Consultation On The Draft Critical And Vulnerable Drug List

​In June 2024, Health Canada committed to publishing a list of drugs that are critical to patients and vulnerable to shortages. This initiative aims to help stakeholders focus their efforts on medications whose shortages could significantly impact public health. The draft Critical and Vulnerable Drug List (CVDL) has been developed for consultation, encompassing drugs whose shortages might present serious health risks and possess characteristics making them more susceptible to supply issues. It’s important to note that inclusion on this list doesn’t necessarily indicate a current or anticipated shortage. ​

Health Canada has proposed amendments to the Food and Drug Regulations that would require Market Authorization Holders (MAHs) to develop and maintain Shortage Prevention and Mitigation Plans (SPMPs) for drugs where shortages could pose serious health risks. Additionally, Drug Establishment Licence (DEL) holders involved in importing or wholesaling such drugs would be mandated to report significant demand surges. These measures are designed to proactively address potential shortages and mitigate their impact on patient care.

The methodology for creating the draft CVDL involved a systematic process, starting with a tool developed through the At-Risk Medicines project led by the University of Toronto. This project, funded by the Canadian Institutes of Health Research (CIHR) and sponsored by Canada’s Drug Agency, developed a risk assessment framework considering clinical importance and vulnerability to shortages. Independent reviewers evaluated 1,650 drugs using this framework, with further validation steps to ensure accuracy and relevance.

Health Canada sought feedback from stakeholders on both the draft CVDL and the methodology used to develop it. This consultation process is part of a broader plan to enhance the resilience of Canada’s health product supply chain and ensure that critical medications remain available to patients who need them.

For more detailed information, you can read the full consultation document here: Consultation on the draft Critical and Vulnerable Drug List