Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law): Key elements for consideration about serious risk (Annex A)

This annex sets out the considerations to be used to determine whether a therapeutic product presents a serious risk of injury to human health. Determining this is complex and is conducted on a case-by-case basis when new information becomes available.

The following non-exhaustive list of elements are used as the starting point for determining serious risk:

1. The seriousness of the adverse health consequence. A serious adverse health consequence includes any untoward occurrence that:
   • results in death
   • is life-threatening
   • requires inpatient hospitalization or prolongs existing hospitalization
   • results in persistent or significant disability/incapacity
   • is a congenital anomaly/birth defect (this is given the most weight when determining serious risk)

   Examples of the seriousness of the adverse health consequence include:

   • a change in the nature or frequency of a serious adverse health consequence posed by the therapeutic product
   • the probability of the serious adverse health consequence upon exposure to the therapeutic product
2. Whether the patient population and/or sub-population exposed to the particular therapeutic product is at higher risk of any potential adverse health consequences. Such populations may include children, the elderly, pregnant and lactating persons, and immunocompromised patients.
3. The extent of the population's exposure to the therapeutic product and the potential public health impact of the exposure.

Each element may have a different influence or "weight" on the determination of serious risk. When determining serious risk, Health Canada will also consider other contextual elements not listed above that are pertinent to the assessment of a particular risk incident. These elements include:

• public health considerations
• international regulatory actions
• chronology of events and previous regulatory actions taken
• past-history of the therapeutic product or its manufacturer