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6-Regulation: Regulatory obstacles thwarting biotechnology in Canada

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TITLE:  Report: Regulatory Obstacles Thwarting Biotechnology
SOURCE: University of Guelph, Canada, News Release
DATE:   15 Feb 2006

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please download the report at:
Convergence in Biotechnology Innovation: Case Studies and Implications
for Regulation

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."

For media questions, contact Communications and Public Affairs: Lori Bona
Hunt, (519) 824- 4120, Ext. 53338, or Rebecca Kendall, (519) 824-4120,
Ext. 56982.


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