David Clement is the North American Affairs Manager with the Consumer Choice Center.

Jeremy Bray, a 30-year-old Manitoban with Type 2 spinal muscular atrophy (SMA), is an awful case study of how health care bureaucracy can jeopardize the health of Canadians.

Mr. Bray made headlines across the country this year when the provincial government decided that it would not approve coverage for risdiplam, sold under the brand name Evrysdi. This is an oral SMA drug that he was taking through a compassionate free-drug program run by the manufacturer, Roche. That free supply was due to end, at an annual list cost of around $300,000.

Luckily for Jeremy, after immense political pressure from the province’s opposition Progressive Conservatives and their Leader, Obby Khan, Manitoba appears to have reversed its denial.

While that is certainly good for Mr. Bray, this case of coverage denial represents a very dark feature of Canada’s process for pharmaceutical approvals.

Prescription drug costs are forcing Canadians to make dangerous trade-offs

At first, the NDP justified that it was denying the request because Canada Drug Agency (CDA), the federal entity with the task of providing recommendations and policy support for drug reimbursement, doesn’t recommend the drug for those over the age of 25. Why the cutoff age? Well, because there is a lack of clinical trial data for those over the age of 25.

The reason why there isn’t clinical trial data is because there is no need for it. In fact, according to a Quebec-based doctor who treats those with SMA, a clinical trial for those over the age of 25 is ridiculous “because there’s so much evidence right now that it’s working.”

And for a moment, think about how cruel it would be to require a clinical trial to take place. Two groups of Canadians with SMA would have to join the trial, with one getting the drug (which we already know works) and the other getting the placebo, guaranteeing the deterioration of their health. This would be both infuriating, and wildly unethical.

The example of Mr. Bray, and SMA, is not stand-alone. There is unfortunately a long list of examples just like this one where the CDA’s guidance has severely limited access to drugs. That list includes Trikafta for cystic fibrosis, Luxturna for rare inherited blindness, and Soliris for paroxysmal nocturnal hemoglobinuria.

Now, it is important to note that the CDA’s guidelines are non-binding, but that raises the question of why have the CDA involved in cost-effectiveness evaluation at all, especially when provinces can (and do) ignore those guidelines?

Canadians can wait years to get drugs regulators have already deemed safe. Why?

Once Health Canada has approved a drug, demonstrating that it is safe and effective, why not remove the CDA from the process altogether to reduce the time it takes to reach patients? Once a drug is deemed approved by Health Canada, we could simply have provincial bodies determine coverage, without the CDA at all.

It might sound like a radical suggestion, but the benefits would be immense.

The CDA’s Health Technology Assessment (HTA) is estimated to add upward of 500 days from when an oncology drug is approved by Health Canada, to when it is approved for reimbursement by a province. Think about the consequences for a Canadian who has to wait 500 days after being diagnosed with a rare disease, even though the drug has already been approved by Health Canada.

For a disease like ALS, for example, that wait can be a death sentence. But the chaos doesn’t stop there.

The CDA’s HTA uses outdated monetary thresholds to determine cost effectiveness, and creates a significant amount of redundant barriers because provinces already negotiate separately. This double work just adds to the compliance cost associated with launching a drug in Canada, all after the drug has already been approved by Health Canada as safe and effective.

And, to make matters worse, the CDA, according to a peer reviewed study in the journal ClinicoEconomics and Outcomes Research, fails to be publicly accountable, transparent, fair and include all stakeholders throughout its processes.

Now is the time to seriously reconsider the CDA’s role in determining cost-effectiveness. Because for the approximately one-in-twelve Canadians who have a rare disease, more bureaucracy is a matter of life and death.