Dr. Anne Snowdon participated in Health Canada’s Regulation and Health Innovation Stakeholder Engagement Session June 27, 2018. The Panel discussion focussed on the evolving role of the regulator in a changing health care environment. Dr. Snowdon shared views on how regulators can effectively balance access to innovative health products while protecting patients by ensuring safety, quality and efficacy of product use.
Currently, health systems are not able to track or trace product use linked to patient outcomes. This limits both regulators’ and health systems’ ability to understand whether products are safe for patients and to identify which products offer the best outcomes for specific groups of patients. Much of the current evidence about product safety and value is based on clinical trial data; however, patients who participate in clinical trials do not closely represent the people who walk through the door of health care settings as they have multiple and complex health challenges. If health systems scanned global standard barcodes on every product, every patient identification (ID) band and provider ID, we could track and trace every product used in care, how and when it was used during the care processes and by provider teams, and then link that information to the patient’s record to accurately determine value and outcomes. Implementing point of care scanning, currently used in most every other sector (e.g., the grocery sector), would automate the flow of data across health systems to offer regulators and health systems the real-world evidence of product use and performance outcomes for patients. This automated system offers the capacity for rapid recall of products as it would identify the exact products that had been used for individual Canadians, to enable providers and regulators to quickly identify patients at risk and intervene early to prevent adverse outcomes.
By using global standard barcode scanning at the point of care, linking products and clinician teams to patient outcomes, Canada’s health systems can identify how best to achieve the safest outcomes for patients. They could use this evidence to inform procurement decisions to purchase products based on value for patients, rather than the current volume-based approach that aims to reduce cost. Regulators can use this real-world evidence to update regulatory decisions for products to ensure only the safest products are approved for use in health systems. This information can also be leveraged by manufacturers to enhance product development and innovation. Canada’s many strengths in Artificial Intelligence can use this data to create predictive analytical tools for clinicians to notify them on which products and care procedures are achieving the best outcomes for patient population segments. This would position Canada as a global leader in predictive, high performing health systems fueled by Artificial Intelligence tools and technologies.
Joining Professor Snowdon for the discussion were Professor Guido Rasi, Executive Director, European Medicines Agency and Professor Catherine Beaudry, Canada Research Chair in the Creation, Development and Commercialization of Innovation, École Polytechnique de Montréal and Ms. Cathy Parker, Director General, Biologics and Genetic Therapies Directorate, Health Canada, as the moderator.