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 approved products.
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.
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