cloning—whether micro or macro, whether for
connection, compatibility, or characteristics—compromises human dignity
and it needs to be prohibited, period. The question, however, is whether
utilitarians or human rights theorists will identify these distinctions as
potentially material to their ethical and regulatory judgments. To simplify
the discussion, let me structure these reflections around the distinction
between micro and macro human reproductive cloning (although the
distinction between cloning for connection, compatibility, or characteristics
will soon have to be fed in).
What would utilitarians make of micro human reproductive cloning?
The most plausible context for such an enterprise is of the kind suggested
by John Harris in his broadside against those who unreflectively condemn
human reproductive cloning.54 What Harris has in mind are hard case
family situationsfor example, why not permit couples whose gametes are
not usable to make use of cloning technology in order to have a genetically
related child (micro cloning for genetic connection), or parents who have
lost their only child, say a much-loved daughter, to clone a child that is as
full a replacement as is genetically possible (micro cloning for genetic
connection and genetic characteristics)? In this kind of setting, micro
cloning is to be viewed simply as a welcome advance in the options
available since the reproductive revolution; and there is no denying that
micro cloning, like IVF, might generate a lot of utility for the individuals
whose parenting ambitions are otherwise frustrated. As Lawrence Wu puts
it: “[Micro cloning] can perform a valuable service for many in an area of
fundamental concernhaving childrenand it does not cause any tangible
harm that science is incapable of perfecting away and that caring parents
are incapable of loving away.”55
Nevertheless, utilitarians would certainly have reasons to pause. First,
so long as the technology is unreliable and so long as it would take
hundreds of failed attempts before such a micro cloning project got close to
succeeding, this would not strike a utilitarian as a sensible allocation of
public resources. Secondly, even if micro cloning were to be resourced
privately, the distress occasioned by failure would militate against licensing
the danger is a recurring one and is likely to exist in situations of genetic
enhancement and diminishment as well.
54.
55.
Id. at 1455.
See John Harris, Clones, Genes, and Human Rights, in THE GENETIC REVOLUTION
AND HUMAN RIGHTS 61, 86-88 (Justine Burley ed., 1999); Brock, supra note 7, at
147-48; Lee Silver, Public Policy Crafted in Response to Public Ignorance Is Bad
Public Policy, 53 HASTINGS L.J. 1037, 1041 (2002) (predicting that the most likely
candidates for access to micro reproductive cloning technology will be single women
who wish to have a child but who do not want to use a sperm donor).
Wu, supra note 8, at 1514.
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
557
such activities.56 Thirdly, even if the technology were reliable, there might
be reasons to doubt that “merits-testing” of applicants for micro cloning
reproductive services (rather like the experience of certifying that a
woman’s case falls under one of the approved reasons for termination of a
pregnancy) would be effective.57
Turning from micro cloning to macro cloning, a utilitarian would
want to be assured that the loss of genetic diversity implicated in such a
project would not unintentionally render humans less resistant to disease.
Utilitarians would also want to be confident that the impact of such a largescale intervention really would produce a better balance of utility than
alternativesafter all, we have been here before, both with the best of
intentions and the worst of intentions, in both fact and fiction.58 Again,
though, until human reproductive cloning technology is reliable, there are
overwhelming reasons for the utilitarian to advocate restraint.
Quite apart from questions of safety and reliability, there is one other
consideration that impels utilitarians to support at least a moratorium or a
for-the-time-being regulatory prohibition on human reproductive cloning
(both micro and macro). This is the fear that, absent a clear prohibition on
human reproductive cloning, a more widespread antipathy towards cloning
might be provoked. If such a backlash interfered with utility-producing
therapeutic cloning applications, this would be unfortunate to say the least.
To avoid this, a clear prohibition on human reproductive cloningthe
slippery slope in the opposite direction, as it weremakes good utilitarian
sense.
What would human rights theorists make of micro cloning
hypotheticals of the kind suggested by Harris? Of course, the argument in
favor of licensing such micro cloning projects would not be that it would
enhance well-being—that there would be delight at the birth of the child.
Rather, it is a matter of recognizing, and giving effect to, a right of
56.
57.
58.
Recall, again, Alan Colman’s warning. See Colman, supra note 6, at 16 (even those
who succeeded in cloning Dolly the sheep, mindful of the many failed attempts,
advocate against attempting reproductive cloning in humans).
For a sophisticated discussion of how selective regulation of human reproductive
cloning might prove counterproductive or ineffective, see CLONING CALIFORNIANS?,
supra note 13, at Part IIB(5).
See, e.g., Jonathan Glover, Eugenics and Genetic Manipulation, in THE GENETIC
REVOLUTION AND HUMAN RIGHTS 101 (Justine Burley ed., 1999); Alan Ryan,
Eugenics and Genetic Manipulation, in THE GENETIC REVOLUTION AND HUMAN
RIGHTS 125 (Justine Burley ed., 1999). Famously in fiction, see generally ALDOUS
HUXLEY, BRAVE NEW WORLD (Harper Collins 1998) (1932), duly noting the caveat
that Huxley’s dystopia actually owes more to nurture than nature. See also MATT
RIDLEY, GENOME 304 (1999); MARGARET ATWOOD, ORYX AND CRAKE (Doubleday
2003).
533569571
558
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
reproductive autonomy.59 If we take such a claim seriouslyalthough, to
be sure, the scope and substance of the right in question (or, perhaps more
accurately, the bundle of rights in question) is far from settled, whether as a
matter of ethics or constitutional right60we need compelling reasons to
justify closing off this option to rights-holders. The most compelling kind
of reason would be that cloning violates the rights of the cloned child and
that the rights at stake take priority over the right of reproductive
autonomy. However, it is unclear how cloning, as such, might be thought to
violate the rights of the clone that becomes a child.61
Following a careful analysis of the right to reproductive freedom, Dan
Brock concludes that the right “presumptively includes both a right to
select the means of reproduction, as well as a right to determine what kind
of children to have, by use of human cloning.”62 Granted, this right is only
presumptive. However, it is very broadly articulated and some human
rights theorists might favor limiting it to cloning for genetic connection,
thereby disabling it from running on to include cloning for genetic
compatibility or for genetic characteristics. To be sure, if embryo selection
for tissue-matching purposes survives human rights scrutiny, cloning for
genetic compatibility might present no fresh difficulties; in which case, the
real sticking point for a community of rights is cloning for genetic
characteristics (in which the parents specify the substantive genetic makeup
that they want their child to have). In fact, human rights theorists might
59.
60.
61.
62.
Cass Sunstein has argued that there is no fundamental constitutional right to engage in
either reproductive or therapeutic cloning, although he believes that the arguments in
favor of the former are more persuasive than those in favor of the latter. See Cass R.
Sunstein, Is There a Constitutional Right to Clone?, 53 HASTINGS L.J. 987 (2002);
Peterson, supra note 17, at 239-40. But see Wu, supra note 8 (arguing that a
fundamental right to reproductive autonomy extends to a negative right against state
prohibition blocking access to cloning technologies). Lawrence Wu contends that the
jurisprudence of the right, going back to Skinner v. Oklahoma, 316 U.S. 535 (1942),
is not limited to protecting individuals against state-mandated sterilization, (nonuse
of) contraception, or abortion; rather, the protection covers not only the capacity to
have children, but the actual having of children. Such an extended right reaches
through quite naturally to the use of assisted reproduction technologies (including
cloning). Indeed, running parallel with (but against) Sunstein, John Charles Kunich
contends that “[i]f anything, the established jurisprudence more firmly embraces and
protects reproductive cloning than it does therapeutic cloning.” Kunich, supra note
11, at 59-60.
See, e.g., Andrews, supra note 7, at 661-69; Nathan A. Adams, IV, Creating Clones,
Kids and Chimera: Liberal Democratic Compromise at the Crossroads, 17 NOTRE
DAME J.L. ETHICS & PUB. POL’Y 71 (2003).
See Shaun D. Pattinson, Reproductive Cloning: Can Cloning Harm the Clone?, 10
MED. L. REV. 295 (2002).
Brock, supra note 7, at 145.
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
559
oppose micro cloning for genetic characteristics on two scores.
First, they might worry that specification of genetic characteristics
will intrude on the prospective autonomy rights of the cloned child. It is
one thing to permit cloning in order to avoid serious diseases (albeit
already one step beyond cloning for mere genetic connection); and it is
another thing to select characteristics that deny the child the opportunity of
having a life with an open future.63 Cass Sunstein expresses this concern in
a colorful way:
Imagine a situation in which cloning was freely permittedin
which individuals could clone themselves, and in which people
interested in children with a certain genetic endowment could
assure themselves of that very endowment. If a family wanted a
terrific athlete, it could obtain a genetic equivalent of, say,
Michael Jordan; if a family wanted a terrific musician, it could
obtain a genetic equivalent of, say, Bob Dylan; if a family
wanted a terrific scientist, it could obtain a genetic equivalent of,
say, Ian Wilmut; if it wanted a terrific philosopher, it could clone
John Rawls. Why would this be objectionable? The reason is that
people would be treating their children-to-be as means, with
prearranged agendas, rather than as ends, to seek their own
path.64
Moreover, in between these poles of damaged goods and finished
goods, we have all manner of characteristics and dispositions (for example,
being a good talker or a good listener) that are not readily classifiable as
legitimate or illegitimate selections. In other words, there is no bright
liberal line to be drawn between legitimate negative cloning and
illegitimate cloning for positive enhancement; and, until human rights
theorists have worked this one through, a precautionary approach seems
advisable.
Secondly, human rights theorists might also worry that licensing
micro cloning for genetic characteristics changes the culture of
reproduction in a way that, in the long run, would be deleterious to a
flourishing community of rights. To treat children as commodities is a
further step toward consumption and markets; and, quite possibly, it
changes the terms of the relationship between parents and children.65 To
63.
64.
65.
See Dena S. Davis, Genetic Dilemmas and the Child’s Right to an Open Future, 28
RUTGERS L.J. 549, 561-67 (arguing that a reflexive application of autonomy values
will set limits to parents’ reproductive autonomy).
Sunstein, supra note 59, at 1000.
The “saviour sibling” cases already raise questions of this kind. See Boseley, supra
note 30, at 1-3. For some hints as to how this idea might be developed in relation to
micro reproductive cloning, see Margaret Jane Radin, Cloning and Commodification,
533569571
560
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
say that this will not be a change for the better, in the sense that it will
diminish the pleasure of parenting is not the point; the question is whether
it will undermine the conditions that enable rights-holders to make sense of
their rights and responsibilities, as well as to come to terms with their own
identities.
Trying to make sense of the idea of the potential corrosion of a
context that supports a community of rights is not easy. Ronald Dworkin
begins to get to grips with this idea when he rightly remarks that the
“boundary between chance and choice is the spine of our ethics and our
morality,” and “any serious shift in that boundary is seriously
dislocating.”66 He continues:
If we were to take seriously the possibility that we are now
exploringthat scientists really have gained the capacity to
create a human being having any phenotype that they or their
prospective parents choosethen we could chart the destruction
of settled moral and ethical attitudes starting at almost any point.
We use the chance/choice distinction not simply in our
assignments of responsibility for situations or events, for
example, but in our assessments of pride, including pride in what
nature has given us.67
Although Dworkin maintains that it would be a confusion to suppose
that “even the most dramatic shifts in the chance/choice boundary
somehow challenge morality itself,”68 he emphasizes that it is in relation to
the assignment of personal and collective responsibility that “the danger of
moral insecurity seems greatest.”69 What this seems to imply is that,
genetic engineering notwithstanding, we can continue to operate with
morality (qua an act morality) that characterizes certain acts, practices, or
states of affairs as morally required, morally permissible, or morally
prohibited. However, the more that our genetic makeup is neither a matter
of chance nor the product of our own choice, the less room that there is for
agent morality (that is, for judgments holding a particular agent responsible
for acting in immoral ways).
In a similar vein, and for similar reasons, Jürgen Habermas agrees
that it is genetic engineering (or, at any rate, genetic enhancement) that is
the door to keep firmly shut.70 The point about genetic enhancement (or
66.
67.
68.
69.
70.
53 HASTINGS L.J. 1123 (2002).
RONALD DWORKIN, SOVEREIGN VIRTUE 444 (2000).
Id. at 445.
Id. at 446.
Id. at 445.
See generally JÜRGEN HABERMAS, THE FUTURE OF HUMAN NATURE (2003); BILL
MCKIBBEN, ENOUGH: GENETIC ENGINEERING AND THE END OF HUMAN NATURE
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
561
positive genetic engineering) is not that it might fundamentally alter the
extent to which we have “free will” and the extent to which the predicates
for human responsibility are met, but that it might affect our perception of
such matters. To the extent that the idea of free will rests on a
phenomenology of choice and responsibility, genetic modification could
make a huge difference to the way in which we perceive ourselves, our
“achievements,” and our “failures.” If we come to see our genetic makeup
as a program that runs us, it will be tempting to think (against free will and
responsibility) that we could not have acted otherwise; and, where our
particular genetic makeup has been specified by others, if there is any
responsibility left in the world, it seems to be with the specifiers rather than
ourselves.71 In other words, genetic enhancement (by way of reproductive
cloning for desired and desirable genetic characteristics) threatens to alter
the context by either undermining notions of free will and responsibility or
by inviting the transfer of responsibility.
If individuals can no longer make much sense of their personal
responsibility for their own actions and omissions, then surely this will
weaken, too, their sense of collective responsibility. In a flourishing
community of rights, it will be accepted that there is a collective
responsibility to make compensatory provision for those who are disabled,
through no fault of their own, from functioning as agents. However, if
agency is itself a devalued commodity, agency deficits no longer seem such
urgent cases for compensationand, anyway, the idea that the community
has a collective responsibility to put this or anything else to rights is no
longer meaningful.
These are complex conjectures. However, put boldly it comes down
to this. First, the more that we are aware of the significance of a person’s
genetic makeup, the more tempting it will be to excuse our actions by
reference to our genetic makeup (even if we do not know what our genetic
makeup is, even if we do not understand how it interacts with the
environment, and even if cloning is no part of the equation). Secondly, if
we are aware of our own particular genetic makeup and what that signifies
for our potentiality, our self-knowledge might be counterproductive in
diminishing our sense of personal achievement (and this holds regardless of
whether our genetic makeup is the product of cloning). Thirdly, if our
genetic makeup is the product of cloning for genetic characteristics, we
might be inclined to transfer responsibility for our actions to those who
specified the particular cloned makeup for us.
If the questions raised by micro cloning are subtle and the perils
rather remote, macro cloning will at once send chills down the spines of
71.
(2003).
See DWORKIN, supra note 66, at 445.
533569571
562
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
human rights theorists. If programs of mass cloning are designed to
produce utility maximizing societies, we can guarantee that this will be at
the price of sacrificing individual rights. These large-scale exercises in
social engineering inevitably prioritize the grander social objectives,
individuals are not taken seriously, and humans are exploited while their
rights are violated. This is not a path that any sensible human rights theorist
can entertain.
These reflections suggest that, if human reproductive cloning
techniques were reliable, human rights theorists might be tempted to
license micro cloning (certainly where its purpose was for genetic
connection) and, in this, they would be supported by utilitarians (provided
that this did not have implications for the regulatory position concerning
therapeutic cloning or for the broader reputation of the scientific
community, and the like).72 However, human rights theorists surely would
unite with the dignitarians in opposing any enthusiasm that utilitarians
might display for macro cloning. The case that needs much further
reflection is that of micro cloning for genetic characteristics. While one
step rapidly follows another in screening embryos for debilitating
disorders,73 the signs are that there is still time for reflection before
scientists announce a “breakthrough” in the technology of genetic
enhancement and before the pressure builds on regulators to permit access
to such technology.
B. Therapeutic Cloning and Human Embryonic Stem Cell Research
Therapeutic cloning (and allied human embryonic stem cell research)
is a particularly interesting case; for, even if the background ethical
judgment is clear, the preferred regulatory position is much more nuanced.
To deal with the background ethics first: the general perception of
therapeutic cloning and stem cell research is that this is a field of very
considerable medical significance. Whether we are thinking about bespoke
stem cells and their derivatives for transplantation or generic lines or
collections for drug testing, it is conceivable that there could be major
benefits resulting from this kind of research. For both utilitarians and
human rights theorists, this is a positive consideration. On the negative
72.
73.
See Brock, supra note 7; Chester, supra note 52 (making similar arguments).
In the latest development in the UK, the regulatory authority has announced that it
will license PGD to screen embryos for a genetic form of bowel cancer. See Mark
Henderson, Cancer-Free “Designer Babies” Get Approval, TIMES (London), Nov. 1,
2004, at 1. This is yet another example of the “incrementalism” that characterizes the
authority’s decision making. See Brownsword, Regulating Stem Cell Research in the
United Kingdom: Filling in the Cultural Background, supra note 4; Brownsword,
Reproductive Opportunities and Regulatory Challenges, supra note 30, at 319-20.
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
563
side, there seem to be no real counterweights: we assume that terminated
embryos do not suffer and nor do they have rights; and, provided that those
who donate eggs or embryos do so on the basis of free and informed
consent, all is well.74
Yet, are we looking hard enough for the negatives? First, are we being
sufficiently careful to check for indirect damage to rights holders? Maybe
human embryos do not have rights; and, in this respect, they are
comparable to other life-forms that do not have rights. However, one
concern about the mistreatment of such life-forms is that it sets a bad
example that leads, indirectly, to a weakening of respect for rights
holders.75 Granted, there is no straight-line connection. Notoriously, Hitler
was a dog lover; and it might be that a person who is cruel to cats, behaves
perfectly properly when dealing with rights-holders. We really do not
know. Secondly, there is an even less straightforward risk of compromising
the context that sustains a community of rights. Just as individual acts of
pollution cumulatively corrode the physical environment, might it be that
resort to therapeutic cloning cumulatively changes the social environment
in a way that undermines the conditions for a flourishing community of
rights? As we have said already, some commentators believe that genetic
engineering poses an insidious risk of this kind. However, although
therapeutic cloning might involve some genetic manipulation, it is not
carried through into social relations in the way that would occur in
reproductive contexts. If there is a risk here it is that people perhaps live
longer or that, thanks to stem cell treatments for Parkinson’s and
Alzheimer’s disease, the quality of life for large classes of elderly people is
considerably improved. These developments might have important
economic consequences as well as consequences for the allocation of
public health care resources; however, if there is some deeper threat to a
rights-respecting community, it is unclear what it is.
If the onus is on those who assert such indirect negatives, then the
burden of proof is liable to be heavy (at any rate, for the time being). We
might conclude, therefore, that therapeutic cloning seems to be ethically
cleanunless, of course, one is a dignitarian; for dignitarians view the
74.
75.
If it is objected that donors of eggs will be “exploited,” this might be a dignitarian
objection against the “instrumentalisation” of women and their gametes, or it might
be a human rights objection (as assumed in the text). If the former, it is no answer to
point to the informed consent basis on which the eggs were donated; this simply
misses the thrust of the objection. See supra note 49 and accompanying text.
However, provided that there really has been informed consent, this is an answer to
alleged infringement of rights.
Cf. BVerwGE 115, 189 (2001) (holding that “playful killing” at a shooting arcade
tended to trivialize violence and might, thus, weaken respect for the well-being of
other agents).
533569571
564
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
creation and use of human embryos for research as a clear case of
compromising human dignity.
Translating these ethical judgmentsthe dignitarian apartinto
preferred regulatory positions is more complex. Assuming that therapeutic
cloning and human embryonic stem cell research is to be permitted,
regulators might hedge their permission in various ways, for example: (1)
by restricting the class of embryos to be available for such research (e.g., to
supernumerary embryos that would be destroyed anyway); (2) by refusing
to allow embryos to be specifically created for research; or (3) by imposing
preconditions relating to the necessity and proportionality of the use of
embryos.
In the United Kingdom, for example, the Human Fertilisation and
Embryology Act 199076 permits the regulatory authority to license research
on human embryos, thus allowing for the use of both supernumerary
embryos as well as embryos donated for research ab initio, and (in defiance
of Article 18(2) of the Convention on Human Rights and Biomedicine)
allowing for the use of embryos specially created for research. However,
research is only to be licensed where the authority judges that it is
necessary77 (in the sense of it not being possible to do the research in any
other way) as well as being necessary or desirable in relation to one of the
approved statutory purposes.78 Yet, why impose such restrictions? Would
they (or more extensive restrictions) make sense from the perspective of
utility or human rights?
Generally speaking, from a utilitarian perspective, the local context
and culture will influence the particular contours of even a permissive
regulatory regime. It follows that utilitarians might advocate some
particular regulatory restrictions in some places at some times, but not in
other places or in any place at other times. Nevertheless, how would we
expect utilitarians to respond to the three restrictions specifically identified
above, namely: (1) prioritizing the use of supernumerary embryos; (2) not
permitting embryos to be created for research; and (3) only permitting the
use of embryos for research where tests of necessity and proportionality are
satisfied?
First, utilitarians would surely accept efficiency arguments in favor of
prioritizing the use of embryos that are surplus to requirement in IVF
programs and that will have to be destroyed anyway. Not only would it
76.
77.
78.
Human Fertilisation and Embryology Act, 1990 (Eng.).
Id. c. 37, sched. 2, para. 3(6).
Originally, there were five such purposes. See id. c. 37, sched. 2, para. 3(2). To clear
the way for human embryonic stem cell research and therapeutic cloning, three
further purposes were added by the Human Fertilisation and Embryology (Research
Purposes) Regulations, (2001) SI 2001/188.
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
565
seem wasteful not to use such supernumerary embryos before turning to
other sources, it might also chime in with public preference and sentiment.
Against such utilities, there might be deficits if the embryos that are
available to be sourced from IVF programs are lower grade and not optimal
for stem cell research. However, if the regulatory position merely
prioritizes the use of supernumerary embryos provided that they are
suitable for research, this does not hinder research and there is no real
difficulty.
Secondly, if the regulatory position prohibits the creation of embryos
specifically for research, this might prove a serious obstacle to stem cell
research which relies on specially designed embryos as its research tools.
To be sure, stem cell research would not grind to a standstill: therapies
might be developed using adult stem cells (or even fetal stem cells); stem
cell lines might be imported; and there would still be supernumerary
embryos available for research. Nevertheless, if the prohibition seriously
interferes with research, utilitarians would need some convincing that it
makes sense. In this light, utilitarians would want to take a hard look at
Article 18(2) of the Convention on Human Rights and Biomedicine (as,
indeed, they would want some convincing that research should be confined
to adult stem cells).79
Thirdly, what would utilitarians make of the twin constraints of
necessity (meaning that the research cannot be carried out without using
human embryosin particular, that it cannot be conducted using
nonhuman animals) and proportionality (meaning that human embryos
should not be used for “trivial” research purposes, such as, to take the
standard example, research into baldness)? On the face of it, neither
restriction would make immediate sense. If research on human embryos
causes no distress, while research on animals causes distress, Peter Singer
and other like-minded utilitarians surely would be quick to point out that
the argument of necessity cuts in the wrong direction.80 They would also
resist the intuition that so-called “trivial” research purposes should be
excluded. If undertaking such research generates more utility than not
doing so, the argument of proportionality tries to rewrite the basic
arithmetic of utilitarian calculation.81 Having said this, where local
79.
80.
81.
There seems to be a large measure of agreement within the scientific community that
a twin-track approach, using both adult and embryonic stem cells, is the right way to
proceed. See, e.g., House of Lords Select Committee Report, supra note 8, at ch. 3.
See PETER SINGER, RETHINKING LIFE AND DEATH passim (St. Martin’s Press, 1994)
(discussing the significance of sentience—sentient life to be valued more highly than
non-sentient life—and purposive agency—purposive sentient life to be valued more
highly then non-purposive sentient life).
The argument of proportionality applied to research on animals is in line with
utilitarian thinking: researchers should not subject animals to great distress unless
533569571
566
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
conditions reveal strong support for constraints of this kind (irrational
though they might seem to be to any straight-thinking utilitarian), the
disutility of opposing these preferences would need to be taken into
account.
Turning to human rights theorists, first, there is no particular rightsrelated reason to prioritize the use of supernumerary embryos. To be sure,
the persons for whom such embryos are now surplus should not be
precluded from donating their embryos; but this is not an argument for their
prioritization.
Secondly, to prohibit the donation of embryos specifically for
research impinges on the autonomy of the donors; and to prohibit the
creation of embryos specifically for research impinges on the freedom of
researchers. Why should such persons not be permitted to make a useful
contribution to medical research? Indeed, if prospective beneficiaries of the
research have, at the very least, a right that the state will not impede
medical research so long as there is no clear violation of right, then
patients’ rights are infringed by any such limitations.
What, then, of necessity or proportionality, or similar restrictions that
are designed to reduce the use of human embryos or make them research
tools of last resort? How do such constraints evince respect for rights?
Under a standard articulation of human rights thinking, neither human
embryos nor nonhuman animals have rights;82 and, thus, there is no direct
rights argument to favor one class of research resource over another. If
there is some indirect argument here to support the necessity restriction, it
needs to be teased out. As for the constraint imposed by proportionality,
human rights theorists certainly hold that more pressing rights should take
priority over less pressing rightswhich perhaps has some purchase on the
priorities that should direct the efforts of the research community.
However, this is quite different from holding that non-rights-bearing
embryos should be used for research only where pressing human rights are
at stake. Once again, unless an argument concerning the indirect impact on
rights is to be teased out, proportionality makes no more sense as a
restriction than necessity. Surprisingly, then, the logic of robust human
rights thinking might be to take up an even more permissive regulatory
position than that indicated by utilitarianism.
82.
such disutility is offset by the utility produced for the human beneficiaries of the
research. Compare the reasoning of the examiners at the European Patent Office in
the Harvard Onco-mouse application. Harvard/Onco-mouse, 1992 O.J. E.P.O. 588,
590 (Examining Div.), reprinted in 1991 E.P.O.R. 525.
But see supra text accompanying notes 45-46 (for reference to a radical precautionary
approach that, recognizing our limited knowledge, allows for at least the possibility of
agency in human embryos and nonhuman animals).
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
567
C. The Slippery Slope
Slippery slope arguments abound in the law. The form of the
argument is thus. If we assume a relatively bright-line rule (or settled
regulatory position), R1, and if we assume that R1 meets the criteria of
adequate regulatory effectiveness,83 then the argument is that R1 should be
maintained lest: (a) having modified R1, it proves difficult for reasons of
principle, or practice, or both to re-establish a bright-line position; and/or
(b) the particular modification to R1 that is proposed, whether for reasons
of principle, or practice, or both, inclines towards a regulatory position, de
facto or de jure or both, that is substantively less defensible than R1.
If the first limb of the argument is about the difficulties of finding a
fresh foothold as regulators are on the slide and, in consequence, about
regulatory ineffectiveness, the second limb is more concerned with the
deepening moral deficit as regulators slide down the slope with a serious
lack of regulatory legitimacy waiting at the bottom. For lawyers, both kinds
of concern are relevant; for bioethicists, it is the latter that is particularly
important.
Now, assuming that R1 is a blanket prohibition on all forms of human
cloning, reproductive and therapeutic, and that the proposal is that R1
should be modified to permit at least some forms of therapeutic cloning,
83.
Even setting the threshold of adequacy well below 100 percent, this is quite a large
assumption. By positing a settled regulatory position, we are already assuming that
there is a clear locus of regulatory authority—which might not be the case. See
Richard A. Merrill & Bryan J. Rose, FDA Regulation of Human Cloning: Usurpation
or Statesmanship?, 15 HARV. J.L. & TECH. 85 (2001). We also assume a clear,
comprehensible and settled rule—which, again, might not be the case. See, e.g.,
Andrews, supra note 7, at 657. Regulatees who are minded to comply will understand
what is prohibited, permitted, or required. However, even with this flying start, R1
might be flawed in ways that assist reluctant regulatees. Even if this is not the case,
R1 might face cultures of regulatee resistance and noncompliance; it might be
accompanied by weak monitoring (e.g., because of agency under-resourcing or lack
of expertise, or in global markets fears about regulatory arbitrage, or the familiar
problem of agency capture); and these problems might then run on to decisions
concerning enforcement (e.g., agency reluctance to bring business people before
criminal courts) and sanction (fines being treated by regulatees as occasional taxes on
conduct)not to mention the jurisdictional difficulties presented by
cybertechnologists. See David R. Johnson & David Post, Law and BordersThe Rise
of Law in Cyberspace, 48 STAN. L. REV. 1367 (1996). For further helpful reflections
on bio-regulability, see Robert G. Lee & Derek Morgan, Regulating Risk Society:
Stigmata Cases, Scientific Citizenship and Biomedical Diplomacy, 23 SYDNEY L.
REV. 297 (2001); and, for an overview of anticipated regulatory ineffectiveness in
relation to nanotechnology, see the helpful discussion in Glenn Harlan Reynolds,
Nanotechnology and Regulatory Policy: Three Futures, 17 HARV. J.L. & TECH. 179
(2003).
533569571
568
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
then slippery slopers will oppose this modification on the following
grounds: (a) that it will create uncertainty; (b) that it will be difficult to
draw a principled distinction between what is permitted and what remains
prohibited; (c) that, in practice, work on permitted forms of cloning will put
in place the know-how to carry out prohibited forms of cloning as well as
creating a stock of cloned embryos (and, thus, increase the likelihood of
such prohibited cloning actually being carried out);84 and (d) that it would
be a moral disaster if the modification to R1 made it easier for human
reproductive cloning to be carried out. For the sake of argument, at least,
let us concede that grounds (a), (b), and (c) are sufficiently plausible to be
taken seriously. This gets us to the core question: what would the
utilitarians, human rights theorists, and dignitarians make of ground (d)?
Conceding, again for the sake of argument, that permitting some forms of
therapeutic cloning might increase the risk of human reproductive cloning
being carried out, would they judge this to be a determinative moral
deficit?
For the dignitarians, the answer is clear and has nothing to do with
consequential considerations. A blanket prohibition is required, not because
licensing therapeutic cloning puts regulators on a slippery slope but
because all forms of cloning compromise human dignity.
Straightforwardly, anything short of a blanket prohibition will not pass
moral muster; and any proposal for relaxation is to be rejected out of hand
as unethical in itself. The more interesting question is what utilitarians and
human rights theorists make of the slippery slope, particularly what they
make of the reasoning in ground (d).
For utilitarians, a world in which human reproductive cloning is
technically feasible is not obviously better or worse than one in which the
technology is not available.85 Like most technologies, human reproductive
cloning has the capacity to generate utility or disutility; and the important
thing is to ensure that the technology is productively applied. If a spin-off
from work on therapeutic cloning is that there is less distress associated
with attempts at human reproductive cloning, then so much the better. At
all events, utilitarians would not judge that the bottom of the slope is to be
avoided at all costs. What they would want to compare would be the utility
calculation if there were to be a blanket prohibition on cloning (under
which, of course, therapeutic cloning would be prohibited) with the
calculation if therapeutic cloning were to be permitted. If the utilitarian
84.
85.
See Alexander M. Capron, Placing a Moratorium on Research Cloning to Ensure
Effective Control over Reproductive Cloning, 53 HASTINGS L.J. 1057 (2002). But see
CLONING CALIFORNIANS?, supra note 13, at Part IIIB(1).
Cf. Brock, supra note 7, at 151 (“[H]uman cloning does not seem to promise great
benefits or uniquely to meet great human needs.”).
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
569
prognosis is, on the one hand, that therapeutic cloning is likely to prove a
source of considerable utility and, on the other hand, that reproductive
cloning is unlikely to be a source of considerable disutility, the argument
for a blanket prohibition will not stack up.
As for human rights theorists, it has been suggested that there are
three strands to their position, namely: strong support for therapeutic
cloning, possibly inclining to support for micro human reproductive
cloning (at any rate, where cloning is for genetic connection only), and
strong opposition to macro human reproductive cloning. This does not
translate straightforwardly into a view about the slippery slope. From this
perspective, the question is whether licensing therapeutic cloning might
pave the way to: (a) micro human reproductive cloning for genetic
connection; (b) micro human reproductive cloning for genetic
characteristics, first against negative characteristics and then for positive
characteristics; or (c) macro human reproductive cloning.
So long as the “risk” is merely (a), human rights theorists would have
no cause for concern; this would be no reason to oppose a regulatory
licence for therapeutic cloning.
If the risk were (b), especially where the line between a negative
(medical condition) and positive (social) characteristic is unclear, this
would be some cause for concern. However, it is permitting (a) that really
threatens a slide to (b); and, if (b) is a concern, then the way to forestall it is
by keeping the door closed on (a).86 To be sure, this involves some
backtracking; but, perhaps the better view is that, provided that (a) is not
authorized, there is no reason to fear a slide to (b) and, thus, therapeutic
cloning alone is to be permitted.
The worst fear for a human rights theorist is (c). Arguably, the
immediate rights-enhancing promise of therapeutic cloning for medical
purposes takes priority over the more remote rights-infringing threat of
macro human reproductive cloning for reasons of the supposed general
good.87 If so, human rights theorists will oppose a blanket prohibition on
human cloning, but their nervousness about the slide from (a) to (b) and on
to (c) might indicate that the permission should not extend beyond
therapeutic cloning.
The upshot of this analysis, therefore, is that neither utilitarian nor
86.
87.
If it were doubted that a narrowly tailored, case-by-case permission for micro human
reproductive cloning for genetic connection could be effectively policed, this would
add to the arguments against taking the first permissive step. See supra note 57 and
accompanying text.
Some commentators view macro reproductive cloning as an extraordinarily remote
prospect“the stuff of nightmares or pipe dreams” in which case, it is a risk to be
heavily discounted. Kunich, supra note 11, at 40. But, then, they might be wrong.
533569571
570
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
[Vol. 39:535
(for the most part) human rights theorists are likely to find the slippery
slope argument convincingat any rate, not when argued in support of a
blanket prohibition.88 Neither is terribly troubled by what might lie at the
bottom of the slope in the foreseeable future; and, in the meantime, a major
pricetoo heavy a priceis being paid for holding the regulatory line at
the top of the slope. As for the dignitarians, while they might
opportunistically back slippery slope objections that argue for the retention
of regulatory prohibitions, their position is independent of, and does not
need, this kind of argument.
CONCLUSION
Human reproductive cloning and therapeutic cloning each raise
questions of life and deathin the former case, the life of a cloned child
against the death of many failures; in the latter, the life of ailing patients
against the death of an embryo.
With regard to the former, human reproductive cloning, the consensus
is that this is not a life-for-death trade that is to be permitted or encouraged.
Yet, the consensus underlying this common position is neither deeply
rooted nor even. It lacks deep roots because it is supported by a mixture of
generally oppositional considerations drawing on utility, human rights, and
human dignity. And, it is not even because the strength of dignitarian
commitment against reproductive cloning is much greater than that of
either utilitarians (whose position is always contingent anyway) or human
rights theorists (whose position is somewhat equivocal).
With regard to the latter, therapeutic cloning, there is no agreement as
to the legitimacy of the proposed life-for-death trade. The dissensus,
reflecting all oppositional points of the bioethical triangle is deeply rooted
and, again, it is uneven with utilitarian calculations caught between the
strong convictions of those who assert a positive right to life-sustaining
therapies and those who insist that the death of the embryo compromises
human dignity.
These are disagreements that can, and do, divide political
communities; and the regulatory positions that we adopt speak to the kind
of community that we are. When a regulatory regime, such as that in the
United States, speaks with several voicesa permissive federal regulatory
voice conjoined with a fiscal policy that refuses to compel public spending
on embryo destruction where this will offend public conscience; and a
range of state voices expressing prohibitive and supportive policies,
88.
If R1 decreed that human reproductive cloning was prohibited but therapeutic cloning
permitted, human rights theorists might accept the force of the slippery slope
argument if the proposal was to relax R1 so that some forms of human reproductive
cloning were taken out of the prohibition to become permitted.
533569571
2005]
2/17/2016 12:05 PM
WHERE THE REGULATORY CONSENSUS FAILS
571
regulatory and fiscalthis smacks of compromise (as, indeed, the not
dissimilar picture in Europe smacks of compromise); but it also testifies to
the breadth and depth of divisions within the community. As with abortion
and euthanasia, these questions of life and death arouse deep emotions.
However, it is also essential to remember that, over and above these
disputes, a democracy is a particular kind of communitythat is, one in
which differences are settled by reasoned debate and where good faith
regulatory settlements are respected. Even if we cannot achieve consensus
as to the substantive regulatory position to be adopted in relation to human
reproductive and therapeutic cloning, it is importantthat is, it is important
for democracies on both sides of the Atlanticthat we hold on to such
consensus as subsists with regard to the way in which we settle our
regulatory differences.89
89.
Cf. DERYCK BEYLEVELD & ROGER BROWNSWORD, LAW AS A MORAL JUDGMENT
(1986) (describing reciprocal theories of political accountability and citizen restraint).
I take this to be the deep point of Ronald Dworkin. See RONALD DWORKIN, LIFE’S
DOMINION (1993); Adams, supra note 60.
533569571
572
2/17/2016 12:05 PM
NEW ENGLAND LAW REVIEW
***
[Vol. 39:535