Biotech industry must consider social impact

Canada has developed one of the best biotechnology regulatory systems in the world, despite its critics and the need for constant improvement, says a biotech company executive.

“Looking at the world, who’s got it right?” Pioneer Hi-Bred International biotech and regulatory affairs Canadian director Don MacKenzie asked during a Jan. 12 discussion at a national agriculture policy conference in Ottawa. “We do.”

But a regulatory expert from the University of Ottawa warned that Canada’s system could face uncertainty and confusion in the future as companies seek to patent higher life forms, including more complex plant and animal genetic modification. The Supreme Court of Canada has issued contradictory rulings on the issue.

Jeremy de Beer said Canada’s biotech regulators and the politicians who make the rules face the complicated task of figuring out how to accommodate social and economic effects in regulatory decisions without undermining the system’s science-based credibility.

He said in a later interview that the controversy around whether to approve GM wheat despite fears of export market losses is a prime example of the dilemma.

“Many people will agree that the question (of biotech regulation) is more than just whether it is safe for human health or not because the issues it raises are so much broader, including economic and social impacts,” said de Beer.

“Somehow, we have to be aware of the social and human impacts of what this is doing.… A science-based system is important, but anyone with a realistic view of what is happening on the ground will realize that people care about the impacts of these decisions, so we have to find some way to deal with them within the system. It is unacceptable to ignore them or dismiss them as not scientific because they are real and people need to find a way to deal with them.”

MacKenzie told the conference that the biotech industry needs robust and credible regulations that are predictable with a transparent process that judges product safety on its merits and not on the technology used to produce it.

He said Canada has developed a system that assesses products with novel traits without judging the process.

“That is not done anywhere else in the world.”

De Beer said industry praise of the Canadian system for its predictability and fairness suggests “we have to be doing something right.”

However, he said the biotech regulatory system must continue to change because it faces serious challenges.

Among the most important are the unpredictability of court decisions. While politicians create laws and bureaucrats develop and administer regulations needed to implement them, disputes are adjudicated by judges who often have little understanding of the implications of the issues.

They are asked to decide a case between two litigants, but the implications can be far broader.

He cited the Supreme Court ruling that a GM mouse developed by Harvard University scientists to study cancer cures could not be patented in Canada, although it had been in other countries. Higher life forms could not be patented.

Later, in a case involving a battle between Saskatchewan farmer Percy Schmeiser and Monsanto Inc., the court ruled that the company’s patent on a canola gene was valid.

“So you can’t patent higher life forms but you can patent higher life form building blocks,” de Beer told the conference, which was organized by the Canadian Agricultural Economics Society.

He said in the later interview that the judicial contradiction adds uncertainty to the future of the regulatory system.

“This is part of the unpredictability because it is only a matter of time before we have more complicated questions on the scope of patents in agriculture dealing with issues like regulation of genetically modified livestock or other animals,” he said.

“It will come to the courts and at this point, the message is mixed.”

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