On April 8, 2008, the federal government tabled legislation in the House of Commons to amend the Food and Drugs Act and to introduce new consumer product safety legislation in Canada. The legislative package introduces legislation that would explicitly give Health Canada the power to regulate consumer products and will effect amendments to the Food and Drugs Act to implement a "progressing licensing" framework in the context of the regulation of food and therapeutic products.
Revisions to the Food and Drugs Act and Progressive Licensing
The proposed changes to the Food and Drugs Act would create a definition for a "therapeutic product" that includes cells, tissues or organs, in addition to drugs and medical devices. The amendments would implement a "progressive licensing" framework for therapeutic products, which represents a shift from a pre-market review regime to a system that allows continuous assessment of a therapeutic product's risks and benefits both before and after it has received a market authorization. The Minister of Health would have the power to impose conditions on a marketing authorization and may amend an authorization on his/her own initiative. The Minister may also require revisions to the label of a therapeutic product if considered necessary to prevent injury to health.
The proposed amendments would give the Minister greater power to request information from holders of clinical trial authorizations, market authorizations and establishment licences. Holders of market authorizations or establishment licences may also be directed to compile information and conduct tests or monitor experience regarding their therapeutic products in the Canadian market and to report the results of these tests and studies to the Minister.
The proposed amendments would impose adverse-reaction reporting requirements on healthcare institutions. Under the current legislation, the onus to report rests with the holders of market authorizations for products. According to the proposed amendments, healthcare institutions would be required to provide the Minister with information about the adverse reactions of treated individuals that are associated with the use of therapeutic products.
The changes would also give the Minister the power to disclose confidential business information to the public, without consent of the owner of the information if the information is about a food therapeutic product that presents a serious and imminent risk of injury to health.
An inspector's powers would be significantly increased: inspectors who believe on reasonable grounds that the Act or regulations have been contravened would be allowed to direct a person to "take a measure that is necessary to identify or respond to a risk of injury to health that is related to the activity that is the subject of the contravention." The amendments would also give the Minister the explicit power to order a recall if he or she believes that a therapeutic product or cosmetic presents a serious or imminent risk of injury to health.
For contraventions of the Act or regulations, fines are proposed to be increased significantly. The most serious offences are punishable by fines of up to $5 million and/or imprisonment for up to two years. If the contravention is willful or reckless, the court would have discretion to determine an appropriate fine, with a maximum prison term of five years. In the case of corporate offenders, directors and officers may be found liable for contraventions of the legislation.
Canada Consumer Product Safety Act
The proposed Canada Consumer Product Safety Act is aimed at preventing and dealing with dangers to human health or safety posed by consumer products. Consumer products under the proposed Act are defined as products, including their components, parts or accessories, that can reasonably be expected to be obtained by an individual to be used for non-commercial purposes. Several classes of consumer products are exempted from the definition of consumer products, including foods, drugs, medical devices and cosmetics as defined under the Food and Drugs Act; pest control products; firearms; vehicles; plants and seeds; and controlled substances as defined under the Controlled Drugs and Substances Act.
The proposed legislation would grant the Minister the right to issue mandatory recalls in respect of consumer products. The legislation also contemplates the appointment of inspectors who would have the power to recall any consumer product that they believe on reasonable grounds is a danger to human health or safety. Inspectors recall orders would be subject to review prior to their enforcement.
The proposed legislation includes a number of provisions aimed at the reporting of an "incident," which is defined as (i) an occurrence in Canada or elsewhere that results, or that could reasonably be expected to have resulted, in an individual's death or in serious adverse effects on their health; (ii) a defect or characteristic that may reasonably be expected to result in an individual's death or in serious adverse effects on their health; (iii) incorrect or insufficient information on a label or in instructions that may reasonably be expected to result in an individual's death or in serious adverse effects on their health; or (iv) a recall or measure that is initiated for human health or safety reasons by a foreign entity, provincial government or public body established by provincial statute.
In the event of an incident, a manufacturer, importer or seller must provide the Minister with all information in their control regarding the incident within two days of becoming aware of it. Further to this, a manufacturer, or importer if the manufacturer is not located in Canada, must provide within seven days a written report to the Minister that includes additional information on any other products they manufacture or import that could be involved in a similar incident as well as measures they propose to take in respect of these additional products.
The proposed legislation would give the Minister the power to disclose any confidential business information to the public, without consent, about a consumer product that is a serious and imminent danger to human health or safety or the environment.
Fines and penalties for contraventions of the Canada Consumer Product Safety Act would be the same as those under the Food and Drugs Act.
Implications for Companies
The proposed changes in the legislative package will impose additional requirements on companies in the already-regulated food and drug industry. For companies selling consumer products in Canada, the creation of consumer product safety legislation will have a significant impact on their business operations in Canada because these types of products will now be explicitly subject to regulation by Health Canada.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.