Reflections: The Challenge of
Biotechnology and Public Policy
Bartha Maria Knoppers”
Rapid developments in the area of biotechnology
within the next decade are likely to have a significant
impact on Canadian society. This article outlines the
practical and ethical issues that will need to be ad-
dressed in the face of scientific advances, and contem-
plates the development of an appropriate policy fame-
work in this regard. Surveying the approaches to policy
development taken thus far, the author notes the un-
derlying need for greater transparency and public par-
ticipation. Rational and effective policies will only re-
sult from additional basic scientific data being made
available to a more informed and engaged Canadian
public.
Les d6veloppements dans le domaine de la bio-
technologic qui surviendront au cours de la prochaine
ddcennie auront vraisemblablement un impact impor-
tant sur Ia societd canadienne. Le present article expose
lea questions pratiques et 6thiques qui seront soulevdes
par ce progr s scientifique, et envisage le d#veloppe-
ment, pour y rdpondre, d’un cadre de politique appro-
pri6. En passant en revue
les diffrents modNes
d’6laboration de politiques en la matinre, l’auteure
souligne la n6cessit6 d’une plus grande ouverture sinsi
que de la participation du public. Des politiques ration-
nelles et efficaces ne pourront naitre que d’une diffu-
sion plus large de l’information scientifique 616men-
taire A un public canadien plus informE et engag6.
. Professor and Senior Researcher, Facultd de droit (CRDP), Universitd de Montr6al.
McGiU Law Journal 2000
Revue de droit de McGil 2000
To be cited as: (2000) 45 McGill W. 559
Mode de rdfdrence: (2000) 45 R.D. McGiU 559
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Introduction
I. Human Genetics
I1. Genomics
I1. The “Humanity” of Future Generations
IV. Policy Framework
Conclusion
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561
Introduction
The next decade will be characterized by three major developments: the prolif-
eration of genetic choice, the emergence of complex systems pertaining to genetics,’
and an increasing public concern and interest in the definition of what is “human”.
While it appears that future genetic choices will largely be private, prospective, and
preventive, their cumulative effect will not be without public implications. Further-
more, rapid progress in the genomic life sciences (animal, plant, and human) and in
informatics are contributing to the emergence of highly dynamic yet complex systems
of information gathering, storage and management that are difficult to characterize
and control. These developments have raised a certain sense of public unease with the
deciphering of the genomes of all living organisms (animal, plant, and human) and a
perceived transgression of our humanness, if not humanity, in this new technocracy.
To understand and analyze the need for a public policy framework (which is as
epigenetic as the subject matter and the social trends the policy would seek to address)
requires a preliminary understanding of how the three developments (i.e., choice,
complexity, and concepts of humanness) will emerge. Developments in both genetics
(part I) and genomics (part H1) have attracted a tremendous amount of media attention.
Less immediately evident but equally important are the effects on future generations
(part m).
I. Human Genetics
Current sequencing and mapping efforts in the human genome project will likely
be completed by the year 2003.2 Creating much hope in the power of sophisticated di-
agnostic and prognostic tools and of informatic capabilities within medicine, the new
“post-mapping” genetic medicine promises: 1) genetic screening of asymptomatic
populations for carrier status and prevention of the onset of genetic conditions; 2)
knowledge of susceptibility status for specific and individualized drug targeting; and
3) genetic testing for individual treatment, reproductive, and lifestyle choices. Ulti-
mately, it will be possible to obtain genetic information prior to embryo implantation,
or during infancy, adolescence, and adulthood. However, until specific genetic mark-
ers are found for a given condition, most genetic information in the post-mapping era
will still come from the contribution of familial pedigrees. This requires the recon-
struction of the biological “genetic” family, partially abandoned today in favour of
consensual, social family forms
‘R.C. Strohman, “Five Stages of the Human Genome Project” (1999) 17 Nature Biotech. 112.
2 See R Collins, “Shattuck Lecture-Medical and Societal Consequences of the Human Genome
Project” (1999) 341 New Engl. J. Med. 28 at 28.
‘ See B.M. Knoppers, ‘Towards a Reconstructing of the ‘Genetic Family’: New Principles?” (1998)
9 Int’l Dig. Health Leg. 241 at 242.
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In short, the exercise of personal genetic choices, currently based largely on risk
estimates, will only become more certain and thus personally significant as basic ge-
netic epidemiological research advances.4 Paradoxically, there are often obstacles set
up to such population data research due to fear of possible misuse or misunderstand-
ing of this enterprise. While perceived to be protective of personal privacy and inti-
macy, these obstacles in fact undermine transparency and public oversight in that they
drive informatics and genetic research into the private sector. While the public has ac-
cepted DNA data banking as useful for criminal surveillance of morally reprehensible
activities, no such acceptance as yet exists for the creation and promotion of popula-
tion data banking (be it of genetic samples or of genetic information).’ It is precisely
the lack of publicly available, basic scientific data at the level of populations that will
exacerbate current discriminatory attitudes towards genetic research.
Indeed, the use of inaccurate and thus unscientific information will have several
untoward effects. First, workplace and insurance screening based on actuarial data
will be inaccurate. The lack of large population data bases will result in an inability to
prove such inaccuracies, thereby inadvertently fostering illegitimate uses of the exist-
ing data. Second, any decision to integrate genetic information into government pro-
grams for public health, planning, promotion and prevention purposes will either be
thwarted for fear of negative public reaction, or (as said before) will be unscientific
and thus unethical. Yet, these population database systems could, if promoted and
used in a transparent way, not only be subject to public surveillance but also contain
the very checks and balances needed to conform to modem privacy goals (i.e., legiti-
macy, authentification, transparency, finality, etc.). Thus, there is a need to prepare
new ethical frameworks for genetic epidemiology that, while inspired by individualis-
tic ethics and sensitive to communitarian ethics (the concerns and cultural concepts of
“collectivities”), address the urgent need for an appropriate methodology specific to
population health.
II. Genomics
Genomics goes well beyond human genetics in that it concerns all living organ-
isms. New life-sciences companies manipulate “life” for therapeutical and environ-
mental properties. Their work includes basic research, the clinical and industrial ap-
plications of DNA-based technologies, the culture and reproduction of plants and
animals, and the study of pharmaceutical properties. Such biotic endeavours place all
living organisms into research and permit the study of homologies and differences
between the species. Ultimately, transgenic “pharming” will not only produce plants
and animals that carry vaccines and have therapeutic properties, but will also enable
the development of tissues or even organs transferable to humans (xenotransplants).
4 See e.g. NJ. Schork, L.R. Cardon & X. Ku, “The Future of Genetic Epidemiology” (1998) 14
Trends in Genet. 266.
See e.g. AJ. Wilcox et aL, “Genetic Determinism and the Overprotection of Human Subjects”
(1999) 21 Nature Genet. 362.
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563
These life-science industries suggest future “biotic” possibilities of increased produc-
tivity, resistance to disease and other adverse events, and the development of nu-
traceuticals. Concerns for the preservation of species integrity and biodiversity, how-
ever, have placed these life sciences at the forefront of public debate. Classical ap-
proaches to the safeguarding of ecosystems may no longer be sufficient. Furthermore,
as humans co-evolve and co-adapt with the plant and animal species, the natural envi-
ronment itself presents new viruses for which there is no treatment available (e.g.,
BSE in animals; the new variant of Creutzfeld-Jakob in humans).’
Together, genetics and genomics will transform life in its pure biological form
and in its lived human forms. Will humans, then, be just another form of living matter
in this new biotic universe?
Ill. The “Humanity” of Future Generations
The acquisition of this knowledge and its possible (ab)uses will affect future gen-
erations as well. Personal and collective ethics will need to reflect an understanding of
the transgenerational effects and the accompanying new and different obligations.
Such obligations may include, for example, deliberate interference in the germ line in
order to avoid the transmission of a given disease to the next generation. The global-
ization of science, economies, and information all elevate transgenerational concerns
beyond the domestic scale to an international one. Similarly, bioethics must move
from the realm of individual concern to that of collective concern, and must ultimately
be considered at a truly universal level.! A complex systems approach that recognizes
the dynamic and epigenetic nature of a new BIOethics at the very level of the cell in
all living organisms needs to be encouraged.
The last half of this century has seen the development of bioethics as a forum for
questioning personal values and the relationship of humans to each other and to the
environment, particularly in relation to quality-of-life issues. In the face of new bio-
technological and informatic possibilities, bioethical debates continue to stress respect
for individual autonomy and privacy. In the medical setting, the principles against
causing harm and favouring the maximization of benefit over risk have predominated
decision-making. Only in the last few years has attention turned to questions of dis-
tributive justice, equity, and, more recently, relational or communitarian ethics (but
not yet to transgenerational ethics). Likewise, questions regarding human rights have
moved beyond individual claims (civil or economic rights) to encompass the concerns
of groups, populations, and communities. Confronted with the new genomic revolu-
6See Bayer Advisory Council on Bioethics, “Creutzfeld-Jakob Disease, Blood and Blood Products:
A Bioethics Framework’ (Working Paper, 13 October 1998) online: Bayer Advisory Council on
Bioethics
7See e.g. Universal Declaration on the Human Genome and Human Rights, UNESCO Gen. Conf.,
29th Sess. (11 November 1997), online: United Nations Educational, Scientific and Cultural Organi-
zation
(date accessed: 22 February
2000).
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tion and the personal and collective choices it presents, what shall be the direction of
public policy?
IV. Policy Framework
Over the last two decades, whether in relation to organ transplants, reproductive
technologies, or human genetics, four approaches to policy development have been
emerging. The first is a constitutional, human rights approach which through its broad
ambit serves to circumscribe the applications of new technologies that otherwise
might encourage discriminatory or stigmatizing practices. In contrast, a “statutory-
specific” approach crafts laws issue by issue to address the implications of scientific
advances through prohibitions, constraints, or moratoria. A third approach is admin-
istrative and regulatory in nature, concentrating on quality assurance, standardization,
and monitoring either through governmental or professional bodies. Finally, a liberal,
market-driven approach theorizes that proper, professional practices will ultimately
“win out’ and, in any event, all new technologies will be subject to the restraining im-
pact of litigation.
There are advantages and disadvantages to each of the four approaches. The con-
stitutional approach relies on existing human rights instruments to interpret the appli-
cations of new technologies. The policy-oriented decisions of high-ranking courts are
strengthened by the intervenor status often afforded to public interest groups, and so
serve to express public values, clarify issues, and set far-reaching precedents. How-
ever, the process of reaching these decisions is both costly and lengthy; furthermore, it
is ad hoc in nature and achieved after a given technology has already been integrated
into research and health-care programs. Lastly, if a court is timorous and refuses to go
beyond the basic facts or issues, this approach is of limitedusefulness.
A statutory-specific method has the advantage of bringing immediate certainty,
clarification, and precision, and is also an expression of political consensus. The dan-
ger remains, however, that highly focused statutes will be of limited scope and impact
beyond the immediate issues, and that they will close public debate thereby encour-
aging complacency. Finally, if such statutes are adopted in rapid succession, there is a
risk of enacting contradictory positions and definitions.
A regulatory-standardization approach, however, allows for the gradual develop-
ment of professional codes of conduct as well as licensing, monitoring, and quality
assurance standards (where necessary) through regulations made pursuant to existing
broad health legislation. Professionally and procedurally oriented, it ensures ready ac-
ceptance of the gradually imposed changes by those affected, resulting in greater ef-
fectiveness and integration into practice. This incremental approach however has its
own drawbacks: it “administers” technologies and fails to explicitly enunciate the
value-choices underlying their acceptance, or to explain why certain constraints are
‘This section is largely abstracted from: B.M. Knoppers, M. Hirtle & K.C. Glass, “Commercializa-
tion of Genetic Research and Public Policy” (1999) 286 Science 2277.
2000]
B.M. KNOPPERs – BIOTECHNOLOGYAND PUBLIC POLICY
placed on access or use of certain forms of research in the codes or standards them-
selves.
Lastly, the liberal, market-driven approach has been seen as the one which is most
flexible and facilitative of scientific research. Technological development depends on
investment, and support is either public or private. Investment is subject, however, to
lobbying by narrow interest groups, including those who stand to gain financially
from public investment (and/or a lack of public control), and those who, for a variety
of reasons, see certain technologies as potentially harmful or in conflict with their
particular values. The inability of these groups to achieve compromise in the broader
public arena inhibits the consensus necessary for successful government-initiated
oversight, thus leaving development of any given technology to the vagaries of the
market, the chilling effect of litigation, and consumer choice.
The choice between these approaches, or a combination thereof, depends not only
on the degree of public trust in the credibility and effectiveness of such research, but
on the state of the debate.
Conclusion
Currently, the state of the debate in Canada is that there is no debate, at least no
public debate. While not usurping the legitimate role of politicians and governmental
policymakers in the framing of policy and in leading the decisional process, it must be
asserted that the current lack of visibility and transparency on the contentious funda-
mental issues constitutes an affront to Canadian citizens. The collective moral failure
of Canadian society to address these issues in a structured and rational process is the
ultimate proof of tunnel vision.
The failure to actively inform and consult the public cannot be remedied simply
by providing more information. Scientists themselves, while responsible for the pro-
duction of the knowledge, cannot be solely accountable for the (ab)uses of ensuing
technologies. Although increasingly sensitive to the social implications of their work,
scientists must nevertheless be free to actively and creatively pursue knowledge. Fur-
thermore, greater public trust in the outcomes and direction of scientific research and
in the regulatory system is severely hampered by the “dread factor”–that is, a per-
ceived lack of public control and of ongoing oversight of the consequences of such
scientific freedom and innovation. Public perception of risk, even when not objec-
tively substantiated, should not be ignored. The intermingling of facts and values can
only be legitimately recognized and given direction by putting into place procedural
mechanisms (such as regional fora, media debates, websites, and public referenda,
etc.) that are both participatory and consultative. It has been argued that the failure of
Bill C-47 on reproductive and genetic technologies was due to its highly prohibitive
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and criminal law approach! This is but one example of why a more consultative ap-
proach to policy development in relation to such issues needs to be adopted.
The personal and political costs of engaging in an ongoing open dialogue with the
nation will be high.” There is no doubt that much courage and patience will be neces-
sary, especially in the early stages when the public will be adjusting to a more demo-
cratic process and strident advocates will likely polarize the initial debate. Abdicating
the responsibility for managing this debate to the scientists, however, or simply legis-
lating and attempting to resolve misunderstandings post hoc, will only further under-
mine public trust in the political process and erode credibility of the nation’s leaders
and governments.
Public policy should be, as the term implies, both public- and policy-oriented. If it
is accepted that the great majority of citizens are morally responsible beings with an
interest in their society, the prospect of “exposing” scientific advances to that same
public should not be frightening. After the first round of polemic and phobia subsides,
there will be clarification of the facts at hand. After such clarification will come a
more sensible and balanced debate respecting diversity and difference, especially in a
multicultural nation such as Canada. After a more public and transparent airing of the
facts and issues, and the provision of information by neutral government sources and
the media, two options will remain: the Swiss model of public referenda (free from
party politics) when public opinion considers it necessary, or a healthy parliamentary
debate culminating in a free vote. Biotechnology and BIOethics cross party lines and
provincial and national boundaries, to say nothing of genomes and generations. The
challenge is to construct a framework and a process that is equally dynamic.
9 See T.M. Caulfield, M. Hirtle & S. Le Bris, “Regulating NRGT’s: Is Criminalization the Solution
for Canada?” (1997) 18 Health L. Can. 3.
“‘In September 1999, the Federal Government created the Canadian Biotechnology Advisory
Commission (“CBAC”). Its mandate is to advise Ministers on the full range of policy issues related to
the development and applications of biotechnology in Canada. It will also address ways to enhance
public awareness and facilitate public debate.
