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News Release

February 15, 2006

Report: Regulatory Obstacles Thwarting Biotechnology

Canada will have to change the way it regulates scientific advances if it’s to benefit economically and socially from biotechnology innovation, according to a new report by a University of Guelph professor.

“Federal and provincial government agencies have made a concerted effort to increase support for biology,” said philosophy professor David Castle, the study’s lead author. “But biotechnology innovation continues to outpace the development of the regulations necessary for product approvals. This problem is highlighted when new biotech products straddle different regulatory authorities.”

The report, “Convergence in Biotechnology Innovation: Case Studies and Implications for Regulation,” was researched and written at the University of Guelph. It is part of an initiative of the Program on Applied Ethics and Biotechnology at the University of Toronto’s Joint Centre for Bioethics and is supported by the Ontario Research and Development Challenge Fund, the Ontario Genomics Institute and Genome Canada.

Released today, the report is posted on the project’s website. The researchers also sent it to the nation’s major regulatory agencies and are inviting officials, industry professionals, patent groups, researchers and individuals to respond with their views and concerns.

“The intent of this report was to consider whether a growing trend in biotechnology that we call ‘convergent’ technology can be handled within the existing regulatory system,” Castle said. “We have identified gaps and obstacles in the regulatory system and have recommended changes in how biotechnology regulation should be governed.”

The report focussed on three novel biotechnology innovations and, in each case, found significant regulatory stumbling blocks. Researchers looked at nutrigenomics, the field of personalized nutrition based on the study of the interaction between nutrients and genes; plant-derived vaccines, the production of vaccines for humans in crop plants; and the Enviropig, a line of pigs genetically modified so their bodies can absorb a normally indigestible form of phosphorus.

The report identifies the regulatory obstacles affecting the three technologies and makes specific recommendations for change. It also proposes overall suggestions for national reform, including establishing new regulatory concepts, definitions, standards, processes and structures.

“This report confirms that there are obstacles in the way of the effective adaptation of the regulatory system of convergent technologies,” Castle said. “Our hope is that the findings will lead to regulatory reform and migratory steps toward new models for governing biotechnology regulation.”