What was heard: Consultation on interim order transition for tools to address drug and medical device shortages

Health Canada consulted with stakeholders about our transition approach to normalize shortage authorities and flexibilities related to shortages. The consultation has ended and this report is a summary of the responses we received.

On this page

• About the interim order
• About the transition approach
• About the consultation
• What stakeholders said
• Next steps

About the interim order

On March 30, 2020, Health Canada made the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 1) in response to the urgent need for access to health products during the COVID-19 pandemic. IO No. 1 also required medical device manufacturers and importers to inform the department about shortages of products considered critical during the COVID-19 pandemic.

IO No. 1 allowed Health Canada to designate certain drugs, medical devices and foods for a special dietary purpose for exceptional importation and sale. This would normally happen when the Canadian-approved product is in shortage. These imported products may not fully meet Canadian requirements, such as licensing and labelling, but meet comparable standards in other countries. IO No. 1 also required industry to report shortages of critical medical devices to us during the pandemic.

IO No. 1 was set to expire on March 30, 2021, a year after its introduction. If IO No. 1 expired without a replacement interim order, then:

• it would be illegal to import and sell products that were previously allowed under IO No. 1
• mandatory reporting of medical device shortages considered critical during the COVID-19 pandemic would have ended

About the transition approach

The COVID-19 pandemic has not ended. For this reason, we published a proposal on January 22, 2021, to remake IO No. 1 before it expired.

Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2) was made by the Minister of Health on March 1, 2021. This new interim order repeals and replaces IO No. 1. It allows the flexibilities and regulatory oversight provided by IO No. 1 to continue and includes changes to account for lessons learned and feedback received from stakeholders.

Specifically, the changes:

• clarify responsibilities for mandatory medical device shortage reporting
• create a formal framework for the exceptional importation and sale of biocides
• address concerns about the availability of information for the safe use of products in both official languages

We also intend to propose regulatory amendments to the Food and Drug Regulations and the Medical Devices Regulations for possible consideration by fall 2021. One purpose of these proposed amendments would be to allow some of the authorities provided by the following interim orders to continue:

• Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply)
• Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19
• Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

These proposed regulatory amendments, planned for consideration by fall 2021, may revise or maintain:

• the exceptional importation option for drugs, biocides and medical devices
• mandatory medical device shortage reporting requirements
• the authority to compel information for drugs and medical devices needed to assess a shortage
• the authority to apply terms and conditions on the authorizations for drugs related to shortages
• the prohibition on distributing outside Canada certain drugs intended for the Canadian market if it could cause or worsen a shortage

We're also planning to end exceptional importation of foods for a special dietary purpose in fall 2021. At that time, we expect that new regulations will give a set period for these imported foods to comply with the normal regulatory process.

About the consultation

We invited stakeholders to submit comments on these proposals by February 11, 2021. They submitted feedback by:

• emailing us
• taking part in interactive stakeholder webinar sessions on January 27, 2021, and January 29, 2021

One hundred and seven people participated in the webinars, including representatives from:

• the pharmacy community
• manufacturers, importers, distributors, wholesalers and associations from these industries:
  • drugs
  • biocides
  • medical devices
  • foods for a special dietary purpose

Afterwards, we received written comments for consideration from:

• stakeholders in the medical devices community
• stakeholders in the pharmaceutical and pharmacy communities

What stakeholders said

Overall comments

Stakeholders expressed support for our plan to remake IO No. 1. Most stakeholders noted support for our proposed changes to the Food and Drug Regulations and the Medical Devices Regulations. There was general support for our efforts to provide for an orderly transition of products designated for import under IO No. 1.

We did not receive any feedback opposed to a plan to transition away from exceptional importation of foods for a special dietary purpose.

Coordination to address drug shortages

Some drug stakeholders expressed interest in greater coordination between Health Canada and other players to address shortages. These stakeholders included:

• provincial and territorial governments
• manufacturers
• importers
• distributors
• hospital group purchasing organizations
• pharmacy stakeholders

Drug manufacturers and importers noted that it is often difficult to know how much product is needed to address a shortage. They suggested that we work with other players to obtain detailed information about demand. Some stakeholders also suggested that the federal government should play a more direct role in procuring and distributing foreign-labelled drugs so that they are sold quickly.

Health Canada and other drug supply stakeholders continue to take a collaborative approach to resolving drug shortages across the health system. We developed IO No. 2 with that approach in mind.

Some respondents also encouraged us to use approval in trusted foreign countries as a direct substitute for meeting Canadian standards for:

• safety
• quality
• efficacy

They suggested that this would bring down the costs of importing drugs by lowering testing and information requirements.

Health Canada assesses each case individually. We will continue to take an approach that prioritizes consumer safety while ensuring the regulatory burden on manufacturers and importers is appropriate.

Clarity on duration of a designation for exceptional importation and sale

Some stakeholders wanted more clarity about how long manufacturers and importers can use the exceptional importation and sale option after we have added their product to a list of products designated to supply a shortage. Manufacturers and importers were concerned that they will be affected if products they sell are removed from the list.

Some stakeholders suggested that:

• the government should consider imported drug products legal for sale until the product's expiry date
• Health Canada should set a definite end date for the sale of imported products before the product is imported

Under IO No. 2, a designated drug, biocide, medical device or food for a special dietary purpose can continue to be imported and sold as long as it's on a list of products designated for exceptional importation and sale. As the supply situation for a product changes, Health Canada may, in communication with the company, remove it from the list. Health Canada will consider formal timelines for imported products when developing regulatory amendments planned for fall 2021.

One stakeholder suggested that we stop allowing exceptional importation of medical devices after IO No. 2 is repealed or expires, if by that time it has been shown that Canada's market has responded to the demand created by COVID-19. We will consider this suggestion in developing regulatory amendments planned for the fall.

Availability of information for safe use in both official languages

Stakeholders requested clarification about new rules that require importers to make safety information available in English and French. Stakeholders asked for clarification on:

• which product lines will be affected
• who will be responsible for drafting safety information
• how and where that information must be available

We address these questions in the guidance documents published as part of the regulatory package for IO No. 2.

Next steps

Health Canada is grateful for all of the feedback provided on the transition proposal, especially considering the short timelines. All comments received as a part of this consultation have been considered and helped to inform the design of:

• IO No. 2
• its accompanying guidance documents

Regulatory amendments are under development and are proposed for publication in the Canada Gazette, Part II as early as fall 2021.