On June 25, 2024, Health Canada initiated an online public consultation to solicit feedback on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations. The initiative is part of the "Building Resilience: Health Canada's Plan to Address Health Product Shortages," a plan which aims to prevent shortages of drugs and medical devices for human use and reduce the impacts of shortages that cannot be prevented.
The impetus for these proposed regulatory changes stems from recent critical national shortages, as well as disruptions experienced during the COVID-19 pandemic. According to Health Canada, while the effects of COVID-19 are less severe now, these disruptions highlighted the vulnerability of global supply chains and underscored the need for a more robust regulatory framework to ensure that Canadians have access to essential health products in times of crisis.
The proposed changes are described below:
Food and Drug Regulations:
- Regulatory scope expansion: Shortage regulations will expand its application to additional drugs or classes of drugs, including a specific subset of non-prescription drugs.
- Mandatory shortage reporting: Compel reporting of any harmful shortages, regardless of current drug shortage reporting rules.
- Exceptional importation: Expand the use of the exceptional importation framework to address harmful shortages and discontinuations by allowing substitute drugs temporarily while patients transition to a new drug.
- Allow foreign-authorized drugs: Permit sale of foreign-authorized, domestically manufactured drugs during shortages.
- Expiration date extensions: Extend drug expiration dates during shortages if data supports extending the shelf life.
- Discontinuation reporting: Shift reporting requirements to 12 months or within 5 days of awareness, from the current 6 months.
- Safety stock maintenance: Require manufacturers to maintain 3 months of safety stock for drugs that are critical and vulnerable to shortage, based on historical demand.
- Shortage mitigation plans: Require manufacturers to develop plans to prevent and reduce shortages.
- Demand surge reporting: Require distributors and wholesalers to report significant demand increases for drugs that are critical and vulnerable to shortage
- Adverse reaction reporting: Require importers of exceptionally imported foreign-authorized to report serious adverse reactions to Health Canada.
Medical Devices Regulations:
- Clarification and separation: Differentiate the requirements for reporting discontinuation related to license cancellation versus discontinuation as a shortage signal.
- Reporting shifts: Move shortage and discontinuation reports to a third-party website.
- Simplified reporting: Eliminate the need for summaries of information used to determine that a medical device shortage exists or is likely to occur as well as remove exemptions for devices with short back orders less than 30 days or for devices with available substitutes.
- Targeted exceptional importation: Specify the use of the exceptional importation framework such t it can be used to address a shortage or risk of shortage that could cause harm as well as require importers to notify Health Canada if a foreign authorization of an exceptionally imported medical device is suspended or cancelled.
- Comprehensive reporting: Manufacturers
and importers will be required to report all discontinuations and
shortages, including:
- Discontinuation of all medical devices that are in scope for medical device shortage reporting, irrespective of whether the discontinuation leads to an actual or anticipated shortage. The discontinuations must be reported on the third-party website at least 12 months before the date of discontinuation or within five days of being known.
- Reporting of shortages at least six months ahead of the anticipated shortages start date or within five days of being known.
- Preparedness procedures: Manufacturers and importers will be required to have documented procedures for shortage assessment and demand management so that they are better prepared to prevent and mitigate shortages.
Timeline and next steps
The consultation will remain open until July 25, 2024. The comments received will support the publication of a regulatory proposal in the Canada Gazette, Part I.
Stakeholders will be able to provide additional comments on the regulatory proposal after its publication in the Canada Gazette Part I. The public comment period is expected to take place in fall 2024.
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