The Pharma in Brief team is looking back at 2025’s most notable legal and regulatory developments in the Canadian pharmaceutical space and highlighting hot topics for 2026. To those who don’t make it to the end of the article, we’ll say it up front: all the best for 2026 & stay tuned to Pharma in Brief!
1. PMPRB Guidelines updates
In June 2025, the Patented Medicine Prices Review Board (PMPRB) released guidelines that came into effect on January 1, 2026 (our report here). Of greatest interest, the Guidelines set out a new process for PMPRB Staff to assess the prices of patented medicines and recommend candidates for a hearing. First, the Canadian list price for a medicine is compared to the highest international price across 11 comparator countries. In addition, the medicine may also be examined for an annual price increase greater than the change in the Consumer Price Index. If either of these thresholds is crossed, the medicine is subjected to an in-depth review, which involves a broader range of price factors. After in-depth review, PMPRB Staff may recommend a hearing to determine whether the medicine’s price is “excessive.”
2. Implementation of national pharmacare
The Pharmacare Act, in force since October 2024, sets out a framework for a first phase of universal, single‑payer, first‑dollar drug coverage across Canada (our report here). The framework moved forward in 2025, despite political changes that called into question the future of national pharmacare. The federal government reached bilateral agreements with four provinces and territories to fund prescription drugs for contraception and diabetes, although no new agreements with the remaining nine provinces and territories have been announced (our report here). In addition, the following steps were taken:
- National formulary: Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) consulted on a proposed list of essential prescription drugs to inform the development of a national formulary (our report here) and provided a final report in October 2025.
- Bulk purchasing strategy: The CDA-AMC also consulted on draft advice for a national bulk purchasing strategy for prescription drugs (our report here) and provided a final report in October 2025.
- Appropriate use strategy: The CDA‑AMC launched an Appropriate Use Strategy (our report here) in September 2025, intended to reduce harm from overuse, underuse and mis‑use of medications.
3. Supreme Court considers patentability of “methods of medical treatment”
In October 2025, the Supreme Court of Canada heard an appeal concerning the patentability of “methods of medical treatment”, in the context of patent claims with dosage regimen elements. The Court reserved its decision. Written and oral arguments are available on the Court’s website. For a summary of the decision under appeal, see our report here. The Court’s decision is expected to be released in the first half of 2026.
4. Health Canada proposes axing phase 3 clinical trials for biosimilar drugs
In June 2025, Health Canada consulted on revised guidance for biosimilar drug submissions (our report here). Under the proposed changes, biosimilar manufacturers would generally not be required to conduct phase 3 clinical trials comparing their drug against the innovator’s biologic drug. Instead, the clinical evidence would generally be limited to a comparative pharmacokinetic study.
Health Canada’s proposed changes align with similar changes made in the United Kingdom, and proposed in the European Medicines Agency and the United States (see our review here and new draft U.S. guidance here). If implemented, the changes may make it faster and cheaper to bring biosimilar drugs to market in Canada, such that biosimilar drug submissions are filed earlier and trigger earlier patent infringement proceedings under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations).
5. Health Canada proposes other key regulatory changes
In 2025, Health Canada launched consultations on other changes to how drugs are regulated in Canada:
- Drug shortages: Health Canada proposed amendments to the Food and Drug Regulations intended to prevent, mitigate, and respond to drug shortages (our report here).
- Terms & conditions: Health Canada proposed new draft guidance documents detailing when and how terms and conditions may be imposed on drugs, including to approve promising new drugs currently approved under the Notice of Compliance with Conditions policy (our report here).
- Clinical Trials: Health Canada proposed new Clinical Trial Regulations and related guidance that would revamp how clinical trials are regulated in Canada.
- Foreign referencing: Health Canada proposed an Order allowing streamlined review of a new drug submission based on earlier decisions by foreign regulatory authorities. In addition, Health Canada and the US Food and Drug Administration announced a program to exchange regulatory information to facilitate the review of new generic drugs.
6. Accelerating access to new drugs
In October 2025, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Province of Ontario announced new pathways to accelerate the funding of new drugs (our report here). The pCPA consulted on two new expedited negotiation pathways: the Early Negotiation Process for certain cancer drugs and the Targeted Negotiation Process for non-complex drug negotiations. In parallel, the Government of Ontario announced a new pilot program, the Funding Accelerated for Specific Treatments (FAST) Program, to provide early funding for high-priority cancer drugs while the pCPA negotiates with the manufacturer.
7. Funding for drugs for rare diseases
A National Strategy for Drugs for Rare Diseases was announced by the Government of Canada in 2023, including up to $1.4 billion of funding over three years for the provinces and territories through bilateral funding agreements with the federal government. After six bilateral agreements were announced in March 2025, all 13 provinces and territories have now agreed to accept funding and provide coverage for certain drugs for rare diseases (our report here). As part of the national strategy, a “common list” of new drugs for rare diseases is being developed; the list currently includes nine drugs.
8. Case law updates
- PMNOC action: In an infringement action under the PMNOC Regulations, the Federal Court upheld the validity of a patent for a biologic drug used to treat a rare blood disorder (our report here). The Court rejected the allegations that the patent was invalid for anticipation or obviousness and granted injunctive relief to the patentee.
- Trademark confusion: The Federal Court of Appeal affirmed a Federal Court decision that the brand name of a biosimilar drug (BYOOVIZ) was confusingly similar with the brand name of a biologic drug (BEOVU), even though the two drugs have different active ingredients (our reports here and here). The FCA held that the notional consumer in the confusion analysis included patients in addition to ophthalmologists and pharmacists, rejecting the argument that patients were not relevant consumers because they do not encounter the BYOOVIZ trademark as used by the manufacturer (e.g., printed on the drug’s packaging).
Areas to Watch in 2026
We expect the following to be hot topics in the Canadian pharma space in 2026:
- Patentable subject matter: The Supreme Court will likely release its decision on the patentability of “methods of medical treatment” and dosage regimens in the first half of 2026.
- Applying PMPRB guidelines: As the new PMPRB guidelines came into force on January 1, 2026, the first recommendations for hearings under the new guidelines may issue this year.
- National pharmacare: The signing of bilateral agreements under the Pharmacare Act appears to have stalled since the federal election in April of 2025. It remains to be seen in 2026 whether the national pharmacare project will move forward or be repealed or reworked.
- US most-favored-nation (MFN) prescription drug pricing: Announced by Executive Order on May 12, 2025, the global effects of the MFN drug pricing policy will continue to roll out in 2026 (our report here). Canadian pharma companies will need to grapple with dual forces to increase prices in response to this policy while maintaining compliance with price-lowering pressure in Canada under the PMPRB and pharmacare initiatives.
- Drug regulation: After consulting on many new draft regulations and guidance in 2025 and early 2026 (see above), Health Canada may finalize some or all of these changes.
The Pharma in Brief Team thanks you for your readership in 2025. We will continue to keep you informed on the latest developments in 2026 and beyond.