On December 6, 2013, Health Minister Rona Ambrose introduced Bill C-17. The bill, entitled “An Act to Amend the Food and Drugs Act” (the “Act”), 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 Act 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 Act gives authority for the government to require the reporting of adverse reactions by health care institutions; 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.
Application of the Act
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.
Summary of Key Provisions of the Act
The key provisions of the Act amend the Food and Drugs Act to allow Health Canada to take certain regulatory actions when a serious health risk is identified for a product. The Act will 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.
Definition of a “Therapeutic Product”
A “therapeutic product” is defined under the proposed Act 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.”
Changes to Post-Market Authority over Therapeutic Products
The proposed legislation grants significant authority to Health Canada for the oversight of therapeutic products in a post-market setting. Specifically, the Act grants powers to the Minister 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 (s. 21.1);
- order the holder of a therapeutic product authorization to modify the product’s label or replace its package (s. 21.2);
- order 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 (ss. 21.3(1)(a) and (b)); and
- order the holder of a therapeutic product authorization 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 (ss. 21.31 and 21.32).
Mandatory Adverse Reaction Reporting
Under the proposed legislation, it would be mandatory for “prescribed” health care institutions to report serious adverse reactions that involve a therapeutic product or a medical device incident that involves a therapeutic product (s. 21.8), within the prescribed time and in the prescribed manner.
The Act contains provisions that impose strict penalties for unsafe products, such as increased fines of up to $5 million per day (compared with the current fine of $5,000) and 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 term not exceeding five years, or both.
Link to the proposed legislation and other information: