Guelph, Ontario
February 15, 2006
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.” |