Notice of intent to amend the regulations to address health product shortages in Canada
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Introduction
Health Canada is proposing to amend the Food and Drug Regulations and the Medical Devices Regulations. The proposed measures are intended to help address and mitigate the harm to public health caused by shortages. They would:
- help prevent shortages of drugs and medical devices for human use
- reduce the impacts of shortages that can't be prevented
The regulatory amendments we're proposing and other actions we plan to take over the next 4 years will help us build better collective capacity in 3 areas:
- Planning
- designing systems and standard operating procedures that promote readiness and rapid response to shortages
- Prevention
- detecting risks of shortages
- intervening to avoid shortages before they happen
- Response
- detecting shortage signals early
- minimizing the impacts of shortages when they occur
- restoring access to needed products quickly
Background
Shortages of health products are a global problem. In Canada, they are becoming more severe and happening more often.
Shortages happen when there are reductions in supply, increases in demand or shifts in both supply and demand. The supply chain can also be disrupted at any point, which can have significant effects elsewhere in the supply chain.
Canada is vulnerable to shortages. We're a small market that represents about 2% of all global sales and we rely heavily on imported health products.
Most drugs, and the ingredients required to make them, are imported into Canada. More than 80% of the activities required to make the drugs sold in Canada are conducted in other countries. Moreover, many drugs used in Canada already come from 1 supplier and the growing consolidation of global supply chains increases the likelihood of more shortages. We face similar challenges with medical devices, where the vast majority are imported. The supply chain for medical devices is also complex given the number of parts and components it takes to manufacture a single device and compatibility issues between devices.
The COVID-19 pandemic highlighted how vulnerable to shortages Canada's supply chain can be for health products.
Although the effects of the pandemic are less severe now, the number of critical drug shortages is as high as it was at the height of the pandemic. However, these shortages are no longer related to products used to treat patients with COVID-19 but are affecting patients with many different health conditions.
For medical devices, while the overall number of reported shortages has decreased, critical shortages for non-COVID-related medical devices are increasing and are more complex.
Recent critical national shortages have highlighted the need to better protect people in Canada from the harms caused by health product shortages. They have also shown how disruptions to this critical supply can cause hardships for people in Canada and put stress on our health care system.
Governments, industry, health care system partners and professionals, and members of the public all have a stake in improving Canada's resilience against shortages. This means being able to withstand, adapt to and recover from supply chain challenges.
Taking action
It's not always possible to anticipate or prevent shortages. But we can develop measures to mitigate their impacts where possible.
This is why Health Canada is taking action to prevent shortages before they happen and reduce the impact of shortages when they cannot be prevented. These actions are highlighted in our 4-year plan on health product shortages.
Learn more about Health Canada's plan:
Part of our plan involves advancing amendments to the Food and Drug Regulations and the Medical Devices Regulations. These amendments would help ensure that people in Canada have access to the health products they need when they need them to reduce the harm caused by shortages.
Our proposed amendments are informed by the online consultation we led from June 5 to August 31, 2023. This consultation was held to identify the challenges and arrive at possible solutions for building a resilient supply of drugs, medical devices and other health products.
We also created an external advisory committee, as well as asked regulated parties, stakeholders and partners for their ideas on how we can better prevent and reduce shortages.
Learn more about Health Canada's consultation:
Proposed changes
Proposed changes to Food and Drug Regulations
We're proposing to amend the Food and Drug Regulations to give the Minister the authority to:
- apply the regulations that deal with shortages to additional drugs or classes of drugs
- such as a specific subset of non-prescription drugs
- compel information about any shortage that could cause harm, regardless of whether the drug is subject to drug shortage reporting
- expand the use of the exceptional importation framework to better address harms to people in Canada posed by shortage and discontinuations:
- addressing all shortages that could cause harm
- applying the framework to address discontinuations that could cause harm by bringing in a substitute drug for a limited time while patients transition to a new drug
- allow the exceptional sale of a foreign-authorized, domestically manufactured drug to address a shortage
- extend the expiration date of a lot or batch of a drug if there's a shortage that could cause harm and if the data supports extending the shelf life
- shift the requirement to report discontinuations on the third-party website from 6 months before the date of discontinuation to 12 months or within 5 days of being known
The proposed changes would also address conduct that increases the likelihood that people in Canada would be harmed by requiring:
- manufacturers to ensure that 3 months of safety stock is maintained in Canada for drugs that are critical and vulnerable to shortage, based on historical demand
- manufacturers to establish, document and maintain plans to reduce and prevent shortages for drugs that are critical and vulnerable to shortage
- distributors and wholesalers to report significant increases in demand for drugs that are critical and vulnerable to shortage
- importers of exceptionally imported foreign-authorized drugs to report serious adverse drug reactions to us
Proposed changes to Medical Devices Regulations
We're also proposing to amend the Medical Devices Regulations to:
- clarify that the requirement to report a discontinuation for the purpose of medical device licence cancellation is separate from the requirement to report a discontinuation as a shortage signal
- shift medical device shortage and discontinuation reports from our website to a third-party website
- remove the requirement for manufacturers or importers to provide a summary of the information used to determine that a medical device shortage exists or is likely to occur
- remove the exemptions to shortage reporting for devices with back orders of less than 30 days or for devices with available substitute devices
- use the exceptional importation framework in a more targeted way to help reduce safety risks, such as by:
- specifying that the framework can be used to address a shortage or a risk of a shortage that could cause harm
- requiring importers to notify us when the foreign authorization of an exceptionally imported medical device is suspended or cancelled
The proposed changes would also require manufacturers and importers to:
- report all discontinuations of all medical devices that are in scope for medical device shortage reporting, regardless of whether the discontinuation leads to an actual or anticipated shortage
- report shortages at least 6 months ahead of the anticipated shortages start date or within 5 days of being known
- report discontinuations on the third-party website at least 12 months before the date of discontinuation or within 5 days of being known
- have documented procedures in place to assess their ability to report shortages and to meet demand so that they are better prepared to prevent and mitigate shortages
Next steps
Input from interested parties on the proposed changes will support the publication of our regulatory proposal in the Canada Gazette, Part I.
To provide input:
Interested parties will be able to provide additional comments on the regulatory proposal after publication in the Canada Gazette, Part I. The public comment period is expected to take place in fall 2024 and last 70 days.
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