On December 18, 2025, Alberta's Bill 23 comes into force, amending the Health Professions Act and reinforcing the province's position as a national leader in health professional regulation. Combined with Health Canada's June 2025 draft guidance on biosimilar approvals, these changes signal a regulatory landscape that is shifting significantly for pharmacists and the broader pharmaceutical sector.
What Bill 23 Changes
Bill 23 introduces amendments to Alberta's Health Professions Act (HPA), the legislation that governs the regulation of more than 30 health professions in the province, including pharmacists and pharmacy technicians.
The amendments focus on governance modernization, public protection enhancements, and regulatory efficiency. Key changes include updated governance structures for regulatory colleges, including requirements for public member representation on councils and committees. The bill also introduces streamlined processes for handling complaints and discipline, enhanced transparency requirements for regulatory decisions, and provisions supporting interprofessional collaboration and scope optimization.
For pharmacy specifically, Bill 23 preserves and builds on Alberta's already expansive pharmacist scope of practice. Alberta pharmacists can prescribe for a broad range of conditions, order and interpret lab tests, administer injections, and manage ongoing drug therapy. The bill's emphasis on reducing regulatory barriers to interprofessional care supports the continued evolution of pharmacists as primary care providers.
Alberta's Leadership in Pharmacist Scope
Alberta has consistently been at the forefront of pharmacist scope of practice in Canada. The province was among the first to authorize pharmacists to prescribe, adapt prescriptions, and administer injections. Alberta pharmacists can initiate therapy for a wide range of conditions, manage chronic diseases, and provide comprehensive medication management.
Bill 23 does not add new clinical authorities directly, but it creates regulatory infrastructure that makes future scope expansions more straightforward. By modernizing the HPA's framework for defining and updating scopes of practice, the bill positions Alberta to respond more quickly to evolving healthcare needs.
Other provinces watch Alberta closely. Regulatory changes that succeed in Alberta often serve as models for other jurisdictions, and Bill 23 is likely to influence health professions legislation across the country.
Health Canada's Biosimilar Guidance: A Parallel Shift
While Bill 23 reshapes provincial regulation, a federal development is poised to transform the pharmaceutical landscape. In June 2025, Health Canada released draft guidance proposing to eliminate mandatory Phase III clinical trials for most biosimilar drug submissions.
Under the proposed framework, biosimilar manufacturers would instead rely primarily on analytical (structural and functional) characterization studies, pharmacokinetic (PK) studies demonstrating equivalent drug absorption and distribution, and pharmacodynamic (PD) studies confirming similar biological activity.
Phase III clinical trials, which are large, expensive, and time-consuming, would be required only when analytical and PK/PD data are insufficient to establish biosimilarity. This approach aligns with evolving international standards and reflects the scientific consensus that modern analytical methods can detect clinically meaningful differences between a biosimilar and its reference biologic.
What This Means for Pharmacists
If finalized, the biosimilar guidance could accelerate the entry of more affordable biologic alternatives into the Canadian market. Pharmacists, who play a central role in biosimilar education and switching programs, will need to stay current on an expanding roster of biosimilar products.
The intersection of provincial scope expansion (exemplified by Bill 23) and federal regulatory modernization (exemplified by the biosimilar guidance) creates both opportunity and responsibility. Pharmacists are gaining more authority to prescribe, manage, and switch therapies at the same time that the therapeutic options available to them are growing.
Preparing for the New Landscape
For pharmacy professionals, the combined effect of Bill 23 and evolving federal guidance requires ongoing education, updated clinical protocols, and systems that support evidence-based decision-making.
At PlusVirtual, we view these regulatory developments as essential progress. A healthcare system that empowers its most accessible providers and streamlines the approval of safe, effective therapies is a system better equipped to serve patients. We remain committed to staying at the forefront of these changes and ensuring our patients benefit from every advancement in pharmacy practice and regulation.