GLOBAL APPROACH TO GENETICS INQUIRY IS ESSENTIAL

Michael Kirby*

          Picture the scene.  One of the most beautiful natural settings on earth.  A palace at the foot of the mountains at Salzburg in Austria.  In the distance, the Bavarian Alps.  Bus tours circle the lake in front of the palace: for this is where Mozart’s patron lived and, more recently, where The Sound of Music was filmed.  Inside the palace, serious debate for a week on some of the most important and urgent problems facing humanity.  Surrounded by gilt and marble, we were discussing the issues presented by the human genome.

          Leading the debate was Dr James Watson – famed co-discoverer in 1953 with Francis Crick of DNA – the basic source material of life.  Watson and Crick were the first to describe the double helix on which are found the genes that control our existence.  Dr Michael Morgan of the British Wellcome Trust – who Time magazine credited with rescuing the publicly funded Human Genome Project when the private enterprise enthusiasts in the United States threatened to complete the genetic map for private profit.  Dr Alan Colman, who works with a brilliant team of scientists in Scotland, who produced “Dolly”, the cloned sheep whose ever present photograph was a metaphor for the potential challenges to ethics and the law if the cloning of the human species proves possible.  Judge Pauline Newman, from Washington, who decides big patent cases at the cutting edge of legal decision-making.  Henry Yang, an exuberant Chinese scientist who constantly reminded the participants that the human genome belonged to the human species everywhere – not just to those living in the advanced countries who stand to profit from genetic discoveries.

          Organised a year earlier, the Salzburg Seminar in July 2000 could hardly have been better timed.  Two weeks earlier a working draft of the total human genome sequence had been unveiled in Washington.  This is the first step on the way to mapping all the genes that make up the human species.  Identifying those genes will eventually reveal the causes of hundreds of human diseases and conditions that make people susceptible to disease.  The participants at Salzburg were aware that this breakthrough will eventually lead to therapies that will save human lives and reduce pain.  But they were also acutely aware of the dilemmas which such new knowledge will present.  After all, Watson – who has never sought to make a cent for himself out of his brilliant scientific discovery – has long been a leading proponent for vigilance about the outcomes.  It was Watson who insisted that between 3-5 per cent of the budget of all enterprises in the United States investing in genetic research should be spent on analysis of the ethical and social issues resulting from genetic discoveries. It is a demand, like the customs of Hamlet’s Denmark, still honoured more in the breach than in the observance.

          A sense of wonderment and excitement filled the baroque palace at Salzburg as the scientists carefully and methodically described the genome project – where we are and where we are going.  Dolly and her cousins peered down at us sweetly from the computer graphics.  “We don’t know how long she will live; but we know she loves posing for the TV cameras” said Colman.  I could not be sure whether he was pulling our leg.

          At the end of the session, the participants from 30 countries on every continent, agreed to a statement setting out their conclusions.  They also agreed that the issues presented were extremely complex and urgent – and that more dialogue was needed.  They quickly concluded that the approaches in different countries would have to be developed within the framework of a common international approach.  What is involved is the very question of what it is to be a human being, how our species is made and how it may be altered.  In a remarkably short space of time – no more than God had taken to create the heavens and the earth according to the Book of Genesis – the seminar agreed on a number of principles that should be adopted to guide responses to the challenge of the genome:

·       Observing respect for fundamental human rights and human dignity, including respect for the special interests of indigenous peoples.

·       Ensuring health and environmental protection.

·       Basing proposals on a detailed understanding of the relevant science.

·       Engaging in effective multidisciplinary dialogue.

·       Initiating an appropriate involvement of the public in decisions affecting them.

·       Maintaining respect for different ethical,  philosophical, and religious viewpoints.

·       Recognising the differing legal traditions and institutions that will necessarily affect our responses.

Given the involvement of a number of participants from developing countries – those that are not the leaders in the research into human genetics – it was perhaps understandable to see the emphasis placed on respect for the rights of indigenous peoples and the insistence on ensuring that “the benefits of the genome accrue to all humanity”.  One of the most vexed subjects discussed, on which tempers commonly flare (including on the part of Watson), was patent law.  The participants of Salzburg insisted that this should be developed “to the greatest public benefit”.  That rather than long term private monopoly rights, the object of any laws permitting patenting of life forms should be just reward for risk taking in the creation of new drugs for the benefit of humanity.  Improved “technology transfer” to developing countries should also be stepped up.  But will the big pharmaceutical companies share these fine aspirations?  Could anything we do in Australia affect the achievement of these objectives given that we are a comparatively small time player in the science and technology of genetics?

The statement urged improved communication by scientists and technologists about their discoveries concerning genetics in language that the general community can understand.  Obviously the media also has an important role in stimulating meaningful public debate beyond superficial “gee whiz” reports and alarmist entertainment.

Top of the list of recommendations addressed to governments was the establishment of multidisciplinary national advisory bodies to address the legal, social and ethical issues presented by gene technology and to consider “what, if any, regulation or deregulation is required”.  Amongst the subjects needing special study were said to be new regulations to:

·       safeguard individual and family privacy in relation to access to genetic data, particularly as collected by genetic tests.

·       prevent and redress discrimination against persons on the basis of their genome or the results of genetic tests.

·       facilitate risk assessment and safety evaluation in the context of the introduction of new genomic developments.

          As well, the Salzburg meeting urged the need to provide and encourage improved:

·       education concerning the basic nature of the genome and its implications for science and society.

·       general knowledge for the community so that informed decisions may be made concerning genomic developments.

·       courses and information for decision-makers in the legislation, executive and judicial branches of government so that their decisions might be informed and not based merely on uninstructed intuition.

          On my return to Australia I found media reports that bore out the importance of these themes.  Several gave specific instances of alleged discrimination against patients resulting from the refusal of loan facilities, full superannuation and insurance cover based on the results of genetic tests.  Insurers were said to be offering discounted premiums to people willing to subject themselves to a spectrum of genetic tests.  But what inference would such a person draw if insurance was then refused?  The problems considered in theory at Salzburg have already arrived in Australia.  The need for a response is clear and urgent.

          Then, on 9 August, the Australian Government announced a national inquiry on the role of gene technology, human rights, privacy and discrimination.  To be conducted by the Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee of the National Health and Medical Research Council, this looks like precisely the kind of multidisciplinary body that the Salzburg Seminar proposed.  As the Federal Attorney General remarked “the issues are complex and significant, the science is only in its infancy but the … issues raised are … far reaching”.  The involvement of the public and experts is to be welcomed.  The established track record of the ALRC in bioethics promises a timely and effective national debate.  Some interim laws might be needed to safeguard the rights of vulnerable people whilst the wheels of law-making grind slowly on.  Science surges ahead.  Making sure that our democracy can respond in an informed and timely way to the genome is a major challenge to our democracy. 

          The Australian inquiry could do worse than launching its inquiry on the basis of the Salzburg Statement on Genetic Regulation.  One thing is sure.  In the matter of genetics – like the Internet and nuclear non-proliferation – no country can go it alone.  We are studying the future of our species.  Nothing less than a global approach will do.


* Justice Michael Kirby of the High Court of Australia is a member of the Ethics Committee of the Human Genome Organisation and of the UNESCO International Bioethics Committee.