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Project Orbis. Accelerating time to patient access?

Timely access to innovative treatments is crucial for those living with cancer. However, for Candians with cancer, the approval process for such treatments can be lengthy and complex. Cancer treatments usually receive Health Canada and subsequent health technology assessment (HTA) review months, and years after the treatment has been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Past studies have shown that Health Canada takes longer to both approve medicines and approves fewer medicines than its American and European counterparts.1,2 The current delay in accessing drugs in Canada is largely due to the time when the drug was submitted for approval (if submitted at all) and subsequent processes which include HTA, pricing negotiations through the pan-Canadian Pharmaceutical Alliance (pCPA) and then time to list from individual provinces. 

In a publication by the Organisation for Economic Development and Cooperation (OECD),3 the total time between the first global authorization of a new substance to the moment of public reimbursement was measured, Canada is ranked 18 of 20, ahead of only New Zealand (which has the fewest new drugs launched and publically reimbursed in the OECD) and Portugal, making it one of the slowest. Canada takes on average 248 days to reach approval, 119 days to launch, and another 559 days to reach its best-case public reimbursement, that is the first province to reimburse.  This translates into a delay of 926 days vs the OECD20 median of 519 days.

Is there hope for faster access to innovative cancer therapies for Canadians? 

In 2019, the FDA Oncology Center of Excellence launched Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries. The program’s goal is to provide concurrent submission, review, and regulatory action for high-impact clinically significant marketing applications among the participating partner countries.4

Current Project Orbis partners include the Health Sciences Authority (HSA) of Singapore, the Therapeutic Goods Administration (TGA) of Australia, the National Health Surveillance Agency (ANVISA) of Brazil, the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland, the Health Products and Food Branch (HPFB) of Health Canada, Canada, the Medicines and Healthcare products Regulatory Agency (MHRA), of the United Kingdom (U.K.), and the Ministry of Health of Israel. 

This could potentially bring innovative cancer medicines to Canadians with cancer faster.

According to a publication5 by the Project Orbis partnership, the program received 60 oncology marketing applications in the first year, representing 16 unique projects, resulting in 38 approvals internationally, including eight approvals by Health Canada. Project Orbis has been shown to reduce the delay between marketing application submission and approval in participating countries, with several applications shown to obtain timelines similar to the FDA.1

To date, 48 oncology products have been approved by Health Canada through Project Orbis. These innovative treatments target a high unmet need for cancer patients or provide significant benefit over existing treatments.

Despite the positive aspects of Project Orbis, Health Canada approval does not translate into immediate funded access for Canadians. The pathway to access is more complicated and nuanced than with other international counterparts with a HTA process.  Of the 48 approved oncology drugs by Health Canada, not all have completed review by Health Technology Assessment (HTA) agencies (CADTH and INESSS) or negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA). And even when treatments have completed the process, they may not be available on public drug plans reluctant to cover more drugs.

The multilayer process of approving drugs in Canada, a small and highly regulated country, in turn creates a less desirable marketplace for manufacturers. Meanwhile Canadians living with cancer across the country are paying the price, being denied timely access to potentially life saving therapies, fewer therapeutic options, and potentially worse health outcomes than those living elsewhere. 

Project Orbis is a step in the right direction towards accelerated access for Canadians living with cancer. However, further action is needed to remove delays throughout the entire system if the objective is to create quicker access for those therapies that are bringing added value to patients and society. For patients, every day counts, and removing the additional unnecessary delays can be the difference between life and death. 



1. Canadian Medical Association Journal (CMAJ). Delays in the submission of new drugs in Canada 2. Frasier Institute Studies in Health Care Policy. Federal Delays in Approving New Medicines 3. OECD. Addressing challenges in access to oncology medicines. Analytical report. 2020 4. U.S. Food and Drug Administration. Project Orbis. A framework for concurrent submission and review of oncology products 5. Clinical Cancer Research. Project Orbis: Global Collaborative Review Program


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