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Will Health Canada’s newfound powers impact Industry and/or the Canadian Legal Landscape?
The Protecting Canadians from Unsafe Drugs Act, also known as “Vanessa’s Law” (the “Act”), introduces significant changes to the Food and Drugs Act1, (an act introduced more than 50 years ago).
Vanessa’s Law is named after Member of Parliament Terence Young’s daughter Vanessa, who died of a heart attack while on a prescription drug that was later deemed unsafe and removed from the market.
The new Act enables Health Canada to:
- Recall unsafe products;
- Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
- Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
- Compel drug companies to revise labels to clearly reflect health risk information in plain language, including updates for health warnings for children;
- Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children;
- Enhance surveillance by requiring mandatory adverse drug reaction reporting by healthcare institutions;
- Require new transparency for Health Canada’s regulatory decisions about drug authorizations, both positive and negative;
- Require information about authorized Canadian clinical trials to be posted on a public registry; and
- Better define confidential business information and disclose such information about a product if it may pose a serious risk to Canadians.2
How Health Canada’s Role has Changed
The goals of the Act are to:
(a) strengthen safety oversight of therapeutic products throughout their life cycle;
(b) improve reporting by certain healthcare institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and
(c) promote greater confidence in the oversight of therapeutic products by increasing transparency.3
Prior to this Act, Health Canada’s ability to gather information about, or take action when problems arose in respect to pharmaceuticals and medical devices was limited once those products were approved and being sold on the market.4
While the new Act now expressly provides Health Canada authority to seek further data, revise label information and/or recall a drug or medical device, it appears limited to situations posing a “serious imminent risk of injury to health” and is not, in any event, mandatory:
21.1 (1) If the Minister believes that a therapeutic product may present a serious risk of injury to human health, the Minister may order a person to provide the Minister with information that is in the person’s control and that he Minister believes is necessary to determine whether the product presents such a risk.
21.2 The Minister may, if he or she believes that doing so is necessary to prevent injury to health, order the holder of a therapeutic product authorization […] To modify the product’s lave or to modify or replace its package.
21.3 (1) If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a persons who sells the product to:
(a) recall the product; or
(b) send the product, or cause it to be sent, to a place specified in the order.
The Act does not define “serious” or “serious, imminent” risk of injury to health. It also does not require Health Canada to act in the face of such risks (using the terminology “may” as opposed to “shall”).
In addition, the new Act still does not include more strengthened oversight or authority over so- called “natural” health products.
Other criticisms include a lack of clarity with respect to how Health Canada will perform its duties and be able to measure its performance thereof (particularly given the criticisms it received in the 2011 report of the Office of the Auditor General of Canada, which, among other things, highlighted Health Canada’s failure to meet its own benchmarks under the old system in respect of reviewing and responding to pharmaceutical safety issues).5
Whether and to what extent Health Canada’s empowerment respecting information gathering (and event reporting requirements) will actually result in speedier, more fulsome analysis and communication of health risks to physicians and consumers, remains to be seen. The extent to which these new powers will actually impact industry, is also unclear at this early stage.
For example, s. 21.6 of the Act states that:
No person shall knowingly make a false or misleading statement to the Minister – or knowingly provide him or her with false or misleading information – in connection with any matter under this Act concerning a therapeutic product.
Will Health Canada pursue violators, i.e., if it is proven either in a lawsuit or by some other means, that a pharmaceutical or medical device company knowingly hid data or other knowledge of serious adverse events or risks thereof associated with their products from Health Canada at the approval and/or post-approval stages? How these provisions will be implemented and enforced may greatly impact the Canadian legal landscape. The extent of this impact will depend on both Health Canada’s use of its new-found powers, as well as the pharmaceutical and medical device industry’s response thereto.
In the United States, the federal drug regulator, the U.S. FDA, is similarly empowered (as Health Canada now is). Litigation in the U.S. with respect to drug/medical device safety and efficacy, whether brought on by states attorney generals or private citizens, has been impacted by this empowerment. For example, in some states, litigation in this regard comes up against “pre- emption” a legal theory that pharmaceutical and/or medical device manufactures are exempt from common law tort claims challenging the safety or effectiveness of FDA-approved products on the basis that federal law trumps state law – it should not be overruled by state law or a state’s common law judgements because the federal FDA’s decision regarding safety and/or efficacy is the “high water mark”6. Whether similar challenges will now infiltrate the Canadian legal landscape, (i.e., whether Health Canada’s new powers will elevate their regulatory decisions beyond reproach), also remains to be seen.
While the changes to the outdated Food and Drugs Act are welcome and appear significant, whether or not and the extent to which they will actually impact Canadian health and safety, industry practices and the legal landscape, is unclear.
1 RSC 1985, c F-27
3 An Act to amend the Food and Drugs Act, (Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)) RSC 1985, c. F-27, as amended 2014, c.24
4 http://www.oha.com/CurrentIssues/LegislativeAnalysis/Documents/Backgrounder Bill C-17.pdf
5https://www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Bill C-17_(Vanessa_s_Law)- FINAL.pdf
6 There is express pre-emption in respect of medical devices, see 21 USC para 360k(a) which states that “no State or political subdivision of a State may established or continue with respect to [a medical device] any requirement…which is different from, or in addition to, any requirement applicable under this Act”. Pre- emption in respect of pharmaceutical drugs and safety and efficacy issues (and failure to warn), is not expressly set out.