Canada's health sciences sector is navigating a period of accelerating change – and the legal profession is at its centre. Artificial intelligence is entering clinical practice in ways that raise novel questions about consent and accountability. Health Canada has overhauled its biosimilar approval pathway, reshaping IP strategies across the industry. And healthcare M&A is growing in scale and sophistication, driven by patent pressures, technological transformation and global competition.
The 2026 Lexpert Special Edition on Health Sciences brings together perspectives from some of Canada's top-ranked health sciences lawyers.
AI scribes: efficiency meets legal accountability
AI-powered medical scribes are appearing across Canada with increasing regularity, promising physicians relief from mounting administrative burdens. They convert clinical conversations into structured documentation, including summaries, action items and diagnostic billing codes.
"It's not just a dictation, [i.e.] a literal transcript," says Teresa Reguly, co-leader of the intellectual property and food and drug regulatory practices at Torys LLP in Toronto. "It's taking in the information at the meeting or at the session, and then distilling it into a summary, and often including action items."
That structured output raises significant legal questions. Consent must cover not just data collection but downstream access and use. Vendor contracts must be scrutinized for secondary use provisions. Physicians cannot simply accept AI-generated documentation at face value. "I don't think they can just use the scribe and then not be proofing it or reviewing it," says Reguly.
Dana Siddle, partner with the technology law group at McCarthy Tétrault LLP in Toronto and co-leader of its health industry group, points to a 2024 incident at an Ontario hospital where an unauthorized AI tool joined and recorded a virtual clinical meeting, exposing patient information. "Privacy of patient information is one of several relevant considerations when assessing AI scribes," says Siddle, adding that algorithmic bias, inaccurate outputs and cybersecurity vulnerabilities must also factor into any pre-deployment assessment.
With Canada's proposed federal AI legislation having died on the order paper in 2025, governance falls to provincial guidance – making robust contractual frameworks the practical frontline of legal protection.
Biosimilars: streamlined approvals, sharper patent competition
Health Canada's May 2025 decision to eliminate routine phase III efficacy trials for biosimilar drugs will reduce development costs and accelerate market entry. Lawyers say it will intensify the ensuing legal competition.
Under the updated framework, a biosimilar demonstrating high similarity to a reference biologic can now be approved for all indications without additional scientific justification. Jordan Scopa, a litigation partner at Goodmans LLP in Toronto and co-chair of its intellectual property group, says brand-side patentees should expect increased regulatory filings and potentially more patent litigation.
One less-discussed consequence is the loss of competitive intelligence. "Previously, biosimilar manufacturers had to register phase III clinical trials, which provided visibility into potential future competitors," says Urszula Wojtyra, a principal at Smart & Biggar LLP in Toronto. Innovators will need to manage their IP portfolios more proactively.
Healthcare M&A: bigger transactions, sharper diligence
Canada's healthcare M&A market has grown markedly in scale. John Emanoilidis, co-head of the M&A practice at Torys LLP, notes that total deal value climbed significantly from approximately $4.5 billion in 2023 to more than $12 billion in 2025, with pharmaceutical and biotechnology transactions leading the increase. "What changed was the size of transactions," says Emanoilidis.
Laurie Turner, leader of the health law group at Fasken Martineau DuMoulin LLP in Toronto, says US and UK buyers are increasingly targeting Canadian virtual care platforms – creating a distinct legal challenge. "These transactions require structures that comply with healthcare regulations while still allowing investors to participate in the economics of the business," says Turner.
Patent expiries are a central driver. Reguly notes that today's most sought-after assets – biologics, precision medicines and specialty therapies – "take longer to develop, require more investment, and often reach the market with less remaining patent life."
Artificial intelligence is among the most difficult factors to value in current deals. "The real value comes from the combination of AI, data and commercial application," says Emanoilidis. "Buyers want to know whether the technology can improve outcomes, create efficiencies or generate new revenue streams."
The lawyers profiled in this special edition advise on the governance risks, patent strategies and transaction structures shaping Canadian health sciences in the years ahead.