Explanatory note

(This note is not part of the Order)

Proposal

The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (the Interim Order), made by the Minister of Health on March 30, 2020, introduces measures for drugs, medical devices, and foods for special dietary purposes that are necessary to help prevent or alleviate the effects of shortages directly or indirectly related to COVID-19. The Interim Order allows the Minister to permit the exceptional importation and sale of drugs, medical devices, and foods for special dietary purposes that do not fully comply with Canadian requirements, but are manufactured according to comparable standards. Additionally, the Interim Order introduces a mandatory mechanism for the Minister to be notified of shortages of medical devices considered to be critical during the COVID-19 pandemic. Finally, the Interim Order modifies certain application requirements to allow for the expedited authorization of biocide drugs, such as hard surface disinfectants and hand sanitizers.

The Minister may make interim orders under subsection 30.1(1) of the Food and Drugs Act, if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment.

Objective

To protect the health and safety of Canadians through exceptional importation of drugs, medical devices, and foods for special dietary purposes that are in shortage as a direct or indirect result of the COVID-19 pandemic and by providing improved access to biocide drugs.

Background

COVID-19 is the infectious respiratory disease caused by the most recently discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The outbreak of COVID-19 began in Wuhan, China, in December 2019. COVID-19 infection is known to cause respiratory symptoms, fever, cough, shortness of breath, and breathing difficulties. In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death.

The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11, 2020. There are now more than 558,900 cases in at least 150 countries and over 25,250 people have lost their lives. The number of confirmed cases in Canada as of March 27, 2020 has exceeded 4,015; however, the situation is changing rapidly.

During the course of the COVID-19 pandemic, there may be shortages of drugs (including hand sanitizer and hard surface disinfectants), medical devices (e.g., personal protective equipment such as masks or gowns), and foods for special dietary purposes (e.g., infant formula). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. This will enable Canada's healthcare system to adapt rapidly to changes in the supply chain to address the needs of Canadians.

On March 16, 2020, Health Canada implemented interim measures using enforcement discretion to facilitate expedited access to supplies of products that do not fully meet regulatory requirements under the Food and Drugs Act. These interim measures were implemented to address an unprecedented demand for hard surface disinfectants, hand sanitizers, and personal protective equipment due to the COVID-19 pandemic. The interim measures enabled Health Canada to facilitate the availability of supplies of these products for Canadians.

At this time, Health Canada is aware of two specific practices that are causing concern and contributing to issues affecting supplies of drugs, medical devices and foods for special dietary purposes. These are:

1. Individual stockpiling during self-isolation is causing localized shortages of drugs, medical devices, and foods for special dietary purposes (e.g, infant formula, face masks, and insulin), and
2. Increased demand of certain drugs and medical devices both locally and in other countries are resulting in manufacturers and distributors needing to ensure sufficient and timely supplies of raw materials, conserve finished product supplies at the distribution level, and manage fair allocation domestically and between countries. As a result, not all countries, provinces or hospitals are receiving adequate quantities of products (e.g., personal protective equipment and inhalers).

Health Canada is engaging multiple partners, including provinces and territories, distributors, and group purchasing organizations to identify solutions. This Interim Order will help Canadians access products necessary for their health and safety during the COVID-19 pandemic.

Implications

This Interim Order allows for the exceptional importation and sale of drugs (including hard surface disinfectants and hand sanitizers), medical devices, and foods for special dietary purposes, to address shortages of these products related directly or indirectly to the COVID-19 pandemic. Products governed by this exceptional importation and sale Interim Order may be imported into Canada, provided these products were manufactured with similar high quality and manufacturing standards to those required for Canadian approved products. In certain limited cases, the Interim Order will also allow the exceptional sale of an unapproved medical device or food for a special dietary purpose that is manufactured in Canada when the product is needed to respond to a shortage. The Minister will maintain up-to-date lists of the drugs, medical devices, and foods eligible for this exceptional importation pathway on Health Canada's website.

Any importer who uses the exemptions in this Interim Order must notify the Minister at least five days before importation, following the requirements in the Interim Order. 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).

The Interim Order also introduces a new requirement for manufacturers of medical devices considered to be critical during the COVID-19 pandemic to notify the Minister about shortages of those medical devices. The notification must happen within five days of becoming aware of a shortage in progress or of an anticipated shortage. The required information must be submitted in a form and manner established by the Minister. The reporting framework aligns with the existing approach to the shortage reporting framework for drugs.

The requirement for notification of shortages of certain medical devices and drugs will help inform the Minister of which products to consider allowing through the exceptional importation pathway. Health Canada will be able to leverage the existing administrative processes used for enforcement discretion (e.g., non-compliant labelling, shelf-life extension, and authorization in other countries) and remain agile in changing circumstances with respect to the COVID-19 pandemic.

Finally, the Interim Order modifies certain application requirements to allow for the expedited authorization of biocide drugs (such as hard surface disinfectants and hand sanitizers) which are critical to irreversibly destroy or reduce viruses such as SARS-CoV-2 or to reduce microbial presence on the skin. The Interim Order exempts anyone conducting activities solely respecting biocide drugs from the requirement to hold an establishment licence. Division 2 of the Food and Drug Regulations (good manufacturing practices) continues to apply.

This Interim Order will not alter Health Canada's existing position respecting personal importation.

Consultation

Representatives of provincial and territorial governments, certain industry associations, and other stakeholders are aware of the use of these mechanisms to address shortages of drugs (including hard surface disinfectants), medical devices, and foods for special dietary purposes, in light of the current COVID-19 global pandemic. Additionally, many of these stakeholders have previously been involved with the use of enforcement discretion and have indicated their support of this mechanism to address potential shortages in Canada. Due to the urgent nature of the Interim Order, broad stakeholder consultation was not possible. However, it is expected that most stakeholders will be supportive of the Interim Order.

Within the Health Portfolio, the Public Health Agency of Canada and the Canadian Food Inspection Agency have been consulted and are supportive of this Interim Order. Additionally, the Canadian Border Services Agency is aware that drugs, medical devices, and foods for special dietary purposes that are authorized or imported under these mechanisms, will be identified at the border.

Contact

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