MEDICAL
JOURNAL OF AUSTRALIA
2000
CHRISTMAS ISSUE
THE
HUMAN GENOME PROJECT IN THE DOCK
Michael
Kirby
Despite the title, the Human Genome Project (HGP)
is not in the dock. It is not even under reasonable
suspicion of wrongdoing. On the contrary, it is still
in innocent infancy. Before it lies a prospect of
great excitement. Overwhelmingly it will prove of
benefit to humanity.
But don't rush away. There are a lot of problems.
Bioethicists, philosophers, religious experts, lawyers and
others are already working on them. I have just returned
from a meeting of the Ethics Committee of HUGO held in London
and a separate meeting of the International Bioethics Committee
of UNESCO (IBC), held in Quito, Ecuador. At international
meetings such as these, in national bodies, in lawmaking
institutions and universities, a lot of minds are identifying
the chief problems of the HGP. Some of them are comparatively
straight-forward. Others are pretty fundamental.
Manageable problems
Let me start with a few problems that are manageable:
§
Privacy and confidentiality: The
basic rule of the healthcare professions has long been that
of respect for the confidences of the patient. This
rule goes back to the Hippocratic Oath. It existed
in ancient civilisations. However, when a disorder
is the result of a genetic characteristic, is the "patient"
solely the individual? Or does the entire family have
rights? Should family members, in some circumstances,
be entitled, by law, to override the wishes of an individual
and to obtain data about that individual's genes relevant
to genetic conditions important for them all? Should
a patient have a right not to know the genetic determinants
of his or her likely future medical problems? How
do we reconcile traditional rights of the individual with
the fact that genetic data may be very important for a lot
of others? How do we prevent discrimination based
on such data?
§
Third party interests: These
questions lead naturally to the legal rights of third parties.
Should an employer have a right to require an employee to
submit to genetic testing to establish the likely future
health status of that employee? If a blanket right
is unacceptable, are there some kinds of employment whose
very nature suggests that such a right, exceptionally, should
exist by law? Are there are other, less intrusive
means available to such employers to monitor relevant health
conditions without resorting to a complete refusal to employ
applicants on the basis of a genetic test? And what
of insurance companies in respect of applicants for insurance?
Until now, sickness and life insurance has largely involved
the sharing of largely unknown risks. To a great extent,
the medical prognosis of individual proponents for insurance
has been uncertain. Now, with near perfect genetic
tests available to insurers, would the use of such data
not shift the scales unfairly to the insurers' advantage?
Would the denial of such data be feasible, given that insurers
can already require those who want their services to undergo
other tests that may point in the direction of genetic predispositions?
§
Intellectual property: One of
the key issues in genetic research concerns the desirability
of permitting the patenting of genetic sequences on the
basis of their future utility for therapeutic applications.
In every country, legal rights in such research will depend
on the terms of the local intellectual property law, governing
patents, copyrights, etc. Such law is usually influenced
by international treaties. Both in plant varieties
and in respect of the genome of humans and of animals, strong
views have been expressed concerning access to patent protection.
Opponents say that the human genome is part of the common
heritage of humanity - like the open sea, outer space
and the environment: we are all involved. Others
argue that it belongs to God, not to the profits of multinationals
or the pretensions of passing generations. Watson
and Crick, who first described DNA and found the key to
unlock the genome, never attempted to secure commercial
advantage for themselves from their scientific discoveries.
On the other hand, pharmaceutical corporations point to
the huge investment and runup costs for developing successful
drugs and therapies. Unless temporary monopolies are
given by law, such companies may not invest the large funds
necessary to maximise practical use of the scientific discoveries.
Medium-term issues
All of the above questions can ultimately be answered
in the traditional way. Parliaments can set up committees
or refer questions to law reform bodies. Nations can
consult with each other. Eventually answers, national
and international, can be found. But, beyond these
problems are others which are more vexing:
§
Criminal responsibility: The
discovery of genetic causes of many disorders raises the
possibility of identifying genes associated with various
forms of antisocial behaviour. Criminal law is normally
based on the premise that it is necessary for the state
to prove both that the accused acted as he did and that
he had the necessary intention (mens rea) to do so.
But what are the implications of discovering that, in some
cases, at least, the actions of the individual may be caused,
or profoundly influenced, by a pre-existing genetic characteristic?
The law accommodates some genetic impairments in determining
criminal responsibility. Proved and relevant impairment
may be taken into account in sentencing. But will
genetic discoveries present an even more profound challenge
for our whole notion of criminal liability? Is it
back to the drawing boards for assumptions about deliberate
criminal wrong-doing?
§
Benefit-sharing: Much genetic
research will be devoted to identifying the genetic differentials
that cause some families or groups to exhibit resistance,
or susceptibility, to life-threatening or disabling conditions.
In such circumstances should a donor of genetic material,
which subsequently yields data useful for the development
of drugs or therapy, receive some share of the huge profits
that may be occasioned by such use? Or should the
donation be put down to philanthropy for the benefit of
humanity? Should something be paid to the donor's
village, tribe or country if a sample proves valuable?
How does the international community ensure that the focus
of immediate research on the human genome includes combating
malaria and river blindness and not just wrinkles in the
ageing rich? How can we promote distributive justice
for humanity rather than selfish use of the HGP for the
illnesses of patients in the wealthy countries?
The big ones
As if the foregoing list did not present us with
enough questions to cause headaches, there are two really
big dilemmas presented by the advance of the HGP:
§
Decision-making: It is important
to realise that not to do anything about the HGP is to make
a decision. It is to accept that science and technology
may take our societies where the imagination of those involved
wants to. That may generally be a good thing.
For example, there has been a great rush to legislate and
regulate reproductive cloning of the human species based
on intuitive objections to the very idea. Later thoughts
have suggested that we may need to give the subject more
consideration before we rush into such total prohibitions.
In the past, there were similar responses, at first, to
AIH (artificial insemination husband) and AID (artificial
insemination donor) and IVF (in vitro fertilisation).
To assume that reproductive cloning would produce exactly
the same human being as its donor is absurd. Every
human being is the product of environmental experience as
well as genetic heritage. Yet apart from a few legislators
(and I would exempt Senator Natasha Stott Despoja) most
politicians would rather run a mile from the complex issues
of the genome. The international community has the
IBC. HUGO has its Ethics Committee. But, effective,
well resourced national and international advisory bodies
are thin on the ground. Getting agreement on a national
level is hard enough, given the competing perspectives.
Securing international agreement is almost impossible.
Yet without international rules, in genomic regulation,
as with nuclear fission and Internet regulation, national
laws can never be fully effective. Faced with legal
prohibition, the scientist may simply move his laboratory
to a less troublesome country.
§
Genetic alteration: Fundamental
questions are also raised by the long term prospects of
genetic alteration of the human species. For example,
we have identified the genes that express themselves in
Huntington's Disease. Should the law permit, encourage
or forbid the elimination of a foetus which manifests these
genes? Elimination of a foetus manifesting likely
intellectual impairment is not now uncommon. But how
far do we go down that track in the quest for the "perfect"
child? Eliminating obesity? Baldness?
Heart disease? Homosexuality (assuming that to be,
in part at least, genetic)? Not to regulate these
developments is, effectively, to permit them all.
Already, in many developing countries, crude steps are taken
to eliminate one of the most common genetic condition at
all: the female gender. Should the law step
in? Or should we go with the flow? When it becomes
possible, by gene shears, to eliminate particular genes
and transplant others, what will prevent the attempted creation
of a super species? Of an under species? Of
an altered human species? These are matters upon which
we must be ready with our answers. It should not be
assumed that sermons, political press releases and the solemn
resolutions of corporate ethics committees will have the
power to prevent developments deemed undesirable by the
majority of humanity.
Public debate
Unless all of the foregoing questions are debated
before the public of the countries affected (including Australia),
it is probable that legal responses, when they come, will
be (as with reproductive human cloning) peremptory, emotional,
intuitive. They may not be informed by knowledge of
the best specific data. It is therefore the responsibility
of the scientific community to inform their fellow citizens
of exactly what is happening. It is the responsibility
of politicians, lawyers and ethicists to engage in the public
debate and to found their decisions or recommendations on
the best available scientific information. These are
not questions to be answered by the headlines of tabloids.
They require careful interdisciplinary dialogue. They
should be seen to involve the community. It has begun.
But it is not well funded. Its dilemmas are often
very complex. It is far easier for most decision-makers
to switch off. The sale of the rest of Telstra or
the alleged misuse of a phone card are much easier issues
for the human imagination to grapple with.
The neglect of the ethical issues raised
by the Manhattan Project ultimately caught up with humanity.
The puzzles of regulating the Internet are with us.
But there is no more profound puzzle than the future of
the human species. This is why the questions I have
asked are of such importance to Australia and the world.
I offer no clear answers. But realising that the questions
must be answered, and soon, is the beginning of wisdom.
Author
Justice Michael Kirby is a member of the HUGO Ethics
Committee and the International Ethics Committee of UNESCO.
His address is: C/- High Court of Australia, Parkes
Place, Canberra, ACT, 2600, Australia: email:
kirbyj@hcourt.gov.au
References
The website of the Human Genome Organisation is:
www.hugo-international.org The Statements of the HUGO
Ethics Committee can be found on the website. They
deal with such topics as "The Principled Conduct of
Genetics Research"; "DNA Sampling: Control
and Access"; "Patenting DNA Sequences"; and
"Benefit Sharing".
