Canada Gazette, Part I, Volume 154, Number 50: ORDERS IN COUNCIL

December 12, 2020

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Order Approving the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply)

P.C. 2020-999 December 4, 2020

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to paragraph 30.1(2)(a)footnote a of the Food and Drugs Actfootnote b, approves the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply), made by the Minister of Health on November 27, 2020.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

The Order in Council (OIC) approves the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) [the Interim Order] made by the Minister of Health on November 27, 2020. The Interim Order introduces new measures to help safeguard the Canadian drug supply by ensuring that bulk importation frameworks, such as the one recently established by the United States, do not cause or exacerbate a drug shortage in Canada.

Objective

The objective of the OIC is to ensure the continued effect of the Interim Order to safeguard the Canadian drug supply.

Background

Drug shortages are a growing global problem with particular implications for vulnerable markets like Canada. Since 2017, approximately 10–15% of drugs have been in shortage at any given time. Canada is a small market representing 2% of global drug sales that sources 68% of its drugs internationally.

The COVID-19 pandemic has made this situation worse by disrupting the availability of drugs and by causing an increase in the demand for certain medicines used to treat and manage COVID-19 infections. By October 20, 2020, Canada had experienced 42 Tier 3 (highest impact) shortages, compared to approximately 10 such shortages in all of 2019. While the supply and demand levels for many drugs are stabilizing, the need for vigilance in maintaining the national drug supply continues, and the Government remains focused on preparing a strong response to a future resurgence of COVID-19.

Drug shortages have a real impact on Canadians. Health care providers rely on access to needed drugs to provide proper and timely treatment. Drug shortages can contribute to adverse patient outcomes, such as delayed or cancelled surgeries, less than optimal care because of the need to use alternative treatments, discontinued treatment where there is no alternative, and drug rationing.

Drug shortages affect all gender and sociodemographic groups in Canada and can have serious impacts on the health care system, causing harm to Canadians. Already vulnerable populations, such as children, older adults, and Indigenous populations may be disproportionately affected by a drug shortage. Canada requires access to a diverse supply of drugs to protect the health and safety of Canadians.

Health Canada (the Department) plays an active role in mitigating the impact of drug shortages on Canadians. The Department works closely with provinces and territories, manufacturers, and others in the drug supply chain to ensure that Canadians have access to the prescription drugs they need. Regulatory requirements for manufacturers to report drug shortages came into force in March 2017 and 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 drug 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, the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health (the Minister) on March 30, 2020, permits the exceptional importation of specified drugs that may not fully meet Canadian regulatory requirements, but are manufactured according to comparable standards, to help alleviate a shortage. Also, the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, made by the Minister on October 16, 2020, provides the Minister with additional tools to address drug shortages. These tools include, but are not limited to, the ability to request specific shortage-related information from those who sell drugs to help prevent or alleviate drug shortages that may be caused or exacerbated by the COVID-19 pandemic. Both of these interim orders were approved by the Governor in Council and are in effect for one year from the date they were made.

These measures provide additional tools to help the Minister address drug shortages. However, they can be used only within the context of COVID-19. New tools are needed to address additional pressures to the Canadian drug supply that increase the risk of drug shortages.

On October 1, 2020, the United States (U.S.) published the final rule on the Importation of Prescription Drugs. The rule comes into effect on November 30, 2020, and creates a pathway to allow licensed U.S. pharmacists or wholesalers to import in bulk certain prescription drugs intended for the Canadian market. There has been significant state-level support for the bulk importation of drugs from Canada. The implementation of importation programs would worsen the existing problem of drug shortages in Canada and put the health of Canadians at risk.

Urgent action is required to put in place tools that help ensure that any participation in bulk importation programs in the United States or in other countries do not cause or exacerbate drug shortages.

On November 27, 2020, the Minister made the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) to safeguard the Canadian drug supply from bulk importation programs that could cause or exacerbate a drug shortage in Canada. Under the Interim Order, certain drugs intended for the Canadian market are prohibited from being sold for consumption outside of Canada if that sale would cause or exacerbate a drug shortage.

The Interim Order also enables the Minister to require companies holding a drug product authorization or establishment licence to provide additional information respecting an existing or potential drug shortage. This Interim Order is in effect for 14 days, which does not provide sufficient time for Health Canada to effectively use these tools to help prevent or alleviate drug shortages related to U.S. bulk importation or any other similar frameworks.

Implications

This OIC approves the Interim Order, 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 enables the objectives of the Interim Order to be met by helping to safeguard the Canadian drug supply from bulk importation programs in other countries and improve the information available for decision-making related to the management of drug shortages in Canada.

The Interim Order prohibits a drug establishment licence (DEL) holder (e.g. a fabricator, wholesaler, or distributor) from distributing certain drugs intended for the Canadian market to another person (i.e. individual or business) for consumption or use outside Canada, unless the DEL holder has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage. This Interim Order applies to all distribution conducted by DEL holders and is focused on drugs for which a shortage would have the highest impact on patient health and safety (e.g. prescription drugs, controlled substances and biologics). The prohibition does not apply to sales made by a person who is not required to hold a DEL (e.g. consumer-level pharmacy) and does not include transfers of drugs within a company. Sales of products manufactured in Canada solely for export are also not included in the scope of the prohibition as long as the conditions for exempt exports, as outlined in subsection 37(1) of the Food and Drugs Act, are met.

A shortage is where, in respect of a drug, a manufacturer is unable to meet the demand for the drug in Canada. The Interim Order does not prohibit the distribution of a drug for consumption outside of Canada if the DEL holder is able to demonstrate that the sale will not cause or exacerbate a shortage. DEL holders are required to maintain a record of this determination. Information about making the determination of whether a sale will cause or exacerbate a shortage has been provided in the guidance document on the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply).

This Interim Order also introduces a new authority for the Minister to require specific information from certain persons to assess existing and potential shortages. This authority to require information has some degree of overlap with the authority in the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, but there are three key differences. First, the Interim Order is limited to regulated parties holding a drug product authorization or establishment licence issued by Health Canada, as opposed to all persons who sell a drug. Second, it applies to all shortages, not only those related to COVID-19 or bulk exportation. Third, the scope of this Interim Order does not include over-the-counter drugs. The authority within this Interim Order provides the Minister with the ability to gather information about a shortage or potential shortage when voluntary compliance with a request for information is not achieved. This information will better inform decision-making and federal interventions to help manage drug shortages.

A person required to provide information must do so electronically in a format 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 that there is a serious or imminent health risk. Further information on the process for providing information and more details about the types of information that may be requested has been provided to industry through the guidance document on the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply).

Enforcement of this Interim Order takes place through inspection, compliance promotion, monitoring, and verification. Health Canada will continue to conduct compliance promotion sessions with DEL holders to increase their understanding of their new obligations and 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 DEL holders violating the terms of the Interim Order include requesting a plan for corrective measures, issuing public advisories or other forms of communication, or suspending or cancelling of the DEL holder’s licence.

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). In instances where Health Canada’s responses have been appropriately escalated, but have still not successfully achieved compliance, Health Canada may make a recommendation for prosecution to Public Prosecution Service of Canada.

Consultation

Comments received from industry and health interest groups to date are supportive of the government of Canada taking immediate action to address the risk of drug shortages presented by the U.S. rule. Since the release of the U.S. Safe Importation Action Plan on July 31, 2019, Health Canada has heard from many Canadians who voiced their concern regarding prescription drug importation proposals from foreign countries and their expectation that the Government take definitive action to safeguard Canada’s drug supply.

Stakeholder consultation on specific aspects of this Interim Order was not possible since the U.S. final rule was only recently published and because of the urgent nature of the risks to the Canadian drug supply. However, in 2019 and earlier in 2020, Health Canada consulted with industry and the broader health care community on the importance of preventing bulk exports of drugs that could cause or exacerbate drug shortages in Canada. Stakeholders in the medical, nursing, pharmacy, and charitable communities were strongly supportive of efforts to prevent bulk exports of drugs intended for the Canadian market.

Contact

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Regions Branch
Health Canada
Address Locator: 1907A
200 Eglantine Driveway
Jeanne Mance Building
7th Floor, Room 705A
Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 613‑946‑6220
Email: hc.prsd-questionsdspr.sc@canada.ca

PUBLIC HEALTH AGENCY OF CANADA

QUARANTINE ACT

Minimizing the Risk of Exposure to COVID-19 in Canada Order (Mandatory Isolation), No. 8

P.C. 2020-967 November 29, 2020

Whereas the Governor in Council is of the opinion, based on the declaration of a pandemic by the World Health Organization, that there is an outbreak of a communicable disease, namely coronavirus disease 2019 (COVID-19), in the majority of foreign countries;

Whereas the Governor in Council is of the opinion that the introduction or spread of the disease would pose an imminent and severe risk to public health in Canada;

Whereas the Governor in Council is of the opinion that the entry of persons into Canada who have recently been in a foreign country may introduce or contribute to the spread of the disease in Canada;

And whereas the Governor in Council is of the opinion that no reasonable alternatives to prevent the introduction or spread of the disease are available;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 58 of the Quarantine Actfootnote c, makes the annexed Minimizing the Risk of Exposure to COVID-19 in Canada Order (Mandatory Isolation), No. 8.

Minimizing the Risk of Exposure to COVID-19 in Canada Order (Mandatory Isolation), No. 8

Definitions

Definitions

1 The following definitions apply in this Order.

Chief Public Health Officer
means the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act. (administrateur en chef)
dependent child
has the same meaning as in section 2 of the Immigration and Refugee Protection Regulations. (enfant à charge)
international single sport event
means an event that is governed by the sport’s International Federation or its regional or continental counterpart, that has a nationally or internationally established qualification process, and that is identified as part of the long-term development plans for high-performance national team athletes of the National Sport Organization for that sport. (événement unisport international)
isolation
means the separation of persons who have reasonable grounds to suspect that they have COVID-19, who have signs and symptoms of COVID-19 or who know that they have COVID-19, in such a manner as to prevent the spread of the disease. (isolement)
permanent resident
has the same meaning as in subsection 2(1) of the Immigration and Refugee Protection Act. (résident permanent)
protected person
means a protected person within the meaning of subsection 95(2) of the Immigration and Refugee Protection Act. (personne protégée)
quarantine
means the separation of persons in such a manner as to prevent the possible spread of disease. (quarantaine)
quarantine facility
means a place that is designated under section 7 of the Quarantine Act or that is deemed to be designated under subsection 8(2) of that Act. (installation de quarantaine)
signs and symptoms of COVID-19
include a fever and a cough or a fever and difficulty breathing. (signes et symptômes de la COVID-19)
temporary resident
means a temporary resident within the meaning of the Immigration and Refugee Protection Act. (résident temporaire)
vulnerable person
means a person who
  • (a) has an underlying medical condition that makes the person susceptible to complications relating to COVID-19;
  • (b) has a compromised immune system from a medical condition or treatment; or
  • (c) is 65 years of age or older. (personne vulnérable)

Requirements Before or When Entering Canada

Quarantine plan — entering by means other than aircraft

1.1 (1) Subject to subsection (2), every person must, before or when entering Canada by a mode of transport other than an aircraft, provide to the Minister of Health a quarantine plan that includes, among other things, the civic address of the place where they plan to quarantine themselves during the 14-day period that begins on the day on which they enter Canada and their contact information for that period.

Exception

(2) Instead of providing the quarantine plan, every person referred to in section 6 or subsection 7.2 (1) must, before or when entering Canada by a mode of transport other than an aircraft, provide their contact information for the 14-day period that begins on the day on which they enter Canada to the Minister of Health.

Quarantine plan — entering by aircraft

(3) Subject to subsection (4), every person must meet the following requirements before boarding an aircraft for a flight to Canada:

Exception

(4) Instead of providing the quarantine plan, every person referred to in section 6 or subsection 7.2(1) must, before boarding an aircraft for a flight to Canada, meet the following requirements:

Persons in transit

(5) Subsections (3) and (4) do not apply to a person who plans to arrive at a Canadian airport aboard an aircraft, in order to transit to a country other than Canada, and to remain in a sterile transit area, as defined in section 2 of the Immigration and Refugee Protection Regulations, until they leave Canada.

Persons Entering Canada

Requirements — questions and information

2 Every person who enters Canada must, during the 14-day period that begins on the day on which they enter Canada or begins again under subsection 3(2) or 4(4),

Designation

2.1 The Chief Public Health Officer may designate any person as a public health official for the purposes of section 2.

Mask or face covering

2.2 (1) Every person who enters Canada and who is required to quarantine or isolate themselves under this Order must, during the 14-day period that begins on the day on which they enter Canada or that begins again under subsection 3(2) or 4(4), wear a non-medical mask or face covering that a screening officer or quarantine officer considers suitable to minimize the risk of introducing or spreading COVID-19

Persons not subject to quarantine

(2) Every person who enters Canada and who, by virtue of section 6 or subsections 7.1(1) or 7.2(1), is not required to enter or remain in quarantine must, during the 14-day period that begins on the day on which they enter Canada, if they are in public settings where physical distancing cannot be maintained, wear a non-medical mask or face covering that a screening officer or quarantine officer considers suitable to minimize the risk of introducing or spreading COVID-19.

Non-application

(3) The requirements in this section do not apply if the non-medical mask or face covering needs to be removed for security or safety reasons.

Asymptomatic Persons

Requirements — asymptomatic persons

3 (1) Any person who enters Canada and who does not have signs and symptoms of COVID-19 must

Period begins again

(2) The 14-day period of quarantine begins again and associated requirements continue to apply if, during the 14-day period, the person develops any signs and symptoms of COVID-19, is exposed to another person subject to this Order who exhibits signs and symptoms of COVID-19 or tests positive for COVID-19.

Cessation — daily reporting

(3) The reporting requirement set out in subparagraph (1)(c)(ii) ends if the person reports that they have developed signs and symptoms of COVID-19 or tested positive for COVID-19.

Unable to quarantine themselves

4 (1) A person referred to in section 3 is considered unable to quarantine themselves if the person cannot quarantine themselves for the 14-day period referred to in that section in a place that meets the conditions set out in subparagraphs 3(1)(a)(i) to (iii).

Requirements — quarantine at quarantine facility

(2) A person who, at the time of entry to Canada or at any other time during the 14-day period referred to in section 3, is considered unable to quarantine themselves must

Change of place

(3) A person referred to in subsection (2) may, with the authorization of a quarantine officer, leave a quarantine facility before the expiry of the 14-day period in order to quarantine themselves in accordance with the requirements of section 3 at a place that is considered suitable by the Chief Public Health Officer, taking into account the conditions set out in subparagraphs 3(1)(a)(i) to (iii).

Period begins again

(4) The 14-day period begins again and the associated requirements continue to apply if, during that 14-day period, the person develops any signs and symptoms of COVID-19, is exposed to another person who exhibits signs and symptoms of COVID-19 or tests positive for COVID-19.

Cessation — daily reporting

(5) The requirement set out in subparagraph (2)(c)(ii) ends if the person reports that they have developed signs and symptoms of COVID-19 or tested positive for COVID-19.

Choice of quarantine facility

5 In choosing a quarantine facility for the purposes of subsection 4(2), the Chief Public Health Officer must consider the following factors:

Non-application — requirement to quarantine

6 Paragraphs 3(1)(a) and (b), subparagraph 3(1)(c)(ii) and section 4 do not apply to

Consultation with Minister of Health

6.1 Conditions that are imposed under paragraph 6(f) must be developed in consultation with the Minister of Health.

Non-application — persons participating in projects

6.2 Paragraphs 3(1)(a) and (b), subparagraph 3(1)(c)(ii) and section 4 do not apply to a person who, under an arrangement entered into between the Minister of Health and the minister responsible for health care in the province where the person enters Canada, is participating in a project to gather information to inform the development of quarantine requirements other than those set out in this Order, if the person complies with any conditions imposed on them by the Minister of Health to minimize the risk of introduction or spread of COVID-19.

Non-application — medical reason

7 (1) Paragraph 3(1)(a) and section 4 do not apply to a person for the duration of any medical emergency or essential medical services or treatments that require the person to visit or be taken to a health care facility that, in the case where the person is in a quarantine facility, is outside that quarantine facility.

Non-application — accompanying person

(1.1) If the person to whom quarantine requirements do not apply by virtue of subsection (1) is a dependent child or requires assistance in accessing medical services or treatments, the exception set out in that subsection extends to one other person who accompanies the dependent child or the person requiring assistance.

Non-application — other cases

(2) The requirements set out in sections 3 and 4 do not apply to a person if

Non-application — compassionate grounds

7.1 (1) Paragraph 3(1)(a) and section 4 do not apply to a person if the Minister of Health

Conditions

(2) The exception in subsection (1) applies if the person

Orders made under Quarantine Act

(3) For the purposes of any order made under section 58 of the Quarantine Act, the non-application of paragraph 3(1)(a) and section 4 under this section is a limited release from quarantine on compassionate grounds.

Non-application — international single sport event

7.2 (1) Paragraphs 3(1)(a) and (b), subparagraph 3(1)(c)(ii) and section 4 do not apply to a person in respect of whom a letter of authorization has been issued under subsection (2) and who enters Canada to take part in an international single sport event as a high-performance athlete or to engage in an essential role in relation to that event, if they are affiliated with a national organization responsible for that sport.

Letter of authorization

(2) The Deputy Minister of Canadian Heritage may, if he or she considers it appropriate, issue a letter of authorization after receiving, from the individual or entity in charge of the international single sport event,

Conditions

(3) The exception in subsection (1) applies if

Consultation with Minister of Health

(4) Conditions that are imposed under paragraph (3)(d) must be developed in consultation with the Minister of Health.

Exception — leaving Canada

8 A person who must quarantine themselves under section 3 or remain in quarantine under section 4 may leave Canada before the expiry of the 14-day period if they quarantine themselves until they depart from Canada.

Symptomatic Persons

Requirements — symptomatic persons

9 Any person who enters Canada and who has reasonable grounds to suspect they have COVID-19, has signs and symptoms of COVID-19 or knows that they have COVID-19 must

Unable to isolate themselves

10 (1) A person referred to in section 9 is considered unable to isolate themselves for the 14-day period referred to in that section if they meet one of the following conditions:

Requirements — isolation at quarantine facility

(2) A person who, at the time of entry to Canada or at any other time during the 14-day period referred to in section 9, is considered unable to isolate themselves must

Change of place

(3) A person referred to in subsection (2) may, with the authorization of a quarantine officer, leave a quarantine facility before the expiry of the 14-day period in order to isolate themselves in accordance with the requirements of section 9 at a place that is considered suitable by the Chief Public Health Officer, taking into account the conditions set out in subparagraphs 9(a)(i) to (iii).

Choice of quarantine facility

11 In choosing a quarantine facility for the purposes of subsection 10(2), the Chief Public Health Officer must consider the following factors:

Non-application — medical reason

12 (1) Paragraph 9(a) and section 10 do not apply to a person for the duration of any medical emergency or essential medical services or treatments that require the person to visit or be taken to a health care facility that, in the case where the person is in a quarantine facility, is outside that quarantine facility.

Non-application — accompanying person

(1.1) If the person to whom isolation requirements do not apply by virtue of subsection (1) is a dependent child, the exception in subsection (1) extends to one other person who accompanies the dependent child.

Non-application — other cases

(2) Sections 9 and 10 do not apply to a person if

Exception — leaving Canada

13 A person who must isolate themselves under section 9 or remain in isolation under section 10 may, at the discretion and in accordance with the instructions of a quarantine officer, leave Canada before the expiry of the 14-day isolation period if they isolate themselves until they depart from Canada in a private conveyance.

Powers and Obligations

Powers and obligations

14 For greater certainty,

Transitional Provision

Entering Canada before November 20, 2020

15 Sections 3, 4, 6, 6.2, 7.1 and 9 and subsection 10(2) of the Minimizing the Risk of Exposure to COVID-19 in Canada Order (Mandatory Isolation), No. 7, as they read immediately before 11:59:59 p.m. Eastern Standard Time on November 20, 2020, continue to apply, after that day and time, to persons who entered Canada before that day and time.

Cessation of Effect

January 21, 2021

16 This Order ceases to have effect at 11:59:59 p.m. Eastern Standard Time on January 21, 2021.

Repeal

Repeal of P.C. 2020-840

17 The Minimizing the Risk of Exposure to COVID-19 in Canada Order (Mandatory Isolation), No. 7footnote 1 is repealed.

Coming into Force

Day order is made

18 This Order comes into force at 11:59:59 p.m. Eastern Standard Time on the day on which it is made.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order in Council, entitled Minimizing the Risk of Exposure to COVID-19 in Canada Order (Mandatory Isolation), No. 8, is made pursuant to section 58 of the Quarantine Act.

The Order repeals and replaces the Order in Council P.C. 2020-840, entitled Minimizing the Risk of Exposure to COVID-19 in Canada Order (Mandatory Isolation), No. 7, which came into force on October 30, 2020.

This Order complements the Orders in Council entitled Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any Country other than the United States) and Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States).

This Order will be in effect from 11:59:59 p.m., Eastern standard time, on the date it is made until 11:59:59 p.m., Eastern standard time, January 21, 2021.

Objective

This Order maintains Canada’s focus on reducing the introduction and further spread of COVID-19 by decreasing the risk of importing cases from outside the country. The Order maintains the previous requirements that all persons who enter Canada, whether by air, land, rail and sea, are required to answer questions to determine if they have signs or symptoms of COVID-19, and, with limited exceptions, quarantine or isolate for 14 days from the day upon which they entered Canada.

The updated Order exempts athletes and support personnel participating in or engaging in certain high-performance international single sport events from the requirement to quarantine under specified conditions.

This Order also removes clauses that are expired, and updates clause references accordingly. In addition, this Order includes minor edits for improved readability, which facilitate understanding without changing the substance of the Order.

Background

COVID-19

COVID-19 is caused by a novel coronavirus capable of causing severe illness, named the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). It is part of a family of viruses that includes Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome coronavirus (SARS-CoV).

COVID-19 was first detected in Wuhan, China, in December 2019. The disease is caused by a new strain of coronavirus never before seen in humans. Therefore, information about the virus, how it causes disease, whom it affects, and how to appropriately treat or prevent illness has been limited and based on best practices approaches to coronaviruses at large. Originally seen to be a local outbreak, COVID-19 has now affected the majority of countries around the globe. The science surrounding the virus is still evolving.

Coronaviruses are spread among humans primarily through the inhalation of infectious respiratory droplets (e.g. when an infected individual coughs or sneezes), and in some situations, through aerosols, created when an infected person coughs, sneezes, sings, shouts, or talks. Coronaviruses are also spread through contact with objects or surfaces contaminated by infectious droplets. Human-to-human transmission is the main driving force of the current COVID-19 outbreak and is exacerbated by a lack of immunity in the general population.

COVID-19 has been clearly demonstrated to be a severe, life-threatening respiratory disease. Patients with COVID-19 present symptoms that may include fever, malaise, dry cough, shortness of breath, and damage to the lungs. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and death. Older individuals and those with a weakened immune system or an underlying medical condition have been seen to be at a higher risk of severe disease. The time from exposure to onset of symptoms is currently estimated to be up to 14 days, with an average of 5 days. Although there have been promising vaccine candidates identified, no vaccine is currently available to protect Canadians from COVID-19. Current treatment is supportive, aimed at relief of symptoms and treatment of associated medical complications.

The World Health Organization (WHO) declared an outbreak of what is now known as COVID-19 to be a Public Health Emergency of International Concern (PHEIC) on January 30, 2020, and a pandemic on March 11, 2020. COVID-19 has demonstrated that it can cause widespread illness if not properly contained. The WHO continues to provide technical guidance and advice to countries for containing the pandemic, including identification of cases and recommendations for measures to prevent further spread. As case numbers continue to rise throughout Canada, there is concern for the domestic capacity to respond to the pandemic. An increase in the number of reported cases in hospitals and intensive care units may overwhelm the health system, further exacerbating the negative health impacts of the virus.

Government of Canada response to COVID-19 pandemic

The Government of Canada’s top priority is the health and safety of Canadians. To limit the introduction and spread of COVID-19 in Canada, the Government of Canada has taken unprecedented action to implement a comprehensive strategy with layers of precautionary measures. Measures include, for example, the establishment of a more than $1 billion COVID-19 Response Fund, restrictions on entry into Canada for optional or discretionary travel, restrictions on cruise ship travel in Canada, and mandatory quarantine and isolation measures to prevent further spread of the virus.

Between February 3, 2020, and November 21, 2020, the Governor in Council has made 34 emergency orders under the Quarantine Act to minimize the risk of exposure to COVID-19 in Canada — to reduce risks from other countries, to repatriate Canadians, and to strengthen measures at the border to reduce the impact of COVID-19 in Canada.

Together, these measures have been effective. By limiting incoming travel to Canada, requiring mandatory quarantine for asymptomatic travellers (with some exceptions) and mandatory isolation for symptomatic travellers, the Government of Canada has reduced the proportion of travel-related COVID-19 infections from greater than 20% in March to less than 3% in all months since April 2020. Canada has also seen a 98% decrease in international arrivals compared to the previous year. While these measures cannot prevent COVID-19 from crossing the borders, they are effective at reducing the risk that community transmission will occur due to international travel.

As the COVID-19 pandemic evolves, the Government of Canada is continuing to evaluate the latest science and situational assessments of what is occurring in jurisdictions across Canada and internationally when considering any changes to border restrictions or border measures. Although domestically Canada saw a decrease in the number of confirmed cases in the summer months, a recent resurgence in case numbers has resulted in many provinces and territories reintroducing public health measures, including lockdowns, to slow the spread of the virus. In jurisdictions where domestic travel restrictions and quarantine requirements remain stringent, such as provinces in the Atlantic region, low case numbers are evidence that such measures limit community transmission of the virus.

At this time, travel continues to present a risk of imported cases and increases the potential for onward community transmission of COVID-19. This is because the global number of cases of COVID-19 is rising at an accelerated pace, with sharp increases in cases in Latin America, Europe, Asia, and the Middle East. The number of cases of COVID-19 in the United States also remains high. The WHO has warned that in many countries, the second wave is already exceeding previous peaks. As of November 15, 2020, there were 10 904 891 detected cases in the United States, 8 814 579 detected cases in India, and 5 848 959 detected cases in Brazil. Canada has seen recent travel-related cases resulting from incoming travellers from India, Mexico and Europe. Domestically, the situation also continues to worsen. For the week of November 16, an average of 4 800 cases was being reported daily, an increase of 15% from the previous week. Several provinces and territories are reintroducing significant lockdown measures to control the spread of the virus and are warning of increasing pressure on health care facilities and long-term care homes. As of November 20, Canada’s case count stood at 320 719, with 52 739 considered active cases.

Based on current review of international experience, broadly easing travel restrictions and mandatory quarantine requirements would continue to present an unacceptable risk of importing cases and increase the potential for onward community transmission of COVID-19. While some countries saw a slight decline in confirmed cases and deaths in the summer months, the easing of lockdown measures and travel restrictions has resulted in a renewed surge in case numbers. As a result, these countries have now reinstated lockdown measures, causing uncertainty for travellers and industry. To avoid a similar outcome, the Government of Canada must proceed cautiously with easing border restrictions.

Adequate scientific support for the role of laboratory testing as part of a multilayered approach to reduce the risk of importation or to ease quarantine measures is not yet available. To reduce the risk of importation, many countries have begun accepting negative test results prior to entry or arrival, or have introduced rapid testing measures for travellers arriving at airports. Further study of such airport testing measures is required to determine how effectively they limit importation and subsequent community transmission. The Government of Canada is working with provincial governments and industry stakeholders to gather data on testing travellers before, at and beyond the border through pilot programs. A recent study with McMaster HealthLabs, supported by the federal government and in partnership with Air Canada and the Greater Toronto Airports Authority, tested 8 600 travellers who arrived at Pearson International Airport between September 3 and October 2; they were also given follow-up tests over the next two weeks. Interim results show that while 99% of travellers tested negative for COVID-19, 1% were found to be positive, with 68.5% of cases detected on the first day, 25.8% on day 7 and 5.6% on day 14. Data gleaned from this and other pilots will inform future approaches to border measures.

Entry prohibitions coupled with mandatory isolation and quarantine remain the most effective means of limiting the introduction of new cases of COVID-19 into Canada. With some countries easing COVID-19 protection measures and the increase of new cases in those countries as a result, the Government of Canada continues to take a precautionary approach by largely maintaining the current border restrictions at this time, with limited exceptions, in an effort to preserve the fragile recovery in Canada.

Changes to international travel restrictions and advice are based on national and international evidence-based risk assessments. The Government recognizes that entry prohibitions and mandatory quarantine requirements place a significant burden on the Canadian economy, Canadians, and their immediate and extended families.

By generally maintaining existing requirements, Canada will continue to reduce the entry of COVID-19 linked to travellers entering Canada to the extent possible. Without these measures, travel-related COVID-19 transmission is likely to increase the number of documented cases in Canada.

Implications

Key impacts for persons entering Canada

As was the case under previous orders, every person who enters Canada must answer any relevant questions asked of them and provide any information or record required, in any manner it may be reasonably requested, for the purposes of administration of this Order. Individuals will continue to be asked to confirm that they have a suitable location in which to either isolate or quarantine, that does not expose them to non-consenting vulnerable persons and provides them with access to the necessities of life.

The Order will continue to require all symptomatic persons who enter Canada to isolate and asymptomatic persons to quarantine for 14 days beginning on the day they enter Canada (subject to extension), with some limited exceptions. All persons who are required to quarantine or isolate must wear a non-medical mask or face covering upon entering Canada and while in transit to their place of 14-day quarantine or isolation, as applicable. Persons who are exempt from quarantine requirements, including those exempted on compassionate grounds, are required to wear a non-medical mask or face covering when they are in public settings when physical distancing is not possible.

The updated Order now exempts certain high-performance athletes and support personnel who are affiliated with the relevant national sports organization, from the requirement to quarantine if they are participating in or engaging in a defined international single sport event. The Deputy Minister of the Department of Canadian Heritage may provide a letter of authorization confirming the exemption status of these high-performance athletes and support personnel for such an event based on information provided by the individual or by the entity in charge of the event. All persons seeking this exemption must have the written authorization prior to entry into Canada and communicate this at the time of arrival into Canada, and must comply with any public health conditions specified in the letter of authorization, which must be developed in consultation with the Minister of Health.

This Order also removes clauses that are expired, and updates clause references accordingly. In addition, this Order includes minor edits for improved readability, which facilitate understanding without changing the substance of the Order.

Penalties

Failure to comply with this Order and other related measures under the Quarantine Act is an offence under the Act. The maximum penalties are a fine of up to $1,000,000 or imprisonment for three years, or both. In addition, fines of up to $1,000 may also be issued for non-compliance pursuant to the Contraventions Act.

Consultation

The Government of Canada has engaged provinces and territories to coordinate efforts and implementation plans. In addition, there has been consultation across multiple government departments, including the Canada Border Services Agency; Immigration, Refugees and Citizenship Canada; Transport Canada; Public Safety and Emergency Preparedness; Health Canada; Canadian Heritage; and Global Affairs Canada, given linkages to departmental mandates and other statutory instruments.

Contact

Kimby Barton
Public Health Agency of Canada
Telephone: 613‑960‑6637
Email: kimby.barton@canada.ca

PUBLIC HEALTH AGENCY OF CANADA

QUARANTINE ACT

Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any Country Other than the United States)

P.C. 2020-966 November 29, 2020

Whereas the Governor in Council is of the opinion, based on the declaration of a pandemic by the World Health Organization, that there is an outbreak of a communicable disease, namely coronavirus disease 2019 (COVID-19), in the majority of foreign countries;

Whereas the Governor in Council is of the opinion that the introduction or spread of the disease would pose an imminent and severe risk to public health in Canada;

Whereas the Governor in Council is of the opinion that the entry of persons into Canada who have recently been in a foreign country may introduce or contribute to the spread of the disease in Canada;

And whereas the Governor in Council is of the opinion that no reasonable alternatives to prevent the introduction or spread of the disease are available;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 58 of the Quarantine Actfootnote c, makes the annexed Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any Country Other than the United States).

Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any Country Other than the United States)

Definitions

1 The following definitions apply in this Order.

Canadian Forces
has the same meaning as in section 2 of the Visiting Forces Act. (Forces canadiennes)
common-law partner
has the same meaning as in subsection 1(1) of the Immigration and Refugee Protection Regulations. (conjoint de fait)
dependent child
has the same meaning as in section 2 of the Immigration and Refugee Protection Regulations. (enfant à charge)
extended family member,
in respect of a person, means
  • (a) an individual who is 18 years of age or older and is in an exclusive dating relationship with the person — who is also 18 years of age or older — and who has been in such a relationship for at least one year and has spent time in the physical presence of the person during the course of the relationship;
  • (b) a dependent child of the person referred to in paragraph (a);
  • (c) a child of the person or of the person’s spouse, common-law partner or the person referred to in paragraph (a) other than a dependent child;
  • (d) a dependent child of the child referred to in paragraph (c);
  • (e) a sibling, half-sibling or step-sibling of the person or of the person’s spouse or common-law partner; or
  • (f) a grandparent of the person or of the person’s spouse or common-law partner. (membre de la famille élargie)
foreign national
has the same meaning as in subsection 2(1) of the Immigration and Refugee Protection Act. (étranger)
immediate family member,
in respect of a person, means
  • (a) the spouse or common-law partner of the person;
  • (b) a dependent child of the person or of the person’s spouse or common-law partner;
  • (c) a dependent child of the dependent child referred to in paragraph (b);
  • (d) the parent or step-parent of the person or of the person’s spouse or common-law partner; or
  • (e) the guardian or tutor of the person. (membre de la famille immédiate)
international single sport event
means an event that is governed by the sport’s International Federation or its regional or continental counterpart, that has a nationally or internationally established qualification process and that is identified as part of the long-term development plans for high-performance national team athletes of the National Sport Organization for that sport. (événement unisport international)
permanent resident
has the same meaning as in subsection 2(1) of the Immigration and Refugee Protection Act. (résident permanent)
protected person
means a protected person within the meaning of subsection 95(2) of the Immigration and Refugee Protection Act. (personne protégée)
study permit
has the same meaning as in section 2 of the Immigration and Refugee Protection Regulations. (permis d’études)
temporary resident
means a temporary resident within the meaning of the Immigration and Refugee Protection Act. (résident temporaire)

Prohibition

2 A foreign national is prohibited from entering Canada if they arrive from any country other than the United States.

Non-application

3 (1) Section 2 does not apply to

Listed institution

(1.1) For the purposes of paragraph (1)(n), a listed institution is an institution that is

Prohibition — signs and symptoms

(2) A foreign national is prohibited from entering Canada from any country other than the United States if they have reasonable grounds to suspect they have COVID-19, if they have signs and symptoms of COVID-19, including a fever and cough or a fever and difficulty breathing, or if they know they have COVID-19.

Prohibition — other orders

(2.1) A foreign national is prohibited from entering Canada from any country other than the United States if, based on the purpose of entry and the length of their stay, they cannot comply with the applicable requirement to quarantine under any order made under section 58 of the Quarantine Act.

Prohibition — optional or discretionary purpose

(3) A foreign national is prohibited from entering Canada from any country other than the United States if they seek to enter for an optional or discretionary purpose, such as tourism, recreation or entertainment.

Non-application — immediate or extended family member

(4) Subsection (3) does not apply to a foreign national who is an immediate family member or extended family member of a Canadian citizen, permanent resident or person registered as an Indian under the Indian Act if the foreign national intends to enter Canada to be with the Canadian citizen, permanent resident or person registered as an Indian and can demonstrate their intent to stay in Canada for a period of at least 15 days.

Non-application — national interest

(5) Subsection (3) does not apply to a foreign national referred to in paragraph (1)(k).

Non-application — compassionate grounds

3.1 Section 2 and subsections 3(2.1) and (3) do not apply to a foreign national if

Non-application — sports

3.2 (1) Section 2 and subsection 3(3) do not apply to a foreign national who is authorized by a letter issued under subsection (2) to enter Canada as a high-performance athlete taking part in or a person engaging in an essential role in relation to an international single sport event, if the athlete or the person is affiliated with a national organization responsible for that sport.

Letter of authorization

(2) The Deputy Minister of Canadian Heritage may, if he or she considers it appropriate, issue a letter of authorization to enter Canada after receiving, from the individual or entity in charge of an international single sport event,

Cancellation or withdrawal of support

(3) Despite subsection (1), a foreign national is prohibited from entering Canada from any country other than the United States to take part in an international single sport event if the Deputy Minister of Canadian Heritage withdraws the letter of authorization for one of the following reasons:

Non-application — order

4 This Order does not apply to

Powers and obligations

5 For greater certainty, this Order does not affect any of the powers and obligations set out in the Quarantine Act.

Repeal

6 The Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any Country Other than the United States)footnote 2 is repealed.

Effective period

7 This Order has effect for the period beginning at 11:59:59 p.m. Eastern Standard Time on the day on which it is made and ending at 11:59:59 p.m. Eastern Standard Time on January 21, 2021.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order in Council, entitled Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any country other than the United States), is made pursuant to section 58 of the Quarantine Act.

The Order repeals and replaces Order in Council P.C. 2020-839 of the same name, which came into force on October 30, 2020.

The new Order complements any Order made under the Quarantine Act imposing isolation or quarantine requirements upon entry into Canada.

This Order will be in effect from 11:59:59 p.m., Eastern standard time, on the date it is made, until 11:59:59 p.m., Eastern standard time, January 21, 2021.

Objective

This Order maintains Canada’s focus on reducing the introduction and further spread of COVID-19 by decreasing the risk of importing cases from outside the country. The Order generally continues to prohibit entry into Canada of foreign nationals arriving from countries other than the United States unless they meet a specified list of exemptions. Even those who are exempted from the general prohibition may not enter if they have COVID-19, or if they exhibit signs and symptoms of COVID-19.

The updated Order clarifies the definition of extended family member in an exclusive dating relationship to specify that both persons in the relationship must be 18 years of age or older.

The updated Order also exempts foreign national athletes and support personnel participating or engaging in certain high-performance international single sport events from the prohibition on entry.

This Order also removes clauses that are expired, and updates clause references accordingly. In addition, this Order includes minor edits for improved readability, which facilitate understanding without changing the substance of the Order.

Background

COVID-19

COVID-19 is caused by a novel coronavirus capable of causing severe illness, named the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). It is part of a family of viruses that includes Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome coronavirus (SARS-CoV).

COVID-19 was first detected in Wuhan, China, in December 2019. The disease is caused by a new strain of coronavirus never before seen in humans. Therefore, information about the virus, how it causes disease, whom it affects, and how to appropriately treat or prevent illness has been limited and based on best practices approaches to coronaviruses at large. Originally seen to be a local outbreak, COVID-19 has now affected the majority of countries around the globe. The science surrounding the virus is still evolving.

Coronaviruses are spread among humans primarily through the inhalation of infectious respiratory droplets (e.g. when an infected individual coughs or sneezes), and in some situations, through aerosols, created when an infected person coughs, sneezes, sings, shouts, or talks. Coronaviruses are also spread through contact with objects or surfaces contaminated by infectious droplets. Human-to-human transmission is the main driving force of the current COVID-19 outbreak and is exacerbated by a lack of immunity in the general population.

COVID-19 has been clearly demonstrated to be a severe, life-threatening respiratory disease. Patients with COVID-19 present symptoms that may include fever, malaise, dry cough, shortness of breath, and damage to the lungs. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and death. Older individuals and those with a weakened immune system or an underlying medical condition have been seen to be at a higher risk of severe disease. The time from exposure to onset of symptoms is currently estimated to be up to 14 days, with an average of 5 days. Although there have been promising vaccine candidates identified, no vaccine is currently available to protect Canadians from COVID-19. Current treatment is supportive, aimed at relief of symptoms and treatment of associated medical complications.

The World Health Organization (WHO) declared an outbreak of what is now known as COVID-19 to be a Public Health Emergency of International Concern (PHEIC) on January 30, 2020, and a pandemic on March 11, 2020. COVID-19 has demonstrated that it can cause widespread illness if not properly contained. The WHO continues to provide technical guidance and advice to countries for containing the pandemic, including identification of cases and recommendations for measures to prevent further spread. As case numbers continue to rise throughout Canada, there is concern for the domestic capacity to respond to the pandemic. An increase in the number of reported cases in hospitals and intensive care units may overwhelm the health system, further exacerbating the negative health impacts of the virus.

Government of Canada response to COVID-19 pandemic

The Government of Canada’s top priority is the health and safety of Canadians. To limit the introduction and spread of COVID-19 in Canada, the Government of Canada continues to take unprecedented action to implement a comprehensive strategy with layers of precautionary measures. Measures include restrictions on entry into Canada for optional or discretionary travel, restrictions on cruise ship travel in Canada, and mandatory quarantine and isolation measures to prevent further spread of the virus.

Between February 3, 2020, and November 21, 2020, the Governor in Council has made 34 emergency orders under the Quarantine Act to minimize the risk of exposure to COVID-19 in Canada — to reduce risks from other countries, to repatriate Canadians, and to strengthen measures at the border to reduce the impact of COVID-19 in Canada.

Together, these measures have been effective. By limiting incoming travel to Canada, requiring mandatory quarantine for asymptomatic travellers (with some exceptions) and mandatory isolation for symptomatic travellers, the Government of Canada has reduced the proportion of travel-related COVID-19 infections from greater than 20% in March to less than 3% in all months since April 2020. Canada has also seen a 98% decrease in international arrivals compared to the previous year. While these measures cannot prevent COVID-19 from crossing the borders, they are effective at reducing the risk that community transmission will occur due to international travel.

As the COVID-19 pandemic evolves, the Government of Canada is continuing to evaluate the latest science and situational assessments of what is occurring in jurisdictions across Canada and internationally when considering any changes to border restrictions or border measures. Although domestically Canada saw a decrease in the number of confirmed cases in the summer months, a recent resurgence in case numbers has resulted in many provinces and territories reintroducing public health measures, including lockdowns, to slow the spread of the virus. In jurisdictions where domestic travel restrictions and quarantine requirements remain stringent, such as provinces in the Atlantic region, low case numbers are evidence that such measures limit community transmission of the virus.

At this time, travel continues to present a risk of imported cases and increases the potential for onward community transmission of COVID-19. This is because the global number of cases of COVID-19 is rising at an accelerated pace, with sharp increases in cases in Latin America, Europe, Asia and the Middle East. The number of cases of COVID-19 in the United States also remains high.

The WHO has warned that in many countries, the second wave is already exceeding previous peaks. As of November 15, 2020, there were 10 904 891 detected cases in the United States, 8 814 579 detected cases in India, and 5 848 959 detected cases in Brazil. Canada has seen recent travel-related cases resulting from incoming travellers from India, Mexico and Europe. Domestically, the situation also continues to worsen. For the week of November 16, an average of 4 800 cases was being reported daily, an increase of 15% from the previous week. Several provinces and territories are reintroducing significant lockdown measures to control the spread of the virus and are warning of increasing pressure on health care facilities and long-term care homes. As of November 20, Canada’s case count stood at 320 719, with 52 739 considered active cases. Based on current review of international experience, broadly lifting travel restrictions would present an unacceptable risk of importing cases and increasing the potential for onward community transmission of COVID-19.

The Government has been considering easing restrictions on travel from countries identified as low risk as part of its COVID-19 recovery planning, but currently there is no internationally accepted standard for assessing a country’s COVID-19 risk. Many countries, including the United Kingdom, Italy, and other G7/G20 allies, have adopted a tiered country-risk classification system in an attempt to ease travel restrictions. Such an approach applies testing requirements and quarantine restrictions to travellers from countries ranked through a risk-based analysis. However, with rates of COVID-19 infection in constant flux, travel corridors and entry requirements remain dynamic, subject to change, and generally unstable. While some countries saw a slight decline in confirmed cases and deaths in the summer months, the easing of lockdown measures and travel restrictions has resulted in a renewed surge in case numbers. Some countries that were believed to have controlled the outbreak, including France, Germany and Italy, are starting to see a resurgence in cases. As a result, these countries have now reinstated lockdown measures, causing uncertainty for travellers and industry. To avoid a similar outcome, the Government of Canada must proceed cautiously with easing border restrictions.

Adequate scientific support for the role of laboratory testing as part of a multilayered approach to reduce the risk of importation or to ease quarantine measures is not yet available. To reduce the risk of importation, many countries have begun accepting negative test results prior to entry or arrival, or have introduced rapid testing measures for travellers arriving at airports. Further study of such airport testing measures is required to determine how effectively they limit importation and subsequent community transmission. The Government of Canada is working with provincial governments and industry stakeholders to gather data on testing travellers before, at and beyond the border through pilot programs. A recent study with McMaster HealthLabs, supported by the federal government and in partnership with Air Canada and the Greater Toronto Airports Authority, tested 8 600 travellers who arrived at Pearson International Airport between September 3 and October 2; they were also given follow-up tests over the next two weeks. Interim results show that while 99% of travellers tested negative for COVID-19, 1% were found to be positive, with 68.5% of cases detected on the first day, 25.8% on day 7 and 5.6% on day 14. Data gleaned from this and other pilot programs will inform future approaches to border measures.

Changes to international travel restrictions and advice are based on national and international evidence-based risk assessments. The Government recognizes that entry prohibitions and mandatory quarantine requirements place a significant burden on the Canadian economy, Canadians, and their immediate and extended families. Entry prohibitions coupled with mandatory isolation and quarantine remain the most effective means of limiting the introduction of new cases of COVID-19 into Canada. With some countries easing COVID-19 protection measures and the increase of new cases in those countries as a result, the Government of Canada continues to take a precautionary approach by largely maintaining the current border restrictions at this time, with limited exceptions, in an effort to preserve the fragile recovery in Canada.

Implications

Key impacts for travellers

By limiting the number of incoming foreign nationals, Canada has taken strict border measures to limit the risk of the introduction or spread of COVID-19 transmitted via travellers from foreign countries, while maintaining critical services and support necessary for Canada.

This Order will continue to generally prohibit foreign nationals from entering Canada from countries other than the United States, unless they meet a specified list of exemptions and are entering for specified permitted purposes. Foreign nationals travelling for any purpose will continue to be denied entry into Canada if they have COVID-19, have reasonable grounds to suspect they have COVID-19 or are exhibiting signs and symptoms of COVID-19, subject to certain narrow exceptions. The enforcement of the prohibition on entry for foreign nationals who arrive exhibiting COVID-19 symptoms, despite having appeared healthy prior to boarding an aircraft or vessel, may be deferred to the extent required to maintain public health and ensure the safety of the commercial transportation system.

The updated Order clarifies the definition of extended family member in an exclusive dating relationship to state that both parties in the relationship must be 18 years of age or older, while maintaining the other requirements, including having been in the relationship for at least one year, and having spent time in the physical presence of each other during the course of the relationship.

The updated Order exempts foreign national athletes and support personnel participating in or engaging in certain high-performance sports or activities from the prohibition on entry. Specifically, this Order introduces new provisions to exempt authorized high-performance athletes, as well as certain support personnel, who are affiliated with the relevant national sports organization from the prohibition on entry if they are participating in or engaging in a defined international single sport event. The Deputy Minister of the Department of Canadian Heritage may provide a letter of authorization confirming the exemption status of high-performance athletes and supporting personnel who will be participating or engaging in a high-performance sporting activity as outlined above based on information provided for consideration, including confirmation of support from the province or territory and the local public health authority where the activity will occur. Foreign nationals must have the written authorization prior to entry into Canada.

This Order also removes clauses that are expired, and updates clause references accordingly. In addition, this Order includes minor edits for improved readability, which facilitate understanding without changing the substance of the Order.

The Government of Canada recognizes that the ongoing general restrictions on entry into Canada have significantly impacted the Canadian economy. However, the measures taken by the Government of Canada continue to be necessary to address the serious health threat posed by COVID-19.

Penalties

Failure to comply with this Order and other related measures under the Quarantine Act is an offence under the Act. The maximum penalties are a fine of up to $1,000,000 or imprisonment for three years, or both. Non-compliance is also subject to fines under the federal Contraventions Act.

Consultation

The Government of Canada has engaged provinces and territories to coordinate efforts and implementation plans. In addition, there has been consultation across multiple government departments, including the Canada Border Services Agency; Immigration, Refugees and Citizenship Canada; Transport Canada; Public Safety Canada; Canadian Heritage; and Global Affairs Canada given linkages to departmental mandates and other statutory instruments.

Contact

Kimby Barton
Public Health Agency of Canada
Telephone: 613‑960‑6637
Email: kimby.barton@canada.ca

PUBLIC HEALTH AGENCY OF CANADA

QUARANTINE ACT

Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States)

P.C. 2020-968 November 29, 2020

Whereas the Governor in Council is of the opinion, based on the declaration of a pandemic by the World Health Organization, that there is an outbreak of a communicable disease, namely coronavirus disease 2019 (COVID-19), in the majority of foreign countries;

Whereas the Governor in Council is of the opinion that the introduction or spread of the disease would pose an imminent and severe risk to public health in Canada;

Whereas the Governor in Council is of the opinion that the entry of persons into Canada who have recently been in a foreign country may introduce or contribute to the spread of the disease in Canada;

And whereas the Governor in Council is of the opinion that no reasonable alternatives to prevent the introduction or spread of the disease are available;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 58 of the Quarantine Actfootnote c, makes the annexed Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States).

Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States)

Definitions

1 The following definitions apply in this Order.

common-law partner
has the same meaning as in subsection 1(1) of the Immigration and Refugee Protection Regulations. (conjoint de fait)
dependent child
has the same meaning as in section 2 of the Immigration and Refugee Protection Regulations. (enfant à charge)
extended family member,
in respect of a person, means
  • (a) an individual who is 18 years of age or older and is in an exclusive dating relationship with the person — who is also 18 years of age or older — and who has been in such a relationship for at least one year and has spent time in the physical presence of the person during the course of the relationship;
  • (b) a dependent child of the person referred to in paragraph (a);
  • (c) a child of the person or of the person’s spouse, common-law partner or the person referred to in paragraph (a) other than a dependent child;
  • (d) a dependent child of the child referred to in paragraph (c);
  • (e) a sibling, half-sibling or step-sibling of the person or of the person’s spouse or common-law partner; or
  • (f) a grandparent of the person or of the person’s spouse or common-law partner. (membre de la famille élargie)
foreign national
has the same meaning as in subsection 2(1) of the Immigration and Refugee Protection Act. (étranger)
immediate family member,
in respect of a person, means
  • (a) the spouse or common-law partner of the person;
  • (b) a dependent child of the person or of the person’s spouse or common-law partner;
  • (c) a dependent child of the dependent child referred to in paragraph (b);
  • (d) the parent or step-parent of the person or of the person’s spouse or common-law partner; or
  • (e) the guardian or tutor of the person. (membre de la famille immédiate)
international single sport event
means an event that is governed by the sport’s International Federation or its regional or continental counterpart, that has a nationally or internationally established qualification process and that is identified as part of the long-term development plans for high-performance national team athletes of the National Sport Organization for that sport. (événement unisport international)
permanent resident
has the same meaning as in subsection 2(1) of the Immigration and Refugee Protection Act. (résident permanent)
protected person
means a protected person within the meaning of subsection 95(2) of the Immigration and Refugee Protection Act. (personne protégée)
study permit
has the same meaning as in section 2 of the Immigration and Refugee Protection Regulations. (permis d’études)
temporary resident
means a temporary resident within the meaning of the Immigration and Refugee Protection Act. (résident temporaire)

Prohibition — signs and symptoms

2 (1) A foreign national is prohibited from entering Canada from the United States if they have reasonable grounds to suspect they have COVID-19, if they have signs and symptoms of COVID-19, including a fever and cough or a fever and difficulty breathing, or if they know they have COVID-19.

Non-application — certain persons

(2) Subsection (1) does not apply to persons referred to in subsection 5(1) or (2) who seek to enter Canada from the United States for the purpose of making a claim for refugee protection.

Prohibition — optional or discretionary purpose

3 (1) A foreign national is prohibited from entering Canada from the United States if they seek to enter for an optional or discretionary purpose, such as tourism, recreation or entertainment.

Non-application — immediate family member

(2) Subsection (1) does not apply to a foreign national who is an immediate family member of a Canadian citizen, permanent resident or person registered as an Indian under the Indian Act if the foreign national intends to enter Canada to be with the Canadian citizen, permanent resident or person registered as an Indian and can demonstrate their intent to stay in Canada for a period of at least 15 days.

Non-application — extended family member

(3) Subsection (1) does not apply to a foreign national who is an extended family member of a Canadian citizen, permanent resident or person registered as an Indian under the Indian Act if the foreign national

Prohibition — extended family member

3.1 A foreign national who is an extended family member of a Canadian citizen, permanent resident or person registered as an Indian under the Indian Act and who intends to enter Canada to be with the Canadian citizen, permanent resident or person registered as an Indian is prohibited from entering Canada from the United States unless the foreign national

Prohibition — other orders

4 (1) A foreign national is prohibited from entering Canada from the United States if, based on the purpose of entry and the length of their stay, they cannot comply with the applicable requirement to quarantine under any order made under section 58 of the Quarantine Act.

Non-application — certain persons

(2) Subsection (1) does not apply to persons referred to in subsections 5(1) or (2) who seek to enter Canada from the United States for the purpose of making a claim for refugee protection.

Prohibition — claim for refugee protection

5 (1) A foreign national is prohibited from entering Canada from the United States for the purpose of making a claim for refugee protection unless the person

Non-application — certain persons

(2) Subsection (1) does not apply to the following persons who seek to enter Canada at any place referred to in paragraph 159.4(1)(a), (b) or (c) of the Immigration and Refugee Protection Regulations:

Prohibition — international students

5.1 (1) A foreign national is prohibited from entering Canada from the United States for the purpose of attending an institution other than a listed institution.

Prohibition — listed institution

(1.1) A foreign national is prohibited from entering Canada from the United States for the purpose of attending a listed institution unless they are

Listed institution

(2) For the purposes of subsections (1) and (1.1), a listed institution is an institution that is

Non-application — compassionate grounds

5.2 Subsection 3(1), section 3.1 and subsection 4(1) do not apply to a foreign national if

Non-application — sports

5.3 (1) Subsection 3(1) does not apply to a foreign national who is authorized by a letter issued under subsection (2) to enter Canada as a high-performance athlete taking part in or a person engaging in an essential role in relation to an international single sport event, if the athlete or the person is affiliated with a national organization responsible for that sport.

Letter of authorization

(2) The Deputy Minister of Canadian Heritage may, if he or she considers it appropriate, issue a letter of authorization to enter Canada after receiving, from the individual or entity in charge of an international single sport event,

Cancellation or withdrawal of support

(3) Despite subsection (1), a foreign national is prohibited from entering Canada from the United States to take part in an international single sport event if the Deputy Minister of Canadian Heritage withdraws the letter of authorization for one of the following reasons:

Non-application — order

6 This Order does not apply to

Powers and obligations

7 For greater certainty, this Order does not affect any of the powers and obligations set out in the Quarantine Act.

Repeal

8 The Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States)footnote 3 is repealed.

Effective period

9 This Order has effect for the period beginning at 11:59:59 p.m. Eastern Standard Time on the day on which it is made and ending at 11:59:59 p.m. Eastern Standard Time on December 21, 2020.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order in Council, entitled Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States), is made pursuant to section 58 of the Quarantine Act.

The Order repeals and replaces Order in Council P.C. 2020-886 of the same name, which came into force on November 21, 2020.

The new Order complements any Order made under the Quarantine Act imposing isolation or quarantine requirements upon entry into Canada.

This Order will be in effect from 11:59:59 p.m., Eastern standard time, on the date it is made until 11:59:59 p.m., Eastern standard time, December 21, 2020.

Objective

This Order maintains Canada’s focus on reducing the introduction and spread of COVID-19 by decreasing the risk of importing cases from outside the country. The Order continues to prohibit entry into Canada of foreign nationals arriving from the United States for an optional or discretionary purpose, with some limited exceptions. Even those who are exempted from the prohibition may not enter if they have COVID-19, or if they exhibit signs and symptoms of COVID-19.

The updated Order clarifies the definition of extended family member in an exclusive dating relationship to specify that both persons in the relationship must be 18 years of age or older.

The updated Order also exempts foreign national athletes and support personnel participating in or engaging in certain high-performance international single sport events from the prohibition on entry.

The updated Order now denies entry to any foreign national enrolled in a learning program unless they hold or may hold a valid study permit, and their institution is a listed institution that has been determined to meet public health readiness requirements.

The Order also includes minor edits for improved readability, which facilitate understanding without changing the substance of the Order.

Background

COVID-19

COVID-19 is caused by a novel coronavirus capable of causing severe illness, named the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). It is part of a family of viruses that includes Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome coronavirus (SARS-CoV).

COVID-19 was first detected in Wuhan, China, in December 2019. The disease is caused by a new strain of coronavirus never before seen in humans. Therefore, information about the virus, how it causes disease, whom it affects, and how to appropriately treat or prevent illness has been limited and based on best practices approaches to coronaviruses at large. Originally seen to be a local outbreak, COVID-19 has now affected the majority of countries around the globe. The science surrounding the virus is still evolving.

Coronaviruses are spread among humans primarily through the inhalation of infectious respiratory droplets (e.g. when an infected individual coughs or sneezes), and in some situations, through aerosols, created when an infected person coughs, sneezes, sings, shouts, or talks. Coronaviruses are also spread through contact with objects or surfaces contaminated by infectious droplets. Human-to-human transmission is the main driving force of the current COVID-19 outbreak and is exacerbated by a lack of immunity in the general population.

COVID-19 has been clearly demonstrated to be a severe, life-threatening respiratory disease. Patients with COVID-19 present symptoms that may include fever, malaise, dry cough, shortness of breath, and damage to the lungs. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and death. Older individuals and those with a weakened immune system or an underlying medical condition have been seen to be at a higher risk of severe disease. The time from exposure to onset of symptoms is currently estimated to be up to 14 days, with an average of 5 days. Although there have been promising vaccine candidates identified, no vaccine is currently available to protect Canadians from COVID-19. Current treatment is supportive, aimed at relief of symptoms and treatment of associated medical complications.

The World Health Organization (WHO) declared an outbreak of what is now known as COVID-19 to be a Public Health Emergency of International Concern (PHEIC) on January 30, 2020, and a pandemic on March 11, 2020. COVID-19 has demonstrated that it can cause widespread illness if not properly contained. The WHO continues to provide technical guidance and advice to countries for containing the pandemic, including identification of cases and recommendations for measures to prevent further spread. As case numbers continue to rise throughout Canada, there is concern for the domestic capacity to respond to the pandemic. An increase in the number of reported cases in hospitals and intensive care units may overwhelm the health system, further exacerbating the negative health impacts of the virus.

Government of Canada response to COVID-19 pandemic

The Government of Canada’s top priority is the health and safety of Canadians. To limit the introduction and spread of COVID-19 in Canada, the Government of Canada continues to take unprecedented action to implement a comprehensive strategy with layers of precautionary measures. Measures include restrictions on entry into Canada for optional or discretionary travel, restrictions on cruise ship travel in Canada, and mandatory quarantine and isolation measures to prevent further spread of the virus.

Between February 3, 2020, and November 21, 2020, the Governor in Council has made 34 emergency orders under the Quarantine Act to minimize the risk of exposure to COVID-19 in Canada — to reduce risks from other countries, to repatriate Canadians, and to strengthen measures at the border to reduce the impact of COVID-19 in Canada.

Together, these measures have been effective. By limiting incoming travel to Canada, requiring mandatory quarantine for asymptomatic travellers (with some exceptions) and mandatory isolation for symptomatic travellers, the Government of Canada has reduced the proportion of travel-related COVID-19 infections from greater than 20% in March to less than 3% in all months since April 2020. Canada has also seen a 98% decrease in international arrivals compared to the previous year. While these measures cannot prevent COVID-19 from crossing the borders, they are effective at reducing the risk that community transmission will occur due to international travel.

As the COVID-19 pandemic evolves, the Government of Canada is continuing to evaluate the latest science and situational assessments of what is occurring in jurisdictions across Canada and internationally when considering any changes to border restrictions or border measures. Although domestically Canada saw a decrease in the number of confirmed cases in the summer months, a recent resurgence in case numbers has resulted in many provinces and territories reintroducing public health measures, including lockdowns, to slow the spread of the virus. In jurisdictions where domestic travel restrictions and quarantine requirements remain stringent, such as provinces in the Atlantic region, low case numbers are evidence that such measures limit community transmission of the virus.

At this time, travel continues to present a risk of imported cases and increases the potential for onward community transmission of COVID-19. Canada continues to have a Level 3 travel health notice for all countries, including the United States, advising Canadians to avoid non-essential travel outside Canada. This is because the global number of cases of COVID-19 is rising at an accelerated pace, with sharp increases in cases in Latin America, Europe, Asia and the Middle East. The number of cases of COVID-19 in the United States also remains high.

The WHO has warned that in many countries, the second wave is already exceeding previous peaks. As of November 15, 2020, there were 10 904 891 detected cases in the United States, 8 814 579 detected cases in India, and 5 848 959 detected cases in Brazil. Domestically, the situation also continues to worsen. For the week of November 16, an average of 4 800 cases was being reported daily, an increase of 15% from the previous week. Several provinces and territories are reintroducing significant lockdown measures to control the spread of the virus and are warning of increasing pressure on health care facilities and long-term care homes. As of November 20, Canada’s case count stood at 320 719, with 52 739 considered active cases. In September 2020, of the travel-related cases identified in Canada for which a country of origin is identified, 23% of cases were attributed to travellers from the United States. Data current to November 15, 2020, shows the United States reporting the highest number of confirmed cases and deaths of all reporting countries. Therefore, there remains significant potential for a resurgence of travel-related cases in Canada if the border restrictions between the United States and Canada were to be broadly lifted at this time.

The Government has been considering easing restrictions on travel from countries identified as low risk as part of its COVID-19 recovery planning, but currently there is no internationally accepted standard for establishing travel thresholds or assessing a country’s COVID-19 risk. Many countries, including the United Kingdom, Italy and other G7/G20 allies, have adopted a tiered country-risk classification system in an attempt to ease travel restrictions. Such an approach applies testing requirements and quarantine restrictions to travellers from countries ranked through a risk-based analysis. However, with rates of COVID-19 infection in constant flux, travel corridors and entry requirements remain dynamic, subject to change, and generally unstable. While some countries saw a slight decline in confirmed cases and deaths in the summer months, the easing of lockdown measures and travel restrictions has resulted in a renewed surge in case numbers. As a result, these countries have now reinstated lockdown measures, causing uncertainty for travellers and industry. To avoid a similar outcome, the Government of Canada must proceed cautiously with easing border restrictions.

Adequate scientific support for the role of laboratory testing as part of a multilayered approach to reduce the risk of importation or to ease quarantine measures is not yet available. To reduce the risk of importation, many countries have begun accepting negative test results prior to entry or arrival, or have introduced rapid testing measures for travellers arriving at airports. As of September 30, some U.S. airlines announced plans to begin pre-flight testing at a cost (US$80–US$250) to passengers. Further study of such airport testing measures is required to determine how effectively they limit importation and subsequent community transmission. The Government of Canada is working with provincial governments and industry stakeholders to gather data on testing travellers before, at and beyond the border through pilot programs. A recent study with McMaster HealthLabs, supported by the federal government and in partnership with Air Canada and the Greater Toronto Airports Authority, tested 8 600 travellers who arrived at Pearson International Airport between September 3 and October 2; they were also given follow-up tests over the next two weeks. Interim results show that while 99% of travellers tested negative for COVID-19, 1% were found to be positive, with 68.5% of cases detected on the first day, 25.8% on day 7 and 5.6% on day 14. Data gleaned from this and other pilot programs will inform future approaches to border measures.

Changes to international travel restrictions and advice are based on national and international evidence-based risk assessments. The Government recognizes that entry prohibitions and mandatory quarantine requirements place a significant burden on the Canadian economy, Canadians, and their immediate and extended families. Entry prohibitions coupled with mandatory isolation and quarantine remain the most effective means of limiting the introduction of new cases of COVID-19 into Canada. With some countries easing COVID-19 protection measures and the increase of new cases in those countries as a result, the Government of Canada continues to take a precautionary approach by largely maintaining the current border restrictions at this time, with limited exceptions, in an effort to preserve the fragile recovery in Canada.

Implications

Key impacts for travellers

By limiting the number of incoming foreign nationals, Canada has taken strict border measures to limit the risk of the introduction or spread of COVID-19 transmitted via travellers from foreign countries, while maintaining critical services and support necessary for Canada.

This Order will continue to generally prohibit foreign nationals from entering Canada from the United States, unless they are entering for non-optional or non-discretionary purposes or other specified permitted purposes. Foreign nationals travelling for any purpose will continue to be denied entry into Canada if they have COVID-19, have reasonable grounds to suspect they have COVID-19 or are exhibiting signs and symptoms of COVID-19, subject to certain narrow exceptions. The enforcement of the prohibition on entry for foreign nationals who arrive exhibiting COVID-19 symptoms, despite having appeared healthy prior to boarding an aircraft or vessel, may be deferred to the extent required to maintain public health and ensure the safety of the commercial transportation system.

The updated Order clarifies the definition of extended family member in an exclusive dating relationship to state that both parties in the relationship must be 18 years of age or older, while maintaining the other requirements, including having been in the relationship for at least one year, and having spent time in the physical presence of each other during the course of the relationship.

The updated Order exempts foreign national athletes and support personnel participating in or engaging in certain high-performance sports or activities from the prohibition on entry. Specifically, this Order introduces new provisions to exempt authorized high-performance athletes, as well as certain support personnel, who are affiliated with the relevant national sports organization from the prohibition on entry if they are participating in or engaging in a defined international single sport event. The Deputy Minister of the Department of Canadian Heritage may provide a letter of authorization confirming the exemption status of high-performance athletes and supporting personnel who will be participating in or engaging in a high-performance sporting activity as outlined above based on information provided for consideration, including confirmation of support from the province or territory and the local public health authority where the activity will occur. Foreign nationals must have the written authorization prior to entry into Canada.

The updated Order now denies entry to any foreign national enrolled in a learning program unless they hold or may hold a valid study permit, and their institution is a listed institution that has been determined to meet public health readiness requirements. The intent of this amendment is to prohibit international students from entering the country for fewer than six months unless their institution is a listed institution.

The Order also includes minor edits for improved readability, which facilitate understanding without changing the substance of the Order.

The Government of Canada recognizes that the ongoing general restrictions on entry into Canada have significantly impacted the Canadian economy. However, the measures taken by the Government of Canada continue to be necessary to address the serious health threat posed by COVID-19.

Penalties

Failure to comply with this Order and other related measures under the Quarantine Act is an offence under the Act. The maximum penalties are a fine of up to $1,000,000 or imprisonment for three years, or both. Non-compliance is also subject to fines under the federal Contraventions Act.

Consultation

The Government of Canada has engaged provinces and territories to coordinate efforts and implementation plans. In addition, there has been consultation across multiple government departments, including the Canada Border Services Agency; Immigration, Refugees and Citizenship Canada; Transport Canada; Public Safety and Emergency Preparedness; Canadian Heritage; and Global Affairs Canada given linkages to departmental mandates and other statutory instruments.

Contact

Kimby Barton
Public Health Agency of Canada
Telephone: 613‑960‑6637
Email: kimby.barton@canada.ca