On Tuesday, April 8, 2008, the federal government tabled
Bills C-51 and C-52 in Parliament for first reading.
Bill C-51: Changes to the Food and Drugs Act
Bill C-51 proposes substantial changes to how Health Canada
regulates drug products, including an expedited approval
process called "progressive licensing". If a drug
manufacturer can establish that a new drug's benefits
outweigh its risks, the drug can receive speedy market
authorization. Progressive licensing would be coupled with
"life-cycle" monitoring or testing after the product
launch and increased adverse reaction reporting. The Minister
of Health would have the authority to approve new drugs
conditionally and to order a recall if at any time he believes
a drug poses a danger to the public.
If passed, this legislation would not affect currently
The Bill contains the broad principles of this new drug
regulatory regime; the details are to be provided in new
regulations which were not released last Tuesday and are not
expected until the fall of 2008 at the earliest. As the
legislation works its way through Parliament and its
Committees, watch for further details of the new regime and a
heated debate on the merits of progressive licensing. The
government has not announced its schedule for Bill-51 to be
passed in the House of Commons and the Senate, and it is
unlikely to be passed before this fall. The Bill has the
support of many organizations including the innovative and
generic drugs trade associations.
Bill C-52: The Canadian Consumer Safety Act
Bill C-52, the Canadian Consumer Safety Act, would
allow the Minister of Health to require consumer product
recalls where the product is unsafe and a danger to human
health or safety. The Act would apply to consumer products that
are used for non-commercial purposes, but would not apply to
food and drug products covered by the Food and Drugs
Act. Again, the Bill outlines the broad principles of the
proposed consumer product regulatory scheme and leaves the
details to the regulations to be enacted. There is broad
support among manufacturers, retailers and the public for the
power to compel a recall of an unsafe consumer product which
poses a danger to human health or safety. Everyone involved
with consumer products should follow the progress of Bill-52 in
Parliament to ensure the final details of the regime are
workable and balanced.
We will provide updates on the progress of the Bills as they
work their way through Parliament and would be pleased to
respond to any questions you may have.
The recent decision of the Ontario Court of Appeal in BMW Financial Services Canada, a Division of BMW Canada Inc. v. McLean provides some useful insight into the relationship between automobile dealers and the financing arms of the manufacturers for whom those dealers are franchisees.
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