On December 6 2013 Health Minister Rona Ambrose introduced Bill C-17, An Act to Amend the Food and Drugs Act. The bill reflects a commitment made in the governor general's October 2013 throne speech, wherein the government promised to ensure that drug labels be written in plain language, and that the potential side effects of medication are accurately indicated. The bill would amend certain provisions of the Food and Drugs Act as it relates to both drugs and medical devices, while specifically excluding natural health products from the definition of a 'therapeutic product'. The bill gives the government authority to require healthcare institutions to report adverse reactions. It would also allow Health Canada to order product recalls and label changes when a health risk is identified.
The bill could come into force some time in 2014.
The provisions of the proposed legislation will apply to prescription drug products, over-the-counter drug products, vaccines, gene therapies, cells, tissues and organs, and medical devices.
The key provisions of the bill would amend the Food and Drugs Act in order to allow Health Canada to take certain regulatory actions when a serious health risk is identified for a product. The bill would allow Health Canada to:
- require mandatory adverse drug reaction reporting;
- recall products;
- provide the courts with the discretion to impose stronger fines if violations are caused intentionally;
- impose stronger penalties, including fines and imprisonment;
- compel drug companies to revise labels to reflect health risk information; and
- compel drug companies to do post-market approval testing on a product.
A 'therapeutic product' is defined under the proposed bill as "a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Product Regulations".
The proposed legislation grants significant authority to Health Canada for the oversight of therapeutic products in a post-market setting. Specifically, the bill gives the minister the power to order:
- a person to provide more information where the minister believes that a therapeutic product may present a serious risk of injury to human health (Section 21.1);
- the holder of a therapeutic product authorisation to modify the product's label or replace its package (Section 21.2);
- a person who sells the therapeutic product to recall the product or send the product to a place specified in the order if the minister believes that the therapeutic product presents a serious or imminent risk of injury to health (Sections 21.3(1)(a) and (b)); and
- the holder of a therapeutic product authorisation to conduct an assessment of the therapeutic product, compile information, conduct tests or studies, or monitor the experience of the therapeutic product, and provide the results of the assessment or tests to the minister (Sections 21.31 and 21.32).
Under the proposed legislation, it would be mandatory for 'prescribed' healthcare institutions to report serious adverse reactions that involve a therapeutic product or a medical device incident that involves a therapeutic product (Sections 21.8) within the prescribed time and in the prescribed manner.
The bill would impose strict penalties for unsafe products, such as:
- increased fines up to C$5 million a day (compared with the existing fine of C$5,000) or up to two years' imprisonment, or both; or
- in cases of knowingly or recklessly undertaking certain actions, a fine at the discretion of the court or a prison term not exceeding five years, or both.?
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