Canada

In May 2026, Health Canada published its Guidance on Information and Submission Requirements for Biosimilar Biologic Drugs. This guidance sets out the regulatory framework under which biosimilar sponsors may seek a Notice of Compliance (NOC) for a biosimilar biologic drug in Canada. Key takeaways: Biosimilars are not generics Health Canada's issuance of an NOC for a biosimilar is a confirmation of a high degree of similarity to the Canadian reference biologic drug, but is not a declaration of equivalence. Biosimilars, unlike generics, are not eligible for authorization through the Abbreviated New Drug Submission pathway due to their inherent heterogeneity and complexity, and submissions are instead filed using the New Drug Submission (NDS) pathway in accordance with section C.08.002 of the Food and Drug Regulations. Canadian reference biologic drug The Canadian reference biologic drug serves as the foundation against which biosimilar sponsors must demonstrate high similarity. To qualify, the originator product must have been originally authorized based on a comprehensive quality, non-clinical and clinical data package and must possess a substantial body of evidence regarding quality, safety, efficacy, and effectiveness. An authorized biosimilar should not itself serve as a Canadian reference biologic drug for another biosimilar submission. Non-Canadian-sourced reference biologic drug Sponsors may use a non-Canadian-sourced reference biologic drug as a proxy for the Canadian reference biologic drug in comparative studies, provided it has the same medicinal ingredients, dose, dosage form, frequency of dosage, and routes of administration as the Canadian reference biologic drug. The non-Canadian-sourced reference biologic drug should be marketed in a jurisdiction with regulatory standards and principles for evaluation of medicines, post-market surveillance activities, and approaches to comparability that are similar to Canada. Intellectual property considerations In a NDS, the biosimilar sponsor should clearly identify the biologic drug authorized in Canada to which it is subsequent. The sponsor should also identify the biologic drug to which it is making a direct or indirect comparison or reference according to the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") and section C.08.004.1 of the Food and Drug Regulations. What biosimilar sponsors can rely on A biosimilar candidate leverages the safety and efficacy information of the Canadian reference biologic drug, benefiting from a reduced non-clinical and clinical package. Clinical studies are generally limited to a comparative pharmacokinetic trial demonstrating pharmacokinetic equivalence, with data on safety and immunogenicity also collected. Comparative clinical efficacy studies are not typically required when the biosimilar can be compared and extensively characterized by appropriate analytical studies. Differences between the biosimilar and the Canadian reference biologic drug may be acceptable if the sponsor demonstrates no impact on safety and efficacy; however, major differences can disqualify the product as a biosimilar. Extrapolation of indications All indications granted to the Canadian reference biologic drug can be applied to the biosimilar candidate without further justification, provided the biosimilar has been shown to be highly similar to the Canadian reference biologic drug in terms of analytical characteristics and in functional properties related to the mechanism of action. A biosimilar may only be authorized for indications that are authorized for the Canadian reference biologic drug. Post-market obligations for biosimilar sponsors Biosimilar sponsors must comply with adverse drug reaction ("ADR") reporting requirements, which must include the unique brand name, non-proprietary name, DIN, and lot number to facilitate traceability of adverse reactions to specific products. If you have questions or need assistance with navigating the drug regulatory framework in Canada, please contact DLA Piper’s Intellectual Property & Technology practice group.

On June 4, 2026, the Government of Canada released AI for All: Canada’s National Artificial Intelligence Strategy, a 50-page, multi-billion-dollar plan positioning Canada as a global AI leader across six strategic pillars (protecting Canada/democracy, empowering Canadians, powering prosperity, sovereign AI infrastructure, scaling Canadian AI, and international partnerships) and five priority sectors (health/life sciences, energy/natural resources, transportation, agriculture, and manufacturing/robotics). It also commits to establishing the federal government as a strategic anchor customer for Canadian AI firms through the Buy Canadian policy. The strategy is presented as a five-year plan, with “trust” described as its “north star” and a stated goal of increasing Canadian business AI adoption from 12% to 60% by 2034, and follows more than 11,000 public submissions and input from a 28-member expert AI Strategy Task Force. Notably, the strategy does not signal any intention to reintroduce standalone AI legislation comparable to the Artificial Intelligence and Data Act (AIDA), which formed part of omnibus Bill C-27 and died on the Order Paper following prorogation in early 2025. AIDA had drawn significant criticism from Canada’s technology sector as potentially more restrictive than the European Union’s Artificial Intelligence Act—an approach seen as untenable for a middle power seeking to attract and retain AI companies. Instead, the strategy points to a more incremental, multi-bill approach. AI-related risks are expected to be addressed through targeted legislation, including promised privacy modernization and online safety bills, rather than through a single comprehensive regulatory framework. The strategy’s release also coincided with the tabling of the Office of the Privacy Commissioner of Canada’s (OPC) 2025–2026 Annual Report, Championing Privacy in the Age of AI, which reported a 109% year-over-year increase in complaints under the Personal Information Protection and Electronic Documents Act and nearly 700 breach reports affecting more than 20 million Canadians. This bulletin summarizes the strategy’s primary commitments (many of which involve substantial public expenditure, though timelines and implementation details remain limited), the regulatory measures it contemplates, and the notable gaps and critiques that have emerged since its release. Overview of key commitments Jobs and workforce While the strategy notes “hard questions about job security” which must be addressed “head on,” it focuses on the creation of up to 250,000 new jobs through AI adoption by 2031, including up to 90,000 AI-related jobs and work placement opportunities for young Canadians. It also commits to assessing training and upskilling offerings for mid-career workers, including in skilled tades, with a priority on developing AI-related skills. More broadly, the strategy projects three percent increase in GDP, representing nearly $200 billion in gains. AI literacy and education Canada will launch a National AI Literacy Initiative to provide entry-level AI training accessible to all Canadians. It aims to have AI literacy content reach one million entry-level post-secondary students and train more than 3,000 educators with AI learning kits in their classrooms. It also commits to providing all post-secondary students access to trusted AI agents. In addition, the government will invest $30 million in the CanCode program to fund not-for-profit organizations to offer free digital skills training (including coding, AI, and emerging technologies) to youth from kindergarten to grade 12, as well as their educators, with a focus on reaching underrepresented groups. Sovereign infrastructure While many private entities have proposed megaproject facilities that would export compute globally, the strategy commits to building a world-leading public supercomputer by 2031 and significantly expanding Canada’s sovereign compute and cloud infrastructure. Public-private partnerships are expected to deliver 850 MW of compute capacity by 2030 (scaling up to 2.3 GW), supported by investments in the tens of billions. The government will continue to roll out more than $2 billion in existing investments in Canadian AI compute capacity, and will provide an additional $700 million to expand the Compute Access Fund, aimed at providing affordable sovereign compute to Canadian small and medium-sized enterprises. Investment and commercialization The strategy proposes a $500 million Canadian Tech Growth Fund to help address the scale-up capital gap facing Canada’s most promising AI companies. The fund would provide flexible growth capital and allow the federal government to take equity stakes in leading AI firms. The government will also invest $500 million to expand and strengthen the Regional Artificial Intelligence Initiative delivered through Regional Development Agencies, along with an additional $130 million for commercialization programs across the National AI Institutes. Health sector initiatives The first AI “mission” will commit $200 million to improving health outcomes for Canadians. This includes $100 million to launch the Health Sector Data Space, in partnership with the Canadian Institute for Health Information, and a further $100 million to expand the VITAL health data platform to five additional provinces. International partnerships Canada will expand the newly formed Sovereign Technology Alliance, launched with Germany in February 2026, to support secure and interoperable AI capabilities and open up procurement opportunities for domestic firms. The strategy notes that Canada has signed 20 new economic and defence partnerships in the past year, securing nearly $100 billion in foreign investment commitments, of which 11 explicitly advance cooperation on AI. Proposed regulatory and legislative measures Privacy legislation The strategy promises to modernize consumer privacy legislation to enshrine a “fundamental right to privacy,” safeguard children’s information from exploitation and harm, and strengthen Canadians’ control over their personal data. It also signals ongoing work to review the federal Privacy Act for the government’s own use of personal information, including considerations around transparency, privacy, and alignment with international standards. However, no timeline has been provided for tabling these bills, and the government has tried (and failed) to modernize privacy laws in the past. Online safety legislation Canada will introduce online safety legislation to protect Canadians in the digital age, particularly children, from digital risks including those posed by AI. Again, the strategy does not indicate when this legislation will be introduced. The last version, on which our comments are here, did not survive the last government change, though momentum continues for a revamped online safety bill (As of publication, Bill C-34 has just been introduced) Bill C-22 is currently under review by the Standing Committee on Public Safety and National Security and may even include a social media ban for minors). AI safety and transparency The strategy commits $50 million to expand the Canadian AI Safety Institute to track emerging AI risks, advance technical research, and conduct transparent evaluations of AI models. It also proposes creating a Canada Trusted AI Certification program to help Canadians identify trustworthy AI products in the marketplace. The government also intends to work on AI transparency initiatives, including tools such as watermarking AI-generated content. Election protection The strategy commits to protecting elections and democratic institutions from AI-enabled misinformation and foreign interference, but does not set out specific regulatory mechanisms or timelines for doing so. Industry and stakeholder reactions The strategy has drawn significant commentary from industry groups, advocacy organizations, opposition parties, and academic commentators. Some stakeholders in the AI sector have welcomed it as a demonstration of what is possible for Canada – in terms of economic growth, support for smaller firms, improved public services, and enhanced research – and have signalled a willingness to partner with government on building trustworthy, values-aligned AI. Open-source and civil society advocates have praised the decision to put openness and technological sovereignty at the centre of the plan, describing it as a significant step toward a more trustworthy AI future that is not dependent on a small number of foreign providers. Some experts have highlighted the absence of clear timelines and key performance indicators as one of the biggest blind spots, noting that Canada is “already late” in delivering the strategy after months of missed deadlines, and that it remains unclear who in government is ultimately accountable for delivering on its commitments. Others have characterized the strategy as ambitious but short on details, calling for strong regulations to safeguard workers, youth, privacy, and energy supply, while observing that every other major industry in Canada, from forestry to banking, is already regulated. Industry voices have noted that while the strategy contains a number of promising ideas, it spreads its priorities broadly and does not yet provide a sufficiently clear roadmap for helping Canadian AI companies grow into globally competitive firms that create and retain economic value in Canada. On the workforce front, despite acknowledging the hard road ahead, the strategy makes no mention of potential layoffs arising from AI adoption and offers no clear plan for supporting displaced workers beyond literacy and skills training (while some labour organizations have expressed appreciation that the federal government is taking AI seriously and engaging proactively with worker concerns, even as they continue to call for stronger regulation, independent oversight, and robust safeguards). The plan does not introduce new regulatory requirements for worker protections, severance guidelines, or retraining mandates for companies that replace workers with AI (though it does expand “support” for employer-led training efforts, including programs intended to help mid-career workers adapt). Instead, the strategy leaves it up to individual organizations to proactively manage their own workforce transitions and reductions. Children’s advocacy groups have raised concerns that the government has prioritized adoption and industry without immediately establishing safeguards, suggesting that the protection of children is taking a back seat to innovation. Professional and standards bodies have reacted cautiously but positively to the focus on “trust” as a guiding principle, while stressing the need for concrete accountability and risk-management mechanisms. On environmental matters, while the strategy references Canada’s cold climate and clean electricity grid, it does not set out specific environmental standards for data centre development. It is also silent on regional emissions concerns, including in Alberta, which accounts for more than 90% of future AI data centre projects and relies on a comparatively high-emissions electricity grid. Finally, the strategy is notably silent on the use of AI in policing and law enforcement contexts, an omission that has drawn criticism given ongoing civil liberties concerns around facial recognition, predictive policing, and automated surveillance technologies. Key takeaways The AI for All strategy represents a significant federal commitment to AI investment, workforce development, and sovereign infrastructure. However, it leaves substantial questions unanswered regarding the content and timing of forthcoming privacy and online harms legislation, the regulatory treatment of large AI companies, the timeline for implementation, mechanisms for governmental accountability, the impact of AI on employment, and environmental safeguards for data centre expansion. For organizations, the key implications are: New legislation is coming, but probably not as a single comprehensive AI bill. AI safeguards will likely be embedded across multiple statutes and through amendments. Organizations may expect overlapping compliance obligations across different instruments.  Privacy standards are converging globally. Combined with the OPC’s assertive enforcement stance, organizations may expect stricter obligations around consent, transparency, and data minimization in AI-driven systems much like in other jurisdictions around the world.  Data residency and sovereignty requirements may follow. The emphasis on sovereign infrastructure and treating data as a “strategic national asset” suggest the potential for new data residency or governance requirements, particularly for organizations relying on foreign cloud or AI services.  Enforcement is not waiting for new legislation. Despite a lack of new legislation, the OPC is actively using existing tools. Organizations are encouraged to ensure their AI governance frameworks, breach reporting mechanisms, and complaint-handling processes are robust under current law.  Monitor closely for legislative introductions. No timetables have been provided. Organizations are encouraged to track parliamentary developments and prepare for consultation processes that may move quickly once bills are tabled.

At a glance Effective 20 October 2026, new “Equal Treatment” wage rules under the Canada Labour Code (the Code) will require equal pay for employees regardless of employment status (full-time, part-time, permanent, or temporary). Employers must avoid differences in wage rates based on an employee’s employment status where the employees perform substantially the same work, apply substantially the same skill, effort, and responsibility, work under similar conditions, and work in the same industrial establishment. Employees may request a wage review, and employers must respond in writing within 90 days. Exceptions apply for systems based on seniority, merit, quantity or quality of production, geographic differences, and red-circling. Temporary help agencies are also covered by similar equal treatment requirements. Background On 6 May 2026, the federal government published regulations (SOR/2026-75) in the Canada Gazette, Part II, bringing into force the “Equal Treatment” provisions of the Code. These provisions were first enacted in 2018 through Bill C-86, the Budget Implementation Act, 2018, No. 2, but required supporting regulations before they could take effect. The regulations clarify key definitions and procedural requirements, and the new rules will come into force on 20 October 2026. For a transitional period of two years until 20 October 2028, existing collective agreements that permit wage differences based on employment status will be exempt from these requirements. Key definitions The regulations define the following key concepts: Employment status means an employee’s status as full-time, part-time, permanent, or temporary. Full-time generally means working an average of 30 or more hours per week. Temporary includes fixed-term, seasonal, casual, or irregular employment. Industrial establishment is determined by reference to Employment Insurance regions (Schedule I of the Employment Insurance Regulations) and may include more than one physical location. For remote workers, this is generally the location where they most often reported for work before their remote working arrangement, or where they would report to work in person if there were no remote working arrangements. For transportation workers, this is the location of their home terminal, station, base, or port. Comparable wages refer only to the same type of rate of wages (time-based rates, mileage rates, commission rates). All time-based wages (hourly, daily, weekly, monthly or annual salaries) can be compared with each other. Exceptions A wage differential is permitted where it is attributable to one or more of the following: a system based on seniority or merit; a system that measures earnings by quantity or quality of production; red-circling (maintenance of a wage rate following demotion or reclassification); increases in wage rates due to recruitment or retention difficulties during labour shortages; differences in the geographic area where the employee works; or differences attributable to travel status. The particulars of any system providing for a difference in wage rates must be communicated in writing to employees or be readily accessible for examination. Wage review requests and enforcement Employees who believe they are not receiving equal pay based on their employment status may request a wage review from their employer. The employer must provide a written response with reasons within 90 days, either confirming the employee’s wage rate has been increased or explaining why the current rate complies with the Code. Employers cannot reduce an employee’s wage rate to achieve compliance. Employers must maintain records of all wage review requests, written responses, and systems relied upon to justify a wage differential. Administrative monetary penalties may apply for violations. The Code also prohibits reprisal against employees who exercise their right to request a wage review. Takeaways for employers To prepare for the new “Equal Treatment” wage rules under the Code taking effect on 20 October 2026, employers should begin now to: Review existing wage rates across employee classifications to assess compliance. Determine whether any of the permitted exceptions apply to existing differences in the wage rates. Update record-keeping practices to ensure the required documentation (particulars of systems that support any differences, wage review requests and responses) is maintained. Prepare internal processes to respond to employee wage review requests within the 90-day window. Note the two-year transitional period for existing collective agreements that permit wage differences based on employment status (expiring 20 October 2028).

Bill C-31’s proposed amendments to the Canada Labour Code signal a shift in the regulation of workplace restrictive covenants in Canada. If enacted, the legislation would significantly limit the use of non-compete clauses for federally regulated employers and continue a broader national trend favouring employee mobility and labour market competition. For employers operating in federally regulated industries, including banking, telecommunications, and transportation, the proposed changes could require a reassessment of employment agreements, executive contracts, and post-employment restriction strategies. What Bill C-31 proposes Bill C-31 would amend the Canada Labour Code to broadly prohibit employers from entering into or enforcing non-compete clauses and certain “other employment-related restrictions” that limit an employee’s ability to work for or operate a competing business after the employment relationship ends. The proposed legislation defines “non-compete clause” broadly. Notably, the amendments are designed not only to invalidate traditional non-competes but also to potentially capture other forms of contractual restrictions that may unreasonably impair labour mobility by way of future regulation. The proposed changes also include anti-reprisal protections for employees, prohibiting employers from dismissing, disciplining, demoting, or otherwise disadvantaging employees who refuse to agree to an unlawful non-compete provision. The legislation places the burden on employers to establish that a disputed restriction is permissible under, including whether it falls within one of the permitted categories of exception. Key exceptions to the proposed amendments Although the legislation would dramatically restrict the use of non-compete clauses, it preserves several important exceptions. Senior executive employees: Bill C-31 would also exempt certain high-level executives from the prohibition. The proposed exemptions include chief executive officers and several senior executives who report directly to the CEO, chief financial officers, chief technology officers, and certain other prescribed executive positions. Sale-of-business transactions: The proposed amendments would continue to permit non-compete clauses where a business, undertaking, or operation is sold or transferred and the seller subsequently becomes an employee of the purchaser. This reflects the long-standing principle that purchasers are entitled to protect the goodwill they acquire in commercial transactions. How the federal changes compare with Ontario’s non-compete prohibition Ontario was the first Canadian jurisdiction to prohibit most employment-related non-compete clauses through amendments to the Employment Standards Act, 2000 that came into force in 2021. While the approach being taken at the federal level is similar, there are some key differences that employers should note. First, Bill C-31 appears broader in scope than Ontario’s legislation. In addition to prohibiting traditional non-compete clauses, the federal proposal contemplates restricting additional categories of “other employment-related restrictions” through future regulations where those restrictions are viewed by the Governor in Council as unreasonably limiting employee mobility. Second, while Ontario’s legislation contains similar primary exception categories (sale-of-business transactions and executives), the proposed federal amendments include more detailed executive categories and expressly places the burden on employers to justify the enforceability of any disputed restriction (which is a statutory codification of the common law burden). Third, Bill C-31 includes proposed anti-reprisal protections and transition provisions addressing existing agreements, which would surpass the worker protections found in Ontario’s legislative framework. What federally regulated employers should do now Although the amendments are not yet in force, Bill C-31 provides a clear indication of where this segment of federal legislation is heading. Employers should not wait for final implementation before reviewing their employment agreements for restrictive covenants generally and non-compete clauses specifically. Some practical considerations include: With non-compete clauses likely to be prohibited for most employees, carefully drafted non-solicitation provisions will become the front line of post-employment protection. Employers should ensure that their non-solicitation clauses clearly define the scope of protected relationships (distinguishing between clients the employee personally serviced versus the broader client base), specify reasonable time limitations, and avoid language so broad that a court could characterise the clause as a de facto non-compete. Employers should review whether their long-term incentive plans, restricted share unit agreements, and deferred bonus arrangements include forfeiture-on-competition provisions that may be captured by the broader "other employment-related restrictions". Equity forfeiture clauses that function as economic deterrents to competition will conceivably fall within that scope. The burden now rests with the employer to show that one of the applicable C-Suite exemptions apply. Accordingly, rather than only relying upon the applicable employment agreement, employers should ensure that organisational charts, job descriptions, and reporting lines clearly evidence that the individual holds one of the prescribed positions and reports directly to the CEO. Bill C-31 provides a one-year transition period from the coming-into-force date, after which time existing non-compete clauses will be void. The transition period should be viewed as an opportunity to prioritize renegotiating agreements with employees in roles where knowledge protection is most critical. Any new agreements will, of course, likely require fresh consideration for signing the new agreement. DLA Piper will be closely monitoring the development of Bill C-31 and will provide updates as they become public.