October 8, 2025 – The Ontario Government has announced more details on the long-awaited cancer therapies pilot dubbed the Funding Accelerated for Specific Treatments (FAST) program. It promises to allow the fast-tracking of access to 7-10 breakthrough cancer therapies at least one year earlier than traditional pathways. The FAST program would make Ontario the first jurisdiction in Canada to expedite access to new and innovative medicines within Canada.
The FAST program is enabled through a three-year pilot program for streamlining Health Canada-approved cancer drugs through Project Orbis. Project Orbis is a U.S. Food and Drug Administration initiative that brought together seven other international regulatory agencies to expedite the review and approval of new cancer drugs. Health Canada has been a partner of Project Orbis since 2019.
The announcement was supported by the Princess Margaret Cancer Centre run by the University Health Network, Breast Cancer Canada and Innovative Medicines Canada, as well as pharmaceutical companies Merck Canada, AbbVie, Novartis Canada, GSK Canada, Novo Nordisk Canada, Sanofi Canada, and AstraZeneca Canada.
Santis Insights
Ontario’s newly launched FAST program is a significant moment in the Canadian pharmaceutical approval process, creating faster market access in Canada’s largest province. But faster access raises a question with billion-dollar implications: who holds the leverage when patients receive drugs before prices are negotiated?
To understand why this matters, it’s important to know how drug pricing has worked in Canada—and what Ontario is now disrupting.
Current Process
Since 2010, provinces have negotiated drug prices collectively through the pan-Canadian Pharmaceutical Alliance (pCPA), pooling their market power to secure lower prices. The FAST program breaks from this model by committing to provide select cancer drugs to patients before completing negotiations – a fundamental reversal of how Canada has funded new medicines for over a decade.
Under the traditional system, new cancer drugs faced a lengthy journey: Health Canada approval first, then an evaluation by Canada’s Drug Agency (CDA), then a price negotiation with the pCPA and finally a decision from the provinces on whether it should be funded. CDA’s role is to evaluate cost effectiveness and clinical effectiveness. This process averages two and a half years in length and is one of the longest among G7 nations. FAST shortcuts this timeline by providing access immediately after the CDA issues a positive recommendation, while price negotiations continue.
Ontario vs. Everybody
Accelerating drug access has been a stated priority for both the Ontario and the federal government for several years. In 2019, Canada joined Project Orbis, an international initiative enabling concurrent drug reviews with the FDA and other regulators to speed regulatory approvals. However, this initiative focused primarily on coordination and process refinement within existing structures. FAST represents something fundamentally different: Ontario’s willingness to bypass established pan-Canadian mechanisms entirely on the post-regulatory review side.
As Ontario advances its own specific provincial plan, the pCPA has decided to adopt a strikingly similar approach. The pCPA announced last Friday two expedited negotiation pathways. The first pathway is the existing Targeted Negotiation Process (TNP) for non-complex drugs. The second pathway is a new Early Negotiation Process (ENP) for cancer therapies under Project Orbis. Both aim to quicken decision-making and enhance access for patients.
Premier Doug Ford championed the need for a FASTer process as the Chair of the Council of Federations and secured agreements from other premiers to develop plans to cut approval times for essential drugs. Despite outreach, other provinces have not yet joined or signalled their support for Ontario’s initiative. This could be due to fiscal concerns about cost implications or a strategic disagreement that undermines pCPA’s collective bargaining power. Regardless of the reason, it has created a fragmentation that would, in theory, allow Ontario residents to receive new cancer treatments before any other province in the country. However, details are still sparse from yesterday’s announcement and it’s too early to do a fair comparison and contrast of Ontario’s initiative and pCPA’s expedited negotiation pathways.
Devil in the Details
The three-year pilot will expedite 7-10 high-priority cancer drugs annually, and for Ontario cancer patients, the benefits are immediate and tangible. They will have access to potentially life-extending treatments up to a year earlier than under the traditional system. At the same time, cancer drug access is already faster than many other therapeutic areas in Canada, so there are equity questions still to be answered.
Even for the pilot itself, the critical question is: Who will pay for the drugs during the pilot or if negotiations with the pCPA fail? The province has yet to disclose payment arrangements, suggesting that they may still be negotiating terms with manufacturers.
There’s also a catch-22. Traditionally, the province’s tight control of market access has given them substantial leverage on pricing, but by providing coverage before costs are finalized, Ontario may weaken its bargaining position. Once a patient is receiving treatment, withdrawing access will be politically untenable. Should negotiations fail or stall, Ontario will face the uncomfortable choice of accepting unfavourable terms or cutting off access to the drug for future patients.
Ontario is testing whether political will for faster patient access can co-exist with fiscal responsibility and effective cost management.
Whither goest thou?
The initial 7-10 drugs chosen for FAST will establish crucial precedents. Which manufacturers will participate? How quickly do negotiations conclude? What prices are ultimately agreed upon? Will other provinces eventually join Ontario’s approach, or will they decide to maintain the pCPA process? Québec, British Columbia, and Alberta—provinces with significant pharmaceutical markets and distinct health care philosophies—will be particularly important to watch.
The stakes extend beyond provincial borders. If FAST succeeds—delivering meaningful patient benefits at manageable costs—it could fundamentally reshape how Canada approves and funds new essential medicines, potentially ending the traditional model entirely. If it fails—marked by unsustainable spending, weak pricing outcomes, or inequitable access—it will reinforce the importance of coordinated, pan-Canadian approaches.
For now, Ontario has made its bet. Premier Ford’s visible leadership and the program’s immediate launch despite a lack of provincial partners demonstrate a political commitment that makes reversal unlikely. The pharmaceutical industry’s enthusiastic response suggests they view this terrain favourably. Patient advocates are celebrating faster access. Those who were not invited to the first dance with Ontario’s Ministry of Health may find it’s not too late to join the party. Still, critical questions about cost, equity, and sustainability remain unanswered.
The next 18 months (and the 2026 Ontario budget) will reveal whether FAST represents a breakthrough or a cautionary tale. What we do know is that the answer will shape Canadian pharmaceutical policy for a generation.
Interested in learning more about the FAST initiative? Need to understand what happens now with the Ontario government and pCPA processes for drug approvals? Contact one of our Santis Health experts today:
- Ross Wallace – ross.wallace@santishealth.ca
- Clare Michaels – clare.michaels@santishealth.ca
- Nabiha Paracha – nabiha.paracha@santishealth.ca
Further Reading
Read the official news release here
Read the news release from Breast Cancer Canada here
Read the news release from Innovate Medicines Canada here
pCPA consultation announcement is here.