Highlights

  • Canada’s Minister of Finance has updated the Customs Tariff descriptions for clarity and alignment with current standards, without affecting duty rates.
  • Health Canada has introduced fees for certain COVID-19 medical devices no longer deemed urgent, with fee reductions for small businesses.
  • Beausoleil First Nation will conduct elections under the First Nations Elections Act, enhancing governance autonomy.
  • Frog Lake First Nations has adopted its own election code, moving away from the Indian Act’s regime to strengthen self-determination.
  • Canada has banned the manufacture and import of lead wheel weights to protect health and the environment, with alternatives being considered.
  • Permanent regulations for COVID-19 medical devices have been established, continuing expedited authorization pathways from an interim order.
  • New regulations allow health officials to access unauthorized drugs during emergencies, streamlining procurement and distribution.
  • Canada has updated sanctions against Myanmar and Russia, targeting military officials and entities involved in disinformation, respectively.
  • Amendments to the Species at Risk Act have been made, adding and reclassifying species to ensure their protection and support recovery efforts.

Canada Updates Customs Tariff Schedule for Clarity and Current Terminology Compliance

The Minister of Finance of Canada has issued an order to amend the Schedule to the Customs Tariff, which involves updating descriptions of goods in both English and French to reflect current terminology and ensure clarity for importers. The amendments include changes to align with gender-based analysis plus (GBA+) guidelines, correct punctuation, and update to new industry standards. The changes are technical and do not affect customs duty rates. The updates were made in consultation with the Canada Border Services Agency (CBSA) and Statistics Canada, and they were not prepublished as they are routine and technical. The updates are not expected to have any adverse impacts on Indigenous rights or modern treaty obligations. The amendments are designed to benefit the trading community by providing clearer and more accurate terminology for the classification of goods, with no additional costs or changes in tariff policy. The CBSA will oversee the implementation and ensure compliance with the updated tariff schedule. [Source]

Canada Implements Fees for Non-Urgent COVID-19 Medical Device Authorizations and Sales

The Canadian Minister of Health has amended the Fees in Respect of Drugs and Medical Devices Order to include fees for COVID-19 medical devices that are no longer considered to be for an urgent public health need (UPHN). The amendments specify that fees will be charged for the examination of applications to amend an authorization for Class II, III, or IV COVID-19 medical devices that are not UPHN devices, as well as for the annual right to sell such devices.

The amendments to the Fees Order are in response to the evolving situation of the COVID-19 pandemic, where the demand for certain medical devices is stabilizing, and the need to incentivize manufacturers with fee exemptions is decreasing. As a result, once a COVID-19 medical device is removed from the UPHN list, the manufacturer will be subject to fees for any amendments to the device’s authorization and an annual fee for the right to sell the device.

Class I COVID-19 medical devices will continue to be exempt from the requirement to hold a Medical Device Establishment Licence (MDEL) and associated fees until they are no longer on the UPHN list. At that point, standard MDEL requirements and fees will apply.

The amendments also include provisions for small business fee mitigation, offering a 25% reduction on annual right to sell fees and a 50% reduction on examination fees for amendments. Performance standards and penalties as per the existing Fees Order will apply.

The changes to the Fees Order will take effect on the same day as the amendments to the Medical Devices Regulations related to COVID-19 medical devices come into force. Health Canada conducted a consultation process, including a public consultation and engagement with medical device stakeholders and associations, and no significant concerns were raised about the fee amendments. The amendments are not part of any formal regulatory cooperation forum and do not have any identified gender-based analysis plus impacts. Forms and webpages will be updated to reflect the changes, and existing performance standards will continue to apply. [Source]

Beausoleil First Nation to Hold Elections Under First Nations Elections Act

The Beausoleil First Nation’s council passed a resolution requesting their inclusion in the schedule to the First Nations Elections Act. In response, the Minister of Indigenous Services has issued an order to add Beausoleil First Nation to the schedule, which will allow them to conduct their elections according to the provisions of this Act. The first election for the council of the Beausoleil First Nation under this Act is set for June 1, 2023. This order will take effect on the day it is registered. [Source]

Beausoleil First Nation Adopts First Nations Elections Act for Enhanced Governance

The Beausoleil First Nation in Ontario has decided to change its electoral system for selecting its Chief and Council. The community has chosen to move away from the election provisions of the Indian Act and adopt the First Nations Elections Act. This decision was formalized through a council resolution on August 10, 2022, and required the Minister of Indigenous Services to make two orders: one to remove the Beausoleil First Nation from the Indian Bands Council Elections Order and another to add it to the schedule to the First Nations Elections Act. The new system will be in effect for the next election, scheduled for June 1, 2023.

The transition to the First Nations Elections Act is expected to enhance the community’s governance autonomy and better address its needs. The new electoral system will also lead to cost savings, as elections will be held every four years instead of every two, allowing for more efficient use of resources and enabling the First Nation to focus on long-term planning and governance improvements.

The change was made at the request of the Beausoleil First Nation and is of interest solely to the community. Consultations were conducted by the First Nation with its members, and no further consultations were deemed necessary. The initiative aligns with the principles of self-determination and the restoration of traditional governance structures, which often included a more diverse range of voices in decision-making processes.

The Orders do not impose any compliance or enforcement requirements, nor do they incur implementation costs. The First Nations Elections Act does, however, set out responsibilities for the conduct of elections and dispute resolution, as well as penalties for election-related offences to ensure fair electoral practices. [Source]

Frog Lake First Nations Adopts Own Election Code, Enhancing Governance Autonomy

The Frog Lake First Nations in Alberta has decided to opt out of the Indian Act’s election regime and conduct its council elections based on its own community election code. This decision was made following a resolution by the Frog Lake First Nations Council and a community ratification process where the majority of voting members supported the move. The Minister of Indigenous Services has therefore revoked the application of the Indian Act’s election provisions for the Frog Lake First Nations through an order. The new community election code ensures secret ballot voting, an independent appeals process, and compliance with the Canadian Charter of Rights and Freedoms. The first election under the new code is scheduled for April 26, 2023. The change aims to enhance the First Nation’s governance autonomy and better address community needs. The Government of Canada will not be involved in the electoral process under the community election system, and any disputes will be resolved according to the community’s election code or through the courts. The transition supports the restoration of traditional governance and promotes the participation of women, youth, elderly people, and other community subgroups. The Department of Indigenous Services will record election results but will not interpret or resolve election appeals. The change aligns with the broader goal of self-determination for Indigenous communities. [Source]

Canada Bans Lead in Wheel Weights to Protect Health and Environment

The Canadian government has enacted the Prohibition of the Manufacture and Importation of Wheel Weights Containing Lead Regulations to reduce environmental and human health risks associated with lead exposure. These regulations prohibit the manufacture and import of wheel weights with more than 0.1% lead by weight, except for those manufactured for export or wheel weights already installed on vehicles. The regulations also do not apply to wheel weights in transit through Canada.

A permit system offers flexibility, allowing for the manufacture or import of lead wheel weights under specific conditions if no alternatives are available or if alternatives are not technically or economically feasible for the applicant. Permits are limited to a maximum of 24 months and can be renewed once.

The regulations require that any analysis to determine lead concentration be performed by an accredited laboratory. Additionally, regulated parties must maintain records demonstrating compliance with the regulations, including details of manufacture or import dates, export intentions, and quantities.

The regulations are expected to eliminate the use of lead wheel weights by 2025, with steel and zinc as the primary alternatives. However, the appropriateness of zinc is still under investigation due to ecological concerns. The regulations are aligned with international standards and are part of Canada’s Chemicals Management Plan, aiming to reduce chemical risks and protect the environment and public health.

Enforcement will follow the Canadian Environmental Protection Act compliance and enforcement policy, with a range of possible responses to violations. The regulations also make consequential amendments to the Regulations Designating Regulatory Provisions for Purposes of Enforcement to reflect the specific provisions designated.

The regulations are projected to have a present value cost of about $30 million over ten years, with the government incurring costs for enforcement and compliance promotion. Benefits include reduced health risks from lead exposure, improved air, water, and soil quality, and reduced risks to ecosystems and wildlife. The benefits are presented qualitatively due to uncertainties in quantifying specific health and societal outcomes. The small business lens applies, as the regulations impact one manufacturer and ten importers, with small businesses expected to pass on compliance costs to customers. The regulations are not expected to introduce new administrative costs unless a permit application is submitted. [Source]

Canada Establishes Permanent Regulatory Framework for COVID-19 Medical Devices

The Canadian government has enacted amendments to the Medical Devices Regulations to establish a permanent framework for the importation and sale of medical devices related to COVID-19. These amendments create a new Part 1.1 in the regulations, which continues the provisions of the previous Interim Order No. 3, allowing over 800 COVID-19 medical devices to remain authorized for use in Canada.

Under Part 1.1, the Minister of Health will maintain a List of Medical Devices for an Urgent Public Health Need (UPHN list), which will be updated as needed. Medical devices on this list will benefit from expedited authorization pathways and regulatory flexibilities, such as exemptions from certain requirements like holding a Medical Device Establishment Licence (MDEL) or having a Quality Management System (QMS) certificate.

Once a device is no longer on the UPHN list, manufacturers will need to comply with additional requirements to continue selling their products in Canada. For Class I devices, manufacturers must apply for an MDEL within 120 days. For Class II to IV devices, manufacturers must initiate the QMS certification process within 120 days and obtain a certificate within two years.

The amendments also specify conditions under which the Minister may refuse or cancel an authorization, such as non-compliance with regulations or if the benefits of a device no longer outweigh the risks. Importers and distributors must continue to hold an MDEL and comply with post-market requirements, including incident reporting and handling complaints.

The regulations also include transitional provisions to ensure a smooth changeover from the interim order to the new regulatory framework. These provisions address ongoing applications, existing authorizations, and the status of devices not yet distributed to end users.

The amendments aim to ensure a stable and predictable supply of COVID-19 medical devices, while maintaining safety, effectiveness, and quality standards. They also provide a mechanism for the government to address any new urgent public health needs related to COVID-19. [Source]

Canada Implements New Regulations for Drug Access During Health Emergencies

The Canadian government has enacted new regulations to improve access to drugs during public health or Canadian Armed Forces health emergencies. These regulations allow public health officials (PHOs) to authorize the sale of specific quantities of drugs not yet approved in Canada for immediate use or for stockpiling in anticipation of emergencies. This framework applies to drugs without a Canadian drug identification number or notice of compliance, including those no longer considered natural health products.

The regulations enable the Minister of Health to issue authorizations to manufacturers to sell drugs to PHOs for emergency use or stockpiling. The drugs can be approved in foreign countries, under development, or previously approved but no longer marketed in Canada. The Minister can also cancel an authorization if the drug poses a serious or imminent health risk.

PHOs at federal, provincial, territorial, and municipal levels, including the Surgeon General of the Canadian Armed Forces and the Chief Medical Officer of Public Health for Indigenous Services, can request drugs. The regulations outline specific labeling, reporting, and monitoring obligations for PHOs to ensure the safe use of these drugs. Hospitals must report serious adverse drug reactions, while the Surgeon General of the CAF must report such reactions within 30 days.

The regulations exempt drugs sold under authorization from most parts of the Food and Drug Regulations and section 12 of the Food and Drugs Act. However, compliance and enforcement provisions of the Act still apply. Additionally, the regulations allow certain PHOs to distribute stockpiled drugs to practitioners for emergency treatment under specific conditions.

The regulations also amend the Natural Health Products Regulations to ensure that authorized drugs for emergencies are not considered natural health products. Furthermore, amendments to the Certificate of Supplementary Protection Regulations under the Patent Act ensure that authorizations under the new framework are not considered as market authorizations for the purposes of supplementary protection.

The regulations aim to provide a clear and predictable framework for accessing unauthorized drugs during emergencies, ensuring rapid procurement and distribution by PHOs, and enhancing the coordination of drug supply during emergencies. The regulations are expected to have minimal financial impact on the government, with some anticipated cost savings from streamlined reporting. The one-for-one rule and small business lens do not apply as the stakeholders are government entities. The regulations are aligned with international practices and do not obligate manufacturers to alter their products for the Canadian market. A strategic environmental assessment was not required, and no significant gender-based analysis plus impacts were identified. The regulations came into force on the day of their publication in the Canada Gazette, Part II. Compliance and enforcement actions will follow existing Health Canada policies. [Source]

Canada Imposes Additional Sanctions on Myanmar Military Officials and Bans Aviation Fuel Exports

The Canadian government has amended the Special Economic Measures (Burma) Regulations in response to the ongoing crisis in Myanmar, where the military regime (Tatmadaw) has escalated violence and human rights violations since the coup against the democratically elected government on February 1, 2021. The situation has led to a serious international crisis, with significant numbers of civilians killed, detained, and displaced, as well as military casualties.

The amendments include the addition of six senior military officials to the sanctions list and a prohibition on the export, sale, supply, or shipment of aviation fuel to Myanmar. These measures aim to pressure the military regime to engage in peace dialogues, halt violence, and allow humanitarian access. They also seek to limit the regime’s ability to conduct air strikes against civilians by restricting access to aviation fuel, which has been used in increasing attacks, including those targeting schools and ethnic armed organizations.

The sanctions are part of Canada’s broader diplomatic efforts to resolve the crisis in Myanmar and align with international actions by like-minded partners. The impact on Canadian businesses is expected to be minimal, as energy exports to Myanmar have been low. The prohibition on aviation fuel is designed to have minimal socio-economic impact on the general civilian population in Myanmar.

The enforcement of these sanctions falls under the Royal Canadian Mounted Police and the Canada Border Services Agency, with penalties for contravention including fines and imprisonment. The amendments demonstrate Canada’s commitment to international peace and security and its support for the pro-democracy movement in Myanmar. [Source]

Canada Expands Sanctions on Russia Targeting Disinformation Agents and Aligns with Global Oil Price Cap Policy

The Canadian government has amended the Special Economic Measures (Russia) Regulations in response to Russia’s actions, which are considered a grave breach of international peace and security. These amendments add 38 individuals and 16 entities to the sanctions list, targeting those involved in disseminating Russian disinformation and propaganda related to the invasion of Ukraine. The listed individuals include media figures, researchers, and cultural icons, while the entities comprise various platforms used for spreading disinformation, such as media outlets and websites.

Additionally, the amendments update an exception related to the price cap on Russian petroleum products, ensuring that goods loaded onto a ship before February 5, 2023, and unloaded at the destination before April 1, 2023, are exempt from certain prohibitions. This aligns with the measures taken by the international community, particularly the G7+ Price Cap Coalition, to limit Russian revenues while maintaining global oil market stability.

The sanctions are part of Canada’s broader response to Russia’s aggression towards Ukraine, which includes financial, military, and humanitarian support for Ukraine, as well as advocacy for the removal of Russian banks from the SWIFT payment system. The sanctions aim to impose economic costs on Russia, expose and penalize those spreading disinformation, and maintain coordination with international partners.

Enforcement of the sanctions falls under the Royal Canadian Mounted Police and the Canada Border Services Agency, with penalties for non-compliance ranging from fines to imprisonment. The amendments are designed to have minimal impact on Canadian businesses and citizens, focusing instead on the targeted individuals and entities. [Source]

Canada Updates Species at Risk Act with New Listings and Reclassifications

The Order Amending Schedule 1 to the Species at Risk Act (SARA) introduces changes to the list of wildlife species at risk in Canada. Nine new species are added as endangered or of special concern, three species are reclassified to reflect their current status, and one species has its scientific name updated. The amendments aim to provide appropriate protections and support the recovery of these species, contributing to biodiversity and ecosystem health.

The newly listed endangered species include Carey’s Small Limestone Moss, Dalton’s Moss, Drooping-leaved Beard-moss, Columbia Quillwort, Dwarf Hesperochiron, Hairy Valerian, and Hairy Paintbrush. These species face threats such as climate change, habitat loss, and competition from invasive species. The American Bumble Bee and Yellow Scarab Hunter Wasp are listed as species of special concern due to factors like pesticide use and habitat modification.

The Peary Caribou’s status is downgraded from endangered to threatened, reflecting a slight population recovery, while the Greater Short-horned Lizard and Goldenseal are down-listed to special concern, indicating they are still at risk but not imminently threatened. The Karner Blue butterfly’s scientific name is updated to Plebejus samuelis, but its extirpated status remains unchanged.

The Order will trigger the development of recovery strategies, action plans, and management plans for the species, as required by their new classifications. These documents will outline conservation measures and identify critical habitats. The Order is expected to have minimal economic impact on stakeholders and Indigenous Peoples, with the government bearing low costs for recovery planning and compliance promotion. The changes support Canada’s commitments to international biodiversity conservation goals and the Federal Sustainable Development Strategy. [Source]

Canada Updates Species at Risk Act with New Amendments

The Order Amending Schedule 1 to the Species at Risk Act (SOR/2023-17) has been established to update the list of species considered at risk in Canada. This amendment adds 12 new species, reclassifies 4 others, and removes 1 species from the list. The species being added include the Harris’s Sparrow, Smoker’s Lung Lichen, and the Mottled Duskywing (Boreal and Great Lakes Plains populations), among others. The Common Nighthawk and Olive-sided Flycatcher are being down-listed from “threatened” to “special concern,” while the Blue Ash and Western Yellow-bellied Racer are being up-listed from “special concern” to “threatened.” The Peregrine Falcon anatum/tundrius subspecies is being delisted as it is no longer considered at risk.

The amendment aims to protect biodiversity and ecosystem productivity by ensuring that species at risk receive appropriate protections under the Species at Risk Act (SARA). This includes prohibitions against harming these species and requirements for recovery planning. The listing of species as “endangered” or “threatened” triggers immediate protection on federal lands and mandates the development of recovery strategies and action plans. Species listed as “special concern” will have management plans developed to prevent them from becoming further at risk.

The Order is expected to have minimal costs to stakeholders and Indigenous peoples, with the majority of costs related to the development of recovery strategies, action plans, or management plans, as well as permit applications and compliance promotion. The overall benefits of the Order include the preservation of socio-economic, cultural, and ecological values associated with the species, as well as contributions to Canada’s biodiversity and fulfillment of international conservation commitments. The Order supports the Federal Sustainable Development Strategy’s goal of healthy wildlife populations and aligns with the United Nations’ 2030 Agenda for Sustainable Development goals. A strategic environmental assessment concluded that the Order will have positive environmental effects. [Source]

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