URL: http://www.globeandmail.com/gam/Science/20010406/COMANNING.html

Date accessed: 9 April 2001

Alone among G7 nations, Canada has no regulatory framework
for research into the human genome, warns PRESTON MANNING,
Opposition critic for science and technology

PRESTON MANNING

Friday, April 6, 2001

Last month scientists associated with the U.S. National Institutes of Health, the Wellcome Trust in Britain, and Celera Genomics Inc. released the results of their 10-year multibillion dollar race to map the human genome.

This three-billion-letter biochemical sequence contains the genes that determine how the body carries out its functions from conception to death. Research developments based on this data are expected to help revolutionize the understanding and treatment of many diseases, while also raising a host of legal, ethical, and social challenges. Every advanced nation, including Canada, requires a policy and legal framework for the support and regulation of genetic science and the technologies based upon it.

On the regulatory front, Canada lags far behind most other G7 countries. It has been eight years since Canada's Royal Commission on Reproductive and Genetic Technologies recommended the establishment of a national regulatory framework. It has been five years since the Liberal government first introduced an ill-conceived bill on this subject -- legislation that died on the Order Paper when the 1997 election was called. A new bill promised by the Health Minister for March has now been delayed until May, and many questions remain concerning the government's approach.

First, what is its policy on the regulation of genetic science and technologies? We cannot legislate in a policy vacuum. Ottawa should specify the objectives of government regulation of reproductive and genetic technologies and the means whereby those objectives are to be achieved.

How does the government propose to reconcile the need for regulation with the need for freedom of inquiry in the laboratory and freedom of enterprise in the marketplace? How does the government propose to encourage good science on the one hand, discourage harmful applications such as human cloning on the other, and avoid conflict of interest between its support and regulatory roles? No clearly defined framework exists -- a deficiency that must be corrected over the next two months.

Second, has the federal government established the best possible constitutional foundation for regulating reproductive and genetic technologies? At present, the answer would appear to be, "No."

The primary responsibility for human health under our Constitution rests with the provinces, including responsibility for the application of new technologies to human health care. Federal authorities, aware that they are treading on shaky ground by legislating in this area, cast about for ways of strengthening federal jurisdiction.

One way of doing so is simply to list a number of activities and applications of concern -- cloning; creation of animal-human hybrids; sex selection for non-medical purposes; buying and selling of sperm, eggs, and embryos; creation of embryos for research purposes only -- and then to legislate criminal sanctions against those engaging in such activities. Because the criminal power under our Constitution is federal, this would strengthen Ottawa's jurisdiction over reproductive and genetic technologies.

But is this really a sound way to approach regulation of the application of new technologies to human health? The Official Opposition urges Ottawa to seek a federal-provincial agreement for the support and regulation of reproductive and genetic technologies. And if the decision is to establish a national regulatory tribunal, it should adequately represent both levels of government, and both should delegate to it the constitutional powers necessary for it to operate in the best interests of all Canadians.

A sound constitutional foundation is an essential prerequisite to establishing a sound regulatory system. Any "DNA Act" must be compatible, in practice and in theory, with the BNA Act and its successors.

Third, what should be the other key characteristics of a national body for the regulation of reproductive and genetic technologies? In discussions with health authorities, scientists, ethicists, and citizens, I've developed some ideas.

We need a body that is flexible -- suggesting regulation by an administrative tribunal rather than by legislation alone. We need it to be independent, suggesting that the administrative tribunal should operate at arm's length from those whose activities it must regulate, including scientists, business, and the government itself.

We need this body to be scientifically informed -- capable of receiving expert advice and testimony from the scientific community, subjecting it to cross-examination, and applying it to the issues and challenges at hand. Yet it must offer "standing" not only to the views of scientists, but also to the views of ethicists and faith communities.

The regulatory body will need an open hearing process and transparent decision making, easily accessible to the public and interest groups, and capable of effective public consultations and communications. It must perform efficiently, including the way it develops guidelines, monitors their application, investigates complaints, and licenses regulated activities. It must be capable of harnessing existing research guidelines and research ethics boards to the overall regulatory task, rather than reinventing the wheel and establishing yet another layer of bureaucracy and red tape.

Finally, the regulatory regime established must have credibility with the public and those whom it is designed to regulate. But "moral authority" may present the greatest problem: As one dedicated medical researcher said to me, "How can politicians tell us what constitutes 'ethical' and 'non-ethical' behaviour, when they are unwilling to hold themselves to even minimal ethical standards?" Before the 37th Parliament can legislate with credibility on the regulation of reproductive and genetic technologies, perhaps it should address the regulation of itself.
Preston Manning, Opposition critic for science and technology, is the Alliance MP for Calgary Southwest.

Category: 32. Genome Project and Genomics, 39. General Issues about Research