What is happening with Vanessa’s Law?
On 6 December 2013, Conservative Member of Parliament for Oakville, Terence Young, introduced the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) in order to provide Canadians with a more stringent drug-monitoring system. Without dissent from any of Canada’s federal political parties, Vanessa’s Law received Royal Assent and became Canadian law on 6 November 2014 as an amendment to the Food and Drugs Act. Vanessa’s Law applies to therapeutic products including prescription and over-the-counter medications, vaccines, gene therapies, cells, tissues and organs, and medical devices.
Vanessa’s Law was named after Terence Young’s daughter, Vanessa, 15, who died suddenly of a heart attack while on a prescription drug that was later deemed to be unsafe and was subsequently recalled from the market.
Many Canadians might be surprised to learn that that prior to Vanessa’s Law becoming law in 2014, Health Canada did not have the authority to recall unsafe products or mandate changes to drug labels. Instead, Health Canada engaged in closed-door negotiations with manufacturers to determine the actions to be taken by manufacturers for products that were shown to be unsafe. Even if Health Canada had evidence of significant harms warranting recall of pharmaceutical and medical device products from the market, and even if other international drug regulators, such as the United States Food and Drug Administration, recalled these products from their markets, Health Canada had no unilateral authority to either mandate labelling changes or recall drug or medical device products from the market.
Canadians may also feel uneasy when they learn that adverse drug reactions, or side effects, can be considered by manufacturers to be “commercially confidential information.” Drug regulators can be bound to nondisclosure of this information to protect the business interests of drug companies. This is significant because when Health Canada cannot disclose information on adverse drug reactions, this information does not reach the public or our doctors. Therefore, if people taking medications experience side effects from a drug that they are taking, but the pertinent side effects information has not been disclosed, doctors may not be able to identify the side effect as resulting from a drug. Instead, the doctors may identify it as a symptom of an unrelated problem for which another medication is prescribed. This also means that physicians may be, in these cases, making underinformed prescribing decisions for their patients.
Prior to Vanessa’s Law, adverse drug reactions that manufacturers had identified in clinical trials and that were reflected in patient-level or study-level data could be withheld from being publicly disclosed by Health Canada. These actions are not in the interest of public health, but rather in the interest of assisting the manufacturer in maintaining and advancing its business interests. When manufacturers opt to classify side effects data as commercially confidential information, the decision is typically made to advance its business interests by preventing other companies from using this data to get their products approved faster. Vanessa’s Law introduced the requirement that Health Canada must define what it considers to be acceptable as commercially confidential information and gives Health Canada the authority to disclose such information about a product should evidence of a serious risk of harm to Canadians arise.
The purpose of Vanessa’s Law is to better protect Canadians who take prescription and over-the-counter medications by introducing new measures including increased transparency and new safeguards that Health Canada can use in its regulation of these products. The following list, quoted and adapted from Government of Canada and Health Canada, expresses the authorities that Health Canada has been assigned with Vanessa’s Law as of 2014. Health Canada can now:
· Recall unsafe products;
· Take quick and appropriate actions when a serious risk is identified (i.e., requiring product recall or requiring a requiring a label change/package modification to make new safety information available to patients and consumers);
· Impose tough new penalties for unsafe products, including jail time and new fines of up to five million dollars per day or two years in prison instead of the current $5,000 to better reflect the seriousness of the nature of the offence;
· 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 to 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 health care institutions;
· Require new transparency for Health Canada’s regulatory decisions about drug authorizations, both positive and negative (i.e., requiring transparency of approval and rejection information of drugs submitted to Health Canada for market approval);
· 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.
The purpose of Vanessa’s Law is to improve patient safety by allowing Health Canada to collect more safety information on marketed therapeutic products and act on the information in the interests of the public. Vanessa’s Law has been Canadian law for over two years now. Health Canada has not yet exercised its new authority to enforce Vanessa’s Law, although there are cases in which it could justifiably act within its current powers under Vanessa’s Law to introduce new safety measures, require additional testing, or recall drugs from the market in order to reduce or prevent the continued risks of known serious harms to Canadians taking certain medications.
Despite that Vanessa’s Law received all-party support without dissent, it has not been an objective of the current government to enforce Vanessa’s Law. The public must become aware that this law exists and understand the importance of the content of this law to the protection of the health of all Canadians. Health Canada must also recognize that it holds not only much of the drug information on medications that Canadians are currently taking, but also the power and ability to help Canadians experience fewer serious adverse drug reactions when this information is available, but not widely known by the public or Canada’s physicians. Canadians of all ages who take, or will ever take, medications depend both on the presence and enforcement of Vanessa’s Law.
This article was written by Adrienne Shnier, who received her PhD in Health Policy & Equity, with a specialization in conflicts of interest, medical education, and pharmaceutical industry promotion, from the School of Health Policy and Management at York University.
This article is part of the Osgoode Health Law Association’s Perspectives in Health column. Keep up to date with the HLA on Facebook (Osgoode Health Law Association, Osgoode Health Law Association Forum) and Twitter (@OsgoodeHLA).
If you would like to write with the Osgoode HLA, please contact Adrienne Shnier (AdrienneShnier2016@osgoode.yorku.ca).