Vanessa was the fifteen-year-old daughter of the then Conservative Member of Parliament Terence Young. Vanessa suffered a stomach ailment and was prescribed medication as a result. Soon after beginning the medication, Vanessa sadly died of a heart attack. The drug she had been prescribed was later found to be unsafe and was pulled from the market. Mr. Young thereafter pushed for more stringent legislation to protect Canadians from unsafe drugs and for a better drug-monitoring system.
The result was the Protecting Canadians from Unsafe Drugs Act passed in November of 2014. It has become known as Vanessa’s Law. It amended the Food and Drugs Act by adding the obligation that prescribed health care institutions (hospitals) were to report any negative experiences with therapeutic medications and medical devices.
Serious Adverse Drug Reactions
A serious adverse drug reaction (SADR) is defined under the legislation as:
[A] noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.
Medical Device Incidents
A medical device incident (MDI) is defined under the legislation as:
[A]n incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user, or other person, or could do so were it to recur.
Amendments to the Regulations
Amendments to the Regulations made under the Food and Drugs Act and Vanessa’s Law are now passed and will come into force on December 16th, 2019. They seek to better outline the scope of the reporting obligation. They will impact virtually all hospitals in Canada.
According to the amendments, the required report must be submitted in writing within thirty days of the reporting incident and must include:
- the name and contact information of a representative of that hospital;
- a description of the Adverse Incident;
- the drug’s brand name or common name, and its DIN; or
- the device’s name or identifier, manufacturer and the lot or serial number;
- the age, sex, and medical condition(s) related to the incident, the names of any other products being used by the patient and the effects of the incident on the patient’s health; and
- the patient’s first use of the product, when the patient stopped using the product and the date of their recovery.
Hospitals are exempted from the reporting requirements where:
- where vaccines have been administered under a routine provincial immunization program;
- where the drugs or devices were used in clinical trials; and
- where drugs or devices that are authorized for sale as part of the Special Access Programme.
Further Guidance From Dedicated Health Law Lawyers
Practicing up-to-date compliance with the law is the best way to avoid litigation in the future. To ensure compliance with all applicable health care regulations and legislation, it’s best to reach out to an experienced health care lawyer who is up to date on all applicable laws and amendments.
At Wise Health Law, we are passionate about helping healthcare organizations, regulated health professionals, and regulated health professional associations understand and protect their legal rights. We follow developments in the law and are consistently at the forefront of change and innovation. Contact us online, or at 416-915-4234 for a consultation.