Background The Role of Law

Welcome to E.LaB!

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


Background

    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 Boston’s 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.

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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

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