The Food and Drugs Act ("Act") has been amended: on October 23, 2014, the Senate passed Bill C-17, Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), received royal assent, and many of the provisions are now into force. As reported in the July 2014 issue of Rx IP Update, the Bill was initially introduced in December 2013, and was amended in the House of Commons before passing through the Senate without any further amendments.
Generally, Vanessa’s Law amends the Act to strengthen oversight of drugs, devices and drug-device combinations post-approval, and once fully in force will allow the Minister of Health to require mandatory adverse drug reaction reporting and permit the Minister to compel further testing on a product. The Minister has new powers to compel and disclose information, order changes to labels and packages and recall products that present serious or imminent risk of injury to health. The changes also impose tough new penalties for contraventions of the Act, including jail time and new fines of up to $5 million per day, and even greater fines if violations were caused intentionally.
Sections now in force include:
- New definitions, including:
- Therapeutic drug product includes drugs and devices, or combinations of the two, but excludes natural health products.
- Confidential business information is information that is not publicly available and “has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors.”
- Minister of Health’s new powers regarding collection and disclosure of information:
- If the Minister believes that a therapeutic product “may present a serious risk of injury to human health,” she may:
- order a person to provide information in that person’s control that the Minister believes is necessary to determine whether the product presents such a risk.
- disclose confidential business information without notifying or obtaining consent from the person to whose business or affairs the information relates.
- The Minister may also disclose confidential business information to defined entities without notification or consent “if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public.”
- Minister of Health’s new powers regarding label changes and recalls:
- If necessary to prevent injury to health, the Minister may compel a modification to the label and/or package.
- If the Minister believes that a product presents a serious or imminent risk of injury to health, she may:
- order the product to be recalled
- prevent the sale of a recalled product
- authorize the sale, with or without conditions, of a recalled product.
- Prohibition of false and misleading statements to the Minister
- Increase in fines and term of imprisonment
The regulations related to the amendments have not yet been published. Once published, comments will be solicited as part of the regulatory development process.
Health Canada has published an FAQ on its website regarding Vanessa’s Law.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.