Canada Gazette, Part I, Volume 155, Number 12: ORDERS IN COUNCIL

March 20, 2021

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Order Approving Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

P.C. 2021-150 March 15, 2021

His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of Health, pursuant to paragraph 30.1(2)(a) footnote a of the Food and Drugs Act footnote b, approves the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 1, 2021.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order in Council approves the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. This new interim order (IO No. 2) was made by the Minister of Health on March 1, 2021. IO No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 1) made by the Minister on March 30, 2020, and approved by the Governor in Council (GIC) on April 8, 2020. It extends and modifies certain measures for drugs, medical devices and foods for special dietary purposes introduced in IO No. 1. These measures continue to be necessary to help prevent and alleviate the effects of shortages that are caused or exacerbated, directly or indirectly, by COVID-19.

Objective

This Order in Council ensures the continued effect of the IO No. 2 to help prevent or alleviate the effects of health product shortages caused or exacerbated, directly or indirectly, by COVID-19.

Background

COVID-19 is a new disease never before seen in humans. It is an infectious respiratory disease caused by a strain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, it may cause pneumonia, severe acute respiratory syndrome, kidney failure and death.

The disease was first detected in Wuhan, China, in December 2019. The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11, 2020. Originally seen to be a local outbreak, COVID-19 has now affected most countries across the globe. There are now more than 109 million cases and over 2 million people have lost their lives. As of February 17, 2021, the number of confirmed cases in Canada has exceeded 800 000. However, the situation continues to evolve.

From the outset, the COVID-19 pandemic created global supply chain challenges. Shortages of health products are a growing global problem with particular implications for smaller markets like Canada. Approximately 83% of drug manufacturing activity is conducted outside of Canada and roughly 68% of drugs in final dosage form are imported. As well, imports account for nearly 75% of Canada's medical device market. Many of these imports are from single suppliers, making Canada particularly vulnerable to unforeseen events that disrupt manufacturing and distribution.

The COVID-19 pandemic has made this situation worse. It has disrupted supply chains and caused an increase in demand for certain health products used to prevent, treat and manage COVID-19. Product categories regulated under the Food and Drugs Act that have experienced an increase of shortages or demand, or where the risk of a shortage has become more pronounced, include

Since March 2020, Health Canada has responded to 45 Tier 3 (highest impact) drug shortages, compared to only 10 Tier 3 shortages in 2019. Of the over 400 medical device shortage reports received as of February 17, 2021, 281 shortages were confirmed and posted. Before IO No. 1 was made, Health Canada was made aware of only 27 medical device shortages from 2015 to February 2020. At that time, there were no mandatory requirements to report medical device shortages in Canada. While the supply and demand levels for some health products are stabilizing, the need for vigilance continues. The federal government remains focused on the health and safety of Canadians during the COVID-19 pandemic.

Health Canada plays an active role in mitigating the impact of shortages on Canadians. The Department works closely with provinces and territories, manufacturers and others in the supply chain to ensure that Canadians have access to the prescription drugs and medical devices they need. Regulatory requirements for manufacturers to report drug shortages came into force in March 2017. These require manufacturers to report certain drug shortage and discontinuation information on a third-party website. There are no other existing requirements in legislation or permanent regulation directly related to medical devices or other health product shortages.

To date, the federal government has put in place a number of temporary measures to support efforts to alleviate shortages that occur and to help prevent new shortages. For example, in March 2020, Health Canada implemented an interim policy to address the unprecedented demand for disinfectants and hand sanitizers in Canada at the start of the pandemic. This interim policy supplements the Canadian supply by facilitating importation of foreign products that do not fully meet regulatory requirements under the Food and Drugs Act but do not compromise the safety of Canadians. These measures have enabled Health Canada to facilitate the availability of supplies of these products for Canadians. As of February 17, 2021, the sale and import of 670 products (surface disinfectants and hand sanitizers) have been permitted under the policy.

As a part of Health Canada's efforts to prevent and alleviate shortages of key products, IO No. 1 was made by the Minister on March 30, 2020. Its approval by the GIC on April 8, 2020, extended its operation by up to a year. IO No. 1 permitted the exceptional importation of specified health products that may not fully meet Canadian regulatory requirements, but are manufactured to comparable standards, to help alleviate a shortage. As of February 17, 2021, 56 drugs, 265 medical devices and 2 foods for a special dietary purpose were permitted for exceptional importation and sale under this interim order. IO No. 1 also mandated the reporting of shortages of select medical devices that are critical during the pandemic, similar to a requirement already in place for drugs. These and other measures undertaken by the Department in partnership with manufacturers and importers have led to the resolution of 25 Tier 3 drug shortages and 118 medical device shortages.

The Minister also made two more interim orders focused on drug shortages over the past year.

The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 was made by the Minister on October 16, 2020, and approved by the GIC on October 23, 2020. This interim order provides additional tools to address drug shortages. These include the ability to require specific information about a shortage related to COVID-19 and to impose terms and conditions on the market authorization for a drug related to a shortage.

The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) was made by the Minister on November 17, 2020, and approved by the GIC on December 4, 2020. This introduces new measures to help prevent the foreign bulk importation of drugs intended for the Canadian market from causing or worsening a drug shortage in Canada. An example is the program recently established in the United States.

Without further action, IO No. 1 would have expired on March 30, 2021. Once IO No. 1 expired, products previously permitted to be imported and sold to address a shortage would no longer be permitted. As well, Health Canada would be unable to permit new products to be imported and sold through exceptional importation. This would worsen the impact of these shortages on Canadians.

Moreover, reporting of medical device shortages would no longer be required, which would have reduced Health Canada's ability to monitor shortages of critical medical devices. Urgent action is required to maintain these authorities, enabling Health Canada to continue helping to prevent and alleviate the effects of health product shortages caused or exacerbated, directly or indirectly, by COVID-19.

On March 1, 2021, the Minister made the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19.

Without this Order in Council approving it, the IO is in effect for 14 days. This does not give Health Canada enough time to use these tools effectively to help prevent and alleviate the effects of health product shortages caused or exacerbated, directly or indirectly, by COVID-19.

Implications

This Order in Council approves IO No. 2, allowing it to remain in effect for one year, in accordance with paragraph 30.1(2)(a) of the Food and Drugs Act. This time frame makes it possible to meet the objectives of the IO.

Exceptional importation

Under IO No. 2, the exceptional importation and sale of drugs, medical devices, and foods for a special dietary purpose will continue to be permitted to address shortages of these products that are caused or made worse, directly or indirectly, by COVID-19. Products governed by IO No. 2 may be imported into Canada, provided they were manufactured with similar high quality and manufacturing standards to those required for Canadian-approved products.

Under IO No. 1, the Minister maintained up-to-date lists of the drugs, medical devices, and foods for a special dietary purpose eligible for exceptional importation on Health Canada's website. These lists are again being incorporated by reference under IO No. 2 and will continue to be maintained. Industry guidance outlines how companies can submit proposals for adding a non-compliant drug, medical device, or food for a special dietary purpose to these lists to address a shortage. Health Canada may also add a product to a list without receiving a specific proposal from a company if requested by a public health official, such as the Chief Public Health Officer of the Public Health Agency of Canada, if necessary to address a potential shortage. Health Canada reviews proposals based on a number of factors, including but not limited to product type and availability of supply.

IO No. 2 also formalizes a regulatory framework to permit the exceptional importation and sale of surface disinfectants (also called biocides) to address increased demand. It modifies the definition of a “biocide” that was defined in IO No. 1 so that the term refers only to disinfectants, and not hand sanitizers, which are regulated differently. The exceptional importation framework for biocides in IO No. 2 will replace Health Canada's earlier interim policy approach for imported disinfectants. An up-to-date list of biocides eligible for exceptional importation will be maintained. Many of the biocides that were eligible for import and sale under Health Canada's previous policy approach will continue to be permitted under IO No. 2.

IO No. 2 modifies regulatory flexibilities previously made available to regulated parties that manufacture, import, and/or sell hand sanitizers, as the domestic production capacity for these products has now stabilized. Under IO No. 1, companies were permitted to conduct activities related to drug-based hand sanitizers without a drug establishment licence (DEL). IO No. 2 reintroduces the requirement for companies to have a DEL to conduct regulated activities related to drug-based hand sanitizers. Companies wishing to continue conducting licensable activities related to drug-based hand sanitizers will have six months to apply for a DEL. After applying, companies can continue those activities until a determination is made with respect to their applications.

In addition, IO No. 2 no longer permits companies to provide Health Canada with label text in place of a label mock-up as part of an application for a drug identification number (DIN) or a new drug submission regarding a drug-based hand sanitizer. However, any application seeking market authorization for a product that is pending a decision at the time IO No. 2 comes into force will be considered under the terms of IO No. 1.

IO No. 2 also modifies Health Canada's approach to official languages for products that arrive in Canada through exceptional importation. Under IO No. 1, guidance for industry indicated the Department's expectation for importers to ensure that information on the safe use of the product be available in French and English. IO No. 2 makes that regulatory requirement explicit. Importers wishing to keep their products in the Canadian market will have six months to come into compliance.

Any importer who is permitted for exceptional importation and sale under IO No. 2 must notify the Minister electronically, in a format that is specified by, or acceptable to, the Minister, at least five business days before importation. These products will still be subject to some of the requirements set out in the Food and Drugs Act and its regulations, including reporting adverse drug reactions, recall requirements and mandatory problem reporting (medical devices).

Medical device shortage reporting

IO No. 2 also continues the requirement for manufacturers and importers of medical devices considered critical during the COVID-19 pandemic to notify the Minister of shortages of those medical devices introduced in IO No. 1. The notification must happen within five business days of becoming aware of an actual or anticipated shortage. Information is to be submitted electronically in a format specified by, or acceptable to, the Minister.

IO No. 2 clarifies that the shortage reporting requirement for substitute devices, components, accessories or parts should be based only on the manufacturer's own capacity, supply and orders. It does not include a situation where the device is on back order for less than 30 days. These changes bring shortage reporting requirements into better alignment with those of the U.S. Food and Drug Administration, thus avoiding confusion for manufacturers. They also clarify the circumstances under which manufacturers should report a shortage and will improve Health Canada's oversight of medical device shortages.

Under IO No. 1, the Minister maintained an up-to-date list of medical device shortages and an up-to-date list of specified medical devices for which shortages must be reported. Products appearing on the list of specified medical devices are selected based on signals from public reports, industry, provinces and territories, or other stakeholders. These lists are being reincorporated under IO No. 2 and will continue to be maintained.

IO No. 1 introduced an authority for the Minister to request additional information about a shortage of a medical device, or its components, accessories, parts or consumable materials, that had been reported to Health Canada. However, the ongoing pandemic has underscored the need for more robust information respecting medical device shortages.

The authority in IO No. 1 was effective in obtaining supplemental information from manufacturers and importers who have reported a shortage to Health Canada. However, while assessing the impact that an actual or anticipated shortage may have had on Canadians, it was often necessary to gather information from additional companies. For example, Health Canada has had to request information from other manufacturers and importers to determine the supply of potential substitute devices. Similarly, Health Canada has also requested supply and demand information from companies to validate signals received from other sources to determine if a risk of shortage existed.

To date, industry has provided this information when requested and Health Canada has worked with companies to address shortages. However, expanding the Minister's authority to compel information on medical device shortages will facilitate timely access to needed information when companies would not voluntarily provide the information. This will enable Health Canada to assess and respond more quickly to an actual or anticipated shortage, which could limit or prevent harm to Canadians.

Therefore, IO No. 2 introduces an expanded authority for the Minister to request information on existing and potential medical device shortages that have not been reported or that are not subject to an obligation to report. The Minister can request this information from a manufacturer, importer or distributor of a medical device if the Minister has reasonable grounds to believe that

The Minister can only use this power to request information that is in the control of a manufacturer, importer or distributor. This power cannot be used to require them to create new information in response to the Minister's request. The decision to compel information through IO No. 2 must be reasonable, factual, and flow logically from the signals available to the Minister. These signals may include complaints, media reports, shortage reports or knowledge of broader supply chain issues. Industry, provinces and territories, or other stakeholders may also identify potential indications of shortages.

A manufacturer, importer or distributor required to provide information must do so electronically in a format that is specified by, or acceptable to, the Minister. The required information is to be submitted within the time frame specified by the Minister. However, the Minister cannot require the information to be submitted with less than 24 hours' notice, unless the Minister has reasonable grounds to believe there is a serious and imminent health risk. Details on the process for providing information, and the types of information that may be requested, have been provided to industry through the guidance document on medical device shortages.

Enforcement and compliance

Enforcement of IO No. 2 takes place through inspection, compliance promotion, monitoring and verification. Health Canada will continue to conduct compliance promotion sessions with regulated parties to increase their understanding of their new obligations and to minimize non-compliance.

Health Canada has a number of enforcement powers available to address non-compliance with the Food and Drugs Act or an issue of public health and safety. Actions that could be taken against regulated parties violating the terms of the IO include

Health Canada will choose the most appropriate tool to help ensure compliance and to mitigate any risks to health, informed by the specifics of each case and in alignment with the Compliance and enforcement policy framework and the Compliance and enforcement policy for health products (POL-0001).

Consultation

Health Canada received comments on IO No. 1 through ongoing discussions with stakeholders, industry conferences and two focused stakeholder engagement sessions held on June 4, 2020, and September 3, 2020. These comments were generally supportive. Stakeholders understood the need to continue the frameworks and authorities put in place through IO No. 1. The Department sought to accommodate stakeholder feedback on IO No. 2 where possible.

Some stakeholders wanted more clarity on how the interim policy previously used to import disinfectants and hand sanitizers would change. IO No. 2 clarifies the Department's approach to these products by placing the agile regulatory measures previously offered through the interim policy in a more formal framework based on a list incorporated by reference. Some stakeholders also raised concerns that the shift from the interim policy to the new framework in IO No. 2 will now only encompass disinfectants that are imported and are not available to Canadian manufacturers. However, Health Canada continues to offer other agile regulatory measures to Canadian manufacturers such as expediting review times for product applications that only contain direct or indirect SARS-CoV-2 claims.

Other concerns raised by biocide stakeholders included

IO No. 2 addresses some of these concerns. It clarifies that importers must make information that permits the safe use of a product available in both French and English and in a manner that is accessible to consumers.

Medical device stakeholders wanted greater clarity about Canadian shortage reporting requirements. IO No. 2 clarifies the reporting requirements by specifying that shortages should be based only on the manufacturer's own capacity, supply and orders, and do not include situations in which the manufacturer produces another device that can be substituted for the device in shortage. In addition, IO No. 2 excludes the reporting of back orders that are less than 30 days. These changes also bring Canadian requirements into closer alignment with the United States.

The expanded authority to request information related to medical device shortages has been designed to address stakeholder concerns by specifying that the Minister can only request information that is in the control of the manufacturer, importer or distributor so that this power cannot be used to require them to create new information. As well, a provision was added that specifies the Minister can only compel information if there are reasonable grounds to believe that the manufacturer, importer or distributor would not provide the information without a legal obligation. Additionally, a minimum timeline of 24 hours for information requests, unless there is a serious and imminent risk of injury to human health, has been included in IO No. 2.

In January and February 2021, Health Canada consulted on IO No. 2 with a range of stakeholders, including

Sessions focused on how IO No. 2 differs from IO No. 1 and how the authorities will be used in the future.

Health Canada also accepted written comments from stakeholders between January 22, 2021, and February 11, 2021. Stakeholders were largely supportive of IO No. 2 and the proposed changes from IO No. 1. A small number of stakeholders consider the new requirement for information to be made available in French and English to be burdensome. However, most stakeholders did not indicate it would impact their choice to make use of the exceptional importation frameworks.

In general, stakeholders indicated that the tools in IO No. 2 were effective in helping to address shortages. They did not raise significant concerns.

Health Canada has been in contact with representatives of provincial and territorial governments and other stakeholders, such as health care providers and patient advocacy groups. They are supportive of IO No. 2 and its measures to address shortages of drugs, biocides, medical devices and foods for a special dietary purpose in light of the current COVID-19 global pandemic.

Contact

Catherine Hudon
Director
Compliance Policy and Regulatory Affairs
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Address Locator: 1907A
200 Eglantine Driveway
Jeanne Mance Building
7th Floor, Room 705A
Tunney's Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 343‑540‑8524
Email: hc.prsd-questionsdspr.sc@canada.ca

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Order Approving Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

P.C. 2021-149 March 15, 2021

His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of Health, pursuant to paragraph 30.1(2)(a) footnote a of the Food and Drugs Act footnote b, approves the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on March 1, 2021.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order in Council approves Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 2) that was made by the Minister of Health on March 1, 2021. In accordance with subsection 30.1(1) of the Food and Drugs Act, the Minister may make an interim order if immediate action may be required to deal with a significant risk, direct or indirect, to health, safety or the environment.

IO No. 2 repeals the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, which came into force on March 18, 2020.

This new interim order maintains many of the flexibilities of the previous interim order, including the consideration of urgent public health needs. These flexibilities are needed to assess evidence that demonstrates the safety and effectiveness of medical devices. IO No. 2 also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim order.

Further, IO No. 2 introduces new requirements for medical devices authorized under this new interim order or the previous interim order

These new requirements align with those in the Medical Devices Regulations.

Without an Order in Council approving it, IO No. 2 would, in accordance with paragraph 30.1(2)(a) of the Act, cease to have effect 14 days after it was made. As a result of this Order in Council, this Interim Order, in accordance with paragraphs 30.1(2)(b) to (d) of the Act, will cease to have effect on the earliest of the day on which it is repealed, the day on which regulations having the same effect come into force, or one year after the day on which IO No. 2 was made.

Objective

The objective of this Order in Council is to enable the continued operation of IO No. 2. IO No. 2 supports Canada's ongoing focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.

It contributes to securing Canada's medical device supply chain by

Background

COVID-19

COVID-19 is a new disease never before seen in humans. It is an infectious respiratory disease caused by a strain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, it may cause pneumonia, severe acute respiratory syndrome, kidney failure and death.

The disease was first detected in Wuhan, China, in December 2019. The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11, 2020. Originally seen to be a local outbreak, COVID-19 has now affected the majority of countries around the globe. According to the COVID-19 Dashboard by the Center for Systems Science and Engineering at Johns Hopkins University, there are now more than 106 million cases and over 2 million people have lost their lives. According to the outbreak update available from the Government of Canada, the number of confirmed cases in Canada as of February 8, 2021, has exceeded 800 000. However, the situation continues to evolve and change.

From the outset, the COVID-19 pandemic has created challenges in global supply chains, including an unprecedented demand for certain medical devices. Medical device manufacturers and importers adapted quickly to meet demands for COVID-19 devices. New manufacturers also stepped in to create additional capacity.

Global efforts are focused on identifying cases and preventing further spread.

Government of Canada's response

The health and safety of Canadians is the Government of Canada's top priority during the COVID-19 pandemic. The Government therefore took action to provide a faster way to authorize the importation and sale in Canada of medical devices that are used to diagnose, treat, mitigate or prevent COVID-19.

The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 has been effective. For instance, over 500 authorizations for COVID-19 medical devices have been issued, including for testing devices and medical devices other than testing devices, such as personal protective equipment. This authorization pathway for COVID-19 medical devices has also helped to secure Canada's medical device supply chain. It did so by facilitating continued expedited access to safe and effective COVID-19 devices for health care workers and other Canadians.

As the pandemic evolves, the Government of Canada continues to evaluate Canada's medical device supply. Without widespread immunization at this time, one of the best options for controlling the spread of the virus and managing its risks is to continue to enhance access to COVID-19 medical devices.

The tools and flexibilities used to authorize the importation and sale of COVID-19 medical devices from the previous interim order are the most effective means for providing an expedited pathway for COVID-19 devices. They also help to facilitate people's access to the devices they need.

Implications

Requirements carried over from the previous interim order

As was the case under the previous interim order, IO No. 2 provides for an expedited authorization pathway for COVID-19 medical devices. This contributes to ensuring Canadians have continued access to COVID-19 medical devices.

IO No. 2 continues to apply to all classes of medical devices and provides three authorization mechanisms:

IO No. 2 still allows the Minister to determine the level of evidence required to demonstrate the safety and effectiveness of devices authorized through the interim order process, in light of the urgent public health need. This new interim order continues to also

Further, any applications that are outstanding when the previous interim order expires will still be considered under IO No. 2.

All authorized COVID-19 devices are subject to post-market requirements. These include incident reporting, reporting of a voluntary recall and record-keeping requirements related to distribution.

The Minister also maintains the ability, at any time, to

Health Canada will continue to monitor the safety and effectiveness of authorized COVID-19 devices. This includes taking immediate action, such as cancelling authorizations if required, to protect people's health and safety.

Manufacturers of medical devices authorized under the Interim Order will not be subject to evaluation, amendment and right-to-sell fees.

New requirements

MDELs

IO No. 2 requires importers and distributors of all COVID-19 devices to

Importers and distributors will

This new MDEL requirement will allow Health Canada to better monitor the medical device supply chain.

Under the Medical Devices Regulations, Health Canada inspects the operations of MDEL holders for various activities. This includes verifying that MDEL holders have procedures in place to maintain records and handle complaints. Inspections are important to verify that MDEL holders can

A six-month transition period for affected stakeholders to comply with the new requirement accomplishes two things. It

Bilingual labelling

Manufacturers, importers and distributors of all COVID-19 medical devices must comply with the labelling content provisions set out in the previous interim order. Now, they must also comply with provisions similar to those of the Medical Devices Regulations to have bilingual labelling under certain circumstances.

This requirement is expected to have minimal impact on existing devices with Interim Order authorizations. Guidance relating to the previous interim order outlined that any medical device authorized under the interim order should have bilingual labelling available as soon as possible.

All manufacturers have six months from when IO No. 2 takes effect to comply with the bilingual labelling requirements. Importers, distributors and retailers have another three months to deplete current stock of medical devices that are labelled in accordance with the previous interim order.

Medical devices authorized under the previous interim order or IO No. 2 must be brought into compliance with the new requirements within the allotted transition period. Those that do not will no longer be able to be imported into or sold in Canada.

Consultation

Health Canada launched a targeted email consultation addressing the proposed regulatory approach for IO No. 2. The consultation was sent to 9 000 stakeholders, including

Health Canada received 72 stakeholder responses in total.

The email-based consultation was chosen in lieu of a broader consultation to target those who were affected by the Interim Order. As IO No. 2 relates to authorizing products for import or sale, a decision was made to focus the consultation on the manufacturers, importers and distributors who are directly impacted by the Interim Order. These included the industry stakeholders listed above, federal government departments, provinces and territories. It was also decided that a targeted consultation with impacted stakeholders would be an efficient mechanism for seeking feedback on IO No. 2, given the urgent need to ensure continued access to devices.

Furthermore, the previous interim order had been in place and public for nearly nine months before the email consultation began. Health Canada had not received any feedback from outside these groups about the Interim Order process. The overall approach was also being largely maintained.

Some of the stakeholder responses about the Interim Order focused on operational issues, such as approval timelines, rather than the proposed regulatory approach, which was the focus of the consultation. Health Canada regularly reviews the Interim Order application and review process in order to gain efficiencies and improve timelines. Health Canada will consider these comments in its next review.

Of the comments concerning the policy approaches in IO No. 2, respondents were generally supportive of the provisions. Some stakeholders gave specific reasons for their support of the previous interim order, such as

These provisions are being carried over as part of IO No. 2.

Respondents also provided feedback on the IO No. 2 new requirements for bilingual labelling and MDELs. Most respondents did not express significant concerns about meeting these new requirements in IO No. 2. However, some international manufacturers were concerned about the new bilingual labelling requirements. Most respondents also indicated that they intend to continue marketing their COVID-19 devices after the pandemic is over.

The bilingual labelling and MDEL requirements are justified given the need for oversight over industry and the fact that these requirements exist under the Medical Devices Regulations. To mitigate these concerns, Health Canada is including transition periods to help offset the burden on industry.

Health Canada also held two stakeholder webinars and presented at the Regulatory MedTech Conference. Health Canada used these sessions to explain the proposed regulatory approach to renewing flexibilities introduced in the previous interim order. Stakeholder feedback during these sessions was consistent with the feedback received in the email consultation. Generally, participants support Health Canada's approach and significant concerns were not raised. The questions raised focused mainly on the same operational issues as those expressed in the written submissions.

Based on the stakeholder feedback from the email consultation and webinars, no further changes were made to IO No. 2.

Health Canada also

PHAC expressed support for the interim order flexibilities to be continued. The provinces, territories and other federal government departments did not have any reservations.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca