Faster Access to Unapproved Treatments
An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)
Summary
- Creates and publishes a federal List of Therapeutic Products Pre-approved for Special Access so practitioners can rapidly access non-marketed therapies for serious or lifeāthreatening conditions or unmet needs, with clear criteria, uses, and any practitioner or setting limits.
- Allows manufacturers to sell and licensed importers to bring in listed products with targeted exemptions from other regulatory provisions, while requiring post-sale/import notifications and practitioner reports to maintain safety oversight.
- Sets a 120-day decision clock for additions to the list, mandates annual public reporting on effectiveness, and consults a non-partisan, unpaid expert advisory committee.
- Establishes transparent criteria and published guidelines for emergency āletters of authorizationā for new drugs, creates a presumption to authorize based on plans from two expert clinicians, and provides a 24/7 support line for urgent cases.
- Clarifies that in emergencies practitioners may temporarily administer available lawful products without prior authorization, subject to after-the-fact notice and ministerial powers to restrict use if risks arise.
Builder Assessment
Overall, the bill streamlines emergency access to therapies while maintaining oversight, which supports innovation, productivity, and efficient service delivery. Safety guardrails, transparency, and timelines largely offset risks of regulatory circumvention.
- Reduces red tape via a preāapproved list, clear criteria, decision timelines, and a 24/7 support line.
- Encourages innovation and investment by recognizing diverse evidence sources, including foreign data, and enabling earlier patient access.
- Improves government efficiency and patient safety with standardized reporting, annual public reviews, and ministerial powers to curb misuse.
- Builders recommend adding statutory service standards (e.g., 24ā72 hours) for letters of authorization and publishing performance dashboards.
- Builders urge realātime safety monitoring and interoperability with provincial systems to track outcomes and adverse events without adding paperwork.
- Builders suggest clear triggers requiring manufacturers to seek full approval after sustained specialāaccess supply, to prevent long-term reliance on exemptions.
- Builders encourage transparency by publishing rationales for additions/removals and ensuring equitable access across provinces and small communities.
Question Period Cards
What specific service standard will the Minister commit to for issuing emergency letters of authorizationāmeasured in hours, not daysāand will those turnaround times be published monthly?
How will the department ensure manufacturers do not use the preāapproved special access list to avoid full regulatory approval, and will there be a mandatory timeline to submit a Notice of Compliance application once a product is routinely supplied under this pathway?
What safeguards will be in place to prevent diversion and ensure quality and traceability when products are imported or sold in anticipation of a request, particularly for rural and remote settings?
Principles Analysis
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Canada should aim to be the world's most prosperous country.
Faster access to lifeāsaving treatments improves health outcomes and workforce participation, and strengthens Canadaās standing as a modern, responsive lifeāsciences jurisdiction.
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Promote economic freedom, ambition, and breaking from bureaucratic inertia (reduce red tape).
Creates a preāapproved access list, sets a 120āday decision timeline, enables sales/imports with narrow exemptions, and offers a 24/7 authorization support lineāreducing caseābyācase bottlenecks for urgent care.
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Drive national productivity and global competitiveness, including removing interprovincial trade barriers and improving labour mobility (one country, one market).
Timely treatments reduce morbidity and downtime, and clearer, faster pathways can attract clinical research and innovative therapies to Canada.
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Grow exports of Canadian products and resources, and move up the value chain by processing resources domestically rather than exporting them raw.
The bill targets domestic patient access; any export gains from a stronger lifeāsciences ecosystem are indirect and uncertain.
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Encourage investment, innovation, and resource development.
Regulatory clarity and acceptance of diverse evidence, including foreign data, lower entry barriers and can encourage biotech investment and earlier market engagement.
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Deliver better public services at lower cost (government efficiency).
Standardized lists, published guidelines, defined timelines, and cost considered in comparability reduce administrative burden and duplication, even as basic safety reporting is retained.
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Reform taxes to incentivize work, risk-taking, and innovation.
No tax measures are affected.
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Focus on large-scale prosperity, not incrementalism.
Improvements are targeted to health access rather than broad prosperity levers; macroeconomic impact is indirect.
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Email [email protected]
PartyMember of Parliament
StatusOutside the Order of Precedence
Last updatedN/A
TopicsHealthcare
Parliament45