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:  [email protected]

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".