(January 7, 1999, Gazette)
Are human genes just a commodity, a type of living silicon chip that can be bought, sold and upgraded?
The market for biotechnology-based products is growing at a rate of about 11 per cent a year, and human genes are an important part of that industry. DNA from Newfoundland families is part of current research into diseases like psoriasis and heart disease, research that may result in profitable products.
But who profits from this, and what are the legal and ethical questions involved in biotechnology? A comprehensive overview of the implications of biotechnology for industry was given Dec. 9 at the medical school by Dr. Bartha Knoppers, a professor of law at the Université de Montréal and a member of the Medical Research Council's standing committee on ethics. Her talk was the fifth in the medical school's 30th Anniversary Lecture Series.
"Like alchemists of the Middle Ages, the biotechnology industry hopes to arrive at therapeutic products that will prolong life and also make a new kind of gold - the profits coming from this link between genetics and pharmaco-genomics."
Dr. Knoppers said the coupling of the fundamental research community with industry is a new phenomenon "and one we're having trouble grappling with." Within the university research community, combining commerce with research causes numerous concerns, not the least of which is what can be patented.
The Supreme Court has already ruled that newly created life forms can be patented within the traditional rules of novelty, inventiveness and economic utility. Clauses found in the main contracts signed by researchers and technology transfer offices with companies thus restrict the kind of information that can be made public.
"Both the patenting clauses and the confidentiality clauses create barriers in the traditional openness and sharing of information between researchers, patients and the public," said Dr. Knoppers.
Patient consent forms are becoming increasingly detailed, and new guidelines require that commercial sponsorship be mentioned in these forms. There are new options, such as what aims the DNA can be used for, if it can be used after the patient's death, and if it can be used by other researchers.
But even with patient consent, the question remains as to who benefits from their DNA. Biotechnology companies are not interested in working with DNA that is not clear of any possible legal suits in the future. But to make sure there is some benefit other than to the company, Dr. Knoppers said we need to develop models whereby the whole community receives part of the profits to improve community resources.
Another dilemma involved in the application of genetic knowledge is genetic testing.
"There's nothing governing paternity testing, in contrast to criminal DNA testing which is governed by the criminal code," she said. "Geneticists have always had the dilemma of finding non-paternity when they weren't looking for it, and now there's the new dilemma of being asked to determine familial relationships for insurance purposes, for real estate purposes and for maintenance following divorce."
Dr. Knoppers said that when familial relations are determined in the private sector without any judicial overview, there is no consideration of the best interests of the child.
Because there are so many complex legal and ethical questions involved in biotechnology, Dr. Knoppers said it is vital that a human rights approach be used in developing legislation governing the use of DNA.
"Big clinical genomic trials run in many countries, and we have to think of re-modelling our system within an international model."