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Proposed Amendments to Bill C-51 - Fact Sheet

Since the introduction of Next link will take you to another Web site Bill C-51 in April 2008, concerns have been raised surrounding the potential impact of the Bill on the regulation of natural health products. Extensive stakeholder consultations have been carried out to better understand these concerns and to explain the underlying intent of the changes proposed in the Bill.

In response, the Government has announced that it would be proposing amendments to Bill C-51 for discussion and consideration by the Standing Committee on Health after Second Reading.

The Proposed Amendments

A Unique Category: Natural health products would be defined within the Act as a unique category apart from food and drugs. The proposed amendments would support the existing Natural Health Products Regulations, which are separate from the framework for the regulation of drugs.

Standards of Evidence: Another proposed amendment would ensure that regulations specific to the approval of natural health products recognize the value of traditional knowledge and history of use in assessing benefits and risks, as is already the case.

Inspector Powers: Proposed amendments would clarify that inspectors must carry out their duties in a reasonable manner and for the purpose of verifying compliance or preventing non-compliance. They would also clarify that the exercise of enforcement powers, such as seizure and detention, would have regard to the risk of a product.

Advisory Committee: Finally, the proposed amendments would require the creation of an Advisory Committee that would provide advice to government to assist in the interpretation of the Act and its regulations. This committee would include representatives with diverse backgrounds, such as consumers, patients, health professionals, and industry.

Next Steps

The Government plans on formally proposing the above amendments to the Health Committee once Bill C-51 passes Second Reading. Members of the public will have the opportunity to provide input and to assist the Committee in deciding whether to adopt the proposed amendments.

For more information, please view the proposed amendments.