Background The Role of Law
The origin of action its efficient, not its final cause is choice, and that of choice is desire and reasoning with a view to an end. This is why choice cannot exist either without reason and intellect or without a moral state.
-- Aristotle, Nicomachean Ethics
Built from the
ground up by Harvard Law School students, E.LaB is a society of
students and faculty working to create a forum for study,
analysis, and debate about how biotechnology ought to be shaped
through the new century.
Committed to the notion that the process of
rule-making for science and health care should be democratic and
informed, the E.LaB Group aims toward a more organic integration
of ethical considerations in academic, government, and
private-sector decision making. We seek to draw upon
Bostons rich community of teaching hospitals, universities,
legal and medical professionals, non-government organizations,
biotechnology firms, and research laboratories to create a
vigorous marketplace of ideas aimed at shaping a policy and
vision for genetics in the new century.
E.LaB stands for Ethics, Law, and
Biotechnology. It represents an intellectual approach to
the complex legal and ethical problems associated with
biotechnology and the new genetics. Genomics
-- mapping the totality of species genetic material and
locating sites important in protein-synthesis has been
called the holy grail of biology. It has also
become the golden grail of the pharmaceutical
industry. Starting as a government- sponsored big
science research program on the scale of the Manhattan
project, the Human Genome Project has become a decentralized
expansion of genomic research and drug development in the private
sector.
Genomics will change human societies in
profound ways, shaping our health care, our environment, our
food, our economy, our science, even our conception of what it is
to be human. These changes carry opportunity for good, and
for evil. The challenge will be to shape these changes in
ways that maximize potential benefits, and minimize insult to
basic human values.
Scientists, entrepreneurs, politicians,
and individuals disagree about the extent to which the new
genetics ought to be controlled and shaped by public
policy. Assuming some regulation is desirable, who
should decide the rules? What should those rules look
like? Can they effectively balance such disparate and
potentially conflicting values as corporate profit, scientific
progress, privacy, and public health?
As critical research in the field of
human genetics moves out of government-funded laboratories and
into private sector firms, one thing is clear: our social
institutions are lagging far behind the science. Because
of the significant long-term consequences of genetic
manipulation, goals must be formulated, policies executed.
The Role of Law
DNA itself has
already been proclaimed a hero of the twenty-first century.
But are legal instruments and concepts such as patents and
informed consent adequate to deal with genetic innovation?
Which legal instruments will most effectively ensure that the
new genetics is pursued without threat to basic human
rights and values?
DNA has certain properties that make it a
complex legal object: it is in code; its functions are difficult
to grasp and still largely obscure, even to scientific experts;
it is part of us, part of each of our cells, and yet is now able
to be manipulated and reproduced; its code is held in common by
all humans with some variations, variations that tend to diminish
among ethnically discrete populations; it has terrific potential
value for public health, and yet deriving value from genetic
information requires large capital investment and is aided by the
study of homogeneous populations.
Legal problems abound. How exactly DNA
comports with notions of property is unclear, and certainly the
patent regime for genes being promoted by the United States
deserves scrutiny. The scientific complexity of genetic
process makes meaningful public participation in law making and
regulation difficult. Further, the unique tensions raised
between the individual and group DNA and also conflicts of
interest of researchers and patients threaten the adequacy of
informed consent as an effective protection against
the infringement of basic rights.
In this age of globalization, international
consensus ought to shape the new genetics, not an
unfettered market process that simply reinforces existing
economic hegemonies. Can the benefits of the new
genetics have an equitable distribution across countries
rich and poor?
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Last update 2/7/02 by Benjamin Hron
Copyright 2002 the President and Fellows of Harvard College